Development of medical laboratory certification system according to Ministry of Public Health standard

Abstract

       The Department of Medical Sciences had developed Laboratory Quality System Certification according to Ministry of Public Health (MOPH) standard which is the policy of the Ministry of Public Health defined as a KPI in fiscal year 2014 in order to strengthen 434 laboratories that had not yet neither been certified nor implemented quality system to be certified according to the MOPH standard. The important steps in implementation of the laboratory certification system are preparation of the medical laboratory standards including management and technical requirements as well as the checklist for audit and assessment 80 items, preparation of the audit process, training on the quality system requirements for all laboratory staff, and preparation of quality manual, requirements and condition of laboratory certification according to the MOPH standard. Two hundred and twenty seven laboratories of the target group and 179 laboratories of non target group, totally 406 laboratories of 934 laboratories, had been certified. The results from the questionnaires to evaluate the satisfaction of the MOPH certification system showed that the satisfaction in the field of service, audit system, and service quality was 85.85, 84.66 and 85.81 percent respectively. All satisfaction were higher than the predefined criteria at 80.00 percent. Thus, the implementation of this established certification system conducted for the MOPH laboratories showed satisfactory achievement and would be extended to the medical laboratories in private sector.