New Guidelines for the Preparation of Blood and Blood Components and for the Use of Blood Components (Hemotherapy) - Alterations, interpretations and Commentary Since July 2000 the new regulations of the production of blood and blood components and of the application of blood products (hemotherapy) edited by the German Federal Chamber of Physicians (Bundeszarztekammer, BAK) and the German Federal Agency for Sera and Vaccines (Paul-Ehrlich-Institut, PEI) are effective. With this article, which will be published in two subsequent issues of this journal, the main changes compared to the regulations of 1996 will be presented, interpreted and commented. The Transfusion Law from 1998 is convened into regulations. The useful division of the Transfusion law into 'collection' (chapter 2) and 'preparation, storage and transport of blood and blood components' (chapter 3) on the one hand and 'application of blood products' (chapter 4) on the other hand has been adopted. A first chapter deals with scope, tasks and topics of the regulations, and with quality management and control. There are considerable differences between the two versions of the regulations. With regard to 15 Transfusion Law the regulations extensively deal with quality management and quality assurance. Many conditions and processes are defined in very derail, reducing the individual scope of action of those concerned. This improves the establishing of quality standards and transparency for the official controlling authorities on the one hand, but also Fosters further bureaucratization on the other. Positive aspects of the new regulations are clear and unequivocal definition of the blood donation requirements reasonably adapted to the Guidelines of the Europe Council, adequate consideration of sterile blood drawing, useful integration of hemapheresis into blood donation in general and omission of unnecessary investigations in hemapheresis as well as clear presentation of the required investigations of donors and quality controls of the various blood components. However, it is regrettable that there is only little room left for individual creativity and independent and responsible medical action, particularly regarding the application of blood products. Moreover, many of the requirements have been extended considerably and in part unnecessarily, leading to an extraordinarily additional personal and financial load particularly for the clinics. This is in contrast to the intention of the government enacting the Transfusion Law and stating its realization to be carried out without additional cost, in view of these fundamental changes, everyone who exactly kept the now annulled regulations before July 2000 must ask himself whether or not he met the state of the art as he was already obliged to do in the past because the old regulations only defined minimal requirements. In addition, the new regulations do not completely meet the demands made on them by 12 and 18 of the Transfusion Law, i.e. to define the generally accepted state of the art in science and technique since they themselves point out several times that, irrespective of the statements in the regulations, the state of the art in science and technique as well as the medical-scientific state of knowledge have to be taken into account. It is true that the official comments on the Transfusion law state that the presumption that the generally accepted state of the ari in science and technique was met when the regulations were followed is refutable in a given particular situation, and reference to the regulations by the law does not exempt the physician from his obligation to trace new scientific developments and to follow them if necessary. However, by claiming the consideration of the state of the art in science and technique as well as the medical scientific state and particularly the actual state of knowledge by the regulations themselves, considerable uncertainties may arise. From our point of view, the spectrum to be considered is extended to new knowledge and experience, and to statements of accepted experts and scientific medical societies. This article wants to make a contribution to the interpretation and discussion of the new regulations. II shall initiate the general discussion about the regulations, which was rather limited before their publication. By publishing Letters to the Editors, Infusion Therapy and Transfusion Medicine offers a platform for this discussion.
