Patient Safety:

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

GAO-12-712: Published: Jul 13, 2012. Publicly Released: Aug 3, 2012.

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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.

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.

For more information, contact Linda T. Kohn at (202) 512-7114 or kohnl@gao.gov.

Status Legend:

More Info
  • Review Pending-GAO has not yet assessed implementation status.
  • Open-Actions to satisfy the intent of the recommendation have not been taken or are being planned, or actions that partially satisfy the intent of the recommendation have been taken.
  • Closed-implemented-Actions that satisfy the intent of the recommendation have been taken.
  • Closed-not implemented-While the intent of the recommendation has not been satisfied, time or circumstances have rendered the recommendation invalid.
    • Review Pending
    • Open
    • Closed - implemented
    • Closed - not implemented

    Recommendations for Executive Action

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: On October 12, 2012, HHS noted that CDC plans to work closely with CMS to resume collection of data on unsafe injection practices from the Ambulatory Surgery Center (ASC) Infection Control Surveyor Worksheet, and strive to implement timely and accurate electronic transmission of these data for inclusion in a centralized database. CDC also plans to explore options for alternate sources of comparable data. In May 2013, CDC noted that the agency continues to work closely with CMS to resume data collection. Specifically, CMS is collecting data for a representative sample of facility surveys conducted in FY2013 and plans to make these data available to CDC for analysis when they are ready. CMS plans to collect data from a representative sample of ASCs every two years thereafter.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: On October 12, 2012, HHS noted that CDC plans to work closely with CMS to examine the collected data on unsafe injection practices from the ASC Infection Control Surveyor Worksheets. CDC also plans to develop state and local health department capabilities to recognize and respond to potential outbreaks stemming from unsafe injection practices. In May 2013, CDC noted that the agency continues to work with CMS to analyze data on unsafe injection practices collected from the ASC Infection Control Surveyor Worksheets. Specifically, CDC has obtained FY2010 and FY2011 survey data from CMS and is in the final stage of data analysis. CDC plans to begin data analysis on the FY2013 data once it is received. Additionally, CDC is also examining ways to strengthen state and local capacity to recognize and respond to potential outbreaks in outpatient settings.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services

    Status: Open

    Comments: On October 12, 2012, HHS noted that CDC is increasingly focused the One and Only Campaign to engage clinicians in the types of health care settings that CDC has identified as having a bloodborne pathogen outbreak related to an unsafe injection practice, including those facilities that are not subject to CMS oversight, such as gastroenterology practices, interventional pain clinics, and outpatient oncology clinics. To communicate with these groups, CDC is building relationships with several professional medical and nursing societies and other partners to inform and engage them in promoting safe injection practices and producing communication pieces that are available to anyone interested in promoting the One and Only Campaign. In May 2013, CDC noted that it continues to accelerate targeted engagement with affected clinical specialties that may have bloodborne pathogen outbreaks related to unsafe injection practices, expand communication efforts, and fund state health departments to disseminate One and Only Campaign materials to priority settings.

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