The Application of Clinical Biochemical Field Comparison Scheme Under ISO 15189 Total Quality Management System
Objective Basing on total quality management system of ISO 15189,to explore various comparison schemes involved in clinical biochemistry laboratory and to further provide references for the optimal use of comparison scheme in daily inspection work.Methods Referring medical laboratory accreditation documents,'National Relevant Health Industry Standards ', CLSI series related documents and by combining with our own working experience,we analyzed the application of various quality assessment programs in clinical biochemical field comparison activities,and sorted out and summarized the comparison schemes involved.Results In this study,11 comparison experiments involved in the field of clinical biochemistry were listed and summarized.The comparison results met the requirements of different situations.Conclusion Through the sorting of different comparison schemes and case analysis,the results can direct the daily inspection work to compare the correct choice of scheme,and improve the quality and capability of laboratory tests.
ISO 15189Accreditation of medical laboratoriesQuality management systemAlignment scheme