Department of Health and Human Services
OFFICE OF 
 
IN  SPECTOR GENERAL 
 
 
 
 
 
 
 
 
A E H :
DVERSE  VENTS IN  OSPITALS   
 
S   R S  
TATE  EPORTING  YSTEMS
 
 
 
 
 
 
    
 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
December 2008 
OEI-06-07-00471   
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 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.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/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 for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities. 
   
 E X E C U T I V E   S U M M A R Y  
OBJECTIVE
 
To identify and describe State adverse event reporting systems and how 
States use the reported information. 
BACKGROUND 
The Tax Relief and Health Care Act of 2006 (the Act) mandates that the 
Office of Inspector General (OIG) report to Congress regarding the 
incidence of never events among Medicare beneficiaries.  Never events 
are a specific list of serious events, such as surgery on the wrong 
patient, that the National Quality Forum (NQF) deemed should never 
occur in a health care setting.  Expanding beyond this specific list, this 
and other OIG reports use the broader term adverse event which 
describes harm to a patient as a result of medical care, such as infection 
because of contaminated equipment.     
This report describes State adverse event reporting systems as of 
January 2008 in all 50 States and the District of Columbia (hereinafter 
referred to as States).  Our review is based on State documents, such as 
regulations, policies and procedures, other materials that reference 
adverse events, and aggregate reports of adverse events provided by 
States with systems.  We conducted structured interviews by telephone 
with staff from each State who were responsible for either the State 
adverse event reporting system or State oversight of patient safety in 
hospitals.   
FINDINGS 
As of January 2008, 26 States had hospital adverse event reporting 
systems and another State had taken action to develop one.  Each of 
the 26 States systems met the criteria that we used.  They were 
authorized through State law, had formal policies and procedures for 
reporting, and were actively collecting data from hospitals.  The 
remaining 25 States did not have adverse event reporting systems, 
although 1 State had passed legislation to authorize a system and was 
developing policies and procedures.  Many of the States systems were 
relatively new, with 10 systems being operational for less than 3 years. 
Reporting systems varied in terms of what events were reported, 
criteria used for selection, and type of information reported.   
Twenty-three States established their own lists of reportable adverse 
events, and three States used NQFs list of Serious Reportable Events.  
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State criteria for determining whether an event is reportable focus 
primarily on the level of harm caused to the patient, although 
additional criteria affect whether the same event would be reportable in 
other States.  Each of the 26 States systems had different requirements 
regarding the information that must be included about the following:  
the event itself, the patient involved in the event, the result of any root 
cause analyses, and any corrective action plans and/or risk reduction 
strategies. 
Most States with systems reported having mechanisms to identify 
underreporting and strategies to improve reporting.  Staff from 15 of 
the 26 States acknowledged that hospitals do not always submit reports 
when adverse events occur.  To identify specific instances of 
underreporting, staff reported that their State:  analyzes reported data 
(11 States); compares hospital reports against complaints, referrals, and 
administrative databases (16 States); and conducts onsite audits  
(3 States).  To motivate hospitals to report, States have several 
strategies, including protection of reported data from improper 
disclosure, monetary penalties for hospitals that fail to report, and 
provision of feedback to hospitals about reported events.     
Twenty-three States reported using data to hold individual hospitals 
accountable; 18 reported using data to promote learning and prevent 
adverse events.  To hold hospitals accountable for their patient care 
performance, staff from 23 of the 26 States with systems explained that 
adverse event reports resulted in desk or onsite audits, and/or State-led 
investigations of the hospitals handling of reported events.  Four of 
these States also reported using adverse event reports in licensing 
decisions for hospitals.  Eighteen of the twenty-six States use reports to 
communicate with hospitals about best practices and Statewide 
incidence of adverse events, to provide early warnings about specific 
patient safety issues, and to provide details about specific events on 
State Web sites.  Of the remaining eight States, three had systems that 
had been in operation for about 1 year at the time of data collection in 
early 2008 and were still developing hospital communication 
mechanisms and five States did not report using adverse event reports 
to provide information to hospitals. 
CONCLUSION 
In the absence of both a national system and Federal guidelines 
regarding State reporting systems, about half of the States have taken 
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the initiative to implement hospital adverse event reporting systems.  
These systems appear to be disparate, with each tracking different 
events, employing different reporting criteria, and requiring differing 
accompanying information.  The differences we found make State 
adverse event reporting systems data unsuitable for use in the 
aggregate to identify national incidence and trends.  Despite these 
distinctions among reporting systems, we noted that most States use 
reported data in similar ways.  To improve patient safety, States use 
reports to assess individual hospitals responses to adverse events, and 
also draw from reports to promote learning and prevent adverse events.  
States may find that opportunities exist to expand their use of reported 
data by employing methods used by other States.  Finally, although the 
26 States require hospitals to report adverse events when they occur, 
staff from most of these States described mechanisms used to identify 
underreporting.  Beyond strategies currently being used, States may 
find it prudent to consider other means to ensure reporting by hospitals.    
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
We received comments on a draft of this report from the Agency for 
Healthcare Research and Quality (AHRQ) and CMS.  AHRQ and CMS 
provided positive comments on the draft report.   
AHRQ called for greater precision when discussing the differences 
between NQFs list of Serious Reportable Events (formerly referred to 
as never events) and CMSs payment policies for hospital-acquired 
conditions.  Although this report does not examine CMSs payment 
policies, we will ensure that other OIG reports on this topic make these 
distinctions clear. 
CMS expressed its belief that the report should more clearly describe 
the impediments facing the Federal Government and CMS in managing 
data identifying adverse events given the existing fragmented systems.  
According to CMS, data from State systems are not useful in 
understanding national issues and trends because of the variability in 
States identification of adverse events.  We modified the reports 
conclusion to underscore that data from State adverse event reporting 
systems are unsuitable for national-level analyses.     
Because of the variability among State-based systems, CMS indicated 
that it would be helpful to identify potential solutions, such as 
amending the Patient Safety Act to make reporting of well-defined 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  iii   
E X E C U T I V E   S U M M A R Y  
adverse events mandatory.  CMS also indicated that it would be helpful 
to identify other partners in reporting system efforts, such as AHRQ.  In 
planning future work in this area, we will consider the issues addressed 
in CMSs comments. 
Finally, CMS stated that it had recently issued a letter to State 
Medicaid Directors about Medicaid payment implications for selected 
adverse events.  CMS explained that the intent of this letter was to offer 
States an opportunity to tie Medicaid payment to performance through 
denial of payment for selected adverse events.  According to CMS, there 
are seven pending State Plan Amendments to restrict payment for 
selected adverse events, and State systems used to prevent or recoup 
Medicaid payments could serve as a model for a national system.   
 
  
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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 
  Twenty-six States had adverse event reporting systems. . . . . . . . . 7 
  Reporting systems varied across States. . . . . . . . . . . . . . . . . . . . . . 8 
States reported having mechanisms to identify underreporting       
and strategies to improve reporting  . . . . . . . . . . . . . . . . . . . . . . . 12 
  States reported using data for accountability and learning . . . . . 14 
 
 
CONC LUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 
  Agency Comments and Office of Inspector General Response . . . 19 
 
 
APPENDIXES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 
  A:  Glossary of Selected Terms. . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 
  B:  National Quality Forum List of Serious Reportable Events . . 22 
  C:  Tax Relief and Health Care Act of 2006. . . . . . . . . . . . . . . . . . 23 
  D:  States With Adverse Event Reporting Systems. . . . . . . . . . . . 25 
E:  State-by-State Reporting Requirements for Hospital                        
Adverse Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 
F:   Agency Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 
 
   
A C K NO WL E D G M E N T S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 
   
 I N T R O D U C T I O N  
OBJECTIVE 
To identify and describe State adverse event reporting systems and how 
States use the reported information. 
BACKGROUND 
The term adverse event describes harm to a patient as a result of 
medical care.  An adverse event indicates that the care resulted in an 
undesirable clinical outcome and that the clinical outcome was not 
caused by an underlying disease.  Adverse events include medical 
errors, such as use of incompatible blood products.  They may also 
include more general substandard care that can result in harm, such as 
infection because of contaminated equipment, incorrect diagnoses, and 
lack of patient monitoring during treatment.  Research, policies, and 
action taken to reduce adverse events often focus on mistakes and 
systemic problems with care.  However, adverse events do not always 
involve errors, negligence, or poor quality of care and may not always be 
preventable. 
A variety of terms, lists, and definitions are used to identify and address 
harmful health care events.  For a glossary of selected terms, see 
Appendix A.  The term never event is used to describe a specific list of 
serious events that the National Quality Forum (NQF) determined 
should never occur in a health care setting and are associated 
primarily with patient death or serious disability.1  NQF currently uses 
the term serious reportable events to describe this list.  For the list of 
NQF Serious Reportable Events, see Appendix B.  Expanding beyond 
the specific events defined by NQF, this and subsequent Office Inspector 
General (OIG) reports use the broader and more common term adverse 
event to provide for a more comprehensive examination of key issues.  
Statutory Mandate and Office of Inspector General Response 
The Tax Relief and Health Care Act of 2006 (the Act) requires that OIG 
study events that cause harm to Medicare beneficiaries.  The Act 
specifically mandates that OIG study the incidence of never events 
among Medicare beneficiaries, payment by Medicare or beneficiaries for 
services furnished in connection with such events, and administrative 
 
1 NQF is a public-private organization created to develop and implement a national 
strategy for health care quality measurement and reporting.  This list is available online at 
http://www.qualityforum.org/about.  Accessed on October 10, 2008. 
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processes of the Centers for Medicare & Medicaid Services (CMS) to 
identify events and deny or recoup payment.  OIG is also to report to 
Congress on the studies conducted, including recommendations for such 
legislation and administrative action as OIG determines appropriate.  
For relevant text of the Act, see Appendix C.   
Following a review of Medicare policies and expenditures, as well as 
consultation with CMS and the Agency for Healthcare Research and 
Quality (AHRQ), we chose to focus much of our work on the hospital 
setting.  In 2006, 12.5 million Medicare beneficiaries were hospitalized,2 
with inpatient hospital costs constituting the largest portion of 
Medicare expenditures (32 percent in 2006).3  Also, many current efforts 
by Federal Government agencies and private entities to research and 
address adverse events target care provided in hospitals. 
OIG is conducting a series of studies through 2009 to fulfill the 
requirements in the Act and to inform decisionmakers regarding 
adverse events.  To facilitate OIG efforts to comply with the Act, we first 
sought to identify key issues regarding adverse events in hospitals to 
provide direction and context for our future work.4   A key issue 
identified was hospital reporting of adverse events.  This study focuses 
on State efforts to operate adverse event reporting systems.  Other OIG 
studies focus on estimating the incidence of adverse events among 
Medicare beneficiaries, Medicare beneficiaries receiving potentially 
inappropriate drug pairs that may reflect medication errors, and 
responses to adverse events in hospitals.      
Adverse Event Reporting Systems 
A State-level adverse event reporting system (hereinafter referred to as 
a system) collects data regarding adverse events that have taken place 
in hospitals and other health care settings.  The Institute of Medicine 
(IOM) report, To Err is Human:  Building a Safer Health Care System, 
outlines key issues associated with reporting and collecting data and a 
 
2 CMS, Statistics Book, Table IV.1:  Medicare/short-stay hospital utilization, 2008,  
p. 43.  Available online at 
http://www.cms.hhs.gov/CapMarketUpdates/Downloads/2008CMSStats_xls.pdf.  Accessed 
on November 12, 2008. 
3 Based on data contained in Congressional Budget Office (CBO) Fact Sheet for CBOs 
March 2007 Baseline:  Medicare, March 7, 2007.  Available online at   
http://www.cbo.gov/budget/factsheets/2007b/medicare.pdf.  Accessed on September 8, 2008. 
4 Adverse Events in Hospitals:  Overview of Key Issues, 2008, OEI-06-07-00470. 
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national plan to address adverse events.5  As part of this plan, IOM 
recommended the creation of a nationwide system that provides for the 
collection of standardized data by State governments when adverse 
events occur.  IOM maintained that reporting has the potential to serve 
two purposes:  to hold individual hospitals accountable for performance 
and to provide information that could lead to improved patient safety.  
To date, no national adverse event system exists and there are no 
Federal standards regarding State systems.  Instead, States may opt to 
require hospitals to report adverse events, identify and define which 
events are reportable, and establish parameters surrounding the 
specific information for hospitals to report.   
As mentioned previously, NQF has identified a list of serious reportable 
events.  This list has six categories of events, five of which relate to the 
provision of care:  surgical, product or device, patient protection, care 
management, and environmental.  The sixth category involves criminal 
events and is included by NQF because such events could indicate an 
unsafe environment for patients.  The criteria for inclusion on this list 
require that events be: 6  
  of concern to the public, health care professionals, and providers; 
  clearly identifiable, measurable, and so feasible to include on a list;  
  such that the risk of occurence is significantly influenced by the 
policies and procedures of a health care facility; and  
  unambiguous, usually preventable, and serious; and  
o  adverse; and/or  
o  indicative of a problem in a health care facilitys safety 
systems; and/or  
o  important for public credibility or accountability.   
A number of Federal and nongovernmental entities receive adverse 
event reports from hospitals and other health care entities.  For 
example, the Food and Drug Administration (FDA) receives information 
 
5 L. T. Kohn, J. M. Corrigan, and M. S. Donaldson, eds., To Err is Human:  Building a 
Safer Health System,  A Report of the Committee on Quality of Health Care in America, 
Institute of Medicine, p. 102.  Washington, DC, National Academy Press, 2000.  
6 NQF, Serious Reportable Events in Healthcare, 2006 Update, 2007, pp. 4, D-4.   
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I N T R O D U C T I O N  
about adverse events involving drugs, biologics, and medical devices.7  
Additionally, hospitals participating in Medicare must report to CMS all 
deaths associated with the use of seclusion or restraints as well as 
develop and maintain systems for tracking adverse events.8  The Joint 
Commission, which establishes standards and accredits hospitals, 
encourages but does not require accredited hospitals to report certain 
adverse events deemed sentinel events to the Joint Commission.9   
Additionally, to address concerns about patient safety, the Patient 
Safety and Quality Improvement Act of 2005 (the Patient Safety Act) 
was enacted.10  The Patient Safety Act requires the Department of 
Health and Human Services to establish a national network of Patient 
Safety Organizations (PSO) to, among other tasks, accept voluntary 
reports of adverse events from hospitals.11  In November 2008, AHRQ 
designated the first 15 PSOs and is continuing to solicit applications for 
additional PSOs.12  AHRQ has also developed common formats for use 
by Patient Safety Organizations, which delineate definitions and data 
elements that allow hospitals to collect and submit standardized 
information regarding adverse events.13   
METHODOLOGY 
Scope  
This report identifies and describes adverse event reporting systems in 
all 50 States and the District of Columbia (hereinafter referred to as 
States) as of January 2008.   
 
 
 
7 21 CFR  314.80(c), 21 CFR  600.80(c), 21 CFR  606.170, 21 CFR Part 803, 21 CFR    
 1271.350.   FDA Safety Information and Adverse Event Reporting Program.  Available 
online at http://www.fda.gov/medwatch/index.html.  Accessed on October 15, 2008.  
8 42 CFR  482.13(g) and 482.21(a)(2). 
9 Sentinel events are defined by the Joint Commission as unexpected occurrences 
involving death or serious physical or psychological injury, or risk thereof.  The Joint 
Commission, Sentinel Event Policy and Procedures.  Available online at 
http://www.jointcommission.org/SentinelEvents/PolicyandProcedures/.  Accessed on   
August 7, 2008. 
10 The Patient Safety Act, P.L. No. 109-41.      
11 Ibid, at  923. 
12 AHRQ, Alphabetical Directory of Listed Patient Safety Organization. Available 
online at http://www.pso.ahrq.gov/listing/psolist.htm.  Accessed on November 20, 2008. 
13 73 Fed. Reg. 50974 (August 29, 2008).   
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Identification of States With Reporting Systems 
For purposes of this report, we considered a State to have an adverse 
event reporting system if its system: 
  was authorized through State statute, rules, or Executive order; 
  had policies and procedures for reporting; and 
  was actively receiving reports from hospitals as of January 1, 2008.   
To identify States with systems, we created a list from the following 
sources:  (1) AHRQs Patient Safety Incident Reporting Systems     
metadatabase,14 (2) the National Academy of State Health Policys 
Patient Safety Toolbox,15 and (3) information from State adverse event 
reporting systems Web sites.  We also called States to confirm the 
information.   
For States without known systems, we gathered information from State 
Web sites as an entry point for locating departments and divisions 
responsible for oversight of patient safety in hospitals.  We then called 
States to confirm that the State did not have a system.  
Data Collection  
We conducted three data collection activities:  (1) a review of State 
statutes and regulations, policy and procedural documents, and other 
documents provided by States, such as annual reports that draw from 
reported events; (2) structured telephone interviews with State staff 
who were responsible for either the State adverse event reporting 
system or State oversight of patient safety in hospitals; and  
(3) collection of the number of adverse events from State annual reports, 
spreadsheets submitted by State staff, and State Web sites.   
Document Review.  We requested and reviewed documentation provided 
by States regarding their systems.  We also collected and reviewed 
documents from States Web sites.  This information included State 
statutes, regulations, policies and procedures, adverse event report 
forms, annual reports, and patient safety alerts/bulletins.   
Structured Interviews With Selected Staff.  We conducted structured 
interviews by telephone with staff from each State who were responsible 
 
14 AHRQ Patient Safety Research Coordinating Center Portal.  Available online at 
https://mdis.s-3.com.  Accessed on October 1, 2007. 
15 National Academy of State Health Policy, Patient Safety Toolbox.  Available online 
at http://www.pstoolbox.org/.  Accessed on February 8, 2007.  
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for either the system or State oversight of patient safety in hospitals.  
We developed and administered separate interview protocols for States 
with systems and States without systems.  
For each State with a system, we asked State staff questions about: 
  system administration, including entities responsible for operating 
the system, State laws and regulations related to reporting, how 
adverse events are defined and reported, and mechanisms to ensure 
reporting;  
  information recorded in the system as an adverse event report, such 
as information about causal analysis (hereinafter referred to as root 
cause analysis), interventions, actions, strategies designed to reduce 
the risk of occurrence (hereinafter referred to as risk reduction 
strategies), and corrective action plans; and 
  how the State uses reported information.  
We asked staff from each State without a system questions about any 
State-sponsored actions to develop one. 
Adverse Event Reports.  We requested that States provide the aggregate 
number of adverse events received from hospitals in 2006 by the type of 
adverse event.16  States provided these data through spreadsheets, 
published annual reports, and/or their Web sites.   
Limitations 
The information in this report reflects State efforts as reported by State 
staff.  We verified this information by reviewing supporting documents 
that staff provided or we accessed through State Web sites.  However, 
we did not independently verify the extent to which States with systems 
are using reported information in the manner described by State staff.     
Data regarding the number of adverse events received by State systems 
in 2006 are not standardized across States.  Therefore, we could not 
aggregate adverse event reports or identify trends or patterns based on 
the number of reported adverse events across States.   
Quality Standards 
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. 
 
16 For some States with reporting systems, 2006 was the most recent full year for which 
data were available at the time of our data request in February 2008. 
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As of January 2008, 26 States had hospital  Each of the 26 States systems met 
adverse event reporting systems and another  the criteria that we used:  they 
were authorized through State law, 
State had taken action to develop one  
had formal policies and procedures 
for reporting, and were actively collecting data from hospitals.  The 
remaining 25 States did not have systems, although 1 State had passed 
legislation authorizing a system and was developing policies and 
procedures.17  Four of the twenty-six States with systems supplement 
reports received from hospitals with reports from hospital staff and the 
public.18  In most of these States, governmental agencies (usually the 
Department of Health or another State department) received reports; 
however, two States contracted with nongovernmental entities to collect 
these data. 
Many of the 26 States systems were relatively new and implemented 
within the last 10 years.  As of January 2008, 10 systems had been in 
operation less than 3 years, 8 had been in operation 49 years, and  
8 had been operating for 10 years or more.  Eighteen States submitted 
the number of adverse events reported by hospitals during 2006.19  For 
this timeframe, the number of adverse events reported by hospitals in 
these States ranged from 6 to 16,442 events.20  However, as we describe 
on the next page, given States differences in the types of events and 
criteria used for selection, it is not surprising that such a wide range of 
reported events exists.  See Appendix D for more information about 
each States system and the number of events reported in 2006 by State.
 
17 Illinois Adverse Health Care Events Reporting Law of 2005, 410 Ill. Comp. Stat 522, 
Article 10.  Although the statute directed that the States system be fully operational by 
January 1, 2008, the system was not actively collecting data from hospitals at the time of 
our data collection and therefore did not meet our criteria for inclusion. 
18 Hospital staff may submit adverse event reports directly to the State in Indiana, 
Kansas, Pennsylvania, and South Dakota.  Members of the public may submit adverse 
event reports directly to the State in Kansas and South Dakota. 
19 Twenty-two States reported collecting data in 2006.  We received aggregate data for 
the entire year from 18 of these 22 States.  Of the remaining four States, one provided data 
that combined totals from hospitals and ambulatory surgical centers; staff from one State 
reported that they could not aggregate reported events; and the other two States began 
collecting data in mid-2006 and, therefore, could not report complete data for the year.   
20 This range does not include the number of near misses reported to Pennsylvania in 
2006. 
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F I N D I N G S  
We examined information 
Reporting systems varied in terms of what events 
reported by State staff in the      
were reported, criteria used for selection,     
26 States with systems and 
and type of information reported 
identified differences in three 
major areas:  the list of reportable events; criteria for determining 
whether events are reportable; and the extent to which adverse event 
details, such as the specific location in which the event occurred or key 
factors that contributed to the event, must also be submitted to the 
State.   
Twenty-three States established their own lists of reportable adverse events, 
and three States used the National Quality Forums list of Serious 
Reportable Events  
Eight of the twenty-three States that established their own lists of 
reportable events used the NQF list of Serious Reportable Events as a 
starting point and modified it by adding events and/or by not using 
some events on the NQF list.21  In general, States that established their 
own lists of events have wide variation in the events that are included.  
Some States identify very specific events.  For example, Ohio requires 
hospitals to report all incidents of postoperative respiratory failure.  
Other States have broad specifications that could capture a range of 
events.  For example, Pennsylvania requires hospitals to report any 
serious event, occurrence, or situation involving the clinical care of a 
patient in a medical facility that results in an unanticipated injury and 
requires additional medical care.22  
State criteria for determining whether an event is reportable focus primarily 
on the level of harm caused to the patient, although additional criteria affect 
whether the same event would be reportable in other States 
All States with systems ask hospitals to gauge whether harm was 
caused to the patient and to assess the severity of this harm when 
determining whether an event should be reported.  We developed five 
categories to describe how systems use severity of harm to determine  
 
21 State staff expressed one of two general opinions about the use of the NQF list.  Most 
of those that used the list believed that it would be useful for sharing information about 
events across States.  Most of those that did not use the list reported that they considered 
the list vague and open to interpretation.  Two States (Maine and Massachusetts) 
reported comparing their State-determined list with the NQF list and found that their 
reporting criteria led to the identification of a much larger number of events.    
22 Medical Care Availability and Reduction of Error Act, P.L. No. 154, No. 13, chapter 3, 
 302 and 313 (a).   
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  8   
FF              II NN DD II NN GG SS   
  
wwhheetthheerr  eevveennttss  aarree  rreeppoorrttaabbllee..    TThheessee  ccaatteeggoorriieess  iinncclluuddee::  
   EEvveennttss  rreessuullttiinngg  iinn  ddeeaatthh.  These events may include death 
unrelated to the patients underlying condition, unanticipated death, 
or death as an outcome of any reportable adverse event.  All States 
use this criterion for at least one reportable event.  For example, 
South Dakota requires hospitals to report any death resulting from 
circumstances other than natural causes, such as accidents, abuse, 
negligence, or suicide.23    
  Events resulting in long term harm or permanent disability.  These 
events may include serious disability or loss of bodily function.  
Twenty-three States use this criterion for at least one reportable 
adverse event.  For example, Maine requires hospitals to report any 
major permanent loss of function that is not present on admission.24   
  Events resulting in harm and likely to require additional medical 
care.  These events may include unanticipated injury or  
life-threatening, serious, or unforeseen complications.  Twenty-four 
States use this criterion for at least one reportable adverse event.  
For example, Connecticut requires hospitals to report any incident 
in which a gas line designated for oxygen to be delivered to a patient 
contains the wrong gas.25   
  Events not resulting in identifiable physical harm.  These events 
may not result in death or physical disability and may not require 
additional medical care.  They are reportable because they happened 
and may reflect vulnerabilities in the hospital environment.  
Twenty-three States use this criterion for at least one reportable 
adverse event.  For example, Tennessee requires hospitals to report 
instances in which there is misappropriation of patient funds.26     
  Near misses.  These events are occurrences that could have resulted 
in an adverse event but the event was averted and the patient was 
not harmed.  Only one State, Pennsylvania, uses this criterion for 
 
23 Administrative Rules of South Dakota,  44:04:01:07. 
24 Maine:  Title 22, chapter 1684,   8752.4(A)(2); 8753. 
25 State of Connecticut Department of Public Health, Legislative Report to the General 
Assembly:  Adverse Event Reporting, October, 2007,  p. 9.  Available online at 
http://www.ct.gov/dph/lib/dph/hisr/hcqsar/healthcare/pdf/adverseeventreportoct2007.pdf.  
Accessed on March 20, 2008. 
26 Tennessee Health Data Reporting Act of 2002 Code,  68-11-211(d)(2)(xx). 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  9   
F I N D I N G S  
reportable adverse events, e.g., when medical staff narrowly avert 
conducting wrong-site surgery. 27 28  Staff from this State explained 
that by requiring hospitals to identify and report near misses, the 
State has the opportunity to bring about changes to prevent an 
event from reaching a patient.  For example, Pennsylvania received 
a near miss report about a patient who nearly died because of 
confusion over the meaning of the patients color-coded wristband.  
Some hospital staff believed that the patients wristband color 
meant do not resuscitate, when it actually meant something else.  
The incident prompted the State to issue an advisory on the risks 
associated with using specific colors to convey clinical information.  
Although harm forms the foundation for reporting criteria, 13 States 
also ask hospitals to evaluate additional criteria, such as the length of 
time the patient experienced a certain outcome (8 States), whether the 
condition persisted at the date of discharge from the hospital (8 States), 
and whether persons other than the patient were also affected by the 
event (4 States).  Hence, the severity of harm coupled with additional 
criteria affects whether the same adverse event is reportable in 
different States.  To illustrate, if a medical device is used or functions 
other than as intended, it is a reportable event in:  
  Georgia if the outcome is death of the patient;29  
  New York if the outcome is death or serious injury to the patient or 
hospital personnel;30 and 
  New Jersey if the outcome is patient death, loss of a body part, 
disability, or loss of bodily function lasting more than 7 days or 
present at discharge.31   
 
27 Pennsylvania Patient Safety Authority, PA-PSRS Automated Data Interface XML 
Specifications, Part 3, Version 6.4, September 19, 2007, p. 12. 
28 Staff from two other States indicated that although mandated by legislation to collect 
data on near misses, they had not implemented this provision as of January 2008. 
29 Georgia Hospital Rules,  290-9-.07(2)(a)1(i). 
30 State of New York Department of Health, NYPORTS, Section 3:  Includes and 
Excludes List, Version 4, 2005, p. 5. 
31 New Jersey Department of Health and Senior Services, Mandatory Patient Safety 
Reporting Requirements for Licensed Health Care Facilities (Revised):  Patient Safety 
Initiative, 2008,  pp. 35.  Available online at: 
http://www.nj.gov/health/ps/documents/final_directions_march08.pdf.  Accessed on        
April 3, 2008. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  10   
F I N D I N G S  
State requirements differ regarding what information hospitals must provide 
in adverse event reports  
Each of the 26 States systems had different requirements regarding the 
information that must be included about the following:  the event itself, 
the patient involved in the event, the result of any root cause analyses, 
and any corrective action plans and/or risk reduction strategies.  See 
Appendix E for a listing of information that should be submitted to each 
State.   
Information that describes the event.  At a minimum, adverse event 
reports in all 26 States with systems must identify the type of adverse 
event and the hospital in which the event occurred.  Twenty-four States 
also require the hospital to submit additional information about the 
adverse event itself, including the date the event occurred and a 
summary description of the event.  Twenty States also require the 
hospital to report the location or service area in which the adverse event 
occurred, such as an emergency department, operating room, 
laboratory, or intensive care unit.   
Information about the patient.  Nineteen of the twenty-six States require 
hospitals to submit information about the patient involved in the event.  
These States all require the hospital to submit the patients date of 
birth.  Other information required includes the patients diagnosis  
(16 States); the impact of the event on the patient (12 States); and 
identifying information such as the patient medical record number  
(5 States) and/or the patient billing number (2 States). 
Results of a root cause analysis.  Seventeen of the twenty-six States 
require the hospital to submit documentation of the results of its root 
cause analysis of the event.32  This documentation must include 
information regarding factors that contributed to the event (16 States), 
any identified cause for the event (12 States), and the names or titles of 
the persons who conducted the root cause analysis (7 States).  
Corrective action plans and/or risk reduction strategies.  Twenty of the 
twenty-six States require the hospital to submit a corrective action plan 
or a risk reduction strategy that the hospital has determined will reduce 
the risk of future occurrences of the event.  Some of these States require 
additional information, such as a timeline for implementation of the 
 
32 Some of these States do not use the term root cause analysis to describe their causal 
analyses, but the elements typically considered as part of root cause analysis were present 
in State reporting forms for each of these States. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  11   
F I N D I N G S  
strategies (11 States), measures of effectiveness (10 States), entities 
responsible for implementation (10 States), and entities responsible for 
monitoring the effectiveness of the risk reduction strategies (9 States).   
 
Staff from 15 of the 26 States 
Most States with systems reported having 
acknowledged that hospitals do 
mechanisms to identify underreporting and 
not always submit reports when 
strategies to improve reporting 
adverse events occur.  However, 
staff from nearly all of these States were reluctant to estimate the 
extent to which adverse events go unreported, typically expressing that 
they could not know how many events actually occur.  Nonetheless, staff 
described methods to identify specific instances of underreporting and 
explained strategies that their States use to encourage hospitals to 
submit reports.   
States identify instances of underreporting by comparing hospitals and by 
matching reports against other data sources 
Staff from 11 of the 26 States with systems explained that their State 
analyzes reported data to identify specific instances of underreporting.  
For example, Pennsylvania identified reporting disparities among 
hospitals by analyzing the number of reports per hospital for every 
1,000 patient-days.33  It found a wide range of reports across hospitals, 
with the top 25 percent of reporting hospitals submitting 36 to  
302 adverse event reports per 1,000 patient-days, and the bottom  
25 percent of hospitals reporting 0 to 8 events per 1,000 patient-days.  
State staff theorized that this range could be explained by hospitals 
differing interpretations of events; systems for identifying events; 
cultures regarding patient safety; and/or patient case mix, which can 
affect the rates of serious events. 
Staff from 16 of the 26 States reported identifying specific instances of 
hospital underreporting by comparing hospital reports against 
complaints, referrals, and administrative databases.  For example, staff 
from one State explained that underreported events are discovered 
through referrals received from its Medicaid contractors.  In one such 
case, the contractor discovered potential adverse events during a 
routine review of the utilization of Medicaid services.  Similarly, staff 
 
33 Pennsylvania Patient Safety Authority, 2007 Annual Report, April 29, 2008, p. 32.  
Available online at http://www.psa.state.pa.us/psa/lib/psa/annual_reports/annual_ 
report_2007.pdf.  Accessed on May 7, 2008. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  12   
F I N D I N G S  
from another State reported receiving referrals from State certification 
surveyors who discover events during onsite reviews.  Other States 
reported actively identifying underreported events by reviewing patient 
death records (two States), administrative databases that contain 
inpatient or emergency room data (two States), and Medicaid claims 
data (one State).  
Finally, staff from three States also reported uncovering events by 
conducting onsite audits of hospitals that rarely file reports.  State staff 
reported that, during these visits, they review committee meeting notes, 
e.g., notes of the operating room committee or the coding committee; 
examine accident report data; and assess the hospitals processes 
related to patient safety and adverse events, all of which may reveal 
unreported events.     
Strategies to improve reporting include legal protections to prevent 
improper disclosure, monetary penalties for failing to report, and provision 
of useful information to hospitals about reported events 
Twenty-five of the twenty-six States with systems reported that 
information submitted to the system is kept confidential.  State staff 
highlighted the importance of maintaining confidentiality by explaining 
that hospitals would be hesitant to send in a report or provide specific 
details about the adverse event if that information were made public.  
One unintended consequence of publicizing hospital-specific information 
is that high numbers of reports by a hospital can be misinterpreted as 
an indicator of poor quality.  As staff explained, hospitals that 
frequently submit reports may be more vigilant about identifying and 
reporting adverse events and that the number of reported events should 
not be viewed as an indicator of quality. 
The extent to which information is kept confidential varies among 
States.  For example, one State posts public reports on its Web site; 
reports include the name of the hospital, the date of the adverse event, 
general information about the event, and the hospitals subsequent 
actions.  The State does not, however, reveal identifying information 
about patients or clinicians.  In contrast, staff from another State 
explained that reporting is completely confidential and that it destroys 
all reports after it takes appropriate action.  
Staff from four States reported that the State may impose monetary 
penalties on hospitals that fail to report adverse events.  For example, a 
hospitals failure to report adverse events within the timeframes 
specified in California regulations could result in an administrative 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  13   
F I N D I N G S  
penalty of $100 day for each day that the adverse event goes 
unreported.34   However, staff from these four States indicated limited 
use of these penalties for hospitals failure to report adverse events.   
Finally, staff from 20 of the 26 States conveyed that using information 
from adverse event reports to assist hospitals can provide incentives for 
hospitals to submit reports.  For example, State staff explained that 
generating early warning alerts about problems discovered from 
adverse event reports and making adverse event data available for use 
in hospital training can benefit hospitals and cause them to be more 
frequent and thorough reporters.   
 
State staff whom we interviewed 
Twenty-three States reported using data to hold 
identified two major purposes for 
individual hospitals accountable; 18 reported 
their adverse event reporting 
using data to promote learning and prevent 
systems:  to hold individual 
adverse events 
hospitals accountable for their 
patient care performance and to disseminate information more broadly 
with the goals of allowing hospitals to learn from others experiences 
and preventing adverse events.  
To hold individual hospitals accountable, States reported conducting 
administrative reviews of data contained in reports  
Staff from 23 of the 26 States with systems explained that all adverse 
event reports resulted in desk audits (21 States), onsite audits  
(2 States), and/or State-led investigations of hospitals handling of 
reported events.  In the remaining three States, officials we spoke with 
did not report using adverse event reports to deal with hospitals 
individually. 
According to staff, these States conduct desk audits of reports to ensure 
that the hospital provided complete information for all required fields.  
The desk audit typically involves reviewing supplemental information, 
such as the hospitals root cause analysis and corrective action plan.  
Based on the quality of the report and supplemental information, the 
State may contact the hospital directly by telephone to gather more 
information or provide instructions on completing the reporting form, 
conducting a root cause analysis, or designing risk reduction strategies.  
If the desk audit or follow-up calls reveal that the hospital did not 
 
34 California Health and Safety Code,  1280.4. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  14   
F I N D I N G S  
handle the event appropriately, staff from 12 of the 21 States reported 
following up with onsite audits, although staff explained that resources 
limited this activity.  According to staff from these States, onsite visits 
typically include a review of relevant records, which may uncover 
additional adverse events that the hospital failed to report.   
Staff from four States also reported using adverse event reports in 
licensing decisions for hospitals.  They explained that known adverse 
events are one of many factors used to decide whether to revoke a 
hospitals license, and that loss of licensure based on a single event has 
not happened.  For example, staff from one of these States explained 
that revocation could occur only after the hospital conducted an 
inadequate investigation of an event that was deemed serious, did not 
develop an appropriate corrective action plan, failed to correct        
State-cited deficiencies, and was in the process of losing or had already 
lost its accreditation status.  As of January 2008, staff reported that a 
single adverse event report had never led to the loss of licensure for a 
hospital operating in this State.  
With the goal of preventing adverse events and promoting learning, States 
generate reports, conduct training, produce patient safety bulletins and 
alerts, and post details about specific events on State Web sites  
Staff from 18 of the 26 States with systems explained that they also use 
reports to communicate with hospitals about best practices and 
Statewide incidence of adverse events, to provide early warnings about 
specific patient safety issues, and to provide details about specific 
events.  Three of the remaining eight States had systems that had been 
in operation for about 1 year at the time of data collection in early 2008, 
and staff said they were still developing hospital communication 
mechanisms.  The other five States did not report using adverse event 
reports to provide information to hospitals for the purpose of promoting 
learning and preventing adverse events.  Generally, States used four 
methods to communicate with hospitals:  annual or semiannual reports, 
State-led patient safety training or other initiatives, patient safety 
bulletins/alerts, and State Web sites.  
Annual or semiannual reports.  Eleven of the twenty-six States draw from 
adverse event reports to issue documents that include information on 
the number of adverse events reported, the number of adverse events by 
category, and information to help readers interpret the data.  These 
States typically release such reports to hospitals on an annual or 
semiannual basis.  They also make the reports public by posting them 
on the State Web site.   
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  15   
F I N D I N G S  
Annual reports in 10 of these 11 States communicate additional 
information regarding trends in reporting over time, findings of root 
cause analyses, or prevention strategies undertaken by the State or 
hospitals.  For example, Minnesotas Adverse Health Events in 
Minnesota report published in January 2008 included the number of 
events reported within a year by category, e.g., wrong site surgery, a 
listing of root cause analysis results by event category, and prevention 
strategies for both hospitals and patients.35   
State-led patient safety trainings or other initiatives.  Twelve of the   
twenty-six States draw from adverse event reports to conduct patient 
safety training or initiatives.  State-led training is typically focused on 
one specific patient-safety issue.  For example, citing high numbers of 
adverse event reports on patient falls, New Jersey conducted a 
workshop in 2006 that led to the development of fall reduction programs 
specific to each participating hospitals needs.36  Such training can also 
serve as a forum to allow hospitals to share best practices to improve 
patient safety.  State-led patient safety initiatives also focus on 
particular patient safety issues to generate broader policy guidance.    
For example, in response to high numbers of surgical errors, New York 
convened a panel to develop preoperative surgery protocols to prevent 
wrong site surgery, wrong procedures, and procedures on the wrong 
patient.  The panel of clinical experts reviewed policies and procedures 
from a variety of sources and released final protocols in 2001 (which 
were cited by the Joint Commission as a helpful reference for other 
States).37 38  
 
35 Minnesota Department of Health, Adverse Events in Minnesota, January 2008.  
Available online at  http://www.health.state.mn.us/patientsafety/ae/aereport0108.pdf.  
Accessed on June 20, 2008. 
36 New Jersey Department of Health and Senior Services, Falls Collaborative, Patient 
Safety Reporting Initiative, February 2006:  Issue 2, p. 1.  Available online at 
http://www.state.nj.us/health/ps/documents/feb2006_newsletter.pdf.  Accessed on           
June 20, 2008. 
37 Joint Commission, Sentinel Event Alert:  A Follow-up Review of Wrong Site Surgery, 
Issue 24, December 5, 2001.  Available online at 
http://www.jointcommission.org/JointCommission/Templates/GeneralInformation.aspx?NR
MODE=Published&NRNODEGUID=%7bA4210FD1-1836-4D34-A068-
76F7FBCBA014%7d&NRORIGINALURL=%2fSentinelEvents%2fSentinelEventAlert%2fse
a_24%2ehtm&NRCACHEHINT=Guest#2.  Accessed on June 20, 2008. 
38 New York State Department of Health, New York State Health Department Releases 
Pre-Operative Protocols to Enhance Safe Surgical Care, February 8, 2001.  Available 
online at http://www.health.state.ny.us/press/releases/2001/preop.htm.  Accessed on       
June 20, 2008. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  16   
F I N D I N G S  
Patient safety bulletins and alerts.  Nine of the twenty-six States draw 
from reports to produce advisory bulletins or patient safety alerts, 
which often focus on one patient safety issue and provide clinical 
direction or describe prevention strategies used by other hospitals.  For 
example, a 2007 issue of Marylands Clinical Alert examines adverse 
events caused primarily by equipment vendors being present during 
surgery, a scenario that had been reported by hospitals.39   
Pennsylvania also uses adverse event reports to produce quarterly 
bulletins that examine a range of patient safety issues and typically 
include clinical reminders, best practice anecdotes, policy alerts, and 
reporting guidance.40 
Web site postings.  After following up on reported events through desk 
or onsite audits or investigations, three States post findings on their 
State Web site that contain details about both the reported event and 
the affected patient.  One State posts summary information for every 
reported event, including the name of the hospital where the event took 
place, the date and description of the event, and several details about 
the affected patient.  These details include the patients gender, age 
range, medical background information, and the reason for admission.  
For example, one posting reported that a female in her 30s with a 
history of traumatic brain injury, who had been admitted for abdominal 
pain, had eloped from the hospital.  Similarly, two other States post the 
results of some investigations spurred by reported events that contain 
patient specific details.  However, these States do not post findings for 
every reported event, only those that are likely to cause serious injury 
or death to the patient.  Each of the three States Web site postings also 
provide information about the results of investigations, including the 
results of root cause analyses, corrective actions taken by the hospital, 
and indications of whether these actions were found to be appropriate 
by the State.    
The public disclosure of adverse event reports and resulting 
investigations on State Web sites could be used to prevent adverse 
events and promote learning.  However, in some of these postings, we 
 
39 Maryland Department of Health and Mental Hygiene, Clinical Alert:  An 
Unnecessary Distraction, Vendors in Operating Room, Vol. 4, No. 3, Winter 2007.  
Available online at http://dhmh.maryland.gov/ohcq/download/alerts/alert-v4-n3-
winter2007.pdf.  Accessed on May 23, 2008. 
40 Pennsylvania Patient Safety Advisory.  Available online at 
http://www.psa.state.pa.us/psa/cwp/view.asp?a=1293&q=445966&psaNav=|.  Accessed on 
June 9, 2008. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  17   
F I N D I N G S  
noticed a level of detail that could be used to identify the patient.  The 
possibility of compromised patient privacy could be heightened under 
certain circumstances, such as when an adverse event involves a patient 
who lives in a smaller community and when media reports about an 
event contain additional information that can be matched with 
information contained in a Web site posting. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  18   
I N T R O D U C T I O N  
 C O N C L U S I O N  
In the absence of both a national comprehensive mandatory system and 
Federal guidelines regarding State reporting systems, about half of the 
States have implemented hospital adverse event reporting systems.  
These systems appear to be disparate, with each tracking different 
events; employing different reporting criteria; and requiring differing 
accompanying information, such as the cause of the event and corrective 
actions to prevent recurrence.  Not surprisingly, a wide range of 
reported events exist across States.  The differences we found make 
State adverse event reporting systems data unsuitable for use in the 
aggregate to identify national incidence and trends.  To the extent that 
States adopt common reporting formats, such as those developed by 
AHRQ for use by Patient Safety Organizations, such differences could 
diminish over time.   
Despite the distinct attributes of each State system, we noted that most 
States reported using data in similar ways to improve patient safety.  
For instance, staff from all but three States reported using data to 
assess individual hospitals response to adverse events, and to work 
with hospitals when their responses are found to be inadequate.  We 
also found similarities in States use of reported information to promote 
learning, with 18 States using information to communicate with 
hospitals about Statewide incidence, best practices, and/or to provide 
early warnings about specific patient safety issues.  States may find 
that opportunities exist to expand their use of reported data by 
employing the communication methods used by other States.   
Finally, although the 26 States require hospitals to report adverse 
events when they occur, staff from most of these States agreed that 
events are underreported.  Although States have identified several 
strategies for improvement, they continue to find instances of hospitals 
failures to submit reports by comparing hospital reports against 
administrative data, through the results of onsite audits, or through 
complaints and referrals.  Beyond measures currently being used, 
States may find it prudent to consider other means to more effectively 
ensure reporting by hospitals.    
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
We received comments on a draft of this report from AHRQ and CMS.  
AHRQ and CMS provided positive comments on the draft report. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  19   
C O N C L U S I O N  
AHRQ called for greater precision when discussing the differences 
between NQFs list of Serious Reportable Events (formerly referred to 
as never events) and CMSs payment policies for hospital-acquired 
conditions.  Although this report does not examine CMSs payment 
policies, we will ensure that other OIG reports on this topic make these 
distinctions clear. 
CMS expressed its belief that the report should more clearly describe 
the impediments facing the Federal Government and CMS in managing 
data identifying adverse events given the existing fragmented systems.  
According to CMS, data from State systems are not useful in 
understanding national issues and trends because of the variability in 
States identification of adverse events.  We modified the reports 
conclusion to underscore that data from State adverse event reporting 
systems are unsuitable for national level analyses.      
Because of the variability among State-based systems, CMS indicated 
that it would be helpful to identify potential solutions, such as 
amending the Patient Safety Act to make reporting of well-defined 
adverse events mandatory.  CMS also indicated that it would be helpful 
to identify other partners in reporting system efforts, such as AHRQ 
and IOM.  In planning future work in this area, we will consider the 
issues addressed in CMSs comments.   
Finally, CMS stated that it had recently issued a letter to State 
Medicaid Directors, which addressed Medicaid payment implications for 
selected adverse events.  CMS explained that the intent of this letter 
was to offer States an opportunity to tie Medicaid payment to 
performance through denial of payment for selected adverse events.  
According to CMS, there are seven pending State Plan Amendments to 
restrict payment for selected adverse events, and that State systems 
used to prevent or recoup Medicaid payments could serve as a model for 
a national system.  CMS noted that hospitals already collect data about 
adverse events and that requiring them to send notice of such reports to 
State and/or Federal Governments could give regulatory authorities 
valuable information at minimal additional expense to hospitals.   
For the full text of AHRQ and CMS comments, see Appendix F.   
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  20   
 A P P E N D I X ~ A  
GLOSSARY OF SELECTED TERMS41 
 
 
Adverse eventHarm (injury or illness) caused by medical care.  
Identifying adverse events indicates that the care resulted in an 
undesirable clinical outcome and that the clinical outcome was not 
caused by an underlying disease, but does not imply an error, 
negligence, or poor quality care. 
Corrective action planPolicy and procedural actions that hospitals 
prepare to respond to an adverse event and to prevent recurrence.  
Medical errorThe failure of a planned action to be completed as 
intended or the use of a wrong plan to achieve an aim.    
Near missAn event or a situation that did not produce patient harm, 
but only because of intervening factors, such as patient health or timely 
intervention.  Also known as a close call. 
Never eventAn event or a situation that should never occur in a health 
care setting.  The National Quality Forum initially used the term never 
events to describe its list of serious events but began in 2005 to refer to 
the list as serious reportable events.  
Patient safetyFreedom from accidental or preventable injuries caused 
by medical care. 
Risk reduction strategiesInterventions, actions, and strategies 
designed to reduce the risk of recurrence of the event.  Typically part of 
a corrective action plan.  
Root cause analysisA focused review of systems and processes to 
identify the basic or contributing factors that cause adverse events.   
 
41  Definitions derived from a variety of sources including E. Flink, C. L. Chevalier, A. 
Ruperto, P. Dameron, F. J. Heigel, R. Leslie, J. Mannion, and R. J. Panzer, Lessons 
Learned from the Evolution of Mandatory Adverse Event Reporting Systems, Advances in 
Patient Safety, 2005;   L. T. Kohn, J. M. Corrigan, and M. S. Donaldson, eds., To Err is 
Human:  Building a Safer Health System, A Report of the Committee on Quality of Health 
Care in America, Institute of Medicine, Washington, DC, National Academy Press, 1999;   
R. M. Wachter, Understanding Patient Safety, McGrawHill, 2008; and the glossary of the 
Agency for Healthcare Research and Quality Patient Safety Network available online at 
http://www.psnet.ahrq.gov/glossary.aspx.  Accessed on October 10, 2008.    
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  21   
 A P P E N D I X ~ B  
 
NATIONAL QUALITY FORUM LIST OF SERIOUS REPORTABLE EVENTS 
The National Quality Forum (NQF) List of Serious Reportable Events is grouped into six 
categories:  surgical, product or device, patient protection, care management, environmental, 
and criminal events.  Serious describes an event resulting in death, loss of a body part, 
disability, or loss of bodily function lasting more than seven days or still present at time of 
discharge.42 
Table 1:  The National Quality Forum List of Serious Reportable Events 
Surgical Events   
A.   Surgery performed on the wrong body part 
B.   Surgery performed on the wrong patient 
C.   Wrong surgical procedure performed on a patient 
D.   Unintended retention of foreign object in a patient after surgery or procedure 
E.   Intraoperative or immediately postoperative death 
Product or Device Events 
A.   Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the health care facility 
B.   Patient death or serious disability associated with use or function of a device in patient care in which the device is used or functions other than as    
intended 
C.   Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility 
Patient Protection Events 
A.   Infant discharged to the wrong person 
B.   Patient death or serious disability associated with patient elopement 
C.   Patient suicide, or attempted suicide, resulting in serious disability while being cared for in a health care facility 
Care Management Events 
A.   Patient death or serious disability associated with a medication error 
B.   Patient death or serious disability associated with a hemolytic reaction due to administration of ABO/HLA-incompatible blood or blood products 
C.   Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while being cared for in a health care facility 
D.   Patient death or serious disability associated with hypoglycemia, the onset of which occurs while patient is cared for in a health care facility 
E.   Death or serious disability associated with failure to identify and treat hyperbilirubinemia in neonates 
F.   Stage III or IV pressure ulcers acquired after admission to a health care facility 
G.   Patient death or serious disability due to spinal manipulative therapy 
H.   Artificial insemination with the wrong donor sperm or wrong egg 
Environmental Events 
A.   Patient death or serious disability associated with an electric shock while being cared for in a health care facility 
B.   Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by  toxic 
substances 
C.   Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility 
D.   Patient death or serious disability associated with fall while cared for in a health care facility 
E.   Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility 
Criminal Events 
A.   Care provided by someone impersonating a health care provider 
B.   Abduction of a patient of any age 
C.   Sexual assault on a patient within or on the grounds of a health care facility 
D.   Death or significant injury resulting from a physical assault that occurs within or on the grounds of the facility 
 
42 NQF, Serious Reportable Events in Healthcare, 2006 Update, 2007, pp. vi and 6. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  22   
 A P P E N D I X ~ C  
TAX RELIEF AND HEALTH CARE ACT OF 2006 
P. L. No. 109-432 
 
DIVISION B  MEDICARE AND OTHER HEALTH PROVISIONS 
TITLE IIMEDICARE BENEFICIARY PROTECTIONS 
SEC 203 OIG STUDY OF NEVER EVENTS 
 
(a) Study. 
(1) In general.The Inspector General in the Department of Health and 
Human Services shall conduct a study on 
(A) incidences of never events for Medicare beneficiaries, including 
types of such events and payments by any party for such events; 
(B) the extent to which the Medicare program paid, denied payment, or 
recouped payment for services furnished in connection with such events 
and the extent to which beneficiaries paid for such services; and 
(C) the administrative processes of the Centers for Medicare & Medicaid 
Services to detect such events and to deny or recoup payments for 
services furnished in connection with such an event. 
(2) Conduct of study.In conducting the study under paragraph (1), the 
Inspector General 
(A) shall audit a representative sample of claims and medical records of 
Medicare beneficiaries to identify never events and any payment (or 
recouping of payment) for services furnished in connection with such 
events; 
(B) may request access to such claims and records from any Medicare 
contractor; and 
(C) shall not release individually identifiable information or facility-
specific information. 
(b) Report.Not later than 2 years after the date of the enactment of 
this Act, the Inspector General shall submit a report to Congress on the 
study conducted under this section.  Such report shall include 
recommendations for such legislation and administrative action, such as 
a noncoverage policy or denial of payments, as the Inspector General 
determines appropriate, including 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  23   
A P P E N D I X   ~   C  
(1) recommendations on processes to identify never events and to deny 
or recoup payments for services furnished in connection with such 
events; and 
(2) a recommendation on a potential process (or processes) for public 
disclosure of never events which 
(A) will ensure protection of patient privacy; and  
(B) will permit the use of the disclosed information for a root cause 
analysis to inform the public and the medical community about safety 
issues involved. 
(c) Funding. Out of any funds in the Treasury not otherwise 
appropriated, there are appropriated to the Inspector General of the 
Department of Health and Human Services $3,000,000 to carry out this 
section, to be available until January 1, 2010. 
(d) Never Events Defined.For purposes of this section, the term never 
event means an event that is listed and endorsed as a serious 
reportable event by the National Quality Forum as of  
November 16, 2006. 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  24   
 A P P E N D I X ~ D  
A   P P E N D I X   ~   AA   
SSTTAATTEESS  WWIITTHH  AADDVVEERRSSEE  EEVVEENNTT  RREEPPOORRTTIINNGG  SSYYSSTTEEMMSS  
Table 2:  Twenty-Six Reporting Systems and Number of Adverse Events Reported in 2006 by State  
Year  Number of 
System  Reportable  Adverse Events 
State   Began  Event List  Agency Receiving Reports   Reported in 2006 
California   2007  Modified NQF*  Department of Public Health, Office of Licensing and  N/A 
Certification   
Colorado   1988  State determined  Department of Public Health and Environment, Health Facilities  391 
and Emergency Medical Services Division 
Connecticut   2002  Modified NQF  Department of Public Health  240 
District of Columbia   2007  Modified NQF  Health Regulation and Licensing Administration  N/A 
Florida   1998  State determined  Agency for Healthcare Administration, Florida Center for Policy  716 
Analysis 
Georgia   2003  State determined  Department of Human Resources, Office of Regulatory Services  136 
Indiana   2006  NQF  Department of Health  79 
Kansas   1988  State determined  Department of Health and Environment  22 
Maine   2004  State determined  Department of Health and Human Services, Division of  24 
Licensing and Regulatory Services 
Maryland   2004  State determined  Department of Health and Mental Hygiene, Office of Health  174 
Care Quality 
Massachusetts   1980  State determined  Department of Public Health, Division of Health Care Quality  782 
Minnesota   2003  NQF  Department of Health  140 
Nevada   2005  State determined  State Health Division, Bureau of Health Planning and Statistics  188 
New Jersey   2005  Modified NQF  Department of Health and Senior Services  450 
New York   1985  State determined  Department of Health, Office of Health Systems Management  16,442 
Ohio   2007  State determined  Department of Health, Office of Health Systems Management  N/A 
Oregon   2006  Modified NQF  Patient Safety Commission  N/A a  
Pennsylvania   2004  State determined  Patient Safety Authority  6,232 b 
Rhode Island   1994  State determined  Department of Health, Division of Environmental and Health  271 
Services Regulation, Office of Facilities Regulation 
South Carolina   1976  State determined  Department of Health and Environmental Control  N/A 
South Dakota   1987  State determined  Department of Health  6 
Tennessee   2000  State determined  Department of Health, Division of Healthcare Facilities  3,585 
Utah   2001  Modified NQF  Department of Health  N/A 
Vermont   2007  NQF  Department of Health  N/A 
Washington   2006  Modified NQF  Department of Health  N/Aa 
Wyoming   2005  Modified NQF  Department of Health, Preventive Health and  Safety Division  13 
Source:  Office of Inspector General analysis of States legislation, statutes and regulations, forms, and 26 interviews, 2008. 
* NQF is the National Quality Forum List of Serious Reportable Events. 
a = States began collecting data in mid-2006 and, therefore, could not report complete data for the year. 
b =  This range does not include the number of near misses reported to Pennsylvania in 2006. 
N/A = Not available; States did not provide the number of adverse event reports for 2006. 
 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  25   
 A P P E N D I X ~ E  
 
    STATE-BY-STATE REPORTING REQUIREMENTS FOR HOSPITAL ADVERSE EVENTS 
Table 3:  Selected Information Submitted by Hospitals to 26 States Adverse Event Reporting Systems  
Root Cause  Corrective Action Plan and 
  Adverse Event Report Information  Patient Information  Analysis  Risk Reduction Strategies 
State  Hospital  Type of Event  Location or Service Area Within the Hospital  Date of Event  Date of Discovery  Detailed Description  Summary Description  Impact of the Event  on the Patient  Patient Age or Date  of Birth  Patient Diagnosis  Patient Medical Record  Number   Patient Billing Number   Root Cause Analysis    Team (Name or Title)  Identified Cause  Contributing Factors  Risk Reduction   Strategies   Entities Responsible   for Implementation  Timeline for   Implementation  Effectiveness Measures  Monitoring Schedule   Entities Responsible ToMonitor Effectiveness  
California  (cid:121)  (cid:121)  (cid:121)  (cid:121)    (cid:121)      (cid:121)                     
         
Colorado  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121)               (cid:121)        
                       
Connecticut  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121)   (cid:121)       (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121)
                           
District of Columbia  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)         (cid:121) (cid:121) (cid:121)    (cid:121)
                     
Florida  (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121)    (cid:121)    
               
Georgia  (cid:121) (cid:121)   (cid:121) (cid:121)   (cid:121)    (cid:121) (cid:121) (cid:121)        (cid:121)        
   
Indiana  (cid:121) (cid:121)                             
         
Kansas  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121)              (cid:121)         
                             
Maine  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121)        (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)
                               
Maryland  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121)   (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)
                       
Massachusetts  (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121)        
                             
Minnesota  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) (cid:121) (cid:121)      (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   
                                   
New Jersey  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)
               
Nevada  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121)          (cid:121) (cid:121)        
                             
New York  (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)  (cid:121)   (cid:121) (cid:121) (cid:121)   (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) 
   
Ohio  (cid:121) (cid:121)                             
                   
Oregon  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)  (cid:121) (cid:121)  (cid:121) (cid:121) (cid:121)        (cid:121) (cid:121)   (cid:121)      
               
Pennsylvania  (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)   (cid:121) (cid:121)          (cid:121) (cid:121)        
                 
Rhode Island  (cid:121) (cid:121)   (cid:121)     (cid:121) (cid:121)   (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121)        
             
South Carolina  (cid:121) (cid:121) (cid:121) (cid:121)    (cid:121)   (cid:121)        (cid:121)            
                   
South Dakota  (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)  (cid:121) (cid:121)  (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121)          
                       
Tennessee  (cid:121) (cid:121)   (cid:121)     (cid:121)   (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) 
                   
Utah  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) (cid:121)  (cid:121) (cid:121)        (cid:121) (cid:121)        
                             
Vermont  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)   (cid:121) (cid:121)    (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121) 
                             
Washington  (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)   (cid:121)         (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121) (cid:121)
     
Wyoming  (cid:121) (cid:121)   (cid:121)     (cid:121) (cid:121)                     
     Total States  26  26  20  24  10  11  18  12  19  16  5  2  7  12  16  20  10  11  10  4  9 
Source: Office of Inspector General analysis of States legislation, forms, guidance documents, and 26 interviews, 2008. 
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AGENCY COMMENTS
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  27   
A P P E N D I X   ~   F  
 
Agency comments (continued) 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  28   
A P P E N D I X   ~   F  
 
Agency comments (continued) 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  29   
 A C K N O W L E D G M E N T S  
This report was prepared under the direction of Kevin K. Golladay, 
Regional Inspector General for Evaluation and Inspections in the Dallas 
regional office, and A. Blaine Collins, Deputy Regional Inspector 
General for Evaluation and Inspections.   
Ruth Ann Dorrill and Christi Macrina served as team leaders for this 
study.  Deborah Cosimo served as the lead analyst.  Other principal 
Office of Evaluation and Inspections staff from the Dallas regional office 
who contributed to this report include Anthony Guerrero-Soto; central 
office staff who contributed to this report include Rita Wurm.  
 
 
 
 
 
 
 
  OEI-06-07-00471  ADVERSE EVENTS IN HOSPITALS:  STATE REPORTING SYSTEMS  30