Department of Health and Human Services 
OFFICE OF 
 
INSPECTOR GENERAL 
 
 
 
 
 
 
 
 
A   E H :
DVERSE  VENTS IN  OSPITALS  
 
M  R
EDI CARE S  ESPONSES TO 
 
A S E  
LLEGED  ERIOUS  VENTS
 
 
 
 
 
 
Daniel R. Levinson  
Inspector General 
 
October 2011 
OEI-01-08-00590   
   
E X EE CX UE TC IUVTE I   VS EU  MSMUAMR MY A  R Y  
OBJECTIVES 
1.  To assess the responses of State survey and certification agencies 
and the Centers for Medicare & Medicaid Services (CMS) to 
complaints that allege serious adverse events. 
2.  To describe hospital responses to complaints that allege serious 
adverse events. 
BACKGROUND 
The term adverse event describes harm to a patient as a result of 
medical care.  In response to the Tax Relief and Health Care Act of 
2006, the Office of Inspector General (OIG) released a series of reports 
regarding adverse events.  In that work, OIG estimated that over 
one-quarter of hospitalized Medicare beneficiaries were harmed during 
their hospital stays in October 2008.  This report examines Medicares 
responses to alleged serious adverse events.  These responses represent 
important patient safety opportunities, yet little attention has been paid 
to their role in improving patient safety. 
Hospitals must meet the Medicare Conditions of Participation (CoP) to 
participate in Medicare.  On behalf of Medicare, State survey and 
certification agencies (State agencies) investigate complaints alleging 
hospital noncompliance with CoPs.  Immediate jeopardy (IJ) complaints 
are the most serious and may allege adverse events.  Also, hospitals 
often conduct their own investigations of adverse events independently 
of State agencies. 
Because no national database of adverse events exists, this report uses 
a random sample of IJ complaints to identify alleged serious adverse 
events to which Medicare responded.  To review the complaints, we used 
data from CMS, State agencies, hospital accreditors, and the hospitals 
associated with the sample. 
FINDINGS 
State agency responses to complaints alleging serious adverse 
events were generally timely and often found problems.  For 75 of 
the 95 alleged events in our sample, State agencies conducted complaint 
surveys at hospitals within 2 days, as required.  For 53 of the 95 alleged 
events in our sample, State agencies cited hospitals for Federal 
deficiencies while investigating the events.  Complaints in our sample 
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E X E C U T I V E   S U M M A R Y  
often included limited information for State agencies to determine the 
priority and timing of their responses.  For half of the complaint 
surveys, CMS set the scope of the survey to address multiple CoPs. 
State agencies and CMS missed opportunities to incorporate patient 
safety principles in their responses.  For complaint surveys at 
accredited hospitals, CMS directed State agencies to assess the CoP on 
performance improvement in only 33 of the 78 surveys and the CoP on 
the hospitals governing body in only 12.  State agencies performed little 
longer term monitoring to verify that hospitals corrective actions 
resulted in sustained improvements.  After completing complaint 
surveys, State agencies required the hospitals to submit performance 
data for only 1 of the 19 complaints that required corrective action 
plans.  State agencies did not always disclose the nature of complaints 
to hospitals, thus limiting hospitals ability to learn from alleged events. 
CMS informed the Joint Commission of few complaints, impeding 
the Joint Commissions oversight of its accredited hospitals.  
Contrary to CMSs policy of notifying accreditors of all complaints 
against the hospitals they accredit, CMS regional offices notified 
accreditors of only 28 of the 88 sampled complaints against accredited 
hospitals. 
Hospitals investigated most complaints in our sample, finding State 
agency responses valuable but disruptive.  Hospitals reported being 
aware of 87 of the complaints in our sample and investigated 75 of 
them, beginning two-thirds of their investigations before State agencies 
arrived to conduct their onsite complaint surveys.  Hospitals 
investigations were multidisciplinary and often involved hospital 
leadership.  Hospitals found that State agency responses lent urgency 
but also disrupted their own responses. 
Hospital corrective actions resulted largely in training coupled with 
policy and process changes.  Hospitals took 1 or more corrective 
actions in response to each of 64 complaints.  Hospitals responses to  
58 of these complaints included training staff as a corrective action, and 
the responses to 42 complaints included policy or process changes.  
Hospitals took disciplinary actions, such as firing staff, in one-third of 
complaints resulting in corrective actions.  For just under one-third of 
complaints resulting in corrective actions, the corrective actions 
included changes to devices, software, or workspaces designed to 
prevent adverse events by forcing staff into a course of action, rather 
than relying on their memory or adherence to procedures. 
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RECOMMENDATIONS 
Require that all Immediate Jeopardy complaint surveys evaluate 
compliance with the Condition of Participation on quality assurance 
and performance improvement.  CMS identifies this CoP as central to 
patient safety and to a hospitals ability to identify, track, analyze, and 
prevent adverse events.  Furthermore, CMS should consider limiting 
the initial scope of the IJ complaint survey to this CoP and the 
allegation itself. 
Ensure that State agencies monitor hospitals corrective actions for 
sustained improvements.  Defining and monitoring outcome measures 
are important elements of quality improvement and, thereby, patient 
safety.  After hospitals have implemented corrective actions, CMS 
should require State agencies to monitor the resultsfor example, by 
collecting and analyzing hospitals performance data or by revisiting 
hospitals.  State agencies should take action when hospitals corrective 
actions fail to yield effective and sustained improvements.  
Amend guidance on disclosure to explain the nature of complaints 
to hospitals.  Improving disclosure to hospitals would provide them 
with opportunities to analyze and learn from alleged adverse events. 
Improve communication with accreditors.  CMS should ensure that 
its regional offices follow its policy on notifying accreditors of complaints 
against accredited hospitals.  CMS could clarify its instructions and 
educate regional office staff on how and when to notify accreditors of 
complaints against accredited hospitals. 
AGENCY COMMENTS 
CMS concurred with our recommendations and described how it will 
increase the prominence of the CoP on quality assessment and 
performance improvement in complaint surveys, enhance monitoring of 
the efficacy of corrective actions, and improve communication with 
hospitals at the outset of complaint surveys.  CMS also stated that it 
will work with its regional offices to improve their compliance with its 
policy to notify accreditation organizations of complaints against 
accredited hospitals. 
We made minor changes to the report based on technical comments 
from CMS. 
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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  ................................................. 13 
State agency responses to complaints alleging serious adverse 
events were generally timely and often found problems ........ 13 
State agencies and CMS missed opportunities to incorporate  
patient safety principles in their responses .................. 16 
CMS informed the Joint Commission of few complaints,  
impeding the Joint Commissions oversight of its accredited  
hospitals .............................................. 18 
 
Hospitals investigated most complaints in our sample,  
finding State agency responses valuable but disruptive ........ 19 
 
Hospital corrective actions resulted largely in training coupled 
with policy and process changes ........................... 22 
 
 
RECO M M END AT I O N S  ...................................... 24 
Agency Comments and Office of Inspector General Response .... 26 
 
 
APP EN DI X ES  .............................................. 27 
  A:  Tax Relief and Health Care Act of 2006 .................. 27 
  B:  Office of Inspector General Series of Reports on Adverse 
Events ............................................. 29 
 
  C:  National Quality Forum Serious Reportable Events ........ 30 
D:  Centers for Medicare & Medicaid Services 
Hospital-Acquired Conditions .......................... 31 
E:  Medicare Hospital Conditions of Participation ............. 32 
F:  Descriptive Tables of Sampled Complaints ................ 33 
 
  G:  Joint Commission Response to Complaints ................ 36 
  H:  Agency Comments ................................... 38 
 
ACKNO WL E DG M E N T S ..................................... 43   
   
 I N T R O D U C T I O N  
OBJECTIVES 
1.  To assess the responses of State survey and certification agencies 
and the Centers for Medicare & Medicaid Services (CMS) to 
complaints that allege serious adverse events. 
2.  To describe hospital responses to complaints that allege serious 
adverse events. 
BACKGROUND 
Statutory Mandate and Office of Inspector General Response 
The Tax Relief and Health Care Act of 2006 requires that the Office of 
Inspector General (OIG) report to Congress regarding the incidence of 
never events among Medicare beneficiaries, among other topics.1  (For 
the relevant text of this Act, see Appendix A.)  To meet the 
requirements of this Act, OIG released a series of reports beginning in 
2008 and will publish additional reports based on ongoing work.  (See 
Appendix B for a list of OIG reports in the series.)  The published 
reports assessed State adverse event reporting systems, public 
disclosure of adverse events, and the national incidence of adverse 
events among the Medicare population.   
This report supplements that body of work by assessing the responses of 
State survey and certification agencies (State agencies) and CMS to 
complaints that allege serious adverse events.  It also describes the 
hospitals responses, which helps in understanding the backdrop against 
which the former responds.  These responses represent important 
patient safety opportunities, yet little attention has been paid to their 
role in improving patient safety. 
Adverse Events in Hospitals 
The health care community now uses the term adverse event more 
commonly than never event.  An adverse event is generally defined as 
patient harm as a result of medical care or in a hospital.  Although an 
adverse event indicates that the care resulted in an undesirable clinical 
outcome and may involve errors, adverse events do not always involve 
errors, negligence, or poor quality of care and are not always 
preventable.2  OIG estimated that in October 2008, 13.5 percent of 
 
1 Tax Relief and Health Care Act of 2006, P.L. 109-432  203. 
2 R.M. Wachter, Understanding Patient Safety, McGraw-Hill, 2008. 
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hospitalized Medicare beneficiaries experienced an adverse event 
during their hospital stays.  Those events resulted in a prolonged 
hospital stay, permanent harm, life-sustaining intervention, or death.  
Furthermore, OIGs analysis estimated that an additional 13.5 percent 
of beneficiaries experienced adverse events that resulted in temporary 
harm, such as prolonged vomiting or hypoglycemia.3 
The Institute of Medicine (IOM) is often credited with first drawing 
attention to adverse events in hospitals.4  More recently, many 
organizations and payers have further defined the harm associated with 
adverse events or developed payment policies related to them.  For 
example, the National Quality Forum (NQF) maintains a list of events 
associated primarily with patient death or serious disability that are 
both egregious and preventable.5  (See Appendix C for the list of 
NQF-defined serious reportable events.)  In addition, on October 1, 
2008, CMS began denying hospitals higher Medicare payments for care 
associated with certain hospital-acquired conditions (HACs).6  Examples 
of HACs include catheter-associated urinary tract infections and patient 
injuries because of falls.7  (See Appendix D for the complete list of 
CMS-defined HACs.)  In January 2009, CMS published three National 
Coverage Determinations denying payment for three surgery-related 
adverse events:  wrong site, wrong patient, and wrong procedure.8, 9, 10 
 
3 OIG, Adverse Events in Hospitals:  National Incidence Among Medicare Beneficiaries, 
OEI-06-09-00090, November 2010. 
4 IOM, To Err is Human:  Building a Safer Health System, 1999. 
5 NQF, Serious Reportable Events in Healthcare 2006 Update.  Accessed at 
http://www.qualityforum.org on December 13, 2010. 
6 Fiscal Year (FY) 2009 Hospital Inpatient Prospective Payment System Final Rule,  
73 Fed. Reg. 48434, 48471-48472 (August 19, 2008); CMS, CMS Manual System, Change 
Request 6189 (Oct. 3, 2008). 
7 The Deficit Reduction Act of 2005, P.L. 109-171  5001(c)(1), required HACs to meet the 
following criteria:  conditions that are high cost, high volume, or both; conditions that, when 
present as a secondary diagnosis, result in a higher payment; conditions that could be 
reasonably prevented by using readily available evidenced-based guidelines; and conditions 
that are identifiable based on one or more unique diagnosis codes. Social Security Act, 
 1886(d)(4)(D)(iv), 42 U.S.C.  1395ww(d)(4)(D). 
8 CMS, Decision Memo for Surgery on the Wrong Body Part, January 15, 2009.  
Accessed at http://www.cms.hhs.gov on December 8, 2010. 
9 CMS, Decision Memo for Surgery on the Wrong Patient, January 15, 2009.  Accessed 
at http://www.cms.hhs.gov on December 8, 2010. 
10 CMS, Decision Memo for Wrong Surgery Performed on a Patient, January 15, 2009.  
Accessed at http://www.cms.hhs.gov on December 8, 2010. 
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Adverse events can be defined more broadly than NQF has done in its 
list of serious reportable events or than CMS has done with its list of 
HACs and nonpayment policies.  For example, the event could result in 
harm that is psychological or that stems from abuse or neglect.  CMS 
uses these broader definitions in its evaluation of harm to Medicare 
beneficiaries.11 
Patient Safety 
Since IOMs seminal work, the health care community has widely 
adopted the goal of improving patient safety.  Experts point to the 
importance of evidence-based medicine and quality improvement 
activities to improve patient safety.12  Such activities generally 
emphasize principles such as learning from adverse events through 
reporting, analysis, and measurement.  Furthermore, experts cite the 
importance of the commitment by a hospitals leadership and staff to 
creating a culture of safety and achieving improved quality.13 
Preventing, identifying, and responding to adverse events are typically 
among the goals of patient safety efforts.  However, identifying adverse 
events is challenging.  Methods to identify adverse eventssuch as 
medical record reviews, examination of hospital incident reporting 
systems, patient interviews, and billing data analysishave strengths 
and limitations and can also be resource intensive.14  Complaints about 
hospitals represent another potential way to identify adverse events. 
Medicares Quality Oversight of Hospitals 
Medicares quality oversight of hospitals is based on the Medicare 
Conditions of Participation (CoP).15  CoPs are minimal health and 
safety requirements that hospitals must meet to be eligible for Medicare 
participation.16  They cover topics ranging from the credentialing and 
 
11 CMS, State Operations Manual (SOM), Pub. 100-07, Appendix Q.  Accessed at 
http://www.cms.gov on September 17, 2010. 
12 Donald M. Berwick, The Science of Improvement, Journal of the American Medical 
Association (JAMA), Vol. 299, No. 10, March 2008, pp. 1182-1184; Lucian L. Leape, Donald 
M. Berwick, and David W. Bates, What Practices Will Most Improve Safety?   
Evidence-Based Medicine Meets Patient Safety, JAMA, Vol. 288, No. 10, July 2002, pp. 
501-507. 
13 James P. Bagian, Patient Safety:  What Is Really at Issue?, Frontiers of Health 
Services Management, Vol. 22, No. 1, Fall 2005, pp. 3-16. 
14 OIG, Adverse Events in Hospitals:  Methods for Identifying Events, OEI-06-08-00221, 
March 2010. 
15 42 CFR pt. 482. 
16 Social Security Act,  1861(e), 42 U.S.C.  1395x(e); 42 CFR  488.3(a)(2). 
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privileging of physicians to the hospitals governing body and 
management.  (See Appendix E for the current list of 23 CoPs.)  Each 
CoP includes related standards that hospitals must meet.17 
Patient safety is encompassed in the CoP on quality assessment and 
performance improvement (QAPI).  The QAPI CoP requires hospitals to 
maintain effective quality assurance and performance improvement 
systems that emphasize feedback and learning.18  It also places 
responsibility for QAPI on the hospitals governing bodies.  Likewise, 
the CoP on the hospitals governing body further states the governing 
bodys accountability for the entire institution.19   
The Department of Health and Human Services (HHS) and CMS 
consider the principles incorporated in these CoPs to be critical to 
promoting patient safety.  HHS recently launched the Partnership for 
Patients, an initiative designed to make health care delivery safer, more 
reliable, and less costly.  Among other things, this initiative emphasizes 
the importance of governing bodies in developing and maintaining a 
culture of safety at hospitals.20  In its comments on OIGs report on the 
national incidence of adverse events among the Medicare population, 
CMS stressed the importance of these CoPs to patient safety.21   
Hospitals may choose accreditation or demonstrate to CMS that they 
meet the CoPs; over 90 percent opt for accreditation.22, 23  Pursuant to 
the Social Security Act, hospitals accredited by certain national 
accreditors are deemed to meet the CoPs; CMS refers to them as 
hospitals with deemed status.24, 25  Hospitals that do not opt for 
accreditation can demonstrate to CMS that they meet the CoPs through 
 
17 SOM, ch. 1,  1016. Accessed at http://www.cms.gov on March 18, 2011. 
18 42 CFR  482.21. 
19 42 CFR  482.12. 
20 HHS, Partnership for Patients.  Accessed at http://www.healthcare.gov on April 28, 
2011. 
21 OIG, Adverse Events in Hospitals:  National Incidence Among Medicare Beneficiaries, 
OEI-06-09-00090, November 2010, pp. 71-72. 
22 Social Security Act,  1864(a), 42 U.S.C.  1395aa(a); 42 CFR  488.10(a)(1). 
23 Social Security Act,  1865, 42 U.S.C.  1395bb; 42 CFR  488.5(a). 
24 Ibid. 
25 Three organizations accredit hospitals for participation in Medicare:  the Joint 
Commission, the American Osteopathic Association, and Det Norske Veritas Healthcare.  
The Joint Commission accredits the majority of accredited hospitals. 
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a survey process by a State survey and certification agency (State 
agency).26 
The accreditation process and the State agency process rely on periodic 
onsite inspectionscalled surveysof hospitals.  Generally, accreditors 
or State agencies conduct surveys to add hospitals to Medicare, 
reevaluate hospitals in the program, and respond to complaints and 
adverse events. 
State Agency Responses to Complaints 
The Social Security Act requires the Secretary to enter into agreements 
with State agencies to investigate allegations that hospitals have not 
complied with Federal requirements.27  Because State agencies are 
responsible for ensuring that participating providers of health care 
services continually meet Federal requirements, CMS requires that the 
agencies promptly review complaints and reports of incidents, 
regardless of providers accreditation status.28 
CMS considers an allegation to be an assertion of improper care or 
treatment that could result in the citation of a Federal deficiency.29  (A 
Federal deficiency means that the hospital is not in full compliance with 
one or more of the CoPs.)  Such allegations may involve adverse events.  
State agencies learn of allegations through their complaint processes.  
The complaint process, therefore, represents a key part of CMSs patient 
safety system because it is a potential resource for identifying and 
responding to adverse events. 
State agencies may receive self-reported allegations from hospitals, or 
they may receive allegations from patients or others in the form of 
complaints.  They may also identify allegations through media reports.  
For the purposes of this study, we will refer to all allegations as 
complaints, regardless of their source. 
The quality and completeness of information provided by a complainant 
plays an important role in the State agencys response.  State agency 
staff and CMS regional office staff rely on the details in the complaints 
to determine the priority and scope of their responses.  For example, 
upon receiving a complaint, a State agency assigns an investigative 
 
26 Social Security Act,  1864(a), 42 U.S.C.  1395aa(a); 42 CFR  488.10(a)(1). 
27 Social Security Act,  1864(a) and (c), 42 U.S.C.  1395aa(a) and (c); 42 CFR  
 488.10 and 488.11. 
28 SOM, ch. 5,  5000.2. Accessed at http://www.cms.gov on September 17, 2010. 
29 SOM, ch. 5,  5010. Accessed at http://www.cms.gov on September 17, 2010. 
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priority based on CMS policy.30  The highest priority is immediate 
jeopardy (IJ), which CMS defines as a situation in which the 
providers noncompliance with one or more requirements of 
participation has caused, or is likely to cause, serious injury, harm, 
impairment, or death....31  IJ complaints trigger an unannounced onsite 
survey within 2 working days of receipt of the complaint.32 
The accreditation status of the hospital involved in the complaint also 
plays an important role in determining how the State agency responds.  
If the hospital is accredited, the State agency must forward the 
complaint to the CMS regional office for approval to conduct a complaint 
survey. 33  The CMS regional office also identifies the CoPs to be covered 
in the complaint survey that the State agency will conduct. 34  By 
identifying the CoPs to be covered, the regional office determines the 
surveys scope.  For nonaccredited hospitals, the State agency 
determines the scope of the complaint survey and does not need the 
regional offices approval.35, 36 
Outcomes of State Agency Responses  
During a complaint survey, the State agency may find that a hospital 
has one or more Federal deficiencies.  The actions that the State agency 
takes are determined by the level of the deficiency (condition or 
standard) and the hospitals accreditation status.37  Actions can include 
requiring the hospital to submit a plan of correction to the State agency.  
CMS states that, in addition to describing corrective actions, a plan of 
correction must describe the monitoring procedure that the hospital will 
 
30 SOM, ch. 5,  5070 and 5075.  Accessed at http://www.cms.gov on September 17, 
2010. 
31 42 CFR  489.3; SOM, ch. 5,  5075.1. 
32 Lower priority complaints may trigger an unannounced onsite survey within 45 days 
or be investigated by the State agency during its next onsite survey.  SOM, ch. 5,  5075.9.  
Accessed at http://www.cms.gov on September 17, 2010. 
33 Ibid. 
34 SOM, ch. 5,  5100.1.  Accessed at http://www.cms.gov on September 17, 2010. 
35 SOM, ch. 5,  5200.1.  Accessed at http://www.cms.gov on September 17, 2010. 
36 The State agency also does not require the CMS regional offices approval to conduct a 
complaint survey of an accredited hospital if the basis of the complaint investigation is 
potential noncompliance with State requirements.  SOM, ch. 5,  5100.1.  Accessed at 
http://www.cms.gov on September 17, 2010.  
37A condition-level deficiency means that the manner and degree of noncompliance 
results in failure to substantially comply with the entire CoP.  A standard-level deficiency 
means that noncompliance exists, but the manner and degree of noncompliance does not 
rise to the level of substantial noncompliance with the entire CoP. 
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use to ensure that corrective actions are effective and sustained.38  State 
agency actions can also include recommending that CMS begin the 
process to terminate the hospital from participating in Medicare.  The 
State agency may also return to the hospital to conduct a full survey 
covering all the CoPs.39 
A nonaccredited hospital must submit a plan of correction for any 
deficiencies.40  An accredited hospital must submit a plan of correction 
only for condition-level deficiencies in certain instances.  When the 
State agency identifies a condition-level deficiency during a complaint 
survey of an accredited hospital, the CMS regional office removes the 
hospitals deemed status and the hospital comes under the State 
agencys jurisdiction.  The State agency must then conduct a full survey 
of the hospital; the results of that survey determine what further steps 
the State agency will take. 
Finally, CMS policy requires CMSs regional offices to notify accreditors 
of all complaints forwarded by State agencies once they are resolved.41 
Investigation of Complaints by Accreditors 
Accreditors may investigate and respond to complaints against 
accredited hospitals regardless of whether State agencies have 
responded.  Like State agencies, accreditors review and assign priorities 
to complaints.  Complaints assigned the highest priority may trigger 
unannounced onsite surveys. 
Other Oversight Entities That May Respond to Adverse Events 
Entities other than State agencies and accreditors may respond to 
adverse events.  For example, the Centers for Disease Control and 
Prevention may respond to infectious disease outbreaks.  State 
protection and advocacy agencies may respond to events involving elder 
abuse.  State professional licensure boards may respond when events 
involve problems with licensed professionals, such as doctors or nurses.  
Local law enforcement may also respond, especially when the events 
involve suicides or crimes, such as assaults.   
 
38 SOM, ch. 2,  2728B.  Accessed at http://www.cms.gov on September 17, 2010. 
39 SOM, ch. 5,  5100.2.  Accessed at http://www.cms.gov on September 17, 2010. 
40 SOM, ch. 5,  5200.1.  Accessed at http://www.cms.gov on September 17, 2010. 
41 SOM, ch. 5,  5100.  Accessed at http://www.cms.gov on September 17, 2010. 
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Hospital Responses to Adverse Events 
Hospitals have a frontline responsibility to respond to adverse events 
and prevent harm from them.  Hospitals can investigate actual or 
alleged adverse events themselves independently of any external 
response (such as from the State agency or accreditor).  Their 
investigations can also precede, coincide with, or follow others 
responses.  Likewise, hospitals can institute their own corrective actions 
based on their investigations.  Hospitals internal systems for 
identifying, tracking, and responding to alleged adverse events are 
critical to promoting patient safety and ensuring that events are 
responded to appropriately. 
Scope 
This report assesses State agencies and CMSs responses to a sample of 
IJ complaints against hospitals.  We use IJ complaints to identify 
serious adverse events because they are likely to signify situations 
involving patient harm and because no national database of adverse 
events exists.  This report includes IJ complaints against accredited and 
nonaccredited hospitals received by State agencies during fiscal year 
(FY) 2008. 
We focus on State agencies because of their role in responding to 
complaints about accredited and nonaccredited hospitals.  We focus on 
CMS because of its role in directing State agency responses. 
Finally, this report also describes hospitals responses to the IJ 
complaints.  We include this information because we believe it provides 
important context about what is happening at hospitals when State 
agencies respond. 
METHODOLOGY 
This study relied on a review of a simple random sample of IJ 
complaints against hospitals, which we used as a proxy for serious 
adverse events.  Our other data sources were CMS, State agencies, 
accreditors, and the hospitals associated with the complaints in our 
sample.  In planning for our review, we conducted structured interviews 
with staff at CMS, accreditors, and other stakeholders. 
Sample Selection 
We first obtained a file from CMSs Automated Survey Processing 
Environment Complaints Tracking System (ACTS) of all IJ complaints 
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against hospitals that State agencies received, investigated, and closed 
during FY 2008.42  After consulting with CMS, we excluded alleged 
violations of the Emergency Medical Treatment and Active Labor Act 
(EMTALA) because they were less likely to represent adverse events 
and because they are monitored differently.43  After we excluded alleged 
EMTALA violations, the file of IJ complaints contained 351 complaints.  
From it, we selected a simple random sample of 100 complaints against 
81 hospitals.  We removed one complaint from the sample after data 
from CMS and State agencies showed that two complaints in our sample 
involved the same alleged event.  Our final sample contained  
99 complaints against 81 hospitals.  (See Appendix F for more 
information about the complaints in our sample.) 
Data Collection 
For each of the complaints in our sample, we collected data from CMS, 
State agencies, hospital accreditors, and hospitals. 
Data from CMS and State Agencies 
From CMS and State agencies we requested: 
 the full Complaint Investigation Report, which contains data and 
o
narrative details on the intake of the complaint, the complaint 
survey, deficiencies cited, and other information; 
 Form(s) 2567, Statement of Deficiencies and Plan of Correction, 
o
resulting from the survey(s) related to the complaint; 
 if applicable, Form 2802, Request for Validation of Accreditation 
o
Survey for Hospital, showing the CMS regional offices approval for 
the State agency to conduct a complaint survey and its approved 
scope, i.e., the CoPs to be covered; 
 if available, other supporting documents, such as correspondence 
o
between the oversight entities and hospitals. 
We received the Complaint Investigation Report for each of the 
99 complaints in our sample.  We received one or more Forms 2567 for 
 
42 We focused on short-term hospitals that generally have an average length of stay of 
fewer than 25 days and do not include long-term care, rehabilitation, psychiatric, or 
childrens hospitals. 
43 Social Security Act  1866(a)(1)(I), 1866(a)(1)(N), and 1867, 42 U.S.C. 
 1395cc(a)(1)(I), 1395cc(a)(1)(N), and 1395dd.  EMTALA sets forth requirements for 
medical screening examinations for medical conditions, as well as necessary stabilizing 
treatment or appropriate transfer of individuals seeking emergency treatment at hospitals. 
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96 of the complaints in our sample.  We received Forms 2802 for 82 of 
the complaints in our sample against accredited hospitals.44  We 
received other supporting documents for 90 of the complaints in our 
sample. 
Data from Hospital Accreditors 
We used data from the three hospital accreditors to determine that 92 of 
the 99 complaints in our sample were against hospitals accredited by 
the Joint Commission.  None of the complaints in our sample were 
against hospitals accredited by the American Osteopathic Association or 
Det Norske Veritas Healthcare. 
We provided the Joint Commission with a list of complaints along with 
the dates and brief descriptions of the alleged events underlying the 
complaints.  We asked the Joint Commission for details regarding its 
awareness of those events and its responses.  The Joint Commission 
provided this information for all of the complaints. 
Data from Hospitals 
To supplement data from CMS, State agencies, and the Joint 
Commission, we sent a questionnaire (the hospital questionnaire) to the 
hospitals associated with the complaints in our sample.  If a hospital 
had more than one complaint in our sample, we sent one questionnaire 
for each complaint.  The hospital questionnaire covered hospitals 
responses to the events and the responses by Medicare and other 
oversight entities.  For nonresponders and for responders with 
questions, we followed up by telephone and email.  (We did not disclose 
any protected health information by email.)  Hospitals did not complete 
questionnaires for three complaints for which they were unaware of the 
underlying adverse events and three complaints for which staff turnover 
or change in hospital ownership hampered access to the necessary 
people and records.  We received no response from two hospitals.  In 
total, we obtained completed questionnaires from 74 hospitals, covering 
91 of the complaints in our sample. 
 
44 We received 86 Forms 2802.  We removed 4 of these forms from our analysis because 
they were for complaints against nonaccredited hospitals, leaving forms that covered 82 of 
the 92 complaints in our sample against accredited hospitals.  Of the remaining  
10 complaints against accredited hospitals, no Form 2802 was required for 2 complaints 
because the State agency conducted the complaint survey under State authority and for  
1 complaint because the State agency was already onsite at the hospital for a different 
survey.  Seven complaints had no Form 2802 because the State agency failed to get CMS 
approval, as required.  We notified CMS of these complaints. 
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Finally, to add context to our understanding, we selected a small, 
purposive subsample of seven complaints against four hospitals to use 
as case studies of the responses from hospitals and oversight entities.  
When we selected this subsample, we considered the nature of the 
events alleged in the complaints and hospital characteristics, including 
location, size, and mission (e.g., nonprofit, for-profit, academic, or 
community).  Case studies consisted of: 
 interviews with hospital staff about the alleged event(s) underlying 
o
the sampled complaints, 
 a review of the hospitals response to the alleged event(s) and 
o
related documentation, and 
 a review of the response(s) by State agencies, CMS, and accreditors. 
o
Analysis 
We removed 4 complaints from our analysis because they alleged unsafe 
conditions but did not allege serious adverse events, leaving  
95 complaints that alleged serious adverse events.  We used data from 
CMS and State agencies to assess their oversight responses to these 
complaints.  We used data from CMS and the Joint Commission to 
assess CMSs role in the oversight responses to the complaints lodged 
against accredited hospitals.  We used data from hospitals completed 
questionnaires to describe their responses to the complaints.  Finally, 
we supplemented our analysis with data from our seven case studies.  
(See Table 1 for a summary of our data sources.)   
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Table 1:  Data Sources by Analysis Topic 
 
Analysis Topic  Number of   Data Source  Number  
  Complaints  Analyzed 
State agency responses for all   95  Complaint investigation reports  95 
hospitals    Forms 2567  92 
Supporting documents from complaint files  87 
  OIG hospital questionnaire  87 
Case studies  7 
 
CMS role in responses for accredited   88  Forms 2802  78 
hospitals    Supporting documents from complaint files  80 
Data from the Joint Commission  88 
 
Hospital responses  87  OIG hospital questionnaire  87 
  Case studies  7 
Hospital investigations  75  OIG hospital questionnaire  75 
  Case studies  7 
Hospital corrective actions  64  OIG hospital questionnaire  64 
  Case studies  7 
Source: OIG analysis of complaint sample. 
 
Limitations 
This study used a sample of IJ complaints from ACTS as a way to 
identify serious adverse events to which State agencies and CMS 
responded.  It relied in part on State agencies initial prioritization of 
complaints, which is based on limited and highly variable information 
from complainants.  This study is not intended to be a comprehensive 
review of State survey agencies responses to all complaints, nor is it 
intended to be a review of ACTS.  We did not determine whether the 
adverse events alleged in the complaints took place.  We did not 
independently verify the data reported to us by CMS, State agencies, 
accreditors, and hospitals.  The results of our review cannot be projected 
to all complaints in ACTS, nor can they be projected to adverse events 
as a whole. 
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation approved by the Council of the Inspectors 
General on Integrity and Efficiency.   
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F I NF DI NI ND GI SN  G S  
State agency responses to complaints alleging  State agencies have no 
serious adverse events were generally timely  control over the quantity 
or quality of complaints 
and often found problems 
that they receive; 
 
nevertheless, they are obligated to take them seriously and respond 
appropriately.  CMS requires that State agencies begin their onsite 
surveys in response to complaints prioritized as IJ complaints within  
2 working days of intake.45   
State agencies conducted complaint surveys for most of the complaints 
in our sample within 2 days, as required 
Although they typically received IJ complaints weeks after adverse 
events allegedly occurred, State agencies responded within 2 days, as 
required, for 75 of the 95 complaints in our sample.  They began the 
remaining surveys from 3 days to as long as 3 months after receiving 
the complaints.  According to CMS staff, CMS clarified its instructions 
to State agencies on investigative priorities and timelines in 2008, the 
year that this study examines.  This may have led State agencies and 
CMS regional offices to reprioritize some complaints from a lower 
investigative priority to the higher IJ priority, resulting in those IJ 
complaints being investigated more than 2 days after intake. 
State agencies cited hospitals for deficiencies while investigating over 
half the complaints in our sample 
State agency investigations of 53 of the 95 complaints in our sample led 
to the hospitals being cited for deficiencies.  Investigations into the  
four most common types of complaintssexual assault, medication 
error, physical abuse by hospital staff, and restraint problemsalong 
with suicide, led to the most citations for deficiencies.  Together, these 
five types of events represented half or more of the IJ complaints in our 
sample that allege adverse events and those with deficiencies.  (See 
Table 2 for deficiencies by type of alleged event.) 
   
 
45 SOM, ch. 5,  5075.9.  Accessed at http://www.cms.gov on December 13, 2010. 
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Table 2:  Deficiencies by Type of Alleged Event 
  Type of Alleged Event  Number of   Number with  
Complaints  Deficiencies 
 
Sexual assault  13  8 
  Medication error  10  4 
Physical abuse by staff  10  7 
  Restraint-related  10  6 
Delay in treatment  5  2 
 
Patient elopement/transport issues  5  1 
  Patient fall  5  3 
Suicide  5  4 
  Neglect  4  1 
Pressure ulcers  4  3 
 
Wrong surgery (site or side)  4  2 
  Foreign object retained  3  2 
Misdiagnosis  3  1 
  Verbal abuse by staff  3  2 
Complications during/following childbirth  2  1 
 
Surgical fire  2  2 
  Inappropriate treatment/handoff  1  1 
Infant to wrong parents  1  1 
  Infectious outbreak  1  0 
Medical device-related injury  1  0 
 
Other fire  1  0 
  Perforation during catheterization  1  1 
Transfusion error  1  1 
       Total  95  53 
Source: OIG analysis of FY 2008 ACTS data.   
Complaints in our sample often included limited information for State 
agencies to determine the priority and timing of their responses  
About half of the complaints in our sample included 10 or fewer 
sentences describing the alleged events.  The initial information 
included in IJ complaints often lacked details such as the pre- and post-
event chronology, patient diagnosis, and the location in the hospital 
where the event occurred.  (See Table 3 for details on information 
contained in complaints.) 
   
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Table 3:  Initial Information Received by State Agencies for a Sample of 
Complaints Alleging Serious Adverse Events 
  Number of 
  Complaints 
Information  (n = 95) 
 
Type of event  93 
 
Description of harm  87 
 
Date of event  73 
 
Gender of patient  69 
 
Chronology pre-event  47 
 
Initial diagnosis  46 
 
Chronology post-event  39 
   
Location in hospital where event occurred  36 
  Time of day when event occurred  36 
  Age of patient  32 
  Procedure being performed  31 
  Staff present when event occurred  21 
Source: OIG analysis of FY 2008 ACTS data.   
For half of the complaint surveys, CMS set the scope of the survey to 
address multiple Conditions of Participation 
As part of CMSs process of approving State agencies complaint surveys 
of accredited hospitals, its regional offices direct State agencies to 
evaluate hospitals compliance with one or more selected Medicare CoPs.  
In half of the 78 surveys of accredited hospitals that CMS regional 
offices approved, the regional offices directed State agencies to evaluate 
compliance with multiple CoPsfrom two to as many as seven.  Overall, 
regional offices directed State agencies to assess compliance with  
199 Medicare CoPs during their 78 complaint surveys of accredited 
hospitals.  State agencies complaint surveys found that hospitals were 
noncompliant with 45 of these CoPs.   
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F I N D I N G S  
Patient safety principles 
State agencies and CMS missed opportunities to 
emphasize quality 
incorporate patient safety principles  
improvement and 
in their responses 
learning from adverse 
events to prevent them from recurring.  Medicares complaint survey 
process offers ways for State agencies and CMS to incorporate patient 
safety principles when responding to alleged adverse events in 
hospitals.  These include the opportunity to evaluate hospitals quality 
improvement systems and governance mechanisms by assessing how 
the hospitals addressed alleged events.  They also include the 
opportunity to monitor and evaluate hospitals corrective actions for 
sustained improvement and to share information with hospitals, 
thereby providing an opportunity for hospitals to learn.  
CMS directed State agencies to assess the hospitals performance 
improvement systems in fewer than half of their complaint surveys at 
accredited hospitals  
In our sample, CMS regional offices directed State agencies to assess 
hospitals compliance with the QAPI CoP for 33 of the 78 complaint 
surveys they approved.  CMS established the QAPI CoP to improve 
patient safety in the hospital setting. 46  Central to this CoP is the idea 
that the hospital should take responsibility for improving its 
performance rather than relying on the survey process and the threat of 
punitive actions.  Patient safety experts contend that a high-functioning 
quality improvement system bolstered by strong hospital leadership 
enables hospitals to detect adverse events, learn from them, and 
prevent their recurrence.47 
CMS rarely directed State agencies to assess governance during their 
complaint surveys at accredited hospitals  
Only 12 of the 78 complaint surveys in our sample included State 
surveyors examining the CoP regarding hospitals governing bodies.  
This CoP states that a hospitals governing body is legally responsible 
for the conduct of the hospital as an institution, including its quality 
improvement system.48  Hospital leadership and medical staff are 
accountable to the governing body.  The governing body ensures that 
medical staff members are properly credentialed and competent to 
 
46 42 CFR  482.21. 
47 James P. Bagian, Patient Safety:  What Is Really at Issue?, Frontiers of Health 
Services Management, Vol. 22, No. 1, Fall 2005, pp. 3-16. 
48 42 CFR  482.12.  
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F I N D I N G S  
deliver safe and effective care.  Experts in patient safety recognize the 
importance of governing bodies in establishing and maintaining a 
culture of safety in health care organizations.49  Executives at case 
study hospitals stated that their governing bodies play an important 
role in demanding medical staff accountability for quality care. 
State agencies performed little monitoring to verify that hospitals corrective 
actions resulted in sustained improvements 
State agencies required hospitals to submit plans of correction in 
response to 19 complaints:  15 against accredited hospitals and  
4 against nonaccredited hospitals.  However, their oversight of these 
plans was limited largely to ensuring that acceptable plans were in 
place.  State agencies visited hospitals to verify initial implementation 
of 17 of the 19 plans.  Only one hospital was required to submit data to 
the State agency showing longer term compliance.  In that case, the 
State agency requested that the hospital submit data monthly, without 
specifying an endpoint.  CMS guidance states that hospitals should 
institute corrective actions that are effective and sustained.50  Indeed, 
patient safety experts stress the importance of hospitals measuring 
outcomes associated with process changes.51 
Even though they were not required to do so, accredited hospitals 
voluntarily submitted plans of correction for standard-level deficiencies 
identified during an additional 31 complaint surveys in our sample.  
None of these plans required hospitals to submit data showing  
longer term compliance.  To verify that hospitals had implemented the 
changes called for in the plans, State agencies followed up on eight of 
these voluntary plans with in-person revisits and one by telephone. 
State agencies did not always disclose the nature of the complaints to the 
hospitals, thereby limiting hospitals ability to learn from alleged events 
State agencies can be an important source of information for hospitals.  
In fact, hospital staff reported in our hospital questionnaire that they 
first learned about 16 of the complaints in our sample when State 
agency surveyors arrived at their hospitals.  However, hospital staff told 
us that they never learned the nature of 3 of the complaints, and staff 
 
49 NQF, Hospital Governing Bodies and Quality of Care:  A Call to Responsibility, 
December 2, 2004. 
50 SOM, ch. 2,  2728B.  Accessed at http://www.cms.gov on September 17, 2010. 
51 James P. Bagian, Patient Safety:  What Is Really at Issue?, Frontiers of Health 
Services Management, Vol. 22, No. 1, Fall 2005, pp. 3-16. 
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FF II NN DD II NN GG SS   
had trouble identifying the nature of 27 complaints in our sample 
without our assistance.  Discussions with hospital personnel during our 
site visits corroborated these concerns; they noted that surveyors 
sometimes declined to share the nature of the complaints they came to 
investigate. 
Such limited disclosure can prevent hospitals from learning about 
alleged events, which may be near misses.  A near miss is an event or 
situation that did not produce patient injury, but only because of 
chance.52  Patient safety experts identify near misses as important 
learning opportunities to prevent recurrence of adverse events.53 
CMS guidance on complaint procedures does not address whether State 
surveyors should reveal the nature of the complaints to hospital staff.  
Rather, CMS guidance on disclosure is limited to protecting the 
confidentiality of the complainant.54  This approach to disclosure 
contrasts with the complaint guidance that CMS provides to nursing 
home surveyors; CMS advises them to disclose the general nature of the 
surveys to the nursing homes administrators while maintaining 
complainant confidentiality.55 
CMS informed the Joint Commission of few  CMSs policy calls for its 
regional offices toonce 
complaints, impeding the Joint Commissions 
complaints are resolved
oversight of its accredited hospitals 
notify accreditors of all 
complaints against hospitals they accredit.56  However, CMS notified 
the Joint Commission of only 28 of the 88 complaints against hospitals 
it accredited. 
Of these 28 complaints, the Joint Commission had records of 
notification from CMS for only 8 complaints.  In total, the Joint 
Commission reported being aware of 23 complaints because, in addition 
to the 8 complaints it learned of from CMS, it learned of 15 other 
complaints from self-reporting hospitals, the media, and others. 
 
52 Agency for Healthcare Research and Quality, Patient Safety Network Glossary.  
Accessed at http://www.psnet.ahrq.gov on September 21, 2010. 
53 J.P. Bagian, J. Gosbee, C.Z. Lee, et al., The Veterans Affairs Root Cause Analysis 
System in Action, Journal on Quality Improvement, Vol. 28, Number 10, Fall 2002,  
pp. 531-545. 
54 SOM, ch. 5,  5010.  Accessed at http://www.cms.gov on September 21, 2010. 
55 SOM, ch. 5,  5300.2.  Accessed at http://www.cms.gov on September 17, 2010. 
56 SOM, ch. 5,  5100.  Accessed at http://www.cms.gov on September 17, 2010. 
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Officials at the Joint Commission told us that its being unaware of 
complaints against its accredited hospitals compromises Medicares 
quality oversight system in several ways.  First, it impedes the ability of 
accreditors to respond to complaints that may be related to adverse 
events or other problems at hospitals they oversee.  This in turn can 
deprive accreditors of important information when reviewing a 
hospitals performance to determine whether to renew its accreditation.  
Finally, not sharing the results of the complaint surveys prevents 
accreditors from using the survey results to improve the consistency 
between the outcomes of accreditation surveys and those of State 
agencies.  Such consistency is a key measure that CMS uses to assess 
the performance of accreditors.57 
See Appendix G for a description of how the Joint Commission 
responded to the complaints in our sample of which it became aware. 
Hospitals investigated most complaints in our sample,  Hospitals reported being 
aware of 87 of the 
finding State agency responses valuable 
complaints in our sample, 
but disruptive 
and they investigated 75 of 
 
them.  We were unable to determine why hospitals did not investigate 
the remainder. 
Two-thirds of hospital investigations started before the State agencies 
began their complaint surveys 
Hospitals began 49 of their 75 investigations before the State agencies 
arrived to conduct their onsite complaint surveys.  Hospitals learned of 
the majority of alleged events underlying complaints from their staff, 
such as someone on the care team treating the patient.  They responded 
most swiftly when they learned of events in this way.  In these cases, 
hospitals began half of their investigations within a day of the events 
and three-quarters within 6 days.  In contrast, investigations took 
longer to start when hospitals learned about the events from an outside 
entity, such as a State agency.  In those cases, hospitals began half of 
their investigations within 22 days of the events and three-quarters 
within 78 days.   
 
57 42 CFR  488.1 and 488.8. 
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FFFF IIII NNNN DDDD IIII NNNN GGGG SSSS     
Hospitals investigations were multidisciplinary and often involved hospital 
leadership 
Of the teams that hospitals assembled to investigate the 75 complaints, 
all but 1 included multiple disciplines; 45 teams drew staff from 4 or 
more disciplines.  The disciplines most commonly represented on the 
investigation teams were nursing, risk management, hospital 
administration, and quality improvement.  Multidisciplinary teams 
enable hospitals to bring a wide range of expertise and experience to 
their investigations. 
Hospitals reported that medical, executive, or clinical leadership was 
involved in all investigations.  Involvement ranged from planning and 
conducting investigations to disseminating the results of 
investigations to hospital staff.  Leadership involvement gives 
prominence to the investigation and demonstrates the hospitals 
institutional commitment to patient safety.58 
Hospitals reported that they informed their governing bodies of 59 of 
the 87 complaints of which they were aware.  Furthermore, hospitals 
reported that their governing bodies participated in their responses to 
about half of complaints, most commonly by disseminating the 
investigation results within the hospital. 
Hospitals reported that State agency responses lent urgency to the 
hospitals responses, promoted awareness of the Medicare CoPs, and 
increased transparency 
Hospitals reported that the presence of State agency surveyors elevated 
the seriousness of their investigations.  They noted that the attention 
contributed not only to the urgency of any corrective actions stemming 
from the alleged events, but sometimes also validated the hospitals 
responses. 
Hospitals also identified the investigations as being valuable because by 
referencing the CoPs, they promoted awareness of them.  The Joint 
Commission accredited nearly all of the hospitals in our sample, and 
thus hospitals tended to be more familiar with its standards than with 
the CoPs. 
Furthermore, some hospitals in our sample reported that the State 
agency complaint surveys helped them reinforce transparency and 
 
58 James P. Bagian, Patient Safety:  What Is Really at Issue?, Frontiers of Health 
Services Management, Vol. 22, No. 1, Fall 2005, pp. 3-16. 
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public accountability in dealing with adverse events.  For example, 
during our site visits, hospital leadership often mentioned the 
important role that the State agency surveysand their publicly 
available reportscan have in the hospitals accountability to its 
patients, its staff, and the public.  HHS and others promote public 
accountability as an important avenue to earning the publics trust.59, 60  
Notably, four hospitals in our sample alerted the media about the 
alleged adverse events by issuing a press release or holding a press 
conference. 
Hospitals reported that State agency responses sometimes disrupted their 
investigations 
Complaint investigations are inherently disruptive for hospitals.  
Hospitals cited the State agencies surveys as disruptive particularly 
when the State agencies were onsite while hospitals investigations or 
corrective actions were still underway.  Twenty-four corrective actions 
were underway when the State agencies began their complaint 
surveys.  For example, one hospital was already making changes 
aimed at preventing additional adverse events.  These changes 
included updating its policies and retraining staff; the hospital was 
retraining staff when the State agency arrived.  The hospital found 
that the State agencys actions disrupted the hospitals efforts and led 
to additional training within a few days of the hospitals initial 
retraining. 
When complaints resulted in multiple responders, the disruption was 
magnified.  With multiple responders, the hospitals sometimes found 
it confusing to navigate multiple investigations, standards, corrective 
actions, and timelines.  In some cases, the hospitals observed that the 
magnitude of the responses appeared to be out of proportion to the 
likelihood of the alleged events recurring.   
 
59 D. M. Dudzinski, P. C. Hebert, M. B. Foglia, et al., The Disclosure Dilemma 
Large-Scale Adverse Events, New England Journal of Medicine, Vol. 363, No. 10, 
September 2010, pp. 978-986. 
60 HHS, Agency for Healthcare Research and Quality, Press Release, Study Recommends 
Disclosure of Medical Mistakes That Affect Multiple Patients, September 1, 2010.  Accessed 
at http://www.ahrq.gov on October 7, 2010. 
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Hospital corrective actions resulted largely in  Hospitals reported taking 
training coupled with policy and process changes  corrective actions when their 
complaint investigations found 
problems and to resolve deficiencies identified by State agencies.  They 
reported taking such actions in 64 of the 87 complaints of which they 
were aware.  (See Table 4 for the corrective actions taken by hospitals.) 
Table 4:  Hospital Corrective Actions in Response to Internal Investigations 
and/or State Agency Complaint Surveys 
 
  Corrective  Action   CNoummp(nbla e=irn   6ots4f  )                     C    Po    em    r  c  p  e  l  an    i  tn    otsf      
  Training staff      58   91% 
  Policy ch ange s  31   48%  
Proces s change s  31   48%  
  Disciplin ary action   22   34%  
  Improvemen ts/upg rades to physical plant  19   30%  
  Source: OIG analysis of  ho spitals' re spon ses to OIG questionn aire.   
                 
Hospitals responses to 58 of the 64 complaints resulting in corrective 
actions included training staff as a corrective action, and the responses 
to 42 complaints included a policy or process change.  Hospitals 
responses to 39 complaints resulting in corrective actions included both 
training staff and changing policies or processes.  For example, one 
hospital changed its policy on administering medication through 
gastronomy tubes and also educated nursing staff on the new policy.  
Another hospital changed its sedation protocol and educated physicians 
on the new process. 
Hospitals took disciplinary actions less frequently, in one-third of 
complaints resulting in corrective actions.  The most common action was 
a personnel action, such as firing or suspending staff.  Hospitals also 
reported taking actions regarding privileging (restricting a 
practitioners scope of practice) and referring staff to law enforcement, 
among other actions. 
For just under one-third of the complaints resulting in with corrective 
actions, the corrective actions included changes to devices, software, or 
workspaces.  Such changes are designed to prevent adverse events by 
forcing staff into a course of action, rather than relying on their memory 
or adherence to procedures.  Examples of such actions taken by 
hospitals include changing the color of ports on intravenous tubing, 
changing screens on software for electronic medical records, and 
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F I N D I N G S  
changing the location of equipment and supplies.  Because such changes 
may require the assistance of vendors and manufacturers, they can take 
more time and be more difficult to implement than policy and process 
changes, which the hospital can make independently. 
Finally, we did not evaluate the appropriateness or effectiveness of 
hospitals corrective actions.  However, as we noted earlier in this 
report, CMS conducted little monitoring to verify that hospitals 
corrective actions resulted in sustained improvement. 
   
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 R E C O M M E N D A T I O N S  
 
Medicare relies on State agencies and CMS to respond to IJ 
complaintsmany of which allege adverse eventsin hospitals.  
Therefore these responses are an important part of Medicares patient 
safety system as well as the regulatory mechanism for ensuring that 
hospitals comply with the Medicare CoPs.  Hospitals responses are also 
critical components in ensuring that adverse events are addressed 
appropriately. 
This report identified missed opportunities for State agencies and CMS 
to incorporate patient safety principles into Medicares responses to 
adverse events.  Such principles include assessing hospitals 
performance improvement systems and governing bodies, monitoring 
hospitals for sustained improvements, and maximizing opportunities for 
hospitals to learn from alleged adverse events.  CMS also often failed to 
inform the Joint Commission of complaints about hospitals it accredits, 
thereby impeding the Joint Commissions oversight. 
Our recommendations address these shortcomings, which can 
undermine the effectiveness of Medicares responses to IJ complaints.  
We recommend that CMS: 
Require that all Immediate Jeopardy complaint surveys evaluate compliance 
with the Condition of Participation on quality assurance and performance 
improvement 
The QAPI CoP requires that hospitals have systems in place to 
identify, track, analyze, and prevent adverse events.  Ensuring that 
hospitals have a robust QAPI system should be a priority.  To 
reinforce the importance of improving the quality and safety of care, 
CMS should elevate the prominence of the QAPI CoP in complaint 
surveys.  CMS should require its regional offices and the State 
agencies to ensure that this CoP is placed on surveyors agendas for 
all IJ complaint surveys of hospitals. 
Furthermore, CMS should consider limiting the initial scope of its 
complaint surveys to the allegation itself and QAPI CoP.  As we have 
shown, State agencies and CMS often learn of IJ complaints weeks after 
adverse events allegedly occurred, often after hospitals began their 
investigations and corrective actions.  Also, when State agencies and 
CMS learn of events, they must determine the scope of complaint 
surveys with little information beyond basic details.  Limiting the initial 
scope of complaint surveys to the allegation itself and the QAPI CoP 
would enable surveyors to focus their initial efforts on investigating the 
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complaints and determining how well the hospitals addressed them.  If 
surveyors find that the hospitals have not adequately addressed the 
problems or that ongoing noncompliance might exist, they should 
broaden their complaint surveys to evaluate compliance with the 
governing-body CoP and other relevant CoPs. 
Ensure that State agencies monitor hospitals corrective actions for 
sustained improvements 
Defining and monitoring outcome measures are important elements of 
quality improvement and, thereby, patient safety.  Accordingly, CMS 
should require State agencies to monitor hospitals' performance when 
they require hospitals to develop plans of correction to resolve 
deficiencies.  Such monitoring should occur after hospitals have 
implemented their plans of correction and might include collecting and 
analyzing hospital performance data or revisiting hospitals to conduct 
onsite reviews of performance data.  State agencies should take action 
when hospital corrective actions fail to yield effective and sustained 
improvements.   
Furthermore, as we have shown, State agencies sometimes followed up 
onsite after accredited hospitals submitted voluntary plans of correction 
in response to standard-level deficiencies.  We recognize that in an 
environment of limited resources and competing priorities such followup 
is not easily provided.  Thus, CMS could give greater weight to following 
up and monitoring accredited hospitals with condition-level deficiencies 
rather than standard-level deficiencies. 
Amend guidance on disclosure to explain the nature of complaints to 
hospitals 
CMS should explore ways to improve communication with hospitals 
during complaint surveys.  For complaint surveys of nursing homes, 
CMSs SOM instructs State agencies to explain the nature of the 
problems they are investigating during the surveys entrance 
conferences while not divulging the exact problems or the identity of the 
complainants.61  However, for complaint surveys of hospitals, the SOM 
instructs State agencies only to conduct an exit conference during which 
surveyors should review survey findings and any deficiencies found.62  A 
culture of learningfor example, learning from adverse events as well 
 
61 SOM, ch. 5,  5300.2.  Accessed at http://www.cms.gov on September 17, 2010. 
62 SOM. ch. 5,  5080.2.  Accessed at http://www.cms.gov on September 17, 2010. 
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R E C O M M E N D A T I O N S  
as from near missesis a basic principle of patient safety.63  To 
maximize the opportunities for hospitals to learn from the complaints 
being investigated, the hospitals must know something about the 
nature of the complaints.  
Improve communication with accreditors 
CMS should ensure that its regional offices follow its policy on notifying 
accreditors.  CMS should clarify its instructions in the SOM and 
educate regional office staff on how and when to notify accreditors of 
complaint surveys against accredited hospitals.  This would improve 
Medicares system of quality oversight by informing accreditors of 
potential problems at hospitals they oversee. 
Furthermore, CMS should work with the Joint Commission and other 
accreditors to ensure that their systems for tracking information 
received from CMS are functioning properly. 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL 
RESPONSE 
CMS concurred with our recommendations and described steps it will 
take to increase the prominence of the QAPI CoP in complaint surveys.  
These steps include issuing guidance on the types of allegations that 
warrant a review of the QAPI CoP, analyzing data to determine 
whether CMS can better direct survey attention to QAPI, and 
developing onsite survey tools to improve assessment of compliance with 
the QAPI CoP.  CMS also described steps it will take to improve 
monitoring the efficacy of corrective actions.  These steps include 
emphasizing to regional offices and State agencies CMSs revisit policy 
(i.e., its policy requiring State agencies to return to hospitals to ensure 
that they are in substantial compliance), reassessing its policy 
regarding followup on deficiency findings in accredited hospitals, and 
examining the use of data to improve followup on plans of correction.  
Finally, CMS stated that it will explore ways to improve communication 
with hospitals about complaint investigations and work with regional 
offices to improve compliance with its policy on notifying accreditation 
organizations of complaints against accredited hospitals. 
For the full text of CMSs comments, see Appendix H.  We made minor 
changes to the report based on technical comments from CMS.   
 
63 IOM, To Err is Human:  Building a Safer Health System, 1999. 
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 A P P E N D I X ~ A  
Tax Relief and Health Care Act of 2006 
P.L. 109-432  203 
 
DIVISION BMEDICARE AND OTHER HEALTH PROVISIONS 
TITLE IIMEDICARE BENEFICIARY PROTECTIONS 
SEC. 203 OIG STUDY OF NEVER EVENTS 
 
(a) Study. 
(1) In general.The Inspector General in the Department of Health and 
Human Services shall conduct a study on 
(A) incidences of never events for Medicare beneficiaries, including 
types of such events and payments by any party for such events; 
(B) the extent to which the Medicare program paid, denied payment, or 
recouped payment for services furnished in connection with such events 
and the extent to which beneficiaries paid for such services; and 
(C) the administrative processes of the Centers for Medicare & Medicaid 
Services to detect such events and to deny or recoup payments for 
services furnished in connection with such an event. 
(2) Conduct of study.In conducting the study under paragraph (1), the 
Inspector General 
(A) shall audit a representative sample of claims and medical records of 
Medicare beneficiaries to identify never events and any payment (or 
recouping of payment) for services furnished in connection with such 
events; 
(B) may request access to such claims and records from any Medicare 
contractor; and 
(C) shall not release individually identifiable information or  
facility-specific information. 
(b) Report.Not later than 2 years after the date of the enactment of 
this Act, the Inspector General shall submit a report to Congress on the 
study conducted under this section.  Such report shall include 
recommendations for such legislation and administrative action, such as 
a noncoverage policy or denial of payments, as the Inspector General 
determines appropriate, including 
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A P P E N D I X ~ A  
(1) recommendations on processes to identify never events and to deny 
or recoup payments for services furnished in connection with such 
events; and 
(2) a recommendation on a potential process (or processes) for public 
disclosure of never events which 
(A) will ensure protection of patient privacy; and  
(B) will permit the use of the disclosed information for a root cause 
analysis to inform the public and the medical community about safety 
issues involved. 
(c) Funding. Out of any funds in the Treasury not otherwise 
appropriated, there are appropriated to the Inspector General of the 
Department of Health and Human Services $3,000,000 to carry out this 
section, to be available until January 1, 2010. 
(d) Never Events Defined.For purposes of this section, the term never 
event means an event that is listed and endorsed as a serious reportable 
event by the National Quality Forum as of November 16, 2006.   
  OEI-01-08-00590  ADVERSE EVENTS IN HOSPITALS:  MEDICARES RESPONSES TO ALLEGED SERIOUS EVENTS   
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   AA PP PP EE NN DD II XX ~~ BB   
Office of Inspector General Series of Reports on Adverse Events 
 
December 2008 
Adverse Events in Hospitals:  Overview of Key Issues, OEI-06-07-00470 
Adverse Events in Hospitals:  State Reporting Systems,  
OEI-06-07-00471 
Adverse Events in Hospitals:  Case Study of Incidence Among Medicare 
Beneficiaries in Two Counties, OEI-06-08-00220 
 
January 2010  
Adverse Events in Hospitals:  Public Disclosure of Information About 
Events, OEI-06-09-00360 
 
March 2010 
Adverse Events in Hospitals:  Methods for Identifying Events,  
OEI-06-08-00221 
 
November 2010 
Adverse Events in Hospitals:  National Incidence Among Medicare 
Beneficiaries, OEI-06-09-00090 
   
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 A P P E N D I X ~ C  
National Quality Forum Serious Reportable Events 
Surgical Events   
A.  Surgery performed on the wrong body part 
B.  Surgery performed on the wrong patient 
C.  Wrong surgical procedure performed on a patient 
D.  Unintended retention of foreign object in a patient after surgery or procedure 
 
E.  Intraoperative or immediately postoperative death 
Product or Device Events 
A.  Patient death or serious disability associated with use of contaminated drugs, devices, or biologics provided by the health care facility 
B.  Patient death or serious disability associated with use or function of a device in patient care in which the device is used or functions   
other than as intended 
C.  Patient death or serious disability associated with intravascular air embolism that occurs while being cared for in a health care facility 
Patient Protection Events 
A.  Infant discharged to the wrong person 
B.  Patient death or serious disability associated with patient elopement 
C.  Patient suicide, or attempted suicide, resulting in serious disability, while being cared for in a health care facility 
Care Management Events 
A.  Patient death or serious disability associated with a medication error 
B.  Patient death or serious disability associated with a hemolytic reaction because of administration of incompatible blood or blood products 
C.  Maternal death or serious disability associated with labor or delivery in a low-risk pregnancy while cared for in a health care facility 
D.  Patient death or serious disability associated with hypoglycemia, the onset of which occurs while patient is being cared for in a health 
care facility 
E.  Death or serious disability associated with failure to identify and treat hyperbilirubinemia in neonates 
F.  Stage III or Stage IV pressure ulcers acquired after admission to a health care facility 
G.  Patient death or serious disability because of spinal manipulative therapy 
H.  Artificial insemination with the wrong donor sperm or wrong egg 
Environmental Events 
A.  Patient death or serious disability associated with an electric shock while being cared for in a health care facility 
B.  Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or is contaminated by 
toxic substances 
C.  Patient death or serious disability associated with a burn incurred from any source while being cared for in a health care facility 
D.  Patient death or serious disability associated with a fall while being cared for in a health care facility 
E.  Patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health care facility 
Criminal Events 
A.  Care provided by someone impersonating a health care provider 
B.  Abduction of a patient of any age 
C.  Sexual assault on a patient within or on the grounds of a health care facility 
D.  Death or significant injury resulting from a physical assault that occurs within or on the grounds of the facility 
 Source:  National Quality Forum, Serious Reportable Events in Health Care 2006 Update:  Consensus Report, Washington, DC, 2007, p. 7. 
 
   
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 A P P E N D I X ~ D  
  Centers for Medicare & Medicaid Services Hospital-Acquired Conditions 
Conditions 
 
1.  Foreign object retained after surgery 
 2.  Air embolism 
3.  Blood incompatibility 
 4.  Pressure ulcers (stages III and IV) 
5.  Falls and Trauma 
 
A.  Fracture 
B.  Dislocation 
 
C.  Intracranial injury 
  D.  Crushing injury 
E.  Burn 
F.  Electric shock 
6.  Manifestations of poor glycemic control 
A.  Hypoglycemic coma 
B.  Diabetic ketoacidosis 
C.  Nonketotic hyperosmolar coma 
D.  Secondary diabetes with ketoacidosis 
E.  Secondary diabetes with hyperosmolarity 
7.  Catheter-associated urinary tract infection 
8.  Vascular catheter-associated infection 
9.  Deep vein thrombosis/pulmonary embolism associated with the following 
A.  Total knee replacement 
B.  Hip replacement 
10.  Surgical site infection 
A.  Mediastinitis after coronary artery bypass graft  
B.  Associated with certain orthopedic procedures involving the 
a.  Spine 
b.  Neck 
c.  Shoulder 
d.  Elbow 
C.  Associated with certain bariatric surgical procedures for obesity 
a.  Laparoscopic gastric bypass 
b.  Gastroenterostomy 
c.  Laparoscopic gastric restrictive surgery 
Source:  Fiscal Year 2009 Hospital Inpatient Prospective Payment System Final Rule, 73 Fed. Reg. 48434,  
4847148472 (Aug. 19, 2008). 
 
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 A P P E N D I X ~ E  
Medicare Hospital Conditions of Participation 
 
Code of Federal  
  Regulations Title 42  
Condition  Citation 
  Compliance with Federal, State, and  
local laws   482.11 
 
Governing body   482.12 
  Patients' rights   482.13 
Quality assessment and performance  
  improvement program   482.21 
  Medical staff   482.22 
Nursing services   482.23 
 
Medical record services   482.24 
  Pharmaceutical services   482.25 
Radiologic services   482.26 
 
Laboratory services   482.27 
  Food and dietetic services   482.28 
  Utilization review   482.30 
Physical environment   482.41 
 
Infection control   482.42 
  Discharge planning   482.43 
Organ, tissue, and eye procurement   482.45 
 
Surgical services   482.51 
  Anesthesia services   482.52 
  Nuclear medicine services   482.53 
Outpatient services   482.54 
 
Emergency services   482.55 
  Rehabilitation services   482.56 
Respiratory care services   482.57 
 
   
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 A P P E N D I X ~ F  
Sampled Complaints by State 
  State   CNoummpblaeirn otsf   
  Tennessee   21 
  Missouri  9 
  California   8 
  North Carolina  8 
Texas  8 
 
Florida   7 
  Iowa  5 
  Kentucky  5 
  West Virginia  5 
  Louisiana  4 
Arkansas  3 
 
Kansas   3 
  Oklahoma  3 
  Connecticut   1 
  District of Columbia   1 
  Illinois  1 
Maryland   1 
 
Minnesota   1 
  New York   1 
  Ohio   1 
  Oregon   1 
  Rhode Island   1 
Vermont   1 
 
     Total  99 
 
Source: Office of Inspector General (OIG)  
  analysis of Fiscal Year (FY) 2008 Automated  
  Survey Processing Environment Complaints  
Tracking System (ACTS) data. 
 
 
   
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A P P E N D I X ~ F  
Alleged Events and Patient Deaths in Sampled Complaints 
  Type of Alleged Event  Number of Complaints  Complaints Including  
a Patient Death 
 
Sexual assault  13  0 
  Medication error  10  4 
  Physical abuse by staff  10  0 
  Restraint-related  10  7 
  Delay in treatment  5  2 
Patient elopement/transport issues  5  0 
 
Patient fall  5  0 
  Suicide  5  5 
  Neglect  4  2 
  Pressure ulcers  4  0 
  Wrong site surgery  4  0 
Foreign object retained  3  0 
 
Misdiagnosis  3  1 
 
Verbal abuse by staff  3  0 
  Complications during/following childbirth  2  2 
  Surgical fire  2  0 
  Inappropriate treatment/handoff  1  1 
  Infant to wrong parents  1  0 
Infectious outbreak  1  0 
 
Medical device-related injury  1  0 
 
Other fire  1  0 
  Perforation during catheterization  1  0 
  Transfusion error  1  1 
  Unsafe conditions  4  0 
     Total  99  25 
 
Source: OIG analysis of FY 2008 ACTS data. 
 
   
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A P P E N D I X ~ F  
Sampled Complaints by National Quality Forum Serious Reportable Events 
  National Quality Forum Serious Reportable Events  CNoummpblaeirn otsf   
   Sheeaxlutha lc aasrsea fualct iloitny  a patient within or on the grounds of the   13 
  Pofa rteiesntrt adinetast ho ro br esderraioiluss  disability associated with the use   7 
 
  Pdiastaiebniltit ys uicide, or attempted suicide resulting in serious   5 
  Surgery performed on the wrong body part  4 
  Pmaetdieicnat tdioena tehr roorr  serious disability associated with a   4 
 
  Shetaaglteh  IcIIa orer  IfVac pilriteys sure ulcers acquired after admission to a   4 
  Rotehteern ptiroonc eodf uar efo reign object in a patient after surgery or   3 
 
  IAnStrAao Cplearsast ivI ep aotrie imnt mediately post-operative death in an   1 
   Pelaotpieenmt edneta (tdhi soar pspeeriaoruasn cdeis)a bility associated with patient   1 
  Pheamtieonlyt tdice aretha cotrio sne rious disability associated with a   1 
   Mora dteerlinvaelr yd eina tah  loorw s-reisriko upsr edgisnaabnicliyty  associated with labor   1 
  Patient death or serious disability associated with a burn  1 
  Not a National Quality Forum event  54 
     Total  99 
 
Source: OIG analysis of FY 2008 ACTS data. 
 
 
Sampled Complaints by Centers for Medicare & Medicaid  
Services Adverse Event Typologies 
  Hospital-Acquired Conditions  Number of  
Complaints 
  Falls and trauma  12 
Pressure ulcer, stage III or IV  4 
 
Foreign object retained after surgery  3 
  Blood incompatibility  1 
Not a hospital-acquired condition  79 
 
     Total  99 
  Source: OIG analysis of FY 2008 ACTS data. 
  Surgery-Related Events  Number of  
Complaints 
 
Surgery on the wrong body part  2 
  Wrong surgery performed on a patient  2 
Not a surgery-related event  95 
       Total  99 
Source: OIG analysis of FY 2008 ACTS data. 
 
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 A P P E N D I X ~ G  
Joint Commission Response to Complaints 
The Joint Commission was aware of 23 of the 95 complaints in our 
sample.  It responded to these complaints through its traditional 
compliance process and its sentinel event process.  In a few cases, it 
responded through both processes.  See Table G-1 for detail on how the 
Joint Commission responded to the complaints.  
Table G-1:  Joint Commission Responses to Complaints 
 
Number of   Percentage of  
  Type of Response  Responses  Responses 
  Traditional compliance process only  11  48% 
Sentinel event process only  8  35% 
 
Both processes  4  17% 
       Total  23  100% 
Source: Office of Inspector General analysis of FY 2008 Joint Commission data. 
 
The Joint Commission responded through its compliance process 
primarily by requesting written responses and conducting onsite 
surveys of hospitals.  For seven of the alleged events in our sample, it 
requested written responses in the form of plans of correction or 
response letters.  The Joint Commission requested a plan of correction 
from a hospital when the Centers for Medicare & Medicaid Services 
notified it that a hospital was out of compliance with the Conditions of 
Participation.  When an event alleged in a complaint was less serious, 
the Joint Commission requested that the hospital write a response 
letter to explain how the hospital had corrected the problem. 
The Joint Commission conducted six onsite surveys in response to six 
complaints in our sample.  It did so when the complaints indicated that 
immediate threats to patient safety might exist at the hospitals.  The 
Joint Commission conducted four onsite surveys within 31 working days 
of receiving the complaints and conducted the other two surveys 39 and 
88 working days after receiving the complaints. 
The Joint Commission responded to 12 complaints with its sentinel 
event process.  The sentinel event process is triggered if a complaint 
alleges an event on the Joint Commissions list of sentinel events.64  
(See Table G-2.)  The process focuses on ensuring that hospitals have 
 
64 The Joint Commission, Comprehensive Accreditation Manual for Hospitals (CAMH) 
SE-3 - SE-4 (2009). 
 
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A P P E N D I X ~ G  
conducted thorough and credible root cause analyses of the events and 
prepared action plans of risk reduction strategies and measures for 
evaluating their effectiveness.65 
Table G-2:  Joint Commission Sentinel Events  
  Description of Sentinel Event 
Event resulting in an unanticipated death or major permanent loss of function, not related to  
  the natural course of the patients illness or underlying condition. 
  or 
Event is one of the following (even if the outcome was not death or major permanent loss of  
  function unrelated to the natural course of the patients illness or underlying condition): 
Suicide of any patient receiving care, treatment, and services in a  
  staffed-around-the-clock care setting or within 72 hours of discharge; 
Unanticipated death of a full-term infant; 
 
Abduction of any patient receiving care, treatment, and services; 
  Discharge of an infant to the wrong family; 
Rape; 
  Hemolytic transfusion reaction involving administration of blood or blood products having  
major blood group incompatibilities (ABO, Rh, other blood groups); 
  Surgical and nonsurgical invasive procedure on the wrong patient, wrong site, or wrong  
procedure; 
 
Unintended retention of a foreign object in a patient after surgery or other procedure; 
  Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter); 
Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any delivery  
  of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose; 
Any other event defined by accredited hospital as a sentinel event. 
  Source: The Joint Commission. 
The Joint Commission followed up on improvements identified by onsite 
surveys and root cause analysis by requiring hospitals to submit 
performance data.  When it cites hospitals for noncompliance with 
standards or when hospitals submit action plans in response to sentinel 
events, the Joint Commission requires hospitals to submit 
documentation and performance data to verify sustained improvement.  
The performance data cover 4 months after improvements were put in 
place and must show that the hospitals are reaching performance 
targets.  Failure to submit data or to show improvement might 
adversely affect a hospitals accreditation status.66, 67  The Joint 
Commission reported that every hospital it cited for noncompliance or 
that submitted a root cause analysis later provided performance data.   
 
65 The Joint Commission, CAMH  SE-2 (2009). 
66 The Joint Commission, CAMH  SE-11 - SE-12 (2009). 
67 The Joint Commission, CAMH  ACC-46 - ACC-47 (2009). 
 
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37  x 
A  P  PEN  D  H 

Agency Comments 
DEPARTMENT OF HEALTH & HUMAN SERVICES  Centers lor Medicare & Medicaid Services 
Administrator 
Washington, DC 20201 
DATE:  AUG 1 8 2011 
TO: 	 Daniel R, Levinson 
Inspector Geru:r.al 
FROM: 	 Donald M. Derwidle M.D. 
Administrator 
SUBJECT: 	 Office ofInspector General (01G) Draft Report: "Adverse Events in Hospitals: 
Medicare's Responses to Alleged Serious Events" (OEI-OI-08-00590) 
Thank you for the opportunity to review and comment on this very timely and important study. 
In this report, the Office of Inspector General (OIG) examines the response of the Center for 
Medicare & Medicaid Services (CMS) and State Survey Agencies (SAs) to allegations of serious 
adverse events in hospitals. An "adverse event" refers in the 01G study to harm to a patient as a 
result of medical care or in a health care setting. 
There is no greater opportunity for far reaching improvement in the experience of individuals 
and families in the United States health care system than in the arena of patient safety - and no 
greater opportunity for savings to the taxpayer and the beneficiary without reducing access to 
care. 
We note that since the incidents reviewed in this report, the Department of Health and Human 
Services (HHS) has launched a new and ambitious public-private partnership entitled the 
"Partnership for Patients." This national Partnership will help improve the quality, safety and 
affordability of health care not just for Medicare beneficiaries, but for all Americans. HHS and 
eMS are working with a wide variety of public and private partners to achieve the two core 
goals ofthis 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. 
In just a few months, more than 4,000 organizations - including more than 2,500 hospitals 
have signed the Partnership Pledge. 

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A P P E N D I X ~ H  
   
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A P P E N D I X ~ H  
 
   
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A P P E N D I X ~ H  
 
 
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 A C K N O W L E D G M E N T S  
This report was prepared under the direction of Joyce M. Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the 
Boston regional office, and Russell W. Hereford, Deputy Regional 
Inspector General. 
Kenneth Price served as the team leader for this study.  Other principal 
Office of Evaluation and Inspections staff from the Boston regional 
office who contributed to the report include Jesse Valente and  
Carolyn Kenline; central office staff who contributed include  
Rita Wurm. 
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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.