DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

INADEQUATE INVESTIGATION OF POTENTIAL PROBLEMS WITH PRACTICES RELATED TO DONOR DEFERRAL RATES



5. Several regions implemented policies tracking donor deferral rates for health history reasons by employee, tracking hematocrit deferral rates by employee and closely observing trained employees. The “hotline” reports indicate a potential problem presented by current management practices related to donor deferral rates. However, BHQ failed to determine whether this is a system problem and to take corrective action to prevent recurrence:
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate a report was received that donors with low hematocrits were being accepted. Results were being re-read “into acceptance” by a second individual.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee reported that managers were instructed to verify the hematocrit readings made by staff. Region reported managers were instructed to review the number of hematocrit deferrals by each staff member and if the number for any employee was “excessive” to observe the employee.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee asked how to lower her history deferral rate without jeopardizing the safety of the blood supply and without providing “false information.” The employee stated it was the regions policy to hold deferrals against collection employees on their performance evaluations. The employee believes this would seem to foster wrongdoing on the part of the collection staff. Collection staff might be tempted to lie about donors’ histories or qualifications to donate so they will be allowed to donate when in fact they should be deferred. The employee also stated that collection staff might destroy blood donation records for donors they had to defer, in order to lower their deferral rates.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee reported that they are being reprimanded when their deferral rate is too high and are instructed by management to improve by decreasing the number of deferrals.
   
   [REDACTED]: The records of investigation provided by ARC indicate employees have reported that since converting only to the finger stick to determine iron levels, the deferral rate has dramatically increased and they are being blamed for this increase. Employees report that management is consistently monitoring them.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee reported that management informed them that their deferral rates are too high, especially for low iron readings. Employee reported that they are required to have a nurse oversee a second test to check hemoglobin levels.
   
   ARC #[REDACTED]: The records of investigation provided by ARC indicate an employee reported that management is instructing employees to accept allogeneic donors with iron levels under 38 percent.
   
   

INVESTIGATION OF SUSPECTED POST TRANSFUSION HEPATITIS (fatality):

6. Procedures do not require a thorough investigation of the occurrence of a clinically significant infection or
   

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."