DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

INADEQUATE INVESTIGATION OF EMPLOYEE ALLEGATIONS OF SIGNIFICANT RECORDKEEPING IRREGULARITIES:

Biomedical Headquarters (BHQ) has failed to properly evaluate all employee allegations of significant record keeping irregularities and take corrective action to prevent recurrence.

1. On 10/6/00, the Vice President of Quality Assurance (QA) submitted a potential system problem. The records of the system problem indicate the issue was “non-concurrent documentation and falsification of records-cases have been identified…” On 10/16/00, this issue was assigned system problem # 511. On 3/27/01, the system problem was closed by the Chief Operating Officer as being “isolated instances” not meeting the definition of a system problem. The cases reviewed involved four reports from National Testing Laboratories (NTLs) and eight reports from the ARC regions. Examples are as follows: following the erroneous release of two plasma products in one region, one employee reported being asked to sign as a second reviewer for a shipment she had not physically counted and that employees were “cutting corners” to increase the amount of product packed. Another region reported that an employee took the health history from the donor, failed to document the reason for deferral of the donor and then discarded the health history record when the reason for deferral could not be recalled.
   
   
2. After closure of the system problem #511 and without BHQ taking any system-wide corrective action allegations of significant record keeping irregularities continued to be received. From December 2001 to January 2002, there were at least three reports of records not reflecting the actual work performed or non concurrent record keeping in the NTLs:
   
   1. In December 2001, a report from one NTL stated that 28 products had been labeled with hemoglobin S results although no test results were recorded on the testing worksheet. This worksheet was also reviewed and signed by two other employees including quality control staff. The report indicates that the quality assurance officer in the NTL stated there was a “culture to hide problems” and “there is a pervasive attitude that the staff can clean problems up so they can never be found.”
      
      
   2. In January 2002, an employee in an NTL reported that another employee “over incubated the antibody plates but had not recorded the correct times on the worksheet.” The investigation revealed the employee who witnessed the problem had reported a similar incident to the supervisor; however, that incident was not investigated at the time. The employee reported fearing retaliation if she was seen reporting a problem to the supervisor.
      
   3. In January 2002, the records indicate there was an “Investigation of Falsification of NAT Test Records.” During that investigation, one employee reported that “verification is to be performed concurrently when possible but due to staffing levels workload, this does not always occur.”
      
3. A special audit was conducted in August 2001 when the region’s management notified regional QA of a “possible falsification of records.” The report states “The fact that only the cumulative loss records were altered would have an affect on donor safety and not product quality.” All staff interviewed “verified they found documents which were

The observations of objectional conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."