Department of Health and Human Services 

OFFICE OF

INSPECTOR GENERAL

 

ADVERSE EVENTS IN HOSPITALS: 

MEDICARE’S RESPONSES TO 

ALLEGED SERIOUS EVENTS 

 

Daniel R. Levinson 

Inspector General 

October 2011 

OEI-01-08-00590 
 

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EXECUTIVE SUMMARY EXECUTIVE SUMMARY

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 Medicare’s 

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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EXECUTIVE SUMMARY

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 hospital’s 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 Commission’s oversight of its accredited hospitals. 

Contrary to CMS’s 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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EXECUTIVE SUMMARY

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 hospital’s 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 results—for 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. 
 

 TABLE OF CONTENTS

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

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

FINDINGS ................................................. 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 Commission’s 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

RECOMMENDATIONS ...................................... 24 

Agency Comments and Office of Inspector General Response .... 26

APPENDIXES .............................................. 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 

ACKNOWLEDGMENTS ..................................... 43
 

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 INTRODUCTION

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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INTRODUCTION

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, OIG’s 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 IOM’s 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 hospital’s 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 events—such as 

medical record reviews, examination of hospital incident reporting 

systems, patient interviews, and billing data analysis—have strengths 

and limitations and can also be resource intensive.14 Complaints about 

hospitals represent another potential way to identify adverse events.

Medicare’s Quality Oversight of Hospitals

Medicare’s 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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INTRODUCTION

privileging of physicians to the hospital’s 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 hospital’s governing body further states the governing 

body’s 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 OIG’s 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

17 SOM, ch. 1, § 1016. Accessed at 

 Hospitals that do not opt for 

accreditation can demonstrate to CMS that they meet the CoPs through 

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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INTRODUCTION

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 inspections—called surveys—of 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

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.

(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 CMS’s patient 

safety system because it is a potential resource for identifying and 

responding to adverse events.

The quality and completeness of information provided by a complainant 

plays an important role in the State agency’s 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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INTRODUCTION

priority based on CMS policy.30 The highest priority is “immediate 

jeopardy” (IJ), which CMS defines as “a situation in which the 

provider’s 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 

survey’s scope. For nonaccredited hospitals, the State agency 

determines the scope of the complaint survey and does not need the 

regional office’s 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 hospital’s accreditation status.37

30 SOM, ch. 5, §§ 5070 and 5075. Accessed at

 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 

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 office’s 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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INTRODUCTION

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

Finally, CMS policy requires CMS’s regional offices to notify accreditors 

of all complaints forwarded by State agencies once they are resolved.

 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 

hospital’s deemed status and the hospital comes under the State 

agency’s 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.

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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INTRODUCTION

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 CMS’s 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 CMS’s Automated Survey Processing 

Environment Complaints Tracking System (ACTS) of all IJ complaints 
 

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INTRODUCTION

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

Data Collection

 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.)

For each of the complaints in our sample, we collected data from CMS, 

State agencies, hospital accreditors, and hospitals.

From CMS and State agencies we requested:

Data from CMS and State Agencies

o the full Complaint Investigation Report, which contains data and 

narrative details on the intake of the complaint, the complaint 

survey, deficiencies cited, and other information;

o Form(s) 2567, Statement of Deficiencies and Plan of Correction, 

resulting from the survey(s) related to the complaint;

o if applicable, Form 2802, Request for Validation of Accreditation 

Survey for Hospital, showing the CMS regional office’s approval for 

the State agency to conduct a complaint survey and its approved 

scope, i.e., the CoPs to be covered;

o if available, other supporting documents, such as correspondence 

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 

children’s 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.

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.

Data from Hospital Accreditors

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.

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.

Data from Hospitals

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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INTRODUCTION

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:

o interviews with hospital staff about the alleged event(s) underlying 

the sampled complaints,

o a review of the hospital’s response to the alleged event(s) and 

related documentation, and

o a review of the response(s) by State agencies, CMS, and accreditors.

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 CMS’s 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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INTRODUCTION

Table 1: Data Sources by Analysis Topic

Number of Number Analysis Topic Data Source Complaints Analyzed

State agency responses for all 95 Complaint investigation reports 95

hospitals Forms 2567

Supporting documents from complaint files

92

87

OIG hospital questionnaire

Case studies

87

7

CMS role in responses 

hospitals

for accredited 88 Forms 2802

Supporting documents from complaint 

Data from the Joint Commission

files

78

80

88

Hospital responses

Hospital investigations

Hospital corrective actions

87

75

64

OIG hospital questionnaire

Case studies

OIG hospital questionnaire

Case studies

OIG hospital questionnaire

Case studies

87

7

75

7

64

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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FINDINGS FINDINGS

State agency responses to complaints alleging 

serious adverse events were generally timely 

and often found problems

State agencies have no 

control over the quantity 

or quality of complaints 

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 complaints—sexual assault, medication 

error, physical abuse by hospital staff, and restraint problems—along 

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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FINDINGS

Table 2: Deficiencies by Type of Alleged Event

Type of Alleged Event Number of 

Complaints

Number with 

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 postevent 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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FINDINGS

Table 3: Initial Information Received by State Agencies for a Sample of 

Complaints Alleging Serious Adverse Events

Information

Type of event

Number of

Complaints

(n = 95)

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 CMS’s 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 CoPs—from 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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FINDINGS

State agencies and CMS missed opportunities to 

incorporate patient safety principles 

in their responses

Patient safety principles 

emphasize quality 

improvement and 

learning from adverse 

events to prevent them from recurring. Medicare’s 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 hospital’s governing body is legally responsible 

for the conduct of the hospital as an institution, including its quality 

improvement system.48

46 42 CFR § 482.21.

 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 

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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FINDINGS

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

State agencies performed little monitoring to verify that hospitals’ corrective 

actions resulted in sustained improvements

 Executives at case 

study hospitals stated that their governing bodies play an important 

role in demanding medical staff accountability for quality care.

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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FINDINGS

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’s policy calls for its 

regional offices to—once 

complaints are resolved—

notify accreditors of all 

complaints against hospitals they accredit.56

CMS informed the Joint Commission of few 

complaints, impeding the Joint Commission’s 

oversight of its accredited hospitals

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.

 However, CMS notified 

the Joint Commission of only 28 of the 88 complaints against hospitals 

it accredited.

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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FINDINGS

Officials at the Joint Commission told us that its being unaware of 

complaints against its accredited hospitals compromises Medicare’s 

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 

hospital’s 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 reported being 

aware of 87 of the 

complaints in our sample, 

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.

Hospitals investigated most complaints in our sample, 

finding State agency responses valuable

but disruptive

57 42 CFR §§ 488.1 and 488.8.
 

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FINDINGS

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 hospital’s 

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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FINDINGS

public accountability in dealing with adverse events. For example, 

during our site visits, hospital leadership often mentioned the 

important role that the State agency surveys—and their publicly 

available reports—can have in the hospital’s accountability to its

patients, its staff, and the public. HHS and others promote public 

accountability as an important avenue to earning the public’s trust.59, 60

Hospitals reported that State agency responses sometimes disrupted their 

investigations

 

Notably, four hospitals in our sample alerted the media about the 

alleged adverse events by issuing a press release or holding a press 

conference.

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 agency’s actions disrupted the hospital’s efforts and led 

to additional training within a few days of the hospital’s 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. Hébert, 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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FINDINGS

 

 

Hospital corrective actions resulted largely in 

training coupled with policy and process changes

Hospitals reported taking 

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

Number of 

Corrective Action Complaints 

(n = 64) 

 Training staff 58

 

Percent of 

Complaints 

91%

Policy changes 31

 

48%

Process changes 31 48%

Disciplinary action 22 34%

Improvements/upgrades to physical 

 Source: OIG analysis of hospitals' re

plant 19

sponses to OIG questionnai

30%

re.

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 

practitioner’s 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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FINDINGS

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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 RECOMMENDATIONS

Medicare relies on State agencies and CMS to respond to IJ 

complaints—many of which allege adverse events—in hospitals. 

Therefore these responses are an important part of Medicare’s 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 Medicare’s 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 Commission’s oversight.

Our recommendations address these shortcomings, which can 

undermine the effectiveness of Medicare’s 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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RECOMMENDATIONS

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, 

CMS’s 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

61 SOM, ch. 5, § 5300.2. Accessed at

 A 

culture of learning—for example, learning from adverse events as well 

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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RECOMMENDATIONS

as from near misses—is 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 

Medicare’s 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 CMS’s 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 CMS’s 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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 APPENDIX~A

Tax Relief and Health Care Act of 2006

P.L. 109-432 § 203

DIVISION B—MEDICARE AND OTHER HEALTH PROVISIONS

TITLE II—MEDICARE BENEFICIARY PROTECTIONS

SEC. 203 OIG STUDY OF NEVER EVENTS

(a) Study.— 

(1) In general.—The Inspector General in the Department of Health and 

Human Services shall conduct a study on— 

(A) incidences of never events for Medicare beneficiaries, including 

types of such events and payments by any party for such events;

(B) the extent to which the Medicare program paid, denied payment, or 

recouped payment for services furnished in connection with such events 

and the extent to which beneficiaries paid for such services; and

(C) the administrative processes of the Centers for Medicare & Medicaid 

Services to detect such events and to deny or recoup payments for 

services furnished in connection with such an event.

(2) Conduct of study.—In conducting the study under paragraph (1), the 

Inspector General— 

(A) shall audit a representative sample of claims and medical records of 

Medicare beneficiaries to identify never events and any payment (or 

recouping of payment) for services furnished in connection with such 

events;

(B) may request access to such claims and records from any Medicare 

contractor; and

(C) shall not release individually identifiable information or 

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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APPENDIX~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.
 

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 APPENDIX~B

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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 APPENDIX~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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 APPENDIX~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, 

48471–48472 (Aug. 19, 2008).
 

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 APPENDIX~E

Medicare Hospital Conditions of Participation

Condition

Code of Federal 

Regulations Title 42 

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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 APPENDIX~F

Sampled Complaints by State

State Number of 

Complaints

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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APPENDIX~F

Alleged Events and Patient Deaths in Sampled Complaints

Complaints Including Type of Alleged Event Number of Complaints 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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APPENDIX~F

Sampled Complaints by National Quality Forum Serious Reportable Events

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

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.

Source: OIG analysis of FY 2008 ACTS data.

National Quality Forum Serious Reportable Events Number of 

Complaints

Sexual assault on a patient within or on the grounds of the 

health care facility 13

Patient death or serious disability associated with the use 

of restraints or bedrails 7

Patient suicide, or attempted suicide resulting in serious 

disability 5

Surgery performed on the wrong body part 4

Patient death or serious disability associated with a 

medication error

4

Stage III or IV pressure ulcers acquired after admission to a 

health care facility 4

Retention of a foreign object in a patient after surgery or 

other procedure 3

Intraoperative or immediately post-operative death in an 

ASA Class I patient 1

Patient death or serious disability associated with patient 

elopement (disappearance) 1

Patient death or serious disability associated with a 

hemolytic reaction 1

Maternal death or serious disability associated with labor 

or delivery in a low-risk pregnancy 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.
 

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 APPENDIX~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

Type of Response

Number of 

Responses

Percentage of 

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 Commission’s 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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APPENDIX~G

Description of Sentinel Event

Event resulting in an unanticipated death or major permanent loss of function, not related to 

the natural course of the patient’s 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 patient’s 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.

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 

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 hospital’s 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).
A P PEN D x 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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­
 

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APPENDIX~H
 

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APPENDIX~H
 

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APPENDIX~H
 

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APPENDIX~H
 

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 ACKNOWLEDGMENTS

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. 
 

Office of Inspector General http://oig.hhs.gov 

The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as 

amended, is to protect the integrity of the Department of Health and Human Services 

(HHS) programs, as well as the health and welfare of beneficiaries served by those 

programs. This statutory mission is carried out through a nationwide network of audits, 

investigations, and inspections conducted by the following operating components:

Office of Audit Services 

The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting 

audits with its own audit resources or by overseeing audit work done by others. Audits 

examine the performance of HHS programs and/or its grantees and contractors in carrying 

out their respective responsibilities and are intended to provide independent assessments of 

HHS programs and operations. These assessments help reduce waste, abuse, and 

mismanagement and promote economy and efficiency throughout HHS.

Office of Evaluation and Inspections 

The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide 

HHS, Congress, and the public with timely, useful, and reliable information on significant 

issues. These evaluations focus on preventing fraud, waste, or abuse and promoting 

economy, efficiency, and effectiveness of departmental programs. To promote impact, OEI 

reports also present practical recommendations for improving program operations. 

Office of Investigations 

The Office of Investigations (OI) conducts criminal, civil, and administrative investigations 

of fraud and misconduct related to HHS programs, operations, and beneficiaries. With 

investigators working in all 50 States and the District of Columbia, OI utilizes its resources 

by actively coordinating with the Department of Justice and other Federal, State, and local 

law enforcement authorities. The investigative efforts of OI often lead to criminal 

convictions, administrative sanctions, and/or civil monetary penalties.

Office of Counsel to the Inspector General 

The Office of Counsel to the Inspector General (OCIG) provides general legal services to 

OIG, rendering advice and opinions on HHS programs and operations and providing all 

legal support for OIG’s internal operations. OCIG represents OIG in all civil and 

administrative fraud and abuse cases involving HHS programs, including False Claims Act, 

program exclusion, and civil monetary penalty cases. In connection with these cases, OCIG 

also negotiates and monitors corporate integrity agreements. OCIG renders advisory 

opinions, issues compliance program guidance, publishes fraud alerts, and provides other 

guidance to the health care industry concerning the anti-kickback statute and other OIG 

enforcement authorities.