학술논문

Evaluation of Sigma Metrics and Westgard Rule Selection and Implementation of Internal Quality Control in Clinical Chemistry Reference Laboratory, Ethiopian Public Health Institute.
Document Type
Academic Journal
Author
Geto Z; Department of Biomedical Science, College of Medicine and Health Science, Wollo University, Dessie, Wollo Ethiopia.; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Getahun T; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Lejisa T; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Tolcha Y; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Bikila D; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Bashea C; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Meles M; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Habtu W; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Ashebir G; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Negasa B; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Sileshi M; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Daniel Y; National Capacity Building Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Gashu A; National Capacity Building Directorate, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.; Challa F; Department of National Reference Laboratory for Clinical Chemistry, Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Source
Publisher: Association of Clinical Biochemists of India Country of Publication: India NLM ID: 8708303 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0970-1915 (Print) Linking ISSN: 09701915 NLM ISO Abbreviation: Indian J Clin Biochem Subsets: PubMed not MEDLINE
Subject
Language
English
ISSN
0970-1915
Abstract
Clinical laboratories are mandated to deliver accurate, reliable, timely and correctly reported result which, used in decision making for disease screening, diagnosis and monitoring. With aid of six sigma principles and metrics it is possible to assess the quality laboratory process and the quality control that is needed to ensure that the desired quality is achieved. Thus, this study was undertaken to evaluate the performance of biochemical parameters by calculating the sigma metrics of individual parameters using internal quality control (IQC) and Proficiency Testing (PT) results. The sigma metrics of 21 clinical chemistry parameters were calculated from COBAS 6000 analyzer with internal quality control (IQC) materials and external quality assurance scheme (EQAS) performance in national clinical chemistry laboratory for the period of six months. We obtained an excellent performance (≥ 6 sigma) for test parameters amylase pancreatic, amylase total, HDL, magnesium, AST, triglyceride, total bilirubin and ALT in both levels of quality control. Urea, creatinine and chloride were failed to meet the minimal sigma performance for both level 1 and 2. Sigma values of 3-6 were observed for ALP, Direct bilirubin, total protein, albumin, glucose, potassium, and phosphate with both levels of quality control. Though, stringent IQC strategy is not mandatory for analytes that scored sigma value ≥ 6. However, continuous monitoring quality control is required for renal function tests and process improvement will be designed for those with poor sigma values.
Competing Interests: Conflict of interestsAuthors state no conflict of interest.
(© Association of Clinical Biochemists of India 2021.)