Correspondence: Imran Siddiqui, Department of Pathology & Microbiology, Aga Khan University, Karachi, Pakistan. E-mail: imran.siddiqui@aku.edu (Received 4 July 2014; accepted 18 January 2015) ORIGINAL ARTICLE Error identification in a high-volume clinical chemistry laboratory: Five-year experience LENA JAFRI, AYSHA HABIB KHAN, FAROOQ GHANI, SHAHID SHAKEEL, AHMED RAHEEM & IMRAN SIDDIQUI Department of Pathology & Microbiology, Aga Khan University, Karachi, Pakistan Abstract Introduction. Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. Materials and methods. Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An ‘error’ was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. Results. In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators – visible hemolysis, failure of proficiency testing and delay in stat tests – were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. Conclusions. Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency. Key Words: Laboratory proficiency testing, quality control, quality indicators, healthcare, errors Abbreviations: CAP, College of American Pathologists; AKUH, Aga Khan University Hospital; JCIA, Joint Commission International Accreditation; SPSS, Statistical Package of Social Sciences; EQAS, External Quality Assurance Surveys. Introduction Quality assurance is the complete program that war- rants that the final results reported by a laboratory are correct. The objective of quality assurance is that the right result is provided on the right specimen at the right time and interpreted according to the right refer- ence data [1,2]. The scientific monitoring of an ongo- ing analytical performance and taking appropriate in time measures to ensure quality results are a part of daily practice in most clinical laboratories but test result reliability cannot be achieved through the con- trol of accuracy in the analytical part of testing process alone. Precision and result accuracy are achieved by both analytical and preanalytical monitoring of processes [3]. To reduce preanalytical errors, clinical laborato- ries emphasize on proper test entry with standardized phlebotomy technique and proper transport and sample storage to be followed [4]. The protocols to reduce post analytical errors include proper entry of results, results to be forwarded to pathologist for verification or rectification, immediate delivery of results and immediate communication of panic results. An important point in improving laboratory quality is the definition of some indicators to be monitored as measures of a laboratory trend [5]. The College of American Pathologist (CAP) defines ‘quality improvement’ as the practice of continuously assessing and adjusting performance using statisti- cally and scientifically accepted procedures [6]. The constant scrutiny of quality indicators and conse- quent corrective actions can help to reduce errors and the risk of errors, thus enhancing the laboratory outcome [7]. In addition, the standardization of risk evaluation techniques and the definition of a set of indicators can eventually contribute to a benchmarking Scandinavian Journal of Clinical & Laboratory Investigation, 2015; Early Online: 1–5 ISSN 0036-5513 print/ISSN 1502-7686 online © 2015 Informa Healthcare DOI: 10.3109/00365513.2015.1010175 Scand J Clin Lab Invest Downloaded from informahealthcare.com by UBO Bib for Hum og Samfunnsviten on 04/20/15 For personal use only.