PATIENT SAFETY

HHS Has Taken Steps 

to Address Unsafe 

Injection Practices, 

but More Action Is 

Needed

Report to the Ranking Member, 

Subcommittee on Health, Committee 

on Energy and Commerce, House of 

Representatives

July 2012

GAO-12-712

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United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-712, a report to the 

Ranking Member, Subcommittee on Health, 

Committee on Energy and Commerce, House 

of Representatives

July 2012

PATIENT SAFETY

HHS Has Taken Steps to Address Unsafe Injection 

Practices, but More Action Is Needed

Why GAO Did This Study

Recent outbreaks of blood-borne 

pathogens—specifically hepatitis B and 

C—that were linked to a specific health 

care facility or clinician have resulted 

when clinicians use unsafe injection 

practices. Such infections can have 

serious long-term consequences for 

patients, including cirrhosis or liver 

cancer. Of the known incidents of 

blood-borne pathogen outbreaks 

attributed to unsafe injection 

practices—which include reusing 

syringes for multiple patients—most 

have occurred in ambulatory care 

settings, such as ASCs and physician 

offices. CMS oversees injection 

practices by setting and enforcing 

health and safety standards that apply 

to ASCs but not physician offices. GAO 

was asked to examine (1) available 

information on the extent and cost of 

blood-borne pathogen outbreaks 

related to unsafe injection practices in 

ambulatory care settings, (2) the 

changes in federal oversight to prevent 

unsafe injection practices in 

ambulatory care settings since 2009, 

and (3) other federal efforts to improve 

injection safety practices in ambulatory

care settings. GAO reviewed CDC and 

CMS documentation and CDC data, 

and interviewed officials from various 

HHS agencies and other stakeholders. 

What GAO Recommends

GAO recommends that HHS 

(1) resume collecting data on unsafe 

injection practices that will permit 

continued monitoring of such practices, 

(2) use those data for continued 

monitoring of ASCs, and (3) strengthen 

the targeting efforts of the One and 

Only Campaign for health care settings 

not overseen by CMS. HHS agreed 

with GAO’s recommendations. 

What GAO Found

Data on the extent and cost of blood-borne pathogen outbreaks related to unsafe 

injection practices in ambulatory care settings are limited and likely 

underestimate the full extent of such outbreaks. An agency within the 

Department of Health and Human Services (HHS), the Centers for Disease 

Control and Prevention (CDC), collects data on outbreaks identified by state and 

local health departments. These data show that from 2001 through 2011, there 

were at least 18 outbreaks of viral hepatitis associated with unsafe injection 

practices in ambulatory settings, such as physician offices or ambulatory surgical 

centers (ASC). CDC officials and others believe that the known outbreaks do not 

represent the full extent of such outbreaks for a number of reasons, such as 

infections often being difficult to detect and trace to specific health care facilities. 

Additionally, comprehensive data on the cost of blood-borne pathogen outbreaks 

to the health care system do not exist, but CDC and other officials believe these 

costs can be substantial for those affected. For example, individuals may face 

treatment costs and health departments may face costs for investigating and 

notifying patients of potential exposure to infection.

Another HHS agency, the Centers for Medicare & Medicaid Services (CMS), has 

expanded its oversight of unsafe injection practices in ASCs since 2009 by 

requiring surveyors who inspect these facilities to use its Infection Control 

Surveyor Worksheet to document the extent to which ASCs are following safe 

injection practices and to survey more facilities to determine compliance with 

CMS’s health and safety standards. Safe injection practices are included under 

several of CMS’s broader health and safety standards that also address a 

number of other topics related to infection control and medication administration. 

As part of implementing the expanded oversight of ASCs, CMS collected and 

plans to analyze detailed information from these surveyor worksheets for fiscal 

years 2010 and 2011. This information will be used to assess CMS’s oversight 

efforts to improve infection control and also allow CDC—with which CMS shared 

its data—to determine a baseline assessment of the extent of unsafe injection 

practices in ASCs nationally. However, in part because of concerns that 

collecting these data is a burden to surveyors, CMS officials said the agency 

stopped collecting data from surveyor worksheets after fiscal year 2011. Without 

some form of continued collection and analysis of injection safety data, CMS will 

lose its capacity to oversee how well surveyors monitor unsafe injection 

practices, and CDC will be unable to determine the extent of these practices.

To improve injection practices, various HHS agencies have taken steps to 

communicate information on safe injection practices to clinicians. For example, 

CDC has developed tools to communicate its evidence-based guidelines to 

clinicians in ambulatory care settings. In partnership with other health-carerelated organizations, CDC also developed an educational campaign—the One 

and Only Campaign—that seeks to broadly educate both clinicians and patients 

about safe injection practices. While the campaign has targeted some types of 

clinicians and health care settings that have experienced a blood-borne pathogen

outbreak related to unsafe injection practices, additional targeted outreach is 

needed for health care settings not overseen by CMS. 

View GAO-12-712. For more information, 

contact Linda T. Kohn at (202) 512-7114 or 

kohnl@gao.gov.
Page i GAO-12-712 Unsafe Injection Practices

Letter 1 

Background 5

Limited Data Are Available on the Extent and Cost of Blood-borne 

Pathogen Outbreaks Resulting from Unsafe Injection Practices 

in Ambulatory Care Settings 9

CMS Has Increased Oversight of Injection Practices in ASCs, but 

Its Decision to Stop Data Collection Will Limit Effectiveness 15

HHS Communicates Information on Safe Injection Practices to 

Clinicians, but Efforts Do Not Target Certain Higher-Risk 

Settings 18

Conclusions 22

Recommendations for Executive Action 24

Agency Comments and Our Evaluation 24

Appendix I Blood-borne Pathogen Outbreaks Related to Unsafe Injection 

Practices in Ambulatory Care Settings, 2001-2011 26

Appendix II Comments from the Department of Health and Human Services 29

Appendix III GAO Contact and Staff Acknowledgments 33

Table

Table 1: Unsafe Injection Practices That Led to the Known Bloodborne Pathogen Outbreaks in Ambulatory Care Settings, 

2001 through 2011 11

Contents
Page ii GAO-12-712 Unsafe Injection Practices

Abbreviations

ASC ambulatory surgical center

CDC Centers for Disease Control and Prevention

CMS Centers for Medicare & Medicaid Services

FDA Food and Drug Administration

HAI health-care-associated infection

HHS Department of Health and Human Services

HICPAC Healthcare Infection Control Practices Advisory Committee

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

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necessary if you wish to reproduce this material separately.
Page 1 GAO-12-712 Unsafe Injection Practices

United States Government Accountability Office

Washington, DC 20548

July 13, 2012

The Honorable Frank Pallone, Jr.

Ranking Member

Subcommittee on Health

Committee on Energy and Commerce

House of Representatives

Dear Mr. Pallone:

Recent outbreaks of blood-borne pathogens—specifically hepatitis B and 

C—resulting from unsafe injection practices in health care settings 

indicate that safe care is not always provided to patients.1 According to 

the Centers for Disease Control and Prevention (CDC), common unsafe 

injection practices that have resulted in blood-borne pathogen 

transmission include the reuse of a syringe for multiple patients or to 

access a medication vial used for multiple patients—both of which can 

transmit infections, even if the needle is changed. For example, in 2008 

about 63,000 patients in Nevada were notified of their potential exposure 

to blood-borne pathogen infections, such as hepatitis B and C and HIV, 

because two related endoscopy clinics reused syringes and contaminated 

single-dose vials that were used for multiple patients, and 9 patients were 

found to be infected with hepatitis C. Similarly, in 2009, 4,600 patients of 

a hematology-oncology clinic in New Jersey were notified of their 

potential exposure to such infections because of the clinic’s mishandling 

of medication vials and reusing of saline bags for multiple patients, and 

29 patients were found to be infected with hepatitis B. Hepatitis B and C 

infections can have serious long-term consequences for patients, 

including causing the development of liver cirrhosis or liver cancer, and 

an estimated 15,000 people die each year in the United States because 

of these types of infections.2

 

1

The Centers for Disease Control and Prevention defines a health-care-associated bloodborne pathogen outbreak as an episode of transmission where two or more patients 

became infected, and where these infections could be epidemiologically linked to a 

specific health care facility or clinician.

Blood-borne pathogen infections from health 

care settings are preventable if clinicians use safe injection practices, 

2

CDC, Disease Burden from Hepatitis A, B, and C in the United States, accessed 

October 28, 2011, www.cdc.gov/hepatitis/PDFs/disease_burden.pdf.

 
 

Page 2 GAO-12-712 Unsafe Injection Practices

such as using a needle and syringe for only one patient and not reusing a 

needle or syringe to reenter a medication vial, even for the same patient.3

Of the incidents of blood-borne pathogen outbreaks attributed to unsafe 

injection practices, most have occurred in ambulatory care settings, such 

as ambulatory surgical centers (ASC) or physician offices, rather than in 

inpatient facilities, such as hospitals. For example, CDC data indicate that 

90 percent of the blood-borne pathogen outbreaks associated with unsafe 

injection practices from 2001 through 2011 occurred in ambulatory care 

settings. Patients are increasingly receiving care in ambulatory care 

facilities and the procedures conducted in these settings are becoming 

more complex and invasive. For example, data from the National Survey 

of Ambulatory Surgery indicates that over 53 million procedures were 

performed in ambulatory care settings in 2006, which is a sharp increase 

from the nearly 32 million procedures performed in these settings in 1996, 

and exceeds the number of procedures performed in inpatient settings.4

Additionally, in 2006, many more invasive procedures were performed in 

ambulatory care facilities than in 1996, such as 273 percent more 

injections of the spinal canal and 200 percent more colonoscopies—an 

increase of nearly 1.5 million procedures and about 4 million procedures, 

respectively.5

Federal agencies within the Department of Health and Human Services 

(HHS)—including CDC and the Centers for Medicare & Medicaid 

Services (CMS)—have established standards and conducted other 

 

3

CDC estimates that in 2009 there were over 50,000 new blood-borne pathogen infections 

of hepatitis B and C in the United States. Health-care-related exposures, including unsafe 

injection practices, are not considered the primary source of hepatitis transmission. 

However, a recent case control study indicates that health-care-related exposures may 

contribute to hepatitis B and C transmission to a greater extent than previously 

recognized. For more information see, J. F. Perz et al., “Case-control Study of Hepatitis B 

and Hepatitis C in Older Adults: Do Healthcare Exposures Contribute to Burden of New 

Infections?” accepted article for Hepatology. 

4

K. A. Cullen, M. J. Hall, and A. Golosinskiy, Ambulatory Surgery in the United States, 

2006, National Health Statistics Reports: number 11 (revised) (Hyattsville, Md.: National 

Center for Health Statistics, Sept. 4, 2009).

5

An invasive medical procedure is one that enters the body, usually by cutting or 

puncturing the skin or by inserting instruments into the body. An endoscopy is a procedure 

that enables a clinician to look inside an organ in the patient’s body by using a scope that 

has a small camera attached to a long thin tube. There are many different types of 

endoscopy, such as a colonoscopy, which uses a scope to see inside the large intestine.
 

Page 3 GAO-12-712 Unsafe Injection Practices

activities aimed at controlling and preventing health-care-associated 

infections (HAI), including blood-borne pathogen infections, in ambulatory 

care settings.6

Starting in 2008, GAO released a series of reports examining efforts to 

prevent HAIs in hospitals and ASCs in the United States.

CDC has established evidence-based guidelines that 

provide clinicians with CDC’s recommended practices for infection 

prevention, including safe injection practices. CMS has developed health 

and safety standards—including those related to infection control—that 

ASCs must comply with in order to participate in the Medicare program. 

As part of CMS’s oversight of these facilities, state survey agencies and 

CMS-approved accrediting organizations survey ASCs to assess their 

compliance with CMS’s health and safety standards. In 2009, CMS 

expanded the scope of its ASC surveys with respect to infection control.

7

1. available information on the extent and cost of blood-borne pathogen 

outbreaks in ambulatory care settings related to unsafe injection 

practices,

Given your 

continuing interest in this area and the concerns you raised about the 

incidents of blood-borne pathogen outbreaks related to unsafe injection 

practices, we examined

2. changes since 2009 in federal oversight to prevent unsafe injection 

practices that may lead to blood-borne pathogen outbreaks in 

selected types of ambulatory care settings, and

3. other federal efforts or plans to improve current injection safety 

practices in order to prevent blood-borne pathogen outbreaks.

To examine available information on the extent and cost of blood-borne 

pathogen outbreaks in ambulatory care settings related to unsafe 

 

6

HAIs are infections that patients may acquire in a health care setting while receiving 

treatment for other conditions. HAIs are distinct from community-acquired infections, 

which are infections that were transmitted to patients outside of any health care facility.

7

See, GAO, Health-Care-Associated Infections in Hospitals: Leadership Needed from 

HHS to Prioritize Prevention Practices and Improve Data on These Infections, 

GAO-08-283 (Washington, D.C.: Mar. 31, 2008); Health-Care-Associated Infections in 

Hospitals: An Overview of State Reporting Programs and Individual Hospital Initiatives to 

Reduce Certain Infections, GAO-08-808 (Washington, D.C.: Sept. 5, 2008); and HealthCare-Associated Infections: HHS Action Needed to Obtain Nationally Representative Data 

on Risks in Ambulatory Surgical Centers, GAO-09-213 (Washington, D.C.: Feb. 25, 2009).
 

Page 4 GAO-12-712 Unsafe Injection Practices

injection practices, we interviewed officials from several HHS agencies, 

including CDC, CMS, the Agency for Healthcare Research and Quality, 

and the Food and Drug Administration (FDA), as well as officials from 

relevant associations and other organizations, such as those focused on 

patient safety and device manufacturers. Additionally, we conducted 

Internet searches and reviewed documentation provided by the officials 

and organizations we interviewed to further identify available information 

on the extent and cost of such outbreaks. Regarding costs, our work 

focused on available estimates of direct financial costs that the 

organizations whose representatives we interviewed or other 

organizations quantified. Lastly, we reviewed CDC data on blood-borne 

pathogen outbreaks resulting from unsafe injection practices in 

ambulatory care settings from 2001 through 2011.8

To examine the changes in federal oversight to prevent unsafe injection 

practices in selected types of ambulatory care settings since 2009—when 

our last report on HAIs was released—we reviewed CMS’s policies and 

procedures, as well as documentation from accrediting organizations that 

survey facilities, to ensure that they meet CMS’s health and safety 

standards.

To assess the 

reliability of the CDC data on blood-borne pathogen outbreaks related to 

unsafe injection practices, we discussed the data with responsible agency 

officials, reviewed related documentation, and examined the data for 

consistency. We determined that the CDC data were sufficiently reliable 

for our purposes in this report.

9 We examined federal oversight of injection safety in terms of 

the scope and content of CMS’s health and safety standards and the 

processes that CMS uses to ensure compliance among the facilities to 

which those standards apply. Our review included those types of 

ambulatory care settings in which CDC has identified one or more bloodborne pathogen outbreaks from 2001 through 2011, specifically ASCs 

and physician offices.10

 

8

While our review focused on hepatitis and HIV infections, patients may also contract 

other HAIs related to unsafe injection practices. For example, from 2001 through 2011, 

over 260 patients developed bacterial infections from unsafe injection practices with the 

majority having required hospitalization.

We also interviewed CMS officials about related 

9

See GAO-09-213. 

10Additional types of ambulatory care settings for which CMS conducts oversight, but 

which were not included in our review, include end-stage renal disease facilities, rural 

health clinics, and federally qualified health centers.
 

Page 5 GAO-12-712 Unsafe Injection Practices

oversight policies and procedures and officials from two main accrediting 

organizations to identify their processes for preventing unsafe injection 

practices in selected ambulatory care settings.11

To examine other federal efforts under way or planned to improve current 

injection safety practices in ambulatory care settings since 2009, we 

interviewed officials from several HHS agencies, including CDC, CMS, 

and FDA, as well as relevant associations and organizations. We also 

reviewed documentation describing federal efforts to improve current 

injection safety practices and identified funding for these efforts. We 

identified these efforts through multiple sources, including interviews with 

federal agencies and other organizations and Internet searches. The 

information we provide may not represent all federal efforts to improve 

current injection safety practices in ambulatory care settings.

Throughout these 

interviews we also gathered information on how CMS works with state 

survey agencies and accrediting organizations to implement the agency’s 

policies to ensure that facilities meet CMS’s health and safety standards, 

including those related to infection control.

We conducted this performance audit from December 2011 to July 2012 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

CDC issues recommendations for clinicians to follow in order to prevent 

and control HAIs. CDC issues these recommendations in the form of 

evidence-based guidelines and other informal communications, such as 

clinical reminders, which are generally recognized as authoritative 

interpretations of the current scientific knowledge base regarding the 

prevention of HAIs. CDC develops these guidelines in collaboration with 

the Healthcare Infection Control Practices Advisory Committee 

(HICPAC)—a federal advisory committee that provides recommendations 

 

11Specifically, we interviewed officials from two of the four CMS-approved accrediting 

organizations for ASCs—the Accreditation Association for Ambulatory Health Care and 

The Joint Commission. The American Association for Accreditation of Ambulatory Surgical 

Facilities, Inc. and the American Osteopathic Association also accredit ASCs.

Background 
 

Page 6 GAO-12-712 Unsafe Injection Practices

to the Secretary of HHS and to CDC and includes members from outside 

the federal government selected for their expertise on infection control.12

In 2007, CDC issued its most recent infection control guideline outlining 

Standard Precautions, which serves as the foundation for preventing 

transmission of infections during patient care in all health care settings, 

and includes recommendations for safe injection practices.13 Examples of 

safe injection practices include administering medication from one syringe 

to only one patient, administering medications from single-dose vials to 

only one patient, and using bags or bottles of intravenous solution for only 

one patient.14

In addition, CMS—consistent with statute—has established and oversees 

compliance with health and safety standards for ASCs as a condition of 

their participation in Medicare.

Additionally, CDC also helps to provide assistance to state 

and local health departments in their investigations of possible bloodborne pathogen outbreaks resulting from unsafe injection practices, and 

maintains information on blood-borne pathogen outbreaks.

15

 

12Representatives from the following government agencies are nonvoting members of 

HICPAC: CMS, the Agency for Healthcare Research and Quality, FDA, the National 

Institutes of Health, the Health Resources and Services Administration, and the 

Department of Veterans Affairs.

An ASC must be certified or deemed 

through accreditation as meeting these standards in order to participate in 

13See J. D. Siegel, E. Rhinehart, M. Jackson, L. Chiarello, and HICPAC, 2007 Guideline 

for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare 

Settings, accessed October 26, 2011, 

http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf.

14In May 2012, CDC released a paper restating its position on the appropriate use of 

single-dose and single-use vials. CDC recommends that clinicians limit the sharing of 

medications whenever possible. In times of critical need, qualified health care personnel 

may repackage unopened single-dose or single-use vials for multiple patients when 

performed in accordance with standards in the United States Pharmacopeia on sterile 

preparations for pharmaceutical compounding, as well as the manufacturer’s 

recommendations for safe storage. See, CDC, Single-dose/Single-use Vial Position and 

Messages (May 2, 2012), accessed May 24, 2012, 

http://www.cdc.gov/injectionsafety/CDCposition-SingleUseVial.html.

15See 42 U.S.C. § 1395k(a)(2)(F)(i). For ASCs, CMS calls its health and safety standards 

“conditions for coverage.” 42 C.F.R. Part 416, Subpart C (2011). For other types of 

ambulatory care facilities, such as end-stage renal disease facilities, rural health clinics, 

and federally qualified health centers, CMS has established different standards for 

participation in Medicare. See 42 C.F.R. Part 405, Subpart U (for end-stage renal disease 

facilities) and 42 C.F.R. Part 491, Subpart A (for rural health clinics and federally qualified 

health centers). 
 

Page 7 GAO-12-712 Unsafe Injection Practices

Medicare and qualify for Medicare facility payments.16 As part of the 

agency’s certification process, CMS contracts with state survey agencies 

to conduct on-site surveys of facilities subject to CMS’s standards. These 

surveys include on-site inspections by a survey team, generally of two or 

more surveyors, who review documents, interview staff and patients, 

observe practices, and examine medical records to ensure compliance 

with CMS’s standards. When surveyors find that a facility’s practices do 

not meet CMS’s health and safety standards, these discrepancies are 

cited as deficiencies and reported to CMS.17 Additionally, ASCs may 

choose to instead undergo accreditation by CMS-approved accrediting 

organizations that CMS has determined meet or exceed its standards.18

Not all ambulatory care settings are subject to CMS’s health and safety 

standards.

Facilities that are deemed as meeting CMS’s standards through this 

means are also eligible to participate in Medicare and receive facility 

payments. As part of this accreditation process, accrediting organizations 

conduct periodic on-site surveys to ensure that facilities meet their 

standards, including those related to infection control.

19

 

16CMS defines an ASC as a distinct entity that operates exclusively for the purpose of 

providing surgical services to patients not requiring hospitalization in which the expected 

duration of services would not exceed 24 hours following an admission, including pre- and 

postoperation care. 42 C.F.R. § 416.2. Various ambulatory care facilities may meet CMS’s 

definition of an ASC, including pain management clinics and endoscopy clinics. For fiscal 

year 2011, 5,356 ambulatory care facilities enrolled in Medicare as ASCs and were thus 

eligible for facility payments.

For example, patients may receive a wide array of services 

similar to those provided at ASCs, such as endoscopy and pain 

management services, in facilities designated as physician offices, which 

17Depending upon the severity of the deficiency, state surveyors issue standard- or 

condition-level deficiencies. CMS requires an ASC to respond to standard-level 

deficiencies with an acceptable plan for correction, while for condition-level deficiencies—

used for substantial levels of noncompliance—an ASC must generally undergo a second 

on-site inspection to demonstrate that it has corrected the deficient practice or else the

Medicare agreement for these facilities would be terminated. The deficiencies are 

recorded in a national database that supports CMS’s survey and certification operations.

18See 42 C.F.R. § 416.26(a). According to CMS, approximately 25 percent of ASCs that 

participate in Medicare—and are thus eligible for facility payment under Medicare—are 

inspected by accrediting organizations to determine compliance with CMS’s health and 

safety standards. The remaining 75 percent of Medicare-participating ASCs are inspected

through state survey agencies.

19With respect to ambulatory care settings not subject to CMS’s oversight, states may 

provide some degree of oversight of injection practices.
 

Page 8 GAO-12-712 Unsafe Injection Practices

may range in scale from a small office facility with a single physician to a 

large clinic with multiple physicians and extensive medical or surgical 

capabilities. However, physician offices are not subject to CMS oversight, 

and thus these facilities do not undergo on-site surveys. In addition, even 

ambulatory care facilities that could potentially meet CMS’s definition of 

an ASC may choose not to participate in Medicare as an ASC. 

Consequently, these facilities would not undergo the Medicare 

certification or deeming processes and not receive ASC Medicare facility 

payments.20

These efforts by CDC and CMS to prevent unsafe injection practices 

represent efforts to change clinical practices, which research shows can 

be challenging. Making clinicians aware of the scientific basis for specific 

practices to achieve patient safety plays a role in changing their behavior, 

but on its own tends to bring about only modest improvement. 

Researchers point to other barriers that need to be overcome, including 

the challenge of integrating the new practice into established work flow 

patterns, organizational cultures in many health care settings that can be 

resistant to change, and the challenge of establishing open 

communication and accountability across distinct professional groups with 

differing hierarchical status, such as nurses and physicians.21 Ongoing 

efforts to ensure that every clinician performs hand washing or other hand 

hygiene prior to contact with each patient is an example of the difficulty of 

achieving consistent compliance with even the most basic and 

noncontroversial patient safety measures.22

 

20Medicare generally pays physicians separately for their services whether the treatment 

takes place in ASCs, for which CMS has established health and safety standards, or in 

other facilities that are not subject to CMS’s health and safety standards, such as 

physician offices.

21See, for example, John Øvretveit, Economics and Effectiveness of Interventions for 

Improving Quality and Safety of Health Care - A Review of Research (Stockholm: Medical 

Management Centre, Karolinska Institute, 2007).

22See Richard Grol and Jeremy Grimshaw, “From Best Evidence to Best Practice: 

Effective Implementation of Change in Patients’ Care,” The Lancet, vol. 362 (2003): 1225-

1230.
 

Page 9 GAO-12-712 Unsafe Injection Practices

Data on the extent of blood-borne pathogen outbreaks related to unsafe 

injection practices in ambulatory care settings are limited and likely 

underestimate the full extent of such outbreaks. Additionally, 

comprehensive data on the cost of blood-borne pathogen outbreaks to 

the health care system do not exist, but CDC and other officials believe 

these costs can be substantial for those affected by such outbreaks, 

including individuals, state and local health departments, and clinicians 

and health care facilities.

According to CDC officials and others we interviewed, there are relatively 

few sources of information available on the extent of blood-borne 

pathogen outbreaks resulting from unsafe injection practices in 

ambulatory care settings, and these data likely underestimate the full 

extent of such outbreaks. Specifically, CDC tracks and keeps records of 

reported blood-borne pathogen outbreaks related to unsafe injection 

practices in the United States, which it identifies through state and local 

health departments seeking investigative assistance for potential 

outbreaks. According to CDC records, from 2001 through 2011, there 

were 18 known outbreaks—episodes of infection transmission where 2 or 

more patients became infected—of viral hepatitis associated with unsafe 

injection practices at ASCs and other ambulatory care settings in the 

United States. In these known outbreaks in ambulatory care settings, 

nearly 100,000 individuals were notified to seek testing for possible 

exposure to viral hepatitis and HIV, and 358 of them were infected with 

viral hepatitis.23

 

23For these 18 outbreaks CDC had sufficient evidence to epidemiologically link the new 

cases of blood-borne pathogen infections with a health care facility. According to CDC 

officials, evidence to link an infection to unsafe injection practices is obtained by methods 

that may include interviewing patients with new infections, testing potentially exposed 

patients for the presence of infection, using molecular epidemiology to determine if the 

infections are related, and investigating health care facilities to review medical records and 

observe or otherwise assess clinicians’ injection safety practices.

 (See app. I for more comprehensive information on the 

18 blood-borne pathogen outbreaks related to unsafe injection practices 

in ambulatory care settings.) In addition, over 17,000 other patients were 

also notified of possible exposure to blood-borne pathogens because of 

Limited Data Are 

Available on the 

Extent and Cost of 

Blood-borne Pathogen 

Outbreaks Resulting 

from Unsafe Injection 

Practices in 

Ambulatory Care

Settings 

Available Data Are Limited 

and Likely Underestimate 

the Full Extent of Bloodborne Pathogen Outbreaks 

in Ambulatory Care 

Settings 
 

Page 10 GAO-12-712 Unsafe Injection Practices

unsafe injection practices in ambulatory care settings outside of these 

18 recognized outbreaks. These notification events were not identified as 

outbreaks because they did not meet CDC’s definition of a blood-borne 

pathogen outbreak, which is an episode of transmission where two or 

more patients became infected and where these infections could be 

epidemiologically linked to a specific health care facility or clinician.24

Our analysis of CDC’s data on the 18 known blood-borne pathogen 

outbreaks in ambulatory care settings indicates that these incidents were 

associated with one or more types of unsafe injection practices and most 

were related to improper use of syringes that led to contaminated 

medication vials or saline bags that were then reused for multiple patients 

(see table 1). These outbreaks were in a number of different ambulatory 

care facility types across multiple states. Specifically, of the 18 outbreaks, 

5 occurred in pain management clinics, 5 occurred in endoscopy clinics, 

3 occurred in alternative medicine clinics, and 2 occurred in hematologyoncology clinics. Additionally, two of the facilities that had outbreaks were 

participating in Medicare as ASCs, according to CDC officials. With the 

exception of these two facilities, the facilities that have experienced 

outbreaks were not subject to CMS’s health and safety standards, which 

require facilities to take steps to prevent unsafe injection practices from 

occurring, because they are considered physician offices. Finally, while 

some states may appear to have more outbreaks than others, CDC 

officials noted that some states are more advanced in identifying, 

investigating, and reporting blood-borne pathogen outbreaks than others, 

which may make them appear to have more outbreaks.

 

24Additionally, CDC data indicate that there have been numerous outbreaks related to 

unsafe practices associated with assisted blood glucose monitoring, which refers to 

monitoring of blood glucose—usually through the use of a glucose meter and finger-stick 

device—that is performed for one or more persons by either a health care clinician or a 

caregiver. Specifically, from 2001 through 2011, at least 22 hepatitis B outbreaks related 

to unsafe practices during the assisted monitoring of blood glucose occurred in U.S. 

health care settings, mainly in assisted-living facilities. In these outbreaks, more than 

1,850 people were screened for possible infections and more than 160 patients were 

infected with hepatitis B.
 

Page 11 GAO-12-712 Unsafe Injection Practices

Table 1: Unsafe Injection Practices That Led to the Known Blood-borne Pathogen Outbreaks in Ambulatory Care Settings, 

2001 through 2011 

Infection control lapse that 

led to outbreak 

Number of 

outbreaks Settings States 

Years of 

outbreaks

Type of 

infection 

Syringe reuse or suspected reuse 

that contaminated medication vials 

or saline bags, and syringe reuse 

from one patient to another or 

from clinician to patient

16 Alternative medicine clinic, 

cardiology clinic, endoscopy 

clinic, hematology-oncology 

clinic, hospital-based 

outpatient radiology clinic, 

hospital-outpatient pain 

management clinic, 

outpatient surgery clinic, 

pain management clinic, 

physician office

CA, FL, NE, 

NV, NY, NC,

OK

2001, 2002,

2003, 2005,

2006, 2007,

2008, 2009,

2010, 2011 

Hepatitis C,

hepatitis B, or 

both

Medication reuse, such as the use 

of saline bags or single-dose vials 

for more than one patient, or multidose vials used for multiple 

patients without appropriate 

infection control practices

12 Alternative medicine clinic, 

cardiology clinic, endoscopy 

clinic, hematology-oncology 

clinic, outpatient surgery 

clinic, pain management 

clinic, physician office

CA, FL, NE, 

NV, NJ, NY, 

NC

2002, 2005,

2006, 2007,

2008, 2009,

2010, 2011 

Hepatitis C, 

hepatitis B, or 

both

Other infection control lapses, 

such as mishandling of medication 

vials or medication preparation, 

such as preparing medication in 

contaminated environment or 

failure to store or prepare 

medication in aseptic conditions

9 Alternative medicine clinic, 

hematology-oncology clinic, 

pain management clinic, 

physician office

CA, FL, NJ, 

NY

2001, 2005,

2009, 2010 

Hepatitis C, 

hepatitis B, or 

both

Source: GAO analysis of CDC data.

Notes: The total number of outbreaks does not add up to 18 because for some outbreaks there was 

more than one infection control lapse that contributed to the outbreak. Moreover, because of variation 

in the way the investigations are conducted by health departments that typically lead outbreak 

investigations, additional lapses may have occurred that were not observed or recorded.

According to CDC officials, there were no known HIV infections linked to unsafe injection practices 

from 2001 through 2011.

For a number of reasons, CDC officials and others we interviewed believe 

that the known outbreaks do not represent the full extent of blood-borne 

pathogen outbreaks related to unsafe injection practices in ambulatory 

care settings. First, blood-borne pathogen infections, regardless of how 

they are contracted, can be difficult to detect. According to CDC officials 

and others we interviewed, as well as published literature we reviewed, 

blood-borne pathogen infections may go undetected because most 

people infected with viral hepatitis either do not have symptoms for years 

or have only mild nonspecific symptoms. For example, a 2010 study by 
 

Page 12 GAO-12-712 Unsafe Injection Practices

the Institute of Medicine reports that about 65 to 75 percent of individuals 

infected with hepatitis are unaware that they are infected.25 Many people 

infected with hepatitis are not aware that they have been infected until 

they have symptoms of cirrhosis or liver cancer many years later. 

Second, when symptoms do occur, it may be too late to determine the 

exact incident that caused the infection. Clinicians are generally required 

to report cases of acute hepatitis B and C infections to their state or local 

health department, though this varies by state. However, according to 

health department officials we interviewed, tracking an infection to a 

specific health care facility can be difficult because treatment in a health 

care facility is not generally considered to be an important risk factor for 

these types of infections. Third, CDC officials said that while state and 

local health departments and even medical staff often may choose to 

notify CDC about potential blood-borne pathogen outbreaks, including 

those possibly related to unsafe injection practices, there is no 

requirement for such reporting.26

 

25Institute of Medicine of the National Academies, Hepatitis and Liver Cancer: A National 

Strategy for Prevention and Control of Hepatitis B and C (Washington, D.C.: the National 

Academies Press, 2010).

CDC officials said that the agency 

generally identifies that potential blood-borne pathogen outbreaks related 

to unsafe injection practices have occurred when state or local health 

departments seek CDC assistance during their investigations of potential 

outbreaks. However, CDC officials said that because of the variability in 

states’ surveillance and investigation capacity, many outbreaks may not 

come to the attention of the health department or CDC. Lastly, available 

evidence indicates that the unsafe injection practices that can cause 

blood-borne pathogen outbreaks may be prevalent in ASCs, which 

increases the likelihood that other such outbreaks are occurring 

undetected in addition to those that have been identified. Specifically, 

CDC researchers found in a 2008 survey of a randomly selected sample 

of 68 ASCs in three states that about 28 percent of ASCs were cited for 

deficiencies related to injection practices or medication handling—

primarily for the use of single-dose vials for more than one patient—and 

26In 2011, the National Quality Forum updated its list of serious reportable events or 

“never” events to include blood-borne pathogen infections related to unsafe injection 

practices. See, National Quality Forum, Serious Reportable Events in Healthcare – 2011 

Update: A Consensus Report (Washington D.C.: 2011). 
 

Page 13 GAO-12-712 Unsafe Injection Practices

about 68 percent were cited for at least one lapse in basic infection 

control.27

According to CDC officials and others we contacted, while the financial 

costs to the health care system of blood-borne pathogen outbreaks 

related to unsafe injection practices can be substantial, there are no 

comprehensive data on the total costs attributed to such outbreaks. CDC 

officials said that assessing such costs is difficult because the costs are 

borne by different groups—for example, individuals, state and local health 

departments, and clinicians and health care facilities—and the costs are 

often intermingled with other health care costs. However, various parties 

have developed estimates of some of the potential and actual costs 

associated with such outbreaks for each of these three groups.

• Individuals. For individuals who are notified that they are at risk of a 

blood-borne pathogen infection, costs may be incurred for testing. For 

example, in response to a large hepatitis C outbreak in Nevada—

which required notification of more than 60,000 patients to seek 

blood-borne pathogen testing—the Southern Nevada Health 

Department estimated that the laboratory costs for testing all of the 

potentially exposed patients would be $13.8 million. Additionally, for 

individuals who are infected, costs include those for short- and longterm treatment. For example, the Southern Nevada Health 

Department estimated that the cost of treatment for an infected patient 

would be about $30,000, including the direct costs for professional 

services, laboratory testing, and medication, but excluding the costs of 

annual monitoring and possible complications related to cirrhosis or 

liver transplants.

• State and local health departments. State and local health care 

departments may incur costs for investigating and responding to 

potential outbreaks, including the costs of notifying and potentially 

providing blood-borne pathogen testing for patients who may have 

 

27This study was conducted in collaboration with CMS. For more information see, M. 

Schaefer et al., “Infection Control Assessment of Ambulatory Surgical Centers,” Journal of 

the American Medical Association, vol. 303, no. 22 (2010): 2273-2279. Similarly, a survey 

conducted by the Premier Safety Institute also showed that clinicians use unsafe injection 

practices to some extent. See G. Pugliese et al., “Injection Practices Among Clinicians in 

United States Health Care Settings, “American Journal of Infection Control, vol. 38, no. 10 

(2010): 789-798.

Comprehensive Data on 

the Costs to the U.S. 

Health Care System of 

Blood-borne Pathogen 

Outbreaks from Unsafe 

Injection Practices Are Not 

Available
 

Page 14 GAO-12-712 Unsafe Injection Practices

been exposed to unsafe injection practices. Generally, according to 

health department officials we interviewed, state and local health 

departments do not track such costs because investigating and 

responding to such outbreaks is considered part of their normal 

duties. One exception is the case of the Nevada outbreak, where 

officials said such costs were calculated because of the magnitude of 

the outbreak. Specifically, the Southern Nevada Health Department 

estimated that from January 2008 through May 2009, the outbreak 

investigation and response cost the health department about 

$830,000, including $255,605 in staff time by health department 

employees.

• Clinicians and health care facilities. Clinicians and health care 

facilities that are directly involved in outbreaks may incur costs 

associated with lawsuits and settlements. For example, following the 

Nebraska outbreak in 2002, the Nebraska Excess Liability Fund—a 

fund administered by the Nebraska Department of Insurance for 

medical professional liability coverage—paid nearly $9 million in 

indemnity costs to settle 83 cases as of December 2010.28 In addition, 

clinicians who cause blood-borne pathogen outbreaks through their 

use of unsafe injection practices may be at risk of losing their medical 

licenses or facing felony charges related to the outbreak. For 

example, the physician and two nurse anesthetists involved in the 

Nevada outbreak currently face state criminal charges tied to the 

outbreak.29

 

28See Nebraska Department of Insurance, Nebraska Hospital-Medical Liability Act Annual 

Report as of December 31, 2010, accessed April 5, 2012, http://www.doi.ne.gov/medmal/. 

Additionally, in relation to the 2008 Nevada outbreak, a drug manufacturer also faced 

lawsuits and is expected to pay $285 million in settlements involving about 150 patients. 

See B. Haynes, “Drug Maker to Pay $285 Million to Settle Hepatitis Lawsuits,” Las Vegas 

Review Journal (Feb. 21, 2012) accessed April 3, 2012, 

http://www.lvrj.com/news/propofol-maker-teva-to-pay-250-million-to-settle-nevadalawsuits-139856843.html.

29See, Indictment, State of Nevada v. Desai, No. 10C265107 (Dist. Ct. Clark County, 

June 4, 2010).
 

Page 15 GAO-12-712 Unsafe Injection Practices

In 2009, CMS substantially expanded its oversight of unsafe injection 

practices in ASCs by increasing both the intensity of the examination of 

safe injection and other infection control practices and the number of onsite surveys conducted in ASCs to determine compliance with CMS’s 

health and safety standards. Within these health and safety standards, 

those relating to infection control specifically require ASCs to maintain an 

infection control and prevention program designed to minimize the 

occurrences of HAIs, such as blood-borne pathogen infections resulting 

from unsafe injection practices, and have a qualified professional direct 

this program.30 Safe injection practices are included under several of 

CMS’s broader health and safety standards, which also address a 

number of other topics related to infection control and medication 

administration. To document whether ASCs are following CMS’s health 

and safety standards related to infection control, which include safe 

injection practices, CMS directed all surveyors who inspect ASCs to use

CMS’s surveyor instrument—the Infection Control Surveyor Worksheet. 

The worksheet includes a section on injection practices that separately 

addresses such topics as the reuse of needles and syringes as well as 

using single- and multi-dose medication vials for multiple patients.31 CMS 

also directed the surveyors to use a tracer methodology in conjunction 

with the worksheet, which according to CMS officials involves observing a 

patient at the beginning and end of a procedure or through his or her 

entire procedure.32

 

30See 73 Fed. Reg. 68502 (Nov. 18, 2008) (requirement for infection control program 

codified at 42 C.F.R. § 416.51, effective 2009). While facilities have some flexibility in 

designing these programs, all are expected to adhere to nationally recognized and 

approved standards and guidelines for their infection control procedures, such as CDC’s 

infection control guidelines, which describe safe injection practices. See Siegel et al., 2007 

Guideline for Isolation Precautions, accessed October 26, 2011, 

http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf.

31The surveyor worksheet was developed in collaboration with CDC and is consistent with 

CDC’s infection control guidelines. To view a copy of the worksheet, see CMS, “Exhibit 

351 – Ambulatory Surgical Centers Infection Control Surveyor Worksheet,” in Chapter 9 – 

Exhibits, Medicare State Operations Manual, accessed January 17, 2012, 

http://www.cms.gov/manuals/downloads/som107_exhibit_351.pdf. 

32CMS officials said that the agency has collaborated with CDC throughout the process of 

expanding its oversight of ASCs. Specifically, CDC has been involved in providing formal 

training to ASC surveyors on CMS’s revised guidance and the surveyor worksheet and 

funding an infection preventionist position within CMS to provide infection-control-related 

expertise to CMS’s survey and certification efforts in fiscal years 2011 and 2012.

CMS Has Increased 

Oversight of Injection 

Practices in ASCs, but 

Its Decision to Stop 

Data Collection Will 

Limit Effectiveness
 

Page 16 GAO-12-712 Unsafe Injection Practices

In addition, for the large majority of ASCs that are surveyed by state 

survey agencies—about 75 percent—CMS expanded the number of 

ASCs that are to be surveyed each year. Specifically, for fiscal years 

2011 and 2012, CMS expects that state survey agencies will survey at 

least 25 percent of nonaccredited ASCs each year, an increase from its 

expectation that at least 10 percent of nonaccredited ASCs would be 

surveyed annually in fiscal year 2009, and 5 percent in fiscal year 2008.33

CMS also required in fiscal years 2010 and 2011 that some of the ASCs 

surveyed by state survey agencies be randomly selected by CMS so the 

agency could obtain a nationally representative sample.34

As part of implementing the expanded oversight of ASCs, CMS collected 

and plans to analyze detailed information from the Infection Control 

Surveyor Worksheets, but only for fiscal years 2010 and 2011. 

Specifically for these 2 fiscal years, CMS required state surveyors to 

submit a completed copy of the worksheet for every ASC that they

surveyed, in addition to their routine reporting of citations for lack of 

compliance with particular standards. According to the CMS officials, the 

agency plans to use the data collected from the surveyor worksheets to 

determine the differences in the type and level of citations given by state 

survey agencies to ASCs identified as noncompliant with the agency’s 

health and safety standards. As of May 2012, CMS officials expected to 

have this analysis completed in July 2012. Additionally, CMS officials said 

that the agency has provided CDC with the surveyor worksheet data to 

examine the extent of infection control problems, including unsafe 

injection practices, in a sample of ASCs nationwide, from which CDC 

officials expect to create a baseline assessment of unsafe injection 

practices in these settings. As of April 2012, CDC officials did not have a 

firm deadline for when they plan to complete this analysis because they 

are uncertain of how long it will take to obtain access to usable data, but 

the officials expect that it will be completed at some point in 2012.

 

33For fiscal years 2009 and 2010, CMS made available $10 million to state survey 

agencies in additional funds to survey nonaccredited ASCs, and in fiscal year 2010 CMS 

expected the survey agencies to survey at least 33 percent of nonaccredited ASCs. 

34This was done in response to a 2009 GAO recommendation. See GAO-09-213 for more 

information.
 

Page 17 GAO-12-712 Unsafe Injection Practices

Although CMS will continue to direct surveyors to use the infection control 

worksheet to guide what surveyors observe in conducting their 

examinations of ASC practices, CMS officials said that the agency 

decided to stop collecting data directly from surveyor worksheets after 

fiscal year 2011. The officials said that this decision was, in part, because 

of the burden that this additional data collection process placed on 

surveyors. According to these officials, surveyor teams—which generally 

consist of at least two individuals—found it time consuming to consolidate 

and transcribe the observations of multiple surveyors into a single 

document and send the consolidated worksheet to CMS, in addition to 

their routine reporting of citations for noncompliance with particular 

standards. Additionally, CMS officials said the agency did not want to 

burden the surveyors with collecting more information from the 

worksheets until CMS had analyzed the information already collected.

However, without continuing to collect the data from the Infection Control 

Surveyor Worksheets after fiscal year 2011, CMS will lose its capacity to 

monitor ASC compliance specifically with respect to safe injection 

practices, which would be necessary to track the effectiveness of its 

increased efforts to prevent unsafe practices. CMS officials reported that 

they do not have access to information that would allow them to identify 

which citations stem in whole or in part from unsafe injection practices 

because the citation reports that are routinely submitted by surveyors 

after an ASC is inspected are based on standards that cover a mix of 

injection-related and other infection control or medication administration 

practices. Furthermore, the lack of the worksheet data will reduce CMS’s 

ability to check the accuracy and completeness of surveyor assessments 

of unsafe injection practices going forward.35

 

35Although CMS has other processes for checking the completeness and accuracy of 

surveys performed by state survey agencies, notably the federal monitoring surveys 

conducted by CMS regional office staff, CMS officials reported that they were not aware of 

any such surveys of ASCs in recent years.

Finally, CMS’s decision to 

stop collecting surveyor worksheet data will prevent CDC from using 

these data to conduct its own analyses of the extent of unsafe injection 

practices in ASCs over time. While CMS has noted that collecting these 

data has been burdensome for surveyors, there may be various ways to 

ameliorate this burden so that CMS could continue to collect the 

information needed to track the effectiveness of its increased oversight of 

ASCs. For example, after 2 years of requiring a completed worksheet for 

every ASC surveyed, CMS could reduce the burden placed on surveyors 
 

Page 18 GAO-12-712 Unsafe Injection Practices

by limiting this requirement to only those ASCs included in a random, 

nationally representative sample. In addition, it could adjust the size of the 

sample or collect the worksheet information less frequently than every 

year.36

In order to help encourage safe injection practices, various HHS agencies 

have developed efforts to communicate information on these practices to 

clinicians since our last report on HAIs was released in 2009. For 

example, to expand awareness and understanding of CDC’s guidelines 

for infection control, CDC released tools targeted to specific health care 

settings in 2011. These tools include a summary guide for ambulatory 

care settings with an accompanying checklist and an infection control and 

prevention plan specifically for outpatient oncology centers, both of which 

provide basic infection prevention guidance and reaffirm adherence to 

CDC’s infection control guidelines, including those related to safe 

injection practices.37

In addition to communicating information on safe injection practices 

through guidance documents, CDC has also been involved in 

communicating such information to clinicians in various health care 

settings through an educational campaign, called the One and Only 

Campaign. CDC developed this educational campaign in collaboration 

with the Safe Injection Practices Coalition—a partnership of health-carerelated organizations that was formed to promote safe injection practices 

in all U.S. health care settings. Organizations participating in the Safe 

Injection Practices Coalition include clinician and facility associations, 

patient advocacy organizations, foundations, industry partners, and 

 

36As noted in GAO-09-213, results reported from smaller random samples are less 

precise, but they can still produce nationally representative information.

37See CDC, Guide to Infection Prevention for Outpatient Settings: Minimum Expectations 

for Safe Care and the Infection Prevention Checklist for Outpatient Settings: Minimum 

Expectations for Safe Care, accessed October 21, 2011, 

http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html. See CDC, 

Basic Infection Control and Prevention Plan for Outpatient Oncology Settings, accessed 

March 1, 2012, http://www.cdc.gov/HAI/settings/outpatient/basic-infection-controlprevention-plan-2011/index.html.

HHS Communicates 

Information on Safe 

Injection Practices to 

Clinicians, but Efforts 

Do Not Target Certain 

Higher-Risk Settings
 

Page 19 GAO-12-712 Unsafe Injection Practices

CDC.38 The campaign was developed in 2009 in response to patients 

who have been notified of possible exposure to blood-borne pathogens, 

in order to help ensure that patients are protected each and every time 

they receive a medical injection.

39 The One and Only Campaign is led by 

CDC and the Safe Injection Practices Coalition and is funded by 

members of the coalition and the agency through the CDC 

Foundation40—an independent, nonprofit organization that connects CDC 

with private-sector organizations and individuals to build public health 

programs.41

Since starting in 2009, the campaign’s education and awareness efforts 

have included developing educational materials for clinicians and 

patients, such as brochures, posters, a video, and a continuing education 

webinar on safe injection practices for clinicians. Additionally, CDC 

funded positions in state health departments to partner with the Safe 

Injection Practices Coalition to help disseminate information from the One 

and Only Campaign and develop state-based activities to raise 

 

38FDA serves as an advisor to the Safe Injection Practices Coalition and supports the 

activities of the One and Only Campaign through the agency’s Safe Use Initiative. The 

Safe Use Initiative is a collaborative effort between FDA and relevant stakeholders to 

measurably reduce preventable harm from medications to improve patients’ health.

39From 2001 through 2011, more than 130,000 patients have been notified of possible 

exposure to blood-borne pathogens from inpatient and ambulatory care settings. See A. 

Guh et al., “Patient Notification for Bloodborne Pathogen Testing due to Unsafe Injection 

Practices in the US Health Care Settings, 2001-2011,” Medical Care, (2012). 

40Since starting the campaign in September 2009, CDC has invested a total of about 

$3 million in the One and Only Campaign’s activities, with $1.3 million awarded to the 

CDC Foundation for the campaign. 

41In addition to being focused on education and awareness efforts, CDC and FDA have 

taken some actions to prevent unsafe injection practices by working to engineer safety 

into health care processes and products. For example, according to FDA officials, in 2009 

FDA—in collaboration with CDC—met with professional organizations whose members 

draw up and administer injectable medications. These organizations identified confusion 

over medication vial labeling as a factor that contributed to misuse of medication vials, 

specifically the use of the terms single use, single dose, and single patient use. FDA and 

CDC are working with the United States Pharmacopeial Convention—a scientific nonprofit 

organization that sets standards for the identity, strength, quality, and purity of medicines, 

among other things—to update the terminology and definitions for medication vials 

containing sterile preparations of pharmaceutical drug products. 
 

Page 20 GAO-12-712 Unsafe Injection Practices

awareness of safe injection practices.42

CDC and the Safe Injection Practices Coalition have used the One and 

Only Campaign to target certain types of clinicians and health care 

settings that have previously experienced blood-borne pathogen 

outbreaks related to unsafe injection practices as well as to focus on 

clinicians more broadly. For example, the Safe Injection Practices 

Coalition disseminated the campaign’s educational materials through the 

American Association of Nurse Anesthetists and the Accreditation 

Association for Ambulatory Health Care, both of which are coalition 

members. Additionally, according to CDC Foundation officials, the One 

and Only Campaign’s educational efforts are also focused generally on all 

health care clinicians, and the demand for the campaign’s educational 

materials does not appear to be driven by a particular group of clinician 

types or health care settings. For example, according to CDC nearly 

50,000 people viewed the Safe Injection Practices Coalition’s continuing 

medical education activity on unsafe injection practices from July 2011 to 

February 2012. Viewers included a wide range of clinicians, such as 

anesthesiologists, surgeons, pediatricians, nurse practitioners, physician 

In message-testing the 

educational materials for the campaign, these state health department 

partners utilized focus groups and surveys to ensure that the contents 

were understandable to both clinicians and patients. According to CDC 

and CDC Foundation officials, the state health department partners also 

developed varied approaches to reach health care clinicians, such as 

developing work groups to target insurance companies to make them 

aware of safe injection practices and developing tool kits for clinicians and 

state and local health departments to promote safe injection practices. 

For example, the State and Local Health Department tool kit was 

released in April 2012 and includes injection safety specific resources 

from CDC and the Safe Injection Practices Coalition, such as an 

educational video, posters, brochures, as well as other resources specific 

to state and local health department needs, such as information on how 

to build a work group and working with the media.

 

42CDC officials said that they used a competitive process to enter into cooperative 

agreements with state health departments for the One and Only Campaign. From fiscal 

years 2009 through 2012, CDC awarded about $1.7 million to two to three state health 

department partners to participate in the campaign. For fiscal year 2012 specifically, CDC 

awarded three state health departments (New Jersey, New York, and North Carolina) 

$434,000 to partner with the One and Only Campaign. Nevada previously participated in 

the One and Only Campaign as a funded partner from fiscal years 2009 through 2011 and 

according to CDC officials now participates in a voluntary capacity.
 

Page 21 GAO-12-712 Unsafe Injection Practices

assistants, pharmacists, and other types of health care clinicians, 

although CDC does not have information on the health care settings in 

which these clinicians practice.43

Though CDC and the Safe Injection Practices Coalition have targeted the 

One and Only Campaign at certain types of clinicians and health care 

settings that have experienced blood-borne pathogen outbreaks in the 

past, these targeted efforts at the national level have generally not 

included other settings that have experienced outbreaks and are not 

overseen by CMS.44

Many of these education and awareness efforts conducted by CDC and 

the One and Only Campaign are part of HHS’s larger, ongoing efforts to 

prevent HAIs. Specifically, HHS is expanding the agency’s consolidated 

effort as described in the National Action Plan to Prevent HAIs: Roadmap 

to Elimination to include certain ambulatory care settings.

All health care settings are at risk for using unsafe 

injection practices, but the settings not overseen by CMS, such as 

physician offices, may be particularly at risk for unsafe injection practices 

because they have not been subject to CMS’s increased oversight efforts, 

including the use of the Infection Control Surveyor Worksheet. 

Furthermore, CDC does not have information on the extent to which the 

general efforts of the campaign have reached these settings not overseen 

by CMS. As a result, it is not clear if these specific settings are being 

reached by the campaign.

45

 

43Additionally, from June 2010 through March 2012, CDC and the CDC Foundation also 

distributed over 50,000 hard copy educational materials from the One and Only Campaign 

to patients, clinicians, and health care facilities.

Specifically, in 

this next phase, HHS addresses prevention of blood-borne pathogen 

outbreaks related to unsafe injection practices and other HAIs in ASCs 

44According to CDC, each of the state health department partners has targeted clinicians 

and health care settings that were identified as problem areas in its states, which in some 

cases included ambulatory care settings that are not overseen by CMS.

45HHS, Department of Defense, and Department of Veterans Affairs, National Action Plan 

to Prevent Healthcare-Associated Infections: Roadmap to Elimination (Draft) (April 2012) 

accessed May 22, 2012, http://www.hhs.gov/ash/initiatives/hai/infection.html.
 

Page 22 GAO-12-712 Unsafe Injection Practices

and end-stage renal disease facilities.46 In April 2012, HHS released a 

draft plan that describes various next steps to prevent HAIs in these 

settings and proposes measurable outcomes and 5-year goals to assess 

progress. For ASCs this includes continuing to disseminate evidencebased guidelines and training for infection control and safe injection 

practices through CDC and the One and Only Campaign. With respect to 

end-stage renal disease facilities, the draft plan calls for identifying the 

prevalence and incidence of hepatitis infections and recommendations to 

prevent hepatitis infections. HHS officials expect this next phase of the 

agency’s consolidated effort to prevent HAIs to be finalized by fall 2012.

Available data from CDC, though limited, indicate that there have been 

repeated, widespread blood-borne pathogen outbreaks related to unsafe 

injection practices in the United States from 2001 through 2011. In these 

outbreaks patients have been infected with blood-borne pathogens—

specifically hepatitis—when receiving health care in ambulatory care 

settings, and these infections are likely more common than is currently 

identified. These infections have long-term consequences that can affect 

a patient’s health and ultimately lead to death, and the costs to all 

involved can be substantial. In light of the blood-borne pathogen 

outbreaks that have occurred, HHS agencies have taken some steps in 

the last few years to help prevent unsafe injection practices that can lead 

to blood-borne pathogen outbreaks in ambulatory care settings. CMS has 

expanded its oversight of health and safety standards in ASCs in ways 

that should help to prevent unsafe injection practices that can lead to 

blood-borne pathogen outbreaks, such as by using the detailed Infection 

Control Surveyor Worksheet to determine if facilities are following safe 

injection practices. If CDC and CMS proceed with their plans to analyze 

data collected from these worksheets, 2 years of data that CMS has 

already collected will be used to establish a baseline assessment of the 

 

46The first phase of the HAI action plan focused on certain HAIs in acute care hospitals 

and was released in 2009 by the Federal Steering Committee for the Prevention of HAIs. 

According to HHS officials this is intended to be a living document that continues to adapt 

to additional priorities as they arise, as well as the most recent scientific evidence, 

evolving policies and programs, and changing cultural norms in health care. For example, 

in late 2009, the steering committee approved an expansion of the HAI Action Plan 

extending its scope to the ambulatory care environment, such as efforts focused on ASCs 

and end-stage renal disease facilities. HHS initiated the steering committee and the action 

plan in response to a 2008 GAO recommendation that HHS provide leadership to improve 

HAI prevention practices and improve data on these infections. For more information, see 

GAO-08-283. 

Conclusions 
 

Page 23 GAO-12-712 Unsafe Injection Practices

extent of unsafe injection practices in ASCs and help CMS assess its 

oversight efforts to improve infection control.

However, CMS may be undermining its efforts by stopping data collection 

after fiscal year 2011, in part because of concerns that the time and effort 

required in collecting the data placed a burden on surveyors. Information 

provided by CMS and CDC indicate that reducing unsafe injection 

practices is a long-term project, and their efforts may take several years 

to show clear results. Without some form of continued data collection, 

CMS will lose its capacity to monitor ASC compliance with its health and 

safety standards related to safe injection practices and to monitor how 

well the state surveyors collect and assess information about unsafe 

injection practices. In addition, CDC would not have a source of nationally 

representative data with which to track overall trends in injection safety in 

ASCs. Instead of eliminating this unique source of data on injection 

practices altogether, CMS could address concerns regarding the burden 

on surveyors through other means. For example, rather than collecting 

the data from all surveyed ASCs, CMS could limit this data collection to a 

random sample of ASCs, and the size of the sample could be adjusted. In 

addition, it may be possible to collect the data less frequently than every 

year.

In addition to CMS’s oversight of health and safety standards for ASCs, 

CDC is leading important efforts to encourage safe injection practices 

through the One and Only Campaign. The campaign has focused on 

making information generally available to all clinicians, as well as 

targeting some types of clinicians and health care settings that have been 

involved in prior blood-borne pathogen outbreaks. While raising 

awareness among clinicians and health care facilities will not, by itself, 

ensure the adoption of safe injection practices, it is an important first step. 

The One and Only Campaign is especially important because CMS’s 

oversight of health and safety standards—one primary way for HHS to 

influence clinicians and health care facilities to use safe practices—is only 

statutorily authorized for certain settings, such as ASCs. Therefore, the 

One and Only Campaign represents a unique opportunity to reach 

clinicians and facilities, such as physician offices, that are not subject to 

CMS’s standards. While the campaign’s efforts so far have targeted some 

types of clinicians and health care settings that have been involved in 

prior outbreaks, additional targeting of the campaign’s efforts to settings 

that are not overseen by CMS, such as physician offices, could help to 

focus available resources on the best opportunities to improve patient 

safety.
 

Page 24 GAO-12-712 Unsafe Injection Practices

To help strengthen HHS efforts aimed at protecting patients from infection 

by preventing unsafe injection practices in ambulatory care settings, we 

recommend that the Secretary of HHS take the following three actions:

• Direct CMS and CDC to work together to resume collecting data on 

unsafe injection practices from the Infection Control Surveyor 

Worksheet, or from any alternative source of comparable data, that 

will permit continued monitoring and assessment of unsafe injection 

practices in ASCs beyond fiscal year 2011.

• Direct CMS and CDC to use the data collected on unsafe injection 

practices for CMS to continue monitoring ASC compliance with health 

and safety standards related to infection control and for CDC to 

continue monitoring trends in the prevalence of unsafe injection 

practices in ASCs.

• Direct CDC to strengthen its targeting of the One and Only Campaign 

to health care settings that CDC has identified as having blood-borne 

pathogen outbreaks related to unsafe injection practices that are not 

overseen by CMS.

We provided a draft of this report to HHS for review, and HHS provided 

written comments, which are reprinted in appendix II. In its comments, 

HHS concurred with our recommendations and stated that CMS and CDC 

have worked together to improve injection safety practices in ASCs, as 

well as other settings, such as dialysis facilities, nursing homes, and 

hospitals. HHS stated that CMS intends to resume collection of the 

Infection Control Surveyor Worksheet data beginning in fiscal year 2013 

for a state-stratified, randomly selected subset of ASCs surveyed in that 

year and repeat this sampling and data collection approximately every 

3 years thereafter. Additionally, HHS stated that CMS will use the data 

collected on unsafe injection practices to continue to monitor ASC 

compliance with the agency’s health and safety standards related to 

infection control. HHS also believes that the data it collects can be used 

to assess trends in injection practices in ASCs over time. Lastly, HHS 

stated that CDC supports targeting the outreach of the One and Only 

Campaign toward specific clinician groups and setting types, though the 

agency further noted that broad outreach also remains critical as 

demonstrated by the wide variety of settings where blood-borne pathogen 

outbreaks and unsafe injection practices have been identified. We agree 

that broad outreach is important and should be ongoing; however, 

additional targeted outreach to settings that are not overseen by CMS 

represents an opportunity to help focus available resources to reach 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
 

Page 25 GAO-12-712 Unsafe Injection Practices

clinicians and facilities that have not been reached through other means, 

such as CMS’s oversight. HHS also provided us with technical comments, 

which we incorporated as appropriate.

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Secretary of Health 

and Human Services and other interested parties. In addition, the report 

will be available at no charge on the GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact 

me at (202) 512-7114 or kohnl@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page 

of this report. GAO staff who made key contributions to this report are 

listed in appendix III.

Sincerely yours,

Linda T. Kohn

Director, Health Care
Appendix I: Blood-borne Pathogen Outbreaks 

Related to Unsafe Injection Practices in 

Ambulatory Care Settings, 2001-2011

Page 26 GAO-12-712 Unsafe Injection Practices

Setting (state) Year

Type of 

infection 

Number of 

individuals 

notified 

Number of 

individuals 

infected Infection control lapses 

Endoscopy clinic 

(NY)a 2001 Hepatitis C 2,009 19 Suspected syringe reuse contaminating 

medication vials

Physician office (NY)b 2001 Hepatitis B 1,042 38 Mishandling of medication vials and injection 

equipment; medication preparation in 

contaminated environment

Hospital outpatient 

pain management 

clinic (OK)c

2002 Hepatitis C, 

hepatitis B, or 

both

908 102 Overt syringe reuse from one patient to another

Hematology-oncology 

clinic (NE)d 2002 Hepatitis C 613 99 Syringe reuse contaminating saline bags used 

as a source of flush for more than one patient

Endoscopy clinic 

(NY)e 2002 Hepatitis C 1,199 4 Suspected needle or syringe reuse 

contaminating medication vials

Ambulatory surgical 

center (pain 

management clinic) 

(CA)f

2003 Hepatitis C 52 4 Suspected syringe reuse contaminating 

medication vials

Alternative medicine 

clinic (FL)g 2005 Hepatitis B 253 7 Mishandling of medication vials; failure to 

prepare and store intravenous infusions under 

aseptic conditions

Alternative medicine 

clinic (CA)h 2005 Hepatitis C 15 7 Reuse of syringes, resulting in contamination of 

a saline bag used for more than one patient

Endoscopy and 

outpatient surgery 

clinics (NY)i

2006 Hepatitis C, 

hepatitis B, or 

both

4,490 12 Suspected syringe reuse contaminating 

medication vials; use of single-dose vials of 

propofol for more than one patient

Pain management 

clinic and physician 

office (NY)j

2007 Hepatitis C 9,000 3 Syringe reuse contaminating medication vials; 

use of single-dose vials of contrast (and 

possible Ketorolac) for more than one patient

Ambulatory surgical 

centers (endoscopy 

clinics) (NV)k

2008 Hepatitis C 63,000 9 Syringe reuse contaminating medication vials; 

use of single-dose vials of propofol for more 

than one patient

Cardiology clinic (NC)l 2008 Hepatitis C 1,205 5 Suspected syringe reuse contaminating multidose vials of saline used for more than one 

patient

Alternative medicine 

clinic (FL)m 2009 Hepatitis C 163 9 Syringe reuse contaminating medication vials; mishandling of medication preparation; use of 

single-dose vials of magnesium sulfate for more 

than one patient

Hematology-oncology 

clinic (NJ)n 2009 Hepatitis B 4,600 29 Mishandling of medication vials; medication 

preparation in contaminated environment; 

common-use saline bag for multiple patients; 

use of single-dose vials for more than one 

patient

Appendix I: Blood-borne Pathogen Outbreaks 

Related to Unsafe Injection Practices in 

Ambulatory Care Settings, 2001-2011
Appendix I: Blood-borne Pathogen Outbreaks 

Related to Unsafe Injection Practices in 

Ambulatory Care Settings, 2001-2011

Page 27 GAO-12-712 Unsafe Injection Practices

Setting (state) Year

Type of 

infection 

Number of 

individuals 

notified 

Number of 

individuals 

infected Infection control lapses 

Endoscopy clinics 

(NY)o 2009 Hepatitis C 3,287 2 Suspected syringe reuse contaminating 

medication vials; use of single-dose vials of 

propofol for more than one patient

Pain management 

clinic (CA)p 2010 Hepatitis C, hepatitis B, or 

both

2,293 2 Syringe reuse contaminating medication vials; 

use of single-dose vials of contrast, lidocaine, 

and sodium bicarbonate for more than one 

patient; failure to use aseptic technique when 

accessing medication vials 

Hospital-based 

outpatient radiology 

clinic (FL)q

2010 Hepatitis C 3,929 5 Syringe reuse; narcotics diversion by clinician 

Pain management 

clinic (NY)r 2011 Hepatitis C 466 2 Suspected syringe reuse contaminating 

medication vials; single-dose vials of propofol 

used for more than one patient

Source: Centers for Disease Control and Prevention (CDC) data.

Notes: According to Centers for Disease Control and Prevention (CDC) officials, there were no known 

HIV infections linked to unsafe injection practices from 2001 through 2011.

a

CDC, “Transmission of Hepatitis B and C Viruses in Outpatient Settings—New York, Oklahoma, 

and Nebraska, 2000-2002,” Morbidity and Mortality Weekly Report, vol. 52, no. 38 (2003): 901-906. 

New York City Department of Health and Mental Hygiene, unpublished data.

b

T. Samandari, N. Malakmadze, S. Balter, J. F. Perz, M. Khristova, L. Swetnam, et al., “A Large 

Outbreak of Hepatitis B Virus Infections Associated with Frequent Injections at a Physician’s Office,” 

Infection Control and Hospital Epidemiology. vol. 26, no. 9 (2005): 745-750. CDC, “Transmission of 

Hepatitis B and C Viruses in Outpatient Settings—New York, Oklahoma, and Nebraska, 2000-2002.” 

c

R. D. Comstock, S. Mallonee, J. L. Fox, R. L. Moolenaar, T. M. Vogt, J. F. Perz, et al., “A Large 

Nosocomial Outbreak of Hepatitis C and Hepatitis B among Patients Receiving Pain Remediation 

Treatments,” Infection Control and Hospital Epidemiology, vol. 25, no. 7 (2004): 576-583. CDC, 

“Transmission of Hepatitis B and C Viruses in Outpatient Settings—New York, Oklahoma, and 

Nebraska, 2000-2002.” 

d

A. Macedo de Oliveira, L. K. White, D. P. Leschinsky, B. D. Beecham, T. M. Vogt, R. L. Moolenaar, 

et al., “An Outbreak of Hepatitis C Virus Infections among Outpatients at a Hematology/Oncology 

Clinic,” Annals of Internal Medicine, vol. 142, no. 11 (2005): 898-902. CDC, “Transmission of 

hepatitis B and C viruses in outpatient settings—New York, Oklahoma, and Nebraska, 2000-2002.” 

e

M. Marx, E. Rizzo, R. Stricof, D. Welss, M. Kacica, K. Bornschlegel, et al., “Acute Hepatitis C 

Infection in Patients of a Private Gastroenterology Clinic—New York [Abstract]” (paper presented at 

the 53rd Annual Epidemic Intelligence Service Conference, Atlanta, Ga., April 2004). New York City 

Department of Health and Mental Hygiene, unpublished data.

f

M. C. Janowski, R. A. Gunn, F. Chai, M. M. Ginsberg, O. Nainan, G. Xia, et al., “Transmission of 

Hepatitis C Virus at a Pain Remediation Clinic—San Diego, California 2003 [Abstract]” (in: Final 

Program and Abstracts, Infectious Diseases Society of America 43rd Annual Meeting, Arlington, Va., 

October 2005 (Abstract 1131)). San Diego County of Department of Health and Human Services, 

unpublished data. 

g

R. A. Sanderson, R. Sneed, F. Leguen, and L. Sandoval, “A Hepatitis B Outbreak Associated with 

Outpatient Chelation Therapy” [Abstract], American Journal of Infection Control, vol. 34, issue: 5 

(2006): E90.

h

California State Department of Health Services, unpublished data.

i

B. J. Gutelius, J. F. Perz, M. M. Parker, R. Hallack, R. Stricof, E. J. Clement, et al., “Multiple Clusters 

of Hepatitis Virus Infections Associated with Anesthesia for Outpatient Endoscopy Procedures,” 

Gastroenterology, vol. 139, no. 1 (2010): 163-170.
Appendix I: Blood-borne Pathogen Outbreaks 

Related to Unsafe Injection Practices in 

Ambulatory Care Settings, 2001-2011

Page 28 GAO-12-712 Unsafe Injection Practices

j

New York State Department of Health, 2007 Press Releases, statement by State Health 

Commissioner Richard F. Daines, M.D., November 14, 2007 (accessed June 26, 2012), 

http://www.health.state.ny.us/press/releases/2007/2007-11-14_daines_hep_c_statement.htm. New 

York State Department of Health, 2007 Press Releases, statement by State Health Commissioner 

Richard F. Daines, M.D., December 14, 2007 (accessed June 26, 2012), 

http://www.health.state.ny.us/press/releases/2007/2007-12-14_finkelstein_statement.htm. New York 

State Department of Health, unpublished data.

k

G. E. Fischer, M. K. Schaefer, B. J. Labus, L. Sands, P. Rowley, I. A. Azzam, et al., “Hepatitis C 

Virus Infections from Unsafe Injection Practices at an Endoscopy Clinic in Las Vegas, Nevada, 2007-

2008,” Clinical Infectious Diseases, vol. 51, no. 3 (2010): 267-273. Southern Nevada Health District, 

Outbreak of Hepatitis C at Outpatient Surgical Centers, Public Health Investigation Report (Las 

Vegas: 2009) accessed December 21, 2011, http://www.southernnevadahealthdistrict.org/hepcinvestigation/index.php. 

l

Z. S. Moore, M. K. Schaefer, K. K. Hoffmann, S. C. Thompson, X. Guo-Liang, Y. Lin, et al., 

“Transmission of Hepatitis C Virus During Myocardial Perfusion Imaging in an Outpatient Clinic,” 

American Journal of Cardiology, vol. 108 (2011): 126-132.

mFlorida Department of Health, unpublished data.

n

R. D. Greeley, S. Semple, N. D. Thompson, P. High, E. Rudowski, E. Handschur, et al., “Hepatitis B 

Outbreak Associated with a Hematology-Oncology Office Practice in New Jersey, 2009,” American 

Journal of Infection Control, vol. 39, no. 8 (2011): 663-670.

o

New York City Department of Health and Mental Hygiene, unpublished data.

p

E. Bancroft and S. Hathaway, “Hepatitis B Outbreak in an Assisted Facility,” in Los Angeles County 

Department of Public Health, Acute Communicable Diseases Program, Special Studies Report 2010, 

33-36, accessed June 26, 2012, 

http://publichealth.lacounty.gov/acd/reports/SpecialStudiesReport2010.pdf. 

q

W. Hellinger, L. Bacalis, R. Kay, and S. Lange, “Cluster of Healthcare Associated Hepatitis C Virus 

Infections Associated with Drug Diversion” [Abstract] (paper presented at the Society for Healthcare 

Epidemiology of America 2011 Annual Scientific Conference, Dallas, Tex. April 2004). W. C. 

Hellinger, L. P. Bacalis, R. S. Kay, N. D. Thompson, G. Xia, Y. Lin, Y. E. Khudyakov, and J. F. Perz, 

“Health Care-Associated Hepatitis C Virus Infections Attributed to Narcotic Diversion,” Annals of 

Internal Medicine. vol. 156, no. 7 (2012): 477-482. “2100 More Patients to Have Hep C Test,” 

News4Jax.com. September 20, 2010.

r

New York City Department of Health and Mental Hygiene, unpublished data.
Appendix II: Comments from the Department 

of Health and Human Services

Page 29 GAO-12-712 Unsafe Injection Practices

Appendix II: Comments from the Department 

of Health and Human Services
Appendix II: Comments from the Department 

of Health and Human Services

Page 30 GAO-12-712 Unsafe Injection Practices
Appendix II: Comments from the Department 

of Health and Human Services

Page 31 GAO-12-712 Unsafe Injection Practices
Appendix II: Comments from the Department 

of Health and Human Services

Page 32 GAO-12-712 Unsafe Injection Practices
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 33 GAO-12-712 Unsafe Injection Practices

Linda T. Kohn, (202) 512-7114 or kohnl@gao.gov

In addition to the contact named above, Will Simerl, Assistant Director; 

George Bogart; Leonard Brown; Rebecca Hendrickson; Krister Friday; 

Eric Peterson; and Pauline Seretakis made key contributions to this 

report.

Appendix III: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(290999)
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