71378 Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 482 

[CMS–3018–F] 

RIN 0938–AN30 

Medicare and Medicaid Programs; 

Hospital Conditions of Participation: 

Patients’ Rights 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), DHHS. 

ACTION: Final rule. 

SUMMARY: This final rule finalizes the 

Patients’ Rights Condition of 

Participation (CoP) which is applicable 

to all Medicare- and Medicaidparticipating hospitals and contains 

standards that ensure minimum 

protections of each patient’s physical 

and emotional health and safety. It 

responds to comments on the following 

standards presented in the July 2, 1999 

interim final rule: Notice of rights; 

exercise of rights; privacy and safety; 

confidentiality of patient records; 

restraint for acute medical and surgical 

care; and seclusion and restraints for 

behavior management. As a result of 

comments received, we have revised the 

standards regarding restraint and 

seclusion and set forth standards 

regarding staff training and death 

reporting. 

DATES: Effective Date: These regulations 

are effective on January 8, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Chmielewski, RN, MS (410) 

786–6899, Janice Graham, RN, MS (410) 

786–8020, Monique Howard, OTR/L 

(410) 786–3869, Jeannie Miller, RN, 

MPH (410) 786–3164, Rachael 

Weinstein, RN, MPA (410) 786–6775. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Overview 

B. Key Statutory Provisions 

C. Regulatory Background 

D. Requirements for Issuance of 

Regulations 

E. Restraint and Seclusion in Other 

Settings 

II. Provisions of the Proposed and Interim 

Final Rules Regarding Patients’ Rights 

III. Comments on and Responses to the 

Provisions of the Interim Final Rule With 

Comment Period 

A. General Comments on the Requirements 

for Use of Restraint and Seclusion 

1. Is There Cause for Concern? 

2. The Difference Between Standards (e) 

and (f) 

3. The Roles of CMS and JCAHO 

4. Applicability of the Patients’ Rights CoP 

5. Debriefing After the Use of Restraint/ 

Seclusion 

B. Comments Received on Specific 

Provisions 

1. The Right to Be Free From Restraint 

(§§ 482.13(e)(1) and (f)(1)) 

2. Definition of ‘‘Restraint’’ and ‘‘Physical 

Restraint’’ (§§ 482.13(e)(1) and (f)(1)) 

3. Definition of a ‘‘Drug Used as a 

Restraint’’ (§§ 482.13(e)(1) and (f)(1)) 

4. Use of Restraints (§§ 482.13(e)(2) and 

(e)(3)(i)) 

5. Ordering of Restraint/Seclusion 

(§§ 482.13(e)(3)(ii) and (f)(3)(ii)) 

a. Definition of Licensed Independent 

Practitioner (LIP) (§§ 482.13(e)(3)(ii) and 

(f)(3)(ii)) 

b. Physician Only 

c. Elimination of Protocols 

d. Initiate versus Order 

6. Prohibition on Standing and PRN Orders 

(§§ 482.13(e)(3)(ii)(A) and (f)(3)(ii)(A)) 

7. Consultation with the Treating Physician 

(§§ 482.13(e)(3)(ii)(B) and (f)(3)(ii)(B)) 

8. Written Modification of the Plan of Care 

(§§ 482.13(e)(3)(iii) and (f)(3)(iii)) 

9. Implementation of and Appropriate Use 

of Restraint/Seclusion 

(§§ 482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), 

and (f)(3)(v)) 

10. Discontinuing the Use of Restraint/ 

Seclusion (§§ 482.13(e)(3)(vi) 

and(f)(3)(vi)) 

11. Assessment, Monitoring, and 

Evaluation of the Restrained/Secluded 

Patient (§§ 482.13(e)(4) and (f)(5)) 

12. Staff Training in the Use of Restraints/ 

Seclusion (§§ 482.13(e)(5) and (f)(6)) 

13. Definition of Seclusion (§ 482.13(f)(1)) 

14. Use of Restraint/Seclusion for Behavior 

Management (§ 482.13(f)(2)) 

15. One Hour Rule (§ 482.13(f)(3)(ii)(C)) 

a. Comments Objecting to a Physician or 

LIP Seeing the Patient Within 1 Hour 

b. Comments Supporting Telephone 

Consultation with a Nurse Onsite 

Performing the Patient Assessment 

c. Comments Opposing Telephone Orders, 

Nurse Evaluation, and LIP Involvement 

d. Comments Stating that the 1-Hour Rule 

Did Not Address the Problem 

16. Limits for Restraint/Seclusion Orders 

(§ 482.13(f)(3)(ii)(D)) 

17. Simultaneous Use of Restraint and 

Seclusion (§ 482.13(f)(4)) 

18. The Use of Video and Audio 

Monitoring 

19. Reporting of Death(s) Related to 

Restraint/Seclusion (§ 482.13(f)(7)) 

IV. Provisions of the Final Rule 

V. Collection of Information Requirements 

VI. Regulatory Impact Analysis 

A. Overall Impact 

B. Anticipated Effects 

1. Effects on Providers 

a. Section 482.13(e) Standard: Restraint or 

Seclusion 

b. Section 482.13(f) Standard: Restraint or 

Seclusion: Staff Training Requirements 

c. Section 482.13(g) Standard: Death 

Reporting Requirements 

2. Effect on Beneficiaries 

3. Effect on the Medicare and Medicaid 

Programs 

C. Alternatives Considered 

Regulations Text 

I. Background 

A. Overview 

This rule set forth final requirements 

for Patients’ Rights in hospitals, 

provides strong patient protections, 

provides flexibility to providers, and is 

responsive to comments. This regulation 

focuses on patient safety and the 

protection of patients from abuse. These 

standards support and protect patients’ 

rights in the hospital setting; 

specifically, the right to be free from the 

inappropriate use of restraint and 

seclusion with requirements that protect 

the patient when use of either 

intervention is necessary. It recognizes 

the legitimate use of restraint for acute 

medical and surgical care as a measure 

to prevent patient injury, as well as the 

use of restraint or seclusion to manage 

violent or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. In addition, this rule finalizes, 

without modification, the standards for 

Notice of Rights, Exercise of Rights, 

Privacy and Safety, and Confidentiality 

of Patient Records. 

B. Key Statutory Provisions 

Sections 1861(e) (1) through (8) of the 

Social Security Act (the Act) define the 

term ‘‘hospital’’ and list the 

requirements that a hospital must meet 

to be eligible for Medicare participation. 

Section 1861(e)(9) of the Act specifies 

that a hospital must also meet such 

other requirements as the Secretary 

finds necessary in the interest of the 

health and safety of the hospital’s 

patients. Under this authority, the 

Secretary has established in regulations 

at 42 CFR part 482 the requirements that 

a hospital must meet to participate in 

the Medicare program. 

Section 1905(a) of the Act provides 

that Medicaid payments may be applied 

to hospital services. Regulations at 

§ 440.10(a)(3)(iii) require hospitals to 

meet the Medicare CoPs to qualify for 

participation in Medicaid. 

The Children’s Health Act of 2000 

(CHA) (Pub. L. 106–310) was enacted 

October 17, 2000. Section 3207 of the 

CHA amended Title V of the Public 

Health Service Act (PHSA) by adding a 

new part H, which contains 

requirements relating to the rights of 

residents of certain facilities. 

Specifically, section 591 of the PHS Act, 

as added by the CHA (42 U.S.C. 290ii), 

establishes certain minimum 

requirements with regard to the use of 

restraint and seclusion in facilities that 

receive support in any form from any 

program supported in whole or in part 


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with funds appropriated to any Federal 

department or agency. In addition, 

Sections 592 and 593 of the PHS Act (42 

U.S.C. 290ii and 290ii–3) establish 

minimum mandatory death reporting 

and staff training requirements. This 

final rule conforms to the requirements 

of the CHA. 

As implementing regulations are 

issued, a critical point for consideration 

is that Title V, part H of the PHS Act 

is not an isolated enactment, but part of 

a trend of legislation and regulations 

aimed at protecting and promoting 

resident, patient, and client rights. Part 

H, section 591(c) of the PHS Act states 

‘‘This part shall not be construed to 

affect or impede any Federal or State 

law or regulations that provide greater 

protections than this part regarding 

seclusion and restraint.’’ The value of 

preserving existing law and regulations 

is recognized while extending 

protections to those facilities that are 

currently without the protection 

intended by the Congress. 

C. Regulatory Background 

In the December 19, 1997 Federal 

Register (62 FR 66726), we published a 

proposed rule entitled ‘‘Medicare and 

Medicaid Programs; Hospital Conditions 

of Participation; Provider Agreements 

and Supplier Approval’’ to revise the 

entire set of CoPs for hospitals found at 

42 CFR part 482. This proposed rule 

included a CoP for patients’ rights. In 

the July 2, 1999 Federal Register (64 FR 

36070), we published the Patients’

Rights CoP as an interim final rule with 

comment. This CoP was separated from 

the other proposed hospital CoPs in 

response to Congressional and public 

interest. Although we have modified 

some of the provisions to address public 

comments, these modifications do not 

lessen protections afforded patients who 

are restricted or secluded. We note that 

we have revised the regulation to 

expand training requirements and have 

added a requirement that the attending 

physician or other licensed independent 

practitioner (LIP) responsible for the 

care of the patient be consulted as soon 

as possible when the ‘‘one hour’’

evaluation of a patient in restraint or 

seclusion is conducted by a trained 

registered nurse (RN) or physician 

assistant (PA). 

D. Requirements for Issuance of 

Regulations 

Section 902 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

amended section 1871(a) of the Act and 

requires the Secretary, in consultation 

with the Director of the Office of 

Management and Budget, to establish 

and publish timelines for the 

publication of Medicare final 

regulations based on the previous 

publication of a Medicare proposed or 

interim final regulation. Section 902 of 

the MMA also states that the timelines 

for these regulations may vary but shall 

not exceed 3 years after publication of 

the preceding proposed or interim final 

regulation except under exceptional 

circumstances. In a notice published 

December 30, 2004 (69 FR 78442), we 

implemented section 902 of the Act by 

announcing that all outstanding interim 

final rules as of December 8, 2003 

would be finalized by December 8, 2006 

or expire. 

This final rule finalizes provisions set 

forth in the July 2, 1999 interim final 

rule with comment. In accordance with 

section 902 and our notice of 2004, this 

final rule is being published within 3 

years of the date of enactment of the 

MMA, which was December 8, 2003, in 

order to finalize the 1999 interim final 

rule with comment. 

E. Restraint and Seclusion in Other 

Settings 

In the preamble of the July 2, 1999 

interim final rule with comment period, 

we explained that we were considering 

the advisability of adopting a consistent 

restraint and seclusion standard that 

would apply not only to hospitals but to 

other kinds of health care entities with 

which CMS has provider agreements, 

including those that provide inpatient 

psychiatric services for individuals 

under 21 years of age (a program under 

Medicaid). We asked the public whether 

we should adopt the same standards 

that appeared in the July 2, 1999 interim 

final rule with comment period, or 

whether we should adopt more stringent 

standards. 

Consumer advocacy groups that 

commented on extending these 

requirements to other settings generally 

argued for more stringent expectations 

for the care of children, citing special 

hazards and concerns that arise when 

children and adolescents are restrained. 

Some commenters encouraged CMS to 

apply the restraints and seclusion 

standards of the interim final rule with 

comment period to all other Medicaidfunded facilities, particularly residential 

treatment centers for children and 

adolescents. 

Other commenters did not agree with 

this approach, arguing that the fields of 

mental health and developmental 

disabilities are very different and that 

similarities between the two should not 

be assumed. For example, some 

commenters stated that little research 

exists on the use of restraint/seclusion 

in mental health, but that in contrast, a 

considerable amount of research in the 

developmental disabilities field 

supports the effectiveness of restraint 

and seclusion for severe behavior 

problems. Thus, the field of 

developmental disabilities already has 

extensive guidelines, standards, and 

rules governing the use of restraint and 

seclusion. 

Some of those commenters who 

supported uniform restraint and 

seclusion standards across settings 

offered detailed suggestions for what 

those standards should require. For 

example, commenters suggested that the 

regulation forbid the use of mechanical 

restraints for children under a certain 

age (these commenters offered varying 

suggestions regarding the threshold age 

(17 and 21 years of age were two of 

these suggestions)), or permit 

therapeutic holding for periods no 

longer than 15 minutes. Some of the 

commenters expressed concern about 

proposing requirements that paralleled 

existing requirements for hospitals 

because of the differences in patient 

acuity and characteristics and treatment. 

We considered the comments we 

received in developing specific restraint 

and seclusion requirements for inpatient 

psychiatric services for individuals 

under 21 years of age. These 

requirements were published in an 

interim final rule with comment period 

entitled, ‘‘Medicaid Program; Use of 

Restraint and Seclusion in Psychiatric 

Residential Treatment Facilities 

Providing Services to Individuals under 

Age 21’’ in the January 22, 2001 Federal 

Register (66 FR 7148). In the May 22, 

2001 Federal Register (66 FR 28110), we 

published an additional interim final 

rule with comment period to amend and 

further clarify the January 22, 2001 

interim final rule with comment period. 

There was little comment on 

extending restraint and seclusion 

requirements to specific non-behavioral 

or non-psychiatric types of settings or 

providers, such as home health 

agencies, ambulatory surgical centers, or 

providers of x-ray services. While a few 

commenters gave blanket support to this 

idea, they did not supply a rationale for 

applying one set of standards versus 

another. Several commenters discussed 

their concern about extending the 

restraint and seclusion requirements to 

the nursing home setting and strongly 

disagreed with any adoption of the 

standards presented in the interim final 

rule with comment period in that 

setting. One nursing home industry 

association argued for consistency in 

terminology and philosophy, but 

recognized that the settings where 

beneficiaries receive services are 

diverse, as are the beneficiaries 


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themselves, and that adopting a blanket 

approach might not be practical or 

appropriate. 

After considering these comments and 

engaging in internal deliberations, we 

have decided that it would not be 

appropriate to adopt a detailed, 

technical approach that would create an 

identical standard for all of the 

providers with which CMS has 

agreements. Instead, the needs of 

specific treatment populations and 

settings should drive the types of 

standards developed. Therefore, we do 

not plan to adopt the hospital 

requirements verbatim for other 

provider types. 

However, we are concerned about 

beneficiaries receiving care in settings 

where no regulatory protections 

regarding the use of restraint or 

seclusion currently exist. The CHA 

provides statutory protection to patients 

at any facility receiving Federal funding. 

While it is impractical, in our view, to 

take the requirements for hospitals, 

nursing homes, or intermediate care 

facilities for the mentally retarded and 

adopt them as a whole in any other 

given setting, we can instead develop 

any new requirements with the same 

philosophical foundation that underlies 

the three existing sets of standards and 

requirements. This foundation 

encompasses the belief that the patient 

has the right to be free from unnecessary 

restraint or seclusion, that using a 

restraint for convenience, punishment, 

retaliation, or coercion is never 

acceptable, and that each patient should 

be treated with respect and dignity. 

These beliefs are true in every care 

setting and are legally enforceable in 

accordance with the CHA. As 

appropriate, we will develop regulations 

that support these concepts. However, 

given the variations in treatment 

populations and settings, the individual 

case setting will drive the type of 

standards developed which will vary as 

appropriate. 

II. Provisions of the Proposed and 

Interim Final Rules Regarding Patients’ 

Rights 

The December 19, 1997 hospital CoP 

proposed rule included a patients’ rights 

CoP that proposed to establish standards 

for the following: 

• Notice of rights. 

• Exercise of rights regarding care. 

• Privacy and safety. 

• Confidentiality of patient records. 

• Seclusion and restraint. 

With the exception of the standard for 

seclusion and restraint, we received few 

comments in response to these proposed 

requirements. 

In the July 2, 1999 Federal Register, 

we published an interim final rule with 

comment period that separated the 

patients’ rights CoP from the other 

hospital CoPs and introduced 

modifications to proposed standard (e) 

and added a new standard (f), governing 

the use of restraint and seclusion. 

Because we received few comments on 

the other provisions of the patients’

rights section (standards a through d), 

these four provisions were not reopened 

for public comment in the July 2, 1999 

interim final rule with comment period. 

In the 1997 proposed rule, standard 

(e) was entitled ‘‘Seclusion and 

restraint,’’ and covered the patient’s 

right to be free of restraint or seclusion 

used as a means of coercion, 

convenience, or retaliation by staff. The 

proposed language set forth several 

basic ideas and expectations; namely, 

that restraint (including 

psychopharmacological drugs used as 

restraints) and seclusion must be used 

in accordance with the patient’s plan of 

care; that restraints or seclusion may be 

used only as a last resort and in the least 

restrictive manner possible to protect 

the patient or others from harm; and 

that restraint or seclusion must be 

removed or ended at the earliest 

possible time. 

The interim final rule with comment 

period introduced two standards on 

restraint and seclusion—one governing 

the use of restraint in the provision of 

acute medical and surgical care and the 

other governing the use of seclusion and 

restraint for behavior management. The 

revised standard (e) included 

definitions that had not specifically 

appeared in the proposed rule and also 

included: (1) A prohibition on standing 

orders or orders on an as needed basis 

(that is, PRN) for restraint; (2) an 

emphasis on continual assessment and 

monitoring; and re-evaluation of the 

condition of the restrained patient; (3) a 

requirement that the hospital notify the 

patient’s treating physician if he/she did 

not issue the restraint order personally; 

and (4) a training requirement for all 

staff with direct patient contact. 

Standard (f) offered definitions and 

provided more prescriptive 

requirements than the proposed or 

revised standard (e). The focus on 

behavior management in standard (f) 

was intended to apply in situations 

where the patient’s aggressive or violent 

behavior creates an emergency situation 

that places his or her safety or that of 

others at risk. The more prescriptive 

elements, such as—(1) requiring a 

physician or licensed independent 

practitioner (LIP) to see and evaluate the 

need for restraint or seclusion within 1- 

hour of the initiation of the 

intervention; (2) the limitation on the 

length of orders and required reevaluation; and (3) the requirement for 

continual face-to-face monitoring or 

continual monitoring using both video 

and audio equipment if restraint and 

seclusion are used simultaneously, were 

meant to be commensurate with the 

increased risk to patient health and 

safety when these interventions are used 

to address violent or aggressive patient 

behavior. 

In both standards (e) and (f) of the 

July 2, 1999 interim final rule with 

comment period, the phrase 

‘‘psychopharmacological drugs used as 

restraints’’ was replaced with the phrase 

‘‘drug used as a restraint,’’ in 

recognition of the idea that singling out 

one type of medication encourages the 

misperception that only one class of 

drugs is used to restrain patients. 

Concern for patient health and safety 

prompted us to make these 

requirements effective on August 2, 

1999. However, given the changes to the 

proposed standard (e) and the addition 

of standard (f), we believed that the 

public should have an opportunity to 

comment on the revised restraint and 

seclusion provisions. For these reasons, 

we published the July 2, 1999 rule as an 

interim final rule with comment period. 

III. Comments on and Responses to the 

Provisions of the Interim Final With 

Comment Period 

We received approximately 4,200 

timely comments on the interim final 

rule with comment period. Comments 

were received from hospitals, mental 

health treatment facilities, physicians, 

nurses, attorneys, professional 

associations, accrediting bodies, state 

agencies, national and State patient 

protection and advocacy groups, and 

members of the general public. Many 

commenters applauded the addition of 

the restraint and seclusion provisions in 

the Patients’ Rights CoP, even if they 

disagreed with specific requirements or 

concepts. A summary of the comments 

received on these provisions (standards 

(e) and (f)) and our responses follows. 

We received comments on issues out 

of the scope of the interim final rule 

with comment period; these comments 

will not be addressed in this final rule. 

A. General Comments on the 

Requirements for the Use of Restraint 

and Seclusion 

Some commenters suggested that the 

1-hour physician or LIP visit and 

assessment were not consistent with the 

goal of creating a government that works 

better and costs less. A few commenters 

stated that the rapid introduction of 

standards (e) and (f) was a ‘‘knee-jerk 


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reaction’’ to the lobbying of certain 

groups and the sensationalized media 

coverage of a limited number of cases. 

One commenter stated, ‘‘It is time the 

legislature and administrative agencies 

stop reacting to sensational headlines 

and layering the health care system with 

costly and time consuming regulations 

to meet.’’ Another commenter 

questioned the validity of the 1998 

Hartford Courant series of articles (cited 

in the preamble to the interim final rule 

with comment period), asserting that the 

articles did not clearly determine that 

the use of restraint and seclusion were 

the proximate and sole cause of deaths 

in the cases cited. The same commenter 

asked in which setting these deaths 

occurred, stating that it makes no sense 

to regulate a hospital on this point if 

there is no evidence that restraintrelated deaths are problematic in 

hospitals. Another commenter 

questioned the FDA’s estimate of at least 

100 deaths per year from improper use 

of restraints, specifically noting that he 

believes that these are not cases where 

restraint use was unmerited. Another 

commenter stated that while the abuse 

and deaths that have occurred are 

unfortunate, they do not represent an 

emergency situation meriting the 

actions that were taken by CMS. The 

commenter made the following 

statement: 

While 142 deaths in 10 years is 

unfortunate, the number pales when 

compared to the 3 million people 

hospitalized per year for adverse drug 

reactions and 150,000 deaths resulting from 

drugs taken properly as prescribed by the 

physician. 

A commenter stated that CMS has 

given too much credence to overdramatized accounts of restraint and 

seclusion use. Many hospitals reported 

having no injuries or deaths associated 

with restraint or seclusion use. A 

number of physicians also noted that 

none of their patients have suffered 

serious injuries or died due to the use 

of restraints. One commenter stated that 

it was unfair to subject the industry as 

a whole to highly prescriptive 

requirements when the events that 

triggered such concern occurred in a 

handful of facilities. The commenter 

argued that only the hospitals where the 

deaths occurred should be governed by 

these rules. Another commenter 

suggested that in the situations where 

these deaths occurred, the practices 

used were out of compliance with the 

hospitals’ own policies and procedures. 

Accordingly, the commenter stated that 

prescriptive regulations do not represent 

the gateway to reduced injuries and 

deaths, and that enforcement of existing 

requirements would be more effective. 

Still other commenters have suggested 

that even if death and injury are of 

concern, CMS has not yet hit upon the 

correct solution. 

To balance these comments, we 

mention those received from advocacy 

groups, patients, and hospital staff. 

Some of the anecdotal information 

provided was clearly disturbing, 

including accounts of patients being 

choked during takedowns even though 

staff had been trained in proper 

procedures, and patients suffering 

broken limbs or other injuries. Other 

commenters described situations where 

patients had been placed in restraints 

for extended periods of time (up to 10 

consecutive hours) and staff did not take 

vital signs regularly, did not offer food, 

fluids, or use of the toilet at all, or 

offered them only once while the 

patient was restrained. Comments also 

related concerns about the over use and 

inappropriate use of restraint or 

seclusion. One commenter stated that a 

lawsuit was filed on behalf of a patient 

dually diagnosed with mental 

retardation and organic brain syndrome 

who was placed in restraints 48 times 

within a six month period. The 

commenter stated that in the six months 

after the lawsuit was settled, the patient 

had only been restrained twice. 

Many commenters applauded the 

regulatory action. Commenters stated 

that the action was long overdue and 

important for the safety of vulnerable 

populations most in need of protection 

from abuse of restraints and seclusion. 

Commenters see this rule as a major step 

forward in addressing issues 

surrounding the use of restraint and 

seclusion in inpatient facilities and 

support further movement toward the 

goals of ultimately eliminating the use 

of seclusion and restraint, and 

preserving patients’ rights and dignity. 

In addition, many commenters stated 

that they would like to see even more 

stringent requirements for the use of 

restraint and seclusion for behavior 

management. 

1. Is There Cause for Concern? 

Given the prevalence of restraint use, 

we believe that awareness and vigilance 

are justified. On October 11, 1998, the 

Hartford Courant reported that of the 

142 deaths it confirmed, 59.6 percent 

occurred in the hospital setting 

(including psychiatric hospitals and 

psychiatric wards of general hospitals). 

The Courant further stated that 47.2 

percent of the 142 deaths involved 

physical restraints or therapeutic holds, 

while 44.1 percent involved mechanical 

restraint, 3.1 percent involved a 

combination of the two, and the 

remaining 5.5 percent were seclusionrelated. Although the Courant did not 

claim that restraint and seclusion use 

were the sole and proxmate cause of 

death in each case, we question the 

usefulness of this criterion in 

determining whether restraint and 

seclusion pose significant risk to health 

and safety. Obviously, when a patient’s 

trachea is crushed during a takedown, 

restraint would constitute the ‘‘sole and 

proximal’’ cause of death. However, a 

case cited by one commenter illustrates 

how this characterization may fail to 

take into account the many times that 

restraint or seclusion can play a part in 

injury. The commenter reported that 

one young man died after suffering a 

severe asthma attack soon after fighting 

with another patient and being 

restrained. The death was ruled to be 

due to natural causes, even though the 

medical examiner found that both the 

stress of the fight and the restraint 

triggered the asthma attack. One cannot 

only consider whether restraint or 

seclusion is the sole cause of death 

when examining whether the use of 

restraint or seclusion poses a significant 

risk to the patient. 

One commenter questioned the 

statistical significance of 142 deaths 

over a 10-year period. This number may 

not reflect the actual number of such 

deaths that occur each year. In 

explaining how it conducted its 

investigation, the Courant noted, 

‘‘Throughout the reporting * * * it 

became clear that many deaths go 

unreported.’’ To better determine the 

national annual death rate, the Courant 

hired statistician Roberta Glass, a 

research specialist for the Harvard 

Center of Risk Analysis at the Harvard 

School of Public Health. The Courant 

reported the following: 

Glass projected that the annual number of 

deaths could range as high as 150. 

‘‘Admittedly, the estimates are only rough 

approximations,’’ Glass said. ‘‘The data 

needed for precise estimation are not 

collected in a systematic way nationwide.’’

On October 26, 1999, Associate 

Director Leslie Aronovitz of the U.S. 

Government Accountability Office 

provided testimony before the Senate 

Committee on Finance entitled, ‘‘Extent 

of Risk from Improper Restraint or 

Seclusion is Unknown.’’ Aronovitz 

testified to the following: 

Neither the federal government nor the 

states comprehensively track the use of 

restraint or seclusion or injuries related to 

them across all types of facilities that serve 

individuals with mental illness or mental 

retardation * * * Because reporting is so 

piecemeal, the exact number of deaths in 

which restraint or seclusion was a factor is 

not known. We contacted the P&As 


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[protection and advocacy agencies] for each 

state and the District of Columbia and asked 

them to identify people in treatment settings 

who died in fiscal year 1998 and for whom 

restraint or seclusion was a factor in their 

death. The P&As identified 24, but this 

number is likely to be an understatement, 

because many states do not require all or 

some of their facilities to report such 

incidents to P&As. 

The lack of systemic information 

collection is an important point. The 

Joint Commission on Accreditation for 

Healthcare Organizations (JCAHO), 

which accredits 80 percent of the 

hospitals that participate in Medicare 

and Medicaid, does not require 

hospitals to report ‘‘sentinel events’’

such as injuries or deaths related to 

restraint or seclusion use, but 

encourages voluntary reporting through 

its sentinel event program. JCAHO 

defines a sentinel event as ‘‘an 

unexpected occurrence involving death 

or serious physical or psychological 

injury, or the risk thereof.’’ Even if each 

of the accredited hospitals scrupulously 

and voluntarily reports sentinel events, 

the 20 percent of Medicare- and 

Medicaid-participating hospitals that 

are non-accredited do not provide this 

information to JCAHO. Since reporting 

is voluntary rather than mandatory, 

accredited hospitals may choose not to 

inform JCAHO. Hospitals may fear that 

reported information might be used 

against them in court, which would 

provide a clear disincentive to 

consistent and voluntary reporting. 

Even if Glass’ projection of up to 150 

deaths per year is correct, some may 

question its statistical significance when 

compared with the number of deaths 

that result from other factors, such as 

medical errors. We believe that while 

deaths are a focal point, it is important 

not to discount patient injuries. If 

deaths are under-reported, injury data 

are even more elusive. Estimating the 

psychological and social impact of 

restraint or seclusion is more 

challenging still. We do not imply that 

most of the nation’s providers recklessly 

seclude or restrain patients without 

regard to their emotional well-being. To 

the contrary, many who commented on 

this regulation stated that restraint or 

seclusion are measures of last resort and 

that they do not undertake these 

interventions unless absolutely 

necessary. However, even when a 

restraint or seclusion is needed, the 

patient may feel dehumanized, isolated, 

or depressed as a result. Physical 

impact, although arguably not simple to 

measure, is more easily monitored and 

reported than impact on the spirit. 

In summary, we suspect that patient 

deaths and injuries are underreported, 

and, even if all parties voluntarily report 

incidents involving restraint or 

seclusion or comply with State and 

local reporting requirements, there are 

gaps in the system that thwart 

conclusive calculation of the number of 

physical injuries and deaths associated 

with restraint and seclusion use. Given 

the prevalence of use, the potential for 

injury, death, or adverse psychological 

impact, we maintain our original 

position—that this area deserves 

regulatory attention to safeguard patient 

health and safety. 

2. The Difference Between Standards (e) 

and (f) 

Comment: Many commenters stated 

that it is unclear which standard applies 

in any given situation. One commenter 

recommended that we delineate a clear, 

objective explanation of when 

application of the behavior management 

standard outside the psychiatric care 

setting is expected. One commenter 

objected to the creation of separate 

requirements for the care of psychiatric 

patients versus those receiving acute 

medical treatment, and asserted that all 

patients should be treated equally. 

However, most commenters agreed that 

different requirements should apply to 

restraints used for violent, aggressive 

patients as opposed to restraints used in 

the provision of medical care; some 

suggested that setting-specific 

requirements are more reasonable than 

behavior-specific ones. 

Response: Based on public comment 

regarding the lack of clarity between the 

application of standard (e) Restraint for 

acute medical and surgical care, and the 

application of standard (f) Restraint and 

seclusion for behavior management, we 

have revised and combined these 

requirements into a single standard in 

the final rule. This combined standard, 

entitled ‘‘Restraint or seclusion,’’ is 

subparagraph (e) under § 482.12 

Patients’ Rights in the final rule. This 

combined standard (e) applies to all 

uses of restraint or seclusion regardless 

of the patient’s location. Although we 

have modified some of the provisions to 

address public comments, these 

modifications do not lessen protections 

afforded patients who are restricted or 

secluded. We note that we have revised 

the regulation to expand training 

requirements, and have added a 

requirement that the attending 

physician or other licensed independent 

practitioner (LIP) responsible for the 

care of the patient be consulted as soon 

as possible when the one-hour restraint 

or seclusion evaluation of the violent or 

self-destructive patient is conducted by 

a trained registered nurse (RN) or 

physician assistant (PA). 

Comment: A few commenters noted 

the challenge of making a determination 

on the standard of care for a patient 

with multiple diagnoses and behaviors. 

Response: We agree that multiple 

diagnosis and behaviors can make 

determination on the standard of care a 

challenge. Therefore, even though 

several requirements were revised based 

on public comments, none of the 

current requirements in standards (e) 

and (f) have been deleted. All of the 

requirements contained in the current 

standard (e) are also contained in the 

current standard (f). These 

requirements, in their entirety, have 

been moved to the combined standard 

(e) in the final rule. All of the 

requirements contained in the current 

standard (f), have also been moved, in 

their entirety, to the combined standard 

(e) in the final rule. 

Comment: One commenter noted the 

difficulty in enforcing behavior-specific 

standards. However, another commenter 

supported writing the standards to focus 

on patient behavior or circumstances 

rather than on the setting. Some 

commenters requested clarification on 

what ‘‘behavior management’’ means. 

Response: For the purpose of clarity 

we have eliminated the term ‘‘behavior 

management’’ and are using more 

specific language. The management of 

violent or self-destructive behavior can 

occur as part of medical and surgical 

care as well as part of psychiatric care. 

The use of the language ‘‘violent or selfdestructive behavior’’ is intended to 

clarify the application of these 

requirements across all patient 

populations. It is not intended to single 

out any particular patient population. 

Based on public comments, we have 

eliminated the language ‘‘behavior 

management,’’ and have used clearer, 

more descriptive language in the final 

rule. Specifically, we have revised the 

regulations text at 482.13(e) to provide 

that restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, a staff 

member, or others, and must be 

discontinued at the earliest possible 

time. This combined standard clearly 

outlines the requirements any time 

restraint or seclusion is used, regardless 

of the patient’s location. We do not 

support a setting-based approach 

because interventions and protections 

provided without considering the 

patient’s behavior and symptoms may 

fail to adequately safeguard the health 

and safety of patients. In addition, this 

standard is not targeted only at patients 

on psychiatric units or those with 

behavioral/mental health care needs. 

The patient protections contained in 

this standard apply to all patients when 


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the use of restraint or seclusion becomes 

necessary. 

Although a patient’s violent or selfdestructive behavior may jeopardize the 

immediate physical safety of the patient, 

a staff member, or others more 

frequently in a psychiatric unit or in a 

psychiatric hospital, this behavior also 

appears in the acute medical/surgical 

care settings, including emergency and 

critical care settings. Some examples 

follow. A patient may experience a 

severe medication reaction that causes 

him or her to become violent. A patient 

may be withdrawing from alcohol and 

having delirium tremors (DTs). The 

patient is agitated, combative, verbally 

abusive, and attempting to hit staff. 

Regardless of facility type, such 

emergencies generally pose a significant 

risk for patients and others. For the 

safety of the patient and others, the use 

of restraint or seclusion may be 

necessary to manage the patient’s 

violent or self-destructive behavior that 

jeopardize the immediate physical 

safety of the patient, a staff member, or 

others when less restrictive 

interventions have been determined to 

be ineffective to protect the patient, 

staff, or others from harm. It is not 

targeted only at patients on psychiatric 

units or those with behavioral/mental 

health care needs. The patient 

protections contained in this standard 

apply to all patients when the use of 

restraint or seclusion becomes 

necessary. 

Comment: One commenter suggested 

adding language in § 482.13(f)(2) to 

indicate that standard (f) applies when 

a restraint or seclusion is used, ‘‘In an 

emergency situation to manage an 

unanticipated outburst of severely 

aggressive or destructive behavior that 

poses an imminent danger to the patient 

or others.’’ Several commenters 

suggested changing the title of standard 

(f), examples include, ‘‘Emergency 

behavior management’’ and ‘‘Seclusion/ 

restraint for patients with primary 

behavioral health care needs.’’

Response: The current standard (e) 

contains two requirements that are more 

stringent, if restraint or seclusion is 

used when a patient jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. They are: time 

limits on length of each order, and the 

1-hour face-to-face evaluation. The 

intent of these more stringent 

requirements is to add additional 

patient protections when restraint or 

seclusion is used for behavior 

management. We do not intend for these 

two more stringent requirements to 

apply to all uses of restraint. We have 

added clarifying language in the final 

rule that these requirements apply when 

restraint or seclusion are used for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. We have also 

specified that seclusion is only 

permitted to manage violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. 

Since publication of the interim final 

rule with comment period, we have 

repeatedly responded to inquiries 

regarding the criteria for differentiating 

between emergency situations where the 

patient’s behavior is violent or selfdestructive and jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others versus the nonemergency use of restraint. Most of the 

individuals to whom we spoke 

indicated that this distinction was clear 

and understandable. Clinicians are 

adept at identifying behavior and 

symptoms, and can readily recognize 

violent and self-destructive behavior 

that jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. Asking them to act based on 

evaluation of the patient’s behavior is 

no different than relying on the clinical 

judgment that they use daily in 

assessing the needs of each patient and 

taking actions to meet those individual 

needs. 

In the final rule, we adopted the 

restraint definition contained in the 

CHA. Because the requirements 

governing the use of restraint or 

seclusion have been combined in a 

single standard, we also have a single, 

consistent definition of restraint. A 

restraint is any manual method, 

physical or mechanical device, material, 

or equipment that immobilizes or 

reduces the ability of a patient to move 

his or her arms, legs, body, or head 

freely; or a drug or medication when it 

is used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. The final rule 

also clarifies that a restraint does not 

include devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). The devices and methods 

described above are typically used in 

medical/surgical care, and would not be 

considered restraints, and thus not 

subject to these requirements. 

The final, combined standard (e) 

applies to the use of restraint, the use of 

seclusion, as well as the simultaneous 

use of restraint and seclusion. To clarify 

this point, we have adopted use of the 

word ‘‘or’’ in the final, combined 

standard for restraint and seclusion. The 

use of ‘‘or’’ imports the ‘‘and,’’ whereas 

‘‘and’’ standing alone requires that both 

happen. It is not our intent that the 

requirements in this standard only 

apply when both restraint and seclusion 

are used. Therefore, throughout the 

regulation text, we have deleted ‘‘and’’

and inserted ‘‘or.’’ The regulations apply 

to the use of restraint or seclusion. This 

means they also apply when both 

restraint and seclusion are used. 

3. The Roles of CMS and JCAHO 

Comment: Regarding any provision 

that was not identical to JCAHO’s 

policy, a host of commenters expressed 

concern that CMS’s standards did not 

parallel or actually ran counter to 

JCAHO’s. One commenter stated that 

these discrepancies would create an 

implementation burden for hospitals. A 

number of commenters expressed 

concern that CMS was straying from its 

stated intent of maintaining consistency 

between Federal and accreditation 

standards. 

Response: In the interim final rule 

with comment period (64 FR 36079), we 

stated, ‘‘We believe it is appropriate to 

recognize JCAHO’s work in this area 

[regarding the length of physician or LIP 

orders] and maintain consistency 

between Federal and accreditation 

standards when possible.’’ We adopted 

JCAHO’s standard for time limited 

orders because, upon examination, we 

found nothing to suggest that these 

timeframes have been found faulty or 

that any more appropriate ones have 

been scientifically determined. 

However, we did not intend to suggest 

that we planned to follow JCAHO’s 

standards in all respects. 

Comment: One commenter suggested 

that the requirement that a physician or 

LIP see a patient who is restrained or 

secluded for behavior management 

within 1-hour is unnecessary because 

current practice provides good patient 

care. The commenter cited JCAHO’s 

revision of its standards regarding 

restraints and seclusion and noted that 

the hospital agreed with JCAHO and 

implemented those standards. Further, 

the commenter reported that the 

hospital has an ongoing improvement 

process, which has significantly 

decreased the use of restraints and 

seclusion for its adult population. 


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To govern the use of restraint and 

seclusion for children, another 

commenter suggested an approach 

similar to JCAHO’s. The commenter 

further suggested that national 

accreditation bodies could establish a 

certification and approval process for 

nonviolent intervention regimes. 

Additionally, the commenter suggested 

that accreditation surveys or regulatory 

reviews could include thorough 

individual and aggregate review of 

documentation of restraint and 

seclusion use. 

Response: The hospital CoPs are 

minimum health and safety standards 

that hospitals must meet to participate 

in the Medicare and Medicaid programs. 

The CoPs are intended to protect patient 

health and safety and to ensure that 

high quality care is provided to all 

patients. While we applaud JCAHO’s 

progress in the areas of examining 

restraint and seclusion use, JCAHO 

accreditation is voluntary and not the 

only way hospitals participate in the 

Medicare and Medicaid programs. 

Twenty percent of the hospitals that 

participate in Medicare and Medicaid 

are non-accredited. Non-accredited 

hospitals are surveyed by State survey 

agencies to determine compliance with 

the CoPs. We have the responsibility to 

ensure that all Medicare- and Medicaidparticipating hospitals have certain 

protections in place. Before July 2, 1999, 

the CoPs contained no requirements 

concerning Patients’ Rights. 

Our minimum requirements need to 

exist in regulatory form in order to carry 

the weight of the law and be 

enforceable. This final rule informs the 

public and provider community of our 

minimum requirements for the 

protection of patient health and safety 

while providing a sound basis for legal 

action if we find that those requirements 

are not met. While quality improvement 

initiatives and other internal efforts to 

track restraints and seclusion use and 

eliminate inappropriate use are 

important, we do not believe that they 

serve as a substitute for stated minimum 

Federal requirements. 

Comment: One commenter stated, 

‘‘Let’s leave the seclusion and restraint 

abusers to the civil courts and JCAHO, 

who are quite capable of creating overregulations without help from CMS.’’

Conversely, another commenter 

asserted, 

‘‘CMS bears a great deal of the blame for 

the deaths, injuries, and serious long-term 

psychological harm which those 

aforementioned patients and their families 

have endured because it did not amend its 

CoPs to assure such desirable outcomes. The 

JCAHO standards were available to CMS 

during those many years but it chose—for 

unexplainable and unacceptable reasons—to 

maintain the status-quo.’’

Response: There were other such 

polarized responses to the interim final 

rule with comment period. However, 

many commenters acknowledged the 

appropriateness of regulation in this 

area even if they disagreed with 

individual provisions of the interim 

final rule with comment period. 

The Congress has charged us with 

creating standards that protect the 

nation’s Medicare and Medicaid 

beneficiaries and ensure that these 

beneficiaries receive high quality care. 

Many commenters came forward with 

ideas about how the regulation could be 

changed and improved. Our task is to 

reconcile these ideas when feasible, and 

determine the best, most reasonable 

approach that promotes patient health 

and safety and yet does not create a 

disincentive for providers to serve those 

populations who most critically need 

their help. 

Comment: A commenter stated that 

CMS’s interest in alerting the public to 

the potential dangers associated with 

the use of restraint and seclusion is 

‘‘faddish.’’

Response: This commenter’s 

statement stood in stark contrast to 

those of many of his contemporaries 

who wrote of their tireless efforts to 

avert the potential hazards associated 

with the use of restraint and seclusion, 

and of the seriousness with which they 

undertake such interventions. While 

accounts of efforts to minimize use of 

restraint and seclusion and assure 

patient safety were heartening, a few of 

the letters we received were disturbing 

in their conceptualization of a restraint 

or seclusion not only as wholly 

appropriate, but as a ‘‘time-honored’’

standard of care. To that argument, we 

reply that standards of care continually 

evolve. For example, at one time patient 

shackles were considered a standard 

intervention. Habit does not justify the 

continued use of an intervention when 

alternative methods that are safer or 

more effective are available. The 

numerous training programs that 

emphasize alternative techniques for 

handling violent or self-destructive 

behavior and symptoms demonstrate 

that clinicians recognize the risks 

inherent in the use of restraint and 

seclusion. Practitioners in the field of 

medicine are constantly searching for 

better ways to manage symptoms and 

conditions that have been traditionally 

treated through the use of restraint or 

seclusion or both. We fully support 

these efforts. 

4. Applicability of the Patients’ Rights 

CoP 

Comment: One commenter stated that 

the preamble should explain the 

application and effect of the new 

regulation on psychiatric hospitals. If 

the regulation applies to psychiatric 

hospitals, the commenter stated the 

requirements specified in standard (f) 

(among others) might not be 

appropriate. 

Response: In the summary of the 

interim final rule with comment period 

(64 FR 36070), we explained, ‘‘The 

Patients’’ Rights CoP, including the 

standard regarding seclusion and 

restraint, applies to all Medicare- and 

Medicaid-participating hospitals, that is, 

short-term, psychiatric, rehabilitation, 

long-term, children’s, and alcoholdrug.’’ This final rule, including its 

provisions concerning the use of 

restraint and seclusion, is explicitly 

intended to apply in the psychiatric 

hospital setting. 

We disagree with the opinion that the 

requirements in the current standard (e) 

might not be appropriate for the 

psychiatric hospital setting. While 

violent or self-destructive patient 

behavior that jeopardizes the immediate 

physical safety of the patient, a staff 

member, or others occasionally occurs 

on an acute care unit in a hospital, it 

occurs more often on a psychiatric unit 

or in a psychiatric hospital. When a 

patient’s behavior becomes violent or 

self-destructive, the immediate physical 

safety of the patient, a staff member, or 

others is at risk. In such an emergency 

situation, it is critical to ensure that staff 

is well trained in alternative 

interventions and techniques; to ensure 

the safety and well being of the patient 

and others; to manage the patient’s 

behavior; and, to competently apply 

restraints or use seclusion. Additionally, 

the protections provided ensure that: 

the restrained or secluded patient is 

appropriately monitored and that the 

patient’s condition is reassessed; the 

patient’s medical and psychological 

conditions are evaluated; and, the 

intervention is ended as quickly as 

possible. Therefore, we believe that the 

protections in the current standard (f) 

that have been relocated to the 

combined standard (e) in the final rule 

are appropriate for the psychiatric care 

setting. 

Comment: One commenter suggested 

that we need to develop a separate 

category of patient rights for children 

that address their developmental needs 

rights and other basic needs. 

Response: The provisions contained 

in the Patients’ Rights CoP apply 

universally to all hospital patients, 


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including children. Although there is no 

separate category for patient’s rights on 

the basis of age, the regulations 

recognize differences. Timeframes on 

orders for the use of restraints or 

seclusion are different based on age. For 

example, for children and adolescents 9 

to 17 years of age, orders for restraint or 

seclusion are limited to a maximum of 

2 hours. When implementing these 

regulations, we expect hospitals to 

develop and implement an approach 

that meets the individualized needs of 

the patient populations that they serve. 

Comment: One commenter stated that 

since there are no attending physicians 

in religious non-medical facilities, 

amendments should be made to 

incorporate the provisions of section 

1861(ss) of the Act. 

Response: Effective January 31, 2000, 

religious non-medical facilities are not 

governed by the hospital CoPs, but by 

their own requirements. The new 

requirements for religious non-medical 

facilities do not permit the use of 

restraint or involuntary seclusion 

(§§ 403.730(c)(4) and (5)). (For 

additional information, see the 

November 30, 1999 and November 28, 

2003 Federal Registers (64 FR 67028) 

and (68 FR 66710), respectively). 

5. Debriefing After the Use of Restraint/ 

Seclusion 

Comment: Many consumer advocates 

suggested creating a requirement for 

debriefing staff and patients following 

each incident of restraint or seclusion, 

and documenting the use of either 

procedure in the patient’s record. The 

debriefing’s purpose would be to—(1) 

develop an understanding of the factors 

that may have evoked the behaviors 

necessitating the use of restraint or 

seclusion; (2) give the patient time to 

verbalize his or her feelings and 

concerns; and (3) identify strategies to 

avoid future use of seclusion or 

restraint. Another commenter 

recommended that staff debriefing, 

followed by patient debriefing, occur 

within 24 hours of each incident of 

restraint or seclusion. One commenter 

noted that its hospital requires staff 

debriefing as part of an approach that 

has dramatically reduced its incidence 

of restraint and seclusion use. 

Another commenter argued that 

debriefing is unnecessary in many cases 

of restraint use. The commenter further 

stated that requiring debriefing after 

each use of restraint or seclusion would 

create unnecessary work. 

‘‘It is not uncommon for patients to require 

restraint or seclusion for multiple episodes of 

aggression in a 24-hour time period. The 

underlying rationale for debriefings, to avoid 

future uses of restraint or seclusion, can be 

handled by other means, including 

consultation with the physician or advance 

practice nurse who authorizes restraint use. 

There could be debriefings when incidents 

are critical in nature.’’

Response: We agree that debriefing 

can be a useful, productive exercise that 

helps both the patient and staff 

understand what has happened and 

how such situations can be averted in 

the future. However, we see the 

argument made by the opposing 

commenter as valid. The use of restraint 

or seclusion is only permitted while the 

unsafe situation persists, and must be 

discontinued at the earliest possible 

time. A patient may have multiple uses 

of restraint or seclusion in a fairly short 

timeframe. Requiring that a debriefing 

occur after each use may be impractical 

or unnecessary. We believe that 

hospitals and clinicians will use 

debriefing as a component of the 

treatment plan designed to safely 

manage violent or self-destructive 

patient behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others as necessary. 

Therefore, we are not requiring 

debriefing. 

Comment: One commenter suggested 

that a multidisciplinary team should 

review each incident within 24 hours. 

Their review should be part of the 

hospital’s quality assurance and peer 

review procedures. 

Response: We believe that hospitals 

will monitor restraint and seclusion use 

through their Quality Assessment 

Performance Improvement (QAPI) 

programs. Mandating that a 

multidisciplinary team review each 

incident within 24 hours would be 

unnecessarily burdensome. Therefore, 

we are not specifying that this must 

occur in this rule. 

B. Comments Received on Specific 

Provisions 

1. The Right To Be Free From Restraint 

(§§ 482.13(e)(1) and (f)(1)) 

We stated that the patient has the 

right to be free from restraints of any 

form that are not medically necessary, 

or are used as a means of coercion, 

discipline, convenience, or retaliation 

by staff. Section 482.13(f)(1) paralleled 

this requirement and stated that the 

patient has the right to be free from 

seclusion and restraints, of any form, 

imposed as a means of coercion, 

discipline, convenience, or retaliation 

by staff. 

Comment: Many commenters agreed 

with this general statement and 

applauded our efforts to eliminate the 

inappropriate use of restraint. However, 

some commenters stated that the 

procedural requirements specified in 

the interim final rule for the appropriate 

use of restraint were too idealistic. 

Response: We appreciate the support 

expressed by many commenters. 

Regarding concerns about the 

practicality of the current requirements, 

we believe that some commenters have 

interpreted current standard to require 

face-to-face monitoring in every clinical 

situation. Our intent is that the 

restrained or secluded patient’s 

condition be assessed and monitored by 

a physician, other licensed independent 

practitioner or trained staff at an 

interval determined by hospital policy. 

In this final rule, we have amended the 

regulatory language at § 482.13(e)(10) to 

reflect this. Hospital policies should 

address the frequency of assessment and 

the assessment parameters (for example, 

vital signs, circulation checks, hydration 

needs, elimination needs, level of 

distress and agitation, mental status, 

cognitive functioning, skin integrity). 

Hospital policies should guide staff in 

how to determine an appropriate 

interval for assessment and monitoring 

based on the individual needs of the 

patient, the patient’s condition, and the 

type of restraint used. It may be that a 

specific patient needs continual face-toface monitoring; or that the patient’s 

safety, comfort, and well-being are best 

assured by periodic checks. Continual 

face-to-face monitoring is only required 

when restraint and seclusion are used 

simultaneously to address violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. The hospital is responsible for 

providing the level of monitoring and 

frequency of reassessment that will 

ensure the patient’s safety. In this final 

rule, we have also added language to 

clarify that a restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). 

Comment: One commenter stated that 

he could not find legal authority for 

health professionals to restrain their 

patients, absent specific court orders. 

The commenter also noted that health 

professionals might be excused for 

restraining patients only if the purpose 

of restraint is to minimize an imminent 

risk of great bodily harm, and only 


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when the need for restraint is not 

provoked by the health professional. 

Response: We agree that consideration 

of the safety of the patient, staff, or 

others is the basis for applying a 

restraint. We have supported this 

approach in combined standard (e) by 

stating that all patients have the right to 

be free from physical or mental abuse, 

and corporal punishment, and have the 

right to be free from restraint or 

seclusion, of any form, imposed as a 

means of coercion, discipline, 

convenience, or retaliation by staff. 

Restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, staff or 

others and must be discontinued at the 

earliest possible time. In the final rule, 

we have also stated that restraint or 

seclusion may only be used when less 

restrictive interventions have been 

determined to be ineffective to protect 

the patient or others from harm. Finally, 

we have stated that the type or 

technique of restraint or seclusion used 

must be the least restrictive intervention 

that will be effective to protect the 

patient or others from harm. 

Comment: Several commenters argued 

that few effective means of therapeutic 

intervention for significant behavioral 

problems exist, and that disallowing the 

use of restraint or seclusion might result 

in a denial of treatment for individuals 

with significant problems because of the 

limitation on what providers can do to 

address symptoms. These commenters 

argued that providers would be 

unwilling to jeopardize staff and others’

safety or incur any liability associated 

with untreated behaviors. Some 

commenters suggested that this 

regulation would result in the increased 

use of other interventions, such as 

psychotropic medications, to address 

behavioral challenges. Some suggested 

that without the use of restraint or 

seclusion, patients would remain 

incapacitated by their problems. Several 

commenters said that CMS 

inappropriately excluded ‘‘therapeutic’’

uses of restraint, such as therapeutic 

holding and medications. 

Response: This final rule does not ban 

the use of restraint or seclusion. 

However, it does prohibit the use of 

restraint or seclusion that are imposed 

as a means of coercion, discipline, 

convenience, or retaliation by staff. This 

final rule also establishes parameters to 

assure patient safety when less 

restrictive interventions have been 

determined to be ineffective to protect 

the patient, staff, or others from harm. 

In the final rule, a restraint is any 

manual method, physical or mechanical 

device, material, or equipment that 

immobilizes or reduces the ability of a 

patient to move his or her arms, legs, 

body, or head freely; or a drug or 

medication when it is used as a 

restriction to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition. A restraint does not 

include devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort. The devices and methods listed 

here that would not be considered 

restraints, and thus not subject to these 

requirements, are typically used in 

medical surgical care. Although 

physical holding of a patient for the 

purpose of conducting routine physical 

exams or tests is not considered a 

restraint, all patients have the right to 

refuse treatment. This patient right is 

addressed at § 482.13(b)(2). The use of 

therapeutic holds to manage violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others would be considered a form of 

restraint and therefore, would be subject 

to the requirements contained in this 

final rule. If the definition of restraint is 

met, then that practice or device 

(whether it is therapeutic holding or a 

mechanical device) is considered a form 

of restraint and may be employed so 

long as all of the requirements for 

restraint use are met. 

In the interim final rule with 

comment period, the definition of ‘‘drug 

used as a restraint’’ specifically 

exempted medications that are used as 

a standard treatment for the patient’s 

medical or psychiatric condition. Some 

commenters criticized this definition as 

being too broad and subjective. This 

regulation is not intended to interfere 

with the clinical treatment of patients 

who are suffering from serious mental 

illness and who need appropriate 

therapeutic doses of medications to 

improve their level of functioning so 

that they can more actively participate 

in their treatment. Similarly, the 

regulation is not intended to interfere 

with appropriate doses of sleeping 

medication prescribed for patients with 

insomnia or anti-anxiety medication 

prescribed to calm a patient who is 

anxious. Thus, those medications that 

are a standard treatment for a patient’s 

condition are not subject to the 

requirements of this regulation. 

In this final rule, we have defined a 

drug used as a restraint as a drug or 

medication that is used as a restriction 

to manage the patient’s behavior or 

restrict the patient’s freedom of 

movement and is not a standard 

treatment or dosage for the patient’s 

condition. We believe this revised 

definition more clearly supports the role 

of medications that facilitate the 

patient’s participation in their care and 

maintenance of the patient’s functional 

status. 

Comment: A commenter suggested 

that the word ‘‘discipline’’ should be 

replaced with ‘‘punishment,’’ since the 

two words are not the same in meaning 

and there are situations where patient 

discipline is necessary. 

Response: The distinction between 

the word ‘‘discipline’’ and 

‘‘punishment’’ is a more relevant issue 

in the developmental disability/mental 

retardation setting, as opposed to the 

psychiatric and acute care settings. 

Therefore, we have retained the use of 

the word ‘‘discipline.’’

Comment: One commenter opined 

that this regulation provides the ‘‘right 

to fall and break a hip’’ or ‘‘crack your 

head open.’’ Another commenter who 

provides care to patients with dementia 

who ‘‘need a vest restraint [commonly 

referred to as a Posey vest] at night to 

prevent them from falling out of bed, or 

getting up and falling in the bathroom,’’

questioned whether allowing these 

patients to fall unnecessarily is more 

humane than restraining them. The 

commenter also stated that while some 

patients can be medicated and 

restrained briefly on an occasional basis, 

others—those with dementia or 

Alzheimers or both, for example, need 

some type of restraint most of the time 

on a permanent basis for their own 

safety. 

Response: The final regulation states 

that devices that protect the patient 

from falling out of bed are not restraints. 

However, when the clinician raises all 

four side rails in order to restrain a 

patient, (defined in this regulation as 

immobilizing or reducing the ability of 

a patient to move his or her arms, legs, 

body, or head freely) to ensure the 

immediate physical safety of the patient 

then the rule applies. Raising fewer than 

four side rails when the bed has more 

than two side rails, would not 

necessarily immobilize or reduce the 

ability of a patient to move as defined 

in this regulation. 

Practitioners and hospitals utilize a 

variety of measures to ensure patient 

safety. Use of a restraint is only one of 

the possible interventions. 


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Comprehensive assessment of the 

patient and the environment, in 

conjunction with individualized patient 

care planning, should be used to 

determine those interventions that will 

best ensure the patient’s safety and wellbeing with the least risk. However, as 

part of clinician’s decision-making, we 

would expect such an assessment to be 

conducted regardless of whether or not 

the intervention to ensure patient safety 

is considered a restraint under this 

regulation. Clinical decision making, 

which includes assessments, would 

govern the use of restrictions that are 

not covered by these requirements. 

Regarding the idea that some patients 

require permanent restraint, we contend 

that every patient is entitled to an 

individualized assessment and 

treatment that takes into account the 

patient’s individual strengths, 

weaknesses, choices, needs, and 

concerns. For example, most adults 

sleep at home in their beds each night 

without being tied down or otherwise 

protected from falling out of bed. All 

use of restrictions, whether governed by 

these regulations or not, should be 

based on an individualized patient 

assessment and the use of all available 

innovative alternatives and approaches 

to address patient care needs. Again, we 

have not prohibited the use of restraints; 

but we do prohibit using restraints as a 

substitute for adequate staffing, 

monitoring, assessment, or investigation 

of the reasons behind patient behavior 

such as wandering or getting up in the 

night, which may be indicative of unmet 

patient care needs. When the use of 

restraints is necessary, the combined 

standard (e) applies. 

Comment: One commenter suggested 

adding the words, ‘‘Or as a replacement 

for adequate levels of staff,’’ to the 

statement that restraint may not be used 

as a means of coercion, discipline, 

convenience, or retaliation by staff. 

Response: The final regulation 

language states that all patients have the 

right to be free from restraint or 

seclusion, of any form, imposed for 

convenience. This language precludes 

using restraint or seclusion as a 

substitute for adequate staffing levels. 

Therefore, we have not accepted this 

comment. 

Comment: One commenter suggested 

removing the words, ‘‘medically 

necessary,’’ from (e)(1), arguing that 

physicians would not order treatments 

that were not medically necessary. 

Another commenter, however, 

described just such a case; namely, 

interventions undertaken at the 

voluntary request of the patient, such as 

a cognitively intact patient asking to 

have his or her bed’s side rails put up. 

This commenter asked if a voluntary 

request would be exempted from 

meeting the regulatory requirements. 

Response: In the final rule, ‘‘not 

medically necessary’’ has been removed 

from the definition of restraint. Restraint 

may only be used to ensure the 

immediate physical safety of the patient, 

staff, or others. In addition, a restraint 

does not include devices, such as 

orthopedically prescribed devices, 

surgical dressings or bandages, 

protective helmets, or other methods 

that involve the physical holding of a 

patient for the purpose of conducting 

routine physical examinations or tests, 

or to protect the patient from falling out 

of bed, or to permit the patient to 

participate in activities without the risk 

of physical harm (this does not include 

a physical escort). 

Often with the best of intentions, a 

patient or the patient’s family may ask 

for a restraint to be applied. For 

example, a concerned husband may ask 

that his frail elderly wife be tied into 

bed to prevent her from wandering. In 

both examples, the concern may be 

valid, and a responsive intervention 

may be appropriate. However, a patient 

or family member may be unfamiliar 

with the many innovative, less 

restrictive alternatives available to 

address a patient’s needs. Such a 

request, like any other patient or family 

request for an intervention, should 

prompt a patient and situational 

assessment to determine whether an 

intervention is needed. If a need is 

confirmed, the practitioner must then 

determine the type of intervention that 

will meet the patient’s needs with the 

least risk and most benefit to the 

patient. A request from a patient or 

family member for the application of a 

restraint which they would consider to 

be beneficial is not a sufficient basis for 

the use of a restraint intervention. 

Regardless of whether restraint use is 

voluntary or involuntary, if restraint (as 

defined by the regulation) is used, then 

the requirements of the regulation must 

be met. Finally, this rule would not 

preclude a patient, or a patient’s family 

member from requesting that his or her 

side rail be raised. 

Comment: One commenter asked 

whether the rule requires adding the 

rights provided by standards (e) and (f) 

to the hospital’s patients’ rights policies 

and procedures and/or a written 

notification provided to the patient. The 

commenter argued that specifically 

stating these rights would require 

increased staff time, would be a risk 

management ‘‘nightmare,’’ and would 

require a patient/family member release 

form to be signed authorizing the use of 

a restraint, even when a restraint is 

medically necessary. 

Response: Standard (a), Notice of 

rights, requires patient notification of 

his or her rights. We are not convinced 

that notifying the patient of the right to 

be free from restraint or seclusion 

imposed as a means of coercion, 

discipline, convenience, or retaliation 

by staff, will take significantly more 

time than informing the patient of his or 

her other rights, particularly since the 

hospital retains extreme flexibility in 

how and when this notice is provided. 

We are also uncertain why informing 

the patient of his or her rights would 

present a risk management ‘‘nightmare.’’

Concerning the commenter’s third 

point, the rule does not require that the 

patient or his or her representative sign 

release forms. A hospital may choose to 

introduce this policy; however, 

depending on the mechanism the 

hospital uses to provide this notification 

(for example, as a standard part of each 

admissions packet; in posted forms in 

the admissions office or emergency 

room area; bundled with existing 

required notices) such a step may be 

unnecessary. 

2. Definition of ‘‘Restraint’’ and 

‘‘Physical Restraint’’ (§§ 482.13(e)(1) 

and (f)(1)) 

In the interim final rule with 

comment period, we stated that the term 

‘‘restraint’’ includes either a physical 

restraint or a drug that is being used as 

a restraint. A physical restraint is any 

manual method or physical or 

mechanical device, material, or 

equipment attached or adjacent to the 

patient’s body that he or she cannot 

easily remove that restricts freedom of 

movement or normal access to one’s 

body. 

Comment: One commenter 

recommended uniform definitions of 

restraint and physical restraint across 

care settings to avoid confusion. 

Another commenter suggested defining 

restraint as, ‘‘the forcible and 

involuntary deprivation of the liberty to 

move about.’’ The same commenter 

recommended classifying restraints in 

three categories: least restrictive 

(manual restraint or holding); 

intermediate (seclusion, to be defined as 

‘‘restricting voluntary movement by 

locking a patient in a room. If an 

individual cannot leave the room at 

will, the room is considered locked, 

whether the door is actually locked or 

not’’); and most restrictive and intrusive 

(mechanical restraints such as belts, 

cuffs, or soft ties). Several other 

commenters argued for similar 

categorization, with corresponding 

monitoring and ordering requirements 


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(that is, with consideration for the 

differences between interventions such 

as a four-point restraint and a restraint 

used for frail patients). One commenter 

argued that physical and mechanical 

restraints should be defined separately 

rather than lumped into one category. 

Response: We agree that a uniform 

definition of restraint across care 

settings is a good approach, adds clarity, 

and avoids confusion. In the final rule, 

we have combined the regulations 

governing the use of restraint or 

seclusion into a single standard, and 

have adopted a single, consistent 

restraint definition. This definition 

applies to all uses of restraint in all 

hospital care settings. A restraint is any 

manual method, physical or mechanical 

device, material, or equipment that 

immobilizes or reduces the ability of a 

patient to move his or her arms, legs, 

body, or head freely; or a drug or 

medication when it is used as a 

restriction to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition. The final rule also 

clarifies that a restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). This definition renders 

unnecessary the otherwise impossible 

task of naming each device and 

practices that can inhibit a patient’s 

movement. 

The concept of liberty of movement as 

proposed in this comment is 

incorporated in the final rule at the 

beginning of combined standard (e). All 

patients have the right to be free from 

restraint or seclusion, of any form, 

imposed as a means of coercion, 

discipline, convenience, or retaliation 

by staff. Restraint or seclusion may only 

be imposed to insure the immediate 

physical safety of the patient, staff, or 

others and must be discontinued at the 

earliest possible time. 

However, we did not break restraints 

into three classes or view seclusion as 

a subset of restraint. We believe that the 

categorization proposed by the 

commenter is somewhat arbitrary, 

particularly in light of the fact that 

several of the deaths reported by the 

Hartford Courant occurred during 

physical holds, which the commenter 

would have categorized as ‘‘least 

restrictive.’’ This fact makes us wary of 

suggesting, even implicitly, that 

physical holds are preferable to 

mechanical restraint. The deaths 

resulting from other traditional 

mechanical devices also persuade us of 

the hazards of using mechanical 

restraints. The type of restraint used is 

not the defining hazard—other 

variables, such as lack of patient 

assessment in choosing the restraint, 

inappropriate application of the 

physical restraint mechanism or 

technique, or inadequate patient 

monitoring could render many 

interventions dangerous. Accordingly, 

given the unique circumstances 

presented by each patient, we believe 

that it would be inappropriate and 

would place patients at risk to 

arbitrarily suggest that one form of 

restraint is categorically preferable to 

another. 

Finally, we have streamlined and 

clarified monitoring requirements in 

combined standard (e). The final rule 

states that the condition of the patient 

who is restrained or secluded must be 

monitored by a physician, other 

licensed independent practitioner or 

trained staff at an interval determined 

by hospital policy. When restraint or 

seclusion is used to manage violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others, the patient must be seen and 

evaluated face-to-face within one hour 

after the initiation of the intervention. 

This final rule provides flexibility for 

trained staff to determine the 

monitoring parameters necessary when 

a restraint or seclusion is used. The 

more stringent continual monitoring 

requirements have been retained only 

for patients who are simultaneously 

restrained and secluded for management 

of violent or self-destructive behavior 

that jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. 

Comment: Some commenters asked 

whether the following constitute 

restraint: therapeutic holding; 

comforting children through holding; 

escorting or touching for de-escalation; 

virtually any type of touching, like 

holding a patient’s arm to prevent him 

from hitting the wall; basket holds; or 

touching to encourage the patient to lie 

still for a procedure. Many commenters 

argued that therapeutic holding is 

necessary, and that the regulation 

should allow individualized treatment. 

Response: Several commenters 

mentioned different types of holding, 

including therapeutic holding. For the 

purposes of this regulation, a staff 

member picking up, redirecting, or 

holding an infant, toddler, or preschoolaged child to comfort the patient is not 

considered restraint. If an intervention 

meets the regulatory definition of 

restraint, then that intervention 

constitutes a restraint and the standards 

for restraint use must be followed. A 

restraint is any method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move his or 

her arms, legs, body, or head freely. A 

restraint does not include devices, such 

as orthopedically prescribed devices, 

surgical dressings or bandages, 

protective helmets, or other methods 

that involve the physical holding of a 

patient for the purpose of conducting 

routine physical examinations or tests, 

or to protect the patient from falling out 

of bed, or to permit the patient to 

participate in activities without the risk 

of physical harm (this does not include 

a physical escort. The devices and 

methods listed here that would not be 

considered restraints, and thus not 

subject to these requirements, are 

typically used in medical surgical care. 

The regulation permits the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests. However, patients 

do have the right to refuse treatment. 

See § 482.13(b)(2). This includes the 

right to refuse physical examinations or 

tests. Holding a patient in a manner that 

restricts the patient’s movement against 

his or her will would be considered a 

restraint. This includes therapeutic 

holds. Many deaths have involved these 

practices and may be just as restrictive 

and potentially dangerous as restraining 

methods that involve devices. However, 

the opportunity for individualized 

treatment of the patient is still available, 

since the regulation does not prohibit 

the use of any particular type of 

restraint. This regulation requires 

individualized patient assessment and 

use of the least restrictive intervention 

when restraint is needed to protect the 

patient, a staff member, or others from 

harm. 

Comment: Several commenters asked 

whether a side rail was a physical 

restraint. One commenter stated that 

‘‘the majority’’ of hospitals require that 

side rails be raised for safety reasons, 

and that patients do not perceive this 

common safety practice as a restraint. 

This commenter also cited a need for 

side rails to be raised to protect patients 

who are confused or disoriented by 

narcotics or controlled substances. 

Another commenter wanted to know if 

crib rails are a restraint. 

Response: The final rule states that a 

restraint does not include methods that 

protect the patient from falling out of 


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bed. It is standard practice to raise the 

side rails when a patient is on a 

stretcher, recovering from anesthesia, 

sedated, experiencing involuntary 

movement, or on certain types of 

therapeutic beds to prevent the patient 

from falling out of the bed. However, the 

use of side rails to prevent a patient 

from exiting a hospital bed may pose 

risk to the patient’s safety, particularly 

for the frail elderly who may be at risk 

for entrapment between the mattress 

and the bed frame. A disoriented patient 

may see the side rail as a barrier to be 

climbed over or may attempt to wriggle 

through split rails or to the end of the 

bed to exit the bed. As a result, this 

patient may have an increased risk for 

a fall or other injury by attempting to 

exit the bed with the side rails raised. 

The risk presented by side rail use 

should be weighed against the risk 

presented by the patient’s behavior as 

ascertained through individualized 

assessment. Clinical judgment 

determines whether or not the use of 

siderails is governed by the rule. When 

the clinician raises all four siderails in 

order to restrain a patient, defined in 

this regulation as immobilizing or 

reducing the ability of a patient to move 

his or her arms, legs, body, or head 

freely to ensure the immediate physical 

safety of the patient, then the rule 

applies. Raising fewer than four 

siderails when the bed has more than 

two siderails, would not necessarily 

immobilize or reduce the ability of a 

patient to move as defined in the 

regulation. 

Regarding the question of whether 

crib rails are a restraint, placement in a 

crib with raised rails is an ageappropriate standard safety practice for 

every infant or toddler. Therefore, 

placement of an infant or toddler in the 

crib with raised rails would not be 

regarded as a restraint. Age or 

developmentally appropriate protective 

safety interventions, such as stroller 

safety belts, swing safety belts, high 

chair lap belts, raised crib rails, and crib 

covers, that a safety-conscious child 

care provider outside a health care 

setting would utilize to protect an 

infant, toddler, or preschool-aged child 

would not be considered restraint or 

seclusion for the purposes of these 

regulations. The use of these safety 

interventions should be addressed in 

hospital policies or procedures. 

Comment: Several commenters 

believed that mechanical restraints 

should never be used in the mental 

health treatment of children and 

adolescents. One commenter suggested 

banning both mechanical restraint and 

seclusion for patients who are 17 years 

of age or younger. Several commenters 

offered permutations of this suggestion, 

such as a ban on the use of mechanical 

restraint for patients under 17 years of 

age. 

Response: Situations exist where it 

may become necessary to restrain or 

seclude a child or adolescent to ensure 

the safety of the patient or others. 

Regardless of age, the selection of an 

intervention must be individualized for 

each patient. When a restraint is used to 

manage self-destructive or violent 

behavior that jeopardizes the immediate 

physical safety of the patient, a staff 

member, or others, a variety of factors, 

such as medical condition, disability, 

psychiatric condition, history of abuse, 

height, and weight, as well as age, must 

be assessed and evaluated to determine 

the least restrictive intervention that 

will effectively ensure the safety of the 

patient and others. In unique 

emergencies, a mechanical restraint may 

be necessary for a patient under 17 years 

of age. For example, if a 250-pound 16- 

year old male is physically attacking 

another patient, staff may have limited 

options to stop the attack. At times, the 

child’s size may eliminate the ability to 

safely use a physical hold with the staff 

available. The child’s medical condition 

(for example, asthma or a fractured 

limb) could also contraindicate the use 

of a physical hold. 

However, we recognize that children 

and adolescents, as well as adults, are 

vulnerable and at risk when restrained 

or secluded to manage violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. Therefore, we 

have retained the time limits on each 

order for restraint or seclusion to 

manage aggressive destructive in 

combined standard (e). Orders are 

limited to 4 hours for adults 18 years of 

age or older; 2 hours for children and 

adolescents 9 to 17 years of age; and 1- 

hour for children under 9 years of age. 

The restraint or seclusion order may 

only be renewed in accordance with 

these limits for up to a total of 24 hours. 

Before writing a new order, a physician 

or licensed independent practitioner 

must see and assess the patient. 

Comment: Many commenters 

indicated that the restraint definition is 

too broad and includes items that are 

typically used in the provision of care, 

such as catheters, drainage tubes, plastic 

casts, and bandages, which can restrict 

freedom of movement. Several 

commenters asked whether adaptive or 

protective devices such as helmets, or 

devices that are used for postural 

support, meet the definition of restraint. 

One commenter asked whether CMS 

would permit the use of devices to assist 

with chronic conditions or for 

physically frail patients. One 

commenter asked that we address the 

use of restraint for dental, diagnostic, 

and surgical procedures. The 

commenter stated that devices used for 

medical immobilization are given an 

exemption by JCAHO. The commenter 

asked if CMS would create a mirroring 

exemption. 

Response: In response to comments, 

we have added language that limits the 

application of this definition. In the 

final rule, a restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). The devices and methods listed 

here that would not be considered 

restraints, and thus not subject to these 

requirements, are typically used in 

medical surgical care. Adaptive devices 

or mechanical supports used to achieve 

proper body position, balance, or 

alignment to allow greater freedom of 

mobility than would be possible 

without the use of such a mechanical 

support is not considered a restraint. 

For example, some patients are unable 

to walk without the use of leg braces, or 

are unable to sit upright without neck, 

head or back braces. Such devices 

generally permit the patient to 

participate more fully in activities 

without the risk of physical harm. 

Comment: Several commenters 

suggested that devices used for security 

purposes should be exempt from the 

regulatory requirements. Another 

commenter argued that forensic 

hospitals or units should be exempted 

from the regulatory requirements 

because they compromise the hospital’s 

ability to manage behavior. 

Response: The use of handcuffs or 

other restrictive devices applied by law 

enforcement officials who are not 

employees of the hospital for custody, 

detention, and public safety reasons are 

not governed by this rule. The law 

enforcement officers who maintain 

custody and direct supervision of their 

prisoner (the hospital’s patient) are 

responsible for the use, application, and 

monitoring of these restrictive devices 

in accordance with Federal and State 

law. However, the hospital is still 

responsible for providing safe and 

appropriate care to the patient. 

Comment: One commenter argued for 

the need for ‘‘programmatic’’ use of 

restraint for mentally retarded patients 


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in a psychiatric or an acute care unit 

and stated that the interim final rule 

with comment period created a barrier 

to using a restraint as part of a treatment 

plan. 

Response: Our expectation is that 

restraint or seclusion will not be a 

standard response to a particular 

behavior or situation. The use of such 

interventions is a temporary measure 

that protects the safety of patients and 

others, but is not a long-term solution 

for handling problematic behavior. 

3. Definition of ‘‘Drug Used as a 

Restraint’’ (§§ 482.13(e)(1) and (f)(1)) 

We stated that a drug used as a 

restraint is a medication used to control 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment for the patient’s 

medical or psychiatric condition. 

Comment: Some commenters 

indicated that the definition of ‘‘drug 

used as a restraint’’ was too broad, 

subjective, and confusing. One 

commenter suggested that we adopt the 

definition of chemical restraint found in 

the long-term care interpretive 

guidelines—that is, ‘‘A medication used 

for discipline or convenience that is not 

required to treat medical symptoms.’’

Several commenters argued that the 

determination of what constitutes a 

‘‘standard treatment’’ for certain 

medical or psychiatric conditions is too 

subjective. One commenter observed 

that physicians may legitimately order 

nonstandard treatments for their 

patients. Another commenter noted that 

problems present in mentally retarded 

patients do not correspond closely to 

any medical or psychiatric diagnosis 

and that the rule only discusses these 

two sorts of standard uses of 

medication. One commenter explained 

that in acute care, medications are 

changed based on the patient’s medical 

condition and symptoms. This 

commenter also stated that this 

regulation creates a burden for the 

administrative staff that will have to 

distinguish a drug used as ongoing 

medical management from a drug that, 

at some point, has evolved into a 

restraint that is not part of standard 

treatment. 

Other commenters grappled with how 

to characterize the appropriate role of 

medications in a patient’s care. For 

example, one commenter expressed 

alarm at the apparent ban on PRN orders 

for medications that might affect a 

patient’s behavior or restrict a patient’s 

movement. The commenter argued that 

medications for behavioral health 

patients are used precisely to affect 

behavior so that the patient can 

participate more fully in his or her care, 

treatment, and therapy. The commenter 

stated that they are administered in 

order to avoid the emergence or 

escalation of specific behaviors that 

might prompt the use of more restrictive 

physical restraints or seclusion. The 

commenter also stated behavioral health 

providers recognize that the use of the 

same drug may be therapeutic in one 

instance and not in another, and have 

indicated that a drug used as a restraint 

should not be applied when its use 

impedes a person’s ability to participate 

in his or her care. Some commenters 

noted that drug therapy should be part 

of an effective treatment plan to manage 

behavior. 

There was little agreement among 

commenters as to how drugs used to 

restrain patients should be handled. 

While a few commenters agreed with 

the concept that a drug used as a 

restraint is not a standard treatment (one 

stating that ‘‘prohibition is critical’’), 

several recommended deleting any 

reference to a drug used as a restraint. 

One commenter argued that the use of 

medications is already closely 

scrutinized through pharmacy oversight 

and the physician ordering process. The 

requirements of the interim final rule 

with comment period add an 

unnecessary layer of oversight. 

Another commenter stated that the 

use of a drug as a restraint should 

appear in its own standard, as the use 

of a medication differs from physical 

interventions. 

The idea of a medication 

‘‘controlling’’ behavior garnered 

considerable comments which included 

the following: 

• All psychotropic medications 

control behavior to the extent that they 

reduce psychiatric symptoms; 

• The idea of a medication 

controlling behavior is not as 

straightforward as it appears; 

• No medication ‘‘controls’’ behavior. 

A better word would be ‘‘directs,’’

‘‘contains,’’ or ‘‘ameliorates;’’

• All drugs have effects as a restraint; 

and 

• The phrase ‘‘control behavior’’

should be removed, and a drug used as 

a restraint should be defined as a drug 

used with the intent to restrain or 

restrict the patient’s freedom of 

movement. 

One commenter asked for clarification 

regarding the classification of paralytic 

drugs, sedatives, and analgesics, and 

how they would be affected by the 

regulation. 

A commenter suggested that if a 

patient has consented to the use of a 

medication, it should not be classified 

as a drug used as a restraint. Another 

commenter argued that if a drug is used 

as a one-time dose to help aid in the 

plan of care but is not part of the care 

plan, it is not a drug used as a restraint. 

Many commenters characterized the 

use of a drug as possibly the least 

restrictive alternative to deal with 

violent or aggressive behavior, arguing 

that its use is more humane than 

allowing the patient to escalate and lose 

self-control. 

Response: Patients have a 

fundamental right to be free from 

restraints that are imposed for coercion, 

discipline, convenience, or retaliation 

by staff, including drugs that are used as 

restraints. In the interim final rule with 

comment period, the definition of ‘‘drug 

used as a restraint’’ was phrased so that 

medications that are used as part of a 

patient’s standard medical or 

psychiatric treatment would not be 

subject to the requirements of standards 

(e) or (f). These regulations are not 

intended to interfere with the clinical 

treatment of patients who are suffering 

from serious mental illness and who 

need therapeutic doses of medication to 

improve their level of functioning so 

that they can more actively participate 

in their treatment. Similarly, these 

regulations are not intended to interfere 

with appropriate doses of sleeping 

medication prescribed for patients with 

insomnia, anti-anxiety medication 

prescribed to calm a patient who is 

anxious, or analgesics prescribed for 

pain management. This language was 

intended to provide flexibility and 

recognize the variations in patient 

conditions. 

A standard treatment for a medication 

used to address a patient’s condition 

would include all of the following: 

• The medication is used within the 

pharmaceutical parameters approved by 

the Food and Drug Administration 

(FDA) and the manufacturer for the 

indications it is manufactured and 

labeled to address, including listed 

dosage parameters. 

• The use of the medication follows 

national practice standards established 

or recognized by the medical 

community and/or professional medical 

association or organization. 

• The use of the medication to treat 

a specific patient s clinical condition is 

based on that patient’s symptoms, 

overall clinical situation, and on the 

physician’s or other LIP’s knowledge of 

that patient’s expected and actual 

response to the medication. 

An additional component of 

‘‘standard treatment’’ for a medication is 

the expectation that the standard use of 

a medication to treat the patient’s 

condition enables the patient to more 

effectively or appropriately function in 

the world around them than would be 


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possible without the use of the 

medication. If the overall effect of a 

medication is to reduce the patient’s 

ability to effectively or appropriately 

interact with the world around the 

patient, then the medication is not being 

used as a standard treatment for the 

patient’s condition. We believe that 

trained practitioners possess the skills 

and abilities necessary to identity when 

a drug or medication is being used as a 

standard treatment for the patient’s 

condition and when it is not. 

Whether or not the use of a 

medication is voluntary, or even 

whether the drug is administered as a 

one time dose or PRN are not factors in 

determining if a drug is being used as 

a standard treatment. The use of PRN 

medications is only prohibited if the 

drug is being used as a restraint. The 

regulation supports existing State laws 

that provide more vigorous promotion 

of the patient’s choice and rights. 

Of course, as with any use of restraint, 

staff must conduct a patient assessment 

to determine the need for other types of 

interventions before using a drug as a 

restraint. For example, a patient may be 

agitated due to pain, an adverse reaction 

to an existing medication, or other 

unmet care need or concern. 

There are situations where the use of 

a medication is clearly outside the 

standard for a patient or a situation, or 

a medication is not medically necessary 

but is used for patient discipline or staff 

convenience (neither of which is 

permitted by the regulation). In such 

situations, the patient has the right to be 

free from the use of a drug as a restraint. 

For example, a patient has 

Sundowner’s Syndrome, a syndrome in 

which a patient’s dementia becomes 

more apparent at the end of the day than 

the beginning of the day. The patient 

may become agitated, angry, or anxious 

at sundown. This may lead to 

wandering, pacing the floors, or other 

nervous behaviors. The unit’s staff find 

the patient’s behavior bothersome, and 

ask the physician to order a high dose 

of a sedative to ‘‘knock out’’ the patient 

and keep him in bed. The patient has no 

medical symptoms or condition that 

indicates that he needs a sedative. In 

this case, for this patient, the sedative is 

being used as a restraint for staff 

convenience. Such use is not permitted 

by the regulation. The regulation does 

not allow a drug to be used to restrain 

the patient for staff convenience, to 

coerce or discipline the patient, or as a 

method of retaliation. 

While the characterization of 

medications as more humane and less 

invasive was quite common in 

comments on the interim final rule with 

comment period, we put forth the caveat 

offered by one physician—that overuse 

of antipsychotic medications can result 

in severe, sometimes irreversible 

neurological side effects or Neuroleptic 

Malignant Syndrome, which is 

potentially fatal. Also increased 

psychotropic medication use may lead 

to excessive sedation and cognitive 

dulling that impairs the patient’s ability 

to benefit from therapy. While 

medications can be a beneficial part of 

a carefully constructed, individualized 

treatment plan for the patient, 

medication use should be based on the 

assessed needs of the individual patient 

and the effects of medications on the 

patient should be carefully monitored. 

We agree with the many comments 

regarding the idea of a medication 

‘‘controlling’’ behavior. To further 

clarify our intent and respond to public 

comments, we have revised the 

definition of ‘‘drugs used as a restraint.’’

In this final rule, a drug used as a 

restraint is now defined as ‘‘a drug or 

medication when it is used as a 

restriction to manage the patient’s 

behavior or restrict the patient’s 

freedom of movement and is not a 

standard treatment or dosage for the 

patient’s condition.’’

Comment: One commenter asked 

whether the time-limited orders and the 

assessment, documentation, and 

monitoring requirements of standards 

(e) and (f) apply to a drug used as a 

restraint. 

Response: Yes. If the use of the 

medication for the patient meets the 

definition of a drug used as a restraint, 

the requirements of combined standard 

(e) apply. 

Comment: One commenter asked that 

orders for PRN medications be deemed 

appropriate. Many commenters objected 

to the ban on PRN orders for drugs used 

as a restraint. 

Response: In the final rule, PRN 

orders for medications are not 

prohibited. The use of PRN orders is 

only prohibited for drugs or medications 

that are being used as restraints. We 

believe that ongoing assessment, 

monitoring, and re-evaluation by the 

ordering practitioner are even more 

critical when a patient is receiving 

treatment that is not standard, or is 

administered in amounts or at a 

frequency greater than recommended by 

the manufacturer or current standard of 

practice, for the patient’s condition. 

Therefore, we are retaining this 

requirement. 

4. Use of Restraints (§§ 482.13(e)(2) and 

(e)(3)(i)) 

Section 482.13(e)(2) states that a 

restraint can only be used if needed to 

improve the patient’s well-being and 

less restrictive interventions have been 

determined to be ineffective. Section 

482.13(e)(3)(i) states that the use of a 

restraint must be selected only when 

other less restrictive measures have 

been judged to be ineffective to protect 

the patient or others from harm. These 

two provisions are redundant, and in 

the final rule we have collapsed them 

into one requirement. We will discuss 

them together, as the public comments 

tended to apply to both. 

Comment: One commenter believed 

that the regulation should include 

illustrations of less restrictive 

interventions and alternative methods 

for handling behavior, including a 

requirement that when there is a history 

of a particular less restrictive 

intervention being ineffective, other 

interventions must be tried. 

Response: Including such illustrations 

in the regulation is not feasible. Putting 

aside the fact that regulations generally 

provide requirements rather than best 

practice suggestions, each care situation 

consists of a unique combination of 

factors. What seems least restrictive for 

one patient may not be an appropriate 

option for another patient. The 

underpinning of this regulation is the 

concept that good patient care hinges on 

looking at the patient as an individual 

and assessing the patient’s needs, 

strengths, weaknesses, and preferences. 

Such an approach relies on caregivers 

who are skilled in individualized 

assessment and in tailoring 

interventions to individual patient’s 

needs after weighing factors such as the 

patient’s condition, behaviors, and 

history. A list of progressive 

interventions that should be taken 

would undermine the emphasis on 

individualized care, and could 

discourage creativity in meeting patient 

needs. However, there are resources 

available. For example, the American 

Psychiatric Association (APA), 

American Psychiatric Nurses 

Association (APNA), and the National 

Association of Psychiatric Health 

Systems (NAPHS), with support from 

the American Hospital Association 

(AHA), have sponsored the publication 

of a document entitled, ‘‘Learning from 

Each Other—Success Stories and Ideas 

for Reducing Restraint/Seclusion in 

Behavioral Health.’’ This document, 

published in 2003, was developed 

through dialogue with the field and 

extensive input from behavioral 

healthcare providers throughout the 

country who have been working to 

reduce the use of restraint and 

seclusion, and to improve care within 

their facilities. To access this document 

and other useful resources, visit the web 

sites of the sponsoring organizations: 


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http://www.naphs.org; http:// 

www.psych.org; http://www.apna.org; 

http://www.aha.org. 

Comment: One commenter argued 

that it would be impossible to comply 

both with the Patients’ Rights CoP 

standard (c), which protects patient 

safety and the patient’s right to be free 

from all forms of harassment, and 

standard (f). The commenter included 

the following example, a manic or 

psychotic patient may be verbally 

abusive to another patient or destructive 

of that patient’s property without 

actually being a physical threat to the 

other patient. The commenter stated 

that such behavior has often been 

handled by the use of seclusion until 

medication can relieve the patient’s 

agitation and abusiveness. 

Response: Standard (c) provides that 

each patient has the right to receive care 

in a safe setting, and the right to be free 

from all forms of abuse or harassment. 

This standard clearly prohibits the 

behavior described by this commenter, 

and some type of intervention would be 

warranted. However, such behavior 

need not prompt the automatic use of 

restraint or seclusion. The training 

requirements in standard (f) of this final 

rule ensure that patients are attended to 

by staff that are trained and skilled in 

utilizing an array of techniques and 

skills for handling aggression. 

Depending on this situation, various 

interventions (other than restraint or 

seclusion) may address the patient’s 

behavior and simultaneously promote 

the right of others to safety and freedom 

from harassment and abuse. 

Comment: One commenter suggested 

that seclusion and restraint should be 

used only when less restrictive 

interventions, such as time-outs and 

one-to-one staffing, are ineffective in 

preventing immediate injury of the 

patient or others. Several commenters 

asked whether less restrictive 

interventions actually had to be tried 

and shown to fail before a more 

restrictive intervention was used. A 

number of these commenters also 

questioned whether the patient or 

another person must be injured before 

more restrictive intervention may be 

undertaken. 

Response: Less restrictive 

interventions should be considered 

before resorting to the use of restraint or 

seclusion. However, it is not always 

appropriate for less restrictive 

alternatives to be attempted prior to the 

use of restraint or seclusion. For 

example, when a patient physically 

attacks another patient, immediate 

action is needed. When a patient’s 

behavior presents an immediate and 

serious danger to the patient or others, 

immediate action is needed. While staff 

should be mindful of using the least 

intrusive intervention, it is critical that 

the intervention selected be effective in 

protecting the patient or others from 

harm. Therefore, we have retained the 

requirement that a restraint or seclusion 

can only be used when less restrictive 

interventions have been determined to 

be ineffective to protect the patient or 

others from harm. 

Comment: One commenter suggested 

adding, ‘‘The patient has the right to be 

treated in a safe manner when special 

procedures are required for the patient’s 

care.’’

Response: While we agree that the 

patient has the right to be treated in a 

safe manner, we believe that this right 

exists regardless of whether or not the 

patient is undergoing a special 

procedure. 

Comment: One commenter suggested 

considering an issue raised by a New 

England Journal of Medicine article; 

specifically, that the regulation should 

state plainly that a competent patient 

may refuse the use of physical restraint 

in the patient’s acute care or treatment. 

The commenter further suggested that 

an incompetent patient’s representative 

should be able to exercise this right to 

refuse physical restraint on the patient’s 

behalf. Similarly, another commenter 

stated that the regulation should 

consider the individual’s right to make 

choices regarding their health care. The 

commenter further stated that after 

complete information is provided about 

the method, risks, and effects of these 

procedures, individuals and families 

should have the right to either reject 

their use or select them as part of an 

overall treatment regime. 

Response: The Patients’ Rights CoP 

promotes the patient’s right to be 

involved in and make decision about 

the patient’s health care. Standard (b)(2) 

states that the patient or his or her 

representative (as allowed under State 

law) has the right to make informed 

decisions regarding his or her care. The 

patient’s rights include being informed 

of his or her health status, being 

involved in care planning and 

treatment, and being able to request or 

refuse treatment. This right must not be 

construed as a mechanism to demand 

the provision of treatment or services 

deemed medically unnecessary. In this 

context, the use of a restraint would be 

considered a ‘‘treatment.’’ Before the 

patient decides to request or refuse the 

use of restraint or seclusion, the patient 

must be informed of the risks associated 

with refusing the use of a restraint. 

While the hospital should work with the 

patient regarding preferences as much 

as possible, the hospital is not obligated 

to come up with a menu of alternative 

options because of the patient’s refusal. 

The hospital may refuse to perform a 

procedure or render care if it believes 

that it is unable to safely and 

appropriately do so because of the 

patient’s refusal to allow certain aspects 

of the prescribed treatment. In addition, 

if the patient’s violent or self-destructive 

behavior jeopardizes the immediate 

physical safety of the patient, a staff 

member, or others, the patient does not 

have the right to refuse the use of 

restraint or seclusion. In this situation, 

the use of restraint or seclusion is an 

emergency measure to protect the safety 

of the patient, staff, or others. If the 

patient or the patient’s representative 

requests the use of restraint or 

seclusion, the attending practitioner 

would need to decide whether the 

intervention is appropriate. 

In conclusion, the restraint or 

seclusion requirements do not prevent 

the patient from making informed 

decisions or participating in the 

patient’s healthcare. The rule 

establishes the patient’s right to be free 

from inappropriate restraint or 

seclusion, and lays out basic protections 

in the event that these interventions are 

needed. 

Comment: One commenter questioned 

whether, because of the ‘‘Patients’’

Rights’’ provisions regarding patient 

privacy and safety, a restrained patient 

must be restrained in a separate, private 

room, and not in the day room. 

Response: A hazard of restraining a 

patient is the damage that may be done 

to the patient’s dignity. The patient may 

feel dehumanized or humiliated, which 

could be exacerbated by having peers 

witness the experience. Certainly, we 

would not expect that a patient put in 

four-point restraint would be placed in 

the midst of the day room in a 

psychiatric facility since this would be 

humiliating to the patient. The 

restrained patient should be afforded as 

much privacy as possible. Since an 

underlying therapeutic goal for any 

psychiatric patient is the development 

of a strong sense of self-worth and 

dignity, the hospital should take steps to 

protect the privacy of the restrained 

patient. 

However, an individual wearing mitts 

to prevent self-mutilating behaviors is 

also being restricted. These individuals 

may desire socialization and group 

activity notwithstanding these restraints 

that a patient in the midst of a 

psychiatric crisis would not. We 

provide these examples to stress that it 

is critical for the hospital to use an 

individualized approach that is in the 

best interest of the patient and promotes 


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the patient’s health, safety, dignity, selfrespect, and self-worth. 

Comment: Several commenters 

believed that the documentation of 

clinical justification for the use of 

seclusion and restraint, the alternative 

methods used, and the reasons for their 

ineffectiveness should be included in 

the patient’s record. Another commenter 

was concerned that staff’s time for direct 

patient care would be diverted into 

creating documentation if we require 

demonstration that less restrictive 

interventions were proven ineffective in 

cases that involve medical 

immobilization. 

Response: We agree with the 

commenters. In the final rule under 

combined standard (e), we have 

specified that when restraint or 

seclusion is used, the following must be 

documented in the patient s medical 

record: 

• The 1-hour face-to-face medical and 

behavioral evaluation when restraint or 

seclusion is used to manage violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others; 

• A description of the patient’s 

behavior and the intervention used; 

• Alternatives or less restrictive 

interventions attempted (as applicable); 

• The patient’s condition or 

symptom(s) that warranted the use of 

the restraint or seclusion; and 

• The patient’s response to the 

intervention used, including the need 

for continued use of the intervention. 

We believe that such documentation 

is a usual and customary recordkeeping 

practice. This information will provide 

a valuable tool for charting the patient’s 

course of treatment as well as examining 

trends of use. 

In response to comments, we have 

added language that limits the 

application of the restraint definition. In 

the final rule, a restraint does not 

include devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). The devices and methods listed 

here, typically used in medical/surgical 

care, would not be considered restraints 

and, therefore, not subject to these 

requirements. We believe that this 

addresses the commenter’s concern 

regarding the burden of documentation 

in such cases. 

Comment: Several commenters asked 

that the word ‘‘determined’’ be replaced 

with the word ‘‘found.’’

Response: We consulted the 

dictionary to determine whether there 

was some significant difference between 

these two words. We found none. When 

we combined the two requirements, we 

retained the word ‘‘determined.’’

Comment: One commenter suggested 

moving the sentence, ‘‘A restraint can 

only be used if needed to improve the 

patient’s well-being and less restrictive 

interventions have been determined 

ineffective,’’ from paragraph (e)(2) to 

paragraph (e)(1). The commenter stated 

that this would place a greater emphasis 

on the fact that less restrictive measures 

must be demonstrated to be ineffective 

first. 

Response: Although we agree that the 

language in paragraph (e)(2) is an 

essential component of standard (e), we 

do not believe that it is necessary to 

relocate this language to paragraph 

(e)(1). We also note that we have revised 

the regulatory text in the final rule to 

state that ‘‘a restraint can only be used 

when less restrictive interventions have 

been determined to be ineffective to 

protect the patient or others from 

harm.’’ We deleted the language ‘‘to 

enhance the patient’s well-being’’ for 

clarity. 

Comment: One commenter asked 

which individual(s) would be 

responsible for making the 

determination that a less restrictive 

intervention was ineffective, and 

suggested that we use the phrase 

‘‘clinically determined’’ to indicate that 

this decision would be made by the 

nursing staff. 

Response: Since any trained clinical 

staff could make such decisions, we 

have decided not to specify further who 

should determine that a less restrictive 

intervention is ineffective for a 

particular patient. 

Comment: One commenter stated that 

positive reinforcement should be used 

prior to restraint or seclusion. 

Response: Combined standard (e) 

specifies that restraint or seclusion may 

only be used when less restrictive 

interventions have been determined to 

be ineffective to protect the patient or 

others from harm. The intent, as 

suggested by the commenter, is to 

encourage staff to use alternative, less 

restrictive methods, such as positive 

reinforcement, in the patient’s 

treatment. 

5. Ordering of Restraint/Seclusion 

(§ 482.13(e)(3)(ii) and (f)(3)(ii)) 

In this section, we stated that the use 

of a restraint must be in accordance 

with the order of a physician or other 

licensed independent practitioner (LIP) 

permitted by the State and hospital to 

order a restraint. Section 482.13(f)(3)(ii) 

reiterated this requirement when a 

restraint is used for behavior 

management, but added that the use of 

seclusion must also be in accordance 

with such an order. 

a. Definition of Licensed Independent 

Practitioner (LIP) (§§ 482.13(e)(3)(ii) and 

(f)(3)(ii)) 

Comment: Many commenters stated 

that the definition of LIP was unclear 

and open to interpretation. These 

commenters were unsure of how 

delegated authority affected whether a 

practitioner was considered an LIP, of 

which ‘‘independent’’ practitioners 

qualify as LIPs, and of how the countersigning of orders affected the 

determination of whether a practitioner 

is independent. 

Several independently licensed health 

professionals, such as nurse 

practitioners and physician assistants, 

applauded our inclusion of the LIP as 

recognition of highly trained 

individuals with strong patient 

assessment skills. These commenters 

stated that it was important to recognize 

the contribution of the multidisciplinary 

team in today’s health care settings. 

Many commenters asked for an 

explanation of who would be 

considered an LIP. Some commenters 

wanted explicit recognition of registered 

nurses as LIPs; one commenter 

suggested replacing ‘‘LIP’’ with the term 

‘‘health care professional,’’ so that 

registered nurses would clearly be 

included. Many licensed professionals 

such as physician assistants, nurse 

practitioners and advanced practice 

registered nurses were concerned that 

narrow interpretation of the term ‘‘LIP’’

might limit their ability to be fully 

involved in patient care. One 

organization stated that ‘‘LIP’’ is the 

most problematic language in JCAHO’s 

standards and argued that use of this 

term might result in inappropriate limits 

on its constituents’ scope of practice. 

This organization explained that the 

phrase is given wide and varied 

interpretations by both hospitals and 

JCAHO surveyors. 

Another concern expressed by 

commenters was that this regulation 

marked the first appearance of this term 

in the CoPs. Several commenters 

questioned how LIPs might be 

introduced in the remaining hospital 

CoPs. 

One commenter viewed the term 

‘‘LIP,’’ with its requirement that the 

practitioner be able to independently 

order restraint or seclusion, as 

restricting existing practice. This 


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commenter argued that such a 

restriction should only occur after a 

finding that the existing practice has 

had an adverse effect on patient care or 

that limiting this authority to physicians 

would improve patient care. The 

commenter believed that neither the 

former nor the latter point have been 

demonstrated or proven. This 

commenter also noted that State law 

usually addresses when an LIP may 

order restraints. 

Response: The introduction of an 

alternative practitioner who could order 

interventions, assess patients, and 

renew orders was an attempt to 

accommodate existing State laws that 

acknowledge the role of non-physicians 

in patient care and treatment. We 

originally used the term ‘‘LIP’’ to 

describe these practitioners to be 

consistent with existing JCAHO 

standards. 

For the purposes of this rule, a LIP is 

any individual permitted by State law 

and hospital policy to order restraints 

and seclusion for patients 

independently, within the scope of the 

individual’s license and consistent with 

the individually granted clinical 

privileges. This provision is not to be 

construed to limit the authority of a 

physician to delegate tasks to other 

qualified healthcare personnel, that is, 

physician assistants and advanced 

practice nurses, to the extent recognized 

under State law or a State’s regulatory 

mechanism, and hospital policy. It is 

not our intent to interfere with State 

laws governing the role of physician 

assistants, advanced practice registered 

nurses, or other groups that in some 

States have been authorized to order 

restraint and seclusion or, more broadly, 

medical interventions or treatments. 

Each State faces the issue of how to 

best provide its citizens with access to 

needed health care services. The issue is 

complex, as some States have special 

considerations such as geographic 

barriers to care delivery, medically 

underserved areas, and special 

population needs, all of which would 

affect how a State resolves this issue. To 

disregard a State’s decision about who 

is qualified to order medical treatments 

and interventions and render patient 

care would be unproductive and 

arbitrary. 

To clarify this, in combined standard 

(e), we have revised the standard to state 

that the use of a restraint or seclusion 

must be in accordance with the order of 

a physician or other licensed 

independent practitioner who is 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law. 

b. Physician Only 

Comment: While some commenters 

supported deferring to the States’

determination of which health 

professionals are allowed to order 

seclusion or restraint, one contingent 

opposed allowing anyone other than a 

physician to order restraint or seclusion, 

evaluate the patient, or renew an order 

for restraint or seclusion. This group 

pushed for the rule to override existing 

State laws that would allow these 

functions to be performed by anyone 

other than a physician. Several of these 

commenters stated that the clinical 

skills and qualifications of some 

licensed therapists are not necessarily 

indicative of an understanding and 

knowledge of the medical needs or risks 

of patients in seclusion or restraint. 

Without this understanding or 

knowledge, there continues to be risk to 

patients if other medical symptoms are 

overlooked. 

Some commenters cited national 

legislation pending at the time that 

would permit only a physician to order 

restraint/seclusion. Advocacy 

organizations charged that by permitting 

someone other than a physician to order 

restraint or seclusion, CMS would be 

allowing any 1 of over 600,000 mental 

health professionals to authorize the use 

of restraint and seclusion, effectively 

undermining the purpose of the rule. 

Many commenters reminded us that the 

motivation behind the promulgation of 

this rule is the increasing concern 

regarding injuries, deaths or harm 

associated with the use of restraint and 

seclusion. One commenter maintained 

that by significantly narrowing the 

categories of clinicians permitted to 

authorize the use, the risk of misuse or 

overuse of restraint and seclusion would 

be minimized. 

Several commenters cited the 

importance of physicians’ clinical 

training, the fact that they are 

individually accountable, and the fact 

that they are distanced from the daily 

stress and conflicts that arise between 

non-physician staff members and 

patients. Other commenters asserted 

that it is reasonable to require that only 

a physician authorize the use of 

procedures that can have serious and 

dangerous consequences for patients. A 

number of factors may lead to a patient 

displaying violent or agitated behavior, 

including inappropriate medication, 

which often times can be corrected 

immediately. One national organization 

representing physicians also opposed 

the recognition of non-physicians as 

being able to order restraints and 

seclusion. 

Response: Some States have issues 

such as geographic barriers to care 

delivery, medically underserved areas, 

and special population needs. States 

have handled these difficult issues 

through a variety of mechanisms. If a 

State has decided that a group of 

practitioners may order medications or 

treatments exclusively, we defer to State 

laws. 

Physicians are individually 

accountable for the care of their 

patients. The physician has the 

discretion to delegate, or to withhold 

the delegation of, tasks or 

responsibilities as he or she deems 

appropriate. We believe that the 

physician is more than capable of 

making the determination regarding 

whether his or her direct oversight is 

necessary, or whether in some 

situations, as permitted by hospital 

policy, these functions can be 

performed by another practitioner. The 

continued physician accountability for 

actions taken under his or her license 

provides a direct incentive for taking the 

decision to delegate very seriously. 

As commenters pointed out, clinical 

psychologists or other practitioners who 

may be authorized by the State to order 

restraint or seclusion may lack the 

technical medical skills and training to 

conduct a comprehensive physical 

assessment. Therefore, the practitioner 

who conducts the 1-hour face-to-face 

evaluation must be able to complete, 

under their scope of practice, both a 

physical and psychological assessment 

of the patient. To ensure physician 

oversight of restraint and seclusion, we 

have retained the requirement that the 

attending physician must be consulted 

as soon as possible if the attending 

physician did not order the restraint or 

seclusion. 

Comment: Some commenters 

representing independent residential 

treatment centers, day programs, skilled 

nursing facilities, and other nonhospital provider types mistakenly 

believed that the requirements in these 

hospital CoPs were applicable to them. 

Accordingly, a number of the 

commenters cited physician access as a 

problem. 

Response: We reiterate that these 

requirements apply to Medicare- and 

Medicaid-participating hospitals only, 

that is, short-term, psychiatric, 

rehabilitation, long-term, children’s and 

alcohol-drug hospitals. The pending 

regulations based on the CHA will 

address the use of restraint and 

seclusion in the other settings noted 

above. 


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Comment: Several commenters 

expressed concern that practitioners 

without psychiatric training may be 

allowed to order seclusion or restraint to 

manage aggressive, self-destructive or 

violent patient behavior. 

Response: We have revised combined 

standard (e) to specify that the use of 

restraint or seclusion must be ordered 

by a physician or other LIP who is 

responsible for the care of the patient 

and authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law. We have also 

tied the order for restraint or seclusion 

to the patient’s attending physician. The 

attending physician must be consulted 

as soon as possible if the attending 

physician did not order the restraint or 

seclusion. We believe that this 

modification will alleviate concerns 

about a practitioner who may not have 

psychiatric training, or is unfamiliar 

with the patient’s condition or diagnosis 

providing orders for the patient’s care. 

Comment: One commenter wrote that 

when fewer staff at the hospital are 

allowed to routinely approve seclusions 

or restraint, there is less likelihood of a 

serious review and a reduction of their 

use. 

Response: As part of a hospital’s QAPI 

program, we would expect the use of 

restraint and seclusion to be monitored 

and evaluated on an ongoing basis. We 

believe that the number of staff 

permitted to order restraint or seclusion 

is irrelevant to the QAPI process. 

Comment: Several commenters were 

concerned that the regulation could be 

interpreted as precluding physicians 

enrolled in residency training programs 

from ordering restraints or seclusion, or 

from evaluating the need for their 

continued use. For example, in 

Maryland, residents generally do not 

hold a State medical license, but are 

authorized to practice without 

completing the usual licensing process. 

A commenter stated this is permitted 

because of the close supervision that 

residents receive during their training, 

and because required licensing is 

impractical since residents often move 

to another State to complete their 

training or to set up permanent practice. 

Response: In many States a resident is 

authorized by State law to practice as a 

physician. Therefore, there is no 

question that a resident can carry out 

the functions reserved for a physician or 

LIP by this regulation in accordance 

with State law. 

Comment: One commenter opined 

that psychologists and behavior 

analysts, not just physicians, should 

assume responsibility for the design and 

oversight of restraint and seclusion. 

Physicians should regulate chemical 

restraint and assume principal 

responsibility for the oversight of 

psychiatric problems and the design of 

pharmacological and psychiatric 

interventions. 

Response: We recognize the important 

role that psychologists and other 

behavioral health professionals play as 

members of the multidisciplinary team. 

We believe that these practitioners 

should participate in the design and 

oversight of restraint and seclusion 

practices, as well as participate in 

patient care. However, we do not 

believe Congress gave us the authority 

to create ordering authority for 

psychologists or other professionals in 

States that have not granted them this 

authority. Wherever State law and 

hospital policy have afforded ordering 

rights to these practitioners, we have 

honored that decision. 

Comment: One commenter stated that 

if the patient or the patient’s surrogate 

voluntarily consents to the use of the 

restraint in the provision of acute 

medical and surgical care, an order from 

the physician or other LIP is not 

required per JCAHO’s requirements. The 

commenter also stated that if restraints 

are clinically justified and consent is 

obtained, the care of the patient is 

consistent with the standards, and no 

order should be needed. 

Response: The current JCAHO 

standard at PC.11.40 requires that 

restraint use be based upon an 

individual order from an LIP. If an 

intervention meets the definition of a 

restraint, the regulatory requirements 

apply regardless of whether use of the 

restraint is voluntary or involuntary. 

This would include the requirement for 

a physician or other LIP order. The use 

of restraint is inherently risky. The risks 

associated with any intervention must 

be considered within the context of an 

ongoing process of assessment, 

intervention, evaluation, and reevaluation. 

c. Elimination of Protocols 

Many commenters discussed the key 

differences between acute medical and 

psychiatric settings and the use of 

protocols in specified situations in each 

of these settings. The more commonly 

cited examples included the use of arm 

boards to protect an IV site, or the 

restraint of a patient’s arms to prevent 

the removal of an endotracheal tube. 

Commenters argued that in these 

situations, the need for restraint could 

be anticipated given the medical 

procedure or symptoms and condition 

of the patient. Before publication of the 

interim final rule with comment period, 

acute medical and postsurgical 

protocols were used to handle such 

situations. Use was triggered by the 

existence of specified criteria. Some 

commenters argued that disallowing 

acute medical and postsurgical 

protocols increases the risk of needless 

reintubating or replacement of IVs. Most 

hospitals use physician-reviewed 

protocols to determine the need for 

restraint in the medical/surgical context, 

a practice that is accepted by JCAHO. 

JCAHO affirmed this, and recommended 

allowing the use of protocols in certain 

situations with medical staff approval. 

JCAHO explained that during the 

treatment of certain specific conditions 

(for example, post-traumatic brain 

injury) or certain specific clinical 

procedures (for example, intubation), 

restraints might often be necessary to 

prevent significant harm to the patient. 

For those conditions or procedures, 

protocols for the use of restraint may be 

established based upon the frequent 

presentation of patient behavior that 

seriously endangers the patient or 

compromises the effectiveness of the 

procedures. Such protocols would 

include guidelines for assessing the 

patient, and criteria for application, 

monitoring, reassessment, and 

termination of the restraint. JCAHO 

stated that it was unaware of any 

evidence or studies indicating that the 

use of protocols in this manner has in 

any way diminished patient care. Some 

commenters expressed strong support 

for these types of protocols. 

One commenter stated that we should 

not prohibit the use of such protocols 

and the use of PRN orders by LIPs or 

physicians, and asked that we expressly 

state that those sorts of protocols are 

acceptable. 

One commenter pointed to a passage 

in the interim final rule with comment 

period (64 FR 36083) which discussed 

the initiation of restraint/seclusion 

according to protocols developed by 

hospital and medical staff, as permitting 

the use of acute medical and surgical 

protocols. 

Response: Protocols are not banned by 

the regulation. A protocol may contain 

information that is helpful for staff, such 

as how a restraint is to be applied and 

monitored. However, a protocol cannot 

serve as a substitute for obtaining a 

physician or other LIP order before 

initiating each episode of restraint or 

seclusion use, and the requirements of 

the regulation must still be met. The 

philosophy that serves as the foundation 

for the regulation is that restraint or 

seclusion use is an exception, not a 

routine response to a certain condition 

or behavior. Each patient should be 

thoroughly assessed. Interventions 

should be tailored to meet the 

individual patient’s needs. The creation 


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of a protocol can run counter to this 

philosophy if it sets up the expectation 

that restraint will be used as a normal 

part of care. The use of restraint or 

seclusion is a last resort when less 

restrictive measures have been 

determined ineffective to protect the 

patient or others from harm, not a 

standard response to a behavior or 

patient need. 

As discussed previously, we have 

added language to combined standard 

(e) that limits the application of the 

definition of restraint. In the final rule, 

a restraint does not include devices, 

such as orthopedically prescribed 

devices, surgical dressings or bandages, 

protective helmets, or other methods 

that involve the physical holding of a 

patient for the purpose of conducting 

routine physical examinations or tests, 

or to protect the patient from falling out 

of bed, or to permit the patient to 

participate in activities without the risk 

of physical harm (this does not include 

a physical escort). The devices and 

methods listed here, typically used in 

medical/surgical care, would not be 

considered restraints and, therefore, not 

subject to these requirements. This 

revision clarifies the definition of a 

restraint and addresses many of the 

examples cited by commenters. 

When implementing a protocol that 

includes the use of an intervention that 

meets the definition of a restraint, a 

separate order must be obtained for the 

restraint. In addition, the patient’s 

medical record must include 

documentation of an individualized 

patient assessment indicating that the 

patient’s symptoms and diagnosis meet 

use-triggering criteria listed in the 

protocol. Hospitals that utilize protocols 

in the situations commenters described 

would be expected to provide evidence 

that there has been medical staff 

involvement in the development, 

review, and quality monitoring of their 

use. 

d. Initiate versus Order 

Comment: Many facilities stated that 

they do not have a physician present 24 

hours a day. One commenter suggested 

that the registered nurse be given the 

ability to assess and respond to 

emergency life threatening situations. 

Another commenter suggested that we 

should permit an emergency protocol 

that could be initiated by a health care 

professional if a physician or LIP was 

not present. 

Several commenters questioned 

whether an order would have to be 

obtained before initiating restraint or 

seclusion and requested clarification 

regarding who may initiate seclusion or 

restraint. One commenter suggested we 

require that, ‘‘If an order cannot be 

obtained prior to instituting restraint or 

seclusion, their use must be authorized 

by a registered nurse, who shall 

document in the patient record both the 

reasons for restraint or seclusion as well 

as the need to use them prior to 

obtaining an order.’’ One commenter 

stated that given the unpredictable 

frequency of emergencies and the need 

for intervention for certain conditions 

and populations, requiring a physician’s 

order for each intervention is 

impractical. Others expressed concern 

that the regulations do not specifically 

say that a registered nurse can initiate 

restraint in an emergency situation, 

which is most often what happens. 

Response: We understand that 

physicians are not always onsite when 

an emergency occurs. Registered nurses 

play a vital role in ensuring patient 

safety and well being. We do not expect 

staff to stand by and let the patient 

injure himself or others without 

intervening simply because a physician 

is not present. The hospital may 

develop emergency procedures that staff 

follow before obtaining the order for 

restraint or seclusion; however, an order 

must be obtained as soon as possible. 

Many types of emergencies can occur, 

and staff are expected to effectively 

respond. In some emergency situations, 

the need for a restraint or seclusion 

intervention may occur so quickly that 

an appropriate order cannot be obtained 

before the application of restraints. In 

these emergency situations, the order 

must be obtained either during the 

emergency application of the restraint or 

seclusion, or immediately after the 

restraint has been applied. The hospital 

should address this process in its 

restraint policies and procedures. These 

hospital procedures should specify who 

could initiate the use of restraint or 

seclusion in an emergency prior to 

obtaining an order from a physician or 

other LIP. 

6. Prohibition on Standing and PRN 

Orders (§ 482.13(e)(3)(ii)(A) and 

(f)(3)(ii)(A)) 

We stated that an order for restraint 

must never be written as a standing or 

on an as needed basis (that is, PRN). 

Section 482.13(f)(3)(ii)(A) contains a 

parallel provision for behavior 

management that also applies to orders 

for seclusion. 

Comment: We received many 

comments arguing that PRN orders for 

medication should be permitted. Many 

commenters, who objected to the PRN 

prohibition stated that it represents a 

departure from current practice. Some 

commenters supported the use of PRN 

medications as humane and efficacious, 

in that their administration may help 

the patient retain self-control and avert 

escalation of behavior that would 

require seclusion or physical restraint. 

These commenters argued that a 

professional registered nurse is able to 

appropriately assess and determine the 

need to administer a PRN. Other 

commenters argued that PRN 

medications are not a form of chemical 

restraint. One such commenter 

requested that we clarify that orders for 

PRN medications are appropriate. 

One commenter argued that the 

elimination of PRN medications could 

inhibit a patient’s efforts to manage his/ 

her own behaviors. Another commenter 

suggested that prohibiting PRN 

medications might backfire and lead to 

more routine orders for behaviorcontrolling medications, with some 

patients receiving more medication than 

they would have received with a PRN 

order. Other commenters stated that 

they were unsure of how the ban on 

PRN orders would effect the 

administration of medications 

prescribed for agitation. 

Conversely, several commenters 

stated that in their experience, PRN 

orders are overused for the convenience 

of staff, and de-escalation techniques are 

less likely to be attempted in any 

meaningful manner if such orders are 

available. 

Response: As discussed earlier, the 

use of PRN orders for medications is 

only prohibited when a medication is 

being used as a restraint. A drug is 

deemed to be a restraint only if it is not 

a standard treatment or dosage for the 

patient’s condition. Using a drug to 

restrain the patient for staff convenience 

is expressly prohibited. 

Comment: Several commenters 

recommended deleting the word, 

‘‘written’’ from the provision, ‘‘The 

order must never be written as a 

standing or on an as needed basis (that 

is, PRN).’’

Response: As we understand it, the 

commenters’ objection to ‘‘written’’ is 

that it fails to acknowledge that orders 

may be given verbally. Under 

§ 482.23(c)(2), all orders need to be 

documented in the patient’s medical 

record either manually or electronically. 

Verbal orders need to be documented in 

the medical record by the person 

accepting the verbal order. This 

regulation does not prohibit the use of 

verbal orders for restraint or seclusion, 

but they must be used infrequently. 

Regardless of whether the order is 

written by the ordering practitioner or 

documented as a verbal order, the order 

may not be written as a standing or on 

an as needed basis. 


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Comment: One commenter asked that 

we replace the word ‘‘must’’ with 

‘‘shall’’ in this section as well as 

throughout the regulation. 

Response: We currently use the word 

‘‘must’’ rather than ‘‘shall’’ in 

regulations. Both terms mean that the 

action/activity is mandatory, and as 

such, the use of ‘‘must’’ provides a solid 

legal basis for enforcement. Therefore, 

we have maintained the use of ‘‘must’’. 

Comment: Several commenters 

indicated that PRN orders for any type 

of restraint or seclusion should never be 

used with children or adolescents and 

that all orders for seclusion should be 

time-limited based on the individual 

needs of the youth. 

Response: We agree and have 

maintained these provisions. An order 

for restraint or seclusion must never be 

written on a PRN basis. Orders for 

restraint or seclusion to manage selfdestructive or violent behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others must be time limited and should 

be tailored to the individual needs of 

the patient. An individualized 

assessment that considers the patient’s 

characteristics, such as age, history, 

size, medical and mental condition, and 

preferences, should be the basis of any 

intervention. The regulation identifies 

maximum time limits on the length of 

order based on age. The physician or 

LIP has the discretion to write the order 

for a shorter length of time. The lengthof-order requirement identifies critical 

points at which there is mandatory 

contact with a physician or LIP 

responsible for the care of the patient. 

In addition, the time limits do not 

dictate how long a patient is in restraint 

or seclusion. Staff should be continually 

assessing and monitoring the patient to 

ensure that the patient is released from 

restraint or seclusion at the earliest 

possible time. Restraint or seclusion 

may only be employed while the unsafe 

situation continues. Once the unsafe 

situation ends, the use of restraint or 

seclusion must be discontinued. In the 

final rule, combined standard (e) 

explicitly states that the intervention 

must be discontinued at the earliest 

possible time, regardless of the length of 

time identified in the order. 

7. Consultation With the Treating 

Physician (§§ 482.13(e)(3)(ii)(B) and 

(f)(3)(ii)(B)) 

We stated that this order must be 

followed by consultation with the 

patient’s treating physician as soon as 

possible if the restraint is not ordered by 

the patient’s treating physician. 

§ 482.13(f)(3)(ii)(B) paralleled that 

requirement in the behavior 

management standard, and imposed the 

same requirement on seclusion if it is 

used. 

Comment: A few commenters 

suggested that the requirement for 

notifying the treating physician be 

deleted. Most comments on this 

provision revolved around the question 

of who the treating physician is, 

particularly when many physicians or 

specialists are involved in the patient’s 

care. One commenter suggested that the 

‘‘treating physician’’ should be the 

physician responsible for the part of 

care that requires the use of restraint, for 

example, the pulmonologist would 

write the order if the patient was on a 

ventilator. Another commenter 

indicated that the treating physician for 

the purposes of an emergency situation 

after hours is the medical officer on call. 

Other commenters stated that each 

hospital should be permitted to 

determine who the patient’s treating 

physician is. 

Response: We agree with the 

commenters who recommended that 

hospital medical staff policies 

determine who is considered the 

treating (attending) physician. In 

addition, we have revised combined 

standard (e) to change the term ‘‘treating 

physician’’ to ‘‘attending physician.’’

We do not believe restraint or seclusion 

use is the only instance where the 

question of who is in charge of 

managing the overall medical care of the 

patient is of concern. Our intent is to 

ensure that the physician who has 

overall responsibility and authority for 

the management and care of the patient 

is aware of and involved in the 

intervention. The attending physician 

information regarding the patient’s 

history may have significant impact on 

selection of a restraint or seclusion 

intervention. 

Comment: Several commenters asked 

what was meant by notification of the 

treating physician ‘‘as soon as possible.’’

Most of those who commented on this 

provision were not in favor of our use 

of ‘‘as soon as possible.’’ One 

commenter noted that when a restraint 

or seclusion incident occurs in the 

middle of the night, it is not realistic to 

request a consultation with the treating 

physician. In such a case, the 

consultation might be delayed 8 hours, 

possibly longer if ordered on a Friday 

evening. The commenter was concerned 

that an oversight review might not 

consider this standard practice as being 

‘‘as soon as possible.’’ To clarify this 

point, the commenter suggested the 

following wording after ‘‘as soon as 

possible’: ‘‘or the next working day if 

after hours, if the restraint or seclusion 

is not ordered by the patient’s treating 

[that is, attending] physician(s).’’

One commenter argued that the more 

familiar the physician present at the 

time of the restraint or seclusion 

intervention is with the individual and 

the treatment plan, the less urgency 

there would be to obtain the required 

notification. One commenter suggested 

incorporating parameters or standards 

for how quickly this communication 

must be initiated and accomplished. 

Response: The purpose of attending 

physician notification is to promote 

continuity of care, to assure patient 

safety, and to elicit information from the 

attending physician that might be 

relevant in choosing the most 

appropriate intervention for the patient. 

Therefore, consultation should occur as 

soon as possible. Hospital policies and 

procedures should address the 

definition of ‘‘as soon as possible’’ based 

on the needs of their particular patient 

population. We have retained the 

requirement that the attending 

physician must be consulted as soon as 

possible if a restraint or seclusion is 

ordered by a practitioner other than the 

patient’s attending physician. 

Comment: One commenter noted that 

primary physicians often have another 

physician on call for their patients when 

they are unavailable, such as during 

surgery or vacation. In these instances, 

the physician on call should be 

considered the treating physician. 

Response: We agree. When the 

attending physician is unavailable and 

has delegated responsibility for a patient 

to another physician, then the covering 

physician is considered the attending 

physician. 

Comment: A commenter indicated 

that this provision is ‘‘cumbersome and 

can lead to problems, especially if the 

treating physician was listed on the 

admission and does not come into the 

hospital for twenty-four hours if the 

patient was admitted on the weekend.’’

Response: This provision does not 

specify that consultation with the 

attending physician be face-to-face. The 

consultation can occur via telephone. In 

addition, when the attending physician 

is not available, responsibility for the 

patient must be delegated to another 

physician who would then be 

considered the attending physician. 

Comment: One commenter asked that 

we clarify that the patient can be under 

the care of a treating LIP other than a 

physician. 

Response: The hospital CoPs do 

permit the patient to be under the care 

of a treating LIP other than a physician. 

Section 482.12(c)(1) requires every 

Medicare patient to be under the care of 

a doctor of medicine or osteopathy; or 


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a doctor of dental surgery or dental 

medicine, a doctor of podiatry, 

chiropractor, or clinical psychologist 

within the scope of their license. The 

individual overseeing the patient’s care 

may be the attending physician or a 

health professional practicing with the 

delegated authority or supervision of a 

doctor of medicine or osteopathy as 

permitted by State law and hospital 

policy. As noted earlier, we also defer 

to State laws that recognize the ordering 

rights of other types of practitioners. For 

the purposes of the use of restraint or 

seclusion, the attending practitioner 

must be able to conduct both a physical 

and psychological assessment of the 

patient in accordance with State law, 

their scope of practice, and hospital 

policy. 

Comment: One commenter stated that 

this requirement was highly prescriptive 

and unusual to be included in a CoP. 

Another commenter stated that this 

notification was unnecessary since the 

treating physician has the opportunity 

before the need for restraint or seclusion 

arises to alert hospital staff and other 

physicians or LIPs that use of restraint 

or seclusion would be an inappropriate 

intervention for the patient. These 

commenters recommended elimination 

of this requirement. 

Response: It is not the information in 

the medical record alone that should 

determine the course of treatment for a 

patient. Decisions about how best to 

manage a patient’s care, engage the 

patient in treatment, and ensure 

continued progress in recovery require 

the oversight of the person with the 

authority and responsibility for the 

patient—the patient’s attending 

physician. 

8. Written Modification of the Plan of 

Care (§§ 482.13(e)(3)(iii) and (f)(3)(iii)) 

We stated in this provision that an 

order for a restraint must be in 

accordance with a written modification 

to the patient’s plan of care. A parallel 

provision in § 482.13(f)(3)(iii) extended 

this provision into situations where 

restraint or seclusion is used to manage 

violent, self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. 

Comment: Several commenters found 

this provision confusing and asked for 

clarification. One commenter was 

unsure of whether this requirement 

entails having the nurse explain the 

patient’s behavior in a note, or having 

the nurse provide a more detailed, 

written plan. Some of these commenters 

suggested that the use of seclusion and 

restraint should not be stated in the 

patient’s plan of care; instead, the 

behavior(s) that caused the use of 

seclusion or restraint and other 

interventions to address the behavior(s) 

should be documented. 

One commenter suggested that as 

written, this provision indicates that a 

modification to the plan of care would 

be required before the order being 

written for seclusion or restraint. The 

commenter observed that written 

modifications might not be possible 

prior to the renewal of the order because 

the review and modification should be 

conducted by the treating physician, 

while the on-call physician may be 

involved in assessing an episode of 

dangerous behavior. This commenter 

preferred to have a review of the 

patient’s treatment plan within a certain 

timeframe after the episode, such as the 

next business day or within 72 hours. 

One commenter stated that because 

restraint and seclusion should be 

exceptional rather than ordinary 

interventions, the regulation should 

incorporate the requirement that 

multiple restraint and seclusion orders 

trigger a re-evaluation of the plan of 

care. Another commenter agreed, 

recommending that the following 

language be added at 

§ 482.13(f)(3)(ii)(D): 

Because multiple restraint and seclusion 

orders may indicate a need to evaluate and 

change the current placement and/or 

behavior management plan, where there are 

two or more restraint and seclusion orders 

within a one-week period, the chart shall 

indicate treatment team actions in evaluating 

the current placement and plan of care and 

the results of that evaluation. 

Response: The regulation does not 

require that a modification to the 

patient’s plan of care be made before 

initiating or obtaining an order for the 

use of restraint or seclusion. The use of 

a restraint or seclusion intervention 

should be reflected in the patient’s plan 

of care or treatment plan based on an 

assessment and evaluation of the 

patient. The plan of care or treatment 

plan should be reviewed and updated in 

writing within a timeframe specified by 

hospital policy. We have not required 

that multiple restraint and seclusion 

episodes trigger a re-evaluation of a 

placement or behavior management 

plan. We are retaining the language 

specified in the interim final rule with 

comment. 

In this final rule, we are specifying 

that the use of restraint or seclusion be 

documented in the patient’s medical 

record. In response to comments, we 

have specified the required elements of 

documentation under the combined 

standard. Such documentation is a 

usual and customary recordkeeping 

practice. Therefore, we are retaining the 

language as specified in the interim 

final rule with comment period. 

Comment: Another commenter feared 

that much detail, such as a description 

of the event, what led to it, and key data 

and information typically available to 

anyone reading the patient’s record, will 

be lost because the provision only 

requires a written modification to the 

plan of care. The commenter suggested 

that facilities would avoid placing such 

information in the patient’s record to 

assure that the facilities are ‘‘discovery 

protected.’’ To remedy this, the 

commenter suggested expanding the 

regulation to require that each instance 

of seclusion or restraint and certain 

details must be entered into the 

patient’s record. 

Response: We agree. We have revised 

combined standard (e) to require that 

the use of restraint or seclusion be 

documented in the patient’s medical 

record and have specified the 

documentation elements. Under 

combined standard (e), the patient’s 

medical record must contain 

documentation that includes: the 1-hour 

face-to-face medical and behavioral 

evaluation if restraint or seclusion is 

used to manage violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others; a description 

of the patient’s behavior and the 

intervention used; alternatives or other 

less restrictive interventions attempted 

(as applicable); the patient’s condition 

or symptom(s) that warranted the use of 

the restraint or seclusion; and the 

patient’s response to the intervention(s), 

including the rationale for continued 

use of the intervention. This type of 

documentation is a usual and customary 

recordkeeping practice. This 

information will provide a valuable tool 

for charting the patient’s course of 

treatment as well as examining trends of 

use. 

Comment: One commenter believed 

that restraint date, time, and duration 

should be documented in the patient’s 

record. Another commenter stated that 

the name, title, and credentials of staff 

members involved in the procedure 

should be included in the record. 

Response: We have required that 

when restraint or seclusion is used, 

certain elements must to be documented 

in the patient’s medical record. We 

believe that some of the information that 

the commenter has suggested would 

indeed appear as part of the patient’s 

medical record. Additional elements of 

documentation, such as name, title, and 

credentials of staff members involved in 

the procedure, should be specified in 

hospital policy. 


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Comment: Several commenters 

recommended removing the word 

‘‘written’’ from the provision, ‘‘in 

accordance with a written modification 

of the patient’s plan of care.’’

Response: We have retained the word 

‘‘written’’ in the provision, ‘‘in 

accordance with a written modification 

of the patient’s plan of care.’’ The use 

of restraint or seclusion constitutes a 

change in a patient’s plan of care. 

Changes in a patient’s plan of care must 

be documented. Documentation in the 

patient’s medical record can be 

‘‘written’’ manually or electronically. 

Comment: One commenter suggested 

that the regulations should provide 

special protections for hearing impaired 

individuals who communicate in sign 

language using their hands and arms. To 

this end, this commenter recommended 

adding language to § 482.13(f)(3): ‘‘For a 

person whose mode of communication 

is through sign language, designed so 

that the person is able to effectively 

communicate in sign language despite 

restraints and/or seclusion.’’

Response: Providers are expected to 

meet the communication needs of their 

atients, whether those patients speak 

another language, are hearing or vision 

impaired, or have other conditions or 

characteristics that merit special 

intervention to assure smooth 

communication. However, there may be 

situations when it is necessary to place 

a patient with special communication 

needs in restraint or seclusion. In these 

situations, the hospital is expected to 

make reasonable efforts to meet these 

needs. 

9. Implementation of and Appropriate 

Use of Restraint/Seclusion 

(§§ 482.13(e)(3)(iv), (e)(3)(v), (f)(3)(iv), 

and (f)(3)(v)) 

We stated that the use of restraint and 

seclusion must be implemented in the 

least restrictive manner possible and 

must be in accordance with safe and 

appropriate restraining techniques. 

No comments were received on these 

provisions. However, based on inquiries 

received after closure of the comment 

period, we have determined that the 

phrase ‘‘used in the least restrictive 

manner’’ needed further clarification; 

for example, how would a four-point 

restraint be used in ‘‘the least restrictive 

manner’’? Our intent is that if a restraint 

is necessary, the least restrictive 

intervention (which may vary, 

depending on the patient’s history and 

condition) that effectively protects the 

patient’s safety or that of others must be 

selected. 

10. Discontinuing the Use of Restraint/ 

Seclusion (§§ 482.13(e)(3)(vi) and 

(f)(3)(vi)) 

We stated that restraint or seclusion, 

whether for acute medical and surgical 

care or for behavior management, must 

be ended at the earliest possible time. 

Comment: While some commenters 

expressed support for this provision as 

written, many hoped to clarify this 

language and offered either new 

wording or guiding concepts to be used 

in developing new wording. Several 

commenters recommended amending 

the regulatory text to read, ‘‘Ended at 

the earliest possible time, namely when 

no longer needed to ensure the patient’s 

physical safety or whenever a less 

restrictive measure would protect the 

patient or others from harm. If restraint 

and seclusion are used simultaneously, 

the restraint and seclusion shall be 

independently evaluated to determine 

when either or both may be ended.’’ A 

few commenters suggested that restraint 

use should be ended when it is no 

longer justified or when the emergency 

situation has subsided, rather than being 

dependent on an arbitrary timeframe. 

One commenter noted that the patient’s 

release from seclusion and his or her 

rapid return to the therapeutic 

environment is desirable. Another 

commenter stated that a patient should 

be restrained or secluded only so long 

as necessary for the patient to regain 

self-control. One commenter noted that 

if the patient is able to take a bathroom 

break or eat a meal without incident, the 

restraint or seclusion should be 

discontinued. These commenters 

believed that the regulation did not 

clearly state that the intervention would 

end when the emergency was over. 

Response: These comments tended to 

be aimed at standard (f) rather than (e); 

overall, they seemed to reflect the 

concern that what constitutes ‘‘at the 

earliest possible time’’ may be subject to 

interpretation. To address this concern, 

we have revised the requirement in 

combined standard (e) to state that 

restraint or seclusion must be 

discontinued at the earliest possible 

time, regardless of the length of time 

identified in the order. 

Comment: One group of commenters 

wanted to allow the patient a trial 

period out of restraints, during which 

the patient would be closely observed. 

If the patient again exhibited the 

symptoms that had prompted the prior 

use of restraints, the patient would be 

placed in restraint again and this 

episode would be considered as part of 

the original episode/order. 

Response: The approach suggested by 

these commenters is equivalent to a 

PRN order, which is not permitted by 

combined standard (e). If staff ends an 

ordered intervention, they have no 

authority to start it again without the 

initiation of a new order. For example, 

a patient is released from restraint or 

seclusion. If this patient later exhibits 

violent or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others that can only be handled through 

the use of restraint or seclusion, a new 

order would be required. Staff cannot 

discontinue an order and then restart it 

because that would constitute a PRN 

order. However, a temporary release that 

occurs for the purpose of caring for a 

patient’s needs, for example, toileting, 

feeding, and range of motion, is not 

considered a discontinuation of the 

intervention. 

11. Assessment, Monitoring, and 

Evaluation of the Restrained/Secluded 

Patient (§§ 482.13(e)(4) and (f)(5)) 

We stated that the condition of the 

restrained patient must be continually 

assessed, monitored, and reevaluated. 

Section 482.13(f)(5) created a parallel 

requirement when a patient is restrained 

or secluded for behavior management. 

Comment: There was much confusion 

over the meaning of ‘‘continually.’’ One 

commenter pointed out that 

‘‘continually’’ appears to refer to 

constant face-to-face observation in one 

portion of the interim final rule with 

comment period, while in another it 

seems to mean ongoing, but not 

constant, monitoring. Several 

commenters misinterpreted the 

requirement as forcing physicians and 

nurses to remain in a restrained 

patient’s room for the duration of the 

restraint use, and argued that this would 

be a poor use of resources. 

Response: Ongoing assessment and 

monitoring of the patient’s condition are 

crucial for prevention of patient injury 

or death. We are still requiring these 

activities, but leave it to staff discretion 

how frequently they are conducted 

based upon hospital policy and an 

individualized patient assessment. In 

the final rule, monitoring and 

assessment may occur periodically (for 

example, every 15 minutes) or 

continually (that is, moment to 

moment), depending on the patient’s 

needs. With the exception of the 

simultaneous use of restraint and 

seclusion, one-to-one observation with a 

staff member in constant attendance is 

not required. To clarify this point, we 

have deleted the word ‘‘continually’’

from the monitoring requirements in 

combined standard (e) with one 

exception. We have retained the word 

‘‘continually’’ in the monitoring 


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requirements for the simultaneous use 

of restraint and seclusion. 

We expect hospital policies to guide 

staff in determining appropriate 

intervals for assessment and monitoring 

based on the individual needs of the 

patient, the patient’s condition, and the 

type of restraint used. For example, 

placing staff at the bedside of a patient 

with wrist restraints may be 

unnecessary. However, for a more 

restrictive or risky intervention and/or a 

patient who is suicidal, self injurious, or 

combative, staff may determine that 

continual face-to-face monitoring is 

needed. The hospital is responsible for 

providing the level of monitoring and 

frequency of reassessment that will 

protect the patient’s safety. Based on 

public comments, we have revised 

combined standard (e) to clarify that the 

condition of the patient who is in 

restraint or seclusion must be monitored 

and assessed by a physician, or other 

licensed independent practitioner or 

trained staff at an interval determined 

by hospital policy. The criteria for staff 

to be considered ‘‘trained’’ are specified 

under § 482.13(f). 

We have also added language to 

clarify that all requirements specified 

under combined standard (e) apply in 

the simultaneous use of restraint and 

seclusion, which is not permitted unless 

the patient is continually monitored. If 

restraint and seclusion are used 

simultaneously to manage selfdestructive or violent patient behavior 

that jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others, the patient must be continually 

monitored, face-to-face, by an assigned, 

trained staff member; or continually 

monitored by trained staff using both 

video and audio equipment. This 

monitoring must be in close proximity 

to the patient. For the purposes of this 

provision, ‘‘continually’’ means ongoing 

without interruption. 

Comment: Some commenters 

requested clarification on the aspects of 

the patient’s physical condition that 

must be monitored when the patient is 

in restraint or seclusion (indicators such 

as vital signs, circulation, hydration, 

level of distress, agitation), when staff 

re-evaluate the need for continued use 

of restraint or seclusion, and when an 

LIP is deciding whether to renew the 

order for the intervention. Some 

commenters also suggested that the 

patient should be permitted bathroom 

breaks and the opportunity to eat meals. 

Response: The importance of 

appropriate assessment and monitoring 

of the patient’s physical, emotional and 

behavioral condition when restraint or 

seclusion is used cannot be 

overemphasized. As the interim final 

rule with comment period stated, 

research indicates that the potential for 

injury or harm with the use of restraint 

is a reality. However, evaluation of the 

situation and each patient’s individual 

medical needs and health status should 

be paramount considerations in 

choosing the intervention method, level 

of monitoring, and frequency of 

assessment. Hospital policies should 

address frequency of assessment and 

monitoring components of monitoring 

(for example, vital signs, hydration and 

circulation, level of distress and 

agitation, mental status, cognitive 

functioning, skin integrity), nutritional 

needs, range of motion, elimination 

needs, and other care needs. We cannot 

provide an exhaustive list of the items 

to be monitored because they will vary 

with the type of intervention used and 

the patient’s condition. For example, the 

use of a restraint that keeps the patient 

immobilized would require a check of 

the patient’s skin integrity and steps to 

prevent skin breakdown. Depending on 

the duration of the intervention, range 

of motion exercises might be necessary. 

The patient’s mental status, as well as 

vital signs, should be assessed, 

particularly when the restraint is 

initiated to manage self-destructive or 

violent behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. The patient 

should be provided the opportunity for 

toileting, hydration, and eating if the 

intervention used impedes these 

activities. 

Reassessments of the patient’s 

condition are essential to assure that the 

intervention ends as soon as possible. 

Again, we expect frequency of 

reassessments to be addressed by 

hospital policies. When the patient’s 

self-destructive or violent behavior 

presents an immediate risk to the 

patient, a staff member, or others, 

frequent reassessments ensure the 

intervention is used only while the 

unsafe situation continues and is 

discontinued at the earliest possible 

time, regardless of the length of time 

identified in the order. 

The interim final rule with comment 

period did not, and this final rule does 

not, require that the practitioner who 

ordered the intervention be physically 

present to re-evaluate the need for 

continuing the intervention. The 

patient’s attending practitioner should, 

however, be contacted with an update 

on the patient’s status and an evaluation 

of the patient’s mental and physical 

condition when the order for restraint or 

seclusion is about to expire if it appears 

that the intervention is still necessary. 

In this final rule, we have retained and 

revised the provision under combined 

standard (e) requiring that after 24 

hours, a physician or other licensed 

independent practitioner who is 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law must see and 

assess the patient before writing a new 

order for the use of restraint or seclusion 

for the management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. We have also 

specified that each order for restraint 

used to ensure the physical safety of the 

non-violent or non-self-destructive 

patient may be renewed as authorized 

by hospital policy. 

Comment: A commenter asked what 

time frames were meant for 

‘‘continuously assessed’’ (that is, every 

5 minutes, every 30 minutes). Some 

members of the public and one hospital 

argued that we should incorporate 

required 15-minute checks for 

restrained and secluded patients, as we 

had mentioned in the December 19, 

1997 proposed rule. One commenter 

suggested that vital signs be taken every 

2 hours, with written documentation of 

such checks in the medical record. 

Some commenters urged retaining 

flexibility in allowing clinical judgment 

to determine timeframes or intervals. 

Some commenters questioned the value 

of continual monitoring for a restrained 

patient who is sleeping or only 

awakening intermittently. 

Response: As discussed previously, 

we expect hospital policies to guide 

staff in determining appropriate 

intervals for assessment and monitoring 

based on the individual needs of the 

patient, the patient’s condition, and the 

type of restraint used. 

Regarding the sleeping patient 

scenario, a staff person may or may not 

need to be permanently posted at a 

sleeping, restrained patient’s bedside. 

The fact that a patient is at one point 

asleep does not guarantee that the 

patient will remain asleep hours on end 

and will therefore need no reassessment 

or monitoring. The selection of an 

intervention and determination of the 

necessary frequency of assessment and 

monitoring should be individualized, 

taking into consideration variables such 

as the patient’s condition, cognitive 

status, risks associated with the use of 

the chosen intervention, and other 

relevant factors. In some cases, checks 

every 15 minutes or vital signs taken 

every 2 hours may not be sufficient to 

ensure the patient’s safety. In others, it 

may be excessive or disruptive to 

patient care (for example, mandating 

that a patient with wrist restraints who 


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is asleep be checked every 15 minutes 

and awakened every 2 hours to take the 

patient’s vital signs may be 

unnecessary). Similarly, depending on 

the patient’s needs and situational 

factors, seclusion may require either 

periodic or constant monitoring. We 

expect staff to determine the appropriate 

level of monitoring and frequency of 

assessment based on hospital policy, an 

individualized patient assessment, and 

type of intervention used. 

Comment: Commenters discussed 

who should perform the assessment, 

monitoring, and re-evaluation. Some 

mental health consumer advocacy 

groups and their members suggested 

that a clinically licensed registered 

nurse should perform these tasks; 

another commenter suggested that they 

be performed by licensed professionals 

trained in mental health procedures. 

Response: We have revised combined 

standard (e) to provide hospitals 

flexibility in determining which staff 

performs the assessment and 

monitoring. This determination, of 

course, must be in accordance with the 

practitioner’s scope of practice and State 

law. For example, assessment and 

monitoring are activities within a 

registered nurse’s scope of practice. 

However, some trained, unlicensed staff 

may perform components of monitoring 

(for example, checking vital signs, 

hydration and circulation; the patient’s 

level of distress and agitation; or skin 

integrity), and may also provide for 

general care needs (for example, eating, 

hydration, toileting, range of motion). 

Standard (f) requires that before 

applying restraints, implementing 

seclusion, or performing associated 

monitoring and care tasks, staff be 

trained and able to demonstrate 

competency in the performance of these 

actions. Combined standard (e) has been 

amended to require that the condition of 

the restrained patient be assessed and 

monitored by a physician, other LIP or 

by trained staff. 

Comment: One commenter suggested 

that a history of sexual victimization 

should be considered when restraining 

a patient. The commenter provided the 

following example: ‘‘Most females who 

are raped are raped in the supine 

position, and therefore supine position 

is more likely to recreate the trauma. 

Similarly, it seems that most males who 

are raped are raped in a prone position, 

therefore prone restraint might well be 

contraindicated.’’

Response: The hospital should 

conduct a thorough individualized 

assessment of the patient that integrates 

the patient’s salient history into the 

treatment plan. However, we will not be 

mandating this particular consideration 

in the regulation’s text. 

Comment: One commenter urged that 

children not be left alone for long 

periods of time, as an hour can seem 

quite long when a child is distressed. 

Another commenter argued that 

children in restraint or seclusion should 

be monitored one-on-one. 

Response: We agree that children, as 

well as adults, may become distressed 

when left alone. We expect staff to 

determine the frequency and level of 

monitoring necessary based on hospital 

policy, an individualized patient 

assessment, and the type of intervention 

used. 

Comment: One commenter suggested 

that because the lack of vigorous 

physical activity may contribute to 

behaviors triggering restraint and 

seclusion, the regulations should 

include a section requiring vigorous 

physical activity for children. 

Response: The multidisciplinary team 

that works with each patient is able to 

create an individualized treatment plan 

that meets the patient’s needs. We do 

not believe that arbitrarily mandating 

vigorous physical activity is wise or 

necessary. 

Comment: One commenter asked how 

continual assessment, monitoring and 

reevaluation would be documented. 

Response: How this information is 

documented will vary with the policies 

and practices of each hospital. 

Comment: One commenter asked 

whether a patient restrained for medical 

purposes could be monitored from a 

distance as long as the patient is kept 

within eyesight. 

Response: A patient restrained under 

combined standard (e) does not have to 

be continually monitored face-to-face 

unless restraint and seclusion are used 

simultaneously or continual face-to-face 

monitoring is clinically indicated. 

12. Staff Training in the Use of 

Restraints/Seclusion (§§ 482.13(e)(5) 

and (f)(6)) 

We stated that all clinical staff that 

have direct patient contact must have 

ongoing education and training in the 

proper and safe use of restraints. Section 

482.13(f)(6) contains a similar 

requirement that specifies that all staff 

who have direct patient contact must 

have ongoing education and training in 

the proper and safe use of seclusion and 

restraint application and techniques and 

alternative methods for handling 

behavior, symptoms, and situations that 

traditionally have been treated through 

the use of restraints or seclusion. 

Comment: These provisions enjoyed 

much support from commenters. 

Several commenters quoted the Hartford 

Courant series (October 11, 1998) as 

naming better staff training as a low cost 

mechanism for averting the situations 

described in the articles. Many hospitals 

agreed that the key to patient safety is 

staff training and competency, 

suggesting that this element more 

directly affects patient care than other 

factors suggested by CMS. One 

commenter stated the following: 

The death of a patient while in restraints 

or seclusion should never occur. To that end, 

steps need to be taken to assure that staff that 

initiate a restraint or seclusion intervention 

and those who later monitor and evaluate the 

patient are appropriately educated, trained, 

and demonstrate competencies in these 

practices. We see these issues as key to the 

safety and well being of patients and staff. 

One commenter reported that it 

provides staff with a minimum of 16 

hours of annual training that 

emphasizes verbal de-escalation 

techniques. This step, in combination 

with others, has resulted in dramatic 

reduction in restraint/seclusion use for 

that hospital in the past 2 years. Many 

other commenters reported that their 

hospitals employ extensive training for 

clinical staff; one commenter noted that 

training direct care staff is a good 

investment of its resources. Another 

commenter voiced its ‘‘complete 

agreement’’ with the training and 

educational requirements. 

One commenter expressed 

enthusiastic support for stringent and 

appropriate training, noting that this 

area needs to be expanded and enforced. 

This commenter stated, ‘‘Until service 

providers are adequately trained in the 

proper use of restraints, all the 

regulations and rules in the world will 

not be able to ensure safety.’’ Another 

commenter suggested that CMS should 

focus on ensuring that restraint and 

seclusion are used properly by 

monitoring training, education, proper 

privileging, and proper/effective staff 

monitoring by appropriate and available 

facility staff. 

Response: We appreciate the support 

expressed by commenters and share the 

belief that without adequate training 

and competency among the direct care 

staff, patients, staff and others are 

placed at risk. Patients have a right to 

the safe application of restraint or 

seclusion by trained and competent 

staff. We recognize the important role 

that staff training and education play in 

the reduction of restraint and seclusion 

use in a hospital. We applaud hospitals 

that currently provide extensive training 

and education for staff as part of a 

comprehensive program to ensure 

patient safety and minimize the use of 

restraint and seclusion. 


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Based on public comments, we have 

revised our regulatory language to 

provide additional requirements for staff 

training that focus on demonstrated 

competencies and building a skill set for 

working with patients. We have also 

moved the training requirements from 

current standards (e) and (f), and created 

a separate standard (standard (f)) that 

addresses staff training. This was done 

to emphasize the importance of staff 

training in the safe use of restraint or 

seclusion. 

Standard (f) requires that staff be 

trained and able to demonstrate 

competency prior to applying restraints, 

implementing seclusion, or performing 

associated monitoring and assessment 

of, or providing care for a patient in 

restraint or seclusion. The hospital must 

require appropriate staff to have 

education, training, and demonstrated 

knowledge based on the specific needs 

of the patient population. Staff must 

demonstrate competencies as outlined 

in standard (f) initially, as part of 

orientation, and subsequently on a 

periodic basis. Individuals providing 

staff training must be qualified as 

evidenced by education, training, and 

experience in techniques used by 

hospitals to address patients’ behaviors. 

Successful completion of training and 

demonstration of competency must be 

documented in staff personnel records. 

Comment: Many hospitals reported 

that they have instituted training 

programs and have made efforts to 

carefully examine and review their use 

of restraints. Some argued that such 

efforts, rather than regulatory standards, 

are the answer to reducing restraintrelated injuries and deaths. 

Response: Some of the commenting 

hospitals stated that they have never 

had an injury or death related to 

restraints or seclusion use, and it is 

appropriate to acknowledge this 

achievement. As its appearance in our 

regulation affirms, we believe that a 

critical piece of ensuring the health and 

safety of the patient, staff, and others is 

comprehensive training. However, 

while training programs are a critical 

step to assuring patient safety, they do 

not serve as a substitute for a statement 

of basic performance expectations. 

Comment: One commenter requested 

that we define, ‘‘direct patient contact.’’

Several commenters questioned whether 

we intended that all staff be trained, 

including nonclinical personnel or 

those who have no part in the provision 

of care (that is, those who would be 

unlikely to take part in a restraint or 

seclusion intervention). Some disagreed 

with a broad training requirement, 

stating that it would be cost-prohibitive. 

These commenters argued that the 

current wording could be construed as 

including housekeeping staff, service 

staff, clerical staff, administrative 

personnel, environmental services staff, 

dietary staff, laboratory staff, and all 

clinical staff. Many commenters argued 

that this level of education should be 

limited to clinical staff who apply and 

remove restraints or who provide 

primary direct care to patients who may 

require restraints. One commenter 

suggested that all staff should be trained 

‘‘commensurate with the amount of 

contact with patients’’ rather than using 

direct contact alone as a criterion. 

Response: We have accepted the 

suggestions of these commenters. We 

have replaced the phrase, ‘‘direct 

patient contact,’’ with more specific 

language to clarify this requirement. We 

have revised our standards to require 

training for the staff who are involved 

with the application of a restraint, 

implementation of seclusion, providing 

care for a patient in restraint or 

seclusion, or with assessing and 

monitoring the condition of the 

restrained or secluded patient. 

Comment: One commenter asked 

whether training would be required for 

house medical staff/covering 

psychiatrists. 

Response: In the final rule, combined 

standard (e) specifies that physician and 

other LIP training requirements must be 

specified in hospital policy. At a 

minimum, physicians and other LIPs 

authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law must have a 

working knowledge of hospital policy 

regarding the use of restraint and 

seclusion. Hospitals have the flexibility 

to identify training requirements above 

this minimum based on the competency 

level of their physicians and other LIPs 

and the needs of the patient population 

that they serve. Physicians receive 

training in the assessment, monitoring 

and evaluation of a patient’s condition 

as part of their medical school 

education. However, physicians 

generally do not receive training 

regarding application of restraint or 

implementation of seclusion as part of 

their basic education. Depending on the 

level and frequency of involvement that 

a physician has in the performance of 

these activities, the physician or other 

LIP may or may not require training. If 

house staff, hospitalists or covering 

psychiatrists are the medical staff that 

are directly involved in the care of a 

patient in restraint or seclusion, a 

hospital may determine that training is 

necessary to insure competency of these 

individuals in this area. We believe the 

hospital is in the best position to 

determine if physician training is 

necessary based on the model of care, 

level of physician competency, and the 

needs of the patient population(s) that 

the hospital serves. Therefore, we have 

only mandated a minimum level of 

physician and other LIP training. 

Instead, we have provided hospitals 

with the flexibility to specify additional 

physician and other LIP training 

requirements, if any, in hospital policy. 

Comment: One commenter suggested 

that staff be required to talk to the 

patient intermittently to assist the 

patient’s efforts to regain self-control 

and to explain what the patient needs to 

do for the restraint or seclusion to end. 

Response: The training requirements 

are intended to equip staff with skills 

that can be used in this fashion. 

Comment: One commenter suggested 

that there should be Federal 

compensation for the added cost of 

providing such training. 

Response: Staff training is generally 

included in administrative costs and is 

recognized in calculating payments 

under the hospital inpatient prospective 

payment system. Therefore, we are not 

providing separate compensation to 

fund this training. 

Comment: Several commenters asked 

about the frequency of training. One 

commenter suggested that the term 

‘‘ongoing’’ should be replaced with 

‘‘annually.’’

Response: We have modified the 

regulatory text to require staff to 

demonstrate the competencies specified 

in standard (f) initially as part of 

orientation and subsequently on a 

periodic basis consistent with hospital 

policy. We believe the hospital is in the 

best position to identify a timeframe for 

ongoing training based on the level of 

staff competency, and the needs of the 

patient population(s) served. 

Comment: Commenters had varying 

ideas about what topics training should 

cover, and whether the regulation 

should specify training content in 

detail. Several commenters asked 

whether training must be obtained from 

Federally-specified programs. 

One commenter urged that 

requirements for the training curriculum 

be described in the regulations. A few 

commenters suggested that the current 

standard (f) training requirement should 

not be limited to the proper and safe use 

of restraints; one commenter suggested 

more emphasis on positive behavioral 

supports and less on ‘‘proper’’ use. One 

commenter supported education on 

alternatives to restraint use and safe 

handling of a patient in restraints. 

Another commenter suggested that the 

training should include personally 

experiencing being restrained. One 

commenter argued that staff should be 


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trained in values clarification, cultural 

diversity, and counter-transference 

since it is commonly acknowledged that 

patients become more agitated and lose 

control when staff responds in a manner 

that provokes the patient. 

Response: We have adopted more 

detailed training requirements in this 

final rule. In addition, we have moved 

the training requirements from the 

current standards (e) and (f), and have 

created a separate standard (f) that 

addresses staff training requirements. 

Standard (f) states that the hospital 

must require appropriate staff to have 

education, training, and demonstrated 

knowledge based on the specific needs 

of the patient population in at least the 

following: 

• Techniques to identify staff and 

patient behaviors, events, and 

environmental factors that may trigger 

circumstances that require the use of 

restraint or seclusion; 

• The use of nonphysical intervention 

skills; 

• Choosing the least restrictive 

intervention based on an individualized 

assessment of the patient’s medical, or 

behavioral status or condition; 

• The safe application and use of all 

types of restraint or seclusion used in 

the hospital, including training in how 

to recognize and respond to signs of 

physical and psychological distress (for 

example, positional asphyxia); 

• Clinical identification of specific 

behavioral changes that indicate that 

restraint or seclusion is no longer 

necessary; 

• Monitoring the physical and 

psychological well-being of the patient 

who is restrained or secluded, 

including, but not limited to, respiratory 

and circulatory status, skin integrity, 

vital signs, and any special 

requirements specified by hospital 

policy associated with the 1-hour faceto-face evaluation; and 

• The use of first aid techniques and 

certification in the use of 

cardiopulmonary resuscitation, 

including required periodic 

recertification. 

Staff need to employ a broad range of 

clinical interventions to maintain the 

safety of the patient and others in the 

provision care. The hospital is expected 

to provide education and training at the 

appropriate level to the appropriate staff 

based upon the specific needs of the 

patient population being served. For 

example, staff routinely providing care 

for violent or self-destructive behavior 

that jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others (such as in an emergency 

department or on a psychiatric unit) 

generally require more in-depth training 

in the areas included in the regulation 

than staff routinely providing medical/ 

surgical care. 

Lastly, we have not required that 

training be obtained from Federallyspecified programs. Hospitals may 

develop and implement their own 

training programs or use an outside 

training program. However, standard (f) 

specifies that individuals providing staff 

training must be qualified as evidenced 

by education, training and experience in 

techniques used to address patients’

behaviors. 

Comment: One commenter suggested 

that training should include instruction 

on—(1) how to identify patients who 

may have conditions that would require 

special attention, (for example, a history 

of respiratory or cardiac problems); (2) 

how to monitor patients in restraints; 

and (3) what conditions are necessary 

for a person to be released from 

restraints. This commenter suggested 

that in standard (f), the training 

requirement should include instructions 

on how to screen patients for special 

problems that could affect the use, type, 

or duration of restraints (for example, 

emotional problems associated with a 

history of abuse or neglect). 

Response: We agree and have 

incorporated the suggested elements in 

standard (f). 

Comment: One commenter suggested 

that staff that has not completed training 

should be prohibited by regulation from 

initiating and complying with orders for 

restraint or seclusion. 

Response: We agree. In standard (f), 

we require that staff be trained and able 

to demonstrate competency before 

applying restraints, implementing 

seclusion, or performing associated 

monitoring and assessment of, or 

providing care for, a patient in restraint 

or seclusion. Application of restraint or 

seclusion by an untrained staff member, 

including contract staff, would 

constitute a violation of this 

requirement. 

13. Definition of Seclusion 

(§ 482.13(f)(1)) 

We defined seclusion as the 

involuntary confinement of a person in 

a room or an area where the person is 

physically prevented from leaving. 

Comment: Several commenters 

suggested adding the word ‘‘alone’’ to 

the definition of seclusion. Several 

commenters pointed out that the 

definition that appeared in the interim 

final rule with comment period would 

define a patient confined involuntarily 

on a locked unit as being secluded. 

Additionally, one commenter believed 

the word ‘‘area’’ was too broad and 

might be read as including being on a 

unit or ward with others. 

Response: In the final rule, we have 

added the word ‘‘alone’’ to this 

definition for clarity and retained the 

use of the word ‘‘area’’. Seclusion does 

not include confinement on a locked 

unit, ward, or other area where the 

patient is with others. Seclusion is not 

just confining a patient to an area but 

involuntarily confining the patient 

alone in a room or area where the 

patient is physically prevented from 

leaving. A situation where a patient is 

restricted to a room or area alone and 

staff are physically intervening to 

prevent the patient from leaving the 

room or area is also considered 

seclusion. In addition, we have clarified 

that seclusion may only be used for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. 

Comment: One commenter stated that 

physical restraint is more frequently 

associated with injury and death than is 

monitored seclusion. This commenter 

argued against categorizing seclusion 

with restraint, stating that its use should 

not be governed by the same 

requirements. Another commenter said 

that linking the terms ‘‘seclusion’’ and 

‘‘restraint’’ is misleading in that it 

creates the inaccurate perception that 

the two interventions are equivalent in 

all respects. This commenter could not 

imagine a death resulting from 

seclusion, other than from self-inflicted 

injury (which would indicate a possible 

need for restraint initially) or from the 

total and gross neglect of an acutely ill 

patient, which no amount of regulation 

would prevent, since this would 

represent unacceptable, deviant 

practice. 

One commenter stated that seclusion 

is therapeutically different from 

restraint. Seclusion is indicated when a 

patient’s behavior poses a significant 

threat to others or is profoundly 

disturbing in the therapeutic 

environment (such as a patient 

disrobing in public). This commenter 

suggested that while this behavior is not 

violent, it is appropriately, humanely, 

and therapeutically addressed through 

seclusion. 

Response: The frequency and level of 

monitoring and assessment of the 

condition of a patient who is in restraint 

or seclusion are determined by staff 

based on hospital policy and an 

individualized patient assessment. 

These parameters would differ based on 

the type of intervention used. We would 

not necessarily expect these parameters 

to be identical for all types of restraint 

and the use of seclusion. 


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In response to the comment about the 

therapeutic use of seclusion, we note 

that the use of seclusion is a means to 

an end, not the end itself. In the 

example given, simply secluding a 

patient who habitually disrobes is not a 

long-term solution to eliminating this 

inappropriate behavior. The patient 

should be assessed and engaged in an 

active, individualized treatment 

program. 

Comment: A commenter, concerned 

about the needs of students receiving 

special education, asked whether this 

regulation would define a child who has 

been restricted from attending a school 

program as having been ‘‘secluded,’’ and 

requested that the regulation prohibit 

this action except when the 

requirements of the regulation are met. 

Response: Not allowing a patient to 

attend a school program or removing a 

patient from a classroom setting would 

not meet the definition of seclusion as 

defined in this rule, and also outside the 

scope of this regulation which addresses 

restraint and seclusion in hospitals. 

Comment: One commenter stated that 

there should be minimum standards for 

the cubic dimensions and ventilation of 

a seclusion room, which were not 

provided in the interim final rule with 

comment period. 

Response: We believe that setting 

these types of standards is beyond the 

scope of this rule. 

Comment: Commenters concerned 

with children’s issues discussed the use 

of ‘‘time outs.’’ Several commenters 

argued that CMS should distinguish 

between seclusion (where a child is 

locked in a room) and a time out, and 

that time outs should not be governed 

by the regulation. These commenters 

believed that a ‘‘time out’’ should be 

defined as actions to require the child 

or adolescent to retire to an alternative 

setting, either in his or her room or in 

a separate quiet room, but without 

restraining or locking up the child. 

Several commenters expressed concern 

that the regulation prohibits so called 

‘‘open door’’ and ‘‘decreased 

stimulation’’ time outs, which are used 

to prevent the escalation of behavior 

leading to emergency situations. One 

commenter asked whether a child 

voluntarily removing himself from a 

current activity and spending 15 

minutes calming his or her emotions 

constitutes seclusion. 

Response: For the purposes of this 

final rule, seclusion is the involuntary 

confinement of a patient alone in a room 

or area from which the patient is 

physically prevented from leaving. 

Seclusion may only be used for the 

management of violent or selfdestructive behavior. If a patient is free 

to leave a time out area whenever the 

patient chooses, this would not be 

considered seclusion based on this 

definition. The key distinction in 

deciding whether an intervention is 

seclusion or a time out is whether the 

patient is physically prevented from 

leaving a room or area. Another 

distinction is the patient’s level of 

personal control. In the case of 

seclusion, boundaries are placed on the 

patient’s behavior based on the clinical 

determination that the patient’s 

behavior poses a risk to the safety of the 

patient or others. In a time out, the 

patient is able to respond to staff 

direction encouraging a time out or to 

independently decide that such action 

is needed. In a time out, the staff and 

patient collaboratively determine when 

the patient has regained self-control and 

is able to return to the treatment milieu. 

In seclusion, this judgment is made by 

the clinicians—that is, an agitated 

patient may feel that he or she should 

be released, even though the patient’s 

behavior continues to be violent or selfdestructive. 

Comment: One commenter inquired 

whether seclusion requires a physician’s 

order and all related monitoring and 

documentation. 

Response: The use of seclusion for the 

management of violent or selfdestructive behavior is regulated by 

combined standard (e). If an 

intervention meets the definition of 

seclusion in standard (e), all of the 

requirements under standard (e) would 

apply, including those related to a 

physician or other LIP’s order, the 

1-hour face-to-face evaluation, 

monitoring and documentation. 

Comment: One commenter expressed 

concern that the definition of 

‘‘seclusion’’ covers typical hospital 

practices, such as keeping visitors and 

patients out of certain areas for purposes 

of infection control, security, patient 

privacy, or prevention of disruption of 

treatment. 

Response: Our modification to the 

definition, that is, adding the word 

‘‘alone,’’ should alleviate this concern. 

In the cases cited, the hospital is 

keeping patients or visitors out of an 

area versus involuntarily confining the 

patient alone within a room or area from 

which the patient is physically 

prevented from leaving for management 

of violent or self-destructive behavior 

that jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. It is not the intent of this rule to 

interfere with hospital infection control 

practices, security measures, patient 

privacy or measures intended to prevent 

the disruption of treatment. 

Additionally, State law outlines 

requirements for quarantining a patient. 

If the need to quarantine a patient 

arises, the hospital would follow State 

law. Quarantining, as governed by State 

law, would not be considered seclusion. 

14. Use of Restraint/Seclusion for 

Behavior Management (§ 482.13(f)(2)) 

We stated that seclusion or restraint 

for behavior management can only be 

used in emergency situations if needed 

to ensure the patient’s, a staff member, 

or others’ physical safety and less 

restrictive interventions have been 

determined to be ineffective. 

Comment: Many commenters stated 

that the use of restraint or seclusion is 

a treatment failure. In contrast, several 

commenters argued that the regulation’s 

requirements are not guided by solid 

clinical information, nor do they take 

into account the realities of inpatient 

psychiatric treatment. One commenter 

stated, ‘‘While I am aware of individuals 

who think that medications and/or 

restraints for [violent, aggressive] 

patients should never be applied, such 

thinking is naı ̈ve, unrealistic, and 

idealistic.’’ The commenter 

recommended that we study how many 

deaths/injuries/assaults are prevented 

by appropriate use of restraints. 

Response: The role of restraint and 

seclusion for behavior management was 

a point of fundamental disagreement 

among commenters. While we believe 

that restraint and seclusion are not 

desirable interventions, we recognize 

the diversity of patients and situations 

that clinicians must address. In some of 

these situations, the patient poses a real 

safety risk to self or others, and 

alternative, less restrictive interventions 

are not sufficient to assure the safety of 

the patient or others. 

Comment: A few commenters strongly 

agreed that restraints should only be 

used for emergency safety situations. 

Some physicians and hospitals 

indicated that they view restraint as a 

last resort which is only used when 

absolutely necessary to protect the 

safety of the patient or others. One 

commenter indicated that seclusion and 

restraint have a valuable place in 

treatment, but only when used 

minimally, such as in cases of extreme 

violence or when needed to protect 

clients. One commenter stated that the 

rule does not define the term 

‘‘emergency,’’ and cited a Maryland 

regulation that defines an emergency as 

a situation in which the patient’s 

behavior poses a serious and imminent 

danger to the physical safety of self or 

others. 

In contrast, a commenter suggested 

removing ‘‘in emergency situations.’’ 

Another commenter agreed with this 


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suggestion, arguing that the rule does 

not permit the use of seclusion and 

restraint as therapeutic interventions as 

part of a treatment plan for serious 

behavioral problems. The commenter 

argued that although short-term, crisisbased use of seclusion and restraint is 

necessary, it is not the only appropriate 

use of restraint, since short-term 

behavioral restrictions can be the most 

humane way to prevent the patient from 

self-injury and reduce the need for 

invasive medical therapies that can have 

serious, long-term adverse 

consequences. 

Response: The use of restraint or 

seclusion should not be a routine 

response when a patient’s behavior 

begins to escalate. Restraint or seclusion 

may only be imposed to ensure the 

immediate physical safety of the patient 

or others. Seclusion may only be used 

for the management of violent or selfdestructive behavior of patients when 

there is an immediate danger of harm to 

the patient, a staff member, or others. 

We recognize that there may be 

circumstances in which the use of 

restraint or seclusion may be necessary 

to prevent a situation from escalating 

into an emergency situation in which a 

patient is in immediate danger of 

harming himself, staff, or others. In the 

therapeutic environment, staff often 

skillfully intervene with alternative 

techniques that redirect the patient, 

engage the patient in constructive 

discussion or activity, or otherwise help 

the patient maintain self-control and 

avert escalation. Therapy is a building 

process in which the patient gains the 

skills necessary to appropriately handle 

daily stressors and situations. The use of 

restraint or seclusion to manage violent 

or self-destructive behavior is an 

emergency measure that temporarily 

protects the safety of the patient, staff, 

and others. However, neither restraint 

nor seclusion is a long-term solution for 

handling problematic behavior. 

Based on public comment, we have 

clarified this provision by replacing the 

reference to emergency situations with 

more descriptive language. Therefore, 

combined standard (e) states that 

restraint or seclusion can only be 

imposed to ensure the immediate 

physical safety of the patient, staff, or 

others, must be discontinued at the 

earliest possible time, and less 

restrictive interventions have been 

determined to be ineffective. Seclusion 

may only be used to manage violent or 

self-destructive behavior of patients that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. 

Comment: One commenter suggested 

permitting the use of restraints to 

control anticipated catastrophic 

behavior associated with conditions 

such as Lesch Nyhan Disease 

(manifested by self-mutilation) or other 

self injurious or assaultive behaviors. 

The commenter argued that such use 

would be appropriate to address 

intractable behaviors that have not 

responded to medications or other 

treatment interventions. This type of use 

would be part of an individualized plan 

of care addressing the underlying cause 

of the behavior and would involve 

rigorous monitoring and active 

treatment to allow for the removal of 

restraints. 

Response: The regulation has not 

barred the use of restraint to manage 

catastrophic behavior. If a patient has a 

diagnosed chronic medical or 

psychiatric condition such as those 

associated with Lesch-Nyhan 

Syndrome, and he or she engages in 

repetitive self-mutilating behavior, the 

use of restraint would need to meet the 

requirements of combined standard (e). 

In these situations where the patient 

exhibits chronic self-injurious behavior, 

a PRN order that is applied in 

accordance with the specific parameters 

established in the treatment plan would 

be permitted (note that PRN application 

of restraint is not otherwise permitted). 

Again, this use of restraint would need 

to be integrated into the plan for the 

patient’s care and treatment. As always, 

the use of alternative interventions 

should be pursued when feasible, and 

use of restraint should be discontinued 

as quickly as possible. Since the use of 

restraints to prevent self-injury for these 

types of rare, severe medical and 

psychiatric conditions have been 

intergrated into the patient’s care and 

treatment plan, the requirement for the 

1-hour face-to-face evaluation and the 

limitation of length of orders (4, 2, or 1 

hour(s) depending on the patient’s age) 

are not applicable. 

Comment: One commenter suggested 

a series of steps for treating a patient 

who has a known history of assault or 

who exhibits aggression. First, the 

patient must have a treatment plan to 

address the problem. Second, if the 

treatment plan does not work, a back-up 

plan must provide the patient relief 

from whatever seems to be provoking 

the attack. Third, if the back-up plan 

fails, staff should try to coach or 

encourage some alternative to assault. 

The commenter suggested that assault is 

almost always goal directed, and that 

staff’s task is to determine the goal and 

suggest an alternative to achieve it. If 

alternatives are not accepted, staff 

should ‘‘reduce their verbiage’’ and 

‘‘exaggerate simple non-verbal 

messages.’’ If an attack is initiated, staff 

should continue the use of verbal deescalation techniques while physically 

evading attack. If all these interventions 

fail and the attack continues, ‘‘some 

form of bodily restraint may be 

justified.’’

Response: We appreciate the 

commenter’s insights. However, the 

level of detail provided is more typical 

of hospital policy on how to handle 

assaultive behavior than of regulatory 

text. When a patient is exhibiting 

violent or self-destructive behavior and 

the patient is in danger of harming 

themselves or others, and less restrictive 

interventions have been determined to 

be ineffective, we expect staff to 

implement appropriate interventions to 

ensure the safety of the patient and 

others. While the steps described by the 

commenter may be appropriate in some 

situations, they may not be appropriate 

in others. For example, a patient is 

attacking another patient. In this 

situation, immediate intervention, that 

is, restraint or seclusion in conjunction 

with ongoing verbal de-escalation and 

communication with the patient may be 

necessary to ensure the safety of all 

involved. The use of less restrictive 

interventions that are ineffective in this 

scenario may, in fact, further jeopardize 

the safety of those involved. Therefore, 

it is critical that staff employ the least 

restrictive interventions that will be 

effective in ensuring the safety of the 

patient, other patients, staff and others. 

Comment: One commenter observed 

that insuring the safety of patients (as 

required by the Patients’ Rights CoP) 

will not be possible unless restraining 

patients who endanger the safety of 

others is permitted. The commenter 

stated that the interim final rule with 

comment period precludes this type of 

use of restraint or seclusion. A second 

commenter agreed, noting that provision 

(f)(2) of the interim final rule with 

comment period contradicts (f)(3)(i) in 

that only patient safety (not that of 

others as provided in (3)(i)) is 

mentioned in (f)(2). One commenter 

suggested the following rewording for 

(f)(2) to remedy this contradiction: 

‘‘Seclusion or restraint can only be used 

in emergency situations if needed to 

ensure the patient’s physical safety or 

the safety of others and less restrictive 

interventions with the patient have 

previously been determined to be 

ineffective.’’ Other commenters echoed 

the concern that the requirement should 

take the safety of other patients and staff 

into account. 

Response: The interim final rule with 

comment period stated that the use of 

restraint or seclusion must be selected 

only when ‘‘less restrictive measures 

have been found ineffective to protect 


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the patient or others from harm.’’ We 

have revised the final rule to state that 

restraint or seclusion may only be used 

when less restrictive interventions have 

been determined to be ineffective to 

protect the patient or others from harm. 

In addition, we have specified the type 

or technique of restraint or seclusion 

used must be the least restrictive that 

will be effective to protect the patient or 

others from harm. 

Comment: One commenter stated that 

‘‘absolute danger’’ cannot be the only 

qualifier for restraint or seclusion use in 

behavior management. The hospital 

cited examples of highly agitated 

behavior that disrupts the treatment 

milieu, such as a patient yelling 

profanities, disrobing, or destroying 

property. In addition, another 

commenter stated that Maryland 

regulation permits the use of seclusion 

or restraint when an individual presents 

a serious disruption to a therapeutic 

environment (behavior of such a grave 

or protracted nature that it significantly 

interferes with the emotional well-being 

of other patients or with their 

treatment). 

Response: We recognize that 

situations do occur in which highly 

agitated behaviors can disrupt the 

therapeutic environment. A disruption 

to the therapeutic environment that 

jeopardizes the safety of patients, staff, 

and others could be a situation where 

the use of restraint or seclusion may be 

necessary. In these situations, there may 

be no other intervention short of the use 

of restraint or seclusion that will assure 

the safety of the patients, staff and 

others. Based on these comments, we 

have revised combined standard (e) to 

state that restraint or seclusion can only 

be used to manage violent or selfdestructive behavior of patients when 

they are in danger of harming 

themselves or others, and less restrictive 

interventions have been determined to 

be ineffective. However, we have not 

accepted the commenter’s 

recommendation regarding ‘‘agitated 

behavior.’’ A patient’s agitated behavior 

may or may not pose a physical safety 

threat to the patient, staff or others. We 

caution against automatic responses, 

where the situation is oversimplified 

and the intervention is not tailored to 

the individual patient. For example, the 

fact that a patient is yelling profanities 

is not an automatic trigger for restraint 

use. A patient might yell because of 

pain or any number of factors, which 

could perhaps be addressed by other 

types of intervention. In the examples 

cited, the patient’s behavior should 

prompt individualized assessment and 

treatment. A patient who is shouting 

profanities may be calmed by one-to-one 

interaction with a staff member. A 

patient who is trying to destroy an 

object can, in some cases, be distracted 

or encouraged to redirect his or her 

energies. Again, we emphasize that the 

decision of how to handle any given 

situation will depend on the patient, the 

patient’s history, the patient’s 

symptoms, and the seriousness and 

immediate danger presented by the 

patient’s behavior. 

Comment: One commenter stated that 

each patient who is restrained or 

secluded should be given a complaint 

form when the intervention ends, with 

instructions on how to fill it out, and 

privacy and protection in submitting it. 

Response: The hospital is required by 

standard (a) to establish a process for 

prompt resolution of patient grievances 

and must inform each patient who to 

contact to file a grievance. If the patient 

or the patient’s representative wants to 

file a grievance, this can be done 

verbally or in writing. 

Comment: One commenter 

recommended sanctions against 

providers who misuse or abuse any 

chemical or physical intervention be 

significant, sure, and swiftly applied. 

Response: We appreciate this 

commenter’s support for vigorous 

enforcement. Hospital noncompliance 

with these requirements is of the same 

gravity as noncompliance with existing 

standards, and could result in 

enforcement action. 

Comment: A commenter stated that 

the regulation should reflect the fact 

that to reduce the use of restraints, it is 

necessary for hospital leadership to 

make clear that this is their policy and 

their goal. The commenter also stated 

that leadership must create an 

atmosphere where the use of restraints 

is not tolerated, unless absolutely 

necessary. 

Response: We agree that hospital 

leadership plays a critical role in the 

reduction of restraint and seclusion use. 

There are many challenges associated 

with initiating and sustaining reduced 

use of restraint and seclusion. Strong 

organizational leadership is essential in 

creating the culture change necessary to 

minimize the use of restraint and 

seclusion. The responsibilities of the 

governing body and Medical staff are 

addressed in other CoPs. 

15. One Hour Rule (§ 482.13(f)(3)(ii)(C)) 

We stated that a physician or other 

licensed independent practitioner must 

see and evaluate the need for restraint 

or seclusion within 1-hour after the 

initiation of this intervention. 

This provision was the lightning rod 

for public comment. Almost every 

commenting physician opposed the 

provision as written, and the majority of 

commenters strenuously objected to it, 

with most asking that the words, ‘‘see 

and’’ be eliminated to leave only the 

requirement for a physician or LIP 

evaluation. A core of commenters from 

advocacy groups and the general public 

stated that this provision should be 

modified by shortening the timeframe to 

half an hour and eliminating the 

recognition of an LIP’s ability to perform 

this function. 

Many commenters asked what the 

face-to-face requirement of the interim 

final rule with comment period 

accomplished. In the preamble of the 

July 2, 1999 interim final rule (64 FR 

36079) we stated the following: 

In situations where a restraint must be 

used for behavior management, increased 

vigilance is required because of the 

heightened potential for harm or injury as the 

patient struggles or resists. Furthermore, 

there is an immediate need for assessment of 

what has triggered this behavior and for 

continuous monitoring of the patient’s 

condition. To address the need for quick 

assessment of the condition, we are 

specifying that the physician or licensed 

independent practitioner see the patient faceto-face within 1-hour of the application of the 

restraint or the use of seclusion. 

The one-hour requirement of the 

interim final rule with comment period 

was intended to assure patient safety 

with a quick assessment by a physician 

or other LIP to rule out possible 

underlying factors that might be 

contributing to the patient’s behavior, to 

assess the patient’s physical and 

psychiatric condition, and to decide 

whether restraint or seclusion continue 

to be necessary. 

Commenters were divided on whether 

this provision would promote patient 

safety or address adequately the 

problems identified by the media. While 

some commenters stated that deaths that 

occur during the first hour of restraint 

or seclusion support the need for this 

mandated onsite physician or LIP 

assessment within the first hour, a 

second group stated that by the time the 

physician arrived in the 59th minute, if 

staff were not properly trained, the 

patient might already be dead. This 

latter group of commenters argued that 

our proposed ‘‘fix’’ did not directly 

address the key problem and that we 

were essentially adding a process 

without proof of an improved outcome 

for patients. 

Some commenters referred us to a 

Pennsylvania policy used in its ten 

State-operated psychiatric hospitals, 

which requires a physician’s face-to-face 

evaluation within half an hour, and 

accompanying data that shows a 

reduction in restraint and seclusion use. 


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The Commonwealth’s policy and data 

were cited as proof that a half-hour 

physician face-to-face assessment 

improves patient care and assures 

patient safety. In preparing the final 

rule, we were interested in the 

Commonwealth’s experience, including 

any outcomes data or research related to 

its half-hour physician assessment 

policy. We asked for and received a 

package of information from the 

Commonwealth that described its 

policies regarding restraint and 

seclusion and data showing use over 

time. 

The Commonwealth’s policies 

provide that—(1) only a physician may 

order restraint or seclusion; (2) orders 

may not exceed 1 hour; (3) if a verbal 

order is given, the physician must 

physically evaluate the patient within 

30 minutes; (4) persons in restraint must 

be kept under constant observation; (5) 

each reorder may not exceed 1-hour and 

requires physical examination; (6) each 

incident must be followed by patient 

debriefing; and (7) each use triggers 

clinical, administrative, and continuous 

quality improvement review, plus a 

revision to the treatment plan. 

After reviewing the information 

received, we did not find any claims by 

the Commonwealth that physician 

assessment within half an hour had 

directly contributed to reduced restraint 

and seclusion use. Furthermore, to make 

such an attribution would be to ignore 

the fact that the Commonwealth 

introduced a multi-pronged approach 

that embraces many methods to address 

the issues of patient and staff safety. An 

important aspect of the approach is that 

physicians are on staff around the clock 

in the Commonwealth’s psychiatric 

facilities. The requirements referenced 

earlier do not exist in isolation, but are 

part of the Commonwealth’s integrated 

approach and ongoing efforts to work 

collaboratively toward the goals of 

restraint and seclusion reduction and 

patient and staff safety. 

To summarize, given the 

comprehensive restraint and seclusion 

policies instituted by the 

Commonwealth, it is simply unclear 

whether one could point to the halfhour evaluation and demonstrate a 

direct, causal effect on the reduction in 

restraint and seclusion initiation and 

duration in Pennsylvania’s State 

psychiatric hospitals. 

Based on our analysis of the 

information supplied by the 

Commonwealth, and given the 

numerous public comments we received 

on this requirement, we have revised 

the regulatory language to broaden the 

types of practitioners who may conduct 

the 1-hour face-to-face evaluation to 

include a trained RN or PA unless 

superseded by State law that is more 

restrictive. We have also addressed the 

criteria by which staff are to be 

considered ‘‘trained’’, and specify the 

components of the 1-hour evaluation. In 

making these changes, we acknowledge 

the comments of many psychiatrists and 

other physicians who noted that they 

are appropriately consulted within 1- 

hour of the initiation of restraint or 

seclusion by the onsite staff. Many such 

commenters argued that a RN is entirely 

capable of assessing the patient’s 

condition, and that to suggest otherwise 

ignores RNs’ training and high level of 

expertise. 

How quickly the patient needs to be 

seen by his or her attending physician 

(or other practitioner, as noted in the 

regulation) is left to the medical 

judgment of the physician or other LIP. 

We have revised standard (f) to state 

that if the 1-hour face-to-face evaluation 

is conducted by a trained RN or PA, the 

attending physician or other LIP 

responsible for the care of the patient 

must be consulted as soon as possible. 

The attending physician or other LIP is 

responsible for assuring that the patient 

receives a timely and adequate face-toface assessment based on the clinical 

need presented by the individual 

patient’s case. 

Comment: One commenter noted that 

in California, the contractual 

relationship between a physician and 

hospital may affect the hospital’s ability 

to ask physicians to meet the 1-hour 

requirement. 

Response: The comments submitted 

(some of which came from physicians 

from California) indicated that a high 

level of physician involvement in the 

patient’s care already exists. Many 

reported routine contact with hospital 

staff if a patient under their care 

becomes violent or self-destructive and 

restraint or seclusion may be indicated. 

Most of these physicians argued for the 

removal of the word ‘‘see,’’ noting that 

they are willing to be and indeed 

already are involved with these sorts of 

decisions, but that their objection was to 

the onsite visit. We have revised the 

requirements to permit a trained RN or 

PA to conduct the 1-hour evaluation, 

and do not require the physician to 

come to the hospital to see and evaluate 

the patient 1-hour after the initiation of 

the restraint or seclusion. Because this 

change permits more flexibility and 

clinical judgment on the physician’s 

part, we believe that the cause for 

physician objection is largely removed. 

a. Comments Objecting to a Physician or 

LIP Seeing the Patient Within 1 Hour 

The majority of commenters objected 

to our requirement that a physician or 

LIP see the patient within 1-hour of the 

initiation of restraint or seclusion for 

behavior management. They provided 

the following arguments regarding this 

requirement as written in the interim 

final rule with comment period. The 

rule—

• Is impractical. By the time the 

physician or LIP arrives, the patient’s 

episode may already be over, leaving 

some physicians asking what they are 

supposed to evaluate when they arrive. 

One physician asked whether he must 

awaken a patient to perform an 

evaluation after the intervention has 

ended if the patient is asleep afterward. 

• Forces free standing facilities to 

hire under qualified and ill-prepared 

physicians to see and evaluate patients 

with whom they are unfamiliar. 

• Pits the physician against staff. 

• Creates hesitation to use an 

intervention to address violent or 

aggressive behavior that places the 

patient, the staff, and other patients at 

risk. One commenter believed that 

psychiatrists will tell nursing staff to 

tolerate aggression or violence until they 

find time to come and see the patient, 

which also places those present at the 

hospital at risk. To provide evidence of 

the risk to staff, commenters referred to 

various data sources: the Occupational 

Safety and Health Administration has 

named health care workers as one of the 

most injured-on-the-job occupational 

groups; the National Institute for 

Occupational Safety and Health has 

found that most non-fatal workplace 

assaults occur in service settings such as 

hospitals, nursing homes, and social 

service agencies. Forty-eight percent of 

nonfatal assaults in the workplace are 

committed by health care patients; and 

the Department of Justice has found that 

mental health professionals rank sixth 

(behind taxi-drivers, police officers, 

security guards, prison guards, and 

bartenders) on a list of occupations with 

the greatest risk of attack. This 

requirement, commenters argued, will 

add risk of on-the-job injury that could 

otherwise be avoided. 

• Inappropriately dictates medical 

practice. Requiring timely and 

appropriate medical evaluation is 

reasonable, but it is not feasible or 

clinically necessary to require a face-toface evaluation by a physician in each 

case. A physician assessment of the 

situation should always be done, but 

whether face-to-face evaluation is 

necessary should be left to the 

physician’s discretion. 


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• Nullifies the professional clinical 

decisions of registered nurses and 

insults their professionalism and 

training. 

• Adversely impacts staff morale, 

recruitment, and retention. One 

physician described getting good staff as 

a continuing challenge since the job is 

inherently dangerous. He believed that 

he will lose staff who decide that the 

increased hassle of inpatient work is not 

worth the trouble when plenty of 

outpatient work is available. Other 

commenters voiced similar concerns, 

noting that nurses must deal with 

belligerent and uncontrollable patients, 

and limiting their available options will 

make retaining nursing personnel 

difficult. 

• Will cause hospitals to place 

patients immediately in restraint 

without trying seclusion (that is, move 

to the most restrictive intervention first) 

so that the physician only has to make 

one visit to assess the patient. 

• Will adversely affect patient access 

to care. Admitting teams will refuse to 

accept any potentially violent or 

disruptive patients because of this 

requirement and thereby increase the 

number of patients routed to State 

hospitals, the criminal justice system, or 

juvenile hall, and increase the number 

of patients who are put out on the street. 

Persons with the most severe mental 

illness will be denied a choice of 

physicians and hospitals although their 

treatment needs are the greatest. 

• May be impossible to implement. 

Existing psychiatrist shortages may 

thwart hospitals’ attempts to hire 

coverage so that this requirement can be 

met. One facility commented that it has 

tried to recruit personnel, but was 

repeatedly told that psychiatrists can 

make more money with considerably 

fewer disruptions in their lives by 

choosing not to do inpatient psychiatry. 

As a result of these regulations, three of 

that facility’s current physicians are 

questioning whether they will continue 

with their inpatient privileges. The 

commenter also states that a nearby 

psychiatric unit may close its inpatient 

services as a result of its entire 

psychiatric staff resigning. Another 

hospital reported that no local 

physicians were willing to be on call 

and onsite within 1 hour. Many 

physicians stated that this provision has 

caused them to question whether they 

should continue rendering inpatient 

services. 

• Cannot be implemented because of 

geographical/logistical issues. While 

large organizations may have house staff 

and residents with which to meet this 

requirement, it will be difficult to 

accomplish in community or rural 

hospitals. 

• May require onsite physicians 

(usually emergency room physicians) to 

leave less stable patients simply to 

comply with this regulation. 

• In effect will require all hospitals to 

have physicians present 24 hours a day, 

7 days a week. One hospital noted that 

hiring an onsite physician would be 

costly and impractical given the low 

occurrence of restraint and seclusion. 

• Has no clear clinical rationale. 

• Will result in patient 

overmedication in an attempt to avoid 

such situations. One physician 

cautioned that overuse of antipsychotic 

medications can result in severe 

(sometimes irreversible) neurologic side 

effects or Neuroleptic Malignant 

Syndrome, which is potentially fatal. 

Increased use of psychotropic 

medications may lead to excessive 

sedation and cognitive dulling, which 

could affect the patient’s ability to 

benefit from therapy and other 

interventions. 

• Will be disruptive of care provided 

to outpatients by requiring that 

practitioners drop everything to come 

into the hospital to meet the 

requirement. This disruptiveness will 

discourage practitioners from providing 

inpatient services, and thereby 

adversely impact patient care and access 

to good practitioners. 

• Is not based in any empirical 

evidence that suggests that a face-to-face 

evaluation by a physician or LIP will 

improve the outcomes of care for 

patients who are secluded or restrained; 

nor is it based on any information that 

suggests that a telephone consultation is 

less effective than a face-to-face 

evaluation. 

• Will cost too much. Various 

hospitals provided estimates that ranged 

from a cost of $62,000 to $750,000 per 

year. One commenter stated that the 

economics of small community facilities 

that provide inpatient psychiatric care 

are tenuous at best. This regulation may 

force these facilities to close or go 

bankrupt. The commenter alleged that 

we have ‘‘tolled the death knell of 

inpatient psychiatric services across the 

country.’’ Another commenter believed 

that most providers will go out of 

business, and those that remain will 

have to pass the increased costs on to 

the payors and patients. One hospital 

stated that this requirement will force it 

to ‘‘close its doors.’’ One physician 

reported that nearly all psychiatric 

facilities and programs operate on a slim 

margin at best. Studies have shown that 

mental health program budgets have 

been reduced by 54 percent over the 

past decade, compared to 7 percent in 

non-psychiatric medical programs. 

Programs that specialize in treating 

geriatric and juvenile patients will be 

severely affected by this rule. It is likely, 

he argued, that administrators will be 

forced to divert resources for staffing 

levels, equipment, patient education, 

case management, and other critical 

patient care activities to offset the cost 

of implementing the rule. One hospital 

sent in a notice of closure as a comment. 

• Will be costly, both in time and 

resources. Each time the physician is 

required to see a restrained/secluded 

patient, there will be an additional fee 

for the visit. Most often, a physician 

who is unfamiliar with the patient will 

have to spend time reading the chart 

and examining the patient, and talking 

to staff. This may also result in 

confusion about treatment. 

• May be used to manipulate the 

physician since the patient can escalate 

his/her behavior, knowing that the 

physician will have to appear within 1- 

hour as a response. 

• Will be ignored by the medical 

community. One physician indicated 

that the unanimous response he has 

received from colleagues is that ‘‘it ain’t 

gonna happen.’’

• Does not allow for treatment that is 

individualized and based on medical 

necessity. 

• Is unreasonable. Physicians in 

independent private practice have full 

out-patient office schedules after 

hospital rounds and cannot be expected 

to cancel an entire schedule and ignore 

the clinical needs of outpatients to drive 

to the hospital on an unpredictable and 

irregular basis. Family practitioners and 

specialists have a full daytime schedule 

and will not be able to provide quality 

services if they are exhausted and 

unpredictable in their schedules. 

b. Comments Supporting Telephone 

Consultation With a Nurse Onsite 

Performing the Patient Assessment 

Many of these commenters suggesting 

deleting the word ‘‘see’’ from the 

requirement to allow staff consultation 

with the physician or LIP by phone. A 

large number of these commenters 

agreed with the revised language 

proposed by the American Hospital 

Association (AHA) and the National 

Association of Psychiatric Health 

Systems (NAPHS), ‘‘A physician or 

other licensed independent practitioner 

must evaluate the need for restraint or 

seclusion within one hour after the 

initiation of this intervention.’’ AHA 

and NAPHS believed that the evaluation 

may be done by the physician or LIP in 

consultation with a registered nurse 

who has demonstrated competency in 

the evaluation of a patient in restraint or 


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seclusion and who is in face-to-face 

contact with the patient. Many 

commenters argued that this change 

would be appropriate because qualified 

registered nurses are more readily 

accessible in emergency situations. 

Because of the RN’s involvement at the 

earliest stages of an event, the RN would 

be able to provide additional 

information about the situation and 

provide the physician with rapid, 

appropriate consultation. The RN would 

carry out the physician’s order and 

direct staff in the use of least restrictive 

methods and in the discontinuation of 

restraint or seclusion at the earliest 

possible time, as specified in the interim 

final rule with comment period. 

The NAPHS further suggested that the 

content of the nurse/physician 

consultation include the following 

elements in order to promote an 

informed evaluation of the patient: (1) 

Consideration of organic causes for the 

behavior; (2) known medical disorders; 

(3) the patient’s medications; (4) the 

patient’s mental status; (5) a brief 

neurological examination; and (6) vital 

signs. If data from this evaluation 

supported the need for a face-to-face 

visit, then the physician would come to 

see the patient. 

Other commenters argued that by 

limiting the ability to assess the patient 

to an LIP or physician, CMS is 

contradicting JCAHO standards which 

permit a RN to assess and document the 

need for restraint. Many commenters 

supported RN or psychiatric nurse 

assessment of the patient. 

One commenter noted that the interim 

final rule with comment period 

permitted the evaluation to be 

performed by ANY physician, even one 

with no training in psychiatry and no 

direct knowledge of the individual’s 

medical and treatment history—but 

would not permit the evaluation to be 

conducted by a psychiatric nurse or 

other licensed professional who is an 

integral part of the patient’s individual 

treatment team. This organization urged 

CMS to ensure that orders for these 

interventions and evaluations following 

initiation of the interventions be 

conducted by licensed practitioners 

who are specially trained and qualified 

to assess and monitor both the inherent 

medical and the psychological risks. 

This may involve physicians or LIPs, or 

nurses or psychologists who are more 

familiar with the individual’s 

psychological history. Another 

commenter echoed this concern, arguing 

that non-psychiatric physicians do not 

necessarily have the competencies for 

treating people with mental illness. 

One commenter interpreted the rule 

to inappropriately devalue and 

undermine the profession of psychiatry, 

as well as psychiatric care, by requiring 

face-to-face assessment for psychiatrists, 

but not for other physicians. This 

commenter asked whether physicians 

who are not psychiatrists have greater 

reasoning ability and better judgment in 

matters that involve assessing the 

appropriateness of restraint and 

seclusion, or whether nurses in medical 

hospitals are somehow more adept at 

reporting reliable and accurate 

information to treating physicians than 

those nurses who work in psychiatric 

hospitals. The commenter also 

supported the use of telephone 

consultation. 

A commenter stated that the 

requirement would in all probability be 

unproductive. The commenter also 

stated, ‘‘Patients requiring seclusion or 

restraint have shown behaviors 

potentially dangerous to themselves or 

others; such behaviors are caused by 

impaired reasoning, distorted thinking, 

or other irrational stimuli. It is 

extremely unlikely that such an event 

would have resolved in an hour; either 

the patient would continue to be 

irrational or would be sedated from 

concomitant therapeutic use of 

medication so that an assessment would 

not be possible.’’ The commenter stated 

that telephone contact between staff and 

physician is perfectly adequate. In 

addition, the commenter noted that an 

appropriate review of the circumstances 

is much more likely several hours (8 to 

12) after the initiation of the 

intervention. 

A few commenters’ disagreements 

were based on the idea that episodes 

requiring restraint and seclusion 

typically involve such gross behavioral 

problems that they cannot be mistaken 

for anything other than emergencies, so 

a physician’s visit to assess the need for 

restraint is not essential. A commenter 

who had experience in a hospital with 

a 2-hour face-to-face rule reported that 

he has never disagreed with a nurse’s 

assessment that a given patient needed 

to be restrained. 

One commenter pointed out that the 

physician is always accountable for the 

medical care his or her patient receives, 

as well as for what actions are taken 

under his or her direction or license. 

Another commenter noted that since the 

order has already been implemented, 

the physician has already accepted 

responsibility, so requiring face-to-face 

evaluation is unnecessary. 

c. Comments Opposing Telephone 

Orders, Nurse Evaluation, and Other LIP 

Involvement 

Some commenters strongly disagreed 

with allowing telephone orders for 

restraint and seclusion and with 

allowing anyone other than a physician 

to perform the face-to-face evaluation of 

the patient. One commenter, an 

RN/PhD, made the following statements: 

This letter comes to urge members of the 

regulatory task force to require that 

physicians complete a face-to-face 

assessment of the patient within the hour 

after initiation of the restraint or seclusion 

and every hour thereafter. There are many 

reasons for a patient to become ‘‘out of 

control,’’ among which are reactions to 

medications, delirium secondary to 

metabolic dysfunction, hypoxia, and so forth. 

These need to be assessed thoroughly and 

with all due respect to my own profession 

[the commenter is a RN and Ph.D.], most 

practicing nurses are not educationally 

equipped to make such evaluations. In my 

years of practice, I have seen patients placed 

in restraints when they had akathesia and 

when they were confused as a result of 

impending pulmonary edema with nurses 

labeling this as ‘‘out of control.’’ In fact, I had 

opportunity to render an expert opinion in a 

lawsuit involving the death of a gentleman 

who died in congestive heart failure—he was 

hypoxic, became confused, and the nurses 

tied him down. It is not a pretty thought that 

he drowned in his own fluid tied to a bed. 

Similarly, another commenter wrote, 

Sometimes it is important for us to do what 

is right instead of what is convenient. For the 

last 40 years that I can remember, we have 

looked for easy ways to restrain 

uncooperative patients without infringing on 

our own time and effort. There is no proper 

way to do it. One hour of restraint or 

seclusion is certainly a maximum that should 

be allowed before personal examination and 

evaluation by someone who is authorized to 

directly give such an order. Think of the 

patient, a decent human being, not yet 

properly evaluated for the patient’s ‘‘bad’’ or 

‘‘uncontrollable’’ behavior. One hour is a 

long time to be physically restrained for no 

or improper reasons. The time allotted to a 

temporary restraining order must be minimal. 

The person providing the evaluation and 

giving the regular order must do so very 

quickly thereafter and be able to accept 

responsibility for doing it without proper 

indication. There will be a lot of opposition 

to this position, as there has been 

continuously ever since these treatments 

were first used. But that does not make it 

right to use them improperly. There is no 

other way to treat our fellow men and 

women. 

d. Comments Stating That the 1-Hour 

Provision Did Not Address the Problem 

Other commenters took issue with the 

idea that the requirement for a 

physician’s onsite visit would prevent 

the sorts of situations described in the 

Hartford Courant’s series. A physician 

who serves as an expert consultant to 

Protection and Advocacy, Inc. has 

reviewed several cases of deaths 

occurring in chronic and acute care 

facilities. He stated, 


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Several of these deaths occurred among 

patients who were at the time of their death 

contained (or in the process of being 

contained) in seclusion or restraints. These 

deaths were tragic and in some cases due to 

serious, preventable errors. However, I do not 

believe that the outcome in any of these cases 

that I have reviewed would have been 

changed by the proposed rule that patients 

requiring seclusion or restraint be evaluated 

face-to-face by a physician or LIP within one 

hour after the initiation of these 

interventions. 

Many facilities that opposed the 

provision reported having had no 

injuries or deaths associated with 

restraints use. Many discussed their use 

of training programs to assure staff 

competency and argued that training 

and monitored staff competency, not the 

1-hour requirement for a physician’s 

onsite visit, was the key to assuring 

patient safety. 

Many commenters argued that better 

training in restraint use, constant or 

frequent monitoring of patients in 

restraints, the banning of dangerous 

techniques such as face-down floor 

holds, and CPR training for all direct 

care workers could prevent the deaths 

associated with restraint use. One 

hospital reported that during a recent 

three-month period, it identified 94 

patients who would have been covered 

by the 1-hour provision. Of these 94 

cases, no restraint-related injury 

occurred. 

Some commenters believed that this 

provision was excessive and 

unnecessary, given that they had no 

problems with deaths or injuries caused 

by restraint. 

Another commenter argued that the 

problems that have caused the reported 

deaths and injuries have been due to the 

administrative policies of the 

problematic facilities. The commenter 

therefore believed that it is unnecessary 

to develop new rules to cover a 

‘‘problem’’ that for the most part does 

not exist. Another commenter affirmed 

this point, stating, 

Several years ago, the California 

Psychiatric Association investigated the 

causes of deaths of persons who had died in 

seclusion and/or restraint in California over 

a period of several years. Our investigation 

found that in nearly every case, the seclusion 

and/or restraint was in violation of the 

hospital’s own policies and procedures. The 

better answer to seclusion and restraint 

deaths is enforcement of existing laws, not 

the enactment of a law which will have the 

unintended consequence of denying the 

sickest of the sick hospitalization. 

One commenter characterized this 

requirement as, ‘‘A very arbitrary 

decision and obviously made without 

much thought at all.’’ The commenter 

further stated, ‘‘While there have been 

instances of deaths, to make an 

unreasonable demand upon all 

physicians because of a few instances 

that can be corrected is extremely 

unreasonable and would greatly change 

how psychiatrists and physicians 

practice medicine in a negative way and 

would not add anything positive in 

terms of health care. Hospitals and 

physicians will work hard with CMS to 

eradicate such abuses as have been 

reported.’’ Another commenter agreed, 

stating the following: 

While it is desirable to remedy the 

shortcomings of our current restraint and 

seclusion practices, it is immediately 

apparent to me that your new requirement 

will result in more patient injuries because 

of the difficulty of compliance with the new 

standard. Since you are demanding a new 

type of treatment protocol, I suggest that the 

burden is yours to demonstrate in a 

controlled trial that your solution will indeed 

be more effective than the existing policy. 

This is the same process by which all 

proposed therapies are judged in our field. 

To do less is to subject all patients to a cruel 

mass experiment. 

One hospital agreed with many of the 

points raised by CMS in the interim 

final rule with comment period, and 

with the position of the National 

Alliance for the Mentally Ill (NAMI), 

and supported standards that protect 

people with mental illness from abuse 

or unnecessary risk. The hospital noted 

that it has adopted most of NAMI’s best 

practices initiatives in their institution. 

However, the hospital stated this 

provision provides no additional benefit 

to the patient and may cripple its ability 

to provide a high standard of care to its 

patients. 

Response: The revised requirement in 

no way prohibits a physician from 

coming to the hospital to assess the 

patient in person. In the final rule, 

combined standard (e) requires that if a 

trained RN or PA conducts the 1-hour 

face-to-face evaluation, the attending 

physician or other LIP responsible for 

the care of the patient must be consulted 

as soon as possible after completion of 

the evaluation. As many commenters 

noted, telephone consultation may be 

effective in this context. Other steps 

may be critical in addressing the 

problems identified in the Hartford 

Courant series. We are not persuaded 

that it is practical or necessary in all 

cases for a physician to physically be 

present within 1-hour to assess the 

patient. We believe that the patient’s 

attending physician or other LIP 

responsible for the care of the patient is 

sufficiently qualified to determine 

whether the patient’s symptoms, 

condition, and history indicate the need 

for an immediate onsite visit. 

Based on the arguments and 

information submitted by the 

commenters, we have revised these 

requirements. When restraint or 

seclusion is used to manage violent or 

self-destructive behavior, a physician or 

other LIP, or a RN or PA trained in 

accordance with the requirements 

specified under § 482.13(f), must see the 

patient face-to-face within 1-hour after 

the initiation of the intervention to 

evaluate: (1) The patient’s immediate 

situation; (2) the patient’s reaction to the 

intervention; (3) the patient’s medical 

and behavioral condition; and, (4) the 

need to continue or terminate the 

restraint or seclusion. As is the case 

with all CoPs, States are free to have 

requirements that are more restrictive 

than these requirements. For example, 

States have the flexibility to limit who 

may conduct the 1-hour face-to-face 

evaluation, require that the evaluation 

be completed in less than an hour, or 

require additional training. Finally, if 

the 1-hour face-to face evaluation is 

conducted by a trained RN or PA, the 

attending physician or other LIP who is 

responsible for the care of the patient as 

specified under § 482.12(c) must be 

consulted as soon as possible after 

completion of the 1-hour face-to-face 

evaluation. 

Comment: One commenter suggested 

that the psychiatrist be thoroughly 

informed of the events that led to the 

need for an intervention, vital signs, and 

other pertinent clinical information by 

telephone, and be required to conduct 

the onsite evaluation ‘‘within a 

reasonable time, not to exceed two 

hours.’’ This wording, the commenter 

noted, will allow some flexibility 

without completely abandoning time 

limits. 

Response: We agree that the attending 

physician (psychiatrist) should be kept 

informed about the patient’s status. The 

final rule specifies that the attending 

physician must be consulted as soon as 

possible if the attending physician did 

not order the restraint or seclusion. It 

also specifies that the attending 

physician or other LIP responsible for 

the care of the patient must be consulted 

as soon as possible after the completion 

of the 1-hour face-to-face evaluation if 

this evaluation is completed by a 

trained RN or PA. During these 

consultations, we would expect that the 

patient’s status and areas suggested by 

the commenter are discussed with the 

attending physician. We do not believe 

that it is necessary to require that the 

attending physician conduct an onsite 

evaluation within 2 hours. How quickly 

the patient needs to be seen by his or 

her attending physician (or other 

practitioner, as noted in the regulation) 


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is left to the medical judgment of the 

physician. 

Comment: One commenter noted that 

under Commonwealth of Virginia law, 

only physicians and licensed clinical 

psychologists are able to order restraint 

and seclusion. The commenter stated 

that the recognition of LIPs in this 

provision did nothing to lessen the 

facility’s burden. 

Response: This regulatory provision is 

applicable unless superseded by State 

law that is more restrictive. It is not our 

intent to interfere with State laws 

governing who may order restraint and 

seclusion. 

Comment: Some commenters argued 

that licensed practitioners such as social 

workers and psychologists (who may be 

recognized under some State laws as 

being LIPs) do not have training in 

physiology or pharmacology and 

therefore may not be able to assess the 

patient appropriately in an emergency 

situation. 

Response: In this final rule, we have 

specified that while these types of 

practitioners may order restraint or 

seclusion if permitted to do so by State 

law and hospital policy, the patient’s 

attending physician (or other 

practitioner) must be contacted to assure 

continued medical oversight and 

continuity of care. The 1-hour face-toface evaluation includes both a physical 

and behavioral assessment of the 

patient. Therefore, the practitioner who 

conducts this evaluation must be able to 

complete both a physical and behavioral 

assessment of the patient in accordance 

with State law, his or her scope of 

practice, and hospital policy. Generally, 

practitioners such as social workers, 

psychologists and other mental health 

workers are not qualified to conduct a 

physical assessment, nor is it in their 

scope of practice. 

Comment: One hospital association 

questioned why we distinguished 

restraint and seclusion from other 

medical interventions initiated when 

the patient undergoes a sudden change 

in condition. 

Response: Our focus on restraint and 

seclusion is not to distinguish these 

interventions from others initiated when 

a patient suddenly undergoes a change 

in status; to the contrary, this focus only 

serves to bring the use of these 

interventions the same level of attention 

and concern. As we read through 

comments, we found that many 

commenters use restraint or seclusion 

only when individualized assessment 

for that particular patient indicates that 

one or both are necessary as a last resort. 

However, some seemed to think that 

restraining a patient was not only 

acceptable, but a standard, sound, or 

unavoidable practice. Restraint and 

seclusion are not standard, benign, or 

desirable interventions to address a 

patient’s behavior. The use of restraint 

or seclusion to manage violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others is of the same 

gravity as other interventions that 

require the physician’s or other 

attending practitioner’s (as noted in the 

regulation) attention and concern. 

Comment: One commenter argued for 

the onsite presence of the attending 

physician, since it would introduce 

someone who did not participate in the 

incidents leading up to the use of 

restraint or seclusion who may be more 

objective in determining whether the 

intervention is appropriate or whether 

the restraint or seclusion was imposed 

as a means of coercion, discipline, 

retaliation, or convenience. 

Response: Including such a 

requirement would be unnecessarily 

burdensome. The regulation requires 

that the attending physician be notified 

as soon as possible if a restraint or 

seclusion has not been ordered by the 

attending physician. The attending 

physician has a vested interest in 

determining whether the intervention is 

appropriate since the physician is 

ultimately responsible for oversight of 

the patient’s care. If the attending 

physician believes that the intervention 

is not needed, he or she may instruct 

staff to release the patient. If the 

attending physician wants to speak to 

the patient or evaluate the patient in 

person to gather more information, he or 

she can do so. 

Comment: Several commenters 

suggested that this standard only be 

applied to those hospitals where deaths 

or other sentinel events related to 

restraints or seclusion have occurred. 

Response: Once codified, this 

standard as well as the entire set of 

existing hospital CoPs are the 

requirements that all hospitals must 

meet to participate in the Medicare and 

Medicaid programs. The CoPs are 

minimum health and safety standards. 

They are intended to protect patient 

health and safety, and to ensure that 

high quality care is provided to all 

patients. Although the majority of 

hospitals are in compliance with the 

requirements, we cannot develop rules 

that only apply to some participants or 

a particular provider group. 

Comment: One commenter asked 

whether any physician who performs 

the assessment can be any physician, or 

whether if it must be the patient’s 

attending physician. 

Response: As revised in this final 

rule, standard (e) permits a physician or 

other LIP, or a trained RN or PA to 

perform the 1-hour face-to-face 

evaluation of the patient. We have not 

specified that the evaluation must be 

completed by the patient’s attending 

physician. However, if the evaluation is 

conducted by a trained RN or PA, the 

attending physician or other LIP 

responsible for the care of the patient 

must be consulted as soon as possible. 

The physician may determine, based on 

clinical need, how soon he or she 

should see the patient. 

Comment: One hospital stated that it 

is the facility’s responsibility to identify 

and provide the right number of 

competent staff to meet the patients’

needs. The hospital opposed the onehour provision as it has adequate, 

competent staff to assure patient safety 

and well being. 

Response: Based on public comment, 

we have amended the 1-hour face-toface evaluation requirement. We agree 

with the commenter’s emphasis on the 

importance of adequate levels of 

competent staff. 

Comment: One commenter suggested 

moving away from the requirement for 

an onsite physician visit, but suggested 

adding language requiring that, ‘‘If the 

evaluation is made by telephone, a 

physician or LIP must personally sign, 

date, and note the time of the telephone 

order within 24 hours of the time the 

order was issued.’’

Response: Signature and review of 

telephone orders arises for other types 

of orders, not just those involving 

restraint or seclusion. We see no need 

to establish separate requirements for 

how orders for these interventions 

would be documented. 

Comment: One commenter alleged 

that hospitals are dodging the 1-hour 

requirement by releasing the patient 

from restraint or seclusion and starting 

over with a new order before reaching 

the 1-hour point. 

Response: Ending the intervention 

prior to the 1-hour point does not mean 

that the mandated assessment and 

consultation are no longer necessary. 

These steps are still required, even if the 

intervention ends within one hour of 

initiation. 

Comment: Many commenters pointed 

out that this provision was not in the 

proposed revision of the hospital CoPs. 

Response: Several organizations used 

this argument as a basis for bringing suit 

against the Secretary to block 

implementation of this provision, but 

the court upheld the validity of the 

regulation. (See National Association of 

Psychiatric Health Systems v. Shalala, 

120 F. Supp. 2d 33 (D.D.C. 2000).) As 

we stated before the court, we believe 

that this provision is a logical outgrowth 


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of the December 19, 1997 proposed rule. 

The court agreed with our position. 

Comment: One commenter asked 

whether the patient has to be released 

from restraint or seclusion if the 

physician is unable to arrive within 1 

hour. 

Response: Since we have revised 

combined standard (e) to no longer 

require a physician’s onsite visit within 

1 hour, this question is no longer 

pertinent. However, if the face-to-face 

evaluation is not completed by a 

physician, other LIP, or a trainer RN or 

PA, the hospital would be out of 

compliance. 

Comment: Several commenters were 

concerned that the onsite visit would 

not be covered by Medicare, since 

additional visits on the same day cannot 

be billed for as per the Medicare Claims 

Processing Internet Only Manual (IOM) 

pub 100–04, chapter 12, section 30.6.9B. 

Response: While multiple visits in the 

same day by the same practitioner (or 

another practitioner within the same 

practice, with the same specialty) 

cannot be separately billed, 

practitioners should select a code that 

reflects all services provided during the 

date of service (Medicare Claim 

Processing Internet Only Manual (10m) 

Pub. 100–04, Chapter 12, section 

30.6.9B). 

Comment: One commenter asked that 

both children and adults be monitored 

by a physician every 15–30 minutes and 

that documentation be provided. 

Response: We do not believe that this 

high degree of physician involvement is 

necessarily merited, practical, or 

reasonable in every case. Based on the 

patient’s status and type of intervention 

used, more frequent monitoring by a 

physician, LIP or other trained staff may 

be necessary. The condition of the 

patient who is restrained or secluded 

must be monitored by a physician, other 

LIP, or trained staffed at an interval 

determined by hospital policy and 

based on assessed patient needs. 

Comment: Several commenters asked 

whether CMS will accept a telemedicine 

evaluation in lieu of face-to-face 

evaluation. 

Response: Since the requirement for 

face-to-face evaluation has been 

changed to include a trained RN or PA, 

there would not necessarily be any need 

to use telemedicine evaluation unless 

clinically indicated. 

Telemedicine is an important 

developing field. We are looking at the 

role of telemedicine in providing 

healthcare. However, telemedicine is 

not addressed in this rule. Telemedicine 

will be addressed at a future date. 

Comment: One commenter asked 

whether an advanced registered nurse 

practitioner can perform the 1-hour 

assessment. 

Response: In the final rule, combined 

standard (e) permits an advanced 

registered nurse practitioner (if 

recognized by State law and hospital 

policy as having these abilities within 

the scope of the individual’s license and 

consistent with individually granted 

clinical privileges) as being able to order 

the intervention as well as perform the 

1-hour face-to-face evaluation. 

Comment: One commenter noted that 

managed care reimbursement for 

psychiatric inpatient services is 

minimal, and the physician will either 

have to demand that the hospital pay for 

the physician’s time or refuse to extend 

his or her time ‘‘to unnecessarily 

observe a patient who has been safely 

contained by competent mental health 

professionals.’’

Response: This final rule permits the 

attending physician or other attending 

practitioner (as noted in the rule) to 

determine whether and how quickly the 

physician’s presence is merited without 

arbitrarily requiring it. 

16. Limits for Restraint/Seclusion 

Orders (§ 482.13(f)(3)(ii)(D)) 

We stated that each written order for 

a physical restraint or seclusion is 

limited to 4 hours for adults, 2 hours for 

children and adolescents ages 9 to 17; 

or 1-hour for patients under 9. The 

original order may only be renewed in 

accordance with these limits for up to 

a total of 24 hours. After the original 

order expires, a physician or licensed 

independent practitioner (if allowed 

under State law) must see and assess the 

patient before issuing a new order. 

Although a few commenters agreed 

with the timeframes for length of order 

specified in the interim final rule with 

comment period, the majority of 

comments on this requirement were 

from advocacy organizations wanting 

further restriction on the time limits and 

seeking clarity on who can renew the 

order. However, one commenter did 

object to the timeframes for length of 

order, arguing that they were not based 

in research and were arbitrary. 

Recommendations on this provision 

varied and included the following: 

• Limiting the timeframes for length 

of order to no more than one-half hour 

for children, 1-hour for adolescents, and 

2 hours for adults. 

• Making the timeframes for length of 

order different for seclusion and 

restraint use. 

• Not using age as the determining 

criterion since it is an arbitrary factor. 

Patients present with a variety of 

clinically important indicators, such as 

size, weight, gender, history of abuse, 

disability and medical conditions that 

should also be used to determine the 

length of time a patient remains in 

restraint or seclusion. 

Other commenters suggested that each 

renewal of the order should be 

accompanied by another face-to-face 

examination of the patient by the 

physician. A few commenters were 

uncertain of who would perform the 

assessment of the patient prior to 

renewing the order for the intervention. 

These commenters asked whether the 

interim final rule with comment period 

required physician or LIP face-to-face 

re-evaluation of the patient before 

renewal of the order. 

Response: We conclude from the 

nature and number of comments that we 

did not emphasize our intent for this 

standard strongly enough. The 

regulation identifies maximum time 

limits on the length of each order for 

restraint or seclusion used for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. The physician 

or LIP has the discretion to write the 

order for a shorter length of time. The 

length-of-order requirement identifies 

critical points at which there is 

mandatory contact with a physician or 

LIP responsible for the care of the 

patient. In addition, the time limits do 

not dictate how long a patient is in 

restraint or seclusion. Staff should be 

continually assessing and monitoring 

the patient to ensure that the patient is 

released from restraint or seclusion at 

the earliest possible time. Restraint or 

seclusion may only be employed while 

the unsafe situation continues. Once the 

unsafe situation ends, the use of 

restraint or seclusion should be 

discontinued. In the final rule, 

combined standard (e) explicitly states 

that the intervention must be 

discontinued at the earliest possible 

time, regardless of the length of time 

identified in the order. For example, if 

a patient’s behavior responds to the 

intervention in 20 minutes, then the 

restraint or seclusion should be 

discontinued, even if the order was 

given for up to 4 hours. If restraint or 

seclusion is discontinued prior to the 

expiration of the original order, a new 

order must be obtained prior to 

reinitiating the use of restraint or 

seclusion. 

We leave to the physician’s or other 

LIP’s discretion whether an onsite 

assessment prior to renewing the order 

(for up to 4 hours, 2 hours, or 1 hour, 

as permitted by the regulation) is 

necessary. While we agree that prompt 

physician involvement is important, 

requiring face-to-face reassessment by a 


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physician prior to renewal of an order 

as proposed by the commenters would 

be overly burdensome. Once the 

physician or other LIP has assessed the 

patient’s condition, the physician or 

other LIP chooses a course of action to 

be followed and directs staff to 

implement it. We believe that an RN can 

follow the physician’s or other LIP’s 

direction and reassess the patient. 

Without evidence indicating that a 

physician’s own evaluation versus that 

of an RN, nurse practitioner, physician’s 

assistant, etc.) somehow better assures 

patient safety, we cannot accept this 

suggestion. However, after 24 hours, a 

face-to-face assessment by a physician 

or other LIP must occur before a new 

order is written for restraints or 

seclusion for the violent or selfdestructive patient. 

We are unaware of any research or 

data that suggest that limiting orders to 

1 hour is better than limiting them to 4 

hours for adults 18 years of age or older, 

2 hours for children and adolescents 9 

to 17 years of age, or 1 hour for children 

under 9 years of age. We stress that the 

timeframes outlined in the regulation 

are maximums. The ordering 

practitioner has the discretion to 

provide an order for a shorter timeframe 

based on the patient’s condition and 

factors suggested by commenters. 

Comment: Some commenters were 

confused by the term ‘‘renewal’’ of an 

order. We were asked to differentiate 

between the original order, a renewal 

order, etc. One commenter stated that 

under policies in place before the 

publication of the interim final rule 

with comment period, continuation of a 

restraint order beyond the 4-hour time 

limit was a decision that could be 

delegated to an RN. The commenter 

asked whether this rule would require a 

repeat order from the physician, or 

whether a 4-hour continuation could be 

decided upon by other qualified staff, 

such as an RN. Some commenters 

supported orders being renewed in this 

manner for up to 24 hours without a 

new (physician’s) order. One 

commenter argued that not allowing 

nurses to evaluate the need to continue 

the use of restraint or seclusion and, 

thus, the need to renew an order would 

create a burden for hospitals. 

Response: Each order for restraint or 

seclusion for the management of violent 

or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others is limited to the maximum 

timeframes in the regulation before the 

physician or other LIP responsible for 

the care of the patient must be contacted 

again. At the end of the timeframe, if the 

continued use of restraint or seclusion 

is deemed necessary based on a patient 

assessment, another order is needed. 

These limited timeframes apply 

regardless of whether each order is 

considered a separate, distinct, original 

order, or whether an order is considered 

a continuation or renewal of the original 

order. Because the use of restraint or 

seclusion is considered an intervention 

that can only be authorized by the order 

of a physician or other LIP, it is 

consistent to require that the 

determination to continue the 

intervention meet this standard as well. 

We believe that it is reasonable to have 

a trained RN reassess the patient when 

the original order is about to expire, and 

then contact the physician or other LIP 

to obtain direction as to whether the 

intervention is to be continued and 

whether other steps are to be taken. The 

key is the continued medical oversight. 

There is no prohibition of telephone 

renewals. We note, however, that at the 

24-hour point, if the patient is still in 

restraint or seclusion for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others, the patient 

must be seen and assessed by a 

physician or other LIP before a new 

order can be written. In the final rule, 

we have also specified that each order 

for restraint used to ensure the physical 

safety of the non-violent or non-selfdestructive patient may be renewed as 

authorized by hospital policy. 

Comment: One commenter agreed that 

this provision is clinically sound and 

warranted. However, the commenter 

believed that once evaluated, the 

physician should have the right, based 

on years of clinical training and 

supervision and board certification, to 

continue seclusion or restraint with 

periodic nursing evaluation for 24 

hours. 

Response: We believe that the 

timeframes for length of order, as 

established by the regulation, are 

reasonable. We note that the regulatory 

timeframes do not mandate how long 

the intervention continues; they only 

provide check points at which the 

ordering practitioner, and subsequently 

the attending physician, must be 

contacted with updated information 

regarding the patient. 

Comment: One commenter suggested 

that the timeframes for seclusion should 

be consistent with professional 

standards of practice, rather than being 

regulated by this rule. 

Response: We believe the timeframes 

for seclusion are consistent with 

professional standards of practice. 

Seclusion should only be employed 

while the unsafe situation persists. Once 

the unsafe situation ends, the use of 

seclusion should be discontinued. The 

length-of-order requirements identify 

intervals at which the ordering 

practitioner, and subsequently the 

patient’s attending physician, must be 

informed of the patient’s condition so 

that he or she can make a decision as 

to how treatment should proceed. 

Comment: One commenter suggested 

that a physician’s review of the 

documentation of the need for restraint 

[for the management of violent or selfdestructive behavior] should be done 

within 24 hours of the order being 

issued. 

Response: A documentation review 

alone may not adequately protect the 

patient. We expect that a physician or 

other LIP will see the patient if the 

patient is still restrained or secluded at 

the 24-hour point. Twenty-four hours of 

restraint or seclusion for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others is an extreme 

measure which could potentially 

seriously harm the patient. 

Comment: One commenter believed 

that allowing 24 hours to elapse before 

the physician is required to physically 

see and reassess the patient is too long 

an interval. If the patient remains 

extremely agitated after 12 hours in 

restraint or seclusion, it is evident that 

the intervention is not successful, and 

some other intervention is needed. 

Another commenter argued that if the 

patient has been restrained or secluded 

for 4 hours, but preferably 3, a physician 

consultation is necessary. The medical 

director needs to be called in to help 

chart a course of action that will get the 

patient out of restraint or seclusion if it 

is proving ineffective. 

Response: We agree with the 

commenter’s concern that a patient’s 

continued agitation may indicate a need 

to consider another course of treatment. 

However, the reason for the use of 

restraint or seclusion is to protect the 

patient or others from harm. The use of 

these interventions must not end efforts 

to treat the underlying cause of the 

behavior; nor is it expected that 

treatment will come to a complete halt. 

We expect that the use of restraint or 

seclusion will only last while the unsafe 

situation persists. Certainly, trained staff 

should work with the patient toward 

release as quickly as possible and use 

other interventions to de-escalate the 

crisis behavior. 

17. Simultaneous Use of Restraint and 

Seclusion (§ 482.13(f)(4)) 

We stated that restraint and seclusion 

may not be used simultaneously unless 


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the patient is—(1) continually 

monitored face-to-face by an assigned 

staff member; or (2) continually 

monitored by staff using both video and 

audio equipment. This monitoring must 

be in close proximity to the patient. 

Comment: One commenter questioned 

whether our intent is that a patient who 

has been medicated and placed in 

seclusion must be continually 

monitored. 

Response: The regulation only 

requires continual monitoring when 

restraint and seclusion are used 

simultaneously. If the use of a drug 

meets the definition of a restraint, and 

the patient is simultaneously placed in 

seclusion, all the requirements related 

to the simultaneous use of restraint and 

seclusion apply, including the 

requirement for continual monitoring. 

Comment: One commenter asked for 

definition of the word ‘‘staff.’’ Another 

commenter asked for more detail 

regarding the type of monitoring and the 

level of expertise of the monitors. One 

commenter argued that children should 

be monitored by a person who is trained 

to interact and counsel. 

Response: The word ‘‘staff,’’ as used 

in the regulation, has the standard 

definition found in any dictionary and 

includes anyone employed by the 

hospital directly or under a contract. 

Staff who monitor the patient face-toface should be trained not only in 

restraint and seclusion techniques, but 

also in how to monitor physical and 

emotional status (taking vital signs, 

checking physical well-being, working 

with the patient to help the patient 

regain self-control, recognizing when 

the emergency situation has abated and 

the interventions (either one or both) 

can be ended). The components of 

continual monitoring must be 

determined by staff based on hospital 

policy, an individualized patient 

assessment, and the intervention used. 

Standard (f) specifies the criteria CMS 

will apply to staff to ascertain whether 

they have been ‘‘trained’’within the 

meaning of our regulation. 

Comment: Some commenters stated 

that the rule does not explain why 

restraint and seclusion would be used 

simultaneously and argued that restraint 

and seclusion should not be used 

simultaneously. Some commenters 

asked to have simultaneous restraint 

and seclusion banned. These 

commenters voiced their belief that 

there is no clinical justification for 

subjecting a patient to both restraint and 

seclusion at the same time, other than 

for convenience of staff, for discipline, 

coercion, or retaliation. If simultaneous 

use continues to be permitted, these 

commenters suggest that patients should 

be constantly monitored by staff that is 

in the room or right outside the 

seclusion room, but in direct visual 

sight. 

Response: Although simultaneous use 

of restraint and seclusion may be 

inappropriate in many cases, clinical 

situations exist where the simultaneous 

use of restraint and seclusion may 

legitimately be needed to protect the 

patient or others from harm. Staff must 

take extra care to protect the safety of 

the patient when more restrictive 

interventions are used. Restraint limits 

a patient’s ability to move or escape 

from harm. Seclusion of a restrained 

patient may be necessary to protect a 

patient from possible abuse, assault or 

self injury during the intervention. For 

example, a patient is restrained alone in 

a room to maintain the patient’s privacy. 

Shielding the patient from contact with 

others may be more humane and 

supportive of personal dignity than 

permitting everyone on the unit to 

witness what is happening to the 

patient. In this situation, it may be 

necessary to lock the door and seclude 

the patient if a staff member is not 

assigned to sit with the patient one on 

one in order to protect the patient. 

When the simultaneous use of 

restraint and seclusion is employed, we 

would expect to see adequate 

documentation that justifies the 

decision for simultaneous use as well as 

vigilance in continuously monitoring 

the patient so that the patient’s care 

needs are met. We would expect that the 

simultaneous use of restraint or 

seclusion be discontinued at the earliest 

possible time, regardless of the length of 

time identified in the order. 

We do not agree with the commenters’

assertions that these uses necessarily 

constitute patient abuse. However, there 

are risks associated with the 

simultaneous use of restraint and 

seclusion. Therefore in this final rule, 

we clarify that all requirements 

specified under standard (e) apply in 

the simultaneous use of restraint and 

seclusion, which is not permitted unless 

the patient is continually monitored 

face-to-face by an assigned, trained staff 

member, or continually monitored by 

trained staff using both video and audio 

equipment. This monitoring must be in 

close proximity to the patient. The 

hospital is responsible for providing the 

level of monitoring and frequency of 

reassessment that will protect the 

patient’s safety. 

Comment: One commenter questioned 

whether the use of a restraint is 

considered to be seclusion when the 

restraint prevents the patient from 

leaving the room. The commenter 

further queried whether a patient 

restrained in a seclusion room with the 

door open and unlocked would be 

considered to be in seclusion, and 

whether a patient restrained in the 

patient’s room would be ‘‘in seclusion.’’

Response: In a situation where the 

patient is being restrained by a 

technique or device that interferes with 

the patient’s mobility, the fact that the 

patient is confined in a room is a 

secondary effect. This situation is not 

equivalent to the use of seclusion. It is 

important to examine what would 

happen if the restraint were removed—

if the patient would be free to leave the 

room if the restraint were removed, the 

patient is not being secluded. 

Conversely, if the restraint were 

removed and the door is locked or the 

staff otherwise physically prevent the 

patient from leaving the room, then the 

patient is being secluded. 

18. Use of Video and Audio Monitoring 

The use of video and audio 

monitoring met with mixed response. 

However, overall, the commenters 

viewed it negatively. Consumer 

advocates tended to see it as 

inappropriately depriving the patient of 

human contact when such contact 

would be beneficial to help the patient 

regain self-control, and as not assuring 

that the patient’s physical and 

psychiatric status are adequately 

monitored. 

Comment: One commenter stated that 

audio/video monitoring would be 

‘‘particularly odious to an individual 

already trussed up, tied down, and left 

alone.’’ The use of video and audio 

equipment further alienates a patient 

who may be craving attention and 

engaging in the only behavior that will 

bring about human contact. 

Another commenter argued that there 

is no substitute for face-to-face 

monitoring with periodic checks of 

patient’s vital signs. The commenter 

recounted two separate instances where 

patients died while in restraints and 

seclusion. In both instances, the 

paramedics were unable to ventilate the 

patients because they were unable to 

place a tube down the throat of the 

patient. The onset of rigor mortis 

demonstrated that these patients had 

been dead for several hours before 

hospital staff discovered them and 

called the paramedics. The nursing logs 

for both patients indicated that the 

patients had been checked every 15 

minutes. In these instances, ‘‘checked’’

meant looked at through a window into 

the seclusion room. 

Some commenters argued that audio 

and video monitoring is costly and 

would result in financial burden to the 

hospitals. One commenter explained 


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that his hospital does not have the 

financial resources to hire additional 

nurses or nurse aides to perform one-toone monitoring, nor does it have the 

resources to buy video systems for 

monitoring. Another commenter 

characterized electronic monitoring as 

costly and invasive of privacy. 

A commenter argued that face-to-face 

monitoring only increases patient 

agitation and that both face-to-face and 

video/audio monitoring confirm the 

misperceptions of psychotic patients 

who are paranoid or delusional. 

Other commenters did not object to 

alternative methods for monitoring, but 

had suggestions about requiring both. 

One commenter asked that we permit 

audio monitoring, but not require it. 

Another commenter suggested that we 

reconsider the need for audio 

monitoring if video monitoring is in 

place. 

One commenter believed that video 

monitoring and taping was appropriate 

to ensure proper patient monitoring and 

quality control; however, this 

commenter believed that the regulations 

should also require staff to be in the 

patient’s room. One commenter 

recommended ongoing audio/video 

monitoring to protect patient safety. 

Another commenter asked for a more 

prescriptive definition of ‘‘close 

proximity.’’ The commenter understood 

that the intent of requiring staff to be in 

close proximity is to assure that hospital 

staff could quickly reach a patient 

should a safety issue arise. 

Response: We agree that audio and 

video monitoring are not substitutes for 

the therapeutic intervention that should 

be occurring to help the patient regain 

self-control or for the level of 

monitoring necessary to assure that the 

patient is safe and that the patient’s care 

needs are met. The use of video and 

audio monitoring equipment does not 

eliminate the need for other therapeutic 

interventions or frequent assessment of 

the patient’s needs and status. For one 

patient, continual monitoring face-toface by an assigned staff member may be 

appropriate and necessary. For another 

patient, the continual presence of an 

assigned staff member may cause the 

patient to become more agitated. In this 

situation, continual monitoring by 

trained staff using both video and audio 

equipment with periodic in-room 

monitoring may be more appropriate. In 

either situation, vigilant monitoring is 

necessary to protect the patient from 

harm, and ensure that the intervention 

is discontinued at the earliest possible 

time. 

The hospital is responsible for 

providing the level of monitoring and 

frequency of reassessment that will 

protect the patient’s safety. Continual 

monitoring cannot happen solely from 

outside the seclusion room. Staff must 

enter the seclusion room in order to—

(1) monitor a patient’s vital signs, 

circulation, hydration needs, 

elimination needs, level of distress and 

agitation, mental status, cognitive 

functioning, etc., and assess and reevaluate the patient; (2) provide for 

nutritional needs; range of motion, and 

elimination needs; and (3) provide other 

necessary therapeutic interventions and 

patient care. In response to comments, 

we have therefore revised combined 

standard (e) to clarify that all 

requirements specified under standard 

(e) apply in the simultaneous use of 

restraint and seclusion. 

In response to comments that 

requested that we reconsider requiring 

both video and audio monitoring, we 

believe that neither video nor audio 

monitoring alone adequately protect 

patient safety when restraint and 

seclusion are used simultaneously. We 

do not require video and audio 

monitoring; instead, it is one method 

the facility can use to monitor its 

patients. 

In response to the request for a more 

prescriptive definition of ‘‘close 

proximity,’’ the intent is to ensure that 

staff is immediately available to 

intervene and render appropriate 

interventions to meet the patient’s 

needs. However, based on the number of 

possible unit configurations, we believe 

an outcome-oriented requirement is 

more appropriate than a more 

prescriptive one. 

Comment: One commenter suggested 

that the regulations should specify that 

under no circumstances should a 

restrained patient be left unattended, as 

a patient in restraint is vulnerable to 

attack or mistreatment from others. 

Response: Including such a 

requirement would be unnecessarily 

burdensome. As discussed earlier, we 

agree that a patient is more vulnerable 

to possible abuse, assault, or self injury 

during a more restrictive intervention. 

We expect staff to take extra care to 

protect the safety of the patient when 

more restrictive interventions are used. 

Regardless of the intervention used, the 

hospital is responsible for providing the 

level of monitoring and frequency of 

assessment necessary to protect the 

patient’s safety. We believe hospitals 

should have the flexibility to provide 

the level of monitoring and frequency of 

assessment necessary to protect the 

patient’s safety based on hospital policy 

and an individualized patient 

assessment. 

Comment: Due to nationwide staff 

shortages, one commenter stated that his 

facility would be unable to meet the 

requirement. 

Response: As one commenter offered 

earlier, it is the hospital’s responsibility 

to assure that it has adequate staff 

available to meet the patients’ needs. 

Given the acuity of a patient in restraint 

and seclusion simultaneously, we 

believe that heightened monitoring and 

intervention are merited. 

Comment: One commenter stated that 

the requirement for face-to-face 

monitoring places staff at higher risk for 

injury. 

Response: We believe that the 

required training elements within this 

regulation will promote staff awareness 

and expertise in handling potentially 

hazardous situations. 

Comment: One commenter suggested 

that a better approach for increasing 

physician oversight and involvement 

would be to require a log of restraint use 

to be kept by the hospital, along with 

quarterly reports generated for local 

peer review organizations to track 

restraint and seclusion use. Patterns of 

excessive use would emerge more 

readily than they would otherwise 

under the current requirements. 

Several commenters suggested 

requiring a restraint/seclusion log, and 

included elements that should be part of 

this log, such as the time initiated, 

discontinued, time physician was 

contacted, documentation of physical 

exams, etc. Additionally, other 

commenters believed that quality 

improvement efforts could more 

appropriately address the concerns 

regarding patient safety and quality of 

care. 

Response: We agree. Although not 

mandated in this rule, we expect a 

hospital will address, as part of its 

quality assessment and performance 

improvement (QAPI) program, patient 

safety and quality of care issues. We 

also believe that this sort of tracking and 

monitoring may be appropriate as part 

of a hospital’s QAPI program. However, 

including such a requirement would be 

unnecessarily burdensome. Hospitals 

should have the flexibility to identify 

and monitor the quality indicators that 

are most critical to the patient 

population(s) that they serve. 

Comment: One commenter questioned 

how face-to-face monitoring should be 

documented. 

Response: The regulation does not 

specify how face-to-face monitoring will 

be documented. This should be 

addressed by hospital policy. 

19. Reporting of Death(s) Related to 

Restraint/Seclusion (§ 482.13(f)(7)) 

We stated that the hospital must 

report to CMS any death that occurs 


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while a patient is restrained or in 

seclusion, or where it is reasonable to 

assume that a patient’s death is a result 

of restraint or seclusion. 

Comment: Several commenters noted 

that all deaths are routinely reported to 

State authorities. 

Response: As noted earlier in this 

preamble, while there may be local 

mechanisms for reporting deaths, there 

is, at present, no nationwide system for 

reporting these deaths. We have 

estimated that the total number of 

deaths related to the use of restraint and 

seclusion in hospitals will be less than 

10 per year. Therefore, given that the 

average number of reports per hospital 

is one or less, we do not believe that it 

is burdensome to ask that the hospital 

notify the CMS regional office if a 

patient dies while in restraint or 

seclusion, or where it is reasonable to 

assume that restraint or seclusion 

contributed directly or indirectly to the 

patient’s death. 

Comment: One commenter who 

supported the provision as written 

opposed requiring more detailed 

reporting and expressed concern about 

routine reporting to the Protection and 

Advocacy organizations (P&As). 

(Providing the P&As with information 

was mentioned in the preamble of the 

interim final rule with comment 

period.) Some commenters echoed this 

concern, expressing serious reservations 

about CMS’s ability to maintain the 

confidentiality of the sensitive 

information provided in accordance 

with the new rule. These commenters 

did not believe that information 

provided to the P&As would be 

protected from disclosure or legal 

discovery. One commenter asked 

whether CMS would maintain the 

confidentiality of the information, or 

share it with outside entities. 

Those commenters who opposed 

sharing the information with other 

entities argued that forcing hospitals to 

report injuries and the circumstances 

around them would in many cases 

require release of information that 

hospitals gather through their own peer 

review activities. Almost all 50 States 

protect information gathered in peer 

review and other quality internal 

improvement processes from discovery 

by lawyers. One commenter referred to 

Bredice v. Doctor’s Hospital, Inc. (50 

FRD 249 (D.D.C. 1970)), citing it as a 

case in which the court found that it 

was in the overwhelming public interest 

to maintain the confidentiality of the 

minutes and reports of medical staff 

meetings during which doctors critically 

analyze the hospital’s medical care. The 

commenter argued that self-critical 

analysis privilege is now judicially 

recognized as a result of this case. 

In contrast, a core of commenters from 

the public and the patient advocacy 

community supported sharing this 

information with the P&As, stressing the 

importance of partnering between CMS 

and P&As. These commenters 

encouraged a mandatory, detailed 

system of reporting to the P&As to 

ensure comprehensive investigations of 

incidents where patients die or are 

injured during restraint or seclusion 

use. 

Response: Since the publication of the 

interim final rule with comment period, 

we have implemented a process for 

restraint or seclusion death reporting. 

We centrally track reports of death from 

restraints or seclusion occurring in 

hospitals. We use this information to: 

Authorize onsite investigations and 

complaint surveys of these hospitals, in 

accordance with the current complaint 

investigation process; and to inform the 

Federally-mandated P&A entity in the 

respective State or territory. P&A 

programs are congressionally authorized 

(in accordance with 42 U.S.C. 10801 et 

seq.) to access facilities and to 

investigate abuse and neglect 

complaints. 

Comment: One commenter asked 

what information must be provided by 

the hospital and the timeframe within 

which the hospital must report the 

information to CMS. Some commenters 

proposed introducing timeframes for 

reporting, such as contacting the CMS 

regional office within 4 days of a patient 

death and the P&A within an additional 

3 days. The commenters who supported 

such timeframes cited proposed 

national legislation, The Children’s 

Health Act of 2000 (the CHA). The 

commenters who asked for definite 

timeframes stated that delays in 

reporting compromise the ability to 

investigate effectively (staff may leave, 

medical/documentary evidence may be 

lost or concealed, and potentially 

deadly practices continue). Other 

commenters suggested that CMS require 

reporting to the P&A within 24 hours of 

an incident. 

Response: The CHA was signed into 

law on October 17, 2000 (Pub. L. 106–

310). Section 592 of the CHA establishes 

minimum death reporting requirements. 

This final rule conforms to these 

requirements. We have revised our 

requirements to specify that the hospital 

report each death to the CMS regional 

office by telephone no later than the 

close of business the next business day 

following knowledge of the patient’s 

death. This information will be relayed 

to CMS central office and the State 

survey agency, inasmuch as it acts as a 

direct agent of CMS. Our central office 

maintains a database to compile 

information related to deaths associated 

with seclusion or restraint. 

Comment: Some commenters 

suggested that the regulation excuses 

hospitals from revealing many deaths 

precipitated by the misuse of restraint or 

seclusion by allowing the hospital to 

make the determination of whether a 

patient’s death is reasonably assumed to 

have resulted from restraint or 

seclusion. These commenters strongly 

believed that providers tend to dismiss 

restraint-related deaths as ‘‘unfortunate 

isolated incidents,’’ not the 

manifestation of individual abuse or 

systemic failures, and that hospitals can 

rationalize that deaths were due to a 

patient’s underlying condition or 

‘‘natural causes.’’ Several commenters 

cited an example of the death of a young 

man who suffered a severe asthma 

attack soon after fighting with another 

patient and being restrained. According 

to the commenters, the death was ruled 

to be due to natural causes, even though 

the medical examiner found that the 

stress of the fight and restraint triggered 

the attack. Some commenters indicated 

that a complicating issue is that death 

may occur after a patient has been 

restrained or secluded in an originating 

facility, and is then transferred to 

another facility. The receiving facility 

may be unaware of what has transpired 

at the originating facility and may not 

report the death. 

To address this issue, these 

commenters suggested that at a 

minimum, CMS specify that any deaths 

that occur within one week of restraint 

or seclusion use be assumed to be the 

result of restraint or seclusion. 

Optimally, however, these commenters 

argued for reporting all deaths of 

patients with a psychiatric diagnosis or 

mental retardation. The commenters 

stated that in this way, CMS could 

remove the subjectivity currently 

permitted by allowing the hospital to 

make a determination that the death is 

‘‘reasonably assumed’’ to be a result of 

restraint or seclusion use. 

These commenters also stated that a 

requirement for reporting the deaths of 

all patients with a mental retardation or 

psychiatric diagnosis would also permit 

CMS and the P&As to capture deaths 

that occurred post-transfer, as a result of 

restraint and seclusion practices at 

another facility. 

Response: We have revised the 

reporting requirements. The hospital 

must report to CMS each death that 

occurs while a patient is in restraint or 

in seclusion or both at the hospital; and, 

each death known to the hospital that 

occurs within 1 week after restraint 


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(whether physical restraint or drugs 

used as a restraint) or seclusion, in cases 

in which it is reasonable to assume that 

use of restraint or placement in 

seclusion contributed directly or 

indirectly to a patient’s death. We have 

also clarified the meaning of 

‘‘reasonable to assume.’’ As a result, 

‘‘reasonable to assume’’ includes, but is 

not limited to, deaths related to 

restrictions of movement for prolonged 

periods of time, or deaths related to 

chest compression, restriction of 

breathing, or asphyxiation. In addition, 

we have moved the reporting 

requirements from standard (f) and 

created a separate standard (standard 

(g)) that addresses these requirements. 

This was done to clarify that all deaths 

associated with the use of seclusion or 

restraint or both must be reported. The 

reporting requirements in standard (g) 

are applicable to restraint and seclusion 

use. 

We are not adopting the commenter’s 

suggestion that all deaths of patients 

with a psychiatric or mental retardation 

diagnosis be reported to CMS; nor will 

we assume that all deaths that occur 

within 1 week of the use of restraint or 

seclusion are the result of restraint or 

seclusion. 

Comment: A commenter stated that 

the reporting process is severely 

deficient because inadequate 

information would be provided to CMS 

and the P&As. The commenter 

suggested specific elements that should 

be reported, including—

• Identity of deceased/injured 

patient; 

• Patient’s age; 

• Identity of patient’s guardian, if 

applicable; 

• Identification of next of kin, in 

cases involving patient death; 

• Date of death/injury; 

• Patient’s home address; 

• Medications patient was taking/ 

other medical services provided; 

• Cause and circumstances of death/ 

injury; 

• Whether/by whom death/injury is 

being investigated; and 

• Identity of person making report. 

Some commenters believed that the 

report submitted to CMS should be 

standardized and in writing. 

Response: We agree that the suggested 

elements should be reported. However, 

to allow some flexibility for hospitals, 

we are not specifying these elements in 

the regulation text. In the final rule, 

standard (g), we have specified that each 

death referenced in this section must be 

reported to CMS by telephone no later 

than the close of business the next 

business day following knowledge of 

the patient’s death. In addition, we have 

added a requirement that staff must 

document in the patient’s medical 

record the date and time the death was 

reported to CMS. 

Comment: One commenter suggested 

replacing the word ‘‘assume’’ with 

‘‘suspicion or belief.’’

Response: We have retained use of the 

word ‘‘assume’’ and added language to 

clarify the meaning of ‘‘reasonable to 

assume.’’

Comment: One commenter indicated 

that the accrediting organization should 

also receive this information as deaths 

would be ‘‘sentinel events’’ under 

JCAHO policy. 

Response: We currently inform the 

hospital’s accrediting organization when 

we receive a death report from a 

hospital. In addition, hospitals should 

report deaths to their accrediting 

organization in accordance with their 

accreditation standards. JCAHO 

instituted a sentinel events reporting 

policy (effective October 31, 1998) that 

encourages hospitals to voluntarily 

report such occurrences within 7 days 

of the incident. 

Comment: One commenter opposed 

the reporting requirement, stating that 

there is no need to increase the number 

of people involved with the monitoring 

and/or investigating patient deaths. 

Another commenter echoed this 

sentiment, noting that this requirement 

is duplicative of JCAHO’s sentinel event 

reporting requirement, and that we 

should simply share data with the 

JCAHO instead. 

In contrast, a private psychiatric 

health system agreed with this 

provision, saying it makes good sense. 

Many commenters supported this 

provision, although they suggested 

measures that they believed would 

strengthen it, such as requiring that 

serious injuries be reported and 

specifying lists of elements to be 

provided to CMS. 

Response: Section 592 of the CHA 

mandates death reporting and this final 

rule incorporates/addresses these 

requirements. These requirements 

address gaps in existing reporting 

systems that inhibit the ability to 

conduct meaningful analysis of trends 

and target problems. JCAHO’s system is 

voluntary, not mandatory, and 20 

percent of the hospitals that participate 

in Medicare and Medicaid are not 

JCAHO accredited. To adequately track 

deaths, mandatory reporting is needed 

by all hospitals. 

We believe that injury reporting is 

beyond the scope of the CHA; and 

therefore, we are not incorporating 

injury reporting provisions in this final 

rule. However, we would expect that 

serious injuries related to the use of 

restraint or seclusion would be 

monitored through the hospital’s QAPI 

program. 

Comment: Several commenters 

suggested that reporting should include 

not only deaths of patients, but injuries 

to staff during the restraint or seclusion 

procedure. 

Response: We do not require reporting 

of staff injuries associated with the use 

of seclusion or restraint. However, 

hospitals may establish their own 

systems for tracking such information. 

Comment: One commenter suggested 

requiring hospitals to report the number 

of seclusion or restraint occurrences; the 

total number of patients secluded or 

restrained; the average number of hours 

per occurrence; and, the average number 

of hours in seclusion or restraint per 

patient. The commenter also 

recommended that we protect patient 

privacy by withholding of identifying 

information but otherwise reporting 

demographic data. 

Response: We believe that the burden 

of such an approach would have the 

opposite effect; that is, it would most 

likely result in hospital under-reporting 

of patients in restraint or seclusion. 

However, although not mandated in this 

rule, we expect that a hospital will 

address utilization of restraint and 

seclusion as part of their QAPI program. 

Regarding the recommendation to this 

information is withheld identifying 

information, required to investigate or 

otherwise follow-up on a reported 

death, if necessary. 

Comment: Some commenters believed 

that serious injuries, both physical and 

psychological, must be reported to be 

proactive and to prevent deaths. These 

commenters realized that there may be 

some additional burden on hospitals, 

but believed that burden could be 

minimized by limiting reports to more 

severe types of injuries. One commenter 

asked that if we do add injury reporting, 

that it be limited to injuries that require 

medical attention. 

Some commenters offered a general 

argument that the P&As would be a 

better entity than CMS to receive the 

information and investigate the 

incidents. For example, commenters 

stated that the P&As have trained 

investigators who are already a part of 

the Department of Health and Human 

Services. Commenters also stated that 

the P&As need to be involved to 

adequately perform the necessary 

investigations. 

In contrast, several commenters 

questioned why the P&As should be 

provided this information, since they 

have no authority to sanction a hospital 

and are not able to act as CMS’s agent. 

The commenters stated that this 


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provision would expose the provider to 

two possible investigations without any 

clear and convincing rationale. 

Response: We are not adding any 

injury reporting requirement in this 

rule. Aside from the issue of hospital 

burden and potential disagreement on 

what constitutes a reportable event, a 

fundamental problem in requiring 

injury reporting for this setting is the 

administrative burden on the program 

itself. Many commenters seemed to 

acknowledge this limitation, in that they 

used it as an argument for the need for 

increased P&A involvement. So, these 

commenters may argue, even if CMS 

cannot administratively handle injury 

reporting, this information could be 

routed to the P&As for investigation or 

made available to the public. 

We believe that this points to a 

misperception of the roles of the various 

agencies. A P&A cannot act as our agent. 

There is no statutory connection 

between CMS and the P&As, as there is 

between CMS and the State survey 

agencies. The P&A cannot take an 

enforcement action on our behalf. While 

we support the role of the P&As, and we 

believe that a coordinated effort 

between agencies is appropriate, we also 

believe that the roles should not blur 

into each other. We have a distinct 

interest in the health and safety of 

patients, which is shared by the P&As. 

However, we also have a statutorilygoverned relationship with the 

providers of services. That relationship 

is built on the expectation of 

confidentiality. We need information 

from the hospitals inasmuch as we 

evaluate whether they are meeting the 

standards for care we have set. 

Comment: Mental health advocacy 

groups and P&A organizations requested 

that the name, address, phone number, 

and brief description of services 

provided by the P&A be required to be 

posted in each hospital. 

Response: We believe requiring that 

this information be posted would be 

unnecessarily burdensome. Hospitals 

are already required to provide patients 

with contact information if the patient 

wishes to file a grievance. 

Comment: One commenter stated that 

if serious injury or death occurs, that 

event needs to be recorded and an 

independent auditor needs to 

investigate the incident. The auditor 

should be clinically oriented, not of an 

administrative background. 

Response: We only require that deaths 

be reported. Upon receipt of the 

information, we can initiate an 

independent investigation of the death. 

We are not requiring that hospitals 

report serious injuries, but this type of 

information could be reviewed while 

surveyors are onsite. In addition, we 

will not require that the hospital hire an 

independent auditor to investigate 

deaths and serious injuries. 

Comment: One commenter charged 

that the reporting requirement is not 

consistent with initiatives to create a 

government that works better and costs 

less. 

Response: We disagree. We do not 

believe that the revised reporting 

requirements are overly burdensome. 

Furthermore, the reporting system 

serves as an outcome indicator that can 

be used to target our investigational 

efforts. 

Comment: One P&A supported the 

reporting of serious injuries, but argued 

for added resources for P&As so that 

meaningful and prompt investigations 

can occur. 

Response: We agree with the 

importance of P&A investigations. 

However, we do not allocate funding for 

the P&A programs. 

Comment: One commenter indicated 

that it is burdensome for a hospital to 

have to review charts on all patient 

deaths to determine if restraints or 

seclusion were used with the patient. 

The commenter questioned whether 

only Medicare and Medicaid beneficiary 

deaths need to be reported, or if all 

patient deaths related to restraint or 

seclusion must be reported. 

Response: The CoPs apply to all 

patients in a Medicare- and Medicaidparticipating hospital, not just 

Medicare/Medicaid beneficiaries. 

Therefore, all patient deaths associated 

with the use of restraint or seclusion or 

both must be reported. We do not view 

this as particularly burdensome since 

these deaths should be infrequent. 

Comment: A commenter stated that 

the regulation does not discuss a 

penalty for failure to report. 

Response: Noncompliance with this 

requirement, as with any of the others 

in these standards, constitutes a 

violation of the CoPs that would 

potentially be subject to termination of 

the hospital provider agreement as 

described at 42 CFR 489.53. 

IV. Provisions of the Final Rule 

For reasons specified in section III of 

the preamble to this final rule, we are 

codifying the Patients’ Rights CoP 

within the current hospital CoPs under 

Subpart B—Administration at § 482.13. 

The eight standards specified in this 

final rule establish minimum 

protections and rights for patients. Any 

changes that have been made to clarify 

or strengthen the provisions that 

appeared in the interim final rule with 

comment period are noted in the 

following description of the provisions. 

The first standard, ‘‘Notice of Rights,’’

requires the patient or the patient’s 

representative, as permitted by State 

law, to be informed of the patient’s 

rights prior to furnishing or 

discontinuing care whenever possible. 

The standard also requires that the 

hospital have a grievance process, that 

the patient be informed of whom to 

contact to file a grievance, and that the 

process include specific elements. This 

standard has not been revised; and 

therefore, is being finalized without 

change. 

The second standard, ‘‘Exercise of 

Rights,’’ provides the patient the right to 

participate in the development and 

implementation of his or her plan of 

care, and to request or refuse treatment. 

This standard supports the patient’s 

right to make decisions regarding his or 

her care and to formulate advance 

directives and have hospital staff and 

practitioners who provide care in the 

hospital comply with these directives, 

in accordance with § 489.102 

(Requirements for providers). This 

standard also supports the patient’s 

right to have a family member or 

representative of his or her choice and 

his or her physician notified promptly 

of the patient’s admission to the 

hospital. This standard has not been 

revised; and therefore is being finalized 

without change. 

The third standard, ‘‘Privacy and 

Safety,’’ which includes the right to 

personal privacy, to receive care in a 

safe setting, and to be free from all forms 

of abuse or harassment. This standard 

has not been revised; and therefore is 

being finalized without change. 

The fourth standard, ‘‘Confidentiality 

of Patient Records,’’ provides the 

patient’s right to the confidentiality of 

his or her records, and to access those 

records. This standard has not been 

revised; and therefore is being finalized 

without change. 

The fifth standard, ‘‘Restraint or 

seclusion,’’ differs both in content and 

in application from the standard 

presented in the interim final rule with 

comment period. We have revised and 

combined the requirements contained in 

standards (e) and (f) in the interim final 

rule into a single, combined standard in 

the final rule. The final, combined 

standard (e) applies to the use of 

restraint, the use of seclusion, as well as 

the simultaneous use of restraint and 

seclusion regardless of patient location. 

The revised, combined standard (e) 

states that all patients have the right to 

be free from physical or mental abuse, 

and corporal punishment. It retains the 

patient’s right to be free from restraint 

or seclusion, of any form, imposed by 

staff as a means of coercion, discipline, 


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convenience, or retaliation. It also states 

that restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, staff or 

others and must be discontinued at the 

earliest possible time. 

A significant change from the interim 

final rule with comment period to this 

final rule is that standard (e) provides a 

revised definition of ‘‘restraint.’’ In the 

final rule, we adopted the restraint 

definition contained in the CHA. A 

restraint is any manual method, 

physical or mechanical device, material, 

or equipment that immobilizes or 

reduces the ability of a patient to move 

his or her arms, legs, body, or head 

freely; or a drug or medication when it 

is used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. The final rule 

also clarifies that a restraint does not 

include devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). The seclusion definition 

contained in the interim final rule with 

comment period has been retained with 

minor content revisions. Seclusion is 

the involuntary confinement of a patient 

alone in a room or area from which the 

patient is physically prevented from 

leaving. Standard (e) also clarifies that 

seclusion may only be used for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others. 

All of the requirements contained in 

the current standard (e) ‘‘Restraint for 

acute medical and surgical care’’ are 

also contained in the current standard 

(f) ‘‘Seclusion and restraint for behavior 

management.’’ These requirements have 

been moved to the combined standard 

(e) in the final rule. The more stringent 

requirements contained in the current 

standard (f), but not in the current 

standard (e) have also been moved to 

the combined standard (e) in the final 

rule. These more stringent requirements 

are: Time limits on the length of each 

order, and the 1-hour face-to-face 

evaluation. The final rule clarifies that 

these two requirements only apply 

when restraint or seclusion are used to 

manage violent or self-destructive 

behavior that jeopardizes the immediate 

physical safety of the patient, a staff 

member, or others. Requirements for the 

simultaneous use of restraint and 

seclusion have also been retained in the 

final rule. 

Standard (e) retains the following 

requirements: Restraint or seclusion 

may only be used when less restrictive 

interventions have been determined to 

be ineffective to protect the patient or 

others from harm; the type or technique 

of restraint or seclusion used must be 

the least restrictive intervention that 

will be effective to protect the patient or 

others from harm; and, the use of 

restraint or seclusion must be in 

accordance with a written modification 

to the patient’s plan of care, and 

implemented in accordance with safe 

and appropriate restraint and seclusion 

techniques as determined by hospital 

policy in accordance with State law. 

Standard (e) retains and clarifies the 

requirement that use of a restraint or 

seclusion must be in accordance with 

the order of a physician or other LIP 

who is responsible for the care of the 

patient as specified under § 482.12(c) 

and is authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law. The standard 

also requires that the restraint or 

seclusion order never be written as a 

standing order or on an as needed basis 

(PRN), and that the attending physician 

must be consulted as soon as possible if 

restraint or seclusion is not ordered by 

the patient’s attending physician. 

Standard (e) also sets limits on the 

length of each order for restraint or 

seclusion used to manage violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others based on the 

age of the patient, and states that the 

order may only be renewed in 

accordance with these limits for up to 

a total of 24 hours unless superseded by 

State law that is more restrictive. After 

24 hours, before writing a new order for 

the use of restraint or seclusion for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others, a physician or 

other LIP (if allowed by State law) must 

see and assess the patient. Each order 

for restraint used to ensure the physical 

safety of the non-violent or non-selfdestructive patient may be renewed as 

authorized by hospital policy. Restraint 

or seclusion must be discontinued at the 

earliest possible time, regardless of the 

length of time identified in the order. 

Further, standard (e) specifies that the 

condition of the patient who is 

restrained or secluded must be 

monitored by a physician, other LIP or 

by trained staff at an interval 

determined by hospital policy. The 

criteria for staff to be considered 

‘‘trained’’ are specified under 

§ 482.13(f). In addition, physician and 

other LIP training requirements must be 

specified in hospital policy. At a 

minimum, physicians and other LIPs 

authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law must have a 

working knowledge of hospital policy 

regarding the use of restraint or 

seclusion. 

A significant change from the interim 

final rule with comment period to this 

final rule is that standard (e) has been 

revised to expand the type of 

practitioners permitted to conduct the 1- 

hour face-to-face evaluation. When 

restraint or seclusion is used for the 

management of violent or selfdestructive behavior that jeopardizes the 

immediate physical safety of the patient, 

a staff member, or others, a physician or 

other LIP, or a RN or PA trained in 

accordance with the requirements 

specified under § 482.13(f), must see the 

patient face-to-face within 1-hour after 

the initiation of the intervention. This 

practitioner must evaluate the patient’s 

immediate situation, the patient’s 

reaction to the intervention, the 

patient’s medical and behavioral 

condition, and the need to continue or 

terminate the restraint or seclusion. As 

specified at § 482.13(e)(13), State law 

(by statute or regulation) regarding the 

1-hour face-to-face evaluation may be 

more restrictive than these 

requirements. If the 1-hour face-to-face 

evaluation is conducted by a trained RN 

or PA, the attending physician or other 

LIP who is responsible for the care of 

the patient as specified under 

§ 482.12(c) must be consulted as soon as 

possible after completion of the 

evaluation. 

Standard (e) clarifies requirements 

related to the simultaneous use of 

restraint and seclusion. All 

requirements specified under standard 

(e) apply in the simultaneous use of 

restraint and seclusion, which is not 

permitted unless the patient is 

continually monitored face-to-face by an 

assigned, trained staff member, or 

continually monitored by trained staff 

using both video and audio equipment. 

This monitoring must be in close 

proximity to the patient. 

Finally, standard (e) has been 

amended to specify elements of 

documentation. When restraint or 

seclusion is used, there must be 

documentation in the patient’s medical 

record of the following: The 1-hour faceto-face medical and behavioral 

evaluation if restraint or seclusion is 

used to manage violent or selfdestructive behavior that jeopardizes the 


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immediate physical safety of the patient, 

a staff member, or others; alternatives or 

other less restrictive interventions 

attempted (as applicable); the patient’s 

condition or symptom(s) that warranted 

the use of the restraint or seclusion; and, 

the patient’s response to the 

intervention(s) used, including the 

rationale for continued use of the 

intervention. When restraint or 

seclusion is used for violent or selfdestructive behavior, documentation 

must also include findings from the 1- 

hour face-to-face assessment. 

Standard (f) is a new standard that 

addresses staff training requirements. A 

patient has a right to the safe 

implementation of restraint or seclusion 

by trained staff. Staff must be trained 

and able to demonstrate competency in 

the application of restraints, 

implementation of seclusion, 

monitoring, assessment, and providing 

care for a patient in restraint or 

seclusion before performing any of these 

actions, as part of orientation, and 

subsequently on a periodic basis 

consistent with hospital policy. 

In addition, standard (f) states that the 

hospital must require appropriate staff 

to have education, training, and 

demonstrated knowledge based on the 

specific needs of the patient population 

in at least the following: 

• Techniques to identify staff and 

patient behaviors, events, and 

environmental factors that may trigger 

circumstances that require restraint or 

seclusion; 

• The use of non-physical 

intervention skills; 

• Choosing the least restrictive 

intervention based on an individualized 

assessment of the patient’s medical, or 

behavioral status or condition; 

• The safe application and use of all 

types of restraint or seclusion used in 

the hospital, including training in how 

to recognize and respond to signs of 

physical and psychological distress (for 

example, positional asphyxia); 

• Clinical identification of specific 

behavioral changes that indicate that 

restraint or seclusion is no longer 

necessary; 

• Monitoring the physical and 

psychological well-being of the patient 

who is restrained or secluded, including 

but not limited to, respiratory and 

circulatory status, skin integrity, vital 

signs, and any special requirements 

specified by hospital policy associated 

with the 1-hour face-to-face evaluation; 

and, 

• The use of first aid techniques and 

certification in the use of 

cardiopulmonary resuscitation, 

including required periodic 

recertification. 

Individuals providing staff training 

must be qualified as evidenced by 

education, training, and experience in 

techniques used to address patients’

behaviors. The hospital must document 

in the staff personnel records that the 

training and demonstration of 

competency were successfully 

completed. 

Standard (g) is a new standard that 

addresses reporting requirements for 

deaths associated with the use of 

restraint or seclusion. The hospital must 

report to CMS each death that: occurs 

while a patient is in restraint or in 

seclusion at the hospital; occurs within 

24 hours after the patient has been 

removed from restraint or seclusion; 

and, each death known to the hospital 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death. For the purposes of this 

regulation, ‘‘reasonable to assume’’

includes, but is not limited to deaths 

related to restrictions of movement for 

prolonged periods of time, or death 

related to chest compression, restriction 

of breathing or asphyxiation. Each death 

referenced in this section must be 

reported to CMS by telephone no later 

than the close of business the next 

business day following knowledge of 

the patient’s death. Staff must document 

in the patient’s medical record the date 

and time the death was reported to 

CMS. Although we have modified some 

of the provisions to address public 

comments, these modifications do not 

lessen protections afforded patients who 

are restrained or secluded. 

V. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 30- 

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 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. 

Section 482.13 of this document 

contains information collection 

requirements; however, these 

information collection requirements are 

currently approved under OMB control 

number 0938–0328, ‘‘Hospital 

Conditions of Participation’’ with a 

current expiration date of January 31, 

2008. 

This document makes changes to the 

requirements in the following 

paragraphs within § 482.13 that contain 

information collection requirements. In 

this final rule, we have combined the 

requirements that were set forth in the 

interim final rule under standard 

§ 482.13(e) Standard: Restraint or 

Seclusion used in the provision of acute 

medical, pre and post surgical care and 

§ 482.13(f) Standard: Seclusion and 

restraint for management of violent, self 

destructive or aggressive behavior into a 

single standard, § 482.13(e) Standard: 

Restraint and seclusion. This change is 

designed to address restraint and 

seclusion use regardless of the treatment 

setting in which it occurs. 

Section 482.13(e) Standard: Restraint or 

Seclusion 

Although we believe many hospitals 

are already complying with the 

requirements in this standard through 

usual and customary practices, the 

revisions, reformatting, and additions to 

the existing regulatory text may result in 

increased burden. However, we believe 

this increased burden should be offset 

by reduced burden upon the physicians 

and LIPs since the need to assess the 

patient within 1-hour of the initiation of 

restraint or seclusion can be performed 

by other qualified LIPS as well. 

Section 482.13(f) Standard: Restraint or 

Seclusion: Staff Training Requirements 

As we have discussed in greater detail 

in sections III. and IV. of the preamble 

to this final rule, revisions have been 

made to the proposed § 482.13(e). 

Paragraph (e)(15) has been added to 

address the documentation 

requirements when restraint and 

seclusion are used simultaneously. We 

believe the majority of hospitals already 

maintain such documentation. 

Therefore, the burden associated with 

this requirement will not impose undue 

hardship on most hospitals. We believe 

that compliance with these standards 

constitutes a usual and customary 

business practice and the burden 

associated with the requirements is 

exempt from the PRA as stipulated 

under 5 CFR 1320.3(b)(2). 


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Section 482.13(g) Standard: Death 

Reporting Requirements 

The requirements contained in this 

section were previously contained in 

paragraph (f)(7) of this section and are 

currently approved under OMB control 

number 0938–0328. See section VI. of 

the preamble to this final rule for a 

summary of the estimated burden hours 

associated with this section. 

If you comment on these information 

collection and recordkeeping 

requirements, please mail copies 

directly to the following: Centers for 

Medicare and Medicaid Services, Office 

of Strategic Operations and Regulatory 

Affairs, Regulations Development 

Group, Room C4–26–05, 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: Carolyn 

Lovett, CMS Desk Officer. Fax (202) 

395–6974. 

VI. Regulatory Impact Analysis 

A. Overall Impact 

We have examined the impact of this 

rule as required by Executive Order 

12866 (September 1993, Regulatory 

Planning and Review), the Regulatory 

Flexibility Act (RFA) (September 19, 

1980, Pub. L. 96–354), section 1102(b) of 

the Social Security Act (the Act), the 

Unfunded Mandates Reform Act of 1995 

(Pub. L. 104–4), and Executive Order 

13132. 

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). This final rule revises the 

restraints and seclusion provisions of 

the Patients’ Rights CoP that were 

published in the July 2, 1999 interim 

final rule with comment period. The 

CoPs are the basic health and safety 

requirements that a hospital must meet 

in order to participate in the Medicare 

program. This rule will implement 

regulations that are intended to reduce 

the use of restraint and seclusion, 

eliminate the potential for adverse 

outcomes when restraint, seclusion or 

both are implemented, and minimize 

the burden associated with compliance 

with the rule. While it is not possible at 

this point to determine definitively the 

additional costs to the Medicare 

program resulting from this rule, we 

estimate that the impact will be below 

$100 million; and therefore, we have 

determined that this final rule is not a 

major rule. 

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 

jurisdictions. Individuals and States are 

not included in the definition of small 

entity. We are not preparing analyses for 

either the RFA or section 1102(b) of the 

Act because we have determined, and 

we certify, that this rule will not have 

a significant economic impact on a 

substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

facilities. In addition, 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 since superseded by 

‘‘core based statistical areas’’ and has 

fewer than 100 beds. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule that may result in expenditures in 

any one year by State, local, or tribal 

governments, in the aggregate, or by the 

private sector, of $120 million. This rule 

has no impact on the expenditures of 

State, local, or tribal governments, and 

the impact on the private sector is 

estimated to be less than $120 million. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

Thus rule will not have any effect on 

State and local governments. 

In the December 19, 1997 Federal 

Register, we issued a proposed rule that 

detailed our plans to revise all of the 

hospital CoPs which emphasized 

lessening Federal regulation to 

eliminate unnecessary structural and 

process requirements, focus on 

outcomes of care, allow greater 

flexibility to hospitals and practitioners 

to meet quality standards, and place a 

stronger emphasis on quality assessment 

and performance improvement. The 

proposed rule indicated our intent to 

include a new Patients’ Rights CoP for 

hospitals that contained rights not 

addressed in the then current CoPs. We 

solicited comments on the Patients’

Rights CoP and received strong support 

for its establishment from the public, 

mental health advocacy groups, media, 

and the Congress. These groups and 

individuals expressed serious concern 

about improper care of patients in the 

hospital setting, particularly with regard 

to the use of seclusion and restraint. 

On July 2, 1999, we issued an interim 

final rule with comment period that set 

forth requirements supporting and 

protecting patients’ rights in the 

hospital setting. It included four 

standards that were finalized to ensure 

minimum protections of each patient’s 

physical and emotional health and 

safety. These standards address each 

patient’s right to: Notification of his or 

her rights; the exercise of his or her 

rights in regard to his or her care; 

privacy and safety; and confidentiality 

of patient’s records. 

Additionally, this interim final rule 

specifically addressed the right to be 

free from the use of seclusion and 

restraint and included various 

requirements to protect the patient 

when use of these interventions is 

necessary. 

B. Anticipated Effects 

1. Effects on Providers 

We anticipate the impact of these 

finalized standards will vary widely 

among hospitals. However, we do not 

have the benefit of several key pieces of 

information. For example, we do not 

have reliable data on the prevalence of 

restraint and seclusion use, data on the 

volume of staff in hospitals, or data on 

the varying levels and qualifications of 

hospital staff who may be involved in 

restraint and seclusion use. Given these 

and a variety of other factors, it would 

be unfair to calculate an estimate based 

on the average of the limited available 

data. In another example, with respect 

to training, this rule will have 

significantly less impact on a hospital 

that already has a proactive training 

program in place and has significantly 

reduced its restraint and seclusion use 

than it will in a hospital that has not 

independently taken such an approach. 

Factors such as size, services 

rendered, staffing, and patient 

populations vary as well. An additional 

consideration was noted when one 

caller who telephoned for clarification 

on the provisions of the interim final 

rule with comment period complained 

that some hospitals specifically screen 

out patients with potentially violent, 


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self-destructive behavior, so that this 

population is diverted to State systems, 

in turn, resulting in these State systems 

potentially bearing the brunt of this 

burden. We are hesitant to make impact 

estimates in this final rule that may not 

account for these and other unforeseen 

variations. Thus, we reserve the right to 

provide estimates when feasible. Below 

we discuss the anticipated effects on 

providers of the standards related to 

restraints and seclusion. 

a. Section 482.13(e) Standard: Restraint 

or Seclusion 

Standard 482.13(e), previously 

entitled ‘‘Restraint for acute medical 

and surgical care’’ in the interim final 

rule with comment period, is now 

entitled ‘‘Restraint or seclusion’’ in this 

final rule. The existing regulation sets 

out the patient’s rights in the event he 

or she is restrained or secluded, and 

limits when and by whom restraint or 

seclusion can be implemented. We have 

combined the existing standards 

482.13(e) and 482.13(f) for clarity since 

it is our goal to have the use of restraint 

or seclusion reduced in all settings of 

the hospital. The revisions, 

reformatting, and additions to the 

existing regulatory language will not 

result in additional impact upon 

hospitals associated with their efforts to 

comply with this regulation. Instead, 

since we have provided more clarity in 

the definition of a restraint with respect 

to medical and surgical services, 

burdens on hospitals should decrease. 

In previous § 482.13(e)(3)(B), we 

stated the patient’s ‘‘treating’’ physician 

be consulted in the event of restraint or 

seclusion. However, based on comments 

we have revised the requirement at 

§ 482.13(e)(7) to reflect the need to 

consult the ‘‘attending’’ physician 

instead of the ‘‘treating’’ physician as 

soon as possible if the attending 

physician did not order the restraint or 

seclusion. 

We have revised and expanded 

§ 482.13(e)(4) to specify, at 

§ 482.13(e)(10), that a physician, other 

licensed independent practitioner or 

trained staff meet the training criteria 

specified in paragraph (f) of this section 

at an interval determined by hospital 

policy. We also recognize there will be 

some impact associated with performing 

patient assessment and monitoring. 

However, we view patient assessment 

and monitoring as a standard 

component of patient care. 

Section 482.13(f)(3)(ii)(c), now 

§ 482.13(e)(7), clarifies that the 

‘‘attending’’ physician must be 

consulted as soon as possible if the 

attending physician did not order the 

restraint or seclusion. Although this 

may minimally increase burden to 

hospitals, we believe it is a best practice 

for patient safety. 

We have added elements at 

§ 482.13(e)(15) that monitoring must 

occur face-to-face by trained staff or by 

using both video and audio equipment, 

when there is simultaneous use of 

restraint and seclusion. We have added 

elements at § 482.13(e)(16) regarding the 

documentation that must be included in 

the patient’s medical record when the 

patient is restrained or secluded, 

including the 1-hour face-to-face 

medical and behavioral evaluation if 

restraint or seclusion is used to manage 

violent or self-destructive behavior, the 

patient’s behavior and intervention 

used, alternatives or other less 

restrictive interventions attempted (as 

applicable), the patient’s condition or 

symptom(s) that warranted restraint or 

seclusion use, and the patient’s 

response to the use of the restraint or 

seclusion intervention, including the 

need for continued use of restraint or 

seclusion. We do not believe additional 

burdens are imposed by this 

requirement since it is a routine and 

customary practice to document the 

circumstances surrounding such an 

event for comprehensiveness of patient 

care. 

In the interim final rule with 

comment period at § 482.13(f)(3)(ii)(c), 

we required that the physician or other 

LIP must see and evaluate the patient’s 

need for restraint or seclusion within 1- 

hour after the initiation of restraint or 

seclusion. This 1-hour on-site physician 

or LIP evaluation was the most 

controversial provision of the interim 

final rule with comment period. 

Limited data has been gathered in the 

industry to date regarding the 

prevalence of restraint and seclusion 

use. However, among the limited data 

that is available, it reflects the use of 

restraint or seclusion for behavior 

management only per the current 

requirement at 482.13(f). 

For example, based on information 

provided to us by the National 

Association of Psychiatric Health 

Systems (NAPHS), fifty NAPHS 

members supplied data for the cost of 

complying with the CMS requirements 

that a physician or LIP evaluate a 

patient face-to-face within 1 hour of the 

initiation of restraint or seclusion. The 

data that was supplied combined: (1) 

The cost of maintaining a physician or 

LIP on call to be available in case there 

is an event of a restraint or seclusion 

and (2) the cost of having a physician or 

LIP come to the facility to evaluate a 

patient within 1 hour when a restraint 

or seclusion episode occurs. The 

average cost was $80,789 per facility per 

year. 

The NAPHS further discussed that 

there are approximately 250 

freestanding specialty hospitals in the 

United States. This number does not 

include the approximately 1,400 

behavioral health units of general 

hospitals or government (state and 

county) psychiatric specialty hospitals. 

The 1 hour rule applies to all these 

facilities. 

An average NAPHS member hospital 

is a 60–80 bed community-based 

specialty hospital. The NAPHS stated 

the average total budget of such 

facilities is approximately $10-$15 

million hence the NAPHS views this 

$80,000 to be a very significant portion 

of its operating budget. 

We heard from many hospitals that 

this requirement was impossible to 

fulfill because of the lack of available 

personnel, geographic challenges, and 

the high costs associated with 

maintaining this degree of coverage. 

This was particularly noted among rural 

hospitals. Furthermore, these 

commenters stated that a required onsite 

visit is costly with no demonstrable 

benefit in many cases. 

We determined that the heightened 

degree of intervention and restriction of 

who can perform this assessment was 

excessive and would not be feasible in 

many rural or remote areas. In response 

to industry concerns, we have expanded 

who may perform the 1-hour face-toface evaluation. Conversely, some 

commenters requested on-site 

mandatory physician presence within 

half an hour of initiation of restraint or 

seclusion. Again, we believe this would 

be too burdensome for hospitals in rural 

or remote areas to comply. 

Thus, we anticipate the expansion of 

who may perform the 1-hour face-toface evaluation will be less burdensome 

to hospitals. We believe the training 

required by this rule will equip staff 

with appropriate skills for handling 

escalating or aggressive patient behavior 

and should reduce overall use of 

restraints. However, we are aware that 

the facility’s size, progress in reducing 

the use of restraint or seclusion, and 

other characteristics will have a varying 

impact upon each facility’s performance 

of this requirement. 

Again, the NAPHS stated their 

respondents reported it took an 

estimated 30 minutes to 1 hour to 

document all the specific elements 

required by CMS after a restraint or 

seclusion episode. This included several 

elements unique to the rule such as 

notifying the attending physician if the 

restraint was ordered by someone other 

than the patient’s attending physician. 


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Thus, our burden estimate is based on 

a median timeframe (that is, 45 minutes) 

that we believe it takes to complete the 

required documentation in the patient’s 

medical record. However, since we are 

unable to estimate the prevalence of 

restraint and seclusion, we can not 

apply this estimate to assess the 

associated burden across behavioral 

health and medical surgical settings. 

b. Section 482.13(f) Standard: Staff 

Training Requirements 

Standard 482.13(f), previously 

entitled ‘‘Restraint or seclusion: 

Seclusion and restraint for behavior 

management,’’ has been revised to read 

‘‘Staff training requirements.’’ This 

standard will specifically address the 

requirements that have been 

significantly changed or are new 

regarding staff training. 

In section 482.13(f) Standard: Staff 

training requirements. Staff training 

requirements have been expanded to 

include various training specifications. 

While we have tried to minimize the 

burden which will be placed on 

hospitals in order to meet this 

requirement, we believe it is important 

for the provision of safe and effective 

restraint or seclusion use. 

We require that before staff apply 

restraints, implement seclusion, perform 

associated monitoring and assessment of 

the restrained or secluded patient, or 

provide care for a restrained or secluded 

patient, the staff must be trained and 

able to demonstrate competency in the 

performance of these actions. We have 

revised the staff training requirements to 

address the following broad areas: 

Training intervals, training contents, 

trainer requirements, and trainer 

documentation. 

When developing this final rule, we 

considered public comments regarding 

the impact associated with the 

requirement that all staff with direct 

patient contact be trained in the use of 

restraint or seclusion. Some argued that 

this broad requirement would entail 

training dietary, administrative, 

housekeeping, and other types of 

nonprofessional staff who are not direct 

care providers and not involved in the 

application or use of restraint or 

seclusion. To reduce burden and create 

a more reasonable requirement while 

assuring patient safety, we have 

mandated that only those staff who are 

involved in the application of restraint 

or seclusion or performing associated 

monitoring and assessment of, or 

providing care for restrained or 

secluded patients have this training. 

While we expect physicians and LIPs to 

be trained in the proper use of restraint 

or seclusion, we do not expect that they 

will be trained with the other hospital 

staff. Thus, we have not included 

physicians and LIPs in the burden 

associated with these requirements. 

Instead, we require the remaining 

hospital staff who have direct contact 

with patients must be trained in 

restraint or seclusion use. 

We also considered 

commenters’suggestions that training be 

provided by a nationally-recognized 

training program, such as the Crisis 

Training Institute. Others asked that we 

provide a list of criteria to be covered 

in this training. In this final rule, we 

have specified broad topics to be 

covered in training, and have not 

required that staff be trained by an 

outside organization. We believe that inhouse training may be more economical 

than sending staff off-site for 

instruction. However, hospitals would 

still have the option of sending either 

selected or all staff to outside training if 

they believe that this is warranted. 

Thus, we have based our burden 

estimate on having the actual number of 

trainers attend such training from an 

outside organization one time. We 

believe that most facilities would, in 

turn, have these trained individuals 

function as program developers and 

trainers of the appropriate hospital staff. 

We believe in most instances this 

professional will be a registered nurse. 

Thus, we used $38.88 as the nursing 

hourly rate in this estimate. 

Train-the trainer programs are the 

way many facilities provide staff 

instruction. The four day instructor 

certification program given by the Crisis 

Prevention Institute (CPI, INC.) costs 

$1,200 dollars in tuition plus travel, 

lodging, and participant salary (http:// 

www.crisisprevention.com). 

We estimate, on average, that 

roundtrip travel for each nurse will cost 

approximately $400 to cover the need 

for either local or distant travel, lodging 

for each nurse will costs approximately 

$120 per night × 3 nights, and the meals 

and incidental expenses (M&IE) will be 

approximately $50 per day depending 

upon the location within the designated 

state. Thus, we anticipate the cost to 

train one nurse per the 6,200 hospitals 

to be $1,200 for the course, an estimated 

$400 airfare based on location, $360 for 

3 days lodging, $150 for 3 days M&IE, 

$112.50 for partial day M&IE, and 

$1,244.16 for the nurse’s salarysat 

$38.88 per hour × 8 hours per day × 4 

days. These expenses would total 

$466.66 per nurse per hospital. If all 

6,200 hospitals were to send one nurse 

to such training, the total cost for the 

6,200 hospitals would be 

$21,493,292.00. 

Hours/est. salary/# of hospitals Annual burden 

hours 

Annual costs 

estimate 

Off-site training of the trainer: 

Cost of course × 1 nurse .................................................................................................................................. ........................ $1,200.00 

Airfare × 1 nurse ............................................................................................................................................... ........................ 400.00 

Lodging × 1 nurse ............................................................................................................................................ ........................ 360.00 

M&IE × 1 nurse ................................................................................................................................................ ........................ 262.50 

Salary for 1 nurse × $38.88 per hr. × 8 hrs. day × 4 days each for a one time training ................................ 32 1,244.16 

Total for 1 nurse per hospital × 6,200 hospitals ....................................................................................... 198,400 21,493,292.00 

To be responsive to requests for more 

detail regarding our expectations and to 

assure staff competency, we have 

described the content to be covered 

during training. Given that most 

facilities already have some type of 

training program, as noted in many 

comments from hospitals, we believe 

that these requirements will only serve 

to refine existing programs, not mandate 

new ones. The current JCAHO standards 

which apply to approximately 80 

percent of the Medicare- and Medicaidparticipating hospitals address staff 

training and competence with respect to 

the use of restraint or seclusion at 

PC.12.30. The current JCAHO standard 

which applies to the hospital 

leadership’s approach to the use of 

restraint for acute medical and surgical 

(non-psychiatric) care at PC.11.10 refers 

to staff orientation and education. In 

effect, these JCAHO standards already 

require training of this kind for staff 

involved with the application of 

restraint or seclusion. Thus, there may 

be some initial cost for revising 


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71424 Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations 

programs’ materials to incorporate the 

elements specified in the regulation. 

Hours/est. salary/# of hospitals Annual burden 

hours 

Annual costs 

estimate 

Developing a new training program (20% of hospitals = 6,200 ÷ 20% = 1,240): 

1 clinical trainer @ $38.88 hr. × 40 hrs. on average one-time × 1,240 hospitals ........................................... 49,600 $1,928,448.00 

Total ........................................................................................................................................................... 49,600 1,928,448.00 

Note: Salary data used in this estimate is based on the salary estimates reported on-line at http://www.salary com. Estimates based on median annual salary ($80,867.00 including benefits) for a Staff nurse-RN divided by 2,080 hours per year worked by a full-time employed Staff RN. 

We require that each individual who 

will potentially be involved in restraint 

and seclusion of a patient have training 

in the proper techniques. According to 

the National Association of Psychiatric 

Health Systems (NAPHS), initial 

training in de-escalation techniques, 

restraint and seclusion policies and 

procedures, and restraint and seclusion 

techniques range from 7 to 16 hours of 

staff and instructor time. 

Using data from the American 

Hospital Association’s (AHA) 2004 

Annual Survey, the average number of 

total full-time and part-time clinical 

employees per hospital are 248 and 113 

respectively. Clinical employees include 

physicians and dentists, medical and 

dental residents and interns, other 

trainees, registered nurses, licensed 

practical (vocational Nurses), and 

nursing assistants. While we recognize 

this does not include clinical staff in 

such areas as rehabilitation services, 

this total of 361 persons per hospital 

should provide an estimate on which to 

base this analysis. We realize that some 

hospitals will have more or less 

employees in which to train. 

Additionally, the CMS’ OSCAR data, 

reveals the average number of beds per 

hospital is 160. We estimate that an 

average size hospital may have 361 staff 

persons who will require this training. 

Hours/est. salary/# of hospitals Annual burden hours 

Annual costs 

estimate 

Attendance in the training program: 

1 clinical trainer @ $38.88 hr. × 8 hrs. × 6,200 hospitals .............................................................................. 49,600 $1,928,448.00 

361 trainees × 16 hours per hospital × 6,200 hospitals ................................................................................ 17,905,600 ..............................

Total ......................................................................................................................................................... 17,955,200 1,928,448.00 

We require that each individual will 

receive annual updates to the training 

and that the annual training will also be 

documented. Again, according to 

NAPHS, annual updates are about 7 

hours of staff and instructor time per 

each employee who has direct patient 

contact. Again, an average size hospital 

has 361 employees who have direct 

patient contact that must be trained in 

de-escalation techniques. 

Hours/est. salary/# of hospitals Annual burden hours 

Annual costs 

estimate 

Annual updates in the training program: 

1 clinical trainer @ $.38.88 hr. × 4 hrs. on average annually × 6,200 hospitals ........................................... 24,800 964,224.00 

361 trainees × 4 hours per hospital × 6,200 hospitals .......................................................................................... 8,952,800 ..............................

Total ......................................................................................................................................................... 8,977,600 964,224.00 

Additionally, we required 

recordkeeping for documenting in each 

trained individual’s personnel record 

that he or she has successfully 

completed training as discussed in 

Section V. of the preamble to this final 

rule. As noted there, we believe that 

such records are kept by the hospital in 

the normal course of business. 

Therefore, we do not believe that these 

requirements would have a significant 

economic impact on hospitals. 

Hours/est. salary/# of hospitals Annual burden hours 

Annual costs 

estimate 

Documenting attendance in the training program: 

1 clinical trainer @ $38.88 hr. × 5 minutes on average × 361 trainees annually × 6,200 hospitals ............. 179,056 6,691,697.20 

Total ......................................................................................................................................................... 179,056 6,961,697.20 

Finally, we require that each hospital 

revise its training program annually as 

needed. We estimate this task to take 

approximately 4 hours annually per 

hospitals. 


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Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations 71425 

Hours/est. salary/# of hospitals Annual burden hours 

Annual costs 

estimate 

Revising the training program: 

1 clinical trainer @ $38.88 hr. × 4 hours per average size hospital × 6,200 hospitals ................................. 24,800 964,224.00 

Total ......................................................................................................................................................... 24,800 964,224.00 

c. Section 482.13(g) Standard: Death 

Reporting Requirements 

This requirement, previously an 

element in the interim final rule with 

comment period, has been revised to be 

a separate standard. In revising this to 

form a separate standard, we have made 

it applicable to all deaths associated 

with the use of restraint or seclusion 

throughout the hospital. We have added 

the requirements at § 482.13(g)(1)(i) that 

a hospital must report to CMS each 

death that occurs while a patient is in 

restraint or seclusion at the hospital, at 

§ 482.13(g)(1)(ii) each death that occurs 

within 24 hours after the patient has 

been removed from restraint or 

seclusion, and at § 482.13(g)(1)(iii) that 

the hospital must report each death 

known to the hospital that occurs 

within 1 week after restraint or 

seclusion where it is reasonable to 

assume that the use of restraint 

seclusion contributed directly or 

indirectly to a patient’s death. 

At § 482.13(g)(2) and § 481.13(g)(3), 

we require that each death referenced in 

this section must be reported to CMS by 

telephone no later than the close of 

business the next business day 

following knowledge of the patient’s 

death. We believe that the number of 

deaths related to restraint or seclusion 

use are still under-reported. In October 

1998, the Hartford Courant cited the 

results of a study that identified 142 

deaths from seclusion and restraint use 

in behavioral health treatment facilities 

over the past 10 years. Since the 

Patients Rights CoP became effective in 

1999, the annual total of patient deaths 

related to restraint and seclusion use 

has been reported to CMS as follows: 

1999 (14), 2000 (34), 2001 (22), 2002 

(19), 2003 (17), 2004 (24), 2005 (30), and 

2006 (5) year-to-date respectively as of 

June 19, 2006. These numbers include 

deaths from seclusion or restraint use in 

behavioral health settings not the 

medical-surgical settings in the hospital. 

Although our goal is to reduce the 

utilization of restraint or seclusion and 

associated deaths, we are aware that the 

actual number of deaths from seclusion 

and restraint use may increase due to 

the increased reporting requirements of 

deaths due to seclusion and restraint 

use in all treatment settings in the 

hospital. Thus, we anticipate there will 

be burden associated with this 

requirement due to the increased 

number of deaths that will be reported 

by the various units within the hospital. 

For the purposes of calculating burden, 

we are assuming the number of deaths 

based on current levels and are not 

considering the reduction in the number 

of deaths we expect to result from this 

regulation. 

Given this historical data, we believe 

the number of reports certainly should 

average less than one per hospital per 

year (that is, the total number of deaths 

in 8 years (165) divided by the total 

number of hospitals 6,200 divided by 8 

years equals .0033). Thus, we believe 

the impact associated with this 

provision (that is, making a telephone 

call and filling in a written form to 

report a death to the CMS) to be 

negligible. 

We estimate that one clerical person 

would report the death to CMS and 

document the death in the patient’s 

medical record. The burden associated 

with the completion of this task would 

be .25 (15 minutes divided by 60 

minutes in one hour) × an average of 20 

occurrences per year throughout the 

6,200 hospitals, .25 × 20 = 5 hours. The 

estimated cost associated would be 5 

hours × $.31 (that is, $18.88 hour 

divided by 60minutes per hour × 15 

minutes = 4.71 × 20 occurrences per 

year = $94.20 annually). 

Hours/est. salary/# of hospitals Annual burden 

hours 

Annual costs 

estimate 

Reporting death to CMS and documenting in medical record: 

1 clerical person @ $18.88 hr. × 15 min. × average of 20 occurrences in hospital annually ......................... 5 $94.20 

Total ........................................................................................................................................................... 5 94.20 

Note: Salary data used in this estimate is based on salary estimates reported on-line at http://www.salary com. Estimates based on median 

annual salary ($39,190.00 including benefits) for an admitting clerk divided by 2,080 hours per year worked by a full-time employed admitting 

clerk. 

2. Effect on Beneficiaries 

The implementation of the Patients 

Rights CoP will serve to protect not only 

Medicare and Medicaid beneficiaries 

but all patients receiving care in all 

Medicare-participating hospitals (that is, 

short-term, psychiatric, rehabilitation, 

long-term, children’s, and alcohol-drug), 

including small rural hospitals. With 

the finalization of standards a–g of the 

Patient’s Rights CoP, we forsee better 

protection regarding notification of the 

patient’s rights, exercise of the patient’s 

rights with regard to his or her care, 

privacy and safety, confidentiality of the 

patient’s records, and restraint and 

seclusion use. Thus, all patients will 

benefit from the hospital’s focus on 

patients’ rights. Through these 

protections, patient care can be 

delivered in an atmosphere of respect 

for an individual patient’s comfort, 

dignity, and privacy. We also believe 

that implementation of this final rule 

will lead to a reduction in the numbers 

of restraint or seclusion related injuries 

and deaths in hospitals. 

3. Effect on Medicare and Medicaid 

Programs 

Given that hospitals have been 

required to comply with the regulations 

at § 482.13(a) through § 482.13(f) since 

1999, we do not expect the 

implementation of the finalized 

Patients’ Rights provisions to generate 

significant cost to the Medicare or 

Medicaid programs. We do not believe 

there will be any additional costs to the 

survey and certification program as 

compliance with this CoP will either be 

reviewed through a routine, 

nonaccredited hospital survey, 


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71426 Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations 

validation survey or as part of the 

existing complaint survey process for 

hospitals. 

C. Alternatives Considered 

We originally considered developing 

one set of very general requirements 

regulating restraint or seclusion use in 

all hospitals for all situations. However, 

based on public comments and recent 

concerns about restraint or seclusion 

use for behavior management situations, 

we concluded that one set of 

requirements did not afford patients 

with adequate protections. In addition, 

we noted that JCAHO has more 

prescriptive standards for behavioral 

health care accreditation than for 

hospital accreditation. 

We considered recognizing only 

physicians as the individuals able to 

order restraints or seclusion. However, 

in recognizing that other types of 

practitioners provide a great deal of care 

in rural and frontier areas, we did not 

adopt that approach. 

We considered keeping standards e 

and f separate as originally proposed. 

However, due to public comment we 

found it to be more prudent to address 

the use of restraint or seclusion in either 

medical-surgical or behavioral treatment 

contexts in a single standard. 

We considered finalizing the training 

section as proposed. In turn, we 

planned to let hospitals establish, 

implement, and monitor their own 

training programs. However, industry 

concerns were the impetus for providing 

further direction regarding training. 

Additionally, we considered mandating 

training for physicians and other LIPs; 

however, the industry believed this was 

too prescriptive. 

Regarding the timeframes in which a 

patient must be evaluated if restraint or 

seclusion is used to manage violent or 

self-destructive behavior, we considered 

more restrictive options including 

adopting the Pennsylvania Office of 

Mental Health policy that requires an 

onsite evaluation by a physician within 

half an hour of initiation of the 

intervention. However, we rejected this 

idea on the basis that it is unrealistic for 

rural areas because of geographical 

barriers and practitioner shortages, cost 

(as noted by commenters). 

We considered adopting more 

restrictive requirements for the 

maximum time frames for the length of 

an order for restraint or seclusion. 

However, since there was no supporting 

literature or studies, we decided to 

adopt the approach and timeframes 

developed and articulated by JCAHO for 

its hospital accreditation and behavioral 

health care accreditation programs. 

These standards were developed by 

experts from the health care field and 

represent consensus on the approach 

and time frames for uses of seclusion or 

restraints. In addition, approximately 80 

percent of the Medicare- and Medicaidparticipating hospitals are already 

subject to these requirements through 

accreditation. Therefore, we believe it is 

reasonable to adopt requirements 

similar to those of JCAHO. 

In accordance with the provisions of 

Executive Order 12866, this regulation 

was reviewed by the Office of 

Management and Budget. 

List of Subjects in 42 CFR Part 482 

Grants programs—health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements. 

■ For the reasons set forth in the 

preamble, the interim rule amending 42 

CFR chapter IV published on July 2, 

1999 Federal Register (64 FR 36070) is 

adopted as final with the following 

changes: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 1. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102 and 1871 of the 

Social Security Act, unless otherwise noted 

(42 U.S.C. 1302 and 1395hh). 

■ 2. Section 482.13 is revised to read as 

follows: 

§ 482.13 Condition of participation: 

Patient’s rights. 

A hospital must protect and promote 

each patient’s rights. 

(a) Standard: Notice of rights. (1) A 

hospital must inform each patient, or 

when appropriate, the patient’s 

representative (as allowed under State 

law), of the patient’s rights, in advance 

of furnishing or discontinuing patient 

care whenever possible. 

(2) The hospital must establish a 

process for prompt resolution of patient 

grievances and must inform each patient 

whom to contact to file a grievance. The 

hospital’s governing body must approve 

and be responsible for the effective 

operation of the grievance process and 

must review and resolve grievances, 

unless it delegates the responsibility in 

writing to a grievance committee. The 

grievance process must include a 

mechanism for timely referral of patient 

concerns regarding quality of care or 

premature discharge to the appropriate 

Utilization and Quality Control Quality 

Improvement Organization. At a 

minimum: 

(i) The hospital must establish a 

clearly explained procedure for the 

submission of a patient’s written or 

verbal grievance to the hospital. 

(ii) The grievance process must 

specify time frames for review of the 

grievance and the provision of a 

response. 

(iii) In its resolution of the grievance, 

the hospital must provide the patient 

with written notice of its decision that 

contains the name of the hospital 

contact person, the steps taken on behalf 

of the patient to investigate the 

grievance, the results of the grievance 

process, and the date of completion. 

(b) Standard: Exercise of rights. (1) 

The patient has the right to participate 

in the development and implementation 

of his or her plan of care. 

(2) The patient or his or her 

representative (as allowed under State 

law) has the right to make informed 

decisions regarding his or her care. The 

patient’s rights include being informed 

of his or her health status, being 

involved in care planning and 

treatment, and being able to request or 

refuse treatment. This right must not be 

construed as a mechanism to demand 

the provision of treatment or services 

deemed medically unnecessary or 

inappropriate. 

(3) The patient has the right to 

formulate advance directives and to 

have hospital staff and practitioners 

who provide care in the hospital comply 

with these directives, in accordance 

with § 489.100 of this part (Definition), 

§ 489.102 of this part (Requirements for 

providers), and § 489.104 of this part 

(Effective dates). 

(4) The patient has the right to have 

a family member or representative of his 

or her choice and his or her own 

physician notified promptly of his or 

her admission to the hospital. 

(c) Standard: Privacy and safety. (1) 

The patient has the right to personal 

privacy. 

(2) The patient has the right to receive 

care in a safe setting. 

(3) The patient has the right to be free 

from all forms of abuse or harassment. 

(d) Standard: Confidentiality of 

patient records. (1) The patient has the 

right to the confidentiality of his or her 

clinical records. 

(2) The patient has the right to access 

information contained in his or her 

clinical records within a reasonable 

time frame. The hospital must not 

frustrate the legitimate efforts of 

individuals to gain access to their own 

medical records and must actively seek 

to meet these requests as quickly as its 

record keeping system permits. 

(e) Standard: Restraint or seclusion. 

All patients have the right to be free 

from physical or mental abuse, and 

corporal punishment. All patients have 

the right to be free from restraint or 

seclusion, of any form, imposed as a 


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means of coercion, discipline, 

convenience, or retaliation by staff. 

Restraint or seclusion may only be 

imposed to ensure the immediate 

physical safety of the patient, a staff 

member, or others and must be 

discontinued at the earliest possible 

time. 

(1) Definitions. (i) A restraint is—

(A) Any manual method, physical or 

mechanical device, material, or 

equipment that immobilizes or reduces 

the ability of a patient to move his or 

her arms, legs, body, or head freely; or 

(B) A drug or medication when it is 

used as a restriction to manage the 

patient’s behavior or restrict the 

patient’s freedom of movement and is 

not a standard treatment or dosage for 

the patient’s condition. 

(C) A restraint does not include 

devices, such as orthopedically 

prescribed devices, surgical dressings or 

bandages, protective helmets, or other 

methods that involve the physical 

holding of a patient for the purpose of 

conducting routine physical 

examinations or tests, or to protect the 

patient from falling out of bed, or to 

permit the patient to participate in 

activities without the risk of physical 

harm (this does not include a physical 

escort). 

(ii) Seclusion is the involuntary 

confinement of a patient alone in a room 

or area from which the patient is 

physically prevented from leaving. 

Seclusion may only be used for the 

management of violent or selfdestructive behavior. 

(2) Restraint or seclusion may only be 

used when less restrictive interventions 

have been determined to be ineffective 

to protect the patient a staff member or 

others from harm. 

(3) The type or technique of restraint 

or seclusion used must be the least 

restrictive intervention that will be 

effective to protect the patient, a staff 

member, or others from harm. 

(4) The use of restraint or seclusion 

must be—

(i) In accordance with a written 

modification to the patient’s plan of 

care; and 

(ii) Implemented in accordance with 

safe and appropriate restraint and 

seclusion techniques as determined by 

hospital policy in accordance with State 

law. 

(5) The use of restraint or seclusion 

must be in accordance with the order of 

a physician or other licensed 

independent practitioner who is 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to order restraint or 

seclusion by hospital policy in 

accordance with State law. 

(6) Orders for the use of restraint or 

seclusion must never be written as a 

standing order or on an as needed basis 

(PRN). 

(7) The attending physician must be 

consulted as soon as possible if the 

attending physician did not order the 

restraint or seclusion. 

(8) Unless superseded by State law 

that is more restrictive—

(i) Each order for restraint or 

seclusion used for the management of 

violent or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others may only be renewed in 

accordance with the following limits for 

up to a total of 24 hours: 

(A) 4 hours for adults 18 years of age 

or older; 

(B) 2 hours for children and 

adolescents 9 to 17 years of age; or 

(C) 1 hour for children under 9 years 

of age; and 

(ii) After 24 hours, before writing a 

new order for the use of restraint or 

seclusion for the management of violent 

or self-destructive behavior, a physician 

or other licensed independent 

practitioner who is responsible for the 

care of the patient as specified under 

§ 482.12(c) of this part and authorized to 

order restraint or seclusion by hospital 

policy in accordance with State law 

must see and assess the patient. 

(iii) Each order for restraint used to 

ensure the physical safety of the nonviolent or non-self-destructive patient 

may be renewed as authorized by 

hospital policy. 

(9) Restraint or seclusion must be 

discontinued at the earliest possible 

time, regardless of the length of time 

identified in the order. 

(10) The condition of the patient who 

is restrained or secluded must be 

monitored by a physician, other 

licensed independent practitioner or 

trained staff that have completed the 

training criteria specified in paragraph 

(f) of this section at an interval 

determined by hospital policy. 

(11) Physician and other licensed 

independent practitioner training 

requirements must be specified in 

hospital policy. At a minimum, 

physicians and other licensed 

independent practitioners authorized to 

order restraint or seclusion by hospital 

policy in accordance with State law 

must have a working knowledge of 

hospital policy regarding the use of 

restraint or seclusion. 

(12) When restraint or seclusion is 

used for the management of violent or 

self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others, the patient must be seen face-toface within 1 hour after the initiation of 

the intervention—

(i) By a—

(A) Physician or other licensed 

independent practitioner; or 

(B) Registered nurse or physician 

assistant who has been trained in 

accordance with the requirements 

specified in paragraph (f) of this section. 

(ii) To evaluate—

(A) The patient’s immediate situation; 

(B) The patient’s reaction to the 

intervention; 

(C) The patient’s medical and 

behavioral condition; and 

(D) The need to continue or terminate 

the restraint or seclusion. 

(13) States are free to have 

requirements by statute or regulation 

that are more restrictive than those 

contained in paragraph (e)(12)(i) of this 

section. 

(14) If the face-to-face evaluation 

specified in paragraph (e)(12) of this 

section is conducted by a trained 

registered nurse or physician assistant, 

the trained registered nurse or physician 

assistant must consult the attending 

physician or other licensed independent 

practitioner who is responsible for the 

care of the patient as specified under 

§ 482.12(c) as soon as possible after the 

completion of the 1-hour face-to-face 

evaluation. 

(15) All requirements specified under 

this paragraph are applicable to the 

simultaneous use of restraint and 

seclusion. Simultaneous restraint and 

seclusion use is only permitted if the 

patient is continually monitored—

(i) Face-to-face by an assigned, trained 

staff member; or 

(ii) By trained staff using both video 

and audio equipment. This monitoring 

must be in close proximity to the 

patient. 

(16) When restraint or seclusion is 

used, there must be documentation in 

the patient’s medical record of the 

following: 

(i) The 1-hour face-to-face medical 

and behavioral evaluation if restraint or 

seclusion is used to manage violent or 

self-destructive behavior; 

(ii) A description of the patient’s 

behavior and the intervention used; 

(iii) Alternatives or other less 

restrictive interventions attempted (as 

applicable); 

(iv) The patient’s condition or 

symptom(s) that warranted the use of 

the restraint or seclusion; and 

(v) The patient’s response to the 

intervention(s) used, including the 

rationale for continued use of the 

intervention. 

(f) Standard: Restraint or seclusion: 

Staff training requirements. The patient 

has the right to safe implementation of 

restraint or seclusion by trained staff. 


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71428 Federal Register / Vol. 71, No. 236 / Friday, December 8, 2006 / Rules and Regulations 

(1) Training intervals. Staff must be 

trained and able to demonstrate 

competency in the application of 

restraints, implementation of seclusion, 

monitoring, assessment, and providing 

care for a patient in restraint or 

seclusion—

(i) Before performing any of the 

actions specified in this paragraph; 

(ii) As part of orientation; and 

(iii) Subsequently on a periodic basis 

consistent with hospital policy. 

(2) Training content. The hospital 

must require appropriate staff to have 

education, training, and demonstrated 

knowledge based on the specific needs 

of the patient population in at least the 

following: 

(i) Techniques to identify staff and 

patient behaviors, events, and 

environmental factors that may trigger 

circumstances that require the use of a 

restraint or seclusion. 

(ii) The use of nonphysical 

intervention skills. 

(iii) Choosing the least restrictive 

intervention based on an individualized 

assessment of the patient’s medical, or 

behavioral status or condition. 

(iv) The safe application and use of all 

types of restraint or seclusion used in 

the hospital, including training in how 

to recognize and respond to signs of 

physical and psychological distress (for 

example, positional asphyxia); 

(v) Clinical identification of specific 

behavioral changes that indicate that 

restraint or seclusion is no longer 

necessary. 

(vi) Monitoring the physical and 

psychological well-being of the patient 

who is restrained or secluded, including 

but not limited to, respiratory and 

circulatory status, skin integrity, vital 

signs, and any special requirements 

specified by hospital policy associated 

with the 1-hour face-to-face evaluation. 

(vii) The use of first aid techniques 

and certification in the use of 

cardiopulmonary resuscitation, 

including required periodic 

recertification. 

(3) Trainer requirements. Individuals 

providing staff training must be 

qualified as evidenced by education, 

training, and experience in techniques 

used to address patients’ behaviors. 

(4) Training documentation. The 

hospital must document in the staff 

personnel records that the training and 

demonstration of competency were 

successfully completed. 

(g) Standard: Death reporting 

requirements: Hospitals must report 

deaths associated with the use of 

seclusion or restraint. 

(1) The hospital must report the 

following information to CMS: 

(i) Each death that occurs while a 

patient is in restraint or seclusion. 

(ii) Each death that occurs within 24 

hours after the patient has been 

removed from restraint or seclusion. 

(iii) Each death known to the hospital 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death. ‘‘Reasonable to assume’’ in this 

context includes, but is not limited to, 

deaths related to restrictions of 

movement for prolonged periods of 

time, or death related to chest 

compression, restriction of breathing or 

asphyxiation. 

(2) Each death referenced in this 

paragraph must be reported to CMS by 

telephone no later than the close of 

business the next business day 

following knowledge of the patient’s 

death. 

(3) Staff must document in the 

patient’s medical record the date and 

time the death was reported to CMS. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: December 14, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: November 16, 2006. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 06–9559 Filed 12–7–06; 8:45 am] 

BILLING CODE 4120–01–P 


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