[External quality assessment for clinical microbiology and good laboratory management]

The Tokyo Metropolitan external quality assessment (EQA) program has revealed some serious problems in private independent microbiology laboratories in Tokyo since 1982. The poor performance in the EQA surveys closely related to poor laboratory managements, the type of training, experience of the medical technologists or technicians, and supervisory ability of the consultant physicians in independent laboratories. Social factors impede the reform of the quality assurance of clinical microbiology. Such factors include poor infrastructure of continuing education for small private laboratories, closure of the central clinical laboratories in the hospitals and outsourcing of laboratory tests due to restructuring in response to economic problems, and limited numbers of certified clinical pathologists of the Japan Society of Clinical Pathology (JSCP). Therefore, the Tokyo Metropolitan EQA Scheme is still confidential and its main role is educational. Good two way communication between participants and the organizers' clinical pathologists is essential, if the quality of laboratory tests is to be improved. The new JSCP edition of the postgraduate training requirement in clinical pathology includes "Laboratory Administration and Management". Good laboratory management(GLM) is an increasingly important component of good laboratory practice. The practice activities of clinical pathologists must include general management in addition to exercising there specialized knowledge in medicine and technology. Whereas leadership of a good clinical pathologist provides the direction of where a good laboratory is going, good management provides the steps of how to get there. And I believe quality system models from business and industry may provide us with strong guidance to build a quality system for the good laboratory that will endure into the next century.