FDA Inspection Reveals Red Cross Violated More Than 200 Federal Blood Safety Laws
The FDA on Friday announced that an inspection revealed that the American Red Cross may have violated more than 200 federal blood safety laws, including being unable to account for "small amounts" of blood infected with HIV and human cytomegalovirus, the Los Angeles Times reports. The 45-page inspection report is the latest information since last year, when a federal court ordered the Red Cross to correct systemic problems from the 10 previous years (Ornstein/Garvey, Los Angeles Times, 12/21). The report identifies violations including lack of management control and quality assurance oversight; data integrity; failure to correct violations from previous inspections, including failure to follow standard operating procedures; and release of "unsuitable" products, the AP/Baltimore Sun reports. The inspectors also said that the Red Cross failed to "screen out" people who were not qualified to donate blood (AP/Baltimore Sun, 12/21). In addition, the agency said that the Red Cross could not account for blood supplies tainted with HIV and human cytomegalovirus, an infection that is "potentially fatal" for infants born to recently infected women and "dangerous" for people with weakened immune systems. The FDA also found evidence of employees falsifying records and shipping orders without carrying out blood testing, including blood labeled as "unsuitable" that was shipped despite the required testing. The agency has had "long-standing problems" with the Red Cross, the Times reports. Last year, a federal judge found the Red Cross in contempt of court for "persistent and serious violations" of blood safety rules, and the FDA said after the ruling that monetary penalties were "the only way to prod the Red Cross into making improvements" (Los Angeles Times, 12/21).
FDA Commissioner Mark McClellan said that the nation's blood supply "is not as safe as it should be"; however, the FDA stressed that people who donate blood are not at risk. "I am troubled by apparent lapses in blood safety," McClellan said (Meckler, AP/Nando Times, 12/20). While the Red Cross acknowledged "some shortcomings," the organization said it had already invested $280 million to improve blood supply safety (Los Angeles Times, 12/21). The Red Cross also said early last week that improvements had been made in recent months, additional staff had been hired and computer systems had been upgraded to improve quality and decrease human error (AP/Baltimore Sun, 12/21). According to Ramesh Thadani, the organization's executive vice president and CEO of biomedical services, "The Red Cross understands more work needs to be done to further strengthen our processes and procedures, and we are fully committed to working collaboratively with the FDA to enhance our system" (Los Angeles Times, 12/21).