ESTABLISHMENT OF A QUALITY ASSURANCE SYST EM IN TRANSFUSION MEDICINE EXEMPLARILY SHOWN FOR THE UNIVERSITY BLOOD-BANK AT HEIDELBERG

Background: The 'Zweite Verordnung zur Anderung der Betriebsverordnung fur 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 q uality assurance system of the university blood bank at Heidelberg is based on the components 'quality of structure', 'quality of process' a nd 'quality of result'. The internal standard is specified in written form for every aspect of structure, process and result by standard ope rating, procedures (SOP). The SOP serve as a basis for the quality sys tem manual and the laboratory reference books. The quality assurance s ystem described here integrates a programme for carrying out internal quality audits as well as a concept for updating SOP at regular interv als. Conclusions: The concept underlying the quality assurance system of the university blood bank at Heidelberg allows continuous quality i mprovement in transfusion medicine; moreover, it offers the chance to integrate quality assurance in transfusion medicine in an interdiscipl inary, patient-orientated, not only regional concept of quality assura nce.