Indiana: Elkhart Hospital Accused of Violating Blood Rules

An Indiana hospital allegedly violated federal regulations by accepting blood last year from a donor who had previously tested positive for hepatitis C virus (HCV) antibodies. While two patients later received the donor's blood, hospital and federal officials said no one received infected blood, and no one became infected.

The donor tested positive for HCV antibodies in November 2007, said Gregory Losasso, Elkhart General Hospital's vice president of operations. The first blood test yielded a "false positive," meaning the donor no longer had the virus, and EGH deemed the blood safe for transfusion, Losasso said.

However, donors who test positive for HCV antibodies must be permanently banned from donating blood, a Food and Drug Administration (FDA) official warned in a letter to EGH's president, according to the South Bend Tribune. Instead, the person donated blood again in April and August of 2008, Losasso acknowledged.

EGH's only mistake was in allowing the HCV-positive donor to donate again five months after testing, rather than waiting for the six months required by federal regulations, Losasso said. However, FDA officials said any confirmatory testing for HCV itself is considered indeterminate when antibodies are present.

The hospital blood center's other FDA violations included not listing as unsuitable, donors who tested positive for HIV and hepatitis B. These donors had given blood for their own use. Most of the violations involved documentation and have now been resolved, Losasso said. The FDA letter said it was largely satisfied with the corrective measures.

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