Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

 

Daniel R. Levinson 

Inspector General 

December 2008 

OEI-06-07-00471 

 

ADVERSE EVENTS IN HOSPITALS: 

STATE REPORTING SYSTEMS 

 
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 OIG’s 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. 
 

Δ EXECUTIVE SUMMARY 

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 NQF’s list of Serious Reportable Events. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS i 
 

EXECUTIVE SUMMARY 

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 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS ii 
 

EXECUTIVE SUMMARY 

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 NQF’s list of Serious Reportable Events (formerly referred to 

as “never events”) and CMS’s payment policies for hospital-acquired 

conditions. Although this report does not examine CMS’s 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 report’s 

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 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS iii 
 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS iv 

EXECUTIVE SUMMARY 

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 CMS’s 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. 

 
 

Δ TABLE OF CONTENTS 

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

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 

FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 

CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 

 

ACKNOWLEDGMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
 

Δ INTRODUCTION 

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 1
 

INTRODUCTION 

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 CBO’s 

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 2
 

INTRODUCTION 

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 facility’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 3
 

INTRODUCTION 

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). 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 4
 

INTRODUCTION 

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) AHRQ’s Patient Safety Incident Reporting Systems 

metadatabase,14 (2) the National Academy of State Health Policy’s 

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 5
 

INTRODUCTION 

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 President’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 6
 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 7

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 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. 

As of January 2008, 26 States had hospital 

adverse event reporting systems and another 

State had taken action to develop one 

Δ)LQ FINDINGS 

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 4–9 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 State’s 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 State’s 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. 
 

FINDINGS 

We examined information 

reported by State staff in the 

26 States with systems and 

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. 

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 the National Quality Forum’s 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). 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 8
 

F INDINGS 

whether events are reportable. These categories include: 

• Events resulting in death. These events may include death 

unrelated to the patient’s 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). 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 9
 

FINDINGS 

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 patient’s color-coded wristband. 

Some hospital staff believed that the patient’s 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. 3–5. Available online at: 

http://www.nj.gov/health/ps/documents/final_directions_march08.pdf. Accessed on 

April 3, 2008. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 10
 

FINDINGS 

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 patient’s date of 

birth. Other information required includes the patient’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 11
 

FINDINGS 

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 

acknowledged that hospitals do 

not always submit reports when 

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. 

Most States with systems reported having 

mechanisms to identify underreporting and 

strategies to improve reporting 

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 12
 

FINDINGS 

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 hospital’s 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 hospital’s 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 

hospital’s failure to report adverse events within the timeframes 

specified in California regulations could result in an administrative 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 13
 

FINDINGS 

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 

identified two major purposes for 

their adverse event reporting 

systems: to hold individual 

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. 

Twenty-three States reported using data to hold 

individual hospitals accountable; 18 reported 

using data to promote learning and prevent 

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 hospital’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 14
 

FINDINGS 

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 

hospital’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 15
 

FINDINGS 

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, Minnesota’s “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 hospital’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 16
 

FINDINGS 

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 Maryland’s “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 patient’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 17
 

FINDINGS 

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 18
 

ΔINTRODUCTION CONCLUSION

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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 19
 

CONCLUSION 

AHRQ called for greater precision when discussing the differences 

between NQF’s list of Serious Reportable Events (formerly referred to 

as “never events”) and CMS’s payment policies for hospital-acquired 

conditions. Although this report does not examine CMS’s 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 report’s 

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 CMS’s 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 20
 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 21

Δ APPENDIX~A 

GLOSSARY OF SELECTED TERMS41

Adverse event—Harm (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 plan—Policy and procedural actions that hospitals 

prepare to respond to an adverse event and to prevent recurrence. 

Medical error—The failure of a planned action to be completed as 

intended or the use of a wrong plan to achieve an aim. 

Near miss—An 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 event—An 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 safety—Freedom from accidental or preventable injuries caused 

by medical care. 

Risk reduction strategies—Interventions, actions, and strategies 

designed to reduce the risk of recurrence of the event. Typically part of 

a corrective action plan. 

Root cause analysis—A 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,” McGraw–Hill, 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. 
 

Δ APPENDIX~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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 22
 

Δ APPENDIX~C 

TAX RELIEF AND HEALTH CARE ACT OF 2006 

P. L. No. 109-432 

DIVISION B – MEDICARE AND OTHER HEALTH PROVISIONS 

TITLE II—MEDICARE 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 facilityspecific 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— 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 23
 

APPENDIX ~ 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. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 24
 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 25

AΔP P E N D I X ~ A APPENDIX~D 

STATES WITH ADVERSE EVENT REPORTING SYSTEMS 

Table 2: Twenty-Six Reporting Systems and Number of Adverse Events Reported in 2006 by State

State 

Year 

System 

Began 

Reportable 

Event List Agency Receiving Reports 

Number of 

Adverse Events 

Reported in 2006 

California 2007 Modified NQF* Department of Public Health, Office of Licensing and 

Certification 

N/A 

Colorado 1988 State determined Department of Public Health and Environment, Health Facilities 

and Emergency Medical Services Division 

391 

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 

Analysis 

716 

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 

Licensing and Regulatory Services 

24 

Maryland 2004 State determined Department of Health and Mental Hygiene, Office of Health 

Care Quality 

174 

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 

Services Regulation, Office of Facilities Regulation 

271 

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.
 

Δ APPENDIX~E 

 STATE-BY-STATE REPORTING REQUIREMENTS FOR HOSPITAL ADVERSE EVENTS 

Table 3: Selected Information Submitted by Hospitals to 26 States’ Adverse Event Reporting Systems 

Adverse Event Report Information Patient Information 

Root Cause 

Analysis 

Corrective Action 

Risk Reduction S

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 

California y y y y y yColorado y y y y y yConnecticut y y y y y y y y y y y y y District of Columbia y y y y y y y y y y y y y Florida y y y y y y y y y y y y y Georgia y y y y y y y y yIndiana y yKansas y y y y y y Maine y y y y y y y y y y y y y Maryland y y y y y y y y y y y y y y Massachusetts y y y y y y y y y y y y yMinnesota y y y y y y y y y y y y y y yNew Jersey y y y y y y y y y y y y y y y y y Nevada y y y y y y y y yNew York y y y y y y y y y y y y y y y y Ohio y yOregon y y y y y y y y y y y y y Pennsylvania y y y y y y y y yRhode Island y y y y y y y y y ySouth Carolina y y y y y y y South Dakota y y y y y y y y y y y yTennessee y y y y y y y y y y y y y Utah y y y y y y y y y y yVermont y y y y y y y y y y y y y y y Washington y y y y y y y y y y y y y Wyoming y y y y y  Total States 26 26 20 24 10 11 18 12 19 16 5 2 7 12 16 20 10 11 10 Source: Office of Inspector General analysis of States’ legislation, forms, guidance documents, and 26 interviews, 2008. 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 
 

Δ APPENDIX ~ F 

AGENCY COMMENTS

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 27
 

APPENDIX ~ F 

Agency comments (continued)

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 28
 

APPENDIX ~ F 

Agency comments (continued)

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 29
 

 O E I - 0 6 - 0 7 - 0 0 4 7 1 ADVERSE E VENTS IN H OSPITALS : S TATE REPORTING S YSTEMS 30

Δ ACKNOWLEDGMENTS 

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.