FDA found problems at Red Cross' new blood centers in Philly and N.C.

Eighteen months ago, the American Red Cross finished setting up new centers in Philadelphia and Charlotte, N.C., to consolidate a crucial part of its blood business - making sure donated blood is safe and recalling it if there is any doubt.

By consolidating these duties, which had been performed in each of 35 regional offices, the Red Cross hoped to increase compliance with government safety rules, streamline operations, and reduce costs.

But the Food and Drug Administration's first - and so far only - inspection last fall found dysfunction and disorder at the new centers.

Both sites had "chronic" understaffing, inadequate training, quality-assurance lapses, and ineffective management, even though the consolidation had been done gradually over two years ending in March 2010, according to inspectors for the FDA, which regulates the collection and screening of blood.

The Red Cross says it has since addressed many of the problems at the new "donor and client support centers."

"The Red Cross and the FDA share a common goal of the safest blood supply possible," Red Cross officials wrote in answer to Inquirer questions submitted to spokesman Roger K. Lowe. "We have made significant progress in improving our regulatory compliance" through "system-wide changes to our donor management operations."

The FDA declined to discuss the inspection report, the possibility of fines, or when it would reinspect the support centers. Inspections are done annually but are unannounced; the report was obtained through a Freedom of Information Act request and is being publicized here for the first time.

Since 1993, the Red Cross has been under a federal court order to improve the way it collects, processes, and tracks blood. The order, called a consent decree, was amended in 2003. Since then, the FDA has fined the Red Cross $37 million for persistent lapses.

Examples of progress

The nonprofit, which has to cover its expenses with revenues, says the fines have added about 50 cents per blood product to the 76 million units it has sold over the last eight years.

Although she would not comment on the inspection report, Mary Malarkey, an FDA compliance office director, said the Red Cross had made progress toward complying with the consent decree.

"Standardization and consolidation of testing labs and improved oversight of the biomedical headquarters are examples of progress we've seen," Malarkey said.

"There is still work to be done," she said. "The progress has been slow."