Regulation of clinical microbiology and infection control--is the gain worth the pain?

In the USA, decreasing money for health has led medical professionals and the public to wonder whether cost containment is hurting patient care. In response to this, several regulatory bodies have instituted extensive review procedures under the label of 'quality assurance'. Anxiety in healthcare workers about the risk of HIV infection and chemical exposures has led to a profusion of rational and less-rational proposals, guidelines, and standards for employee protection. Concern about the validity of laboratory diagnostic tests has triggered laws, codes and rubrics about procedures and proficiency testing. A major premise of government now seems to be that 'an unregulated industry is an unsafe industry'. As a result, US hospitals find themselves reviewed, surveyed, examined, regulated and codified to a degree never before experienced. This quantity of review has been accompanied by problems of review quality, in the form of conflicting, vague and wasteful standards and regulations. What is at issue is finding the most efficient ways to address these problems. We must campaign for close cooperation between regulatory groups, clear distinction between sociopolitical and scientific justification for regulation, and cost-benefit analysis of the regulations and their impact. Laboratory and hospital infection control personnel are important to this effort because the epidemiological skills required for these tasks are the same abilities used to make clinical microbiology and hospital infection control effective and efficient. Similar problems and solutions may exist in other countries as well. The issue is particularly pertinent to the discussion of standards for hospital infection control in the European countries now preparing for economic unification.