Report Template Version = 06-15-05_rev.08 

Department of Health and Human Services


OFFICE OF 

INSPECTOR GENERAL 

HOSPITAL REPORTING


 OF DEATHS RELATED TO 


RESTRAINT AND SECLUSION


Daniel R. Levinson


Inspector General 


September 2006


OEI-09-04-00350

Report Template Version = 06-15-05_rev.08 

Office of Inspector General 
 http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 

as amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components: 

Office of Audit Services 

The Office of Audit Services (OAS) provides all auditing services for HHS, either by 

conducting audits with its own audit resources or by overseeing audit work done by 

others. Audits examine the performance of HHS programs and/or its grantees and 

contractors in carrying out their respective responsibilities and are intended to provide 

independent assessments of HHS programs and operations. These assessments help 

reduce waste, abuse, and mismanagement and promote economy and efficiency 

throughout HHS. 

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on 

significant issues. Specifically, these evaluations focus on preventing fraud, waste, or 

abuse and promoting economy, efficiency, and effectiveness in departmental programs. 

To promote impact, the reports also present practical recommendations for improving 

program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative 

investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 

and of unjust enrichment by providers. The investigative efforts of OI lead to criminal 

convictions, administrative sanctions, or civil monetary penalties. 

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support in OIG’s internal operations. OCIG imposes program exclusions and civil 

monetary penalties on health care providers and litigates those actions within HHS. 

OCIG also represents OIG in the global settlement of cases arising under the Civil False 

Claims Act, develops and monitors corporate integrity agreements, develops compliance 

program guidances, renders advisory opinions on OIG sanctions to the health care 

community, and issues fraud alerts and other industry guidance. 
Report Template Version = 06-15-05_rev.08 

ΔINTROD UCT ION EXECUTIVE SUMMAR Y 

OBJECTIVE 

To (1) determine whether hospitals fail to report restraint and 

seclusion-related deaths, as required, to the Centers for Medicare 

& Medicaid Services (CMS); and (2) evaluate CMS and State survey 

agency responsiveness, guidance, and monitoring concerning the 

reporting requirement. 

BACKGROUND 

Pursuant to section 1861(e)(9) of the Social Security Act, the Secretary 

of the Department of Health and Human Services establishes 

Conditions of Participation (CoP) that hospitals must meet to 

participate in the Medicare and Medicaid programs. In December 1997, 

CMS published a proposed rule to revise all existing hospital CoPs and 

to include a new Patients’ Rights CoP. The new CoP was, in part, a 

response to reports of violations of patients’ rights in hospitals. The 

new rule became final on July 2, 1999. CMS contracts with State 

survey agencies to assess hospital compliance with these CoPs. 

The Patients’ Rights CoP establishes, among other things, a reporting 

requirement for all hospital deaths associated with the use of restraint 

or seclusion for behavior management (42 CFR § 482.13(f)(7)). The term 

restraint includes either a physical restraint or a drug used as a 

restraint. A physical restraint is any manual method or device used to 

restrict freedom of movement or access to one’s body. A drug used as a 

restraint is a medication that is used to control behavior or restrict 

movement, which is not standard treatment for a patient’s medical or 

psychiatric condition. Seclusion is defined as involuntary confinement 

of a patient to a room or area from which the person is physically 

prevented from leaving. Hospitals must report deaths associated with 

restraint or seclusion for behavior management to their CMS regional 

office prior to close of business on the day following the event.1 This 

provision became effective on August 2, 1999. 

CMS requirements establish timeframes for CMS regional offices and 

State survey agencies to ensure that (1) investigations concerning 

hospital compliance with the Patients’ Rights CoP are timely and 

(2) information about deaths related to restraint and seclusion is 

1 The reporting requirement does not apply to deaths associated with the use of restraint 

for acute medical and surgical care. 

 OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N i 
Report Template Version = 06-15-05_rev.08 

EXE CUTIVE S U MMAR Y 

communicated both to Protection and Advocacy agencies and to the 

CMS central office in a timely manner. 2 The CMS central office 

compiles a roster of deaths related to restraint and seclusion based on 

reports that hospitals forward to regional offices. 

To determine whether hospitals report to CMS all deaths related to 

restraint and seclusion, we compared reports received by CMS to those 

received by State survey agencies, Protection and Advocacy agencies, 

and the Food and Drug Administration for deaths that occurred 

between August 2, 1999 (when the reporting requirement became 

effective), and December 31, 2004. We also gathered information from 

CMS central and regional offices about CMS policies and death 

reporting procedures, interactions with State survey agencies, record 

keeping, and collection of information by the CMS central office. 

FINDINGS 

Hospitals failed to report to CMS 44 of 104 documented deaths 

related to restraint and seclusion between August 2, 1999, and 

December 31, 2004. We received information from CMS, State survey 

agencies, Protection and Advocacy agencies, and the Food and Drug 

Administration concerning 104 behavior management-related deaths 

associated with restraint and seclusion that occurred during this time 

period. Hospitals did not report 44 of these deaths directly to CMS. Of 

those deaths that hospitals reported directly to CMS, fewer than 

one-third were reported timely. 

CMS and State survey agencies do not consistently take action in 

response to reported deaths in a timely manner, limiting their ability 

to address potentially harmful conditions. State survey agencies and 

CMS regional offices regularly fail to meet CMS’s timelines for taking 

action in response to deaths related to restraint and seclusion that are 

reported by hospitals. 

State survey agencies do not provide regular guidance on the 

reporting requirement. Only 52 percent of the State survey agencies 

indicated that, at some point, they had disseminated information to 

hospitals about the reporting requirement. Furthermore, fewer than 

2 Protection and Advocacy agencies, established pursuant to the Developmental 

Disabilities Act of 1975, provide advocacy and legal representation for people with physical 

or mental disabilities within the 50 States, the District of Columbia, Puerto Rico, and the 

U.S. Virgin Islands. 

 OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N ii 
Report Template Version = 06-15-05_rev.08 

EXE CUTIVE S U MMAR Y 

20 percent of State survey agencies provide information on an ongoing 

basis. Therefore, we conclude that hospitals may not understand fully 

the mandatory reporting requirement. 

CMS does not maintain comprehensive and reliable information 

about reported deaths related to restraint and seclusion. CMS does 

not track deaths accurately because its roster excludes relevant deaths 

and includes others for which there is no reporting requirement. CMS 

regional offices do not request information from other agencies about 

hospital deaths related to restraint or seclusion, which would enable 

CMS to identify some unreported deaths. 

RECOMMENDATIONS 

To improve hospital reporting, the accuracy of data, and CMS’s timely 

identification of deaths related to restraint and seclusion, CMS should: 

Seek legislation to establish intermediate sanctions for hospitals 

that fail to report directly to CMS deaths related to restraint and 

seclusion. Currently, termination is the only remedy available to CMS 

if a hospital fails to comply with the CoP. Intermediate sanctions, such 

as civil monetary penalties, would provide CMS with a more 

appropriate remedy for hospitals that do not report timely and directly 

to CMS restraint-related deaths. 

Consider regulatory changes that would require reporting all deaths 

related to the use of restraint and seclusion. If hospitals have 

difficulty distinguishing between medical and behavioral restraint, it 

may prevent them from reporting deaths as required under the current 

reporting requirement. Requiring hospitals to report deaths related 

both to use of restraint and seclusion for behavior management and to 

use of restraint for acute medical and surgical care could improve 

hospital compliance with the reporting requirement. In addition, 

clarifying the language in the regulation that states that a hospital 

must report deaths “where it is reasonable to assume that a patient’s 

death is a result of restraint or seclusion” would eliminate further 

confusion. Hospitals then would have more definitive guidance to assist 

them in determining if a death is subject to the reporting requirement. 

Instruct its regional offices and State survey agencies to adhere to 

timelines. CMS will be able to respond more quickly to patient safety 

issues if it ensures that regional offices and State survey agencies 

adhere to required timelines. Regional offices should hold State survey 

 OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N iii 
Report Template Version = 06-15-05_rev.08 

EXE CUTIVE S U MMAR Y 

agencies accountable for forwarding death reports and conducting 

complaint investigations in a timely manner. 

Encourage State survey agencies to provide to hospitals ongoing 

training about the mandatory reporting requirement. Survey 

agencies could disseminate information to hospital officials regarding 

their reporting responsibilities during onsite reviews or annually. 

Instruct regional offices to request periodic updates about deaths 

related to restraint and seclusion from other Federal and State 

agencies. We found that State survey agencies, Protection and 

Advocacy agencies, and the Food and Drug Administration have 

information regarding deaths related to restraint and seclusion for 

which CMS had no documentation. Improving communication with 

other agencies that receive and document deaths related to restraint 

and seclusion would help CMS identify some deaths that hospitals did 

not report directly to them and to maintain more comprehensive data. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS generally concurred with our recommendations. CMS is 

considering proposing future changes that would simplify requirements 

for hospital reporting of restraint and seclusion-related deaths. CMS 

also indicated it will issue a Survey & Certification Memorandum to 

ensure that regional offices and survey agencies receive written 

instructions that reinforce the hospital death reporting timelines. 

Furthermore, CMS will instruct its regional offices to contact 

periodically survey agencies and other Federal agencies to request 

information regarding restraint and seclusion-related deaths. 

In response to our recommendation that CMS work with Congress to 

establish intermediate sanctions for hospitals that fail to report deaths 

related to restraint or seclusion, CMS indicated that this change would 

be addressed most appropriately through legislative changes by 

Congress. We modified the recommendation to clarify that CMS should 

seek legislation that would allow CMS to impose intermediate sanctions 

against hospitals that do not comply with the reporting requirement. 

 OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N iv 
Report Template Version = 06-15-05_rev.08 

Δ T ABLE OF CONTENTS 

EXECUTIVE SUMMARY .................................... i

INTR O D U C T I ON ........................................... 1

FINDI NGS ................................................ 10

Hospitals failed to report one-third of deaths ................ 10

Untimely response to reported deaths ...................... 11

Limited guidance to hospitals............................. 12

Records not comprehensive or reliable...................... 13

RECOM M E NDATI O NS ..................................... 15

Agency Comments and Office of Inspector General Response . . . 16 

APPENDI X ................................................ 18

 Agency Comments...................................... 18

ACKN O W LEDGMENTS .................................... 20
Report Template Version = 06-15-05_rev.08 

ΔD ESIGN DR AFT INTRODU C TION 

OBJECTIVE 

To (1) determine whether hospitals fail to report restraint and 

seclusion-related deaths, as required, to the Centers for Medicare 

& Medicaid Services (CMS); and (2) evaluate CMS and State survey 

agency responsiveness, guidance, and monitoring concerning the 

reporting requirement. 

BACKGROUND 

Medicare’s Hospital Conditions of Participation 

Title XVIII of the Social Security Act (the Act) establishes coverage and 

benefits under Part A of the Medicare program for inpatient hospital 

services. Section 1861(e)(9) of the Act specifies that a hospital also must 

meet other requirements that the Secretary of the Department of 

Health and Human Services (Secretary) finds necessary in the interest 

of the health and safety of the hospital’s patients. Pursuant to this 

authority, the Secretary established the Conditions of Participation 

(CoP), which hospitals must meet to participate in the Medicare and 

Medicaid programs (42 CFR Part 482). 

CMS contracts with State survey agencies to assess hospital compliance 

with CoPs. Pursuant to section 1865 of the Act, hospitals accredited by 

the Joint Commission on Accreditation of Healthcare Organizations (the 

Joint Commission) or other accrediting organizations approved by CMS, 

such as the American Osteopathic Association, are deemed to be in 

compliance with the CoPs.3 Hospitals that are not accredited, but want 

to participate in the Medicare and/or Medicaid programs, receive 

certification through State survey agencies. State survey agencies 

conduct routine hospital reviews of most nonaccredited short-term acute 

hospitals every 3 years.4 In addition, State survey agencies are required 

to conduct complaint surveys in response to allegations that hospitals 

are out of compliance with CoPs. 

In December 1997, CMS published a proposed rule to revise all existing 

hospital CoPs and include a new Patients’ Rights CoP (62 FR 66726). 

The new CoP was shaped, in part, by reports of patients’ rights 

3 The Joint Commission and the American Osteopathic Association conduct onsite 

surveys at least every 3 years. 

4 Office of Inspector General, “CMS Oversight of Short-Term Acute Care Nonaccredited 

Hospitals” (OEI-01-04-00020), August 2005. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 1 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

violations involving illegal and harmful uses of restraint and seclusion. 

On July 2, 1999, CMS published an interim final rule for the new 

Patients’ Rights CoP for hospitals.5 This provision became effective on 

August 2, 1999. Among other issues, the CoP addresses hospitals’ use of 

restraint and seclusion. Pursuant to section 902 of the Medicare 

Prescription Drug, Improvement, and Modernization Act of 2003, CMS 

must publish the final rule for the Patients’ Rights CoP by December 

2006.6 

The Patients’ Rights CoP defines both restraint and seclusion. A 

restraint is either a physical restraint or a drug used as a restraint. A 

physical restraint is any manual method or device used to restrict 

freedom of movement or access to one’s body, whereas a drug used as a 

restraint is a medication that is not standard treatment for the patient’s 

medical or psychiatric condition used to control behavior or restrict 

freedom of movement. Under the Patients’ Rights CoP, seclusion occurs 

when a patient is confined involuntarily to a room or area and 

physically prevented from leaving. 

Hospital Reporting Requirement for Deaths Related to Restraint and 

Seclusion 

The Patients’ Rights CoP contains two standards related to the use of 

restraint and seclusion: (1) restraint for acute medical and surgical care 

(42 CFR § 482.13(e)) and (2) restraint and seclusion for behavior 

management (42 CFR § 482.13(f)). The behavior management standard 

contains a reporting requirement that states, “. . . a hospital must 

report to CMS any death that occurs 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.”7 Under the reporting requirement, 

hospitals must report the death to their CMS regional office prior to 

close of business on the day following the event.

8 The reporting 

5 64 FR 36070, Medicare and Medicaid Programs; Hospital Conditions of Participation: 

Patients’ Rights. 

6 The Patients’ Rights CoP interim final rule will expire after December 2006 unless the 

Secretary publishes a continuation of the regulation that indicates why CMS did not comply 

with the standard 3-year timetable for publication of final regulations. 

7 For the purpose of this report, we will refer to 42 CFR § 482.13(f)(7) as the “reporting 

requirement.” 

8 Hospitals that must report include acute care, psychiatric, rehabilitation, long term 

care, children’s, and alcohol-drug facilities. State hospitals must report if the restraint or 

seclusion-related death occurred in a part of the hospital that is certified for Medicare 

participation. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 2 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

requirement only applies to deaths associated with the use of restraint 

or seclusion for behavior management, not those associated with the use 

of restraint for acute medical and surgical care. Hospitals that fail to 

report deaths related to restraint and seclusion are subject to 

termination from the Medicare program under section 1866 of the Act. 

In 1999, both the Senate and the House of Representatives introduced 

legislation to authorize intermediate sanctions, including civil monetary 

penalties, for hospitals’ failure to comply with CMS’s death reporting 

requirements.

9 However, neither bill was enacted. 

Appendix A of the CMS “State Operations Manual” describes the 

conditions under which the death reporting requirement applies. 

Pursuant to the requirements, the behavior management standard 

applies in “emergency or crisis situations if a patient’s behavior becomes 

aggressive or violent, presenting an immediate, serious danger to 

his/her safety or that of others.”10 The requirement further clarifies 

that the behavior management standard does not apply to situations in 

which a hospital restrains a “confused” patient who is removing his or 

her intravenous lines or ventilator intubation tube, or a patient who is 

“attempting to get out of bed with an unstable fractured leg.” These 

situations, and others in which a patient is nonviolent, nonaggressive, 

or otherwise cooperative, “may be governed” by the acute medical and 

surgical care standard, which does not have a death reporting 

requirement. 

Hospitals must report any death that occurs while a patient is in 

restraint or seclusion for purposes of behavior management and any 

death that occurs after behavior management restraint or seclusion has 

been discontinued and when the patient’s death could be “reasonably 

related to that patient having been in restraint or seclusion.”11 

However, the “State Operations Manual” does not provide specific 

guidance for hospitals to use in determining when a patient’s death 

should be considered “reasonably related” to restraint or seclusion use. 

CMS Process and Death Reporting Responsibilities 

The CMS “State Operations Manual” includes requirements, first issued 

in a memorandum on March 23, 2000, for CMS regional offices, the 

9 Freedom From Restraint Act of 1999 (S. 736) and Patient Freedom From Restraint Act 

of 1999 (H.R. 1313). 

10 CMS, “State Operations Manual,” Appendix A, section A-0075. 

11 CMS, “State Operations Manual,” Appendix A, section A-0075. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 3 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

CMS central office, and State survey agencies concerning restraint and 

seclusion-related death reporting.12 When a hospital reports a death 

related to restraint or seclusion, the regional office determines whether 

the situation involved the use of restraint or seclusion for purposes of 

behavioral management, based on the information provided. If the 

regional office determines that restraint or seclusion was used for 

behavior management, the regional office authorizes the State survey 

agency to conduct an investigation into the “hospital’s compliance with 

the Patient’s Rights CoP at 42 CFR § 482.13 (including investigating 

the reported death).”13 

The CMS central office is responsible for maintaining a central roster of 

all restraint and seclusion-related death reports and for communicating 

with regional offices as needed until the investigations are completed. 

The CMS central office also is required to maintain a copy of all report 

worksheets collected from the regional offices. 

CMS requirements establish a timeline for regional offices and State 

survey agencies. For behavior management-related deaths associated 

with restraint or seclusion: 

o Regional offices must authorize the State survey agency to conduct 

a complaint investigation into the hospital’s compliance with the 

Patient’s Rights CoP within 2 working days of receiving a restraint 

or seclusion-related death report; 

o State survey agencies must forward information about hospital 

deaths related to restraint or seclusion to their regional office the 

same day they receive information directly from a hospital or other 

source; 

o State survey agencies must complete their investigations within 

5 working days of receiving the survey authorization from the 

regional office; and 

o Regional offices must notify the central office, the relevant State

Protection and Advocacy agency, and the hospital’s accrediting 

organization, if accredited, within 2 working days of receiving a 

restraint or seclusion-related death report. 

12CMS, “State Operations Manual,” Chapter 5, section 5240. 

13 In accordance with the CMS “State Operations Manual,” the State survey agency 

handles each restraint/seclusion death report as a complaint investigation. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 4 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

Additional Sources of Restraint and Seclusion-Related Death Information 

Protection and Advocacy agencies. In addition to CMS, Protection and 

Advocacy agencies (P&As) receive and collect reports of restraint and 

seclusion-related deaths from other sources, such as caregivers and 

patient advocates. These agencies, established pursuant to the 

Developmental Disabilities Act of 1975, provide advocacy and legal 

representation for people with physical or mental disabilities within the 

50 States, the District of Columbia, Puerto Rico, and the U.S. Virgin 

Islands. The Developmental Disabilities Act of 1975 created the 

Protection and Advocacy for Persons with Developmental Disabilities 

Program (42 U.S.C. 15001). The Developmental Disabilities Act 

mandated that each State establish its own P&A program to legally 

protect the rights of persons with developmental disabilities. In 1986, 

Congress passed the Protection and Advocacy for Individuals with 

Mental Illness Act, which extended the P&A system to protect 

individuals with mental illness (42 U.S.C. 10801). Pursuant to 

42 CFR § 51.42, P&As have the authority to investigate deaths and 

incidents of abuse and neglect of individuals with mental illness if the 

incidents are reported to their systems or if there is probable cause to 

believe that the incidents occurred. 

Food and Drug Administration. Through the Medical Device Reporting 

Program, manufacturers, importers, and user facilities such as hospitals 

send reports to the Food and Drug Administration (FDA) about adverse 

events associated with medical devices. The program requires hospitals 

to report any death associated with a medical device, including 

restraints, to FDA and the manufacturer within 10 working days of the 

event. As part of its Hospital Bed Safety Work Group initiatives, FDA 

agreed to forward restraint and seclusion-related adverse event reports 

to CMS beginning in April 2001.14 FDA faxes the relevant reports to 

CMS. This process is described in the CMS “State Operations 

Manual.”15 

OE I-09-04-00 350

14 The MEDSTAT Group, Inc., “Implementation Planning Study for the Integration of 

Medical Event Reporting Input and Data Structure for Reporting to AHRQ, CDC, CMS, and 

FDA, Final Report,” for the Agency for Healthcare Research and Quality, June 2002. 

Available online at http://interprofessional.washington.edu/ptsafety/files/room_for_improve 

.pdf. Accessed March 2006. 

15 CMS, “State Operations Manual,” Chapter 5, section 5240. 

H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 5 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION

Previous Studies on Restraint and Seclusion Reporting 

In August 2000, the Office of Inspector General (OIG) issued an 

evaluation entitled “Restraints and Seclusion: State Policies for 

Psychiatric Hospitals” (OEI-04-99-00150). The report found that many 

State policies met the CoP, but others fell short for both public and 

private psychiatric hospitals with respect to the requirements for 

initiating restraint and seclusion use, time limits, and patient 

monitoring. OIG recommended that CMS work with States and 

accreditation organizations to improve psychiatric hospitals’ compliance 

with the Patients’ Rights CoP, with particular attention to private 

psychiatric hospitals. CMS’s comments on the report indicated that 

CMS already had initiated efforts to provide education and training on 

the CoP to State survey agencies, P&As, accrediting organizations, and 

agency staff. 

In October 1999, the Government Accountability Office (GAO) testified 

before the Senate Finance Committee on the topic of “Mental Health: 

Extent of Risk From Improper Restraint or Seclusion is Unknown” 

(GAO-T-HEHS-00-026). The testimony indicated that (1) the lack of 

comprehensive reporting requirements makes it impossible to identify 

all deaths related to restraint and seclusion; and (2) policies governing 

restraint and seclusion vary among Federal programs, States, and types 

of facilities. GAO recommended that facilities should report any injury 

or death associated with restraint or seclusion to the State licensing 

body and the P&A. 

METHODOLOGY 

Determining Hospital, CMS, and State Survey Agency Adherence to the 

Reporting Requirements 

To determine whether hospitals failed to report deaths related to 

restraint and seclusion to CMS as required, we compared death reports 

and related documentation received by CMS to those received by State 

survey agencies, P&As, and FDA for deaths that occurred between 

August 2, 1999 (when the reporting requirement became effective), and 

December 31, 2004. We used CMS documentation (primarily the report 

worksheets completed by CMS regional offices) to examine CMS and 

State survey agencies’ adherence to timelines for receiving, processing, 

and investigating death reports. We also conducted interviews with 

CMS staff from its central office and the 10 regional offices that are 

responsible for receiving and assessing hospital restraint and seclusionrelated death reports. The purpose of these interviews was to gather 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 6 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

information about CMS policies and death reporting procedures, the

reporting process used by hospitals, interactions with State survey 

agencies, record keeping, and collection of information by the CMS 

central office. We analyzed the responses to these interviews to 

supplement information contained on the report worksheets.

Collecting CMS death reporting documentation. We collected information 

about hospital deaths related to restraint and seclusion from CMS 

central and regional offices. First, we obtained copies of report 

worksheets for deaths that occurred between August 2, 1999, and 

December 31, 2004, from CMS central office staff. We also obtained 

copies of CMS central and regional office correspondence regarding 

restraint and seclusion-related death investigations. After entering 

information received from the CMS central office about deaths related 

to restraint and seclusion into an electronic database, we asked regional 

offices to indicate whether they had received information about any 

additional deaths. We then entered any additional information into a 

consolidated restraint and seclusion death database. We used this 

consolidated database to conduct our analysis of hospital reporting and 

to determine regional offices’ and State survey agencies’ responsiveness 

to reported hospital deaths. 

Collecting P&A and State survey agency documentation. We mailed a survey 

and data request to all 50 State P&As and State survey agencies, as 

well as those in the District of Columbia, Puerto Rico, and the 

U.S. Virgin Islands.16 The survey requested information about P&As 

and State survey agency communications with CMS central and 

regional offices and the process of receiving and forwarding reports. We 

received 53 completed surveys from P&As and 44 completed surveys 

from State survey agencies for a response rate of 100 percent and 

83 percent, respectively. In addition to the survey, we requested that 

P&As and State survey agencies provide a list of all the reports they 

received for behavior management restraint and seclusion-related 

hospital deaths that occurred between August 2, 1999, and December 

31, 2004. For each death report, we requested that P&As and State 

survey agencies provide data such as patient name, facility name, and 

date of death. We matched this information with CMS reports. 

Additionally, we requested that P&As and State survey agencies 

16 The CMS regional office in New York acts as the State survey agency for the U.S. 

Virgin Islands. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 7 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION

provide information about the source of the initial report and any 

documentation that P&As and State survey agencies collected during 

any investigation of a restraint or seclusion-related death. We received 

29 completed data requests from P&As and 24 completed data requests 

from State survey agencies. The remaining 24 P&As and 20 State 

survey agencies indicated that they did not receive any reports of 

hospital deaths related to restraint or seclusion during this period. 

Collecting FDA documentation. We identified 18 behavior managementrelated restraint and seclusion deaths that were included in the 

Manufacturer and User Facility Device Experience (MAUDE) database. 

The MAUDE database contains information about device-related 

adverse events, including restraint deaths, reported after July 31, 1996. 

We requested that FDA conduct a search of all medical device-related 

events in hospitals that resulted in death between August 2, 1999, and 

December 31, 2004. FDA searched for any hospital death report 

associated with medical devices that (1) are categorized officially as 

restraints, (2) are otherwise categorized but were used to restrain a 

patient’s mobility or access to his/her body, and (3) were used while a 

patient was in seclusion. We also identified hospital deaths related to 

restraint and seclusion by searching the MAUDE online public 

database. We used keywords and specific restraint-related product 

codes for hospital deaths that were reported between August 2, 1999, 

and December 31, 2004. 

Comparing documentation among agencies. We received information about 

104 behavior management-related deaths associated with restraint and 

seclusion that occurred between August 2, 1999, and 

December 31, 2004, from CMS, State survey agencies, P&As, and FDA. 

The 104 deaths were comprised of 36 reports maintained by State 

survey agencies, P&As, and FDA, and 68 reports contained in CMS’s 

records. 

Data limitations. This evaluation does not identify the proportion of 

deaths related to restraint and seclusion that hospitals failed to report 

directly to CMS as required. This would have required reviewing 

thousands of records for patients who died during or following a hospital 

stay to determine the proportion of hospital deaths that were associated 

with the use of restraint or seclusion, and the proportion of hospital 

deaths related to restraint and seclusion that were reported to CMS. 

Due to time and resource constraints, we developed the alternative 

strategy of comparing death reports received by CMS to those collected 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 8 
Report Template Version = 06-15-05_rev.08 

INTROD UCT ION 

by other agencies to determine hospital compliance with the reporting 

requirement. 

We did not gather directly from hospitals information about why they 

did not report behavior management deaths related to restraint and 

seclusion to CMS as required. Because many of the deaths occurred 

years before our data collection, we determined that a number of 

relevant records would have been archived and that hospital staff with 

first-hand knowledge of the circumstances surrounding the restraint or 

seclusion-related death would have been difficult to contact for 

interviews. 

We did not receive responses from 9 of the 53 State survey agencies. It 

is possible that those nine State survey agencies had information about 

hospital deaths related to restraint and seclusion that were not reported 

directly to CMS. Because of this missing information, our analysis may 

undercount the number of deaths that hospitals did not report as 

required. Furthermore, the number of deaths related to restraint and 

seclusion may be understated because our data collection was limited to 

deaths that were documented by State survey agencies, P&As, and 

FDA. 

This study was conducted in accordance with the “Quality Standards for 

Inspections” issued by the President’s Council on Integrity and 

Efficiency and the Executive Council on Integrity and Efficiency. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 9 
Report Template Version = 06-15-05_rev.08 

Δ FINDINGS

Hospitals failed to report to CMS 44 of 104 

documented deaths related to restraint and seclusion 

between August 2, 1999, and December 31, 2004 

Using CMS, State survey agency, 

P&A, and FDA documentation, we 

identified 104 behavior 

management deaths related to 

restraint and seclusion that occurred between August 2, 1999, and 

December 31, 2004. Hospitals did not report 44 of these deaths directly 

to CMS as required. Hospitals must report to CMS any death that 

occurs while a patient is restrained or in seclusion for behavior 

management, or when it is reasonable to assume that a patient’s death 

is the result of restraint or seclusion.17 As illustrated in Table 1, we 

identified unreported behavior-management deaths related to restraint 

and seclusion based on our analysis of information from State survey 

agencies, P&As, and FDA, as well as in documentation maintained by 

CMS. 

Table 1: Behavior Management Restraint and Seclusion Deaths 

Documented by CMS and Other Agencies 

State survey agency-, P&A-, and FDA-documented deaths not reported 

by hospitals to CMS regional offices 36 

CMS-documented deaths not reported directly by hospitals to CMS 

regional offices, but received second hand from other agencies 8 

Total documented deaths not reported directly to CMS 44 

CMS-documented deaths reported directly by hospitals to regional offices 60 

 Total deaths documented by CMS and other agencies 104 

Source: Office of Inspector General analysis of CMS, State survey agency, P&A, and FDA death reports, 2005. 

We identified 36 of the 44 unreported deaths by comparing CMS 

documentation to that of State survey agencies, P&As, and FDA. We 

forwarded all of the death reports we received from other agencies to the 

respective CMS regional office to determine whether the deaths were 

associated with restraint or seclusion for purposes of behavior 

management and, therefore, reportable under the requirement. 

According to CMS, 36 of these deaths were reportable. Based on our 

review of CMS documentation, hospitals failed to report an additional 

eight deaths directly to CMS, although CMS received the information 

second hand from State survey agencies or P&As. Hospitals reported 

17 42 CFR § 482.13(f)(7). 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 10 
Report Template Version = 06-15-05_rev.08 

F I NDING S 

six of the eight deaths to other entities (such as the State survey agency 

or P&A) rather than directly to CMS. Hospitals did not report two of 

the eight deaths to any agency. State survey agencies discovered these 

deaths during a complaint investigation or routine survey and 

forwarded the information to CMS. 

Most deaths that hospitals reported directly to CMS were reported late 

Of the 60 behavior management restraint and seclusion-related death 

reports provided directly to CMS by hospitals, fewer than one-third 

were reported to CMS before the close of business on the day after the 

patient’s death, as required. The median number of days between a 

patient’s death and hospitals’ notification to CMS was 7.18 

CMS and State survey agencies do not consistently 

take action in response to reported deaths in a timely 

manner, limiting their ability to address potentially 

harmful conditions 

CMS regional offices and State 

survey agencies regularly fail to 

meet CMS’s timelines for taking 

action in response to deaths 

related to restraint and seclusion 

that are reported by hospitals. CMS established timelines for regional 

office and State survey agency responsibilities to ensure that 

investigations proceed in a timely manner. As illustrated in Table 2, 

neither regional offices nor State survey agencies consistently met these 

timelines. This analysis is based on a total of 51 deaths that were 

identified as behavioral management-related in CMS documentation 

and were reported directly to CMS. We included only deaths that 

occurred after March 23, 2000 (when CMS first issued these 

requirements to regional offices and State survey agencies), in these 

calculations. 

State survey agencies did not provide regional offices with timely 

information about relevant deaths in approximately 50 percent of cases. 

Regional offices and State survey agencies authorized and started 

complaint investigations later than required for approximately 

one-third of the deaths for which documentation is available. In 

addition, regional offices often failed to forward information about 

deaths related to restraint and seclusion to P&As and CMS central 

office within 2 days after the receipt of the death report, as required. 

18 Regional offices received death reports, on average, 37 days after a patient’s death. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 11 
Report Template Version = 06-15-05_rev.08 

F I NDING S 

CMS’s and State survey agencies’ delayed actions may limit their 

effectiveness in addressing unsafe conditions in hospitals. State agency 

surveyors must address underlying problems quickly because other 

patients may be at risk for harm. Despite this, complaint investigations 

were not started until after the required time period for more than 

one-third of the reported deaths. 

Table 2: Comparison of CMS-Established Timelines to Actual Death Report 

Timelines for Behavioral Management-Related Deaths 

Action 

Policy 

Guideline 

(Days) 

Actual 

Median 

Time (Days) 

Percentage of Deaths That 

Did Not Meet the Guideline19 

State survey agency to regional office 

notification (N=31) 

0 

(same day) 1.0 49% 

Regional office contact to authorization of 

investigation (N= 29) 2 2.0 28% 

Regional office authorization to State survey 

agency starting investigation (N=30) 5 4.5 33% 

Regional office contact to P&A notification 

(N=47) 2 3 38% 

Regional office contact to central office (N=45) 2 6 51% 

Source: Office of Inspector General analysis of CMS restraint and seclusion-related death documentation, 2005. 

CMS’s policy requires that regional offices notify P&As of relevant 

restraint and seclusion deaths in hospitals within 2 working days. This 

notification provides P&As with information that could allow them to 

undertake their own investigations into the circumstances surrounding 

a patient’s death. Regional offices’ untimely notification may make it 

more difficult for P&As to initiate investigations while hospital staff 

members are still available and familiar with the circumstances 

surrounding the death. 

CMS requirements state that 

State survey agencies are 

State survey agencies do not provide regular 

guidance on the reporting requirement 

responsible for educating 

hospitals about the reporting requirement. Despite this, only 23 of the 

19 Deaths were excluded from the analysis if the documentation was missing 

information about the date on which one of the actions occurred. We used a 360-day 

calendar to calculate the number of days between these actions (30 days for each month). 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 12 
Report Template Version = 06-15-05_rev.08 

F I NDING S 

44 (52 percent) State survey agencies that provided data on this issue 

indicated that, at some point, they had disseminated information about 

the CoP to hospitals. In addition, only 8 of the 44 (18 percent) State 

survey agencies provide reporting requirement information to hospitals 

on an ongoing basis. According to P&A survey responses, hospitals’ 

lack of information about the reporting requirement may contribute to 

their failure to comply. 

Hospitals may not understand fully the mandatory reporting 

requirement for deaths related to restraint and seclusion. Despite the 

availability of written standards for the reporting requirement, CMS 

regional offices noted that hospitals may have difficulty determining 

whether the reporting requirement applies to a particular death. Six of 

10 regional offices indicated that it is not always clear whether a patient 

is being restrained for behavior management or for acute medical or 

surgical care. The reporting requirement applies to situations in which 

a patient is restrained or secluded for violent, aggressive, or assaultive 

behavior. In cases in which patients are described as “confused,” 

“disorientated,” or “uncooperative,” hospital staff may be unsure 

whether the reporting requirement applies. In addition, hospital staff 

may have difficulty determining when it is “reasonable to assume” that 

a death that follows restraint or seclusion use was the “result of 

restraint or seclusion.” 

The CMS roster is of limited 

CMS does not maintain comprehensive and reliable value because it excludes 

information about reported restraint and information about relevant 

seclusion-related deaths death reports and, in some 

cases, includes deaths for which 

there is no reporting requirement. We determined that deaths reported 

by hospitals to CMS regional offices or discovered by other Federal or 

State agencies are not always included in the central roster. 

CMS’s requirement states: “The CMS Central Office contact will 

maintain the central death report roster and a copy of all death report 

worksheets collected.”20 We identified several problems with CMS’s 

central roster and other documentation that central and regional offices 

maintain about deaths related to restraint and seclusion: 

20 CMS, “State Operations Manual,” Chapter 5, section 5240. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 13 
Report Template Version = 06-15-05_rev.08 

F I NDING S 

• CMS’s central roster does not include information about all 

deaths for which regional offices maintain documentation. 

These deaths may not have been included in the central roster 

because (1) the regional office did not forward the information 

to the central office; (2) the regional office forwarded the 

information, but it was not received by the appropriate central 

office contact; or (3) the central office contact received the 

information, but did not include it in the roster. 

• Although the reporting requirement only applies to deaths 

related to restraint or seclusion for behavior management, 

CMS’s central roster includes information about both 

behavioral and acute medical deaths without clearly 

distinguishing between the two. This may occur because the 

requirement does not state specifically that only behavioral 

deaths should be included in the central roster. As a result, 

CMS is not able to identify how many death reports in their 

central roster apply to the reporting requirement. 

• Almost one-third of the death reports maintained by CMS 

central and regional offices include no information about 

whether the death was associated with behavioral or medical 

restraint use. Regional offices may not have been able to make 

this determination at the time the initial death reports were 

received from the hospital. Regional offices did not update 

their records after staff determined whether the deaths were 

associated with behavioral or medical restraint use. 

• CMS’s documentation does not include information about 

reportable deaths that have been identified by other agencies. 

CMS regional offices do not communicate regularly with other 

Federal or State agencies to compare information about 

hospital deaths related to restraint and seclusion. Therefore, 

they remained unaware of a number of deaths to which the 

reporting requirement applies. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 14 
Report Template Version = 06-15-05_rev.08 

Δ RECOMME NDA TIONS 

To improve hospital reporting, the accuracy of data, and CMS’s timely 

identification of deaths related to restraint and seclusion, CMS should: 

Seek Legislation To Establish Intermediate Sanctions for Hospitals That Fail 

To Report Deaths Related to Restraint and Seclusion Directly to CMS 

CMS’s current sanction options are limited. When CMS discovers 

previously unreported deaths, hospitals must submit a plan of 

correction. If the deficiencies are not resolved satisfactorily, CMS’s only 

recourse is to initiate termination proceedings. Instituting civil 

monetary penalties for hospitals’ failure to report deaths related to 

restraint and seclusion, as required, may give hospitals more incentive 

to report these deaths directly to CMS in a timely manner. 

Consider Regulatory Changes That Would Require Reporting of All Deaths 

Related to Restraint and Seclusion 

If hospitals have difficulty distinguishing between medical and 

behavioral restraint, it may prevent them from reporting deaths as 

required under the current reporting requirement. Requiring hospitals 

to report deaths related to restraint and seclusion for both behavior 

management and acute medical and surgical care may remove this 

uncertainty and improve hospital compliance. In addition, clarifying 

the language in the regulation that states that a hospital must report 

deaths “where it is reasonable to assume that a patient’s death is a 

result of restraint or seclusion” would eliminate further confusion. 

Instruct its Regional Offices and the State Survey Agencies To Adhere to 

Timelines 

CMS will be able to respond more quickly to patient safety issues if it 

can ensure that regional offices and State survey agencies adhere to its 

guidelines. Regional offices should hold State survey agencies 

accountable for reporting deaths and conducting complaint 

investigations in a timely manner. Because hospitals rarely undergo 

routine reviews to address restraint and seclusion death reporting, 

timely complaint investigations are an important opportunity for 

surveyors to ensure that hospital policies and procedures are 

appropriate. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 15 
Report Template Version = 06-15-05_rev.08 

R E C0MMENDA T I O N S 

Encourage State Survey Agencies To Provide Ongoing Training to 

Hospitals About the Mandatory Reporting Requirement 

State surveyors could educate hospital staff on their reporting 

obligations during routine onsite reviews or on an annual basis. P&A 

survey responses suggest that hospitals’ lack of awareness of the 

reporting requirement may contribute to their failure to report. P&As’ 

most common suggestion for improving hospital reporting of deaths 

related to restraint and seclusion was for CMS to improve education 

and communication about the requirement. CMS also could work with 

the Joint Commission and the American Osteopathic Association to 

make restraint and seclusion-related death reporting a more prominent 

part of their hospital review process. 

Instruct Regional Offices To Request Periodic Updates About Deaths 

Related to Restraint and Seclusion From Other Federal and State Agencies 

We found that State survey agencies, P&As, and FDA maintained records 

of a number of deaths related to restraint and seclusion for which CMS 

had no documentation. Improving communication with other agencies 

that receive and document deaths related to restraint and seclusion would 

help CMS identify some deaths that hospitals did not report directly to 

them and maintain more comprehensive data. 

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

CMS generally concurred with our recommendations. CMS is 

considering proposing future changes that would simplify requirements 

for hospital reporting of restraint and seclusion-related deaths. CMS 

also indicated it will issue a Survey & Certification Memorandum to 

ensure that regional offices and survey agencies receive written 

instructions that reinforce the hospital death reporting timelines. 

Furthermore, CMS will instruct its regional offices to contact 

periodically survey agencies and other Federal agencies to request 

information regarding restraint and seclusion-related deaths. 

In response to our recommendation that CMS work with Congress to 

establish intermediate sanctions for hospitals that fail to report deaths 

related to restraint or seclusion, CMS indicated that this change would 

be addressed most appropriately through legislative changes by 

Congress. We modified the recommendation to clarify that CMS should 

seek legislation that would allow CMS to impose intermediate sanctions 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 16 
Report Template Version = 06-15-05_rev.08 

R E C O MMENDA T I O N S 

against hospitals that do not comply with the reporting requirement. 

CMS’s comments are included in their entirety in the Appendix. 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 17 
Report Template Version = 06-15-05_rev.08 

ΔAPP E N D I X ~ A  APPENDIX 

AGENCY COMMENTS 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 18 
Report Template Version = 06-15-05_rev.08 

APP E N D I X

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 19 
Report Template Version = 06-15-05_rev.08 

ΔAPP E N D I X ~ B  ACKNOWLEDGMENTS 

This report was prepared under the direction of Paul A. Gottlober, 

Regional Inspector General for Evaluation and Inspections in the 

San Francisco regional office, and Deborah W. Harvey, Assistant 

Regional Inspector General. Other principal Office of Evaluation and 

Inspections staff who contributed include: 

Camille Harper, Project Leader 

China Eng, Program Analyst 

Michael Henry, Program Analyst 

Doris Jackson, Program Specialist 

Tricia Davis, Director, Medicare Branch 

OE I-09-04-00 350 H O S P I TA L RE P O R T I N G OF DE ATHS RE L AT E D T O RESTRA I N T AND S E C LUSI O N 20