ADVOCATES COALITION FOR THE APPROPRIATE USE OF RESTRAINTS

July 18, 2001

Centers for Medicare and Medicaid Services

Department of Health and Human Services

Attention: HCFA-2065-IFC2

P.O. Box 8010

Baltimore, MD 21244-8010

Re: HCFA-2065-IFC2

Dear Administrator:

We, the Advocates Coalition for The Appropriate Use of Restraints, submit the following comments in reference to the amendment to the interim final rule on the use of restraint and seclusion in psychiatric residential treatment facilities (PRTFs) for individuals under the age of 21, as published in the Federal Register (Vol. 66, No. 99) on May 22, 2001. Our Coalition is comprised of a number of national organizations
Close concerned with preventing death and serious injury resulting from restraint and seclusion use. The Coalition is dedicated to improving the quality and appropriateness of treatment for persons with mental illness, children with serious emotional disturbance, and persons with mental retardation and other developmental disabilities.

The Coalition greatly appreciates the promulgation of regulations on the use of restraint and seclusion for PRTFs serving children and youth, and we especially appreciate the fact that the revised rules retain many important protections, including requirements concerning face-to-face assessments, debriefings and reporting of serious occurrences. However, a number of the amendments to the regulations would significantly weaken protections for this vulnerable population. Our comments below address these particular concerns in detail.

In addition, the amendments do not at all address the concerns we raised in our comments on the original January 22, 2001 interim final rule (66 Fed. Reg. 7147). We assume that these particular issues are still under consideration by CMS, and that our concerns (and those of other commenters) will be addressed in future amendments to the regulations. For instance, we remain very concerned regarding the requirements for facility reporting (section 483.374). As we stated earlier, the final regulations should omit the provision in paragraph (b) which permits facilities to refrain from reporting serious occurrences to P&As, if such reporting is prohibited by state law. We believe that permitting state law to pose a barrier to such reporting is inconsistent with the authorizing legislation for these regulations. Also, the regulation should be revised to require that reports of serious occurrences be submitted to P&As in writing and that they provide detailed information on the resident’s diagnosis, condition and other issues which are necessary to assist the P&A in its investigation.

In a few instances, we repeat below suggestions contained in our comments on the January 22 rule, because some of the amendments to the rule directly impact the same underlying concerns precipitating these comments. For ease of reference, we are attaching those earlier comments.

Section 483.352 Definitions – Personal Restraint

The definition of “personal restraint” is revised to expressly exempt from the definition “briefly holding without undue force a resident in order to calm or comfort him or her, or holding a resident’s hand to safely escort a resident from one area to another.” Accordingly, such holds are not covered by the regulations. The regulatory preamble contains only a very brief explanation as to why this amendment was incorporated into the regulations. The preamble (at page 28111) states that this revision was made in response to the concern raised by many commenters that the definition in the original regulation was “so broad that staff would be prohibited from comforting an upset resident, or holding a resident’s hand to safely escort him or her across a street. This was not our intention, and we are concerned that this reading could prevent facilities from participating in the Medicaid program and result in needless displacement of Medicaid beneficiaries.”

There is no explanation, however, regarding how this standard was developed or chosen to meet these concerns, and whether a different approach was considered. This amendment raises significant concerns, given that there is no objective guidance in the rules concerning what might constitute a “brief” hold, what amounts to “undue force,” and how to determine whether such a hold is genuinely used for the purpose of calming or comforting. More importantly, even if such holds are well-intentioned, without applying the regulations’ safeguards that are applicable to other types of restraints, these holds certainly will continue to be misused and could cause serious injury and deaths.

Indeed, most of the deaths that are related to the use of restraint apparently are associated with physical holds. This conclusion is supported by the database of restraint and seclusion deaths created by the Hartford Courant. That database catalogued 142 deaths resulting from restraint and seclusion nationwide in selected facilities. The database found that there was information available for 127 of these deaths regarding the type of intervention (either physical holds, mechanical restraints or seclusion) used -- and that 64 of these deaths were caused by physical holds (the other 63 deaths were related to seclusion or mechanical restraints). The database is available on line at: http://courant.ctnow.com/projects/restraint.

This amendment is inconsistent with the definition of “restraints” contained in the authorizing legislation for the regulations, the Children’s Health Act, Public Law 106-310. As amended by Section 3207 of the Children’s Health Act (CHA), the Public Health Service Act (PHSA) at section 591(d)(1) defines “restraints” as including a “personal restriction that immobilizes or reduces the ability of an individual to move his or her arms, legs or head freely.” The statute here clarifies that the definition does not include a “physical escort.” In turn, the PHSA at section 591(d)(3) defines “physical escort” as “the temporary touching or holding of the hand, wrist, arm, shoulder or back for the purpose of inducing a resident who is acting out to walk to a safe location.”

No where does the CHA carve out an exemption, as the regulatory amendment does, for “briefly holding” an individual “without undue force.” It is unreasonable to create by regulation another exception to this statutory standard where, as here, no such exception is either expressed or implied in the statute. Indeed, a basic rule of statutory construction provides that where a statute sets forth one or more specific exceptions to a general rule, no other such exceptions may be inferred. Thus, if the hold – however, brief or limited in force (even if intended to “calm or comfort”) – “reduces the ability of an individual to move his or her arms, legs or head freely,” it must be subject to the statutory and regulatory requirements for a restraint. Facility staff should always try to de-escalate threatening situations through means other than physical holds, and if such physical restraint is necessary, it must be subject to the same restrictions and safeguards as any other intervention which reduces the ability of an individual to move freely.

Accordingly, we urge CMS to omit from the final rule the language which states that a personal restraint does not include the use of brief holds. However, we believe that the final regulation should retain the clarification that such restraints do not include holding a resident’s hand to safely escort him or her from one area to another – as this exemption is consistent with the language of the CHA. Further, as we noted in our comments on the January 22 interim final rule, the regulation here should be revised to include a clarification as to when a physical escort escalates into a restraint (similar to the language in the Texas Department of Protective and Regulatory Services regulations regarding 24 hour care licensing requirements for restraint use, see Texas Administrative Code, Section 720.1001(11)). Thus, language such as the following should be added to the definition of “personal restraint”:

However, an intervention shall be considered a personal restraint, and not a physical escort, when an attempt to re-direct or guide an individual is physically resisted and the situation escalates into the need to physically force the individual to move.

Further, it has been documented that certain specific types of physical restraint techniques are associated with serious injuries and deaths, especially in children. And some states have expressly prohibited these techniques. See, e.g., Texas Administrative Code, section 720.1007(c)(2). Accordingly, the final regulations should do likewise by including language like the following:

The following personal restraint techniques are prohibited under any circumstances: restraints that place an individual face-down and/or place pressure on the individual’s back; restraints that obstruct the airways of the resident or otherwise impair breathing; restraints that obstruct the care giver’s view of the individual’s face; and restraints that restrict the individual’s ability to communicate.

Section 483.358 Orders for the Use of Restraint or Seclusion

This section in paragraph (a) has been revised to permit orders for restraint or seclusion to be issued by “a physician, or other licensed practitioner permitted by the State and the facility to order restraint or seclusion and trained in the use of emergency safety interventions.” Prior to its amendment, the rule had provided that such order may be issued only by a board certified psychiatrist, or a physician licensed to practice medicine with training related to the treatment of mental diseases.

This amendment is quite troubling because the types of professionals who may be viewed as licensed practitioners presumably will vary widely among the states, and may include professionals with minimal or no relevant credentials. It is clear that states have not established meaningful experience and training requirements – related to the care of persons with mental illness – for all such licensed practitioners.

Further, this amendment is inconsistent with the parallel requirement in the regulations regarding restraint use in hospitals – which provides that orders may only be issued by licensed “independent” practitioners (or physicians). 42 CFR 482.13(f)(3)(ii). The use of the term “independent” in this context creates an important distinction. As the preamble to the hospital regulations explained (at 64 Fed. Reg. 36079), “A licensed independent practitioner is any individual permitted by law and by the hospital to provide care and services, without direction or supervision, within the scope of the individual’s license and consistent with individually granted clinical privileges.” States have higher standards regarding the licensing of independent practitioners than other practitioners. These higher standards relate to attainment of education and experience requirements which are critical to ensure appropriate independent decisions about treatment.

Accordingly, we urge CMS to use the term “independent” in the final regulation. Indeed, the final regulation should specify that the professional (other than a physician) who may be permitted to issue restraint and seclusion orders must be “a licensed independent mental health practitioner.” Without the qualification that one be a mental health professional, it is quite possible that facilities will rely on any one of a number of practitioners with little or no experience regarding the treatment of troubled youth with mental illness (e.g., a marriage counselor). Further, as discussed below, we strongly recommend that the regulations be revised to further strengthen the training requirements for licensed practitioners.

Similarly, paragraph (f) of this section has been revised to permit a physician or other “licensed practitioner” to conduct the face-to-face assessment of the physical and psychological well being of the resident who is in restraint or seclusion. Under the prior rule, such assessments (to be conducted within one hour of the intervention) were to be done by a physician or clinically qualified registered nurse. The concerns discussed above with regard to the issuance of the restraint or seclusion orders are equally applicable to persons permitted to conduct these assessments – which are critical to ensuring that restraint and seclusion does not result in serious injury or death. Indeed, professionals performing these assessments must have significant diagnostic and treatment skills. Accordingly, the regulation should be revised to permit only physicians and licensed independent mental health practitioners to perform these assessments.

Moreover, we note that the basis of the amendments relating to staff authorized to issue orders and conduct assessments was, as stated in the preamble, a national shortage of registered nurses and psychiatrists. This staffing shortage may very well be a temporary condition; indeed, there appears to be a national effort to train more registered nurses. Accordingly, we strongly recommend that CMS monitor the availability of both psychiatrists and registered nurses, and revise the regulations to reinstate the requirements from the January 22 rule regarding the role of these professionals, in the event that they become more readily available.

Section 483.376 Education and Training

In light of the amendments to the regulation permitting licensed practitioners to issue orders (rather than board certified psychiatrists) regarding restraint and seclusion and perform physical and psychological assessments (rather than clinically qualified registered nurses), we believe there is a great need to enhance the regulations’ training requirements. Even if the regulations were revised, as we suggest above, to specify that such persons must be licensed independent mental health practitioners, enhanced training is critical to compensate for the fact that these professionals almost certainly will have lesser skills and experience – as compared to psychiatrists and registered nurses.

The regulations at paragraph (a) require staff to have demonstrated knowledge in three general areas. We strongly recommend that regulations be revised to require staff to demonstrate competence in the following additional areas related to diagnosis and medical intervention issues: taking vital signs; the physical and psychological impact of restraint and seclusion, including positional asphyxia; recognizing nutrition and hydration needs; checking circulation and range of motion in extremities; addressing hygiene and elimination; monitoring and addressing physical and psychological status and comfort; and recognizing when to contact a medical professional in order to evaluate and/or treat the resident. (Please also see our recommendations related to education and training contained in our comments on the original regulation.)

These areas of knowledge are required, under section 595(b)(1)(B) of the PHSA, with respect to persons who impose restraint and seclusion in non-medical community based facilities for children and youth. It is imperative that a similar national baseline standard regarding competency also be imposed with regard to PRTF staff who may or may not be required to have such skills under state law and facility policy.

Thanks very much for your consideration of our comments.

Sincerely,

Gary Gross

Senior Public Policy Counsel

National Association of Protection and Advocacy Systems

   on behalf of

The Arc: Kathy McGinley

Bazelon: Laurel Stine

CHADD: Clarke Ross

NAMI: Kim Encarnation

NCCBH: Pope Simmons

NAPAS: Gary Gross and Curt Decker

NMHA: Brian Coopper

Enclosure