Process control procedures to augment quality control of leukocyte-reduced red cell blood products.
Stat Med
; 18(10): 1279-89, 1999 May 30.
Article
em En
| MEDLINE
| ID: mdl-10363345
ABSTRACT
Quality control of leukocyte-reduced packed red cell units (LRprc) produced in blood facilities must conform to regulatory criteria, which state that units may not contain more than 1 x 10(6) to 5 x 10(6) white blood cells (WBC) per unit. The post-filtration WBC content of a total of n = 386 LRprc units was counted with a Nageotte chamber to model the probability that a unit would not meet the regulatory criteria. The distribution of the residual leukocyte counts is close to a negative binomial distribution (NBD) and is independent of the packed red cell volume filtered. The observed probability that a unit of blood has a residual WBC greater than 5 x 10(6) is 2.6 +/- 2.6 x 10(-3). A power analysis of the two-sample Kolmogorov-Smirnov (KS) test in this application shows that a sample size of 20 is sufficient for determining that the process is in control when an out of control process has a k NBD parameter greater than or equal to that of the in control process. The three out of control processes observed to date appear to have this property. A sample of size 80 may be necessary for confirming that process validation data sets conform to the larger 'reference' database (n = 386) for processes that are out of control in such a way that their k NBD parameter is less than the k parameter of the in control process.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Remoção de Componentes Sanguíneos
/
Transfusão de Eritrócitos
Tipo de estudo:
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Stat Med
Ano de publicação:
1999
Tipo de documento:
Article