Evaluation Public Hospitals’ Laboratories Performance Using the Basic Standards of Total Quality Management- A Study in Khartoum State – Sudan

Abstract

This study was carried out in Khartoum state during the period from 2005-2008, situation and aimed to evaluating 38 governmental hospitals laboratories laboratories performance on Quality Indicators With international standards scale & factors affecting the implementation of quality, the laboratories are assessed for compliance against the International Standard, CPA, ISO 17025 and ISO 15189.all the quality management systems operational within the organization and the technical competence of the laboratories to perform the tests are assessed. 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 automation used in clinical chemistry laboratories 5%, the errors of laboratories 60% were observed in the preanalytical phase of testing, 37% in the postanalytical phase, and only 3% in the analytical phase, continues assessment for laboratories auditing 26%, 55% of laboratories had calibration system. The quality control program 67% had internal quality control, 33% had national quality control no laboratories had international quality control , the quality control in this study done for 15 tests most of clinical chemistry tests required in laboratories used normal and pathological control sera the results found CV% For : glucose normal sera 19.1% pathological sera15.5 % acceptable results 74% , CV% urea normal sera 18.9% pathological sera 19.6% acceptable 64.4%, CV% creatinine normal sera 29.65 pathological sera 24.6% acceptable results 67.4%, CV% Sodium normal sera4.4% pathological sera5.1 % acceptable results 88.5 %, CV% potassium normal sera16.6% pathological sera 11.6 % acceptable results 80.5%, CV% Calcium normal sera 10.4% pathological sera13.9 % acceptable results 45%, CV% phosphate normal sera 11% pathological sera13.4 % acceptable results 81%, CV% uric acid normal sera 27.8% pathological sera 20.1% acceptable results 74%, CV% cholesterol normal sera 20.6% pathological sera 12.4 % acceptable results 91.5%, CV% triglyceride normal sera 21.4% pathological sera18.1% acceptable results 81.5%%, CV% albumin normal sera13.9% pathological sera10.6 % acceptable results 92%, CV% total bilirubin normal sera 34.2% pathological sera 22.7 % acceptable results 71%, CV% Alk. ph normal sera 49.1 % pathological sera 41.4% acceptable results 51.5 %, CV% AST normal sera 75.5% pathological sera 50.8% acceptable results 47.5% ,CV% ALT normal sera82.4 % pathological sera 50.8% acceptable results 42 %, the acceptability of results for all laboratories is 72%, total absolute error 55.56% , inaccuracy (variation) 11.5%, imprecision CV 25.1%. The evolution of clinical laboratory In vitro diagnostic kits 41 reagents for 8 parameters products by 10 manufactures different companies only 52% of companies had international standards certificate such as TUV, ISO13485, IVD, ISO 9001. The results of evaluation the kits the Uncertainty of glucose diagnostic kits is 9.4% total errors 6.4. Uncertainty of urea diagnostic kits is 6.4% total errors13.2%, Uncertainty of creatinine diagnostic kits is 13.7% total errors14.4%, Uncertainty of uric acid diagnostic kits is 9.8% total errors11.7 %, Uncertainty of calcium diagnostic kits is 7.9% total errors 9.2 %, Uncertainty of cholesterol diagnostic kits is 9.4% total errors 6.4 %, Uncertainty of triglyceride diagnostic kits is11.8 % total errors10.3 %, Uncertainty of albumin diagnostic kits is 10.1% total errors10.8 %. The total assessment for all diagnostic kits the CV 4.9 % .Variation7.2%, repeatability 1.34, Uncertainty 9.8% and the absolute total errors10.3%. The assessment of control sera use glucose and urea tests, commercial control sera found CV% between 9.1% to 26% uncertainty 18.2% to 42%, stability 4 to 30 days when the prepared sera recommended by WHO CV% between 1.5% to 2.9% uncertainty 3.0% to 58% and stability more than one year. The results analysis situation of our laboratories in this study on international standards should be need and stimulate the adoption of this standard and promote harmonization of accreditation programs at an international level. Quality assessment process needs to introduce regulation for external quality control, quality auditing, and management of reagents, calibration and quality control material this factors affecting the reliability and accuracy of laboratories results.