The FDA fined American Red Cross a record $4.2 million for improper screening of potential blood donors and also for other safety problems.
The Food and Drug Administration yesterday disclosed the fine amount which follows $5.7 million in previous fines since 2003, calling attention to a disturbing pattern of quality control failures.
The Red Cross is a humanitarian organization which depends heavily on volunteers, handles about 45 percent of the nation's blood supply. The Red Cross follows FDA rules for the identification as well as barring of donors with infectious diseases like AIDS, West Nile viral disease, the human form of mad cow disease, etcetera.
The Red Cross was made to remove around 12,000 units of questionable blood and blood products from its shelves. Following this they voluntarily recalled it from hospitals and treatment centers across the nation. According to the FDA, the recalls ``were preventable."
None of the recalled units had any evidence of contamination with a transmissible infectious agent. However the agency did acknowledge that in such voluntary blood recalls patients who received blood from batches that were later recalled were not routinely tracked.
A 2003 consent decree governs the Red Cross which permits the FDA to levy significant fines for failure of compliance with federal regulations. The organization said it takes the fine ``seriously" and ``is committed to full compliance."
Margaret Glavin, FDA's associate commissioner for regulatory affairs said, ``It is not acceptable that the quality system has failed in this way." The agency did order the Red Cross to review the quality-control breaches that have occurred and to take actions to ensure that it is not repeated.
The Red Cross has said that it would respond to the FDA concerns that they received on Thursday, within 20 days.
Usually blood centers ask donors a series of questions to screen out people with actual or potential blood-borne infections that could be passed to people who receive blood donations after accidents, surgeries, and childbirth.
The Red Cross erred at this point by accepting blood from donors who had not completely filled out questionnaires. Dr. Jay Epstein, director of the FDA's Office of Blood Research and Review said that by failing to check the donor's travel history, for instance, the Red Cross opened the ``remote" possibility of donation by people who would normally be deferred.
These could have included donors who had lived in England when mad cow infection rates rose in animals and spread to humans, and donors who had traveled to regions where malaria risks were high.
Besides this the Red Cross also distributed blood products despite incomplete or problem results from laboratory tests for infections like hepatitis B that the centers run to certify blood donations are safe before use.
Susan Bro, an FDA spokeswoman said, the fine was driven by the number of units of blood the Red Cross voluntarily recalled, but also serves ``as an incentive to address the issues."