Research on the Reform and Practice of Medical Laboratory Personnel Training Mode Under the Guidance of Laboratory Developed Tests (LDTs)

Vollständiger Abstract

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With the rapid development of precision medicine, Laboratory Developed Tests (LDTs) have become critical for clinical diagnosis and translational research. China’s LDTs sector faces dual challenges: improved regulation and a shortage of high-quality interdisciplinary talents. Based on domestic and foreign regulatory and quality management requirements, this paper identifies key problems in medical laboratory personnel training: overemphasis on theory over practice, overemphasis on verification over research and development (R&D), and weak regulatory awareness. Guided by Outcome-Based Education (OBE), Project-Based Group Study (PBGS), and the"isomorphism and equivalence"concept, this study proposes an integrated training model featuring medicine-science-engineering intersection and industry-university-research collaboration. By reconstructing the curriculum, strengthening whole-process quality management training, and establishing a diversified evaluation mechanism, we aim to cultivate innovative, quality-conscious and compliant medical laboratory professionals to meet the demands of the LDTs era.