Frequency and specificity of the Trima Accel "verify WBCs" advisory: considerations for product management.
BACKGROUND
The Trima Accel displays a "verify WBCs" message if the plateletpheresis product (PLT) may not be leukoreduced (LR). Most blood banks require sensitive white blood cell (WBC) testing of these PLTs by flow or Nageotte. We evaluated how often these PLTs were non-LR by European or US Food and Drug Administration (FDA) criteria and whether sensitive WBC testing is necessary.


METHODS
Phase 1 reviewed the frequency of this message with various procedure types and the flow WBC results for PLTs with or without the message. Phase 2 assessed how many FDA LR failures were detectable by a hematology analyzer. In Phase 3, PLTs were managed by hematology analyzer results.


RESULTS
In Phase 1, 3.8% of PLT-only and 11.1% of PLT-plasma collections had the "verify WBCs" message. Only 1% of "verify" PLTs contained more than 1 × 10(6)  WBCs and only 0.5% were FDA LR failures. In Phase 2, 10 of 670 "verify" PLTs and one nonflagged PLT were FDA LR failures. Six of 11 LR failures had hematology analyzer WBC concentrations of 0.4 × 10(9) /L or higher. In Phase 3, "verify" PLTs were allowed in inventory if hematology analyzer WBC concentration was below 0.4 × 10(9) /L; inventory quality control showed no FDA LR failures by flow. Trima Version 6.0 software lowered the "verify" message frequency in PLT-plasma procedures but not in PLT-only procedures.


CONCLUSIONS
Four percent of Trima PLT collections have the "verify WBCs" message but almost all of these are LR by European and FDA criteria. Fifty percent of FDA LR failures were detectable by a hematology analyzer. Sensitive WBC testing of all "verify WBCs" PLTs may not be necessary to satisfy LR quality assurance requirements.
Stanford Blood Center, 3373 Hillview Avenue, Palo Alto, CA 94304, USA. susangal@stanford.edu
Susan A
SA
Galel
Juliana
J
Gaitan
Darlene T
DT
Yu
Lorna
L
Tolentino
Jan
J
Webster
Elaine
E
Sugasawara
Jo Ann
JA
Wilson
Cynthia
C
Boone
Patricia
P
Lendio
D006801:Humans; D047589:Leukocyte Reduction Procedures; D010983:Plateletpheresis; D014481:United States; D014486:United States Food and Drug Administration