Veterans' Health Care: Oversight of Tissue Product Safety

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Testimony issued by the Government Accountability Office with an abstract that begins "Data from the Veteran's Health Administration (VHA), within the Department of Veterans Affairs (VA), do not show evidence of VHA receiving contaminated tissue products, although, it is difficult to link adverse events in recipients to such products. VA's National Center for Patient Safety (NCPS), which began operation in 1999, has not issued any patient safety alerts—mandates for action to address actual or potential threats to life or health—or advisories—guidance to address issues such as equipment design and product failure—related to tissue products potentially received by VA medical centers ... continued below

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United States. Government Accountability Office. April 2, 2014.

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Testimony issued by the Government Accountability Office with an abstract that begins "Data from the Veteran's Health Administration (VHA), within the Department of Veterans Affairs (VA), do not show evidence of VHA receiving contaminated tissue products, although, it is difficult to link adverse events in recipients to such products. VA's National Center for Patient Safety (NCPS), which began operation in 1999, has not issued any patient safety alerts—mandates for action to address actual or potential threats to life or health—or advisories—guidance to address issues such as equipment design and product failure—related to tissue products potentially received by VA medical centers (VAMC) in the last 10 years. NCPS issues patient safety alerts and advisories for recalls that require specific clinical actions to ensure patient safety. Since NCPS began issuing and recording data on recalls in November 2008, NCPS has notified VAMCs of 13 recalls for tissue products from vendors from which VHA could have received affected products—none of these recalls have resulted in patient safety alerts or advisories. For 6 of the recalls, 27 VAMCs reported to NCPS that they had identified and removed the recalled products from their inventories. For the other 7 recalls, none of the VAMCs had the affected tissue products in their inventories. The 13 recalls were not issued for known tissue product contamination. Instead, most were initiated because of the possibility of contamination, such as compromise of product sterility and incomplete donor records. Further, VHA officials told us that their analysis of VHA data found no evidence of reported adverse events among VHA patients that were caused by contaminated tissue products. According to officials from the Food and Drug Administration (FDA), post-surgical infections often occur, even in the absence of tissue use, and it is often not possible to definitively attribute such infections to a tissue product."

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Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

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  • April 2, 2014

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  • June 12, 2014, 7:50 p.m.

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United States. Government Accountability Office. Veterans' Health Care: Oversight of Tissue Product Safety, text, April 2, 2014; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc302464/: accessed May 20, 2018), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.