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

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.

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. 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. Blood-borne pathogen infections from health  care settings are preventable if clinicians use safe 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.

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. 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.

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). activities aimed at controlling and preventing health-care-associated  infections (HAI), including blood-borne pathogen infections, in ambulatory  care settings. 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   Given your prevent HAIs in hospitals and ASCs in the United States. 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  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. 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. 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. We also interviewed CMS officials about related  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. 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  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).

Limited Data Are Available on the Extent and Cost of Blood-borne Pathogen Outbreaks Resulting from Unsafe Injection Practices in Ambulatory Care Settings

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.

Available Data Are Limited and Likely Underestimate the Full Extent of Blood- borne Pathogen Outbreaks in Ambulatory Care Settings

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.

Comprehensive Data on the Costs to the U.S. Health Care System of Blood-borne Pathogen Outbreaks from Unsafe Injection Practices Are Not Available

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.

CMS Has Increased Oversight of Injection Practices in ASCs, but Its Decision to Stop Data Collection Will Limit Effectiveness

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.

HHS Communicates Information on Safe Injection Practices to Clinicians, but Efforts Do Not Target Certain Higher-Risk Settings

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.

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

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.

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

Appendix III: GAO Contact and Staff Acknowledgments

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.

Question: What data is available regarding the effects of blood-borne pathogen outbreaks in ambulatory care settings?

Answer: 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.

Question: How is the data collected?

Answer: 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.

Question: What does this data reveal?

Answer: 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).

Question: To what extent are these findings comprehensive?

Answer: 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.

Question: How has CMS expanded its injection oversight?

Answer: 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.

Question: How does CMS address safe injection practices?

Answer: 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.

Question: What data did CMS collect?

Answer: 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.

Question: How will the data be used?

Answer: 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.

Question: Why was data collection stopped?

Answer: 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.

Question: Why is the continued collection of data critical?

Answer: 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.

Question: How have HHS agencies taken steps to improve injection practices?

Answer: To improve injection practices, various HHS agencies have taken steps to communicate information on safe injection practices to clinicians.

Question: What steps has CDC taken?

Answer: 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.

Question: What are the limits of this campaign?

Answer: 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.