Management of donor registration forms found to be incomplete or lacking donor's signature following donation

A medical director at a medium-sized donor center in the US wonders how other centers manage donor registration forms that are incompletely filled out or that lack the donor's signature. When they catch such an error, they quarantine the unit. If the questions that are unanswered relate to risk behavior associated with HIV infection, they discard the unit. If the unanswered questions are travel-related, they contact the donor, and if the donor provides satisfactory answers, they use the unit. If the form is lacking the donor’s signature, and if the donor is willing to come back to the center and sign the form, they use the unit. If they can not get the missing information or signature within several days of the donation, the donation is discarded.

The following comments have been received.

ADDENDA Oct. 16, 2006

1. A colleague at an academic medical center in a New York Borough reports that her hospital's blood donor center used to follow a procedure similar to that described above by the medical director of the medium-sized donor center. However, during a recent FDA inspection the New Yorker's hospital was informed that they should not use donated blood if the donor record had a clerical omission until such a variance was approved by FDA. Consequently, the hospital requested a variance to 21 CFR 640.3(a) under the authority of 21 CFR 640.120, to permit them to contact individuals after blood donation in order to obtain missing donor screening information. However, the FDA response reportedly was: "We have completed the review of your submission and your request cannot be approved. We do not believe that is appropriate to approve a general variance request that allows contacting donors after the day of donation to obtain the information. However, we would entertain similar variance requests on a case-by-case basis".

ADDENDA Oct. 18, 2006

2. A colleague in Virginia comments that if one looks at reports of errors that are submitted to the FDA/CBER by Blood Establishments, the highest percentage surrounds the Donor History Form, i.e missed questions, poor or no documentation, lack of signatures, etc. Since the overall percentage seems to be fairly consistent from year to year, the Virginian wonders if corrective actions beyond training, changes in SOPs, etc, are necessary. He points out that software products are available, such as an Audio Visual Touch Screen Computer Assisted Interview System. Systems like this can help to reduce the error rate associated with donor history records by preventing the interviewer from missing a question, since if each required element of the donor history and physical examination is not recorded, no Donor History Form will print, unless there is a deferral.
   
   
3. A colleague at the New York Blood Center reports that "The FDA has told us that once a donor leaves the donation site there is to be no further communication. This would mean discarding the unit. A deviation was requested for innocuous omissions and was denied".

ADDENDA Oct. 26, 2006

4. In contrast to the October 16, 2006 posting from New York, a Quality Assurance Director in Tennessee comments that in the October 6, 2006 issue of AABB Weekly Report it states:
   
   "FDA shared its current thinking on exceptions and alternate procedures approved under 21 CFR 640.120 and, specifically, on what alternate process variances would likely be approved in the future. FDA noted that it will be less likely to approve a variance that is actually a workaround for process control problems that are within the control of the blood establishment, although such requests will continue to be evaluated on a case-by-case basis. (For example, a temperature excursion occurred in a storage refrigerator because procedures were not followed.) The more appropriate application of 640.120, according to FDA, is a variance submitted for an alternate process for an issue that is out of the manufacturer’s control. As an example, FDA reviewed situations with temperature excursions that occurred post-Hurricane Katrina, and a facility’s entire inventory was involved."
   
   "Participants also discussed the need to obtain clarification on donor qualification issue(s) post-phlebotomy. This variance is related to 21 CFR 640.3. According to FDA, it is acceptable to contact a donor post-phlebotomy to clarify a donor history question if the clarification is part of a deviation investigation. In this situation, the establishment must use the same standard to ensure donor identification and privacy as is required during the normal collection process."
   
   
5. Editors' Note: At the "Ask the FDA" session on October 24, 2006 at the AABB Annual Meeting & TXPO in Miami Beach, a similar question had been submitted to the panel. The panelist commented that according to 21CFR 640.3, donor suitability determination shall be made on the day of collection, therefore, any efforts to complete a partial qualification must occur on the same day. Questions about specific qualification issues should be directed to the Consumer Safety Officer, and a Consumer Safety Officer is on call at any time.

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