Quality systems in automated plateletpheresis in hospital-based blood transfusion service in north India.

The issues of providing quality blood products and maintaining donor safety are primary aims of blood transfusion services. A comprehensive quality system should be in place to fulfill these aims, which can be attained through strict adherence to the established standard operating procedures (SOPs). The Drugs and Cosmetics Act of India, which controls the licensing of blood transfusion services, does not provide clear guidelines regarding plateletpheresis procedure. We, therefore, established our own SOP and operational flow chart for plateletpheresis that can be easily followed by other centers in India. A total of 100 plateletpheresis procedures performed using two cell separators (CS3000 Baxter Healthcare, Round Lake, IL; MCS3p, Haemonetics Corporation, Braintree, MA) were evaluated following our established SOP. The mean platelet yield in CS3000 was 2.9 +/- 0.84 x 10(11) and in MCS3p it was 2.88 +/- 0.75 x 10(11)per unit. However, only 4-7% of SDPs showed WBC levels <5 x 10(6) due to lack of appropriate methods to quantitate residual WBC counts. Six of 100 donors complained of hypocalcemic symptoms. The operational flow chart designed in this study was found to be simple and easy to adapt by blood transfusion services in this country. (c) 2005 Wiley-Liss, Inc.