FDA fines city Red Cross in training irregularity


The federal Food and Drug Administration has fined the Baltimore branch of the American Red Cross $718,000 for failing to thoroughly investigate and correct a training irregularity involving blood inspection, the FDA said yesterday.

In a letter to the Red Cross dated July 27, the FDA said the failure to report the training error at the Greater Chesapeake and Potomac Region office "reflects a troubling and recurrent pattern and presents serious potential health risks."

On Aug. 9, 2005, according to the letter, an employee and her supervisor signed the employee's training record indicating that she had been trained and was competent to perform 12 separate blood collection tasks, though the employee had been trained to perform only seven of them.

The letter said the inadequate training could have resulted in whole-blood number mix-ups, which could result in an HIV-positive donor not being contacted about that status.

About two months later, Red Cross officials discovered the problem and began investigating.

Dr. Peter Page, Atlantic division vice president for blood services for the Red Cross, said the employee had been transferred from another region, where training procedures vary. The employee had performed only one of the procedures that she was not properly trained to do - inspection of bags holding blood, Page said.

The Red Cross conducted an investigation at the time of the incident, noting the failure of the education coordinator to compare the employee's previous training transcript with the training requirements for whole-blood collections staff at the Baltimore office and that the employee signed the training record without realizing she had not been adequately trained. The Red Cross said then it would fully retrain its employees.

But the FDA ruled the investigation was inadequate because it did not say why the employee and supervisor signed the erroneous training record.

"FDA has previously notified [the Red Cross] of its failure to adequately investigate record keeping irregularities, or allegations of such irregularities, at other facilities," the letter stated. "Moreover, the erroneous record indicates a problem with the integrity of GCPR's records, and the incomplete investigation does not allow for adequate corrective measures, including measures to address systemic records integrity problems."

The Red Cross has since opened a second investigation to remedy the situation, Page said. It has until Aug. 11 to respond.

"We agreed with the FDA at the time, that our investigation was not appropriate," Page said. "This is a serious matter which we take seriously and we'll work with the FDA in resolving it."

Page said the organization has money budgeted specifically for such fines and its operation would not be adversely affected.

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