Evaluation of The Reality of Applying the Item of Administrative Requirements According to ISO 15189: 2012: A Case Study in The Educational Laboratory in The Department Of Educational Medicine City

Abstract

The research aims to identify the level of application of administrative requirements in accordance with ISO15189:2012 and to determine the size of the gap between the actual reality of the application of the fourth item on administrative requirements، the quality and efficiency management system of medical laboratories was chosen in the educational laboratories in the Medical City Hospital of the Ministry of Health / Environment as a research sample. Quantitative and qualitative methods were adopted in data collection and analysis. Where quantitative methods were used، such as the weighted arithmetic mean، percentage measurement، and measuring the size of the gap، while the qualitative methods included visits، personal observation، access to documents، records، and interviews. Quality management system، document control axis، service agreements، referral laboratories، external services and supplies، advisory services، complaints، control of non-conformity checks، preventive measures، corrective actions، continuous improvement، record monitoring، evaluation and control، administrative review)، which fall under The fourth item to assess the application of administrative requirements in order to diagnose the extent of the implementation of the fourth item of the standard.، in addition to identifying the departments that succeeded in implementing those items. The extent of application of the axes was diagnosed، and which axes were most and least applied. The research reached a set of important results about the reality of the application of administrative requirements، which was that there was a gap in the level of the actual application of the fourth item of the specification in the researched laboratory، where it was found that there was a gap and it was distributed on the stage of responsibility of management and organization by (5%)، the quality management system by (5%). 25%) Referral laboratories by (90%)، consulting services by (25%)، control and control examinations by (25%)، corrective measures by (33.3%)، preventive measures by (25%)، continuous improvement by 25%، Records control 25%، evaluation and review 75%، management review 50%. In addition، ISO 15189: 2012 Quality and Efficiency Requirements - Medical laboratories is an internationally recognized specification that contains the requirements for testing and diagnostic laboratories to prove their efficiency in providing reliable laboratory services. When applied، it builds an administrative system for medical laboratories and allows laboratories to organize their practical procedures.