Clin Chem Lab Med. 2026 Jul 29. doi: 10.1515/cclm-2026-0875. Online ahead of print.
ABSTRACT
BACKGROUND: 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 tests.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
PMID:42517887 | DOI:10.1515/cclm-2026-0875