Department of Health and Human Services 

OFFICE OF

INSPECTOR GENERAL

 

 

HOSPITAL 

ST

INCIDENT REPORTING 

SY EMS DO NOT CAPTURE 

MOST PATIENT HARM 

Daniel R. Levinson 

Inspector General 

January 2012 

OEI-06-09-00091 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM i

 

 EXECUTIVE SU MMARY

EXECUTIVE SUMMARY

OBJECTIVES

1. To describe how hospitals use incident reporting systems and 

incident reports.

2. To determine the extent to which hospital incident reporting 

systems capture patient harm that occurs within hospitals.

3. To determine the extent to which accreditors review incident 

reporting systems when assessing hospital compliance with 

Federal requirements to track instances of patient harm. 

BACKGROUND

The term “adverse event” describes harm to a patient as a result of 

medical care. This report is one in a series about adverse events in 

hospitals. Hospitals must track and analyze instances of patient harm 

as a condition of participation in the Medicare program. Incident 

reporting systems are a common means that hospitals use to meet this 

condition. Hospitals can demonstrate their compliance with this and all 

other conditions through a survey by a State survey agency or 

accreditation under an approved Medicare accreditation program. 

To standardize hospital event reporting, the Agency for Healthcare 

Research and Quality (AHRQ) developed a set of event definitions and 

incident reporting tools known as the Common Formats. 

In a 2010 report, the Office of Inspector General found that 13.5 percent 

of hospitalized Medicare beneficiaries experienced adverse events 

during their hospital stays that resulted in prolonged hospitalization, 

required life-sustaining intervention, caused permanent disability, or 

resulted in death. An additional 13.5 percent experienced temporary 

harm events that required treatment. For this report, we collected 

incident reports from hospitals where these adverse and temporary 

harm events (events) occurred and interviewed administrators from 

hospitals and representatives of accreditors. 

FINDINGS

All sampled hospitals had incident reporting systems to capture 

events, and administrators we interviewed rely heavily on these 

systems to identify problems. All of the 189 hospitals we surveyed 

reported using incident reporting systems designed to capture instances 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM ii

 

EXECUTIVE SUMMARY

of patient harm. Administrators from all hospitals with reported events

(34 hospitals) indicated that they rely on incident reporting systems to 

capture a large portion of the information about events that they use to 

conduct patient safety improvement activities. The administrators 

acknowledged that incident reporting systems provide incomplete 

information about how often events occur, but they continue to rely on 

the systems primarily because they value staff accounts of events.

Hospital staff did not report 86 percent of events to incident 

reporting systems, partly because of staff misperceptions about 

what constitutes patient harm. Of the events experienced by Medicare 

beneficiaries discharged in October 2008, hospital incident reporting 

systems captured only an estimated 14 percent. In the absence of clear 

event reporting requirements, administrators classified 86 percent of 

unreported events as either events that staff did not perceive as 

reportable (62 percent of all events) or that staff commonly reported but 

did not report in this case (25 percent). 

Nurses most often reported events, typically identified through the 

regular course of care; 28 of the 40 reported events led to 

investigations and 5 led to policy changes. Nurses most often 

identified events through patient observation and routine hospital safety 

assessments. Information regarding one-quarter of events was not 

accessible to the staff responsible for monitoring patient safety within the 

hospitals and for making policy changes. Hospitals investigated the 

events they considered most likely to yield information that would inform 

quality and safety improvement efforts and made few changes to policy or 

practices as a result of reported events.

Hospital accreditors reported that in evaluating hospital safety 

practices, they focus on how event information is used rather than

how it is collected. Accreditors view incident reports within the 

context of larger hospital quality and patient safety efforts. Officials 

indicated that to assess hospitals, surveyors are most likely to review 

the results rather than review the methods used to track hospital 

adverse events. Surveyors would not specifically investigate these 

methods, such as incident reporting systems, unless evidence of a 

problem emerged through the survey process. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM iii

 

EXECUTIVE SUMMARY

RECOMMENDATIONS

Because hospitals rely on incident reporting systems to track and 

analyze events, improving the usefulness of these systems is critical to 

hospital efforts to improve patient safety. As Federal health care 

research and oversight agencies, AHRQ and the Centers for Medicare & 

Medicaid Services (CMS) are positioned to provide guidance and 

incentives to hospitals to use incident reporting systems more fully. We 

recommend the following actions:

AHRQ and CMS should collaborate to create a list of potentially 

reportable events and provide technical assistance to hospitals in 

using the list. AHRQ and CMS should create and promote a list for use 

by hospitals, other health care providers, and clinical educators, such as 

medical and nursing schools. The list would educate hospital staff about 

the full range of patient harm that occurs in hospitals and would assist 

hospital administrators in assessing incident reporting systems. AHRQ 

and CMS should make it clear in promoting the list that listed events do 

not need to be reported outside the hospital, but rather that the list is a 

learning tool intended to broaden and improve staff understanding. The 

agencies could promote this list through guidance and training documents 

aimed at hospitals, other health care settings, and clinical education 

settings, as well as through guidance documents to State and accrediting 

surveyors. AHRQ could also promote the list through technical assistance 

targeted at encouraging hospital use of the Common Formats.

CMS should provide guidance to accreditors regarding surveyor 

assessment of hospital efforts to track and analyze events and 

should scrutinize survey processes when approving accreditation 

programs. CMS is testing draft interpretive guidelines for surveyors 

regarding the requirement to track and analyze events. We recommend 

that this guidance include information about how surveyors should 

assess the adequacy of hospital event collection efforts, including 

incident reporting systems, and should include the list of potentially 

reportable events to be developed by AHRQ and CMS. CMS should also 

suggest that surveyors evaluate the information collected by hospitals 

using AHRQ’s Common Formats. Additionally, CMS should scrutinize 

survey standards for assessing hospital compliance with the 

requirement to track and analyze events and reinforce assessment of 

incident reporting systems as a key tool to improve event tracking. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM iv

 

EXECUTIVE SUMMARY

AGENCY COMMENTS

We received comments on the draft report from AHRQ and CMS. 

AHRQ concurred with our recommendation directed to it, stating that it 

will collaborate with CMS to create a list of potentially reportable 

events and provide technical assistance to hospitals in using the list. 

AHRQ stated that it will meet with CMS staff to continue collaboration 

on the potential use of Common Formats with surveyors and hospital 

adverse event reporting systems. CMS concurred with both of our 

recommendations, stating that strengthening hospital reporting 

systems and practices is an essential component of efforts to prevent 

patient harm. CMS stated that a voluntary list of adverse events used 

for informational purposes could be highly beneficial for improving 

incident reporting practices. CMS also indicated that it is developing 

draft guidance for surveyors regarding assessment of patient safety 

improvement efforts within hospitals. 

 
 TABLE OF CONTENTS

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

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

FINDINGS ................................................. 10

All sampled hospitals had incident reporting systems to capture 

events, and administrators we interviewed rely heavily on these 

systems to identify problems .............................. 10

Hospital staff did not report 86 percent of events to incident 

reporting systems, partly because of staff misperceptions about 

what constitutes patient harm ........................... 12 

Nurses most often reported events, typically identified through

the regular course of care; 28 of the 40 reported events led to 

investigations and 5 led to policy changes ................... 14 

Hospital accreditors reported that in evaluating hospital safety 

practices, they focus on how event information is used rather 

than how it is collected .................................. 18 

RECOMMENDATIONS ..................................... 20

Agency Comments and Office of Inspector General Response.... 22

APPENDIXES ............................................. 24

A: Example Incident Report.............................. 24 

B: Content Analysis of the Sample Event Incident Reports ..... 25 

C: Estimates, Confidence Intervals, and Key Statistics ........ 28

D: Rates of Reporting by Event Category ................... 29

E: Agency Comments ................................... 31

ACKNOWLEDGMENTS ..................................... 35
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 1

 

 INTRODUCTION

OBJECTIVES 

1. To describe how hospitals use incident reporting systems and 

incident reports.

2. To determine the extent to which hospital incident reporting 

systems capture patient harm that occurs within hospitals.

3. To determine the extent to which accreditors review incident 

reporting systems when assessing hospital compliance with 

Federal requirements to track instances of patient harm. 

BACKGROUND

Office of Inspector General Reports About Adverse Events

This report follows a series of Office of Inspector General (OIG) reports

about adverse and temporary harm events in hospitals.1 For this series 

of reports, we defined “adverse events” as significant harm experienced 

by patients as a result of medical care. We defined “temporary harm 

events” as harm that required medical intervention but did not cause 

lasting harm. Although an adverse or temporary harm event indicates 

that the care resulted in an undesirable clinical outcome and may 

involve medical errors, adverse events do not always involve errors, 

negligence, or poor quality of care and may not always be preventable.2

Hospital Incident Reporting Systems 

 

Practices and policies to ensure patient safety and reduce the incidence 

of adverse events often involve identifying and learning from causes and 

contributing factors. Efforts to meet this objective often rely on 

hospital-staff-generated incident reports. 

Hospitals use incident reporting systems to monitor adverse events and 

other patient safety issues.3

1 The most recent reports in the series are Adverse Events in Hospitals: Methods for 

Identifying Events, OEI-06-08-00221, March 2010; and Adverse Events in Hospitals: 

National Incidence Among Medicare Beneficiaries, OEI-06-09-00090, November 2010.

 Incident reporting systems, which vary in 

design and functionality, capture and maintain reports of 

patient-safety-related events documented by physicians, nursing staff, 

or other hospital staff. Reported patient safety events could include 

2 R.M. Wachter, Understanding Patient Safety, McGraw-Hill, 2008.

3 D.O. Farley, “Adverse-Event-Reporting Practices by US Hospitals: Results of a 

National Survey,” Quality and Safety in Health Care, 17, 2008, pp. 416–423. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 2

 

INTRODUCTION

adverse events, “near-misses,” or situations with the potential to harm 

patients. Completed reports typically include first-person accounts and 

other descriptive information about the events. Incident reports may 

also include information about the impact of the event on the patient 

and the causes of the events, if known. Hospital staff can submit 

reports in writing or electronically, depending on the reporting system. 

See Appendix A for an example of an incident report.

The 1999 Institute of Medicine (IOM) report, To Err Is Human: 

Building a Safer Health System, encouraged the use of incident 

reporting systems, maintaining that hospitals can address patient 

safety problems only if events are identified and adequately described 

by caregivers.4, 5 In a followup report, IOM recommended that hospitals 

develop comprehensive patient safety improvement plans based on data 

collected from internal incident reporting systems and other event 

detection methods.6

Incident reporting systems have limitations. First, it can be difficult to 

determine incidence rates based on reported data because of variability 

in the rate and consistency of reporting.

 IOM advised hospitals to analyze these data to 

identify the causes of events and to develop strategies to prevent 

recurrence. 

7 Second, research suggests 

that incident reporting systems capture only a small percentage of 

adverse events and that some categories of events are 

underrepresented.8, 9 Additionally, the rate and consistency of event 

reporting by hospital staff often varies.10

4 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, 

2000, p. 100.

 

5 P.J. Provonost, “Using Incident Reporting to Improve Patient Safety: A Conceptual 

Model,” Journal of Patient Safety, 3(1), 2007, pp. 27–33. 

6 P. Aspden, Patient Safety: Achieving a New Standard for Care, The National 

Academies Press, Washington, D.C., 2004.

7 Agency for Healthcare Research and Quality (AHRQ), Users Guide: AHRQ Common 

Formats Version 1.1, March 2010, p. 1-2. 

8 T.K. Nuckols, “Rates and Types of Events Reported to Established Incident Reporting 

Systems in Two US Hospitals,” Quality and Safety in Health Care, 16, 2007, pp. 164–168.

9 OIG, Adverse Events in Hospitals: Case Study of Incidence Among Medicare 

Beneficiaries in Two Counties, OEI-06-08-00220, December 2008.

10 AHRQ, Users Guide: AHRQ Common Formats Version 1.1, March 2010, p. 1-2. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 3

 

INTRODUCTION

Despite these limitations, stakeholders note that incident reporting 

systems have advantages. These include systems’ familiarity among 

hospital staff and the advantages derived from involving frontline 

personnel in identifying safety hazards for the organization.11 

Compared to other event detection methods commonly used in hospitals, 

incident reporting systems are thought to capture a wider range of 

events at a lower cost to hospitals.12

Requirements To Improve Patient Safety by Measuring Adverse Events

 

As a condition of participation (CoP) in Medicare, Federal regulations 

require that hospitals develop and maintain a Quality Assessment and 

Performance Improvement (QAPI) program.13 To satisfy QAPI 

requirements, hospitals must “track medical errors and adverse patient 

events, analyze their causes, and implement preventive actions and 

mechanisms that include feedback and learning throughout the 

hospital.”14 To accomplish this, hospitals must “measure, analyze, and 

track quality indicators, including adverse patient events, and other 

aspects of performance that assess processes of care, hospital service, 

and operations.”15 Federal regulations do not specify means for meeting 

the requirements, nor do they explicitly define what “quality indicators” 

or “adverse patient events” hospitals should measure.16

Hospital Accreditation

 

Most hospitals (89 percent) demonstrate their compliance with QAPI 

and the other CoPs to the Centers for Medicare & Medicaid Services 

(CMS) through a survey by a State survey agency or accreditation under 

an approved Medicare accreditation program, a process known as 

“deeming.”17, 18 Currently, three national accreditors review hospitals: 

the Joint Commission, the American Osteopathic Association (referred 

11 AHRQ, Voluntary Patient Safety Event Reporting (Incident Reporting). Accessed at

http://www.psnet.ahrq.gov/primer.aspx?primerID=13 on March 31, 2011.

12 K.G. Shojania, “The Elephant of Patient Safety: What You See Depends on How You 

Look,” The Joint Commission Journal on Quality and Patient Safety, 36, 2010, pp. 399–401.

13 42 CFR § 482.21.

14 42 CFR § 482.21(c)(2).

15 42 CFR § 482.21(a)(2).

16 68 Fed. Reg. 3435, 3438–39 (Jan. 24, 2003). 

17 CMS, CMS Financial Report: Fiscal Year 2009.

18 Social Security Act, § 1861(e), 42 U.S.C. § 1395x(e).
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 4

 

INTRODUCTION

to as “HFAP”), and Det Norske Veritas (DNV) Healthcare.19 The 

Secretary of Health and Human Services (HHS) granted deeming 

authority to each of these accreditors after CMS determined that the 

accreditation programs’ standards met or exceeded the requirements 

listed in the CoPs.20 Hospitals that do not opt for accreditation can be 

certified as meeting CoPs by State survey and certification agencies.21 

The accreditation and certification processes rely on periodic, onsite 

inspections—called surveys—of hospitals. CMS provides guidance to 

State survey and certification agencies for conducting surveys in its 

State Operations Manual.22

All three accreditors include QAPI-based quality, safety, and 

performance provisions in their hospital requirements. These 

provisions, like the QAPI CoP, typically include identifying adverse 

events as part of broader quality and performance improvement 

requirements and do not specify the means hospitals should use to 

identify and analyze events. For example, one accreditor’s manual 

specifies that hospitals should “use data and information to guide

decisions” and have an “organization-wide, integrated patient safety 

program.”

 

23 This is similar to the QAPI CoP requirement that hospitals 

“must develop, implement, and maintain an effective, ongoing, 

hospital-wide, data-driven quality assessment and performance 

improvement program.”24 Each of the three accreditors defines what 

constitutes an adverse event. Their lists of events vary and include 

events that cause harm to patients, such as adverse medication 

reactions; and process breakdowns that could lead to harm, such as 

erroneous laboratory reports.25, 26

19 CMS, CMS-Approved Accreditation Organization Contact Information, 2011.

20 Social Security Act, § 1865, 42 U.S.C. § 1395bb.

21 The remaining 11 percent of hospitals were certified in compliance with the CoPs by 

State survey and certification agencies. According to CMS, the percentage of hospitals 

certified by State survey and certification agencies will begin to decrease after 2010 because 

CMS has directed these agencies to prioritize other activities over initial hospital 

certifications. CMS, CMS Financial Report Fiscal Year: 2010, pp. 130–131.

22 CMS, State Operations Manual, Pub. 100-07.

23 The Joint Commission, Hospital Accreditation Operations Manual, LD.03.02.01 and 

LD 04.04.05. 

24 42 CFR § 482.21.

25 The Joint Commission, Hospital Accreditation Operations Manual, PI.01.01.01.

26 DNV, NIAHO Standards and Interpretive Guidelines, QM 7 SR 1-18.
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 5

 

INTRODUCTION

AHRQ’s Common Format Event Reporting Tools

To support and standardize hospital event reporting, AHRQ developed a 

set of event definitions and incident reporting tools known as the 

Common Formats.27 AHRQ defines the Common Formats as “clinical 

definitions and technical requirements developed for the uniform 

collection and reporting of patient safety data.” AHRQ developed the 

Common Formats to assist hospitals in developing standardized 

reporting methods and in reporting information to PSOs.28 Under 

AHRQ’s oversight, PSOs receive adverse event reports from hospitals, 

analyze the reports in aggregate, and provide hospitals with analysis 

and recommendations for improving patient safety.29 AHRQ announced 

Common Formats Version 1.1 in the Federal Register on March 31, 

2010. Version 1.1 includes instructions for reporting events that harm 

patients and “near-misses” (circumstances that have the capacity to 

cause harm).30

The Common Formats include descriptions of patient safety events and 

unsafe conditions to be reported, specifications for aggregate event 

reports and individual event summaries, delineation of data elements to 

be collected for specific types of events, a user’s guide, and technical 

specifications for electronic data collection and reporting. The Common 

Formats allow PSOs to aggregate event and contributing factor 

information from across hospitals for comparisons and trend analyses. 

The Common Formats’ three event reporting forms focus on specific 

areas: information describing the event, information describing the 

impact on the patient, and summary and contributing factor 

information. The Common Formats also contain event-specific modules 

that provide additional detail for high-volume or high-harm events.

 

27AHRQ developed the Common Formats as part of HHS’s congressional mandate to 

provide technical assistance to Patient Safety Organizations (PSO) on matters such as 

methodology, communication, data collection, and privacy concerns. Public Health Service 

Act, § 925, 42 U.S.C. § 922b-25. 

28 Sections 923 and 924 of the Public Health Service Act, which were added by the 

Patient Safety and Quality Improvement Act of 2005, required HHS to determine that 

PSOs meet certain criteria to perform “patient safety activities” and establish a network of 

patient safety databases to receive, analyze, and report on patient safety information 

submitted by the PSOs. Patient Safety and Quality Improvement Act of 2005, 

P.L. 109-41 § 2; Public Health Service Act, §§ 923 and 924; 42 U.S.C. §§ 299b-23 and 24. 

29 73 Fed. Reg. 70733 (Nov. 21, 2008). 

30 75 Fed. Reg. 16140, 16141-42 (Mar. 31, 2010).
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 6

 

INTRODUCTION

National Incidence of Adverse Events

In a November 2010 report, OIG estimated the national incidence rate 

of adverse and temporary events in hospitals.31

To determine the national incidence rate, we selected a sample of 

beneficiaries. Of the 999,645 beneficiaries discharged from acute care 

hospitals during October 2008, we selected a random sample of 785. We 

excluded 5 beneficiaries as ineligible because the hospitals where they 

were treated were under OIG investigation, resulting in a sample of 780 

beneficiaries. These sample beneficiaries had a combined total of 838 

hospital stays with discharges in October 2008.

 We found that 

27 percent of hospitalized Medicare beneficiaries experienced at least 

one adverse event (13.5 percent) or temporary harm event (13.5 percent) 

during hospitalizations that ended in October 2008. These rates were 

projected to all beneficiaries hospitalized during October 2008. 

To identify adverse events experienced by sampled beneficiaries, we 

conducted a two-stage review of their medical records. During the first 

stage, we identified cases that met one or more of the following 

conditions: (1) a certified medical coder identified a diagnosis in the 

Medicare claims data that was coded as not present when the 

beneficiary was admitted to the hospital, (2) nurse reviewers found 

evidence of a potential adverse event in the medical records, or (3) the

beneficiary was readmitted to the hospital within 30 days after 

discharge following a hospital stay ending in October 2008.32

Based on findings from the first stage of review, we advanced 420 cases 

to the second stage, in which physicians reviewed the beneficiaries’ 

hospital medical records to identify events. Physicians identified 

128 adverse events that met at least one of three criteria: 

(1) events on the National Quality Forum’s (NQF) list of Serious 

Reportable Events;

 

33 (2) events for which CMS will no longer pay a 

31 OIG, Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries, 

OEI-06-09-00090, November 2010. 

32 The nurse reviewers used a modified version of the Institute for Healthcare 

Improvement’s Global Trigger Tool. F.A. Griffin and R.K. Resar, IHI Global Trigger Tool 

for Measuring Adverse Events, Institute for Health Care Improvement Innovation Series 

2007, pp. 4–5. 

33 NQF, Serious Reportable Events, October 2008. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 7

 

INTRODUCTION

higher Medicare reimbursement (known as hospital-acquired conditions 

(HAC));34

METHODOLOGY

and (3) events resulting in a prolonged hospital stay, 

permanent harm, life-sustaining intervention, or death. Physicians also 

identified 174 temporary harm events, which we defined as events 

requiring intervention but not rising to the level of patient harm 

associated with adverse events. In total, they identified 302 patient 

harm events. 

Scope

This report estimates the national rate at which hospital incident 

reporting systems captured events experienced by Medicare 

beneficiaries discharged from acute care hospitals during 

October 2008. This reporting rate and hospital administrators’ 

explanations for the reasons staff did not report events are projectable 

nationwide to all Medicare beneficiaries hospitalized during this period. 

To determine the estimated rate of reporting, we requested incident 

report information from the 195 hospitals associated with the 

302 events that we identified for the national incidence study. This 

report also provides findings regarding hospital use of incident 

reporting systems and information included in reports, which pertain 

only to the sample of reported events and are not projectable. Lastly, 

this report provides information about how hospital accreditors assess 

incident reporting systems during hospital surveys.

Data Collection

Hospital surveys. To determine whether the hospitals associated with 

the events had incident reporting systems designed to capture patient 

harm events, we sent a survey to each of 195 hospitals associated with 

the events. In the survey, we asked the hospitals to describe each of the 

incident reporting systems they used to capture event information and 

the types of information they expected to collect through the systems. 

We received responses from 189 of the 195 hospitals describing 293 of 

the 302 events (a 97-percent response rate). 

34 CMS, Hospital-Acquired Conditions (HAC) in Acute Inpatient Prospective Payment

System (IPPS) Hospitals, October 2010. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 8

 

INTRODUCTION

Information requests

We also obtained supporting documentation from hospitals for all 

captured events. Supporting documentation included incident reports, 

copies of infection-tracking logs, skin-care management logs, peer 

review documentation, and patient safety committee minutes. See 

Appendix B for a description of the information in the completed

incident reporting system forms provided by the hospitals. 

. To identify which of the 302 events hospitals 

captured in internal incident reporting systems, we sent information 

requests to each of the 195 hospitals associated with the events. Each 

information request identified the patient who experienced the event, 

the stay in which the event occurred, and a description of the event that 

physician reviewers identified. We asked each of the hospitals whether 

the identified events had been captured by an incident reporting system 

and, if so, to provide supporting documentation. If an event was not 

captured, we asked the hospital for an explanation. Because we sent 

the information requests along with the hospital surveys and received 

information from each of the hospitals that returned a survey, we 

received information for 293 events (a 97-percent response rate).

Hospital interviews. We conducted structured interviews with 

administrative staff from each of the 34 hospitals in which an event was 

reported to an incident reporting system.35 We conducted the 

interviews in response to a request from CMS to determine what actions 

the hospitals took following the reports of events. We asked each 

hospital administrator to describe how information about an event was 

shared within the hospital, the extent to which staff analyzed the event, 

and whether the reporting of the event led to policy or process changes. 

Findings pertaining to these interviews are not projectable and 

represent only the actions of the 34 hospitals. 

Accreditation organization interviews. We interviewed staff from the 

three hospital accreditors. We gathered information on the extent to 

which the accreditors review incident reporting systems when 

evaluating hospital compliance with accreditation standards related to 

quality and safety.

35 In almost all cases, we interviewed the hospitals’ risk managers, patient safety 

officers, and/or quality improvement specialists. We refer collectively to these staff 

members as hospital administrators. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 9

 

INTRODUCTION

We focused on accreditors because they certified compliance for 

89 percent of all hospitals in 2008. Within our sample of 189 hospitals, 

CMS deemed 98 percent to be in compliance with Medicare’s CoPs

following accreditation by one of the three hospital accreditors: the 

Joint Commission accredited 89 percent of sample hospitals, HFAP 

accredited 5 percent, and DNV accredited 4 percent. 

Data Analysis

We calculated the percentage of events that hospitals indicated their 

incident reporting systems captured among the 293 events identified in 

our national sample and included in our analysis. We also calculated 

percentages for the reasons hospitals reported that incident reporting 

systems did not capture the other events. We computed all rates and 

corresponding 95-percent confidence intervals using the computer 

program Sudaan, which provides standard errors for complex sampling 

designs. See Appendix C for estimates, confidence intervals, and key 

statistics.

Limitations

Hospitals may not have provided information about all events captured 

by incident reporting systems. This could be due to a number of factors, 

including the 2-year interval between the events and our information 

request, concern about preserving the confidentiality of sensitive report 

documents and potential liability in releasing such information, and 

lack of effective hospital recordkeeping. These limitations could result 

in our underestimating the extent to which hospital incident reporting 

systems capture events. 

Standards

This study was conducted in accordance with the Quality Standards for 

Inspection and Evaluation issued by the Council of the Inspectors 

General on Integrity and Efficiency.
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 10

 

All sampled hospitals had incident reporting systems 

to capture events, and administrators we interviewed 

rely heavily on these systems to identify problems

 FINDINGS

All of the 189 hospitals in 

which an event occurred 

reported using general incident 

reporting systems designed to 

capture information about 

instances of patient harm from across hospital departments. 

Additionally, most hospitals used specialized incident reporting systems 

to capture events within specific hospital departments, such as 

pharmacy; or to capture specific types of adverse events, such as patient 

falls. The most common specialized systems focused on infections, 

medication events, and patient complaints. See Table 1 for the types of 

incident reporting systems that hospitals used to capture events.

Table 1: Types of Hospital Incident Reporting Systems (n=189) 

Type of System 

Number of 

Hospitals With 

System

General incident reporting system designed to capture 

all instances of patient harm 189 

Specialized incident reporting system 132

Infection tracking 98

Pharmacy or medication error tracking 43

Patient complaint tracking 40

Security issues 14

Harm to staff 7

Regulatory compliance 4

Source: OIG analysis of information requests completed by the 189 hospitals where the 293 events occurred.

Hospital administrators indicated that they encourage staff to report any 

instance of patient harm to incident reporting systems 

During followup interviews, administrators at 34 of the 189 hospitals 

indicated that they expect staff to report any instance of patient harm 

and even circumstances that could lead to harm. They explained that 

staff have broad instructions to report all patient safety problems. 

Additionally, these hospitals typically provide training focused on 

reporting specific types of events commonly understood as patient harm, 

such as pressure ulcers. However, none of the hospitals maintained a 

list of events required to be reported to incident reporting systems. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 11

 

FINDINGS

Hospital administrators we interviewed explained that they rely heavily on 

incident reporting systems to identify safety problems

Administrators from all 34 hospitals indicated that they rely on incident 

reporting systems to capture much of the information used to conduct 

patient safety improvement activities. Many administrators reported 

that they combine reported information with data collected through 

other event detection methods, including medical record reviews 

(18 administrators), administrative data screening (17), manual or 

automated review for evidence of hospital-acquired infections (8), and 

postprocedure checklists to identify complications (8). 

Administrators also reported a number of benefits to capturing 

information through incident reporting systems. Foremost, 

administrators explained that reports from staff who are directly 

involved with events provide greater detail and insight about the 

patient, circumstances, and possible contributing factors (such as 

specific breakdowns in processes) than information provided by other 

event detection methods. Other reported benefits of incident reporting 

systems include identifying a broad range of events (reported by 

12 administrators) and focusing staff attention on patient safety issues 

(reported by 9). 

Hospital administrators we interviewed also noted several factors that limit 

the usefulness of incident reporting systems 

Although administrators largely expressed confidence in their systems 

to generate useful information, many identified limitations. 

Twenty-two of the thirty-four administrators indicated that 

underreporting of events by hospital staff leads to inaccurate 

measurement of patient harm. Administrators expressed concern that 

underreporting can affect patient safety efforts by potentially skewing

resources toward prevention of more easily identifiable occurrences that 

happen at a point in time (such as patient falls) rather than complex 

events that occur over a longer period and are more difficult to detect 

(such as blood clots). Sixteen administrators noted that reports to their 

systems often require additional investigation, such as a root-cause 

analysis, to provide meaningful information. Further, 

10 administrators noted that it is sometimes difficult to interpret data 

from their systems. For example, an increase in reports about a certain 

type of event could reflect either an increase in occurrences or improved 

reporting. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 12

 

FINDINGS

Hospital staff did not report 86 percent of events to 

incident reporting systems, partly because of staff 

misperceptions about what constitutes patient harm

Despite the existence of incident 

reporting systems, hospital staff did 

not report most events that harmed 

Medicare beneficiaries. Of the 

events experienced by a national sample of beneficiaries discharged in 

October 2008, hospital incident reporting systems captured only an 

estimated 14 percent of events.36

Administrators conceded that it was likely not clear to staff which events 

to report, given the wide range of patient harm that can occur in hospitals 

In the absence of clear reporting requirements for events, it is difficult 

for staff to determine hospital expectations for reporting incidents. 

Although administrators indicated that they want staff to report all 

instances of harm, when asked about specific events administrators

conceded that staff may often be confused about what constitutes harm 

and is, therefore, reportable. For each of the events that staff did not 

report (86 percent of all events), hospital administrators indicated 

whether they would expect staff to recognize the events as reportable 

patient harm. They classified most unreported events as events that 

hospital staff most likely did not perceive as reportable (62 percent of all 

events) and the remaining unreported events (25 percent) as events that 

 Further, hospital staff reported only 

2 of the 18 most serious events in our sample (i.e., those events that 

resulted in permanent disability or death). Serious events not captured 

by incident reporting systems included hospital-acquired infections, 

such as a case of septic shock leading to death; and medication-related 

events, such as four cases of excessive bleeding because of the

administration of blood-thinning medication that also led to death. 

Incident reporting systems did not capture any of the five NQF Serious 

Reportable Events and only one of the eight Medicare HAC events in 

our sample. Medicare does not require hospitals to capture information 

about these events through incident reporting systems. However, 

because events on the NQF and Medicare HAC lists are widely 

recognized among medical professionals as constituting patient harm, 

many among the public and in the health care community may expect 

them to be reported by hospital staff.

36 Because we found no statistically significant difference in reporting rates between 

adverse and temporary harm events, we refer to adverse events and temporary harm events 

collectively as “events.” The Cochran-Mantel-Haenszel chi-square test was not significant 

at the 95-percent confidence level (p=0.7380).
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 13

 

FINDINGS

staff commonly reported but did not report in this particular case. See 

Table 2 for detailed information on why staff didn’t report events. 

Table 2: Events by Reporting Category and Reasons 

Administrators Gave for Why Staff Did Not Report (n=293)

Event Category Percentage of 

All Events

Events Captured by Incident Reporting Systems (n=40) 14%

Events Not Captured by Incident Reporting Systems (n=253) 86%

 Event was not reported; staff did not perceive event as reportable 

 because: 62%*

Event was not caused by a perceptible error 12%

Event was an expected outcome or side effect 12% 

Event caused little harm and/or harm was ameliorated 11% 

Event was not on hospital’s mandatory reporting list 9%

Event occurs frequently in hospitals 8%

Event symptoms became apparent after discharge 5%

Event occurred in patient with a history of similar events 4% 

No reason given for why staff did not perceive event as reportable 2% 

 Event was not reported although event type is commonly reported 25%*

 Total 100%

Source: OIG analysis of the 293 information requests completed by hospitals where events occurred.

* Percentages do not sum to 86 percent because of rounding. 

For the 62 percent of events not reported because staff did not perceive 

them as reportable, administrators indicated that staff likely did not 

recognize that the event caused harm or realize that they should 

complete a report. The most common reason administrators gave for 

staff underreporting was that no perceptible error occurred (12 percent), 

indicating that staff commonly equate the need to complete incident 

reports with medical errors. Other reasons for underreporting include 

staff becoming accustomed to common occurrences and therefore not 

submitting reports, such as events that were expected side effects 

(12 percent) or occurred frequently (8 percent). For example, staff 

reported only 1 of 17 sample events related to catheter usage 

(e.g., infection and urinary retention), a common cause of harm to 

Medicare beneficiaries. In other cases, the symptoms of the event did 

not become apparent until after the hospital discharged the patient 

(5 percent). Administrators reported that such events are unlikely to be 

captured by hospital incident reporting systems unless patients return 

to the hospital and staff uncover a causal link with the prior 

hospitalization. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 14

 

FINDINGS

Administrators indicated that the remaining 25 percent of events were 

types of harm that staff commonly report to incident reporting systems 

and that they would expect staff to report. Administrators believed 

these events were clearly reportable because hospital staff received 

specific training to report this type of event and/or the event had 

characteristics that staff commonly associated with patient harm, such 

as the result of a specific action. For example, staff reported all patient 

falls, an event that is often the focus of hospital safety efforts. If 

hospital staff had reported the 25 percent of events that are commonly 

reported, the rate of reporting would have increased from 

14 to 38 percent. It is difficult to determine why staff did not report 

these events, but administrators suspected both limited staff time and 

misperceptions that other staff would report the event. 

Nurses most often reported events, typically identified 

through the regular course of care; 28 of the 40 reported 

events led to investigations and 5 led to policy changes

Information in incident reports 

typically described the reported 

event and its impact on the 

patient. Administrators from each 

of the hospitals with a reported event (34 hospitals) indicated that they 

attempted to use the information to improve patient safety, typically as 

a starting place for further investigation and analysis. Hospitals 

conducted investigations for two-thirds of events, although few events 

resulted in changes to hospital policies or practices. 

Nurses reported 31 of the 40 events to incident reporting systems, with 

the remaining 9 events reported by a variety of other hospital staff 

The hospitals designed most incident reporting systems to allow 

reporting by any staff member or associated clinician, such as 

physicians and therapists; in some cases the systems also allowed 

reporting by parties other than hospital staff, such as patients and 

families. Hospital administrators said that they encourage all staff to 

report, including those in specialized departments and those following 

patients through a course of care. For example, one administrator said 

that his or her hospital relies on case managers to identify events that 

transpire over multiple days or are the result of patient transfers 

between departments. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 15

 

FINDINGS

Nurses discovered 24 reported events through observation of patients in 

the regular course of care. Nurses and other staff, such as infection 

control specialists and case managers, discovered the remaining 16 

reported events by completing hospital safety assessments designed to 

identify problems. When staff identified events through hospital safety 

assessments, the results of the assessments prompted staff to create 

incident reports. Staff identified 10 of these 16 events using 

criteria-based patient evaluations (such as skin assessments required 

for all patients at risk for developing pressure ulcers) and the remaining 

6 events through more general screening of patient records (such as a 

nurse’s review of patient condition at the end of a shift). See Table 4 for 

a list of how staff first identified the events they reported. 

Table 4: Hospital Detection Methods That Identified Events 

Reported to Incident Reporting Systems (n=40)

Method of Event Identification Events 

Identified 

Identified by Staff Through Patient Observation During the 

Regular Course of Care 24

Identified After Criteria-Based Patient Status Reviews 10

Skin integrity assessment 3 

Blood culture analysis to identify patients likely to develop an 

infection 2 

Chart review of patient who met hospital-defined criteria 1 

Medication review following emergency rescue medication 1 

Medication review following potential contraindication 1 

Potential complication questionnaire following procedure 1 

Chart review following patient complaint 1 

Identified Through Routine Screening of Hospital Tests 6

Blood culture analysis 2 

Case management review 2 

Skin care assessment 2 

Source: OIG analysis of interviews with administrators at hospitals where the 40 reported events 

occurred.

Information regarding one-quarter of events was not immediately accessible 

to the staff responsible for monitoring patient safety within hospitals

Hospital staff reported 29 events to general incident reporting systems 

that staff responsible for hospitalwide event tracking and monitoring 

(e.g., patient safety staff, such as risk managers or patient safety 

officers) used to monitor event occurrence. These systems either 

automatically sent an alert to relevant staff (e.g., event specialists or 

department managers) or stored the event in a database for later 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 16

 

FINDINGS

review. The hospital administrators we interviewed reported that 

patient safety staff reviewed events captured by these systems daily or 

at the end of each shift. 

Hospital staff reported the other 11 events to department-specific 

specialized systems (e.g., infection tracking systems), making them 

immediately accessible to centralized patient safety staff. In most of 

these cases, centralized patient safety staff became aware of the events 

only after receiving aggregate event summaries generated by these 

systems. Hospital administrators reported that patient safety staff 

generally do not have immediate access to the information collected in 

these specialized systems and rely on the system managers to forward 

reports periodically. For example, in one instance when a nurse entered 

a pressure ulcer event into a skin wound event tracking log, patient 

safety staff had access to the information only after a summary was 

forwarded at the end of the month. Hospital administrators also 

indicated that high rates of reporting to department-specific systems 

that are not readily accessible to centralized patient safety staff can 

lead to compartmentalization of information. They stated that this can 

impede efforts to track and monitor adverse events across the hospital. 

Hospitals investigated the events they considered most likely to inform 

quality and safety improvement activities 

The hospital administrators we interviewed reported that they 

investigated and analyzed 28 of the 40 events for evidence of system 

failures or medical errors to inform quality and safety improvement 

activities. Patient safety staff conducted half of these investigations 

(14 events); the rest were conducted by managers of departments where 

the events occurred or by clinical event specialists, such as wound care 

nurses or infection-control specialists. These reviews ranged from 

informal reviews immediately following the incidents to structured 

analyses intended to comprehensively identify errors that contributed to 

adverse events (i.e., root-cause analyses). Hospital administrators 

reported that they did not investigate the remaining 12 events because 

they suspected that the events were isolated incidents unlikely to recur. 

Therefore little benefit would derive from a quality improvement 

investigation. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 17

 

FINDINGS

The most common type of investigation was a clinical review of a single 

event, but hospital administrators reported that they regularly analyze 

events in aggregated event reviews. Aggregated event reviews involved 

reviewing data about multiple events to identify trends and common 

causes. Administrators indicated that clinical reviews are usually 

conducted by patient safety staff or department managers in 

collaboration with the staff members directly involved with the event. 

These clinical reviews were similar to root-cause analyses but contained 

less detail and used fewer resources. The most frequently discussed 

questions during these clinical reviews included whether staff correctly 

assessed patients before treatment began; whether the standard of care 

was met by the attending physicians; and what contributing factors led 

to the event, such as medication mislabeling or poor communication 

during shift changes. 

Hospitals made few changes to policies or practices as a result of the 

reported events

Hospital administrators reported that only 5 of the 40 sample incident 

reports led to a hospital policy or practice change. Two of these events 

led directly to changes in hospital policy or practice, and staff included 

the other three in an aggregate event review that led to changes. 

According to administrators, the remaining 35 reported events did not 

result in a policy or practice change primarily because hospitals 

reviewed the event information and determined that the occurrences did 

not represent systemic quality problems within the hospitals. 

Administrators reported that changes to hospital policies or practices as 

a result of a single event are rare unless the event is found to represent 

a systemic problem within the hospital. In other cases, hospital 

administrators reported that they may already have procedures in place 

to avoid a specific type of event. For example, hospitals may use special 

pressure-reducing mattresses and have rigorous policies and training 

regarding patient turning, yet still see some pressure ulcers develop.
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 18

 

FINDINGS

In interviews, officials 

from hospital accreditors

noted the importance of 

incident reporting systems 

to hospital patient safety efforts. However, they also reported that they 

are unlikely to scrutinize the effectiveness of event detection methods, 

such as incident reporting systems, during hospital surveys. 

Hospital accreditors view incident reporting systems within the context of 

larger hospital quality and patient safety efforts

Officials from the three accreditors confirmed that their standards 

require hospitals to track adverse events to inform safety improvement 

efforts, as mandated by QAPI CoP, and that hospitals often use incident 

reporting systems to satisfy this requirement. Officials indicated that 

their surveyors are directed to assess hospital efforts by reviewing the 

results of patient safety improvement efforts. Surveyors would not 

specifically investigate mechanisms of hospital adverse event tracking 

unless evidence of a problem emerged through their standard survey 

process. 

As an example, one accreditor described how surveyors assessed a 

hospital’s efforts to track hospital-acquired infections. In this case, 

surveyors focused on the care provided to individual patients as part of 

the survey protocol. If a selected patient developed an infection, the 

surveyor would investigate the circumstances of the infection, including 

whether it was detected by an automated surveillance tool and reported 

to an incident reporting system. The surveyor reviewed the report and

any noted corrective action. Although the review was described as fairly 

thorough by the official, it was dependent upon whether a selected 

patient contracted an infection or experienced some other reportable 

event. 

Surveyors may view data in an incident reporting system as part of 

their review but do little investigation of the specific incident reporting 

system, the mechanism of reporting, usability by staff, or typical 

information in the reports (including the frequency of reported events). 

One accreditation official explained that hospital administrators could 

choose to demonstrate their incident reporting system as an example of 

QAPI compliance or could choose to highlight event detection methods, 

such as an electronic surveillance system or a medical record review 

process. 

Hospital accreditors reported that in evaluating 

hospital safety practices, they focus on how event 

information is used rather than how it is collected 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 19

 

FINDINGS

Accreditors cited a number of reasons their surveyors do not scrutinize 

incident reporting systems or other event detection methods during 

hospital surveys. Most of the reasons rested on the perception that 

event detection methods are complex and varied. First, hospitals collect 

event data from a variety of sources, and it can be difficult to discern 

which information is from a report and which is from a surveillance 

record or medical record review. Second, surveyors may not have the 

expertise to assess the reporting mechanism itself and provide 

recommendations to improve reporting. Third, officials questioned the 

value of requiring hospitals to collect event information in a particular 

way, arguing that a prescribed approach may inhibit innovation. Given 

this, some officials reasoned that it was better to focus on the output 

than on the systems, but they conceded that this lack of focus on how 

hospitals collect event information meant there was little scrutiny of the 

reporting systems’ event data that hospitals use to inform their patient 

safety improvement efforts.
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 20

 

 RECOMMENDATIONS

Previous OIG work determined that, despite significant attention from 

stakeholders in recent years, adverse events continue to pose a serious 

risk to hospitalized Medicare beneficiaries. Identifying events helps 

hospital administrators set goals for improvement, direct resources, and 

assess the effectiveness of prevention strategies. Hospital 

administrators indicated that, although they employ a number of 

methods to detect patient safety problems, incident reporting by staff is 

the primary tool used to identify events. However, we found that 

incident reporting systems did not capture 86 percent of events that 

caused patient harm in a national sample of Medicare beneficiaries. 

Further, hospital staff often did not report events because they did not 

perceive them as causing reportable patient harm. 

AHRQ and CMS are positioned to provide guidance and incentives for 

hospitals to more effectively track and analyze adverse events. AHRQ 

oversees critical research efforts, the PSO program, and the Common 

Format event reporting tools. CMS oversees hospital accreditation, 

which includes ensuring that hospitals have a data-driven performance 

improvement plan that meets the standards detailed in the Medicare 

CoP.

Therefore, we recommend the following:

AHRQ and CMS should collaborate to create a list of potentially 

reportable events and provide technical assistance to hospitals in using 

the list

Hospital staff identification of patient harm is critical to the success of 

patient safety efforts. Hospital administrators reported that the most 

common reason hospital staff do not report patient harm is that they do 

not perceive the harm as a reportable event. As such, hospital efforts to 

improve patient safety may be limited by focusing on only a small 

subset of events that get more attention because they are more often 

reported by staff. Given the importance of incident reporting to hospital 

safety efforts, AHRQ and CMS should take steps to improve reporting 

by hospital staff. 

AHRQ and CMS should collaborate to create and promote a list of 

potentially reportable events for hospitals, other health care providers, 

and clinical educators, such as medical and nursing schools. We do not 

recommend that AHRQ or CMS require hospitals to report the events 

on the list. Rather, the list of events would educate hospital staff about 

the full range of patient harm that occurs in hospitals and should be 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 21

 

RECOMMENDATIONS

reported to incident reporting systems. The list should go beyond the 

fairly rare harm events included in the NQF and Medicare HAC lists 

and include a comprehensive range of possible patient harm. Events on 

the list could include those identified in prior OIG work and by other 

researchers.37

The two agencies could promote this list as a guidance and training 

document for hospitals, other health care settings, and clinical 

education settings, as well as for State and accrediting surveyors. 

AHRQ could also promote the list through technical assistance targeted 

at encouraging hospital use of the Common Formats. 

 The list could also include “near-miss” occurrences, given 

that AHRQ has promoted the reporting of near-misses as important for 

improving practices. AHRQ and CMS should be clear in publishing the 

list that they do not require external hospital reporting of listed events, 

but provide the list to broaden and improve staff understanding. 

CMS should provide guidance to accreditors for assessment of hospital 

efforts to track and analyze events and should scrutinize survey processes 

when approving accreditation programs 

Under the Medicare QAPI CoP, hospitals must track and analyze 

adverse events. Administrators indicated that incident reporting 

systems are critical to identifying and tracking events. Although 

reporting systems captured few events, we found that accreditors do not 

routinely assess incident reporting systems or other methods for 

identifying events during hospital surveys. 

CMS is testing draft interpretive guidelines for surveyors regarding the 

QAPI CoP, including guidance about how surveyors are to assess 

hospital operations for tracking patient harm. To facilitate more 

extensive hospital detection of events, we recommend that this guidance 

include information about how surveyors should assess hospital event 

collection efforts, including incident reporting systems, and should 

include the list of potentially reportable events to be developed by 

AHRQ and CMS (addressed in our first recommendation).

CMS should also suggest that surveyors evaluate the information 

collected by hospitals and compare it to the data elements of AHRQ’s 

37 Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries, 

OEI 06-09-00090, pp. 51–61. See Appendix D for rates of reporting within the subcategories 

of events identified in the national incidence study. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 22

 

RECOMMENDATIONS

Common Format event reporting tools, which include the information 

that AHRQ has found to be most useful in patient safety efforts. This 

comparison could serve not only to assess the quality of reported 

information but also would further promote use of the Common Formats 

by hospitals in developing their internal incident reporting systems. 

Additionally, CMS should scrutinize survey standards for assessing 

hospital compliance with the requirement to track and analyze events 

and reinforce assessment of incident reporting systems as a key tool to 

improve event identification and tracking. Given the low reporting 

rates and lack of assessment by accreditors during hospital surveys, 

CMS should ensure that accreditation survey practices bring about a 

meaningful examination of systems that identify events, including 

mechanisms for reporting events, and hospital efforts to address 

underreporting and use information.

AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 

RESPONSE 

We received comments on the draft report from AHRQ and CMS.

AHRQ. AHRQ concurred with our recommendation to collaborate with 

CMS in creating a list of potentially reportable events and providing

technical assistance to hospitals in using the list. AHRQ stated that it 

will meet with CMS staff to continue collaboration on the potential use 

of Common Formats by surveyors and hospital adverse event reporting 

systems.

CMS

In response to our recommendation that CMS collaborate with AHRQ in

creating a list of potentially reportable events, CMS stated that a 

voluntary list of adverse events used for informational purposes could 

be highly beneficial for improving incident reporting practices, and it 

has initiated this collaboration. In response to our recommendation 

that CMS provide guidance to accreditors, CMS stated that it is

. CMS concurred with our recommendations and stated that 

strengthening hospital reporting systems and practices is an essential 

component of efforts to prevent patient harm. CMS provided 

information about future plans to improve patient safety, including the 

public-private “Partnership for Patients,” a national initiative intended 

to reduce adverse events and complications caused during transitions 

from hospitals to other health care settings. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 23

 

RECOMMENDATIONS

developing draft guidance for surveyors regarding assessment of the 

QAPI CoP within hospitals. This guidance will include the expectation 

that hospitals provide staff with “detailed, unambiguous instructions on 

the types of events that should be reported.” Further, CMS stated that 

it will recommend that hospitals use both the list of potentially 

reportable events and the AHRQ Common Formats in developing these 

staff instructions. 

For the full text of AHRQ and CMS comments, see Appendix E. 

We made minor changes to the report based on technical comments.
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 24

 

APPENDIX~A APPENDIX ~ A APPENDIX ~ A

Example Incident Report

Below is a reproduction of an incident report we received during data 

collection. We redacted all patient and hospital information. 

Incident Info: Patient Fall People Involved: 

Incident Number: 8726 (Reporting Employee Name ) 

Log Date: 10/01/2008 2:25:21 PM Other People Involved: 

Incident Date: 10/01/2008 2:20:00 PM Witness

Location: BATHROOM (Attending Physician Name) 

Primary Person Involved: (Patient Name) (Employee Reviewer Name) 

Account Number: (Employee Reviewer Name) 

Birth Date: (Employee Reviewer Name) 

Comments/Incident Description/Additional Details

Review Comment Made by: (Employee Name)

RN and LPN had walked patient to bathroom several times. Patient used call light and or they checked in with her and 

walked her back from bathroom. At the time of this fall, the patient unexpectedly got up unassisted and fell. C/o rib pain,

physician notified, no injury confirmed per radiology. The plan of care was updated with communication regarding nature of 

fall.

Details

Falls Patient Outcomes

Type of Fall -To/In bathroom

Were the healthcare 

personnel caring for the 

patient notified?

-Yes

Injury Type

-Other: LT RIB DISCOMFORT

-Abrasion/ Laceration/ 

Bruise

Restraints/Siderails -Mattress sensor

-SR up x2

Was additional treatment 

provided to the patient? -No

Physician -Physician was notified Patient Outcomes -14 Other: PAIN LT RIB

-03 Abrasion/Bruise

Was equipment involved? -No Severity of Injury

Mental status at time of 

fall

-Other: FORGETFUL -Alert 

and oriented x3 Severity of Injury:

-MINOR-NO TREATMENT 

REQUIRED OR MINIMAL 

TREATMENT (FIRST AID)

Current Documented Risk 

Assessment Level Prior to 

this Fall

-High

Level 1 Review

Contributing Factors -N/A

Could medication have 

been factor in fall? -No Follow Up Actions -Additional Data Collection

Level 2 Review

Was the bill adjusted? -N/A

Level 3 Review

Has a memo been drafted to 

Medical Staff Leadership? -N/A
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 25

 

 APPENDIX ~ B

Content Analysis of the Sample Event Incident Reports

Supporting Documentation Provided by Hospitals

Hospitals provided supporting documentation for each of the 40 events 

reported by staff to an incident reporting system. Of the 40 supporting 

documents, 19 consisted of full copies of the report forms that hospital 

staff completed when they reported events to an incident reporting 

system. We refer to these as incident reporting forms. For the other 21 

reported events, hospitals did not provide the full incident report. In 

these cases, hospitals had not retained the full report but provided 

archived information to confirm that a report was made. This often 

included only basic information, such as the event type and date and did 

not represent the initial incident report. Therefore, we did not include 

the provided information for these 21 events in our content analysis. 

We examined each of the 19 incident report forms and compared them 

to the Agency for Healthcare Research and Quality (AHRQ) Common 

Formats.38, 39

Analysis of Data in the Incident Reports 

 AHRQ did not provide hospitals with the Common 

Formats until after our sample hospitals reported these events, and 

even now their use by hospitals is voluntary. However, the Common 

Formats represent a Federal effort to determine what information 

hospitals should include in incident reports, and in the absence of 

Federal requirements for report content, we used the Common Formats

as a tool to compare the information in sample hospital incident reports. 

We compared the individual data points in each incident reporting form 

to specific AHRQ Common Formats data elements. To determine 

whether an element was present, we reviewed the forms for fields 

indicating that the hospital requested the information from the reporter 

and that the request was fulfilled. If the information was requested but 

not completed (indicated by a blank field), we did not consider the 

element present. We collapsed the Common Format data elements into 

three categories based on AHRQ’s event reporting forms: basic event 

38AHRQ, Common Formats. Accessed at https://www.psoppc.org/web/patientsafety on 

March 31, 2011.

39 We used AHRQ’s Common Formats event reporting tools because they represent 

AHRQ’s efforts to consolidate the necessary elements of an incident report for the purposes 

of patient safety improvement. AHRQ announced Version 1.0 of the Common Formats in 

the Federal Register in September 2009 and Version 1.1 in March 2010. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 26

 

APPENDIX~B APPENDIX~ B

information, patient impact information, and summary and contributing 

factors. 

Results of Content Analysis 

In assessing these 19 incident reports, we found that report form and 

content were largely similar among hospital incident reporting systems. 

Incident reports most often focused on information that is likely readily 

available to staff who report, such as when and where the event 

occurred and the type of event. When compared to the AHRQ Common

Formats, most incident reports contained basic event information and 

patient impact information, but few contained summary information 

and details about factors contributing to the event. Table B-1 provides a 

summary of the 19 incident reports listed by the categories and 

elements suggested in the AHRQ Common Formats. 

Table B-1: Common Format Data Elements Present on the 

Complete Incident Reports (n=19)

Element Description

Number of 

Reports With 

Element

Basic Event Information

Date the event was discovered 19

Location of the event 19

Clinical category of the event 19

Whether the event was an adverse event, near-miss, or 

unsafe condition 17

Narrative description of the event 16

Patient Impact Information

Time between event and assessment of harm 16

Whether rescue steps were taken 16

Level of harm caused by event 14

Whether the event prolonged the patient’s length of stay 2 

Contributing Factor Information

Whether and which factors contributed to the event 10

Patient safety staff’s summary of the event and followup 6 

Preventability of the event 6 

Whether the event was a National Quality Forum Serious 

Reportable Event 0 

Whether a patient handoff was associated with the event 3 

Source: Office of Inspector General analysis of 19 full incident reports associated with reported events.

Basic Event Information. Each of the 19 incident reports included basic 

event information. The incident reports generally captured and 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 27

 

APPENDIX~ B

summarized basic information about the event and the patient involved, 

including the date, location, and type of event. Most incident reports 

(17 of 19 reports) also included elements for assessing whether the 

incident caused patient harm (an actual event) or represented only a 

near-miss or unsafe condition. To capture this information, reports 

used a structured format with specific questions and scaled responses, 

which hospital administrators indicated are useful for initially sorting 

events. For example, administrators reported that they often review 

the frequency of particular types of events using preset categories, such 

as “excessive bleeding” or “surgical-site infection.” They reported that 

more detailed reviews may then be targeted at more frequent events. 

Patient Impact Information. Incident reports commonly included 

descriptions of the impact of the event on the patient and actions taken 

by staff as a result of the event, such as the time between the event and 

an assessment (16 of 19 reports) and whether rescue steps were taken 

(16 of 19 reports). Hospital administrators indicated that patient 

impact information is often used to prioritize event investigations and, 

in the case of severe events, trigger special procedures. For example, 

one administrator said that when staff report events that have caused 

severe harm, alerts are sent automatically to specially trained response 

staff. 

Contributing Factor Information. Incident reports were not likely to 

contain analytic information included in the Common Formats, such as 

factors that contributed to the event (10 of 19 reports). A number of 

hospital administrators indicated that this is the most useful 

information for conducting patient safety activities because it enables 

them to understand whether particular contributing factors, such as 

confusing medication labels, are a common cause of multiple types of 

events. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 28

 

 APPENDIX ~ C

Estimates, Confidence Intervals, and Key Statistics 

We computed incidence rates and corresponding 95-percent confidence 

intervals using appropriate statistical methods based on the sample. 

Table C-1: Estimates and Confidence Intervals

Events and Reasons Events Were Not Reported Percentage 

Estimate

95-Percent 

Confidence Interval

Lower 

Bound

Upper 

Bound

Reporting Rate of Adverse and Temporary Harm Events (n=293) 

Events not captured 86.4% 81.6% 90.0%

Events captured 13.7% 10.0% 18.4% 

Commonly reported to incident reporting system 24.6% 19.0% 31.2% 

Not commonly reported to incident reporting system 61.8% 55.4% 67.8% 

Not caused by a perceptible error 12.0% 8.5% 16.5% 

Was an expected outcome or side effect 11.6% 8.3% 16.0% 

Caused little harm and/or harm was ameliorated 10.6% 7.4% 14.9% 

Was not on hospital’s mandatory reporting list 8.5% 5.5% 12.9% 

Occurs frequently in hospitals 7.9% 5.2% 11.6%

Symptoms became apparent after discharge 5.1% 2.8% 9.1% 

Occurred in patient with a history of similar events 3.8% 2.1% 6.7% 

Administrator did not provide a reason* 2.4% 1.2% 4.9%

Events captured and events commonly reported to incident 

reporting systems 38.2% 32.2% 44.6% 

Reporting Rate of Adverse Events (n=124)

Captured adverse events 12.9% 8.3% 19.6% 

Reporting Rate of Temporary Harm Events (n=169)

Captured temporary harm events 14.2% 9.4% 20.8% 

*Given the small proportions, confidence intervals for projected numbers exceed 50-percent relative precision. 

Source: Office of Inspector General (OIG) analysis of surveys associated with the 293 events identified by OIG.

Figure C-1: Statistical Test Results

Statistical Test

P-Value for 

Difference in 

Proportions

Test for relationship among harm events (i.e., adverse event or temporary harm event) 

and whether incident reporting systems captured the events 0.7380

Note: Weighted chi-square and Cochran-Mantel-Haenszel chi-square produced similar results. 

Source: OIG analysis of surveys associated with the 293 events identified by OIG. 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 29

 

 APPENDIX ~ D

Rates of Reporting by Event Category

Table D-1 contains information about the rate of reporting for events 

identified in the sample by type of event.

Table D-1: Rates of Reporting by Event Category (n=293)

 

 

Type of Event

Number of 

Sample 

Events

Number of 

Captured

Events

Percentage 

of Captured 

Events

Events Related to Medication 111 14 13%

Acute renal insufficiency (kidney failure) 6 0 0%

Allergic reaction or side effect related to skin 6 0 0%

Allergic reaction to blood or related product 2 1 50%

Delirium or change in mental status 29 7 24% 

Dysrhythmia 3 0 0%

Excessive bleeding 15 2 13% 

Gastrointestinal complication 4 0 0%

Hypoglycemic event 17 2 12%

Hypotension 5 1 20%

Other events related to medication 2 0 0%

Respiratory complication 6 1 17%

Severe allergic reaction 3 0 0%

Severe headache or dizziness 3 0 0%

Severe hypotension 4 0 0%

Thrush and other opportunistic infection 6 0 0%

Events Related to Patient Care 95 15 16%

Aspiration 11 1 9%

Deep vein thrombosis, pulmonary embolism 5 0 0%

Exacerbation of preexisting medical condition 4 0 0%

Failure to treat constipation or obstipation 3 0 0%

Intravenous infiltrate with symptoms 5 1 20%

Intravenous volume overload 24 0 0%

Other events related to patient care 5 2 40%

Patient fall with injury 5 5 100%

Skin tear, laceration, abrasion, or other breakdown 9 1 11%

Stage I, Stage II, or unstaged pressure ulcer 19 5 26%

Stage III pressure ulcer 3 0 0%

Tachycardia or dysrhythmia 2 0 0%

continued on next page
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 30

 

APPENDIX~D

Table D-1: Rates of Reporting by Event Category (n=293) (Continued)

Type of Event

Number of 

Sample 

Events

Number of 

Captured

Events

Percentage 

of Captured 

Events

Events Related to Surgery or Other Procedures 62 7 11%

Acute coronary syndrome 1 0 0%

Blood clot and other occlusion 2 0 0%

Cardiac complication 6 2 33%

Excessive bleeding 11 1 9%

Iatrogenic pneumothorax 3 1 33%

Other events related to surgery or other procedures 5 0 0%

Postoperative ileus 3 0 0%

Postoperative or postprocedural hypotension 2 0 0%

Postoperative urinary retention 3 0 0%

Prolonged nausea and vomiting 2 0 0%

Respiratory complication 6 2 33%

Severe hypotension 4 1 25%

Surgical tear or laceration 3 0 0%

Urinary catheter-associated trauma 3 0 0%

Urinary retention 8 0 0%

Events Related to Infection 25 4 16%

Bacterial infection 1 0 0%

Other bloodstream infection 4 1 25%

Respiratory infection 5 1 20%

Surgical or procedural site infection 4 1 25%

Urinary tract infection 6 0 0%

Vascular catheter-associated infection (central or peripheral line) 5 1 20%

Source: Office of Inspector General (OIG) analysis of incident reports associated with the 293 events identified by OIG.
A P PEN D x E 

Agency Comments 

Agency for Healthcare Research and Quality 

DEI',\RT)'1ENT or HEAI:rH ;\\if) HUMAN SERVICES 	 Agency for Healthcare 

Research and Quality 

540 Gaither Road 

RocKville. MD 20850 

www.ahrq.gov 

NOV 1 6 2011 

TO: Inspector General, Department of Health and Human Services 

FROM : Director 

SUBJECT: OEllnspection Number OEI-06-09-00091 

Thank you for the opportunity to review and comment on the Office of Inspector General's draft report 

entitled, OEI-06-09-00091, Hospital/ncident Reporting Systems Do Not Capture Most Patient Harm. 

Recommendation: AHRQ and eMS should col/aborate to create a list ofpotentially reportable events 

and provide technical assistance to hospitals using the list. 

AHRQ concurs with this recommendation . AHRQ has begun meeting with CMS to explore the role of the 

Common Formats as the foundation for a list of reportable events. 

Recommendation: CMS should provide guidance to accreditors regarding surveyor assessment of 

hospital efforts to track and analyze events, and should scrutinize survey processes when approving 

accreditation programs. 

AHRQ concurs with this recommendation. AHRQ will meet with CMS staff to continue collaboration on 


the potential use of Common Formats with surveyors and hospital adverse event reporting systems. 


Other technical notes for OIG staff: 


Page 5 -last sentence· The Common Formats' three event reporting forms focus on specific areas: 


information describing the event, information describing the patient, and summary and contributing 


factors. 


We suggest adding a new sentence: "The Common Formats also contain event specific modules that 


provide additional detail for high volume or high harm events." 


If you or your staff have any questions, please feel free to contact Dr. Bill Munier, Director, Center for 


Quality Improvement and Patient Safety at Will iam.munier@Jahrq.hhS.gov or 301-427-1921 


Carolyn M. Clancy 

OEI-06-09-00091 HOSPITAL INCIDENT REPORTING SYSTEMS Do NOT CAPTURE MOST PATIENT HARM 31 
Centers for Medicare & Medicaid Services 

~~ttv.('~~ 

~~~"' A'''' ~. Jt'C-	 DEPARTMENT OF FIEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 

-."'.:I~"',J't(1 ::j Administrator 

Washington. DC 20201 

NOV 1 8 2011 DATE: 

TO: 	 Daniel R. Levinson 


Inspector General 


FROM: 	 Donald M. Berwick, M.D. 


Administrator 


SUBJECT: 	 Office oflnspector General (OIG) Draft Report: Hospital Incident Reporting 

Systems Do Not Capture Most Patient Harm (OEI-06-09-0009J) 

Thank you for the opportunity to review and comment on this very timely and important study. 

In the subject report, the OIG examines whether hospitals identified adverse events on their own 

and, if so, the types of follow-up actions they took. The OIG reviewed the characteristics of 

hospitals' internal incident reporting systems, as well as the methods used by hospital accrediting 

organizations in evaluating hospital safety practices. There is a significant opportunity for farreaching improvement in the experience of individuals and families in the United States health 

care system and the patient safety arena, as well as, an opportunity for savings to the taxpayer 

and the beneficiary. 

We note that since the incidents reviewed in this report, the Department of Health and Human 

Services (HHS) has launched a new and ambitious public-private partnership entitled the 

"Partnership for Patients." This national Partnership will help improve the quality, safety and 

affordability of health care for Medicare, Medicaid and CHIP beneficiaries, and for all 

Americans. More than 6,200 organizations - including more than 2,800 hospitals - have signed 

the Partnership Pledge. 

HHS and the Centers for Medicare & Medicaid Services (CMS) are working with a wide variety 

of public and private partners to achieve the two core goals of this Partnership: 

• 	 Keeping patients from getting injured or sicker in the health care system, and 

• 	 Helping patients heal without complication by improving transitions from acute-care 

hospitals to other care settings, such as home or a skilled nursing facility. 

Hospitals' ability to identify patient harm that has occurred is an essential component oftheir 

efforts to prevent future such harm. We are very appreciative of the contribution that the OIG is 

making to our knowledge of common hospital approaches to identifying harm, the limitations of 

the existing methods employed, and the OIG's recommendations for improvement. The 

recommendations in this OIG report will help us strengthen the Partnership for Patients initiative 

as we work with hospitals and other health care providers to improve patient safety. 

OEI·06·09·00091 HOSPITAL INC IDENT REPORTING SYSTEMS Do NOT CAPTURE MOS T PATIENT HARM 32 

A P PEN D x E 
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 33

 

APPENDIX ~ E

Centers for Medicare & Medicaid Services (continued)
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 34

 

APPENDIX ~ E

Centers for Medicare & Medicaid Services (continued)
 

 

OEI - 0 6 - 0 9 - 00091 H OSPITAL I NCIDENT REPORTING S YSTEMS D O N OT CAPTURE MOST PATIENT HARM 35

 

APPENDIXD

 ACKNOWLEDGMENTS

This report was prepared under the direction of Kevin K. Golladay, 

Regional Inspector General for Evaluation and Inspections in the Dallas 

regional office; A. Blaine Collins, Deputy Regional Inspector General; 

and Ruth Ann Dorrill, Deputy Regional Inspector General.

Jeremy Moore served as the lead analyst for this study. Other principal 

Office of Evaluation and Inspections staff from the Dallas regional office 

who contributed to the report include Amy Ashcraft and Maria 

Balderas; central office staff who contributed include Rob Gibbons, 

Sandy Khoury, Tasha Trusty, and Rita Wurm.
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.