{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,21]],"date-time":"2026-10-21T16:44:37Z","timestamp":1792601077293,"version":"4.5.0"},"reference-count":32,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T00:00:00Z","timestamp":1791331200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Clin Biochem"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In recent years, the error rate in the analytical stage of laboratory testing has been drastically reduced due to automation, good-quality reagents, standardized assays, and increased participation of laboratories in proficiency testing programs. Nevertheless, high error rates in extra-analytical phase remain a critical vulnerability impacting diagnostic performance and patient safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The present observational study was designed to quantify error rates and evaluate efficiency of extra-analytical processes, using quality indicators on the Sigma metrics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We examined extra-analytical errors in 51,072 test requests received in the Clinical Biochemistry Laboratory of GIPMER Delhi, India from March to August 2025. Extra-analytical phase quality standards for sample testing conformed to the IFCC quality indicators. Minitab software was used to calculate Six Sigma from the collected data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Our investigation revealed that 1572 errors, accounting for about 90% of the total, occurred during extra-analytical phase. Manual entry of test request information in the autoanalyzer during the pre-analytical stage and transcription of test results into patient reports in the post-analytical stage accounts for 35% of all laboratory errors in this study. Pre-analytical errors were chiefly Test transcription (39%) and haemolysis (27%), while post-analytic errors were delay in TAT (43%) and manual result entry errors (41%), expressed as percentage of total pre-analytical and post-analytical errors, respectively. Sigma values for all QIs were acceptable ranging from 4\u20134.9 for the pre-analytical and 4.2\u20135 in the post-analytical processes of laboratory testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Clinical biochemistry laboratories can significantly improve extra-analytical phase quality using Six Sigma based Quality Indicator framework.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/00045632261499295","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T14:45:43Z","timestamp":1791384343000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Quality indicator driven sigma scale assessment of extra-analytical phases in clinical chemistry laboratory-Insights from a tertiary care hospital"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5911-3558","authenticated-orcid":false,"given":"Jitender","family":"Sharma","sequence":"first","affiliation":[{"name":"GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roopali","family":"Rajput","sequence":"additional","affiliation":[{"name":"VPCI"},{"name":"University of Delhi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Himanshu","family":"Sharma","sequence":"additional","affiliation":[{"name":"AIIMS Bathinda"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pradeep K","family":"Dabla","sequence":"additional","affiliation":[{"name":"GB Pant Institute of Postgraduate Medical Education and Research (GIPMER)"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,7]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1258\/acb.2011.011177"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2012.32.1.5"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1258\/acb.2011.011126"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6890-1-5"},{"key":"e_1_3_4_6_2","doi-asserted-by":"publisher","DOI":"10.1258\/acb.2009.009222"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.cll.2016.09.015"},{"key":"e_1_3_4_8_2","unstructured":"Westgard JO. 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