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Montana Administrative Register Notice 37-526 No. 22   11/26/2010    
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BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES OF THE

STATE OF MONTANA

 

In the matter of the adoption of New Rules I through IX, the amendment of ARM 37.106.1130 and 37.106.1845, and the repeal of ARM 37.106.1001 pertaining to licensing requirements for outpatient facilities for primary care

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION, AMENDMENT, AND REPEAL

 

TO: All Concerned Persons

 

            1. On December 16, 2010 at 10:30 a.m., the Department of Public Health and Human Services will hold a public hearing in the Wilderness Room of 2401 Colonial Drive, at Helena, Montana, to consider the proposed adoption, amendment, and repeal of the above-stated rules.

 

            2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact Department of Public Health and Human Services no later than 5:00 p.m. on December 7, 2010, to advise us of the nature of the accommodation that you need. Please contact Gwen Knight, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-9503; fax (406) 444-9744; or e-mail dphhslegal@mt.gov.

 

            3. The rules as proposed to be adopted provide as follows:

 

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

 

            AUTH: 50-5-103, 53-6-106, MCA

            IMP:     50-5-103, 50-5-106, 50-5-114, 50-5-116, 50-5-201, 50-5-204, 50-5-207, MCA

 

            NEW RULE II  SCOPE (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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, 50-5-114, 50-5-116, 50-5-201, 50-5-204, 50-5-207, MCA

 

            NEW RULE III DEFINITIONS (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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, 50-5-114, 50-5-116, 50-5-201, 50-5-204, 50-5-207, MCA

 

            NEW RULE IV MINIMUM STANDARDS FOR OUTPATIENT CENTERS FOR PRIMARY CARE (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 [New Rule V] 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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, 50-5-114, 50-5-116, 50-5-201, 50-5-204, 50-5-207, MCA

 

            NEW RULE V WRITTEN POLICIES AND PROCEDURES (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.

 

            AUTH: 50-5-103, 53-6-106, MCA

            IMP:     50-5-103, 50-5-106, MCA

 

            NEW RULE VI MINIMUM STANDARDS FOR OUTPATIENT CENTERS FOR PRIMARY CARE: BIRTH CENTERS (1) If an outpatient center for primary care operates a birth center, the birth center shall:

            (a) comply with the requirements of [New Rule IV];

            (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 [New Rule VII]; and

            (c) establish a coordinated transfer of care through a mutually established agreement to the nearest hospital 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 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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, MCA

 

            NEW RULE VII OPERATION STANDARDS FOR OUTPATIENT CENTERS FOR PRIMARY CARE: BIRTH CENTERS (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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-201, MCA

 

            NEW RULE VIII MINIMUM STANDARDS FOR OUTPATIENT FACILITIES: IMAGING SERVICES (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.

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, 50-5-201, MCA

 

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

 

AUTH: 50-5-103, 53-6-106, MCA

IMP:     50-5-103, 50-5-106, MCA

 

4. The rules as proposed to be amended provide as follows, new matter underlined, deleted matter interlined:

 

            37.106.1130 MEDICAL ASSISTANCE FACILITIES: OUTPATIENT SERVICES (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 37.106.1001 [New Rule IV].

            (2) The department hereby adopts and incorporates by reference ARM 37.106.1001 [New Rule IV], which contains the licensure standards for facilities having outpatient services. A copy of ARM 37.106.1001 [New Rule IV] 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.

 

AUTH: 50-5-103, MCA

IMP:    50-5-101, 50-5-103, 50-5-204, MCA

 

            37.106.1845 SPECIALTY MENTAL HEALTH FACILITY: OUTPATIENT SERVICES (1) If the specialty mental health facility provides outpatient services, each outpatient must be examined by a psychiatrist licensed in Montana and the services must meet the standards contained in ARM 37.106.1001 [New Rule IV].

            (2) The department hereby incorporates by reference ARM 37.106.1001 [New Rule IV], which contains minimum licensure standards for outpatient facilities. Copies of ARM 37.106.1001 [New Rule IV] 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.

 

AUTH: 50-5-103, MCA

IMP:     50-5-103, 50-5-201, MCA

 

5. The department proposes to repeal the following rule:

 

            37.106.1001 MINIMUM STANDARDS FOR AN OUTPATIENT FACILITY, is found on page 37-26155 of the Administrative Rules of Montana.

 

AUTH: 50-5-103, 50-5-404, MCA

IMP:     50-5-103, 50-5-204, 50-5-404, MCA

 

            6. Statement of Reasonable Necessity:

 

The Department of Public Health and Human Services (the department) is proposing the adoption of New Rules I through IX pertaining to the licensure of outpatient centers for primary care, to include birth centers and imaging facilities. In establishing these rules the department has outlined a set of general or "core requirements", which are applicable to any outpatient license. Following the core requirements, the department proposes regulatory language unique to the specific outpatient endorsement for birth centers and imaging services.

 

The rule for outpatient center for primary care has been in effect since June 13, 1980. This rule was general and easily open to broad interpretation. The department proposes to strengthen the rule language and add endorsements to this license for birth centers and imaging services.

 

Currently birth centers can operate under the independent scope of practice of the health care professional and these professionals are seeking facility licensure under the existing outpatient center for primary care authority. Birth centers have sought a facility license for purposes of Medicaid reimbursement. Birth centers provide an alternative choice in our state for birthing mothers and the rules will establish minimum requirements that the department deems as being necessary, not just for the licensure of these facilities, but for the overall health and safety of both the birthing mother and her baby.

 

Imaging services exist as free-standing services, and like birth centers, operate under an independent scope of practice. The providers of imaging services also seek facility licensure for purposes of Medicaid reimbursement and the proposed rules establish the minimum requirements deemed necessary by the department not only for facility licensure of imaging services but for the overall care provided to persons utilizing imaging services.

 

New Rule I and New Rule II

 

These rules are being proposed under the authority of Title 50, part 5, subparts 1 and 2, MCA to establish the licensing requirements for outpatient centers for primary care to include specifications for facilities operating as birth centers and for those providing radiological imaging services.

 

New Rule III

 

This rule is being proposed to identify the various terms used throughout the rule.

 

New Rule IV

 

The department proposes to repeal ARM 37.106.1001 and include the existing minimum standards for outpatient facilities in New Rule IV. In doing so, the minimum standards for outpatient facilities will be required for all outpatient centers for primary care. Cross references in ARM 37.106.1130 and 37.106.1845 would be updated accordingly.

 

New Rule V

 

Health care facilities would be required to develop, implement, and maintain a policy and procedure manual for the overall operation of their facility. In the past, these documents were not required in the rules pertaining to outpatient centers for primary care. However, outpatient centers for primary care are included in the definition of a "health care facility" under 50-5-101(23), MCA and must have established policies and procedures for their operation.

 

New Rule VI and New Rule VII

 

The rules being proposed in New Rule VI and New Rule VII have been written in order to protect the health of the birthing mother and her baby. The department proposes that if an outpatient center for primary care operates a birthing center, the center must show evidence of accreditation by the Commission for the Accreditation of Birth Centers (CABC) or alternatively meet the set of standards outlined in New Rule VII. This proposed rule provides a basic tool for measuring the overall health and safety of both the mother and the baby. The requirement for accreditation is proposed because as a national "designation of approval" accredited programs generally meet or exceed the minimum requirements proposed through a licensing process. In other areas of health care facility licensure, the department has acknowledged accreditation as a basis for licensure. The department acknowledges that not all facilities can afford nor have the desire to become accredited. New Rule VII establishes an equivalent set of health and safety requirements allowing a birth center to operate in a manner consistent with acceptable standards of practice.

 

Outpatient centers are limited to provide care for periods of less than 24 hours. If a mother or a baby need care beyond the 24 hour care limitation or need care beyond what the facility can provide, the department requires in proposed New Rule VI(1)(c) and (d) that the center have formal arrangements for the immediate transfer of the mother and/or baby to a hospital. The rule requires the facility to indicate the process and the records to be sent with the patient for a coordinated transfer of care.

 

New Rule VIII

 

This proposed rule provides minimum standards of operation for radiological imaging services.

 

ARM 37.106.1130 and 37.106.1845

 

The department is proposing to update language in ARM 37.106.1130 and 37.106.1845 to reflect the proposed New Rule IV.

 

ARM 37.106.1001

 

The department is proposing to repeal ARM 37.106.1001 and move the language to New Rule IV.

 

            7. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Gwen Knight, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; fax (406) 444-9744; or e-mail dphhslegal@mt.gov, and must be received no later than 5:00 p.m., December 27, 2010.

 

            8. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

            9. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency. Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 7 above or may be made by completing a request form at any rules hearing held by the department.

 

            10. An electronic copy of this proposal notice is available through the Secretary of State's web site at http://sos.mt.gov/ARM/Register. The Secretary of State strives to make the electronic copy of the notice conform to the official version of the notice, as printed in the Montana Administrative Register, but advises all concerned persons that in the event of a discrepancy between the official printed text of the notice and the electronic version of the notice, only the official printed text will be considered. In addition, although the Secretary of State works to keep its web site accessible at all times, concerned persons should be aware that the web site may be unavailable during some periods, due to system maintenance or technical problems.

 

            11. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

 

/s/ John Koch                                     /s/ Anna Whiting Sorrell                   

Rule Reviewer                                               Anna Whiting Sorrell, Director

                                                                        Public Health and Human Services

 

Certified to the Secretary of State November 15, 2010

 

 

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