(a) "Current state health plan" means the compilation of components containing guidelines for determining need for health care facilities and services subject to certificate of need review that is most recently adopted by the governor and a statewide health coordinating council appointed by the governor; a separate component adopted by the statewide health coordinating council and the governor for a single type of service or facility is part of the current state health plan.

(b) "Health service" means a major subdivision, as determined by the department, within diagnostic, therapeutic, or rehabilitative areas of care, including alcohol, drug abuse, and mental health services, that may be provided by a health care facility. Specific treatments, tests, procedures, or techniques in the provisions of care do not, by themselves, constitute a health service.

(i) "Health service" includes radiological diagnostic health services offered in, at, through, by, or on behalf of a health care facility, including services offered in space leased or made available to any person by a health care facility except when the capital expenditure for the addition to or replacement of the same service is less than $750,000.

(c) "Major medical equipment" is defined as provided in 50-5-101 , MCA, and the department interprets the phrase "substantial sum of money" in that definition to mean "more than $750,000".

(d) "Swing bed" means a licensed hospital or medical assistance facility bed that is also certified for the provision of long-term care pursuant to 42 CFR 482.66.

(2) The following terms appear in the Montana Code Annotated, are not defined in the statutes, and are interpreted by the department to mean the following:

(a) The phrase "enforceable capital expenditure commitment", as used in 50-5-305 , MCA, means an obligation incurred by or on behalf of a health care facility when:

(i) an enforceable contract is entered into by such facility or its agent for the construction, acquisition, lease or financing of a capital asset;

(ii) a formal internal commitment of funds by such a facility which constitutes a capital expenditure; or

(iii) in the case of donated property, the date on which the gift vested.

(b) The phrase "office of a private physician, dentists or other physical or mental health care professionals, including chemical dependency counselors", used in 50-5-301 , MCA, as an exception from the definition of "health care facility", to mean the private offices of those professionals, whether practicing individually or as a group, and associated facilities that are:

(i) located on the premises of the professional's offices;

(ii) operated as an integral part of the professional's private practice; and

(iii) primarily available only to the professionals whose offices are located on the premises. Such facilities may include outpatient services and observation beds, but may not include inpatient services.

(a) it is licensed to provide the level of care in question; or

(b) it has received certificate of need approval pursuant to ARM 37.106.126 for the establishment of swing beds, is certified to provide long-term care in such swing beds, and the provision of long-term care is limited to such swing beds.

(2) A hospital may provide long-term care only if:

(a) it has received certificate of need approval from the department for the establishment of swing beds, is certified to provide long-term care in such swing beds, and the provision of long-term care is limited to such swing beds; or

(b) whenever the number of beds in which long term care is provided is five or fewer, the facility is certified to provide long-term care in those beds as swing beds, and the provision of long-term care is limited to such swing beds.

(a) name of applicant;

(b) proposal title;

(c) a detailed statement outlining whether the proposal involves:

(i) the addition of a new service, 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 health care facility that did not previously exist or is being replaced;

(iii) the construction, remodeling, renovation, or replacement of a health care facility requiring a capital expenditure of more than $1,500,000;

(iv) 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;

(v) the expansion of a geographic service area of a home health agency;

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

(vii) 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) For letters of intent submitted under (1) of this rule, in determining whether or not a capital expenditure for equipment is over $750,000, the department will review the list submitted by the applicant pursuant to (1) (e) of this rule and will include in the cost calculation the cost of any support equipment necessary to the proper function of the item of major medical equipment in question.

(3) Any person or persons desiring to acquire or enter into a contract to acquire 50% or more of an existing health 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 health 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.

(4) Any person proposing to increase or relocate from one facility or site to another no more than 10 beds or 10% of the licensed beds 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.

(5) As required by 50-5-302 (2) , MCA, persons who acquire health care facilities but who do not file the notice of intent required by (3) of this rule are subject to certificate of need review for the purposes of this subchapter.

(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 six 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.

(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.

(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.

(c) The notice must indicate:

(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.

(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 health plan, including but not limited to waiting lists, projected service volumes, differences in cost and quality of services, and availability of services; or

(iii) is consistent with the current state health plan.

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

(c) the availability of less costly quality-equivalent or more effective alternative methods of providing 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 health services by the person proposing the health 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 health 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 health services by the person proposing the construction project;

(j) the distance, convenience, cost of transportation, and accessibility of health services 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) above, the department will consider the following in making its decision:

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

(b) whether patients will experience problems including, but not limited to, cost, availability, or accessibility in obtaining care of the type proposed in the absence of the proposed new service.

(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) .

(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.

(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.

(c) Reconsideration of the department's decision may be requested by the holder and will be granted if the requester:

(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.

(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 or medical assistance facility 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 is subject to certificate of need review only if, as required by 50-5-301 (1) (c) , 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.

(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, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT 59620-2953. The cover letter must accompany the original and each of the six copies of the information required by ARM 37.106.134.

(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) ;

(c) the five-year projected 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 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 health plan (a copy of which may be obtained from the Department of Public Health and Human Services, Health Policy Services Division, Health Systems Bureau, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951) . 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;

(c) any changes in the ownership of the applicant during the past year;

(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;

(c) term and interest rate of loan;

(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;

(c) feasibility study (include a copy) ;

(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) ;

(c) alternatives which have been considered to provide the service proposed by the project.

(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 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 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 JCAH 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;

(c) 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 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 new born 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.

(1) Every hospital shall submit an annual financial report to the department on a form provided by the department and no later than 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;

(c) detail of deductions for both acute and long-term care units, including:

(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) (i) 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;

(ii) 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) ;

(iii) 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.

(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;

(c) utilization information, including:

(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.

(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;

(c) a discussion of the organizational aspects of the project, including the following information:

(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, specialty hospital, or medical assistance facility 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 2010 edition of the 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, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953; and at the following web site http://www.fgiguidelines.org/guidelines2010.php;

(b) NFPA 101, "Life Safety Code", 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, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953; and at the following web site http://www.nfpa.org/aboutthecodes/AboutTheCodes.asp?DocNum=101&cookie%5Ftest=1;

(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, Quality Assurance Division, 2401 Colonial Drive, P.O. Box 202953, Helena, MT, 59620-2953; and at the following web site http://webstore.ansi.org/RecordDetail.aspx?sku=ICC+A117.1-2009;

(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 achieved accreditation by a recognized accrediting organization; 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) A two-year license may be offered to any facility:

(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.

(c) 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.

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;

(c) documentation of employee orientation, signed by the employee; and

(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 2012 Edition of the NFPA Life Safety Code 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 Life Safety Code. 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;

(c) The code sequence must be posted in the vicinity of each keypad and may be inconspicuous;

(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;

(c) provisions for medication storage and preparation;

(d) telephone access; and

(e) a nurse call system in compliance with table 2.1-4 as found in the 2010 Edition of the AIA Guidelines for Design and Construction of Hospital 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 2010 Edition of the AIA Guidelines for Design and Construction of Hospital and Healthcare facilities include:

(a) a work counter;

(b) a refrigerator;

(c) storage cabinets;

(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;

(c) general lighting in food preparation areas must be a minimum of 50 foot-candles of light; and

(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;

(c) the names of other health care facilities, if any, which were 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.

(c) sort and store soiled laundry in an area separate from that used to sort and store clean laundry;

(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;

(c) supply each resident at all times with clean towels and washcloths;

(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.

(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 482.66(b) revised as of October 1, 2002.

(3) The department hereby adopts and incorporates by reference 42 CFR 482.2 through 482.62 and 42 CFR 482.66(b) , revised as of October 1, 2002. 42 CFR 482.2 through 482.62 set forth the conditions of participation a hospital must meet to participate in the medicare program. 42 CFR 482.66(b) 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, Quality Assurance Division, 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;

(c) physical examinations performed on 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;

(c) physical examination report;

(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) 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.

(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

(c) is aware of medical or emotional conditions under which the request would contribute to severe emotional distress.

(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;

(c) either parent;

(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.

(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;

(c) emergency drugs;

(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.

(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;

(c) emergency drugs.

(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;

(c) anesthesia used on patient;

(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.

(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.

(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.

(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.

(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) "Accreditation Association for Ambulatory Health Care (AAAHC)" means the organization nationally recognized by that name and surveys outpatient centers for surgical services upon their request and grants accreditation status to the outpatient center for surgical services that it finds meets its standards and requirements.

(2) "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.

(3) "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.

(4) "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 the Accreditation Association for Ambulatory Health Care (AAAHC) 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;

(c) preoperative assessment;

(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;

(c) methods to determine if the recalled product is present at the facility;

(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:

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

(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;

(c) a quality improvement program that:

(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

(c) the outpatient center must keep a schedule for clinical staff, to make sure all shifts are adequately covered.

(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;

(c) preoperative diagnostic studies, if performed;

(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;

(c) the timely entry of data in records; and

(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;

(c) a process for reducing and avoiding medication errors; and

(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

(c) a certified registered nurse anesthetist (CRNA).

(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;

(c) mental status and level of consciousness, or both;

(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;

(c) only authorized persons are allowed in the surgical or treatment areas; and

(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) The following table indicates an absolute minimum staffing pattern below which an acceptable level of care and safety cannot be maintained. Even with this staffing it would be difficult. Therefore, it is recommended that the quantity and quality of staffing should be determined by the administrator in consultation with his director of nursing. This decision should be based on the nursing needs of the patients and should reflect the current concepts of restorative and geriatric care.

                                            DAY                                                  EVENINGS                             NIGHTS

No. of Beds Licensed	R.N.* Hours	L.P.N. Hours	Aide** Hours	R.N. Hours	L.P.N. Hours	Aide** Hours	R.N. Hours	L.P.N. Hours	Aide** Hours
4-8	8	0	0	0	8	0	0	8	0
9-15	8	0	4	0	8	0	0	8	0
16-20	8	0	8	0	8	4	0	8	0
21-25	8	0	12	0	8	8	0	8	4
26-30	8	0	16	0	8	8	0	8	8
31-35	8	0	20	0	8	12	0	8	8
36-40	8	0	24	0	8	16	0	8	8
41-45***	8	8	28	0	8	16	0	8	12
46-50	8	8	32	0	8	20	0	8	16
51-55	8	8	36	8	0	24	0	8	16
56-60	8	8	40	8	0	24	0	8	16
61-65	8	8	44	8	0	28	0	8	20
66-70	8	8	48	8	0	32	0	8	24
71-75	8	8	52	8	0	32	8	0	24
76-80	8	16	48	8	8	32	8	0	24
81-85	8	16	52	8	8	32	8	8	20
86-90	8	16	56	8	8	32	8	8	24
91-95	16	16	52	8	8	36	8	8	24
96-100	16	16	56	8	8	40	8	8	24

Staffing of homes with more than 100 beds will be given individual consideration.
* The two relief shifts could be provided by an L.P.N. up to 40 beds.
** The term "aide" includes orderlies.
*** In a home of 41 beds or more one R.N. in this pattern is to be the full-time director of nursing service.

(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.

(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;

(c) present illness;

(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.

(2) The department hereby adopts and incorporates by reference 42 CFR 442, Subpart G, which is a federal agency rule setting forth administrative, personnel, programmatic, and health standards that must be met by any intermediate care facility for the mentally retarded in order to be medicaid eligible. A copy of 42 CFR 442, Subpart G, 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 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, updated through May 2005. The department adopts and incorporates by reference 42 CFR 485 Subpart F, updated through May 2005. A copy of the cited requirements 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.

(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;

(c) is located in a county where the percentage of the population age 65 or older exceeds the statewide average; or

(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;

(c) patients undergoing surgery; or

(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

(c) a bodily organ or part would be seriously damaged.

(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 482.2 through 482.62. The department adopts and incorporates by reference 42 CFR 482.2 through 482.62 as revised on May 16, 2012, which set 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 42 CFR 482.2 through 482.62 may 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.

(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;

(c) selection of impact study consultant and scope finalization;

(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

(c) consultant selection.

(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

(c) pay the costs of that study.

(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;

(c) the operational impacts upon existing health care facilities; and

(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;

(c) address all areas designated within the scope of the study; and

(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

(c) employs or contracts with existing or proposed qualified staff adequate to operate the facility.

(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;

(c) transfer all necessary records for continuing the care for the patient; and

(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;

(c) establishes written policies and procedures for all facility human resource services;

(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;

(c) family size;

(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;

(c) community of interest; and

(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) 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) "Commission for the Accreditation of Birth Centers" means the organization nationally recognized by that name and that surveys outpatient birth center facilities upon their request and grants accreditation status to the outpatient birth center that it finds meets its standards and requirements.

(2) "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.

(3) "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.

(4) "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.

(5) "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;

(c) act as a liaison for the center with community physicians, hospital staff, and other professionals and agencies; and

(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;

(c) present illness;

(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;

(c) informing patients of the policy and procedures for patient complaints and grievances;

(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 the Commission for the Accreditation of Birth Centers 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

(c) ensure continuity of leadership and quality of care.

(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

(c) providers who practice midwifery and support the normal birth process including:

(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;

(c) staff members who are trained according to the policies and procedures of the birth center;

(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;

(c) educates clients on self-care in pregnancy, including:

(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.

(1) As used in this chapter, unless the context indicates otherwise, the following definitions apply:

(a) "Facility" means a medical assistance facility as defined in 50-5-101 , MCA.

(b) "Nurse practitioner" means a person who is licensed as a professional registered nurse and approved by the Montana board of nursing as a nurse practitioner specialist.

(c) "Physician" means a person licensed to practice medicine in Montana by the Montana board of medical examiners.

(d) "Physician's assistant" means a person who is approved by the Montana board of medical examiners as meeting the qualifications in its rules and Title 37, chapter 20, MCA, required of assistants to primary care physicians.

(e) "Practitioner" means a physician, nurse practitioner, or physician's assistant.

(a) Ensures that the medical 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 and meet the requirements of (3) below and ARM 37.106.1104;

(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, and judgment.

(b) Appoints a chief executive officer who is responsible for managing the facility.

(c) In accordance with a written policy, ensures that:

(i) Every patient is either under the care of a physician or under the care of a nurse practitioner or physician's assistant supervised by a physician;

(ii) Whenever a patient is admitted to the facility by a physician's assistant or nurse practitioner, the facility's sponsoring physician is notified of that fact, by phone or otherwise, within 24 hours after the admission, and that a written notation of that consultation and of the physician's approval or disapproval is kept in the patient's record;

(iii) A physician, nurse practitioner, or physician's assistant is on duty or on call and physically available at the facility within one hour at all times, unless the procedure described in (iv) is adopted and implemented;

(iv) If the facility cannot ensure that a practitioner is available within one hour after a patient first contacts the facility, within that hour, the director of nursing or alternate:

(A) evaluates the condition of the patient;

(B) determines whether a practitioner can reach the facility before the hour is up; and

(C) if the practitioner will not be available, arranges for the transport of the patient to another facility capable of providing the appropriate level of care; and

(v) No patient is cared for in the facility for more than 96 hours.

(d) Prepares, adopts, and reviews and updates annually an overall institutional plan which includes the following:

(i) An annual operating budget that is prepared according to generally accepted accounting principles and includes all anticipated income and expense; and

(ii) Projected capital expenditures, if any, for at least a three-year period.

(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.

(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 such staff member provides health services within the scope of his or her license, certification, or registration.

(1) The facility must have a medical staff that includes at least one physician, may also include one or more physician's assistants and/or nurse practitioners, and does the following:

(a) Examines the credentials of candidates for medical staff membership and makes recommendations to the governing board on the appointment of the candidate;

(b) Adopts bylaws containing the following, and enforces the bylaws after their approval by the governing body:

(i) A description of the qualifications a medical 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 staff (e.g., physician, physician's assistant, nurse practitioner) ; and

(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.

(2) A physician on staff must:

(a) Provide medical direction for the facility's health care activities and consultation for, and medical supervision of, non-physician health care staff;

(b) In conjunction with the physician's assistant and/or nurse practitioner staff members, participate in developing, executing, and periodically reviewing the facility's written policies and the services provided patients;

(c) Review and sign the records of each patient admitted and treated by a physician's assistant or nurse practitioner no later than one month after that patient's discharge from the facility;

(d) Provide health care services to the patients in the facility, whenever needed and requested;

(e) Prepare guidelines for the medical management of health problems, including conditions requiring medical consultation and/or patient referral; and

(f) At intervals no more than 30 days apart, be physically present in the facility for a sufficient period of time to provide the medical direction, medical care services, staff consultation and supervision required by this rule, and when not present, either be available through direct telecommunication for consultation, assistance with medical emergencies, or patient referral, or ensure that another physician is available for the purpose; however, the physical site visit for a given 30-day period is not required if, during that period, no patients have been treated by the facility.

(3) A physician's assistant and/or nurse practitioner must:

(a) Participate in the development, execution, and periodic review of the guidelines and written policies governing the services furnished by the facility;

(b) Participate with a physician in a periodic review of each patient's health records;

(c) Provide health care services to patients in accordance with the facility's policies;

(d) Arrange for, or refer patients to, needed services that are not provided at the facility; and

(e) Assure that adequate patient health records are maintained and transferred as necessary when a patient is referred.

(4) A physician's assistant must keep on file at the facility and available for review by the department, upon request, a copy of his or her utilization plan currently approved by the board of medical examiners.

(5) At all times, either a physician, nurse practitioner, or physician assistant must be on duty or on call and available physically to the facility within one hour, unless the facility has implemented the procedure required by ARM 37.106.1103(c) (iv) to deal with occasions in which a practitioner is unavailable.

(a) The facility must employ adequate personnel to ensure prompt and systematic completion, filing, and retrieval of records.

(b) If the medical record supervisor is not a record administrator or technician registered or accredited by the American medical record association (AMRA) , the facility must ensure that the supervisor receives consultation from an AMRA registered record administrator or accredited record technician.

(c) The facility must create and maintain a record for each person receiving 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.

(d) Each record must include the signatures of the physician or other health care professional authoring the record entries.

(e) Records of a discharged patient must be completed within 30 days of the discharge date.

(f) The facility must 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 record information may be released and to whom;

(iii) Specify when the patient's written consent is required for release of information, in accordance with Title 50, chapter 16, part 5, MCA, the Uniform Health Care Information Act.

(a) Periodic review, not less than semi-annually, of the following, in order to determine whether utilization of services was appropriate, established policies were followed, and any changes are needed:

(i) the utilization of facility services, including at least the number of patients served and the volume of services;

(ii) a representative sample consisting of not less than 10% of both active and closed patient records; and

(iii) the facility's health care policies.

(b) Consideration by the facility's medical staff of the findings of the evaluation and the taking of subsequent remedial action, if necessary.

(c) Evaluation of all services provided by contractors.

(d) Implementation of a discharge planning program that facilitates the provision of post discharge care and:

(i) Ensures that discharge planning for each patient is initiated in a timely manner;

(ii) Ensures that each patient, along with necessary medical information, is transferred or referred to appropriate facilities, agencies, or outpatient services, as needed, for continued, follow up, or ancillary care; and

(iii) Includes a formal referral agreement with one or more hospitals ensuring acceptance by that hospital of the facility's patients needing hospital level care.

(e) 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.

(a) Have in effect a utilization review plan to review services furnished by the facility and by members of its medical staff to patients.

(b) Contract with the state peer review organization (PRO) or its department approved equivalent to do the following:

(i) Certify whether all admissions to the facility in the facility's first 12 months of operation were medically necessary;

(ii) During the facility ' s first 12 months of operation provide consultation to the facility sometime between the 48th and 72nd hour of the stay of each patient admitted to the facility during that period concerning discharge plans for the patient (e.g. transfer to the hospital, discharge to a skilled nursing facility, discharge to home) ;

(iii) Periodically sample facility cases and review them to determine the medical necessity of the professional services furnished, including drugs and biologicals; during the facility's first 12 months of operation, the review must include retrospective review of 25% of the cases of patients admitted to the facility during that period.

(2) After the medical assistance facility's first 12 months of operation, the facility must collaborate and cooperate with the state PRO or its department approved equivalent, pursuant to a written agreement, in projects designed to identify and assess opportunities to improve the quality of patient care, the utilization of the facility, and the appropriateness of the discharge planning and the disposition of each of the facility's patients following treatment. Collaboration by the facility must include:

(a) Participating in the design of the projects;

(b) Providing medical records to the state PRO or its department approved equivalent for abstraction or completing the abstraction of records on site and submitting the results to the state PRO or its department approved equivalent;

(c) Assessing the results of the abstraction; and

(d) Developing plans necessary to ensure continuous improvement in the care provided to patients at the facility.

(a) Ensure the facility constitutes a sanitary environment adequate to avoid sources and prevent transmission of infections and communicable diseases.

(b) Designate a member of the medical staff as infection control officer and ensure that the officer:

(i) develops and implements policies governing control of infections and communicable diseases;

(ii) develops a system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel; and

(iii) maintains a log of incidents related to infections and communicable diseases.

(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 licenses.

(d) The nursing staff must develop and keep current a nursing care plan for each patient.

(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 and the specialized qualifications and competence of the nursing staff available.

(f) All drugs and biologicals must be administered by, or under the supervision of, nursing or other 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 facility's 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 initialled 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.

(a) The facility must have either a pharmacy directed by a registered pharmacist or a drug storage area under the supervision of a consulting pharmacist who must develop, supervise, and coordinate all the pharmacy services activities.

(b) The pharmacy or drug storage area must be administered in accordance with accepted professional principles.

(c) When a pharmacist is not available, drugs and biological may be removed from the pharmacy or storage area only by personnel designated in writing in medical staff and pharmaceutical services policies, in accordance with federal and state law.

(d) All compounding, packaging, and dispensing of drugs and biologicals must be under the supervision of a pharmacist and performed in a manner consistent with federal and state law.

(e) Drugs and biologicals must be kept in a locked storage area.

(f) Outdated, mislabeled, or otherwise unusable drugs and biologicals must be removed from the facility and destroyed; and

(g) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending practitioner.

(a) The radiologic services must be free from radiation hazards for patients and personnel.

(b) Periodic inspection of equipment must be made and hazards identified must be promptly corrected.

(c) Radiation workers must be checked periodically by the use of exposure meters or badge tests, to determine the amount of radiation to which they are routinely exposed.

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

(e) Only personnel designated as qualified by the medical staff, and meeting requirements of state law, may use the radiographic equipment and administer procedures.

(f) The radiologist or other practitioner who provides radiology services must sign each report containing his/her interpretations.

(g) The facility must maintain any radiographic studies and their interpretations for at least five years.

(a) The facility, at a minimum, must provide basic laboratory services essential to the immediate diagnosis and treatment of the patients, including:

(i) chemical examinations of urine by stick or tablet methods, or both (including urine ketones) ;

(ii) microscopic examinations of urine sediment;

(iii) hemoglobin or hematocrit;

(iv) blood sugar;

(v) gram stain;

(vi) examination of stool specimens for occult blood;

(vii) pregnancy tests;

(viii) primary culturing for transmittal to a medicare-certified laboratory; and

(ix) sediment rate, CBC.

(b) The facility must have a contractual agreement with a medicare-approved hospital or independent laboratory for any additional laboratory services that are needed by a patient.

(c) Emergency provision of basic laboratory services must be available 24 hours a day.

(d) The facility must assign personnel to direct and conduct the laboratory services.

(e) Only personnel designated as qualified by the medical staff by virtue of education, experience, and training may perform and report laboratory test results.

(a) The facility must assign an employee or contract with a consultant to direct the food and dietetic service and to be responsible for the daily management of the dietary service who is qualified by experience and training as a food service supervisor.

(b) The facility must utilize a qualified dietitian, full-time, part-time, or on a consultant basis.

(c) A therapeutic diet for a patient must be prescribed by the practitioner responsible for the care of that patient.

(d) Nutritional needs must be met in accordance with recognized dietary practices and, at a minimum, the recommended daily dietary allowances established by the Food and Nutrition Board of the National Research Council, National Academy of Sciences, 8th edition, 1974.

(e) A current therapeutic diet manual approved by the dietitian and medical staff must be readily available to all medical, nursing, and food service personnel.

(f) The department hereby adopts and incorporates by reference the recommended daily dietary allowances published in 1974 by the Food and Nutrition Board of the National Research Council, National Academy of Sciences, 8th edition, which set the minimum amounts of all nutrients required daily by most normal persons living in the U.S. under usual environmental stresses in order to maintain health, depending upon the age and sex of the individual. Copies of the recommended daily 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) If a medical assistance facility provides outpatient services, each outpatient must be examined by a practitioner and the services must meet the standards contained in ARM 37.106.1008.

(2) The department adopts and incorporates by reference ARM 37.106.1001, which contains the licensure standards for facilities having outpatient services. A copy 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.

(a) Emergency services must be organized under the direction of a practitioner member of the medical staff.

(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) The emergency services must comply with the rules governing emergency medical services, subchapters 2, 3 and 4 of ARM Title 37, chapter 104.

(e) The department hereby adopts and incorporates by reference subchapters 2, 3 and 4 of ARM Title 37, chapter 104, which contain the standards for all the various types of emergency medical services which may be provided. A copy of the above 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.

(a) a provider of inpatient hospital care;

(b) a provider of specialized diagnostic imaging or laboratory services that are not available at the facility;

(c) a skilled nursing facility;

(d) a home health agency.

(2) If any of the agreements referred to in (1) are not in writing, there must be evidence that patients referred to another provider by the facility are being accepted and treated.

(3) If the facility is unable to ensure that a practitioner is physically available to the facility within one hour after s/he is contacted, the facility must enter into a written agreement with a licensed ambulance service committing the service to be available to commence transport of a patient, within one hour after that patient first contacts the facility, to a facility providing the level of care needed by the patient.

(2) An inpatient chemical dependency treatment center which is established in a general acute-care hospital does not require separate licensure. However, the certificate of need requirements of Title 50, chapter 5, subchapter 3, MCA, may apply.

(3) Freestanding detoxification and freestanding inpatient chemical dependency treatment centers shall be licensed separately as chemical dependency treatment centers.

(4) A chemical dependency treatment center must satisfy the program requirements set forth in ARM Title 37, chapter 27, subchapter 1.

(5) The department hereby adopts and incorporates by reference ARM Title 37, chapter 27, subchapter 1, with the exception of the following: ARM 37.27.101, 37.27.106, 37.27.128(6) (a) , 37.27.129(5) (a) , 37.27.130(5) (a) and 37.27.135(5) (a) . ARM Title 37, chapter 27, subchapter 1 are rules which have been adopted by the department of public health and human services setting forth program requirements for alcohol and drug abuse facilities to receive approval from the department of public health and human services. Copies of these rules 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) This subchapter establishes the licensing requirements for acute inpatient chemical dependency facilities, residential inpatient community-based chemical dependency facilities, and low and medium intensity residential halfway house treatment facility services.

(2) If the rules in this subchapter conflict with ARM Title 37, chapter 106, subchapter 3, the requirements of this subchapter will apply.

(3) This subchapter is applicable to treatment levels of care classified as ASAM Level:

(a) III.1 Clinically Managed Low-Intensity Residential Treatment;

(b) III.3 Clinically Managed Medium-Intensity Residential Treatment;

(c) III.5 Clinically Managed High-Intensity Residential Treatment; and

(d) III.7 Medically Monitored Inpatient Treatment.

(4) Title 37, chapter 106, subchapter 14 are applicable to all community-based substance use disorder inpatient and residential halfway house treatment facilities.

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 treatment and responsible for operation of the agency providing such services.

(2) "Admission" means specific tasks necessary to admit a person to community-based substance use disorder treatment services. Tasks include but are not limited to:

(a) completion of admission forms;

(b) notification of client rights and confidentiality regulations;

(c) explanation of the general nature and goals of services;

(d) review of the intake policies and procedures of the service program;

(e) orientation to the service structure; and

(f) financial determination for services.

(3) "Adult" means a person 21 years of age or older for purposes of services in community-based substance use disorder inpatient and residential halfway house treatment.

(4) "American Society of Addiction Medicine Patient Placement Criteria 2R (ASAM PPC-2R) or (ASAM)" establishes the level of care for substance use disorder treatment and is required to be used by all licensed community-based substance use disorder inpatient and residential halfway house treatment facility providers. The department adopts and incorporates by reference the American Society of Addiction Medicine Patient Placement Criteria, Second Edition-Revised; Copyright 2001 by the American Society of Addiction Medicine, Inc.; ISBN 1-880425-06-8, which sets forth the level of care for substance use disorder treatment. A copy of ASAM PPC-2R may be obtained from American Society of Addiction Medicine, 4601 N. Park Avenue, Upper Arcade #101, Chevy Chase, MD 20815; phone (301) 656-3920; fax (301) 656 3815; or email@asam.org.

(5) "Biopsychosocial assessment" means an assessment of a person's medical (biological), psychological, and social history based on the six dimensions of ASAM. The six assessment dimensions include:

(a) acute intoxication and/or withdrawal potential;

(b) biomedical conditions and complications;

(c) emotional, behavioral, or cognitive conditions and complications;

(d) readiness to change;

(e) relapse, continued use or continued problem potential; and

(f) recovery/living environment.

(6) "Child or adolescent" means a person under 21 years of age for purposes of services in community-based substance use disorder inpatient and residential halfway house treatment.

(7) "Client" means a person being treated for a substance use disorder who is formally admitted to services within the admission criteria set by the program.

(8) "Confidentiality" means a program requirement concerning client information, including client records. The disclosure of any information related to an individual client shall be governed by requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the requirements of Title 42 Part 2.22 (a)(1) and (2) of the Code of Federal Regulations (CFR).

(9) "Continuing care plan" means a written plan outlining anticipated therapeutic interventions to move a client along the continuum of care, which may include the level of treatment, clinical needs, and rationale for moving from one level of care to another.

(10) "Co-occurring" means an individual has at least one mental disorder and a substance use disorder.

(11) "Detoxification (detox)" means care and treatment of a person while the person recovers from the transitory effects of acute or chronic intoxication or withdrawal from alcohol or other drugs.

(12) "Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or (DSM)" establishes criteria for diagnosing an individual with a substance use or dependence disorder and is published by the American Psychiatric Association. The department adopts and incorporates by reference the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), Fourth Edition, (ISBN 0-89042-061-0 (hardback) or ISBN 0-89042-062-9 (paperback), which sets forth criteria for diagnosing an individual with a substance use or dependence disorder. A copy of the DSM-IV may be obtained from American Psychiatric Publishing, Inc., 1000 Wilson Boulevard, Suite 1825, Arlington, VA 22209; phone (703) 907-7322 or (800) 368-5777; fax (703) 907-1091; or e-mail appi@psych.org.

(13) "Dual diagnosis capable (DDC)" means treatment programs address co-occurring mental and substance-related disorders in their policies and procedures, assessment, treatment planning, program content, and discharge planning are described as "dual diagnosis capable". Such programs have arrangements in place for coordination and collaboration with mental health services. They also can provide psychopharmacologic monitoring and psychological assessment and consultation, either on-site or through coordination consultation with off-site providers. Program staff is able to address the interaction between mental and substance-related disorders and their effect on the patient's readiness to change, as well as relapse and recovery environment issues, through individual and group content. Nevertheless, the primary focus of DDC programs is the treatment of substance-related disorders.

(14) "Dual diagnosis enhanced (DDE)" describes treatment programs that incorporate policies, procedures, assessments, treatment, and discharge planning processes that accommodate patients who have co-occurring mental and substance-related disorders. Mental health symptom management groups are incorporated into addiction treatment. Motivational enhancement therapies specifically designed for those with co-occurring mental and substance-related disorders are more likely available (particularly in outpatient settings) and, ideally, there is close collaboration or integration with a mental health program that provides crises back-up services and access to mental health case management and continuing care. In contrast to dual diagnosis capable services, dual diagnosis enhanced services place their primary focus on the integration of services for mental and substance-related disorders in their staffing, services, and program content.

(15) "Eligible licensed addiction counselor (ELAC)" means an individual who meets requirements set forth in 37-35-202, MCA, and ARM 24.154.407 to provide addiction counseling services under supervision of a licensed addiction counselor. References in this subchapter to licensed addiction counselor or LAC include an eligible licensed addiction counselor or ELAC providing addiction counseling services within the scope of this supervision.

(16) "First aid" means emergency treatment by someone who has received appropriate training. The provider and all staff who provide or supervise client care must complete required training and hold current certification in first aid and cardiopulmonary resuscitation (CPR).

(17) "Halfway house" means a community residential facility for treatment of substance use disorders.

(18) "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.

(19) "Licensure bureau" means the area of the department responsible for licensing chemical dependency facilities.

(20) "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.

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

(22) "Program" means a community-based substance use disorder inpatient and residential facility.

(23) "Treatment plan" means a written document identifying the clinical needs, goals, objectives, and interventions the client agrees to follow to help the client understand and meet these treatment objectives.

(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 chemical dependency facility.

(1) Each service provider must develop and implement a policy and procedure manual that includes:

(a) the philosophy of the program;

(b) the program goals;

(c) a description of the population the facility is able to serve;

(d) procedures governing the treatment and care of adolescents, if served in the program;

(e) a delineation of all of the services to be provided;

(f) identification or a description of critical populations and mechanisms to address their needs;

(g) admission criteria which shall include at a minimum:

(i) how admissions will be prioritized;

(ii) program limitations and exclusions;

(iii) methods to be followed when a person is found ineligible for services; and

(iv) steps to follow for a wait list that includes how interim services will be provided when appropriate.

(h) procedures outlining how facilities and services shall provide for privacy and separation by gender;

(i) organizational chart showing:

(i) the lines and delegation of authority with supervisory responsibility clearly identified; and

(ii) responsibilities, structure, and reporting relationships explicitly stated and all staff positions delineated and functions identified.

(j) implementation process of state and federal regulations on client confidentiality, including at a minimum:

(i) providing written summary and verbal confidentiality notification at the time of admission or as soon thereafter as the client is capable of rational communication. The minimum required elements of the written summary must include but are not limited to the following:

(A) a general description of the limited circumstances under which a program may acknowledge that an individual is present at a facility or disclose outside the program information identifying a patient as an alcohol or drug abuser;

(B) a statement that information related to a patient's commission of a crime on the premises of the program or against personnel of the program is not protected; and

(C) a statement that reports of suspected child abuse or neglect made under state law to appropriate state or local authorities are not protected.

(k) a client grievance process;

(l) reporting requirements to notify the department within 24 hours by e-mail or fax; of a client, staff, volunteer, or visitor death where the death occurs on-site or in service related activities;

(m) reporting requirements to notify the department within 24 hours or next business day of any fire, accident, or other incident resulting in significant damage to the service site;

(n) reporting any suspected abuse or neglect in accordance with 41-3-201 or 52-3-811, MCA, to the state child abuse hotline at (866) 820-5437;

(o) notification of the department's licensing bureau in writing within 24 hours of any allegations of client abuse including child abuse or neglect and elder abuse or neglect:

(i) the provider must indicate in writing that the proper authorities have been contacted and the abuse or neglect reported.

(p) steps to ensure smoking is not permitted per the Montana Clean Indoor Air Act;

(q) the management, storage, and disposal of prescription and over the counter drugs if applicable; and

(r) client transportation, if provided by facility.

(1) The program shall have written personal policies including the following:

(a) selection, training, and supervision of all personnel;

(b) maintaining a current job description for each position. For contract staff, formal agreements or personnel contracts, which describe the nature and extent of client care services, may be substituted for job descriptions;

(c) maintaining a process governing volunteer (if utilized) activities and establishing appropriate training requirements;

(d) assuring annual performance reviews for all staff;

(e) actions to be taken if staff members misuse alcohol or other drugs;

(f) assuring staff orientation prior to assumption of duties including but not limited to:

(i) defining staff ethical standards and conduct, including reporting of unprofessional conduct to appropriate authorities;

(ii) staff grievance procedures;

(iii) the facility disaster/evacuation plan;

(iv) review of policy and procedure manual; and

(v) review of client rights as defined in ARM 37.106.1450.

(1) The administrator or designee must ensure there is a current secured personnel file for each employee and trainee and for each student, volunteer, and contract staff person who provides or supervises client care. The file must include:

(a) the results of a tuberculin test upon employment and annually thereafter;

(b) a criminal justice information network (CJIN) background information check on each staff person having direct contact with clients;

(c) evidence that all staff who provide or supervise client care have current and valid certification in cardio-pulmonary resuscitation (CPR) and in first aid techniques;

(d) an annual performance review that is:

(i) conducted by the appropriate supervisor of each staff member; and

(ii) signed and dated by the employee and supervisor.

(e) copies of registration or licensure applicable to employee's job duties;

(f) evidence of an independent contractor status and contractual agreements for contracted personal;

(g) a signed statement acknowledging the employee has been oriented and agrees to abide by confidentiality requirement to maintain confidentiality of client information;

(h) resume or job application;

(i) disciplinary actions and grievances; and

(j) a copy of a current job description, signed and dated by the employee and supervisor which includes:

(i) job title;

(ii) minimum qualifications for the position; and

(iii) summary of duties and responsibilities.

(1) If programs participate in a trainee/intern practicum or have volunteers, they must have the following:

(a) policies and practices assuring the safety of clients;

(b) a description of the program and any limitations;

(c) a description of how supervision will be provided;

(d) policies and practices to assure volunteers meet the qualifications of the position to which the person is assigned; and

(e) a written agreement with each educational institution using the treatment agency as a setting for student practice to include but not limited to:

(i) a description of the nature and scope of student activity at the treatment settings; and

(ii) a plan for supervision of student activities.

(a) staffing requirements to include assurance there is an identified clinical supervisor who is a licensed addiction counselor and oversees the implementation of services to assure quality and appropriateness of care rendered to clients;

(b) critical population requirements to include how pregnant woman resources and referral options will be made available so staff can make referrals as indicated by client needs including:

(i) ensuring a pregnant woman who is not seen by a private physician, physician assistant-certified, nurse practitioner, or advanced practice registered nurse is referred to one of these providers for determination of prenatal care needs; and

(ii) discussing pregnancy specific issues and resources.

(c) therapy service requirements to include but not limited to:

(i) ensuring utilization of the DSM and the ASAM admission, continued stay, and discharge criteria for patient placement decisions in the initial and the ongoing assessment of the client throughout the course of treatment;

(ii) ensuring a person needing detoxification will be immediately referred to a detoxification provider, if available, unless the person needs acute care in a hospital; and

(iii) limitations and requirements of group counseling sessions to include client/staff appropriate for the level of care being rendered.

(d) clinical policies addressing:

(i) the assignment of work to a client by a licensed addiction counselor when the assignment is part of the treatment program and has therapeutic value;

(ii) the use of self-help groups;

(iii) arranging for medical consultation when clinically needed;

(iv) arranging for psychiatric consultation when clinically indicated;

(v) how laboratory testing is to be done including but not limited to:

(A) testing methods (urine, saliva, blood, breath, etc.); and

(B) collection and storage.

(vi) how drug and alcohol screening testing is to be done including but not limited to:

(A) a guide how testing is used as part of the therapeutic process in a nonpunitive manner;

(B) requirements to ensure the use of drug testing becomes part of the clients treatment plan; and

(C) client refusal to submit for testing and confirmation testing.

(e) policies addressing a facility's ability to provide dual diagnosis services to include at a minimum the following:

(i) mental health screening; and

(ii) procedures to assure mental health treatment if identified as a co-occurring client.

(f) a description of services showing there are arrangements in place for coordination and collaboration to provide services with the following, at a minimum, if not provided on-site:

(i) mental health services;

(ii) pregnancy services;

(iii) human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) services;

(iv) tuberculosis (TB) services;

(v) Hepatitis B and C services; and

(vi) sexually transmitted diseases treatment services.

(g) case management services policies and procedures provided in conjunction with or as part of the client's substance use disorder treatment and recovery;

(h) treatment planning process policies and procedures including but not limited to:

(i) how a treatment plan will be jointly developed with the client and the staff who has responsibility for the client;

(ii) assurance the treatment plan is initiated by the third contact visit for outpatient services and within three days of admission for residential services;

(iii) a provision for review and signature by the client and the staff person providing treatment services to the client;

(iv) documentation of regular reviews of the treatment plan with the client in the progress notes;

(v) having measurable objectives and therapeutic interventions with target dates appropriate to the client's clinical needs;

(vi) the clinical problems identified in the client's biopsychosocial assessment;

(vii) when clinically appropriate, implementing a targeted case management plan;

(viii) the engagement or disengagement and documentation of family members and significant others involvement and participation in the treatment process including but not limited to:

(A) offering family sessions and regularly scheduled group and educational activities for family members and significant others; and

(B) how clinical decisions are made and documented regarding the need to involve or not to involve the family and significant others in the treatment process.

(ix) how the facility will conduct reviews as part of a multidisciplinary staffing and how documentation in the client record will reflect all staff who participated in the review;

(x) documenting patient response to treatment and achievement of the treatment plan objectives in the progress notes; and

(xi) a policy to assure the client has a continuing care plan prior to discharge which at a minimum addresses:

(A) support group recommendations;

(B) continuing care service provider's contact name, contact number, and initial appointment;

(C) healthcare and/or medication follow-up; and

(D) goals for continuing care.

(1) At a minimum the program is required to have written policies and procedures including supporting evidence of implementation of each of the following items:

(a) clients are admitted to treatment without regard to race, color, creed, national origin, religion, sex, sexual orientation, age, or disability, except for bona fide program criteria;

(b) clients are reasonably accommodated in case of sensory or physical disability, limited ability to communicate, limited English proficiency, or cultural differences;

(c) clients are treated in a manner sensitive to individual needs and which promote dignity and self-respect;

(d) all clinical and personal information is treated in accordance with state and federal confidentiality regulations;

(e) clients have the opportunity to review their own treatment records in the presence of the administrator or designee;

(f) clients are fully informed of fees charged, including fees for copying records to verify treatment and methods of payment available;

(g) clients are protected from abuse, harassment, and exploitation by staff or from other clients who are on agency premises;

(h) clients will receive a copy of client grievance procedures describing the submission and disposition of complaints by client and right to appeal without threat of reprisal;

(i) client consent must be obtained for each release of information to any other person or entity. This consent for release of information must include:

(i) name of the consenting client;

(ii) name or designation of the provider authorized to make the disclosure;

(iii) name of the person or organization to whom the information is to be released;

(iv) nature and limits of the information to be released;

(v) purpose of the disclosure, as specific as possible;

(vi) specification of the date or event on which the consent expires;

(vii) statement that the consent can be revoked at any time, except to the extent that action has been taken in reliance on it;

(viii) signature of the client or parent, guardian, or authorized representative, when required, and the date; and

(ix) a statement prohibiting further disclosure unless expressly permitted by the written consent of the person to whom it pertains.

(j) in the event of a program closure or treatment service cancellation, each client must be:

(i) given 30 days notice;

(ii) assisted with relocation into similar treatment services;

(iii) given refunds to which the person is entitled; and

(iv) advised how to access records to which the person is entitled.

(k) the provider must post a copy of clients' rights in a conspicuous place in the facility accessible to clients and staff; and

(l) client orientation to program rules, responsibilities, and any sanctions that may be imposed for failure to comply with the program's rules.

(1) Each service provider must have a comprehensive client record system maintained in accord with recognized principles of health record management. The service provider must ensure:

(a) a designated individual is responsible for the record system;

(b) a secure storage system which protects active and inactive files from damage;

(c) client record policies and procedures addressing:

(i) who has access to records;

(ii) content of active and inactive client records;

(iii) a systematic method of identifying and filing individual client records so each can be readily retrieved;

(iv) assurance each client record is complete and authenticated by the person providing the observation, evaluation, or service;

(v) retention of client records for a minimum of six years three months after the discharge or transfer of the client; and

(vi) procedures for destruction of client records.

(d) procedures for maintaining electronic client records (if applicable).

(2) In case of an agency closure, the provider closing its treatment agency must arrange for continued management of all client records. The closing provider must notify the department in writing of the mailing and street address where records will be stored and specify the person managing the records. The closing provider may:

(a) continue to manage records and give assurance they will respond to authorized requests for copies of client records within a reasonable period of time;

(b) transfer records of clients who have given written consent to another certified provider;

(c) enter into a service organization agreement with a state approved chemical dependency provider to store and manage records, when the outgoing provider will no longer be a business and provide a copy of the agreement to the department.

(1) The service provider must ensure client record content includes:

(a) demographic information;

(b) a substance related disorder diagnosis and supporting documentation for diagnosis;

(c) biopsychosocial assessment including diagnosis showing the rationale for admission;

(d) documentation the client was informed of federal confidentiality requirements and received a copy of the client notice;

(e) assurance all clients have an orientation to the program's treatment services, infectious disease information, and disaster plan;

(f) voluntary consent to treatment signed and dated by the client or legal guardian;

(g) treatment plan;

(h) progress notes;

(i) discharge summary;

(j) medication records, if applicable;

(k) laboratory reports, if applicable;

(l) properly completed authorizations for release of information;

(m) copies of all correspondence related to the client, including any court orders and reports of noncompliance; and

(n) documentation showing client received a copy of client grievance policies and procedures.

(1) The program shall have a quality management committee representative of administration and staff.

(2) The quality management committee is responsible for:

(a) developing a written plan for a continuous quality improvement program organization wide;

(b) implementing the quality improvement plan and monitoring the quality and appropriateness of services;

(c) meeting at least on a quarterly basis;

(d) identifying problems, taking corrective action as indicated, and monitoring results of those actions; and

(e) at least annually, reviewing and updating the quality improvement plan.

(3) The quality improvement program must at a minimum include but not be limited to:

(a) administrative processes;

(b) fiscal processes;

(c) clinical services; and

(d) client outcomes.

(1) At a minimum, the quality management committee must monitor:

(a) services to critical populations including priority in the following order:

(i) pregnant injecting drug users;

(ii) pregnant substance abusers.

(b) injecting drug users and those individuals infected with the etiologic agent for AIDS;

(c) women with dependent children;

(d) clients receiving Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI);

(e) homeless clients; and

(f) aging clients.

(2) Outcome evaluations shall include but not be limited to the following measures:

(a) abstinence and reduction of the use of alcohol and other drugs;

(b) decreased involvement with the criminal justice system;

(c) stable employment, school, or training;

(d) safe stable housing;

(e) social connectedness and supports;

(f) retention in treatment and early unplanned discharges;

(g) increased access to treatment services;

(h) clients perception of care;

(i) cost effectiveness of the program; and

(j) use of evidence-based practices.

(3) Programs must collect outcome data at:

(a) admission and discharge; and

(b) six months and one year after discharge.

(i) If unsuccessful in follow up for the six-month and one-year measurement, documentation must be provided as to reason for no follow up data.

(1) The administrator is responsible for the overall management of the program facility(s).

(2) Building requirements include but are not limited to the following:

(a) facilities must be accessible to a person with a physical disability. If a facility is unable to provide access to an individual with a physical disability, the program must make arrangements for a referral or other accommodations to assure the person receives appropriate services;

(b) 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;

(c) a patient or resident may not be admitted, housed, treated, or cared for in an addition or altered area until the area is inspected and approved by the department or in new construction until licensed by the department;

(d) facilities must be constructed and maintained in a manner to prevent entrance and infestation by rats, mice, insects, flies, or other vermin; and

(e) providers must ensure each facility, exterior grounds, and component parts such as but not limited to fences, equipments, outbuildings, and landscape items are safe, free of hazards, clean, and maintained in good repair.

(3) Water supply, sewage, and waste disposal requirements include but are not limited to the following:

(a) facilities must meet water and sewer system requirements of the municipality or jurisdiction in which it is located;

(b) hot water temperatures supplied to hand washing and bathing facilities must not exceed 120ºF;

(c) garbage and refuse must be 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;

(d) refuse and recycling containers stored outside the residence, dumpsters, compactors, and compactor systems must be easily cleanable, must be provided with tight-fitting lids, doors, or covers, and shall be kept covered when not in actual use;

(e) containers designed with drains must have drain plugs in place at all times, except during cleaning; and

(f) garbage and refuse must be disposed of daily and removed from the property at least weekly to prevent the development of odor and attraction of insects and rodents.

(4) Physical environmental requirements include but are not limited to the following:

(a) deodorants may not be used for odor control in lieu of proper ventilation;

(b) all operable windows must have a screen in good repair;

(c) a minimum of 10 foot-candles of light must be available in all hallways and bathrooms;

(d) each room or area occupied by children under age five or residents with unsafe behaviors must have tamper resistant electrical outlets;

(e) facilities must have adequate private space for personal consultation with a client, staff charting, and therapeutic and social activities, as appropriate;

(f) all electrical, mechanical, plumbing, fire protection, heating, and sewage disposal systems must be kept in operational condition;

(g) each facility must have an annual inspection by the local fire authority;

(h) each facility must have floors covered with an easily cleanable surface; and

(i) all walls and ceilings, including doors, windows, skylights, and similar closures must be maintained in good repair.

(5) Laundry requirements include but are not limited to the following:

(a) the program must ensure that laundry facilities, equipment, and laundry handling and processes will ensure linen and laundered items provided to residents are clean, in good repair, and adequate to meet the needs of residents.

(6) Bedding and linen requirements include but are not limited to the following:

(a) the program must ensure bedding and linen provided to residents are clean, in good repair, and adequate to meet the needs of residents including but not limited to:

(i) assuring each resident has a bed, a moisture-proof mattress cover, and mattress pad in good condition; and

(ii) assuring the facility or resident keep a supply of:

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

(B) clean individual towels and washcloths; and

(C) adequate blankets for each resident to maintain warmth while sleeping.

(7) Bathroom requirements include but are not limited to the following:

(a) the provider must ensure private or common-use toilet rooms and bathrooms are available to residents including the provision for:

(i) a minimum of one toilet and hand washing sink for every four residents, or fraction thereof;

(ii) a sink is located in or immediately accessible to each toilet room;

(iii) a minimum of one bathing fixture for every six residents;

(iv) hand cleansing soap or detergent must be available at each lavatory in the facility. The use of a communal bar soap is prohibited;

(v) provision for individual towels must be available at each lavatory; and

(vi) a waste receptacle must be located near each lavatory.

(8) Bedroom requirements include but are not limited to the following:

(a) the program shall ensure residents have an accessible, clean, well-maintained room with sufficient space and light for sleeping and personal activities including but not limited to ensuring:

(i) bedrooms are at least 60 square feet per person in a multiple person room except where construction or cost would be prohibitive;

(ii) 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 resident's bedroom;

(iii) each bedroom has one operable outside window with visual privacy; and

(iv) each bedroom is equipped with:

(A) a bed;

(B) one or more noncombustible waste containers; and

(C) a wardrobe, dresser, or closet with shelving for storing a reasonable amount of clothing.

(9) Disaster plan requirements include but are not limited to the following:

(a) each facility must have an evacuation and disaster plan;

(b) there must be a fire evacuation plan for use in the event of a fire, addressing:

(i) a procedure for accounting for all residents and staff during and after the emergency and the meeting location after evacuation; and

(ii) making provisions for emergency medications, food, water, clothing, shelter, heat, and power.

(c) the posting of evacuation routes on the premises where services are being provided in a place where they can be easily viewed by clients, participants, and staff; and

(d) the program must conduct and document a drill of the fire and evacuation plan at least once a year.

(10) Infectious disease prevention and control requirements include but are not limited to the following:

(a) a program shall develop and follow a written infection control plan for both staff and clients, including but not limited to:

(i) implementation of universal precautions for communicable diseases; and

(ii) provision for patient and staff education necessary to implement infection control policies and procedures.

(11) Emergency procedure requirements include but are not limited to the following:

(a) facilities must have written procedures to be followed in the event of a medical or other emergency;

(b) poison control and emergency contacts must be posted at the telephone; and

(c) facilities must have a first aid kit readily available.

(12) Facility maintenance requirements include but are not limited to the following:

(a) each facility shall have evidence of a maintenance program and procedures that are utilized to keep the building and equipment in good repair and free from hazards;

(b) facilities must assure adequate housekeeping services, procedures, and or supplies are available to assure a clean, safe, and sanitary environment in all areas of the facility;

(c) facilities must be kept clean and free of odors; and

(d) facilities must use a dishwasher or use hot soapy water for hand washed utensils, dishes, and equipment.

(13) Pest control requirements include but are not limited to the following:

(a) effective measures intended to minimize the presence of rodents, flies, cockroaches, and other vermin on the premises;

(b) measures to ensure containers of poisonous and toxic materials be stored safely and bear a legible manufactures label or Material Safety Data (MSD) sheets; and

(c) maintenance and cleaning tools must be maintained and stored in a safe and orderly manner.

(14) Food and nutrition requirements include but are not limited to the following:

(a) the program must ensure resident food preparation, handling, and storage is adequate to meet the needs of residents including but not limited to the following:

(i) food must be stored in a clean, dry location where it is not exposed to contamination;

(ii) conveniently located refrigeration facilities or effectively insulated facilities must be provided to assure maintenance of potentially hazardous food;

(iii) food that isn't stored in original containers must be dated, labeled, and covered;

(iv) food cannot be stored on the floor;

(v) refrigerated foods must be maintained at a temperature of 41 to 44ºF;

(vi) frozen foods must be kept frozen;

(vii) raw fruits and vegetables 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;

(viii) all home canned products are prohibited;

(ix) sinks used for preparation of foods must be cleaned and sanitized;

(x) food preparers shall wash their hands before engaging in food preparation, and during preparation as often as necessary to remove soil and contamination, and to prevent cross contamination when changing tasks; and

(xi) food preparers and other authorized persons shall maintain a high degree of personal cleanliness and shall conform to good hygiene practices during food preparation.

(15) Pet management requirements include but are not limited to the following:

(a) facilities are allowed to have pets in residence based upon facility policy and ensuring all animals are current on vaccinations.

(1) To be licensed to provide freestanding adult and adolescent medically monitored intensive inpatient ASAM Level III.7 substance related disorders treatment services, a provider must meet the following:

(a) staffing requirements include but are not limited to the following:

(i) a physician, nurse practitioner, or physician assistant licensed under Title 37, MCA, to conduct a physical examination and screening of a client within 24 hours of the person's admission to a service to identify health problems and screen for communicable diseases;

(ii) a nurse licensed under Title 37, MCA, on-site or on call 24 hours a day, seven days a week; and

(iii) a physician licensed under Title 37, MCA, available to provide medical consultation either as an employee of the service or through written agreement.

(b) service requirements include but are not limited to the following:

(i) family services are made available;

(ii) direct affiliation with an acute care hospital; and

(iii) daily scheduled professional services; such services must include and are not limited to medical services and medication management, individual, group, family, and educational services.

(c) if community-based day treatment services as defined in ASAM are provided, there must be access to services provided under ASAM Level III.7.

(2) To be licensed to provide community-based residential program for adults and adolescents with ASAM Level III.5 substance use disorders, a provider must meet the following:

(a) staffing requirements include but are not limited to the following:

(i) a licensed physician, physician assistant, nurse practitioner, or registered nurse as defined as a licensed health care professional in 50-5-101, MCA, to conduct an assessment and evaluation of a client within 72 hours of admission to service; and

(ii) a nurse licensed under Title 37, MCA, on-site, on call, or access to medical services 24 hours a day, seven days a week.

(b) service requirements including the following program policies must address:

(i) how the programs treat persons with substance use disorders and related problems;

(ii) admission criteria to include service limitations; and

(iii) daily scheduled professional services, such services may include but not be limited to medical services, nursing services, individual and group counseling, psychotherapy, family therapy, educational groups, occupational and recreational therapies, art, music, or movement therapies, physical therapy, and vocational rehabilitation activities.

(1) The most intensive level of care, outside of an acute care hospital, is defined as medically monitored care to clients whose withdrawal symptoms are sufficiently severe to require 24-hour inpatient care with observation, monitoring, and treatment available and delivered by a multidisciplinary team including 24-hour nursing care under the supervision of a Montana licensed physician.

(2) To be licensed to provide medically monitored detoxification (ASAM Level III.7), a provider must meet the following:

(a) facility requirements include but are not limited to the following:

(i) the facility shall be equipped for clients who are impaired due to substances and who require safety rails on beds, handrails on showers, and other related equipment to assure the safety of impaired clients; and

(ii) oxygen or other emergency equipment according to the physician-prescribed protocols for responding to client health emergencies.

(b) staffing requirements include but are not limited to the following:

(i) a physician licensed under Title 37, MCA, available on call 24 hours a day, 7 days a week to evaluate clients and prescribe medications;

(ii) staff available in sufficient numbers and trained to respond to substance-related and co-occurring disorders of admitted clients;

(iii) a registered nurse licensed under Title 37, MCA, who is responsible for the supervision of nursing staff and the administration of detox protocols; and

(iv) support staff such as licensed practical nurses, certified nurse assistants, rehabilitation aides etc. in sufficient numbers to assure the safety of clients.

(c) service requirements include but are not limited to the following:

(i) a written agreement with a state approved chemical dependency treatment facility to provide ongoing care following client discharge from the detoxification service;

(ii) there shall be a discharge note that addresses the referral and service needs of the client for follow-up treatment or care;

(iii) medication administration and on-going assessment of the client which are documented in the client record;

(iv) written medication orders specifying the name, dose, and route of administration signed by the prescribing physician;

(v) meals and snacks in sufficient quantities to assure the nutritional needs of the clients are met; and

(vi) written policies and procedures specifying how the facility will provide for the transfer of patients when indicated, to an acute care hospital.

(3) To be licensed to provide community-based social detoxification as defined as ASAM Level III-D, III.2-D, and III.7-D for individuals with substance use disorders as defined by ASAM, a provider must meet the following:

(a) facility requirements include but are not limited to the following:

(i) the facility shall be equipped for clients who are impaired due to substances and who require safety rails on beds, handrails on showers, and other related equipment to assure the safety of impaired clients.

(b) staffing requirements include but are not limited to the following:

(i) physician approved protocols for the monitoring of clients in withdrawal including when and under what circumstances clients should be transferred to a health care facility;

(ii) a written agreement with the health care facility or physician providing for emergency services when needed;

(iii) written procedures specifying how staff will respond to emergencies and for the transfer of medically unstable patients;

(iv) sufficient staff on duty trained in CPR and the detox protocols on each shift to be followed to assure clients safe withdrawal from substances; and

(v) if medications are provided, there is a current prescription in the client's name and staff are trained in medication administration procedures which are documented in policies and procedures.

(c) service requirements include but are not limited to the following:

(i) an initial physical examination by a qualified professional that assures the client can be safely detoxified in a nonmedical setting and documented in the client record;

(ii) regular vital signs are taken and recorded by staff trained to recognize symptoms indicating the client is becoming physically unstable;

(iii) meals and snacks in sufficient quantities to meet the nutritional needs of the client;

(iv) there shall be a written discharge plan that assures necessary referrals and continuing treatment services;

(v) all entries in the client record will be signed and dated by staff providing the service; and

(vi) a written agreement with an approved addiction treatment provider assuring acceptance of client for treatment upon discharge from the detoxification service.

(1) Halfway house community-based residential programs consist of the following program settings:

(a) halfway house community-based parent and children residential homes (ASAM Level III.3 high intensity treatment);

(b) halfway house community-based single gender homes (ASAM Level III.5 high intensity treatment);

(c) halfway house community-based single gender residential homes (ASAM Level III.3 medium intensity treatment); and

(d) halfway house community-based single gender residential homes (ASAM Level III.1 low intensity treatment). This treatment level is also known as sober housing.

(1) The community-based parent and children residential homes for individuals with substance use disorders serve parent(s) with dependent child(ren) who are in need of 24-hour supportive housing while undergoing on- or off-site treatment services for substance use disorder and life skills training for independent living. To be licensed to provide community-based parent and children residential homes for individuals with substance use disorders ASAM Level III.3 medium intensity treatment, a provider must meet the following:

(a) 24-hour staffing patterns or security patterns to afford sufficient security to assure the safety of residents, with the availability of 24-hour telephone consultation of a licensed clinician with competence in the treatment of substance dependence disorders. 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) the delivery of ASAM Level III.3 treatment services either on- or off-site;

(ii) admission criteria indicating individuals appropriate for these settings;

(iii) how the treatment needs of both the parent(s) and child(ren) are identified and addressed;

(iv) how life skills training is provided as part of the daily living regimen and includes a curriculum to address independent living skills, vocational skills, and parenting skills;

(v) how services are coordinated to meet special needs of this population such as childcare, legal services, medical care, and transportation;

(vi) how age appropriate services are made available for children as needed;

(vii) assurance of a single gender of parent will be living at the facility;

and

(viii) assurance for safe visitation.

(1) The community-based single gender residential homes for individuals with substance use disorders serve individuals who are in need of 24-hour supportive housing while undergoing on- or off-site treatment services for substance use disorder and life skills training for independent living. To be licensed to provide community-based single gender residential homes for individuals with substance use disorders ASAM Level III.5 high intensity treatment, a provider must meet the following:

(a) 24-hour staffing patterns or security patterns to afford sufficient security to assure the safety of residents, with the availability of 24-hour telephone consultation of a licensed clinician with competence in the treatment of substance dependence disorders. 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) the delivery of ASAM Level III.5 treatment services either on- or off-site;

(ii) admission criteria indicating individuals appropriate for these settings;

(iii) how the treatment needs are identified and addressed;

(iv) how life skills training is provided as part of the daily living regimen and includes a curriculum to address independent living skills and vocational skills;

(v) how services are coordinated to meet special needs of this population such as legal services, medical care, and transportation; and

(vi) assurance for safe visitation.

(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.

(1) The single gender facility functions as a safe, alcohol and drug-free environment for individuals in early stages of recovery from substance use disorders or individuals who are transitioning to less intensive levels of treatment services and in need of such housing. To be licensed to provide community-based residential sober housing homes for individuals with substance use disorders ASAM Level III.1 low 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 and orientation to the facilities 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) admission and length of stay criteria defining individuals appropriate for this setting;

(ii) how all treatment and supportive services are generally off-site in community-based agencies; and

(iii) assurance the program is designed and focused on helping individuals with limited life skills and generally focus on helping individuals achieve employment, maintain a daily schedule of work, support group meetings, assigned treatment sessions, and learning how to cooperate and assume responsibility in a community setting.

(1) A home health agency shall comply with the Conditions of Participation for Home Health Agencies as set forth in 42 CFR 405, Subpart L. A copy of the cited rule 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.

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

(c) a client's legally appointed guardian cannot or will not give consent.

(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

(c) be buried 18 inches below grade.

(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;

(c) provisions for secured medication storage and preparation; and

(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;

(c) storage cabinets;

(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;

(c) storage facilities; and

(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;

(c) client discharge and transfer procedure;

(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;

(c) addressing relevant types of natural or client-caused emergency situations; and

(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;

(c) the client's medical and behavioral condition; and

(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;

(c) a description of the client's behavior and the intervention used;

(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;

(c) services provided by the facility;

(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;

(c) preparation and service of meals;

(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;

(c) a process for providing the client with written notice of the decision that contains:

(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) "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.

(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;

(c) the name of the person or persons who will manage or supervise 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.

(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.

(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.

(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.

(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.

(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;

(c) services provided by the facility;

(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.

(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;

(c) an initialed copy of the employee's job description; and

(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.

(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;

(c) informing patients of the policy and procedures for patient complaints and grievances;

(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.

(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 facility patient treatment programs and services.

(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;

(c) diagnostic impressions;

(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.

(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;

(c) case manager, if the patient has one; and

(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;

(c) assistance with activities of daily living;

(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.

(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.

(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.

(a) securing the treatment unit;

(b) development of an emergency, fire, disaster, evacuation, and response plan; and

(c) summoning outside assistance from local emergency responders in the event of an emergency.

(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.

(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.

(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;

(c) transport will be provided through appropriate medical means; and

(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.

(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.

(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.

(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

(c) all staff shall use proper hand washing techniques before and after providing direct care to a patient.

(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.

(2) Facility administrators will ensure that provisions are made to accommodate patient laundry and housekeeping to assure a safe and clean environment.

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.

(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.

(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.

(c) In accordance with a written policy ensures that:

(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.

(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.

(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.

(c) Ensure that the medical staff adopts and enforces bylaws approved by the governing body that include:

(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.

(2) Staff development programs must be outlined in the facility's policies and procedures, with annual updates.

(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.

(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.

(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.

(c) contain a lavatory unless each patient room served by that toilet contains a lavatory for handwashing.

(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.