BEFORE THE DEPARTMENT OF PUBLIC
HEALTH AND HUMAN SERVICES OF THE
STATE OF MONTANA
In the matter of the adoption of New Rules I and II, the amendment of ARM 37.106.301, 37.106.302, 37.106.306, 37.106.310, 37.106.313, 37.106.314, 37.106.320, 37.106.321, 37.106.322, 37.106.330, and 37.106.331, and the repeal of 37.106.311 pertaining to minimum standards for all health care facilities
NOTICE OF ADOPTION, AMENDMENT, AND REPEAL
TO: All Concerned Persons
1. On June 20, 2013, the Department of Public Health and Human Services published MAR Notice No. 37-640 pertaining to the public hearing on the proposed adoption, amendment, and repeal of the above-stated rules at page 1029 of the 2013 Montana Administrative Register, Issue Number 12.
2. The department has amended ARM 37.106.302, 37.106.306, 37.106.310, 37.106.313, 37.106.314, 37.106.320, 37.106.321, 37.106.322, and 37.106.331, and repealed ARM 37.106.311 as proposed.
3. The department has adopted the following rules as proposed with the following changes from the original proposal. Matter to be added is underlined. Matter to be deleted is interlined.
NEW RULE I (37.106.315) MINIMUM STANDARDS FOR ALL HEALTH CARE FACILITIES: EMPLOYEE FILES (1) and (2) remain as proposed.
(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) and (b) remain as proposed.
AUTH: 50-5-103, MCA
IMP: 50-5-103, 50-5-106, 50-5-204, MCA
NEW RULE II (37.106.316) MINIMUM STANDARDS FOR ALL HEALTH CARE FACILITIES: SECURED CARE UNIT WITHIN A LICENSED LONG-TERM HEALTH CARE FACILITY (1) through (4) remain as proposed.
(5) Observation beds cannot be located in secured care units.
(5) through (9) remain as proposed, but are renumbered (6) through (10).
AUTH: 50-5-103, MCA
IMP: 50-5-103, 50-5-204, MCA
4. The department has amended the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
37.106.301 DEFINITIONS The following definitions apply in this subchapter:
(1) through (4) remain as proposed.
(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.
(a) 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.
(b) Observation beds cannot be located in secured care units.
(6) and (7) remain as proposed.
AUTH: 50-5-103, MCA
IMP: 50-5-101, 50-5-103, 50-5-104, 50-5-105, 50-5-106, 50-5-107, 50-5-108, 50-5-201, 50-5-202, 50-5-203, 50-5-204, 50-5-207, 50-5-208, 50-5-210, 50-5-211, 50-5-212, 50-5-225, 50-5-226, 50-5-227, 50-5-228, MCA
37.106.330 MINIMUM STANDARDS FOR ALL HEALTH CARE FACILITIES: WRITTEN POLICY AND PROCEDURE (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,
and visitors 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.
AUTH: 50-5-103, MCA
IMP: 50-5-103, 50-5-204, MCA
5. The department has thoroughly considered the comments and testimony received. A summary of the comments received and the department's responses are as follows:
COMMENT #1: One comment was received regarding the proposed definition of an observation bed. To illustrate his point, the commenter used an example involving an emergency room (ER) patient. The commenter's organization opposes the adoption of the definition as proposed.
RESPONSE #1: The department agrees that observation is a service provided by a hospital, critical access hospital, or medical assistance facility; the department further agrees that observation services may be provided in an ER or other area of a hospital. The department believes the commenter's discussion concerning the use of an ER patient bed is moot because regardless of where the patient is, they are not determined to be in an observation or inpatient status until ordered so by a physician. The patient then remains in the physician-ordered status until he or she is admitted, transferred, or discharged. A health care facility can always use an inpatient bed for observation services; however, the facility cannot use an observation bed for inpatient purposes. This rule seeks to clarify when and where observation services can be provided and at what point those services should be terminated.
COMMENT #2: One comment was received indicating that the observation definition was an extraneous piece of administrative rule.
RESPONSE #2: The department disagrees. Observation services are frequently provided in hospitals and critical access hospitals and are a service often discussed with the department. The discussions typically involve questions which serve to clarify observation services. As a result of these discussions, this rule seeks to clarify what, when, and where an observation service can be provided. To further address the commenter's concerns, the department will remove (5)(b) from ARM 37.106.301 and insert this language in New Rule II.
COMMENT #3: One comment was received indicating that it is not appropriate for Montana to adopt administrative policies related to insurance as a definition related to licensing.
RESPONSE #3: The department disagrees with the comment. The proposed language was not derived from insurance standards; however, the department agrees that CMS limits observation services to 48 hours in critical access hospitals. The department did look to the CMS standard to be consistent and concurs that the 48-hour limitation is reasonable. By utilizing this timeframe, the department eliminates any potential conflicting definitions, especially for facilities in the rural areas of the state.
Further, it is the department's opinion that observation of a patient within a 48-hour timeframe is a sufficient amount of time for the physician to determine whether that patient needs to be admitted to inpatient services, transferred, or discharged. To indicate otherwise has immense impact to the people of Montana. The department frequently hears from people who are asking for clarification around the consequences of observation status.
COMMENT #4: One comment was received with respect to New Rule I. The commenter is concerned that the department's intent and use of the word "volunteer" is too broad. The commenter indicates that volunteers serve in facilities in a variety of ways not all of which pertain to direct caregiving duties. To require all "volunteers" to participate in a formal orientation process would be an unnecessary burden to facilities.
RESPONSE #4: The department agrees. The intent of this proposed regulation was not to prohibit those volunteers who entertain, serve cake and ice cream at birthday parties, or call numbers at bingo from engaging in those activities in facilities such as nursing homes or assisted living; rather, the intent is to require the formal orientation process to be completed by those volunteers who are performing duties which are commonly performed by staff. The department has amended the proposed rule.
COMMENT #5: Two comments were received with regard to proposed New Rule II concerning secured-care units. The first comment asks why the department simply doesn't refer to the Life Safety Code when discussing regulations concerning special locking arrangements or acceptable alternatives. The second comment is in regard to (3) of New Rule II which discusses the need for a nurse's station within the locked unit and the requirement that a medication storage and preparation area be included. The commenter indicates that some facilities have one central medication storage area and should be allowed to continue using it. It is the commenter's contention that one central storage area may allow for better monitoring of medications by the facility and allow for better safeguards.
RESPONSE #5: With respect to the first comment, the department is not precluding facilities from using the Life Safety Code; a facility may always use the more stringent standards contained within the Life Safety Code. What the department is proposing is an equivalent or alternative means of compliance. This alternative means may be less disruptive to the daily living needs of the unit, while providing the appropriate degree of safety.
With respect to the second comment, the department disagrees. Secured units are considered completely separate from all other areas of the health care facility; thus, the secured area must be self-contained, meaning the secured unit must independently meet all the facility requirements. Central to that concept is the nursing station.
Coordination with a central medication storage area could certainly be permissible; however, the actual dispensing of the medication must be provided within the secured unit. If this were being done, the department would have to review the facility's policies and procedures to determine whether the intent of the rule was being met.
COMMENT #6: One comment was received regarding the amendment of ARM 37.106.310 striking subsections (1)(c) and (d). The commenter is not clear whether the department no longer planned to charge a fee or whether the department was simply removing the fee out of the rules. If the fee is going to be continued, the commenter requests the department place this information back into the rule so that if, and when, changes take place, interested parties can be notified.
RESPONSE #6: The rule is being stricken because it already exists in 50-5-202(1) and (2), MCA. As such, it is not necessary to repeat this in the administrative rule. With respect to the commenter's concerns about fee changes, because this information is statutory, changes would be subject to the legislative process. This process includes an opportunity for interested parties to comment for or against.
COMMENT #7: One comment was received regarding the length of time a facility is required to maintain a medical record. The commenter believes the five year retention period is appropriate and should be retained.
RESPONSE #7: Montana law indicates that medical records for health care facilities (excluding hospitals) must be retained for five years following the date of discharge or death. However, facilities that participate in the Medicaid, Medicare, or both programs typically keep all medical records for those programs' minimum retention periods, which is six years. Since this rule concerns all health care facilities, and most facilities have involvement with Medicaid and Medicare at some level, it made sense to add the additional time to records retention.
COMMENT #8: One comment was received regarding the amendment to ARM 37.106.330. The commenter takes exception to the department's proposed language allowing visitors to have access to the facility policy and procedure manual. Specifically, the commenter feels that the rule is unreasonable and alludes to an expectation that a facility's policies and procedures are open to everyone, thereby indiscriminately contributing to disclosure of policies and procedures with competitors. The commenter asks the department to change the wording of the rule to reflect only what the state may legitimately regulate.
RESPONSE #8: It was never the department's intent to require disclosure such as the commenter believes could occur. Rather, the intent was facility "policy and procedure transparency" for residents, family members, and staff. However, the department understands the commenter's concerns and has amended the rule in ARM 37.106.330.
/s/ Kurt R. Moser /s/ Richard H. Opper
Kurt R. Moser Richard H. Opper, Director
Rule Reviewer Public Health and Human Services
Certified to the Secretary of State November 4, 2013.