The focus on ''closing the window'' of infectious risks in transfusion
has concentrated limited health care resources on marginal increases
in blood safety in the name of quality assurance (QA). Significant inv
estments in testing and medical history additions have been made to re
strict further any release of unsuitable blood and apheresis donations
. As funds are used in a disproportionate manner with regard to these
quality benefits, the depletion of resources precludes investment in q
uality enhancements (e.g. potency) other than safety, and actually may
reduce quality over all. Although safety is an important element of q
uality, it is not the only element. Increasingly, blood center custome
rs expect, but are unwilling to pay for, limited increases in product
safety, such as anti-HCV 3.0 and HIT p24 antigen testing; they should
be encouraging improved potency and efficacy for QA. In the future, bl
ood service providers must demonstrate the value of additional QA acti
vities-otherwise, they will not receive reimbursement. Total quality r
emains the objective goal. However, the investment in QA efforts must
yield a benefit equal to, or greater than, investment in the quality a
ssurance process. (C) 1997 Elsevier Science Ltd.