[Risk management from the perspective of the hematologist]

The present paper deals with the physician's accountability during the implementation of hemotherapeutic measures. Since July 1, 1998 a Transfusion Law ('Transfusionsgesetz') regulates the clinical use of blood products in Germany in accordance with the guidelines established by the German Medical Association and the Paul Ehrlich Institute, which are regularly revised and adapted on the basis of current professional knowledge and technology. The therapeutic freedom allowed under the Code of Professional Medical Conduct is taken into account by the fact that the responsibility for hemotherapy in each individual case lies with the attending physician, no matter whether this applies to the diagnosis, the patient counselling or the administration of the transfusion itself. The administration of blood products, whether in hospital or a doctor's office, must follow certain quality-assumed rules governing transfusions as stipulated by the Transfusion Law. The responsibility for establishing regulations for hemotherapy and the introduction of a quality assurance system lies with the management of the treatment centre who appoint a specific physician as the hemovigilant ('Transfusionsverantwortlichen') who is responsible for meeting both these duties. The hemovigilant must be assisted by physicians specially appointed for transfusion measures (Transfusionsbeauftragte) who are responsible for the implementation of the hemotherapy regulations and quality assurance measures in the individual medical departments. As it is the hospital management's responsibility to ensure quality assurance, its duty also extends to monitoring the quality assurance system. Therefore a quality manager ('Qualitätsbeauftragter') will have to be appointed who must not be subject to directives. In case the management of the patient care centre does not fulfill the legal requirements or, for example, does not take action when shortcomings are discovered by the hemovigilant or quality manager that can only be dealt with by the management, then the organisational responsibility lies with the hospital management. Experience to date has demonstrated the success of the Transfusion Law. Whereas previously hospital managements have often failed to respond to suggestions for change or improvement, their attention may now be drawn to this law. This has led to blood products being increasingly used according to the same standards and keeping transfusing physicians on safe legal ground.