Who Assesses the Assessors? Qualification Gaps and Competence Deficits in Medical Laboratory Accreditation: A Multi-Centre Observational Study from India

Who Assesses the Assessors? Qualification Gaps and Competence Deficits in Medical Laboratory Accreditation: A Multi-Centre Observational Study from India | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Who Assesses the Assessors? Qualification Gaps and Competence Deficits in Medical Laboratory Accreditation: A Multi-Centre Observational Study from India SWAPAN SAMANTA, Nirmal Sultania, Mukul Roychoudhury, Surendra Sharma, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8810124/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The credibility of any accreditation system ultimately rests on the competence and integrity of its assessors. Despite the rapid expansion of laboratory accreditation in India through the National Accreditation Board for Testing and Calibration Laboratories (NABL), the qualifications and capabilities of individuals empowered to evaluate complex medical laboratories have received remarkably little scrutiny. Objectives To systematically evaluate the educational backgrounds, professional experience, and demonstrated competencies of assessors operating within the NABL framework, and to document instances where qualification gaps may compromise assessment quality. Methods This multi-centre observational study examined assessor profiles across 86 NABL-accredited medical laboratories over a 15-year period (2010–2025). We documented educational qualifications, clinical experience, and assessment performance for 63 assessors. Additionally, we conducted structured interviews with 47 pathologists and 19 laboratory managers to capture reported instances of assessor knowledge gaps. Results Sixty-three percent of assessors (40/63) held non-medical qualifications. Mean clinical laboratory experience was significantly lower among non-medical assessors (2.3 ± 2.8 years) compared to medical assessors (12.4 ± 6.8 years, p < 0.001). We documented 18 instances of fundamental misunderstanding of laboratory measurements, quality control principles, or clinical significance. The four-day training program qualifying assessors has no published validation studies demonstrating its effectiveness. Conclusions Significant qualification gaps exist among laboratory accreditation assessors, with the majority lacking medical training or substantial clinical experience. The current training and credentialing pathway appears inadequate for ensuring competent assessment of complex medical laboratory operations. We propose evidence-based reforms including mandatory medical qualifications for clinical laboratory assessors, extended competency-based training, and independent validation of assessor performance. laboratory accreditation assessor competence quality assurance NABL ISO 15189 medical laboratory qualification standards Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8810124","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":602802698,"identity":"57840a27-9b63-4ac7-b056-3eea6468d64e","order_by":0,"name":"SWAPAN SAMANTA","email":"data:image/png;base64,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","orcid":"","institution":"Post Graduate Institute of Medical Education and Research","correspondingAuthor":true,"prefix":"","firstName":"SWAPAN","middleName":"","lastName":"SAMANTA","suffix":""},{"id":602802699,"identity":"ff3ddbcd-952a-4860-9f33-1bd9e391444c","order_by":1,"name":"Nirmal Sultania","email":"","orcid":"","institution":"Post Graduate Institute of Medical Education and Research","correspondingAuthor":false,"prefix":"","firstName":"Nirmal","middleName":"","lastName":"Sultania","suffix":""},{"id":602802700,"identity":"e19e3aa0-5e22-460d-81d8-99d3ce7394bf","order_by":2,"name":"Mukul Roychoudhury","email":"","orcid":"","institution":"Post Graduate Institute of Medical Education and Research","correspondingAuthor":false,"prefix":"","firstName":"Mukul","middleName":"","lastName":"Roychoudhury","suffix":""},{"id":602802701,"identity":"b8d727d9-0025-4228-81f1-52df38cfb08a","order_by":3,"name":"Surendra Sharma","email":"","orcid":"","institution":"Post Graduate Institute of Medical Education and Research","correspondingAuthor":false,"prefix":"","firstName":"Surendra","middleName":"","lastName":"Sharma","suffix":""},{"id":602802702,"identity":"afdc9e87-091b-4968-94a9-8e4291810c1c","order_by":4,"name":"Paritosh Mitra","email":"","orcid":"","institution":"Post Graduate Institute of Medical Education and Research","correspondingAuthor":false,"prefix":"","firstName":"Paritosh","middleName":"","lastName":"Mitra","suffix":""}],"badges":[],"createdAt":"2026-02-06 18:38:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8810124/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8810124/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[],"financialInterests":"No competing interests reported.","formattedTitle":"Who Assesses the Assessors? Qualification Gaps and Competence Deficits in Medical Laboratory Accreditation: A Multi-Centre Observational Study from India","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"laboratory accreditation, assessor competence, quality assurance, NABL, ISO 15189, medical laboratory, qualification standards","lastPublishedDoi":"10.21203/rs.3.rs-8810124/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8810124/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe credibility of any accreditation system ultimately rests on the competence and integrity of its assessors. Despite the rapid expansion of laboratory accreditation in India through the National Accreditation Board for Testing and Calibration Laboratories (NABL), the qualifications and capabilities of individuals empowered to evaluate complex medical laboratories have received remarkably little scrutiny.\u003c/p\u003e\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003eTo systematically evaluate the educational backgrounds, professional experience, and demonstrated competencies of assessors operating within the NABL framework, and to document instances where qualification gaps may compromise assessment quality.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis multi-centre observational study examined assessor profiles across 86 NABL-accredited medical laboratories over a 15-year period (2010\u0026ndash;2025). We documented educational qualifications, clinical experience, and assessment performance for 63 assessors. Additionally, we conducted structured interviews with 47 pathologists and 19 laboratory managers to capture reported instances of assessor knowledge gaps.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eSixty-three percent of assessors (40/63) held non-medical qualifications. Mean clinical laboratory experience was significantly lower among non-medical assessors (2.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8 years) compared to medical assessors (12.4\u0026thinsp;\u0026plusmn;\u0026thinsp;6.8 years, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). We documented 18 instances of fundamental misunderstanding of laboratory measurements, quality control principles, or clinical significance. The four-day training program qualifying assessors has no published validation studies demonstrating its effectiveness.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eSignificant qualification gaps exist among laboratory accreditation assessors, with the majority lacking medical training or substantial clinical experience. The current training and credentialing pathway appears inadequate for ensuring competent assessment of complex medical laboratory operations. We propose evidence-based reforms including mandatory medical qualifications for clinical laboratory assessors, extended competency-based training, and independent validation of assessor performance.\u003c/p\u003e","manuscriptTitle":"Who Assesses the Assessors? 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