7148 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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.

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 Medicaidfunded 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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

7150 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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 § 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 § 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

§§ 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 § 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 7151

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 § 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 § 483.358, we are also requiring

that within 1 hour of the initiation of an

emergency safety intervention, a face-toface 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 § 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

7152 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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

§ 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-toface.

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 § 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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

7154 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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 § 441.152.

The certification requirement of this

section is not new. The paperwork

burden is contained in the referenced

§ 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

7156 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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.

§ 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 § 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

§ 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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 Statedesignated 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

§ 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 § 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

7158 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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 Statedesignated 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.

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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)

1Less 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

7160 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

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 appealsrelated 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 onetenth 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 programshealth, 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:

§ 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 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 § 441.152.

(b) Inpatient psychiatric services

furnished in a psychiatric residential

treatment facility as defined in

§ 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

§§ 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

§ 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.

§ 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 selfinflicted 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 selfcontrol.

§ 483.354 General requirements for

psychiatric residential treatment facilities.

A psychiatric residential treatment

facility must meet the requirements in

§ 441.151 through § 441.182 of this

chapter.

§ 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.

7162 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

(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.

§ 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.

§ 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.

§ 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.

§ 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

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 7163

assessing, monitoring, and evaluating

the physical and psychological wellbeing 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.

§ 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.

§ 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.

§ 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.

§ 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.

§ 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 § 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 Statedesignated 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 Statedesignated 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

7164 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

well as in the incident and accident

report logs kept by the facility.

§ 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 deescalation, 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