Blood supply scrutinized: FDA report cites more than 200 violations.

The American Red Cross is responding to federal findings of more than 200 blood safety violations by launching several initiatives and pledging to work with the Food and Drug Administration (FDA) to enhance blood safety.

A recently completed FDA inspection of records at American Red Cross (ARC) headquarters in Washington, D.C., found hundreds of blood safety violations at the organization, which supplies roughly half of the nation's blood.

ARC maintains that the nation's blood supply is "as safe as it has ever been," although it would not provide a spokesperson for further comments.

The FDA alleges in the report that ARC released unsuitable blood products, had problems with donor deferral, possibly falsified records, mislabeled blood products, and that headquarters failed to properly investigate all employee allegations of significant record keeping irregularities.

"The observations do raise serious concerns here at FDA," said FDA spokesman Jason Brodsky.

The report's observations are the latest in an ongoing attempt to fix systematic problems at ARC, which has been under a legally binding consent agreement for nearly 10 years.

ARC has spent hundreds of millions of dollars on a so-called "tranformation" project for the blood system that it declared completed several years ago. The "transformation" project has decreased the numbers of examples in areas the FDA views as needing improvement in the past decade, according to an ARC statement.

ARC officials aren't talking. A spokeswoman referred questions to a newly created Web site (bloodsafety.org) and previously posted statements.

Some of the report's preliminary findings are chilling.

In one case, an appropriate computer code wasn't assigned to a donor who tested positive for H1V because of a "bug" in the system. ARC provided a manual workaround, but the "bug" isn't currently scheduled for correction and could lead to the erroneous release of blood components, according to the FDA.

ARC doesn't perform thorough investigation of suspected post transfusion hepatitis as required in the Consent Decree, according to the FDA report. A total of 134 suspected post-transfusion hepatitis cases across 36 regions from January; 2000 to June, 2002 weren't investigated because of ARC policies, according to the FDA.

After a patient received two units of ARC manufactured blood product and later died, records indicated ARC didn't do any further donor testing or donor follow up when learning the patient had a presence of hepatitis B infection before death, according to the FDA. ARC's investigation concluded that "each donor denied a prior history of hepatitis or recent exposure to hepatitis at the time of donation" and donors were found to be "normal for all hepatitis related tests," government documents said.

Allan Ross, senior vice president and chief operating officer of ARC Biomedical Services, said in a statement that hospital records indicate the patient in question died of symptoms unrelated to a hepatitis infection. The statement added ARC's policy for limiting investigations of patients diagnosed with hepatitis "after being transfused with blood products from more than 10 donors was accepted by the FDA."

The Northern Ohio region received an exemption to ARC policy for investigating a suspected posttransfusion hepatitis case and found a blood donor involved in a previous suspected post-transfusion hepatitis case that wouldn't have been found and deferred except for the region's request to investigate, the report said.

"The fact that there is evidence of disease transmitted by Red Cross blood is the first time that has been acknowledged," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "They actually have some infected bodies in this case."

Since the FDA's last inspection in April, 2000, ARC couldn't determine the disposition of 1,062 blood products, including one which tested positive for HIV.

Ross said in the statement that ARC processes more than 14 million blood products each year and "take very seriously if even one product is not within our control at all times."

An ARC official said in a written statement that five of the lost products outlined in the report as unsuitable for release had no blood bag labels and were unlikely to be transfused.

Blood products from approximately 48 donors were collected and distributed even though some donors related a history of hepatitis or other information that should've made them ineligible, according to the report.

Elsewhere, blood products that were recalled, withdrawn or returned to an ARC facility were later reissued, including one found positive for sickle cell.

According to the FDA report, an ARC employee said there was a "culture to hide problems" and a "pervasive attitude that the staff can clean problems up so they can never be found."

Records existed at ARC headquarters for this review. But, there is still a "general theme that raises questions about data integrity," said FDA spokesman Brodsky. "Our observations appear to show continuing evidence of a culture that is willing to accept noncompliance."

"We take very seriously the 'culture' issues raised in the FDA report and will continue to encourage confidential communication so employees can raise concerns with supervisors," Ross said in a statement.

The report leads attorney Michael Feldman to believe "that nothing's changed in the almost 20 years since they were making decisions that were designed not with the safety of the public in mind, but with the production of their product in mind."

Feldman, an attorney with Ashcraft and Gerel's Washington, D.C., office, worked on blood transfusion litigation that involved the ARC during the 1990s and is currently investigating a similar case.

Ramesh Thadani, executive vice president and CEO of ARC Biomedical Services, said in a written statement that ARC's "top priority" is "the safety and availability of nearly half the nation's blood supply?'

ARC usually responds to such reports in 30-60 days, an ARC spokeswoman said.

The FDA is staying abreast of developments.

Brodsky of the FDA said," We intend to follow up quickly on these preliminary findings, and we will take further action as warranted."