Red Cross fined by FDA for record-keeping failures

BALTIMORE — The Food and Drug Administration has fined the American Red Cross $718,000 for failing to investigate and correct record-keeping irregularities at the Greater Chesapeake and Potomac Region office in Baltimore, the FDA said yesterday.

In a letter dated Thursday, the FDA said a failure to document why a training error occurred “reflects a troubling and recurrent pattern, and presents serious potential health risks.”

According to the letter, on Aug. 9, a Greater Chesapeake and Potomac Region (GCPR) worker and her supervisor signed the employee’s training record showing that she had been trained and was competent to perform 12 blood collection tasks, although the employee underwent training for only seven of those tasks.

The Red Cross discovered the problem two months later. The worker had performed one task for which she was not trained, but the report does not say how many times the employee performed that task, nor does the report say exactly what the task was.

The FDA letter said the task, if performed improperly, could lead to whole blood number mix-ups.

This could mean a unit of blood could be linked to the wrong donor, which could prevent notification of the donor if his or her blood is found to be infected with HIV, hepatitis or other diseases.

After Greater Chesapeake became aware of the issue, an investigation classified the incident as “moderate risk,” the FDA letter said.

In November, the Red Cross proposed retraining affected employees.

In January, Greater Chesapeake ended its investigation, but its problem file does not show that GCPR conducted a thorough probe to find why the employee and supervisor signed the erroneous training record, the FDA letter said.

“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 said. “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 fine, the FDA said, was calculated at $2,000 for each day from Aug. 9, through Oct. 11; $3,000 for each day from Oct. 11 through Jan. 19, when the FDA first notified the Red Cross about its inadequate probe; $4,000 for each day from Jan. 20 through March 30, when the Red Cross submitted its inadequate response to the FDA; and $1,000 for each day from March 31 through April 13, when the FDA reviewed the response.

Spokesmen for the Greater Chesapeake and Potomac Region office and the American National Red Cross did not return phone calls for comment.