Review of the quality monitoring methods used by countries using or implementing universal leukoreduction

Several countries are implementing or have implemented universal leukoreduction (ULR). Specifications, leukocyte counting, and monitoring methods were essential elements in achieving process confidence and conformance. A review of these protocols is presented. A questionnaire was prepared, agreed, and circulated, and responses were collated. Different specifications have been adopted as well as disparate approaches to leukocyte counting and residual leukocyte monitoring. Parametric, nonparametric, and pass-rate methods of analysis were used. Despite these differences, users were satisfied that the methodologies were providing assurance of component quality.