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| Montana Administrative Register Notice 37-726 | No. 2 01/22/2016 | |
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BEFORE THE DEPARTMENT OF PUBLIC HEALTH AND HUMAN SERVICES OF THE STATE OF MONTANA
TO: All Concerned Persons
1. On September 24, 2015, the Department of Public Health and Human Services published MAR Notice No. 37-726 pertaining to the public hearing on the proposed adoption and amendment of the above-stated rules at page 1424 of the 2015 Montana Administrative Register, Issue Number 18.
2. The department has amended the following rules as proposed: ARM 37.106.1901, 37.106.1902, and 37.106.1906.
3. The department has adopted the following rules as proposed: New Rule I (37.106.1601), II (37.106.1603), III (37.106.1602), IV (37.106.1604), V (37.106.1605), VI (37.106.1608), VII (37.106.1609), VIII (37.106.1610), IX (37.106.1611), X (37.106.1614), XII (37.106.1616), XV (37.106.1621), XVI (37.106.1622), XVII (37.106.1623), and XVIII (37.106.1624).
4. The department has adopted the following rules as proposed, but with the following changes from the original proposal, new matter underlined, deleted matter interlined:
NEW RULE xi (37.106.1615) Security (1) through (10) remain as proposed. (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
AUTH: 50-5-103, MCA IMP: 50-5-103, 50-5-201, 50-5-204, MCA
NEW RULE XIII (37.106.1617) RESTRAINT AND SECLUSION (1) through (6) remain as proposed. (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. (a) through (d) remain as proposed. (8) remains as proposed, but is renumbered (9). (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. (9) through (14) remain as proposed, but are renumbered (11) through (16). (17) The use of simultaneous restraint and seclusion is prohibited.
AUTH: 50-5-103, MCA
NEW RULE XIV (37.106.1618) STAFFING REQUIREMENTS (1) remains as proposed. (2) Employees must receive orientation and training in areas relevant to the employee's duties and responsibilities including: (a) through (c) remain as proposed. (d) rights of persons served; (e) safety and emergency response procedures (f) basic first aid; and (g) certification in cardiopulmonary resuscitation (CPR). (3) remains as proposed. (4) CPR certification must be kept current. (4) through (8) remain as proposed, but are renumbered (5) through (9). (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. (9) through (11) remain as proposed, but are renumbered (11) through (13).
AUTH: 50-5-103, 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: A commenter believes that New Rule XIII, as drafted, is well done and appropriately addresses the most important aspects of a restraint and seclusion.
Response #1: The department appreciates and acknowledges the comment.
Comment #2: A commenter is very gratified that the proposed rules have been issued. The commenter believes the need for step-down facilities is great for those who have committed felonies but who are mentally ill.
Response #2: The department appreciates and acknowledges the comment.
Comment #3: A commenter agrees with these rules being designed and operated as a mental health facility for this population.
Response #3: The department appreciates and acknowledges the comment.
Comment #4: A commenter believes that staff should be required to be trained in first-aid techniques and certified in CPR.
Response #4: The department agrees with the commenter and has added the requirement for basic first-aid training and certification in cardiopulmonary resuscitation in New Rule XIV.
Comment #5: A commenter states the definition of mechanical restraint, in New Rule V(9), is so broad that it would allow even antiquated and dangerous methods for mechanical restraint. The commenter believes shackles, straitjackets, face masks, restraint chairs, and other methods should be specifically prohibited.
Response #5: The department does not agree that the definition of mechanical restraint should include prohibited methods. The definition of mechanical restraints is identical to the Code of Federal Regulations. New Rule XIII requires the facility to implement restraint or seclusion in accordance with safe and appropriate restraint and seclusion techniques as developed by facility policy.
Comment #6: A commenter states that the definition of seclusion in New Rule V allows facilities to confine clients to their bedrooms during medication administration or shift changes without any limitation of duration of this confinement allows seclusion for exclusively the convenience of staff.
Response #6: The department does not agree that the proposed rule allows confinement to bedrooms during shift changes without limitation on the duration of time allowed. Proposed New Rule XI limits the duration of time for shift changes to 30 minutes, and no more than three changes in a 24-hour period. However, the department inadvertently left out a time limit for medication administration. Proposed New Rule XI has been amended by adding the time limit for medication administration.
Comment #7: The commenter strongly supports the requirement for single occupancy rooms found in New Rule VII.
Response #7: The department appreciates and acknowledges the comment.
Comment #8: A commenter indicates the rule as written can be read to address only situations where the patient, to be involuntarily medicated, was a danger to self or others, it can also apply to other situations where the patient at issue is not the danger causing the emergency. The commenter suggests the language be amended to make it clear that it only applies to those situations where the patient to be medicated is a danger to self or others.
The commenter suggests the rule was not written to incorporate the due process standards from Washington v. Harper, 494 U.S. 210 (1990), for involuntary medication of an inmate and recommends the rule be amended to include medication must be given in the patient's medical interest.
Response #8: The department disagrees that the rule is not clear that medication may only be administered to the patient that is a danger to himself or others. The rule specifically addresses involuntary medication administration to clients and is clearly defined in the definition section of the rule. The rule defines involuntary medication and outlines circumstances which must be present to administer the medication as well as requires the facility to have a formal administrative review process for the use of involuntary medication when 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 department has incorporated the due process standard in the case cited and rule includes the medication that must be clinically indicated.
Comment #9: A commenter believes the rules as proposed in New Rule XIII do not address the possibility of simultaneous restraint and seclusion and suggests language from the Code of Federal Regulations.
Response #9: The department agrees the rule does not address the possibility of simultaneous restraint and seclusion and has amended the rule to prohibit the use of simultaneous restraint and seclusion.
Comment #10: A commenter applauds the similarity of the rules in New Rule XIII to the Code of Federal Regulations; however, the commenter indicates the type of mechanical restraints allowed should be defined as suggested in Comment #5.
Response #10: See Response #5.
Comment #11: A commenter offered specific recommendations to policies for when restraint and seclusion may be allowed to improve clarity and effectiveness of the rule for school staff.
Response #11: The department disagrees with the commenter's suggestions as the rule was specifically written for adults and is similar to the federal language used for adult populations.
Comment #12: A commenter suggests including a requirement, in New Rule XIII, for a debriefing with students and staff involved after every incident of restraint and seclusion.
Response #12: See Response #10.
Comment #13: Two commenters are concerned staff members may interpret the rules as meaning once they have initiated a restraint they must continue the restraint until a licensed health care practitioner evaluates the client and authorizes the restraint. One commenter also believes the staff may not be monitoring the client prior to the one-hour face-to-face evaluation with the licensed health care practitioner which may result in staff missing a client's negative or life-threatening reaction to the restraint.
Response #13: The department disagrees as the rule requires a restraint or seclusion be discontinued at the earliest possible time regardless of the time identified in the order. The rule allows the facility to develop policies that outline monitoring of a client by a licensed health care professional as appropriate. The rule is written in accordance with the Code of Federal Regulations. In addition, the rule requires all staff to be trained in clinical identification of specific behavioral changes that indicate restraint or seclusion is no longer necessary.
Comment #14: A commenter indicates that in New Rule XIII continuous monitoring of the client by trained staff should be required. If continuous monitoring is not required the staff may not observe a client's negative or life-threatening reaction to the restraint.
Response #14: The department agrees and has amended the proposed rule.
Comment #15: A commenter believes that in New Rule XIII the department has incorporated many of the most important requirements that result in a successful rule regarding restraint and seclusion.
Response #15: The department appreciates and acknowledges the comment.
Comment #16: A commenter believes the New Rule XIII, requiring that a licensed health care practitioner must authorize the use of restraint and seclusion, is in conflict with 53-21-146, MCA, and is confusing. The commenter believes the staffing requirements in New Rule XIV anticipates the facility will be principally staffed by RN supervisors who are not licensed health care practitioners but may authorize restraint and seclusion under the statute cited.
A commenter states Montana State Hospital policy, as approved by CMS, does not require a licensed health care practitioner to authorize restraint or seclusion. The commenter states licensing requirements which are more intensive than those in an acute care hospital is inconsistent with both the statute and the concept of a forensic mental health facility.
The commenter suggested the rule be amended to reflect a professional person and not a licensed health care practitioner must authorize seclusion or restraint lasting more than one hour.
Response #16: The department has carefully reviewed 53-21-146, MCA, MSH Policy TX-16, and the Code of Federal Regulations for hospital settings. The department agrees that the definition of a "professional person" as defined in 53-21-102, MCA, is not the same as the definition of a "licensed health care practitioner" in the proposed rule. However, the language in the statute does not prohibit the department from writing a rule that is more restrictive based on the population the facility serves. The statute encompasses all levels of mental health center providers serving clients that range in acuity level from psychiatric treatment facilities to outpatient mental health offices. The FMHF provides forensic psychiatric treatment to adults that are currently residing at MSH and require a more secure setting. Due to the level of acuity, restraint or seclusion should be ordered and monitored by a licensed health care practitioner acting within the scope of their license. The department disagrees that the FMHF will be principally staffed by RN supervisors. A mental health center must employ or contract with a medical director who is a licensed physician by the Montana Board of Medical Examiners. The department acknowledges the proposed rule lacked clarity regarding the requirements for the licensed health care practitioner and has amended the proposed rule. The rule has been amended to allow a registered nurse to perform the assessment/evaluation required within one hour of the restraint or seclusion. The assessment/evaluation is within the scope of practice for a registered nurse. The licensed health care practitioner must still order the restraint or seclusion. The commenter cited MSH policy incorrectly as MSH Policy TX-16 requires a physician/licensed independent practitioner to order a restraint or seclusion. MSH Policy PS 03 defines licensed independent practitioner as the attending physician or advanced practiced registered nurse with a clinical specialty in psychiatric mental health nursing.
Comment #17: New Rule XIII: A commenter indicates proposed New Rule XIII, requiring an order to be renewed every eight hours by a licensed health care practitioner, exceeds 53-21-146, MCA, of every 24 hours. The commenter states the rule exceeds the requirement in MSH policy.
Response #17: The department disagrees with the commenter's interpretation of statute. Section 53-21-146, MCA, states the written order is effective for no more than 24 hours. The proposed rule does not exceed the 24 hours allowed in statute. The statute does not prohibit the department to require the order to be renewed prior to 24 hours. The commenter stated the proposed rule is more restrictive than MSH policy. The department has carefully reviewed 53-21-146, MCA, MSH Policy TX-16, and the Code of Federal Regulations for hospital settings during the rule-writing process and when responding to these comments. MSH policy states that orders for restraint and seclusion are valid for a maximum of four hours and must be renewed by the physician/licensed independent practitioner every four hours up to 24 hours. The proposed rule extended the order to be valid for up to eight hours; the proposed rule is less restrictive than MSH policy.
Comment #18: The commenter believes New Rule XIII has an ambiguous description of the procedure to renew an order of restraint and seclusion that has lasted 24 hours. The procedure should allow the professional person to authorize restraint and seclusion for another 24 hours.
Response #18: The department disagrees with the commenter as the proposed rule outlines the requirements for each order for restraint and seclusion. After 24 hours a licensed health care practitioner must see and assess the client prior to writing a new order.
/s/ Susan Callaghan /s/ Richard H. Opper Susan Callaghan, Attorney Richard H. Opper, Director Rule Reviewer Public Health and Human Services
Certified to the Secretary of State January 11, 2016
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