CDC issues recommendations for clinicians to follow in order to prevent and control HAIs. CDC issues these recommendations in the form of evidence-based guidelines and other informal communications, such as clinical reminders, which are generally recognized as authoritative interpretations of the current scientific knowledge base regarding the prevention of HAIs. CDC develops these guidelines in collaboration with the Healthcare Infection Control Practices Advisory Committee (HICPAC)—a federal advisory committee that provides recommendations to the Secretary of HHS and to CDC and includes members from outside the federal government selected for their expertise on infection control. 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. 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. 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. 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). Medicare and qualify for Medicare facility payments. 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. Additionally, ASCs may choose to instead undergo accreditation by CMS-approved accrediting organizations that CMS has determined meet or exceed its standards. Facilities that are deemed as meeting CMS’s standards through this means are also eligible to participate in Medicare and receive facility payments. As part of this accreditation process, accrediting organizations conduct periodic on-site surveys to ensure that facilities meet their standards, including those related to infection control. Not all ambulatory care settings are subject to CMS’s health and safety standards. 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 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. 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. 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. 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). Data on the extent of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings are limited and likely underestimate the full extent of such outbreaks. Additionally, comprehensive data on the cost of blood-borne pathogen outbreaks to the health care system do not exist, but CDC and other officials believe these costs can be substantial for those affected by such outbreaks, including individuals, state and local health departments, and clinicians and health care facilities. According to CDC officials and others we interviewed, there are relatively few sources of information available on the extent of blood-borne pathogen outbreaks resulting from unsafe injection practices in ambulatory care settings, and these data likely underestimate the full extent of such outbreaks. Specifically, CDC tracks and keeps records of reported blood-borne pathogen outbreaks related to unsafe injection practices in the United States, which it identifies through state and local health departments seeking investigative assistance for potential outbreaks. According to CDC records, from 2001 through 2011, there were 18 known outbreaks—episodes of infection transmission where 2 or more patients became infected—of viral hepatitis associated with unsafe injection practices at ASCs and other ambulatory care settings in the United States. In these known outbreaks in ambulatory care settings, nearly 100,000 individuals were notified to seek testing for possible exposure to viral hepatitis and HIV, and 358 of them were infected with (See app. I for more comprehensive information on the viral hepatitis.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 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. 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. 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 the Institute of Medicine reports that about 65 to 75 percent of individuals infected with hepatitis are unaware that they are infected. 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. 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 about 68 percent were cited for at least one lapse in basic infection control. According to CDC officials and others we contacted, while the financial costs to the health care system of blood-borne pathogen outbreaks related to unsafe injection practices can be substantial, there are no comprehensive data on the total costs attributed to such outbreaks. CDC officials said that assessing such costs is difficult because the costs are borne by different groups—for example, individuals, state and local health departments, and clinicians and health care facilities—and the costs are often intermingled with other health care costs. However, various parties have developed estimates of some of the potential and actual costs associated with such outbreaks for each of these three groups. Individuals. For individuals who are notified that they are at risk of a blood-borne pathogen infection, costs may be incurred for testing. For example, in response to a large hepatitis C outbreak in Nevada— which required notification of more than 60,000 patients to seek blood-borne pathogen testing—the Southern Nevada Health Department estimated that the laboratory costs for testing all of the potentially exposed patients would be $13.8 million. Additionally, for individuals who are infected, costs include those for short- and 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 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. 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. In 2009, CMS substantially expanded its oversight of unsafe injection practices in ASCs by increasing both the intensity of the examination of safe injection and other infection control practices and the number of on- site surveys conducted in ASCs to determine compliance with CMS’s health and safety standards. Within these health and safety standards, those relating to infection control specifically require ASCs to maintain an infection control and prevention program designed to minimize the occurrences of HAIs, such as blood-borne pathogen infections resulting from unsafe injection practices, and have a qualified professional direct this program. 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. 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. 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. 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. 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. 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. 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 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. In order to help encourage safe injection practices, various HHS agencies have developed efforts to communicate information on these practices to clinicians since our last report on HAIs was released in 2009. For example, to expand awareness and understanding of CDC’s guidelines for infection control, CDC released tools targeted to specific health care settings in 2011. These tools include a summary guide for ambulatory care settings with an accompanying checklist and an infection control and prevention plan specifically for outpatient oncology centers, both of which provide basic infection prevention guidance and reaffirm adherence to CDC’s infection control guidelines, including those related to safe injection practices. 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 CDC. 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. 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—an independent, nonprofit organization that connects CDC with private-sector organizations and individuals to build public health programs. 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 awareness of safe injection practices.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 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. 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. 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. 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. 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. and end-stage renal disease facilities.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 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 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. To help strengthen HHS efforts aimed at protecting patients from infection by preventing unsafe injection practices in ambulatory care settings, we recommend that the Secretary of HHS take the following three actions: Direct CMS and CDC to work together to resume collecting data on unsafe injection practices from the Infection Control Surveyor Worksheet, or from any alternative source of comparable data, that will permit continued monitoring and assessment of unsafe injection practices in ASCs beyond fiscal year 2011. Direct CMS and CDC to use the data collected on unsafe injection practices for CMS to continue monitoring ASC compliance with health and safety standards related to infection control and for CDC to continue monitoring trends in the prevalence of unsafe injection practices in ASCs. Direct CDC to strengthen its targeting of the One and Only Campaign to health care settings that CDC has identified as having blood-borne pathogen outbreaks related to unsafe injection practices that are not overseen by CMS. We provided a draft of this report to HHS for review, and HHS provided written comments, which are reprinted in appendix II. In its comments, HHS concurred with our recommendations and stated that CMS and CDC have worked together to improve injection safety practices in ASCs, as well as other settings, such as dialysis facilities, nursing homes, and hospitals. HHS stated that CMS intends to resume collection of the Infection Control Surveyor Worksheet data beginning in fiscal year 2013 for a state-stratified, randomly selected subset of ASCs surveyed in that year and repeat this sampling and data collection approximately every 3 years thereafter. Additionally, HHS stated that CMS will use the data collected on unsafe injection practices to continue to monitor ASC compliance with the agency’s health and safety standards related to infection control. HHS also believes that the data it collects can be used to assess trends in injection practices in ASCs over time. Lastly, HHS stated that CDC supports targeting the outreach of the One and Only Campaign toward specific clinician groups and setting types, though the agency further noted that broad outreach also remains critical as demonstrated by the wide variety of settings where blood-borne pathogen outbreaks and unsafe injection practices have been identified. We agree that broad outreach is important and should be ongoing; however, additional targeted outreach to settings that are not overseen by CMS represents an opportunity to help focus available resources to reach 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. Number of individuals notified 3,287 2 Suspected syringe reuse contaminating medication vials; use of single-dose vials of propofol for more than one patient hepatitis B, or both 2 Syringe reuse contaminating medication vials; use of single-dose vials of contrast, lidocaine, and sodium bicarbonate for more than one patient; failure to use aseptic technique when accessing medication vials 5 Syringe reuse; narcotics diversion by clinician 2 Suspected syringe reuse contaminating medication vials; single-dose vials of propofol used for more than one patient Florida Department of Health, unpublished data. 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. New York City Department of Health and Mental Hygiene, unpublished data. 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. W. Hellinger, L. Bacalis, R. Kay, and S. Lange, “Cluster of Healthcare Associated Hepatitis C Virus Infections Associated with Drug Diversion” (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. New York City Department of Health and Mental Hygiene, unpublished data. In addition to the contact named above, Will Simerl, Assistant Director; George Bogart; Leonard Brown; Rebecca Hendrickson; Krister Friday; Eric Peterson; and Pauline Seretakis made key contributions to this report.

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