The costs and consequences of management fads and politically driven regulatory oversight

The period from the mid-1980s to the present has seen a virtual revolution in how blood collection, testing, and transfusion are carried out. Most of the changes that have occurred represent changes in organization, underlying paradigms of transfusion safety, and approaches to solutions to perceived problems, rather than technical or scientific advances. These changes were instituted with little or no data to support their safety and efficacy, much less their cost-effectiveness.

Using data on changes in fees charged by regional blood centers during this period, an estimate was generated of the costs attending the purely administrative and organizational changes in the field of transfusion medicine.

The additional expenditures, excluding inflation, are in the range of $226 million per year. This figure does not include changes in infectious disease testing on donated blood, the substantive scientific advance during this period.

In addition to the questions of safety and efficacy, which are traditionally considered prior to clinical or procedural changes of this magnitude, the question remains whether these expenditures are a reasonable trade-off of cost versus benefit. Similar applications of federal regulatory standards intended for manufacturing (eg, good manufacturing practices) and industrial management theory (eg, total quality management) are now being implemented or proposed for hospitals, health care delivery systems, and individual 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.