Assessment of Quality Assurance for Medical Laboratory Services in Sudan

Abstract

Abstract Clinical laboratory errors may arise mainly from the lack of awareness and adoption of the quality assurance program. Today, quality assurance is essential to meet the needs of clients and customers satisfaction (patients, clinical personnel and researchers), those who responsible for the care of those patients. This study was conducted in eight Sudanese states (Khartoum, Gazira, North Kordofan, White Nile, River Nile, Red Sea, Gadaref and Kassala state), during the period from 2009-2012, aimed to assess the current situation of quality assurance and factors affecting laboratory proficiency, as well as to identify gaps for implementing quality assurance program, of the international standard ISO 15189. in the first experiment (phase one), 130 laboratories were randomly selected, and 520 samples of pathological lyophilized control sera well prepared were distributed to assess the performance to measure 4 parameters (Glucose, Urea, Uric Acid and Creatinine) as routine blood chemistry assay. (5 types of reagents were used, R (1, 2, 3, 4 and 5) and 3 types of equipments (fully automated, semi-automated and manual machine) in deferent laboratory levels A, B and C and deferent laboratory sectors Governmental, and Private based on the standard deviation index SDI (Z score) evaluation method. While in the second experiment (phase two) 200 samples of control sera were distributed in 6 laboratory Governmental and private, level A, B and C using the same reagents and equipments and every sample was tested 20 times. The results in phase one showed that poor perfomance was noticed as in glucose only 31 laboratories have succeeded (24%), while 99 have failed 76%. In Urea 56 laboratories were succeeded 43% while 74 were failed (57%). ln Uric Acid 33 laboratories were succeeded (25%)

while 97 failed 75%. In Creatinine 71 laboratories succeeded (55%) while 59 were failed 45%. The implementation of full (IQC) 19%, full (EQA) 11%, full (SOPs) 8%, organizational chart in the laboratory l7%, Job description of laboratory personnel 3%, storage reagents at optimum temperature 15%, calibration of equipments 5%, sample rejection criteria 5%, request form including clinical remarks 3%, quality control sera in every run l2%, computer software for reporting archiving results 23% system of critical value 6%, enough laboratory space ll% air condition inside the laboratory 20%, waste disposal managements 5% and immunization of personnel against HBV & HCV 4%. Moreover, the second experiment (phase two) showed reagent (4) result an out of control reading in glucose and urea level compared with the other reagent which were showed variant readings which will considered clinically significant. Low level of quality assurance and poor performance of laboratories were evident in selected states, in order to obtain reliable and accurate results.