The costs and consequences of management pads and politically driven regulatory oversight - The case of blood transfusion

Context-The period from the mid-1980s to the present has seen a virtual rev olution in how blood collection, testing, and transfusion are carried out. Most of the changes that have occurred represent changes in organization, u nderlying paradigms of transfusion safety, and approaches to solutions to p erceived problems, rather than technical or scientific advances. These chan ges were instituted with little or no data to support their safety and effi cacy, much less their cost-effectiveness, Design.-Using data on changes in fees charged by regional blood centers dur ing this period, an estimate was generated of the costs attending the purel y administrative and organizational changes in the field of transfusion med icine. Results.-The additional expenditures, excluding inflation, are in the range of $226 million per year. This figure does not include changes in infectio us disease testing on donated blood, the substantive scientific advance dur ing this period. Conclusions.-In addition to the questions of safety and efficacy, which are traditionally considered prior to clinical or procedural changes of this m agnitude, the question remains whether these expenditures are a reasonable tradeoff of cost versus benefit. Similar applications of federal regulatory standards intended for manufacturing leg, good manufacturing practices) an d industrial management theory leg, total quality management) are now being implemented or proposed for hospitals, health care delivery systems, and i ndividual physician's practices. Thus, the case of transfusion medicine may provide some cautionary lessons for future proposed changes in health care delivery and medical practices.