[Federal Register Volume 66, Number 14 (Monday, January 22, 2001)]
[Rules and Regulations]
[Pages 7148-7164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1649]
[[Page 7147]]
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Part X
Department of Health and Human Services
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Health Care Financing Administration
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42 CFR Parts 441 and 483
Medicaid Program; Use of Restraint and Seclusion in Psychiatric
Residential Treatment Facilities Providing Psychiatric Services to
Individuals Under Age 21; Final Rule
Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules
and Regulations
[[Page 7148]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 441 and 483
[HCFA-2065-IFC]
RIN 0938-AJ96
Medicaid Program; Use of Restraint and Seclusion in Psychiatric
Residential Treatment Facilities Providing Psychiatric Services to
Individuals Under Age 21
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Interim final rule with comment period.
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SUMMARY: This interim final rule with comment period establishes a
definition of a ``psychiatric residential treatment facility'' that is
not a hospital and that may furnish covered Medicaid inpatient
psychiatric services for individuals under age 21. This rule also sets
forth a Condition of Participation (CoP) that psychiatric residential
treatment facilities that are not hospitals must meet to provide, or to
continue to provide, the Medicaid inpatient psychiatric services
benefit to individuals under age 21. Specifically, this rule
establishes standards for the use of restraint or seclusion that
psychiatric residential treatment facilities must have in place to
protect the health and safety of residents. This CoP acknowledges a
resident's right to be free from restraint or seclusion except in
emergency safety situations. We are requiring psychiatric residential
treatment facilities to notify a resident (and, in the case of a minor,
his or her parent(s) or legal guardian(s)) of the facility's policy
regarding the use of restraint or seclusion during an emergency safety
situation that occurs while the resident is in the program. We believe
these added requirements will protect residents against the
inappropriate use of restraint or seclusion.
DATES: Effective date: These regulations are effective on March 23,
2001.
Comment date: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on March
23, 2001.
ADDRESSES: Mail written comments (one original and three copies) to the
following address ONLY: Health Care Financing Administration,
Department of Health and Human Services, Attention: HCFA-2065-IFC, P.O.
Box 8010, Baltimore, MD 21244-8010.
If you prefer, you may deliver your written comments (one original
and three copies) by courier to one of the following addresses: Room
443-G, Hubert H. Humphrey Building, 200 Independence Avenue, SW.,
Washington, DC 20201, or C5-15-03, Central Building, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
Comments mailed to those addresses may be delayed and could be
considered late.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HCFA-2065-IFC.
Comments received timely will be available for public inspection as
they are received, generally beginning approximately 3 weeks after
publication of a document, in Room 443-G of the Department's offices at
200 Independence Avenue, SW., Washington, DC, on Monday through Friday
of each week from 8:30 a.m. to 5 p.m. (Phone (202) 690-7890).
For comments that relate to information collection requirements,
mail a copy of comments to: Health Care Financing Administration,
Office of Information Services, Security and Standards Group, Division
of HCFA Enterprise Standards, Room N2-14-26, 7500 Security Boulevard,
Baltimore, MD 21244-1850, Attn: Julie Brown, HCFA-2065-IFC.
FOR FURTHER INFORMATION CONTACT: Mary Kay Mullen, (410)786-5480.
SUPPLEMENTARY INFORMATION:
I. Background
Section 1902(a)(9)(A) of the Social Security Act (the Act) requires
the State health agency or other State medical agency to establish and
maintain health standards for private and public institutions in which
recipients of medical assistance, under the State plan, may receive
care or services. Section 1905(h) of the Act defines the term
``inpatient psychiatric hospital services for individuals under age
21'' as inpatient services that are provided in an institution (or
distinct part thereof) that is a psychiatric hospital or in another
inpatient setting that the Secretary has specified in regulations. In
this interim final rule, we are defining psychiatric residential
treatment facilities as an inpatient setting in conformity with the
definition of an institution as set forth in section 1905(h).
The Medicaid program makes Federal funding available for State
expenditures under an approved State Medicaid plan for inpatient
psychiatric services for eligible individuals under 21 years of age in
hospital and nonhospital settings. Nonhospital settings, which we are
defining as psychiatric residential treatment facilities (facilities),
are rapidly replacing hospitals in treating children and adolescents
with psychiatric disorders. These facilities are generally a less
restrictive alternative to a hospital for treating children and
adolescents whose illnesses are less acute but who still require a
residential environment.
On November 17, 1994, we published in the Federal Register (56 FR
59624) proposed regulations to establish standards for nonhospital
psychiatric residential treatment facilities, to be contained in a new
subpart F of 42 CFR part 483. Among the proposed standards was a
prohibition on physical restraints and psychoactive drugs for purposes
of discipline or convenience, when not required to treat the resident's
psychiatric symptoms, or when not specified in the plan of treatment.
Also included was a prohibition on the use of involuntary seclusion.
Moreover, limitations were proposed on the use of drugs in doses that
would interfere with the resident's daily living activities, or the use
of drugs to control inappropriate behavior. These drugs would not be
used unless they were an integral part of a plan of care directed
specifically toward reducing and eventually eliminating that behavior,
or when the harmful effects of the behavior clearly outweighed the
potential harmful effects of the drugs.
We, as well as the Congress, have grown increasingly concerned
about the danger posed to residents in psychiatric residential
treatment facilities as a result of improper restraint and seclusion
practices. Improper restraint and seclusion practices can lead to
serious injury and even death of residents as well as staff. In March
1999, during the first session of the 106th Congress, members of the
Senate and House of Representatives introduced three separate bills (S.
736, S. 750 and H.R. 1313) intended to protect individuals from the
improper use of restraint or seclusion in Medicare and Medicaid-funded
facilities. These bills were incorporated into the enactment of the
Children's Health Act of 2000, which was signed by the President on
October 17, 2000.
Advocates for persons with mental illness as well as the media have
raised the public's awareness of restraint and seclusion practices that
can lead to serious injury and death. The Hartford Courant (Courant), a
Connecticut newspaper, published a series of articles in October 1998
citing the results of a
[[Page 7149]]
50-state survey that confirmed 142 deaths, that occurred during the
previous decade, while or shortly after a patient was restrained or
secluded. The first of a series of articles entitled ``A Nationwide
Pattern of Death,'' was published October 11, 1998. The survey focused
on mental health and mental retardation facilities and group homes
nationwide. According to a statistical estimate commissioned by the
Courant that was conducted by the Harvard Center for Risk Analysis,
between 50 and 150 deaths related to the use of restraint or seclusion
occur every year across the country. The article further stated that of
the 142 restraint-related deaths confirmed by the Courant's
investigation, ages could be confirmed in 114 cases, and that more than
26 percent of those were children--nearly twice the proportion they
represent in mental health institutions.
In 1999, at the request of the Congress, the General Accounting
Office (GAO) conducted a study that focused on individuals receiving
services in mental health and mental retardation facilities and group
homes nationwide that receive public funding, primarily from the
Medicare and Medicaid programs. Some objectives of the study were to
determine the dangers of restraint and seclusion, the extent to which
restraint and seclusion are used in inpatient and residential treatment
facilities for individuals with mental illness or mental retardation,
and the number of related injuries and deaths from their use. To gain
at least a partial indication of the scope of the problem, the GAO
obtained data on the number of deaths related to restraint or seclusion
investigated by the Protection and Advocacy agencies in all 50 states
and the District of Columbia in fiscal year 1998. On the basis of the
partial information available from the 51 agencies, the GAO identified
24 deaths associated with restraint or seclusion during fiscal year
1998.
In September of 1999, the GAO issued a report titled ``Improper
Restraint or Seclusion Use Places People at Risk'' (GAO/HEHS-99-176),
which concluded that the improper use of restraint and seclusion can be
dangerous to both people receiving treatment and to staff. The report
stated that the full extent of related injuries and deaths from
improper restraint or seclusion is unknown because there is no
comprehensive reporting system to track injuries and deaths, or to
track the rates of restraint or seclusion use by facility. In addition,
according to the report, most facilities are not even required to
report these data to oversight agencies. The report stated that because
reporting is so fragmentary, there may be many more deaths related to
the use of restraint or seclusion than are being reported.
The Courant series and the GAO report underscore our concern for
the safety and welfare of children and adolescents when restraints or
seclusion are employed in residential treatment facilities. We have
therefore developed standards that describe the conditions under which
restraint or seclusion can be used; that set an upper limit on the
permissible length of time for each instance of restraint or seclusion
use; that require education and training of staff, including the safe
use of restraint and the safe use of seclusion; that require staff to
directly monitor residents who are restrained or secluded for the
entire duration of the procedure; and that prohibit the simultaneous
use of restraints and seclusion.
On July 2, 1999, we published in the Federal Register an interim
final rule that addressed, in part, the use of restraint and seclusion
in hospitals, including psychiatric hospitals, entitled ``Medicare and
Medicaid Programs; Hospital Conditions of Participation; Patients'
Rights'' (64 FR 36070). We conducted substantial academic research on
the issue of restraint and seclusion, which was discussed in the
referenced hospital interim final rule. Although the research primarily
involved elderly patients, its findings, we believe, are also relevant
to individuals under age 21. As we said there: ``Research indicates
that the potential for injury or harm with the use of restraint is a
reality. In a 1989 article published in the Journal of the American
Geriatrics Society, Evans and Strumpf pointed to an association between
the use of physical restraint and death during hospitalization (Evens,
LK and Strumpf, NE: Tying down the elderly: A review of the literature
on physical restraint. J Am Geriatr Soc (1989) 37:65-74; also see
Robbins, LJ, Boyko E, Lane, J, et al.: Binding the elderly: A
prospective study of the use of mechanical restraint in an acute care
hospital. J Am Geriatr Soc (1987) 35:290; Frengley, JD and Mion, LC:
Incidence of physical restraints on acute general medical wards. J Am
Geriatr Soc (1986) 34:565; Strumpf, NE and Evans, LK: Physical
restraint of the hospitalized elderly: Perceptions of patients and
nurses. Nursing Research (1998) 37:132.) The FDA estimates that at
least 100 deaths from the improper use of restraints may occur
annually. Mion et al. further noted that `Some evidence exists that the
use of physical restraints is not a benign practice and is associated
with adverse effects, such as longer length of hospitalization, higher
mortality rates, higher rates of complications, and negative patient
reactions. Physical restraints have a detrimental effect on the
psychosocial well-being of the patient' (see Mion et al.: A further
exploration of the use of physical restraints in hospitalized patients.
J Am Geriatr Soc (1989) 37:955; Schafer, A: Restraints and the elderly:
When safety and autonomy conflict. Can Med Assoc J (1985) 132:1257-
1260.)''
``Research findings on the impact of restraints use have lead to
research on and development of alternative methods for handling the
behaviors and symptoms that historically prompted the application of
restraint. However, various studies provide evidence that restraint is
still being used when alternate solutions are available (see Donat, DC:
Impact of a mandatory behavior consultation on seclusion/restraint
utilization in psychiatric hospitals. J Behav Ther Exp Psychiatry (1998
March) 29:1, 13-9; Dunbar, J: Making restraint-free care work. Provider
(1997 May) 75-76, 79; and Moss RJ: Ethics of mechanical restraints.
Hasting Center Report (1991 Jan-Feb) 21 (1):22-25.)''
In the preamble of the July 1999 hospital interim final rule, we
asked for comments on whether we should apply the hospital behavioral
health standards on the use of restraint and seclusion to psychiatric
residential treatment facilities that provide inpatient psychiatric
services to individuals under age 21, or whether more stringent
standards were warranted. Consumer advocacy groups that commented on
extending the restraint and seclusion requirements to other types of
providers and settings generally agreed that more stringent regulations
should be applied with respect to the treatment of children. Their
opinion was that the restraint of children and adolescents in these
settings presents special hazards and concerns. Those comments will be
addressed more specifically in the hospital final rule. Additionally,
the 1999 GAO report described a study sponsored by the Center for
Mental Health Services which indicated that there are higher restraint
rates for children, including one State in which children in State-run
facilities were restrained four times more frequently than adults. This
report also noted that children are smaller and weaker than adults, so
staff who are used to overpower adults may apply too much preasure or
force when restraining children. For all of these reasons, HCFA has
included standards in this rule that provide greater protection than
those in
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existence or required by the Children's Health Act of 2000.
Generally, the requirements set forth in this rule governing the
use of restraint and seclusion are consistent with both the November
1994 proposed rule and the July 1999 hospital interim final rule.
Moreover, this rule also meets the specific requirements of section
3207 of the Children's Health Act of 2000 (Pub. L. 106-310) which
requires that health care facilities receiving support in any form from
any program supported in whole or in part with funds appropriated to
any Federal department or agency shall protect and promote the rights
of each resident of the facility, including the right to be free from
any restraints or involuntary seclusion imposed for purposes of
discipline or convenience. Specifically, section 591(c) of the
Children's Health Act permits the Secretary to issue regulations that
afford residents greater protections regarding restraint and seclusion
than the standards published in the new law. Consistent with this
section, this rule provides greater protections than those required in
section 3207.
Psychiatric residential treatment facilities are fast replacing
hospitals in providing long-term mental health services to children and
adolescents, a highly vulnerable population. The dangers associated
with the inappropriate use of restraint and seclusion, especially with
this population were well documented in the GAO Report and the Courant
series. According to the GAO Report, children are subjected to
restraint and seclusion at higher rates than adults and are at greater
risk of injury. Based on the mounting evidence of harm that can result
from the use of restraint and seclusion, we are being more prescriptive
in the way our restraint and seclusion standards are applied in
psychiatric residential treatment facilities.
II. Provisions of the Interim Final Rule Effect of This Rule on the
Survey and Certification Requirements
This interim final rule implements only one of the conditions of
participation (CoPs) set forth in our November 1994 proposed rule. We
are not implementing the remainder of the CoPs in that proposed rule at
this time because many of the comments we received on that proposed
rule are still under evaluation. We plan to address the remainder of
the CoPs in our November 1994 proposed rule in a separate rule in the
future. As discussed below, we are moving forward with this CoP because
evidence indicates a pressing need for the promulgation and enforcement
of restraint and seclusion rules for psychiatric residential treatment
facilities.
Requiring psychiatric residential treatment facilities to meet
these CoPs will require us to develop additional survey protocols and
implementing guidelines to enforce these new requirements. We will
solicit public comment on these survey protocols. Until such protocols
are issued, we are requiring each psychiatric residential treatment
facility that provides inpatient psychiatric services to individuals
under age 21 under a State plan to attest, in writing, that the
facility is in compliance with the standards set forth in this rule
governing the use of restraint and seclusion. This attestation must be
signed by the facility director. In addition, we are requiring the
facility to provide the State Medicaid agency with its attestation of
compliance. Since the facility will need time to implement these
restraint and seclusion standards before it can come into compliance,
we are allowing the facility 120 days from the effective date of this
interim final rule to provide the State Medicaid agency with its
attestation of compliance.
We will work with the States to develop a process for sampling
psychiatric residential treatment facilities to validate their
attestations of compliance with the restraint and seclusion standards.
This interim final rule establishes a definition of a psychiatric
residential treatment facility as a facility other than a hospital that
provides inpatient psychiatric services and sets forth a CoP entitled
``Use of Restraint or Seclusion in Psychiatric Residential Treatment
Facilities Providing Inpatient Psychiatric Services for Individuals
Under Age 21.'' This CoP is in addition to the existing regulatory
requirements for these facilities in 42 CFR 441.151 through 441.182,
which specify requirements applicable if a State plan provides for
inpatient psychiatric services to individuals under age 21.
Section 441.151 General Requirements
This regulation amends Sec. 441.151 by redesignating existing
paragraphs, by adding explicit reference to residential treatment
facilities, and by adding a new paragraph (b) to establish a CoP in
part 483, subpart G, that facilities must meet in order to provide
these services.
Section 483.352 Definitions
We have included in this section, definitions of terms as they
apply to the standards in this rule governing the use of restraint and
seclusion in psychiatric residential treatment facilities.
The definitions we have employed for ``mechanical restraint'' and
``personal restraint'' in this rule are modeled on the hospital
definition of ``restraint'' codified in Sec. 482.13(f)(1). In this
rule, we distinguish between ``personal'' and ``mechanical'' restraint
to clarify that mechanical restraint means any device attached or
adjacent to a person's body, while personal restraint means the
application of physical force on a person's body without the use of any
device.
Section 483.354 General Requirements for Psychiatric Residential
Treatment Facilities
This section clarifies that in addition to the requirements
specified in this rule, psychiatric residential treatment facilities
must meet the requirements in Secs. 441.151 through 441.182 of this
chapter.
Section 483.356 Protection of Residents
The purpose of this CoP is to protect residents in psychiatric
residential treatment facilities from the inappropriate use of
restraint or seclusion by addressing the right of each resident to be
free from restraint or seclusion, in any form, imposed as a means of
coercion, discipline, convenience, or retaliation.
An example of the inappropriate use of seclusion or restraint for
purposes of coercion would be the use of seclusion or restraint with a
resident whose behavior would not require its use, and who is not
endangering others, but where seclusion or restraint is being used
until the resident takes prescribed medications or attends a required
group therapy session. We are seeking public comment on the use of the
term coercion.
The CoP provides for the use of restraint or seclusion only in
emergency safety situations to ensure the safety of the resident or
others, and only until the emergency safety situation ends. An order
for restraint or seclusion cannot be issued as a standing order. We
also are prohibiting the simultaneous use of restraint and seclusion in
psychiatric residential treatment facilities. Combining a mechanical
restraint intervention with isolation (seclusion) is extremely
restrictive and dangerous.
In Sec. 483.356(c) we are requiring each facility to inform both
the resident and, in the case of a minor, his or her parent(s) or legal
guardian(s) of its policy regarding the use of restraint or seclusion.
To comply with Executive Order 13166 (Improving Access to
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Services for Persons with Limited English Proficiency) which was issued
on August 11, 2000, each facility is required to communicate its
restraint and seclusion policy in a language that the resident, or his
or her parent(s) or legal guardian(s) understands (including American
Sign Language, if appropriate) and that, when necessary, interpreters
or translators are provided. We believe that the resident (and, in the
case of a minor, the parent(s) or legal guardian(s)) must be informed
of the facility's restraint and seclusion policy at the time of
admission to foster the selection of a provider best suited to meet the
physical and mental health needs of the resident. We are also requiring
the facility to provide a copy of the facility's policy to the
resident, and if a minor, a copy to both the resident and the
resident's parent(s) or legal guardian(s). The facility's policy must
provide the information needed for contacting the State Protection and
Advocacy Organization.
Section 483.358 Orders for the Use of Restraint or Seclusion
Under this new standard, restraint or seclusion may be imposed only
in emergency safety situations.
This standard provides that only a board-certified psychiatrist, or
a licensed physician with specialized training and experience in
diagnosing and treating mental disorders, may order restraint or
seclusion in emergency safety situations. This person must be the
resident's treatment team physician, if available. When he or she is
not available, the physician covering for the treatment team physician
may order restraint or seclusion. The covering physician must meet
these same requirements for training and experience.
We are limiting the authority to order the use of restraint and
seclusion in psychiatric residential treatment facilities to a board-
certified psychiatrist or a licensed physician with specialized
training and experience in diagnosing and treating mental disorders.
Our requirement that only a board-certified psychiatrist or a licensed
physician may order restraint or seclusion is consistent with existing
physician admission and certification of need for services requirements
applicable if a State provides inpatient psychiatric services to
individuals under age 21 in psychiatric facilities. Regulatory
requirements at 42 CFR part 441, subpart D and part 456, subpart D
require that inpatient psychiatric services for individuals under age
21 be provided under the direction of a physician, and that a physician
must certify, in writing, that inpatient psychiatric services are
necessary in the setting in which they will be provided.
Any order for restraint or seclusion must be the least restrictive
intervention that is most likely to be effective in resolving the
emergency safety situation based on consultation with staff and must be
limited to no longer than the duration of the emergency safety
situation. If the physician is not present in the facility to order the
use of restraint or seclusion, we are requiring in Sec. 483.358(d) that
a registered nurse obtain the physician's verbal order at the time the
emergency safety intervention is initiated by staff. The physician's
verbal order must be followed with the physician's signature verifying
the verbal order. The ordering physician must be available to staff at
least by phone for the duration of the restraint or seclusion to ensure
the resident's safety.
The time limits for restraint or seclusion orders in this rule are
consistent with the July 1999 hospital interim final rule: no more than
4 hours for residents ages 18 to 21, 2 hours for residents ages 9 to
17, and 1 hour for residents under age 9. We are soliciting comments on
these time limits.
In Sec. 483.358, we are also requiring that within 1 hour of the
initiation of an emergency safety intervention, a face-to-face
assessment of the physical and psychological well-being of the resident
be conducted. We believe this assessment is necessary to ensure the
safety of the resident during and immediately after he or she is
restrained or secluded. We believe that requiring that this assessment
be performed by a physician would be unrealistic because unlike
hospitals, a psychiatric residential treatment facility may not have a
physician present 24 hours a day. Therefore, when a physician is not
present, we are allowing a clinically qualified registered nurse
trained in the use of emergency safety interventions to perform the
face-to-face assessment. Both the face-to-face assessment and the
restraint or seclusion order must be documented in the resident's
record by staff involved in the emergency safety intervention before
the end of their shifts. The ordering physician must sign the order as
soon as possible.
Section 483.360 Consultation With Treatment Team Physician
If the physician who orders the use of restraint or seclusion is
not part of the resident's treatment team, the facility must consult
with the resident's treatment team physician as soon as possible. We
believe it is important that the team physician be made aware of any
circumstances that have disrupted the physical or psychological well-
being of the resident as soon as possible so that the team physician
can evaluate the situation(s) that required the resident to be
restrained or secluded and make appropriate modifications to the
resident's plan of treatment. We are requiring documentation in the
resident's record that the treatment team physician was contacted.
Section 483.362 Monitoring of the Resident in and Immediately After
Restraint
We are requiring that clinical staff trained in the use of
emergency safety interventions be physically present, continually
assessing and monitoring the resident in restraint. If the emergency
safety situation continues beyond the time limits of the order, a
registered nurse must immediately contact the ordering physician in
order to receive further instructions. A physician or registered nurse
must evaluate the resident immediately after the restraint is removed.
We believe these requirements will futher ensure resident safety.
Section 483.364 Monitoring of the Resident in and Immediately After
Seclusion
We are requiring a resident in seclusion to be continually
monitored and assessed by clinical staff, trained in the use of
emergency safety interventions and that the staff monitoring the
resident must be physically present in or immediately outside the
seclusion room to ensure the safety of the resident. Video monitoring
of the resident in seclusion will not meet this requirement because
such monitoring cannot determine if a resident is experiencing a
medical emergency such as cardiac arrest or asphyxiation.
This standard also specifies the characteristics of a room used for
seclusion, including the requirements that the interior of the
seclusion room be fully visible to staff and be free of any potentially
hazardous conditions. We also are requiring that a physician or
registered nurse evaluate the resident immediately after the resident
is removed from seclusion. As stated in the discussion of Sec. 483.262,
we believe these requirements will ensure resident safety.
Section 483.366 Notification of Parent(s) or Legal Guardian(s)
We are requiring the facility to notify the parent(s) or legal
guardian(s) whenever a resident who is a minor (as defined in this
subpart) is restrained or
[[Page 7152]]
secluded. Notification must be made as soon as possible after the
initiation of each emergency safety intervention and must be documented
in the resident's record.
Section 483.368 Application of Time Out
We have defined ``time out'' in Sec. 483.352 ``Definitions'' to
clarify that it is not a form of seclusion, because the resident in
time out is not physically prevented from leaving the time out area.
The regulation also clarifies that time out can take place away from
other residents (exclusionary) or in the area of activity or in the
presence of other residents (inclusionary). This section further
requires staff to monitor the resident while he or she is in time out.
We considered establishing time limits for time out, but because age,
maturity level, health status, and other factors must be considered, we
believe that the duration of time out should be based on professional
judgement. We welcome comments on this issue.
Section 483.370 Postintervention Debriefings
In order to ensure the safety of resident's and others, we believe
it is critical that the facility begin to quickly assess the
circumstances that warranted the use of restraint or seclusion and to
identify alternatives to reduce or eliminate their use. Therefore, we
are requiring that within 24 hours after a resident has been restrained
or secluded, staff involved in the emergency safety intervention and
the resident, participate in a face-to-face discussion. This discussion
can also include other staff and the resident's parent(s) or legal
guardian(s) when it is deemed appropriate by the facility. As stated
earlier, the facility must ensure that such discussions are conducted
in a language that is understood by the resident and the resident's
parent(s) or legal guardian(s). The discussion will provide both the
resident and staff involved an opportunity to discuss the circumstances
that resulted in the use of restraint or seclusion and strategies that
all parties could employ to prevent the need for restraint or
seclusion. However, we recognize that there may be clinical reasons why
it may not be appropriate for a particular staff person involved in the
emergency safety intervention to be part of the debriefing. If the
presence of a particular staff person jeopardizes the well-being of the
resident, it may not be advisable to include that staff person in a
debriefing session. Therefore, this rule provides an exception to the
requirement for those situations when the presence of a particular
staff person jeopardizes the well-being of the resident.
We also are requiring a separate debriefing of staff involved in
the emergency safety intervention, and a review by appropriate
supervisory and administrative staff of the situation that required the
use of restraint or seclusion. However, we are not requiring that this
debriefing be face-to-face.
We believe staff debriefings may identify areas requiring
modification of administrative policy and procedures pertaining to the
use of restraint or seclusion, and may serve to reduce use of restraint
or seclusion. We believe the debriefing is critical to ensuring the
safety of the resident and others and should take place within 24 hours
after the use of restraint or seclusion. We are specifically requesting
comments regarding the 24 hour requirement for debriefings involving
staff and a resident, as well as debriefings between staff involved in
an intervention and appropriate administrative and supervisory staff.
Section 483.372 Medical Treatment for Injuries Resulting from an
Emergency Safety Intervention
This standard requires qualified medical personnel to immediately
provide medical treatment to a resident who is injured during restraint
or seclusion and to document these injuries in the resident's record.
Injuries sustained by staff during the restraint or seclusion of a
resident must also be documented in the resident's record. We believe
this information will be important in assisting the facility in
identifying measures to improve the safety of its staff through
modifications of existing policies and procedures in the safe use of
restraint and seclusion, and modificaion of training programs. We are
also requiring staff involved in an emergency safety intervention that
results in injury to the resident or staff to meet with supervisory
staff to evaluate the circumstances that caused the injury and develop
a plan to prevent future injuries.
In our November 1994 proposed rule, we proposed a separate
condition of participation in Sec. 483.220 entitled ``Health
Services,'' which would require each facility to have written transfer
agreement(s) in effect with one or more Medicaid-approved hospitals
that reasonably ensures a resident will be transferred in a timely
manner from the facility to the hospital when transfer is medically
necessary for medical care or acute psychiatric care. In addition, we
proposed to require that medical and other information needed for care
of the resident be exchanged between the institutions, and that medical
care be available to each resident 24 hours a day as may be necessary.
We received one comment on the transfer agreement requirement
stating that it would be difficult to meet this requirement because
most facilities are not affiliated with a hospital and that admission
criteria and placement authority rests with each county and insurance
provider. We considered the commenter's rationale but believe these
agreements are necessary because the use of restraint or seclusion may
place a resident at risk for an acute medical crisis. Therefore, we are
incorporating in this CoP the requirement that each facility have
written transfer agreement(s) or affiliations in place.
Section 483.374 Facility Reporting
According to the GAO report, reporting requirements play a central
role in reducing restraint use and improving the safety of individuals
in treatment settings. The report further states that in addition to
tracking restraint rates, reporting of deaths or other significant
events to an independent agency can contribute to improved safety for
individuals in treatment settings. The GAO report specifically
recommended that we mandate that any hospital or residential facility
that treats persons with mental illness or mental retardation, as a
requirement for receiving Medicare and Medicaid funds, report promptly
to the State licensing body and the appropriate State Protection and
Advocacy (P&A) system, all patient deaths and serious injuries among
persons with mental illness or mental retardation, and to indicate
whether restraint or seclusion was used during or immediately prior to
the death or injury.
This interim final rule requires each facility to report a
resident's death, any serious injury to a resident as defined in this
subpart, and a resident's suicide attempt to the State Medicaid agency
and, unless prohibited by State-law, the State-designated P&A system.
These serious occurrences involving a resident must be reported to the
State Medicaid agency and the State-designated P&A system no later than
the close of business the next business day following the occurrence.
We are also requiring each facility to document all serious occurrences
in the resident's record. In the case of a minor, we are requiring the
facility to notify (within 24 hours of the occurrence) the resident's
parent(s) or legal guardian(s) in order to provide the parent(s) or
legal guardian(s) the opportunity to participate in decisions that may
have to
[[Page 7153]]
be made regarding the resident. We are requiring staff to document in
the resident's record that these contacts were made. It should be noted
that the facility reporting requirements in this rule exceed the
minimum requirements for facility reporting in section 3207 of the
Children's Health Act of 2000.
Regulations titled ``Substance Abuse and Mental Health Services
Administration; Requirements Applicable to Protection and Advocacy of
Individuals with Mental Illness' published by the Department of Health
and Human Services on October 15, 1997 (62 FR 53548) grant the P&A
system the authority to protect and advocate for the rights of
individuals with mental illness and to investigate reports of abuse and
neglect in residential facilities that care for and treat individuals
with mental illness. The P&As may have access to public and private
facilities, residents, and clients, and to facilities' records of
individuals with mental illness for the specific purpose of conducting
independent investigations of incidents of abuse and neglect.
Under seperate guidance or rulemaking (as appropriate), we will
direct the State Medicaid agency to report serious occurrences
involving a resident of a psychiatric residential treatment facility to
the State survey agency. Section 1902(a)(33)(B) of the Act requires
States to survey institutional providers, to certify that they meet our
regulations for participation in the Medicaid program under the State
plan.
Section 483.376 Education and Training
We are requiring the facility to provide ongoing education and
training for staff including training in the safe and appropriate use
of restraint and seclusion, as well as alternative nonintrusive
behavior modification techniques. We also are requiring that staff be
certified in the use of cardiopulmonary resuscitation. This training
must be performed by individuals qualified by education, training, and
experience. Staff must be able to successfully demonstrate, in
practice, all techniques learned related to emergency safety
interventions. Staff personnel records must document that this training
was successfully completed. Staff must demonstrate their competencies
on a semiannual basis. Each facility must make all training programs
and materials available for review by HCFA, the State Medicaid agency,
and the State survey agency. It should be noted that the education and
training requirements in this rule exceed the minimum requirements for
education and training in section 3207 of the Children's Health Act of
2000.
We believe this training is essential because restraint and
seclusion can be dangerous to both the individual being restrained or
secluded and to staff applying restraint or seclusion. Restraining
individuals can involve physical struggle, pressure on the chest, or
other interruptions in breathing. Having staff trained in alternative
techniques to avoid restraint use is important, but staff should also
be trained in the proper application and removal of restraints and in
how to monitor individuals in restraint or seclusion. The GAO report
stated that the Joint Commission on Accreditation of Health Care
Facilities (JCAHO) had reviewed 20 restraint-related deaths and found
that in 40 percent, the cause of death was asphyxiation, while
strangulation, cardiac arrest, or fire had caused the remainder. The
report recommended that we require any inpatient or residential
facility that treats persons with mental illness to ensure that staff
regularly receives training and refresher courses in alternate methods
to handle agitated or potentially violent patients and document their
receipt of training as a requirement for receiving Medicare and
Medicaid funds.
III. Response to Comments on November 1994 Proposed Standards
Governing Restraints and Seclusion
In response to our November 1994 proposed rule, we received the
following comments, which specifically addressed our proposed standards
for restraints. Most of the commenters suggested that our standards
address seclusion as well as restraints. We agree with the commenters
and have included in this interim final rule standards addressing the
use of both seclusion and restraint.
One commenter stated that we should prohibit the use of any type of
restraint, including seclusion and time-out rooms. Six commenters
stated we should prohibit restraints because they are not therapeutic
and if they are allowed for one purpose, they cannot be monitored for
other uses.
While we recognize that serious consequences can result from the
inappropriate use of restraint or seclusion as discussed previously, we
believe that restraint or seclusion used only in an emergency safety
situation to ensure the safety of the resident or others is permissible
when staff have been properly trained in the safe use of such
interventions. Therefore, we have rejected these comments because we
believe that the type of intervention used to ensure the safety of a
resident or others during an emergency safety situation should be the
decision of the professionals involved in the situation.
Three commenters contended that restraints/seclusion should not be
included in the plan of care and should be used only when an individual
is a danger to himself or others, or is a serious disruption to the
therapeutic environment. They also stated that restraints should be
used only as long as physical danger continues. We generally agree with
these comments, and as discussed previously, have limited the use of
restraint or seclusion to emergency safety situations to ensure the
safety of the resident or others in the facility. We are permitting the
use of restraint or seclusion only until the emergency safety situation
has ceased and the safety of the resident or safety of others can be
ensured, even if the restraint or seclusion order has not expired. We
are specifically prohibiting the use of standing orders for restraint
or seclusion in these facilities.
Two commenters suggested deleting ``involuntary'' before seclusion
in the proposed ``freedom from abuse standard'' and suggested we
include seclusion under our ``restraint'' standard. We are not
including a standard entitled ``freedom from abuse'' in this rule.
Rather, we have separately defined restraint, seclusion, and time out
in this rule. We believe our definitions of seclusion and time out
sufficiently address the difference between ``voluntary'' and
``involuntary seclusion'' and therefore address the commenter's
concerns.
Seven commenters stated that we should allow seclusion because it
is less intrusive and restrictive than restraints, but that we should
specify procedures governing its use, including authorization by the
attending physician within a brief period before it is imposed,
observation at frequent intervals and access to meals and toilet. These
commenters stated that parents should be notified within 24 hours and
that the treatment team should meet as soon as possible but within 24
hours to discuss any potential modification of the treatment plan based
on the conditions that led to seclusion, and that a discussion with the
individual should take place following seclusion. As noted previously,
we have included standards governing the use of seclusion as well as
restraints in this rule including the requirement that a physician must
order restraint or seclusion. We are allowing a registered nurse to
obtain the physician's verbal order at the time that restraint or
[[Page 7154]]
seclusion is initiated, but are requiring that the physician's verbal
order be followed up with the physician's signature verifying the
order. We are requiring that staff be physically present continually
assessing and monitoring a resident in restraint or seclusion. We are
also requiring that if a resident is a minor as defined in this
subpart, the parent or guardian must be notified of the use of
restraint or seclusion as soon as possible after the initiation of an
emergency safety intervention. While we are not requiring that the
treatment team meet within 24 hours of a resident being restrained or
secluded, we are requiring that if the physician ordering the use of
restraint or seclusion is not the resident's treatment team physician,
then the ordering physician or a registered nurse must consult with the
resident's treatment team physician as soon as possible. Some of these
commenters recommended that seclusion be supervised by a psychiatrist
or licensed psychologist. We agree with the need for supervision of a
resident in restraint as well as seclusion but do not agree that
supervision should be performed by a psychiatrist or licensed
psychologist because the services of a psychiatrist or licensed
psychologist may not always be available in these facilities. However,
to ensure resident safety, we are requiring that clinical staff
continually monitor and assess a resident in restraint or seclusion.
One commenter stated that only the least intrusive passive
restraints for the protection of the individual or others be used and
that we not allow seclusion or time out rooms or chemical restraints,
mechanical restraints or adverse conditioning. We are not adopting the
recommendation that we restrict a facility's use of restraints to the
least intrusive passive restraints. While we recognize the commenter's
concern, we believe that the type of intervention used to protect a
resident should be the decision of the professionals involved with the
situation. Our standards governing orders for restraint and seclusion
require a physician to order the least restrictive intervention that is
most likely to be effective in the emergency safety situation.
Furthermore, we have included standards requiring that staff receive
education and training in identifying behavior and events that may
trigger an emergency safety situation, as well as education and
training in the use of nonphysical intervention skills such as de-
escalation, active listening and mediation conflict resolution. With
regard to the comment that time out not be allowed, we have defined
``time out'' to clarify that it is not a form of seclusion, because the
resident in time out cannot be physically prevented from leaving the
time-out area.
Four commenters stated we should entirely prohibit the use of
restraints on youngsters and that only time out and other means should
be used in times of crisis. As stated above, we believe that the type
of intervention used to ensure the safety of a resident or others in an
emergency safety situation should be the decision of the professionals
involved in that specific situation. These commenters also contended
that restraints are too often justified on the basis of self-protection
when they are really used for staff convenience, and that if restraints
are allowed in certain circumstances, it is not possible to monitor for
improper use. We recognize the commenter's concern and, therefore, our
restraint and seclusion policy states that a resident has the right to
be free from restraint or seclusion, of any form, used as a means of
coercion, discipline, convenience, or retaliation. We believe that the
standards governing restraint and seclusion, including allowing only a
board-certified psychiatrist or a licensed physician to order restraint
or seclusion, imposing time limits on the use of restraint and
seclusion that are consistent with JCAHO standards, requiring continual
monitoring and assessment of residents in restraint or seclusion, and
requiring that a resident's record be documented each time restraint or
seclusion is used, will serve to ensure the safety of residents and
diminish the inappropriate use of restraint and seclusion.
One commenter stated that a resident's parents should be notified
within 24 hours whenever seclusion is used and that the treatment team
should meet as soon as possible to discuss any needed modification to
the plan. The commenter suggested that plan modifications should be
based on analysis of the conditions leading to seclusion and discussion
with the individual following seclusion. We partially agree with these
comments and are requiring a facility to notify the parent(s) or legal
guardian(s) of a minor resident who is restrained or placed in
seclusion as soon as possible after the initiation of each emergency
safety intervention. In addition, we are requiring that
postintervention debriefings be conducted within 24 hours after the use
of restraint or seclusion. The first debriefing will provide the
resident and staff involved in the use of a restraint or seclusion the
opportunity to discuss the circumstances that resulted in its use, as
well as opportunity for the resident and staff to develop strategies
that can be employed to prevent the future use of restraint or
seclusion. A second debriefing between appropriate supervisory and
administrative staff and staff directly involved in the restraint or
seclusion of a resident must be provided to allow for a review and
discussion of the situation that required the use of restraint or
seclusion, including a discussion of alternative techniques that staff
might have employed and procedures staff could implement to prevent
future restraint or seclusion. We are requiring that changes identified
through these debriefings be documented in the resident's treatment
plan.
One commenter suggested we delete the provision that a facility may
not administer any psychoactive drugs for purposes of discipline or
convenience from our standard on restraints. The commenter stated that
facilities do not ``use'' drugs, and stated that drugs are prescribed
by a physician as clinically appropriate in his or her opinion. The
commenter asserted that this provision interferes with the practice of
medicine. We agree and have not included this language in our standards
governing restraints in this interim final rule. However, we are
prohibiting the use of any form of restraint or seclusion used as a
means of coercion, discipline, convenience, or retaliation.
One commenter stated that we need program standards for the
prescription and administration of medication, especially psychoactive
medication. We have rejected the suggestion that we set standards
governing the use of medications because we believe to do so would
amount to our practicing medicine. We have generally declined to set
standards that would limit or preclude the professional discretion of
physicians. However, we are prohibiting the use of any form of
restraint when used for coercion, discipline, or convenience because
these uses are medically unnecessary. Another commenter argued that the
standard governing drugs is much too loose and suggested six conditions
relating to drug therapy that we should include as part of our
standard. As stated above, we do not believe that we have authority to
set standards of practice regarding the use of medications. Two
commenters suggested we establish a separate condition of participation
for pharmacy services because medication is a primary component of
active treatment, and risk of medication error is substantial. We have
rejected this suggestion at this time because we are currently
publishing only standards
[[Page 7155]]
governing the use of restraint and seclusion in this interim final
rule.
IV. Response to Comments on This Interim Final Rule
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this document, and, when we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
V. Waiver of Proposed Rulemaking
In accordance with the requirements of the Administrative
Procedures Act (APA), we ordinarily publish a notice of proposed
rulemaking in the Federal Register and invite public comment on the
proposed rule before the final rule is made effective. The notice of
proposed rulemaking required by the APA includes a reference to the
legal authority under which the rule is proposed, and the terms and
substance of the proposed rule or a description of the subject matter
and issues involved. Consistent with that practice, the November 1994
proposed rule proposed limitations on the use of restraint and
seclusion by psychiatric residential treatment facilities that provide
inpatient psychiatric services to individuals under age 21 that we have
clarified and further developed in this interim final rule. In
addition, we provided the public with notice of our heightened concern
on this issue in our request for comment in the July 1999 interim final
rule on hospital restraint and seclusion standards.
We have made some important additions to the 1994 proposed rule
based both on comments received in response to the proposed rule and on
the information sources referenced in this preamble. To the extent that
there are provisions of this interim final rule that are not a logical
outgrowth of the 1994 proposed rule, we are waiving the APA rulemaking
procedure. The APA rulemaking procedure can be waived if the agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
We believe that the danger and risks to children and adolescents
from inappropriate restraint and seclusion practices are substantiated
by continued reports of deaths and serious injuries that are occurring
in residential settings. To protect the health and safety of residents,
we believe we are justified in applying more prescriptive standards in
this interim final rule governing the use of restraint and seclusion in
psychiatric residential treatment facilities than those proposed in the
November 1994 proposed rule or those promulgated in the July 1999
hospital interim final rule.
Significant public attention has been focused on restraint and
seclusion practices in psychiatric residential treatment facilities
providing services to children and adolescents. In response to concerns
about the inappropriate use of restraint and seclusion in these
facilities, the Congress passed and the President signed in October
2000, legislation to regulate the use of restraint and seclusion in
facilities that receive Medicare and Medicaid funding. That
legislation, the Childrens Health Act of 2000, provides additional
explicit statutory authority for many of the provisions of this rule.
As we noted, the Courant articles of October 1998 reported that 142
individuals had died in restraint-related incidents in the preceding
decade. It was reported that many of these deaths were the result of
improper use of mechanical restraints and that some could have been
prevented by routine monitoring of the individual. One-third of the
deaths reported by the Courant were due to asphyxia, and one-quarter
were due to cardiac-related causes. As noted earlier, a GAO report
published in September 1999, identified 24 deaths associated with
restraint or seclusion in fiscal year 1998. The GAO indicated that the
source of the data on the number of deaths reported was restraint or
seclusion-related deaths that were investigated by the Protection and
Advocacy agencies in all 50 states and the District of Columbia in
fiscal year 1998. The GAO study concluded that the full extent of
related injuries and deaths from improper restraint or seclusion
practices is unknown because there is no comprehensive reporting system
to track injuries and deaths, or a system that tracks the rates of
restraint or seclusion use by a facility. The report stated that
because reporting is so fragmentary, many more deaths related to
restraint or seclusion may have occurred. And finally, even as we
prepare to publish this rule, the media continue to investigate and
report abusive practices, including deaths and injuries to children
that are the result of inappropriate use of restraint and seclusion in
psychiatric residential treatment facilities.
Therefore, we find good cause to waive the notice of proposed
rulemaking and to issue this final rule on an interim basis because
delaying the effective date of the rule would be contrary to public
interest. We are providing a 60-day period for public comment.
VI. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide a 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act
of 1995 (PRA) requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
sections that contain information collection requirements.
Section 441.151 General Requirements
Paragraph (a)(4) of this section requires that inpatient
psychiatric services for individuals under age 21 must be certified in
writing to be necessary in the setting in which the services will be
provided (or are being provided in emergency circumstances) in
accordance with Sec. 441.152.
The certification requirement of this section is not new. The
paperwork burden is contained in the referenced Sec. 441.152, which
specifies the certification requirements, has been approved under OMB
#0938-0754.
Section 483.356 Protection of Residents
Paragraph (c) of this section, ``Notification of facility policy,''
requires facility staff to inform each incoming resident (and, in the
case of a minor, the resident's parent(s) or legal guardian(s)) at
admission, of the facility's policy regarding the use of restraint or
seclusion during an emergency safety situation that may occur while the
resident is in the facility. Staff must obtain an acknowledgment, in
writing, from the resident, or in the case of a minor, the
[[Page 7156]]
resident's parent(s) or legal guardian(s), that he or she has been
informed of the facility's policy. Staff must file the written
acknowledgment in the resident's record.
In order to estimate the burden of this requirement on facilities,
we used data from National Center for Health Statistics, Health, United
States published in 1999 (page 278) which indicated that there were 459
psychiatric residential treatment facilities in 1994, the latest year
for which data are available. We estimate an annual growth rate in the
number of these facilities to be 2 percent. Using this growth rate, we
determined that there would be approximately 475 to 500 psychiatric
residential treatment facilities nationally as of FFY 2001. These data
showed that there are approximately 70 residents per facility at any
one time. This equates to a total nationwide bed capacity approximating
35,000 beds. Through an informal survey of providers, we estimate an
average resident length of stay to be 9 months and based on a 9-month
stay, each facility would admit an estimated average of 95 residents
per year, or an estimated total of up to 47,500 residents nationally.
We believe it will take each facility 8 hours to develop a policy
statement regarding the use of restraints and seclusion, and an average
of 30 minutes to present the information to each incoming resident and
the parent(s) or guardian(s), and to obtain and file the
acknowledgment.
Thus, there will be a one-time burden of 4,000 hours nationwide to
develop the statement and an annual burden of 48 hours per psychiatric
residential treatment facility and 23,750 hours nationally to disclose
the policy.
Section 483.358 Orders for the Use of Restraint or Seclusion
In accordance with paragraph (d) of this section, a physician's
verbal order must be obtained by a registered nurse at the time the
emergency safety intervention is initiated by staff if a written order
cannot be easily obtained, and the verbal order must be followed with
the physician's signature verifying the verbal order.
While the information collection requirement in this paragraph is
subject to the PRA, we believe the burden associated with it is exempt
as defined in 5 CFR 1320.3(b)(2) because the time, effort, and
financial resources necessary to comply with the requirement are
incurred by persons in the normal course of their activities.
In accordance with paragraph (h) of this section, each order for
restraint or seclusion must be documented in the resident's record.
Documentation must include--
(1) The ordering physician's name;
(2) The date and time the order was obtained;
(3) The emergency safety intervention ordered, including the length
of time for which the physician authorized its use;
(4) The time the emergency safety intervention actually began and
ended;
(5) The time and results of any 1 hour assessments required in
paragraph (f) of this section.
(6) The emergency safety situation that required the resident to be
restrained or put in seclusion; and
(7) The name, title, and credentials of staff involved in the
emergency safety intervention.
There are an estimated average of 47 situations per month per
psychiatric residential treatment facility where restraint or seclusion
is used, or approximately 282,000 situations nationally, per year. We
estimate that it will take approximately 30 minutes per situation, or
282 hours annually per psychiatric residential treatment facility, for
a national total of 141,000 hours annually to comply with the
documentation requirements.
In accordance with paragraph (i) of this section, the facility must
maintain an aggregate record of all emergency safety situations, the
interventions used, and their outcomes.
Based on 15 minutes per situation, we estimate that it will take
141 hours per psychiatric residential treatment facility, and a
national total of 70,500 hours annually to comply with this
documentation requirement.
In accordance with paragraph (j) of this section, the physician
ordering the restraint or seclusion must sign the order in the
resident's record as soon as possible, but no later than 24 hours after
the order is issued.
While these information collection requirements are subject to the
PRA, we believe the burden associated with them is exempt as defined in
5 CFR 1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with the requirement are incurred by persons in the
normal course of their activities.
Sec. 483.360 Consultation With Treatment Team Physician
Paragraph (a) of this section requires that, if the physician
ordering the use of restraint or seclusion is not part of the
resident's treatment team, the facility must consult with the
resident's treatment team physician as soon as possible and inform the
team physician of the emergency safety situation that required the
resident to be restrained or placed in seclusion. Paragraph (f) of this
section requires the facility to document in the resident's record the
date and time the team physician was consulted.
We estimate that it will take approximately 30 minutes per
situation, 282 hours annually per psychiatric residential treatment
facility, or 141,000 hours nationally to comply with the documentation
and disclosure requirements of this section, based on an assumption
that approximately half of the situations will require that the
facility staff separately notify the treatment team physician.
Section 483.366 Notification of Parent(s) or Legal Guardian(s)
If the resident is a minor as defined in Sec. 483.352, paragraph
(a) of this section requires the facility to notify the parent(s) or
legal guardian(s) of a resident who has been restrained or placed in
seclusion as soon as possible after the initiation of each emergency
safety intervention.
Paragraph (b) of this section requires the facility to document in
the resident's record that the parent(s) or legal guardian(s) has been
notified of the emergency safety intervention, including the date and
time of notification and the name of the staff person providing the
notification.
We estimate that it will take 30 minutes to notify a parent or
guardian and 15 minutes to document that notification. The total annual
burden will be 423 hours per psychiatric residential treatment facility
and 211,500 hours nationally, based on the assumption that virtually
all of the residents will be minors as defined in Sec. 483.352.
Section 483.370 Postintervention Debriefings
Paragraph (c) of this section requires that staff document in the
resident's record that the debriefing sessions required by this section
took place.
This documentation will take approximately 30 minutes per
situation, or an annual burden of 282 hours per psychiatric residential
treatment facility and 141,000 hours nationally.
Section 483.372 Medical Treatment for Injuries Occurring as a Result
of an Emergency Safety Situation
Paragraph (b) of this section requires the psychiatric residential
treatment facility to have affiliations or written transfer agreements
in effect with one or more hospitals approved for participation under
the Medicaid program that reasonably ensure that--
(1) A resident will be transferred from the facility to the
hospital and admitted
[[Page 7157]]
in a timely manner when a transfer is medically necessary for medical
care or acute psychiatric care;
(2) Medical and other information needed for care of the resident
in light of such a transfer, will be exchanged between the institutions
in accordance with State medical privacy law, including any information
needed to determine whether the appropriate care can be provided in a
less restrictive setting; and
(3) Services are available to each resident 24 hours a day, 7 days
a week.
Paragraph (c) of this section requires that staff document in the
resident's record all injuries that occur as a result of an emergency
safety situation, including injuries to staff resulting from that
intervention.
While these information collection requirements are subject to the
PRA, we believe the burden associated with them is exempt as defined in
5 CFR 1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with the requirement are incurred by persons in the
normal course of their activities.
Section 483.374 Facility Reporting
Paragraph (a) of this section requires each psychiatric residential
treatment facility that provides inpatient psychiatric services to
individuals under age 21 to attest, in writing, that the facility is in
compliance with our standards governing the use of restraint and
seclusion. This attestation must be signed by the facility director.
We estimate that it will take 8 hours per facility to be able to
attest to compliance with the standards. This is a one-time burden. The
national burden will be 500 multiplied by 8, or 4,000 hours.
Paragraph (b) of this section requires that the facility report
serious occurrences involving a resident to both the State Medicaid
Agency and, unless prohibited by State law, the State-designated
Protection and Advocacy System. The report must include the name of the
resident involved in the serious occurrence, a description of the
occurrence, and the name, street address, and telephone number of the
facility. In the case of a minor, the facility must also notify the
parent(s) or legal guardian(s) of the resident involved in a serious
occurrence.
Staff must document in the resident's record that the contacts
above were made.
The burden for notifying parent(s) or legal guardian(s) is
addressed under Sec. 483.366.
We estimate that it will take an additional 15 minutes to document
that these contacts were made, for an average annual burden of 141
hours per psychiatric residential treatment facility, with an annual
national total of 70,500 burden hours.
Section 483.376 Education and Training
Paragraph (f) requires facilities to provide for assessments of
staff education and training needs by requiring staff to demonstrate
their competencies related to the use of emergency safety interventions
on a semiannual basis. This section also provides for staff to
demonstrate, on an annual basis, their competency in the use of
cardiopulmonary resuscitation.
Paragraph (g) of this section requires the facility to document in
the staff personnel records that the training required by Sec. 483.376
was successfully completed.
While these information collection requirements are subject to the
PRA, we believe the burden associated with them are exempt as defined
in 5 CFR 1320.3(b)(2) because the time, effort, and financial resources
necessary to comply with the requirement are incurred by persons in the
normal course of their activities.
Comments
If you comment on these information collection and recordkeeping
requirements, please mail copies directly to the following:
Health Care Financing Administration, Office of Information Services,
Security and Standards Group, Attn: Julie Brown, Room N2-14-26, 7500
Security Boulevard, Baltimore, MD 21244-1850;
and
Office of Information and Regulatory Affairs, Office of Management and
Budget, Room 10235, New Executive Office Building, Washington, DC
20503, Attn: Brenda Aguilar, HCFA Desk Officer.
VII. Regulatory Impact Statement
A. Overall Impact
We have examined the impact of this interim final rule as required
by Executive Order 12866 and the Regulatory Flexibility Act (RFA)
(Public Law 96-354). Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity).
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government agencies. Most
hospitals and most other providers and suppliers are small entities,
either by nonprofit status or by having revenues of $5 million or less
annually. For purposes of the RFA, all psychiatric residential
treatment facilities are considered to be small entities. Individuals
and States are not included in the definition of a small entity.
Consistent with the RFA, we prepare a regulatory flexibility analysis
unless we certify that a rule will not have a significant economic
impact on a substantial number of small entities.
Also, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. That
analysis must conform to the provisions of section 604 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds. This regulation does not
have an impact on small rural hospitals. However, to the extent the
rule may have significant effects on psychiatric residential treatment
facilities and their residents, or be viewed as controversial, we
believe it is desirable to inform the public of our projections of the
likely effects of the proposals.
The Unfunded Mandates Reform Act of 1995 requires (in section 202)
that agencies prepare an assessment of anticipated costs and benefits
for any rule that may result in a mandated expenditure in any 1 year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more. This rule has no mandated
consequential effect on State, local, or on tribal governments, or the
private sector. We have described the anticipated effects of this
regulation below.
We have reviewed this interim final rule with comment under the
threshold criteria of Executive Order 13132, Federalism. We have
determined that this interim final rule with comment does not
significantly affect the rights, roles, and responsibilities of States.
This rule is the product of serious concern about improper use of
restraints and seclusion in psychiatric residential treatment
facilities. This led us to set forth this interim final rule with
comment to ensure the protection of residents of these facilities from
improper restraint and seclusion
[[Page 7158]]
practices that could contribute to death or serious injury.
B. Anticipated Effects
1. Effect on Psychiatric Residential Treatment Facilities
We believe that many psychiatric residential treatment facilities
are already in compliance with this rule because of State laws
governing the use of restraint and seclusion, as well as their own
quality assurance and improvement systems. Additionally, psychiatric
residential treatment facilities must meet current Federal requirements
for accreditation in order to provide inpatient psychiatric services to
individuals under age 21. We are aware that the national accrediting
organizations are currently in the process of revising their standards
governing the use of restraint and seclusion. Therefore, the impact of
this rule will not be determinable to the extent that the accrediting
organizations' revised restraint and seclusion standards are or are not
compatible with the requirements of this rule.
There are several provisions that will have an impact on
psychiatric residential treatment facilities. The facilities will have
to notify a parent(s) or a legal guardian(s) when restraint or
seclusion is used, and ensure that staff are provided with initial and
ongoing education and training in the proper and safe use of seclusion
and the proper and safe use of restraint, and in techniques and
alternative methods for handling resident behavior, symptoms, and
situations that traditionally have been treated by the use of
restraints or seclusion.
There will be facility costs associated with developing a policy on
the use of restraint and seclusion in emergency safety situations and
ensuring that this policy statement is available to residents and
family members as well as facility staff.
We anticipate that some facilities will need additional registered
nurses to be present during all shifts, including weekends, because we
are requiring that, when a physician is not present to order the use of
restraint or seclusion, a registered nurse must be present to obtain
the physician's verbal order, and to contact the ordering physician
should an emergency safety situation continue beyond the time limit of
the physician's order. In addition, when a physician is not available,
we are requiring a registered nurse to perform the 1 hour assessment of
an individual who is restrained or secluded, and to evaluate the
resident's well-being after he or she is removed from restraint or
seclusion.
While psychiatric residential treatment facilities generally offer
a less restrictive alternative to hospital treatment of psychiatric
conditions, they are recognized as an inpatient setting for the
purposes of providing mental health services under the Medicaid
Inpatient Psychiatric Services Under Age 21 benefit. Unlike hospitals,
which have a full cadre of medical professional staff present on a 24-
hour basis, psychiatric residential treatment facilities may not be
required to provide 24-hour coverage by licensed medical professional
staff. In our informal research, we found that some facilities employ
medical professional staff on a less than 24-hour basis. One facility
contracts with a physician to provide 24-hour ``on-call'' coverage
which does not equate to continual onsite coverage by medical staff.
Since these facilities are providing medically necessary services in an
inpatient setting, we believe that medical professional staff should be
present on a 24-hour basis.
An emergency safety situation involving a resident of a facility
can occur at any time, requiring staff to use restraints or seclusion
as an emergency intervention to ensure the resident's safety or the
safety of others. These emergencies often occur in the evening or on
weekends when staffing levels may be lower than during the day. When
such a situation occurs in a hospital, trained medical professional
staff are onsite 24 hours a day to assist in the proper and safe
application and monitoring of restraints. However, while psychiatric
residential treatment facilities provide essentially the same inpatient
care to vulnerable children and adolescents, trained medical
professional staff are not required to be present 24 hours a day. This
disparity creates increased risk for serious injury or even death when
staff are faced with an emergency safety situation requiring the use of
restraint or seclusion. Therefore, we believe that it is not only
reasonable but critical to resident safety that we require these
facilities to provide 24-hour onsite coverage by a registered nurse. It
would be irresponsible not to extend the same level of protections to
children and adolescents in these facilities that are provided in a
hospital.
In addition, this rule requires psychiatric residential treatment
facilities to report both to the State Medicaid agency and the State-
designated P&A system, any serious occurrence, including a resident's
death, a serious injury to a resident, or a resident's suicide attempt.
In the case of a minor, the facility must also notify the parent(s) or
legal guardian(s) of the resident involved in a serious occurrence. We
believe that this new reporting requirement will have only a minimal
cost impact on facilities.
The Hartford Courant, a Connecticut newspaper, heightened public
awareness of this issue with a series of articles in October 1998
citing the results of a study that identified 142 deaths from the use
of seclusion and restraint in behavioral health treatment facilities
over the past 10 years. However, this number includes deaths from the
use of seclusion and restraint in more than just the psychiatric
residential treatment facility setting. We believe the nationwide
reporting of deaths and serious injuries in psychiatric residential
treatment facilities will contribute to the reduction of deaths or
serious injuries that result from the inappropriate use of restraint
and seclusion.
We believe that there will be costs associated with developing and
implementing training programs for facility staff. However, we are not
prescribing how facilities will meet the training requirements.
Therefore, psychiatric residential treatment facilities will be
afforded the flexibility to provide the training directly through ``in-
house'' training or to obtain a contractor to provide the training
either at the facility or off-site.
2. Effect on Beneficiaries
The implementation of this regulation will serve to protect
residents and staff of psychiatric residential treatment facilities. We
anticipate that the benefits will include a significant reduction in
the inappropriate use of restraint and seclusion which will result in a
reduction in the number of deaths and serious injuries to residents and
facility staff.
3. Effect on Medicaid Program
We expect the implementation of this regulation will generate some
costs to the Medicaid program. There will be additional facility costs
as described in the table below.
C. Summary of Estimated Costs
The following are the assumptions and the methodology we used to
derive the estimated costs for implementing this rule. We are
soliciting public comments regarding any available information that may
affect the cost estimates associated with the implementation of this
rule.
[[Page 7159]]
Annual Cost
[$ Millions]
----------------------------------------------------------------------------------------------------------------
FY 2001 FY 2002 FY 2003 FY 2004 FY 2005
----------------------------------------------------------------------------------------------------------------
Psych. Residential Treatment
Facility Costs:
Medicaid--Federal Share..... 16 31 31 33 34
Medicaid--State Share....... 12 24 24 25 26
Other Payers................ 1 3 3 3 3
-------------------------------------------------------------------------------
Total................... 29 58 58 61 63
===============================================================================
State Medicaid Administrative
Costs:
Federal Share............... 1 1 1 1 1
State Share................. 1 1 1 1 1
-------------------------------------------------------------------------------
Total................... 2 2 2 2 2
===============================================================================
Fed. Admin. Costs for Survey and
Certification
Total................... \(1)\ \(1)\ \(1)\ \(1)\ \(1)\
----------------------------------------------------------------------------------------------------------------
\1\Less than $0.5 million.
Psychiatric Residential Treatment Facility Costs
Psychiatric residential treatment facility costs are comprised of
three categories: (1) additional registered nursing staff, (2) staff
training, and (3) facility reporting.
Data from Health, United States, 1999 (National Center for Health
Statistics, p. 278) indicate that there were 459 psychiatric
residential treatment facilities in 1994, the latest year for which
data are available. Resident care staff in these facilities totaled
about 44,000 in that same year. Using a 2 percent growth rate trend
developed from the Health US 1999 data above, we projected the number
of facilities and the number of resident care staff for Federal fiscal
years (FFY) 2001 through 2005.
1. New staff costs. The Health US 1999 data on staffing for
psychiatric residential treatment facilities shows an average of 3.2
full-time-equivalent (FTE) registered nurses per facility. The
requirement for 24 hour per day registered nurse coverage would require
a minimum of 4.2 FTEs (168 hours per week divided by 40 hours per week
per FTE). Each facility would, at a minimum, have to provide for an
average of one additional FTE registered nurse. For these estimates we
have assumed an increase of 1.5 FTE registered nurses per facility,
which translates into a requirement for approximately 790 additional
registered nurses to provide the necessary coverage in all psychiatric
residential treatment facilities in FFY 2001. We trended the registered
nurse staffing requirement forward through 2005 based on our estimation
that resident population growth would approximate 2 percent per year.
The numbers of registered nurses needed to provide coverage in years
subsequent to FFY 2001 will vary with changes in the numbers of
residents. We assumed the total annual compensation (salary and fringe
benefits) for each registered nurse to be $56,000 in FFY 2001,
totalling $44.2 million nationally. The total costs are estimated to
increase by 3 percent per year thereafter. Data taken from the Nursing
Department Compensation Report 1999-2000 (Hospital and Healthcare
Compensation Service, Oakland New Jersey, page 18) indicate that the
annual national average base salary for inpatient hospital psychiatric
nursing positions (equivalent in skills and payment level to the nurses
working in psychiatric residential treatment facilities) would
approximate $19.99 per hour or $41,580 annually for 1999, the latest
year for which data are available. The Report indicates that the
average increase in psychiatric nursing salaries approximates 3 percent
per year. Using a 3 percent growth rate we projected the annual salary
for psychiatric nurses for Federal fiscal years 2001 through 2005. We
added a factor of 27.0 percent to psychiatric nurses salary for fringe
benefit costs. The term fringe benefits includes paid leave,
supplemental pay, insurance, retirement, savings and other benefits.
The 27.0 percent was shown for nurse fringe benefit costs in the
publication: Employer Costs for Employee Compensation, 1986-1998, Table
2, Employer Costs Per Hour Worked for Employee Compensation and Costs
as a Percent of Total Compensation: Civilian Workers, by Occupational
and Industry Group, March 1998'' (U.S. Department of Labor, Bureau of
Labor Statistics, page 10). The rate of fringe benefits to salary
ranged from 27.0 to 27.7 percent over the period from March 1994
through March 1998, with the majority at 27.0 percent, as shown in
Tables 2, 18, 34, 50, and 66 of the same publication. The year 1998 is
the latest period for which such data are available. As a result, we
used 27.0 percent as a constant in our cost projection for Federal
fiscal years 2001 through 2005 as any variation in rate would represent
a very limited change in projected fringe benefit costs.
2. Training costs. Existing Federal Medicaid regulations at 42 CFR
441.151 require that a psychiatric facility that provides inpatient
psychiatric services to individuals under age 21 be accredited by the
Joint Commission on Accreditation of Healthcare Organizations (JCAHO),
the Commission on Accreditation of Rehabilitation Facilities, the
Council on Accreditation of Services for Families and Children, or by
any other accrediting organization, with comparable standards that is
recognized by the State. Most of these facilities are currently
accredited by JCAHO. In August 2000, JCAHO published its Comprehensive
Accreditation Manual for Hospitals, which includes revised behavioral
health care standards governing the use of restraint and seclusion.
These revised restraint and seclusion standards apply to all behavioral
health care settings, including residential treatment centers.
Specifically, JCAHO strengthened existing standards governing training
requirements for direct care staff in the safe use of restraint and
seclusion and the requirement for education and assessment of staff
competence in minimizing the use of restraint and seclusion. These new
standards will take effect January 1, 2001.
We have made the following assumptions with regard to staff
training: (1) That the revised JCAHO
[[Page 7160]]
training requirements for facility accreditation will not fully meet
the training requirements under this interim final rule, and therefore
have included estimated costs for staff training which we obtained
through research on consultants who provide this specific service; (2)
that, at a minimum, staff training to meet the requirements of this
rule would cost approximately $250 per staff person for initial
training, and approximately $100 annually for ongoing staff training,
and (3) that only 10 percent of staff would fully meet the training
requirements under this rule.
We estimated that by FFY 2001 the facility staff would have grown
to approximately 50, 000 from the 44,000 staffing estimate for 1994
(see page 69). We assume that approximately 90 percent of the facility
staff, or about 45,000 employees would require training in the use of
restraint and seclusion,. We estimate that approximately 75 percent of
the staff to be trained, or 33,750, would require initial training at
an estimated $250 per person, totaling approximately $8.4 million. The
remaining 11,250 staff would require ongoing training at about $100 per
employee, amounting to an estimated $1.1 million.
In addition to direct training costs, we also assumed that
facilities would incur related consulting costs averaging 10 hours per
month per facility at a cost of $40 per hour. Inflation for all
training and related costs was assumed to be 5 percent per year.
3. Reporting costs. In the absence of any current verifiable data
on serious occurrences involving residents in psychiatric residential
treatment facilities, we have assumed the costs of the required
reporting of these events to be approximately $250 per facility, per
year. We are soliciting comments regarding any available information on
actual reporting costs.
Total estimated facility costs of compliance, as shown in the above
table, are estimated to be $58 million in the first full year of
implementation (FFY 2002). This figure represents about 1.6 percent of
the total projected expenditures of $3.3 billion for psychiatric
residential treatment facilities in that year, as derived from the
Health US 1999 data.
State Medicaid Administration Costs
States will have additional responsibilities and costs for survey
and certification requirements associated with the requirements of this
regulation. Beginning in Federal fiscal year 2001, we project there
will be 500 residential treatment facilities, or an average of 10
facilities per state. For each state, we estimated an annual survey
agency cost equivalent to 5 days to conduct 2 onsite reviews (20
percent sample) to validate facility attestation to our new restraint
and seclusion standards. We also estimated that documentary reviews of
facility attestations, including any necessary follow up with
facilities in conjunction with the attestation would require the survey
agency to incur costs equivalent to 5 days. We also estimated costs
associated with restraint and seclusion complaints which would require
investigation by the survey agency. We estimated 2 complaints annually
requiring onsite follow up by the survey agency, including enforcement
activities and appeals-related activities. We estimated each complaint
would require 2 days for onsite visits, 2 days for follow up and 1 day
for appeals-related activities for a total of 10 days for 2 complaints.
We assumed the need for an additional one-tenth of an FTE per state to
support this additional workload.
Current expenditures indicate an average cost (salary and benefits)
of $50,000 for state survey agency professional personnel; one-tenth of
one FTE would cost $5,000 per year. Because these are Medicaid-only
facilities, the survey and certification costs will be paid under the
Medicaid program. Based on the current 75/25 Federal-state match, the
average expenditures for each state would be $3,750 in Federal Medicaid
funds, and $1,250 in state-matching funds.
Other Assumptions
Available evidence indicates that residents of psychiatric
residential treatment facilities are overwhelmingly Medicaid-eligible.
Therefore, we have assumed that 95 percent of the costs incurred by
these facilities to implement these new regulations would be defrayed
by the Medicaid program and 5 percent by other payers. We are assuming
that States will continue to fully fund the costs of this benefit.
D. Alternatives Considered
We originally considered developing one set of requirements
regulating the use of restraint and seclusion for all provider types in
the Medicare and Medicaid programs. However, based on public comments
received in response to the interim final regulation addressing a
similar CoP for hospitals, and recent concerns about restraint and
seclusion use for behavior management situations, we concluded that one
set of requirements did not afford all patients (or residents) with
adequate protections. Moreover, with the enactment of the Children's
Health Act of 2000, the Secretary no longer has the discretion to leave
this benefit unregulated.
E. Conclusion
The CoP for psychiatric residential treatment facilities sets forth
a series of requirements to ensure each resident's physical and
emotional health and safety. These requirements address each resident's
right to be free from restraint or seclusion, of any form, used as a
means of coercion, discipline, convenience, or retaliation. The CoP is
a new requirement for facilities that provide inpatient psychiatric
residential treatment services to Medicaid eligible individuals under
age 21. In accordance with the Regulatory Flexibility Act, we have
examined the burden this rule may impose on small entities and certify
that this rule will not have a significant impact on a substantial
number of intities.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 441
Family planning, Grant programs-health, Infants and children,
Medicaid, Penalties, Reporting and recordkeeping requirements.
42 CFR Part 483
Grant programs-health, Health facilities, Health professionals,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
For the reasons set forth in the preamble, 42 CFR chapter IV is
amended as follows:
PART 441--SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC
SERVICES
A. Part 441 is amended as set forth below:
1. The authority citation for part 441 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
2. Section 441.151 is revised to read as follows:
Sec. 441.151 General requirements.
(a) Inpatient psychiatric services for individuals under age 21
must be:
(1) Provided under the direction of a physician;
(2) Provided by--
(i) A psychiatric hospital or an inpatient psychiatric program in a
hospital, accredited by the Joint Commission on Accreditation of
Healthcare Organizations; or
[[Page 7161]]
(ii) A psychiatric facility that is not a hospital and is
accredited by the Joint Commission on Accreditation of Healthcare
Organizations, the Commission on Accreditation of Rehabilitation
Facilities, the Council on Accreditation of Services for Families and
Children, or by any other accrediting organization with comparable
standards that is recognized by the State.
(3) Provided before the individual reaches age 21, or, if the
individual was receiving the services immediately before he or she
reached age 21, before the earlier of the following--
(i) The date the individual no longer requires the services; or
(ii) The date the individual reaches 22; and
(4) Certified in writing to be necessary in the setting in which
the services will be provided (or are being provided in emergency
circumstances) in accordance with Sec. 441.152.
(b) Inpatient psychiatric services furnished in a psychiatric
residential treatment facility as defined in Sec. 483.352 of this
chapter, must satisfy all requirements in subpart G of part 483 of this
chapter governing the use of restraint and seclusion.
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
B. Part 483 is amended as set forth below:
1. The authority citation for part 483 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
2. A new subpart G, consisting of Secs. 483.350 through 483.376, is
added to part 483 to read as follows:
Subpart G--Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
Sec.
483.350 Basis and scope.
483.352 Definitions.
483.354 General requirements for psychiatric residential treatment
facilities.
483.356 Protection of residents.
483.358 Orders for the use of restraint or seclusion.
483.360 Consultation with treatment team physician.
483.362 Monitoring of the resident in and immediately after
restraint.
483.364 Monitoring of the resident in and immediately after
seclusion.
483.366 Notification of parent(s) or legal guardian(s).
483.368 Application of time out.
483.370 Postintervention debriefings.
483.372 Medical treatment for injuries resulting from an emergency
safety intervention.
483.374 Facility reporting.
483.376 Education and training.
Subpart G--Condition of Participation for the Use of Restraint or
Seclusion in Psychiatric Residential Treatment Facilities Providing
Inpatient Psychiatric Services for Individuals Under Age 21
Sec. 483.350 Basis and scope.
(a) Statutory basis. Sections 1905(a)(16) and (h) of the Act
provide that inpatient psychiatric services for individuals under age
21 include only inpatient services that are provided in an institution
(or distinct part thereof) that is a psychiatric hospital as defined in
section 1861(f) of the Act or in another inpatient setting that the
Secretary has specified in regulations. Additionally, the Children's
Health Act of 2000 (Pub. L. 106-310) imposes procedural reporting and
training requirements regarding the use of restraints and involuntary
seclusion in facilities, specifically including facilities that provide
inpatient psychiatric services for children under the age of 21 as
defined by sections 1905(a)(16) and (h) of the Act.
(b) Scope. This subpart imposes requirements regarding the use of
restraint or seclusion in psychiatric residential treatment facilities,
that are not hospitals, providing inpatient psychiatric services to
individuals under age 21.
Sec. 483.352 Definitions.
For purposes of this subpart, the following definitions apply:
Drug used as a restraint means any drug that--
(1) Is administered to manage a resident's behavior in a way that
reduces the safety risk to the resident or others;
(2) Has the temporary effect of restricting the resident's freedom
of movement; and
(3) Is not a standard treatment for the resident's medical or
psychiatric condition.
Emergency safety intervention means the use of restraint or
seclusion as an immediate response to an emergency safety situation.
Emergency safety situation means unanticipated resident behavior
that places the resident or others at serious threat of violence or
injury if no intervention occurs and that calls for an emergency safety
intervention as defined in this section.
Mechanical restraint means any device attached or adjacent to the
resident's body that he or she cannot easily remove that restricts
freedom of movement or normal access to his or her body.
Minor means a minor as defined under State law and, for the purpose
of this subpart, includes a resident who has been declared legally
incompetent by the applicable State court.
Personal restraint means the application of physical force without
the use of any device, for the purpose of restricting the free movement
of a resident's body.
Psychiatric Residential Treatment Facility means a facility other
than a hospital, that provides psychiatric services, as described in
subpart D of part 441 of this chapter, to individuals under age 21, in
an inpatient setting.
Restraint means a ``personal restraint,'' ``mechanical restraint,''
or ``drug used as a restraint'' as defined in this section.
Seclusion means the involuntary confinement of a resident alone in
a room or an area from which the resident is physically prevented from
leaving.
Serious injury means any significant impairment of the physical
condition of the resident as determined by qualified medical personnel.
This includes, but is not limited to, burns, lacerations, bone
fractures, substantial hematoma, and injuries to internal organs,
whether self-inflicted or inflicted by someone else.
Staff means those individuals with responsibility for managing a
resident's health or participating in an emergency safety intervention
and who are employed by the facility on a full-time, part-time, or
contract basis.
Time out means the restriction of a resident for a period of time
to a designated area from which the resident is not physically
prevented from leaving, for the purpose of providing the resident an
opportunity to regain self-control.
Sec. 483.354 General requirements for psychiatric residential
treatment facilities.
A psychiatric residential treatment facility must meet the
requirements in Sec. 441.151 through Sec. 441.182 of this chapter.
Sec. 483.356 Protection of residents.
(a) Restraint and seclusion policy for the protection of residents.
(1) Each resident has the right to be free from restraint or seclusion,
of any form, used as a means of coercion, discipline, convenience, or
retaliation.
(2) An order for restraint or seclusion must not be written as a
standing order or on an as-needed basis.
[[Page 7162]]
(3) Restraint or seclusion must not result in harm or injury to the
resident and must be used only--
(i) To ensure the safety of the resident or others during an
emergency safety situation; and
(ii) Until the emergency safety situation has ceased and the
resident's safety and the safety of others can be ensured, even if the
restraint or seclusion order has not expired.
(4) Restraint and seclusion must not be used simultaneously.
(b) Emergency safety intervention. An emergency safety intervention
must be performed in a manner that is safe, proportionate, and
appropriate to the severity of the behavior, and the resident's
chronological and developmental age; size; gender; physical, medical,
and psychiatric condition; and personal history (including any history
of physical or sexual abuse).
(c) Notification of facility policy. At admission, the facility
must--
(1) Inform both the incoming resident and, in the case of a minor,
the resident's parent(s) or legal guardian(s) of the facility's policy
regarding the use of restraint or seclusion during an emergency safety
situation that may occur while the resident is in the program;
(2) Communicate its restraint and seclusion policy in a language
that the resident, or his or her parent(s) or legal guardian(s)
understands (including American Sign Language, if appropriate) and when
necessary, the facility must provide interpreters or translators;
(3) Obtain an acknowledgment, in writing, from the resident, or in
the case of a minor, from the parent(s) or legal guardian(s) that he or
she has been informed of the facility's policy on the use of restraint
or seclusion during an emergency safety situation. Staff must file this
acknowledgment in the resident's record; and
(4) Provide a copy of the facility policy to the resident and in
the case of a minor, to the resident's parent(s) or legal guardian(s).
(d) Contact information. The facility's policy must provide contact
information, including the phone number and mailing address, for the
appropriate State Protection and Advocacy organization.
Sec. 483.358 Orders for the use of restraint or seclusion.
(a) Only a board-certified psychiatrist, or a physician licensed to
practice medicine with specialized training and experience in the
diagnosis and treatment of mental diseases, may order the use of
restraint or seclusion.
(b) If the resident's treatment team physician is available, only
he or she can order restraint or seclusion. If the resident's treatment
team physician is unavailable, the physician covering for the treatment
team physician can order restraint or seclusion. The covering physician
must meet the same requirements for training and experience described
in paragraph (a) of this section.
(c) The physician must order the least restrictive emergency safety
intervention that is most likely to be effective in resolving the
emergency safety situation based on consultation with staff.
(d) If the physician is not available to order the use of restraint
or seclusion, the physician's verbal order must be obtained by a
registered nurse at the time the emergency safety intervention is
initiated by staff and the physicians verbal order must be followed
with the physician's signature verifying the verbal order. The ordering
physician must be available to staff for consultation, at least by
telephone, throughout the period of the emergency safety intervention.
(e) Each order for restraint or seclusion must:
(1) Be limited to no longer than the duration of the emergency
safety situation; and
(2) Under no circumstances exceed 4 hours for residents ages 18 to
21; 2 hours for residents ages 9 to 17; or 1 hour for residents under
age 9.
(f) Within 1 hour of the initiation of the emergency safety
intervention, a physician or clinically qualified registered nurse
trained in the use of emergency safety interventions must conduct a
face-to-face assessment of the physical and psychological well being of
the resident, including but not limited to--
(1) The resident's physical and psychological status;
(2) The resident's behavior;
(3) The appropriateness of the intervention measures; and
(4) Any complications resulting from the intervention.
(g) Each order for restraint or seclusion must include--
(1) The ordering physician's name;
(2) The date and time the order was obtained; and
(3) The emergency safety intervention ordered, including the length
of time for which the physician authorized its use.
(h) Staff must document the intervention in the resident's record.
That documentation must be completed by the end of the shift in which
the intervention occurs. If the intervention does not end during the
shift in which it began, documentation must be completed during the
shift in which it ends. Documentation must include all of the
following:
(1) Each order for restraint or seclusion as required in paragraph
(g) of this section.
(2) The time the emergency safety intervention actually began and
ended.
(3) The time and results of the 1-hour assessment required in
paragraph (f) of this section.
(4) The emergency safety situation that required the resident to be
restrained or put in seclusion.
(5) The name of staff involved in the emergency safety
intervention.
(i) The facility must maintain a record of each emergency safety
situation, the interventions used, and their outcomes.
(j) The physician ordering the restraint or seclusion must sign the
order in the resident's record as soon as possible.
Sec. 483.360 Consultation with treatment team physician.
If the physician ordering the use of restraint or seclusion is not
the resident's treatment team physician, the ordering physician or
registered nurse must--
(a) Consult with the resident's treatment team physician as soon as
possible and inform the team physician of the emergency safety
situation that required the resident to be restrained or placed in
seclusion; and
(b) Document in the resident's record the date and time the team
physician was consulted.
Sec. 483.362 Monitoring of the resident in and immediately after
restraint.
(a) Clinical staff trained in the use of emergency safety
interventions must be physically present, continually assessing and
monitoring the physical and psychological well-being of the resident
and the safe use of restraint throughout the duration of the emergency
safety intervention.
(b) If the emergency safety situation continues beyond the time
limit of the physician's order for the use of restraint, a registered
nurse must immediately contact the ordering physician in order to
receive further instructions.
(c) A physician, or a registered nurse trained in the use of
emergency safety interventions, must evaluate the resident's well-being
immediately after the restraint is removed.
Sec. 483.364 Monitoring of the resident in and immediately after
seclusion.
(a) Clinical staff, trained in the use of emergency safety
interventions, must be physically present in or immediately outside the
seclusion room, continually
[[Page 7163]]
assessing, monitoring, and evaluating the physical and psychological
well-being of the resident in seclusion. Video monitoring does not meet
this requirement.
(b) A room used for seclusion must--
(1) Allow staff full view of the resident in all areas of the room;
and
(2) Be free of potentially hazardous conditions such as unprotected
light fixtures and electrical outlets.
(c) If the emergency safety situation continues beyond the time
limit of the physician's order for the use of seclusion, a registered
nurse must immediately contact the ordering physician in order to
receive further instructions.
(d) A physician, or a registered nurse trained in the use of
emergency safety interventions, must evaluate the resident's well-being
immediately after the resident is removed from seclusion.
Sec. 483.366 Notification of parent(s) or legal guardian(s).
If the resident is a minor as defined in this subpart:
(a) The facility must notify the parent(s) or legal guardian(s) of
the resident who has been restrained or placed in seclusion as soon as
possible after the initiation of each emergency safety intervention.
(b) The facility must document in the resident's record that the
parent(s) or legal guardian(s) has been notified of the emergency
safety intervention, including the date and time of notification and
the name of the staff person providing the notification.
Sec. 483.368 Application of time out.
(a) A resident in time out must never be physically prevented from
leaving the time out area.
(b) Time out may take place away from the area of activity or from
other residents, such as in the resident's room (exclusionary), or in
the area of activity or other residents (inclusionary).
(c) Staff must monitor the resident while he or she is in time out.
Sec. 483.370 Postintervention debriefings.
(a) Within 24 hours after the use of restraint or seclusion, staff
involved in an emergency safety intervention and the resident must have
a face-to-face discussion. This discussion must include all staff
involved in the intervention except when the presence of a particular
staff person may jeopardize the well-being of the resident. Other staff
and the resident's parent(s) or legal guardian(s) may participate in
the disussion when it is deemed appropriate by the facility. The
facility must conduct such discussion in a language that is understood
by the resident's parent(s) or legal guardian(s). The discussion must
provide both the resident and staff the opportunity to discuss the
circumstances resulting in the use of restraint or seclusion and
strategies to be used by the staff, the resident, or others that could
prevent the future use of restraint or seclusion.
(b) Within 24 hours after the use of restraint or seclusion, all
staff involved in the emergency safety intervention, and appropriate
supervisory and administrative staff, must conduct a debriefing session
that includes, at a minimum, a review and discussion of--
(1) The emergency safety situation that required the intervention,
including a discussion of the precipitating factors that led up to the
intervention;
(2) Alternative techniques that might have prevented the use of the
restraint or seclusion;
(3) The procedures, if any, that staff are to implement to prevent
any recurrence of the use of restraint or seclusion; and
(4) The outcome of the intervention, including any injuries that
may have resulted from the use of restraint or seclusion.
(c) Staff must document in the resident's record that both
debriefing sessions took place and must include in that documentation
the names of staff who were present for the debriefing, names of staff
that were excused from the debriefing, and any changes to the
resident's treatment plan that result from the debriefings.
Sec. 483.372 Medical treatment for injuries resulting from an
emergency safety intervention.
(a) Staff must immediately obtain medical treatment from qualified
medical personnel for a resident injured as a result of an emergency
safety intervention.
(b) The psychiatric residential treatment facility must have
affiliations or written transfer agreements in effect with one or more
hospitals approved for participation under the Medicaid program that
reasonably ensure that--
(1) A resident will be transferred from the facility to a hospital
and admitted in a timely manner when a transfer is medically necessary
for medical care or acute psychiatric care;
(2) Medical and other information needed for care of the resident
in light of such a transfer, will be exchanged between the institutions
in accordance with State medical privacy law, including any information
needed to determine whether the appropriate care can be provided in a
less restrictive setting; and
(3) Services are available to each resident 24 hours a day, 7 days
a week.
(c) Staff must document in the resident's record, all injuries that
occur as a result of an emergency safety intervention, including
injuries to staff resulting from that intervention.
(d) Staff involved in an emergency safety intervention that results
in an injury to a resident or staff must meet with supervisory staff
and evaluate the circumstances that caused the injury and develop a
plan to prevent future injuries.
Sec. 483.374 Facility reporting.
(a) Attestation of facility compliance. Each psychiatric
residential treatment facility that provides inpatient psychiatric
services to individuals under age 21 must attest, in writing, that the
facility is in compliance with HCFA's standards governing the use of
restraint and seclusion. This attestation must be signed by the
facility director.
(1) A facility with a current provider agreement with the Medicaid
agency must provide its attestation to the State Medicaid agency by
July 21, 2001.
(2) A facility enrolling as a Medicaid provider must meet this
requirement at the time it executes a provider agreement with the
Medicaid agency.
(b) Reporting of serious occurrences. The facility must report each
serious occurrence to both the State Medicaid agency and, unless
prohibited by State law, the State-designated Protection and Advocacy
system. Serious occurrences that must be reported include a resident's
death, a serious injury to a resident as defined in Sec. 483.352 of
this part, and a resident's suicide attempt.
(1) Staff must report any serious occurrence involving a resident
to both the State Medicaid agency and the State-designated Protection
and Advocacy system by no later than close of business the next
business day after a serious occurrence. The report must include the
name of the resident involved in the serious occurrence, a description
of the occurrence, and the name, street address, and telephone number
of the facility.
(2) In the case of a minor, the facility must notify the resident's
parent(s) or legal guardian(s) as soon as possible, and in no case
later than 24 hours after the serious occurrence.
(3) Staff must document in the resident's record that the serious
occurrence was reported to both the State Medicaid agency and the
State-designated Protection and Advocacy system, including the name of
the person to whom the incident was reported. A copy of the report must
be maintained in the resident's record, as
[[Page 7164]]
well as in the incident and accident report logs kept by the facility.
Sec. 483.376 Education and training.
(a) The facility must require staff to have ongoing education,
training, and demonstrated knowledge of--
(1) Techniques to identify staff and resident behaviors, events,
and environmental factors that may trigger emergency safety situations;
(2) The use of nonphysical intervention skills, such as de-
escalation, mediation conflict resolution, active listening, and verbal
and observational methods, to prevent emergency safety situations; and
(3) The safe use of restraint and the safe use of seclusion,
including the ability to recognize and respond to signs of physical
distress in residents who are restrained or in seclusion.
(b) Certification in the use of cardiopulmonary resuscitation,
including periodic recertification, is required.
(c) Individuals who are qualified by education, training, and
experience must provide staff training.
(d) Staff training must include training exercises in which staff
members successfully demonstrate in practice the techniques they have
learned for managing emergency safety situations.
(e) Staff must be trained and demonstrate competency before
participating in an emergency safety intervention.
(f) Staff must demonstrate their competencies as specified in
paragraph (a) of this section on a semiannual basis and their
competencies as specified in paragraph (b) of this section on an annual
basis.
(g) The facility must document in the staff personnel records that
the training and demonstration of competency were successfully
completed. Documentation must include the date training was completed
and the name of persons certifying the completion of training.
(h) All training programs and materials used by the facility must
be available for review by HCFA, the State Medicaid agency, and the
State survey agency.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: December 21, 2000.
Robert A. Berenson,
Acting Deputy Administrator, Health Care Financing Administration.
Dated: December 28, 2000.
Donna E. Shalala,
Secretary.
[FR Doc. 01-1649 Filed 1-19-01; 8:45 am]
BILLING CODE 4120-01-P