Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
HOSPIT  AL INCIDENT REPORTING 
 
S D N C  
YSTEMS  O  OT  APTURE 
 
M  OST PATIENT HARM 
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
January 2012 
OEI-06-09-00091    
   
 EE XX EE CC UU TT II VV EE    SS UU MM MM AA RR YY   
 E X E C U T I V E   S U M M A R Y  
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 
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E X E C U T I V E   S U M M A R Y  
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.   
 
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E X E C U T I V E   S U M M A R Y  
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 AHRQs 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.   
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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.          
  
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 T A B L E   O F   C O N T E N T S  
EX ECUT I VE  SUM M ARY  .....................................i 
 
 
I NT RO DU CT I O N  ............................................ 1 
 
 
F I NDI NG S  .................................................  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 
 
RECO M M END AT I O N S  .....................................  20 
Agency Comments and Office of Inspector General Response ....  22 
 
APP EN DI X ES  .............................................  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 
 
ACKNO WL E DG M E N T S .....................................  35    
   
 I N T R O D U C T I O N  
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  
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.   
Hospital Incident Reporting Systems  
Hospitals use incident reporting systems to monitor adverse events and 
other patient safety issues.3  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 
 
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. 
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. 416423.   
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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  IOM advised hospitals to analyze these data to 
identify the causes of events and to develop strategies to prevent 
recurrence.  
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.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. 2733. 
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. 164168. 
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. 
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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. 399401. 
13 42 CFR  482.21. 
14 42 CFR  482.21(c)(2). 
15 42 CFR  482.21(a)(2). 
16 68 Fed. Reg. 3435, 343839  (Jan. 24, 2003).  
17 CMS, CMS Financial Report:  Fiscal Year 2009. 
18 Social Security Act,  1861(e), 42 U.S.C.  1395x(e). 
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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 
inspectionscalled surveysof 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 accreditors 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. 130131. 
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. 
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AHRQs 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 
AHRQs 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 users 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 HHSs 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). 
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National Incidence of Adverse Events 
In a November 2010 report, OIG estimated the national incidence rate 
of adverse and temporary events in hospitals.31  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 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. 
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 Forums (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 
Improvements 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. 45.    
33 NQF, Serious Reportable Events, October 2008.   
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higher Medicare reimbursement (known as hospital-acquired conditions 
(HAC));34 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.   
METHODOLOGY 
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.      
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Information requests.  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). 
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.   
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.     
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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 Medicares 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. 
 
 
 
   
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 F I N D I N G S  
All of the 189 hospitals in 
 All sampled hospitals had incident reporting systems 
which an event occurred 
to capture events, and administrators we interviewed 
reported using general incident 
rely heavily on these systems to identify problems 
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) 
  Number of 
Type of System   Hospitals With 
System 
General incident reporting system designed to capture 
  189 
all instances of patient harm 
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  10 
          
   
F I N D I N G S  
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  11 
          
   
F I N D I N G S  
Despite the existence of incident 
 Hospital staff did not report 86 percent of events to 
reporting systems, hospital staff did 
incident reporting systems, partly because of staff 
not report most events that harmed 
misperceptions about what constitutes patient harm 
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  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. 
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 
 
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  12 
          
   
F I N D I N G S  
staff commonly reported but did not report in this particular case.  See      
Table 2 for detailed information on why staff didnt report events.   
  Table 2:  Events by Reporting Category and Reasons 
Administrators Gave for Why Staff Did Not Report (n=293) 
Percentage of 
Event Category 
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                 
62%* 
   because:   
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 hospitals 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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  13 
          
   
F I N D I N G S  
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  Information in incident reports 
through the regular course of care; 28 of the 40 reported  typically described the reported 
events led to investigations and 5 led to policy changes  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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  14 
          
   
F I N D I N G S  
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 
nurses 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) 
   Events 
Method of Event Identification 
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 
2 
infection  
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  15 
          
   
F I N D I N G S  
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.        
 
 
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F I N D I N G S  
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. 
 
 
 
 
 
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F I N D I N G S  
Hospital accreditors reported that in evaluating  In interviews, officials 
hospital safety practices, they focus on how event  from hospital accreditors 
noted the importance of 
information is used rather than how it is collected  
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 
hospitals 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.  
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F I N D I N G S  
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  19 
          
   
 RR EE CC OO MM MM EE NN DD AA TT II OO NN SS   
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  20 
          
   
R E C O M M E N D A T I O N S  
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 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.   
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.    
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 AHRQs 
 
37 Adverse Events in Hospitals:  National Incidence Among Medicare Beneficiaries,     
OEI 06-09-00090, pp. 5161.  See Appendix D for rates of reporting within the subcategories 
of events identified in the national incidence study.     
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RR EE CC OO MM MM EE NN DD AA TT II OO NN SS   
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.  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.   
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 
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  22 
          
   
R E C O M M E N D A T I O N S  
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  23 
          
   
 AA PP APP PEE NNP DDE IIN XXD~  I~AX   ~A 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 
-Other:  LT RIB DISCOMFORT  personnel caring for the  -Yes 
Injury Type  -Abrasion/ Laceration/  patient notified? 
Bruise 
       
-Mattress sensor  Was additional treatment 
Restraints/Siderails  -No 
-SR up x2  provided to the patient? 
       
-14 Other:  PAIN LT RIB 
Physician  -Physician was notified  Patient Outcomes 
-03 Abrasion/Bruise 
       
Was equipment involved?  -No  Severity of Injury 
       
-MINOR-NO TREATMENT 
Mental status at time of  -Other:  FORGETFUL -Alert 
Severity of Injury:  REQUIRED OR MINIMAL 
fall  and oriented x3 
TREATMENT (FIRST AID) 
       
Current Documented Risk  Level 1 Review 
Assessment Level Prior to  -High     
this Fall  Contributing Factors  -N/A 
       
Could medication have  -No  Follow Up Actions  -Additional Data Collection 
been factor in fall? 
   
    Level 2 Review 
       
    Was the bill adjusted?  -N/A 
       
    Level 3 Review 
       
Has a memo been drafted to 
    -N/A 
Medical Staff Leadership? 
       
   
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  24 
          
   
 
 A P P E N D I X ~ 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  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.   
Analysis of Data in the 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 AHRQs event reporting forms:  basic event 
 
38AHRQ, Common Formats.  Accessed at https://www.psoppc.org/web/patientsafety on 
March 31, 2011. 
39 We used AHRQs Common Formats event reporting tools because they represent 
AHRQs 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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  25 
          
   
AA PP PP EE NN DD II XX ~~ BB   
  
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) 
Number of 
Element Description  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 
17 
unsafe condition 
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 patients length of stay  2 
Contributing Factor Information 
Whether and which factors contributed to the event  10 
Patient safety staffs summary of the event and followup  6 
Preventability of the event   6 
Whether the event was a National Quality Forum Serious 
0 
Reportable Event 
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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  26 
          
   
A P P E N D I X ~ 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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  27 
          
   
 A P P E N D I X ~ 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 
95-Percent  
    Percentage  Confidence Interval 
Events and Reasons Events Were Not Reported 
Estimate 
Lower  Upper 
Bound  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 hospitals 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 
38.2%  32.2%  44.6% 
reporting systems 
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  
P-Value for 
Statistical Test  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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  28 
          
   
 A P P E N D I X ~ 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) 
 
Number of  Number of  Percentage 
  Type of Event  Sample   Captured  of Captured 
   Events  Events  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-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  29 
          
   
A  P P E N D I X ~ D  
 
 
 
Table D-1:   Rates of Reporting by Event Category  (n=293) (Continued) 
Number of  Number of  Percentage 
Type of Event  Sample   Captured  of Captured 
Events  Events  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. 
 
 
 
   
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  30 
        x 
A  P  PEN  D  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 William.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  A  P  PEN  D  x  E 
Centers for Medicare & Medicaid Services 
~~ttv.('~~ 
!.~~~"' Jt'~AC''''- 	
~.  DEPARTMENT OF FIEALTH & HUMAN SERVICES  Centers for Medicare & Medicaid Services 
-. ::j 
"'.
:I~"',J't(1 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 far
reaching 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 ofhealth 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. 
OEI060900091  HOSPITAL INC IDENT REPORTING SYSTEMS Do NOT CAPTURE MOS T PATIENT HARM  32    
   
A P P E N D I X   ~   E  
 
 
Centers for Medicare & Medicaid Services (continued) 
   
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  33 
          
   
A P P E N D I X   ~   E  
 
   
Centers for Medicare & Medicaid Services (continued) 
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  34 
        A P P E N D I X ~ D  
 
  
   
 A C K N O W L E D G M E N T S  
This report was prepared under the direction of Kevin K. Golladay, 
Regional Inspector General for Evaluation and Inspections in the Dallas 
regional office; 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. 
 
 
 
 
 
  OEI-06-09-00091  HOSPITAL INCIDENT REPORTING SYSTEMS DO NOT CAPTURE MOST PATIENT HARM  35 
         
Office of Inspector General 
http://oig.hhs.gov 
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 
amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits 
examine the performance of HHS programs and/or its grantees and contractors in carrying 
out their respective responsibilities and are intended to provide independent assessments of 
HHS programs and operations.  These assessments help reduce waste, abuse, and 
mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 
HHS, Congress, and the public with timely, useful, and reliable information on significant 
issues.  These evaluations focus on preventing fraud, waste, or abuse and promoting 
economy, efficiency, and effectiveness of departmental programs.  To promote impact, OEI 
reports also present practical recommendations for improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 
of fraud and misconduct related to HHS programs, operations, and beneficiaries.  With 
investigators working in all 50 States and the District of Columbia, OI utilizes its resources 
by actively coordinating with the Department of Justice and other Federal, State, and local 
law enforcement authorities.  The investigative efforts of OI often lead to criminal 
convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support for OIGs internal operations.  OCIG represents OIG in all civil and 
administrative fraud and abuse cases involving HHS programs, including False Claims Act, 
program exclusion, and civil monetary penalty cases.  In connection with these cases, OCIG 
also negotiates and monitors corporate integrity agreements.  OCIG renders advisory 
opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG 
enforcement authorities.