Abstract

The research aims to identify the level of application of the requirements of quality and efficiency of medical laboratories in accordance with ISO15189:2012 and to determine the size of the gap in the research laboratories in Baghdad between the actual reality and the requirements of the standard. The research stems from the problem that laboratories suffer from and the availability of requirements for the quality and efficiency of medical laboratories according to the specification, as the comparative approach was adopted and the actual reality of the extent of the application of the specification was diagnosed in (the educational laboratory of the Medical City Hospital and Sama Al-Wathiq Al-Ahly Laboratory). Dependence on the checklist, which included twenty-one axes (administration and organization responsibility, quality management system, document control axis, service agreements, referral laboratories, external services and supplies, advisory services, complaints, control of non-conforming examinations, preventive measures, corrective measures, continuous improvement, Records control, evaluation and control, administrative review, personnel, accommodation and environmental conditions, laboratory equipment, pre-examination processes, examination procedures, quality assurance of examination results, post-test procedures, laboratory information management), which fall under the requirements of the specification and adopted a set of statistical methods that included (weighted arithmetic mean, percentage measure, gap size measure). The extent of application of the specification requirements was diagnosed, and which requirements were more and less applied. The research found that there are differences in the application rates for the researched laboratories, as the educational laboratory occupied the first place with an application rate of (76%) according to the triple scale, while the Sama Al-Wathiq Al-Ahly laboratory occupied the second place with a percentage of (64%).