{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:33:53Z","timestamp":1786984433284,"version":"build-2736575974"},"reference-count":26,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T00:00:00Z","timestamp":1786924800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pre-analytical venous blood specimen rejection can delay clinical decision-making and may increase laboratory workload, yet multicenter benchmarking remains limited by inconsistent rejection definitions and denominator selection. This study aimed to support denominator-consistent benchmarking, transferable implementation, and quality monitoring across heterogeneous-resource settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a retrospective quality-indicator study across 10 hospitals in Western China using routine venous blood specimen data collected from January 1, 2023, to April 30, 2024. Rejection reasons were standardized with a prespecified mapping dictionary. Center-level rejection rates, defects per million opportunities (DPMO), and Six Sigma values were calculated using monthly venous specimen volume as the primary denominator. Percentile-based benchmarks, pooled estimates, and a month-adjusted random-intercept generalized linear mixed-effects model were used to assess performance and residual between-center heterogeneity.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 21,319,200 venous specimens, 42,060 were rejected, yielding a pooled rejection rate of 0.197%. The leading standardized rejection categories were clot\/aggregation, insufficient or incorrect volume, and container\/tube error. Rejection patterns varied across centers and clinical settings: inpatient and emergency events were dominated by clotting and volume problems, whereas outpatient and physical examination events more often showed order, timing, or identification errors. After temporal adjustment, measurable between-center heterogeneity persisted (intraclass correlation coefficient\u202f=\u202f0.045).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This multi-center quality-indicator study provides a reproducible, denominator-consistent framework for benchmarking venous blood specimen rejection across multiple centers. Percentile-based benchmarks and standardized reason spectra may support local implementation and transferable Six Sigma monitoring in healthcare systems with heterogeneous resources.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1878028","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:10:07Z","timestamp":1786983007000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Establishing denominator-consistent Six Sigma benchmarks for venous blood specimen rejection: a multi-center retrospective quality-indicator study using 21 million specimens in Western China"],"prefix":"10.3389","volume":"13","author":[{"given":"Chunbao","family":"Xie","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine, Sichuan Provincial People\u2019s Hospital, University of Electronic Science and Technology of China","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Changrui","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Sichuan Provincial People\u2019s Hospital, University of Electronic Science and Technology of China","place":["Chengdu, Sichuan, China"]},{"name":"Sichuan Provincial Key Laboratory for Human Disease Gene Study","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Xiao","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Zigong First People\u2019s Hospital","place":["Zigong, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Ya\u2019an People\u2019s Hospital","place":["Yaan, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengxi","family":"Jia","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Liangshan Prefecture People\u2019s Hospital","place":["Xichang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fangkui","family":"Xiong","sequence":"additional","affiliation":[{"name":"Medical Laboratory, Jinniu District People\u2019s Hospital of Chengdu","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zehong","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine, Medical Center Hospital of Qionglai City","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulian","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hengyong","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Qianjiang District TCM Hospital of Chongqing","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huan","family":"Ding","sequence":"additional","affiliation":[{"name":"Depariment of Clinical Laboratory, Zhongxian People\u2019s Hospital of Chongqing","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yifeng","family":"Huang","sequence":"additional","affiliation":[{"name":"Chengdu Wenjiang District People's Hospital","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoting","family":"Zhan","sequence":"additional","affiliation":[{"name":"Department of Medical Laboratory, The Affiliated Hospital of Southwest Medical University","place":["Luzhou, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangcheng","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Medicine, Affiliated Hospital of North Sichuan Medical College","place":["Nanchong, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiawei","family":"Zeng","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China","place":["Mianyang, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi","family":"Huang","sequence":"additional","affiliation":[{"name":"Medical Administration Department, Sichuan Academy of Medical Sciences and Sichuan Provincial People\u2019s Hospital","place":["Chengdu, Sichuan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,17]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"691","DOI":"10.1093\/clinchem\/48.5.691","article-title":"Errors in laboratory medicine","volume":"48","author":"Bonini","year":"2002","journal-title":"Clin Chem"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"750","DOI":"10.1515\/CCLM.2006.123","article-title":"Errors in clinical laboratories or errors in laboratory medicine?","volume":"44","author":"Plebani","year":"2006","journal-title":"Clin Chem Lab Med"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"720","DOI":"10.1515\/CCLM.2007.167","article-title":"Risk management in the preanalytical phase of laboratory testing","volume":"45","author":"Lippi","year":"2007","journal-title":"Clin Chem Lab 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improvement: in quality we trust","volume":"51","author":"Lippi","year":"2013","journal-title":"Clin Chem Lab Med"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"1478","DOI":"10.1515\/cclm-2017-0412","article-title":"Defining a roadmap for harmonizing quality indicators in laboratory medicine: a consensus statement on behalf of the IFCC working group \"laboratory error and patient safety\" and EFLM task and finish group \"performance specifications for the extra-analytical phases.\"","volume":"55","author":"Sciacovelli","year":"2017","journal-title":"Clin Chem Lab Med"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"35","DOI":"10.1016\/j.cca.2019.07.007","article-title":"Pre-analytical quality indicators in laboratory medicine: performance of laboratories participating in the IFCC working group \"laboratory errors and patient safety\" project","volume":"497","author":"Sciacovelli","year":"2019","journal-title":"Clin Chim Acta"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"357","DOI":"10.1515\/cclm-2014-1051","article-title":"Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) working group for preanalytical phase (WG-PRE)","volume":"53","author":"Lippi","year":"2015","journal-title":"Clin Chem Lab Med"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"662","DOI":"10.1515\/cclm-2022-0117","article-title":"Preanalytical quality improvement \u2013 an interdisciplinary journey","volume":"60","author":"Cadamuro","year":"2022","journal-title":"Clin Chem Lab Med"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"187","DOI":"10.1515\/cclm-2012-0582","article-title":"Towards harmonization of quality indicators in laboratory medicine","volume":"51","author":"Plebani","year":"2013","journal-title":"Clin Chem Lab Med"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1515\/CCLM.2008.168","article-title":"Preanalytical quality control program \u2013 an overview of results (2001-2005 summary)","volume":"46","author":"Alsina","year":"2008","journal-title":"Clin Chem Lab Med"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/10408363.2019.1664391","article-title":"Managing hemolyzed samples in clinical laboratories","volume":"57","author":"Simundic","year":"2020","journal-title":"Crit Rev Clin Lab Sci"},{"key":"ref25","first-page":"85","article-title":"Quality indicators to detect pre-analytical errors in laboratory testing","volume":"33","author":"Plebani","year":"2012","journal-title":"Clin Biochem Rev"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1016\/j.cca.2013.07.033","article-title":"Quality indicators to detect pre-analytical errors in laboratory testing","volume":"432","author":"Plebani","year":"2014","journal-title":"Clin Chim Acta"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1878028\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:10:08Z","timestamp":1786983008000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1878028\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,17]]},"references-count":26,"alternative-id":["10.3389\/fmed.2026.1878028"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1878028","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,17]]},"article-number":"1878028"}}