United States General Accounting Office

GAO Testimony

Before the Committee on Finance, U.S. Senate

For Release on Delivery

Expected at 10:00 a.m.

Tuesday, October 26, 1999

MENTAL HEALTH

Extent of Risk From

Improper Restraint or

Seclusion Is Unknown

Statement of Leslie G. Aronovitz, Associate Director

Health Financing and Public Health Issues

Health, Education, and Human Services Division

GAO/T-HEHS-00-26

Mental Health: Extent of Risk From

Improper Restraint or Seclusion Is

Unknown

Mr. Chairman and Members of the Committee:

We are pleased to be here today to discuss the effect of improper restraint

and seclusion on some of the country’s most vulnerable citizens—people

with serious mental illness or mental retardation. About 5.5 million adults

experience severe mental illness each year, about 240,000 of them

requiring residential treatment in mental hospitals, centers, or group

homes. In addition, an estimated 360,000 adults and children with mental

retardation lived in intermediate care facilities or smaller residential

settings in 1998. Medicare, the federal program of health insurance for the

elderly and disabled, and Medicaid, the federal and state program of health

insurance for the poor, help pay for the treatment of eligible individuals in

these settings. Because members of the Congress became concerned

about the safety of patients after a series of articles in the Hartford

Courant reported on restraint-related deaths, we were asked to evaluate

the risks involved in using restraint and seclusion, the adequacy of current

federal reporting requirements and other protections, and what certain

states had done to address restraint and seclusion.

In brief, as we recently reported, improper restraint and seclusion can be

dangerous to people receiving treatment for mental illness or mental

retardation and to staff in treatment facilities.1

 While there is no

comprehensive system to track injuries or deaths, we found that at least 24

deaths that state protection and advocacy agencies (P&A) investigated in

fiscal year 1998 were associated with the use of restraint or seclusion. We

believe there may have been more deaths because only 15 states require

any systematic reporting to P&As to alert them to serious injuries and

deaths. We also found that federal and state regulations that govern the

reporting of injuries and deaths and that govern the use of restraint and

seclusion are not consistent for different types of facilities. The experience

of several states demonstrates that having regulatory protections and

reporting requirements can reduce the use of restraint and seclusion and

improve safety for individuals receiving treatment as well as for facility

staff. In our September 1999 report, we made several recommendations

that, if adopted, should improve the safety of patients and staff in a variety

of treatment settings.

Background People with mental illness or mental retardation who receive residential

treatment—and may be subject to restraint or seclusion—do so in a variety

1

Mental Health: Improper Restraint or Seclusion Use Places Patients at Risk (GAO/HEHS-99-176, Sept.

7, 1999).

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of settings. Psychiatric patients may receive inpatient treatment in

traditional state hospitals, private psychiatric hospitals, or community

hospitals with psychiatric units. The trend toward less restrictive

community-based settings has led to more individuals with mental illness

or mental retardation living in smaller facilities and group homes.

Federal funding through Medicare and Medicaid accounts for about 40

percent of the revenue for mental health treatment facilities. Medicare

provides limited mental health coverage for individuals older than 65 and

some individuals younger than 65 who are disabled. In 1994, Medicare

spent about $4.5 billion for mental health services in private psychiatric

hospitals and general hospitals. The Medicaid program covers certain

low-income individuals for residential services to treat mental disabilities.

Medicaid covers children and, at state option, aged adults with mental

illness, and it covers adults and children with mental retardation. Medicaid

provides inpatient mental health services for children younger than 21 in

general hospitals, psychiatric hospitals, and nonhospital settings.

Individuals aged 65 and older may receive inpatient mental health services

in a hospital or nursing home. Medicaid spending for inpatient psychiatric

treatment totaled more than $2 billion in fiscal year 1996. In the same year,

Medicaid spent about $9.6 billion for intermediate care facilities for the

mentally retarded (ICF-MR), which provide long-term residential care and

treatment. In addition, Medicaid covers care for children with mental

illness and adults and children with mental retardation through the home

and community-based waiver programs, which allow states to cover a

broader range of services in less restrictive settings such as group homes.

State Medicaid programs spent $5.6 billion in federal and state funding on

home and community-based waiver services in fiscal year 1996, some of

which was used to provide residential treatment. The federal government

through the Health Care Financing Administration (HCFA) administers

Medicare and HCFA and the states administer Medicaid.

Restraint and

Seclusion Can Injure

Patients and Staff

Restraint and seclusion present real risks of injury and death to individuals

in treatment and the staff who care for them. Restraint is the partial or

total immobilization of a person through the use of drugs, mechanical

devices such as leather cuffs, or physical holding by another person.

Seclusion refers to a person’s involuntary confinement, usually solitary.

Restraint and seclusion can be dangerous because restraining people can

involve physical struggling, pressure on the chest, or other interruptions in

breathing. Staff can be injured while struggling to get residents into

restraints or seclusion.

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Clinicians, providers, and patient advocates generally agree that when

patients lose control to the extent that they or others are at imminent risk

of being physically harmed, staff can legitimately restrain or seclude them

in emergencies. However, many patient advocates, state mental health

program officials, and representatives of the psychiatric physician and

nursing profession disagree as to whether there is any other appropriate

clinical use of restraint and seclusion or whether they should be used only

as a last resort.

The dangers of restraint and seclusion have been recognized in the mental

health community. The Joint Commission for Accreditation of Healthcare

Organizations (JCAHO), which accredits most hospitals participating in

Medicare and Medicaid, recently sent an advisory to hospitals warning

about the dangers of restraint and seclusion. JCAHO documented 20 deaths

since 1996 caused by asphyxiation, strangulation, cardiac arrest, and fire

while people were in restraint or seclusion. These were similar to the

causes of death the Courant listed in its investigation, which included

asphyxia, blunt trauma, cardiac complications, drug overdoses or

interactions, strangulation or choking, and fire or smoke inhalation.

Children are subjected to restraint and seclusion at higher rates than

adults and are at particular risk. Several of the states that took part in a

study sponsored by the Department of Health and Human Services (HHS)

Center for Mental Health Services reported higher restraint rates for

children, including one state in which children in state-run inpatient

facilities were restrained four times more frequently than adults. Children

are smaller and weaker than adults are, so staff used to overpowering

adults may apply too much pressure or force when restraining children.

The following cases reported by the National Alliance for the Mentally Ill

illustrate the dangers of restraining children:

• In February 1999, a 16-year-old girl died in California of respiratory arrest

with her face on the floor while being restrained by four staff members.

• Basket holds—arms crossed in front of the body with the wrists held from

behind—were involved in the death of a 17-year-old girl in a Florida

residential treatment center in November 1998 and the death of a

9-year-old boy in North Carolina in March 1999 after being restrained

following a period of seclusion.

The use of restraint and seclusion can also result in serious injury and

abuse. During fiscal year 1998, P&As received about 1,000 complaints

regarding restraint and seclusion and documented instances of bruising

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and broken bones. In one instance, a 24-year-old man suffered a severe

fracture in his right arm while facility staff were struggling to restrain him

and was subsequently placed in four-point restraints and left for 12 hours

with the broken arm, despite his requests for medical attention.2

Even if no physical injury is sustained, patients can be severely

traumatized while being restrained, especially those who had previously

been sexually abused. A Massachusetts task force reported that research

indicates that at least half of all women treated in psychiatric settings have

a history of physical or sexual abuse. The task force found that the use of

restraints on patients who have been abused often results in their

re-experiencing the trauma and contributes to a set-back in the course of

treatment.

Restraint and seclusion can also lead to the injury of health care workers.

The occupation of mental health care worker has been found to be more

dangerous than construction work. Studies have documented that the

largest percentage of patient assaults on staff members occurs during

restraint or seclusion and that most staff injuries are sustained while staff

are trying to control patients who are being violent.

Incomplete Reporting

Leaves the Full Extent

of Patient Risk

Unknown

While restraint and seclusion can injure patients and staff, the full extent

of that risk is not known. HCFA requires treatment facilities that participate

in Medicare and Medicaid to fulfill certain requirements but before August

of this year did not require hospitals—including psychiatric hospitals—to

report deaths that might be associated with restraint or seclusion. The lack

of comprehensive reporting makes it impossible to determine all deaths in

which restraint or seclusion was a factor. However, through a survey of

each of the P&As for the 50 states and the District of Columbia, we

identified 24 deaths during fiscal year 1998 that were related to restraint or

seclusion.

Reporting Requirements

Are Not Comprehensive

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.

Federal requirements on reporting injuries and deaths and restraint or

seclusion differ by type of facility. Starting in August of this year, hospitals

are now required, as a condition of participating in Medicare or Medicaid,

to report to HCFA deaths that occur during—or can reasonably be assumed

2

Four-point restraints immobilize a person on a bed with a cuff around each wrist and ankle.

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to be related to—restraint or seclusion.3 Other facilities that provide

residential services to mentally ill or mentally retarded individuals and

that are paid by Medicare or Medicaid are not required to report such

deaths to HCFA. Federal regulations require ICF-MRs and nursing homes to

provide, during their regular oversight surveys, information that can be

used for tracking the use of restraint and seclusion. However, there are no

federal reporting requirements on the use of restraint and seclusion for

any other type of facility, such as community-based group homes funded

under the Medicaid waiver program or residential treatment centers for

children.

Most states do not comprehensively track data on either the use of

restraint or related injuries. Further, JCAHO recently surveyed states

regarding their requirements to report sentinel events. “Sentinel event” is

defined as an unexpected occurrence involving death or serious physical

or psychological injury or the risk of such death or injury. While the

results are preliminary, only half the states that had responded by

March 1999 indicated that they had a law that required reporting sentinel

events to a state agency. In our survey of P&As, we found that only 11

states track restraint use in private psychiatric facilities.

JCAHO does not require hospitals to report sentinel events but encourages

voluntary reporting. JCAHO reports that since it adopted its current policy

on voluntary reporting of sentinel events in 1996, it has received reports of

24 restraint-related deaths in facilities it accredits. It published a Sentinel

Event Alert based on these reports in November 1998 with a summary of

the analyses of 20 restraint-related deaths from the sentinel event

database. However, voluntary reporting to JCAHO is not complete. JCAHO

found out about at least three deaths that had not been reported to it as a

result of the Hartford Courant’s report of deaths. Even if a sentinel event is

not reported to it, JCAHO expects hospitals to conduct an internal review to

determine how to avoid similar incidents.

Deaths Reported to

Protection and Advocacy

Agencies Understate the

Problem

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 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 a P&A.

3

Federal Register, Vol. 64, No. 127, 36070 (July 2, 1999).

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The Congress has required the states to establish or designate P&As to

protect people with mental illness or mental retardation from abuse and

neglect by providers when state oversight is insufficient. This system

began for individuals with mental retardation in 1975, following the

discovery of severe patient neglect and abuse at a state-run facility for the

mentally retarded in New York, and it was expanded to individuals with

mental illness when the Congress learned of similarly appalling conditions

in psychiatric hospitals in 1985. P&As are charged with investigating reports

of abuse, neglect, and other violations of the rights of mentally disabled

individuals in institutional care and with pursuing legal and administrative

remedies. In most states, the same P&A agency serves both individuals with

mental illness and those with mental retardation.

Despite their charge, P&A representatives told us that they do not learn of

all the deaths that may be related to restraint or seclusion. Only 15 of the

51 P&As receive any kind of systematic reports of deaths from their states

or psychiatric facilities. Of the 15, 9 receive death reports for state

facilities only and not for private facilities.

Because of the lack of reporting requirements in so many states, most P&As

learn about deaths through complaints from family, patients, and staff as

well as from on-site monitoring. Even with these ad hoc methods, only 22

of these agencies had deaths reported to them in 1998 by any means. Of

the deaths reported to the P&As in fiscal year 1998, just 5 states accounted

for more than two-thirds, and no deaths were reported to the P&As in 28

states.

P&As investigated only about 30 percent of the deaths they learned about.

One agency in New York accounted for almost one-third of all the death

investigations, while four other agencies investigated 107 deaths

combined. P&A officials also told us that their ability to conduct

investigations is hindered by limited resources and obstacles in obtaining

records, particularly the incident reports and medical records that enable

them to thoroughly investigate deaths. According to some P&A officials,

health facilities often claim that these records are part of the peer review

process—a process in which medical professionals in a facility review

incidents. While P&As may have legal rights to review the records, a P&A

may have to litigate to obtain them. This can use up its limited resources

and delay needed investigations.

Information may be even more difficult to obtain from private facilities.

Obtaining information from private facilities is becoming increasingly

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important as more individuals with mental illness are being served in

them. While many state agencies may gather data from their own facilities,

private psychiatric facilities are usually not required to report data to

either the state or the P&As.

Policies Governing

Restraint and

Seclusion Vary Among

Federal Programs,

States, and Facilities

Policies covering restraint and seclusion vary among federal programs,

states, and types of facilities. The federal government regulates the use of

restraint and seclusion in nursing homes and ICF-MRs but until recently had

no such regulations for hospitals, including psychiatric hospitals. In

August 1999, HCFA incorporated patients’ rights provisions that address

restraint and seclusion into the hospital conditions of participation. These

requirements establish the right to freedom from restraint or seclusion for

purposes of coercion, discipline, or staff convenience. Restraint and

seclusion can be used only for medical and surgical care and in

emergencies to ensure a patient’s physical safety and only after less

restrictive interventions have been found ineffective to protect a patient or

others from harm. However, current regulations do not protect patients

receiving psychiatric care in nonhospital settings such as residential

treatment centers for children and group homes.

The states have varying degrees of regulation and oversight for restraint

and seclusion. Some states have different standards for their state-run

facilities and private providers. In addition, private psychiatric hospitals

are frequently not subject to the same degree of oversight as the state-run

facilities. Some states like New York and Pennsylvania that have extensive

regulation of their public hospitals have not imposed the same

requirements on privately operated facilities—even though they may be

state-licensed or may be receiving federal or state funding.

HCFA relies primarily on the accreditation process to determine whether

privately operated facilities such as hospitals are eligible to participate in

Medicare and Medicaid. We found that representatives of health care

providers and family advocates differed on whether the accreditation

process alone is sufficient to protect patients from improper restraint and

seclusion. JCAHO, which accredits about 80 percent of the hospitals that

participate in Medicare, applies the same standards on restraint and

seclusion in hospitals as it applies in nonhospital behavioral health care

treatment facilities. In JCAHO’s accreditation survey, the surveyors review

records to determine whether restraint or seclusion is being used and

documented according to facility policy. It does not set standards

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regarding training and clinical issues such as the frequency of monitoring

and the types of restraint that are preferable.

Representatives of health care providers told us that they believe that the

accreditation process is the most appropriate way to ensure that patients

are protected from improper restraint and seclusion. They said that a

voluntary review process allows the facility to address any systemic

clinical problems and develop plans for improving quality. In contrast,

many advocates are concerned that the accreditation process is not

sufficient to establish consistent patient protection because it stresses

compliance with each facility’s own policies. JCAHO surveyors tour

facilities and talk with patients and staff to better understand their care

issues. However, advocates have noted that the process emphasizes

paperwork reviews that can miss ongoing problems with the quality of

care. The HHS Inspector General recently reported that the accreditation

process plays a positive role in the improvement of quality but cannot be

relied upon alone to ensure patient protection.4

Some of the advocates and state administrators we interviewed believe

that the most effective monitoring system involves a combination of

internal and external oversight. External monitors complement internal

quality control systems by providing an independent perspective. In some

cases, courts have appointed independent monitors to ensure compliance

with specific requirements and the safeguarding of basic patient rights in

facilities that have had serious problems. In addition to using accreditation

or state licensing surveyors and P&As, some states allow trained lay

monitors to visit mental health facilities unannounced and assess

environmental conditions. In Delaware, for example, if a monitor reports a

concern about conditions in the state psychiatric hospital, the facility must

respond within 10 days. Because staff at the facilities know that

management reviews the reports and acts on them, they sometimes inform

monitors about concerns that affect patient care, such as low staffing

levels.

4

HHS, Office of Inspector General, The External Review of Hospital Quality: A Call for Greater

Accountability (Washington, D.C.: July 20, 1999).

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Mental Health: Extent of Risk From

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Restraint and

Seclusion Can Be

Reduced Through

Regulation, Reporting,

Staffing, and Training

Several states have successfully lowered the use of restraint and seclusion

in their public psychiatric health systems and put reporting requirements

into place. Restraint and seclusion rates in Pennsylvania’s state hospital

system declined by more than 90 percent between 1993 and 1999. In

Delaware, the state’s ICF-MR introduced an initiative that reduced its

restraint rate by 81 percent between 1994 and 1997. Typically, successful

strategies to reduce restraint and seclusion rates have similar components:

a defined set of principles and policies to clearly outline when these

measures can be used, strong management commitment, the reporting of

restraint and seclusion use, oversight and monitoring, and intensive staff

training in behavioral assessment, nonviolent intervention, and using safe

restraint techniques as a last resort.

Delaware, Massachusetts, New York, and Pennsylvania have adopted

strategies to reduce restraint use in their public mental health or mental

retardation service systems. The officials we met with at the state health

departments indicated that the primary element for their success in

reducing restraint use is management commitment. Management

philosophy, not the severity of patients’ mental disability, was the most

important factor in determining restraint use among different state

hospitals, according to a 1994 study conducted by the New York

Commission on Quality of Care.5

 Management can take responsibility for

shaping the overall culture in which restraint and seclusion are considered

either routine practice or last-resort measures. An integral part of this

commitment is a clearly delineated set of policies and procedures

governing the use of restraint and seclusion for staff to follow.

For example, Pennsylvania, which administers a system of 10 facilities

with more than 3,000 residential psychiatric patients, was able to reduce

both restraint and seclusion hours by more than 90 percent between 1993

and 1999. The state mental health leadership accomplished this by first

emphasizing to all hospital administrators and staff that restraint and

seclusion are not treatment but, rather, represent an emergency response

to a treatment failure that resulted in a patient’s loss of control. The

Department of Mental Health issued policies that specified that restraint or

seclusion can be used only after all other interventions have failed and

only when there is imminent danger of the patient or others coming to

physical harm. A physician’s on-site assessment is required within 30

minutes. According to state officials, there was some initial opposition to

these policies within the facilities, but the department’s emphasis on

5

New York State Commission on Quality of Care for the Mentally Disabled, Restraint and Seclusion

Practices in New York State Psychiatric Facilities (Albany, N.Y.: 1994).

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maintaining adequate staffing and improving crisis management training

allowed it to gain the support of psychiatrists and direct care workers.

Reporting requirements are central to lowering restraint use and

improving patient safety. Officials in New York and Pennsylvania stated

that accurate and complete reporting allows hospital administrators to

compare their facilities with others. This creates an incentive for

administrators with high restraint rates to find ways to reduce them so

that they are more in line with those of their peers. A 1999 survey by the

National Association of State Mental Health Program Directors indicates

that 18 states currently collect data on restraint or seclusion in their public

hospitals.

In addition to tracking restraint rates, the reporting of deaths and sentinel

events to an independent agency can help improve patient safety. New

York is unique among the states in its longstanding, comprehensive

reporting requirement. All licensed hospitals that provide inpatient

psychiatric care must report all deaths to the Commission on Quality of

Care as well as to the relevant state agency and must indicate whether a

patient was secluded or restrained within the 24 hours before his or her

death. Mandatory reporting and investigation allow an independent entity

to analyze events at multiple facilities. Because the commission and other

agencies review information from the entire state, they can determine

whether incidents that appear to be isolated events from the perspective

of individual providers are actually part of a pattern. For example,

comprehensive incident reviews led to the discovery that the use of two

authorized restraints—the prone wrap-up, which immobilizes a person in a

face-down position, and a towel to prevent biting or spitting—were

associated with several injuries and deaths throughout the state.6

 As a

result of these analyses, these two types of restraint were banned.

Clinicians, advocates, labor unions representing direct-care mental health

workers, program administrators, and providers consistently stress that

training and adequate staff-to-patient ratios are essential to safely

minimize the use of restraint and seclusion. Nurses and direct-care staff

need to have effective alternative methods for handling potentially violent

patients if they are to reduce their use of restraint and seclusion. In the

states we visited, training programs that address how to handle potentially

6

Certain hospitals have authorized the use of a towel as a precaution against biting and spitting during

take-down and the use of restraints to protect staff against possible infection. The commission

indicated that no objects should ever be placed over or near a patient’s face because of the danger of

asphyxiation, and it recommended that staff wear gloves and masks and, if necessary, wrap the patient

in a “calming blanket” to provide the staff with a safe barrier.

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violent or aggressive patients were an integral part of the effort to safely

reduce reliance on restraint and seclusion. In HCFA’s interim final rule

implementing new general and psychiatric hospital conditions of

participation in Medicare and Medicaid, the agency has added

requirements that hospitals train their staff in alternative techniques to

lessen the use of restraint and seclusion, but these requirements do not

extend to other facility types.

Delaware, Massachusetts, New York, and Pennsylvania have initiated

training programs that emphasize crisis prevention. The goal of training is

to provide staff with the skills to assess potentially violent situations and

intervene early to help patients regain control. State officials as well as

labor union representatives stressed that direct-care staff must be trained

in alternative techniques if a facility is serious about reducing restraint and

seclusion.

Delaware ICF-MR officials told us that patient and staff injuries decreased

after staff had been trained in alternative ways of managing patient

behavior. According to a patient advocate, Delaware’s emphasis on

reducing restraint rates was precipitated by a 1994 restraint-related death

in the state ICF-MR. Following the implementation of a new training

program that emphasized patient-centered training in crisis prevention and

new management priorities, this facility reduced the number of emergency

restrictive procedures by 81 percent between 1994 and 1997, with the

number of procedures per resident falling from 1.38 to 0.29 during that

time. Along with this reduction in restraint, the number of major injuries

to residents fell by 78 percent and resident behavior improved. A

psychologist from Delaware’s ICF-MR noted that once staff have

experienced success in calming a patient through alternative means when

they would have otherwise used restraint, the new techniques become

“self-reinforcing” because staff prefer to use the less drastic measures.

The mental health program officials we met with indicated that training in

alternatives to restraint and seclusion and maintaining adequate staff

levels are costly but that they can save money in the long run by creating a

safer treatment and work environment. Data from state hospitals in New

York indicated that usually facilities with higher restraint and seclusion

rates had higher rates of staff injury and lost staff time. A New York

official noted that many of the injuries classified as assaults actually take

place during restraint and seclusion procedures. According to state

officials, staff training has been found to save the state money by directly

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reducing the frequency of restraint-related staff injuries, which represent

the costs of sick leave and overtime payments for staff to cover the shifts.

Concluding

Observations

The experience of several states shows that the use of restraint and

seclusion can be reduced and that patients and staff are safer as a result.

Successful strategies include ensuring management commitment,

providing clear guidelines and a comprehensive reporting requirement,

maintaining adequate staffing levels, and providing training.

The federal government has a major role in funding services for people

with mental illness and mental retardation. HCFA has taken positive steps

to ensure better reporting and patient protection through its new hospital

conditions of participation. However, we believe that more can be done to

ensure that Medicare and Medicaid patients with mental illness or mental

retardation are protected from improper seclusion and restraint and from

injuries and deaths. In our recently released report, we recommended that

HCFA should develop consistent policies to ensure that mentally ill or

mentally retarded individuals are given protection against inappropriate

restraint and seclusion in every treatment setting that Medicare and

Medicaid fund. We recommended that the use of restraint and seclusion

and any associated injuries or deaths be reported to the state licensing

body and state P&A. In addition, we recommended that facility staff

regularly receive training in safe methods to handle agitated individuals,

including training in alternatives to using restraint and seclusion. HCFA

officials said that they would review and consider implementing each of

our recommendations in the near future.

Mr. Chairman, this concludes my statement. I will be happy to answer your

questions.

(201008) Page 12 GAO/T-HEHS-00-26
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