Not all ambulatory care settings are subject to CMS’s health and safety  standards. 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. 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. 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. 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. Clinicians and health care facilities. 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. 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. 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. 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. 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. 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. 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. Recommendations for Executive Action

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 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.
Why GAO Did This Study

Recent outbreaks of blood-borne pathogens--specifically hepatitis B and C--that were linked to a specific health care facility or clinician have resulted when clinicians use unsafe injection practices. Such infections can have serious long-term consequences for patients, including cirrhosis or liver cancer. Of the known incidents of blood-borne pathogen outbreaks attributed to unsafe injection practices--which include reusing syringes for multiple patients--most have occurred in ambulatory care settings, such as ASCs and physician offices. CMS oversees injection practices by setting and enforcing health and safety standards that apply to ASCs but not physician offices. GAO was asked to examine (1) available information on the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings, (2) the changes in federal oversight to prevent unsafe injection practices in ambulatory care settings since 2009, and (3) other federal efforts to improve injection safety practices in ambulatory care settings. GAO reviewed CDC and CMS documentation and CDC data, and interviewed officials from various HHS agencies and other stakeholders.

What GAO Found

Data on the extent and cost of blood-borne pathogen outbreaks related to unsafe injection practices in ambulatory care settings are limited and likely underestimate the full extent of such outbreaks. An agency within the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), collects data on outbreaks identified by state and local health departments. These data show that from 2001 through 2011, there were at least 18 outbreaks of viral hepatitis associated with unsafe injection practices in ambulatory settings, such as physician offices or ambulatory surgical centers (ASC). CDC officials and others believe that the known outbreaks do not represent the full extent of such outbreaks for a number of reasons, such as infections often being difficult to detect and trace to specific health care facilities. Additionally, comprehensive data on the cost of blood-borne pathogen outbreaks to the health care system do not exist, but CDC and other officials believe these costs can be substantial for those affected. For example, individuals may face treatment costs and health departments may face costs for investigating and notifying patients of potential exposure to infection.
Another HHS agency, the Centers for Medicare & Medicaid Services (CMS), has expanded its oversight of unsafe injection practices in ASCs since 2009 by requiring surveyors who inspect these facilities to use its Infection Control Surveyor Worksheet to document the extent to which ASCs are following safe injection practices and to survey more facilities to determine compliance with CMS's health and safety standards. Safe injection practices are included under several of CMS's broader health and safety standards that also address a number of other topics related to infection control and medication administration. As part of implementing the expanded oversight of ASCs, CMS collected and plans to analyze detailed information from these surveyor worksheets for fiscal years 2010 and 2011. This information will be used to assess CMS's oversight efforts to improve infection control and also allow CDC--with which CMS shared its data--to determine a baseline assessment of the extent of unsafe injection practices in ASCs nationally. However, in part because of concerns that collecting these data is a burden to surveyors, CMS officials said the agency stopped collecting data from surveyor worksheets after fiscal year 2011. Without some form of continued collection and analysis of injection safety data, CMS will lose its capacity to oversee how well surveyors monitor unsafe injection practices, and CDC will be unable to determine the extent of these practices.
To improve injection practices, various HHS agencies have taken steps to communicate information on safe injection practices to clinicians. For example, CDC has developed tools to communicate its evidence-based guidelines to clinicians in ambulatory care settings. In partnership with other health-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.

What GAO Recommends

GAO recommends that HHS (1) resume collecting data on unsafe injection practices that will permit continued monitoring of such practices, (2) use those data for continued monitoring of ASCs, and (3) strengthen the targeting efforts of the One and Only Campaign for health care settings not overseen by CMS. HHS agreed with GAO's recommendations.