The relevance, usefulness, quality, and cost of performance of many clinical microbiology laboratories have been questioned. Major, common constraints under which most microbiology laboratories operate in the United States include lack of trained manpower, wide variation in the level and sophistication of clinical microbiology service, lack of physician-laboratory communication and interaction, inadequacies in medical education, and often inadequate laboratory space. Governmental regulations, requirements, and standards have improved the quality of many laboratories' work, but also result in greatly increased costs, excesses of often trivial procedures, and diversion of trained manpower from clinical service to regulatory procedures, with a resulting increase in manpower needs. The usefulness, relevance, and cost of regulatory requirements and procedures are unknown. Lack of reliable, standardized reagents impedes utilization of rapid and low cost procedures, and proliferation of complex tests results in costly additional demands on existing manpower.