The role of regional research laboratories of the local government in administering regional EQA programs

In 1981, the Japanese Ministry of Health and Welfare revised the enforcement of regulations of the Medical Technologists' Act. The amendments stipulate that all independent laboratories are legally obliged to introduce laboratory quality assurance programs and are responsible for the quality of all test results. To ensure adherence to these regulations, regional research laboratories of local governments such as the Tokyo Metropolitan Research Laboratory of Public Health should conduct regional external quality assessment (EQA) programs. We did a survey, in the form of a questionnaire, of the regional research laboratories of public health across the country. We found that commitment to the regional EQA in almost all of these public laboratories is insufficient. The main problem is that restructuring of local governments has resulted in lower budgets and so they are short of human resources. Nationwide EQA programs are only able to detect gross errors and use invalid methods for evaluating routine performance. We conclude that the regional EQA should be further developed.