{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T17:09:34Z","timestamp":1790010574112,"version":"4.0.1"},"reference-count":20,"publisher":"Walter de Gruyter GmbH","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Patient risk management has become central to clinical laboratory quality standards, including the Clinical and Laboratory Standards Institute (CLSI) EP23 2nd edition (CLSI EP23-ED2), International Organization for Standardization (ISO) 15189:2022, ISO 22367:2026, and ISO 14971:2019. A key component of risk analysis is estimating the severity of harm (SoH) that may result from erroneous laboratory results. We present here the Severity of Harm Evidence Database, a structured, multi-study resource that integrates survey-based SoH assessments from the published independent studies. The database provides ordinal distributions and pooled SoH for 196 unique laboratory\u00a0tests.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n A canonical five-level scale (negligible, minor, serious, critical, catastrophic) was adopted, aligned with ISO 14971:2019. For the 19 tests common to both studies, direct count pooling was performed by summing category-level respondent counts. Wilson score confidence intervals were calculated for all proportions. The database is organized into nine relational sheets and is accompanied by an interactive web application.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Out of the 196 tests covered, 19 have pooled estimates from both studies (total n=781 respondents). Pooled analysis confirms that cardiac biomarkers, blood gases, coagulation parameters, electrolytes (potassium, sodium), and therapeutic drug concentrations (digoxin, lithium) consistently receive the highest severity ratings, while certain endocrine markers receive lower scores.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n The SoH evidence database offers the first publicly available, structured repository of SoH assessments for clinical laboratory tests. It supports compliance with risk management requirements, informs risk-based strategies per CLSI EP23-ED2, and provides an evidence-based foundation for laboratory risk analysis.<\/jats:p>\n <\/jats:sec>","DOI":"10.1515\/cclm-2026-0875","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T14:57:42Z","timestamp":1785250662000},"source":"Crossref","is-referenced-by-count":1,"title":["The severity of harm score database: an evidence-based foundation for laboratory test risk analysis"],"prefix":"10.1515","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5321-9354","authenticated-orcid":false,"given":"Hikmet Can","family":"\u00c7ubuk\u00e7u","sequence":"first","affiliation":[{"name":"Department of Medical Biochemistry , Sincan Training and Research Hospital , Ankara , T\u00fcrkiye"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1579-0412","authenticated-orcid":false,"given":"Oswald","family":"Sonntag","sequence":"additional","affiliation":[{"name":"Independent Consultant , Munich , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-3501-7218","authenticated-orcid":false,"given":"Nathan","family":"Lorde","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry , University Hospitals Birmingham NHS Foundation Trust , Birmingham , UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8887-376X","authenticated-orcid":false,"given":"Charles R.","family":"Lef\u00e8vre","sequence":"additional","affiliation":[{"name":"Laboratoire de Biochimie-Toxicologie , CHU de Rennes , Rennes , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0678-0277","authenticated-orcid":false,"given":"Chiara","family":"Cosma","sequence":"additional","affiliation":[{"name":"Department of Medicine , University of Padova , Padua , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2304-5298","authenticated-orcid":false,"given":"Annelien Van","family":"Dalem","sequence":"additional","affiliation":[{"name":"Department of Clinical Biology , Universitair Ziekenhuis Brussel , Brussels , Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-7176","authenticated-orcid":false,"given":"Panagiotis N.","family":"Kanellopoulos","sequence":"additional","affiliation":[{"name":"Central Laboratory , General Hospital of Athens, \u201cLaiko\u201d Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1502-5705","authenticated-orcid":false,"given":"Marija","family":"Kocijancic","sequence":"additional","affiliation":[{"name":"Institute of Clinical Chemistry and Pathobiochemistry , University Hospital T\u00fcbingen , T\u00fcbingen , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2903-3135","authenticated-orcid":false,"given":"Guilaine","family":"Boursier","sequence":"additional","affiliation":[{"name":"CHU Montpellier, Department of Molecular Genetics and Cytogenomics , National Reference Laboratory of Autoinflammatory Diseases, French National Reference Center of Autoinflammatory Diseases and Amyloidosis (CeR\u00e9MAIA), IRMB, INSERM U1183, Univ Montpellier , Montpellier , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4945-6637","authenticated-orcid":false,"given":"Pika Me\u0161ko","family":"Brguljan","sequence":"additional","affiliation":[{"name":"Department of Clinical Chemistry , University Clinic for Respiratory and Allergic Diseases , Golnik , Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2641-9817","authenticated-orcid":false,"given":"Neda","family":"Milinkovic","sequence":"additional","affiliation":[{"name":"Department of Medical Biochemistry , Faculty of Pharmacy, University of Belgrade , Belgrade , Serbia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5454-990X","authenticated-orcid":false,"given":"Marith van Schrojenstein","family":"Lantman","sequence":"additional","affiliation":[{"name":"SKML, Foundation for Quality Assessment in Medical Laboratory Diagnostics , Nijmegen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1771-669X","authenticated-orcid":false,"given":"Marc","family":"Thelen","sequence":"additional","affiliation":[{"name":"SKML , Nijmegen , The Netherlands"},{"name":"Department of Laboratory Medicine , Radboud University Medical Center , Nijmegen , The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3916-1357","authenticated-orcid":false,"given":"Amitava","family":"Dasgupta","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine , University of Kansas Medical Center , Kansas City , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9523-9054","authenticated-orcid":false,"given":"Giuseppe","family":"Lippi","sequence":"additional","affiliation":[{"name":"Section of Clinical Biochemistry , University of Verona , Verona , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0270-1711","authenticated-orcid":false,"given":"Mario","family":"Plebani","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine , University Hospital\u00a0\u2013\u00a0Padova, University of Padova , Padova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,7,29]]},"reference":[{"key":"2026073105563952718_j_cclm-2026-0875_ref_001","doi-asserted-by":"crossref","unstructured":"Rohr, UP, Binder, C, Dieterle, T, Giusti, F, Messina, CG, Toerien, E, et al.. 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Clin Chem Lab Med 2025;63:1084\u201398. https:\/\/doi.org\/10.1515\/cclm-2024-1451.","DOI":"10.1515\/cclm-2024-1451"},{"key":"2026073105563952718_j_cclm-2026-0875_ref_004","unstructured":"International Organization for Standardization. ISO 15189:2022. Medical laboratories\u00a0\u2013\u00a0requirements for quality and competence. Geneva: International Organization for Standardization; 2022."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_005","unstructured":"International Organization for Standardization. ISO 22367:2026 medical laboratories \u2013 application of risk management to medical laboratories. Geneva: International Organization for Standardization; 2026."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_006","unstructured":"Clinical and Laboratory Standards Institute. CLSI document EP23-ED2:2023\u00a0\u2013\u00a0laboratory quality control based on risk management, 2023. 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ISO 14971:2019 medical devices \u2013 application of risk management to medical devices. Geneva: International Organization for Standardization; 2019."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_010","unstructured":"International Organization for Standardization. ISO 24971:2020 medical devices \u2013 guidance on the application of ISO 14971. Geneva: International Organization for Standardization; 2020."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_011","doi-asserted-by":"crossref","unstructured":"Agresti, A, Coull, BA. Approximate is better than \u201cexact\u201d for interval\u00a0estimation of binomial proportions. Am Statistician 1998;52:119\u201326. https:\/\/doi.org\/10.2307\/2685469.","DOI":"10.1080\/00031305.1998.10480550"},{"key":"2026073105563952718_j_cclm-2026-0875_ref_012","unstructured":"Van Rossum, G, Drake, FL. Python 3 reference manual. Scotts Valley, CA: CreateSpace; 2009."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_013","unstructured":"Streamlit \u2022 A faster way to build and share data apps. Available at: https:\/\/streamlit.io\/ [Accessed 12 Apr 2023]."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_014","unstructured":"Team, TPD. Pandas-dev\/pandas. Zenodo: Pandas; 2020."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_015","unstructured":"Collaborative data science publisher: Plotly Technologies Inc. Available at: https:\/\/plot.ly [Accessed 21 Jun 2023\u00a02015]."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_016","unstructured":"Gazoni, E, Clark, C.: A Phyton library to read\/write Excel (Version 3.1.5) 2024."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_017","unstructured":"Canny, S. Python-docx (Version 1.2.0) 2025. https:\/\/pypi.org\/project\/python-docx\/"},{"key":"2026073105563952718_j_cclm-2026-0875_ref_018","unstructured":"Devera, JL, Barnes, DK, Lewis, WR. AHRQ patient safety network (PSNet) collection A fatal twist in pseudohyperkalemia. WebM&M: case studies. Rockville (MD): Agency for Healthcare Research and Quality (US); 2019."},{"key":"2026073105563952718_j_cclm-2026-0875_ref_019","doi-asserted-by":"crossref","unstructured":"Kalra, D, Tesfazghi, M. Falsely elevated digoxin levels in patients on enzalutamide. Circ Heart Fail 2020;13:e007008. https:\/\/doi.org\/10.1161\/circheartfailure.120.007008.","DOI":"10.1161\/CIRCHEARTFAILURE.120.007008"},{"key":"2026073105563952718_j_cclm-2026-0875_ref_020","doi-asserted-by":"crossref","unstructured":"\u00c7ubuk\u00e7u, HC. QC constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories. 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