oversight

Patient Safety: HHS Has Taken Steps to Address Unsafe Injection Practices, but More Action Is Needed

Published by the Government Accountability Office on 2012-07-13.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                             United States Government Accountability Office

GAO                          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




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GAO-12-712
                                             July 2012

                                             PATIENT SAFETY
                                             HHS Has Taken Steps to Address Unsafe Injection
                                             Practices, but More Action Is Needed
Highlights of GAO-12-712, a report to the
Ranking Member, Subcommittee on Health,
Committee on Energy and Commerce, House
of Representatives



Why GAO Did This Study                       What GAO Found
Recent outbreaks of blood-borne              Data on the extent and cost of blood-borne pathogen outbreaks related to unsafe
pathogens—specifically hepatitis B and       injection practices in ambulatory care settings are limited and likely
C—that were linked to a specific health      underestimate the full extent of such outbreaks. An agency within the
care facility or clinician have resulted     Department of Health and Human Services (HHS), the Centers for Disease
when clinicians use unsafe injection         Control and Prevention (CDC), collects data on outbreaks identified by state and
practices. Such infections can have          local health departments. These data show that from 2001 through 2011, there
serious long-term consequences for           were at least 18 outbreaks of viral hepatitis associated with unsafe injection
patients, including cirrhosis or liver       practices in ambulatory settings, such as physician offices or ambulatory surgical
cancer. Of the known incidents of
                                             centers (ASC). CDC officials and others believe that the known outbreaks do not
blood-borne pathogen outbreaks
                                             represent the full extent of such outbreaks for a number of reasons, such as
attributed to unsafe injection
practices—which include reusing
                                             infections often being difficult to detect and trace to specific health care facilities.
syringes for multiple patients—most          Additionally, comprehensive data on the cost of blood-borne pathogen outbreaks
have occurred in ambulatory care             to the health care system do not exist, but CDC and other officials believe these
settings, such as ASCs and physician         costs can be substantial for those affected. For example, individuals may face
offices. CMS oversees injection              treatment costs and health departments may face costs for investigating and
practices by setting and enforcing           notifying patients of potential exposure to infection.
health and safety standards that apply
to ASCs but not physician offices. GAO       Another HHS agency, the Centers for Medicare & Medicaid Services (CMS), has
was asked to examine (1) available           expanded its oversight of unsafe injection practices in ASCs since 2009 by
information on the extent and cost of        requiring surveyors who inspect these facilities to use its Infection Control
blood-borne pathogen outbreaks               Surveyor Worksheet to document the extent to which ASCs are following safe
related to unsafe injection practices in     injection practices and to survey more facilities to determine compliance with
ambulatory care settings, (2) the            CMS’s health and safety standards. Safe injection practices are included under
changes in federal oversight to prevent      several of CMS’s broader health and safety standards that also address a
unsafe injection practices in                number of other topics related to infection control and medication administration.
ambulatory care settings since 2009,         As part of implementing the expanded oversight of ASCs, CMS collected and
and (3) other federal efforts to improve     plans to analyze detailed information from these surveyor worksheets for fiscal
injection safety practices in ambulatory
                                             years 2010 and 2011. This information will be used to assess CMS’s oversight
care settings. GAO reviewed CDC and
                                             efforts to improve infection control and also allow CDC—with which CMS shared
CMS documentation and CDC data,
and interviewed officials from various       its data—to determine a baseline assessment of the extent of unsafe injection
HHS agencies and other stakeholders.         practices in ASCs nationally. However, in part because of concerns that
                                             collecting these data is a burden to surveyors, CMS officials said the agency
What GAO Recommends                          stopped collecting data from surveyor worksheets after fiscal year 2011. Without
                                             some form of continued collection and analysis of injection safety data, CMS will
GAO recommends that HHS
                                             lose its capacity to oversee how well surveyors monitor unsafe injection
(1) resume collecting data on unsafe
                                             practices, and CDC will be unable to determine the extent of these practices.
injection practices that will permit
continued monitoring of such practices,
(2) use those data for continued             To improve injection practices, various HHS agencies have taken steps to
monitoring of ASCs, and (3) strengthen       communicate information on safe injection practices to clinicians. For example,
the targeting efforts of the One and         CDC has developed tools to communicate its evidence-based guidelines to
Only Campaign for health care settings       clinicians in ambulatory care settings. In partnership with other health-care-
not overseen by CMS. HHS agreed              related organizations, CDC also developed an educational campaign—the One
with GAO’s recommendations.                  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
View GAO-12-712. For more information,
contact Linda T. Kohn at (202) 512-7114 or
                                             outbreak related to unsafe injection practices, additional targeted outreach is
kohnl@gao.gov.                               needed for health care settings not overseen by CMS.

                                                                                        United States Government Accountability Office
Contents


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 Blood-
                        borne Pathogen Outbreaks in Ambulatory Care Settings,
                        2001 through 2011                                                 11




               Page i                                    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



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Page ii                                              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 Blood-borne pathogen infections from health
                                   care settings are preventable if clinicians use safe injection practices,



                                   1
                                    The Centers for Disease Control and Prevention defines a health-care-associated blood-
                                   borne 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.
                                   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 1                                             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 2                                               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 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.

Starting in 2008, GAO released a series of reports examining efforts to
prevent HAIs in hospitals and ASCs in the United States. 7 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

1. available information on the extent and cost of blood-borne pathogen
   outbreaks in ambulatory care settings related to unsafe injection
   practices,

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 Health-
Care-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 3                                                 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 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.

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. 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 blood-
borne pathogen outbreaks from 2001 through 2011, specifically ASCs
and physician offices. 10 We also interviewed CMS officials about related



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.
9
See GAO-09-213.
10
  Additional 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 4                                                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 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.

             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.

             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
Background   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


             11
               Specifically, 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.




             Page 5                                            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 Additionally, CDC also helps to provide assistance to state
and local health departments in their investigations of possible blood-
borne pathogen outbreaks resulting from unsafe injection practices, and
maintains information on blood-borne pathogen outbreaks.

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. 15 An ASC must be certified or deemed
through accreditation as meeting these standards in order to participate in



12
  Representatives 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.
13
  See 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.
14
  In 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.
15
  See 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 6                                                  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
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.

Not all ambulatory care settings are subject to CMS’s health and safety
standards. 19 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


16
  CMS 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.
17
  Depending 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.
18
  See 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.
19
  With respect to ambulatory care settings not subject to CMS’s oversight, states may
provide some degree of oversight of injection practices.




Page 7                                                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




20
  Medicare 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.
21
  See, 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).
22
  See 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 8                                              GAO-12-712 Unsafe Injection Practices
                             Data on the extent of blood-borne pathogen outbreaks related to unsafe
Limited Data Are             injection practices in ambulatory care settings are limited and likely
Available on the             underestimate the full extent of such outbreaks. Additionally,
                             comprehensive data on the cost of blood-borne pathogen outbreaks to
Extent and Cost of           the health care system do not exist, but CDC and other officials believe
Blood-borne Pathogen         these costs can be substantial for those affected by such outbreaks,
Outbreaks Resulting          including individuals, state and local health departments, and clinicians
                             and health care facilities.
from Unsafe Injection
Practices in
Ambulatory Care
Settings
Available Data Are Limited   According to CDC officials and others we interviewed, there are relatively
and Likely Underestimate     few sources of information available on the extent of blood-borne
the Full Extent of Blood-    pathogen outbreaks resulting from unsafe injection practices in
                             ambulatory care settings, and these data likely underestimate the full
borne Pathogen Outbreaks     extent of such outbreaks. Specifically, CDC tracks and keeps records of
in Ambulatory Care           reported blood-borne pathogen outbreaks related to unsafe injection
Settings                     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 (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


                             23
                               For 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.




                             Page 9                                                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 hematology-
oncology 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.




24
  Additionally, 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 10                                              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           Number of                                                            Years of         Type of
led to outbreak                        outbreaks Settings                             States               outbreaks         infection
Syringe reuse or suspected reuse                16 Alternative medicine clinic, CA, FL, NE,               2001, 2002,        Hepatitis C,
that contaminated medication vials                 cardiology clinic, endoscopy NV, NY, NC,               2003, 2005,        hepatitis B, or
or saline bags, and syringe reuse                  clinic, hematology-oncology OK                         2006, 2007,        both
from one patient to another or                     clinic, hospital-based                                 2008, 2009,
from clinician to patient                          outpatient radiology clinic,                           2010, 2011
                                                   hospital-outpatient pain
                                                   management clinic,
                                                   outpatient surgery clinic,
                                                   pain management clinic,
                                                   physician office
Medication reuse, such as the use               12 Alternative medicine clinic, CA, FL, NE,               2002, 2005,        Hepatitis C,
of saline bags or single-dose vials                cardiology clinic, endoscopy NV, NJ, NY,               2006, 2007,        hepatitis B, or
for more than one patient, or multi-               clinic, hematology-oncology NC                         2008, 2009,        both
dose vials used for multiple                       clinic, outpatient surgery                             2010, 2011
patients without appropriate                       clinic, pain management
infection control practices                        clinic, physician office
Other infection control lapses,                  9 Alternative medicine clinic,       CA, FL, NJ,         2001, 2005,        Hepatitis C,
such as mishandling of medication                  hematology-oncology clinic,        NY                  2009, 2010         hepatitis B, or
vials or medication preparation,                   pain management clinic,                                                   both
such as preparing medication in                    physician office
contaminated environment or
failure to store or prepare
medication in aseptic conditions
                                           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 11                                                    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 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




25
  Institute 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).
26
  In 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 12                                             GAO-12-712 Unsafe Injection Practices
                              about 68 percent were cited for at least one lapse in basic infection
                              control. 27


Comprehensive Data on         According to CDC officials and others we contacted, while the financial
the Costs to the U.S.         costs to the health care system of blood-borne pathogen outbreaks
Health Care System of         related to unsafe injection practices can be substantial, there are no
                              comprehensive data on the total costs attributed to such outbreaks. CDC
Blood-borne Pathogen          officials said that assessing such costs is difficult because the costs are
Outbreaks from Unsafe         borne by different groups—for example, individuals, state and local health
Injection Practices Are Not   departments, and clinicians and health care facilities—and the costs are
Available                     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 long-
                                   term 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



                              27
                                This 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.




                              Page 13                                              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




28
  See 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-nevada-
lawsuits-139856843.html.
29
  See, Indictment, State of Nevada v. Desai, No. 10C265107 (Dist. Ct. Clark County,
June 4, 2010).




Page 14                                             GAO-12-712 Unsafe Injection Practices
                         In 2009, CMS substantially expanded its oversight of unsafe injection
CMS Has Increased        practices in ASCs by increasing both the intensity of the examination of
Oversight of Injection   safe injection and other infection control practices and the number of on-
                         site surveys conducted in ASCs to determine compliance with CMS’s
Practices in ASCs, but   health and safety standards. Within these health and safety standards,
Its Decision to Stop     those relating to infection control specifically require ASCs to maintain an
Data Collection Will     infection control and prevention program designed to minimize the
                         occurrences of HAIs, such as blood-borne pathogen infections resulting
Limit Effectiveness      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




                         30
                           See 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.
                         31
                           The 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.
                         32
                           CMS 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.




                         Page 15                                               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.




33
  For 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.
34
  This was done in response to a 2009 GAO recommendation. See GAO-09-213 for more
information.




Page 16                                            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 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


35
  Although 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.




Page 17                                             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
HHS Communicates          have developed efforts to communicate information on these practices to
Information on Safe       clinicians since our last report on HAIs was released in 2009. For
                          example, to expand awareness and understanding of CDC’s guidelines
Injection Practices to    for infection control, CDC released tools targeted to specific health care
Clinicians, but Efforts   settings in 2011. These tools include a summary guide for ambulatory
Do Not Target Certain     care settings with an accompanying checklist and an infection control and
                          prevention plan specifically for outpatient oncology centers, both of which
Higher-Risk Settings      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-care-
                          related 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




                          36
                            As noted in GAO-09-213, results reported from smaller random samples are less
                          precise, but they can still produce nationally representative information.
                          37
                            See 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-control-
                          prevention-plan-2011/index.html.




                          Page 18                                           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
Foundation 40—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




38
  FDA 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.
39
  From 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).
40
  Since 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.
41
  In 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 19                                                GAO-12-712 Unsafe Injection Practices
awareness of safe injection practices. 42 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.

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


42
  CDC 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 20                                             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 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.

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. 45 Specifically, in
this next phase, HHS addresses prevention of blood-borne pathogen
outbreaks related to unsafe injection practices and other HAIs in ASCs




43
  Additionally, 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.
44
  According 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.
45
  HHS, 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 21                                              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 evidence-
              based 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
Conclusions   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


              46
                The 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.




              Page 22                                              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 23                                       GAO-12-712 Unsafe Injection Practices
                      To help strengthen HHS efforts aimed at protecting patients from infection
Recommendations for   by preventing unsafe injection practices in ambulatory care settings, we
Executive Action      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
Agency Comments       written comments, which are reprinted in appendix II. In its comments,
and Our Evaluation    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


                      Page 24                                    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




Page 25                                     GAO-12-712 Unsafe Injection Practices
Appendix I: Blood-borne Pathogen Outbreaks
                                                   Appendix I: Blood-borne Pathogen Outbreaks
                                                   Related to Unsafe Injection Practices in
                                                   Ambulatory Care Settings, 2001-2011


Related to Unsafe Injection Practices in
Ambulatory Care Settings, 2001-2011

                                                              Number of       Number of
                                     Type of                 individuals     individuals
Setting (state)                 Year infection                  notified        infected Infection control lapses
Endoscopy clinic                2001 Hepatitis C                  2,009               19 Suspected syringe reuse contaminating
     a
(NY)                                                                                     medication vials
                        b
Physician office (NY)           2001 Hepatitis B                  1,042               38 Mishandling of medication vials and injection
                                                                                         equipment; medication preparation in
                                                                                         contaminated environment
Hospital outpatient             2002 Hepatitis C,                   908              102 Overt syringe reuse from one patient to another
pain management                      hepatitis B, or
           c
clinic (OK)                          both
Hematology-oncology             2002 Hepatitis C                    613               99 Syringe reuse contaminating saline bags used
           d
clinic (NE)                                                                              as a source of flush for more than one patient
Endoscopy clinic                2002 Hepatitis C                  1,199                4 Suspected needle or syringe reuse
     e
(NY)                                                                                     contaminating medication vials
Ambulatory surgical             2003 Hepatitis C                     52                4 Suspected syringe reuse contaminating
center (pain                                                                             medication vials
management clinic)
     f
(CA)
Alternative medicine            2005 Hepatitis B                    253                7 Mishandling of medication vials; failure to
           g
clinic (FL)                                                                              prepare and store intravenous infusions under
                                                                                         aseptic conditions
Alternative medicine            2005 Hepatitis C                     15                7 Reuse of syringes, resulting in contamination of
           h
clinic (CA)                                                                              a saline bag used for more than one patient
Endoscopy and                   2006 Hepatitis C,                 4,490               12 Suspected syringe reuse contaminating
outpatient surgery                   hepatitis B, or                                     medication vials; use of single-dose vials of
            i
clinics (NY)                         both                                                propofol for more than one patient
Pain management                 2007 Hepatitis C                  9,000                3 Syringe reuse contaminating medication vials;
clinic and physician                                                                     use of single-dose vials of contrast (and
            j
office (NY)                                                                              possible Ketorolac) for more than one patient
Ambulatory surgical             2008 Hepatitis C                 63,000                9 Syringe reuse contaminating medication vials;
centers (endoscopy                                                                       use of single-dose vials of propofol for more
             k
clinics) (NV)                                                                            than one patient
                            l
Cardiology clinic (NC)          2008 Hepatitis C                  1,205                5 Suspected syringe reuse contaminating multi-
                                                                                         dose vials of saline used for more than one
                                                                                         patient
Alternative medicine            2009 Hepatitis C                    163                9 Syringe reuse contaminating medication vials;
           m
clinic (FL)                                                                              mishandling of medication preparation; use of
                                                                                         single-dose vials of magnesium sulfate for more
                                                                                         than one patient
Hematology-oncology             2009 Hepatitis B                  4,600               29 Mishandling of medication vials; medication
           n
clinic (NJ)                                                                              preparation in contaminated environment;
                                                                                         common-use saline bag for multiple patients;
                                                                                         use of single-dose vials for more than one
                                                                                         patient




                                                   Page 26                                           GAO-12-712 Unsafe Injection Practices
                                          Appendix I: Blood-borne Pathogen Outbreaks
                                          Related to Unsafe Injection Practices in
                                          Ambulatory Care Settings, 2001-2011




                                                        Number of                 Number of
                            Type of                    individuals               individuals
Setting (state)        Year infection                     notified                  infected Infection control lapses
Endoscopy clinics      2009 Hepatitis C                        3,287                             2 Suspected syringe reuse contaminating
     o
(NY)                                                                                               medication vials; use of single-dose vials of
                                                                                                   propofol for more than one patient
Pain management        2010 Hepatitis C,                       2,293                             2 Syringe reuse contaminating medication vials;
           p
clinic (CA)                 hepatitis B, or                                                        use of single-dose vials of contrast, lidocaine,
                            both                                                                   and sodium bicarbonate for more than one
                                                                                                   patient; failure to use aseptic technique when
                                                                                                   accessing medication vials
Hospital-based         2010 Hepatitis C                        3,929                             5 Syringe reuse; narcotics diversion by clinician
outpatient radiology
           q
clinic (FL)
Pain management        2011 Hepatitis C                           466                            2 Suspected syringe reuse contaminating
           r
clinic (NY)                                                                                        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.




                                          Page 27                                                              GAO-12-712 Unsafe Injection Practices
Appendix I: Blood-borne Pathogen Outbreaks
Related to Unsafe Injection Practices in
Ambulatory Care Settings, 2001-2011




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/hepc-
investigation/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.
m
    Florida 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.




Page 28                                                     GAO-12-712 Unsafe Injection Practices
Appendix II: Comments from the Department
             Appendix II: Comments from the Department
             of Health and Human Services



of Health and Human Services




             Page 29                                     GAO-12-712 Unsafe Injection Practices
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
                  Appendix III: GAO Contact and Staff
                  Acknowledgments



Acknowledgments

                  Linda T. Kohn, (202) 512-7114 or kohnl@gao.gov
GAO Contact
                  In addition to the contact named above, Will Simerl, Assistant Director;
Staff             George Bogart; Leonard Brown; Rebecca Hendrickson; Krister Friday;
Acknowledgments   Eric Peterson; and Pauline Seretakis made key contributions to this
                  report.




(290999)
                  Page 33                                     GAO-12-712 Unsafe Injection Practices
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