Patient Safety: HHS Has Taken Steps to Address Unsafe Injection Practices, but More Action Is Needed
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.
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.
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.
Recommendations for Executive Action
|Department of Health and Human Services||To help strengthen HHS efforts aimed at protecting patients from infection by preventing unsafe injection practices in ambulatory care settings, the Secretary of HHS should 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.||
In collaboration with CDC, CMS resumed collection of Infection Control Surveyor Worksheets for a random sample of ASCs for fiscal years 2013 and 2016. With these data, CMS and CDC intend to monitor ASC compliance with regards to safe injection practices and determine the extent of such practices in the United States.
|Department of Health and Human Services||To help strengthen HHS efforts aimed at protecting patients from infection by preventing unsafe injection practices in ambulatory care settings, the Secretary of HHS should 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.||
CDC and CMS have implemented this recommendation by using the data collected on unsafe injection practices at ambulatory surgical centers (ASC), working within data limitations. CMS and CDC first collected data for fiscal year 2013 and identified data limitations, but were able to use the data to improve monitoring activities, improve training, improve prevention activities, and improve outbreak investigations. CMS and CDC also revised the data collection tools and process for the fiscal year 2016 data collection period, and examined these data with the intent to use it for monitoring trends in the prevalence of unsafe practices over time, despite ultimately determining that data limitations prevented trend analysis.
|Department of Health and Human Services||To help strengthen HHS efforts aimed at protecting patients from infection by preventing unsafe injection practices in ambulatory care settings, the Secretary of HHS should 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.||
In response to GAO's recommendation CDC has expanded the reach of the One and Only Campaign, including to many types of outpatient settings that are not typically subject to CMS oversight. For example, CDC reports that since 2014 the number of states that receive funding through the Campaign to promote safe injection practices has increased and these states have reached out to settings not typically overseen by CMS, including plastic surgery settings and physician offices. Additionally, according to CDC, in 2015 the Campaign accomplished its goals of distributing materials and outreach, as it distributed 15 percent more materials than it did in 2014 and reached more than 6,500 attendees at conferences, trainings, and presentations. CDC has also developed setting specific materials for the One and Only Campaign, such as a poster that educates clinicians in pain clinics about safe injection practices. As a result of these efforts, CDC has improved its educational efforts targeted to health care settings that experience infection outbreaks but are not subject to CMS oversight.