Validation and implementation of a new hemoglobinometer for donor screening at Canadian Blood Services.
Transfusion
; 52(7 Pt 2): 1607-13, 2012 Jul.
Article
em En
| MEDLINE
| ID: mdl-22780942
ABSTRACT
BACKGROUND:
Hemoglobin (Hgb) determination is an essential part of donor qualification. We assessed and implemented a new spectrophotometer for donor Hgb determination. STUDY DESIGN ANDMETHODS:
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.CONCLUSION:
We successfully implemented a new spectrophotometer, which resulted in greater efficiency, improved ease of use, and decreased deferrals.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Seleção do Doador
/
Equipamentos e Provisões
/
Testes Hematológicos
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
/
Screening_studies
/
Sysrev_observational_studies
Aspecto:
Implementation_research
Limite:
Adult
/
Female
/
Humans
/
Male
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Transfusion
Ano de publicação:
2012
Tipo de documento:
Article
País de afiliação:
Canadá