Validation and implementation of a new hemoglobinometer for donor screening at Canadian Blood Services.
BACKGROUND
Hemoglobin (Hgb) determination is an essential part of donor qualification. We assessed and implemented a new spectrophotometer for donor Hgb determination.


METHODS
Precision, accuracy, and ease of use were assessed on a prototype DiaSpect analyzer (DiaSpect Medical, GmBH, Sailauf, Germany). A protocol to qualify the analyzer was developed and executed preimplementation. Samples were developed for periodic quality control (QC). Postimplementation performance was assessed based on QC results and trending of deferral rates.


RESULTS
Precision was excellent, with a coefficient of variation of 0.53%-1.14% per sample. The correlation coefficient between capillary DiaSpect and venous laboratory autoanalyzer measurements was 0.736. After 169 out of 223 analyzers failed to qualify on our initial protocol, all were successfully qualified with the use of a modified protocol, adjusted to avoid sources of variability. Because commercial controls proved inadequate, in-house samples were developed for periodic QC. Postimplementation, all analyzers had adequate QC results. Deferral rates decreased from 10.1 to 8.1% (p < 0.0001) for female donors and from 0.8 to 0.6% for male donors (p < 0.0001). The system was faster and easier to use compared with our previous two-step process.


CONCLUSIONS
We successfully implemented a new spectrophotometer, which resulted in greater efficiency, improved ease of use, and decreased deferrals.
Donor and Transplantation Services, Canadian Blood Services, Ottawa, Ontario, Canada. mindy.goldman@blood.ca
Mindy
M
Goldman
Samra
S
Uzicanin
Qi-Long
QL
Yi
Jason
J
Acker
Sandra
S
Ramirez-Arcos
D000328:Adult; D001771:Blood Banks / Q000592:standards; D001782:Blood Donors; D002170:Canada; D046148:Donor Selection / Q000379:methods; D004864:Equipment and Supplies; D005260:Female; D006284:Health Plan Implementation / Q000379:methods; D006403:Hematologic Tests / Q000295:instrumentation* / Q000592:standards; D006452:Hemoglobinometry / Q000295:instrumentation / Q000592:standards; D006801:Humans; D008297:Male; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000094902:Blood Banking / Q000379:methods