2. A new subpart G, consisting of Secs. 483.350 through 483.376, is

added to part 483 to read as follows:

Subpart G--Condition of Participation for the Use of Restraint or

Seclusion in Psychiatric Residential Treatment Facilities Providing

Inpatient Psychiatric Services for Individuals Under Age 21

Sec.  483.350 Basis and scope.

483.352 Definitions.

483.354 General requirements for psychiatric residential treatment

facilities.

483.356 Protection of residents.

483.358 Orders for the use of restraint or seclusion.

483.360 Consultation with treatment team physician.

483.362 Monitoring of the resident in and immediately after

restraint.

483.364 Monitoring of the resident in and immediately after

seclusion.

483.366 Notification of parent(s) or legal guardian(s).

483.368 Application of time out.

483.370 Postintervention debriefings.

483.372 Medical treatment for injuries resulting from an emergency

safety intervention.

483.374 Facility reporting.

483.376 Education and training.

Subpart G--Condition of Participation for the Use of Restraint or

Seclusion in Psychiatric Residential Treatment Facilities Providing

Inpatient Psychiatric Services for Individuals Under Age 21

Sec. 483.350 Basis and scope.

(a) Statutory basis. Sections 1905(a)(16) and (h) of the Act

provide that inpatient psychiatric services for individuals under age

21 include only inpatient services that are provided in an institution

(or distinct part thereof) that is a psychiatric hospital as defined in

section 1861(f) of the Act or in another inpatient setting that the

Secretary has specified in regulations. Additionally, the Children's

Health Act of 2000 (Pub. L. 106-310) imposes procedural reporting and

training requirements regarding the use of restraints and involuntary

seclusion in facilities, specifically including facilities that provide

inpatient psychiatric services for children under the age of 21 as

defined by sections 1905(a)(16) and (h) of the Act.

(b) Scope. This subpart imposes requirements regarding the use of

restraint or seclusion in psychiatric residential treatment facilities,

that are not hospitals, providing inpatient psychiatric services to

individuals under age 21.

Sec. 483.352 Definitions.

For purposes of this subpart, the following definitions apply:

Drug used as a restraint means any drug that--

(1) Is administered to manage a resident's behavior in a way that

reduces the safety risk to the resident or others;

(2) Has the temporary effect of restricting the resident's freedom

of movement; and

(3) Is not a standard treatment for the resident's medical or

psychiatric condition.

Emergency safety intervention means the use of restraint or

seclusion as an immediate response to an emergency safety situation.

Emergency safety situation means unanticipated resident behavior

that places the resident or others at serious threat of violence or

injury if no intervention occurs and that calls for an emergency safety

intervention as defined in this section.

Mechanical restraint means any device attached or adjacent to the

resident's body that he or she cannot easily remove that restricts

freedom of movement or normal access to his or her body.

Minor means a minor as defined under State law and, for the purpose

of this subpart, includes a resident who has been declared legally

incompetent by the applicable State court.

Personal restraint means the application of physical force without

the use of any device, for the purpose of restricting the free movement

of a resident's body.

Psychiatric Residential Treatment Facility means a facility other

than a hospital, that provides psychiatric services, as described in

subpart D of part 441 of this chapter, to individuals under age 21, in

an inpatient setting.

Restraint means a ``personal restraint,'' ``mechanical restraint,''

or ``drug used as a restraint'' as defined in this section.

Seclusion means the involuntary confinement of a resident alone in

a room or an area from which the resident is physically prevented from

leaving.

Serious injury means any significant impairment of the physical

condition of the resident as determined by qualified medical personnel.

This includes, but is not limited to, burns, lacerations, bone

fractures, substantial hematoma, and injuries to internal organs,

whether self-inflicted or inflicted by someone else.

Staff means those individuals with responsibility for managing a

resident's health or participating in an emergency safety intervention

and who are employed by the facility on a full-time, part-time, or

contract basis.

Time out means the restriction of a resident for a period of time

to a designated area from which the resident is not physically

prevented from leaving, for the purpose of providing the resident an

opportunity to regain self-control.

Sec. 483.354 General requirements for psychiatric residential

treatment facilities.

A psychiatric residential treatment facility must meet the

requirements in Sec. 441.151 through Sec. 441.182 of this chapter.

Sec. 483.356 Protection of residents.

(a) Restraint and seclusion policy for the protection of residents.

(1) Each resident has the right to be free from restraint or seclusion,

of any form, used as a means of coercion, discipline, convenience, or

retaliation.

(2) An order for restraint or seclusion must not be written as a

standing order or on an as-needed basis.

(3) Restraint or seclusion must not result in harm or injury to the

resident and must be used only--

(i) To ensure the safety of the resident or others during an

emergency safety situation; and

(ii) Until the emergency safety situation has ceased and the

resident's safety and the safety of others can be ensured, even if the

restraint or seclusion order has not expired.

(4) Restraint and seclusion must not be used simultaneously.

(b) Emergency safety intervention. An emergency safety intervention

must be performed in a manner that is safe, proportionate, and

appropriate to the severity of the behavior, and the resident's

chronological and developmental age; size; gender; physical, medical,

and psychiatric condition; and personal history (including any history

of physical or sexual abuse).

(c) Notification of facility policy. At admission, the facility

must--

(1) Inform both the incoming resident and, in the case of a minor,

the resident's parent(s) or legal guardian(s) of the facility's policy

regarding the use of restraint or seclusion during an emergency safety

situation that may occur while the resident is in the program;

(2) Communicate its restraint and seclusion policy in a language

that the resident, or his or her parent(s) or legal guardian(s)

understands (including American Sign Language, if appropriate) and when

necessary, the facility must provide interpreters or translators;

(3) Obtain an acknowledgment, in writing, from the resident, or in

the case of a minor, from the parent(s) or legal guardian(s) that he or

she has been informed of the facility's policy on the use of restraint

or seclusion during an emergency safety situation. Staff must file this

acknowledgment in the resident's record; and

(4) Provide a copy of the facility policy to the resident and in

the case of a minor, to the resident's parent(s) or legal guardian(s).

(d) Contact information. The facility's policy must provide contact

information, including the phone number and mailing address, for the

appropriate State Protection and Advocacy organization.

Sec. 483.358 Orders for the use of restraint or seclusion.

(a) Only a board-certified psychiatrist, or a physician licensed to

practice medicine with specialized training and experience in the

diagnosis and treatment of mental diseases, may order the use of

restraint or seclusion.

(b) If the resident's treatment team physician is available, only

he or she can order restraint or seclusion. If the resident's treatment

team physician is unavailable, the physician covering for the treatment

team physician can order restraint or seclusion. The covering physician

must meet the same requirements for training and experience described

in paragraph (a) of this section.

(c) The physician must order the least restrictive emergency safety

intervention that is most likely to be effective in resolving the

emergency safety situation based on consultation with staff.

(d) If the physician is not available to order the use of restraint

or seclusion, the physician's verbal order must be obtained by a

registered nurse at the time the emergency safety intervention is

initiated by staff and the physicians verbal order must be followed

with the physician's signature verifying the verbal order. The ordering

physician must be available to staff for consultation, at least by

telephone, throughout the period of the emergency safety intervention.

(e) Each order for restraint or seclusion must:

(1) Be limited to no longer than the duration of the emergency

safety situation; and

(2) Under no circumstances exceed 4 hours for residents ages 18 to

21; 2 hours for residents ages 9 to 17; or 1 hour for residents under

age 9.

(f) Within 1 hour of the initiation of the emergency safety

intervention, a physician or clinically qualified registered nurse

trained in the use of emergency safety interventions must conduct a

face-to-face assessment of the physical and psychological well being of

the resident, including but not limited to--

(1) The resident's physical and psychological status;

(2) The resident's behavior;

(3) The appropriateness of the intervention measures; and

(4) Any complications resulting from the intervention.

(g) Each order for restraint or seclusion must include--

(1) The ordering physician's name;

(2) The date and time the order was obtained; and

(3) The emergency safety intervention ordered, including the length

of time for which the physician authorized its use.

(h) Staff must document the intervention in the resident's record.

That documentation must be completed by the end of the shift in which

the intervention occurs. If the intervention does not end during the

shift in which it began, documentation must be completed during the

shift in which it ends. Documentation must include all of the

following:

(1) Each order for restraint or seclusion as required in paragraph

(g) of this section.

(2) The time the emergency safety intervention actually began and

ended.

(3) The time and results of the 1-hour assessment required in

paragraph (f) of this section.

(4) The emergency safety situation that required the resident to be

restrained or put in seclusion.

(5) The name of staff involved in the emergency safety

intervention.

(i) The facility must maintain a record of each emergency safety

situation, the interventions used, and their outcomes.

(j) The physician ordering the restraint or seclusion must sign the

order in the resident's record as soon as possible.

Sec. 483.360 Consultation with treatment team physician.

If the physician ordering the use of restraint or seclusion is not

the resident's treatment team physician, the ordering physician or

registered nurse must--

(a) Consult with the resident's treatment team physician as soon as

possible and inform the team physician of the emergency safety

situation that required the resident to be restrained or placed in

seclusion; and

(b) Document in the resident's record the date and time the team

physician was consulted.

Sec. 483.362 Monitoring of the resident in and immediately after

restraint.

(a) Clinical staff trained in the use of emergency safety

interventions must be physically present, continually assessing and

monitoring the physical and psychological well-being of the resident

and the safe use of restraint throughout the duration of the emergency

safety intervention.

(b) If the emergency safety situation continues beyond the time

limit of the physician's order for the use of restraint, a registered

nurse must immediately contact the ordering physician in order to

receive further instructions.

(c) A physician, or a registered nurse trained in the use of

emergency safety interventions, must evaluate the resident's well-being

immediately after the restraint is removed.

Sec. 483.364 Monitoring of the resident in and immediately after

seclusion.

(a) Clinical staff, trained in the use of emergency safety

interventions, must be physically present in or immediately outside the

seclusion room, continually

[[Page 7163]]

assessing, monitoring, and evaluating the physical and psychological

well-being of the resident in seclusion. Video monitoring does not meet

this requirement.

(b) A room used for seclusion must--

(1) Allow staff full view of the resident in all areas of the room;

and

(2) Be free of potentially hazardous conditions such as unprotected

light fixtures and electrical outlets.

(c) If the emergency safety situation continues beyond the time

limit of the physician's order for the use of seclusion, a registered

nurse must immediately contact the ordering physician in order to

receive further instructions.

(d) A physician, or a registered nurse trained in the use of

emergency safety interventions, must evaluate the resident's well-being

immediately after the resident is removed from seclusion.

Sec. 483.366 Notification of parent(s) or legal guardian(s).

If the resident is a minor as defined in this subpart:

(a) The facility must notify the parent(s) or legal guardian(s) of

the resident who has been restrained or placed in seclusion as soon as

possible after the initiation of each emergency safety intervention.

(b) The facility must document in the resident's record that the

parent(s) or legal guardian(s) has been notified of the emergency

safety intervention, including the date and time of notification and

the name of the staff person providing the notification.

Sec. 483.368 Application of time out.

(a) A resident in time out must never be physically prevented from

leaving the time out area.

(b) Time out may take place away from the area of activity or from

other residents, such as in the resident's room (exclusionary), or in

the area of activity or other residents (inclusionary).

(c) Staff must monitor the resident while he or she is in time out.

Sec. 483.370 Postintervention debriefings.

(a) Within 24 hours after the use of restraint or seclusion, staff

involved in an emergency safety intervention and the resident must have

a face-to-face discussion. This discussion must include all staff

involved in the intervention except when the presence of a particular

staff person may jeopardize the well-being of the resident. Other staff

and the resident's parent(s) or legal guardian(s) may participate in

the disussion when it is deemed appropriate by the facility. The

facility must conduct such discussion in a language that is understood

by the resident's parent(s) or legal guardian(s). The discussion must

provide both the resident and staff the opportunity to discuss the

circumstances resulting in the use of restraint or seclusion and

strategies to be used by the staff, the resident, or others that could

prevent the future use of restraint or seclusion.

(b) Within 24 hours after the use of restraint or seclusion, all

staff involved in the emergency safety intervention, and appropriate

supervisory and administrative staff, must conduct a debriefing session

that includes, at a minimum, a review and discussion of--

(1) The emergency safety situation that required the intervention,

including a discussion of the precipitating factors that led up to the

intervention;

(2) Alternative techniques that might have prevented the use of the

restraint or seclusion;

(3) The procedures, if any, that staff are to implement to prevent

any recurrence of the use of restraint or seclusion; and

(4) The outcome of the intervention, including any injuries that

may have resulted from the use of restraint or seclusion.

(c) Staff must document in the resident's record that both

debriefing sessions took place and must include in that documentation

the names of staff who were present for the debriefing, names of staff

that were excused from the debriefing, and any changes to the

resident's treatment plan that result from the debriefings.

Sec. 483.372 Medical treatment for injuries resulting from an

emergency safety intervention.

(a) Staff must immediately obtain medical treatment from qualified

medical personnel for a resident injured as a result of an emergency

safety intervention.

(b) The psychiatric residential treatment facility must have

affiliations or written transfer agreements in effect with one or more

hospitals approved for participation under the Medicaid program that

reasonably ensure that--

(1) A resident will be transferred from the facility to a hospital

and admitted in a timely manner when a transfer is medically necessary

for medical care or acute psychiatric care;

(2) Medical and other information needed for care of the resident

in light of such a transfer, will be exchanged between the institutions

in accordance with State medical privacy law, including any information

needed to determine whether the appropriate care can be provided in a

less restrictive setting; and

(3) Services are available to each resident 24 hours a day, 7 days

a week.

(c) Staff must document in the resident's record, all injuries that

occur as a result of an emergency safety intervention, including

injuries to staff resulting from that intervention.

(d) Staff involved in an emergency safety intervention that results

in an injury to a resident or staff must meet with supervisory staff

and evaluate the circumstances that caused the injury and develop a

plan to prevent future injuries.

Sec. 483.374 Facility reporting.

(a) Attestation of facility compliance. Each psychiatric

residential treatment facility that provides inpatient psychiatric

services to individuals under age 21 must attest, in writing, that the

facility is in compliance with HCFA's standards governing the use of

restraint and seclusion. This attestation must be signed by the

facility director.

(1) A facility with a current provider agreement with the Medicaid

agency must provide its attestation to the State Medicaid agency by

July 21, 2001.

(2) A facility enrolling as a Medicaid provider must meet this

requirement at the time it executes a provider agreement with the

Medicaid agency.

(b) Reporting of serious occurrences. The facility must report each

serious occurrence to both the State Medicaid agency and, unless

prohibited by State law, the State-designated Protection and Advocacy

system. Serious occurrences that must be reported include a resident's

death, a serious injury to a resident as defined in Sec. 483.352 of

this part, and a resident's suicide attempt.

(1) Staff must report any serious occurrence involving a resident

to both the State Medicaid agency and the State-designated Protection

and Advocacy system by no later than close of business the next

business day after a serious occurrence. The report must include the

name of the resident involved in the serious occurrence, a description

of the occurrence, and the name, street address, and telephone number

of the facility.

(2) In the case of a minor, the facility must notify the resident's

parent(s) or legal guardian(s) as soon as possible, and in no case

later than 24 hours after the serious occurrence.

(3) Staff must document in the resident's record that the serious

occurrence was reported to both the State Medicaid agency and the

State-designated Protection and Advocacy system, including the name of

the person to whom the incident was reported. A copy of the report must

be maintained in the resident's record, as

[[Page 7164]]

well as in the incident and accident report logs kept by the facility.

Sec. 483.376 Education and training.

(a) The facility must require staff to have ongoing education,

training, and demonstrated knowledge of--

(1) Techniques to identify staff and resident behaviors, events,

and environmental factors that may trigger emergency safety situations;

(2) The use of nonphysical intervention skills, such as de-

escalation, mediation conflict resolution, active listening, and verbal

and observational methods, to prevent emergency safety situations; and

(3) The safe use of restraint and the safe use of seclusion,

including the ability to recognize and respond to signs of physical

distress in residents who are restrained or in seclusion.

(b) Certification in the use of cardiopulmonary resuscitation,

including periodic recertification, is required.

(c) Individuals who are qualified by education, training, and

experience must provide staff training.

(d) Staff training must include training exercises in which staff

members successfully demonstrate in practice the techniques they have

learned for managing emergency safety situations.

(e) Staff must be trained and demonstrate competency before

participating in an emergency safety intervention.

(f) Staff must demonstrate their competencies as specified in

paragraph (a) of this section on a semiannual basis and their

competencies as specified in paragraph (b) of this section on an annual

basis.

(g) The facility must document in the staff personnel records that

the training and demonstration of competency were successfully

completed. Documentation must include the date training was completed

and the name of persons certifying the completion of training.

(h) All training programs and materials used by the facility must

be available for review by HCFA, the State Medicaid agency, and the

State survey agency.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program)

Dated: December 21, 2000.

Robert A. Berenson,

Acting Deputy Administrator, Health Care Financing Administration.

Dated: December 28, 2000.

Donna E. Shalala,