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(1) Any person proposing an activity other than those to which (2) and (3) apply and that is subject to review under 50-5-301 , MCA, and not exempt under 50-5-309, MCA, shall submit to the department a letter of intent that contains the following:

(a) name of applicant;

(b) proposal title;

(i) the addition of a new service that is offered by or on behalf of the long-term care facility that was not offered by or on behalf of the long-term care facility within the 12-month period before the month in which the service would be offered, and, if so, an estimate of the annual operating and amortization expenses required to provide it;

(ii) the construction, development, or other establishment of a long-term care facility that did not previously exist or is being replaced;

(iii) a change in bed capacity through an increase in the number of beds or a relocation of beds from one facility or site to another;

(iv) the use of hospital beds to provide nursing or intermediate developmental disability care and, if so, the number of beds involved;

(v) the provision of hospital beds to provide long-term care; or

(vi) other (explain);

(d) a narrative summary of the proposal;

(e) an itemized estimate of proposed capital expenditures, including a list of proposed major medical equipment with a description of each and the cost of the construction of any building, including remodeling, necessary to house it;

(f) anticipated methods and terms of financing the proposal;

(g) effects of the proposal on the cost of patient care in the service area affected;

(h) projected dates for commencement and completion of the proposal;

(i) the proposed geographic area to be served;

(j) an itemized estimate of increases in annual operating and/or amortization expenses resulting from new health services;

(k) the location of the proposed project, including its street address;

(l) if the person desires comparative review of their proposal with that of another applicant, the name of the other applicant;

(m) the name of the person to contact for further information, including city, state, zip code and telephone number; and

(n) the dated signature of an authorized representative of the applicant.

(2) Any person or persons desiring to acquire or enter into a contract to acquire 50% or more of an existing long-term care facility (whether through a single transaction or by adding to a portion already owned) must submit to the department a written letter noting intent to acquire the facility and containing the following:

(a) the services currently provided by the long-term care facility and the present and proposed bed capacity of the facility;

(b) any additions, deletions, or changes in such services which will result from the acquisition; and

(c) the projected cost of care at the facility compared to the cost under the current ownership, as well as any other factors which may cause an increase in the cost of care.

(3) Any person proposing to increase or relocate from one facility or site to another 10 beds or less or 10% or less of the licensed beds, and no beds have been added or relocated in the two years prior, must submit to the department a letter of intent containing the following as one of the conditions that 50-5-301(1)(b), MCA, requires to be met in order to be exempt from certificate of need review for the change:

(a) the licensed capacity of the facility, the number of beds to be added or relocated, and in the latter case, the facilities or sites in question; and

(b) the cost of the addition or relocation and its likely effect on the cost of patient care.

(4) When a person incurs an obligation by or on behalf of a long-term care facility for a capital expenditure that exceeds $5 million and does not otherwise require a certificate of need, the person shall upon completion of the project:

(a) notify the department of the total amount of the expenditure; and

(b) provide the department a description of the project.

(5) Persons who acquire 50% or more of an existing long-term care facility but who do not file the notice of intent required by (2) and 50-5-302(2), MCA, are subject to certificate of need review for the purposes of this subchapter and as required by 50-5-301(1)(c), MCA.

(6) The person must send a letter of intent to the Department of Public Health and Human Service, Office of Inspector General, Certificate of Need Program, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) An application will be accepted only after submission of a letter of intent.

(2) The deadline set by the department for submission of an application will not exceed 90 days unless the department and all affected applicants agree to a longer period.

(3) No application for a proposal will be accepted earlier than the deadline set by 50-5-302(5), MCA, for receipt of a letter of intent requesting comparative review with that proposal, with the exception of a proposal for which a letter of intent was submitted requesting comparative review with an earlier proposal.

(4) The application must contain, at a minimum, the information as specified by the department pursuant to ARM 37.106.133 and 37.106.134.

(5) The original and two copies of the application must be submitted to the department.

(6) If the application is received without the full fee ($500 or 0.3% of the application's projected capital expenditure, whichever is larger) , it will not be considered submitted to the department until the date the full fee due is received by the department. The fee must be paid by check made out to the department of public health and human services.

(7) Within 20 working days after receipt of an application, if the application is determined to be incomplete, the department shall notify the applicant in writing by mail of that fact and of the specific information that is necessary to complete the application. The department shall also indicate a time, which may be no less than 15 calendar days, within which the department must receive the additional information requested. Within 15 working days after receipt of the additional information, the department shall determine whether the application is complete.

(8) If an applicant does not submit adequate information within the time specified, their application will be considered withdrawn.

(9) If the applicant materially changes the proposal or the capital expenditures projected are increased by 15% or $150,000, whichever is greater, after the department declares the application complete, the department may cease review of the original application and require the applicant to begin the process again by filing a new letter of intent for the revised proposed project if it desires a certificate of need for it. If, after the department gives the applicant notice that the department considers the original proposal so altered that the review process must begin again, the department will continue on the original review schedule if the applicant notifies the department that it chooses to have review continue on the original application, rather than to commence a new review process on the revised application.

(10) The department may, in its discretion, conduct a comparative review of competing applications if such applications are being reviewed concurrently, if such comparative review can be conducted consistently with all other time constraints imposed by Title 50, chapter 5, part 3, MCA, and this subchapter, and if, as required by 50-5-302(12), MCA, they pertain to similar types of facilities or equipment affecting the same health service area, subject to the limitation that a proposal for which a letter of intent is submitted requesting comparative review, pursuant to 50-5-302(5), MCA, will not be reviewed comparatively with a proposal for which a letter of intent is filed after the 30-day deadline referred to in 50-5-302(5), MCA.

(1) When an application is determined to be complete, the department shall issue a letter of acceptance.

(2) When an application is determined to be incomplete after the applicant has been given an opportunity to submit additional information, the department will issue the applicant a letter declaring the application is effectively withdrawn.

(1) Any affected person may request an informational hearing to be held during the course of the review period by writing to the department. The department may also hold a hearing on its own initiative.

(2) Whenever an application is received by the department, the department will publish a notice of that fact in a newspaper of general circulation in the area to be served by the proposal, unless the application is subject to comparative review with another, in which case the newspaper notice will be published after receipt of all of the applications to be comparatively reviewed. A hearing request must be received by the department within 30 calendar days after the date the newspaper notice is published.

(3) Notice of the informational hearing will be given at least 14 calendar days before the hearing date by the following means:

(a) Written notice must be sent by mail to the person requesting the hearing, the applicant, and all other applicants assigned for comparative review with the applicant, if any. Other persons who have requested notice will be notified by mail.

(b) Notice to all other affected persons will be by legal advertisement in a newspaper with general circulation in the service area affected by the application.

(i) the date of the hearing;

(ii) the time of the hearing;

(iii) the location of the hearing; and

(iv) the person to whom written comments may be sent prior to the hearing.

(4) Whenever a hearing is held for an application which is being comparatively reviewed with another application, the hearing will be conducted as a joint hearing on all such applications.

(5) Any person may comment during the hearing, and all comments made at the hearing will be tape-recorded and retained by the department until the project is completed or the certificate of need expires.

(6) The hearing will be informal, and neither the Montana Administrative Procedure Act nor the Rules of Civil Procedure will apply.

(7) Any person wishing to make a factual allegation at the hearing must first swear or affirm that his testimony is true.

(8) No person other than the department may conduct reasonable questioning of any person who makes relevant factual allegations.

(1) The criteria listed in (a) through (k) are statutory criteria required by 50-5-304, MCA, and will be considered by the department in making its decision:

(a) the degree to which the proposal being reviewed:

(i) demonstrates that the service is needed by the population within the service area defined in the proposal;

(ii) provides data that demonstrates the need for services contrary to the current state long-term care facilities plan, including waiting lists, projected service volumes, differences in cost and quality of services, and availability of services; or

(iii) is consistent with the current state long-term care facilities plan.

(b) the need that the population served or to be served by the proposal has for the services;

(d) the immediate and long-term financial feasibility of the proposal as well as the probable impact of the proposal on the costs of and charges for providing long-term care services by the person proposing the long-term care service;

(e) the relationship and financial impact of the services proposed to be provided to the existing health care system of the area in which such services are proposed to be provided;

(f) the consistency of the proposal with joint planning efforts by health care providers in the area;

(g) the availability of resources, including health manpower, management personnel, and funds for capital and operating needs, for the provision of services proposed to be provided and the availability of alternative uses of the resources for the provision of other health services;

(h) the relationship, including the organizational relationship, of the long-term care services proposed to be provided to ancillary or support services;

(i) in the case of a construction project, the costs and methods of the proposed construction, including the costs and methods of energy provision, and the probable impact of the construction project reviewed on the costs of providing long-term care services by the person proposing the construction project;

(j) the distance, convenience, cost of transportation, and accessibility of services offered by long-term care facilities for persons who live outside urban areas in relation to the proposal; and

(k) in the case of a project to add long-term care facility beds:

(i) the need for the beds that takes into account the current and projected occupancy of long-term care beds in the community;

(ii) the current and projected population over 65 years of age in the community; and

(iii) other appropriate factors.

(2) In addition to the statutory criteria cited in (1), the department will consider the following in making its decision:

(a) whether the medically underserved population, as well as all other people within the geographical area documented as served by the applicant, will have equal access to the subject matter of the proposal; and

(b) whether patients will experience problems including cost, availability, or accessibility in obtaining care of the type proposed in the absence of the proposed new service.

(1) If the department fails to reach and issue a decision within the deadlines established by 50-5-302 , MCA, a certificate of need will not automatically issue unless the delay is due to an abuse of discretion by the department and the applicant obtains a writ of mandamus ordering the department to issue the certificate.

(2) If the certificate of need is issued with conditions, the conditions must be directly related to the project under review, and to the criteria listed in 50-5-304 , MCA, and ARM 37.106.113, and cannot increase the scope of the project.

(3) The basis for the decision of the department must be expressed in written findings of fact and conclusions of law, which must be sent via certified mail to the applicant and all other applicants assigned for comparative review with the applicant, along with a notice of the right to a reconsideration hearing pursuant to 50-5-306 , MCA, and the deadline for requesting such a hearing. The findings, conclusions, and notice will be made available, upon request, to others for cost.

(4) Notice, in summary form, of the department's decision, the right to request a reconsideration hearing, and the deadline for such a request will also be sent to each health care facility of the type affected by the application or applications in question within the geographic area affected by the application(s) .

(1) Any affected person who requests a hearing to reconsider the department's decision must submit a check for $500 to the department along with the request. No hearing will be scheduled or held unless the department has received the fee.

(2) Immediately after receipt of a request for a hearing, a copy of the request will be sent to all affected persons, as defined in 50-5-101 , MCA, who participated in any informational hearing that was held concerning the affected proposal.

(3) Notice of the date and time of a reconsideration hearing will be sent to the affected person requesting the hearing and, if the applicant did not request the hearing, the applicant as well.

(4) If a hearing to reconsider a decision is requested, any affected person, other than the requestor of the hearing, who wishes to participate in the hearing must, at least two weeks after the date the request for hearing is received, submit a written notice of intent to participate to the department along with a check for $500, unless the affected person is an applicant whose proposal was approved and is the subject of the hearing, in which case only the notice of intent must be received by the department.

(5) The fees required by (1) and (4) above must be paid by check made out to the department of public health and human services.

(6) Counsel for the department and the health planning staff may participate in the hearing to provide testimony and exhibits, and to cross-examine witnesses, but are not considered parties for the purposes of 2-4-613 , MCA.

(7) A copy of any pre-hearing motion filed by an affected person must be served by mail upon the department and any other affected person participating in the hearing.

(8) The department's hearing officer may require the direct testimony of the witnesses of each affected person participating in the hearing to be in writing and filed prior to hearing with the department, with copies served upon the department and every other participating affected person.

(9) At the reconsideration hearing, the parties or their counsel will be given the opportunity to present written or oral evidence or statements concerning the department's action and the grounds upon which it was based.

(10) The department shall send the written findings of fact and conclusions of law that state the basis for its decision to all parties participating in the hearing. Any other person upon request may receive a copy for cost.

(11) The decision of the department following the reconsideration hearing shall be considered the department's final decision for the purpose of appealing the decision to district court.

(12) The hearing, any discovery, and other related matters are subject to the Montana Administrative Procedure Act, Title 2, chapter 4, part 6, MCA, and ARM 1.3.215 through 1.3.225 and ARM 1.3.230 through 1.3.233.

(13) The department hereby adopts and incorporates by reference ARM 1.3.215 through 1.3.225 and ARM 1.3.230 through 1.3.233, which contain attorney general's model rules for contested cases, implementing the Montana Administrative Procedure Act. Copies of the rules may be obtained from the Department of Public Health and Human Services, Office of Legal Affairs, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951, phone: (406)444-9503.

(1) The department may, after notice and opportunity for a hearing, suspend or revoke a certificate of need upon a finding that the holder of the certificate is in violation of the certificate of need law, this chapter, or the terms of the certificate of need. The notice and hearing provisions of the Montana Administrative Procedure Act (Title 2, chapter 4, part 6, MCA) will apply.

(2) (a) A holder of a certificate of need may submit to the department a written request for a 6-month extension of his certificate of need, for good cause. The request must set forth the reasons constituting good cause for the extension and must be received by the department by 5:00 p.m. on the expiration date if it is to be considered.

(b) Within 20 days after receipt of the request, the department must issue its written decision granting or denying the extension. The decision must be sent to the applicant by certified mail, and distributed at cost to others who request it.

(i) presents significant relevant information not previously considered by the department; or

(ii) demonstrates that there have been significant changes in factors or circumstances relied upon by the department in reaching its decision.

(d) "Good cause" for the purpose of (2) (a) includes, but is not limited to, emergency situations which prevent the recipient of the certificate of need from obtaining necessary financing, commencing construction, or implementing a new service.

(3) A certificate of need, once granted to an applicant, may not be transferred to another person. In addition to a transfer from one person to another, such a transfer will be considered to have taken place if the applicant to which the certificate was granted is an organization and there is a change of ownership of 50% or more of that organization.

(1) The recipient of a certificate of need shall report to the department any increase in the cost of an approved project in excess of $150,000 or 15% of the approved budget for the project, whichever is greater. Any cost increase that exceeds the foregoing threshold must be approved by the department.

(1) A certificate of need may be issued to a hospital, medical assistance facility, or critical access hospital to establish swing-beds only if, in addition to compliance with all other applicable provisions of 50-5-304, MCA, and ARM 37.106.113:

(a) existing licensed long-term care facilities in the service area, which provide the level of care proposed to be provided by the hospital or medical assistance facility, have an aggregate average occupancy level of at least 95% during the three years prior to the date of the application for certificate of need; and

(b) no more than 50% of the excess bed capacity of the hospital, medical assistance facility, or critical access hospital will be approved as swing-beds. Excess bed capacity is the difference between the number of licensed beds in the facility and the average acute care occupancy level of the facility over the three years prior to the date of the application for certificate of need.

(2) The utilization of swing-beds by a medical assistance facility or critical access hospital is subject to certificate of need review only if, as required by 50-5-301(1)(b), MCA, the facility did not offer long-term care during the 12 months prior to the month the service is scheduled to commence and the service will add annual operating and amortization expenses of $150,000 or more.

(1) It is suggested that the applicant contact the health planning program before completing and submitting the necessary information. If an early contact is made, the applicant will be made aware of what will be required in specific cases before a formal application is completed and submitted.

(2) The applicant must send a cover letter, containing the information included in the original letter of intent with any pertinent revisions, to the Department of Public Health and Human Services, Office of Inspector General, Certificate of Need Program, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953. The cover letter must accompany the original and each of the two copies of the information required by ARM 37.106.134.

The following must be included in a certificate of need application:

(1) An explanation of the need for the facility or service, including the following information:

(a) the geographic area the proposed project will serve and the criteria being used for determining this service area;

(b) the current population of that service area (identify the source of information) ;

(d) the percent of the population in that service area expected to be served;

(e) in terms of age, ethnic background and economic status, a description of the specific population which will be served by the proposed new institution or service. The applicant shall indicate the number of people matching this description in the service area (general public should be indicated if the facility is for non-specific population) ;

(f) an explanation of current and projected future trends in health care which might affect facility usage which were given consideration in the development of this project (identify source of information) ;

(g) a patient origin study for the last three years of operation;

(h) why the service or institution is needed in the identified service area;

(i) the purposes and goals of the project;

(j) whether there is a waiting list of persons desiring the proposed services. If so, a copy of the list must be provided.

(2) A description of the project's accessibility to the public. In particular, the following information must be included:

(a) the location of the proposed long-term care facility;

(b) the manner in which the architectural plan promotes access for the physically handicapped;

(c) other health care institutions which serve this area or portions thereof and provide similar services to those proposed in this application;

(d) if there are no similar services in the area, the nearest facility or facilities providing these services must be identified.

(3) A discussion of planning and environmental considerations, including the following information:

(a) an explanation of how the proposed service or facility is compatible with the current state long-term care facilities plan (a copy of which may be obtained from the Department of Public Health and Human Services, Office of Inspector General, Certificate of Need Program, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953). If it is not compatible, an explanation of why it should be approved must be included;

(b) whether a short, long-range, master plan or capital expenditure plan is available for the facility. If so, a copy must be provided. The applicant shall also provide applicable city, county or regional land use, zoning, transportation, utilities or parking plans;

(c) a description of existing or proposed working relationships or joint planning efforts with other providers or services in the community or service area. If there are no such efforts, an explanation must be provided;

(d) whether the affected consumer/provider and related groups in the service area have indicated support for the proposal (agencies, groups, and their reactions must be listed) ;

(e) a discussion of environmental considerations, including architectural compatibility, waste disposal, traffic impacts, economic and social impacts on the area, etc.

(4) A discussion of the organizational aspects of the project, including the following information:

(a) the type of organization or entity responsible for the day-to-day operation of the facility (e.g., state, county, city, federal, hospital district, church related, nonprofit corporation, individual, partnership, business corporation) ;

(b) whether the controlling organization leases the physical plant from another organization. If so, the name and type of organization that owns the plant;

(d) the name and title of the chief administrator of the applicant's facility, and whether employed by the applicant or another organization as identified in (e) below;

(e) if the controlling organization has placed responsibility for the administration of the facility with another organization, the name and type of organization that manages the facility;

(f) if the facility is operated as a part of a multi-facility system (e.g., medical center, chain of hospitals owned by a religious order, etc.) the name and address of the parent organization;

(g) whether the applicant's facility has received or intends to apply for state licensure or federal certification.

(5) A discussion of the program staffing and operational capabilities of the project, including the following information:

(a) an itemized list of full-time-equivalent staff positions (current and after completion of project) , and estimated number of personnel available, including:

(i) administration;

(ii) physician services;

(iii) nursing services;

(iv) social services;

(v) other professional/technical;

(vi) all other (specify) ;

(b) if the applicant operates an existing facility, whether it meets current staffing standards.

(6) A discussion of the physical structure and services to be provided, including the following information:

(a) a narrative description of the project, including:

(i) size, type construction, floor space to be added or renovated, beds, square feet per bed, parking, etc.;

(ii) description of both old and new facilities where applicable;

(iii) time frame(s) for construction;

(iv) a line drawing of proposal;

(b) a discussion of legal considerations, including:

(i) whether the project will correct non-conforming conditions;

(ii) whether the project is in conformance with current local zoning laws (city or county) ;

(iii) whether the structures meet current safety and building codes;

(c) a listing of current licensed beds, certified medicare or medicaid beds, and beds to be added in each of the basic service categories;

(d) for home health agencies, the current and proposed number of patient visits and consultations, and the reporting period;

(e) in order to show utilization levels, indication of each of the following for the applicant's facility, if already in existence, and for every other facility of the same kind within the same service area, for each of the past full three years and the current year, as well as utilization projections for each of the foregoing facilities for one, two, and three years:

(i) average daily census;

(ii) percent occupancy;

(iii) average length of stay;

(iv) total discharges;

(v) outpatient visits;

(vi) home care visits;

(vii) surgical procedures, inpatient and outpatient.

(f) If the applicant's facility is not yet in existence, the applicant must submit all of the above for any other parallel facility in the same service area, along with projections for (i) through (vii) above for the first, second, and third years of operation of the proposed facility.

(7) A discussion of capital expenditure requirements, including the following information:

(a) the approximate date that obligation of funds will be incurred for the proposal;

(b) (i) the source of funds (specify cash on hand, commercial or government loans, grants, net earnings and reserve, bequests and endorsements, charitable fund raising, revenue bonds, other) ;

(ii) amount available;

(iii) amount to be borrowed;

(d) copies of the complete financial operating statements for the last three years and, if available, audited statements;

(e) copies of the following:

(i) projected revenue and expense statements with supportive population and utilization assumptions both during construction and the first two years of operation;

(ii) utilization projections demonstrating need for the project.

(8) Estimated project costs for each of the following:

(a) consultant, legal, architect, engineering, and construction supervision;

(b) financing fees;

(d) interest, principle to be borrowed, reserves related to public bond issue;

(e) land acquisition, site development, and construction.

(9) (a) Effect of project on costs and charges for room rates or specific services;

(b) discussion of operating fund demands and budget factors, including the following:

(i) the sources of operating revenue in percentages (specify medicare, medicaid, private pay, or insurance) ;

(ii) if grant support is provided for the project, how the service will be financed upon termination of this support;

(iii) whether depreciation will be funded;

(iv) explanation of plans for meeting possible operating deficits;

(c) effect the proposed capital expenditure will have on annual operating costs. Whether the operating costs will be increased or decreased and by how much;

(10) A discussion of cost containment factors, including the following information:

(a) how the proposal demonstrates superior community cost-benefit or community cost-effectiveness;

(b) description of shared services which are available as an alternative to duplication (explain in detail);

(11) A discussion specifically addressing the review criteria listed in 50-5-304, MCA and ARM 37.106.113.

(12) The signature of a responsible representative of the applicant, the title of the signatory, and the date of signing.

(1) Every hospital and critical access hospital shall submit an annual report to the department on a form provided by the department by the deadline specified on the form. The annual reports must be signed by the hospital administrator and must include whichever of the following information is requested on the form:

(a) whether the hospital has received accreditation, and if so, for what period;

(b) beginning and ending dates of the hospital's reporting period, and whether the facility has been in operation for 12 full months at the end of the most recent reporting period;

(i) the type of organization or entity responsible for the day-to-day operation of the hospital (e.g., state, county, city, federal, hospital district, church related, nonprofit corporation, individual, partnership, business corporation);

(ii) whether the controlling organization leases the physical plant from another organization, and if so, the name and type of organization that owns the plant;

(iii) any changes in the ownership, board of directors or articles of incorporation during the past year;

(iv) the name of the current chairman of the board of directors;

(v) if the controlling organization has placed responsibility for the administration of the hospital with another organization, the name and type of organization that manages the facility. A copy of the latest management agreement must be provided;

(vi) if the hospital is operated as a part of a multi-facility system (e.g., medical center, chain of hospitals owned by a religious order, etc.) the name and address of the parent organization;

(d) whether the hospital provides primarily general medical/surgical services, or specialty services (specify);

(e) specific facilities and services provided by the hospital, bed capacities for each service (where applicable), and whether such services are provided full or part-time, by hospital personnel, or by contracting providers;

(f) newborn nursery statistics, including:

(i) number of bassinets set up and staffed;

(ii) total number of births;

(iii) total newborn days;

(iv) neonatal intensive care admissions and inpatient days;

(g) surgery statistics, including:

(i) number of inpatient and outpatient surgery suites;

(ii) number of inpatient and outpatient operations performed;

(iii) number of adult and pediatric open-heart surgical operations performed;

(iv) total adult and pediatric cardiac catheterization and intracardiac and/or coronary artery procedures;

(h) number of beds set up and staffed and total inpatient days (excluding newborns) in each basic inpatient service category;

(i) inpatient statistics, including:

(i) number of licensed hospital beds (excluding bassinets and long-term care beds);

(ii) number of admissions (excluding newborns);

(iii) number of discharges (including deaths);

(iv) number of deaths (excluding fetal deaths);

(v) census on last day of reporting period (excluding newborns);

(j) information on other services, including number of rooms or units, number of inpatient and outpatient procedures, and number of outpatient visits in at least the following areas:

(i) emergency room;

(ii) organized outpatient department;

(iii) x-ray, ultrasound, nuclear medicine, cobalt therapy, CT scans;

(iv) physical therapy;

(v) respiratory therapy;

(vi) renal dialysis;

(vii) other ancillary services;

(k) information on changes in total number of beds during the reporting period;

(l) whether there is a separate long-term care unit, and if so, how many beds;

(m) patient origin data, including every town of origin and number of discharges;

(n) total medicare and medicaid admissions and inpatient days;

(o) size of medical and non-medical staff, including number of active and consulting physicians, medical residents and trainees, registered and licensed professional or vocational nurses, and all other personnel;

(p) name of person to contact in the event the department has questions concerning the information provided in the annual report.

(2) Any facility failing to timely report such information to the department may be subject to corrective action.

(1) Every hospital and critical access hospital shall submit an annual financial report to the department on a form provided by the department by the deadline specified on the form. The annual financial report must be signed by the hospital administrator and must include whichever of the following information is requested on the form:

(a) hospital revenues for both acute and long-term care units, including:

(i) gross revenue from inpatient and outpatient service;

(ii) deductions for contractual adjustments, bad debts, charity, etc.;

(iii) other operating revenue;

(iv) nonoperating revenue (such as government appropriations, mill levies, contributions, grants, etc.);

(b) hospital expenses for both acute and long-term care units, including:

(i) payroll expenses for all categories of personnel;

(ii) nonpayroll expenses, including employee benefits, professional fees, depreciation expense, interest expense, others;

(i) bad debts;

(ii) contractual adjustments (specifying medicare, medicaid, blue cross or other);

(iii) charity/Hill-Burton;

(iv) other;

(d) medicaid and medicare program revenue for both acute and long-term care units;

(e) unrestricted fund assets, including dollar amounts of:

(i) current cash and short-term investments;

(ii) current receivables and other current assets;

(iii) gross plant and equipment assets; deductions for accumulated depreciation;

(iv) long-term investments;

(v) other;

(f) unrestricted fund liabilities, including dollar amounts of:

(i) current liabilities;

(ii) long-term debts;

(iii) other liabilities;

(iv) unrestricted fund balance;

(g) restricted fund balances, with identification of specific purposes for which funds are reserved, including plant replacement and expansion, and endowment funds;

(h) capital expenditures made during the reporting period, including expenditures, disposals and retirements for land, building and improvements, fixed and moveable equipment, and construction in progress;

(i) whether a permanent change in bed complement or in the number of hospital services offered will result from any capital acquisition projects begun during the reporting period (specify);

(j) whether a certificate of need was received for any projects during the reporting period, and if so, the total capital authorization included in such approvals.

(2) Any facility failing to timely report such information to the department may be subject to corrective action.

(1) Every long-term care facility shall submit an annual report to the department on a form provided by the department by the deadline specified on the form. The annual report must be signed by the facility administrator and must include whichever of the following information is requested on the form:

(a) the facility's reporting period, and whether the facility was in operation for a full 12 months at the end of the reporting period;

(b) a discussion of the organizational aspects of the facility, including the following information:

(i) the type of organization or entity responsible for the day-to-day operation of the facility (e.g., state, county, city, federal, hospital district, church related, nonprofit corporation, individual, partnership, business corporation);

(ii) whether the controlling organization leases the physical plant from another organization. If so, the name and type of organization that owns the plant;

(iii) any changes in the ownership, board of directors or articles of incorporation of the facility during the past year;

(iv) the name of the current chairman of the board of directors of the facility;

(v) if the controlling organization has placed responsibility for the administration of the facility with another organization, the name and type of organization that manages the facility. A copy of the latest management agreement must be provided;

(vi) if the facility is operated as a part of a multi-facility system (e.g., medical center, chain of hospitals owned by a religious order, etc.) the name and address of the parent organization;

(i) licensed bed capacity (skilled and intermediate);

(ii) whether the facility is certified for medicare or medicaid;

(iii) number of beds currently set up and staffed;

(iv) total patient census on first day of reporting period; total admissions, discharges, patient deaths, and patient-days of service during the reporting period;

(v) patient census on last day of reporting period, broken down by sex and age categories;

(d) financial data, including:

(i) total annual operating expenses (payroll and non- payroll);

(ii) closing date of financial statement;

(iii) sources of operating revenue, indicating percent received from medicare, medicaid, private pay, insurance, grants, contributions, and other;

(e) staff information, including number and classification of full and part-time medical personnel, as required on the survey form;

(f) patient origin data, including patients' counties of residence, and number of admissions from state institutions and from out-of-state;

(g) name of person to contact should the department have any questions regarding the information on the report.

(2) Any facility failing to timely report such information to the department may be subject to corrective action.

(1) Every home health agency shall submit an annual report to the department on a form provided by the department and no later than the deadline specified on the form. The report must be signed by the administrator of the agency and must include whichever of the following information is requested on the form:

(a) whether the agency has medicare certification, and if so, the term of such certification;

(b) the agency's reporting period, and whether the agency was in operation for a full 12 months at the end of the reporting period;

(i) the type of organization or entity responsible for the day-to-day operation of the agency (e.g., state, county, city, federal, hospital district, church related, nonprofit corporation, individual, partnership, business corporation) ;

(ii) whether the home health agency is owned by the same organization that controls it. If not, the name and type of organization that owns the agency;

(iii) any changes in the ownership, board of directors or articles of incorporation of the agency during the past year;

(iv) the name of the current chairman of the board of directors of the agency;

(v) if the controlling organization has placed responsibility for the administration of the agency with another organization, the name and type of organization that manages the facility. A copy of the latest management agreement must be provided;

(vi) if the agency is operated as a part of a multi-facility system (e.g., medical center, chain of hospitals owned by a religious order, etc.) the name and address of the parent organization;

(d) a listing of specific services provided by the agency, and the number of people served and number of visits made for each service;

(e) a description of the geographic area served by the agency;

(f) the number of persons served by the agency and the number of new cases acquired by the agency during the reporting period;

(g) financial data, including:

(i) payroll and non-payroll expenses;

(ii) closing date of financial statement;

(iii) sources of operating revenue, indicating percentage received from medicare, medicaid, private pay, insurance, grants, contributions, other;

(h) staff information, including number of full, part-time and contracted registered and licensed professional nurses, home health aids, student nurses, and others;

(i) the name of the person to contact should the department have questions regarding the information on the report.

The following definitions apply in this subchapter:

(1) "Administrator" means the individual responsible for the day-to-day operation of a health care facility.

(2) "Communicable disease" means a disease that may be transmitted directly or indirectly from one individual to another.

(3) "Inpatient" means a person who has been admitted to a hospital for bed occupancy for purposes of receiving inpatient hospital services.

(4) "Medical record" means a written document which is complete, current, and contains sufficient information for planning a patient's, resident's, or client's care, reviewing and evaluating care rendered, evaluating a patient's, resident's, or client's condition, and for providing a means of communication among all persons providing care.

(5) "Observation bed or unit" means a bed or unit within a hospital, critical access hospital, or specialty hospital that includes ongoing short-term treatment, assessment, and reassessment, and is not considered an inpatient bed. Patient stays in observation beds are limited to 48 hours during which time a decision must be made whether a patient requires further treatment as an inpatient.

(6) "Outpatient" means a person receiving health care services and treatment at a facility for a period of less than 24 hours without being admitted as an inpatient to the facility.

(7) "Secured care unit" means a licensed facility or unit of a facility that provides care in an environment where the doors are secured by delayed egress locks 24 hours a day.

(1) The provisions of this subchapter apply to all health care facilities licensed or to be licensed by the department. To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of facility-specific rules, the specific facility rules will apply.

(2) The construction of, alteration, or addition to a health care facility shall comply with:

(a) the 2018 edition of the "American Institute for Architects (AIA) Guidelines for Design and Construction of Hospitals and Health Care Facilities," which the department adopts and incorporates by reference, which sets forth the minimum construction equipment requirements deemed necessary by the state Department of Public Health and Human Services to ensure health care facilities can be efficiently maintained and operated to furnish adequate care. Copies of the cited edition are available at the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953;

(b) "NFPA 101: Life Safety Code Handbook," 2012 edition published by the National Fire Protection Association, which the department adopts and incorporates by reference, which sets forth construction and operation requirements designed to protect against fire hazards. Copies of the cited edition are available at the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953;

(c) the 2009 "American National Standards Institute A117.1," which the department adopts and incorporates by reference, which sets forth standards for buildings and facilities providing accessibility and usability for physically handicapped individuals. Copies of the cited edition are available at the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953;

(d) the water supply system requirements of ARM 37.111.115; and

(e) the sewage system requirements of ARM 37.111.116.

(3) A patient or resident may not be admitted, housed, treated, or cared for in an addition or altered area until inspected and approved, or in new construction until licensed.

(1) Prior to beginning construction of a new health care facility or before construction of an addition or alteration to a health care facility, the following plans and specifications must be submitted to the department for approval:

(a) schematic plans which include but are not limited to:

(i) single line drawings of each floor;

(ii) the name of each room and the relationship of the various departments or services to each other and the room arrangement in each department must be noted;

(iii) total floor area and number of beds must be noted on the plans;

(iv) the proposed roads and walks, service and entrance courts, and parking must be shown on the site plan; and

(v) if requested by the department, submission of a narrative regarding a specific schematic function to clarify and provide additional information.

(b) the plans must be complete and adequate for bid, contract, and construction purposes, and include but are not limited to a complete set of the following:

(i) civil;

(ii) landscape;

(iii) architectural;

(iv) structural;

(v) mechanical;

(vi) plumbing;

(vii) electrical; and

(viii) special systems which include, but are not limited to, nurse call systems, fire alarms systems, and secured units.

(c) specifications supplementing the working drawings to fully describe types, sizes, capacities, workmanship, finishes, and other characteristics of all materials and equipment.

(2) All submitted plans and specifications must be stamped by an engineer or architect licensed to practice in Montana.

(3) The department's approval of an alteration or addition to a health care facility shall terminate one year after issuance or upon completion and acceptance of the project.

(a) A six-month extension is permitted upon request. The request must verify that plans are still the same and no changes have been made to the specifications.

(1) A completed license application form must be submitted to the department.

(a) The application must be obtained from the department.

(b) The administrator or designee of the health care facility must sign the completed license application form.

(2) On receipt of a new or renewal license application, the department or its authorized agent will inspect the health care facility to determine if the facility meets the minimum regulatory standards set forth in this subchapter and other rules specific to the facility type as applicable.

(3) If minimum regulatory standards are met and the proposed staff is qualified, the department may issue a license for periods of up to three years.

(a) A three-year license may be offered to any facility:

(i) that has received a deficiency-free survey;

(ii) that has been granted accreditation by an accreditation entity approved by the U.S. Centers for Medicare & Medicaid Services; or

(iii) that has received a survey from another recognized department entity and the results of that survey determine that the facility meets the minimum requirements for issuance of a license.

(b) The facility must submit or make available to the department the full accreditation entity or department inspection report.

(i) that has received minor deficiencies, but those deficiencies do not significantly affect or threaten the health, safety, and welfare of any facility patient or resident.

(d) A one-year license may be offered to any facility:

(i) that has been in operation for less than one year;

(ii) upon a change in ownership; or

(iii) that has received deficiencies within the preceding 12 months that threaten the health, safety, and welfare of residents or staff.

(4) Licensed premises must be open to inspection by the department or its authorized agent and access to all records must be granted to the department at all reasonable times.

This rule has been repealed.

(1) All health care facilities shall develop and implement an infection prevention and control program. At a minimum, the facility must develop, implement, and review, at least annually, written policies and procedures regarding infection prevention and control which must include but are not limited to:

(a) procedures to identify high risk individuals; and

(b) the identification of methods used to protect, contain, or minimize the risk to patients, residents, staff, and visitors.

(2) The administrator or infection control officer will be responsible for the direction, provision, and quality of infection prevention and control services.

(1) A health care facility must initiate and maintain a safe, secure, and confidential medical record for each patient, resident, or client.

(2) A health care facility, excluding a hospital, shall retain a patient's, resident's, or client's medical records for no less than six years following the date of the patient's, resident's, or client's discharge or death, or upon the closure of the facility.

(1) The facility is responsible for maintaining a file on each employee and substitute personnel. Employee files may be inspected by the department at any time. If the file is not maintained at the facility it must be available to the department within 24 hours of request.

(2) At a minimum, the employee file must contain:

(a) the employee's name;

(b) a job description signed by the employee;

(d) a copy of current credentials, certification, or professional licenses required to perform the duties described in the job description.

(3) Volunteers may be utilized at a health care facility, but may not be included in the facility staffing plan in lieu of employees. All volunteers who are performing duties which are commonly performed by facility staff must have a file which is maintained at the facility and documents the following:

(a) orientation to the facility and its residents; and

(b) orientation to and training of the duties to be performed.

(1) All rules in this subchapter apply to secured care units.

(2) Special locking arrangements as specified in the "NFPA 101: Life Safety Code Handbook", 2012 Edition must be utilized, or an acceptable alternative is based on an equivalency for the automatically releasing, panic hardware required by section 7.2.1.6.1 of the "NFPA 101: Life Safety Code Handbook", 2012 Edition. Where local authorities having jurisdiction allow, the following conditions apply to this alternative:

(a) All locks must be electromagnetic. The use of mechanical locks, such as a deadbolt is not permitted;

(b) All of the secured doors must have a manual electronic keypad release. The keypad must release the lock(s) on the door(s) after entry of the proper code sequence;

(d) Provisions must be made for the rapid removal of occupants by such reliable means as the remote control of the locks. Typically this is done by placing a staff-accessible switch at the nurse's station which is capable of releasing all doors; and

(e) All the locks on all secured doors must automatically release upon any of the following conditions:

(i) the actuation of the approved supervised automatic fire alarm system;

(ii) the actuation of an approved supervised automatic sprinkler system; and

(iii) upon the loss of power controlling the lock(s) or locking mechanism.

(3) A secured care unit is considered a separate nursing unit and must have a nurse station located within the secured care unit. At a minimum, the nurse station must provide the following:

(a) provisions for charting;

(b) provisions for hand washing;

(d) telephone access; and

(e) a nurse call system in compliance with table 2.1-4 as found in the 2018 Edition of the AIA Guidelines for Design and Construction of Hospitals and Health Care Facilities.

(4) The nurse call system for the secured care unit must report to the secured care unit nurse station, but may also annunciate the call at another location, such as a main nurse station.

(5) Observation beds cannot be located in secured care units.

(6) Space within the secured care unit used for dining, activities, and day space must be provided at a ratio of 35 square feet per resident, with at least 20 square feet per resident dedicated to the dining space.

(7) No more than two secured care unit residents can reside in a single room.

(8) Each secured care unit resident must have access to a toilet without entering the corridor.

(a) Doors to bathrooms may be removed in private rooms.

(9) A secured care unit must provide for a nourishment station. The minimum standards for a nourishment station as indicated in section 2.5-2.2.6.7 of the 2018 Edition of the AIA Guidelines for Design and Construction of Hospitals and Health Care Facilities include:

(a) a work counter;

(b) a refrigerator;

(d) space for trays and dishes used for nonscheduled meal service;

(e) an icemaker dispenser unit for patient ice consumption within or in close proximity to the secured care unit;

(f) a sink for preparing nourishments between meals; and

(g) hand washing facilities that are in or immediately accessible from the nourishment station.

(10) A secured care unit must provide secured care unit residents access to large group activities when provided for the general population, such as holiday activities and special events as determined appropriate.

(1) Each facility must have a written maintenance program describing the procedures to keep the building, grounds, and equipment in good repair and free from hazards.

(2) A health care facility must provide housekeeping services on a daily basis.

(3) All electrical, mechanical, plumbing, fire protection, heating, and sewage disposal systems must be kept in operational condition.

(4) Floors must be kept clean and in good repair at all times.

(5) Walls and ceilings must be kept in good repair and be of a finish that can be easily cleaned.

(6) Every facility must be kept clean and free of odors. Deodorants may not be used for odor control in lieu of proper ventilation.

(7) The temperature of hot water supplied to handwashing and bathing facilities must not exceed 120°F.

(1) A health care facility must be constructed and maintained so as to prevent entrance and harborage of rats, mice, insects, flies, or other vermin.

(2) Hand cleansing soap or detergent and individual towels must be available at each lavatory in the facility. A waste receptacle must be located near each lavatory.

(3) Cleaners used to clean bathtubs, showers, lavatories, urinals, toilet bowls, toilet seats, and floors must contain fungicides or germicides with current EPA registration for that purpose.

(4) Cleaning devices used for lavatories, toilet bowls, showers, or bathtubs may not be used for other purposes. Those tools used to clean toilets or urinals must not be allowed to contact other cleaning devices.

(5) A minimum of 10 foot-candles of light must be available in all rooms and hallways, with the following exceptions:

(a) all reading lamps must have a capacity to provide a minimum of 30 foot-candles of light;

(b) all toilet and bathing areas must be provided with a minimum of 30 foot-candles of light;

(d) hallways must be illuminated at all times by at least a minimum of five foot-candles of light at the floor.

(1) All health care facilities must develop a written disaster plan as follows:

(a) skilled nursing facilities (long-term care), outpatient centers for primary care, outpatient centers for surgical services, critical access hospitals, hospitals, residential hospice facilities, inpatient hospice facilities, and infirmaries must develop a written disaster plan in conjunction with other emergency services in the community;

(b) these procedures must be developed such that they can be followed in the event of a natural or man-caused disaster.

(2) The health care facilities identified in (1) must conduct a review or physical exercise of such procedures at least once a year. After a review or exercise a health care facility shall prepare and retain on file for a minimum of three years a written report including but not limited to the following:

(a) date and time of the review or exercise;

(b) the names of staff involved in the review or exercise;

(d) the names of other persons involved in the review or exercise;

(e) a description of all phases of the procedure and suggestions for improvement; and

(f) the signature of the person conducting the review or exercise.

(3) Adult day care facilities, adult foster care homes, assisted living facilities, chemical dependency treatment centers, eating disorder centers, end-stage renal dialysis facilities, intermediate care facilities for the developmentally disabled, mental health centers, outdoor behavioral facilities, residential treatment facilities, retirement homes, and specialty mental health facilities must develop a written disaster plan for their facility, and conduct a documented review of the disaster plan with all facility staff annually. This documentation must be maintained at the facility for a minimum of three years. The disaster plan must include:

(a) plans for remaining at the facility during and subsequent to the disaster. Plans must include such elements as acquisition of additional blankets, water, food, etc.; and

(b) plans for resident evacuation and identification of at least one off-site evacuation point. A written agreement must be maintained in the facility record and updated annually.

(4) Fire drills must be conducted at all health care facilities.

(a) health care facilities that house patients or residents must conduct at least four fire drills annually, no closer than two months apart, with at least one drill occurring on each shift. Drill observations must be documented and maintained at the facility for at least two years. The documentation must include:

(i) location of the drill;

(ii) documentation that identifies participating staff;

(iii) problems identified during the drill;

(iv) steps taken to correct such problems; and

(v) signature of the individual responsible for the day-to-day operation of the health care facility.

(1) A current written policy and procedure manual that describes all services provided in the health care facility must be developed, implemented, and maintained at the facility. The manual must be available to staff, residents, resident family members, resident legal representatives, and the department and must be complied with by all facility personnel and its agents. Policies and procedures must be reviewed at least annually by either the administrator or the medical director with written documentation of the review.

(1) If a health care facility processes its laundry on the facility site, it must:

(a) use rooms solely for laundry purposes;

(b) equip the laundry room with at least one mechanical washer and hot air tumble dryer, handwashing facilities, mechanical ventilation to the outside, a fresh air supply, and a hot water supply system which supplies the washer with water of at least 160�F (71�C) during each use. If the laundry water temperature is less than 160�F, chemicals and detergent suitable to the water temperature and the manufacturer's recommended product time of exposure must be utilized.

(d) provide well maintained carts or other containers impervious to moisture to transport laundry, keeping those used for soiled laundry separate from those used for clean laundry;

(e) dry all bed linen, towels, and washcloths in a manner that protects against contamination;

(f) protect clean laundry from contamination; and

(g) ensure that facility staff handling laundry cover their clothes while working with soiled laundry, use separate clean covering for their clothes while handling clean laundry, and wash their hands both after working with soiled laundry and before they handle clean laundry.

(2) If laundry is cleaned off-site, the health care facility must utilize a commercial laundry which satisfies the requirements stated in (1)(a) through (g).

(3) A health care facility with beds must:

(a) keep each resident bed dressed in clean bed linen in good condition;

(b) keep a supply of clean bed linen on hand sufficient to change beds often enough to keep them clean, dry, and free from odors;

(d) provide each resident bed with a moisture-proof mattress or a moisture-proof mattress cover and mattress pad; and

(e) provide each resident with enough blankets to maintain warmth while sleeping.

(1) A hospital shall comply with the Conditions of Participation for Hospitals in 42 CFR subchapter G part 482.

(2) If a hospital provides skilled nursing care or intermediate nursing care, as those levels of care are defined in 50-5-101 , MCA, the hospital shall comply with the skilled nursing facility requirements listed in 42 CFR subchapter G part 483.

(3) The department adopts and incorporates by reference 42 CFR subchapter G part 482 and 42 CFR subchapter G part 483. 42 CFR subchapter G part 482 sets forth the conditions of participation a hospital must meet to participate in the Medicare program. 42 CFR subchapter G part 483 sets forth the skilled nursing facility requirements a hospital provider of long term care services must meet to participate in the Medicare program. A copy of the regulations may be obtained from the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

Medical records shall comply with the following requirements:

(1) A patient's entire medical record must be maintained, in either its original form or that allowed by ARM 37.106.314(3) , for not less than 10 years following the date of a patient's discharge or death, or, in the case of a patient who is a minor, for not less than 10 years following the date the patient either attains the age of majority or dies, if earlier.

(2) An obstetrical record shall be developed for each maternity patient and must include the prenatal record, labor notes, obstetrical anesthesia notes and delivery record.

(3) A record must be developed for each newborn, and shall include, in addition to the information in (2) , the following information:

(a) observations of newborn after birth;

(b) delivery room care of newborn;

(d) temperature of newborn;

(e) weight of newborn;

(f) time of newborn's first urination;

(g) number, character and consistency of newborn's stool;

(h) type of feeding administered to newborn;

(i) phenylketonuria report for newborn;

(j) name of person to whom newborn is released.

(4) A patient's entire medical record may be abridged following the dates established in (1) to form a core medical record of the patient's medical record. The core medical record or the microfilmed medical record should be maintained permanently but must be maintained not less than 10 years beyond the periods provided in (1) . A core record shall contain at a minimum the following information:

(a) identification of patient data which includes name, maiden name if relevant, address, date of birth, sex, and, if available, social security number;

(b) medical history;

(d) consultation reports;

(e) report of operation;

(f) pathology report;

(g) discharge summary, except that for newborns and others for whom no discharge summary is available, the final progress note must be retained;

(h) autopsy findings;

(i) for each maternity patient, the information required by (2) ; and

(j) for each newborn, the information required by (3) .

(5) Nothing in this rule may be construed to prohibit retention of hospital medical records beyond the period described herein or to prohibit the retention of the entire medical record.

(6) Diagnostic imaging film and electrodiagnostic tracings must be retained for a period of five years; their interpretations must be retained for the same periods required for the medical record in (1) , but need not be retained beyond those periods.

(1) Hospital records must be maintained.

(1) A hospital laboratory shall comply with the Conditions for Coverage of Services of Independent Laboratories as set forth in 42 CFR 405.1310, 405.1311, 405.1314, 405.1316, and 405.1317. A copy of the cited rules is available at the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) This rule is adopted to implement Chapter 219, Laws of 1987, which amended both the Uniform Anatomical Gift Act, Title 72, chapter 17, MCA, and the Montana Health Care Facility Licensing Act, Title 50, chapter 5, part 2, MCA. Sections (2) through (5) of this rule paraphrase 72-17-211 , MCA of the Uniform Anatomical Gift Act and are included here to clarify the requirements for hospitals in cases of patients who are suitable organ donors. For a full text of the Uniform Anatomical Gift Act, reference should be made to Title 72, chapter 17, MCA.

(2) When, according to generally accepted medical standards, a patient is a suitable candidate for donation of body parts as defined in 72-17-102 (8) , MCA, the hospital administrator or his/her designated representative shall communicate to the next-of-kin (as defined in (3) below) the option of donating all or any part of the patient's body and of the next-of-kin's option to decline. In addition to communicating such options, the hospital administrator or his/her designee must also request the next-of-kin to consent to an anatomical gift. The foregoing obligations of the administrator must be carried out unless the administrator or his/her designee:

(a) has actual notice of opposition to the gift by the decedent or the next-of-kin as defined in (3) below; or

(b) has reason to believe that an anatomical gift is contrary to the decedent's religious beliefs; or

(3) "Next-of-kin" as provided in 72-17-201 (2) , MCA, means one of the following persons in order of priority listed:

(a) the spouse;

(b) an adult son or daughter;

(d) an adult brother or sister; and

(e) a guardian of the person of the decedent at the time of death.

(4) The medical record of each patient who dies in a hospital and who is determined (under the hospital's protocol established under (6) below) to be a suitable candidate for donation of body parts must contain an entry setting forth the following:

(a) the name and affiliation of the individual who communicated the option to donate to the next-of-kin and who made the request for anatomical gift under (1) above;

(b) the name, relationship to the patient, and response of the individual to whom the option to donate was communicated and of whom the request for anatomical gift was made; and

(c) if no communication of an option or if no request for anatomical gift was made, the reason why no such request was made.

(5) An anatomical gift by a next-of-kin may be made in writing or by telegraphic, recorded telephonic, or other recorded message.

(6) By November 1, 1987, every hospital shall establish and have on file a written protocol that:

(a) assures identification of potential organ and tissue donors;

(b) assures that next-of-kin of patients who are suitable candidates for donation of body parts are made aware of their option to make an anatomical gift and are requested to consent to an anatomical gift of all or any part of the patient's body, unless one of the exceptions in (2) (a) , (2) (b) or (2) (c) applies;

(c) encourages discretion and sensitivity with respect to the circumstances, views, and beliefs of families of potential organ donors; and

(d) provides for notification of an appropriate federally approved organ procurement organization when potential organ donors are identified in the hospital.

(7) Upon request, every hospital must make its adopted written protocol available to department personnel for their review.

(8) The protocol must, at a minimum, in addition to the items in (6) above, address and provide for the following aspects of an organ donation notification/request/referral program:

(a) method(s) by which the public is notified that the hospital has an organ procurement program;

(b) determination of medical suitability of potential donors of body parts, including consideration of factors such as donor age, previous disease history, and presence of infection; and documentation of non-suitability of patients initially identified as potential donors;

(c) a training and educational program conducted on a yearly basis in conjunction with a procurement organization (or the equivalent) to instruct appropriate hospital staff or others to convey organ donation information to next-of-kin and to make requests from next-of-kin, which program consists of formal training, seminars, in-service workshops, or other training (or a combination thereof) leading to a knowledge of and familiarity with the following:

(i) general historical, medical, legal and social concepts involved in organ donation and transplantation;

(ii) psychological and emotional considerations when dealing with bereaved families;

(iii) religious, cultural, and ethical considerations associated with organ donation; and

(iv) procedures for approaching donors and/or donors' next-of-kin, including physician notification, timing and location of contact, content(s) of communication concerning donor cards, consent forms, donation costs (if any) , and actual requests for donation;

(d) orientation and instruction on a yearly basis in conjunction with a procurement organization (or the equivalent) in the respective disciplines of hospital staff and/or other personnel who will or may be participating in the hospital's organ procurement program, such as chief of staff, attending physicians, nursing staff, social workers, clergy, or a team combining any of such persons; and

(e) the following forms to be used by the hospital to document that next-of-kin of medically suitable patients have been notified of the option to consent to an anatomical gift and have been requested to authorize such donation(s) as required in (2) above (and, if any such contact has not been made, the reason(s) why not) :

(i) patient authorization;

(ii) consent of next-of-kin; and

(iii) notification of organ procurement organization(s) .

(9) The hospital administrator shall designate a person or persons to represent him/her for the purpose of communicating to the next-of-kin the option of an anatomical gift and to make requests for anatomical gifts, in cases where the administrator is unable or will not be making such requests personally. Such persons shall receive the training specified in (8) above, and a list of such person(s) must be made available upon request to department personnel.

(10) A person who acts in good faith in accordance with the terms of (2) of this rule is not liable for damages in any civil proceeding or subject to prosecution in any criminal proceeding that might result from this action.

If a hospital provides a coronary care unit, the unit shall comply with the following requirements:

(1) When a patient is cared for in a coronary care unit, a licensed registered nurse shall be on duty.

(2) At a minimum, the following equipment and supplies must be available in a coronary care unit:

(a) oxygen, oxygen and suction apparatus;

(b) defibrillator, resuscitator and respirator;

(d) oscilloscope;

(e) heart-rate meter with an alarm system;

(f) an electrocardiograph which is activated simultaneously with the alarm system and which may also be activated manually or at predetermined intervals;

(g) external pacemaker.

If a hospital provides an intensive care unit, the unit shall comply with the following requirements:

(1) When a patient is cared for in an intensive care unit, a licensed registered nurse shall be on duty.

(2) At a minimum, the following equipment and supplies must be available in an intensive care unit:

(a) oxygen, oxygen and suction apparatus;

(b) defibrillator, resuscitator and respirator;

If a hospital provides obstetrical services, the hospital shall comply with the following requirements:

(1) Obstetrical services must be under the supervision of a licensed registered nurse on a 24-hour basis.

(2) A maternity patient shall only be placed in a room with other maternity patients. The use of maternity rooms for other than maternity patients shall be restricted to noninfected gynecological and surgical patients. A maternity patient with infection shall be isolated in a separate room outside of the obstetrical service.

(3) An equipped room must be provided for each patient in labor.

(4) At least one delivery room must be provided.

(5) A delivery record shall be made for a maternity patient delivering and include, but not be limited to, the following information:

(a) starting time of patient's labor;

(b) time of birth of patient's newborn;

(d) whether an episiotomy was performed on patient;

(e) whether forceps were used in delivery;

(f) names of attending physicians;

(g) names of attending nurses;

(h) names of all other persons attending delivery;

(i) sex of the newborn;

(j) time of eye prophylactic treatment and name of drug used.

(6) A newborn must be marked for identification before removal from the delivery area.

If a hospital provides a newborn nursery, the nursery shall comply with the following requirements:

(1) The newborn nursery must be under the supervision of a licensed registered nurse on a 24-hour basis.

(2) An individual bassinet must be provided for each newborn.

(3) Each newborn must have separate equipment and supplies for bathing, dressing and other handling.

(4) At least one incubator must be provided in the nursery.

(5) Oxygen, oxygen and suction equipment must be available and adapted to the size of newborns. When oxygen is administered, the concentration within the incubatory and near the newborn's head shall be determined by means of a reliable oxygen analyzer. These measurements shall be recorded on the newborn's chart.

(6) Formula prepared in the hospital shall be prepared by terminal heat method using separate equipment furnished for formula preparation.

If a hospital provides pediatric and adolescent services, the hospital shall comply with the following requirements:

(1) Pediatric and adolescent services must be under the supervision of a licensed registered nurse.

(2) At a minimum pediatric and adolescent services shall provide the following:

(a) an examination and treatment room with equipment and supplies designed for the care of children;

(b) oxygen and suction equipment designed for children.

If a hospital provides psychiatric services, the hospital shall comply with the following requirements:

(1) Psychiatric services must be under the supervision of a licensed psychiatrist on a 24-hour basis.

(2) Psychiatric service staff must include a sufficient number of adjunctive therapists to provide restorative and rehabilitation services for the number of patients accommodated.

(3) A licensed registered nurse or a licensed practical nurse under the supervision of a registered nurse shall be in charge 24 hours a day.

If a hospital provides respiratory therapy, the hospital shall comply with the following requirements:

(1) Respiratory therapy services must be under the supervision of a licensed physician appointed from the active medical staff.

(2) An internal and external quality control program must be provided for all parameters of acid-base testing.

(3) Written policies and procedures must be developed describing the control measures to be followed in order to eliminate the transfer of infection from the use of respiratory equipment.

(1) The purpose of these rules is to establish the minimum licensing requirements for the licensure of outpatient centers for surgical services.

(1) For purposes of this subchapter, outpatient centers for surgical services include facilities described at 50-5-101(42), MCA.

(1) "Medical director" means a physician licensed under Title 37, chapter 3 MCA, who oversees the services provided in an outpatient center for surgical services. The medical director may also serve in the outpatient center as a licensed health care professional. The medical director can also serve as the outpatient center administrator.

(2) "Outpatient center" for purposes of this subchapter, refers to an outpatient center for surgical services. Outpatient centers are limited to provide care for periods of less than 24 hours.

(3) "Safe manner" means that physicians and other clinical staff must follow acceptable surgical standards of practice in all phases of a surgical procedure, beginning with the preoperative preparation of the patient, through to the postoperative recovery and discharge.

(1) An outpatient center must:

(a) meet the requirements of ARM Title 37, chapter 106, subchapter 3 relating to the minimum standards for all health care facilities;

(b) to the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the rules in this subchapter will apply;

(c) have a written policy and procedure manual as described in ARM 37.106.507 available to, and followed by, all personnel;

(d) establish a coordinated transfer of care for patients who require services longer than 24 hours or for patients requiring care beyond the capabilities of the outpatient center. This coordinated transfer of care must include one of the following:

(i) a written transfer agreement with the receiving hospital;

(ii) one or more physicians with surgical privileges in the outpatient center must have admitting privileges at the receiving hospital and are present in the outpatient center during any surgical procedure; or

(iii) the receiving hospital writes a coordinated transfer policy and specifies the respective roles and responsibilities of the outpatient center upon arrival at the receiving hospital; and

(e) in transferring patients, the outpatient center must:

(i) coordinate and provide notice to the receiving hospital, including the reason for the transfer prior to the patient's transfer; and

(ii) provide the patient's medical records to the receiving hospital during the transfer.

(2) An outpatient center may:

(a) show written evidence of current accreditation by an accreditation entity approved by the U.S. Centers for Medicare & Medicaid Services including recommendations for future compliance as a condition of licensure; or

(b) meet the standards as specified in ARM 37.106.507 through 37.106.515.

(1) Each outpatient center must maintain a policy and procedure manual. The policy and procedure manual must be reviewed by the medical director or administrator and updated as necessary, but at least annually. The manual must contain policies and procedures for:

(a) preadmission;

(b) patient education;

(d) postoperative assessment;

(e) observation and recovery;

(f) discharge planning;

(g) emergency procedures of the outpatient center to include information on the transfer agreement with the receiving hospital;

(h) anesthesia policies as described in ARM 37.106.514;

(i) business practices; and

(j) patient and staff security.

(2) The policy and procedure manual must include a current organizational chart delineating the lines of authority, responsibility, and accountability for the administration and provision of all outpatient center patient services.

(3) Each outpatient center must have policies and procedures that address the criteria for clinical staff privileges and the process the governing body uses when reviewing physician credentials and determining whether to grant privileges.

(4) The outpatient center must implement a policy and a process which addresses the Food and Drug Administration (FDA) or manufacturer recall of drugs, vaccines, blood and blood products, medical devices, equipment, and supplies. The policy must address:

(a) the sources of information;

(b) methods for notifying staff;

(d) documentation of response to the recalled product;

(e) disposition or return of the recalled product; and

(f) patient notification as appropriate.

(1) An outpatient center is organized under a governing body that sets policy and is responsible for the organization. This governing body must meet regularly, but at least quarterly.

(2) The outpatient center administration must:

(a) operate under clearly defined mission, goals, and objectives for the organization;

(b) employ qualified personnel, both medical and managerial;

(c) adopt policies and procedures necessary for the orderly conduct of the organization, including the scope of clinical and surgical activities;

(d) ensure that the quality of care is evaluated and that identified problems are appropriately addressed;

(e) maintain effective communication throughout the organization, including ensuring a correlation between quality management and improvement activities and other management functions of the organization; and

(f) follow generally accepted accounting principles.

(3) Facility requirements for an outpatient center include:

(b) an emergency plan for use in the event of fire or natural disaster and documents exercise of the plan on an annual basis. The "exercise" may involve a functional review of the process. That review must be documented accordingly.

(4) Each outpatient center for surgical services will have a quality management and improvement plan which must include:

(a) a peer review process that includes:

(i) at least two licensed health care professionals one of whom is a physician, and operating within their scope of practice; and

(ii) that the results of the peer review are reported to the governing body.

(b) a credentialing process that provides a monitoring function to ensure the continued maintenance of licensure and certification, or both, of professional personnel who provide health care services at the outpatient center;

(i) is ongoing;

(ii) is data-driven;

(iii) is broad in scope;

(iv) addresses clinical and administrative issues as well as actual patient outcomes;

(v) has a defined set of quality improvement goals and objectives;

(vi) actively seeks patient feedback, evaluates complaints and suggestions, and works to improve patient satisfaction;

(vii) includes the active participation of the medical staff;

(viii) respects the health care rights of all patients, including the right to privacy;

(ix) at least annually conducts evaluation of outpatient center effectiveness;

(x) describes to the outpatient center's governing board the reports, findings, and activities relating to quality improvement; and

(xi) analyzes ongoing comprehensive self-assessment of the quality of care, including medical necessity of care or procedures performed and appropriateness of care. The findings from this process should be used to update facility policies and procedures.

(d) a risk management plan that:

(i) has a designated individual or committee that is responsible for the risk management program; and

(ii) addresses safety of patients and other important issues including:

(A) consistent application of the risk management program throughout the organization;

(B) review of all deaths, trauma, or other adverse incidents including reactions to drugs and materials;

(C) review and analysis of all actual and potential infection control occurrences and breaches, surgical site infections, and other health care acquired infections;

(D) review of patient complaints;

(E) impaired health care professionals;

(F) establishment and documentation of coverage after normal working hours;

(G) methods for prevention of unauthorized prescribing; and

(H) periodic review of clinical records and clinical record policies.

(1) Staffing and personnel requirements for an outpatient center for surgical services include:

(a) professional staff who are licensed under Title 37, MCA, to practice in their profession and have the knowledge and skills required to provide the services offered by the outpatient center;

(b) all personnel assisting in the provision of health care services are appropriately trained, qualified, and supervised according to the policies and procedures of the outpatient center; and

(1) An individual clinical record must be established for each person receiving care. Each record must be accurate, legible, and promptly completed. The record must include at least the following:

(a) patient identification;

(b) significant medical history and results of physical examination;

(d) findings and techniques of the operation including a pathologist's report on all tissues removed during surgery, except those exempted by the governing body;

(e) any allergies and abnormal drug reactions;

(f) entries related to anesthesia administration;

(g) documentation of properly executed informed patient consent which includes notice of transfer when deemed appropriate;

(h) discharge diagnosis; and

(i) discharge recommendations and instructions given to the patient.

(2) To ensure confidentiality, security, and physical safety of a patient's medical record, the outpatient center must designate a person to oversee and manage the clinical records.

(3) The outpatient center must have policies concerning clinical records. The policies must include:

(a) the retention of active records;

(b) the retirement of inactive records;

(d) the release of information contained in records.

(1) The outpatient center must maintain an infection control program that seeks to minimize infections and communicable diseases. The outpatient center is responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases, and for immediately implementing corrective and preventive measures that result in improvement.

(a) The infection prevention and control program must include documentation that the outpatient center has considered, selected, and implemented nationally recognized infection control guidelines.

(b) The infection prevention and control program is under the direction of a designated and qualified infection control officer who is a licensed health care professional and has training in infection control.

(2) The outpatient center must have written policies that also address cleaning of patient treatment and care areas to include:

(a) cleaning before use; and

(b) cleaning between patients.

(3) The outpatient center will have policies and processes in place for:

(a) the monitoring and documentation of the cleaning, high level disinfection, and sterilization of medical equipment, accessories, instruments, and implants; and

(b) minimizing the sources and transmission of infections, including adequate surveillance techniques.

(4) The outpatient center must designate a safety officer who is responsible for the facility's safety plan.

(5) The outpatient center must have a safety program which addresses the organization's environment of care and safety for all patients, staff, and others. The elements of the safety program include:

(a) a process for identifying hazards, potential threats, near misses, and other safety concerns;

(b) a process for reporting known adverse incidents to proper authorities;

(d) prevention of falls or physical injuries involving patients, staff, and others.

(6) The outpatient center must have a written emergency and disaster preparedness plan. The plan must address both internal and external emergencies and must also address provision for the safe evacuation of individuals during an emergency, especially for individuals who are at greater risk.

(a) The outpatient center must complete a written evaluation of each drill and promptly implement any corrections identified during the drill. This documentation must be on site at the facility for the period of licensure.

(7) The outpatient center must have a policy concerning the training of outpatient center staff in terms of the emergency and disaster plan.

(8) Products, including medications, reagents, and solutions that carry an expiration date are monitored and disposed of accordingly.

(9) Prior to use, appropriate education is provided to intended operators of newly acquired devices or products to be used in the care of patients.

(10) A system must exist for the proper identification, management, handling, transport, storage, and disposal of biohazardous materials and wastes, whether solid, liquid, or gas.

(1) The outpatient center must:

(a) prohibit the use of flammable anesthesia;

(b) have a policy which defines the types of anesthesia that will be used within the facility. Similarly, the outpatient center must address in this policy the level of American Society of Anesthesiologists (ASA) Physical Status Classification System level appropriate to receive surgical services in these types of facilities;

(c) conduct an assessment prior to the patient's admission as well as prior to surgery to evaluate the risk of anesthesia and of the procedure to be performed; and

(d) have policies that address the basis or criteria used in conducting the assessments.

(2) Supplies and exhaust systems for windowless anesthetizing locations must be arranged to automatically vent smoke and products of combustion.

(a) Ventilating systems for anesthetizing locations using general anesthesia must be provided that automatically:

(i) prevent recirculation of smoke originating within the surgical suite; and

(ii) prevent the circulation of smoke entering the system intake, without, in either case, interfering with the exhaust function of the system.

(3) Anesthesia must be administered only by:

(a) a qualified anesthesiologist;

(b) a physician qualified to administer anesthesia; or

(4) Before discharge, each patient must be evaluated by a physician or by an anesthetist in accordance with applicable state health and safety laws, standards of practice, and facility policy. This postanesthesia assessment must include evaluation of:

(a) respiratory function, including respiratory rate, airway patency, and oxygen saturation;

(b) cardiovascular function, including pulse rate and blood pressure;

(d) temperature;

(e) pain;

(f) nausea and vomiting; and

(g) postoperative hydration.

(1) Surgical procedures must be performed in a safe manner by qualified physicians functioning within their scope of practice and who limit the surgical procedures to those that are approved by the governing body in accordance to the facility policies and procedures.

(2) The outpatient center uses acceptable standards of practice to ensure proper identification of the patient and the surgical site in order to avoid wrong site/wrong person/wrong procedure errors. Generally accepted procedures to avoid such errors include:

(a) a preprocedure verification process to make sure all relevant documents and related information are available, are correctly identified, match the patient, and are consistent with the procedure the patient and the surgical staff are expecting to perform;

(b) marking of the intended procedure site by the physician who will be performing the procedure so that is it is clear where the procedure is to be performed on the patient's body;

(c) verification that a current health history is complete which includes a list of current prescription and nonprescription medications and dosages, physical examination, and pertinent preoperative diagnostic studies have been completed; and

(d) a recheck of the procedures listed in (a) through (c).

(3) Each operating or procedure room is designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and ensures the physical safety of all persons in the area. Only nonflammable agents are to be present in the operating or procedure room.

(4) All personnel with direct patient contact will maintain skills in basic cardiac life support and are available whenever there is a patient in the facility.

(5) A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross-infection, is ensured through the provision of adequate space, equipment, supplies, and personnel including:

(a) all persons entering the operating or procedure room are properly attired as defined by the governing body;

(b) acceptable aseptic techniques are used by all persons in the surgical area;

(d) measures are implemented to prevent skin and tissue injury from chemicals, cleaning solutions, and other hazardous exposure.

(6) The outpatient center has established protocols for instructing patients in self-care following surgery.

(7) The outpatient center has a procedure to address when sponge, sharps, and instrument counts will occur.

(8) Suitable equipment for rapid and routine sterilization is available to ensure the operating room materials are sterile. Sterilized materials are packaged, labeled, and stored in a manner to maintain sterility and identify sterility dates. Sterility requirements also include:

(a) processes for cleaning and sterilization of supplies and equipment must comply with manufacturer's instructions and recommendations; and

(b) internal and external indicators are used to demonstrate the safe processing of items undergoing high level disinfection and sterilization.

(9) Periodic calibration and preventive maintenance, or both of equipment is provided.

(10) An alternate source of power must be available in the event of power shortages, surges, or loss of utility.

(a) In accordance to National Fire Protection Association (NFPA) 110 Standard the outpatient center must have a generator which automatically starts within 10 seconds of loss of the utility. An Uninterrupted Power Supply (UPS) system is not acceptable as a substitute in any location using general anesthesia.

(b) UPS systems are permitted in settings where a patient is not under general anesthesia.

(1) A skilled nursing care facility shall comply with the Conditions of Participation for Skilled Nursing Facilities as set forth in 42 CFR subchapter G part 483. An intermediate care facility shall comply with the requirements set forth in 42 CFR subchapter G subpart I. A copy of the cited requirements may be obtained from the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

This rule has been repealed.

(1) Medication shall be released to a patient at discharge only on the written authorization of his licensed physician.

(2) Self-administration of medication by a patient is not permitted except on order of his licensed physician.

(3) Any deviation from the prescribed drug dosage, route or frequency of administration and unexpected drug reactions shall be reported immediately to the patient's licensed physician with an entry made on the patient's medical record and on an incident report.

(4) A current medication reference book must be provided at each nurses station.

(1) The infirmary shall provide patients with licensed physician care.

(2) The infirmary shall provide skilled nursing services. A licensed registered nurse shall serve as charge nurse on the day shift; and a licensed registered or practical nurse shall serve as charge nurse on evening and night shifts.

(3) Nurse staffing schedules must be maintained on file in the infirmary for the preceding six months.

(4) The infirmary shall maintain a medical record for each patient which includes, but is not limited to the following information:

(a) identification data;

(b) chief complaint;

(d) medical history;

(e) physical examination;

(f) laboratory and x-ray reports;

(g) treatment administered;

(h) tissue report;

(i) progress reports;

(j) discharge summary.

(5) If a modified diet is ordered by a physician for a patient, facilities must be available for its preparation and service.

This rule has been repealed.

(1) A kidney treatment center shall comply with the requirements set forth in 42 CFR 405, Subpart U.

(2) The department hereby adopts and incorporates by reference 42 CFR 405, Subpart U, which sets standards that suppliers of end-stage renal disease services must meet in order to be certified for reimbursement from the federal medicare or medicaid programs. A copy of 42 CFR 405, Subpart U, is available from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A critical access hospital must comply with the conditions of participation for critical access hospitals under 42 CFR 485 Subpart F. The department adopts and incorporates by reference 42 CFR 485 Subpart F. A copy of the cited requirements may be obtained from the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(2) A critical access hospital may maintain up to 25 inpatient beds that can be used interchangeably for acute care or swing-bed services. A critical access hospital granted a waiver under Section 123(i) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) may maintain an additional ten beds to be used only for skilled nursing facility or nursing facility level services. A critical access hospital may not add the additional beds granted under a waiver through capital expenditure for new construction.

(3) A facility qualifies as a necessary provider of health care services to residents of the area where the facility is located if the facility:

(a) is located in a county with fewer than six residents per square mile;

(b) is a state licensed facility located within the boundaries of an Indian reservation;

(d) has combined inpatient days for Medicare and Medicaid beneficiaries that account for at least 50% of its total acute inpatient days in the last full year for which data is available.

(4) A critical access hospital must provide emergency services meeting the emergency needs of patients following acceptable standards of practice, including the following standards:

(a) Emergency services must be organized under the direction of a practitioner member of the medical staff. A practitioner is a physician, physician's assistant certified, or an advanced practice registered nurse.

(b) The services must be integrated with other departments of the facility.

(c) The medical staff must establish and assume continuing responsibility for policies and procedures governing medical care provided in the emergency services.

(d) A practitioner is on duty or on call and physically available at the facility within one hour at all times, unless the procedures described in (4)(e) are adopted and implemented.

(e) Facilities with ten or fewer beds that are located in frontier areas having fewer than six persons per square mile and who have one medical provider regularly available in the area may provide emergency services through a registered nurse if they have requested and been granted a waiver by the state survey agency for Medicare and Medicaid. In these instances:

(i) an on-call practitioner must be immediately available by phone or radio for the registered nurse to contact, following completion of a nursing assessment, to determine whether the patient requires discharge, further examination, treatment or stabilization, and transfer to a facility capable of providing the appropriate level of care;

(ii) all registered nurses providing emergency service coverage must have documented education and competency in emergency care;

(iii) a registered nurse meeting the qualifications specified in (3)(e)(ii) is either on duty or on call and physically available at the facility within 30 minutes at all times; and

(iv) the facility may not use a registered nurse to provide emergency services coverage for more than a 72-hour continuous period of time.

(5) These requirements are in addition to those licensure rule provisions generally applicable to all health care facilities.

(6) A facility aggrieved by a denial, suspension, or termination of licensure may request a fair hearing under ARM 37.5.117.

(1) The purpose of these rules is to establish the general requirements for the licensure of specialty hospitals. These rules outline the process for application, including the submission of results of an impact study; and the development and implementation of charity care policies for the nondiscrimination of persons who are unable to pay for health care services provided in specialty hospitals.

(1) A specialty hospital is a subclass of a hospital that is intended to diagnose, care, or treat patients with:

(a) cardiac conditions;

(b) orthopedic conditions;

(d) patients being treated for cancer-related diseases and receiving oncology services.

(2) A specialty hospital is subject to the general requirements applicable to all hospitals and must be licensed according to the rules as outlined in this subchapter.

(1) "Administrator" means the individual responsible for the day-to-day operations of a specialty hospital. This individual may also be known as, but not limited to, "chief executive officer," "executive director," or "president."

(2) "Charity care" or financial assistance" means free or discounted health services provided to persons who meet the organization's criteria for financial assistance and are unable to pay for all or a portion of the services.

(3) "Emergency care services" means health care items and services furnished or required to evaluate and treat an emergency medical condition.

(4) "Emergency medical condition" means a condition manifesting itself by symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected to result in any of the following:

(a) the person's health would be in serious jeopardy;

(b) the person's bodily functions would be seriously impaired; or

(5) "Impact study" means the examination and analysis of the financial and operational effects of a proposed specialty hospital on existing health care facilities in the service area.

(6) "Independent consultant" means an individual or group of individuals who for a fee examine and analyze the financial and operational impacts of a proposed specialty hospital on existing health care facilities in the service area. In order to be deemed an independent consultant, the individual or group of individuals must not be an employee of, not otherwise related to, or affiliated with the owners or operators of a proposed specialty hospital or an existing health care facility in the service area.

(7) "Joint venture relationship" means an express agreement or contract between two or more parties to create the joint venture.

(8) "Service area" means that geographic location in which local residents are the primary recipients of provided specialty hospital services. A nonresident is not prohibited from receiving services from the specialty hospital.

(9) "Transfer of care" means relocating an individual to the care of another health care facility or health care provider consistent with federal transfer requirements imposed by EMTALA when an adequate continuum of care is not possible.

(1) A specialty hospital must comply with the requirements under 42 CFR subchapter G subpart E. The department adopts and incorporates by reference 42 CFR subchapter G subpart E, which sets forth the Centers for Medicare and Medicaid Services Conditions of Participation for Hospitals as the standard for the operation of specialty hospitals in Montana. A copy of the cited requirements may be obtained from the Department of Public Health and Human Services, Office of Inspector General, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) As indicated in ARM 37.106.804 a condition of application for a proposed specialty hospital is that it must conduct an impact study that analyzes the financial and operational impacts of the proposed specialty hospital on existing health care facilities in the service area. The impact study must be completed prior to submitting the application for licensure.

(2) The impact study process will consist of:

(a) notification of specialty hospital formation intent;

(b) public participation on impact study consultant selection and scope;

(d) impact study completion and submission; and

(e) department review and determination.

(3) The consultant selection process will include:

(a) department review of consultant qualifications;

(b) consideration of public comment on consultants; and

(4) consultant responsibilities include:

(a) measure and analyze changes to health care access in services area; and

(b) prepare and submit report of findings.

(5) The scope of the impact study will focus on health care costs, access, and impact to existing health care facilities.

(6) The applicant for a proposed specialty hospital:

(a) must provide the department with an overview of the proposed specialty hospital including, but not limited to:

(i) type of services to be provided in the proposed specialty hospital;

(ii) the number and type of patients or residents for which care is to be provided; and

(iii) the number of employees in all job classifications.

(b) must provide to the department a list of independent consultants who could conduct the impact study; and

(7) The department must provide for an opportunity for public comment and participation, including opportunity to comment on the list of consultants, into the study process. Prior to designating an independent consultant to conduct the impact study, the department will afford the public an opportunity to provide comment on the independent consultants and scope of the impact study. At the discretion of the department, a public meeting may be held in lieu of a formal hearing as an additional means of soliciting public comment.

(8) The department will determine the scope of the impact study. After the department approves the consultant, the scope of the study will be finalized. The study will assess the potential positive and adverse impacts on access to the health care system in the applicant's service area. The scope of the study may include, but is not limited to:

(a) the impact on health care costs in the service area;

(b) the impacts on access to emergency care, mental health care, and other subsidized services provided in the proposed service area;

(d) the need for the services proposed in the health service area.

(9) The independent consultants utilized in these studies must:

(a) have the necessary resources to conduct and complete the impact study within the required timeframes;

(b) not allow the results of the study or the manner in which the study is conducted to be controlled by the proposed specialty hospital applicant or members of the joint venture;

(d) prepare a written report documenting the findings of the impact study which the applicant will submit to the department with the license application.

(10) The impact study must be completed within 180 days of the date the department finalizes the scope.

(11) If as a result of the impact study, the department finds that a proposed specialty hospital will have an adverse influence on an existing hospital or to the community's health care delivery system, the department will:

(a) impose conditions to mitigate the adverse effect; or

(b) deny the request for license.

(1) Application for a specialty hospital must be made on an application form provided by the department. At least 30 days prior to the opening of a facility, an applicant must submit to the department:

(a) a completed license application form which must contain the following information:

(i) the name and address of the applicant if an individual; the name and address of each member of a firm, partnership, or association; or the name and address of each officer if a corporation;

(ii) the location of the proposed specialty hospital facility;

(iii) the name of the person or persons who will administer, manage, or supervise the specialty hospital facility;

(iv) the number and type of patients or residents for which care is to be provided;

(v) the number of employees in all job classifications;

(vi) a copy of the contract, lease agreement, or other document indicating the person legally responsible for the operation of the specialty hospital facility if the specialty hospital is operated by a person other than the owner;

(vii) the designated name of the specialty hospital to be licensed; and

(viii) the owner or operator of a health care facility must sign the completed license application form.

(b) the results of an impact study showing the analysis of the financial and operational impacts of the proposed specialty hospital on existing health care facilities in the area;

(c) a signed transfer of care agreement with a hospital capable of providing emergency care services and acceptable continuum of care services; and

(d) each application form must be accompanied by the applicable license fee:

(i) $20.00 license fee for a specialty hospital with 20 beds or less;

(ii) $1.00 per bed license fee for a specialty hospital with 21 beds or more.

(2) The department will renew the license for a period of one to three years if the specialty hospital:

(a) makes written application for renewal on an application form provided by the department at least 30 days prior to the expiration date of its current license;

(b) meets the minimum licensure standards; and

(3) On receipt of a new or renewal license application, the department or its authorized agent will inspect the specialty hospital to determine if the proposed staff is qualified and the facility meets the minimum standards set forth in this subchapter. If minimum standards are met and the proposed staff is qualified, the department will issue a license for a period of one to three years.

(a) The department may issue a provisional license for a period of less than one year if continued operation of the specialty hospital will not result in undue hazard to patients or if demand for the accommodations offered is not met in the community.

(4) A patient may not be admitted or cared for in a specialty hospital unless the facility is licensed.

(5) Licensed premises must be open to inspection by the department or its authorized agent and access to all records must be granted to the department at all reasonable times.

(6) The designated name of the specialty hospital may not be changed without first notifying the department in writing.

(1) Prior to accepting patients, a specialty hospital must have in place a signed transfer of care agreement with a hospital capable of providing emergency care services appropriate to the patient's medical needs. A specialty hospital must also have written policies that result in medically appropriate transfers.

(2) Prior to transferring a patient from a specialty hospital, the specialty hospital must:

(a) notify the receiving hospital before the patient is transferred and receive confirmation from the receiving hospital that services necessary to treat the patient are available;

(b) use medically appropriate life support measures to stabilize the patient before the transfer and to sustain the patient during the transfer;

(d) in cases of nonemergent care services ensure that the patient or legally responsible person acting on the patient's behalf are informed of the risk and benefit of transfer.

(1) Each specialty hospital must have an administrator who:

(a) maintains daily overall responsibility for the facility operations;

(b) develops and oversees the implementation of all policies and procedures pertaining to the operation of the specialty hospital;

(d) establishes a process for patient complaints and grievances;

(e) establishes a patient incident report file on all patient incidents or allegation of abuse;

(f) develops and maintains an organizational chart that delineates the current lines of authority, responsibility, and accountability for the administration and provision of all facility patient treatment programs and services; and

(g) develops and implements written orientation and training procedures on all facility policies and procedures for all employees or contractors, relief workers, temporary employees, students, interns, volunteers, and trainees to include, but not limited to:

(i) defining responsibilities, limitations, and supervision of students, interns, and volunteers working for the specialty hospital; and

(ii) verifying each professional staff member's credentials, when hired, and annually thereafter, to ensure the continued credentialing of required licenses.

(2) The administrator must develop policies and procedures for screening, hiring, and assessing staff which include practices that assist the employer in identifying employees that may pose a risk or threat to the health, safety, or welfare of any resident and provide written documentation of findings and the outcome in the employees file.

(3) In the absence of the administrator, a staff member must be designated to oversee the operation of the facility during the administrator's absence. The administrator or designee must be in charge, on call, and physically available on a daily basis as needed, and must ensure there are sufficient, qualified staff so that the care, health, safety, and welfare needs of the patient are met at all times.

(4) If the administrator is absent for more than 30 calendar days, the department must be given written notice of the individual who has been appointed as the designee.

(1) Every specialty hospital must have a charity care policy that is actively implemented. The charity care policy should reflect the organization's mission statement, organizational goals and objectives, and legal and resource constraints.

(2) A specialty hospital devising a charity care policy should clearly identify the difference between charity care and bad debt.

(3) For any specialty hospital that has a For Profit tax status, the facility's charity care policy must be commensurate to the policies which exist for any nonprofit hospital in the service area.

(4) In addition to (1), the charity care policy criteria should include a mixture of the following factors:

(a) individual or family income or net worth;

(b) employment status and earning capacity;

(d) other financial obligations;

(e) other sources of payment for the services rendered;

(f) type of services provided, whether elective or emergency;

(g) costs to provide services exceeds third-party payments for services; and

(h) in the case of emergency department visits only, failure of the patient to cooperate with billing inquiries when the patient lives in a zip code known to have a per capita income below the federal poverty level.

(1) Each specialty hospital must have a joint venture relationship with a hospital or a signed statement from a nonprofit hospital in the community acknowledging that the hospital declined a bona fide, good faith opportunity to participate in a joint venture with the specialty hospital applicant.

(2) To qualify as a joint venture, the agreements must contain the following four elements:

(a) an express agreement or contract creating and defining the joint venture;

(b) a common purpose among the parties;

(d) equal right to control of the venture.

(1) The department may deny an application for a specialty hospital as a result of an adverse impact study or for any reason as outlined in 50-5-207, MCA.

(2) If an application for a specialty hospital is denied for any reason, the department will issue a written denial of the license, the grounds for denial, and the right of the applicant to an appeal pursuant to 50-5-208, MCA.

(3) A decision to deny an application or to impose conditions upon an applicant or licensee may be appealed by the applicant by filing a request for a hearing, in writing, to the department's Office of Fair Hearings.

(4) Hearing requests must be received by the Office of Fair Hearings at P.O. Box 202953, 2401 Colonial Drive, Third Floor, Helena, MT 59620-2953, within 30 days after the date of mailing of notice of the department's decision.

This rule has been repealed.

(1) The purpose of these rules is to establish the licensing requirements for the licensure of outpatient centers for primary care.

(1) For purposes of this subchapter, outpatient centers for primary care include the facilities described at 50-5-101(41), MCA, outpatient birth centers and radiological imaging facilities.

(1) "Low risk patient" means a pregnant woman with a normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health.

(2) "Medical director" means a physician licensed under Title 37, MCA, who oversees the services provided in an outpatient center for primary care. The medical director may also serve in the outpatient center for primary care as a licensed health care professional.

(3) "Outpatient birth center" means a facility that provides comprehensive prenatal, delivery, and newborn care to ambulatory, low risk patients under the direction of a health care provider who is licensed under Title 37, MCA, and is operating within the scope of practice allowed by the health care provider's license. Outpatient birthing services are provided on an outpatient basis for a period of generally less than 24 consecutive hours, unless requiring transfer to another level of care if medically indicated.

(4) "Outpatient center for primary care" means a facility that provides, under the direction of a licensed physician, either diagnosis or treatment, or both, to ambulatory patients and that is not an outpatient center for surgical services.

(1) An outpatient center for primary care must meet the requirements of ARM Title 37, chapter 106, subchapter 3 relating to minimum standards for all health care facilities.

(2) An outpatient center for primary care shall have a written policy and procedure manual as described in 37.106.1010 available to and followed by all personnel.

(3) Each outpatient center for primary care shall employ, or contract with, a medical director who shall:

(a) coordinate with and advise the staff of the center on clinical matters;

(b) provide direction, consultation, and training regarding the center operations as needed;

(d) ensure the quality of treatment and related services through participation in the center's quality assurance process as outlined in the center's policies and procedures.

(4) Nursing services must be provided by or under the supervision of a licensed registered nurse.

(5) Standing orders utilized for emergency or post-operative care shall be recorded in each patient's medical record and dated and signed by the patient's licensed health care professional.

(6) An outpatient center for primary care shall maintain a medical record for each patient that includes the following information:

(a) identification data;

(b) chief complaint;

(d) medical history;

(e) physical examination;

(f) laboratory and imaging reports;

(g) treatment administered;

(h) tissue report;

(i) progress reports; and

(j) discharge summary.

(1) Each outpatient center for primary care shall maintain a policy and procedure manual. The policy and procedure manual shall be reviewed and updated as necessary, but at least annually. The manual shall contain policies and procedures for:

(a) notifying staff of all changes in policies and procedures;

(b) addressing patient rights, including a procedure for informing patients of their rights;

(d) addressing and reviewing ethical issues faced by staff and reporting allegations of ethics violations to the applicable professional licensing authority;

(e) emergency procedures of the birth center;

(f) establishing fiscal policies governing the management of organization; and

(g) developing and implementing policy(s) for security.

(2) The policy and procedures manual must include a current organizational chart delineating the lines of authority, responsibility, and accountability for the administration and provision of all facility patient services.

(1) If an outpatient center for primary care operates a birth center, the birth center shall:

(a) comply with the requirements of ARM 37.106.1008;

(b) show written evidence of current accreditation by an accreditation entity approved by the U.S. Centers for Medicare & Medicaid Services including recommendations for future compliance or meet the standards as outlined in ARM 37.106.1014; and

(c) establish a coordinated transfer of care through a mutually established agreement to the nearest hospital or critical access hospital that provides obstetrical and surgical services as required by the patient's acuity or the outpatient birth center 24 hour length of stay limitation.

(d) A transfer of care agreement must show that a physician who has admitting privileges at the hospital or critical access hospital that provides obstetrical and surgical services has agreed to admit and treat patients of the birthing center should the need arise. In transferring patients, the birth center shall:

(i) before transfer, coordinate and provide notice to the hospital, including the reason for the transfer; and

(ii) during transfer, provide the medical records related to the patient's current condition.

(1) A birth center organization:

(a) maintains a governing body that meets regularly; and

(b) actively seeks and takes appropriate action on feedback from its consumers.

(2) A birth center administration shall:

(a) operate under a clearly defined mission, philosophy, and goals;

(b) follow generally accepted accounting principles and take measures to make sure it is fiscally responsible, including a plan to cover shortfalls; and

(3) Facility requirements for a birth center include:

(a) compliance with regulations established in the local jurisdiction, including applicable local and state codes for construction, fire prevention, public safety and access, annual inspections by the fire department, building inspector, and other officials concerned with public safety as determined by the local jurisdiction; and

(b) an emergency plan in the event of fire and natural disasters and documents practice of the plan on an annual basis.

(4) Equipment requirements for a birth center include:

(a) a readily available emergency cart or tray for the mother and newborn that is equipped to carry out the written emergency procedures of the birth center and securely placed with a written log of routine maintenance; and

(b) regular inspections of all medical equipment and documents accordingly.

(5) A birth center shall maintain sufficient supplies, including basic medical supplies for both mothers and babies, on hand, for the number of childbearing families served at the birth center.

(6) Quality of service requirements for a birth center include:

(a) respect for health care rights of all clients, including privacy;

(b) standard HIPAA practices; and

(i) careful screening for potential complications;

(ii) honoring the mother's needs and desires throughout labor;

(iii) assisting the mother in managing pain; and

(iv) paying close attention to the mother and baby's status in labor.

(d) limits its services to normal labor, therefore it does not utilize interventions such as:

(i) vacuum extraction;

(ii) medications to speed up labor;

(iii) continuous electronic monitoring; and

(iv) epidural nerve block.

(7) The birth center has a specific plan for transferring to a hospital if complications arise before, during labor, or after birth and interventions are required.

(8) Staffing and personnel requirements for a birth center include:

(a) professional staff and consulting specialists licensed to practice their profession and having the knowledge and skills required to provide the services offered by the birth center;

(b) at least two staff members attending every birth who are trained and certified in CPR and newborn resuscitation;

(d) the birth center must keep a schedule for clinical staff on call, to make sure all shifts are covered, day and night, seven days a week; and

(e) the birth center must conduct regular emergency drills to make sure staff members are prepared to manage unexpected situations with laboring mothers and newborns.

(9) Health record requirements for a birth center include:

(a) forms appropriate for use in a birth center, and clinicians document patient care accordingly;

(b) use of the chart supports a full prenatal exam to ensure that all clients are low risk;

(i) nutritional counseling;

(ii) informed decision-making about pain relief in labor; and

(iii) newborn care.

(10) The birth center maintains a plan for coordinating the transfer of the patient chart to another facility if the mother or newborn needs to be transferred and clearly communicates this plan to the mother.

(11) Quality assessment and improvement activity requirements for a birth center include:

(a) a well defined quality improvement program;

(b) reviews of its practices and clinical outcomes on a regular basis to ensure that it follows its own policies;

(c) procedures to actively seek client feedback, and then evaluate complaints and suggestions and work to improve client satisfaction on a regular basis; and

(d) staff must be evaluated on a regular basis to ensure competency and alignment with birth center policies.

(1) If an outpatient center for primary care provides diagnostic imaging services, the center must meet the following standards:

(a) a qualified full-time, part-time, or consulting radiologist must be utilized to interpret radiographic tests that are determined by the medical staff to require a radiologist's specialized knowledge;

(b) only personnel designated as qualified by the medical staff, and meeting requirements of state law, may use the radiographic equipment and administer procedures;

(c) each report that contains interpretations must be signed by the radiologist or other practitioner who provided the radiological services; and

(d) the facility must maintain diagnostic imaging film and electrodiagnostic tracings:

(i) for at least five years; and

(ii) interpretations must be retained for the same periods required for the medical records provided by ARM 37.106.402.

(1) Outpatient centers for primary care are subject to inspection requirements provided in 50-5-116 and 50-5-204, MCA.

This rule has been repealed.

(1) This subchapter establishes the licensing requirements for substance use disorder facilities (SUDFs) as outlined in the ASAM Criteria.

(2) This subchapter is applicable to treatment levels of care classified as:

(a) ASAM 3.7 Medically Monitored Intensive Inpatient Services;

(b) ASAM 3.7-WM Medically Monitored Withdrawal Management Services;

(d) ASAN 3.3 Clinically Managed Population-Specific High Intensity (adult only) Residential Services;

(e) ASAM 3.2-WM Clinically Managed Residential Withdrawal Management Services;

(f) ASAM 3.1 Clinically Managed Low Intensity (adult or adolescent) Residential Services;

(g) ASAM 2.5 Partial Hospitalization Services; and

(h) Outpatient Substance Use Disorder Facility.

In addition to the terms defined in 53-24-103, MCA, the following definitions shall apply in the interpretation and enforcement of the rules in this subchapter:

(1) "Administrator" means the person in charge, care, or control of the substance use disorder facility (SUDF).

(2) "Admission" means specific tasks necessary to admit a person to a SUDF.

(3) "Adolescent" means a person 17 years of age or younger for purposes of receiving services in a SUDF. Persons 18, 19, and 20 may be defined as an adolescent if enrolled in accredited secondary school and the client assessment completed by a LAC or mental health professional determines their appropriateness for adolescent treatment.

(4) "Adult" means a person 18 years of age or older for purposes of receiving services in a SUDF.

(5) "American Society of Addiction Medicine (ASAM) Criteria" means guidelines for placement, continued stay, and transfer/discharge of individuals with addiction and co-occurring conditions, developed by the American Society of Addiction Medicine.

(6) "Biopsychosocial assessment" means a comprehensive multidimensional assessment that includes risk ratings, addresses immediate needs, is organized in accordance with the six dimensions as described in the ASAM Criteria, and includes the following:

(a) presenting problem(s) and history of problem(s);

(b) family history;

(d) substance use history;

(e) personal/social history;

(f) legal history;

(g) psychiatric history;

(h) medical history;

(i) spiritual history;

(j) diagnostic interview and mental status examination;

(k) physical health impressions;

(l) diagnostic impressions;

(m) needs, strengths, skills, and resources in each dimension; and

(n) treatment recommendations.

(7) "Care management" means the management and coordination of services to meet individual treatment needs of a client and includes:

(a) conducting a needs assessment;

(b) developing, implementing, revising, or monitoring the care plan;

(d) continuity of care provided by a designated member of the treatment team.

(8) "Care manager" means a designated staff member on the care team that delivers care management services to clients and works directly with each client to ensure they receive the right care at the right time by coordinating services and referrals and tracking clinical outcomes.

(9) "Clinical director" means a Licensed Addiction Counselor, Licensed Clinical Social Worker, Licensed Clinical Professional Counselor, Licensed Marriage Family Therapist, or Clinical Psychologist responsible for the supervision and provision of skilled treatment services provided in a substance use disorder facility. The clinical director cannot be a licensure candidate.

(10) "Continuing care plan" means a plan outlining anticipated interventions needed at the time of discharge or transfer to another level of care.

(11) "Co-occurring" means an individual that is diagnosed with at least one mental health disorder along with a substance use disorder.

(12) "Critical population" means an individual who may be in need of additional services and is a priority admission to a SUDF in the following order of priority:

(a) pregnant injecting drug users;

(b) pregnant substance abusers;

(d) individuals infected with the etiologic agent for acquired immune deficiency, Hepatitis B and/or C, tuberculosis (TB),or any sexually transmitted infection; and

(e) women with dependent children.

(13) "Diagnostic and Statistical Manual of Mental Disorders or (DSM)" means the American Psychiatric Association's classification of mental disorders manual. The DSM is the standard reference for clinical practice in the mental health field.

(14) "Direct care" means the provision of providing awake supervision, treatment, or services to clients in a SUDF.

(15) "Educational group" means structured service provided in a group setting designed to educate clients about substance abuse and the consequences of substance abuse.

(16) "Guardian" means a person appointed by a court to make medical, and possibly financial, decisions as provided in Title 72, chapter 5, MCA.

(17) "Individualized treatment plan" means a written document as described in ARM 37.106.1440, identifying the client's medical needs, clinical needs, goals, objectives, and interventions.

(18) "Interdisciplinary team" means a group of licensed or certified individuals trained in different professions, disciplines, or service areas who function interactively and interdependently in conducting a client's biopsychosocial assessment, individualized treatment plan, and treatment services.

(19) "Licensed addiction counselor (LAC)" means an individual who meets the requirements set forth in 37-35-202, MCA, and ARM Title 24, chapter 154, rules implementing 37-35-202, MCA, to provide addiction counseling.

(20) "Medical director" means a physician, licensed under requirements set forth in Title 37, chapter 3, MCA, who establishes and oversees written protocols for the provision of medical services and medication management provided in a medically monitored inpatient substance use disorder residential facility.

(21) "Medication administration" means the direct application of a medication or device by ingestion, inhalation, injection, or any other means, whether self-administered by a resident, or administered by a parent or guardian (for a minor), or an authorized health care provider.

(22) "Mental health professional" means a clinical psychologist, licensed clinical social worker (LCSW), licensed clinical professional counselor (LCPC), and licensed marriage and family therapist (LMFT), licensed under requirements pursuant to Title 37, chapters 17, 22, 23, or 37, MCA; or a social worker licensure candidate; professional counselor licensure candidate; or marriage and family therapist licensure candidate, registered under requirements pursuant to Title 37, chapters 22, 23, or 37, MCA. Mental health professionals cannot assume the role of care manager.

(23) "Nurse practitioner" means a person licensed under Title 37, chapter 8, MCA.

(24) "Parent" means the individual who has legal custody of the child.

(25) "Physical restraint" means a personal restriction that immobilizes or reduces the ability of the free movement of an individual's arms, legs, or head. The term does not include physical escort. Physical restraint may be imposed only in emergency circumstances and only to ensure the immediate physical safety of the adolescent, a staff member, or others, when less restrictive interventions have been determined to be ineffective.

(26) "Physician" means a person licensed under requirements pursuant to Title 37, chapter 3, MCA.

(27) "Physician assistant" means a person licensed under requirements pursuant to Title 37, chapter 20, MCA.

(28) "Progress note" means a written record of a treatment session or service contact. It is individualized to each client for each separate session or service, and includes the following:

(a) date, time in/time out, and duration of session;

(b) participant name;

(d) client's participation;

(e) documentation of measurable progress toward ITP goals and objectives;

(f) the name and signature (with date of completion) of the staff member providing the session or service; and

(g) documentation in the client's file within seven days of the treatment session or service contact, or there must be documentation why this did not occur.

(29) "Psychosocial rehabilitation" means a service that includes assisting adults with restoring skills related to exhibiting appropriate behavior and living with greater independence and personal choice. Services maximize the skills needed to function in the home, workplace, and community setting. Services can be provided by a rehabilitation aide.

(30) "Recovery residence" means a substance-free living environment that supports individuals in recovery from substance use disorders. Recovery residences do not provide clinical services and are excluded from licensure by the department.

(31) "Registered nurse" means a person licensed under requirements pursuant to Title 37, chapter 8, MCA.

(32) "Rehabilitation aide" means a staff member of the SUDF who provides direct services to clients. Rehabilitation aides can provide psychosocial rehabilitation services under the supervision of the LAC or mental health professional staff and has documentation of training in the service provided. Rehabilitation aides must have a minimum of a high school diploma, high school equivalency test (HiSET), or general equivalency diploma (GED).

(33) "Self-administration assistance" means providing necessary assistance to any resident in taking their medication, including:

(a) removing medication containers from secured storage;

(b) providing verbal suggestions, prompting, reminding, gesturing, or providing a written guide for self-administrating medications;

(c) handing a prefilled, labeled medication holder, labeled unit dose container, syringe or original marked, labeled container from the pharmacy, or a medication organizer as described in ARM 37.106.2848 to the resident;

(d) opening the lid of the marked, labeled container for the resident;

(e) guiding the hand of the resident to self-administer the medication;

(f) holding and assisting the resident in drinking fluid to assist in the swallowing of oral medications; and

(g) assisting with removal of a medication from a container for residents with a physical disability which prevents independence in the act.

(34) "Serious incident" means any one of the following events that occurs at the facility or while participating in a facility activity:

(a) death;

(b) suicide attempt;

(d) physical or sexual assault;

(e) use of physical force or restraints;

(f) event that causes or contributes to serious injury, illness, or death of any person or poses a serious risk to the health, safety, or welfare of any person;

(g) serious physical plant damage;

(h) a severe weather event that presents a substantial threat to facility operation or client safety;

(i) bomb threat; and

(j) alleged unlawful conduct or criminal activity.

(35) "Skilled treatment services" means structured services such as individual and group counseling, medication management, family therapy, educational groups, occupational and recreational therapy, and other therapies provided to the client. Skilled treatment services do not include attendance at self/mutual help meetings, volunteer activities, or homework assignments such as watching videos, journaling, and workbooks. Skilled treatment services must be provided by clinical staff licensed pursuant to requirements adopted under Title 37, MCA.

(36) "Staff member" means a person that provides any type of service in the SUDF and is either employed, contracted, a volunteer, or participating in a trainee/intern program.

(37) "Substance use disorder" means chemical dependency, as defined in 53-24-103, MCA.

(38) "Substance use disorder facility (SUDF)" means a chemical dependency facility, as defined in 50-5-101, MCA.

(39) "Treatment plan review" means clinical review of the client's progress in treatment and determination of whether the client meets the continuing, transfer, or discharge criteria outlined in the ASAM Criteria for the current level of care.

(40) "Withdrawal management" means services required for dimension one in the ASAM Criteria; acute intoxication and/or withdrawal potential.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the terms of this subchapter shall apply to a substance use disorder facility.

(1) A substance use disorder facility (SUDF) must have a written client confidentiality policy pursuant to 42 CFR Part 2.

(2) The confidentiality policy must be reviewed with the client at the time of admission or as soon thereafter as the client is capable of rational communication.

(3) Policy requirements must include activities to:

(a) inform clients that federal law and regulations protect the confidentiality of alcohol and drug abuse client records; and

(b) provide clients with a summary in writing of the federal law and regulations.

(4) The written summary required in (3)(b) must include:

(a) a general description of limited circumstances under which a SUDF may acknowledge a client is present at a facility or disclose information identifying a client as an alcohol or drug abuser;

(b) a statement that violation of the federal law and regulations by a SUDF is a crime and suspected violations may be reported to appropriate authorities in accordance with these regulations;

(c) a statement that information related to a client's commission of a crime on the premises of the SUDF or against staff members of the SUDF is not protected;

(d) a statement that reports of suspected child abuse or neglect made under state law to appropriate state or local authorities are not protected; and

(e) a citation to the federal law and regulations.

(5) Client consent must be obtained for each release of information to any other person or entity if required under 42 CFR Part 2. The consent for release of information must have specific information pursuant to 42 CFR Part 2.

(1) Each substance use disorder facility (SUDF) must develop and implement a policy and procedure manual that includes:

(a) the philosophy of the SUDF;

(b) the SUDF goals;

(d) a delineation of the services to be provided;

(e) screening procedures for all referrals;

(f) admission criteria which includes addressing priority admission protocols for critical populations;

(g) program limitations and exclusions;

(h) methods to be followed when a person is found ineligible for services including active referral to a level of care deemed appropriate through the biopsychosocial assessment;

(i) steps to follow for a wait list that includes unique client identifiers, referrals to other treatment facilities, and removing clients only when they cannot be located or refuse treatment;

(j) procedures outlining how facilities and services must provide for privacy and separation by sex;

(k) steps to ensure smoking is not permitted, as required under the Montana Clean Indoor Air Act;

(l) the management, storage, and disposal of prescription and over the counter drugs if applicable as stated in ARM 37.106.1457;

(m) client transportation;

(n) drug and alcohol laboratory testing methods, collection, and storage procedures, including:

(i) how testing is used as part of a non-punitive therapeutic process including how the use of testing and results become part of the client's treatment plan; and

(ii) process addressing client refusal to submit for laboratory testing or drug and alcohol screening and confirmation testing;

(o) arranging for medical and mental health services when clinically indicated in the biopsychosocial assessment or treatment plan reviews for all clients and within 48 hours of admission for critical populations;

(p) screening clients for critical populations at the time of admission;

(q) limitations and requirements of group counseling sessions to include client/staff member ratio, appropriate for the level of care being rendered;

(r) provision of services to family members and significant others;

(s) medical emergencies;

(t) youth program policies in ARM 37.106.1455; and

(u) any additional policy and procedures as required by this subchapter.

(1) The substance use disorder facility (SUDF) must establish a governing body or oversight committee with responsibility for operating and maintaining the SUDF.

(2) The governing body or oversight committee must provide organizational oversight to ensure that adequate resources are available to ensure staff members provide safe and adequate care.

(3) The governing body or oversight committee must establish written policies and procedures that:

(a) govern the organization and functions of the SUDF;

(b) establish procedures for selecting and periodically evaluating a qualified administrator to ensure the administrator carries out the goals and policies of the governing body or oversight committee;

(d) establish accounting and fiscal procedures;

(e) describe how updates and changes are reviewed with and implemented by staff member(s); and

(f) include annual review of the quality improvement report by the governing body or oversight committee.

(4) Each SUDF must have an administrator that is responsible for, and must be familiar with the daily operation of, the SUDF.

(5) The administrator must;

(a) be qualified through appropriate knowledge, experience, and capabilities to supervise and administer the services properly;

(b) be available, or ensure a designated alternate who has similar qualifications is available, to carry out the goals, objectives, and standards of the governing body or oversight committee and to implement the rules of this subchapter; and(c) review progress on the quality improvement plan with the governing body or oversight committee on a quarterly basis.

(6) The SUDF must maintain professional liability and general liability insurance.

(1) All serious incidents, as defined in ARM 37.106.1413, must be reported to the Department of Public Health and Human Services, Office of Inspector General, Licensure Bureau, within 24 hours. The report must be in writing and must include:

(a) the date and time of the incident;

(b) all clients and staff members involved; and

(2) A copy of the incident report must be maintained at the SUDF.

(3) A SUDF must report a change in administrator prior to the effective date of change.

(4) Changes in the facility location, use, or number of facility beds cannot be made without written notice to, and written approval received from, the department.

(1) A substance use disorder facility (SUDF) must require each staff member to read and sign a statement that:

(a) clearly defines child abuse and neglect as defined in 41-3-102, MCA;

(b) clearly defines abuse, neglect, and exploitation of an older person or a person with a developmental disability as defined in 52-3-803 MCA; and

(c) outlines the individual's responsibility to report all known or suspected incidents of abuse, neglect, or exploitation of any client within 24 hours.

(2) Any SUDF staff member who knows or has reasonable cause to suspect an incident of child abuse or neglect has occurred must make a report within 24 hours of the incident to the SUDF administrator, or a person designated by the SUDF administrator, and to the state child abuse hotline (866) 820-5437 as required in 41-3-201, MCA.

(3) Any SUDF staff member who knows or has reasonable cause to suspect an incident of abuse, neglect, or exploitation of a vulnerable adult has occurred must make a report within 24 hours of the incident to the SUDF administrator, or a person designated by the SUDF administrator and to Adult Protective Services or other bodies as required in 52-3-811, MCA.

(4) In addition to reporting requirements in (2) and (3), the SUDF must also make a report to the Office of Inspector General, Licensing Bureau in writing within 24 hours of any allegations of client abuse, neglect, or exploitation within the SUDF.

(5) The SUDF must document, in writing, that the proper authorities have been contacted and the abuse, neglect, or exploitation has been reported.

(6) The SUDF must fully cooperate with any investigation conducted because of the report.

(7) The SUDF must have written policies for handling suspected incidents of abuse, neglect, or exploitation, including:

(a) procedures for ensuring staff members suspected of abuse, neglect, or exploitation do not continue to provide direct care until an investigation is completed;

(b) development of a safety plan, approved by the department, which protects the client and staff member until the investigation is complete; and

(c) procedures for taking appropriate disciplinary measures against any staff member involved in an incident of client abuse, neglect, or exploitation upon validation of the allegation, including:

(i) termination of employment;

(ii) retraining of the staff member; or

(iii) any other appropriate action by the SUDF geared toward the prevention of future incidents of client abuse, neglect, or exploitation.

(1) The substance use disorder facility (SUDF) must have a written personnel policy manual which includes the following:

(a) screening and hiring procedures for all applicants including criminal and protective service history disqualifiers the SUDF uses in making an employment fitness determination;

(b) job qualifications for each position;

(c) job descriptions or contract agreements which describe the nature and extent of client care services of each position;

(d) organizational chart including the supervisory structure;

(e) process for conducting staff member performance evaluations;

(f) actions to be taken if staff members misuse alcohol or other drugs;

(g) defining staff member ethical standards of conduct, including reporting of unprofessional conduct to appropriate authorities;

(h) staff member grievance procedures; and

(i) trainee/intern or volunteer requirements as required in ARM 37.106.1435.

(1) The substance use disorder facility (SUDF) must maintain a current secured personnel file for each staff member. The file must include:

(a) a criminal history background information check;

(b) a Montana Child Protective Services check for SUDFs serving or housing adolescents;

(d) an annual performance review signed and dated by the staff member and supervisor;

(e) copies of certification or licensure documents necessary for the staff member's position and/or title;

(f) evidence of an independent contractor status and contractual agreements for contracted staff members;

(g) a signed statement acknowledging the staff member has been oriented and agrees to abide by all confidentiality requirements;

(h) resume or job application;

(i) disciplinary actions and grievances; and

(j) a copy of a current job description which includes:

(i) job title;

(ii) minimum qualifications for the position; and

(iii) summary of duties and responsibilities.

(1) A substance use disorder facility (SUDF) must have written policies, procedures, and initial and ongoing training curriculum to meet minimum requirements in this rule.

(2) All staff members supervising, or providing, direct contact with clients must complete orientation training prior to supervising, or providing, direct care consisting of the following requirements:

(a) an overview of the SUDF policies, procedures, organization, and services;

(b) mandatory adult and child abuse, neglect, and exploitation reporting laws;

(d) confidentiality;

(e) suicide ideation and referral procedures;

(f) emergency medical procedures;

(g) documentation requirements;

(h) client rights and client grievance process;

(i) blood and air-borne pathogens;

(j) crisis prevention and de-escalation techniques; and

(k) upon completion of the orientation, the SUDF must complete a competency assessment for each staff member's ability to apply knowledge of material learned. Assessment results must be documented in each staff member's personnel file.

(3) Staff members supervising or providing direct care to clients must complete the following certification training within six months of hire:

(a) first aid;

(b) cardio-pulmonary resuscitation (CPR) that includes direct instruction of the practical and demonstrated applications of CPR methods as taught by an instructor from an accredited entity; and

(4) Staff members must maintain and update trainings and certifications in (3) as required.

(5) Staff members providing direct care to clients must not work unsupervised with clients without completing requirements in (3).

(6) The SUDF must ensure 20 hours of annual training is provided for staff members providing direct care to improve proficiency in their knowledge and skills for the level of care provided.

(7) All training must be documented and kept on file for each staff member.

(8) All staff members working with adolescents must have training in adolescent development.

(1) If the substance use disorder facility (SUDF) participates in a trainee/intern practicum or has volunteers, they must have the following:

(a) policies and practices assuring the safety of clients;

(b) a description of the training or volunteer work to be provided at the SUDF for trainees, interns, or volunteers, respectively, and any limitations;

(d) policies and procedures to ensure trainee/interns or volunteers meet the qualifications of the position to which the person is assigned; and

(e) a written agreement with each educational institution using the SUDF as a setting for student practice, including:

(i) a description of the nature and scope of student activity at the SUDF.

(2) Volunteers must not be part of client/staff ratios or provide unsupervised direct care to clients.

(3) Volunteers must meet the requirements of ARM 37.106.1432(1)(a), (b), (c).

(4) For purposes of this subchapter, trainees/interns are considered to be a staff member of the SUDF.

(1) Each client must have an individualized treatment plan (ITP) developed by an interdisciplinary treatment team.

(2) ITPs must include:

(a) the client's name, diagnoses, treatment plan date, and treatment plan review dates;

(b) the names of treatment team members who are involved in the client's treatment;

(d) the problem area(s) that will be the focus of treatment to include symptoms, behaviors, and/or functional impairments;

(e) the treatment goals, objectives, and interventions that are person centered and recovery oriented;

(f) the description of the type, duration, and frequency of the intervention(s) and services(s);

(g) expected dates of completion;

(h) an educational plan for youth; and

(i) the client's level of functioning that will indicate when a service is no longer required.

(3) ITPs and treatment plan reviews must be completed with the client and include the client's legal guardian and at least one qualified licensed professional. The treatment plan and treatment plan reviews must be signed and dated by interdisciplinary team members, the client, and the client's legal guardian (if applicable).

(a) Additional service providers must be contacted and encouraged to participate as clinically indicated.

(4) ITPs must be completed within:

(a) 24 hours of admission for ASAM 3.7, 3.7-WM and 3.2-WM;

(b) 48 hours of admission for ASAM 3.5;

(d) five contacts or 21 days from the first contact, whichever is later, for outpatient facilities.

(5) Treatment plan reviews must be completed:

(a) every three days from the admission date for ASAM 3.7, 3.7-WM and 3.2-WM.

(b) every seven days from the admission date for ASAM 3.5;

(d) every 14 days for from the admission date for ASAM 2.5; and

(e) every 90 days from the admission date for outpatient facilities.

(6) Treatment plan reviews must include:

(a) documentation regarding the client's response to treatment;

(b) review of the client's progress in all six dimensions; and

(c) progress towards goals and objectives that result in either an amended ITP or a statement of the continued appropriateness of the existing plan.

(7) A continuing care plan must be given to the client and, if applicable, the client's legal guardian/parent, representative or guardian at the time of discharge and must include, if applicable:

(a) client's name, date of birth, admission and discharge dates, and reason for placement and discharge;

(b) a written summary of services provided, including the client's participation and progress in the SUDF, contact information of licensed health care providers who conducted evaluations and treatment, and condition of the client at the time of discharge;

(d) community substance use treatment provider's contact name, contact number, and time and date of an initial appointment;

(e) health care follow-up including provider's contact name, contact number, and initial appointment (if necessary);

(f) current medications, dosage taken, number of times per day, and name of prescribing licensed health care professional;

(g) name and contact number of the client's recovery supports;

(h) housing and employment plan;

(i) medical, dental, and psychiatric care received during placement;

(j) adolescent's educational status (if applicable); and

(k) signature of the client and of the staff member who prepared the plan.

(1) The substance use disorder residential facility (SUDF) must develop and maintain a client rights policy that supports and protects the state and federal constitutional and statutory rights, including civil rights, of all clients. These must include the right to:

(a) receive treatment free of unlawful discrimination;

(b) receive reasonable accommodations, consistent with federal and state law;

(c) receive treatment in the least restrictive environment, consistent with law, in a manner sensitive to individual needs and which promotes dignity and self-respect;

(d) have clinical and personal information treated in accordance with state and federal statutes and regulations;

(e) the opportunity to review their own treatment records in the presence of the administrator or designee, consistent with 45 CFR 164.524 and other state and federal confidentiality statutes and regulations;

(f) be fully informed of fees charged, including fees for copying records to verify treatment and methods of payment available;

(g) be free from abuse, neglect, harassment, and financial exploitation by staff members or clients;

(h) have grievances considered in a fair and timely manner, with respect to infringements of rights described in this rule;

(i) educational services provided to adolescents within inpatient/residential settings in accordance with Montana state law;

(j) client orientation to SUDF rules, responsibilities, and any sanctions that may be imposed for failure to comply with the SUDF rules;

(k) reasonable visitation and access to telephone communication within inpatient/residential settings;

(l) send and receive mail within inpatient/residential settings;

(m) regular physical exercise several times per week within inpatient/residential settings; and

(n) be given a 30-day notice in the event of a SUDF closure or treatment service cancellation and:

(i) provided assistance with relocation into similar treatment services, if available;

(ii) be given refunds to which the client is entitled; and

(iii) be advised how to access records to which the client is entitled.

(2) The SUDF must inform each client and his or her representative, in an understandable manner, of the rights policy, treatment methods, and rules applicable to the client, at the time of admission or as soon thereafter as the client is capable of rational communication.

(3) The client and staff member reviewing the policy must sign a statement acknowledging the review. The statement must be maintained in the client's record.

(4) The SUDF must post a copy of clients' rights in a conspicuous place in the facility accessible to clients and staff members.

(1) Each substance use disorder facility (SUDF) must have a comprehensive secure client record system maintained in accordance with 42 CFR Part 2.

(2) Each SUDF must have written procedures which regulate and control access to and use of client records.

(3) In case of a SUDF closure, the SUDF closing its treatment agency must arrange for continued management of all client records.

(1) The�substance use disorder�residential facility (SUDF)�must�develop and implement procedures to�ensure each client record�is available on-site and�includes:

(a) demographic information;

(b) a substance related disorder diagnosis and supporting documentation for diagnosis;

(d) signed documentation the client was informed of federal confidentiality requirements and received a copy of the client notice as required in ARM 37.106.1416;

(e)�signed documentation the client received�orientation to the SUDF's treatment services, infectious disease information, and disaster plan described in ARM 37.106.322;

(f) a voluntary consent to treatment signed and dated by the client or legal guardian;

(g) individualized treatment plan and treatment plan reviews;

(h) progress notes;

(i) clinical notes;

(j) continuing care plan;�

(k) medication records, if applicable;

(l) laboratory reports, if applicable;

(m)�authorizations for release of information, as needed;

(n) copies of all correspondence related to the client, including any court orders and reports of noncompliance; and

(o) documentation�pertaining to client receipt of�grievance policies and procedures.

(p)�documentation of any client-filed written grievances and resolution;

(q)�documentation the client received a copy of the client rights policy and the client's signature indicating he/she received the policy; and

(r)�documentation of school educational courses attended or provided.

�

(1) In addition to policies required throughout this rule, a SUDF licensed to serve adolescents must have written policies and procedures that address:

(a) limiting admission to adolescents 17 years of age or younger or adolescents 18, 19, and 20 years of age if a client is enrolled in certified secondary school, and the assessment completed by a LAC or mental health professional with substance use in the scope of their license determines their appropriateness for adolescent treatment;

(b) age-appropriate treatment;

(d) separation of adolescents from adults in all non-treatment aspects including eating, sleeping, bathing, and recreation activities; and

(e) staffing patterns to ensure staff members of the same sex as clients are present at all times.

(2) The SUDF must maintain the minimum client to direct care staff

ratios:

(a) from 7:00 a.m. to 11:00 p.m.: eight adolescents to one direct care staff;

(b) from 11:00 p.m. to 7:00 a.m.: 12 adolescents to one direct care staff; and

(3) The SUDF must:

(a) allow communication between the adolescent and the adolescent's parent or legal guardian a minimum of one time per week and facilitate the communication when clinically appropriate;

(b) provide family therapy as indicated in the individualized treatment plan or document reasons why family therapy may not be provided;

(c) notify the parent or legal guardian within two hours of any serious incident as defined in ARM 37.106.1413 involving the adolescent;

(d) discharge the adolescent to the care of the adolescent's parent or legal guardian. For emergency discharge and when the parent or legal guardian is not available, the program must contact the appropriate authority; and

(e) only admit adolescents with the written consent of the adolescent's parent or legal guardian.

(4) The SUDF must have protocols for evaluating the treatment implications and safety concerns for determining whether being placed in a room with another specific adolescent is appropriate.

(5) In no circumstances should adolescents of more than three years age difference be placed in the same room.

(6) Adolescent facilities utilizing physical restraints must have written policies and procedures governing the appropriate use of crisis intervention and physical restraint strategies including:

(a) training for all staff in crisis intervention, de-escalation, and physical restraint by a state approved or nationally recognized program;

(b) that crisis prevention and de-escalation techniques are the preferred methods and must be used first to manage behavior;

(c) physical restraint must only be used to safely control an adolescent until the adolescent can regain control of the adolescent's own behavior;

(d) prohibit the use of physical restraint if an adolescent has a documented physical condition that would contradict its use unless a health care professional has previously and specifically authorized its use in writing. Documentation must be maintained in the adolescent's client record; and

(e) prohibiting the use of prone physical restraints.

(7) Physical restraint must only be used in the following circumstances:

(a) when the adolescent has failed to respond to de-escalation techniques, and it is necessary to prevent harm to the adolescent or others; or

(b) when an adolescent's behavior puts themselves or others at substantial risk of harm and the adolescent must be forcibly moved.

(8) Physical restraint must be used only by staff members who are specifically trained and certified in physical restraint techniques.

(9) The SUDF must document the following for each physical restraint:

(a) adolescent's behavior which required the physical restraint;

(b) specific attempts to de-escalate the situation before using physical restraint;

(c) length of time the physical restraint was applied, including documentation of the time the restraint began and ended;

(d) identity of specific staff member(s) involved in administering the physical restraint;

(e) type of physical restraint used;

(f) any injuries to the adolescent resulting from the physical restraint; and

(g) a face-to-face debriefing completed within 24 hours of the restraint, including:

(i) the staff member(s) and adolescent involved in the physical restraint;

(ii) providing the adolescent and staff involved the opportunity to discuss the circumstances resulting in the use of the restraint; and

(iii) strategies that could be used by the staff, the adolescent, and/or others that could prevent the future use of restraint.

(10) The SUDF must provide access to an educational program appropriate to the needs of the youth and comply with state school attendance laws, as provided in Title 20, chapter 5, MCA.

(11) Group counseling sessions must be provided by a licensed addiction counselor or mental health professional and must not exceed eight adolescents to one adult staff member.

(12) All staff members working directly with adolescents must be at least 21 years of age.

(13) The SUDF must not employ any staff member that has a substantiation of child abuse or neglect.

(1) In addition to the requirements established in this subchapter, each SUDF must provide care management services and comply with the requirements established in this rule.

(2) A care manager must have a bachelor's degree in a human services field, an equivalent combination of education and experience, or a minimum of two years of experience serving individuals with behavioral health issues. Evidence of experience must be documented in the employee personnel record.

(3) Care management services must be provided by staff whose primary duty is the provision of care management services.

(4) The SUDF must develop written policies and procedures addressing the independence of the care manager and care management program. At a minimum, the policies and procedures must address:

(a) the care manager's role in conflicts between the client and the SUDF or other agencies;

(b) the ability of the care manager to freely advocate for services from the SUDF or other agencies on behalf of the client;

(d) the obligation to report information to the SUDF staff that the client has requested to be kept confidential; and

(e) the ability of the care manager to contact an advocacy organization if the care manager believes the SUDF is unresponsive to the needs of the client.

(1) A substance use disorder facility (SUDF) must have a written policy addressing requirements for the storage, administration, and disposal of prescription, nonprescription, and over-the-counter medication.

(a) Policies must include protocols for daily monitoring, counting of stored narcotics and other medication that has the potential for abuse.

(2) All medication must be:

(a) kept in a locked non-portable container or in a locked medical room; and

(b) stored in its original container with the original prescription label.

(3) For assistance with self-administration of medications outside of the facility, all medications must be in the possession of a staff member trained to assist with the self-administration of medications.

(4) Staff members assisting with medication self-administration must be trained to assist in proper medication procedures.

(a) Upon completion of the training, the SUDF must test each staff member's knowledge and observe staff demonstrating the skills of such materials. Test results must be documented in each staff member's personnel file.

(5) All medications must be ordered by a licensed health care professional working within the scope of his/her practice. All prescription orders must contain the dosage to be given.

(6) A written record of all medications self-administered by a client must be maintained. The record must include:

(a) client's name;

(b) name and dosage of medication;

(d) name of the staff member who assisted in the self-administration of the medication; and

(e) documentation of any medication error, the results of such error, any effects observed, and any action taken to address such error.

(7) A written record of all medications administered by a licensed health care professional must be maintained and meet documentation requirements for medication administration under the professional's individual license.

(8) Prescribed medication must not be stopped or changed in dosage or administration without first consulting a licensed health care professional, as defined in ARM 37.106.2805. Consultation results must be recorded in the client's record. The licensed health care professional must document, in writing, any changes to medication. This documentation must be kept as part of the client's record.

(9) Placing case workers, parents, or custodial guardians must be notified of all medications prescribed to adolescents, including medication changes.

(10) All unused and expired medication must be properly disposed of and documented in the client's record.

(11) A SUDF cannot require clients to discontinue the use of any medication prescribed by a licensed health care professional for admission.

(1) The SUDF must develop and implement an infection prevention and control program and review the program annually.

(2) The SUDF must have written policies and procedures regarding infection prevention and control which include:

(a) procedures to identify high risk individuals;

(b) specific procedures to address tuberculosis (TB), Hepatitis A, Hepatitis C, sexually transmitted infections (STI), and human immunodeficiency virus (HIV); and

(c) the identification of methods used to protect, contain, or minimize the risk to clients, staff members, and visitors.

(3) The administrator or designated person is responsible for the direction, provision, and quality of infection prevention and control services.

(4) Facilities must implement TB screening for all staff members and clients based upon an annual TB Risk assessment as set forth by the Montana Tuberculosis Prevention and Control Program pursuant to ARM Title 37, chapter 114, subchapter 10. Risk assessment and TB manuals are found at https://dphhs.mt.gov/publichealth/cdepi/diseases/Tuberculosis/.

(1) The substance use disorder facility (SUDF) must have a quality management committee that is representative of the SUDF's administration and staff members.

(2) The quality management committee must meet on a quarterly basis and is responsible for:

(a) developing a written plan for a continuous quality improvement program that is applicable to the entire organization;

(b) implementing the quality improvement plan and monitoring the quality and appropriateness of services;

(d) at least annually, reviewing and updating the quality improvement plan.

(3) The quality improvement program must include at a minimum:

(a) administrative processes;

(b) fiscal processes;

(d) client outcomes; and

(e) a process for reviewing serious incidents, grievances and complaints, and medication errors.

(4) The SUDF must prepare and maintain on file an annual report including improvements made as a result of the quality management plan.

This rule has been repealed.

(1) When pets are kept on the premises, the SUDF must write and adhere to procedures for their care and maintenance.

(2) When animals are kept on the premises, the following conditions must be met:

(a) proof of current vaccinations must be kept on file at the facility;

(b) pets not confined in enclosures must be under control;

(d) pets are not permitted in food preparation, storage, or dining areas during meal preparation time or during meal service or in an area where their presence would create a significant health or safety risk to others;

(e) staff members and clients must wash their hands after handling animal food and animal waste;

(f) pets must be kept clean and disease-free;

(g) pet enclosures, bedding, equipment, and supplies are kept clean and in good repair; and

(h) protocols are in place to address how reasonable accommodations will be made for clients and staff members with allergies to animals housed in the facility or who may visit the facility as part of a therapeutic treatment program.

(3) The SUDF will not keep or bring in ferrets, turtles, iguanas, lizards, or other reptiles, psittacine birds (birds of the parrot family), or any wild or dangerous animals.

(4) This rule does not apply to service animals.

(1)�An inpatient or residential SUDF must establish policies and procedures for standards relative to safe food handling, storage, preparation, and serving, to prevent food spoilage and the transmission of infectious disease.�The policies and procedures must include provisions that:��

(a)�all food must be from an approved source and shall be transported, stored, covered, prepared, and served in a sanitary manner to prevent contamination;

(b)�food must be free from adulteration or other contamination and must be safe for human consumption;

(c)�food removed from the original container must be dated, labeled, and sealed;

(d)�milk and other dairy products must be pasteurized;

(e)�use of home canned foods other than jams, jellies, and fruits is prohibited;

(f)�use of thermometers is required to check food temperatures;

(g)�cold storage of potentially hazardous food must be at 41�F or below;

(h)�frozen food must be kept frozen;

(i)�hot storage of potentially hazardous food must be 135�F or above;

(j)�each type of food must be stored and arranged so that cross-contamination of one type with another is prevented;

(k)�raw fruits and vegetable must be thoroughly washed in potable water to remove soil and other contaminants before being cut, combined with other ingredients, cooked, served, or offered for human consumption in ready-to-eat form.�Fruits and vegetables may be washed by using chemicals approved by the U.S. Environmental Protection Agency;

(l)�food packages must be in good condition and protect their contents, so that the food is not exposed to adulteration or potential contaminants; and

(m)�packaged food may not be stored in direct contact with water or undrained ice if the food package could allow water entry.

(2)�The facility must have conveniently located hand washing facilities, supplied with hand soap, disposable towels kept clean in a dispenser, and a cleanable trash can.

(3)�Staff handling or preparing food shall thoroughly wash hands, wrists, and exposed arms with soap and warm running water for at least 20 seconds:

(a)�before touching anything used to prepare food;

(b)�before touching food that will not be cooked;

(c)�after touching raw meat, fish, or poultry;

(d)�after cleaning, handling dirty dishes, removing garbage, or storing supplies;

(e)�after using the toilet facilities;

(f)�after eating or drinking;

(g)�after touching the face, hair, or skin;

(h)�after blowing the nose, coughing, or sneezing; and

(i)�after touching any soiled object.

(4)�After handwashing, hands must be dried, and faucets turned off with a clean paper towel.

(5)�If used, chemical hand sanitizers must be followed by thorough hand rinsing before contact with food.

(6)�General health and safety requirements include the following:

(a)�use of clean cutting boards, knives, can openers, and other equipment and utensils for each type of food preparation to prevent cross-contamination;

(b)�a person with symptoms of a communicable disease that can be transmitted to foods or who is a carrier of such a disease may not work with food, clean equipment, or clean utensils;

(c)�kitchenware, tableware, and food contact surfaces must be washed, rinsed, and completely dried after each use; and

(d)�sinks used for food preparation must be cleaned before beginning the preparation of the food.

(7)�A domestic style dishwasher may be used only if it is equipped with a heating element and the following conditions are met:

(a)�the dishwasher must have water at a temperature of at least 165�F when it enters the machine, if it uses hot water for sanitization; and

(b)�at least a two-compartment sink must be available as a backup in the event the dishwasher becomes inoperable.

(8) �If a two-compartment sink is used, all dishware, utensils, and food service equipment must be thoroughly cleaned in the first sink compartment with a hot detergent solution that is kept clean and at a concentration indicated on the manufacturer's label and sanitized in the second compartment by immersion in any chemical sanitizing agent.

(9) �Food must be served in amounts and variety sufficient to meet the nutritional needs of each client.

(10) �At least three meals must be offered daily and at regular times, with not more than a 12-hour span between an evening meal and breakfast unless a nutritious snack is available in the evening, then up to 14 hours may lapse between a substantial evening meal and breakfast.

(11) �Records of menus as served must be on file for three months after the date of service for review by the department.

(12) �The SUDF must provide for therapeutic or special diets ordered by the client's licensed health care professional.

(13) �A minimum of a one-week supply of non-perishable foods and a two-day supply of perishable foods must be available on the premises.

�

(1) To be licensed to provide SUD services in an outpatient setting, a SUDF must meet the following staffing requirements:

(a) clinical director;

(b) licensed addiction counselors or mental health professionals in sufficient numbers to provide counseling and therapy services to patients with substance use disorders as described by this chapter and in accordance with the patients' individualized treatment plans; and

(c) care managers in sufficient numbers to provide services to patients required by this chapter and in accordance with the patients' individualized treatment plans.

(2) Skilled treatment services must be provided by an interdisciplinary team of appropriately licensed, certified, and/or trained staff.

(3) An outpatient substance use disorder facility must provide crisis telephone services and comply with the following requirements:

(a) ensure crisis telephone services are available 24 hours a day, seven days a week;

(b) answering services or other individuals may be used to transfer calls to individuals trained to respond to crisis calls.

(4) The facility must have written policies and procedures outlining crisis telephone services that include:

(a) training requirements for individuals responding to crisis calls;

(b) ensuring a licensed addition counselor or mental health professional provides consultation and backup, as indicated, for unlicensed individuals responding to crisis calls; and

(5) The facility must maintain documentation for each crisis call that includes:

(a) the date and time of the call;

(b) the staff involved;

(d) the nature of the emergency, including a screening of safety and risk, strengths and resources, and medical concerns related to the crisis; and

(e) the result of the intervention.

(6) Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care and supportive housing services must be available through direct affiliation or referral processes.

(1) To be licensed to provide ASAM 2.5 services as outlined in the ASAM Criteria, a SUDF must meet the following staffing requirements:

(a) clinical director;

(b) licensed addiction counselors or mental health professionals in sufficient numbers to provide counseling and therapy services to clients with substance use disorders as described by this chapter and in accordance with the clients' individualized treatment plans;

(c) care managers in sufficient numbers to provide services to clients required by this chapter and in accordance with the clients' individualized treatment plans; and

(d) rehabilitation aides in sufficient number to provide direct care services and supervision of clients.

(2) The SUDF must have direct access by consultation or referral to medical and psychiatric services within eight hours by telephone or 48 hours in person.

(3) Weekly scheduled skilled treatment services must be provided by an interdisciplinary team of appropriately licensed and trained staff a minimum of 20 hours per week.

(4) If treatment services cannot be provided a minimum of 20 hours in a given week due to unforeseen issues such as illness, medical appointments, or other similar circumstances, the program must document the following:

(a) reason for not meeting the minimum hourly requirements; and

(b) attempts to follow-up and reschedule client treatment services.

(5) Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care and supportive housing services must be available through direct affiliation or referral processes.

(1) In addition to requirements found in ARM 37.106.320, substance use disorder facilities (SUDF) must comply with additional requirements in this rule.

(2) Facilities must be accessible to a person with a physical disability. If a SUDF is unable to provide access to a person with a physical disability, the program must make arrangements for a referral or other accommodations to assure the person receives appropriate services.

(3) Facilities must meet all applicable building and fire codes and be approved by the authority having jurisdiction to determine if the appropriate building and fire codes are met.

(4) An inpatient or residential SUDF must have an annual fire inspection conducted by the state fire marshal or by the authority having jurisdiction, and must maintain a record of the inspection for at least three years following the date of the inspection.

(5) Exit doors shall not include locks which prevent evacuation, except as approved by the fire marshal and building codes agency having jurisdiction.

(6) Stairways, halls doorways, passageways and exits from rooms and from the facility must be kept unobstructed at all times.

(7) All exterior pathways, entrances, and exit ways shall be of hard, smooth material, and be unobstructed and in good repair at all times.

(8) A 2A10BC portable fire extinguisher shall be available on each floor of the facility or as required by the fire authority having jurisdiction.

(9) Portable fire extinguishers must be inspected, recharged, and tagged at least once a year by a person certified by the state to perform these services.

(10) A smoke detector, approved by a recognized testing laboratory, which is properly maintained and regularly tested, must be located on each level and in all sleeping areas, bedroom hallways, and common living areas, with the exception of the kitchen and bathrooms of a SUDF or as required by the fire authority having jurisdiction.

(11) If individual battery-operated smoke detectors are used, the following maintenance is required:

(a) smoke detectors must be tested at least once a month to ensure that they are operating correctly;

(b) new operating batteries must be installed at least once each calendar year; and

(12) Garbage and refuse must be:

(a) kept in durable, easily cleanable, insect and rodent proof containers that do not leak and do not absorb liquids. Plastic bags and wet strength paper bags may be used to line these containers; and

(b) disposed of daily and removed from the property at least weekly to prevent the development of odor and attraction of insects and rodents.

(13) Refuse and recycling containers stored outside the facility, dumpsters, compactors, and compactor systems must be easily cleanable, must be provided with tight-fitting lids, doors, or covers, and must be kept covered when not in actual use.

(14) All operable windows must have a screen in good repair.

(15) Each room or area occupied by children under age five or clients with unsafe behaviors must have tamper resistant electrical outlets and hardware.

(16) Facilities must have adequate private space for personal consultation with a client, staff member charting, and therapeutic and social activities, as appropriate.

(17) Poison control and emergency contacts must be posted at each telephone.

(18) Facilities must have a first aid kit readily available on each floor.

(19) Measures must be in place to ensure containers of poisonous and toxic materials are stored safely and contain a legible manufacturer's label or material safety data (MSD) sheets.

(20) Maintenance and cleaning tools must be maintained and stored in a safe and orderly manner.

(21) Bathroom requirements include the following:

(a) a minimum of one toilet and hand washing sink for every four clients;

(b) a sink located in or immediately accessible to each toilet room;

(d) hand cleansing soap or detergent must be available. The use of a communal bar soap is prohibited;

(e) individual towels must be available; and

(f) a waste receptacle must be located in each bathroom.

(22) Bedroom requirements include the following:

(a) single occupancy rooms must be at least 100 square feet;

(b) multiple person bedrooms must be at least 60 square feet per person (includes children in parent and children recovery homes);

(d) direct access to a hallway, living room, lounge, the outside, or other common use area without going through a laundry or utility area, a bath or toilet room, or another client's bedroom;

(e) each bedroom has one outside window with visual privacy;

(f) a bed for each client;

(g) one noncombustible waste container; and

(h) a wardrobe, dresser, or closet with shelving for storing a reasonable amount of clothing.

(1) �To be licensed to provide ASAM 3.1 services as outlined in the ASAM Criteria, a SUDF must meet the following staffing requirements:�

(a)�clinical director;

(b)�licensed addiction counselors or mental health professionals in sufficient numbers to provide counseling and therapy services to clients with substance use disorders as described by this chapter and in accordance with the clients' individualized treatment plans;

(c)�care managers in sufficient numbers to provide services to clients required by this chapter and in accordance with the clients' individualized treatment plans;

(d)�rehabilitation aides in sufficient numbers to provide�direct care support�services�as outlined in the clients' individualized treatment plans; and

(e)�on-site awake staffing whenever clients are present in the facility.

(2)�Weekly scheduled clinical skilled treatment services in addition to other scheduled psychosocial rehabilitation services must be provided on-site or off-site a minimum of five hours per week. Documentation of skilled treatment services provided both on-site and off-site must be available at the facility.

(3)�Life skills training provided in a one on one or classroom setting, as part of the daily living regiment, must utilize an evidence-based practice addressing independent living skills, vocational skills, and parenting skills.

(4)�Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care must be available through direct affiliation or referral processes.

�

(1) To be licensed to provide ASAM 3.3 services as outlined in the ASAM Criteria, a SUDF must provide on-site 24-hour awake staffing and meet the following staffing requirements:

(a) a physician, physician assistant, or advanced practice registered nurse acting within the scope of the license issued by the Department of Labor and Industry available for consultation within 24 hours in person or by telephone;

(b) clinical director;

(c) licensed addiction counselors or mental health professionals in sufficient numbers to provide counseling and therapy services to clients with substance use and mental disorders as described by this chapter and in accordance with the clients' individualized treatment plans;

(d) a licensed addiction counselor or mental health professional must be on-site or on call 24 hours a day, seven days a week;

(e) care managers in sufficient numbers to provide services to clients required by this chapter and in accordance with the clients' individualized treatment plans; and

(f) rehabilitation aides in sufficient number to provide direct care support services as outlined in the clients' individualized treatment plans.

(2) Daily clinical skilled treatment services in addition to other scheduled psychosocial rehabilitation services must be provided on-site. Services must be adapted to the client's developmental stage and level of comprehension in accordance with the client's individualized treatment plan.

(3) Individuals with significant cognitive deficits require specialized services to be offered at a slower, repetitive pace.

(4) The SUDF must provide recreational activities daily.

(5) Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care must be available through direct affiliation or referral processes.

(1) To be licensed to provide ASAM 3.5 services as outlined in the ASAM Criteria, a SUDF must provide on-site 24-hour awake staffing and meet the following staffing requirements:

(b) clinical director;

(d) a licensed addiction counselor or mental health professional must be on-site or on call 24 hours a day, seven days a week;

(e) care managers in sufficient numbers to provide services to clients required by this chapter and in accordance with the clients' individualized treatment plans; and

(f) rehabilitation aides in sufficient number to provide direct care support services as outlined in the clients' individualized treatment plans.

(2) Daily clinical skilled treatment services, in addition to other scheduled psychosocial rehabilitation services, must be provided on-site a minimum of 30 hours per week.

(3) The SUDF must provide recreational activities daily.

(4) The SUDF must coordinate transfers with other licensed health care facilities or correctional facilities.

(1) To be licensed to provide ASAM 3.7 services, as outlined in the ASAM criteria, a substance use disorder facility (SUDF) must meet the following staffing requirements:

(a) a medical director that oversees the treatment process, medication management, and all medical services;

(b) a physician, nurse practitioner, or physician assistant licensed under Title 37, chapters 3 or 20, MCA, available on-call 24 hours a day, seven days a week to provide medical consultation, evaluate clients, and prescribe medications;

(c) a registered nurse (RN) licensed under Title 37, MCA, on-site or on call 24 hours a day, seven days a week to supervise nursing services;

(d) a RN or licensed practical nurse (LPN) on-site 24 hours a day, seven days a week;

(e) additional RNs, LPNs or certified nurse aides (CNA) in sufficient numbers to assist in the administration of medical protocols and assure the client's safety. LPNs and CNAs must be under the supervision of the RN;

(f) licensed addiction counselors or mental health professionals in sufficient numbers to provide therapeutic services to clients with substance use and mental disorders, as described by this chapter and in accordance with the clients' individualized treatment plans;

(g) a licensed addiction counselor or mental health professional must be on-site or on-call 16 hours a day, seven days a week;

(h) care managers in sufficient numbers to provide adequate services to clients; and

(i) rehabilitation aides in sufficient number to provide on-site 24 hours a day, seven days a week staffing patterns to ensure the safety of clients and to provide direct care services and appropriate supervision of clients.

(2) Medical service must be provided, according to written physician approved protocols, 24 hours a day, seven days a week and must include:

(a) a physical examination and screening conducted by a physician, nurse practitioner, or a physician assistant of clients on-site within 24 hours of admission, to identify medical needs for health problems and screen for communicable diseases;

(b) a comprehensive nursing assessment that includes a mental health screening and evaluates the need for acute intoxication and withdrawal management services completed by a registered nurse at the time of admission; and

(3) Daily clinical skilled treatment services and medical services must be provided on-site by an interdisciplinary team seven days a week.

(4) The SUDF must provide recreational activities seven days a week.

(5) All progress notes must be completed in a timely manner and before the next session of the same type or there must be documentation why this did not occur.

(6) The SUDF must ensure a coordinated transfer to an acute care hospital or other licensed health care facilities.

(7) Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care must be available through direct affiliation or referral processes.

(1) To be licensed to provide clinically managed residential withdrawal management defined as ASAM 3.2-WM, a provider must be licensed as an inpatient or residential health care facility program pursuant to 50-5-101, MCA, and meet the following:

(a) The facility must be equipped for clients who are impaired due to substances and may require safety rails on beds pursuant to ARM Title 37, chapter 106, subchapter 29, handrails on showers, and other related equipment to assure the safety of impaired clients.

(b) The SUDF must have physician approved protocols for the monitoring of clients in withdrawal including when and under what circumstances clients should be transferred to another health care facility.

(c) The SUDF must have a written agreement with the health care facility or physician providing for emergency services when needed.

(d) The SUDF must have written procedures specifying how staff will respond to emergencies and for the transfer of medically unstable clients.

(e) The SUDF must have sufficient staff on duty 24 hours a day, seven days a week to supervise, observe, and support clients who are intoxicated or experiencing withdrawals.

(f) The SUDF must train staff in physician approved protocols for monitoring clients in withdrawal and in medication management if medication is administered.

(g) The SUDF must have licensed addiction counselors (LAC) or mental health professionals in sufficient numbers to provide counseling and therapy services as described in this chapter and in accordance with the client's individualized treatment plan.

(h) The initial biopsychosocial assessment indicating this level of care must be reviewed by a licensed physician, nurse practitioner, or physician assistant during the admission process.

(i) The SUDF must provide daily clinical skilled treatment services to address the needs of each client. Clinical skilled treatment services may include medical services, individual and group therapy, and withdrawal support as required in the client's individualized treatment plan.

(j) The SUDF must ensure regular vital signs are taken and recorded by staff trained to recognize symptoms indicating the client is becoming physically unstable.

(k) All progress notes must be completed in a timely manner and before the next session of the same type, or there must be documentation why this did not occur.

(l) Coordination of necessary services (medical, laboratory, toxicology, psychiatric, psychological, emergency) or other levels of care must be available through direct affiliation or referral processes.

(2) The facility providing clinically managed residential withdrawal management (ASAM 3.2) must not exceed the number of inpatient or residential beds licensed for pursuant to 50-5-101 MCA.

(3) To be licensed to provide medically managed inpatient withdrawal, as defined as ASAM Level 3.7-WM, a provider must be licensed as an inpatient substance use disorder facility and meet the requirements under ARM 37.106.1475 and the following:

(a) a RN must be on-site 24 hours a day, seven days a week to monitor clients receiving acute intoxication or withdrawal management services and administer services according to physician approved protocols;

(b) the facility must be equipped for clients who are impaired due to substances and who require assistive safety devices, as written in the physician approved protocols;

(d) emergency equipment to include:

(i) oxygen;

(ii) automatic external defibrillator (AED);

(iii) suction machine; and

(iv) other emergency equipment according to the physician approved protocols for responding to client health emergencies.

This rule has been repealed.

(1) In addition to the licensing requirements in ARM 37.106.1471, a SUDF operating as a single sex parent and children ASAM 3.1 facility, must meet the following requirements:

(a) care management services must address the needs of the client's children in care;

(b) parenting skills must be addressed with evidence-based models that focus on the demands of being a parent in recovery; and

(c) the SUDF must provide age-appropriate services to meet the children's needs. Services include childcare, medical appointments, legal services, transportation, educational services, and recreational services.

(2) Cleaning materials, flammable liquids, detergents, aerosol cans, and other poisonous and toxic materials must be kept in their original containers and in a place inaccessible to children. The materials must be used in such a way that will not contaminate play surfaces, food, food preparation areas, or constitute a hazard to the children.

(3) No extension cords can be used as permanent wiring. All appliances, lamp cords, and exposed light sockets must be suitably protected to prevent electrocution.

(4) Indoor and outdoor play areas must be clean, reasonably neat, and free from accumulation of dirt, rubbish, or other health hazards.

(5) Any outdoor play area must be maintained free from hazards such as wells, machinery, and animal waste. If any part of the play area is adjacent to a busy roadway, drainage or irrigation ditch, stream, large holes, or other hazardous areas, the play area must be enclosed with a fence in good repair that is at least four feet high without any holes or spaces greater than four inches in diameter or natural barriers to restrict children from these areas.

(6) Outdoor play areas must be designed to ensure all areas are always visible and easily supervised by staff members.

(7) Outdoor equipment, such as climbing apparatus, slides, and swings, must be anchored firmly, and placed in a safe location according to manufacturer's instructions. Recommended ground covers under these items include sand, fine gravel, or woodchips with a depth of the ground cover being at least six inches.

(8) Trampolines are prohibited for use by children in care.

(9) Toys, play equipment, and any other equipment used by children must be of substantial construction and free from rough edges, sharp corners, splinters, unguarded ladders on slides, and must be kept in good repair and well maintained.

(10) Toys and objects with a diameter of less than one inch (2.5 centimeters), objects with removable parts with a diameter of less than one inch (2.5 centimeters), plastic bags, Styrofoam objects, and balloons must not be accessible to children who are still placing objects in their mouths.

(11) The Emergency Montana Poison Control Center number, (800) 222-1222, must be posted at all telephone locations in the facility.

(12) Use of waterbeds, water mattresses, gel pads, or sheepskin covers for children's sleeping surfaces is prohibited.

(13) Each infant under 18 months of age must be provided with a crib for sleeping.

(14) Each child 18 months of age and older must be provided with a bed for sleeping.

(15) Cribs must be made of durable, cleanable, nontoxic material, and have secured latching devices.

(16) Cribs must have no more than 2 and 3/8 inches of space between vertical slats.

(17) Cribs must meet requirements for full-size baby cribs and non-full-size baby cribs as specified by the Consumer Product Safety Commission at 16 CFR Part 1219 and 16 CFR Part 1220 (2011), incorporated by these references. Copies of the requirements for full-size baby cribs and non-full-size baby cribs are available at https://www.cpsc.gov/SafeSleep.

(18) Crib mattresses must fit snugly to prevent the infant from being caught between the mattress and crib siderail. Crib mattresses must be waterproof and easily sanitized.

(19) Cribs, cots, or mats must be thoroughly cleansed before assignment to another infant or toddler.

(20) Age-appropriate feeding equipment must be provided for every four infants or toddlers. This includes safe high-chairs, baby feeding tables, booster seats, and child-size tables and chairs. This equipment must be used in accordance with the manufacturer's instructions and must be appropriate for the age of the child using the equipment. Portable high-chairs that hook onto tables are prohibited.

(21) If the SUDF chooses to lock the facility door to prevent unauthorized access to the facility or to prevent a child from escaping, the facility must have no lock or fastening device which prevents free escape from the interior. Requirements include:

(a) locking devices must not require a key, a tool, or special knowledge or effort to open the door from the inside; and

(b) locked doors must be easily opened with one motion from the inside of the facility.

This rule has been repealed.

(1) Community-based single gender residential homes for individuals with substance use disorders may be located in residential neighborhoods, comparable to other homes in the neighborhood, and shall reflect the environment of a home. To be licensed to provide community-based residential homes for individuals with substance use disorders ASAM Level III.3 medium intensity treatment, a provider must meet the following:

(a) staffing or security measures sufficient to assure the safety of residents, staffing requirements may include but are not limited to:

(i) licensed addiction counselor (LAC);

(ii) individuals trained in managing co-occurring disorders;

(iii) case managers that have a minimum of two years of higher education or four or more years of related work experience and orientation to the facility's policies and procedures; and

(iv) rehabilitation aides that have a minimum of a high school diploma or GED and orientation to the facilities policies and procedures.

(b) service requirements including but not limited to the following program policies must address:

(i) these homes as transitional versus permanent living environments and how they provide interim supports and services for persons with substance use disorders and related problems;

(ii) admission criteria indicating that the individual is appropriate for these settings;

(iii) define the criteria for the length of stay in the facilities;

(iv) how clinical treatment is provided either on- or off-site; and

(v) how life skills training including vocational services is incorporated into daily residential living to prepare residents to assume permanent housing and independent living.

This rule has been repealed.

(1) A home health agency shall comply with the Conditions of Participation for Home Health Agencies as set forth in 42 CFR subchapter G part 484. A copy of the cited requirements may be obtained from the Department of Public Health and Human Services, Office of Inspector General, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

This rule has been repealed.

(1) These rules establish minimum standards for a licensed mental health center to operate a secured forensic mental health facility (FMHF) for adults who are committed for custody, care, treatment, or evaluation pursuant to Title 46, chapter 14, MCA, or who are inmates of a correctional facility receiving treatment in a separate mental health setting.

(1) A forensic mental health facility (FMHF) of a licensed mental health center provides twenty-four hour, seven days a week, secured nonhospital-based forensic mental health services for adults who are:

(a) committed to a mental health facility for evaluation of fitness to proceed pursuant to 46-14-202(2), MCA;

(b) committed to the custody of the director of the department to be placed for treatment to gain fitness to proceed pursuant to 46-14-221, MCA;

(c) committed to the custody of the director of the department to be placed for custody, care, and treatment under 46-14-301, MCA;

(d) admitted to an FMHF under a court order for a mental evaluation to be included in a pre-sentence investigation under 46-14-311, MCA;

(e) sentenced to be committed to the custody of the director of the department to be placed for custody, care, and treatment under 46-14-312, MCA;

(f) in the custody of the Department of Corrections and transferred to an FMHF under 53-21-130, MCA, or accepted for voluntary admission following such a transfer under 53-21-111, MCA; or

(g) committed to the Montana State Hospital under 53-21-127, MCA, while serving a sentence at a correctional facility.

(1) In addition to the requirements established in this subchapter, a licensed mental health center operating a forensic mental health facility (FMHF) must have an FMHF program endorsement issued by the department. To receive an FMHF program endorsement, the licensed mental health center must establish, to the department's satisfaction, that it meets the requirements stated in these rules.

(1) In addition to the requirements established in this subchapter, each licensed mental health center operating a forensic mental health facility (FMHF) must comply with all the requirements established in ARM Title 37, chapter 106, subchapter 3, with the exception of ARM 37.106.302 and 37.106.316.

(2) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the terms of this subchapter will apply to an FMHF.

(1) "Adult" means an individual 18 years of age and older.

(2) "Emergency situation" has the meaning given to it by 53-21-102, MCA.

(3) "Forensic mental health services" means mental health services for persons referred for care, custody, treatment, or evaluation by or through the criminal justice system.

(4) "Immediate emergency" means a situation involving a client that jeopardizes the immediate physical safety of a client, a staff member, or others.

(5) "Involuntary medication" means medication administered to a client when one or more of the following circumstances are present:

(a) administration of medication is against the specific wish of a client, made evident by verbal or nonverbal behavior reasonably interpreted as an objection;

(b) a client who does not have a legally appointed guardian lacks capacity to give informed consent; or

(6) "Licensed health care practitioner" means a licensed physician, physician assistant, or advanced practice registered nurse who is practicing within the scope of the license issued by the Department of Labor and Industry under Title 37 of the MCA.

(7) "Licensed health care professional" means a licensed physician, physician assistant, advanced practice registered nurse, or registered nurse who is practicing within the scope of the license issued by the Department of Labor and Industry under Title 37 of the MCA.

(8) "Medication administration" means an act in which a prescribed drug or biological is given to a client by an individual who is authorized under state laws and regulations governing such acts.

(9) "Restraint" means:

(a) any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a client to move his or her arms, legs, body, or head freely;

(b) a drug or medication when it is used to restrict the patient's behavior or freedom of movement and is not a standard treatment or dosage for the patient's condition;

(c) restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a client for the purpose of conducting routine physical examinations or tests, or to protect the client from falling out of bed, or to permit the client to participate in activities without the risk of physical harm (this does not include a physical escort); or

(d) restraint does not include medications administered during an immediate emergency which are individually prescribed to assist a client to regain control of the client's dangerous behavior.

(10) "Sally port" means a secure entry way that consists of a series of doors or gates.

(11) "Seclusion" means the involuntary confinement of a client alone in a room or area from which the client is physically prevented from leaving. Confining clients to his or her bedrooms during medication administration, shift changes, or facility emergencies does not constitute seclusion for the purposes of this rule.

(1) Prior to construction or operation of a forensic mental health facility (FMHF), floor plans for the FMHF must be submitted to the department for review, comment, and approval. The department must also inspect and approve any new construction or any addition or alteration to an FMHF prior to occupancy.

(2) Prior to occupancy of an FMHF, or any addition or alteration to an FMHF, the FMHF must undergo an onsite inspection and receive the approval of the department's License Bureau, Construction Consultant.

(3) Any building used as an FMHF must be classified at a minimum as International Conference of Building Officials (ICBO) Construction type I-FR, or greater.

(4) All areas of an FMHF must be protected by automatic fire suppression. In unsupervised client areas, sprinkler heads must be recessed or of a design to restrict client access. An FMHF must provide the following:

(a) an operable UL listed fire alarm system with automatic response notification on alarm; and

(b) supervised smoke detectors throughout the facility reporting to the fire alarm system.

(5) An FMHF must meet the water supply system requirements of ARM 37.111.115.

(6) An FMHF must meet the sewage system requirements of ARM 37.111.116.

(7) An FMHF must have a double fence installed around any client accessible area.

(8) Each fence must be a minimum of 12 feet high, and

(a) have unclimbable security mesh fabric installed on the top five feet;

(b) have concertina wire installed on the top; and

(9) There must be a minimum 12 feet between the two fences that is free of all above ground obstructions.

(10) An FMHF must have an outside assembly area of refuge for facility evacuation during an emergency. The area must be:

(a) fenced and secured and large enough to safely hold all clients and staff; and

(b) far enough from the building to be considered a safe public way.

(1) A forensic mental health facility (FMHF) must have one or more separate secured unit(s) within the facility for housing clients that includes bedrooms and common space.

(2) A secured unit must be staffed at all times clients are present in the unit.

(3) A secured unit must have a staff station to include the following:

(a) provisions for charting;

(b) provisions for hand washing;

(d) telephone access.

(4) A secured unit must have access to a nourishment station or to a kitchen that must include the following:

(a) a work counter;

(b) a refrigerator;

(d) a sink;

(e) space for trays and dishes used for nonscheduled meal service;

(f) hand washing facilities immediately accessible to clients and staff; and

(g) ice for client consumption provided by icemaker-dispenser units or periodically made available during the day.

(5) A common space within each secured unit must be provided at a ratio of 35 square feet per client.

(6) The corridors of a secured unit must have general illumination with provisions for reducing light levels at night.

(7) No more than one client must reside in a bedroom.

(8) Client bedrooms must be at a minimum of 70 square feet and must include the following:

(a) a bed with a waterproof mattress;

(b) a small wardrobe, dresser, shelves, or bed compartment for storage of clients' personal items;

(c) general lighting and night lighting, control for night lighting may be located outside the room at the room entrance;

(d) electrical outlets that are tamper-resistant and GFI-protected, outlets may be controlled from outside of the room;

(e) a window with a minimum of 248 square inches of glazing which must be designed to limit the opportunity for clients to inflict serious harm as a result of breaking the window and using pieces to inflict harm on themselves or others. Windows:

(i) must be of tempered glass or laminated safety glass to resist impact loads; and

(ii) if operable, must have security locks.

(9) Sinks and toilets may be provided in client rooms. The fixtures may be controlled from outside of the room.

(10) An FMHF must not use automatic door closures unless required. If required, such closures must be mounted on the public side of the door within view of a staff work station or under video surveillance.

(11) An FMHF must use doors that:

(a) have door hinges designed to minimize points for hanging (i.e., cut hinge type); and

(b) have tamper-resistant fasteners.

(12) An FMHF must provide:

(a) at least one toilet for every eight clients;

(b) at least one bathing unit for every twelve clients, a shower or tub is not required if the FMHF utilizes a central bathing unit for all clients; and

(c) doors to toilet rooms or bathing units that swing out or slide into the wall and which must be capable of being unlocked from the outside.

(13) Toilet rooms and bathing units may be under key control by staff.

(14) An FMHF must not use towel bars, clothing rods, hooks, or lever handles.

(1) A forensic mental health facility (FMHF) must have an area for social activities at a minimum of 25 square feet per client.

(2) An FMHF must have a quiet area for clients to utilize according to facility policy.

(3) An FMHF must have a dining space at a minimum of 35 square feet per client. The dining space may be located off a secured unit in a central area.

(4) An FMHF must have a minimum of two classrooms with work tables or desks for client use.

(5) If an FMHF has a vocational training area, it must be equipped with appropriate tools and code-compliant equipment for client use.

(6) An FMHF must have a gymnasium and a separate client exercise room which includes appropriate exercise equipment in sufficient quantity for client use.

(7) An FMHF must have a secured outside recreational exercise area with both an enclosed individual client area and a large fenced group area.

(8) An FMHF must have examination or treatment rooms for private consultation. These rooms must have at a minimum the following:

(a) 100 square foot floor area;

(b) a hand-washing station;

(d) a desk, counter, or shelf space for writing or electronic documentation.

(1) A forensic mental health facility must designate specific room(s) designed for observation, seclusion, and restraint purposes.

(2) The location of these rooms must facilitate staff observation and monitoring of clients in these areas.

(3) The room must be equipped with video and audio monitoring equipment.

(4) The room must have a minimum of 60 square feet and a ceiling height of nine feet. Ceilings in seclusion rooms must be monolithic.

(5) Rooms used for observation, seclusion, and restraint must be designed to prevent injury to clients. All finishes, light fixtures, vents and diffusers, and sprinklers must be tamper resistant. These rooms must not have: electrical outlets, medical gas outlets or similar devices; sharp corners, edges, or protrusions. The wall must be free of objects or accessories of any kind. Doors must swing out or be a slide in pocket door and have hardware on the exterior side only. The door must be a minimum width of 44 inches and include an impact resistant view panel for discreet staff observation of the client. The use of impact resistant one-way observation windows is permitted.

(1) As required in ARM 37.106.1908, a forensic mental health facility (FMHF) must maintain a policy and procedure manual. The policy and procedure manual must be reviewed and updated as necessary, but at a minimum annually.

(2) In addition to the other requirements of ARM 37.106.1908, the manual must include policies and procedures for:

(a) security;

(b) involuntary administration of medication;

(d) client rights and grievances;

(e) client admission criteria;

(f) restraint and seclusion;

(g) establishing fiscal policies governing the management of organizational and individual funds;

(h) establishing and maintaining staffing requirements;

(i) informing clients of policies pertaining to the FMHF;

(j) food services; and

(k) the detection, reporting, and investigation of abuse and neglect.

(3) The policy and procedure manual must include a current organizational chart delineating the current lines of authority, responsibility, and accountability for the administration and provision of all FMHF client treatment programs and services.

(1) A forensic mental health facility (FMHF) must develop security policies and procedures. At a minimum the policies and procedures must address the following:

(a) securing the facility;

(b) summoning outside assistance in the event of an emergency;

(d) contraband searches.

(2) An FMHF must have security vestibules or secured car ports or Sally Ports at all facility entrances.

(3) An FMHF security system must be capable of containing clients within secured units when necessary according to FMHF policy.

(4) An FMHF security system must be designed to prevent contraband smuggling and must include provisions for monitoring and controlling visitor access and egress.

(5) All openings into and out of and within the FMHF, e.g., windows, doors, and gates, must be equipped with manual, electric, or magnetic locks.

(6) An FMHF must provide visual control, i.e., electronic surveillance, of all FMHF corridors, dining areas, classrooms, and social areas.

(7) Except for use in seclusion or observation rooms, electronic surveillance is not permitted in client bedrooms, bathing units, or toilets.

(8) Electronic surveillance of a secured unit does not substitute for direct supervision where required by facility policy.

(9) Special design considerations for injury or suicide prevention must be given to all facility details, finishes, and equipment.

(10) An FMHF must provide an enclosed secured car port for the receiving, discharge, transfer, or the transportation of clients. The car port must be separated using Underwriters Laboratory or Factory Mutual rated construction providing a minimum of two-hour fire resistance.

(11) Staff may confine clients to their rooms for all scheduled medication passes, for all staff shift changes, and during any facility emergency. Medication administration and shift changes will last no longer than 30 minutes, and must be limited to no more than three 30-minute periods in a 24-hour period.

(1) A forensic mental health facility (FMHF) must develop and implement a policy for involuntary medication administration that includes:

(a) procedures for use in an immediate emergency or an emergency situation to ensure the physical safety of the client, a staff member, or others;

(b) an administrative review process for use when involuntary medication is clinically indicated for a client who is gravely disabled or poses a likelihood of serious harm to themselves, others, or property as a result of a mental disease or disorder. The process must include:

(i) a formal review within five working days of beginning the involuntary administration of medication, by a medication review committee which includes the medical director of the FMHF, the designee, or both and at least one qualified psychiatrist who is not employed at the FMHF. No committee member may be directly involved in the client's care;

(ii) an opportunity for the client to appear before the panel in person and with a representative of the client's choice, and to provide testimony and evidence;

(iii) written advance notice of the review and the right to participate which must be given to the client, guardian, and Mental Disabilities Board of Visitors;

(iv) an opportunity for review of the decision of the panel by the director of the licensed mental health center;

(v) review by the committee at 14 and 90 days after the initial authorization of involuntary administration of medication.

(c) procedures for seeking and implementing a court order authorizing involuntary administration of medication for clients who are placed at the FMHF under 46-14-221, MCA, and for whom the sole purpose of involuntary medication is to gain fitness to proceed.

(2) Attempts must be made to administer medications with the full consent of the client receiving those medications. Such attempts must be documented.

(3) Involuntary medications must be discontinued when no longer necessary as determined by a licensed health care practitioner.

(1) A forensic mental health facility (FMHF) must be capable of providing restraint or seclusion and must ensure that such restraint or seclusion is performed in compliance with 53-21-146, MCA.

(2) The use of medication solely for restraint is prohibited.

(3) Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the client, staff, or others from harm.

(4) The type and technique of restraint or seclusion must be the least restrictive intervention that will be effective to protect the client, staff, or others from harm.

(5) The use of restraint or seclusion must be implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by facility policy.

(6) Orders for the use of restraint or seclusion must never be written as a standing order or on an as-needed basis (PRN).

(7) A verbal or written order must be obtained from the licensed health care practitioner prior to initiation or as soon as possible after emergency initiation of seclusion or restraint.

(8) A licensed health care practitioner or registered nurse, in accordance with facility policy, must see the client face-to-face within one hour of the initiation of restraint or seclusion to evaluate:

(a) the client's immediate situation;

(b) the client's reaction to the intervention;

(d) the need to continue or terminate the restraint or seclusion.

(9) Each original order and renewal order authorizing the use of restraint or seclusion is limited to eight hours, up to a total of 24 hours. After 24 hours and before writing a new order, a licensed health care practitioner must see and assess the client.

(10) Staff must provide clients in restraint or seclusion with constant in-person observation for the first hour; after the first hour in-person observation can be replaced by audio and visual equipment according to facility policy.

(11) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order.

(12) A licensed health care professional must monitor the condition of the client who is restrained or secluded at an interval determined by facility policy.

(13) Each incident of restraint or seclusion must be documented in the client's medical record and must include:

(a) each order and renewal order;

(b) the one-hour face-to-face medical and behavioral evaluation;

(d) start and end times of the restraint or seclusion and the names of staff implementing interventions;

(e) alternatives or other less restrictive interventions attempted, as applicable;

(f) the client's condition or symptom(s) that warranted the use of restraint or seclusion;

(g) the client's response to the intervention(s) used, including the rationale for continued use of the intervention; and

(h) monitoring of the client in restraint or seclusion as required by facility policy.

(14) Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a client in restraint or seclusion. The training must include:

(a) techniques to identify staff and client behaviors, events, and environmental factors that may trigger circumstances that require the use of a restraint or seclusion;

(b) the use of nonphysical interventions skills;

(c) choosing the least restrictive interventions based on an individual assessment of the client's medical or behavioral status or condition;

(d) the safe application and use of all types of restraint or seclusion used in the facility, including training in how to recognize and respond to signs of physical and psychological distress; and

(e) clinical identification of specific behavioral changes that indicate restraint or seclusion is no longer necessary.

(15) Staff must receive training prior to performing any actions specified in this rule and annually thereafter.

(16) An FMHF must document in the staff personnel records that training and demonstration of competency was successfully completed.

(17) The use of simultaneous restraint and seclusion is prohibited.

(1) Employees of a forensic mental health facility (FMHF) must be 18 years of age and possess a high school diploma or general equivalency diploma (GED) at a minimum.

(2) Employees must receive orientation and training in areas relevant to the employee's duties and responsibilities including:

(a) an overview of the FMHF policy and procedure manual in areas relevant to the employee job responsibilities;

(b) a review of the employee job description;

(d) rights of persons served; and

(e) safety and emergency response procedures;

(f) basic first aid; and

(g) certification in cardiopulmonary resuscitation (CPR).

(3) All direct-care staff must receive full orientation before providing direct client care or treatment. In addition to meeting these requirements, direct-care staff must be trained to perform the services established in each client's treatment plan.

(4) CPR certification must be kept current.

(5) Direct-care staff must have knowledge of each client's needs and any events about which the employee should notify the administrator or the administrator's designated representative.

(6) An FMHF must have a sufficient number of qualified staff on duty 24 hours a day to meet the scheduled and unscheduled needs of each client, to respond in emergency situations, and to provide all related services including:

(a) maintenance of order, safety, and cleanliness;

(b) assistance with medication regimens;

(d) housekeeping services and assistance with laundry; and

(e) assurance that each client receives the supervision and care required by the treatment plan.

(7) Site-based supervisors must be on-duty 24 hours a day, seven days per week.

(8) An FMHF must be staffed by a registered nurse (RN) 24 hours a day, seven days per week. The RN may also serve as a supervisor.

(9) An FMHF must provide access to ancillary services such as laboratory or radiological services directly or by contracting with a facility licensed to provide such services.

(10) An FMHF must employ at least one licensed health care practitioner to monitor and evaluate the client's medical and psychiatric treatment. At all times, a licensed health care practitioner must be on duty or on call and available physically to the facility within one hour. The licensed health care practitioner may also be the medical director.

(11) An FMHF must have a sufficient number of qualified licensed mental health professionals on staff to meet the needs of the clients as outlined in facility policies and the clients' individualized treatment plans.

(12) An individual on each work shift must have keys to all relevant client care areas and access to all items needed to provide appropriate client treatment and care.

(13) An FMHF must provide ongoing staff training a minimum of 20 hours annually.

(1) A forensic mental health facility (FMHF) must develop and implement a written policy regarding admission into the facility for the persons identified in ARM 37.106.1602. The policy must include a screening process to identify and exclude from admission persons who need a hospital level of care.

(1) A forensic mental health facility (FMHF) must develop and implement a discharge and transfer policy for discharging a client from the FMHF to another facility.

(2) The policy must include procedures for secure transportation of clients.

(3) The facility must ensure coordinated transfers with other licensed health care facilities or correctional facilities.

(1) Clients admitted to a forensic mental health facility (FMHF) must be afforded all of the rights provided for persons admitted to a mental health facility in Title 53, chapter 21, part 1, MCA.

(2) A copy of these rights must be posted in each secure unit of the facility.

(3) These rights must also be explained at the time of admission to the client in terms that the client can understand.

(4) An FMHF must develop a written client grievance policy to include:

(a) procedures for the submission of client's written or verbal grievance to the FMHF;

(b) time frames in which the FMHF must review a grievance and reach a decision;

(i) the name of the facility contact person;

(ii) the steps taken on behalf of the client to investigate the grievance;

(iii) the results of the grievance process; and

(iv) the date of completion.

(1) A forensic mental facility (FMHF) must establish and maintain standards relative to food sources, refrigeration, refuse handling, pest control, storage, preparation, procuring, serving, handling food, and dish washing procedures that are sufficient to prevent food spoilage and the transmission of infectious disease. These standards must include the following:

(a) a requirement that food must be obtained from sources that comply with all laws relating to food and food labeling;

(b) a prohibition of the use of home-canned foods;

(c) a requirement that food subject to spoilage is removed from its original container and kept sealed, labeled, and dated.

(2) Foods must be served in amounts and with enough variety to meet the nutritional needs of each client. An FMHF must provide therapeutic diets when prescribed by the client's practitioner. At least three meals must be offered daily and at regular times, with not more than a 12-hour span between an evening meal and breakfast unless a nutritious snack is available in the evening, then up to 16 hours may lapse between a substantial evening meal and breakfast.

(3) Records of menus as served must be filed on the premises for three months after the date of service.

(4) An FMHF must have an approved dietary manual for reference when preparing meals for clients requiring therapeutic or special diets. Dietitian consultation must be provided as necessary and documented for clients requiring therapeutic or special diets.

(5) Potentially hazardous food, such as meat and milk products, must be stored at 41° F or below. Hot food must be kept at 140° F or above during preparation and serving.

(6) Freezers must be kept at a temperature of 0° F or below and refrigerators must be kept at a temperature of 41° F or below. Thermometers must be placed in the warmest area of the refrigerator and freezer to ensure proper temperature. Temperatures must be monitored and recorded at least once a month and records must be maintained at the facility for one year.

(7) Employees must maintain a high degree of personal cleanliness and must conform to good hygienic practice and food handling requirements when working in food service.

(8) Food service employees must not work in the FMHF food service area while infected with a communicable disease that can be transmitted by foods.

(1) A behavioral health inpatient facility (BHIF) is intended to provide secured inpatient psychiatric treatment for up to 16 persons, 18 years of age or older, involuntarily committed or detained, or to persons seeking treatment voluntarily. While a BHIF is defined at 53-21-102, MCA, as a mental health facility, a BHIF shall be subject to all health care facility/service standards found at Title 50, chapter 5, parts 1 and 2, MCA, in order to be licensed.

(1) The purpose of these rules is to establish minimum state health care facility/service licensing standards for secured nonhospital based inpatient psychiatric treatment for persons who may also have co-occurring substance use disorders; who are involuntarily committed or detained; or to persons seeking behavioral health treatment voluntarily. While a BHIF is not a hospital, it may be collocated with a hospital.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the terms of this subchapter shall apply to a behavioral health inpatient facility.

For the purposes of this subchapter, the following definitions apply:

(1) "Administrator" means the person designated on the facility application or by written notice to the department as the person responsible for the daily operation of the facility and for the daily inpatient treatment provided in the facility.

(2) "Assessment" means an active process that utilizes a multidisciplinary team throughout the care and treatment of an individual.

(3) "BHIF" means behavioral health inpatient facility as defined at 53-21-102, MCA.

(4) "Clinical record" means a written document which is complete, current, and contains the information required by 53-21-165, MCA.

(5) "Emergency situation" has the meaning assigned to it by 53-21-102, MCA.

(6) "Governing body" means a group of designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operations of the facility.

(7) "Licensed health care professional" means a licensed health care professional as defined at 50-5-101, MCA.

(8) "Medical director" means a physician, psychiatrist, or advanced practice registered nurse who oversees the medical care and other designated care and services in a behavioral health inpatient facility. The medical director is responsible for coordinating medical care and helping to develop, implement, and evaluate patient care policies and procedures that reflect current standards of practice.

(9) "Mental health professional" means a mental health professional as defined at 53-21-102, MCA.

(10) "Professional person" means a professional person as defined at 53-21-102, MCA.

(11) "Supervisor" means a site based certified mental health professional person.

(12) "Treatment plan" means a planned program of active treatment developed by a multidisciplinary team to meet an individual's recovery and care.

(1) Application for a health care facility/service license accompanied by the required fee shall be made to the Department of Public Health and Human Services, Quality Assurance Division, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953 upon forms provided by the department and shall include full and complete information as to:

(a) the name and address of the applicant if an individual, the name and address of each member if a firm, partnership, or association; or the name and address of each officer if a corporation;

(b) the location of the facility;

(d) the number and type of patients or residents for which care is provided;

(e) any information which the department may require pertaining to the number, experience, and training of employees; and

(f) information on ownership, contract, or lease agreement if operated by a person other than the owner.

(2) The fee for licensure is $20.00.

(3) Every facility shall have a distinct identification or name and shall notify the department in writing within 30 days prior to changing such identification or name, changing ownership, or relocating the facility.

(1) The licensee must establish a governing body with responsibility for operating and maintaining the BHIF. The governing body must include the facility's medical director and the facility administrator. The governing body provides organizational guidance and oversight to ensure the provision of safe, effective patient treatment and care to include but not limited to:

(a) adopting, reviewing, and updating as necessary, at least on an annual basis, policies that:

(i) govern the organization and functions of the BHIF;

(ii) provide a process for grievance and conflict resolution for both staff and patients; and

(iii) provide clear lines of authority for administering, managing, and operating the facility.

(b) establishing procedures for recruiting, hiring, and at least annually evaluating the qualified administrator to assure implementation of the facility goals, objectives, and policies and procedures as approved by the governing body;

(c) review all written facility policies and procedures, to ensure they implement all rules and regulations; are current; known to all staff, and available to all staff, patients, law enforcement, or the public; and

(d) approving facility human resource procedures to assure the facility establishes safe hiring and continued employment practices.

(1) Each facility shall employ or contract with a medical director who shall:

(a) coordinate with and advise the staff of the facility on clinical matters;

(b) provide direction, consultation, and training regarding the facility programs and operations as needed;

(c) act as a liaison for the facility with community physicians, hospital staff, and other professionals and agencies with regard to psychiatric services; and

(d) ensure the quality of treatment and related services through participation in the facility quality assurance process.

(2) The facility physician, psychiatrist, or advanced practice registered nurse may also serve as the facility medical director.

(1) Each facility shall employ an administrator who shall:

(a) be responsible for operation of the facility at all times and shall ensure 24-hour supervision of the patients;

(b) maintain daily overall responsibility for the facility operations;

(c) develop and oversee the implementation of all policies and procedures pertaining to the operation and services of the facility;

(d) establish written policies and procedures for all facility human resource services;

(e) establish a process for patient complaints and grievances, to include an opportunity for appeal, and to inform patients of the availability of advocacy organizations to assist them;

(f) establish a patient incident report file on all patient incidents or allegation of abuse;

(g) develop and maintain an organizational chart that delineates the current lines of authority, responsibility, and accountability for the administration and provision of all facility patient treatment programs services; and

(h) develop and implement written orientation and training procedures on all facility policies and procedures for all employees or contractors, relief workers, temporary employees, students, interns, volunteers, and trainees to include but not limited to:

(i) defining the responsibilities, limitations, and supervision of students, interns, and volunteers working for the BHIF; and

(ii) verifying each professional staff member's credentials, when hired, and annually thereafter, to ensure the continued credentialing of required licenses.

(2) The administrator shall develop policies and procedures for screening, hiring, and assessing staff which include practices that assist the employer in identifying employees that may pose risk or threat to the health, safety, or welfare of any resident and provide written documentation of findings and the outcome in the employee's file.

(1) In the absence of the administrator, a staff member must be designated to oversee the operation of the facility during the administrator's absence. The administrator or designee shall be in charge, on call and physically available on a daily basis as needed, and shall ensure there are sufficient, qualified staff so that the care, active treatment, health, welfare, and safety needs of the residents are met at all times.

(2) If the administrator will be absent from the facility for more than 30 consecutive calendar days, the department shall be given written notice of the individual who has been appointed the designee.

(1) Employees shall receive orientation and training in areas relevant to the employee's duties and responsibilities including:

(a) an overview of the facility's policies and procedure manual in areas relevant to the employee's job responsibilities;

(b) a review of the employee's job description;

(d) rights of persons served; and

(e) safety and emergency response procedures.

(2) In addition to meeting the requirements of (4), direct care staff shall be trained to perform the services established in each patient treatment plan.

(3) All direct care staff must receive full orientation before providing direct patient care or treatment.

(4) The following must be met in staffing the facility:

(a) direct care staff shall have knowledge of the patient's needs and any events about which the employee should notify the administrator or the administrator's designated representative;

(b) the facility shall have a sufficient number of qualified staff on duty 24 hours a day to meet the scheduled and unscheduled needs of each patient, to respond in emergency situations, and to provide active treatment and provision of all related services including but not limited to:

(i) maintenance of order, safety, and cleanliness;

(ii) assistance with medication regimens;

(iii) preparation and service of meals;

(iv) housekeeping services and assistance with laundry; and

(v) assurance that each patient receives the supervision and care required by the treatment plan to meet the patient's basic needs.

(c) an individual on each work shift shall have keys to all relevant patient care areas and access to all items needed to provide appropriate patient treatment and care.

(5) The facility will employ registered nurses. The facility must be staffed by a registered nurse 24 hours a day, seven days per week. The RN may also serve as a supervisor.

(6) Ancillary services such as laboratory or radiological services must be available to BHIF patients. A BHIF may either provide ancillary services directly or contract with a facility licensed to provide such services. If the ancillary services are not provided in the BHIF, the BHIF must make arrangements with the ancillary service provider for each individual patient prior to the patient's ancillary services.

(1) The facility is responsible for establishing, maintaining, and securing a file on each employee, substitute personnel, intern, volunteer, and contractor.

(2) The following documentation from personnel files must be made available to the department at all reasonable times, but shall be made available to the department within 24 hours after the department requests to review the files.

(a) the employee's name;

(b) a copy of current credentials, certifications, or professional licenses as required to perform the job description;

(d) initialed documentation of employee orientation and ongoing training.

(3) The facility shall keep a personnel file that meets the requirements set forth in (2) for the administrator of the facility, even when the administrator is also the facility owner.

(1) Each BHIF shall maintain a policy and procedure manual. The policy and procedure manual shall be reviewed and updated as necessary, but at least annually.

(2) The manual shall contain but not be limited to policies and procedures for:

(a) notifying staff of all changes in policies and procedures;

(b) addressing patient rights, including a procedure for informing patients of their rights;

(d) addressing and reviewing ethical issues faced by staff and reporting allegations of ethics violations to the applicable professional licensing authority;

(e) admitting criteria and process to initiate behavioral treatment services to patients;

(f) developing procedures for the transfer of a patient to another hospital or facility;

(g) establishing fiscal policies governing the management of organizational and individual funds;

(h) developing and implementing policy(s) for security;

(i) establishing and maintaining a facility staffing procedure;

(j) assessment criteria for new admissions;

(k) informing patients of policies pertaining to secured treatment, suspension of treatment, transfer to other facilities, or discontinuation of services for voluntary patients;

(l) suspending or discontinuing facility services with the following information to be provided to the patient:

(i) the reason for suspending or discontinuing services or access to programs;

(ii) the conditions that must be met to resume services or access to programs;

(iii) the grievance procedure that may be used to appeal the suspension or discontinuation; and

(iv) what services, if any, will be continued to be provided even though participation in a particular service or program may be suspended or discontinued.

(m) referring patients to other providers or services that the facility does not provide; and

(n) conducting quality assessment and improvement activities.

(1) A patient clinical record shall be created upon the patient's admission to the BHIF. The clinical records must comply with the requirements of 53-21-165 and 53-21-166, MCA. Clinical records must be retained for five years following the date of discharge or death. However, facilities that participate in Medicaid or Medicare programs must keep the clinical records for the applicable minimum retention period.

(1) The facility shall utilize a multidisciplinary team which may include but is not limited to the patient, social workers, addiction counselors, licensed mental health professionals, licensed practical nurses, mental health technicians, peer support staff, registered nurses, psychologists, case managers, certified mental health professional persons, clergy, and family members.

(2) Each facility shall initiate a clinical intake assessment within 12 hours after admission for program services. Intake assessments must be conducted by a licensed mental health professional or licensed health care professional trained in clinical assessments and must include the following information in a narrative form to substantiate the patient's diagnosis and provide sufficient detail to individualize treatment plan goals and objectives:

(a) presenting problem and history of problem;

(b) mental status;

(d) initial treatment plan goals;

(e) risk factors to include suicidal or homicidal ideation;

(f) psychiatric history;

(g) substance use/abuse and history;

(h) current medication and medical history;

(i) financial resources;

(j) family relationships;

(k) housing history and housing arrangements;

(l) nutritional needs;

(m) cultural and spiritual needs;

(n) education and/or work history;

(o) legal history relevant to history of illness, including guardianships, civil commitments, criminal mental health commitments, current and prior criminal background, and current legal status; and

(p) anticipated discharge needs.

(3) Based on the patient's clinical needs, the facility shall conduct additional assessments which may include, but are not limited to, physical, psychological, emotional, behavioral, psychosocial, recreational, vocational, psychiatric, and chemical dependency evaluations.

(1) Based upon the findings of the assessment(s), the facility shall initiate an individualized treatment plan for each patient within 24 hours of admission. The treatment plan must conform to requirements outlined in 53-21-162, MCA, be completed within ten days of admission, and:

(a) identify treatment team members, from within and outside of the facility, who are involved in the patient's treatment or care;

(b) specifically state measurable treatment plan objectives that serve the patient in the least restrictive and most culturally appropriate therapeutic environment;

(c) describe the service or intervention with sufficient specificity to demonstrate the relationship between the service or intervention and the stated objective;

(d) identify the staff person and program responsible for each treatment service to be provided;

(e) include the patient's guardian or power of attorney's signature indicating participation in the development of the treatment plan. If the patient's or guardian's participation is not possible or inappropriate, written documentation must indicate the reason;

(f) include the signature and date of the facility's licensed mental health professional and of the person(s) with primary responsibility for implementation of the treatment plan indicating development and ongoing review of the plan; and

(g) state the criteria for discharge, including the patient's level of functioning which will indicate when a particular service is no longer required.

(2) The treatment plan must be reviewed at least every 30 days for each patient and whenever there is a significant change in the patient's condition. A change in level of care or referrals for additional services must be included in the treatment plan.

(3) The treatment plan review must be conducted by at least one licensed mental health professional from the facility and include persons with primary responsibility for implementation of the plan. Other staff members must be involved in the review process as clinically indicated.

(4) A treatment team meeting for establishing an individual treatment plan and for treatment plan review must be conducted face-to-face and include:

(a) the patient as clinically appropriate;

(b) the patient's guardian or the holder of the patient's power of attorney if applicable;

(d) peer support, or adult friend or family member may be invited to participate in the treatment planning or treatment plan review meeting, at the request of and upon written consent of the patient, and as deemed clinically appropriate by the patient's treatment team, prior to the scheduling of the meeting.

(5) The treatment plan review must be comprehensive with regard to the patient's response to treatment and result in either an amended treatment plan or a statement of the continued appropriateness of the existing plan. The results of the treatment plan review must be entered into the patient's clinical record. The documentation must include a description of the patient's functioning and justification for each patient goal.

(6) If the facility develops separate treatment plans for each service, the treatment plans must be integrated with one another and a copy of each treatment plan must be kept in the patient's record.

(7) Minimum components of treatment plans include:

(a) assessment, medication administration and management;

(b) discharge planning;

(d) patient education;

(e) individual, group, and family therapies; and

(f) physical activity.

(8) Patient need and the patient's treating psychiatrist or mental health professional determine the length of stay.

(a) The maximum length of stay for a patient who is involuntarily committed is limited to the period authorized by the court order of commitment. Extension of commitment to a BHIF pursuant to 53-21-128, MCA, is not permitted.

(1) The facility must be capable of providing restraint or seclusion and must ensure that the restraint or seclusion is performed in compliance with 53-21-146, MCA.

(2) Restraint and seclusion must be performed in a manner that is safe, proportionate and appropriate to the severity of the behavior, the patient's size, gender, physical, medical, and psychiatric condition, and personal history.

(3) Restraint or seclusion may be used in emergency situations when needed to ensure the physical safety of the individual patient or other patients or staff of the facility and when less restrictive measures have been found to be ineffective to protect the resident or others from harm.

(4) Restraint and seclusion procedures must be implemented in the least restrictive manner possible in accordance with a written modification to the patient's health care/treatment plan and discontinued when the behaviors that necessitated the restraint or seclusion are no longer in evidence.

(5) "Whenever needed" or "as needed" PRN standing orders for use of restraint or seclusion are prohibited.

(6) A physician or other authorized health care provider must authorize use of the restraint or seclusion within one hour of initiating the restraint or seclusion.

(7) Each order of restraint or seclusion is limited in length of time to four hours.

(8) A facility will have at a minimum one "comfort/safe" room per 16 beds for use for patient seclusion as prescribed by the facility's policy and procedures, and in accordance with applicable state and federal standards.

(1) Patients admitted to a behavioral health inpatient facility shall be afforded all of the rights of a patient provided for in Title 53, chapter 21, part 1, MCA, Treatment of the Seriously Mentally Ill.

(2) A copy of these rights shall be posted in a conspicuous place within the facility.

(3) These rights will also be explained to the patient in terms that the patient can understand.

(1) The facility shall develop security policies which address the following:

(a) securing the treatment unit;

(b) development of an emergency, fire, disaster, evacuation, and response plan; and

(1) Each facility shall implement and maintain an active quality assessment program using information collected to make improvements in the facility's policies, procedures, and services. At a minimum, the program must include procedures for:

(a) conducting patient satisfaction surveys, at least annually, for all facility programs. The survey must address:

(i) whether the patient, parent, or guardian is adequately involved in the development and review of the patient's treatment plan;

(ii) whether the patient, parent, or guardian was informed of patient's rights and the facility's grievance procedure;

(iii) the patient's, parent's, or guardian's satisfaction with all facility programs in which the patient participated; and

(iv) the patient's, parent's, or guardian's recommendations for improving facility's services.

(b) maintaining records on the occurrence, duration, and frequency of seclusion and physical restraints used; and

(c) reviewing, on an ongoing basis, incident reports, grievances, complaints, medication errors, and the use of seclusion and/or physical restraint with special attention given to identifying patterns and making necessary changes in how services are provided.

(2) Each facility shall prepare and maintain on file an annual report of improvements made resulting from the quality assessment program.

(1) The patient must be provided with an aftercare plan upon discharge.

(2) Each facility shall prepare a discharge plan for each patient no longer receiving services. The discharge plan must include:

(a) the reason for discharge;

(b) a summary of the services provided by the facility including recommendations for aftercare services and referrals to other services, if applicable;

(c) an evaluation of the client's progress as measured by the treatment plan and the impact of the services provided by the facility;

(d) diagnosis and response to medications; and

(e) the signature of the staff member who prepared the report and the date of preparation.

(3) The discharge summary must be filed in the clinical record within 72 hours after patient is discharged from the BHIF.

(1) A patient may be discharged and transferred to another facility pursuant to 53-21-111, MCA, at any time. Transfer protocols include but are not limited to:

(a) transferring facility will contact the receiving facility to determine if a bed is available;

(b) transferring facility will contact the receiving facility to determine if appropriate staff are or will be available to treat incoming individual;

(d) an individual's available medical documentation will accompany the individual to the receiving facility.

(2) A patient who has been involuntarily committed to a BHIF pursuant to 53-21-127, MCA, may be transferred to another facility if the court which committed the patient to the BHIF has issued an order to transfer or an order committing the patient to the other facility.

(3) A patient for whom a petition for extension of commitment has been filed pursuant to 53-21-128, MCA, may be transferred to another facility if the court in which the petition is filed has issued an order to transfer or an order committing the patient to the other facility.

(4) If an emergency situation exists, the patient may be involuntarily transferred for admission to Montana State Hospital without a court order in accordance with 53-21-129, MCA, until the next business day.

(5) The patient's medical information and commitment order must accompany the patient.

(1) The building shall be considered an I - 2 occupancy for purpose of issuing a building permit.

(2) The building shall be classified as a New Health Care Occupancy or Existing Health Care Occupancy as found in Chapter 18 or Chapter 19 of the 2001, NFPA 101 - Life Safety Code. Copies of the codes may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169-7471, phone 1-617-770-3000.

(1) At least two separate social spaces, one appropriate for noisy activities and one for quiet activities, shall be provided. The combined area shall be at least 25 square feet for each of the two spaces. This space may be shared by dining activities if an additional 15 square feet per patient is added; otherwise, provide 20 square feet for patient dining. Dining facilities may be located off the nursing unit in a central area.

(1) There must be at least one toilet available for every four patients in the facility.

(2) There must be at least one bathing unit for every six patients in the facility. A shower or tub is not required if the facility utilizes a central bathing unit for every six patients.

(3) All doors to toilet rooms or bathing unit must swing out or slide into the wall and shall be able to be unlocked from the outside. Toilet rooms and bathing facilities may be under key control by staff.

(1) The facility must establish and maintain infection control policies and procedures sufficient to provide a safe environment and to prevent the transmission of disease. Such policies and procedures must, at a minimum, include the following:

(a) any employee contracting a communicable disease that is transmittable to residents through food handling or direct care must not appear at work until the infectious disease(s) can no longer be transmitted;

(b) diagnosis and treatment of communicable or infectious disease occurrence and that appropriate safety measures are taken on behalf of that patient, of other patients, staff, and visitors; and

(2) The facility shall comply with statutes and rules regarding the handling and disposal of biohazardous waste.

(1) Facilities shall comply with the regulations concerning food service establishments which are located at ARM Title 37, chapter 110, subchapter 2.

(2) Facilities shall provide for the patient's nutritional needs as prescribed by the patient's doctor.

(1) Laundry and housekeeping services must be provided by the facility. A contracted service provider or the facility directly may provide laundry and housekeeping services.

(2) Facility administrators will ensure that provisions are made to accommodate patient laundry and housekeeping to assure a safe and clean environment.

(1) To the extent that other licensure rules in this chapter conflict with the terms of ARM 37.106.1802, 37.106.1805, 37.106.1810 through 37.106.1814, 37.106.1820, 37.106.1821, 37.106.1825 through 37.106.1829, 37.106.1831 through 37.106.1833, 37.106.1841 through 37.106.1845, 37.106.1851 through 37.106.1853, the terms of ARM 37.106.1802, 37.106.1805, 37.106.1810 through 37.106.1814, 37.106.1820, 37.106.1821, 37.106.1825 through 37.106.1829, 37.106.1831 through 37.106.1833, 37.106.1841 through 37.106.1845, 37.106.1851 through 37.106.1853 will apply to specialty mental health facilities.

As used in ARM 37.106.1801, 37.106.1802, 37.106.1805, 37.106.1810 through 37.106.1814, 37.106.1820, 37.106.1821, 37.106.1825 through 37.106.1829, 37.106.1831 through 37.106.1833, 37.106.1841 through 37.106.1845, 37.106.1851 through 37.106.1853, the following definitions apply:

(1) "Specialty mental health facility" means a health care facility that provides specialty mental health services in a residential setting to patients with mental health conditions associated with eating disorders, pathological gambling, and sexual disorders and may include a specialty unit attached to another type of licensed health care facility.

(2) "Addiction" includes habituation, and means a psychological dependence upon a substance or behavior for the purpose of achieving euphoria or temporary relief from painful stimuli, whether or not the stimuli are internal or external in origin, and which is associated with an eating disorder, pathological gambling, or a sexual disorder.

(1) A specialty mental health facility must maintain a medical records system in accordance with written policies and procedures, as well as meet the following standards:

(a) Employ adequate personnel to ensure prompt and systematic completion, filing, and retrieval of records.

(b) Create and maintain a record for each person receiving specialty mental health care services from the facility that includes, if applicable:

(i) identification and social data;

(ii) admitting diagnosis;

(iii) pertinent medical history;

(iv) properly executed consent forms;

(v) reports of physical examinations, diagnostic and laboratory test results, and consultation findings;

(vi) all physician's orders, nurses' notes, and reports of treatments and medications;

(vii) final diagnosis;

(viii) discharge summary; and

(ix) any other pertinent information necessary to monitor the patient's prognosis.

(c) Include in each record the signatures of the physician or other health care professional authoring the record entries.

(d) Complete records of a discharged patient within 30 days after the discharge date and include, in addition to the information cited in (b) above, a recapitulation of the patient's period of treatment, a recommendation of the appropriate follow up or aftercare services for the patient, and a brief summary of the patient's medical and mental condition on discharge.

(e) Have written policies and procedures ensuring the confidentiality of patient records, and safeguards against loss, destruction or unauthorized use, in accordance with applicable state and federal law and including policies and procedures which:

(i) govern the use and removal of records from the record storage area;

(ii) specify the conditions under which information may be released and by whom;

(iii) specify when the patient's consent is required for release of information, in accordance with Title 50, chapter 16, part 5, MCA, the Uniform Health Care Information Act.

(f) In addition to the above, adhere to the provisions of ARM 37.106.314.

(2) The department hereby adopts and incorporates by reference ARM 37.106.314, which contains medical records requirements for types of health care facilities other than hospitals. Copies may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A specialty mental health facility must have a governing body that is legally responsible for the conduct of the facility and that:

(a) Ensures that the medical and professional staff of the facility:

(i) are appointed by the governing body to the medical staff after the governing body considers the recommendations of the existing members of the medical staff;

(ii) have bylaws and written policies that are approved by the governing body;

(iii) are accountable to the governing body for the quality of care provided to patients; and

(iv) are selected on the basis of individual character, competence, training, experience, judgment, and professional qualifications according to the specific areas in which they are to provide medical treatment.

(b) Appoints a chief executive officer who is responsible for managing the facility.

(i) every patient is under the care of a psychiatrist; and

(ii) whenever a patient is admitted to the facility, the admission procedures required by ARM 37.106.1851 are followed.

(d) Prepares, adopts, reviews, and updates annually an overall institutional plan that includes the following:

(i) a system of financial management and accountability; and

(ii) a system that assures that members of the governing body and appropriate administrative and professional staff have adequate and comprehensive liability insurance.

(e) Maintains a list of all contracted services, including the scope and nature of the services provided, and ensures that a contractor providing services to the facility:

(i) furnishes services that permit the facility, including the contracted services, to comply with all applicable licensure standards; and

(ii) provides the services in a safe and effective manner that will ensure that a patient may be able to return to a community setting as soon as possible.

(f) Ensures that the medical and nursing staff of the facility are licensed, certified, or registered in accordance with Montana law and rules and that each staff member provides health services within the scope of his or her license, certification, or registration.

(1) A specialty mental health facility must have an administrator who has formal training and/or experience, preferably in the administration of a mental health facility, which demonstrates an ability to perform the functions and duties required by these licensure rules.

(2) The facility must ensure that the administrator is on the premises the number of hours necessary to manage and administer the facility in compliance with these licensure rules.

(1) A specialty mental health facility must:

(a) Have a single, organized professional staff with overall responsibility for the quality of all clinical care provided to patients and the professional practices of its members;

(b) Employ or contract with the numbers of qualified mental health professional and support staff necessary to adequately evaluate patients and to sufficiently participate in each individual treatment plan to its completion; thoroughly document such participation; formulate written, individualized, and comprehensive treatment plans; provide active treatment measures; and engage in discharge planning.

(i) a description of the qualifications a medical and professional staff candidate must meet in order to be recommended to the governing body for appointment;

(ii) a statement of the duties and privileges of each category of medical and professional staff.

(iii) a requirement that a physical examination be made and medical history taken of a patient by a member of the medical staff no more than seven days before or 24 hours after the patient's admission to the facility.

(d) Ensure that the medical staff includes at least one Montana-licensed psychiatrist.

(e) Ensure that a staff psychiatrist does the following:

(i) Provides medical direction for the facility's residential mental health care activities and consultation for, and medical supervision of, mental health professional and non-physician health care staff;

(ii) Reviews and signs the records of each patient admitted; and

(iii) is directly involved with the mental health treatment of each admitted patient as determined in each individual treatment plan and documents that direct involvement.

(1) A staff development program must be provided for administrative, professional, and support personnel, and must be supervised and directed by a staff committee or qualified person.

(2) Staff development programs must be outlined in the facility's policies and procedures, with annual updates.

(1) A specialty mental health facility must have a multi-disciplinary treatment team supervised and directed by the admitting psychiatrist, and consisting of adequate numbers of individuals licensed, registered, or certified in the mental health disciplines appropriate to the condition of each patient.

(2) The treatment team for each patient must meet at least weekly with the supervising psychiatrist and document the progress of each patient according to each patient's individual treatment plan.

(1) The governing body of the facility must ensure that there is an effective, ongoing, facility wide written quality assurance program and implementation plan in effect which ensures, monitors, and evaluates the quality of the patient care provided there and which includes the following:

(a) Identification of all health and safety aspects of each patient's individual treatment plan;

(b) Development and documentation of indicators that are used to monitor and evaluate the health and safety aspects of patient treatment and care;

(c) Documentation and evidence that the findings, conclusions, and results of corrective actions to improve patient care which are identified through the quality assurance program are applied in a manner which improves patient treatment and care.

(d) Consideration and documentation by the facility's medical and professional staff of the findings of the evaluation and the taking of subsequent remedial action, if necessary.

(e) Evaluation, with complete documentation, of all services provided by contractors.

(f) The taking and documentation of appropriate remedial action to address deficiencies found through the quality assurance program, as well as documentation of the outcome of the remedial action.

(g) Periodic review of all quality assurance activities, at least semi-annually, which is submitted in writing to the governing body and also made a part of the facility's medical records file.

(1) A specialty mental health facility must have in effect a utilization review plan to review services furnished by the facility to patients, either through contracted services or by members of its medical staff to patients, in order to determine through semi-annual review, whether utilization of services was appropriate, established policies were followed, and any changes are needed.

(2) Such a review mechanism shall consider, during each semi-annual review period, at least the following:

(a) the utilization of facility services, including at least the number of patients served and the volume of services;

(b) sample facility cases consisting of not less than 10% of both active and closed patient records;

(c) review of the sample cases to determine the medical necessity of the medical and professional services furnished, including drugs and biologicals; and

(d) the facility's health care policies.

(1) Each patient room in a specialty mental health facility must meet the following standards:

(a) No more than four patients may be housed in a room.

(b) Patient room areas, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules, must be at least 100 square feet (9.29 square meters) in single-bed rooms and 80 square feet (7.43 square meters) per bed in multiple-bed rooms; minor encroachments, including columns and lavatories, that do not interfere with functions, may be ignored when determining space requirements for patient rooms.

(c) Multiple-bed rooms must allow a minimum clearance of 3 feet 8 inches (1.12 meters) at the foot of each bed to permit the passage of equipment and beds.

(d) Each room must have a window in accordance with section 7.28A(11) of the Guidelines for Construction and Equipment of Hospital and Medical Facilities (1992-1993 edition) published by the American institute of architects.

(e) In new construction, handwashing facilities must be provided.

(f) If a room is renovated and/or modernized, the lavatory must be added if it does not already exist, unless, in the case of a single bed room or a two-bed room, a water closet and lavatory are provided in a toilet room designed to serve that room.

(g) Each patient must have within his/her room a separate wardrobe, locker, or closet suitable for hanging full-length garments and for storing personal effects.

(2) A toilet room must:

(a) serve no more than four beds and not more than two patient rooms.

(b) contain a water closet and a door that either swings outward or is double-acting.

(d) have a floor area of not less than 15 square feet if it has one toilet and one lavatory.

(3) Separate toilet facilities and lockers shall be provided for employees.

(4) The facility's water supply system must meet the standards contained in ARM 17.38.207 and 37.111.115.

(5) The facility's wastewater system must meet the standards contained in ARM 16.20.636.

(6) Fixtures must meet the following standards:

(a) Toilets must be:

(i) provided in numbers ample for use according to the number of residents, at least one toilet for every four residents or fraction thereof.

(ii) if for resident use, provided with grab bars of a type approved by the department on at least one side.

(iii) ventilated, with a mechanical system vented to the outdoors that provides a minimum of four air changes per hour.

(iv) where more than one toilet is provided in the same room, partitioned each from the other, including a door capable of remaining closed which affords full visual privacy.

(v) be accessible to each resident without the resident having to enter a kitchen, dining room, living area, or another resident's room.

(b) Sinks and handwashing fixtures must be:

(i) provided close to each work station and in each utility room;

(ii) if used by staff, equipped with valves which can be operated without the use of hands;

(iii) provided separately in the main kitchen and located so that the person in charge may supervise handwashing by food service personnel; and

(iv) supplied with a paper towel dispenser, soap dispenser, and a covered wastebasket.

(7) A bathroom must:

(a) when individual bathing facilities are not provided in patient rooms, include a bathtub or shower with approved grab bars and serve no more than 12 licensed beds or fraction thereof.

(b) be ventilated by a mechanical system to the outdoors providing a minimum of 10 air changes per hour.

(c) have a floor entirely covered with a non-absorbent covering approved by the department. [Note: A continuous solid covering is preferred over block tile, but is not mandatory.]

(d) contain an adequate supply of toilet tissue, towels, soap, and wastebaskets.

(e) if it contains a shower or bath serving more than one patient, provide a private area for bathing, drying, and dressing.

(8) At least one resident bathroom for residents with physically handicapping conditions must be provided that has space for a wheelchair and an assisting attendant, whether or not any of the residents are classified as handicapped.

(9) Service areas must meet the following standards:

(a) The services noted below must be located in or readily available to each nursing unit.

(i) Administrative center or nurses' station.

(ii) Nurses' office for floor staff.

(iii) Administrative supplies storage.

(iv) A lavatory for handwashing.

(v) Charting facilities.

(vi) Toilet room(s) for staff.

(vii) Staff lounge facilities; these may be on another floor so long as they are centrally located.

(viii) Closets or cabinet compartments for the personal effects of nursing personnel; however, coats may be stored in closets or cabinets on each floor or in a central staff locker area.

(ix) Multipurpose room(s) for staff and patient conferences, education, demonstrations, and consultation; such a room may be on another floor if convenient for regular use and may serve several nursing units and/or departments.

(x) Examination and treatment room(s) , unless all rooms in the facility are single-bed patient rooms; the room(s) may serve several nursing units and may be on a different floor if conveniently located for routine use.

(xi) Clean workroom or clean holding room.

(xii) Soiled workroom.

(xiii) Drug distribution station.

(xiv) Clean linen storage in each nursing unit.

(xv) Nourishment station.

(xvi) An ice machine in each nursing unit to provide ice for treatments and nourishment.

(xvii) Equipment storage room.

(xviii) Showers, bathtubs, and sitz baths.

(xix) Emergency equipment storage space.

(xx) At least two separate social spaces, one appropriate for noisy activities and one for quiet activities.

(xxi) Space for group therapy.

(xxii) Occupational therapy unit.

(b) The size and location of each service area will depend upon the numbers and types of beds served.

(c) Identifiable spaces are required for each of the service areas listed in (a) above, but where the area is described as a room or office, a separate, enclosed space for the area is required; otherwise, the described area may be a specific space in another room or common area.

(d) Each service area may be arranged and located to serve more than one nursing unit but, unless noted otherwise in this subsection, at least one of each type of service area must be provided on each nursing floor.

(e) Examination rooms must have a minimum floor area of 120 square feet (11.2 square meters) excluding space for vestibule, toilets, and closets, and contain a lavatory or sink equipped for handwashing, storage facilities, and a desk, counter, or shelf space for writing.

(f) A clean workroom or clean holding room used must contain:

(i) a work counter and handwashing and storage facilities if it is used for preparing patient care items.

(ii) storage facilities alone if the room is used only for storage and holding as part of a system to distribute clean and sterile supply materials.

(g) A soiled work room must contain:

(i) a clinical sink or equivalent flushing-rim fixture, a sink equipped for handwashing, a work counter, waste receptacles, and a linen receptacle. Rooms used only for temporary holding of soiled material need not contain handwashing sinks or work counters. However, if the flushing-rim sink is omitted, other provisions for disposal or liquid waste at each unit may be added.

(h) A drug distribution station must:

(i) be made for 24-hour distribution of medications, for example, by distributing medications from a medicine preparation room or unit or utilizing a self-contained medicine dispensing unit, or by another system;

(ii) if a medicine preparation room or unit, be under visual control of nursing staff; contain a work counter, sink, refrigerator, and locked storage for controlled drugs; and have a minimum area of 50 square feet (4.65 square meters) ;

(iii) if a self-contained medicine dispensing unit, be located at the nurses station, in the clean workroom, or in an alcove.

(iv) have convenient access to handwashing facilities; handwashing facilities do not include cup-sinks.

(i) Clean linen storage must:

(i) be located either within the clean workroom, a separate closet, or some other distribution system on each floor that is approved by the department; and

(ii) if a closed cart system is used, be out of the path of normal traffic, e.g. in an alcove.

(j) A nourishment station must:

(i) contain a sink, work counter, refrigerator, storage cabinets, and equipment for serving nourishment between scheduled meals;

(ii) include provisions and space for separate temporary storage of unused and soiled dietary trays not picked up at meal time; and

(iii) have convenient access to a lavatory.

(k) Ice-making equipment must:

(i) either be located in the clean work room or at the nourishment station under staff control; and

(ii) if producing ice for human consumption, be a self-dispensing ice maker.

(l) Emergency equipment storage space must meet the following standards:

(i) The space, such as a cardiopulmonary resuscitation (CPR) cart, must be under direct control of the nursing staff;

(ii) The space must be directly accessible from the unit or floor and may serve more than one nursing unit on a floor;

(iii) In addition to separate janitor's closets that may be required for the exclusive use of specific services, at least one janitor's closet per floor must contain a service sink or receptor and provisions for storage of supplies.

(m) Social spaces:

(i) must contain at least 40 square feet (3.72 square meters) per patient in their combined area;

(ii) must contain at least 120 square feet (11.1 square meters) in each; and

(iii) may share space with dining activities.

(n) Group therapy space may be combined with the social space designated for quiet activities when the treatment unit accommodates no more than 12 patients, and when the space in question contains at least 225 square feet (21 square meters) in an enclosed private area.

(o) An occupational therapy unit:

(i) must contain 15 square feet (1.39 square meters) of separate space per patient in a treatment unit for occupational therapy, with a minimum total area of at least 200 square feet (18.6 square meters) , whichever is greater;

(ii) must provide handwashing facilities, work counters, and storage;

(iii) may serve more than one nursing unit; and

(iv) may perform its functions within the noisy activities area, if at least an additional 10 square feet (0.9 square meters) per patient served is included and the treatment unit contains less than 12 beds.

(p) One lavatory may serve the nurses' station, drug distribution station, and nourishment center so long as it is convenient to each.

(q) Closets or cabinets for the personal effects of nursing personnel must be securable and, at a minimum, large enough for purses and billfolds.

(10) Where the requirements of this section appear in conflict with those of NFPA 101, chapters 22 and 23, the requirements of this section shall apply.

(11) The department hereby adopts and incorporates by reference:

(a) section 7.28A(11) of the Guidelines for Construction and Equipment of Hospital and Medical Facilities (1992-1993 edition) published by the American Institute of Architects, a manual which specifies architectural requirements to ensure comfort, aesthetics, and safety in hospital and medical facilities. A copy of section 7.28A(11) or the entire manual may be obtained from the American Institute of Architects Press, 1735 New York Avenue NW, Washington, DC 20006.

(b) ARM 17.38.207, stating maximum microbiological contaminant levels for public water supplies, and ARM 37.111.115, which outlines the department construction, operation, and maintenance standards for springs, wells, and cisterns and other water supply system minimum requirements. Copies of the rules may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(c) ARM 16.20.636, outlining department construction and operation standards and other minimum requirements for sewage systems. A copy of the rule may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A specialty mental health facility must be in compliance with the provisions of the 1994 National Fire Protection Association (NFPA) 101 Life Safety Code, chapters 22 and 23, residential occupancy.

(2) The department hereby adopts and incorporates by reference the 1994 NFPA 101 Life Safety Code, chapters 22 and 23, residential occupancy. Copies of the codes may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) The facility must maintain adequate facilities for its services, the extent and complexity of facilities being determined by the services offered.

(2) The facility must be constructed, equipped, and maintained to protect the health and safety of patients, personnel, and the public.

(3) The facility must be constructed to prevent vermin problems.

(4) The facility must be kept clean and free of odors.

(5) Daily housekeeping services must be provided.

(6) Walls, ceilings, floors, and furniture must be kept clean and in good repair.

(7) Electrical, mechanical, plumbing, and heating systems must be in good, safe condition.

(8) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.

(9) The facility must establish a written preventive maintenance program to ensure that all equipment is operative.

(1) A specialty mental health facility must be constructed and maintained so as to prevent entrance and harborage of rats, mice, insects, flies or other vermin.

(2) Hand cleansing soap or detergent and individual towels must be available at each lavatory in the facility. A waste receptacle must be located near each lavatory.

(3) The facility must develop and follow a written infection surveillance program describing the procedures that must be utilized by the entire facility staff in the identification, investigation, and mitigation of infections acquired in the facility.

(4) Cleaning devices used for lavatories, toilet bowls, urinals, showers, or bathtubs may not be used for other purposes, and those utensils used to clean toilets or urinals must not be allowed to contact other cleaning devices.

(1) A specialty mental health facility must ensure that:

(a) the facility has an effective facility wide infection control surveillance program developed for the identification, investigation, prevention and control of nosocomial infections.

(b) the facility has written policies and procedures that describe the types of surveillance carried out to monitor the rates of nosocomial infections, the systems used to collect and analyze data, and the activities carried out to prevent and control infection.

(c) A staff member is designated as a manager of the infection control program who has education, training or experience related to infection control, that facility records contain documented evidence of the manager's qualifications, and that the manager participates in continuing education in the area of infection control.

(d) A multidisciplinary committee oversees the program for surveillance, prevention, and control of infection, a committee that includes the designated infection control manager and representatives from the professional staff; administration; and housekeeping, laundry, dietary, maintenance and pharmacy services; and meets whenever the committee members determine the facility needs such a meeting.

(e) Each department, including housekeeping, laundry, dietary, maintenance, pharmacy, and nursing/medical, develops and implements policies and procedures which reflect current and accepted infection control standards of practice, and that these policies are updated and reviewed annually by the infection control committee.

(2) The facility must be in compliance with Title 75, part 10, MCA, the Infectious Waste Management Act.

(3) The department hereby adopts and incorporates by reference Title 75, part 10, MCA, containing requirements for health care facilities in handling of infectious wastes. A copy of the law may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) The facility must ensure that patients have access to emergency services and to more intensive levels of care, including acute or inpatient psychiatric care.

(2) The facility must have an agreement with an outside source for emergency medical and inpatient psychiatric services to ensure that they are immediately available to patients who may need such services.

(1) A specialty mental health facility must develop a disaster plan in conjunction with other emergency services in the community which includes a procedure that will be followed in the event of a natural or man-caused disaster.

(1) If a specialty mental health facility processes its own laundry on the facility site, it must:

(a) Set aside a room for laundry and utilize it solely for that purpose.

(b) Equip the laundry with a mechanical washer and dryer (or additional machines if necessary to handle the laundry load) , handwashing facilities, mechanical ventilation to the outside, a fresh air supply, and a hot water supply system which supplies the washer with water of at least 160 º F (71 º C) during each use for 25 minutes, or, if lower temperatures are used, with chemicals suitable for low temperature washing.

(d) Provide well maintained carts or other containers impervious to moisture to transport laundry, keeping those used for soiled laundry separate from those used for clean laundry.

(e) Dry all bed linen, towels, and washcloths in a mechanical dryer.

(f) Protect clean laundry from contamination.

(g) Ensure that facility staff use hygienic techniques while handling soiled and clean laundry, including:

(i) covering their clothing while working with soiled laundry;

(ii) using separate clean covering for their clothes while handling clean laundry; and

(iii) washing their hands both after working with soiled laundry and before they handle clean laundry.

(2) The facility must maintain a linen supply adequate to provide changes of bed and bath linens at appropriate intervals.

(1) A specialty mental health facility must:

(a) Provide an individually planned regimen of 24-hour evaluation, care, and treatment for each patient with mental health conditions associated with the addiction that the regimen is designed to treat, prepared and delivered by mental health professionals, pursuant to a defined set of written policies and procedures;

(b) Have permanent facilities that include, at least, inpatient beds;

(c) Utilize a multi-disciplinary mental health staff appropriate and sufficient to care for patients whose emotional/behavioral problems are severe enough to require specialty mental health treatment services as determined through individual psychiatric evaluations and detailed admission criteria; and

(d) Provide 24-hour staff observation to patients, and have medical and/or mental health monitoring and treatment available to them by qualified professionals on a 24-hour basis;

(2) If medical monitoring and treatment is necessary for a patient on a continuous basis, then that individual must be transferred to an appropriate inpatient facility immediately.

(1) A specialty mental health facility must have nutrition services that are directed and staffed by adequate personnel and meet the following standards:

(a) The facility must assign an employee or contract with a consultant who is qualified by experience and training as a food service supervisor to direct the food and nutrition service and to be responsible for the daily management of the nutrition service.

(b) The facility must utilize a nutritionist licensed in Montana, on a full-time, part-time, or consultant basis.

(d) Nutritional needs must be met in accordance with recognized dietary and nutrition practices and, at a minimum, the recommended daily dietary allowances established by the Food and Nutritional Board of the National Research Council, National Academy of Sciences, 10th edition, 1989.

(2) The department hereby incorporates by reference the recommended daily dietary allowances established by the Food and Nutritional Board of the National Research Council, National Academy of Sciences, 10th edition, 1989, which set minimum nutrition requirements for human beings. A copy of the above dietary allowances may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A specialty mental health facility must provide 24-hour nursing services and meet the following standards:

(a) The director of nursing services must be a licensed registered nurse and must:

(i) determine the types and numbers of nursing personnel and staff necessary to provide nursing care; and

(ii) schedule adequate numbers of licensed registered nurses, licensed practical nurses, and other personnel to provide nursing care as needed.

(b) A registered nurse must be on duty at least eight hours per day, and the director of nursing or another registered nurse designated as the director's alternate must be on call and available within 20 minutes at all times.

(c) The nursing service must have a procedure to ensure that all nursing personnel have valid and current Montana nursing licenses.

(d) The nursing staff must develop and keep current a nursing care plan for each patient when a nursing care plan is required.

(e) Upon admission of a patient to the facility, a registered nurse must assign the nursing care of that patient to other nursing personnel in accordance with the patient's needs as determined by the admitting psychiatrist and the specialized qualifications and competence of the nursing staff.

(f) All drugs and biologicals must be administered by, or under the supervision of, nursing or other qualified medical personnel in accordance with federal and state law and rules, including applicable licensing requirements, and in accordance with medical staff policies and procedures which have been approved by the governing body.

(g) Each order for drugs and biologicals must be consistent with federal and state law and be in writing and signed by the practitioner who is both responsible for the care of the patient and legally authorized to prescribe.

(h) When an oral or telephonically-transmitted order must be used, it must be:

(i) accepted only by personnel that are authorized to do so by the medical staff policies and procedures, consistent with federal and state law; and

(ii) signed or initialed by the prescribing practitioner as soon as possible and in conformity with state and federal law.

(i) The facility must adopt a procedure for reporting to the attending practitioner adverse drug reactions and errors in administration of drugs.

(1) A specialty mental health facility must have pharmaceutical services that meet the needs of the patients and include either a pharmacy directed by a registered pharmacist or a drug storage area under the supervision of a consulting pharmacist who develops, supervises, and coordinates all the facility's pharmacy services.

(2) The facility must ensure that:

(a) The pharmacy or drug storage area is administered in accordance with accepted professional principles.

(b) When a pharmacist is not available, drugs and biologicals are removed from the pharmacy or storage area solely by the personnel designated in writing in medical staff and pharmaceutical services policies, and in a manner consistent with federal and state law.

(c) All compounding, packaging, and dispensing of drugs and biologicals is under the supervision of a pharmacist and performed in a manner consistent with federal and state law and rules.

(d) Drugs and biologicals are kept in a locked storage area.

(e) Outdated, mislabeled, or otherwise unusable drugs and biologicals are removed from the facility and destroyed.

(f) Drug administration errors, adverse reactions, and incompatibilities are immediately reported to the attending practitioner.

(1) If the specialty mental health facility provides outpatient services, each outpatient must be examined by a psychiatrist licensed in Montana and the services must meet the standards contained in ARM 37.106.1008.

(2) The department incorporates by reference ARM 37.106.1008, which contains minimum licensure standards for outpatient facilities. Copies of ARM 37.106.1008 may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1)��A specialty mental health facility must develop, maintain, and implement admission procedures designed to ensure that no client is admitted prior to the facility's documented determination of its ability to meet the needs of the client based on a documented appraisal of the client's individual service needs.��

(2)��The facility must assign a psychiatrist licensed in Montana to admit all patients according to a defined set of admission criteria based upon the Diagnostic and Statistical Manual III-R (DSM III-R) of the American Psychiatric Association and may admit only those patients whose mental health conditions are associated with addictions related to eating disorders (codes 307.10, 307.50, 307.51, 307.52, and 307.53 in the DSM III-R), pathological gambling (code 312.31 in the DSM III-R), or sexual disorders (codes 302.20, 302.30, 302.40, 302.71, 302.72, 302.79, 302.81, 302.82, 302.83, 302.84, 302.89, and 302.90 in the DSM III-R).

(3)��Whenever a patient is admitted to the facility by a physician other than a psychiatrist, the facility must assure that the physician consults with the facility psychiatrist, by phone or otherwise, within 12 hours after admission, that a written notation of that consultation and the psychiatrist approval of the admission for a mental health condition or suspected mental health condition is made and kept in the patient's records, and that a psychiatric evaluation is conducted in accordance with the standards in (4) below prior to admission.

(4)��Each patient must receive a psychiatric evaluation that must be completed by a psychiatrist licensed in Montana prior to admission unless (5) below applies; include a medical history; contain a record of mental status; note the onset of illness and the circumstances leading to admission; describe attitudes and behavior; estimate intellectual functioning, and orientation; and include an inventory of the patient's assets in descriptive rather than interpretive fashion.

(5)��If an individual seeks admission or is referred to the facility outside of the hours of 6:00 a.m. to 7:00 p.m., Monday through Friday, or during national holidays, then the facility may allow that person temporary occupancy under the direction of a Montana licensed physician or Montana licensed psychiatrist until the psychiatric evaluation can be conducted during the facility's next regularly scheduled business day.

(6) If an individual is referred to the facility by a licensed psychiatrist or licensed physician who is not affiliated with the facility, the psychiatric evaluation must still be completed by the facility's staff psychiatrist within the time frame otherwise prescribed for such an evaluation. If a psychiatric evaluation has been conducted by a Montana-licensed psychiatrist not affiliated with the facility, the staff psychiatrist must review and approve the evaluation and note such review and approval in the patient's records.

(7) When indicated, a complete neurological examination must be conducted within 72 hours of admission.

(8) A licensed physician must conduct a physical examination of each patient within 24 hours after or seven days prior to that patient's admission.

(9) The department hereby incorporates by reference codes 302.20, 302.30, 302.40, 302.71, 302.72, 302.79, 302.81, 302.82, 302.83, 302.84, 302.89, 302.90, 307.10, 307.50, 307.51, 307.52, 307.53, and 312.31 of the DSM III-R of the American Psychiatric Association, which contain descriptions of various diagnoses of mental disorders associated with eating disorders, pathological gambling, and sexual disorders. A copy of the manual may be obtained from the American Psychiatric Association, 1700 18th Street NW, Washington, D.C. 20009.

(1) A specialty mental health facility may not admit as a patient any person who:

(a) does not voluntarily seek admission;

(b) requires physical or chemical restraints;

(d) may have impaired judgment or is incapable of appropriate physical action for self-preservation under emergency conditions;

(e) requires a medication regime:

(i) to orient him or her to reality;

(ii) for stabilization or any other purpose related to behavior modification;

(iii) for a mental health condition unrelated to an eating disorder, pathological gambling, or sexual dysfunction; or

(iv) that would otherwise suggest that the person is in need of inpatient psychiatric treatment on such medications;

(f) requires intensive supervision or specialized therapeutic interaction where medical or psychiatric attention or monitoring and treatment is necessary on a continuous basis as determined through a medical or psychiatric evaluation;

(g) requires a treatment that focuses on management of a psychiatric condition that may endanger the person, facility, staff, or others, as determined through a psychiatric evaluation prior to admission;

(h) requires electro-convulsive therapy;

(i) requires a locked environment; or

(j) requires treatment for a mental health condition other than one associated with an addiction.

(2) For purposes of this rule, a person is ambulatory if he or she is capable of self-mobility, either with or without mechanical assistance; if mechanical assistance is necessary, a person is considered ambulatory only if he or she can, without help from another person, utilize the mechanical assistance, exit and enter the facility, or access all common areas in the facility.

(1) Each patient must have an individual comprehensive treatment plan that must be based on an inventory of the patient's strengths and disabilities or mental impairment as defined by the mental health professionals on the multi-disciplinary treatment team and approved by the evaluating or staff psychiatrist.

(2) An initial treatment plan for each patient must be formulated, written and interpreted to the staff by the staff psychiatrist as a part of the admission process.

(3) A comprehensive treatment plan for each patient must be formulated no later than three full working days after admission by a multi-disciplined treatment team and the staff psychiatrist, and placed in the patient's records immediately following approval by the evaluating or staff psychiatrist. The staff psychiatrist and multi-disciplinary professional staff must also participate in the preparation of any major revisions of the comprehensive plan.

(4) The comprehensive treatment plan must:

(a) be based on the patient's psychiatric evaluation;

(b) include clinical consideration of the patient's physical, developmental, psychological, age appropriate, family, educational, social, and recreational needs;

(c) specify the reason for admission and specific treatment goals, stated in measurable terms, including a projected timeframe for completed treatment; treatment modalities to be used; staff who are responsible for coordinating and carrying out the treatment; and expected length of stay and appropriate aftercare planning.

(5) The facility must supply, to each individual being admitted and his or her family, significant other, or referral source, a description, in writing or publication form, of the treatment modalities it provides, including content, methods, equipment, and personnel involved. Each treatment program must conform to the stated purpose and objectives of the facility.

(6) A multi-disciplinary treatment team must provide:

(a) daily clinical services to each patient to assess and treat the person's individual needs, services including appropriate medical, psychological, and health education services; and

(b) individual, family and group psychological counseling; and

(c) access to family members or spouses as part of the treatment plan of each patient when such involvement can be beneficial.

(7) Upon admission of each patient, implementation of a discharge planning program must begin which will ensure that:

(a) discharge planning is documented in the individual treatment plan for each patient; and

(b) each patient, along with the necessary medical and other treatment information, is transferred or referred to appropriate facilities, agencies, or outpatient services, as needed, for continued, follow up, or ancillary care.

(1) A specialty mental health facility shall have written policies and procedures to assure the individual patient the right to dignity, privacy, and safety, and shall support and protect the basic human, civil, and constitutional rights of the individual patient.

(2) A written policy and procedure approved by the governing body shall provide a description of the patient's rights and the means by which these rights are protected and exercised.

(3) At the point of admission, the facility shall provide the patient and family, designated relative, guardian, or custodian, with a clearly written and readable statement of patients' rights and responsibilities. The statement shall be read to the patient and family, guardian, or custodian if any cannot read, and shall cover, at a minimum:

(a) each patient's access to treatment, regardless of race, religion or ethnicity;

(b) each patient's right to recognition and respect of his or her personal dignity in the provision of all treatment and care;

(d) each patient's right to an individualized treatment plan;

(e) each patient's and family's participation in planning for treatment;

(f) the nature of care, procedures, and treatment that he or she will receive;

(g) the risks, side effects, and benefits of all medications and treatment procedures used;

(h) the right, to the extent permitted by law, to refuse the specific medications or treatment procedures and the responsibility of the facility when the patient refuses treatment, or, in accordance with legal and professional standards, to terminate the relationship with the patient upon reasonable notice; and

(i) the patient and family members' right to access to a patient advocate.

(4) The rights of patients must be written in language which is understandable to the patient, his or her family, custodian, or guardian, and must be posted in appropriate areas of the facility.

(5) The policy and procedure concerning patient rights shall assure and protect the patient's personal privacy within the constraints of his or her treatment plan. These rights to privacy shall at least include:

(a) visitation by the resident's family, relatives, guardian, or custodian in a suitable private area of the facility;

(b) sending and receiving mail without hindrance or censorship; and

(6) If any rights to privacy must be limited, the patient and his or her family, guardian, or custodian shall receive a full explanation. Limitations must be documented in the patient's record and their therapeutic effectiveness must be evaluated and documented by professional staff every seven days.

(7) The right to initiate a complaint or grievance procedure and the means for requesting a hearing or review of a complaint must be specified in a written policy approved by the governing body and made available to patients, family, guardians, and custodians responsible for the patient. The procedure shall indicate:

(a) to whom the grievance is to be addressed; and

(b) steps to be followed for filing a complaint, grievance, or appeal.

(8) The patient and his or her family, guardian, or custodian must be informed of the current and future use and disposition of products of special observation and audio visual techniques such as one-way vision mirrors, tape recorders, television, movies, or photographs.

(9) The policy and procedure regarding patient's rights shall ensure the patient's right to confidentiality of all information recorded in his record maintained by the facility. The facility shall ensure the initial and continuing training of all staff in the principles of confidentiality and privacy.

(10) The patient may be allowed to work for the facility only under the following conditions:

(a) the work is part of the individual treatment plan;

(b) the work is performed voluntarily;

(d) the work project complies with applicable law and regulations; and

(e) the performance of tasks related to the responsibilities of family-like living, such as laundry and housekeeping, are not considered work for the facility and need not be compensated or voluntary.

(11) Measures utilized by the facility to discipline patients must be:

(a) established by written policy and procedure developed in consultation with professional and direct care staff and approved by the governing body;

(b) fully explained to each patient and the patient's family, guardian, or custodian;

(12) The facility shall prohibit all cruel and unusual disciplinary measures, including but not limited to the following:

(a) corporal punishment;

(b) forced physical exercise;

(d) group punishment for individual actions:

(e) verbal abuse, ridicule, or humiliation;

(f) denial of three balanced nutritional meals per day;

(g) denial of clothing, shelter, bedding or personal hygiene needs;

(h) denial of access to educational services;

(i) denial of visitation, mail, or phone privileges for punishment;

(j) exclusion of the patient from entry to his or her assigned living quarters; and

(k) restraint or seclusion as a punishment or employed for the convenience of the staff.

(13) Written policy shall prohibit patients from administering disciplinary measures upon one another and shall prohibit persons other than professional or direct care staff from administering disciplinary measures to patients.

(14) Written rules of patient conduct must be:

(a) developed in consultation with the professional and direct care staff and approved by the governing body;

(b) developed with the participation of patients to a reasonable and appropriate extent; and

(15) The application of disciplinary measures should correlate with the violation of established rules.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3, conflict with the terms of this subchapter, the terms of this subchapter will apply to licensed mental health centers.

In addition to the definitions in 50-5-101, MCA, the following definitions apply to this subchapter:

(1) "Administrator" means a designated individual having daily overall management responsibility for the operation of a mental health center.

(2) "Adult day treatment" means a program which provides a variety of mental health services to adults with mental illnesses.

(3) "Chemical dependency services" means:

(a) screening of a client for substance abuse issues by the mental health center through its clinical intake assessment;

(b) as indicated by the substance abuse screening, the provision or arrangement by the mental health center for a client to be evaluated by a licensed addiction counselor;

(c) in accordance with the evaluation by a licensed addiction counselor, the provision or arrangement by the mental health center of chemical dependency treatment by a licensed addiction counselor or state-approved chemical dependency treatment program; and

(d) the integration and coordination by the mental health center of the client's mental health treatment with the chemical dependency treatment.

(4) "Client" means an adult, child or adolescent, or resident receiving services from a mental health center.

(5) "Community-based psychiatric rehabilitation and support" means the definition as defined in ARM 37.88.901.

(6) "Community residential facility" means the definition provided in 76-2-411, MCA.

(7) "Comprehensive school and community treatment program (CSCT)" means a comprehensive, planned course of community mental health outpatient treatment provided in cooperation and under written contract with the school district where the youth attends school. The program must be provided by a licensed mental health center with an endorsement under ARM 37.106.1955, 37.106.1956, 37.106.1960, 37.106.1961, and 37.106.1965.

(8) "Crisis telephone services" means 24 hour telephone response to mental health emergencies for the mental health center's clients.

(9) "Department" means the Department of Public Health and Human Services.

(10) "Forensic mental health facility" (FMHF) means 24-hour, seven days a week, secured nonhospital-based forensic psychiatric treatment for adults who are committed by a court of competent jurisdiction for the purpose of psychiatric treatment or evaluation.

(11) "Guardian" means a person appointed by a court to make medical, and possibly financial, decisions as provided in Title 72, chapter 5, MCA.

(12) "Individualized education program" (IEP) means a written plan developed and implemented for each student with a disability in accordance with 34 CFR 300.320 through 300.325 amended as of October 30, 2007. The department adopts and incorporates by reference 34 CFR 300.320 through 300.325. A copy of the regulations may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(13) "Individualized treatment plan" means a written plan that outlines individualized treatment activities for maximum reduction of mental disability and restoration of the client's ability to function adequately in the family, at work or school, and as a member of the community.

(14) "Inpatient crisis stabilization facility" means 24 hour supervised treatment for adults with a mental illness for the purpose of stabilizing the individual's symptoms.

(15) "In-training practitioner services" means the definition as defined in ARM 37.88.901.

(16) "Licensed health care professional" means a licensed physician, physician assistant, advanced practice registered nurse, or registered nurse who is practicing within the scope of the license issued by the Department of Labor and Industry.

(17) "Licensed mental health professional" means:

(a) a physician, clinical psychologist, social worker, or professional counselor licensed to practice in Montana;

(b) an occupational therapist licensed to practice in Montana who has had at least three years' experience dedicated substantially to serving persons with serious mental illnesses and is working in a youth day treatment program or adult day treatment program; or

(c) a registered nurse who has had at least three years experience dedicated substantially to serving persons with serious mental illnesses and is licensed to practice in Montana.

(18) "Medical director" means a physician licensed by the Montana Board of Medical Examiners who oversees the mental health center's clinical services and who has:

(a) at least a three-year residency in psychiatry; or

(b) at least three years' post-graduate psychiatric training in a program approved by the Counsel on Medical Evaluation of the American Medical Association; or

(c) at least three years of experience in a medical practice dedicated substantially to serving persons with serious mental illnesses.

(19) "Mental health group home" means a community residential facility as defined in ARM 37.88.901.

(20) "Mental illness" means that condition of an individual in which there is either psychological, physiological, or biochemical imbalance which has caused impairment in functioning and/or behavior.

(21) "Outpatient therapy services" means the provision of psychotherapy and related services by a licensed mental health professional acting within the scope of the professional's license or these same services provided by an in-training practitioner in a mental health center.

(22) "Program supervisor" means a designated licensed mental health professional having daily overall responsibility for the operation of a mental health center area of endorsement.

(23) "Program therapist" means a licensed mental health professional with the training and knowledge to provide psychotherapy.

(24) "Representative payee" means a payee appointed by the Social Security Administration when a beneficiary is unable to manage their social security benefits, supplementary security income or Medicare benefits.

(25) "Seclusion" means staff initiating or escorting a youth to a seclusion time-out room to calm down and appropriately manage their behavior.

(26) "Severe disabling mental illness" means, with respect to a person who is 18 or more years of age, that the person meets the requirements defined in ARM 37.86.3502.

(27) "Serious emotional disturbance" means, with respect to a youth, that the youth meets the requirements defined in ARM 37.87.303.

(28) "Site based" means a specific location where the treatment services are consistently provided.

(29) "Targeted case management " means the activities of a single person or team that assists individuals with mental illness to make informed choices for community services which seek to maximize their personal abilities and enable growth in some or all aspects of the individual's vocational, educational, social, and health related environments.

(30) "Time-out" means staff or youth initiating a time-out generally away from the group activity to enable the youth to calm down and appropriately manage their behavior.

(31) "Youth" means a person 17 years of age or younger and includes students up to 20 years of age who still attend a secondary public school.

(32) "Youth day treatment" means a program which provides an integrated set of mental health, education, and family intervention services to youth with a serious emotional disturbance.

(1) Each applicant for licensure must submit a license application to the department requesting approval to provide the services in (3) and may request approval to provide one or more of the services in (4).

(2) Services provided by a mental health center must be rendered by a single administration in a discrete physical facility or multiple facilities or by written agreement or contract with licensed health care professionals, licensed mental health professionals or other facilities such as hospital, clinics, or educational institutions which may combine to provide services.

(3) For a mental health center to be licensed, it must provide to its clients all of the following services:

(a) crisis telephone services;

(b) medication management services;

(d) community-based psychiatric rehabilitation and support; and

(e) chemical dependency services.

(4) A licensed mental health center, with the appropriate license endorsement, may provide one or more of the following services:

(a) youth targeted case management;

(b) adult targeted case management;

(d) adult day treatment;

(e) adult foster care;

(f) mental health group home;

(g) an inpatient crisis stabilization facility;

(h) an outpatient crisis response facility;

(i) a comprehensive school and community treatment program; or

(j) a forensic mental health facility.

(5) Each service listed in (4) that is endorsed by the department must be recorded on the mental health center's license.

(6) A mental health center may not condition a client's access to one of its services upon the client's receipt of another service provided by the mental health center unless continuity and quality of care require that services be provided by the same agency.

(7) Mental health center services must be available to recipients continuously throughout the year.

(8) A mental health center must report to the department, in writing, any of the following changes within at least 30 days before the planned effective date of the change:

(a) a change of administrator;

(b) a change of medical director;

(d) a change in the name of the agency;

(e) the addition of any endorsement service site; or

(f) the discontinuation of providing a service for which the mental health center has an area of endorsement.

(1) Each mental health center shall employ or contract with an administrator who shall:

(a) maintain daily overall responsibility for the mental health center's operations;

(b) develop and oversee the implementation of policies and procedures pertaining to the operation and services of the mental health center;

(c) establish written orientation and training procedures for all employees including new employees, relief workers, temporary employees, students, interns, volunteers, and trainees. The training must include orientation on all the mental health center's policies and procedures;

(d) establish written policies and procedures:

(i) defining the responsibilities, limitations, and supervision of students, interns, and volunteers working for the mental health center;

(ii) for verifying each professional staff member's credentials, when hired, and thereafter, to ensure the continued validity of required licenses; and

(iii) for client complaints and grievances, to include an opportunity for appeal, and to inform clients of the availability of advocacy organizations to assist them.

(e) develop an organizational chart that accurately reflects the current lines of administration and authority; and

(f) maintain a file for all client incident reports.

(2) Each mental health center shall employ or contract with a medical director who shall:

(a) coordinate with and advise the staff of the mental health center on clinical matters;

(b) provide direction, consultation, and training regarding the mental health center's programs and operations as needed;

(c) act as a liaison for the mental health center with community physicians, hospital staff, and other professionals and agencies with regard to psychiatric services; and

(d) ensure the quality of treatment and related services through participation in the mental health center's quality assurance process.

(1) Each mental health center shall maintain a policy and procedure manual. The manual must be reviewed and approved, at least annually, by the medical director and administrator. The manual must contain policies and procedures for:

(a) notifying staff of all changes in policies and procedures;

(b) addressing client rights, including a procedure for informing clients of their rights;

(c) addressing and reviewing ethical issues faced by staff and reporting allegations of ethics violations to the applicable professional licensing authority;

(d) informing clients of the policy and procedures for client complaints and grievances;

(e) initiating services to clients;

(f) informing clients of rules governing their conduct and the types of infractions that can result in suspension or discontinuation of services offered by the mental health center;

(g) suspending or discontinuing program services with the following information to be provided to the client:

(i) the reason for suspending or discontinuing services or access to programs;

(ii) the conditions that must be met to resume services or access to programs;

(iii) the grievance procedure that may be used to appeal the suspension or discontinuation; and

(iv) what services, if any, will be continued to be provided even though participation in a particular service or program may be suspended or discontinued.

(h) referring clients to other providers or services that the mental health center does not provide; and

(i) conducting quality assessment and improvement activities.

(2) If the mental health center provides representative payee services, the center must comply with the accounting and reporting procedures established by the Commissioner of Social Security as identified in section 1631 (a) (2) of the Social Security Act and must further ensure that clients are involved in budgeting their money and that budget sheets be used which require client signatures.

(1) Each mental health center shall:

(a) collect assessment data and maintain clinical records on all clients who receive services and ensure the confidentiality of clinical records in accordance with the Uniform Health Care Information Act, Title 50, chapter 16, part 5, MCA. At a minimum, the clinical record must include:

(i) a clinical intake assessment;

(ii) additional assessments or evaluations, if clinically indicated;

(iii) a copy of the client's individualized treatment plan and all modifications to the treatment plan;

(iv) progress notes which indicate whether or not the stated treatment plan has been implemented, and the degree to which the client is progressing, or failing to progress, toward stated treatment objectives;

(v) medication orders from the prescribing physician and documentation of the administration of all medications;

(vi) signed orders by a licensed mental health professional for any restrictions of rights and privileges accorded clients of the mental health center including the reason(s) for the restriction; and

(vii) a discharge summary when the client's file is closed.

(1) Each mental health center shall complete a clinical intake assessment within 12 hours after admission for crisis stabilization program services and within three contacts, or 14 days from the first contact, whichever is later, for other services. Intake assessments must be conducted by a licensed mental health professional trained in clinical assessments and must include the following information in a narrative form to substantiate the client's diagnosis and provide sufficient detail to individualize treatment plan goals and objectives:

(a) presenting problem and history of problem;

(b) mental status;

(d) initial treatment plan goals;

(e) risk factors to include suicidal or homicidal ideation;

(f) psychiatric history;

(g) substance use/abuse and history;

(h) current medication and medical history;

(i) financial resources and residential arrangements;

(j) education and/or work history; and

(k) legal history relevant to history of illness, including guardianships, civil commitments, criminal mental health commitments, and prior criminal background.

(2) Based on the client's clinical needs, each mental health center shall conduct additional assessments which may include, but are not limited to, physical, psychological, emotional, behavioral, psychosocial, recreational, vocational, psychiatric, and chemical dependency evaluations.

(3) Each mental health center shall maintain a current list of providers who accept referrals for assessments and services not provided by the center.

(1) Based upon the findings of the assessment(s) conducted in accordance with ARM 37.106.1915, each mental health center must establish an individualized treatment plan for each client within 24 hours after admission for crisis stabilization program services and within five contacts, or 21 days from the first contact, whichever is later, for other services. The treatment plan must:

(a) identify treatment team members, from within and outside of the mental health center, who are involved in the client's treatment or care;

(b) specifically state measurable treatment plan objectives that serve the client in the least restrictive and most culturally appropriate therapeutic environment;

(c) for each objective, describe the service(s) or intervention(s) with sufficient specificity to demonstrate the relationship between the service(s) or intervention(s) and the stated objective;

(d) identify the staff person and program responsible for each treatment service to be provided;

(e) include the signature of the client or parent/legal representative/guardian and date indicating participation in the development of the treatment plan. If participation of the client or parent/legal representative/guardian is not possible or inappropriate, written documentation must indicate the reason such participation is not possible;

(f) include the signature and date of the mental health center's licensed mental health professional and of the person(s) with primary responsibility for implementation of the plan, indicating development and ongoing review of the plan. If intensive care management is the only service being received by the client from the mental health center, a program supervisor must sign the treatment plan indicating the supervisor's review and approval for appropriateness; and

(g) state the criteria for discharge, including the client's level of functioning which will indicate when a particular service is no longer required.

(2) The treatment plan must be reviewed at least every 90 days for each client and whenever there is a significant change in the client's condition. A change in level of care or referrals for additional mental health services must be included in the treatment plan.

(3) The treatment plan review must be conducted by at least one licensed mental health professional from the mental health center, and include persons with primary responsibility for implementation of the plan. Other staff members must be involved in the review process as clinically indicated. Outside service providers must be contacted and encouraged to participate in the treatment plan review, as clinically indicated.

(4) If a client is receiving case management and/or medication management services along with one or more other services from the mental health center, the treatment plan review must be conducted by at least one licensed mental health professional from the mental health center and include persons with primary responsibility for implementing the treatment plan. Other staff members must be involved in the review process as clinically indicated. Outside service providers must be contacted and encouraged to participate in the treatment plan review, as clinically indicated.

(5) A treatment team meeting for establishing an individual treatment plan and for treatment plan review must be conducted and include:

(a) the client as clinically appropriate;

(b) the client's legal representative/guardian if applicable;

(c) the client's parents or legal representative/guardian if the client is a youth and the involvement by the parent or legal representative/guardian is clinically appropriate;

(d) case manager, if the client has one; and

(e) in the case of an adult client, an adult friend or family member may be invited to participate in the treatment planning or treatment plan review meeting, at the request of and upon written consent of the client, and as deemed clinically appropriate by the client's treatment team, prior to the scheduling of the meeting.

(6) The treatment plan review must be comprehensive with regard to the client's response to treatment and result in either an amended treatment plan or a statement of the continued appropriateness of the existing plan. The results of the treatment plan review must be entered into the client's clinical record. The documentation must include a description of the client's functioning and justification for each client goal.

(7) If the mental health center develops separate treatment plans for each service, the treatment plans must be integrated with one another and a copy of each treatment plan must be kept in the client's record.

(1) Each mental health center shall prepare a discharge summary for each client no longer receiving services. The discharge summary must include:

(a) the reason for discharge;

(b) a summary of the services provided by the mental health center including recommendations for aftercare services and referrals to other services, if applicable;

(c) an evaluation of the client's progress as measured by the treatment plan and the impact of the services provided by the mental health center; and

(d) the signature of the staff member who prepared the report and the date of preparation.

(2) Discharge summaries reports must be filed in the clinical record within one month of the date of the client's formal discharge from services or within three months of the date of the client's last service when no formal discharge occurs.

(3) For cases left open when a client has not received services for over 30 days, documentation must be entered into the record indicating the reason for leaving the case open.

(1) For each employee or contracted individual, the mental health center shall maintain the following information on file:

(a) a current job description;

(b) if a licensed mental health professional, documentation of current licensure and certification; and

(1) Each mental health center shall implement and maintain an active quality assessment program using information collected to make improvements in the mental health center's policies, procedures and services. At a minimum, the program must include procedures for:

(a) conducting client satisfaction surveys, at least annually, for all mental health center programs. The survey must address:

(i) whether the client, parent or guardian is adequately involved in the development and review of the client's treatment plan;

(ii) whether the client, parent or guardian was informed of client rights and the mental health center's grievance procedure;

(iii) the client's, parent's or guardian's satisfaction with all mental health center programs in which the client participated; and

(iv) the client's, parent's, or guardian's recommendations for improving mental health center's services.

(b) maintaining records on the occurrence, duration and frequency of seclusion and physical restraints used;

(d) a quarterly review with the appropriate school district of the effectiveness, financial status, staffing patterns, and staff caseload of any CSCT program provided pursuant to an endorsement under ARM 37.106.1955, 37.106.1956, 37.106.1960, 37.106.1961 and 37.106.1965.

(2) Each mental health center shall prepare and maintain on file an annual report of improvements made as a result of the quality assessment program.

(1) Each mental health center shall ensure that its facilities, buildings, and homes:

(a) meet all applicable state and local building and fire codes;

(b) have a workable portable fire extinguisher on each floor, with a minimum rating of 2 A10BC. Extinguishers must be readily accessible at all times; and

(c) have a properly maintained and regularly tested smoke detector, approved by a recognized testing laboratory, on each floor. Building exits must be unobstructed and clearly marked.

(2) Each mental health center shall ensure its facilities, buildings, homes, equipment, and grounds are clean and maintained in good repair at all times for the safety and well being of its clients, staff, and visitors.

(1) Each mental health center providing a mental health group home or a crisis intervention stabilization facility must ensure that no more than four residents reside in a single bedroom. Each multi-bedroom must contain at least 80 square feet per bed, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules. Each center must further provide:

(a) one toilet for every four residents;

(b) a toilet and sink in each toilet room;

(d) showers and tubs with non-slip surfaces.

(2) Any provision of this rule may be waived at the discretion of the department if conditions in existence prior to the adoption of this rule or construction factors would make compliance extremely difficult or impossible and if the department determines that the level of safety to residents and staff is not diminished.

(1) Each mental health center shall develop a written plan for emergency procedures. At a minimum, the plan must include:

(a) emergency evacuation procedures to be followed in the case of fire or other emergency;

(b) procedures for contacting emergency service responders; and

(2) Telephone numbers of the hospital, police department, fire department, ambulance, and poison control center must be posted by each telephone.

(1) In addition to the requirements established in this subchapter, each mental health center providing youth and adolescent and adult targeted case management services shall comply with the requirements established in this rule.

(2) Each mental health center providing targeted case management program services shall:

(a) ensure each targeted case manager is meeting with a supervisor at least once per month, as necessary based on the case manager's documented skills and skill sets such as developing treatment plans, facilitating family or caregivers treatment team meetings, and educating the youth and the youth's family or caregivers about the mental health system. In addition, targeted case managers must have access to clinical consultation through the treatment team meeting;

(b) employ or contract with case managers who have the knowledge and skills needed to effectively perform targeted case management duties. Minimum qualifications for a case manager are a bachelor's degree in a human services field with at least one year of full-time experience serving people with mental illnesses. Individuals with other educational backgrounds who, as providers, consumers, or advocates of mental health services have developed the necessary skills, may also be employed as targeted case managers. The mental health center's targeted case management position description must contain equivalency provisions;

(c) train the supervisor and program staff in the therapeutic de-escalation of crisis situations to ensure the protection and safety of the clients and staff. The training must include the use of physical and non-physical methods of managing clients and must be updated, at least annually, to ensure the maintenance of necessary skills;

(d) develop a written protocol for case managers and supervisors that includes a minimum of 20 hours of initial training, and 20 hours of annual continuing education. Areas of focus should include:

(i) competencies in key skill sets such as developing treatment plans, facilitating treatment team meetings, and educating the youth and the youth's family or caregivers about the mental health system; and

(ii) training on suicide prevention, including crisis and safety planning.

(e) maintain progress notes for each client. The progress notes must be entered into the client's clinical record at least every 30 days and upon the occurrence of any significant change in the client's condition;

(f) ensure caseload sizes are sufficiently small to permit case managers to respond flexibly to differing service needs of youth and families, including frequency of contact;

(g) develop written policies and procedures addressing the independence of the targeted case manager and targeted case management program. At a minimum, the policies and procedures must address:

(i) the targeted case manager acting as a client's advocate in involuntary commitment proceedings;

(ii) the targeted case manager's role in conflicts between the client and the mental health center or other agencies;

(iii) the ability of the targeted case manager to freely advocate for services from or outside of the mental health center on behalf of the client;

(iv) the relationship between the primary therapist, if the client has one, and the case manager;

(v) the obligation to report information to the mental health center staff that the client has requested to be kept confidential; and

(vi) the ability of the targeted case manager to contact an advocacy organization if the case manager believes the mental health center is unresponsive to the needs of the client.

(3) The availability of targeted case management services may not be made contingent upon a client's willingness to receive other services. A client suspended or excluded from other programs or services provided by the mental health center may not be restricted or suspended from targeted case management services solely due to the action involving the other program or services.

(4) Targeted case management services are largely provided throughout the community rather than in an office or a facility. All contacts with clients must occur in a place that is convenient for the client. More than 50% of a case manager's in person contacts with clients must be outside of the mental health center's facility. Restrictions may not be placed on a case manager's ability to meet with a client in any reasonable location.

(1) In addition to the requirements established in this subchapter, each mental health center providing a child and adolescent day treatment program shall comply with the requirements established in this rule.

(2) The Child and Adolescent Day Treatment program must be site based and occur in a location separate from the child and adolescent's regular classroom. Appropriate, supplemental day treatment services may be delivered off site. The program shall:

(a) operate at least five days per week for at least three hours per day, unless school holidays preclude day treatment activities. Preschool day treatment programs shall operate at least three days a week, three hours a day, unless school holidays preclude day treatment activities;

(b) employ or contract with a program supervisor who is knowledgeable about the service and support needs of children and adolescents with serious emotional disturbances. The program therapist or program supervisor must be site based;

(c) establish admission criteria which assess the child or adolescent's needs and the appropriateness of the services to meet those needs. Students still in school, 18 years of age or older, remain eligible for the program;

(d) provide mental health services according to the individualized treatment plan which may include individual therapy, family and group therapy, social skills training, life skills training, pre-vocational training, therapeutic recreation services and ensure access to emergency services;

(e) coordinate its services with educational services provided through full collaboration with a school district recognized by the office of public instruction;

(f) provide referral and aftercare coordination with inpatient facilities, residential treatment programs, or other appropriate out-of-home placement programs;

(g) establish policies and procedures regarding the use of time-out and seclusion. Time-out and seclusion may not be used with a locked door. Mechanical restraints may not be used. If time-out is used, intermittent to continuous staff observation is required, as clinically indicated. If seclusion is used, continuous staff observation is required. Written permission from the parent or legal guardian must be obtained for the use of non-aversive and aversive interventions and must be placed in the client's clinical record. The clinical record must include signed orders by a licensed mental health professional for use of seclusion, a detailed description of the circumstances warranting such action, and the date, time and duration of the seclusion;

(h) require and ensure that the program supervisor and all staff shall each have a minimum of six contact hours of annual training relating to child and adolescent mental illnesses and treatment; and

(i) maintain progress notes for each client. The progress notes must be entered into the client's clinical record at least every 30 days and upon the occurrence of any significant change in the client's condition.

(3) The day treatment staff shall attend all child study team (CST) meetings and individual education planning meetings when clinically indicated and permission has been granted by the parent or legal guardian or child, when age appropriate. If the client requires an individualized education program (IEP) , a copy of the IEP must be included in the client's treatment plan unless the parent or legal guardian or child, when age appropriate, refuses to authorize release to the mental health center.

(4) The program supervisor and day treatment program staff must be trained in the therapeutic de-escalation of crisis situations to ensure the protection and safety of the clients and staff. The training must include the use of physical and non-physical methods of managing children and adolescents and must be updated, at least annually, to ensure that necessary skills are maintained.

(5) Each program therapist or in-training practitioner therapist in the program shall carry an active caseload not to exceed 12 day treatment clients. The therapist who carries the caseload must also provide the therapy and must be on site during the entire day treatment hours of operation unless the therapist is attending a meeting offsite that pertains to one of the day treatment client's treatment. The program supervisor may carry a caseload of up to six day treatment clients.

(6) There must be at least one full-time equivalent (FTE) clinical or mental health staff member for every six clients in the program. Support staff means an adult, under the supervision of the program supervisor or therapist, with experience in working with children and adolescents with severe emotional disturbances. For the purpose of this ratio, the number of participants in the program must be based on the average daily attendance. This ratio includes the site based therapist or program supervisor, if the therapist or supervisor spends at least half of the time with the class and is readily available at other times when the need arises. The program therapist's office must be in close proximity to the day treatment classroom to provide timely interventions to clients. Mental health staff must not be shared with other programs. Either the mental health support staff member, the therapist or the supervisor must be in the classroom at all times during operation of the program.

(1) In addition to the requirements established in this subchapter, each mental health center providing adult day treatment shall comply with the requirements established in this rule.

(2) The adult day treatment program shall:

(a) operate at least two days a week, for at least four hours a day;

(b) employ or contract with a program supervisor who is knowledgeable about the service and support needs of individuals with a mental illness, day treatment programming and psychosocial rehabilitation. The program supervisor or program therapist must be site based;

(c) provide, by means of a variety of individual and group treatment modalities, therapy and rehabilitation in the areas of independent living skills, crisis intervention, pre-vocational and vocational skill building, socialization, and recreational activities;

(d) structure its treatment activities to promote increasing levels of independence in the client's functioning;

(e) require the program supervisor and all program staff to each have a minimum of six contact hours of annual training relating to adult mental illness and treatment;

(f) maintain progress notes for each client. The progress notes must be entered into the client's clinical record at least every 30 days and upon the occurrence of any significant change in the client's condition; and

(g) maintain a client to staff ratio that may not exceed ten clients to one staff member.

(3) The program supervisor and day treatment program staff must be trained in the therapeutic de-escalation of crisis situations to ensure the protection and safety of the clients and staff. The training must include the use of physical and non-physical methods of managing clients, and must be updated, at least annually, to ensure that necessary skills are maintained.

(1) In addition to the requirements established in this subchapter, each mental health center providing a mental health group home shall comply with the requirements established in this rule.

(2) The purpose of a mental health group home is to provide residential treatment for adults with a mental illness.

(3) The mental health group home is considered to be a community residential facility for the purposes of local zoning and building codes reviews.

(4) The mental health group home must be annually inspected for compliance with fire codes by the state fire marshal or the marshal's designee. The home shall maintain a record of such inspection for at least one year following the date of the inspection.

(5) The mental health group home shall:

(a) employ or contract with a program supervisor who is knowledgeable about the service and support needs of individuals with mental illnesses;

(b) maintain staffing at least eight hours daily. Additional staff hours and supervision shall be dictated by the needs of the group home residents;

(c) ensure that 24 hour a day emergency mental health care is available through the mental health center or other contracted entities;

(d) structure its treatment activities to promote increasing levels of independence in the client's functioning;

(e) establish admission criteria which assess the individual's needs and the appropriateness of the services to meet those needs. At a minimum, admission criteria must require that the person:

(i) be 18 years of age or older and be unable to maintain the stability of their mental illness in an independent living situation;

(ii) be diagnosed with a mental illness;

(iii) be medically stable;

(iv) not be an immediate danger to self or others;

(v) requires a transitional residential level of care from a short acute hospital stay or long-term commitment, or requires some ongoing residential structure or supervision;

(vi) sign a contract to follow group home rules.

(f) assess new admissions to the mental health group home and offer ongoing treatment and training in the following areas:

(i) community adjustment (ability to use community resources such as stores, professional services, recreational facilities, government agencies, etc.) ;

(ii) personal care (grooming, food preparation, housekeeping, money management, etc.) ;

(iii) socialization; and

(iv) recreation/leisure.

(g) maintain progress notes for each client. The progress notes must be entered into the client's clinical record at least every 30 days and upon the occurrence of any significant change in the client's condition.

(6) Staff working in the mental health group home must:

(a) be 18 years of age;

(b) possess a high school diploma or GED;

(d) be capable of implementing each resident's treatment plan; and

(e) be trained in the Heimlich maneuver and maintain certification in cardiopulmonary resuscitation (CPR) .

(7) The program supervisor shall orient new staff on how to deal with client rule violations, new admissions, emergency situations, after hour admissions and client incident reports. Written policies and procedures for handling day-to-day operations must be available at the group home.

(8) The program supervisor and all program staff must each have a minimum of six contact hours of annual training relating to adult mental illness and treatment.

(9) The program supervisor and group home program staff must be trained in the therapeutic de-escalation of crisis situations to ensure the protection and safety of the residents and staff. The training must include the use of physical and nonphysical methods of managing residents, and must be updated, at least annually, to ensure that necessary skills are maintained.

(10) Upon admission, each resident must be provided with:

(a) a written statement of resident rights which, at a minimum, include the applicable patient rights in 53-21-142 , MCA;

(b) a copy of the mental health center grievance procedure; and

(11) At the time of a resident's discharge from the group home, the staff shall assist the resident in making arrangements for housing, employment, education, training, treatment, and/or other services needed for adequate adjustment to community living.

(1) In addition to the requirements established in this subchapter, each mental health center shall provide crisis telephone services and comply with the following requirements:

(a) ensure that crisis telephone services are available 24 hours a day, seven days a week. Answering services and receptionists may be used to transfer calls to individuals who have been trained to respond to crisis calls;

(b) employ or contract with appropriately trained individuals, under the supervision of a licensed mental health professional, to respond to crisis calls. An appropriately trained individual is one who has received training and instruction regarding:

(i) the policies and procedures of the mental health center for crisis intervention services;

(ii) crisis intervention techniques;

(iii) conducting assessments of risk of harm to self or others, and prevention approaches;

(iv) the process for voluntary and involuntary hospitalization;

(v) the signs and symptoms of mental illness; and

(vi) the appropriate utilization of community resources.

(c) ensure that a licensed mental health professional provides consultation and backup, as indicated, for unlicensed individuals responding to crisis calls;

(d) establish written policies and procedures governing in-person contacts between crisis responders and crisis callers. The policies and procedures must address the circumstances under which the contacts may or may not occur and safety issues associated with in-person contacts;

(e) maintain documentation for each crisis call. The documentation must reflect:

(i) the date of the call;

(ii) the staff involved;

(iii) identifying data, if possible;

(iv) the nature of the emergency, including an assessment of dangerousness/lethality, medical concerns, and social supports; and

(v) the result of the intervention.

(2) No individual may respond to crisis calls until the mental health center documents in writing in the individual's personnel file that the individual has received the training and instruction required in (1) (b) above. Additional training and instruction must be provided to crisis responders based upon an ongoing assessment of presenting problems and responder needs and to ensure that necessary crisis intervention skills are maintained.

(1) In addition to the requirements established in this subchapter, each mental health center providing an inpatient crisis stabilization program shall comply with the requirements established in this rule.

(2) The facility must be annually inspected for compliance with fire codes by the state fire marshal or the marshal's designee. The facility shall maintain a record of such inspection for at least one year following the date of the inspection.

(3) The inpatient crisis stabilization program shall:

(a) employ or contract with a program supervisor knowledgeable about the service and support needs of individuals with mental illness experiencing a crisis. The program supervisor or a licensed mental health professional must be site based;

(b) require staff working in the crisis stabilization program:

(i) be 18 years of age;

(ii) possess a high school diploma or GED; and

(iii) be capable of implementing each resident's treatment plan;

(c) ensure that the program supervisor and all staff each have a minimum of six contact hours of annual training relating to the service and support needs of individuals with mental illness experiencing a crisis;

(d) orient staff prior to assuming the duties of the position on:

(i) the types of mental illness and treatment approaches;

(ii) suicide risk assessment and prevention procedures; and

(iii) program policies and procedures, including emergency procedures;

(e) orient staff within eight weeks from assuming the duties of the position on:

(i) therapeutic communications;

(ii) the legal responsibilities of mental health service providers;

(iii) mental health laws of Montana regarding the rights of consumers;

(iv) other services provided by the mental health center; and

(v) infection control and prevention of transmission of blood borne pathogens;

(f) maintain written program policies and procedures at the facility;

(g) train staff in the abdominal thrust maneuver and ensure staff maintain current certification in cardiopulmonary resuscitation (CPR);

(h) maintain 24 hour awake staff;

(i) maintain a staff-to-patient ratio dictated by resident need. A procedure must be established to increase or decrease staff coverage as indicated by resident need;

(j) establish admission criteria which assess the individual's needs and the appropriateness of the services to meet those needs. At a minimum, admission criteria must require that the person:

(i) be at least 18 years of age;

(ii) be medically stable (with the exception of the person's mental illness);

(iii) be willing to enter the program, follow program rules, and accept recommended treatment;

(iv) be willing to sign a no-harm contract, if clinically indicated;

(v) not require physical or mechanical restraint;

(vi) be in need of frequent observation on a 24-hour basis;

(k) establish written policies and procedures:

(i) for completing a medical screening and establishing medical stabilization, prior to admission;

(ii) to be followed should residents, considered to be at risk for harming themselves or others, attempt to leave the facility without discharge authorization from the licensed mental health professional responsible for their treatment; and

(iii) for the secure storage of toxic household chemicals and sharp household items such as utensils and tools;

(l) when clinically appropriate, provide each resident upon admission, or as soon as possible thereafter:

(i) a written statement of resident rights which, at a minimum, include the applicable patient rights in 53-21-142, MCA;

(ii) a copy of the mental health center grievance procedure; and

(iii) the written rules of conduct including the consequences for violating the rules;

(m) ensure hospital care is available through a transfer agreement for residents in need of hospitalization;

(n) maintain progress notes for each resident. The progress notes must be entered at least daily into the resident's clinical record. The progress notes must describe the resident's physical condition, mental status, and involvement in treatment services; and

(o) make referrals for services that would help prevent or diminish future crises at the time of the resident's discharge. Referrals may be made for the resident to receive additional treatment or training or assistance such as securing housing.

(4) The program supervisor and program staff must be trained in the therapeutic de-escalation of crisis situations to ensure the protection and safety of the residents and staff. The training must include the use of physical and nonphysical methods of managing residents and must be updated, at least annually, to ensure that necessary skills are maintained.

(1) Each mental health center shall make medication management services available to the clients it serves for medications needed to treat their mental illnesses.

(2) Medication management services shall be provided by licensed health care professionals, acting within the scope of their licenses, who are either employed by or contracted with the mental health center.

(3) A mental health center shall have medication management policies and procedures in its policy procedure manual which include, at minimum, the following:

(a) maintaining a current, chronological and dated record of medication orders by the client's licensed health care professional in the client's clinical records;

(b) self-administration of medications by clients;

(d) adjusting dosages or prescribing new medications for clients to include the rationale for the use of and changes in the client's medication;

(e) monitoring the client's response to medication or dosage changes;

(f) maintaining a medication administration record for each client documenting medications and dosages prescribed, the client's compliance in taking prescribed medications, doses taken or not taken, any measure taken to obtain compliance, and the reason for omission of any scheduled dose of medication;

(g) documenting any medication errors;

(h) reporting and addressing in a timely manner, any medication errors and adverse drug reactions to the licensed health care professional who prescribed the client's medication, and to the program supervisor and medical director;

(i) providing and documenting education about the effects, side effects, contraindications and management procedures of the client's medication;

(j) providing safe and secure storage of all medications;

(k) providing refrigeration for medication segregated from food items, within the temperature range specified by the manufacturer for medication that requires refrigeration; and

(l) storing medication in the container dispensed by the pharmacy or in the container in which it was purchased in the case of over-the-counter medication, with the label intact and clearly legible.

(1) In addition to the requirements established in this subchapter, a licensed mental health center providing a comprehensive school and community treatment program (CSCT) must have a CSCT program endorsement issued by the department. To receive a CSCT program endorsement, the licensed mental health center must establish to the department's satisfaction that it meets the requirements stated in ARM 37.106.1955, 37.106.1956, 37.106.1960, 37.106.1961, and 37.106.1965.

(2) The licensed mental health center's CSCT program must have written admission and discharge criteria.

(3) The licensed mental health center must have a written contract with the school district in accordance with ARM 37.87.1802.

(1) For any youth receiving CSCT services, the CSCT program must be able to provide the following services to each youth as specified in that youth's individualized treatment plan (ITP):

(a) individual, group, and family therapy;

(b) behavioral intervention;

(c) other evidence and research-based practices effective in the treatment of youth with a serious emotional disturbance (SED);

(d) direct crisis intervention services during the time the youth is present in a school-owned or operated facility;

(e) a crisis plan that identifies a range of potential crisis situations with a range of corresponding responses including physically present face-to-face encounters and telephonic responses 24/7, as appropriate;

(f) treatment plan coordination with substance use disorder and mental health treatment services the youth receives outside the CSCT program;

(g) access to emergency services;

(h) referral and aftercare coordination with inpatient facilities, psychiatric residential treatment facilities, or other appropriate out-of-home placement programs; and

(i) continuous treatment that must be available twelve months of the year. The program must provide a minimum of four service days per month of CSCT services in summer months. For any youth who does not receive CSCT services in the summer, providers must document in the youth's medical record the reason why the youth did not receive such services, as well as a summary of attempts to engage the youth and family.

(2) CSCT services for youth with SED must be provided according to an ITP designed by a licensed or in-training mental health professional who is a staff member of a CSCT program team.

(3) The CSCT ITP team must include:

(a) licensed or in-training mental health professional;

(b) school administrator or designee;

(d) the youth, as appropriate; and

(e) other person(s) who are providing services, or who have knowledge or special expertise regarding the youth, as requested by the parent(s), legal representative/guardian, or the agencies.

(4) Providers must inform the youth and the parent(s)/legal representative/guardian that Medicaid requires coordination of CSCT with home support services and outpatient therapy.

(5) The CSCT program must employ sufficient qualified staff to deliver all CSCT services to the youth as outlined in the ITP for the youth and in accordance with the contract between the school and the licensed mental health center.

(6) The CSCT team may be assigned to provide services in two schools if the CSCT team responds to crisis situations for youth enrolled in CSCT in each school building during typical school hours.

(7) The CSCT program must employ or contract with a program supervisor who has daily overall responsibility for the CSCT program and who is knowledgeable about the mental health service and support needs of the youth. The program supervisor may provide direct CSCT services, but this position may not fill the functions of the staff positions described in (8) and (9) for more than six months.

(8) Each CSCT team must include a mental health professional, who may be a licensed or in-training mental health professional, as defined in ARM 37.87.702(3). In-training mental health professionals must be:

(a) supervised by a licensed mental health professional; and

(b) supervised according to ARM 24.219.422.

(9) Each CSCT team may include up to two behavioral aides. A behavioral aide must work under the clinical oversight of a licensed mental health professional and provide services for which they have received training that do not duplicate the services of the licensed or in-training mental health professional. All behavioral aides initially employed after July 1, 2013 must have a high school diploma or a GED and at least two years:

(a) experience working with emotionally disturbed youth;

(b) providing direct services in a human services field; or

(10) The licensed mental health center CSCT program supervisor and an appropriate school district representative must meet regularly, at least four times per calendar year, during the time period CSCT services are provided to mutually assess program effectiveness utilizing the following indicators:

(a) progress on the individual treatment plan of each youth receiving CSCT services;

(b) attendance;

(d) contact with law enforcement;

(e) referral to a higher level of care; and

(f) discharges from the program.

(1) The CSCT program must be delivered by adequately trained staff. Training should be competency-based and must be documented and maintained in personnel files.

(2) All CSCT program staff are required to receive a minimum of 18 hours of orientation training during the first three months of employment which addresses all of the following:

(a) certified de-escalation training inclusive of physical and nonphysical methods;

(b) child development;

(d) crisis planning;

(e) roles�and responsibilities of CSCT staff in the school setting;

(f) school culture;

(g) confidentiality requirements;

(h) staff and program supervision; and

(i) CSCT program procedures.

(3) All CSCT program staff are required to receive a minimum of 18 hours training per year in�topics that support staff competency in working with�youth with serious emotional disturbance (SED) to decrease severity of presenting symptoms. Training must include:

(a) positive behavioral intervention planning and support;

(b) classroom and youth behavior management techniques that include certified de-escalation training inclusive of physical and nonphysical methods;

(d) progress monitoring techniques to inform treatment decisions; and

(e) trauma-informed practices.

�

(1) In addition to any clinical records required in ARM 37.85.414 or elsewhere in these rules, the licensed mental health center's CSCT program must maintain the following records for youth with serious emotional disturbance (SED):

(a) a signed verification indicating the parent(s), legal representative, or guardian has been informed by the licensed mental health center that Medicaid requires coordination between CSCT, home support services, and outpatient therapy;

(b) a copy of the clinical assessment which documents the presence of SED;

(d) daily progress notes from each team member that document individual therapy sessions and other direct services provided to the youth and family throughout the day including:

(i) when any therapy or therapeutic intervention begins and ends; and

(ii) the sum total number of minutes spent each day with the youth.

(e) 90-day treatment plan reviews;

(f) discharge plan; and

(g) the Comprehensive School and Community Treatment Data Collection Template, that must be completed each March and September for each youth enrolled in CSCT and submitted to the Children's Mental Health Bureau by the licensed mental health center. The department adopts and incorporates by reference the Comprehensive School and Community Treatment Data Collection Template (form), dated November 1, 2021. A copy of this form may be obtained from the department by a request in writing to the Department of Public Health and Human Services, Developmental Services Division, Children's Mental Health Bureau, 111 N. Sanders, P.O. Box 4210, Helena, MT, 59604-4210 or at found at https://dphhs.mt.gov/dsd/CMB/.

(2) In addition to any clinical records required in ARM 37.85.414 or elsewhere in these rules, records for youth referred to CSCT regardless of their diagnosis as described in ARM 37.87.1803(4) must include the following:

(a) progress notes for each individual therapy session and other direct services provided to the youth and family throughout the day; and

(b) discharge plan with referral to additional services, if appropriate.

(3) Records for youth referred to CSCT and denied acceptance into the program must include documentation detailing the reason for the denial.

(1) The licensed mental health center's CSCT program must be coordinated with the individualized education program (IEP) of the youth, if the youth is identified as a child with a disability and is receiving special education services under the Individuals with Disabilities Education Act (IDEA).

(2) The licensed or in-training mental health professional or behavioral aide, as appropriate, must attend the IEP meeting when requested by the parent(s)/legal representative/guardian or the school.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3, conflict with the terms of this subchapter, the terms of this subchapter will apply to outpatient crisis response facilities.

In addition to the definitions in 50-5-101 , MCA, the following definitions apply to this subchapter:

(1) "Inpatient crisis stabilization program" means 24-hour supervised treatment for adults with a mental illness for the purpose of stabilizing the individual's symptoms.

(2) "Outpatient crisis response facility" means an outpatient facility operated by a licensed hospital or a licensed mental health center that provides evaluation, intervention, and referral for individuals experiencing a crisis due to serious mental illness or a serious mental illness with a co-occurring substance use disorder. The facility may not provide services to a client for more than 23 hours and 59 minutes from the time the client arrives at the facility. The facility must discharge or transfer the client to the appropriate level of care.

(1) Each applicant for licensure shall submit a license application to the department requesting approval to provide outpatient crisis services.

(a) A licensed hospital does not have to comply with the requirements found at ARM 37.106.1906(3) to provide outpatient crisis response services.

(2) Services provided by an outpatient crisis response facility must be rendered by:

(a) a single administration in a discrete physical facility or multiple facilities; or

(b) written agreement or contract with:

(i) licensed health care professionals;

(ii) licensed mental health professionals; or

(iii) other facilities such as hospital, clinics, or educational institutions which may combine to provide crisis services.

(3) Outpatient crisis response facility services must be available to clients continuously throughout the year.

(4) An outpatient crisis response facility must report to the department, in writing, any of the following changes within at least 30 days before the planned effective date of the change:

(a) a change of administrator;

(b) a change of medical director;

(d) a change in the name of the agency; or

(e) the discontinuation of services.

(1) Each crisis response facility shall employ or contract with an administrator who shall:

(a) maintain daily overall responsibility for the crisis response facility's operations;

(b) develop and oversee the implementation of policies and procedures pertaining to the operation and services of the crisis response facility;

(d) develop an organizational chart that accurately reflects the current lines of administration and authority; and

(e) maintain a file for all client incident reports.

(2) Each outpatient crisis response facility shall employ or contract with a medical director who shall:

(a) coordinate with and advise the staff of the outpatient crisis response facility on clinical matters;

(b) provide direction, consultation, and training regarding the outpatient crisis response facility's programs and operations as needed;

(c) act as a liaison for the outpatient crisis response facility with community physicians, hospital staff, and other professionals and agencies with regard to psychiatric or hospital services; and

(d) ensure the quality of treatment and related services through participation in the outpatient crisis response facility's quality assurance process.

(3) Each outpatient crisis response facility shall employ or contract with a program supervisor knowledgeable about the service and support needs of individuals with co-occurring mental illness and intoxication/addiction disorders who may be experiencing a crisis. The program supervisor must be site based.

(4) Each outpatient crisis response facility shall employ or contract with a licensed health care professional as defined in 50-5-101 (34) , MCA for all hours of operation. The licensed health care professional may be the program supervisor.

(1) In addition to the requirements established in this subchapter, each outpatient crisis response facility shall comply with the requirements established in this rule. The outpatient crisis response facility shall require staff working in the facility:

(a) to be at least 18 years of age;

(b) possess a high school diploma or GED; and

(2) The facility must ensure the program supervisor and all staff each have a minimum of six contact hours of annual training relating to the service and support needs of individuals with mental illness experiencing a crisis.

(3) The facility must orient direct care staff, prior to their contact with clients, on the following:

(a) the types of mental illness and treatment approaches;

(b) alcohol and drug intoxication treatment approaches;

(d) suicide risk assessment and prevention procedures; and

(e) program policies and procedures, including emergency procedures.

(4) The facility must orient staff within four weeks of employment on the following:

(a) therapeutic communications;

(b) legal responsibilities of mental health service providers;

(d) other services provided by mental health centers and substance abuse providers; and

(e) infection control and prevention of transmission of blood borne pathogens.

(5) The facility must annually train staff in the abdominal thrust maneuver and ensure staff maintain current certification in cardiopulmonary resuscitation (CPR) .

(6) The facility must maintain locked and secured storage for all medications kept on site.

(7) The facility must maintain 24-hour awake staff.

(8) The facility must maintain staff-to-patient ratio dictated by client need.

(9) The facility must establish admission criteria that assess the individual client's needs and the appropriateness of the services to meet those needs. At a minimum, admission criteria must require that the client:

(a) be at least 18 years of age;

(b) be medically stable, with the exception of the person's mental illness or serious mental illness with a co-occurring substance use disorder; and

(10) The facility must provide each client upon admission, or as soon as possible if not clinically appropriate upon admission with:

(a) a written statement of client rights which, at a minimum, includes the applicable patient rights in 53-21-142 , MCA;

(b) a copy of the crisis response facility grievance procedure; and

(11) The facility must ensure inpatient care is available through a transfer agreement for clients in need of a higher level of care.

(12) The facility must maintain progress notes for each client. The progress notes must be entered following the clinical intake assessment and updated by the end of each shift into the client's clinical record. The progress notes must describe the client's physical condition, mental status, and involvement in treatment services.

(13) The facility must make referrals for services that would help prevent or diminish future crises at the time of the client's discharge. Referrals include, but are not limited to, additional treatment or training or assistance such as securing housing.

(14) The program supervisor and program staff must be trained in the therapeutic de-escalation of crisis situations to ensure the protection and safety of clients and staff. The training must:

(a) include the use of physical and nonphysical methods of managing clients; and

(b) be updated at least annually to ensure that necessary skills are maintained.

(1) Each outpatient crisis response facility shall maintain a policy and procedure manual. The manual must be reviewed and approved, at least annually, by the medical director and administrator. The manual must, at a minimum, contain policies and procedures for:

(a) defining the responsibilities, limitations, and supervision of students, interns, and volunteers working for the crisis response facility;

(b) verifying each professional staff member's credentials, when hired, and annually thereafter, to ensure the continued validity of required licenses;

(c) client complaints and grievances, to include an opportunity for appeal, and to inform clients of the availability of advocacy organizations to assist them;

(d) completing a medical screening and determining methods for medical stabilization and criteria for transfer to appropriate level of medical care that may include emergency care in a hospital;

(e) interacting with clients considered to be at risk for harming themselves or others who attempt to leave the facility without discharge authorization from the licensed mental health professional responsible for their treatment;

(f) increasing or decreasing staff coverage as indicated by client need;

(g) identifying client rights, including a procedure for informing clients of their rights;

(h) addressing and reviewing ethical issues faced by staff and reporting allegations of ethics violations to the applicable professional licensing authority;

(i) informing clients of the policy and procedures for client complaints and grievances;

(j) initiating services to clients;

(k) informing clients of rules governing their conduct and the types of infractions that can result in suspension or discontinuation of services offered by the crisis response facility;

(l) suspending or discontinuing program services with the following information to be provided to the client:

(i) the reason for suspending or discontinuing services or access to programs;

(ii) the conditions that must be met to resume services or access to programs;

(iii) the grievance procedure that may be used to appeal the suspension or discontinuation; and

(iv) what services, if any, will be continued to be provided even though participation in a particular service or program may be suspended or discontinued.

(1) Each crisis response facility shall collect assessment data and maintain clinical records on all clients who receive services.

(2) Each facility must ensure the confidentiality of clinical records in accordance with the Health Information Portability and Accountability Act (HIPAA) .

(3) At a minimum, the clinical record must include:

(a) a clinical intake assessment;

(b) additional assessments or evaluations, if clinically indicated;

(d) progress notes which indicate whether or not the stated treatment plan has been implemented, and the degree to which the client is progressing, or failing to progress, toward stated treatment objectives;

(e) medication orders from the prescribing physician and documentation of the administration of all medications;

(f) signed orders by a licensed mental health professional for any restrictions of rights; and, privileges accorded clients of the crisis response facility including the reasons for the restriction; and

(g) a discharge summary which must be completed within one week of the date of discharge.

(1) Each outpatient crisis response facility shall employ or contract with licensed mental health professionals to conduct clinical intake assessments which may be abbreviated assessments focusing on the crisis issues and safety.

(a) Abbreviated intake assessments must be conducted by a licensed mental health professional trained in clinical assessments including chemical dependency screening. The clinical intake assessment must include sufficient detail to individualize crisis plan goals and objectives.

(2) Based on the client's clinical needs, each crisis response facility will refer any necessary additional assessments to appropriate and qualified providers. Additional assessments may include, but are not limited to, physical, psychological, emotional, behavioral, psychosocial, recreational, vocational, psychiatric, and chemical dependency evaluations.

(3) Each crisis response facility shall maintain a current list of providers who accept referrals for assessments and services not provided by the facility.

(1) Each outpatient crisis response facility shall prepare a discharge summary for each client no longer receiving services. The discharge summary must include:

(a) the reason for discharge;

(b) a summary of the services provided by the crisis response facility including recommendations for aftercare services and referrals to other services, if applicable;

(c) an evaluation of the client's progress as measured by the treatment plan and the impact of the services provided by the facility; and

(d) the signature of the staff member who prepared the report and the date of preparation.

(2) Discharge summary reports must be filed in the clinical record within one week of the date of the client's formal discharge from services.

(1) The facility must develop and implement written policies and procedures that govern the management of inappropriate client behavior only as allowed in 42 CFR 482.13(f) (1) through (6) .

(2) The department adopts and incorporates by reference 42 CFR 482.13(f) (1) through (6) (July 2, 1999) , which contains standards for use of seclusion and restraint for behavioral management.

(3) The policies and procedures must:

(a) specify all facility-approved interventions to manage inappropriate client behavior and designate these interventions on a hierarchy to be implemented, ranging from most positive or least intrusive, to least positive or most intrusive;

(b) ensure, prior to the use of more restrictive techniques, that the client's record documents that programs incorporating the use of less intrusive or more positive techniques have been tried systematically and demonstrated to be ineffective; and

(i) the use of observation and seclusion rooms;

(ii) the use of time-out procedures;

(iii) the use of appropriate medication to manage inappropriate behavior;

(iv) the staff members who may authorize the use of specified interventions; and

(v) a mechanism for monitoring and controlling the use of such interventions.

(4) Interventions to manage inappropriate client behavior must be employed with sufficient safeguards and supervision to ensure that the safety, welfare, and civil and human rights of each client are adequately protected.

(5) Techniques to manage inappropriate client behavior must never be used for disciplinary purposes, for the convenience of staff or as a substitute for a treatment and habilitation program.

(6) The use of systematic interventions to manage inappropriate client behavior must be incorporated into the client's crisis facility treatment plan.

(7) Standing or as needed programs to control inappropriate behavior are not permitted.

(1) For each employee or contracted individual, the outpatient crisis response facility shall maintain the following information on file:

(a) a current job description;

(b) if a licensed mental health professional, documentation of current licensure and certification; and

(1) Each outpatient crisis response facility shall implement and maintain an active quality assessment program using information collected to make improvements in the facility's policies, procedures and services. At a minimum, the program must include procedures for:

(a) conducting client satisfaction surveys, at least annually;

(b) maintaining records on the occurrence, duration, and frequency of seclusion and physical restraints used; and

(2) Each crisis response facility shall prepare and maintain on file an annual report of improvements made as a result of the quality assessment program.

(1) Each outpatient crisis response facility shall ensure that its facilities, buildings, and homes:

(a) meet all applicable state and local building and fire codes. The facility must be annually inspected for compliance with fire codes by the state fire marshal or the marshal's designee, and the facility shall maintain a record of such inspection for at least one year following the date of the inspection;

(b) have a workable portable fire extinguisher on each floor, with a minimum rating of 2A10BC. Extinguishers must be readily accessible at all times;

(c) have a properly maintained and monthly tested smoke detector, approved by a recognized testing laboratory, on each floor of the facility; and

(d) have building exits which must be unobstructed and clearly marked.

(2) Each facility shall ensure its facilities, buildings, homes, equipment, and grounds are clean and maintained in good repair at all times for the safety and well being of its clients, staff, and visitors.

(1) Each outpatient crisis response facility must ensure that no more than four clients reside in a single treatment room. Each treatment room must contain at least 80 square feet per client, exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules. Each center must further provide:

(a) one toilet for every four clients;

(b) a hand washing sink in each toilet room;

(d) showers and tubs with nonslip surfaces and handicap grab bars capable of supporting a sustained weight of 250 lbs.

(1) Each outpatient crisis response facility shall develop a written plan for emergency procedures. At a minimum, the plan must include:

(a) emergency evacuation procedures to be followed in the case of fire or other emergency;

(b) procedures for contacting emergency service responders; and

(2) Telephone numbers of the hospital, police department, fire department, ambulance, and poison control center must be posted by each telephone.

(1) In addition to the requirements established in this subchapter, each mental health center providing foster care for mentally ill adults shall utilize only foster care providers licensed by the department pursuant to ARM Title 37, chapter 100, subchapter 1.

(1) Each mental health center that has a foster care program endorsement shall have policy and procedures in place to make initial and periodic assessment of the foster care provider's ability to meet the following criteria:

(a) ability to provide necessary services and supports to the client; and

(b) ability to support the client's rights as outlined in 53-21-142 , MCA.

(2) The mental health center shall provide an orientation session prior to the mental health center entering into a client placement agreement with the foster care provider, and at least annually on issues that at minimum address the following:

(a) the types of mental illnesses, etiology of mental illnesses, treatment approaches and recovery from mental illnesses;

(b) community resources and available mental health center services;

(d) program policies and procedures, including emergency procedures;

(e) legal responsibilities of mental health service providers and client rights;

(f) infection control and prevention of transmission of blood borne pathogens; and

(g) cardiopulmonary resuscitation (CPR) and Heimlich maneuver.

(1) For each foster care provider, the mental health center shall maintain the following information on file:

(a) initial and annual assessments of the provider's ability to provide necessary services and supports to the client and ability to support the client's rights as outlined in 53-21-142 , MCA; and

(b) documentation of the orientation session prior to entering into a client placement agreement, and annually thereafter.

(2) For each client, the mental health center shall maintain the following information on file:

(a) the mental health center's individual placement agreement with each client which sets forth the terms of the client's placement and the responsibilities of the foster care provider, the mental health center, the client, and when appropriate the guardian as defined in ARM 37.106.1902; and

(b) documentation that the client has received an assessment to ensure the appropriateness of foster care services in meeting the client's needs as provided in ARM 37.106.2015.

(1) A mental health center providing foster care shall employ a program supervisor who is experienced in providing services to individuals with mental illnesses. The program supervisor shall supervise all foster care specialists and ensure the program complies with the requirements of this subchapter. The program supervisor may perform the duties of an adult foster care specialist if the mental health center has not more than 10 adult foster care clients.

(2) A mental health center providing foster care shall train the program supervisor and adult foster care specialists in the therapeutic de-escalation of crisis situations. The training must include the use of physical and non-physical methods of managing clients and must be updated, at least annually.

(3) The mental health center shall provide periodic training to reinforce and update the initial training outlined in this rule.

(1) A mental health center providing foster care shall employ or contract with at least one adult foster care specialist.

(2) The adult foster care specialist shall have the knowledge and skills needed to effectively perform foster care specialist duties. Minimum qualifications for a foster care specialist are a bachelor's degree in a human services field with one year of full time experience serving people with mental illnesses. Individuals with other educational backgrounds who, as providers, consumers or advocates of mental health services have developed the necessary skills, may also be employed as foster care specialists. The mental health center's foster care specialists position description may contain equivalency provisions.

(3) The adult foster care specialist shall:

(a) implement and coordinate mental health services to clients;

(b) carry a case load of not more than 16 foster care clients;

(c) meet with the foster care provider at least weekly in his or her home or whenever there is a significant change in the client's condition, to assess, at a minimum, the following:

(i) the provider's ability to continue to meet the needs of the client as determined by the treatment plan; and

(ii) whether supports for the foster care provider are adequate; and

(d) document bi-weekly summaries or sooner if there is a significant change in the client's condition regarding the client's treatment in the client's clinical record.

�

(1) A mental health center providing foster care shall establish admission criteria which assesses the client's needs and the appropriateness of foster care services to meet those needs. At a minimum, the admission criteria must require that a client:

(a) be 18 years of age or older;

(b) be unable to maintain the stability of their mental illness in an independent living situation;

(d) be medically stable;

(e) not be an immediate danger to self or others; and

(f) be able to take medications when prompted.

(2) A mental health center providing foster care shall assess the needs of each newly-admitted client in the following areas:

(a) the client's ability to appropriately use community resources to access professional services, and to obtain services from public agencies;

(b) the client's personal care skills;

(d) the likelihood the client will benefit from adult foster care.

(1) A mental health center providing foster care shall implement a treatment plan for each client that:

(a) structures rehabilitation and treatment activities to promote increasing levels of independence;

(b) articulates a detailed crisis plan; and

(i) housing;

(ii) employment;

(iii) education and training;

(iv) treatment; and

(v) any other services needed for independent living.

(2) A mental health center providing foster care shall maintain progress notes for each client. The progress notes must be entered into the client's clinical record at least every 30 days, and upon the occurrence of any significant change in the client's condition.

�

(1) The mental health center shall enter into an individual placement agreement which sets forth the terms of the client's placement, the responsibilities of the foster care provider, the mental health center, the client, and when appropriate, the guardian.

(2) The placement agreement must be signed with copies dispersed to all parties who are a part of the agreement.

(3) The placement agreement shall be reviewed quarterly by all parties who are part of the agreement to determine the need for any amendments to the agreement.

(1) Upon admission a mental health center providing foster care shall provide each client with:

(a) a written statement of the client's rights which, at a minimum, include the rights found in 53-21-142 , MCA;

(b) a copy of the mental health center grievance procedure; and

(1) In addition to the requirements established in this subchapter, each mental health center providing a secured inpatient crisis stabilization program shall comply with all the requirements established in ARM 37.106.1945 and 37.106.1946 with the exclusion of ARM 37.106.1946(3)(j).

(2) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of this subchapter, the terms of this subchapter will apply to secured crisis stabilization facilities.

(1) This rule is intended to apply to all state licensed mental health centers or hospitals providing a secured crisis stabilization service as part of the crisis service continuum.

In addition to the definitions in 50-5-101, MCA, the following definitions apply to this subchapter:

(1) "Crisis plan" means an initial, brief, individualized plan that:

(a) lists client problems identified by the secured crisis stabilization facility's mental health crisis assessment;

(b) lists the individual's strengths and resources;

(d) identifies support network options; and

(e) identifies referral and transition activities that will occur at discharge.

(2) "In-patient crisis stabilization program" means 24-hour supervised treatment for adults with a mental illness for the purpose of reducing the severity of an individual's mental illness symptoms.

(3) "Secured crisis stabilization facility (SCSF)" means a secure in-patient facility operated by a licensed hospital, critical access hospital, or a licensed mental health center that provides evaluation, intervention, and referral for individuals experiencing a crisis due to serious mental illness or a serious mental illness with a co-occurring substance use disorder. The facility may only provide secured services to a client when a detention exists as defined in 53-21-129, MCA.

(1) Prior to construction, floor plans for the secured in-patient crisis stabilization facility must be submitted to the Licensure Bureau of the Department of Public Health and Human Services for review, comment, and approval.

(a) Prior to occupancy, the facility shall undergo an onsite inspection and receive the written approval of all authorities having jurisdiction.

(2) A SCSF is considered a separate mental health unit requiring a staff station located within the secured unit.

(a) The unit shall be staffed at all times patients are placed in the secured unit.

(3) The SCSF staff station (at a minimum) will provide the following:

(a) provisions for charting;

(b) provisions for hand washing;

(d) telephone access.

(4) The SCSF will provide access to a nourishment station or kitchen as required in 2001 Edition of the Guidelines for the Design and Construction of Hospitals and Health Care Facilities, Section 8.2.C9, For Serving Nourishments Between Meals. A copy of this publication can be obtained from the Department of Public Health and Human Services, Quality Assurance Division, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena MT 59620-2953.

(5) A nourishment station will contain the following:

(a) a work counter;

(b) refrigerator;

(d) a sink;

(e) space for trays and dishes used for nonscheduled meal service;

(f) hand washing facilities in or immediately accessible; and

(g) ice for patient consumption will be provided by icemaker-dispenser units or periodically set up individually during the day.

(6) A dining/activities/day space within the unit must be provided at a ratio of 35 square feet per resident, with at least 14 square feet dedicated to dining space.

(7) Patient rooms will be at a ratio of 80 square feet for single bedrooms. The room square footage does not include bathrooms, door swings, alcoves, or vestibules. No more than one patient shall reside in a single room in a secured unit.

(1) There will be at least one toilet available for every four patients in the facility.

(2) There will be at least one bathing unit for every six patients in the facility. A shower or tub is not required if the facility utilizes a central bathing unit for every six patients.

(3) All doors to toilet rooms or bathing units must swing out or slide into the wall and shall be unlockable from the outside.

(4) Toilet rooms and bathing facilities may be under key control by staff.

(1) The facility must follow the provisions of the 2000 Edition of the NFPA 101, Life Safety Code, (LSC). A copy of this publication can be obtained from the Department of Public Health and Human Services, Quality Assurance Division, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena MT 59620-2953.

(2) The 2000 Edition of the NFPA 101, Life Safety Code, (LSC), has the following requirements for special locking arrangements for a secured SCSF unit. LSC 5-2.1.6.1 states:

(a) In buildings protected throughout by an approved supervised automatic fire detection system or approved supervised automatic sprinkler system and when permitted by chapters 8 through 30, doors in low or ordinary hazard areas, as defined by LSC 4-2.2, may be equipped with approved, listed, locking devices which shall:

(i) unlock upon actuation of an approved supervised automatic fire detection system or approved supervised automatic sprinkler system installed in accordance with LSC 7-6 or 7-7; and

(ii) unlock upon loss of power controlling the lock or locking mechanism; and

(iii) initiate an irreversible process which will release the lock within 15 seconds whenever a force of not more than 15 pounds (67N) is continuously applied, for a period of not more than three seconds to the release device required in LSC 5-2.1.5.3. Relocking of such doors shall be by manual means only. Operation of the release device shall activate a signal in the vicinity of the door for assuring those attempting to exit that the system is functional. Exception to this subsection: The authority having jurisdiction may approve a delay not to exceed 30 seconds provided that reasonable life safety is assured pursuant to LSC 5-2.1.6.2. A sign shall be provided on the door adjacent to the release device which reads:

PUSH UNTIL ALARM SOUNDS

DOOR CAN BE OPENED IN 15 SECONDS

(A) Sign letters shall be at least one inch (2.5cm) high and one eighth inch (0.3cm) wide stroke.

(3) The department shall grant an SCSF exception to the LSC code - Special Locking Arrangements, based on an equivalency for the automatically releasing, panic hardware required by LSC 5-2.1.6.1. All of the following conditions shall apply to granting the exception:

(a) the use of mechanical locks, such as dead bolt, is not permitted. All locks used must be electromagnetically controlled;

(b) all secured doors in the unit must have a manual electronic key pad which must release the door after entry of the proper code sequence;

(i) the actuation of the approved supervised automatic fire alarm system;

(ii) the actuation of an approved supervised automatic sprinkler system;

(iii) loss of the public utility power controlling locks; and

(iv) a staff accessible switch at the staff station which is capable of releasing all doors.

(1) A SCSF must be capable of providing restraint or seclusion and must ensure that the restraint or seclusion is performed in compliance with 42 CFR 482.13(f)(1) through (7). The department adopts and incorporates by reference 42 CFR 482.13(f)(1) through (7) (July 2, 1999), which contains standards for use of seclusion and restraint for behavioral management.

(2) Restraint and seclusion must be performed in a manner that is safe, proportionate, and appropriate to the severity of the behavior, the patient's size, gender, physical, medical, and psychiatric condition and personal history.

(3) Seclusion or restraint may only be used in emergency situations needed to ensure the physical safety of the individual patient, other patients, or staff of the facility and when less restrictive measures have been found to be ineffective to protect the resident or others from harm.

(4) Seclusion and restraint procedures must be implemented in the least restrictive manner possible in accordance with a written modification to the patient's health care/treatment plan and discontinued when the behaviors that necessitated the restraint or seclusion are no longer in evidence.

(5) "Whenever needed" or "prescribed as needed" standing orders for use of seclusion or restraint are prohibited.

(6) A physician or other authorized health care provider must authorize use of the restraint or seclusion within one hour of initiating the restraint or seclusion. Each original order and renewal order is limited to four hours.

(7) Each order of restraint or seclusion is limited in length of time to a total of 24 hours.

(8) A SCSF will have a minimum one "comfort/safe" room for use for patient seclusion as prescribed by the facility's policy and procedures, and in accordance with applicable state and federal standards.

(1) The facility will develop and implement a written policy outlining the admission criteria for placing a client into the secured service.

(1) The facility shall develop and implement discharge and transfer criteria for discharging a client from the secured setting. At the end of the detention the facility must:

(a) discharge the patient;

(b) refer the patient to a licensed nonsecured inpatient stabilization program;

(d) transfer the client to an appropriate level of acute in-patient treatment.

(2) The facility must ensure in-patient care is available through a critical access hospital or hospital transfer agreement for clients in need of an acute level of medical treatment.

(1) Each SCSF shall employ or contract with a site based administrator who has daily overall management responsibility for the operation of the SCSF. The administrator of the mental health center or hospital if they are site based to the secured crisis stabilization or, if the SCSF is part of a hospital per ARM 37.106.2027(2) may assume this responsibility.

(2) Each SCSF facility shall employ or contract with a program supervisor knowledgeable about the service and support needs of individuals with co-occurring mental illness and intoxication/addiction disorders who may be experiencing a crisis. The program supervisor must be site based.

(3) Each SCSF shall employ or contract with a licensed health care professional as defined in 50-5-101(34), MCA, for all hours of operation. The licensed health care professional may be the program supervisor.

(1) Each SCSF shall employ or contract with licensed mental health professionals to conduct clinical intake assessments which may be abbreviated assessments focusing on the crisis issues and safety.

(2) Based on the client's clinical needs, each SCSF will refer any necessary additional assessments to appropriate and qualified providers. Additional assessments may include, but are not limited to:

(a) physical;

(b) psychological;

(d) behavioral;

(e) psychosocial;

(f) recreational;

(g) vocational;

(h) psychiatric; and

(i) chemical dependency evaluations.

(3) Each SCSF shall maintain a current list of providers who accept referrals for assessments and services not provided by the facility.

(1) Each SCSF shall prepare a discharge summary for each client no longer receiving services. The discharge summary must include:

(a) the reason for discharge;

(b) a summary of the services provided by the SCSF including recommendations for aftercare services and referrals to the other services, if applicable;

(c) an evaluation of the client's progress as measured by the treatment plan and the impact of the services provided by the facility; and

(d) the signature of the staff member who prepared the report and the date of preparation.

(2) Discharge summary reports must be filed in the clinical record within one week of the date of the client's formal discharge from services.

(1) Each SCSF shall develop a written plan for emergency procedures. At a minimum, the plan must include:

(a) emergency evacuation procedures to be followed in the case of fire or other emergency;

(b) procedures for contacting emergency service responders; and

(2) Telephone numbers of the hospital, police department, ambulance, and poison control center must be posted by each telephone.

(1) To the extent that other licensure rules in ARM Title 37 conflict with the provisions of this subchapter, the provisions of this subchapter will apply to intermediate care facility for the developmentally disabled ( ICF /DD) .

(2) Notwithstanding the requirements of this chapter, the facility shall comply with the terms and conditions of an order issued by a court of competent jurisdiction, including, but not limited to, the observance of any limitations placed upon a client's rights by the court.

(1) "Abuse" is defined at 52-3-803 , MCA.

(2) "Administrator" means a designated individual having daily overall management responsibility for the operation of a facility.

(3) "Client" means an adult resident, 18 years of age or older, receiving services from a facility.

(4) "Comprehensive functional assessments" identify the client's presenting problems, disabilities, specific developmental strengths, specific developmental and behavioral management needs, and need for services. This assessment must take into consideration the client's age and the implications for treatment and habilitation at each stage.

(5) "Department" means the department of public health and human services.

(6) "Direct care staff" means present on-duty staff that provide personal care and habilitation services in each defined residential living unit as well as client support services.

(7) "Direct care services" are services provided by direct care staff of the facility.

(8) "Exploitation" is defined at 52-3-803 , MCA.

(9) "Facility" means an intermediate care facility for the developmentally disabled.

(10) "Guardian" means a person or entity appointed by a court in a proceeding under Title 72, chapter 5, MCA, to make decisions on behalf of an incapacitated adult.

(11) "Habilitation" is defined at 53-20-102 , MCA.

(12) "Individual treatment plan" means a written plan that outlines individualized treatment activities for the treatment and habilitation of the client.

(13) "Interdisciplinary team" means individuals representing the professions, disciplines or service areas that are relevant to identifying and serving the client's needs. The team uses comprehensive functional assessments to develop and maintain the individual treatment plan for each client.

(14) "Intermediate care facility for the developmentally disabled ( ICF /DD) " means a long term care facility that provides intermediate developmental disability care.

(15) "Intermediate developmental disability care" is defined at 50-5-101 , MCA.

(16) "Long term care facility" is defined at 50-5-101 , MCA.

(17) "Neglect" is defined at 52-3-803 , MCA.

(18) "Preliminary evaluation" means evaluation of client's background information as well as currently valid assessments of functional, developmental, behavioral, social, health and nutritional status to determine if the facility can provide for the client's needs and if the client is likely to benefit from placement in the facility.

(19) "Program staff" means facility staff serving the needs of the client within the scope of their education and training.

(20) "Sexual abuse" is defined at 52-3-803 , MCA.

(1) The facility must identify an individual or individuals to constitute the governing body of the facility. The governing body must:

(a) exercise general policy, budget, and operating direction over the facility; and

(b) appoint the administrator of the facility.

(2) The administrator appointed by the governing body shall, at a minimum:

(a) hold a current Montana nursing home administrator license;

(b) be a licensed health care professional; or

(1) The facility must be in compliance with all applicable provisions of state and local laws, regulations and codes.

(1) The facility must develop and maintain a recordkeeping system that includes a separate record for each client and that documents the client's health care, treatment and habilitation, including preliminary evaluation, comprehensive functional assessments, individual treatment plan, progress notes, social information, and protection of the client's rights.

(2) The facility must keep confidential all information contained in the client's records, regardless of the form or storage method of the records.

(3) The facility must develop and implement policies and procedures governing the release of any client information, including consents necessary from the client or legal guardian.

(4) Any individual who makes an entry in a client's record must make it legibly, date it, and sign it.

(5) The facility must provide a legend to explain any symbol or abbreviation used in a client's record.

(6) The facility must provide each identified residential living unit with appropriate aspects of each client's record.

(1)��If a service required under this subchapter is not provided directly, the facility must have a written agreement with an outside program, resource, or service to furnish the necessary service, including emergency and other health care.

(2)��The agreement must:

(a)��contain the responsibilities, functions, objectives, and other terms agreed to by both parties; and

(b)��provide that the facility is responsible for assuring that the outside services meet the standards for quality of services contained in this subchapter.

(3)��The facility must assure that outside services meet the needs of each client.�

(1) The facility must ensure the rights of all of the clients and must:

(a) inform each client or legal guardian of the client's rights and the rules of the facility;

(b) inform each client or legal guardian of the client's medical condition, developmental and behavioral status, attendant risks of treatment, and of the right to refuse treatment;

(c) inform the individual client of their rights as a client of the facility, including the right to file complaints, the right to protection against any retaliation when filing a complaint and the right to due process;

(d) allow the individual client to manage their financial affairs and teach them to do so to the extent of their capabilities;

(e) ensure that each client is not subjected to abuse, sexual abuse, neglect, exploitation or punishment;

(f) ensure that each client is free from unnecessary drugs and unnecessary physical restraints;

(g) provide each client with the opportunity for personal privacy and ensure privacy during treatment and care of personal needs;

(h) ensure that each client is not compelled to perform services for the facility and ensure that each client who does work for the facility is compensated for their efforts at prevailing wages and commensurate with their abilities;

(i) ensure each client the opportunity to communicate, associate and meet privately with individuals and to send and receive unopened mail, except that these rights may be restricted as provided in Title 53, part 20, MCA;

(j) ensure that each client has access to telephones with privacy for incoming and outgoing local and long distance calls, except that these rights may be restricted as provided in Title 53, part 20, MCA;

(k) ensure that each client has the right to retain and use appropriate personal possessions and clothing, and ensure that each client is dressed in their own clothing each day, except that these rights may be restricted as provided in Title 53, part 20, MCA;

(l) ensure the client the opportunity to participate in social, religious and community group activities, except that these rights may be restricted as provided in Title 53, part 20, MCA; and

(m) permit a husband and wife who both reside in the facility to share a room. This right may only be limited by written order of the individual treatment planning team when there is no less restrictive means for preventing imminent bodily harm to either partner, or when either partner requests a separate room. The written order must explain the reason for the restriction and must be reviewed monthly by the individual treatment planning team if the restriction is to be continued.

(2) Any rights to which residents are entitled under this subchapter may be limited as provided in Title 53, part 20, MCA.

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(1) The facility must establish and maintain a system that:

(a) assures a full and complete accounting of each client's personal funds entrusted to the facility on behalf of each client; and

(b) precludes any commingling of a client's funds with facility funds or with the funds of any person other than another client.

(2) The client's financial record must be available on request to the client or legal guardian.

(1) The facility must:

(a) promote participation of the legal guardian in the process of providing treatment and habilitation to a client unless their participation is unobtainable or inappropriate;

(b) answer communications from the client's family and friends promptly and appropriately;

(c) permit visits by the guardian to any area of the facility that provides direct client care services to the client, consistent with the right of that client's and other clients' privacy;

(d) notify the client or client's guardian of changes in the client's condition including, but not limited to, serious illness, accident, death, abuse, or unauthorized absence in a timely manner as indicated by an assessment of the individual incident.

(1) The facility must develop and implement written policies and procedures to prevent abuse, sexual abuse, neglect, or exploitation of the client.

(2) Facility staff must report all known or suspected incidents of client abuse, sexual abuse, neglect or exploitation to the facility administrator, and the facility administrator or his or her designee shall report said incidents to the department in accordance with the requirements of Title 52, chapter 3, part 8, MCA.

(3) The facility must develop and implement written policies and procedures for the investigation of allegations of client abuse, sexual abuse, neglect or exploitation.

(4) The results of all facility investigations of client abuse, sexual abuse, neglect or exploitation must be reported to the department when the investigation has been initiated and upon completion. If an allegation of client abuse, sexual abuse, neglect or exploitation is verified, appropriate corrective action must be taken.

(1) Each client must receive the professional program services necessary to implement the treatment and habilitation program defined by each client's individual treatment plan. In providing these services, professional program staff must work directly with each client and with paraprofessional, nonprofessional and other professional program staff who work with each client.

(2) The facility must have available program staff to carry out and monitor the interventions in accordance with the stated goals and objectives of every individual treatment plan.

(3) Program staff must participate as members of the interdisciplinary team in relevant aspects of the treatment and habilitation process.

(4) Professional program staff must be licensed, certified, or registered, as applicable, by the state of Montana to provide professional services.

(5) Program staff must serve the special needs of the client as defined by the individual treatment plan.

(1) The facility must not depend upon the client or volunteers to perform direct care services for the facility.

(2) There must be responsible direct care staff on duty and awake on a 24 hour basis, when any client is present, to take prompt, appropriate action in case of injury, illness, fire or other emergency.

(3) The facility must provide sufficient support staff so that direct care staff are not required to perform support services to the extent that these duties interfere with the exercise of their primary direct client care duties.

(1) The facility must provide sufficient direct care staff to manage and supervise each client in accordance with their individual treatment plan.

(2) Direct care staff must be provided by the facility in the following minimum ratios of direct care staff to clients:

(a) a staff to client ratio of 1 to 3.2 for each defined residential living unit serving:

(i) any severely and profoundly retarded client;

(ii) a client with severe physical disabilities;

(iii) any client who is aggressive, assaultive , or a security risk; or

(iv) any client who manifests severely hyperactive or psychotic-like behavior.

(b) for each defined residential living unit who serves any moderately retarded client, the staff to client ratio is 1 to 4.

(c) for each defined residential living unit who serves any client who functions within the range of mild retardation, the staff to client ratio is 1 to 6.4.

(3) The above staff to client ratios shall be calculated for each defined residential living unit based on the number of direct care staff who are present and on-duty during all shifts in a 24 hour period.

(1) The facility must provide each staff member with initial and continuing training that enables the employee to perform his or her duties effectively, efficiently, and competently.

(2) For staff members who work with any client, training must focus on skills and competencies directed toward the client's developmental, behavioral, and health needs.

(3) Staff must be able to demonstrate the skills and techniques necessary to administer interventions to manage the inappropriate behavior of any client.

(4) Staff must be able to demonstrate the skills and techniques necessary to implement the individual treatment plan for each client for whom they are responsible.

(1) Each client must be offered a treatment and habilitation program which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services and related services described in this subchapter, that is directed toward:

(a) the acquisition of the behaviors necessary for the client to function with as much self determination and independence as possible; and

(b) the prevention or deceleration of regression or loss of current optimal functional status.

(1) Admission decisions must be based on a preliminary evaluation of the client that is conducted or updated by the facility or by outside sources, except that admission procedures regarding clients which have been committed to the facility by a court of competent jurisdiction shall be conducted pursuant to Title 53, chapter 20, part 1, MCA.

(2) A preliminary evaluation must contain background information as well as currently valid assessments of functional, developmental, behavioral, social, health and nutritional status to determine if the facility can provide for the client's needs and if the client is likely to benefit from placement in the facility.

(3) If a client is to be either transferred or discharged from the facility, the facility must:

(a) have documentation in the client's record that the client was transferred or discharged for good cause; and

(b) provide a reasonable time to prepare the client or guardian for the transfer or discharge (except in emergencies) .

(4) At the time of the discharge, the facility must:

(a) develop a final summary of the client's developmental, behavioral, social, health and nutritional status and, with the consent of the client or legal guardian, provide a copy to authorized persons and agencies; and

(b) provide a post-discharge plan of care that will assist the client in adjusting to the new living environment.

(5) A resident has a right to a fair hearing to contest an involuntary transfer or discharge as provided at ARM 37.5.116.

(1) Each client must have an individual treatment plan developed by an interdisciplinary team that represents the professions, disciplines or service areas that are relevant to:

(a) identifying the client's needs, as described by the comprehensive functional assessments required in (3) ; and

(b) designing programs that meet the client's needs.

(2) Appropriate facility staff must participate in interdisciplinary team meetings. Participation by other agencies serving the client is encouraged. Participation by the client or the client's legal guardian is required unless that participation is unobtainable or inappropriate.

(3) Within 30 days after admission, the interdisciplinary team must perform accurate assessments or reassessments as needed to supplement the preliminary evaluation conducted prior to admission. The comprehensive functional assessment must take into consideration the client's age (for example a young adult, an elderly person) and the implications for treatment and habilitation at each stage, as applicable, and must:

(a) identify the presenting problems and disabilities and where possible, their causes;

(b) identify the client's specific developmental strengths;

(d) identify the client's need for services without regard to the actual availability of the services needed; and

(e) include physical development and health, nutritional status, sensory motor development, affective development, speech and language development and auditory functioning, cognitive development, social development, adaptive behaviors or independent living skills necessary for the client to be able to function in the community, and as applicable, vocational skills.

(4) Within 30 days after admission, the interdisciplinary team must prepare for each client an individual treatment plan that states the specific objectives necessary to meet the client's needs, as identified by the comprehensive assessment required by (3) , and the planned sequence for dealing with those objectives. These objectives must be:

(a) stated separately, in terms of a single behavioral outcome;

(b) assigned projected completion dates;

(d) organized to reflect a developmental progression appropriate to the individual; and

(e) assigned priorities.

(5) Each written training program designed to implement the objectives in the individual treatment plan must specify:

(a) the methods to be used;

(b) the schedule for use of the method;

(d) the type of data and frequency of data collection necessary to be able to assess progress toward the desired objectives;

(e) the inappropriate client behavior(s) , if applicable; and

(f) provision for the appropriate expression of behavior and the replacement of inappropriate behavior, if applicable, with behavior that is adaptive or appropriate.

(6) The individual treatment plan must also:

(a) describe relevant interventions to support the individual toward independence;

(b) identify the location where program strategy information (which must be accessible to any person responsible for implementation) can be found;

(c) include, for each client who lacks them, training in personal skills essential for privacy and independence (including, but not limited to, toilet training, personal hygiene, dental hygiene, self-feeding, bathing, dressing, grooming, and communication of basic needs) until it has been demonstrated that the client is developmentally incapable of acquiring them;

(d) identify mechanical supports, if needed, to achieve proper body position, balance, or alignment. The plan must specify the reason for each support, the situations in which each is to be applied, and a schedule for the use of each support;

(e) provide that each client who has multiple disabling conditions spend a major portion of each waking day out of bed and outside the bedroom area, moving about by various methods and devices whenever possible; and

(f) include opportunities for client choice and self-management.

(7) Relevant portions of each client's individual treatment plan must be made available to appropriate staff, including staff of other agencies who work with the client and to the client or legal guardian.

(1) As soon as the interdisciplinary team has formulated a client's individual treatment plan, each client must be offered a continuous treatment and habilitation program consisting of needed interventions and services in sufficient number and frequency to support the achievement of the objectives identified in the individual treatment plan.

(2) Except for those facets of the individual treatment plan that must be implemented only by licensed personnel, each client's individual treatment plan must be implemented by all staff who work with the client.

(1) Data relative to accomplishment of the criteria specified in client individual treatment plan objectives must be documented in measurable terms.

(2) The facility must document significant events that are related to the client's individual treatment plan and assessments and that contribute to an overall understanding of the client's ongoing level and quality of functioning.

(3) The facility staff must prepare progress notes which indicate whether or not the stated individual treatment plan has been implemented, and the degree to which the client is progressing, or failing to progress, toward stated treatment objectives. The progress notes must be entered into the client's clinical record at least weekly and upon the occurrence of any significant change in the client's condition.

(1) At least annually the comprehensive functional assessment of each client must be reviewed by the interdisciplinary team for relevancy and updated as needed, and the individual treatment plan must be revised, as appropriate, repeating the process set forth in ARM 37.106.2133(3) .

(2) The individual treatment plan for each client must be reviewed by the interdisciplinary team every 90 days and whenever there is a significant change in the client's condition. The individual treatment plan must be revised, as appropriate.

(3) The facility must designate and use a specially constituted committee or committees consisting of members of facility staff, legal guardians, clients (as appropriate) , qualified persons who have either experience or training in contemporary practices to change inappropriate client behavior, and persons with no ownership or controlling interest in the facility to:

(a) review, approve, and monitor individual treatments designed to manage inappropriate behavior and other treatments that, in the opinion of the committee, involve risks to client protection and rights;

(b) ensure that these treatments are conducted only after the client or legal guardian has been informed; and

(i) drug usage;

(ii) physical restraints;

(iii) time out rooms;

(iv) application of painful or noxious stimuli;

(v) control of inappropriate behavior;

(vi) protection of client rights and funds; and

(vii) any other area that the committee believes needs to be addressed.

(1) The facility must develop and implement written policies and procedures for the management of conduct between staff and the client. These policies and procedures must:

(a) promote the growth, development and independence of the client;

(b) address the extent to which the client's choice will be accommodated in daily decision-making, emphasizing self-determination and self-management, to the extent possible;

(d) be available to all staff, the client and the legal guardian.

(2) To the extent possible, each client must participate in the formulation of these policies and procedures.

(3) The client must not discipline any other client, except as part of an organized system of self-government, as set forth in facility policy.

(1) The facility must develop and implement written policies and procedures that govern the management of inappropriate client behavior only as allowed in 53-20-146 , MCA. These policies and procedures must be consistent with the provisions of ARM 37.106.2139, and must:

(a) specify all facility-approved interventions to manage inappropriate client behavior;

(b) designate these interventions on a hierarchy to be implemented, ranging from most positive or least intrusive, to least positive or most intrusive;

(c) ensure, prior to the use of more restrictive techniques, that the client's record documents that programs incorporating the use of less intrusive or more positive techniques have been tried systematically and demonstrated to be ineffective; and

(d) address the following:

(i) the use of secured units;

(ii) the use of observation and seclusion rooms;

(iii) the use of physical restraints;

(iv) the use of time out procedures;

(v) the use of appropriate medication to manage inappropriate behavior;

(vi) the application of painful or noxious stimuli;

(vii) the staff members who may authorize the use of specified interventions; and

(viii) a mechanism for monitoring and controlling the use of such interventions.

(2) Interventions to manage inappropriate client behavior must be employed with sufficient safeguards and supervision to ensure that the safety, welfare and civil and human rights of each client are adequately protected.

(3) Techniques to manage inappropriate client behavior must never be used for disciplinary purposes, for the convenience of staff or as a substitute for a treatment and habilitation program.

(4) The use of systematic interventions to manage inappropriate client behavior must be incorporated into the client's individual treatment plan.

(5) Standing or as needed programs to control inappropriate behavior are not permitted.

(1) A client may be placed in a an observation and seclusion room from which egress is prevented only as allowed in 53-20-146 , MCA and only if the following conditions are met:

(a) The placement is required because of an emergency situation requiring immediate action or for other therapeutic purposes.

(b) The client is under the direct constant visual supervision of designated staff.

(d) A licensed professional shall examine the client and provide written approval within the first three hours of placement unless the client has a long history of episodic violence. In these cases the examination and approval shall be obtained within the first 12 hours of placement.

(2) Placement of a client in an observation and seclusion room must be reassessed and documented in writing every hour. A client cannot be placed in an observation and seclusion room for more than 24 continuous hours.

(3) A client placed in an observation and seclusion room must be protected from hazardous conditions including, but not limited to, presence of sharp corners and objects, uncovered light fixtures, unprotected electrical outlets.

(4) A record of observation and seclusion activities must be kept.

(5) An intermediate care facility for the developmentally disabled shall:

(a) designate specific rooms designed for observation/ seclusion purposes; and

(b) develop policies and procedures for the use and maintenance of the observation/seclusion rooms.

(1) The facility may employ physical restraint only as allowed in 53-20-146 , MCA and only as:

(a) an emergency measure, but only if absolutely necessary to protect the client or others from injury; or

(b) a health-related protection prescribed by a physician, but only if absolutely necessary during the conduct of a specific medical or surgical procedure, or only if absolutely necessary for client protection during the time that a medical condition exists.

(2) The facility must not issue orders for restraint on a standing or as needed basis.

(3) A client placed in restraint must be checked at least every 30 minutes by staff trained in the use of restraints, released from the restraint as quickly as possible, and a record of these checks and usage must be kept.

(4) Restraints must be designed and used so as not to cause physical injury to the client and so as to cause the least possible discomfort.

(5) Opportunity for motion and exercise must be provided for a period of not less than 10 minutes during each two hour period in which restraint is employed, and a record of such activity must be kept.

(6) A licensed professional shall examine the client and provide written approval for restraint within the first three hours of placement and shall monitor and record the client's progress every 24 hours thereafter.

(1) Drugs used for control of inappropriate behavior must be approved by the interdisciplinary team and be used only as an integral part of the client's individual treatment plan that is directed specifically toward the reduction of and eventual elimination of the behaviors for which the drugs are employed.

(2) Drugs used for control of inappropriate behavior must not be used until it can be justified that the harmful effects of the behavior clearly outweigh the potentially harmful effects of the drugs.

(3) Drugs used for control of inappropriate behavior must be monitored closely, in conjunction with the physician and the drug regimen review requirement at ARM 37.106.2153, for desired responses and adverse consequences by facility staff.

(1) The facility must ensure the availability of physician services 24 hours a day.

(2) The physician must develop, in coordination with licensed nursing personnel, a medical care plan of treatment for a client if the physician determines that an individual client requires 24 hour licensed nursing care. This plan must be integrated in the individual treatment plan.

(3) The facility must provide or obtain preventive and general medical care as well as annual physical examinations of each client that at a minimum include the following:

(a) evaluation of vision and hearing;

(b) immunizations, using as a guide the recommendations of the public health service advisory committee on immunization practices or of the committee on the control of infectious diseases of the American academy of pediatrics;

(c) routine screening laboratory examinations as determined necessary by the physician, and special studies when needed; and

(d) tuberculosis control, appropriate to the facility's population, and in accordance with the recommendations of the American college of chest physicians or the rule of diseases of the chest of the American academy of pediatrics, or both.

(4) To the extent permitted by Montana law, the facility may utilize physician assistants and nurse practitioners to provide physician services as described in this rule.

(5) A physician must participate in:

(a) the establishment of each newly admitted client's initial individual treatment plan; and

(b) if appropriate, the review and update of an individual treatment plan as part of the interdisciplinary team process either in person or through written report to the interdisciplinary team.

(1) The facility must provide each client with nursing services in accordance with their needs, including:

(a) participation as appropriate in the development, review, and update of an individual treatment plan as part of the interdisciplinary team process;

(b) the development, with a physician, of a medical care plan of treatment for a client when the physician has determined that an individual client requires such a plan;

(i) be by a direct physical examination;

(ii) be by a licensed nurse;

(iii) be on a quarterly or more frequent basis depending on client need;

(iv) be recorded in the client's record; and

(v) result in any necessary action (including referral to a physician to address client health problems) ;

(d) other nursing care as prescribed by the physician or as identified by client needs; and

(e) implementation of appropriate protective and preventive health measures that include, but are not limited to:

(i) training any client and staff as needed in appropriate health and hygiene methods;

(ii) control of communicable diseases and infections, including the instruction of other personnel in methods of infection control; and

(iii) training of direct care staff in detecting signs and symptoms of illness or dysfunction, first aid for accidents or illness, and basic skills required to meet the health needs of the client.

(2) The facility must:

(a) employ or arrange for licensed nursing services sufficient to care for the client's health needs including any client with a medical care plan;

(b) utilize registered nurses as appropriate and required by Montana law to perform the health services specified in this rule;

(c) have a formal arrangement with a registered nurse to be available for verbal or on site consultation to the licensed practical or vocational nurses (if utilizing only licensed practical or vocational nurses to provide health services) ; and

(d) permit non-licensed nursing personnel who work with any client under a medical care plan to do so only under the supervision of licensed persons.

(3) Nurses providing services in the facility must have a current license to practice in Montana.

(1) The facility must provide or make arrangements for comprehensive dental diagnostic and treatment services for each client from qualified personnel, including licensed dentists and dental hygienists either through organized dental services in-house or through arrangement.

(2) If appropriate, dental professionals must participate in the development, review and update of an individual treatment plan as part of the interdisciplinary process either in person or through written report to the interdisciplinary team.

(3) The facility must provide education and training in the maintenance of oral health.

(4) Comprehensive dental diagnostic services must include:

(a) a complete extraoral and intraoral examination, using all diagnostic aids necessary to properly evaluate the client's oral condition, not later than one month after admission to the facility (unless the examination was completed within 12 months before admission) ;

(b) periodic examination and diagnosis performed at least annually, including radiographs when indicated and detection of manifestations of systemic disease; and

(5) Comprehensive dental treatment services must include:

(a) the availability for emergency dental treatment on a 24 hour basis by a licensed dentist; and

(b) dental care needed for relief of pain and infections, restoration of teeth, and maintenance of dental health.

(6) If the facility maintains an in-house dental service, the facility must keep a permanent dental record for each client with a dental summary maintained in the client's living unit. If the facility does not maintain an in-house dental service, the facility must obtain a dental summary of the results of dental visits and maintain the summary in the client's living unit.

(1) The facility must provide or make arrangements for the provision of routine and emergency drugs and biologicals to each client. Drugs and biologicals may be obtained from community or contract pharmacists or the facility may maintain a licensed pharmacy.

(2) A pharmacist with input from the interdisciplinary team must review the drug regimen of each client at least quarterly, and:

(a) report any irregularities in the client's drug regimen to the prescribing physician and interdisciplinary team; and

(b) prepare a record of each client's drug regimen reviews which must be maintained by the facility.

(3) As appropriate, the pharmacist must participate in the development, implementation, and review of each client's individual treatment plan either in person or through written report to the interdisciplinary team.

(4) The facility must maintain an individual medication administration record for each client.

(1) The facility must have an organized system for drug administration that identifies each drug up to the point of administration. The system must assure that:

(a) all drugs are administered in compliance with the physician's orders;

(b) all drugs, including those that are self-administered, are administered without error;

(c) each client is taught how to administer their own medications if the interdisciplinary team determines that self-administration of medications is an appropriate objective, and if the physician does not specify otherwise;

(d) the client's physician is informed of the interdisciplinary team's decision that self-administration of medications is an objective for the client;

(e) no client self-administers medications until he or she demonstrates the competency to do so;

(f) drugs used by any client while not under the direct care of the facility are packaged and labeled in accordance with Montana law; and

(g) drug administration errors and adverse drug reactions are recorded and reported immediately to a physician.

(2) The facility must:

(a) store drugs under proper conditions of sanitation, temperature, light, humidity, and security;

(b) keep all drugs and biologicals locked except when being prepared for administration, and only permit authorized persons to have access to the keys to the drug storage area, except that any client who has been trained to self-administer drugs may have access to keys to their individual drug supply;

(d) on a sample basis, periodically reconcile the receipt and disposition of all controlled drugs in schedules II through IV of the Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C . 801 et seq., as implemented by 21 CFR part 308; and

(e) comply with the regulations of controlled drugs if the facility maintains a licensed pharmacy.

(3) Labeling of drugs and biologicals must:

(a) be based on currently accepted professional principles and practices; and

(b) include the appropriate accessory and cautionary instructions, as well as the expiration date, if applicable.

(4) The facility must remove from use:

(a) outdated drugs; and

(b) drug containers with worn, illegible, or missing labels.

(5) Drugs and biologicals packaged in containers designated for a particular client must be immediately removed from the client's current medication supply if discontinued by the physician.

(1) If a facility chooses to provide laboratory services, the laboratory must meet the requirements specified in 42 CFR part 493.

(2) If the laboratory chooses to refer specimens for testing to another laboratory, the referral laboratory must be certified in the appropriate specialties and subspecialities of service in accordance with the requirements of 42 CFR part 493.

(1) The facility must not:

(a) house any client of a grossly different age, developmental level, and social need in close physical or social proximity unless the housing is planned to promote the growth and development of all those housed together; or

(b) segregate the client solely on the basis of their physical disabilities. It must integrate the client who has ambulation deficits or who is deaf, blind, or has a seizure disorder, etc., with others of comparable social and intellectual development.

(2) Bedrooms must:

(a) be rooms that have at least one outside wall;

(b) be equipped with or located near toilet and bathing facilities;

(d) measure at least 80 square feet per client in multiple client bedrooms and at least 100 square feet in single client bedrooms; and

(e) have walls that extend from floor to ceiling.

(3) If a bedroom is below ground level, it must have a window that is:

(a) usable as a second means of escape by the client occupying the room; and

(b) no more than 44 inches (measured to the window sill) above the floor unless the facility is surveyed under the health care occupancy chapter of the Life Safety Code ( LSC ) , 2000 edition, in which case the window must be no more than 36 inches (measured to the window sill) above the floor.

(4) The facility must provide each client with:

(a) a separate bed of proper size and height for the convenience of the client;

(b) a clean, comfortable mattress;

(d) functional furniture and individual closet space in the client's bedroom with clothes racks and shelves accessible to the client and appropriate to the client's needs.

(5) The facility must provide:

(a) space and equipment for daily out-of-bed activity for each client who is not yet mobile, except those who have a short-term illness or any client for whom out-of-bed activity is a threat to health and safety; and

(b) suitable storage space, accessible to the client, for personal possessions, such as TVs, radios, prosthetic equipment and clothing.

(6) The facility must:

(a) provide toilet and bathing facilities appropriate in number, size and design to meet the needs of the client;

(b) provide for individual privacy in toilets, bathtubs and showers; and

(c) in areas of the facility where the client who has not been trained to regulate water temperature and is exposed to hot water, ensure that the temperature of the water does not exceed 110 � F.

(7) Each client bedroom in the facility must have:

(a) at least one window to the outside; and

(b) direct outside ventilation by means of windows, air conditioning or mechanical ventilation.

(8) The facility must:

(a) maintain the temperature and humidity within a normal comfort range by heating, air conditioning or other means; and

(b) ensure that the heating apparatus does not constitute a burn or smoke hazard to the client.

(9) The facility must have:

(a) floors that have a resilient, nonabrasive and slip-resistant surface;

(b) nonabrasive carpeting, if the area used by a client is carpeted and serves a client who lies on the floor or ambulates with parts of their bodies, other than feet, touching the floor; and

(c) exposed floor surfaces and floor coverings that promote mobility in an area used by a client and promote maintenance of sanitary conditions.

(10) The facility must:

(a) provide sufficient space and equipment that includes adequately equipped and sound treated areas for hearing and other evaluations if they are conducted in the facility. This enables staff to provide the client with needed services as required by this subchapter and as identified in each client's individual treatment plan in:

(i) dining;

(ii) living;

(iii) health services;

(iv) recreation; and

(v) program areas;

(b) furnish and maintain in good repair and teach the client to use and to make informed choices about the use of:

(i) dentures;

(ii) eyeglasses;

(iii) hearing and other communications aids;

(iv) braces; and

(v) other devices identified by the interdisciplinary team as needed by the client; and

(11) The facility must:

(a) use lead free paint inside the facility; and

(b) remove or cover interior paint or plaster containing lead so that it is not accessible to the client.

(1) The facility must develop and implement detailed written plans and procedures to meet all potential emergencies and disasters such as fire, severe weather, and a missing client.

(2) The facility must communicate, periodically review, make the plan available and provide training to the staff.

(3) The facility must hold evacuation drills at least quarterly for each shift of personnel and under varied conditions to:

(a) ensure that all personnel on all shifts are trained to perform assigned tasks;

(b) ensure that all personnel on all shifts are familiar with the use of the facility's fire protection features; and

(4) The facility must:

(a) actually evacuate the clients during at least one drill each year on each shift;

(b) make special provisions for the evacuation of a client with a physical disability;

(d) investigate all problems with evacuation drills, including accidents, and take corrective action; and

(e) during fire drills, a client may be evacuated to a safe area in the facility certified under the health care occupancies chapter of the LSC .

(1) A secured unit within a facility shall have a written policy outlining resident admission criteria, transfer criteria and discharge criteria for the secured unit.

(2) Provisions should be made for secured unit residents to access large group activities when provided by the facility, e.g., holiday activities, etc. except as contraindicated by factors identified within their individual treatment plans.

(3) A secured unit within a facility is considered a separate unit. A staff station shall be located within the secured unit. The station shall provide at a minimum the following:

(a) provisions for charting;

(b) provisions for hand washing;

(d) telephone access; and

(e) a nurse/staff call system as required by the "Guidelines for the Construction and Equipment of Hospital and Medical Facilities", as adopted in ARM 37.106.302.

(4) The nurse/staff call system for a secured unit within a facility shall report to the unit nurse/staff station. The call system may also annunciate the call at another location, such as a main nurse station.

(5) A secured unit within a facility shall provide for a nourishment station. The nourishment station shall contain a work counter, refrigerator, storage cabinets and a sink for serving nourishments between meals. Ice for patient consumption should be provided by icemaker-dispenser units. The nourishment station should include space for trays and dishes used for nonscheduled meal service. Hand washing facilities shall be in or immediately accessible from the nourishment station.

(6) Dining, activities and day space must be provided at a ratio of 30 square feet per resident, with at least 14 square feet dedicated to the dining space.

(7) Resident rooms must be at a ratio of 100 square feet for single bedrooms and 80 square feet for multiple bedrooms. The room square footage should not include bathrooms, door swings, alcoves or vestibules. No more than four residents shall reside in a single room, except in new construction which limits single rooms to two residents.

(8) Each resident must have access to a toilet without requiring them to enter the corridor except as contraindicated by factors identified within their individual treatment plans.

(9) A secured unit within a facility shall comply with the following requirements for special locking arrangements. In buildings protected throughout by an approved supervised automatic fire detection system or approved supervised automatic sprinkler system, the doors in low and ordinary hazard areas may be equipped with approved, listed, locking devices which shall:

(a) unlock upon actuation of an approved supervised automatic fire detection system or approved supervised automatic sprinkler;

(b) unlock upon loss of power controlling the lock or locking mechanism;

(d) all secured doors must have a manual electronic key release;

(e) provisions must be made for the rapid removal of occupants by such reliable means as the remote control of the locks. Typically, this is done by placing a staff accessible switch at the nurses station which is capable of releasing all doors; and

(f) all the locks on all secured doors must automatically release upon any of the following conditions:

(i) the actuation of the approved supervised automatic fire alarm system;

(ii) the actuation of an approved supervised automatic sprinkler system; or

(iii) upon the loss of the power controlling the locks or locking mechanisms.

(1) The facility must meet the applicable provisions of either the health care occupancies chapters or the residential board and care occupancies chapter of the Life Safety Code ( LSC ) , 2000 edition, of the National Fire Protection Association ( NFPA ) , 2000 edition, which is incorporated by reference. A copy of the LSC , 2000 edition, may be obtained from the National Fire Protection Association, Batterymarch Park, Quincy, MA 02269.

(a) The department may apply a single chapter of the LSC to the entire facility or may apply different chapters to different buildings or parts of buildings as permitted by the LSC .

(b) A facility that meets the LSC definition of a residential board and care occupancy and that has 16 or fewer beds must have its evacuation capability evaluated in accordance with the Evacuation Difficulty Index of the LSC (Appendix F) .

(2) For facilities that meet the LSC definition of a health care occupancy:

(a) the department may waive, for a period it considers appropriate, specific provisions of the LSC if:

(i) the waiver would not adversely affect the health and safety of the clients; and

(ii) rigid application of specific provisions would result in an unreasonable hardship for the facility.

(1) The facility must provide a sanitary environment to avoid sources and transmission of infections. There must be policies and procedures for the prevention, control and investigation of infection and communicable diseases.

(2) The facility must implement successful corrective action in affected problem areas.

(3) The facility must maintain a record of incidents and corrective actions related to infections.

(4) The facility must prohibit employees with symptoms or signs of a communicable disease from direct contact with the client and their food.

(5) All staff shall use the proper hand washing techniques after providing direct care to a resident.

(1) Each client must receive a nourishing, well-balanced diet including modified and specially-prescribed diets.

(2) A qualified dietitian must be employed either full-time, part-time or on a consultant basis at the facility's discretion.

(3) If a qualified dietitian is not employed full-time, the facility must designate a person to serve as the director of food services.

(4) The client's interdisciplinary team, including a qualified dietitian and physician, must prescribe all modified and special diets including those used as a part of a treatment to manage inappropriate client behavior.

(5) Foods proposed for use as a primary reinforcement of adaptive behavior are evaluated in light of the client's nutritional status and needs.

(6) Unless otherwise specified by medical needs, the diet must be prepared at least in accordance with the "Nutrition and Your Health: Dietary Guidelines for Americans", 2000, 5th edition of the recommended dietary allowances published by the Food and Nutrition Board of the National Research Council, National Academy of Sciences, adjusted for age, sex, disability and activity.

(7) Each client must receive at least three meals daily, at regular times comparable to normal mealtimes in the community with:

(a) not more than 14 hours between a substantial evening meal and breakfast of the following day, except on weekends and holidays when a nourishing snack is provided at bedtime, 16 hours may elapse between a substantial evening meal and breakfast; and

(b) not less than 10 hours between breakfast and the evening meal of the same day.

(8) Food must be served:

(a) in appropriate quantity;

(b) at appropriate temperature;

(d) with appropriate utensils.

(9) Food served to the client individually and uneaten must be discarded.

(10) Menus must:

(a) be prepared in advance;

(b) provide a variety of foods at each meal;

(d) include the average portion sizes for menu items.

(11) Menus for food actually served must be kept on file for 60 days.

(12) The facility must:

(a) serve meals for each client, including persons with ambulation deficits, in dining areas, unless otherwise specified by the interdisciplinary team or a physician;

(b) provide table service for each client who can and will eat at a table, including a client in a wheelchair;

(c) equip areas with tables, chairs, eating utensils, and dishes designed to meet the developmental needs of each client;

(d) supervise and staff dining rooms adequately to direct self-help dining procedure, to assure that each client receives enough food and to assure that each client eats in a manner consistent with his or her developmental level; and

(e) ensure that each client eats in an upright position, unless otherwise specified by the interdisciplinary team or a physician.

(1) A facility has the right to appeal licensure decisions as outlined in 50-5-208 , MCA.

(2) The department shall follow the hearing procedure for fair hearings as outlined at ARM 37.5.117.

(1) To the extent that other licensure rules in this chapter conflict with the terms of ARM 37.106.2202 and 37.106.2203, the terms of ARM 37.106.2202 and 37.106.2203 will apply to residential treatment facilities.

AND HUMAN SERVICES

(1) A residential treatment facility must meet the requirements of the following:

(a) the standards for the following categories, contained in the Joint Commission on Accreditation of Health Care Organizations′ 2017 Comprehensive Accreditation Manual for Behavioral Health Care:

(i) Care, Treatment, and Services (CTS);

(ii) Environment of Care (EC);

(iii) Emergency Management (EM);

(iv) Human Resource Management (HRM);

(v) Infection, Prevention, and Control (IC):

(vi) Leadership (LD);

(vii) Life Safety (LS);

(viii) Medication Management (MM):

(ix) National Patient Safety Goals (NPSG);

(x) Performance Improvement (PI);

(xi) Record of Care, Treatment, and Services (RC);

(xii) Rights and Responsibility of the Individual (RI); and

(xiii) Waived Testing (WT).

(2) A residential treatment facility may not share direct care staff or provide joint activities or treatment in conjunction with another type of facility, even if both facilities are under the same management, unless the joint activity involves facilities under a single management and is a specific treatment program that is clinically appropriate for all of the children engaged in it (e.g., appropriate for patients of both a residential treatment facility and an inpatient acute psychiatric facility).

(3) The number of residents admitted to the facility and the number of beds in use and/or ready for use may not exceed the number of beds for which the facility is licensed, as indicated on the face of the license issued to it.

(4) The department adopts and incorporates by reference the Joint Commission on Accreditation of Healthcare Organizations, 2017 Comprehensive Accreditation Manual for Behavioral Health Care.

(5) The department adopts and incorporates by reference Title 42 CFR 440.160 (2010) and Title 42 CFR, part 441, subpart D (2010).

(6) The residential treatment facility must have 24-hour onsite nursing care by a registered nurse.

(7) The youth must be evaluated by a physician within 24 hours of admission.

(8) All legal representatives of the youth must be consulted and invited to participate in the development and review of the treatment plan. Valid reasons must be indicated if such a plan is not clinically appropriate or feasible.

(9) A comprehensive discharge plan directly linked to the behaviors and symptoms that resulted in admission and estimated length of stay must be developed upon admission.

(10) If the youth is a student with disabilities, an individualized education plan (IEP) must be in place that provides programs and services consistent with requirements under the Individuals with Disabilities Education Act (IDEA) and state special education requirements. If the youth is not a student with disabilities, educational services and programs must be designed to meet the educational needs of the youth.

(1) Separate residential treatment facility licenses are not required for separate buildings within the same community if they are utilized to provide residential psychiatric care under the same management.

(1) The following definitions apply in this rule and ARM 37.106.2305 and 37.106.2311:

(a) "Bereavement" means that period of time during which survivors mourn a death and experience grief.

(b) "Bereavement services" means support services to be offered during the bereavement period.

(c) "Contract services" means persons or organizations who, under written agreement, provide goods and services to the hospice and its patients and their families.

(d) "Core services" means physician services, nursing services, pastoral counseling, services provided by trained volunteers, and counseling services routinely provided by hospice staff.

(e) "Family" means individuals who are closely linked with the hospice patient, including the immediate family, the primary care giver, and individuals with significant personal ties.

(f) "Hospice" or "hospice program" means a public agency or private organization (or a subdivision thereof) as defined in 50-5-101(22), MCA, which is primarily engaged in providing hospice care.

(g) "Hospice care" means palliative and supportive care to meet the needs of a terminally ill patient and the patient's family arising out of physical, psychological, spiritual, social, and economic stresses experienced during the final stages of illness and dying, and that includes a formal bereavement component.

(h) "Hospice staff" means paid or unpaid persons, including volunteers, who are directly supervised by the hospice program.

(i) "Interdisciplinary team" means the number of appropriately qualified interdisciplinary health care professionals and volunteers that are needed to meet the hospice's patients' care needs.

(j) "Managed directly by" means that core services are provided by a hospice program.

(k) "Palliation" means controlling pain and other symptoms which are manifested during the dying process and are consistent with professional practice and regulations of the Montana Board of Pharmacy.

(l) "Respite care" means short-term in-patient care provided to the individual only when necessary to relieve the family members or other persons caring for the individual.

(2) A hospice program may be licensed to operate either:

(a) as a part of a licensed hospital without its own license when the department finds that the hospital's hospice program meets the requirements set forth in this rule; or

(b) with its own hospice license when the department finds that it meets the requirements set forth in this rule.

(3) A hospice program must have the following organizational components:

(a) a formally established governing body, individual, group, or corporation with authority to make decisions affecting the operation of the hospice;

(b) an organization chart defining reporting relationships among hospice workers;

(d) established policies for the administration and operation of the program, including but not limited to:

(i) written criteria for program admission and discharge;

(ii) procedures for bereavement referrals and assistance;

(iii) development of a plan of care;

(iv) agreements with other licensed health care facilities for proper transfer of patients and follow up of plans of care;

(v) system(s) for recordkeeping;

(vi) patient care procedures; and

(vii) in-service education.

(e) development of annual budgets; and

(f) annual evaluation of each aspect of the hospice program, including the program's quality assessment and improvement measures and a system to implement recommendations for future program planning.

(4) A hospice program must have an interdisciplinary team responsible for the provision of hospice care. The interdisciplinary team must:

(a) confer or meet regularly;

(b) have responsibility for implementation of each individual plan of care as directed by an identified coordinator; and

(c) encourage the patient/family to participate in developing the interdisciplinary team plan of care and in the provision of hospice services.

(5) A hospice program must assure that each patient has a physician who is the patient's primary physician and assists in the development of the patient's care plan.

(6) A hospice program must maintain a medical record for every individual accepted as a hospice patient. The medical record must include:

(a) patient identification, diagnosis, and prognosis;

(b) patient's medical history:

(d) a record of doctor's hospice orders;

(e) progress notes, dated and signed; and

(f) evidence of timely action by the patient care team.

(7) A hospice program which utilizes volunteers must provide volunteer training which includes:

(a) information concerning hospice philosophy;

(b) instruction on the volunteer's role, responsibilities, restrictions, and expectations; and

(8) A hospice program must allow the patient and the patient's family to make the decision to participate in a hospice program and shall encourage the patient and the patient's family to assume as much responsibility for care as they choose.

(9) A hospice program must assure that all services identified in the hospice plan of care for a patient, including skilled nursing services, are offered to the patient.

(10) A hospice program must:

(a) have a plan for providing bereavement follow up for families desiring it;

(b) monitor and assess the quality of contract services through annual review;

(d) hire, train, and supervise hospice staff and ensure that hospice staff adhere to hospice policies; and

(e) establish, update, and implement infection control policies and procedures that are sufficient to prevent transmission of disease.

(11) The hospice program must comply with ARM 37.106.2901, 37.106.2902, 37.106.2904, 37.106.2905, and 37.106.2908, pertaining to restraints, safety devices, assistive devices, and postural supports.

(1) In addition to complying with the standards contained in ARM 37.106.2301, an inpatient hospice facility must comply with the requirements of the conditions of participation for hospices providing inpatient care directly, as set forth in 42 CFR Part 418, subparts C through E. Those conditions of participation include, but are not limited to, requirements concerning the following:

(a) 24-hour nursing service;

(b) disaster preparedness;

(d) fire protection;

(e) fire protection waivers;

(f) patient areas;

(g) patient rooms and toilet facilities;

(h) bathroom facilities;

(i) linen;

(j) isolation areas;

(k) meal service, menu planning, and supervision; and

(l) pharmaceutical hospice service.

(2) The department hereby adopts and incorporates by reference 42 CFR Part 418, subparts C through E, which contain the conditions that a hospice must meet in order to participate in the medicare program. A copy of the above conditions of participation may be obtained from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A residential hospice facility must meet all of the requirements contained in ARM 37.106.2301 in addition to those contained in this rule.

(2) A residential hospice facility must be managed directly by a licensed hospice program.

(3) A residential hospice facility must be staffed with qualified personnel in numbers sufficient to provide required core services and those indicated in each patient's hospice plan of care, including:

(a) nursing services;

(b) therapies;

(d) timely response to emergency situations;

(e) volunteer services; and

(f) recreational and social activities.

(4) A residential hospice must assure that individuals providing personal care to residential hospice patients have received, prior to delivering such care, documented training that includes the following elements, or the documented equivalent of such training:

(a) hospice philosophy and orientation;

(b) basic needs of the frail elderly and/or physically disabled persons;

(d) basic techniques in observation of patient's mental and physical health;

(e) basic personal care procedures, including grooming;

(f) methods of making patients comfortable;

(g) bowel and bladder care;

(h) assisting patient mobility, including transfer (e.g. from bed to wheelchair);

(i) techniques in lifting;

(j) food and nutrition;

(k) basic techniques of identifying and correcting potential safety hazards in the home; and

(l) health oriented record keeping.

(5) A residential hospice facility must meet the life-safety requirements set forth in the 2012 NFPA 101 Life Safety Code for residential board and care occupancies.

(6) In patient areas, a residential hospice must:

(a) provide areas that ensure private patient and patient family visiting;

(b) provide or arrange for accommodations for family members to remain with the patient overnight;

(d) ensure that hospice visiting hours are flexible and that children or pets are not excluded;

(e) provide a handicapped accessible telephone for patient use;

(f) be equipped with furnishings which are home-like in design and function and contribute to a safe environment; and

(g) provide one or more areas for dining, recreation and/or social activities, and refrain from utilizing these areas for corridor traffic.

(7) In patient bedrooms, a residential hospice must:

(a) allow each patient to bring personal items to locate in the patient's bedroom so long as the health and safety of any patient, patient's family members, or hospice staff are not jeopardized;

(b) allow no more than two beds per patient room and ensure that each patient bedroom is located at or above ground level, has a window to the outside of the facility, and has a direct entry from the corridor;

(c) provide at least 100 square feet in one-bed rooms and 80 square feet per bed in two-bed rooms, exclusive of closets, lockers, wardrobes, alcoves, or vestibules;

(d) provide each bedroom with a comfortable, appropriately sized bed for each occupant, equipped with a mattress protected by waterproof material, mattress pad, and comfortable pillow, as well as a comfortable chair and other furniture as appropriate to the decor and patient needs;

(e) provide a separate dresser and wardrobe or closet space for each occupant in a bedroom;

(f) provide clean, flame-resistant shades or the equivalent for every bedroom window;

(g) in each two-bed room, provide either flame-resistant cubicle curtains for each bed or movable flame-resistant screens to provide privacy upon request of a patient; and

(h) if the needs of a patient require a call system or communication device to be in place, make it available; otherwise, the hospice may, but is not required to, provide a patient bedroom with a call system or communication device that is connected to an area in the hospice that is consistently staffed.

(8) A residential hospice must provide the following bathroom and toilet facilities:

(a) a toilet and lavatory in each toilet room and at least one toilet for every four patients;

(b) at least one bathing facility for every 12 patients;

(c) grab bars at each toilet, shower, and tub, with a minimum of 1-1/2 inch clearance between the bar and the wall and strength and anchorage sufficient to sustain a concentrated 250-pound load;

(d) at least one bathroom and one toilet accessible to individuals with mobility impairments;

(e) all doors to resident bathrooms shall open outward or slide into the wall and shall be unlockable from the outside. Dutch doors, bi-folding doors, sliding pocket doors, and other bi-swing doors may be used if they do not impede the bathroom access width and are approved by the department. A shared bathroom with two means of access is also acceptable; and

(f) if the needs of a patient require a call system or communication device to be in place in the patient's bathroom, make it available; otherwise, the hospice may, but is not required to, provide a patient bathroom with a call system or communication device that is connected to an area in the hospice that is consistently staffed.

(9) A residential hospice must do the following for infection control:

(a) either be equipped to provide an isolation area for patients who have diseases with a high risk of transmission or have in place a method to ensure that such patients are transferred to a health care facility which is adequately equipped to admit such a patient;

(b) develop a procedure to monitor the infection control program on a regular basis; and

(10) A residential hospice must meet the following meal service, menu planning, and supervision standards:

(a) foods must be served in amounts and variety to meet the needs of each hospice patient.

(b) the hospice must provide a practical freedom-of-choice diet to patients and assure that patients' favorite foods are included in their diets whenever possible.

(c) the food service must establish and maintain standards relative to food sources, refrigeration, refuse handling, pest control, storage, preparation, procuring, serving, and handling that are sufficient to prevent food spoilage and transmission of infectious disease.

(d) a staff member trained or experienced in food management must be appointed to:

(i) provide diets as indicated on the plan of care for each patient; and

(ii) supervise meal preparation and service.

(e) if a hospice patient or patient's family wishes to provide meal services for an individual independent of the required food service of the hospice, either on a periodic or continuous basis, the hospice and patient, and patient's family when appropriate, must work out reasonable arrangements so that the hospice staff may plan accordingly.

(11) In order to provide pharmaceutical services to patients, a residential hospice must:

(a) develop and maintain a system for the administration and provision of pharmaceutical services that are consistent with the drug therapy needs of the patient as determined by the hospice medical director and patient's primary physician;

(b) ensure that medications ordered are consistent with the hospice philosophy which focuses on palliation;

(c) ensure that all prescription medications are ordered in writing by someone licensed to write prescriptions under Montana state law, dispensed by a licensed pharmacy, received by the patient, the patient's family, or other designated individual(s), and maintained in the hospice;

(d) unless the pharmacy provides a unit dose system, ensure that all prescription drugs are labeled with a label that includes:

(i) name of pharmacy;

(ii) name of patient;

(iii) name of prescribing physician;

(iv) date prescription filled;

(v) prescription number;

(vi) name of medication;

(vii) directions and dosage;

(viii) expiration date; and

(ix) quantity dispensed.

(e) document all medication administration in the patient's record;

(f) ensure that medications are administered only by one of the following individuals:

(i) a licensed nurse, physician, or physician assistant;

(ii) the patient or patient's family if the physician allows them to do so and an order acknowledging that fact is noted in the hospice care plan; and

(iii) anyone authorized to administer medications by 37-8-103, MCA.

(g) allow medications to be left at the bedside of a hospice patient when to do so is approved in the hospice plan of care, and, whenever such approval exists, provide for the storage of such medications in a safe and sanitary manner;

(h) ensure that medications not stored at the bedside are maintained in locked storage in a central location in the hospice that is near or adjacent to an area for medication preparation and has appropriate refrigeration, a sink for handwashing, and locking cabinets;

(i) destroy medications when the label is mutilated or indistinct, the medication is beyond the expiration or shelf life date, or unused portions remain due to discontinuance of use or death or discharge of the patient; and

(j) develop and follow written policies and procedures for destruction of legend drugs that include listing the type of drug(s) destroyed and the amount destroyed.

(12) The department adopts and incorporates by reference the 2012 NFPA 101 Life Safety Code which establishes building construction requirements for residential board and care occupancies. Copies of the above standards may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MD 02169, or by using their web site, www.nfpa.org.catalogue.

(13) Respite care may be provided only on an occasional basis for no more than five consecutive days at a time.

In addition to the definitions in 50-5-101, MCA, the following definitions apply to this subchapter:

(1) "Antineoplastic" means a pharmaceutical that has the capability of killing malignant cells.

(2) "Biological safety cabinet" means a containment unit suitable for the preparation of low to moderate risk agents.

(3) "Critical area" means an area where sterilized products or containers are exposed to the environment during aseptic preparation.

(4) "Enteral" means a preparation compounded in an ISO Class 5 environment, dispensed by a pharmacist, and administered by way of the intestine.

(5) "Home infusion therapy (HIT) services" means the preparation, administration, or furnishing of parenteral medications, or parenteral or enteral nutritional services to an individual in that individual's residence. The services include an educational component for the patient, the patient's caregiver, or the patient's family member.

(6) "ISO Class 5" means a classification of air cleanliness as defined in United States Pharmacopoeia (USP) USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations.

(7) "Licensed health care professional" means a physician (M.D. or D.O.), a physician assistant-certified, a nurse practitioner, or a registered nurse practicing within the scope of their license.

(8) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of the skin with infusion administration time determined by the recommendation of the pharmaceutical manufacturer.

(9) "Pharmacist" means a person licensed by the state to engage in the practice of pharmacy and who may affix to the person's name the term "R.Ph."

(10) "Pharmacist-in-charge or their designee" means a licensed pharmacist who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy and the distribution of drugs, and who is personally in full and actual charge of such pharmacy.

(11) "Pharmacy" means an established location, either physical or electronic, registered by the Board of Pharmacy where drugs or devices are dispensed with pharmaceutical care or where pharmaceutical care is provided.

(12) "Prescribing practitioner" means a licensed health care professional authorized by state statute or federal law to prescribe pharmaceuticals and/or treatments.

(13) "Sterile pharmaceutical or product" means an aseptic dosage form free from living micro-organisms.

(1) Where a home infusion therapy agency directly provides either the home infusion therapy services or skilled nursing services and arranges for the provision of the other services, the parties must enter into a written contract defining the nature and scope of the services to be provided by each party. The contract must:

(a) describe the services to be provided by each party; and

(b) specify the responsibilities of each party in the provision, coordination, supervision, and evaluation of the care or services provided. This must include each party's role in:

(i) the patient admission process;

(ii) the patient assessment process;

(iii) the patient education process;

(iv) the development, review, and revision of the patient plan of care;

(v) the development, review, and revision of the patient medical record;

(vi) the provision of clinical services;

(vii) the timely reporting of adverse reactions to treatment, medical symptoms, or abnormal lab values;

(viii) the timely reporting of the patient failing to comply with the home infusion regiment;

(ix) the patient care conferences; and

(x) discharge planning.

(1) Each home infusion therapy agency must employ an administrator who shall:

(a) organize and direct the home infusion therapy agency's ongoing functions;

(b) be responsible for ongoing oversight of the home infusion therapy agency's quality assessment system, including the establishment of policies and procedures which address the safe control, accountability, distribution, and administration of infusion products;

education and evaluation; and

(d) be familiar with and assure compliance with the rules

of this subchapter.

(2) For a pharmacy which is licensed as a home infusion therapy agency, the pharmacist-in-charge may serve as the administrator.

(3) All services provided by the home infusion therapy agency and its employees must be provided in accordance with state laws, regulations, and home infusion therapy agency policies and procedures.

(4) The home infusion therapy agency must maintain, at all times, a pharmacist-in-charge (or designee) and a Montana licensed nurse that are both accessible and physically able to respond 24 hours a day, seven days per week.

(5) The home infusion therapy agency shall document in the employee record:

(a) all professional employee orientation;

(b) competency assessments;

(d) a current license.

(6) The pharmacist-in-charge may be assisted by supportive personnel. Supportive personnel must work under the immediate supervision of a licensed pharmacist and have specialized training in the field of home infusion therapy. The duties and responsibilities of these personnel must be consistent with their training and experience.

(7) The licensed health care professional providing skilled nursing services shall:

(a) provide those services in accordance with the plan of care;

(b) dictate or write clinical notes at the time of service. Clinical notes must be signed, recorded, and incorporated into the patient's medical record within three working days of providing the service;

(d) notify the pharmacist, the prescribing practitioner, and the home infusion therapy agency's personnel responsible for the care of the patient, of any significant changes in the patient's condition.

This rule has been repealed.

(1) Each home infusion therapy agency shall prepare and maintain on file an annual report of improvements made as a result of a quality assessment program.

(1) Each home infusion therapy agency, and any contracted party providing services to the patient, together, shall:

(a) provide the patient or the patient's caregiver with education and counseling on proper storage, scheduling, and risks associated with specific drugs and infusion therapy in general, the proper disposal of unused or outdated medications, and document the counseling sessions in the patient's medical record;

(b) provide to the patient and/or patient caregiver written educational material which must include at a minimum:

(i) drug information sheets for prescribed therapy;

(ii) compounding, admix technique, adding medications to solutions, and withdrawing medications from vials;

(iii) function, operation, and troubleshooting durable medical equipment when prescribed; and

(iv) supplies and training for safe and proper handling and disposal of antineoplastic, infectious, and hazardous waste.

(c) reassess on an ongoing basis, the patient's competency or the patient's caregiver's competency, in managing home infusion therapy in the home environment and document the reassessment process in the patient's medical.

(1) Each home infusion therapy agency shall establish and maintain for each patient accepted for care, a medical record which must be accessible to home infusion therapy personnel and which must include the following information:

(a) admission data, including the:

(i) name;

(ii) current address;

(iii) date of birth;

(iv) sex;

(v) date of admission;

(vi) name and contact information of the patient's caregiver or family member; and

(vii) name and contact information of the pharmacist-in-charge and the prescribing practitioner.

(b) admission diagnosis and pertinent health information relevant to the plan of care;

(c) any allergies and known adverse reactions to drugs and food. This information must be given such prominence in the record so as to make it obvious to any persons who provide food or medication to the patient;

(d) laboratory reports;

(e) documentation that a list of patient rights and responsibilities have been made available to each patient or the patient's caregiver;

(f) the plan of care;

(g) clinical assessments and services documentation;

(h) the prescribing practitioner's order for home infusion therapy;

(i) a monthly clinical therapy summary for any patient receiving services 30 days or longer; and

(j) a discharge summary of therapy at the end of treatment.

(2) The responsibilities of the patient and the home infusion therapy agency, including any contracted parties, in the areas of delivery of care and monitoring of the patient, must be clearly documented in the patient's medical record.

(3) The home infusion therapy agency, and any contracted party providing services to the patient, together, shall develop a plan of care within three working days of the initiation of therapy, which must include:

(a) a diagnosis;

(b) the types of services and equipment required;

(d) the estimated length of service;

(e) a statement of treatment goals;

(f) the regimen and prescription ordered;

(g) the concurrent legend and over the counter drugs;

(h) an assessment of mental status;

(i) permitted activities;

(j) the prognosis, discharge, transfer or referral plan; and

(k) instructions to patient and family.

(4) All records of dispensed sterile pharmaceuticals must be a part of the patient's medical record.

(1) All medications and treatments administered by the home infusion therapy agency's personnel or contracted parties must be administered by a Montana licensed health care professionals.

(1) In addition to the minimum requirements for a pharmacist and a pharmacy established by Title 37, chapter 7, MCA, and ARM Title 24, chapter 174, any parenteral or enteral solution provided by the home infusion therapy agency or obtained through contract with a third party pharmacy and provided to patients of the home infusion therapy agency must be dispensed by a licensed pharmacist in a Montana licensed pharmacy, whom and which are in compliance with the requirements of ARM 37.106.2404, 37.106.2407, 37.106.2422, 37.106.2423, and 37.106.2430 through 37.106.2433.

(1) The home infusion therapy agency shall develop a policy and procedure manual for the organization and operation of the home infusion therapy agency. A copy of the manual must be kept current at all times, and be readily available at all times, and to all who request it.

(2) The manual must include an organizational chart delineating the lines of authority, responsibility, and accountability for the administration and patient care services of the agency.

(3) The manual must specifically detail the storage, stability, handling, compounding, labeling, dispensing, and delivery of all sterile pharmaceuticals and address requirements relating to:

(a) security measures, which ensure that the premises where sterile pharmaceuticals are present are secured, and which prevent access to patient records by unauthorized personnel;

(b) sanitation, including the methodology of cleaning biological safety cabinets and laminar flow hoods, and of inspecting filters for deterioration and microbial contamination;

(d) the orientation of personnel;

(e) the duties and qualifications of staff;

(f) record keeping requirements;

(g) medication profiles;

(h) the administration of parenteral therapy to include infusion devices, drug delivery systems, and monitoring;

(i) the pharmacy patient evaluation and documentation;

(j) prescription processing;

(k) clinical services;

(l) drug and product selection;

(m) 24-hour emergency access to a pharmacist;

(n) the handling of antineoplastic agents, a description of which must include protective apparel to be worn by compounding personnel;

(o) drug destruction, returns, and proper waste management;

(p) equipment management, including tracking, cleaning, and testing of infusion pumps;

(q) end product testing;

(r) a quality assessment program;

(s) a risk management program including incident reports,

adverse drug reactions, product contamination, and drug recalls;

(t) education and training of the patient or the patient's caregiver;

(u) emergency drug and supply procurement;

(v) guidelines for handling investigational drug administration;

(w) reference materials; and

(x) an emergency preparedness plan.

(1) The department adopts and incorporates by reference United States Pharmacopoeia (USP) 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations, June 1, 2008, which sets practice standards to help ensure that compounded sterile preparations are of high quality. A copy of USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations may be obtained from USP Headquarters, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, telephone (800) 227-8772 or http://www.usp.org/products/797Guidebook.

(1) The pharmacy must have a designated area with entry restricted to designated personnel for preparing sterile products. This area must be:

(a) a separate room with a closed door, isolated from other areas with restricted entry or access, and designed to avoid unnecessary traffic and airflow disturbances from activity as required by United States Pharmacopoeia (USP) USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

(b) used only for the preparation of sterile pharmaceuticals;

(c) of sufficient size to accommodate a laminar airflow hood and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security; and

(d) one with cleanable work surfaces, walls, and floors.

(2) If a home infusion therapy agency elects to use a Compounding Aseptic Isolator (CAI), the "separate room" requirement of (1)(a) is not required, provided that the home infusion therapy agency maintains documentation of meeting the standards for this exception of CAIs set forth in USP 31 General Chapter 797.

(3) The pharmacy preparing the sterile products must have:

(a) appropriate environmental control devices capable of maintaining at least an ISO Class 5 in the workplace where critical activities are performed. The devices must be capable of maintaining this condition during normal activity. Examples of appropriate devices include vertical and horizontal laminar airflow hoods and zonal laminar flow of high efficiency particulate air filtered air. All airflow hoods used by the home infusion therapy agency must be certified as able to maintain an ISO Class 5 environment as required by USP 31 General Chapter 797 Pharmaceutical Compounding - Sterile Preparations;

(b) appropriate disposal containers for used needles, syringes, etc., and if applicable, for antineoplastic waste from the preparation of antineoplastic agents and infectious wastes from patients' homes;

(d) temperature controlled delivery containers, when necessary;

(e) infusion devices, when necessary;

(f) a sink with hot and cold running water which is convenient to compounding area for the purpose of hand scrubs prior to compounding; and

(g) a refrigerator/freezer with a thermometer.

(4) The pharmacy shall maintain supplies and provide attire adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(5) The pharmacy shall maintain sufficient current reference materials relating to sterile products to meet the needs of the pharmacy personnel.

(6) The pharmacy shall document a chain of possession for all controlled substances including return or disposal of unused controlled substances.

(7) All pharmacies utilized by or part of a home infusion therapy agency must be able to deliver to the home infusion therapy agency patient any needed medications and therapies within 24 hours of the need being recognized. If a pharmacy is not able to ensure a 24-hour response time, a current contract with a pharmacy that is able to ensure a 24-hour response time is required, and must be kept at the home infusion therapy agency.

(8) If the home infusion therapy agency utilizes a pharmacy located outside the state of Montana, documentation must be maintained at the home infusion therapy agency site that the pharmacy utilized has a current Montana pharmacy license per Board of Pharmacy requirements, and that it meets the requirements of this rule.

(1) The pharmacy shall maintain a record of each sterile pharmaceutical dispensed for at least two years after the last dispensing activity. This record must include, but not be limited to:

(a) the products and quantity dispensed;

(b) the date dispensed;

(d) the directions for use;

(e) the identification of the dispensing pharmacist and preparing pharmacy technician, if appropriate;

(f) the manufacturer lot number and expiration date, stability date (or recall policy if the lot number is not recorded);

(g) the compounding or special instructions, if applicable; and

(h) the next scheduled delivery date.

This rule has been repealed.

(1) Parenteral pharmaceuticals dispensed to patients must have a permanent label with the following information:

(a) the name and contact information of the pharmacy including a phone number which provides access to a pharmacist 24 hours per day, seven days per week;

(b) the date the product was prepared;

(d) the patient's full name;

(e) the name of the prescribing practitioner;

(f) the directions for use including infusion rate and infusion device, if applicable;

(g) the name of each component, its strength, and amount;

(h) the expiration date of the product based on published data;

(i) the appropriate ancillary instructions such as storage instructions or cautionary statements including antineoplastic warning when applicable; and

(j) the identity of the pharmacist compounding and dispensing the product.

(1) The following requirements must be met by those pharmacies that prepare antineoplastic drugs to ensure the protection of the personnel involved:

(a) All antineoplastic drugs must be compounded in a vertical flow, Class II, biological safety cabinet.

(b) Protective apparel must be worn by personnel compounding antineoplastic drugs according to the home infusion agency's policies and procedures. This must include gloves, gowns with tight cuffs, and appropriate equipment as necessary.

(c) Appropriate safety and containment techniques for compounding antineoplastic drugs must be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals.

(d) Written procedures for handling both major and minor spills of antineoplastic agents must be included in the policy and procedure manual.

(e) Prepared doses of antineoplastic drugs must be dispensed, labeled with proper precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.

(1) Disposal of antineoplastic, infectious, and hazardous waste is governed by the Infectious Waste Management Act, Title 75, chapter 10, part 10, MCA.

(1) The home infusion therapy agency shall ensure that medications are delivered according to the prescribed start of therapy so that the prescription for sterile pharmaceuticals can be implemented as ordered. Once therapy has been initiated, the home infusion therapy agency shall continue to provide sterile pharmaceuticals in a timely fashion so as not to interrupt ongoing therapy.

(2) If the start of therapy is to be delayed for more than two hours from the prescribed start time, the home infusion agency shall notify both the patient and the prescribing practitioner.

(3) Patients must be notified in advance of delivery of the products. Patients must be provided with a receipt for all sterile products and supplies delivered to them.

(4) The pharmacy shall document a chain of possession for all controlled substances.

(5) The home infusion therapy agency shall ensure the environmental control of all products shipped. All compounded, sterile pharmaceuticals must be shipped or delivered to a patient in appropriate, temperature-controlled delivery containers as defined by the United States Pharmacopeia/National Formulary and stored appropriately in the patient's therapy setting.

In addition to those definitions in 50-5-101 , MCA, the following definitions apply to this subchapter:

(1) "Bedding" means mattresses, box springs, mattress covers, mattress pads, sheets, pillow slips, pillows, pillow covers, blankets, comforters, quilts and bedspreads.

(2) "Building authority" means the building codes bureau, Montana department of labor and industry, or a local government building inspector enforcing a local building code enforcement program certified by the department of labor and industry.

(3) "Fire authority" means the state fire marshal or the state fire marshal's authorized agent.

(4) "Fixtures" means a shower, bathtub, toilet, toilet seat, urinal, lavatory, kitchen sink, janitor and custodial sink, utensil sink and all exposed plumbing integral to them.

(5) "Floors" means sub-flooring and floor coverings of all rooms including stairways, hallways, and lobbies.

(6) "Furnishings" includes, but is not limited to, cups, glasses, pitchers, utensils, draperies, curtains, blinds, light fixtures, lamps and lamp shades, chairs, tables, desks, shelves, books, magazines, bookcases, dressers, bedsteads, mattress springs other than box springs, towels, wash cloths, soap, toilet tissue, radios, television sets, coffee makers, water heaters, pictures, mirrors, cabinets, closets and refrigerators.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapters 3, 4, 6, 10, 11, 14, 15, 22 and 23, conflict with the terms of this subchapter, the terms of this subchapter will apply to retirement homes.

(1) The construction of or alteration, addition, or renovation to a retirement home must:

(a) meet all applicable local and state building and fire codes;

(b) be approved in writing by the building authority; and

(2) A retirement home must be inspected and certified on an annual basis for compliance with the local and state fire codes by the fire authority. A retirement home must maintain a record of such inspection and certification for at least one year following the date of the inspection.

(1) The construction and operation of any swimming pool, spa, or other water feature, which serves a retirement home must comply with the licensing procedures and requirements of Title 50, chapter 53, MCA, and ARM 37.115.102, 37.115.103, and 37.115.106.

(1) A retirement home must comply with the local and state building code and fire code.

(2) A retirement home must comply with the following physical requirements:

(a) There must be adequate and convenient janitorial facilities including a sink and storage area for equipment and chemicals.

(b) Floors and walls in toilet and bathing rooms, laundries, janitorial closets, and other rooms subject to large amounts of moisture, must be smooth and non-absorbent.

(c) The floor mounted and wall mounted furnishings must be easily moveable to allow for cleaning or mounted in such a manner as to allow for cleaning around and under such furnishings.

(d) Bathing facilities must be equipped with:

(i) anti-slip surfaces; and

(ii) handicapped grab bars, capable of supporting a concentrated load of 250 pounds.

(3) Each bedroom in a retirement home must include:

(a) floor to ceiling walls;

(b) one door which can be closed to allow privacy for residents;

(d) access to a toilet room without entering through another resident's room.

(4) If a retirement home elects to provide furnishings as part of its services, the retirement home must provide in each bedroom an adequate closet or wardrobe, bureau or dresser or its equivalent, and at least one arm chair, for every two residents.

(5) Traffic to and from any room shall not be through a resident's bedroom.

(6) No occupied room shall have as its means of access a trap door, ladder, or folding stairs.

(7) No required path of travel to the outside shall be through rooms that are subject to locking or otherwise controlled by a person other than the person seeking to escape.

(8) No more than four residents may reside in a single bedroom.

(9) Exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules, each single bedroom must contain at least 100 square feet, and each multi-bedroom must contain at least 80 square feet per bed.

(10) With respect to any conditions in existence prior to July 4, 1996, any requirement of ARM 37.106.2510 may be waived at the discretion of the department if:

(a) physical limitations of the retirement home would require disproportionate expense or effort to comply with a requirement, with little or no increase in the level of safety to the residents and staff; or

(b) compliance with a requirement would involve unreasonable hardship or unnecessary inconvenience, with little or no increase in the level of safety to the residents and staff.

(11) With respect to any conditions in existence prior to July 4, 1996, the specific requirements of ARM 37.106.2510 may be modified by the department to allow alternative arrangements that will provide the same level of safety to the residents and staff, but in no case shall the modification afford less safety than that which, in the discretion of the department, would be provided by compliance with the corresponding requirement in ARM 37.106.2510.

(1) Hand cleansing soap or detergent and individual towels must be available at each sink in food preparation areas and commonly shared areas of the facility. Towels for common use are not permitted.

(2) A waste receptacle must be located near each sink.

(3) A minimum of 10 foot-candles of light must be available in all rooms, with the following exceptions:

(a) All reading lamps must have a capacity to provide a

minimum of 30 foot-candles of light;

(b) All toilet and bathing areas must be provided with a minimum of 30 foot-candles of light;

(d) Hallways must be illuminated at all times by at least a minimum of five foot-candles of light at the floor.

(1) The department hereby adopts and incorporates by reference ARM 17.38.207, stating maximum microbiological contaminant levels for public water supply systems, and the following circulars establishing construction, operation, and maintenance standards for spring, surface water, wells and cisterns:

(a) Circular WQB-1 entitled "Montana Department of Health and Environmental Sciences Standards for Water Works" (1992 Edition) ;

(b) Circular WQB-3 entitled "Montana Department of Health and Environmental Sciences Standards for Small Water Systems" (1992 Edition) ;

(c) Circular #17 entitled "Cisterns for Water Supplies." Copies of ARM 17.38.207 and circulars WQB-1, WQB-3 and #17 may be obtained from the Water Quality Bureau (WQB) , Department of Environmental Quality (DEQ) , Metcalf Building, 1520 East 6th Avenue, P.O. Box 200901, Helena, MT 59620-0901.

(2) A retirement home must provide an adequate and potable supply of water. The retirement home must:

(a) connect to a public water supply system approved by the department of environmental quality; or

(b) if the retirement home is not utilized by more than 25 persons daily at least 60 days out of the calendar year, including guests, staff, and residents, and an adequate public water supply system is not accessible, utilize a nonpublic system whose construction and operation meet those standards established in one of the following circulars:

(i) Circular WQB-1 entitled "Montana Department of Health and Environmental Sciences Standards for Water Works" (1992 Edition) ;

(ii) Circular WQB-3 entitled "Montana Department of Health and Environmental Sciences Standards for Small Water Systems" (1992 Edition) ;

(iii) Circular #17 entitled "Cisterns for Water Supplies."

(3) If a nonpublic water supply system is used in accordance with (2) (b) , a retirement home must:

(a) submit a water sample at least quarterly to a laboratory licensed by the department of environmental quality to perform microbiological analysis of water supplies in order to determine that the water does not exceed the maximum microbiological contaminant levels stated in ARM 17.38.207.

(4) A retirement home must replace or repair the water supply system serving it whenever the water supply:

(a) contains microbiological contaminants in excess of the maximum levels contained in ARM 17.38.207; or

(b) does not have the capacity to provide adequate water for drinking, cooking, personal hygiene, laundry, and water-carried waste disposal.

(5) Handsinks and bathing facilities must be provided with water at a temperature of at least 100 º F and not more than 120 º F.

(6) Ice must be:

(a) obtained from a licensed supplier if it is not made from the retirement home's water supply;

(b) manufactured, stored, handled, transported and served in a manner which is approved by the department or local health authority as preventing contamination of the ice.

(7) Where open bin ice storage is provided, an ice scoop must be readily available for use by residents or the management and stored either inside the bin or in a closed container protected from contamination.

(8) Ice storage bins may not be connected directly to any trap, drain, receptacle sink or sewer which discharges waste or to any other source of contamination. A minimum of a four inches air gap is required between the ice storage bin drain and any waste discharge.

(1) The department hereby adopts and incorporates by reference ARM Title 17, chapter 36, subchapter 9, on site subsurface wastewater treatment systems. A copy of ARM Title 17, chapter 36, subchapter 9 may be obtained from the Department of Environmental Quality, Permitting and Compliance Division, 1520 East 6th Avenue, P.O. Box 200901, Helena, MT 59620-0901.

(2) In order to ensure sewage is safely and completely disposed of, a retirement home must:

(a) connect to a public water supply system approved by the department of environmental quality; or

(b) if the retirement home is not utilized by more than 25 persons daily at least 60 days out of the calendar year, including guests, staff, and residents, and an adequate public sewage system is not available, utilize a nonpublic system whose construction and use meet the construction and operation standards in ARM Title 17, chapter 36, subchapter 9;

(1) In order to ensure that solid waste is safely stored and disposed of, a retirement home must:

(a) store all solid waste between collections in containers which have lids and are corrosion resistant, flytight, watertight, and rodent proof;

(b) utilize exterior collection stands for the storage containers, which prevent them from being tipped, protect them from deterioration, and allow easy cleaning below and around them;

(d) transport or utilize a private or municipal hauler to transport the solid waste at least weekly to an approved landfill site in a covered vehicle or in covered containers.

(1) Laundry facilities utilized by a retirement home for laundering of its soiled laundry, including but not limited to bed linen, towels and washcloths, must be provided with:

(a) a mechanical washer and hot air tumble dryer. Manual washing and line drying of bed linen, towels and washcloths is prohibited. Dryers must be properly vented to prevent maintenance problems;

(b) a hot water supply system capable of supplying water at a temperature of 54 E C (130 E F) to the washer during all periods of use, or if a temperature of 54 E C (130 E F) cannot be attained or maintained, manufacturer documentation showing the cleansing products effectiveness at lower water temperatures by exponentially increasing the time laundry is exposed to the product;

(d) separate carts for transporting soiled and cleaned laundry; and

(e) hand washing facilities including a sink, soap, and disposable towels. A soak sink may double as a handwashing sink.

(2) Sheets, pillow covers, towels and washcloths must be dried in a hot air tumble dryer or ironed at a minimum temperature of 150 E C (300 E F) .

(3) Facility staff handling laundry must cover their clothes while working with soiled laundry, use separate clean covering for their clothes while handling clean laundry, and wash their hands both after working with soiled laundry and before they handle clean laundry.

(4) The provisions of ARM 37.106.2520 do not apply to laundry facilities provided by the retirement home for the personal use of its residents.

(1) A retirement home must provide maintenance services. With respect to the provision of maintenance services, and housekeeping services, where a retirement home elects to provide those services to individual residents within their rooms, the retirement home must ensure that:

(a) each janitor room is clean, ventilated and free from odors;

(b) mop heads, when used, are changed frequently using laundered replacements;

(c) toilets, bathtubs, lavatories, and showers are not used for washing and rinsing of mops, brooms, brushes, or any other cleaning devices;

(d) the transporting, handling and storage of clean bedding, where provided by the retirement home, is performed in such a manner as to preclude contamination by soiled bedding or from other sources;

(e) any cleaner used in cleaning bathtubs, showers, lavatories, urinals, toilet bowls, toilet seats, and floors contains fungicides or germicides;

(f) deodorizers and odor-masking agents are not used unless the room in which the agent is used is clean to sight and touch;

(g) cleaning devices used for lavatories, showers and bathtubs are not used for any other purpose;

(h) dry dust mops and dry dust cloths are not used for cleaning purposes. Dusting and cleaning must be accomplished using treated mops, wet mops, treated cloths, or moist cloths to prevent the spread of soil from one place to another;

(i) the retirement home is free of insects, rodents and other vermin;

(j) all bedding, towels, and wash cloths, where provided by the retirement home, are clean and in good repair. Bedding, towels, and wash cloths, where provided by the retirement home, must be made available to each resident on a daily or weekly basis;

(k) all furnishings, where provided by the retirement home, fixtures, floors, walls, and ceilings are clean and in good repair;

(l) cleaning compounds and pesticides are stored, used, and disposed of in accordance with the manufacturer's instructions;

(m) glasses, pitchers, ice buckets, and other utensils used for food or drink and provided in units for use by residents are not washed or sanitized in any lavatory or janitor sink. Approved facilities for washing, rinsing, and sanitizing glasses, pitchers, ice buckets, and other utensils must be provided by the retirement home. In the absence of approved washing facilities, single service utensils must be used; and

(n) all utensils used for food or drink and provided in units for use by residents are stored, handled, and dispensed in a manner which precludes contamination of the utensil prior to use by a resident.

(1) The department hereby adopts and incorporates by reference ARM Title 37, chapter 110, subchapter 2 which sets sanitation and food handling standards for food service establishments. A copy of ARM Title 37, chapter 110, subchapter 2 may be obtained from the Department of Public and Human Services, Health Policy Services Division, Communicable Disease Control and Prevention Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.

(2) Where a food service is operated as an integral part of a retirement home, compliance with ARM Title 37, chapter 110, subchapter 2, is required.

(3) If the food service is available only to residents and staff of the retirement home, licensure as a food service establishment is not required, but compliance with ARM Title 37, chapter 110, subchapter 2, is required.

(1) A retirement home must maintain a register of all residents currently residing at the retirement home, noting for each resident, at a minimum, the resident's name and:

(a) room or apartment number;

(b) date of arrival; and

(2) The register must be kept on the retirement home premises and be available for review and verification by the department during inspections.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of ARM Title 37, chapter 106, subchapter 26, the terms of subchapter 26 will apply to adult day care centers.

(1) An adult day care center shall provide the staff assistance to clients that each requires for activities of daily living, including but not limited to eating, walking, and grooming.

(2) If an adult day care center is operated on the premises of another licensed health care facility:

(a) the other facility may provide to day care clients any of the services for which the other facility is licensed, subject to the limitation that overnight service to a client may be provided for no more than seven successive nights;

(b) adequate facilities and staff must be provided to appropriately serve the clients of each licensed facility; and

(3) An adult day care center that is not operated on the premises of another licensed health care facility may not provide overnight service.

(4) The center must provide recreational and social activities for clients, post a calendar of those activities where clients can see it, and retain a copy of each calendar for at least one year after the date of the last event recorded on it.

(5) An adult day care center must provide an area in which clients desiring to do so may rest. A bed or lounge chair, as well as blankets and pillows, must be available and furnished to those who need them. If the center provides a bed or beds, it must:

(a) keep each bed dressed in clean bed linen in good condition;

(b) keep on hand a supply of clean bed linen sufficient to change beds often enough to keep them clean, dry, and free from odors; and

(6) There must be a written agreement between the center and each client or other person responsible for the client pertaining to cost of care, type of care, services to be provided, and the manner by which the responsible party will be notified of significant changes in the client's condition and the need to seek emergency care for the client.

(7) The family member or other person responsible for a client must be notified promptly if the client is removed from the center. A notation of the date of the contact and the person contacted must be made in the client's record.

(8) Each client must have access to a telephone at a convenient location within the center.

(9) The center shall make adequate provisions for identification of client's personal property and for safekeeping of valuables, including keeping an accounting of any personal funds handled for the client by the center.

(10) A client who is ambulatory only with mechanical assistance may only be kept on the ground floor of the center.

(11) Each adult day care center must employ a manager who must be in good physical and mental health, be of reputable and responsible moral character, and exhibit concern for the safety and well being of clients, and who:

(a) is at all times responsible for the center and ensures appropriate supervision of the clients;

(b) has completed high school or has a general education development (GED) certificate;

(12) The owner of an adult day care center who meets the qualifications listed in (11) above may serve as the manager.

(13) The manager must:

(a) oversee the day to day operation of the center, including, but not limited to:

(i) services to clients;

(ii) record keeping; and

(iii) employing, training and/or supervising employees.

(b) protect the safety of clients;

(d) post the current license at all times at a place in the center that is conspicuous to the public;

(e) provide documented orientation to all employees that includes information on the following:

(i) an overview of the center's policies and procedures manual and a presentation regarding how the policies and procedures are to be used and implemented;

(ii) a review of the employee's job description;

(iii) services provided by the facility;

(iv) simulated fire prevention, evacuation, and disaster drills;

(v) basic techniques of identifying and correcting potential safety hazards in the facility; and

(vi) emergency procedures, such as basic first aid.

(f) review every accident and/or incident causing injury to a client or employee, take appropriate corrective action, and ensure that a record of all accidents and/or incidents and the corrective measures taken is maintained;

(g) comply with the provisions of the Montana Elder and Developmentally Disabled Abuse Prevention Act, 52-3-801 et seq., MCA;

(h) ensure that the center has a policies and procedures manual that governs the operations of the center, that is available to and followed by all employees, and that is available to clients upon request;

(i) maintain a personnel record for each employee, including for substitute personnel, that meets the requirements of ARM 37.106.2620(3) , and retain it for at least one year after the employee terminates employment;

(j) maintain a list of the names, addresses, and telephone numbers of all employees, including substitute personnel, and ensure that all such lists for the prior 12 months are retained on the premises; and

(k) maintain an ongoing census of clients, documenting their attendance, and retain census data covering at least the past 12 months.

(14) At least one employee must be present at the center at all times in which a client is present at the center.

(15) Written daily work schedules for employees showing the personnel on duty at any given time must be kept at least one year.

(16) The individual in charge of each work shift shall have keys to all doors in his/her possession.

(17) The center must at all times employ sufficient staff to provide the services required by the number and characteristics of its clients.

(1) The center shall have a written policies and procedures manual that must:

(a) be available to and followed by all personnel;

(b) be available to clients upon request;

(i) a description of all services provided to clients;

(ii) policies and procedures ensuring the confidentiality of client records and safeguarding against loss, destruction, or unauthorized use of those records;

(iii) infection control policies and procedures meeting the requirements of ARM 37.106.2609; and

(iv) a disaster and fire plan meeting the requirements of ARM 37.106.2608.

(2) If an adult day care center is operated on the premises of another licensed health care facility, the center's manual may refer to the policies and procedures of the other licensed health care facility, as appropriate. The center manual must also include policies and procedures which are applicable to the center itself and which reflect how services between the two facilities are integrated.

(1) Any construction of or alteration, addition, or renovation to an adult day care center must meet all applicable local building and fire codes and be approved by the officer having jurisdiction to determine if the building codes are met by the facility and by the state fire marshal or his/her designee.

(2) An adult day care center must have an annual fire inspection conducted by the appropriate local authorities and maintain a record of such inspection for at least one year following the date of the inspection.

(3) An adult day care center must meet the water supply system requirements of ARM 37.111.115 and the sewage system requirements of ARM 37.111.116.

(4) The department hereby adopts and incorporates by reference ARM 37.111.115, which sets forth requirements for construction and maintenance of water supply systems, and ARM 37.111.116, which sets forth requirements for construction and maintenance of sewage systems. Copies of the materials cited above are available from the Department of Public Health and Human Services, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) An adult day care center must be constructed and maintained so as to prevent as much as is practically possible the entrance and harborage of rats, mice, insects, flies, or other vermin.

(2) Hand cleansing soap or detergent and individual towels must be available at each sink in the center. A waste receptacle must be located near each sink.

(3) A minimum of 10 foot-candles of light must be available in all rooms and hallways, with the following exceptions:

(a) All reading lamps must have a capacity to provide a minimum of 30 foot-candles of light;

(b) All toilet and bathing areas must be provided with a minimum of 30 foot-candles of light;

(d) Hallways must be illuminated at all times by at least a minimum of five foot-candles of light at the floor.

(1) An adult day care center shall develop a disaster and fire plan in conjunction with other emergency services in the community that includes a procedure that will be followed in the event of a natural or human caused disaster. This plan must be included in the center's policies and procedures manual.

(2) An adult day care center shall conduct a drill of such procedure at least once a year. After a drill, the center shall prepare and retain on file a written report including, but not limited to, the following:

(a) date and time of the drill;

(b) the names of staff involved in the drill;

(d) the names of other persons involved in the drill;

(e) a description of all phases of the drill procedure and suggestions for improvement; and

(f) the signature of the person conducting the drill.

(1) An adult day care center must ensure that each of its employees provides the center, prior to the time of employment, with documentation from a physician stating that the employee is free from communicable tuberculosis, and with the same documentation annually thereafter.

(2) The center must ensure that, on the first day of service and annually thereafter, each client in that center provides documentation from a physician showing that the client is free from communicable tuberculosis.

(3) The adult day care center must establish and maintain infection control policies and procedures sufficient to provide a safe environment and to prevent the transmission of disease. Such policies and procedures must include, at a minimum, the following guidelines:

(a) Any employee contracting a communicable disease that is transmissible to clients through food handling or personal care may not appear at work until the infectious disease can no longer be transmitted. The decision to return to work must be made by the manager in accordance with the policies and procedures instituted by the center; and

(b) If, after admission, a client is suspected of having a communicable disease that would endanger the health and welfare of other clients, the manager shall contact the client's physician and shall ensure that appropriate safety measures are taken on behalf of that client and the other clients.

(1) Each adult day care center shall have a written maintenance program describing the procedures that must be utilized by maintenance personnel to keep the building and equipment in repair and free from hazards.

(2) All electrical, mechanical, plumbing, fire protection, heating, and sewage disposal systems must be kept in operational condition.

(3) The temperature of hot water supplied to handwashing and bathing facilities must not exceed 120 E F.

(4) An adult day care center shall provide housekeeping services on a daily basis or as needed.

(5) Cleaners used in cleaning bathtubs, showers, sinks, urinals, toilet bowls, toilet seats, and floors must contain fungicides or germicides with current EPA registration for that purpose.

(6) Floors must be covered with an easily cleanable covering.

(7) Carpets are prohibited in bathrooms, kitchens, laundries, or janitor closets.

(8) Walls and ceilings must be kept in good repair and be of a finish that can be easily cleaned.

(9) An adult day care center must be kept clean and free of odors. Deodorants may not be used for odor control in lieu of proper ventilation.

(1) If an adult day care center that is not located on the premises of another licensed health care facility elects to process its laundry on the center site, it must:

(a) set aside and utilize an area solely for laundry purposes;

(b) equip the laundry room with a mechanical washer and a dryer vented to the outside, handwashing facilities, a fresh air supply, and a hot water supply system that supplies the washer with water of at least 110 E F during each use;

(c) have a separate area or room designed for use as a laundry, including an area for sorting soiled and clean linen and clothing. No laundry may be done in a food preparation or dishwashing area;

(d) provide well maintained containers to store and transport laundry that are impervious to moisture, keeping those used for soiled laundry separate from those used for clean laundry;

(e) dry all bed linen, towels, and wash cloths in the dryer;

(f) protect clean laundry from sources of contamination; and

(g) ensure that center staff handling laundry cover their clothes while working with soiled laundry, use separate clean covering for their clothes while handling clean laundry, and wash their hands both after working with soiled laundry and before they handle clean laundry.

(1) An adult day care center must provide:

(a) at least one meal a day to clients who stay at the center up to 10 hours;

(b) two meals per day to clients who stay at the center over 10 hours;

(2) Snacks must be offered between meals.

(3) The center must establish and maintain standards relative to food sources; refrigeration; refuse handling; pest control; storage, preparation, procuring, serving, and handling food; and dishwashing procedures that are sufficient to prevent food spoilage and the transmission of infectious disease, including the following:

(a) Food must be obtained solely from sources that comply with all laws and rules relating to food and food labeling;

(b) The use of home canned foods is prohibited;

(d) Food subject to spoilage must be dated.

(4) Foods must be served in amounts and a variety to meet the nutritional needs of each client.

(5) Foods must be cut, chopped, and ground to meet individual needs.

(6) Potentially hazardous food, such as meat and milk products, must be stored at 45 º F or below. Hot food must be kept at 140 º F or above during preparation and serving.

(7) Freezers must be kept at a temperature of 0 º F or below and refrigerators must be kept at a temperature of 45 º F or below. Thermometers must be placed in the warmest area of the refrigerator and freezer to assure proper temperature.

(8) Produce, food, and containers of food must be stored a minimum of six inches above the floor in a manner that protects the food from splash and other contamination.

(9) Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practice during all working periods in food service.

(10) No food service employee who is either infected with a disease in a communicable form that can be transmitted by foods, a carrier of organisms that cause such a disease, or afflicted with a boil, an infected wound, or an acute respiratory infection, may work in the food service area in any capacity in which there is a likelihood of that person contaminating food or food contact surfaces with pathogenic organisms or transmitting disease to other persons.

(11) Tobacco products may not be used in the food preparation area.

(12) If an adult day care center contracts with another establishment to prepare food for the clients, a record of each such contract must be maintained for at least one year.

(1) An adult day care center shall prepare a record for each client composed of at least the following information: name; address; sex; social security number; date of birth; marital status; insurance or financial responsibility information; religious affiliation; next of kin; the first day of service and the last day of service; the client's physician's name, address, and telephone number, if appropriate; required medications, if applicable; the date and time of visit to or by his/her physician; and a record of medications taken by the client as required in ARM 37.106.2621(3) .

(2) The center shall retain all client records for no less than five years following the last day of service to the client or the client's death, whichever date is earlier.

(3) The center must maintain a personnel record for each employee, including for substitute personnel, that includes at least the following:

(a) employment application;

(b) employment contract;

(d) references;

(e) performance appraisals; and

(f) a description of any significant incident involving both the employee and a client and its consequences.

(1) If a client is required to take medication while at the center, the client must be capable of taking his/her own medications, with the following assistance from staff:

(a) reminding the client to take the medication at the proper time;

(b) removing medication containers from storage;

(d) guiding the hand of the client; and

(e) observing the client take the medication.

(2) All medications must remain in locked storage until the client is discharged.

(3) The center must maintain for each client a medication administration record listing all medications used and all doses taken or not taken by the client.

This rule has been repealed.

(1) The rules in this chapter pertain to facilities which provide personal care services. These rules constitute the basis for the licensure of assisted living facilities by the Montana department of public health and human services.

(1) The purpose of these rules is to establish standards for assisted living A, B, C, and D facilities. Assisted living facilities are a setting for frail, elderly, or disabled persons which provide supportive health and service coordination to maintain the residents' independence, individuality, privacy, and dignity.

(2) An assisted living facility offers a suitable living arrangement for persons with a range of capabilities, disabilities, frailties, and strengths. In general, however, assisted living is not appropriate for individuals who are incapable of responding to their environment, expressing volition, interacting, or demonstrating any independent activity. For example, individuals in a persistent vegetative state who require long term nursing care should not be placed or cared for in an assisted living facility.

(1) Category A facilities must meet the requirements of ARM 37.106.2801 through 37.106.2866.

(2) Category B facilities must meet the requirements of ARM 37.106.2801 through 37.106.2885.

(3) Category C facilities must meet the requirements of ARM 37.106.2801 through 37.106.2885 and ARM 37.106.2891 through 37.106.2898.

(4) Category D facilities must meet the requirements of ARM 37.106.2801 through 37.106.2885 and ARM 37.106.2899 through 37.106.2899H.

(1) To the extent that other licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of ARM Title 37, chapter 106, subchapter 28, the terms of subchapter 28 will apply to assisted living facilities.

The following definitions apply in this subchapter:

(1) "Activities of daily living (ADLs) " means tasks usually performed in the course of a normal day in a resident's life that include eating, walking, mobility, dressing, grooming, bathing, toileting, and transferring.

(2) "Administrator" means the person designated on the facility application or by written notice to the department as the person responsible for the daily operation of the facility and for the daily resident care provided in the facility.

(3) "Advance directive" means a written instruction, such as a living will, a do not resuscitate (DNR) order, or durable power of attorney (POA) for health care, recognized under state law relating to the provision of health care when the individual is incapacitated.

(4) "Ambulatory" means a person is capable of self mobility, either with or without mechanical assistance. If mechanical assistance is necessary, the person is considered ambulatory only if they can, without help from another person, transfer, safely operate, and utilize the mechanical assistance, exit and enter the facility, and access all common living areas of the facility.

(5) "Assisted living facility" is defined at 50-5-101 , MCA.

(6) "Change of ownership" means the transfer of ownership of a facility to any person or entity other than the person or entity to whom the facility's license was issued, including the transfer of ownership to an entity which is wholly owned by the person or entity to whom the facility's license was issued.

(7) "Department" means the department of public health and human services.

(8) "Direct care staff" means a person or persons who directly assist residents with personal care services and medication. It does not include housekeeping, maintenance, dietary, laundry, administrative, or clerical staff at times when they are not providing any of the above-mentioned assistance. Volunteers can be used for direct care, but may not be considered part of the required staff.

(9) "Health care plan" means a written resident specific plan identifying what ongoing assistance with activities of daily living and health care services is provided on a daily or regular basis by a licensed health care professional to a category B, C, or D resident under the orders of the resident's practitioner. Health care plans are developed as a result of a resident assessment performed by a licensed health care professional who may consult with a multi-disciplinary team.

(10) "Health care service" means any service provided to a resident of an assisted living facility that is ordered by a practitioner and required to be provided or delegated by a licensed, registered, or certified health care professional. Any other service, whether or not ordered by a physician or practitioner, that is not required to be provided by a licensed, registered, or certified health care professional is not to be considered a health care service.

(11) "Involuntary transfer or discharge" means the involuntary discharge of a resident from the licensed facility or the involuntary transfer of a resident to a bed outside of the licensed facility. The term does not include the transfer of a resident from one bed to another within the same licensed facility, or the temporary transfer or relocation of the resident outside the licensed facility for medical treatment.

(12) "License" means the document issued by the department that authorizes a person or entity to provide personal care or assisted living services.

(13) "Licensed health care professional" means a licensed physician, physician assistant-certified, advanced practice registered nurse, or registered nurse who is practicing within the scope of the license issued by the department of labor and industry.

(14) "Mechanical assistance" means the use of any assistive device that aids in the mobility and transfer of the resident. Assistive devices include braces, walkers, canes, crutches, wheelchairs, and similar devices.

(15) "Medication administration" means an act in which a prescribed drug or biological is given to a resident by an individual who is authorized in accordance with state laws and regulations governing such acts.

(16) "Mental health professional" means:

(a) a certified professional person under Title 53, chapter 21, part 1, MCA;

(b) a physician licensed under Title 37, chapter 3, MCA;

(d) a psychologist licensed under Title 37, chapter 17, MCA;

(e) a social worker licensed under Title 37, chapter 22, MCA;

(f) a marriage and family therapist under Title 37, chapter 37, MCA;

(g) an advanced practice registered nurse, as provided for in 37-8-202, MCA, with a clinical specialty in psychiatric mental health and mental disorders nursing; or

(h) a physician assistant licensed under Title 37, chapter 20, MCA, with a clinical specialty in psychiatric mental health.

(17) "Nursing care" means the practice of nursing as governed by 37-8-102(7), MCA and by administrative rules adopted by the Board of Nursing, found at ARM Title 24, chapter 159.

(18) "Personal care" means the provision of services and care for residents who need some assistance in performing the activities of daily living.

(19) "Practitioner" means an individual licensed by the Department of Labor and Industry who has assessment, admission, and prescription authority.

(20) "PRN medication" means an administration scheme, in which a medication is not routine, is taken as needed, and requires the licensed health care professional or individual resident's own cognitive assessment and judgement for need and effectiveness.

(21) "Resident" means anyone at least 18 years of age accepted for care in an assisted living facility.

(22) "Resident agreement" means a signed, dated, written document that lists all charges, services, refunds, and move out criteria and complies with ARM 37.106.2823.

(23) "Resident certification" means written certification by a licensed health care professional that the facility can adequately meet the particular needs of a resident. The licensed health care professional making the resident certification must have:

(a) visited the resident on site; and

(b) determined that the resident's health care status does not require services at another level of care.

(24) "Resident's legal representative" or "resident's representative" means the resident's guardian, or if no guardian has been appointed, then the resident's family member or other appropriate person acting on the resident's behalf.

(25) "Self-administration assistance" means providing necessary assistance to any resident in taking their medication, including:

(a) removing medication containers from secured storage;

(b) providing verbal suggestions, prompting, reminding, gesturing, or providing a written guide for self-administrating medications;

(c) handing a prefilled, labeled medication holder, labeled unit dose container, syringe or other labeled container from the pharmacy or a medication organizer as described in ARM 37.106.2847 to the resident;

(d) opening the lid of the above container for the resident;

(e) guiding the hand of the resident to self-administer the medication;

(f) holding and assisting the resident in drinking fluid to assist in the swallowing of oral medications; and

(g) assisting with removal of a medication from a container for residents with a physical disability which prevents independence in the act.

(26) "Service coordination" means that the facility either directly provides or assists the resident to procure services including, but not limited to:

(a) beauty or barber shop;

(b) financial assistance or management;

(d) laundry;

(e) recreation activities;

(f) shopping;

(g) spiritual services; and

(h) transportation.

(27) "Service plan" means a written plan for services developed by the facility with the resident or resident's legal representative which reflects the resident's capabilities, choices and, if applicable, measurable goals and risk issues. The plan is developed on admission and is reviewed and updated annually and if there is a significant change in the resident's condition. The development of the service plan does not require a licensed health care professional.

(28) "Severe cognitive impairment" means the loss of intellectual functions, such as thinking, remembering, and reasoning, of sufficient severity to interfere with a person's daily functioning. Such a person is incapable of recognizing danger, self-evacuating, summoning assistance, expressing need, and/or making basic care decisions.

(29) "Significant change" means a resident status or condition change that results in a change in service and care needs. This includes:

(a) admission to, or discharge from hospice services;

(b) a change in categorization; or

(30) "Therapeutic diet" means a diet ordered by a physician or practitioner as part of treatment for a disease or clinical condition or to eliminate or decrease specific nutrients in the diet, (e.g., sodium) or to increase specific nutrients in the diet (e.g., potassium) or to provide food the resident is able to eat (e.g., mechanically altered diet) .

(31) "Third party services" means care and services provided to a resident by individuals or entities who have no fiduciary interest in the facility.

(32) "Treatment" means a therapy, modality, product, device, or other intervention used to maintain well-being or to diagnose, assess, alleviate, or prevent a disability, injury, illness, disease, or other similar condition.

(1) Application for a license accompanied by the required fee shall be made to the Department of Public Health and Human Services, Office of Inspector General, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953 upon forms provided by the department and shall include full and complete information as to the:

(a) identity of each officer and director of the corporation, if organized as a corporation;

(b) identity of each general partner if organized as a partnership or limited liability partnership;

(d) name, address, and phone number of the management company if applicable;

(e) physical location address, mailing address, and phone number of the facility;

(f) maximum number of A beds, B beds, C beds, and D beds in the facility;

(g) policies and procedures as outlined in ARM 37.106.2815; and

(h) resident agreement, as outlined in ARM 37.106.2823, intended to be used.

(2) Every facility shall have distinct identification or name and shall notify the department in writing within 30 days prior to changing such identification or name.

(3) Each assisted living facility shall promptly report to the department any plans to relocate the facility at least 30 days prior to effecting such a move.

(4) In the event of a facility change of ownership, the new owners shall provide the department the following:

(a) a completed application with fee;

(b) a copy of the fire inspection conducted within the past year;

(c) policies and procedures as prescribed in ARM 37.106.2815 or if applicable, a written statement indicating that the same policies and procedures will be used as required;

(d) a copy of the resident agreement as outlined in ARM 37.106.2823 to be used; and

(e) documentation of compliance with ARM 37.106.2814.

(5) Under a change of ownership, the seller shall return to the department the assisted living license under which the facility had been previously operated. This information must be sent to the Department of Public Health and Human Services, Office of Inspector General, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) A license is not subject to sale, assignment, or other transfer, voluntary or involuntary.

(2) A license is valid only for the premises for which the original license was issued.

(3) The license remains the property of the department and shall be returned to the department upon closing or transfer of ownership.

(a) The address for returning the license is Department of Public Health and Human Services, Office of Inspector General, Licensure Bureau, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953.

(1) Each assisted living facility shall employ an administrator. The administrator is responsible for operation of the assisted living facility at all times and shall ensure 24-hour supervision of the residents.

(2) The administrator must meet the following minimum requirements:

(a) be currently licensed as a nursing home administrator in Montana or another state; or

(b) has successfully completed all of the self study modules of "A Management Reference for Executive Directors - Admin Level 1 Certificate Program," a component of the assisted living training system published by the Senior Living University (SLU) or an alternate, approved program; or

(3) The administrator must show evidence of at least 16 contact hours of annual continuing education relevant to the individual's duties and responsibilities as administrator of the assisted living facility.

(a) A nursing home administrator license or the SLU certification may count as 16 hours of annual continuing education but only for the calendar year in which the license or certification was initially obtained.

(4) In the absence of the administrator, a staff member must be designated to oversee the operation of the facility. The administrator or designee shall be in charge, on call, and physically available on a daily basis as needed, and shall ensure there are sufficient, qualified staff so that the care, well-being, health, and safety needs of the residents are met at all times.

(a) If the administrator will be absent from the facility for more than 30 continuous days, the department shall be given written notice of the individual who has been appointed the designee. The appointed designee must meet all the requirements of (1) and (2).

(5) The administrator or designee may not be a resident of the facility.

(a) A designee must:

(i) be age 18 or older; and

(ii) have demonstrated competencies required to assure protection of the safety and physical, mental, and emotional health of residents.

(6) The administrator or designee shall:

(a) ensure that the current facility license or licenses are posted at a place in the facility that is accessible to the public at all times;

(b) oversee the day-to-day operation of the facility including:

(i) all personal care services for residents;

(ii) the employment, training, and supervision of staff and volunteers;

(iii) maintenance of buildings and grounds; and

(iv) record keeping; and

(7) The facility shall notify the department within five days of an administrator's departure or a new administrator's employment.

(8) The administrator or designee shall initiate transfer of a resident through the resident and/or the resident's practitioner, appropriate agencies, or the resident's legal representative when the resident's condition is not within the scope of services of the assisted living facility.

(9) The administrator or designee shall accept and retain only those residents whose needs can be met by the facility and who meet the acceptance criteria found in 50-5-226 , MCA.

(10) The administrator or designee must ensure that a resident who is ambulatory only with mechanical assistance is:

(a) able to safely self-evacuate the facility without the aid of an elevator or similar mechanical lift;

(b) have the ability to move past a building code approved occupancy barrier or smoke barrier into an adjacent wing or building section; or

(11) The administrator or designee shall ensure and document that orientation is provided to all employees at a level appropriate to the employee's job responsibilities.

(12) The administrator or designee shall review every accident or incident causing injury to a resident and document the appropriate corrective action taken to avoid a reoccurrence.

(13) The owner of an assisted living facility may serve as administrator, or in any staff capacity, if the owner meets the qualifications specified in these rules.

(1) A policies and procedures manual for the organization and operation of the assisted living facility shall be developed, implemented, kept current, reviewed every other year and as necessary to assure the continuity of care and day to day operations of the facility. Each review of the manual shall be documented, and the manual shall be available in the facility to staff, residents, residents' legal representatives, and representatives of the department at all times.

(2) The manual must include an organizational chart delineating the lines of authority, responsibility, and accountability for the administration and resident care services of the facility.

(3) New policies, as developed, must be submitted to the department for review.

(1) The administrator shall develop minimum qualifications for the hiring of direct care staff and support staff.

(2) The administrator shall develop policies and procedures for conducting criminal background checks, hiring, and assessing staff, which include practices that assist the employer in identifying employees who may pose risk or threat to the health, safety, or welfare of any resident and provide written documentation of findings and the outcome in the employee's file.

(a) A name-based or FBI fingerprint background check shall be conducted on all employees who have accepted employment at an assisted living facility.

(i) If an applicant has lived outside the state within the past five years, the assisted living facility must complete background checks in every state in which the applicant has resided within the past five years unless the name-based background check yields nationwide results, or the facility may conduct a FBI fingerprint background check.

(b) The administrator may allow an employee to work provisionally pending the background check results so long as there are no indications the employee poses a risk or threat to the health, safety, or welfare of the residents in the facility.

(3) New employees shall receive orientation and training in areas relevant to the employee's duties and responsibilities, including:

(a) an overview of the facility's policies and procedures manual in areas relevant to the employee's job responsibilities;

(b) a review of the employee's job description;

(d) the Montana Elder and Persons with Developmental Disabilities Abuse Prevention Act found at 52-3-801 et seq., MCA;

(e) the Montana Long-Term Care Resident Bill of Rights Act found at 50-5-1101 et seq., MCA;

(f) staff who are responsible for assisting with self-administration of medication will receive orientation and training on resident Medication Administration Records (MARs) and the five rights of medication administration; and

(g) all direct care staff will receive, at minimum, two hours of training in dementia care upon hire and annually thereafter.

(4) In addition to meeting the requirements of (3) , direct care staff shall be trained to perform the services established in each resident service plan.

(a) Direct care staff will review each resident's current service plan or health care plan and document that they have reviewed the plan and can perform the services required.

(5) Direct care staff shall be trained in the use of the abdominal thrust maneuver and basic first aid. If the facility offers cardiopulmonary resuscitation (CPR) , at least one person per shift shall hold a current CPR certificate.

(6) The following rules must be followed in staffing the assisted living facility:

(a) direct care staff shall have knowledge of the resident's needs and any events about which the employee should notify the administrator or the administrator's designated representative;

(b) the facility shall have a sufficient number of qualified staff on duty 24 hours a day to meet the scheduled and unscheduled needs of each resident, to respond in emergency situations, and all related services, including:

(i) maintenance of order, safety, and cleanliness;

(ii) assistance with medication regimens;

(iii) preparation and service of meals;

(iv) housekeeping services and assistance with laundry; and

(v) assurance that each resident receives the supervision and care required by the service or health care plan to meet the resident's basic needs;

(c) an individual on each work shift shall have keys to all relevant resident care areas and access to all items needed to provide appropriate resident care;

(d) direct care staff may not perform any service for which they have not received appropriate documented training; and

(e) facility staff may not perform any health care service that has not been appropriately delegated under the Montana Nurse Practice Act or in the case of licensed health care professionals, that is beyond the scope of their license.

(7) Employees and volunteers may perform support services, such as cooking, housekeeping, laundering, general maintenance and office work after receiving an orientation to the appropriate sections of the facility's policy and procedure manual. Any person providing direct care, however, is subject to the orientation and training requirements for direct care staff.

(8) Volunteers may be utilized in the facility, but may not be included in the facility's staffing plan in lieu of facility employees. In addition, the use of volunteers is subject to the following:

(a) volunteers must be supervised and be familiar with resident rights and the facility's policies and procedures which apply to their duties as a volunteer; and

(b) volunteers shall not assist with medication administration, delegated nursing tasks, bathing, toileting, or transferring.

(9) Residents may participate voluntarily in performing household duties and other tasks suited to the individual resident's needs and abilities, but residents may not be used as substitutes for required staff or be required to perform household duties or other facility tasks.

(1) The facility is responsible for maintaining a file on each employee and substitute personnel.

(2) The following documentation from employee files must be made available to the department at all reasonable times, but shall be made available to the department within 24 hours after the department requests to review the files:

(a) the employee's name;

(b) a copy of current credentials, certifications, or professional licenses as required to perform the job description;

(d) initialed documentation of employee orientation and ongoing training including documentation of abdominal thrust maneuver training, basic first aid, and CPR; and

(e) the result of the employee's criminal background check.

(3) The facility shall keep an employee file that meets the requirements set forth in (2) for the administrator of the facility, even when the administrator is the owner.

(4) The employer must have evidence of contact to verify that each certified nursing assistant has no adverse findings entered on the nurse aid registry maintained by the department in the certification bureau.

(a) A facility may not employ or continue employment of any person who has adverse findings on the nurse aide registry maintained by the department's certification bureau.

(1) All facilities must develop a written application procedure for admission to the facility which includes the prospective resident's name and address, sex, date of birth, marital status, and religious affiliation (if volunteered).

(2) The facility shall determine whether a potential resident meets the facility's admission requirements and that the resident is appropriate to the facility's license endorsement as either a category A, category B, category C, or category D facility, as specified in 50-5-226, MCA.

(3) Prior to admission, the facility shall conduct an initial resident needs assessment to determine the prospective resident's needs.

(4) The initial resident's needs assessment must include documentation of the following:

(a) cognitive patterns to include short-term memory, long term memory, memory recall, decision making, and change in cognitive status/awareness, or thinking disorders;

(b) sensory patterns to include hearing, ability to understand others, ability to make self understood, and ability to see in adequate light;

(c) activities of daily living (ADL) functional performance to include ability to transfer, locomotion, mobility devices, dressing, eating, use of toilet, bladder continence, bowel continence, continence appliance/programs, grooming, and bathing;

(d) mood and behavior patterns, sadness or anxiety displayed by resident, wandering, verbally abusive, physically abusive, and socially inappropriate/disruptive behavior;

(e) health problems/accidents;

(f) weight/nutritional status to include current weight and nutritional complaints;

(g) skin problems;

(h) current medication use including over-the-counter and/or prescription medications; and

(i) use of restraints, safety, or assistive devices.

(5) The department shall collect a fee of $100 from a prospective resident, resident or facility appealing a rejection, or relocation decision made pursuant to ARM 37.106.2821, to cover the cost of the independent nurse resident needs assessment.

(6) The resident's needs assessment shall be reviewed and updated annually or at any time the resident's needs change significantly.

(1) Based on the initial resident's needs assessment, an initial service plan shall be developed for all category A residents within 24 hours of admission. The initial service plan shall be reviewed or modified within 60 days of admission to assure the service plan accurately reflects the resident's needs and preferences.

(2) The service plan shall include a written description of:

(a) what the service is;

(b) who will provide the service;

(d) where and how often the service is provided;

(e) changes in service and the reasons for those changes;

(f) if applicable, the desired outcome;

(g) an emergency contact with phone number; and

(h) the prospective resident's practitioner's name, address, and telephone number and whether there are any health care decision making instruments in effect if applicable.

(3) The resident service plan shall be reviewed and updated annually, or at any time the resident has a significant change.

(4) A copy of the resident service plan shall be given to the resident or resident's legal representative and be made part of the resident file.

(1) An assisted living facility shall enter into a written resident agreement with each prospective resident prior to admission to the assisted living facility. The agreement shall be signed and dated by a facility representative and the prospective resident or the resident's legal representative. The facility shall provide the prospective resident or the resident's legal representative and the resident's practitioner, if applicable, a copy of the agreement and shall explain the agreement to them. The agreement shall include at least the following items:

(a) the criteria for requiring transfer or discharge of the resident to another facility providing a different level of care;

(b) a statement explaining the availability of skilled nursing or other professional services from a third party provider to a resident in the facility;

(d) a statement explaining the resident's responsibilities including house rules, the facility grievance policy, facility smoking policy, facility policy regarding pets, and the facility policy on medical and recreational marijuana use;

(e) a listing of specific charges to be incurred for the resident's care, frequency of payment, facility rules relating to nonpayment of services, and security deposits, if any are required;

(f) a statement of all charges, fines, penalties, or late fees that shall be assessed against the resident;

(g) a statement that the agreed upon facility rate shall not be changed unless 30 days' advance written notice is given to the resident and/or the resident's legal representative; and

(h) an explanation of the assisted living facility's policy for refunding payment in the event of the resident's absence, discharge, or transfer from the facility and the facility's policy for refunding security deposits.

(2) When there are changes in services, financial arrangements, or in requirements governing the resident's conduct and care, a new resident/provider agreement must be executed or the original agreement must be updated by addendum and signed and dated by the resident or the resident's legal representative and by the facility representative.

(1) Residents shall be given a written 30 day notice when they are requested to move out. The administrator or designee shall initiate transfer of a resident through the resident's physician or practitioner, appropriate agencies, and the resident's legal representative, as applicable, when:

(a) the resident's needs exceed the level of ADL services the facility provides;

(b) the resident exhibits behavior or actions that repeatedly and substantially interfere with the rights, health, safety, or well-being of other residents and the facility has tried prudent and reasonable interventions;

(i) documentation of the interventions attempted by the facility shall become part of the resident's record;

(c) the resident, due to severe cognitive decline, is not able to respond to verbal instructions, recognize danger, make basic care decisions, express needs, or summon assistance, except as permitted by ARM 37.106.2891 through 37.106.2898;

(d) the resident has a medical condition that is complex, unstable, or unpredictable and treatment cannot be appropriately developed in the assisted living environment;

(e) the resident has had a significant change in condition that requires medical or psychiatric treatment outside the facility and at the time the resident is to be discharged from that setting to move back into the assisted living facility, appropriate facility staff have re-evaluated the resident's needs and have determined the resident's needs exceed the facility's level of service. Temporary absence for medical treatment is not considered a move out;

(f) the resident has failed to pay charges after reasonable and appropriate notice; or

(g) the facility ceases to operate.

(2) The resident's 30 day written move out notice shall, at a minimum, include the following:

(a) the reason for transfer or discharge;

(b) the effective date of the transfer or discharge;

(d) a statement that the resident has the right to appeal the action to the department; and

(e) the name, address, and telephone number of the state long term care ombudsman.

(3) A written notice of discharge in less than 30 days may be issued for the following reasons:

(a) if a resident has a medical emergency;

(b) the resident exhibits behavior that poses an immediate danger to self or others; or

(4) A resident has a right to a fair hearing to contest an involuntary transfer or discharge.

(a) Involuntary transfer or discharge is defined in ARM 37.106.2805.

(b) A resident may exercise his or her right to appeal an involuntary transfer or discharge by submitting a written request for fair hearing to the Department of Public Health and Human Services, Office of Inspector General, Office of Fair Hearings, P.O. Box 202953, 2401 Colonial Drive, Helena, MT 59620-2953, within 30 days of notice of transfer or discharge.

(c) The parties to a hearing regarding a contested transfer or discharge are the facility and the resident contesting the transfer or discharge. The department is not a party to such a proceeding, and relief may not be granted to either party against the department in a hearing regarding a contested transfer or discharge.

(d) Hearings regarding a contested transfer or discharge shall be conducted in accordance with ARM 37.5.304, 37.5.305, 37.5.307, 37.5.313, 37.5.322, 37.5.325, and 37.5.334, and a resident shall be considered a claimant for purposes of these rules.

(e) The request for appeal of a transfer or discharge does not automatically stay the decision of the facility to transfer or discharge the resident. The hearing officer may, for good cause shown, grant a resident's request to stay the facility's decision pending a hearing.

(f) The hearing officer's decision following a hearing shall be the final decision for the purposes of judicial review under ARM 37.5.334.

(5) The facility must assist with discharge to ensure safe and appropriate placement of the resident.

(1) The facility shall comply with the Montana Long-Term Care Residents' Bill of Rights, found at 50-5-1101 , et seq., MCA. This includes the posting of the facility's statement of resident rights in a conspicuous place. Prior to or upon admission of a resident, the assisted living facility shall explain and provide the resident with a copy of the Montana Long-Term Care Residents' Bill of Rights.

(2) Residents have the right to execute living wills and other advance health care directives, and to have those advance directives honored by the facility in accordance with law.

(3) Prior to admission of a resident, the assisted living facility must inform a potential resident in writing of:

(a) their right (at the individual's option) to make decisions regarding medical care, including the right to accept or refuse medical treatment, and the right to formulate an advance directive; and

(b) explain and provide a copy of the facility's policies regarding advance directives, including a policy that the facility cannot implement an advance directive, either because of a conscientious objection (under 50-9-203 , MCA) , or, for some other reason as stated in facility policy (under 50-9-203 , MCA) .

(4) If the facility policy is not to implement an advanced directive the facility shall:

(a) take all reasonable steps to transfer the resident to a facility which has no prohibition against implementation of advance directives; or

(b) shall inform the resident in writing of any limitations placed upon implementation of the resident's advance directive by the facility.

(5) An assisted living facility may not require an execution of an advance directive as a condition for admission.

(1) At the time of admission, a separate file must be established for each category A, category B, category C, or category D resident. This file must be maintained on site in a safe and secure manner and must preserve the resident's confidentiality.

(2) The file shall include at least the following:

(a) a completed resident agreement, in accordance with ARM 37.106.2823;

(b) updates of resident/provider agreements, if any;

(d) resident's weight on admission and at least annually thereafter for category A residents or more often as the resident, or the resident's licensed health care professional, determine a weight check is necessary;

(e) reports of significant events including:

(i) documentation of the notice to the resident's practitioner;

(ii) steps taken to safeguard the resident; and

(iii) facility contacts with family members or another responsible party;

(f) a record of communication between the facility and the resident or their representative if there has been a change in the resident's status or a need to discharge; and

(g) the date and circumstances of the resident's final transfer, discharge, or death, including notice to responsible parties and disposition of personal possessions.

(3) The resident file must be kept current. The file must be retained for a minimum of three years following the resident's discharge, transfer or death.

(1) A resident may purchase third party services provided by an individual or entity, licensed if applicable, to provide health care services under arrangements made directly with the resident or resident's legal representative under the provisions of 50-5-225 (2) (a) and (b) , MCA.

(2) The resident or resident's legal representative assumes all responsibility for arranging for the resident's care through appropriate third parties.

(3) Third party services shall not compromise the assisted living facility operation or create a danger to others in the facility.

(1) A planned, diversified program of resident activities shall be offered daily for residents, including individual or group activities, on or off site, to meet the individual needs and well being of residents. Resident activities should promote and encourage self care and continuity of normal activities.

(2) The activities program shall be developed based on the activity needs and interest of residents as identified through the service plan.

(3) The facility shall provide directly, or by arrangement, local transportation for each resident to and from health care services provided outside the facility and to activities of social, religious or community events in which the resident chooses to participate according to facility policy.

(4) The activities program shall develop and post a monthly group activities calendar, which lists social, recreational, and other events available to residents. The facility shall maintain a record of past monthly activities, kept on file on the premises for at least three months.

(1) A resident of an assisted living facility who uses a wheelchair or walker for mobility, or who is a category B, category C, or category D resident, must not be required to use a bedroom on a floor other than the first floor of the facility that is entirely above the level of the ground, unless the facility is designed and equipped in such a manner that the resident can move between floors or to an adjacent international conference of building code officials approved occupancy/fire barrier without assistance and the below grade resident occupancy is or has been approved by the local fire marshal.

(2) Each resident bedroom must satisfy the following requirements:

(a) in a previously licensed facility, no more than four residents may reside in a single bedroom;

(b) in new construction and facilities serving residents with severe cognitive impairment, occupancy must be limited to no more than two residents per room;

(c) exclusive of toilet rooms, closets, lockers, wardrobes, alcoves, or vestibules, each single bedroom must contain at least 100 square feet, and each multi-bedroom must contain at least 80 square feet per resident;

(d) each resident must have a wardrobe, locker, or closet with minimum clear dimensions of 1 foot 10 inches in depth by 1 foot 8 inches in width, with a clothes rod and shelf placed to permit a vertically clear hanging space of 5 feet for full length garments;

(e) a sufficient number of electrical outlets must be provided in each resident bedroom and bathroom to meet staff and resident needs without the use of extension cords;

(f) each resident bedroom must have operable exterior windows which meet the approval of the local fire or building code authority having jurisdiction;

(g) the resident's bedroom door may be fitted with a lock if approved in the resident service plan, as long as facility staff have access to a key at all times in case of an emergency. Deadbolt locks are prohibited on all resident bedrooms. Resident bedroom door locks must be operable, on the resident side of the door, with a single motion and may not require special knowledge for the resident to open;

(h) kitchens or kitchenettes in resident bedrooms are permitted if the resident's service plan permits unrestricted use and the cooking appliance can be removed or disconnected if the service plan indicates the resident is not capable of unrestricted use.

(3) A hallway, stairway, unfinished attic, garage, storage area or shed, or other similar area of an assisted living facility must not be used as a resident bedroom. Any other room must not be used as a resident bedroom if it:

(a) can only be reached by passing through a bedroom occupied by another resident;

(b) does not have an operable window to the outside; or

(4) Any provision of this rule may be waived at the discretion of the department if conditions in existence prior to the adoption of this rule or construction factors would make compliance extremely difficult or impossible and if the department determines that the level of safety to residents and staff is not diminished.

(1) Each resident in an assisted living facility must be provided the following at a minimum by the facility:

(a) an individual towel rack;

(b) a handicap accessible mirror mounted or secured to allow for convenient use by both wheelchair bound residents and ambulatory persons;

(c) clean, flame-resistant, or non-combustible window treatments or equivalent, for every bedroom window. In a category D facility or unit, the use of blinds or curtains is not permissible. A flame-resistant or non-combustible window valence, not exceeding 14 inches in length, may be used;

(d) an electric call system comprised of a fixed manual, pendant cordless or two way interactive, UL or FM listed system which must connect resident rooms to the care staff center or staff pagers. A resident room that is designated as double occupancy must be equipped with a call system for both occupants. In category D facilities or units, resident bedroom call cords or strings in excess of 6 inches shall not be permitted; and

(e) for each multiple-bed room, either flame-resistant privacy curtains for each bed or movable flame-resistant screens to provide privacy upon the request of a resident.

(2) Following the discharge of a resident, all of the equipment and bedding used by that resident and owned by the facility must be cleaned and sanitized.

(1) The facility must provide:

(a) a dining room of sufficient size to accommodate all the residents comfortably with dining room furnishings that are well constructed and tables designed to accommodate the use of wheelchairs;

(b) at least one centrally located common area in which residents may socialize and participate in recreational activities. A common area may include, without limitation, a living room, dining room, enclosed porch or solarium. The common area must be large enough to accommodate those to be served without overcrowding; and

(2) All common areas must be furnished and equipped with comfortable furniture and reading lights in quantities sufficient to accommodate those to be served.

(3) Any provision of this rule may be waived at the discretion of the department if conditions in existence prior to the adoption of this rule or construction factors would make compliance extremely difficult or impossible and if the department determines that the level of safety to residents and staff is not diminished.

(1) The facility shall provide:

(a) at least one toilet for every four residents;

(b) one bathing facility for every 12 residents; and

(2) All resident rooms with toilets or shower/bathing facilities must have an operable window to the outside or must be exhausted to the outside by a mechanical ventilation system.

(3) Each resident room bathroom shall:

(a) be in a separate room with a toilet. A sink need not be in the bathroom but shall be in close proximity to the toilet. A shower or tub is not required if the facility utilizes a central bathing unit or units; and

(b) have at least one towel bar per resident, one toilet paper holder, one accessible mirror and storage for toiletry items.

(4) All doors to resident bathrooms shall open outward or slide into the wall and shall be unlockable from the outside.

(a) Dutch doors, bi-folding doors, sliding pocket doors and other bi-swing doors may be used if they do not impede the bathroom access width and are approved by the department. A shared bathroom with two means of access is also acceptable.

(b) Resident bathroom door locks must be operable, on the resident side of the door, with a single motion and may not require special knowledge for the resident to open.

(5) In rooms used by category C or other special needs residents, the bathroom does not have to be in a separate room and does not require a door.

(6) Each resident must have access to a toilet room without entering another resident's room or the kitchen, dining, or living areas.

(7) Each resident bathroom or bathing room shall have a fixed emergency call system accessible to an individual collapsed on the floor that reports to the staff location with an audible signal. The device must be silenced at that location only. Vibrating systems are acceptable.

(8) In category D facilities or units, bathroom call cords or strings in excess of 6 inches shall not be permitted.

(9) Any provision of this rule may be waived at the discretion of the department if conditions in existence prior to December 27, 2002, or construction factors would make compliance extremely difficult or impossible and if the department determines that the level of safety to residents and staff is not diminished.

(1) The assisted living facility shall provide a clean, comfortable and well maintained home that is safe for residents and employees at all times.

(2) A minimum of 10 foot candles of light must be available in all rooms, with the following exceptions:

(a) all reading lamps must have a capacity to provide a minimum of 30 foot candles of light;

(b) all toilet and bathing areas must be provided with a minimum of 30 foot candles of light;

(d) hallways must be illuminated at all times by at least a minimum of five foot candles of light at the floor.

(3) Temperature in resident rooms, bathrooms, and common areas must be maintained at a minimum of 68°F.

(4) A resident's ability to smoke safely shall be evaluated and addressed in the resident's service or health care plan. If the facility permits resident smoking:

(a) the rights of non-smoking residents shall be given priority in settling smoking disputes between residents; and

(b) if there is a designated smoking area within the facility, it shall be designed to keep all contiguous, adjacent or common areas smoke free.

(5) An assisted living facility may designate itself as non-smoking provided that adequate notice is given to all residents or all applicants in the facility residency agreement.

(1) Personal care assistance must be provided to each resident in accordance with their established agreement and needs. Assistance must include, but is not limited to assisting with:

(a) personal grooming such as bathing, hand washing, shaving, shampoo and hair care, nail filing or trimming and dressing;

(b) oral hygiene or denture care;

(d) eating;

(e) the use of crutches, braces, walkers, wheelchairs or prosthetic devices, including vision and hearing aids; and

(f) self-medication.

(2) Evidence that the facility is meeting each resident's needs for personal care services include the following outcomes for residents:

(a) physical well being of the resident means the resident:

(i) has clean and groomed hair, skin, teeth and nails;

(ii) is nourished and hydrated;

(iii) is free of pressure sores, skin breaks or tears, chaps and chaffing;

(iv) is appropriately dressed for the season in clean clothes;

(v) risk of accident, injury and infection has been minimized; and

(vi) receives prompt emergency care for illnesses, injuries and life threatening situations;

(b) behavioral and emotional well being of the resident includes:

(i) an opportunity to participate in age appropriate activities that are meaningful to the resident if desired;

(ii) a sense of security and safety;

(iii) a reasonable degree of contentment; and

(iv) a feeling of stable and predictable environment;

(i) free to go to bed at the time desired;

(ii) free to get up in the morning at the time desired;

(iii) free to have visitors;

(iv) granted privacy;

(v) assisted to maintain a level of self care and independence;

(vi) assisted as needed to have good oral hygiene;

(vii) made as comfortable as possible by the facility;

(viii) free to make choices and assumes the risk of those choices;

(ix) fully informed of the services that are provided by the facility;

(x) free of abuse, neglect and exploitation;

(xi) treated with dignity; and

(xii) given the opportunity to participate in activities, if desired.

(3) In the event of accident or injury to a resident requiring emergency medical, dental or nursing care or, in the event of death, the assisted living facility shall:

(a) immediately make arrangements for emergency care or transfer to an appropriate place for treatment;

(b) immediately notify the resident's practitioner and the resident's legal representative.

(4) A resident shall receive skin care that meets the following standards:

(a) the facility shall practice preventive measures to identify those at risk and maintain a resident's skin integrity. Risk factors include:

(i) skin redness lasting more than 30 minutes after pressure is relieved from a bony prominence, such as hips, heels, elbows or coccyx; and

(ii) malnutrition/dehydration, whether secondary to poor appetite or another disease process; and

(b) an area of broken or damaged skin must be reported within 24 hours to the resident's practitioner. Treatment must be provided as ordered by the resident's practitioner.

(5) A person with a stage 3 or 4 pressure ulcer may not be admitted or permitted to remain in a category A facility.

(6) The facility shall ensure records of observations, treatments and progress notes are entered in the resident's record and that services are in accordance with the resident health care plan.

(7) Direct care staff shall receive training related to maintenance of skin integrity and the prevention of pressure sores by:

(a) keeping residents clean and dry;

(b) providing residents with clean and dry bed linens;

(d) maintaining or restoring healthy nutrition; and

(e) keeping the residents physically active and avoiding the overuse of wheelchairs, sitting no longer than one hour or remaining in one position for longer than two hours at one time, and other sources of skin breakdown in ADLs.

(1) With the exception of resident medication organizers as discussed in ARM 37.106.2848, all medication must be stored in the container dispensed by the pharmacy or in the container in which it was purchased in the case of over-the-counter medication, with the label intact and clearly legible.

(2) Medications that require refrigeration must be segregated from food items and stored within the temperature range specified by the manufacturer.

(3) All medications administered by the facility shall be stored in locked containers in a secured environment such as a medication room or medication cart. Residents who are responsible for their own medication administration must be provided with a secure storage place within their room for their medications. If the resident is in a private room, locking the door when the resident leaves will suffice.

(4) Over-the-counter medications or home remedies requested by the resident shall be reviewed by the resident's practitioner or pharmacist as part of the development of a resident's service plan. Residents may keep over-the-counter medications in their room with a written order by the residents' practitioners.

(5) The facility shall develop and implement a policy for lawful disposal of unused, outdated, discontinued or recalled resident medications. The facility shall return a resident's medication to the resident or resident's legal representative upon discharge.

(1) Medication and treatment orders shall be carried out as prescribed. The resident has the right to consent to or refuse medications and treatments. The practitioner shall be notified if a resident refuses consent to an order. Subsequent refusals to consent to an order shall be reported as required by the practitioner.

(2) A prescription medication for which the dose or schedule has been changed by the practitioner must be noted in the resident's medication administration record.

(3) Current practitioners' orders shall be documented and kept in all resident files.

(1) All category A facility residents must self-administer their medication. Those category B facility residents that are capable of, and who wish to self-administer medications, shall be encouraged by facility staff to do so.

(2) Any direct care staff member who is capable of reading medication labels may be made responsible for providing necessary assistance to any resident in taking their medication, as defined in ARM 37.106.2805.

(3) Resident medication organizers may be prepared up to four weeks in advance and injectable medications as specified in (4) (c) by the following individuals:

(a) a resident or a resident's legal representative;

(b) a resident's family care giver, who is a person related to the resident by blood or marriage or who has full guardianship; or

(4) The individual referred to in (3) must adhere to the following protocol:

(a) verify that all medications to be set up carry a practitioner's current order;

(b) set up medications only from prescriptions in labeled containers dispensed by a registered pharmacist or from over-the-counter drug containers with intact, clearly readable labels; and

(c) set up injectable insulin up to seven days in advance by drawing insulin into syringes identified for content, date and resident. Other injectable medications must be set up according to the recommendations provided by the pharmacy.

(5) The facility may require residents to use a facility approved medication dispensing system or to establish medication set up criteria, but shall not require residents to purchase prescriptions from a specific pharmacy.

(6) No resident or staff member may be permitted to use another resident's medication.

(1) An accurate medication record for each resident shall be kept of all medications, including over-the-counter medications, for those residents whose self-administration of medication requires monitoring and/or assistance by the facility staff.

(2) The record shall include:

(a) name of medication, reason for use, dosage, route, and date and time given;

(b) name of the prescribing practitioner and their telephone number;

(c) any adverse reaction, unexpected effects of medication, or medication error, which must also be reported to the resident's practitioner;

(d) allergies and sensitivities, if any;

(e) resident specific parameters and instructions for PRN medications;

(i) documentation of when and why a PRN was administered or self-administered and follow up documentation as to the effectiveness of the PRN;

(f) documentation of treatments with resident specific parameters;

(g) documentation of doses missed or refused by resident and why;

(h) initials of the person monitoring and/or assisting with self-administration of medication; and

(i) review date and name of reviewer.

(3) When using paper Medication Administration Records (MARs), the facility shall maintain legible signatures of staff who monitor and/or assist with the self-administration of medication, either on the medication administration record or on a separate signature page. Electronic MARs must include the names associated with the initials of those staff documenting administration of medications.

(4) A medication record need not be kept for those residents for whom written authorization has been given by their practitioner to keep their medication in their rooms and to be fully responsible for taking the medication in the correct dosage and at the proper time. The authorization must be renewed on an annual basis.

(5) The facility shall maintain a record of all destroyed or returned medications in the resident's record or closed resident file in the case of resident transfer or discharge.

(1) A resident who requires the use of oxygen:

(a) shall be permitted to self-administer the oxygen if the resident is capable of:

(i) determining their need for oxygen; and

(ii) administering the oxygen to themselves or with assistance.

(2) The direct care staff employed by the facility shall monitor the ability of the resident to operate the equipment in accordance with the orders of the practitioner.

(3) The facility shall ensure that all direct care staff who may be required to assist resident's with administration of oxygen have demonstrated the ability to properly operate the equipment.

(4) The following rules must be followed when oxygen is in use:

(a) oxygen tanks must be secured and properly stored at all times;

(b) no smoking or open flames may be allowed in rooms in which oxygen is used or stored, and such rooms must be posted with a conspicuous "No Smoking, Oxygen in Use" sign;

(c) a backup portable unit for the administration of oxygen shall be present in the facility at all times when a resident who requires oxygen is present in the facility, this includes when oxygen concentrators are used;

(d) the equipment used to administer oxygen must be in good working condition; and

(e) the equipment used to administer oxygen is removed from the facility when it is no longer needed by the resident.

(1) The facility shall comply with the rules governing the use, in long term care facilities, of restraints, safety devices, assistive devices, postural supports, and seclusion rooms. The provisions of ARM 37.106.2901, 37.106.2902, 37.106.2904, 37.106.2905, and 37.106.2908 shall apply.

(1) The assisted living facility must establish and maintain infection control policies and procedures sufficient to provide a safe, sanitary, and comfortable environment to help prevent the development and transmission of communicable diseases and infections. Such policies and procedures must include, at a minimum, the following requirements:

(a) a system for preventing, identifying, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, and visitors;

(b) standard and transmission-based precautions to be followed to prevent spread of infections;

(i) the type and duration of the isolation, depending upon the infectious agent or organism involved; and

(ii) a requirement that the isolation should be the least restrictive possible for the resident under the circumstances;

(d) any other circumstances under which the facility must prohibit employees with a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit disease;

(e) if, after admission to the facility, a resident is suspected of having a communicable disease that would endanger the health and welfare of other residents, the administrator or designee must contact the resident's practitioner and assure that appropriate safety measures are taken on behalf of that resident and the other residents; and

(f) all staff shall use proper hand washing technique after providing direct care to a resident.

(2) The facility, where applicable, shall comply with applicable statutes and rules regarding the handling and disposal of hazardous waste.

(1) Unless the facility disallows it, residents in an assisted living facility may keep household pets, as permitted by local ordinance, subject to the following provisions:

(a) pets must be clean and disease-free;

(b) the immediate environment of pets must be kept clean;

(c) birds must be kept in appropriate enclosures, unless the bird is a companion breed maintained and supervised by the owner; and

(d) pets that are kept at the facility shall have documentation of current vaccinations, including rabies, as appropriate.

(2) The administrator or designee shall determine which pets may be brought into the facility. Upon approval, family members may bring pets to visit, if the pets are clean, disease-free and vaccinated as appropriate.

(3) Facilities that allow birds shall have procedures that protect residents, staff and visitors from psittacosis, ensure minimum handling of droppings and require droppings to be placed in a plastic bag for disposal.

(4) Prior to admission of companion birds, documentation of the import, out-of-state veterinarian health certificate and import permit number provided by the pet store or breeder will be provided and maintained in the owners records. If the health certificate and import permit number is not available, or if the bird was bred in-state, a certificate from a veterinarian stating that the bird is disease free is required prior to residency. If the veterinarian certificate cannot be obtained by the move-in date the resident may keep the bird enclosed in a private single occupancy room, using good hand washing after handling the bird and bird droppings until the veterinarian examination is obtained.

(5) Pets may not be permitted in food preparation, storage or dining areas during meal preparation time or during meal service or in any area where their presence would create a significant health or safety risk to others.

(1) The facility must establish and maintain standards relative to food sources, refrigeration, refuse handling, pest control, storage, preparation, procuring, serving and handling food, and dish washing procedures that are sufficient to prevent food spoilage and the transmission of infectious disease. These standards must include the following:

(a) food must be obtained from sources that comply with all laws relating to food and food labeling;

(b) the use of home-canned foods is prohibited;

(2) Foods must be served in amounts and a variety sufficient to meet the nutritional needs of each resident. The facility must provide therapeutic diets when prescribed by the resident's practitioner. At least three meals must be offered daily and at regular times, with not more than a 14-hour span between an evening meal and breakfast unless a nutritious snack is available in the evening, then up to 16 hours may elapse between a substantial evening meal and breakfast.

(3) Records of menus as served must be filed on the premises for three months after the date of service for review by the department.

(4) The facility shall take into consideration the preferences of the residents and the need for variety when planning the menu. Either the current day or the current week's menu shall be posted for resident viewing.

(5) The facility shall employ food service personnel suitable to meet the needs of the residents.

(a) Foods must be cut, chopped, and ground to meet individual needs or as ordered by the resident's physician or practitioner.

(b) If the cook or other kitchen staff must assist a resident with direct care outside the food service area, they must properly wash their hands before returning to food service.

(d) A facility, whose kitchen and dining services are inspected by the local county health department, must provide the department a copy of their most recent inspection at the time of survey.

(6) If the facility admits residents requiring therapeutic or special diets, the facility shall have an approved dietary manual for reference when preparing a meal. Dietitian consultation shall be provided as necessary and documented for residents requiring therapeutic diets.

(7) A minimum of a one-week supply of non-perishable foods and a two-day supply of perishable foods must be available on the premises.

(8) Potentially hazardous food, such as meat and milk products, must be stored at 41°F or below. Hot food must be kept a 140°F or above during preparation and serving.

(9) Freezers must be kept at a temperature of 0°F or below and refrigerators must be kept at a temperature of 41°F or below. Thermometers must be placed in the warmest area of the refrigerator and freezer to assure proper temperature. Temperatures shall be monitored and recorded at least once a month in a log maintained at the facility for one year.

(10) Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practice during all working periods in food service.

(11) A food service employee, while infected with a disease in a communicable form that can be transmitted by foods may not work in the food service area.

(12) Tobacco products may not be used in the food preparation and kitchen areas.

(1) Laundry service must be provided by the facility, either on the premises or off the facility site.

(2) If an assisted living facility processes its laundry on the premises it must:

(a) equip the laundry room with a mechanical washer and a dryer vented to the outside, hand washing facilities, a fresh air supply and a hot water supply system which supplies the washer with water of at least 110°F during each use;

(b) have ventilation in the sorting, holding and processing area that shall be adequate to prevent heat and odor build-up;

(d) ensure that facility staff handling laundry wash their hands both after working with soiled laundry and before they handle clean laundry.

(3) Resident's personal clothing must be laundered by the facility unless the resident or the resident's family accepts this responsibility. If the facility launders the resident's personal clothing, the facility is responsible for returning the clothing. Residents capable of laundering their own personal clothing and wishing to do so shall be provided the facilities and necessary assistance by the facility.

(4) The facility shall provide a supply of clean linen in good condition at all times that is sufficient to change beds often enough to keep them clean, dry and free from odors. Facility provided linens must be changed at least once a week and more often if the linens become dirty. In addition, the facility must ensure that each resident is supplied with clean towels and washcloths that are changed at least twice a week, a moisture-proof mattress cover and mattress pad, and enough blankets to maintain warmth and comfort while sleeping.

(5) Residents may use their own linen in the facility if they choose.

(1) The following housekeeping rules must be followed:

(a) Supplies and equipment must be properly stored and must be on hand in a quantity sufficient to permit frequent cleaning of floors, walls, woodwork, windows and screens;

(b) Housekeeping personnel must be trained in proper procedures for preparing cleaning solutions, cleaning rooms and equipment and handling clean and soiled linen, trash and trays;

(c) Cleaners used in cleaning bathtubs, showers, lavatories, urinals, toilet bowls, toilet seats and floors must contain fungicides or germicides with current EPA registration for that purpose; and

(d) Garbage and trash must be stored for final disposal in areas separate from those used for preparation and storage of food and must be removed from the facility daily. Garbage containers must be kept clean.

(i) Containers used to store garbage in the kitchen and laundry room of the facility must be covered with a lid unless the containers are kept in an enclosed cupboard that is clean and prevents infestation by vermin. These containers shall be emptied daily and kept clean.

(1) An assisted living facility must be constructed and maintained so as to prevent as much as possible the entrance and harborage of rats, mice, insects, flies and other vermin.

(2) The facility and facility grounds shall be kept orderly and free of litter and refuse and secure from hazards.

(3) When required by the building code authority having jurisdiction, at least one primary grade level entrance to the facility shall be arranged to be fully accessible to disabled persons.

(4) All exterior pathways or accesses to the facility's common use areas and entrance and exit ways shall be of hard, smooth material, accessible and be maintained in good repair.

(5) All interior or exterior stairways used by residents shall have sturdy handrails on one side installed in accordance with the uniform building code with strength and anchorage sufficient to sustain a concentrated 250-pound load to provide residents safety with ambulation.

(6) All interior and exterior materials and surfaces (e.g., floors, walls, roofs, ceilings, windows and furniture) and all equipment necessary for the health, safety and comfort of the resident shall be kept clean and in good repair.

(7) Carpeting and other floor materials shall be constructed and installed to minimize resistance for passage of wheelchairs and other ambulation aids. Thresholds and floor junctures shall also be designed and installed for passage of wheelchairs and to prevent a tripping hazard.

(8) The facility shall install grab bars at each toilet, shower, sitz bath and tub with a minimum of one and one half inches clearance between the bar and the wall and strength and anchorage sufficient to sustain a concentrated 250-pound load. If a toilet grab bar assist is used over a toilet, it must be safely stabilized and secured in order to prevent mishap.

(9) Any structure such as a screen, half wall or planter which a resident could use for support while ambulating shall be securely anchored.

(10) The bottoms of tubs and showers must have surfaces that inhibit falling and slipping.

(11) Hand cleansing soap or detergent and single use individual towels must be available at each sink in the commonly shared areas of the facility. A waste receptacle must be located near each sink. Cloth towels and bar soap for common use are not permitted.

(12) Hot water temperature supplied to hand washing, bathing and showering areas may not exceed 120°F.

(13) The facility shall provide locked storage for all poisons, chemicals, rodenticides, herbicides, insecticides and other toxic material. Hazardous material safety sheets and labeling shall be kept available for staff for all such products used and stored in the facility.

(14) Flammable and combustible liquids shall be safely and properly stored in original or approved, properly labeled containers in areas inaccessible to residents in accordance with the uniform fire code in amounts acceptable to the fire code authority having jurisdiction.

(15) Containers used to store garbage in resident bedrooms and bathrooms are not required to be covered unless they are used for food, bodily waste or medical waste. Resident containers shall be emptied as needed, but at least weekly.

(16) If the facility utilizes a non-municipal water source, the water source is tested at least once every 12 months for total coliform bacteria and fecal coliform or E. coli bacteria and corrective action is taken to assure the water is safe to drink. Documentation of testing is retained on the premises for 24 months from the date of the test.

(17) If a non-municipal sewage system is used, the sewage system must be in working order and maintained according to all applicable state laws and rules.

(1) Any construction of or alteration, addition, modification, or renovation to an assisted living facility must meet the requirements of the building code and fire marshal agencies having jurisdiction and be approved by the officer having jurisdiction to determine if the building and fire codes are met by the facility.

(2) When a change in use, ownership, or building code occupancy classification occurs, licensure approval shall be contingent on meeting the building code and fire marshal agencies' standards in effect at the time of such a change. Changes in use include adding a category B, C, or D license endorsement to a previously licensed category A facility.

(3) Changes in the facility location, use or number of facility beds cannot be made without written notice to, and written approval received from, the department.

(4) Exit doors must be operable on the resident side of the door with a single motion and may not require special knowledge for the resident to open, except as approved by the fire marshal and building codes agencies having jurisdiction or in a secured unit or building that services category C or category D residents.

(5) Stairways, halls, doorways, passageways, and exits from rooms and from the building, shall be kept unobstructed at all times.

(6) All operable windows and outer doors that may be left open shall be fitted with insect screens.

(7) An assisted living care facility must have an annual fire inspection conducted by the appropriate local fire authority or the state fire marshal's office and maintain a record of such inspection for at least three years following the date of the inspection.

(8) An employee and resident fire drill must be conducted at least two times annually, no closer than four months apart, and include residents, employees and support staff on duty and other individuals in the facility. A resident fire drill includes making a general announcement throughout the facility that a resident fire drill is being conducted or sounding a fire alarm.

(9) Records of employee and resident fire drills must be maintained on the premises for 24 months from the date of the drill and include the date and time of the drill, names of the employees participating in the drill, and identification of residents needing assistance for evacuation.

(10) A 2A10BC portable fire extinguisher shall be available on each floor of a facility licensed for 20 or more residents. Facilities licensed for less than 20 residents shall comply with the requirements of the fire authority having jurisdiction with respect to the number and location of portable fire extinguishers.

(11) Portable fire extinguishers must be inspected, recharged, and tagged at least once a year by a person certified by the state to perform such services.

(12) Smoke detectors installed and maintained pursuant to the manufacturer's directions shall be installed in all resident rooms, bedroom hallways, living room, dining room, and other open common spaces or as required by the fire authority having jurisdiction. An annual maintenance log of battery changes and other maintenance services performed shall be kept in the facility and made available to the department upon request.

(13) If there is an inside designated smoking area, it shall be separate from other common areas, and provided with adequate mechanical exhaust vented to the outside.

(1) An assisted living category B endorsement to the license shall be made by the licensing bureau of the department only after:

(a) initial department approval of the facility's category B policy and procedures;

(b) evidence of the administrator's and facility staff qualifications; and

(2) An assisted living category B facility shall employ or contract with a registered nurse to provide or supervise nursing service to include:

(a) general health monitoring on each category B resident;

(b) performing a nursing assessment on category B residents when and as required;

(c) assistance with the development of the resident health care plan and, as appropriate, the development of the resident service plan; and

(d) routine nursing tasks, including those that may be delegated to licensed practical nurses (LPN) and unlicensed assistive personnel in accordance with the Montana Nurse Practice Act.

(1) An assisted living category B facility must be administered by a person who, in addition to the requirements found in ARM 37.106.2814, has one or more years experience working in the field of geriatrics or caring for disabled residents in a licensed facility.

(2) Providers in existence on the date of the final adoption of this rule will be granted one year to meet the category B administrator requirements found in (1) .

(1) In addition to the requirements found in ARM 37.106.2816, each nonprofessional staff providing direct care in an assisted living category B facility shall show documentation of in-house training related to the care and services they are to provide under direct supervision of a registered nurse or supervising nursing service providing category B care, including those tasks that may be delegated to licensed practical nurses (LPN) and unlicensed assistive personnel in accordance with the Montana Nurse Practice Act.

(2) Staff members whose job responsibilities will include supervising or preparing special or modified diets, as ordered by the resident's practitioner, shall receive training prior to performing this responsibility.

(3) Prior to providing direct care, direct care staff must:

(a) work under direct supervision for any direct care task not yet trained or properly oriented; and

(b) not take the place of the required certified person.

(1) Within 21 days of admission to a category B status, the administrator or designee shall assure that a written resident health care assessment and resident certification is performed on each category B resident.

(2) Each initial health care assessment by the licensed health care professional shall include, at a minimum, evaluation of the following:

(a) cognitive status;

(b) communication/hearing patterns;

(d) physical functioning and structural problems;

(e) continence;

(f) psychosocial well being;

(g) mood and behavior patterns;

(h) activity pursuit patterns;

(i) disease diagnosis;

(j) health conditions;

(k) oral nutritional status;

(l) oral dental status;

(m) skin condition;

(n) medication use; and

(o) special treatment and procedures.

(3) A written resident health care plan shall be developed. The resident health care plan shall include, but not be limited to the following:

(a) a statement which informs the resident and the resident's practitioner, if applicable, of the requirements of 50-5-226 (3) and (4) , MCA;

(b) orders for treatment or services, medications, and diet, if needed;

(d) the specific goals of treatment or services, if appropriate;

(e) the time intervals at which the resident's response to treatment will be reviewed; and

(f) the measures to be used to assess the effects of treatment;

(g) if the resident requires care or supervision by a licensed health care professional, the health care plan shall include the tasks for which the professional is responsible.

(4) The category B resident's health care plan shall be reviewed quarterly, and if necessary revised upon change of condition.

(5) The health care plan shall be readily available to and followed by those staff and licensed health care professionals providing the services and health care.

(1) In order to maintain normal bladder and bowel functions, the facility shall provide individualized attention to each resident that meets the following minimum standards:

(a) the facility shall provide a resident who is incontinent of bowel or bladder adequate personal care services to maintain the person's skin integrity, hygiene and dignity and to prevent urinary tract infections.

(2) Evidence that the facility is meeting each resident's needs for maintaining normal bowel and bladder functions include the following outcomes for residents at risk for incontinence:

(a) the resident is checked during those periods when they are known to be incontinent, including the night;

(b) the resident is kept clean and dry;

(d) if the resident can benefit from scheduled toileting, they are assisted or reminded to go to the bathroom at regular intervals.

(3) Indwelling catheters are permissible, if the catheter care is taught and supervised by a licensed health care professional under a practitioner's order. Observations and care must be documented.

(4) Facility staff shall not:

(a) withhold fluids from a resident to control incontinence; or

(b) have a resident catheterized to control incontinence for the convenience of staff.

(1) A resident shall receive skin care that meets the following standards:

(a) the facility shall practice preventive measures to identify those at risk and maintain a resident's skin integrity; and

(b) an area of broken or damaged skin must be reported within 24 hours to the resident's practitioner. Treatment must be as ordered by the resident's practitioner.

(2) A person with an open wound or having a pressure or stasis ulcer requiring treatment by a health care professional may not be admitted or permitted to remain in the facility unless:

(a) the wound is in the process of healing, as determined by a licensed health care professional, and is either:

(i) under the care of a licensed health care professional; or

(ii) can be cared for by the resident without assistance.

(3) The facility shall ensure records of observations, treatments and progress notes are entered in the resident record and that services are in accordance with the resident health care plan.

(4) No over the counter products such as creams, lotions, ointments, soaps, iodine or alcohol shall be put on an open pressure or stasis wound unless ordered by the resident's practitioner after an appropriate evaluation of the wound.

(5) Evidence the facility is meeting those resident's identified as a greater risk for skin care needs include the following outcomes for residents:

(a) the facility has identified those residents who are at greater risk of developing a pressure or stasis ulcer. Primary risk factors include but are not limited to:

(i) continuous urinary incontinence or chronic voiding dysfunction;

(ii) severe peripheral vascular disease (poor circulation to the legs) ;

(iii) diabetes;

(iv) chronic bowel incontinence;

(v) sepsis;

(vi) terminal cancer;

(vii) decreased mobility or confined to bed or chair;

(viii) edema or swelling of the legs;

(ix) chronic or end stage renal, liver or heart disease;

(x) CVA (stroke) ;

(xi) recent surgery or hospitalization;

(xii) any resident with skin redness lasting more than 30 minutes after pressure is relieved from a bony prominence, such as hips, heels, elbows or coccyx, is at extremely high risk in that area; and

(xiii) malnutrition/dehydration whether secondary to poor appetite or another disease process.

(b) direct care staff have received training related to maintenance of skin integrity and the prevention and care of pressure sores from a licensed health care professional who is trained to care for that condition;

(d) the resident is kept clean and dry;

(e) the resident is provided clean and dry bed linens;

(f) the resident is kept hydrated;

(g) the resident is turned and repositioned;

(h) the wound is getting smaller;

(i) there is no evidence of infection;

(j) wound bed is moist, not dried out or scabbed over;

(k) the resident has less restriction of movement; and

(l) the resident's pain level has diminished.

This rule has been repealed.

(1) Written, signed practitioner orders shall be documented in all category B resident facility records by a legally authorized person for all medications and treatments which the facility is responsible to administer. Medication or treatment changes shall not be made without a practitioner's order. Order changes obtained by phone must be confirmed by written, signed orders within 21 days.

(2) All medications administered to a category B resident shall be administered by a licensed health care professional or by an individual delegated the task under the Nurse Practice Act and ARM Title 24, chapter 159. Those category B residents, who are capable of medication self-administration shall be given the opportunity and encouraged to do so.

(3) Residents with a standing PRN medication order, who cannot determine their own need for the medication by making a request to self-administer the medication or in the case of the cognitively impaired cannot respond to caretaker's suggestions for over-the-counter PRN pain medications shall:

(a) have the medication administered by a licensed health care professional after an assessment and the determination of need has been made; and

(b) be classified as a category B resident because a nursing decision to determine the resident's need for the medication was required.

(4) Medication and treatment orders shall be carried out as prescribed. The resident or the person legally authorized to make health care decisions for the resident has the right to consent to, or refuse medications and treatments. The practitioner shall be notified if a resident refuses consent to an order. Subsequent refusals to consent to an order shall be reported as required by the practitioner.

(5) Only the following individuals may administer medications to residents:

(a) a licensed physician, physician's assistant, certified nurse practitioner, advanced practice registered nurse, or a registered nurse;

(b) licensed practical nurse working under supervision;

(c) an unlicensed individual who is either employed by the facility or is working under third party contract with a resident or resident's legal representative and has been delegated the task under ARM Title 24, chapter 159; and

(d) a person related to the resident by blood or marriage or who has full guardianship.

This rule has been repealed.

(1) An assisted living category C facility must be administered by a person who meets the conditions of ARM 37.106.2814 and has:

(a) three or more years experience in working in the field of geriatrics or caring for disabled residents in a licensed facility; or

(b) a documented combination of education and training that is equivalent to the experience required in (1) , as determined by the department.

(2) At least eight of the 16 hours of annual continuing education the administrator must complete under ARM 37.106.2814(3) shall pertain to caring for persons with severe cognitive impairments.

(1) In addition to meeting all other requirements for direct care staff stated in this subchapter, assisted living category C facility direct care staff must receive additional documented training in:

(a) the facility or unit's philosophy and approaches to providing care and supervision for persons with severe cognitive impairment;

(b) the skills necessary to care for, intervene and direct residents who are unable to perform activities of daily living;

(i) wandering;

(ii) hallucinations, illusions and delusions; and

(iii) impairment of senses;

(d) therapeutic programming to support the highest possible level of resident function including:

(i) large motor activity;

(ii) small motor activity;

(iii) appropriate level cognitive tasks; and

(iv) social/emotional stimulation;

(e) promoting residents' dignity, independence, individuality, privacy and choice;

(f) identifying and alleviating safety risks to residents;

(g) identifying common side effects and untoward reactions to medications; and

(h) techniques for dealing with bowel and bladder aberrant behaviors.

(2) Staff must remain awake, fully dressed and be available in the facility or on the unit at all times to provide supervision and care to the resident as well as to assist the residents in evacuation of the facility if a disaster occurs.

(1) Within 21 days of admission of a resident to an assisted living category C facility, a resident certification must be conducted, and a written health care plan shall be developed which meets the requirements of ARM 37.106.2875, and which also includes detailed assessment, therapeutic management and intervention techniques for the following behaviors and resident needs:

(a) memory;

(b) judgement;

(d) ability to solve problems;

(e) mood and character changes;

(f) behavioral patterns;

(g) wandering; and

(h) dietary needs.

(1) Each assisted living category C facility or unit must, prior to admission, inform the resident's legal representative in writing of the following:

(a) the overall philosophy and mission of the facility regarding meeting the needs of residents afflicted with severe cognitive impairment and the form of care or treatment offered;

(b) the process and criteria for move-in, transfer, and discharge;

(d) the process used to establish and implement a health care plan, including how the health care plan will be updated in response to changes in the resident's condition;

(e) staff training and continuing education practices;

(f) the physical environment and design features appropriate to support the functioning of cognitively impaired residents;

(g) the frequency and type of resident activities;

(h) the level of involvement expected of families and the availability of support programs; and

(i) any additional costs of care or fees.

(2) The facility must provide a resident or a resident's legal representative with written documentation of the information specified in (1). A copy of this exchange must be kept as part of the resident file.

(1) In addition to meeting all other requirements for assisted living facilities stated in this subchapter, if a secured distinct part or locked unit within a category C assisted living facility is designated for the exclusive use of residents with severe cognitive impairment, the facility must:

(a) staff the unit with direct care staff at all times there are residents in the unit;

(b) provide a separate dining area, at a ratio of 30 square feet per resident on the unit; and

(c) provide a common day or activities area, at a ratio of 30 square feet per resident on the unit. The dining area listed in (1) (b) or day rooms, sun porches and common areas accessible to all residents, may serve this purpose.

(1) Category D services must be provided in a secured care unit and meet all requirements in ARM 37.106.316.

(2) A category D facility will be either:

(a) a stand-alone secured facility; or

(b) a separate, secured unit attached to a category A, B, and/or C facility.

(3) A category D unit attached to a category A, B, and/or C facility must have a separate entrance/exit and impenetrable doors used to separate the category D unit from the other units.

(4) The facility must devise a policy on how it plans to maintain security of the facility or unit.

(5) A category D facility or unit must have at least one seclusion room for every 24 residents. The room must meet the requirements set forth in ARM 37.106.2899H.

(6) A category D facility or unit must not use automatic door closures unless required. If required, such closures must be mounted on the public side of the door.

(7) All hardware and lights used in a category D facility or unit must be tamper-proof.

(8) All resident room doors must include a sight window.

(9) No more than one client must reside in a resident room.

(1) In addition to requirements in ARM 37.106.2873, an administrator for a category D facility must have a least three years of experience in the field of mental health and mental disorders.

(2) Of the 16 hours of annual continued education training required in ARM 37.106.2814, eight hours must be in the field of mental health and mental disorders.

(1) Each assisted living category D facility or unit must, prior to admission, inform the resident or resident's legal representative in writing of the following:

(a) the overall philosophy and mission of the facility regarding meeting the needs of residents with mental illness and the form of care or treatment offered;

(b) the process and criteria for admission and discharge;

(d) the process used to establish and implement a health care plan, including how the health care plan will be updated in response to changes in the resident's condition;

(e) staff training and continuing education practices;

(f) the physical environment and design features appropriate to support the functioning of mentally disabled residents, including features for the resident who requires seclusion and restraint;

(g) the frequency and type of resident activities; and

(h) any additional costs of care or fees.

(2) The facility must obtain from the resident or resident's legal representative a written acknowledgment that the information specified was provided. A copy of this written acknowledgment must be kept as part of the permanent resident file.

(1) A category D facility must have the following staff:

(a) a registered nurse (RN) must be on duty or on call and available physically to the facility within one hour;

(b) a licensed mental health professional who must be site-based; and

(c) direct care staff in sufficient number to meet the needs of the residents. Direct care staff must be certified nursing assistants.

(2) In addition to requirements in ARM 37.106.2816, all staff must:

(a) be at least 18 years old;

(b) complete an FBI fingerprint background check upon hiring;

(d) complete training requirements in ARM 37.106.2908; and

(e) complete training on de-escalation techniques and methods of managing resident behaviors.

(3) All staff must remain awake, fully dressed, and available on the unit at all times when they are on duty.

A category D facility must obtain or conduct three types of resident assessments for each resident:

(1) Prior to move in, the facility shall obtain the court determination documentation required in 53-21-199, MCA, as applicable, as well as a full medical history and physical and mental health and mental disorders assessment.

(2) A resident needs assessment must be completed within seven days prior to admission to facility. The assessment must be reviewed/updated quarterly, and upon significant change in status.

(3) The administrator, or designee, will request and retain copies of the healthcare assessment and written order for care completed monthly by the practitioner as defined in 50-5-226(5), MCA.

(1) In addition to requirements in ARM 37.106.2875, the health care plan for a category D resident must include:

(a) de-escalation techniques individualized to the resident;

(b) circumstances when the resident may need to be isolated from other residents;

(d) the requirements listed in ARM 37.106.2905.

(2) The health care plan must be reviewed and updated quarterly and upon significant change in status.

(3) Each direct care staff must document that they have reviewed and are capable of implementing each resident's health care plan.

(1) All category D residents must be assessed on their ability and be encouraged to self-administer their own medication. If a resident is unable or unwilling to self-administer his or her medication, a licensed nurse shall administer all medication and the resident must be classified as a category B resident.

(2) When a resident refuses a medication, the resident's practitioner shall be notified within 24 hours and notification documented.

(1) A comprehensive discharge plan directly linked to the behaviors and symptoms that resulted in admission and estimated length of stay must be developed upon admission.

(2) A resident's diversion order is discontinued when:

(a) the resident and facility choose to allow continued residency; a resident needs assessment must be completed to determine category and placement within the facility;

(b) the resident chooses not to remain in the facility; the facility shall issue a 30-day notice and conduct discharge planning. Discharge planning must include involvement from community resources.

(3) A resident may be involuntarily discharged in less than 30 days if the resident:

(a) has a medical emergency;

(b) is suffering from an acute psychotic episode; or

(4) All discharges must be discussed with the resident or resident's legal representative and the resident's practitioner to ensure collaboration on a safe and appropriate discharge location.

(1) A category D facility or unit must have at least one room designated to be used for seclusion for every 24 beds.

(2) The location of these rooms must facilitate staff observation and monitoring of residents in these rooms.

(3) Seclusion rooms may only be used by one resident at a time.

(4) Seclusion rooms must:

(a) be a minimum of 60 square feet, and a minimum of 80 square feet if restraint beds are used;

(b) be a minimum length of 7 feet and maximum wall length of 11 feet;

(d) be accessed by an anteroom or vestibule that provides direct access to a toilet room;

(e) have door openings to the anteroom and toilet room with a minimum clear width of 3 feet 8 inches;

(f) be constructed to prevent hiding, escape, injury, or suicide;

(g) have walls designed to withstand direct and forceful impact and have materials that meet Class A or Class B finishes as defined by the 2012 National Fire Protection Association (NFPA) 101;

(h) have monolithic ceilings;

(i) not contain outside corners or edges;

(j) have doors that swing out, have a clear opening of 3 feet 8 inches, and permit staff observation through a vision panel, while maintaining provisions for privacy;

(k) have tamper resistant fixtures, such as light fixtures, vent covers, and cameras;

(l) have electrical switches and outlets that are restricted within the seclusion room; and

(m) have door lever handles that point downward when in the latched or unlatched position, except for specifically designed anti-ligature hardware.

(5) A licensed nurse must provide residents with constant one-on-one supervision when in the seclusion room.

(1) The provisions of the rules in this subchapter that govern the use of restraints do not apply to a category A personal care facility as defined in 50-5-227 (2) (a) , MCA, because such a facility is prohibited by law from accepting and serving any resident who is in need of medical, chemical or physical restraint.

The following definitions, in addition to those contained in 50-5-1202 , MCA, apply to this chapter:

(1) "Assistive device" means any device whose primary purpose is to maximize the independence and the maintenance of health of an individual who is limited by physical injury or illness, psychosocial dysfunction, mental illness, developmental or learning disability, the aging process, cognitive impairment or an adverse environmental condition. If the device is primarily used to restrict an individual's movement, it is considered a safety device or restraint rather than an assistive device.

(2) "Licensed health care professional" means a physician, a physician assistant-certified, a nurse practitioner or a registered or practical nurse licensed in the state of Montana.

(3) "Medical symptom", as defined in 50-5-1202 , MCA, means an indication of a physical or psychological condition or of a physical or psychological need expressed by the patient. For example, a concern for the resident's physical safety by any person listed in 50-5-1201 (1) , MCA, or a resident's fear of falling may constitute a medical symptom.

(4) "Postural support" means an appliance or device used to achieve proper body position and balance, to improve a resident's mobility and independent functioning, or to position rather than restrict movement, including, but not limited to, preventing a resident from falling out of a bed or chair. A postural support does not include tying a resident's hands or feet or otherwise depriving a resident of their use.

(5) "Restraint" means any method (chemical or physical) of restricting a person's freedom of movement that prevents them from independent and purposeful functioning. This includes seclusion, controlling physical activity, or restricting normal access to the resident's body that is not a usual and customary part of a medical diagnostic or treatment procedure to which the

resident or the authorized representative has consented.

(6) "Safety devices", as defined in 50-5-1202 , MCA, means side rails, tray tables, seat belts and other similar devices. The department interprets that definition to mean that a safety device is used to maximize the independence and the maintenance of health and safety of an individual by reducing the risk of falls and injuries associated with the resident's medical symptom.

(1) The application or use of a restraint, safety device, or postural support is prohibited except to treat a resident's medical symptoms and may not be imposed for purposes of coercion, retaliation, discipline, or staff convenience.

(2) A restraint may be a safety device when requested by the resident or the resident's authorized representative or physician to reduce the risk of falls and injuries associated with a resident's medical symptoms and used in accordance with 50-5-1201, MCA.

(3) To the extent that a resident needs emergency care, restraints may be used for brief periods:

(a) to permit medical treatment to proceed unless the health care facility has been notified that the resident has previously made a valid refusal of the treatment in question; or

(b) if a resident's unanticipated violent or aggressive behavior places the resident or others in imminent danger, in which case the resident does not have the right to refuse the use of restraints. In this situation:

(i) the use of restraints is a measure of last resort to protect the safety of the resident or others and may be used only if the facility determines and documents that less restrictive means have failed;

(ii) the size, gender, physical, medical, and psychological condition of the resident must be considered prior to the use of a restraint;

(iii) a licensed nurse shall contact a resident's physician for restraint orders within one hour of application of a restraint;

(iv) the licensed nurse shall document in the resident's file the circumstances requiring the restraints and the duration;

(v) a restrained resident must be monitored as their condition warrants, and restraints must be removed as soon as the need for emergency care has ceased, and the resident's safety and the safety of others can be assured; and

(vi) a licensed nurse must provide one on one supervision to a resident who has a restraint applied for the reasons listed in (3).

(4) In accordance with the Montana Long-Term Care Residents' Bill of Rights, the resident or authorized representative is allowed to exercise decision-making rights in all aspects of the resident's health care or other medical regimens, with the exception of the circumstances described in (3) (b) .

(5) Single or two quarter bed rails that extend the entire length of the bed are prohibited from use as a safety or assistive device; however, a bed rail that extends from the head to half the length of the bed and used primarily as a safety or assistive device is allowed.

(6) Physician-prescribed orthopedic devices used as postural supports are not considered safety devices or restraints and are not subject to the requirements for safety devices and restraints contained in these rules.

(7) Whenever a restraint, safety device, or postural support is used that restricts or prevents a resident from independent and purposeful functioning, the resident must be provided the opportunity for exercise and elimination needs at least every two hours, or more often as needed, except when a resident is sleeping.

(8) All methods of restraint, safety devices, assistive devices, and postural supports must be properly fastened or applied in accordance with manufacturer's instructions and in a manner that permits rapid removal by the staff in the event of fire or other emergency.

(1) Prior to the use of a restraint or safety device, the following items must be included in the resident's record:

(a) a consent form signed by the resident or authorized representative that includes documentation that:

(i) the resident or the resident's authorized representative was given a written explanation of the alternatives and any known risks associated with the use of the restraint or safety device;

(ii) cites any pre-existing condition that may place a patient at risk of injury; and

(b) written authorization from the resident's primary physician that specifies the medical symptom that the restraint or safety device is intended to address and the type of circumstances and duration under which the restraint or safety device is to be used.

(2) When a restraint or safety device is used, the following items must be documented in the resident's record:

(a) frequency of monitoring in accordance with documented facility policy;

(b) assessment and provision of treatment if necessary for skin care, circulation and range of motion; and

(3) During a quarterly re-evaluation, a facility must consider:

(a) using the least restrictive restraint or safety device to restore the resident to a maximum level of functioning;

(b) causes for the medical symptoms that led to the use of the restraint or safety device; and

(c) alternative safety measures if a restraint or safety device is removed. Before removing a restraint or safety device, the resident or the authorized representative and the attending physician must be consulted.

(1) Restraints, safety devices or postural supports may only be applied by staff who have received training in their use, as specified below and appropriate to the services provided by the facility.

(2) Staff training shall include, at a minimum, information and demonstration in:

(a) the proper techniques for applying and monitoring restraints, safety devices or postural supports;

(b) skin care appropriate to prevent redness, breakdown and decubiti;

(d) assessment of blood circulation to prevent obstruction of blood flow and promote adequate circulation to all extremities;

(e) turning and positioning to prevent skin breakdown and keep the lungs clear;

(f) potential risk for residents to become injured or asphyxiated because the resident is entangled in a bed rail or caught between the bed rail and mattress if the mattress or mattress pad is ill-fitted or is out of position;

(g) provision of sufficient bed clothing and covering to maintain a normal body temperature;

(h) provision of additional attention to meet the physical, mental, emotional and social needs of the resident; and

(i) techniques to identify behavioral symptoms that may trigger a resident's need for a restraint or safety device and to determine possible alternatives to their use. These include:

(i) observing the intensity, duration and frequency of the resident's behavior;

(ii) identifying patterns over a period of time and factors that may trigger the behavior; and

(iii) determining if the resident's behavior is:

(A) new or if there is a prior history of the behavior;

(B) the result of mental, emotional, or physical illness;

(3) Training described in (2) must meet the following criteria:

(a) training must be provided by a licensed health care professional or a social worker with experience in a health care facility; and

(b) a written description of the content of this training, a notation of the person, agency, organization or institution providing the training, the names of staff receiving the training, and the date of training must be maintained by the facility for two years.

(4) Refresher training for all direct care staff caring for restrained residents and applying restraints, safety devices or postural supports must be provided at least annually or more often as needed. The facility must:

(a) ensure that the refresher training encompasses the techniques described in (2) of this rule; and

(b) for two years after each training session, maintain a record of the refresher training and a description of the content of the training.

(1) In addition to these rules, an EDC must comply with licensure rules in ARM Title 37, chapter 106, subchapter 3. To the extent that licensure rules in ARM Title 37, chapter 106, subchapter 3 conflict with the terms of ARM Title 37, chapter 106, subchapter 12, the terms of subchapter 12 will apply to an EDC.

(1) "Clinical director" means a social worker, psychologist, or clinical professional counselor licensed under Title 37, MCA, who oversees an EDC's clinical services. A clinical director cannot be a licensure candidate.

(2) "Eating disorder" means any of several psychological disorders such as anorexia nervosa, bulimia nervosa, binge eating disorder, pica, rumination disorder, avoidant/restrictive food intake disorder, or other specific feeding or eating disorders characterized by serious disturbances to a person's eating behaviors.

(3) "Intensive outpatient program" means a program that provides more structure and support than standard outpatient therapy.

(4) "Meal support" means the provision of support during meal times, focused specifically on helping the individual to consume the food on their meal plan and redirecting behaviors that sabotage eating and recovery.

(5) "Medical director" means a psychiatrist licensed under Title 37, MCA, who oversees an EDC's services.

(6) "Mental health professional" means a psychologist, social worker, or professional counselor licensed under Title 37, MCA, or a licensure candidate registered under Title 37, MCA.

(1) The department shall issue a license from one to three years in duration for an EDC to any applicant meeting all the requirements established by these rules and the governing statutes, as determined by the department after a licensing survey.

(2) The department will issue a renewal license for a period of one to three years in duration for an EDC if:

(a) the EDC makes written application for renewal at least 30 days prior to the expiration date of the current license; and

(b) the EDC continues to meet all requirements established by these rules and governing statutes, as determined by the department after a licensing survey.

(3) If an EDC makes timely application for renewal of a license, but the department does not complete the relicensing survey before the expiration date of the previous year's license, the previous year's license will continue in effect for the time necessary for the department to complete the relicensing survey and to determine compliance with licensing requirements.

(4) The department may in its discretion issue a provisional license for any period up to six months to any applicant which:

(a) has met all licensing requirements for fire safety; and

(b) has agreed in writing to comply fully with all licensing requirements established by these rules within the time covered by the provisional license.

(c) the department may, in its discretion, renew a provisional license if the applicant shows good cause for failure to comply fully with all licensing requirements within the time covered by the prior provisional license, but the total time covered by the initial provisional license and renewals may not exceed one year.

(5) The department may consider as eligible for licensure, during the accreditation period, an EDC that furnishes written evidence, including the recommendation for future compliance statements, of accreditation of its programs by the Commission on Accreditation of Rehabilitation Facilities or The Joint Commission. The department may inspect an EDC considered eligible for licensure to ensure compliance with state licensure standards.

(1) An application for an EDC license must be made on an application form provided by the department and include plans required by ARM 37.106.306.

(2) The EDC must submit all written program management policies and procedures to the department for approval with the initial application. Policies and procedures must comply with requirements outlined in this subchapter. The EDC shall submit to the department any significant changes to policies and procedures for approval.

(3) Upon receipt of a complete application for license or renewal of license and applicable fees pursuant to 50-5-202, MCA, the department will conduct a licensing survey to determine if the applicant meets applicable licensing requirements.

(4) If the department determines during the survey that the applicant is out of compliance with applicable licensing requirements, the department will notify the applicant of the specific deficiencies, and the applicant must submit a written plan of correction within ten working days of the department's notification of noncompliance specifying how compliance will be achieved.

(5) The department must approve the plan of correction prior to issuing a license.

(6) The department will not issue a license or renew a license until it receives all required or corrected information.

(1) In addition to requirements in ARM 37.106.330, the EDC policy and procedure manual must include information for:

(a) eligibility for services;

(b) client screenings and assessments;

(d) client rights and grievances;

(e) monitoring the client's weight and food related behaviors;

(f) maintaining clinical records;

(g) establishing fiscal policies governing the management of organizational funds;

(h) establishing and maintaining orientation and ongoing staffing requirements;

(i) informing clients of policies pertaining to the EDC;

(j) screening, hiring, and assessing staff which include conducting practices that assist the EDC in identifying employees that may pose a risk or threat to the health, safety, or welfare of any resident, and provide written documentation of the findings and the outcome in the employee's file;

(k) reporting suspected abuse or neglect in accordance with Title 52, chapter 3, part 8, MCA, for adults; and in accordance with Title 41, chapter 3, part 2, MCA, for children.

(l) reporting requirements to notify the department's Quality Assurance Division, by e-mail or fax within 24 hours, of a client, staff, volunteer, or visitor death where the death occurs on-site or in service related activities; of any fire, accident, or other incident resulting in significant damage to the service site;

(m) defining staff ethical standards and conduct, including investigating and reporting of unprofessional conduct to the applicable professional licensing authority;

(n) discharge;

(o) meal support, if applicable;

(p) the management, storage, and disposal of any prescription and over-the-counter drugs;

(q) client transportation, if provided by the EDC;

(r) crisis intervention services; and

(s) conducting staff criminal background checks including convictions that disqualify individuals from employment.

(2) The policy and procedure manual must include a current organizational chart delineating the current lines of authority, responsibility, and accountability for the administration and provision of all client services.

(1) An EDC must provide the follow services:

(a) outpatient therapy;

(b) family therapy;

(d) nutritional counseling; and

(e) crisis services.

(1) An EDC must have written policies and procedures for determining eligibility for services that include:

(a) the criteria to determine eligibility for services;

(b) the information required to be collected to determine eligibility for services;

(d) the procedures for accepting referrals.

(2) The EDC must have a policy and procedures for managing wait lists for services.

(1) An EDC must have a screening procedure for the early detection of risk of imminent harm to self or others. The procedure must:

(a) be completed on the first contact; and

(b) include a process for responding when an immediate risk of harm is identified.

(2) An EDC must complete a clinical intake assessment within three contacts, for each client, and must be updated annually.

(3) Clinical intake assessments must be conducted by a licensed mental health professional trained in clinical assessments and must include the following information in a narrative form to substantiate the client's diagnosis and provide sufficient detail to plan of care goals and objectives:

(a) presenting problem and history of problem;

(b) mental status;

(d) initial plan of care goals;

(e) risk factors to include suicidal or homicidal ideation;

(f) psychiatric history;

(g) substance use/abuse and history;

(h) current medication and medical history;

(i) financial resources and residential arrangements;

(j) education and/or work history; and

(k) legal history relevant to history of illness, including guardianships, civil commitments, criminal mental health commitments, and prior criminal background.

(4) The clinical intake assessment must include an assessment of the client's food-related behaviors including the client's beliefs, perceptions, attitudes, and behavior regarding food. The assessment may include family observations regarding the individual's food-related behavior when available.

(5) Within two weeks of admission into the program the EDC must perform or make a documented referral for the following tests, screenings, and procedures based on the needs of the client:

(a) complete blood count;

(b) comprehensive serum metabolic profile, including phosphorus and magnesium;

(d) electrocardiogram (ECG), if clinically indicated;

(e) body mass index;

(f) screenings for eating disorder behaviors; and

(g) any additional laboratory testing, as determined appropriate.

(6) The EDC may accept test results required in (5) from other health care professionals completed within two weeks prior to acceptance for services.

(7) The EDC must maintain a current list of providers who accept referrals for assessments and services not provided by the EDC.

(1) An EDC must have a multi-disciplinary plan of care that is supervised and directed by the admitting psychiatrist, and consisting of adequate numbers of individuals licensed, registered, or certified in the physical and mental health disciplines appropriate to the condition of each client.

(2) Based upon the findings of an assessment, the EDC must establish an individualized plan of care for each client within five contacts or 21 days from the first contact, whichever is later. The plan of care must:

(a) specify a diagnosis based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), or the International Classification of Diseases, Tenth Revision (ICD-10);

(b) identify plan of care team members, from within and outside of the EDC, who are involved in the client's treatment and care;

(d) include objectives that include identified steps to achieve the goal;

(e) include nutritional rehabilitation to support regular and consistent weight when indicated;

(f) include measurable improvement in eating disorders behavior;

(g) identify projected timeframe for completion of goals and objectives as determined by the behavioral health needs of the client;

(h) identify the staff person responsible for each treatment service to be provided;

(i) include family participation in treatment unless such participation is contraindicated. Written documentation must indicate the reason participation is contraindicated;

(j) include signatures from the client, the client's legal guardian (if applicable), the licensed mental health professional and any other person responsible in implementation of the plan; and

(k) describe how the EDC will monitor the client's weight and food-related behaviors.

(3) The plan of care must be reviewed face-to-face at least every:

(a) 90 days for outpatient therapy;

(b) 30 days for intensive outpatient programs; or

(4) Plan of care reviews must include:

(a) the client;

(b) the client's legal guardian (if applicable);

(d) any person with responsibility in implementation of the plan;

(e) documentation on progress towards objectives and goals; and

(f) date and signature of all persons indicating participation in the review.