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Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

H R
OSPITAL  EPORTING

D R
 OF  EATHS  ELATED TO 

R S
ESTRAINT AND  ECLUSION

Daniel R. Levinson

Inspector General 

September 2006

OEI-09-04-00350
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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 OIGs 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  
I N T R O D U C T I O N
  E X E C U T I V E   S U M M A R 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 ones 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 patients 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.   
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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 CMSs 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. 
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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 CMSs 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 patients 
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 
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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. 
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  T A B L E   O F   C O N T E N T S  

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

I N T RO DUC T IO N  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  1

F I N D IN G S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  10

Hospitals failed to report one-thirdof deaths  . . . . . . . . . . . . . . . .  10

Untimelyresponse to reported deaths. . . . . . . . . . . . . . . . . . . . . .  11

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

Records notcomprehensive or reliable. . . . . . . . . . . . . . . . . . . . . .  13

R E C O MMEN D A T ION S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  15

Agency Comments andOffice of Inspector General Response . . .  16 

APPENDIX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18

  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  18

A C K NO WL E D G M E N T S  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  20
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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 
Medicares 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 hospitals 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. 
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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 ones body, whereas a drug used as a 
restraint is a medication that is not standard treatment for the patients 
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 patients 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, childrens, 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. 
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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 CMSs 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 patients 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 patients 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 patients 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. 
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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 hospitals compliance with 
the Patients 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 hospitals compliance with the 
Patients 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 hospitals 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. 
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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 
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. 
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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. CMSs 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 seclusion-
related death reports. The purpose of these interviews was to gather 
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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. 
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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 management-
related 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 
patients 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 CMSs 
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 
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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 Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
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  F I N D I N G S

Hospitals failed to report to CMS 44 of 104  Using CMS, State survey agency, 
documented deaths related to restraint and seclusion  P&A, and FDA documentation, we 
between August 2, 1999, and December 31, 2004  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 patients 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 
36 
by hospitals to CMS regional offices 
CMS-documented deaths not reported directly by hospitals to CMS 
8 
regional offices, but received second hand from other agencies 
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). 
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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 
patients death, as required. The median number of days between a 
patients death and hospitals notification to CMS was 7.18 
CMS and State survey agencies do not consistently  CMS regional offices and State 
take action in response to reported deaths in a timely  survey agencies regularly fail to 
meet CMSs timelines for taking 
manner, limiting their ability to address potentially 
action in response to deaths 
harmful conditions 
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 patients death. 
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CMSs 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 
Policy  Actual 
Percentage of Deaths That 
Action  Guideline  Median 
Did Not Meet the Guideline19 
(Days)  Time (Days) 
State survey agency to regional office  0 
1.0  49% 
notification (N=31)  (same day) 
Regional office contact to authorization of 
2  2.0  28% 
investigation (N= 29) 
Regional office authorization to State survey 
5  4.5  33% 
agency starting investigation (N=30) 
Regional office contact to P&A notification 
2  3  38% 
(N=47) 
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. 
CMSs 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 patients 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. 
State survey agencies do not provide regular  CMS requirements state that 
State survey agencies are 
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). 
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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. 
CMSs 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 CMSs 
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. 
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 CMSs 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, 
CMSs 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. 
	 CMSs 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. 
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  R E C O M M E N D A T I O N S  

To improve hospital reporting, the accuracy of data, and CMSs 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 
CMSs 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, CMSs 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 patients 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.  
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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 
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against hospitals that do not comply with the reporting requirement. 
CMSs comments are included in their entirety in the Appendix.    
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A P P E N D I X   ~   A  
  A P P E N D I X  
AGENCY COMMENTS 
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A P P E N D I X

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  A C K N O W L E D G M E N T S  

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 
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