The different tools in quality management
Authors: Grunnet N. 
Published: June 2007

Background  Since the mid 1980s hospital‐based blood banks, all parts of the public healthcare system in Denmark, have been inspected regularly by the Danish Medical Agency, a division of the National Health Authority. Blood components for transfusion were regarded as medicaments and should therefore fulfill some pharmaceutical requirements.

Evolution  From the time of ‘the surgical approach’ to blood transfusion, i.e. drawing whole blood and using it as such for treatment, a process of refinements have taken place within all aspects of transfusion medicine in the blood bank setting in Europe. In Denmark, blood banks are separate hospital departments covering all aspects of the transfusion activity with specially trained medical doctors (separate medical specialty), donor selection, production of blood components, testing for selected infectious markers, blood grouping and compatibility testing, investigation of adverse reactions/complications to transfusions and constructive dialogues with representative users of the services from the blood bank and blood bank personnel in the Hospital Transfusion Committees to secure appropriate use (clinical doctors and nurses) and relevant accessibility of blood components and laboratory testing (the blood bank output). At present, the level of implementation of quality management in transfusion centres in Denmark is at the accreditation level with reference to the EU Blood Directives the Danish Blood Law and orders in many aspects equivalent to the ISO 15189 standard.

The tools of quality management  The overall demand is to go ‘one‐way’. This can be achieved by having a quality manual (overall objectives), master description of procedures (master plans), standard operating procedures (SOPs) and a well‐prepared feedback system using quality control measurements of blood components and laboratory tests, through reports of variations (deviation from intended result or SOP), complaints, systematic internal audits, updated educational records of all personnel involved in the activities of the blood bank (nurses, secretaries, laboratory technologists, medical doctors, others), assurance that all equipment and utensils are only taken in use after proper validation/qualification and that a maintenance plan or acceptance test are in action. Furthermore, a relevant number of external proficiency testings are carried out to secure the analytical quality of all key parameters in the laboratory. Every second year the blood bank will be inspected by the Danish Medical Agency and identified issues must be addressed in a written response within a time limit. The issues pointed out can deal with the building, personnel, apparatuses, equipment, utensils, processing, data management, corrective actions and other issues relevant for the fulfillment of the requirements of a European blood bank setting in 2007. In addition, the area of transfusion is surveyed at a national level (blood components/blood donor accidents/clinical practice of transfusion treatments).

Conclusions  The benefits of quality management surpass the costs by creating high‐quality products and services for the benefit of patients, blood donors, hospitals and personnel in the blood bank.