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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (03): 227-233. doi: 10.3877/cma.j.issn.2095-5820.2026.03.006

• Review • Previous Articles    

Smart clinical laboratory: Current status, challenges, and implementation strategies

Dayang Chen, Dixian Luo, Xiuming Zhang()   

  1. Medical Laboratory, Shenzhen Luohu Hospital Group, Shenzhen Guangdong 518000, China
  • Received:2026-04-21 Online:2026-08-28 Published:2026-08-28
  • Contact: Xiuming Zhang

Abstract:

The development of smart clinical laboratories has gradually evolved from isolated functional applications toward integrated, end-to-end process collaboration. However, three core challenges remain: weak data governance infrastructure, inadequate organizational coordination, and limited data sharing and reuse. These factors collectively constrain the substantive transition from "informatization" to "intelligentization". This article, grounded in the ISO 15189 quality management framework, conducts a systematic analysis across 4 dimensions: Connotative characteristics, current development status, challenges faced, and implementation strategies. Accordingly, it proposes a phased construction pathway based on a "unified data foundation plus scenario-based applications" an organizational collaboration mechanism characterized by "laboratory-led, IT-coordinated, and management-involved" governance, and a data governance framework that ensures security, compliance, and trusted sharing. The value of this article lies in advancing the emerging concept of smart clinical laboratories from vague understanding to actionable strategic design, offering practical references for medical institutions pursuing intelligent transformation.

Key words: clinical laboratory medicine, smart laboratory, quality management, implementation strategies

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