Blood Collection Center replies: (some of these centers may also issue blood for transfusion)

Center #1: We do not have the QA Unit review all results, temperatures and other paperwork before batch review. We have been thinking of doing this but have not devised a system to accomplish this. We would like to know what the other facilities are doing concerning this subject.

Center #2: The QA unit at a very large blood collection center does not perform a review of all records (lot release) prior to the release of blood products. Rather, they do require an operational review of the following records prior to product release:

Donor Registration records
Hemapheresis donor records
Apheresis run sheet
RBC and Plasma Cumulative donation record
Hemapheresis QC
QC records-collections, components and hospital services
Collection packing record
Laboratory testing records and QC
Daily record review worksheet
Quarantine/destruction/ release notification
SCD record and QC
Component transformation record
Automated RBC collection record
Irradiator log

The QA unit audits this record review process on a regular basis.

Center #3: Processing records are reviewed only by Processing Supervisory staff prior to release for labeling.

Center #4: Yes, actually, we do review all records. Because we send out viral marker testing, we actually have organized the "process of processing the units" such that all reviews are able to be completed prior to the labeling of the unit. An overview of the review process includes:

1. Review of the Donor History cards (this is a second review by staff in the Transfusion Service; the first review occurred by Senior Nursing staff in the Donor Center on the day of collection). If a donor took an aspirin containing medication and platelet concentrates were prepared, that they are appropriately labeled with a "aspirin pool only" label (so they won't be used as a single unit transfused to a neonate, they will only be used in a pool.) All units needing irradiation (DD, etc) are labeled as "to be irradiated" / appropriate "flags" in the computer.
2. Review of Quality Control for reagents used to perform ABO/Rh, antibody screen - QC complete and results are acceptable.
3. Review of the Fractionation log - time of preparation of all components is acceptable; (FFP prepared/frozen solid in appropriate time; platelet concentrates prepared in appropriate time / volume / time on the rotator / etc.); complete tracking of who performed which step in processing / fractionating the unit and when.
4. Comparison of ABO/Rh information provided by the viral marker testing laboratory, as compared to the serologic results obtained from the segment (tested by our laboratory).
5. Review of on-line data; data entered into the computer for ABO/Rh, antibody screen, historical ABO/Rh of the donor; if an antibody screen is positive, that FFP is made into recovered plasma/ appropriate disposition of platelets; appropriate labeling of RBC unit.
6. Review of the Transport log of all coolers delivering the blood from collection site to fractionation area; time of transport and temperature upon receipt / which units arrived in which cooler / all units accounted.
7. Online review and comparison of viral marker test results (this is actually a third review;) Verification of data entry.
8. Review of Plateletpheresis QC to verify total platelet yield for all products; verification of preparation of appropriate products (single product has appropriate count, double products truly meet requirements to be a double, etc).
9. Quarantine check - verification that the units in quarantine have a documented reason to be there; all units accounted - no excess units; all documentation complete. Then we go to the labeling process. Disclaimer -- we also have an approx. 40-step process in reviewing the viral marker test results -- looking for prior donations that are in stock that now need to be quarantined, appropriate biohazard labeling of Autologous units, etc, etc. that is on ANOTHER checklist; the "final" processing checklist includes verification that this viral marker checklist has been completed.

Center #5: We require a second person or a computer to review every critical process (including but not limited to history cards, records, product labels).

ADDENDA Dec. 15, 2000

We are a donor center with a centralized transfusion service, collecting about 32,000 units yearly. We recently implemented a standardized format for review of all records prior to release for labeling. Essentially we have created a Process Control form. The donor area signs off after they have reviewed all donor records for the previous day, as well as all QC (scales, temps, Hemacue etc) for each collection site such as mobile and in-house. This form then is forwarded to the lab where another person makes sure that temp QC was done on all blood storage units and centrifuges, and scales were QC'd etc (all equipment that could affect the quality of the component prep or product storage process). After all QC is reviewed this information is passed to the lab staff responsible to review and release donor units based on testing, so that any products deemed unsuitable can be quarantined until investigated.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator