OFfICE O}" INSPECTOR (;l~NEllAL 
JUL  1 9 2012 
TO: 	 Marilyn Tavenner 
Acting Administrator 
Centers for Medicare & Medicaid Services 
FROM:  Stuart Wright 
Deputy Inspector General 
for Evaluation and Inspections 
SUBJECT: 	 Memorandum Report:  Few Adverse Events in Hospitals Were Reported to 
State Adverse Event Reporting Systems, OEI-06-09-00092 
This memorandum report provides information requested by officials of the Centers for 
Medicare & Medicaid Services (CMS) about hospital reporting of adverse events to State 
reporting systems.  The Office of Inspector General (OIG) collected this information 
while conducting a 2001-2012 series of studies about adverse events in hospitals. 
SUMMARY 
Previous ora work found that an estimated 27 percent of Medicare beneficiaries 
hospitalized in October 2008 experienced harm from medical care, either serious adverse 
events (defined as events resulting in prolonged hospitalization, permanent disability, 
life-sustaining intervention, or death) or temporary hann events (defined as events 
requiring intervention but not resulting in lasting harm).  To determine this rate of 
adverse and temporary harm events (referred to collectively as events), we examined 
medical records for a nationall.y representative sample of 780 hospitalized Medicare 
beneficiaries in October 2008.  Prior OIG work also found that in 2008, about half of 
States operated adverse event reporting systems to monitor the occurrence ofevents in 
hospitals.  Typically, these States required hospitals to report only specific types of 
events and analyzed the events in aggregate.  This memorandum extends our prior work 
by providing national estimates for the extent to which events experienced by Medicare 
beneficiaries occurred in States that operated adverse event reporting systems, whether 
States required reporting of the identified events, and whether the hospitals reported the 
events to the State systems. 
We found that an estimated 60 percent of adverse and temporary harm events nationally 
occurred at hospitals in States with reporting systems, yet only an estimated 12 percent of 
events nationally met State requirements for reporting.  We also found that hospitals 
reported only 1 percent of events.  Most of the events that States required to be reported, 
but that hospitals did not report, were not identified by internal hospital incident reporting 
systems. This suggests that low reporting to State systems is more likely the result of 
hospital failure to identify events than from hospitals neglecting to report known events.  Page 2  Marilyn Tavenner 
 
 
BACKGROUND 
Adverse Events in Hospitals  
Beginning in 2008, OIG released a series of reports regarding adverse events in hospitals.  
For the report Adverse Events in Hospitals:  National Incidence Among Medicare  
Beneficiaries, we conducted a physician review of medical records for a nationally 
representative sample of 780 Medicare beneficiaries hospitalized in October 2008.  We  
found that an estimated 13.5 percent of hospitalized Medicare beneficiaries experienced 
adverse events. An additional 13.5 percent of beneficiaries experienced temporary harm  
events.1       
 
For the report Hospital Incident Reporting Systems Do Not Capture Most Patient Harm,  
we determined whether the 189 hospitals where these events occurred had identified the 
events through their internal incident reporting systems.  We found that all the hospitals 
had incident reporting systems designed to capture staff reports regarding adverse events, 
yet hospital staff reported only 14 percent of events experienced by Medicare 
beneficiaries.2  Hospital administrators indicated that staff often did not report events 
because they identified them not as patient  harm, but rather as expected side effects. 
  
State Adverse Event Reporting Systems  
In the 2008 report Adverse Events in Hospitals:  State Reporting Systems, we found that 
25 States and the District of Columbia (hereinafter referred to  as 26 States) operated 
systems to collect adverse event data submitted by hospitals.3  All these State systems 
received event descriptions and hospital names, but varied as to whether they made 
reporting voluntary or mandatory, what types of events they specified should be reported, 
and what additional information they asked hospitals to report.  Most State systems 
required hospitals to report a subset of adverse events, usually serious events resulting in 
permanent disability or death, and events likely to affect the broader hospital population, 
such as infections. To date, no Federal standards require States to operate adverse event 
reporting systems.   
 
States with adverse event reporting systems used the reported information both to hold 
hospitals accountable and to promote learning about adverse events.   Twenty-three of the 
twenty-six States with reporting systems routinely investigated reported events.  
Additionally, 18 of the 26 States used event reports to provide patient safety information 
and educational tools to hospitals, including the State incidence of adverse events, early 
warnings of new or widespread threats to patient safety, and analysis of contributing 
factors.4  
 
 
 
 
1 OIG,  Adverse Events in Hospitals:  National Incidence Among  Medicare Beneficiaries, 
OEI-06-09-00090, November  2010. 
2 OIG,  Hospital Incident Reporting Systems Do Not Capture Most  Patient  Harm,  OEI-06-09-00091, 
January 2012. 
3 OIG,  Adverse Events in Hospitals:  State Reporting Systems, OEI-06-07-00471, December 2008. 
4 Ibid.  Page 3  Marilyn Tavenner 
 
 
METHODOLOGY 
We reviewed State policies to determine which events identified in our previous study 
were ones that States required hospitals to report.  We then collected any reports about 
these events that hospitals sent to States.  Based on the national random sample of 
hospitalized Medicare beneficiaries, we projected rates for the following:  events 
experienced by Medicare beneficiaries that occurred in States that operated adverse event 
reporting systems in 2008 and events that these States required hospitals to report to the 
State systems.  Appendix A contains estimates and confidence intervals for these 
statistics. We also determined which events hospitals reported to these State systems.   
 
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. 
RESULTS  
Although half of States operated adverse event reporting systems in 2008, only  
12 percent of events met State requirements for reporting 
An estimated 60 percent of adverse and temporary harm events nationally occurred at 
hospitals in States with reporting systems, yet only an estimated 12 percent of events 
nationally met State requirements for reporting.  Of the events that States required to be 
reported, over half occurred in Pennsylvania, which required reporting of all events 
regardless of severity.5  Table 1 breaks down the events by whether they were required to 
be reported to State systems.   
 
Table 1:  Percentage of Hospital Events, by State and Whether State Required    
Event to be Reported 
Whether State Required Event to  be Reported   Percentage of  All Events  
Event  Occurred in State With  Adverse Event Reporting System    60%
     Event did not meet State reporting requirements   49%* 
     Event met State reporting requirements   12%* 
Event Occurred in State Without Adverse Event Reporting System   40% 
Total Events   100% 
Source: OIG analysis of the 293 information requests completed by hospitals  where events occurred.  
* Percentages do not  sum  to 60 percent because of rounding.  
 
Hospitals reported very few sampled events that States required to be reported  
Within our sample, hospitals reported only 3 of the 35 events required to be reported to a 
State reporting system.  All 3 of these reported events occurred in Pennsylvania, which 
had a total of 22 events among sampled beneficiaries Statewide.  All three of the reported 
events caused temporary harm to beneficiaries and were of types commonly targeted by 
hospital patient safety efforts (allergic reaction, fall, and pressure ulcer).   
 
 
5 Pennsylvania:  40 P.S.  1303.313.  Page 4  Marilyn Tavenner 
 
 
Nearly all unreported events also went undetected by internal hospital incident reporting 
systems.  Of the 32 events that hospitals did not report to State systems as required, 
hospitals identified only 1 event within an internal incident reporting system.  For the 
remaining 31 events, hospitals had no record indicating that staff recognized the event 
had occurred. This suggests that the low rate of reporting to State adverse event reporting 
systems is due largely to hospital staff not identifying incidents of harm as reportable 
events. 
 
Many of the events not reported to State systems as required involved serious harm to 
hospitalized Medicare beneficiaries.  Six of the thirty-two events contributed to patient 
death, including cases involving lack of patient monitoring and missed diagnoses.  For 
example, one patient death was the result of acute renal failure caused by the hospital not 
recognizing and treating a serious systemic inflammatory response syndrome 
(bacteremia).  Another patient death was the result of poor insulin management escalating 
to a hypoglycemic coma.  Other unreported events required the use of life-sustaining 
interventions, indicating that hospital staff were clearly alerted to a problem but still did 
not report the events. 
 
Further, the less serious, temporary harm events that hospitals did not report included 
many events that can become serious if not ameliorated, such as excessive bleeding and 
intravenous volume overload.  The treatment required to stop the progression of these 
events also implies that in each case, hospital staff were likely aware of the patients 
condition but did not perceive the condition as an event.   
 
Table 2 lists the events in our sample that States required to be reported to adverse event 
reporting systems, whether hospital staff reported these events to incident reporting 
systems within the hospitals, and whether the events were reported to the State systems.   
  Page 5  Marilyn Tavenner 
 
 
Table 2:  Adverse Events That Required Hospital Reporting to State Adverse 
Event Reporting Systems (n=35) 
Reported  Reported to 
State   Type of Event   Level of Harm 
within Hospital   State System  
CA  Excessive bleeding  Contributed to death     
CO  Blood stream infection  Contributed to death     
IN  Fall  Prolonged hospital stay     
IN  Pulmonary embolism   Prolonged hospital stay     
KS  Excessive bleeding  Contributed to death     
MD  Excessive bleeding  Prolonged hospital stay      
MD  Excessive bleeding  Prolonged hospital stay     
MD  Hypoglycemic coma  Life-sustaining intervention     
MD  Hypotension  Prolonged hospital stay     
MD  Catheter infection  Prolonged hospital stay     
NJ  Excessive bleeding  Contributed to death     
NJ  Hypoglycemic coma  Contributed to death     
NY   Blood stream infection  Contributed to death     
PA  Acute renal failure  Temporary harm     
PA  Acute renal failure  Permanent harm     
PA  Allergic reaction  Temporary harm       
PA  Allergic reaction  Temporary harm     
PA  Congestive heart failure  Prolonged hospital stay     
PA  Dysrhythmia   Temporary harm     
PA  Excessive bleeding  Temporary harm     
PA  Excessive bleeding  Temporary harm     
PA  Fall  Temporary harm       
PA  Nausea and vomiting  Temporary harm     
PA  Pressure ulcer   Temporary harm       
PA  Pulmonary embolism   Prolonged hospital stay     
PA  Sepsis  Life-sustaining intervention     
PA  Skin tear  Temporary harm     
PA  Surgical tear  Temporary harm     
PA  Urinary retention   Temporary harm     
PA  Urinary tract infection  Permanent harm     
PA  Intravenous volume overload   Prolonged hospital stay     
PA  Intravenous volume overload   Temporary harm     
PA  Intravenous volume overload   Temporary harm     
PA  Intravenous volume overload   Temporary harm     
TN   Acute renal failure  Prolonged hospital stay     
Source:  OIG analysis of information provided by hospitals regarding 293 identified events, 2011.  Level of harm from the National  
Coordinating Council for Medication Errors Reporting and Prevention Index for Categorizing Errors, Press Release,  Medication  
Errors Council Revises and Expands Index for Categorizing Errors:  Definitions of Medication Errors Broadened, June 12, 2001. 
 
CONCLUSION 
Although half of States operated adverse event reporting systems in 2008, hospitals 
reported few events to State systems.  For all but one event that was not reported to State 
systems as required, the hospitals did not identify the events within internal incident 
reporting systems.  This indicates that low reporting to State systems is more likely to 
result from hospital failure to identify events than from hospitals neglecting to report 
known events. CMS, States, and other stakeholders should be aware of this low rate of 
reporting to State systems as they consider strategies to reduce adverse events in 
hospitals.  
 
This report is being issued directly in final form because it contains no recommendations.  
If you have comments or questions about this memorandum report, please provide them 
within 60 days. Please refer to report number OEI-06-09-00092 in all correspondence. 
 
  Page 6  Marilyn Tavenner 
 
 
APPENDIX A 
 
Estimates and Confidence Intervals   
 
We computed estimates and corresponding 95-percent confidence intervals using 
appropriate statistical methods based on the sample.  
 
Table A:  Hospital Adverse Events and State Reporting (n=293)  
95-Percent 
Point  Confidence Interval  
Adverse Event  
Estimate   Lower  Upper 
Bound  Bound 
Event  Occurred in State With Event Reporting  System   60.4%  52.5%  67.8% 
     Event did not meet State reporting requirements  48.5%  40.9%  56.1% 
     Event met State reporting requirements   12.0%  8.2%   17.2%  
Event Occurred in State Without Event Reporting System   39.6%  32.2%  47.5%  
Total Events      
 
Source: OIG analysis of the 293 information requests completed by hospitals  where events occurred.