American Red Cross Cited by FDA for Blood-Safety Rule Violations

American Red Cross Cited by FDA for Blood-Safety Rule Violations

January 16th, 2012 // 1:31 pm @

The American Red Cross, the biggest U.S. supplier of donated blood, failed to correct violations of blood-safety rules, raising the risk that ill-suited blood will be used in transfusions, U.S. regulators said.

The U.S. Food and Drug Administration fined the Red Cross $9.59 million, according to a letter from the agency to the Red Cross made public on Jan. 13. The organization has been cited 14 times since 2003 and fined about $46 million for similar offenses.

The Red Cross didn’t ensure that all staff had adequate blood-safety training and hasn’t created a complete list of prospective donors who were disqualified from giving blood, according to the letter. The Washington- based consumer group Public Citizen this month urged the agency to levy sanctions. “Many of the violations recounted in this letter are virtually identical to violations charged” in previous letters from the agency, the FDA said. The Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”

The FDA didn’t find evidence that the lapses led to any serious health consequences for blood recipients, said Mary Malarkey, head of compliance at the agency’s Center for Biologics Evaluation and Research, in a telephone interview.

Blood Supply Safety

“The safety of the nation’s blood supply is one of our top priorities, and we have no reason to believe that it has been compromised,” Malarkey said. “It’s very important to note that people who need transfusions should continue to take their doctors’ advice, and we encourage people to donate blood.”

The 2003 consent decree set penalties for failing to follow U.S. standards aimed at preventing blood contamination. The latest fines focused on an inspection conducted 15 months ago at the Red Cross’ Donor and Client Support Center in Philadelphia, the organization said yesterday in an e-mailed statement.

The blood supply is “safer today than ever before and people should not hesitate to give or receive blood,” the Red Cross responded in a statement. “We are disappointed that the FDA believed it necessary to issue a fine for an inspection conducted so long ago and it is important to know we have already taken corrective steps to address those matters,” according to the statement. The organization is “fully committed to meeting all FDA standards, has made significant progress in working with the FDA to comply with their regulations,” according to the statement.

Red Cross Comment

Red Cross spokeswoman Stephanie Millian declined a request for an interview with top officials from the organization, saying, “We don’t discuss our relationship with the FDA.” The 2010 violations included a failure to ensure that staff handling donated blood have enough training and experience to ensure “competent performance of their assigned functions” and make sure donated blood is safe, the FDA said in the letter. FDA inspectors found that the Red Cross “has not established an accurate and complete list” of people who have been disqualified from donating because of potential health problems such as infectious diseases. Inadequate record-keeping increases the risk of distributing blood that shouldn’t have been accepted for donation, the agency said. Public Citizen urged U.S. Health and Human Services Secretary Kathleen Sebelius in a Jan. 6 letter to levy the $9.59 billion fine on the Red Cross after reviewing 2010 inspection reports. The FDA is part of the department.

$37 Million in Fines

“Since the FDA and American Red Cross’s 2003 agreement, the Red Cross has been previously fined $37 million, but the substandard performance of critical Red Cross blood handling functions continues,” said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a Jan. 6 statement. Wolfe didn’t respond to an e-mail seeking comment on the FDA’s decision to levy the fines. Many of the problems cited by the FDA were related to the Red Cross’s consolidation of blood collection activities previously handled at 35 regional offices into two facilities in Philadelphia and Charlotte, North Carolina. The centers were “chronically understaffed” during the consolidation that occurred from May 2008 to March 2010, the FDA said. “In response to the internal audits,” the facilities “repeatedly promised corrective actions, some of which had not been completed or were ineffective at the time of the FDA inspection in September and October 2010,” the FDA said. The Red Cross said it was aware of the challenges from the consolidation and was taking action to address them. The agency fined the Red Cross $16 million in 2010 for mismanagement of blood products and manufacturing violations. Those lapses didn’t endanger any patients, the agency said at the time.

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