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Analysis of safety reporting in the clinical laboratory of a large academic medical center: frequency, type, and classification by phase of testing

Am J Clin Pathol. 2026 May 5;165(5):aqag033. doi: 10.1093/ajcp/aqag033.

ABSTRACT

OBJECTIVES: To study and classify electronic safety reports assigned to the clinical laboratory of a large academic medical center, focusing on types of reporters, event classification, and severity of reported events.

METHODS: We performed a retrospective review of laboratory/pathology safety reports in 2023 at the Massachusetts General Hospital. Data included types of events, where the error occurred, the level of harm to the patient, and reporting patterns.

RESULTS: A total of 2334 reports were filed, with nearly three-fourths involving specimen/testing errors (76%). Most events (72%) originated in the preanalytical phase of testing, including labeling, collection, and transport issues. Of all reports, 56.7% indicated they did not reach the patient, 36.4% caused no harm but impacted the patient, 6% led to minor harm, and 0.6% resulted in permanent or major harm/damage. One case was severity level 4 (death). Laboratory technologists/technicians submitted most reports, while nursing was the primary reporter for events that pathology was required to resolve.

CONCLUSIONS: A large number of safety reports are generated in our large academic medical center. Most involve the preanalytical phase but do not result in direct patient harm. Despite improvements in information technology to improve the reliability of the preanalytical phase of testing, most reports reflect incidents outside the clinical laboratory.

PMID:42145078 | DOI:10.1093/ajcp/aqag033

By Nevin Manimala

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