Clinical microbiology quality assurance program: a Taiwan experience.

Abstract

Quality assurance programs have been established during the last two decades in developed countries to promote high quality performance in clinical laboratories. In Taiwan, such a program for clinical microbiology laboratories has been in place since July 1987. It has been supported by the Department of Health, Executive Yuan, R.O.C. and was set up by the authors. The manpower status, facilities and equipment, and performance of clinical laboratories were investigated during the first year and standards of laboratory quality were recommended. Since then, under a continuing education program, we have conducted seminars, symposia, workshops, short-courses or panel discussions approximately 4 times a year. There have been about 150 participants per session and they have come from local hospitals (primary care hospitals), regional hospitals (secondary care hospitals) and medical centers (tertiary care hospitals). Proficiency test specimens or external unknown specimens were sent to all the laboratories twice a year and approximately 3 specimens were used each time for the evaluation of each laboratory's diagnostic capability and quality of service. Results indicated that there were tremendous improvements in the quality of laboratory performance. At the same time, several laboratory manuals describing the methods of quality control of clinical specimens, test procedures, media and reagents, personnel management and a compilation of reports etc. were published as guidelines of basic requirements for each level of the laboratories. For local hospital laboratories in remote areas, several regional hospitals or medical centers with high quality laboratories were selected to serve as back-ups. Our evaluation has shown that the performance and quality of service provided by most clinical microbiology laboratories in Taiwan have now reached nearly the level of those found in the so-called "developed countries".