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Introduction: The international standard Clinical Pathology Accreditation UK , WHO-AFRO accreditation and ISO 15189 Medical laboratories -Particular requirements for quality and competence are the basis for this accreditation. These requirements not only require a management system and manual in the medical laboratory but also require that the laboratory be found competent to perform specific medical tests or types of tests.
Objective: The study aimed to assessment Governmental Hospitals’ Laboratories situation and their performance according to international standards scale.
Methods: The present study designed descriptive Series of case studies in thirty eight Government Hospitals’ Laboratories located in Khartoum state, the intervention application of Continuous Quality Improvement techniques to assess laboratories processes; total Quality Systems standards into laboratories were measured by Checklist contain standards elements and score of each element was conducted according to their importance of international standards. The quality control in this study was carried out for 15 tests, used control sera.
Results: Results availability of international standards for total quality management implementation in the laboratories is between 36% -86% the mean 65%, the safe laboratory design and organization 77.5%, laboratory organization 48.5%, document and management system 45.5%, quality of Personnel management 55.5%. The observed errors of laboratories in the preanalytical phase of testing were 60% and 37% in analytical phase, only 3% errors was reported in the post-analytical phase, continual improvement for laboratories auditing 26% . The quality control program 67% had internal quality control, 33% had national quality control, and the acceptability of quality control results for all laboratories was 72%, total absolute error 55.56%, inaccuracy (variation) 11.5%, imprecision CV 25.1%.
Conclusion: This study showed significant correlation between adoption of international standards and improved of accuracy and reliability on medical laboratories tests.
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Author(s): Ali AE Holi MAI Osman MM Elmahadi SA
Quality Management System, Quality control, ISO/IEC 17025, ISO 15189, CPA