March 20, 2001
Health Care Financing Administration Department of Health and Human Services Attention: HCFA-2065-IFC P.O. Box 8010 Baltimore, MD 21244-8010
Attn: File Code HCFA-2065-IFC
NAMI, the National Alliance for the Mentally Ill, with a nationwide grassroots membership of 220,000 persons directly affected by severe mental illness-submits the following comments in reference to the interim final rule on the use of restraint and seclusion in psychiatric residential treatment facilities for individuals under the age of 21, as published in the Federal Register (Vol. 66, No. 14) on January 22, 2001.
NAMI greatly appreciates the promulgation of regulations on the use of restraint and seclusion for psychiatric residential treatment facilities serving children and youth. A major NAMI priority has been to advocate for the issuance of single national standard on restraint use, particularly as it covers residential treatment centers for children. As acknowledged in the preamble, residential treatment facilities are rapidly replacing hospitals in treating children and adolescents with severe mental illness, as these facilities are generally less restrictive than hospitals for children who are in need of residential treatment. Many NAMI members and families utilize residential treatment facilities for treating their children with severe mental illness and want the necessary safeguards in place.
We are pleased that this new rule will establish several important requirements relating to the use of restraint and seclusion including provisions on orders, physician consultation, monitoring, reporting, parental/guardian notification, debriefing and education/training. Although we are generally pleased with the new rules, we do hold some concerns with the standards for safeguarding children and youth in residential treatment facilities. We also recognize that the Department has solicited comments on a number of areas. We have addressed these areas in the discussion below.
Section 483.352: Definitions
Drug Used as a Restraint.
Comment: NAMI recommends that the definition of “drug used as a restraint” also include that medication should never be used for the purposes of discipline or staff convenience.
Emergency Safety Intervention
Comment: NAMI strongly feels that the use of involuntary restraint or seclusion is only justified as an emergency safety measure in response to imminent danger to one’s self or others. These extreme measures should only be used by trained staff only so long as, and to the extent that, the individual cannot commit to the safety of themselves and others.
Comment: Mechanical restraint should be generally avoided and used only in rare circumstances to protect the child or adolescent from self-harm and harm to others in emergency situations. NAMI feels that mechanical restraints should only be authorized by a physician following a face to face evaluation and repeated on the hour if reauthorization of such mechanical restraints is required by emergency safety situations. When treating children and adolescents with mental illnesses, mechanical restraint, brief physical holding and “therapeutic holding” should be differentiated. Brief physical holding is a form of temporary physical restraint and is different than “therapeutic holding.” “Therapeutic holding” is not supported by adequate scientific evidence or detailed practice guidelines, and therefore, is not supported by NAMI as an accepted form of treatment. Brief physical holding should only be carried out by professionally recognized and trained mental health professionals. Escorting and immediate physical separation of children and adolescents in conflict and should not be considered restraint.
Seclusion & Time-Out
Comment: NAMI recommends that HCFA should differentiate between seclusion, inclusionary time-outs and exclusionary time-outs. Seclusion should be defined as the involuntary placement of a child or adolescent, for any period of time, in a locked room where the child or adolescent is separated from his/her peers. Inclusionary time-out should be defined as an involuntary procedure where a child or adolescent is separated from his/her peers in the presence of his/her peers. Exclusionary time-out should be defined as an involuntary procedure where a child or adolescent is separated in a designated area away from his/her peers but is not physically prevented from leaving.
Section 483.356: Protection of Residents
NAMI strongly supports the prohibition on the simultaneous use of restraint and seclusion. Further, NAMI also supports the use of the word “coercion” as an inappropriate use of restraint and seclusion.
In addition, the final regulations should provide, consistent with the statute and HCFA’s regulations for hospitals, that restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective.
The regulation at paragraph (c) also should be revised to specify that the notification regarding the facility policy must include an opportunity for both the resident, and in the case of a minor, the parent(s) or legal guardian(s), to prepare a pre-crisis advance directive. We believe that an advance directive can serve as an important tool to help minimize the use of seclusion and restraint when a patient is in a psychiatric emergency and hope that the interpretive guidelines describing aspects particular to advance directive will also include a statement encouraging there use. Also, discussions on measures staff can take that would be most effective in calming the resident or helping the resident regain control during an emergency safety situation should also be included. This requirement is necessary to protect consumer choice and minimize unnecessary trauma.
NAMI also recommends that paragraph (d) of this section be revised to include along with the facilities policy and contact information for the appropriate State protection and advocacy agency a description of the services provided by the organization. Such description shall inform residents that the agency provides information about the legal rights of persons with disabilities and investigates abuse or neglect such as improper use of restraint and seclusion or the failure to provide appropriate treatment. We also recommend facility policies include a focus on helping the child or youth resolve the emergency safety situation or crisis.
Section 483.358: Orders for the Use of Restraint and Seclusion
NAMI believes that time limited orders should be established, but use of the emergency safety intervention should be discontinued once the emergency is over, even if the time order has not yet expired. Time limits of two hours should be set for older children. Use should always be authorized by a physician who sees the child or adolescent within ½ hour of the use of the emergency safety intervention and one hour after. The physician recommendation should be documented in the treatment record. Also, time-outs should be limited to no more than two hours.
Section 483.360: Consultation with Treatment Team Physician
NAMI recommends that paragraph (a) of this section be revised to require that, in addition to providing the information referenced in this paragraph, the physician ordering the restraint or seclusion should also inform the treatment team physician of any complications resulting from the intervention and the resident’s current physical and psychological status.
Section 483.362: Monitoring of the Resident In and Immediately After Restraint
We recommend the resident’s record include documentation on the name of the physician or registered nurse who evaluated the resident’s well-being immediately after the restraints were removed.
We strongly support the Department’s belief that it is critical to the resident’s safety to have medical professional staff (at least a registered nurse) present and available on a 24 hour basis, since these facilities provide medically necessary services in an inpatient setting.
Section 483.364: Monitoring of the Resident In and Immediately After Seclusion
We recommend that the regulations be revised to require that the resident’s record include documentation on the name of the physician or registered nurse who evaluated the resident’s well-being immediately after the resident was removed from seclusion.
Section 483.366: Notification of Parent(s) or Legal Guardians
We commend the Department for requiring each facility to notify the parent(s) or legal guardian(s) (in the case of resident minors) each time their child is restrained or secluded.
Section 483.370: Post Intervention Debriefings
In the case of resident minors, parent(s) or legal guardian(s) should always have the option to participate in debriefing sessions. NAMI recommends that the parents or legal guardians be given the opportunity to participate in any debriefing sessions, and that the Department delete “when it is deemed appropriate by the facility.”
In addition, the regulation should be revised to require that the debriefing discussion is conducted in a language that is understood by the resident, as well as by his or her parent or legal guardian, and that staff use simple language that is free of jargon and is clear to the resident and parents/legal guardians. The current regulation references only the parent/legal guardian and does not assure that simple terminology will be used.
The final regulation should be revised to specify that - during the debriefing session between the resident, parent or legal guardian and staff involved in the emergency safety situation - the resident shall be encouraged to express his or her views and experiences about being restrained or secluded. In addition, the final regulation should provide that the debriefing required under paragraph (b) involving supervisory staff shall discuss and attempt to develop strategies to address any psychological trauma to the resident that may have resulted from the intervention. Both of these activities will have positive therapeutic value.
We strongly support the use of two 24 hour de-briefing sessions and believe holding the sessions within 24 hours of the intervention is not too remote from the time the emergency safety situation occurred. We would oppose extending this time beyond the 24 hours. We also believe the debriefing session between staff involved in the emergency safety situation and appropriate supervisory and administrative staff need not be face to face. This requirement can be satisfied by telephone conferencing or any other way that provides the opportunity for a meaningful discussion between the staff required to participate.
We recommend that the regulation be revised to require that the resident’s treatment team physician participate in the debriefing session with staff involved in the emergency safety intervention and the supervisory and administrative staff. This is necessary to facilitate the involvement of the primary physician overseeing the care of the resident in any necessary modifications to the resident’s treatment plan resulting from the debriefings (which must be documented by staff).
Section 483.372: Medical Treatment for Injuries
We strongly support requiring psychiatric residential treatment facilities to have affiliations or written transfer agreements in effect with one or more hospitals approved for participation under the Medicaid program when a transfer of a resident, injured as a result of restraint or seclusion, is medically necessary for medical care or acute psychiatric care. We believe these arrangements are extremely crucial in these settings where the capacity to treat the medical and psychological injuries that may result from the interventions may be limited.
NAMI also feels that staff should be trained in cardiopulmonary resuscitation.
Section 483.374: Facility Reporting
We commend the Department for mandating reporting of serious occurrences (as defined by this regulation) to P&As around the country and to the State Medicaid agency. In particular, we are very pleased that the reporting requirement extends to serious injuries and suicide attempts, as well as to deaths. It is critical that P&As be provided this information so that they can conduct investigations as appropriate and pursue corrective action.
NAMI strongly recommends that the Department remove the phrase, “unless prohibited by state law” so that the facility is not obstructed to report to the State protection and advocacy agency. Facilities should be required to report directly to P &A’s because of the agency’s unique authority to address the misuse of restraint and seclusion. A fundamental mandate of the P & A system is to investigate reports of abuse and neglect in facilities that serve persons with disabilities and to monitor facility conditions relating to health and safety. They may initiate an investigation if there is evidence presented to them of abuse and neglect, and are authorized to pursue all appropriate remedies to ensure that the human and civil rights of persons with disabilities are protected.
Reports must be in writing and contain sufficient information, and be provided to the State Medicaid agency and to the State protection and advocacy agency within a specific time frame. At a minimum, the reports should provide the following information: (1) the identity of the child; (2) his or her age; (3) the identity of the individuals guardian, (if he or she has one); (4) the identity of the child’s next of kin (in case of a death); (5) the date of death or injury; (6) the child’s home address; (7) the medications the child was taking and other medical services that were provided; (8) the cause and circumstances of the death or injury; (9) whether and by whom the death or injury is being investigated; and (10) the identity of the person making the report.
Section 483.376: Education and Training
We believe that the requirements in this section will go a long way toward ensuring that staff are sensitized and competent with regard to the use of restraint and seclusion. Education and training on de-escalation techniques and alternative to the use of restraint and seclusion will help in reducing the use of these dangerous interventions.
Thank you for the opportunity to provide comments.
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