The Food and Drug Administration has fined the American Red Cross Greater Chesapeake and Potomac Region office in Baltimore US$718,000 for failing to investigate and correct record-keeping irregularities. The investigation began after a Red Cross employee was found to be performing blood collection tasks they had not been trained for.
The Red Cross submitted a report but failed to disclose how many times the employee performed that task, or say exactly what the task was. Reviewing this report, the FDA notified the Red Cross of its failure to adequately investigate record keeping irregularities stating
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 Greater Chesapeake and Potomac Region office and the American National Red Cross refused to comment.
Source The Washington Times August 2006