Abstract

The study aims to identify the level of application of the requirements of quality and efficiency of the medical laboratory in accordance with the ISO15189:2012 standard and to determine the size of the gap in the research laboratories in Baghdad between the actual reality and the requirements of the international standard ISO 15189:2012 for the quality and efficiency of medical laboratories. The research stems from the problem that laboratories suffer from, which is that medical laboratories have procedures to review the results before issuing them, taking into account the internal quality control and medical information, if any, in addition to that, there is a need for documented procedures to address the quality of samples and issue the results, as the case study approach was adopted and Diagnosing the reality of applying the requirements of the quality and efficiency of the medical laboratory in the laboratories of the Specialized Surgery Hospital. Field visits and access to documents, records, and interviews. The data and information collection was mainly based 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, controlling non-conforming checks, preventive measures, corrective measures, continuous improvement, monitoring records, evaluation and control, references. Administrative, personnel, accommodation and environmental conditions, laboratory equipment, pre-examination processes, examination procedures, quality assurance of examination results, post-examination procedures, laboratory information management) which fall under the requirements of the specification and adopted a set of statistical methods that included (weighted arithmetic mean, measurement of Percentage, a measure of the size of the gap). The extent of application of the specification axes was diagnosed, and which axes were the most and least applied. The research reached a set of important results about the reality of the application of the requirements of the standard, which is that the total rate of application of the standard in the laboratories investigated came with a matching rate of 87% and a gap size estimated at 13% and this percentage is considered high in the case of application to the requirements of the standard, as these requirements provide reliability in the case of The quality requirements were carried out correctly.