[Establishing a quality assurance system in transfusion medicine exemplified by the Heidelberg University Blood Bank].

Abstract

Background: The 'Zweite Verordnung zur Anderung der Betriebsverordnung für pharmazeutische Unternehmer vom 13. Juli 1994' requires a quality assurance system for the manufacturing of blood products.

Methods: On the basis of national law and guidelines we worked out a concept for establishing a quality assurance system at a university blood bank and applied it to the university blood bank at Heidelberg.

Results: The quality assurance system of the university blood bank at Heidelberg is based on the components 'quality of structure', 'quality of process' and 'quality of result'. The internal standard is specified in written form for every aspect of structure, process and result by standard operating procedures (SOP). The SOP serve as a basis for the quality system manual and the laboratory reference books. The quality assurance system described here integrates a programme for carrying out internal quality audits as well as a concept for updating SOP at regular intervals.

Conclusions: The concept underlying the quality assurance system of the university blood bank at Heidelberg allows continuous quality improvement in transfusion medicine; moreover, it offers the chance to integrate quality assurance in transfusion medicine in an interdisciplinary, patient-orientated, not only regional concept of quality assurance.