Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
March 16, 2026Journal of Clinical Laboratory AnalysisOpen Access

A Hybrid Qualitative–Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022

View Full Paper
Ask AI
Bookmark
Share

Authors

MWMengqi WeiPeking University Shenzhen HospitalMLMingyang LiSichuan UniversityYLYu LinQueensland University of Technology

Discussion

Loading...

Member takes

Implication

This case study demonstrates a hybrid model for risk management in clinical laboratory automation, indicating improved safety and quality.

Key Points

  • To establish a standardized risk assessment model for laboratory automation by integrating ISO 15189:2022 and FMEA.
  • Created a hybrid qualitative-quantitative model combining FMEA and ISO 15189:2022.
  • Conducted risk assessments in clinical laboratory settings.
  • Implemented targeted interventions based on risk evaluation results.
  • Enhanced objectivity in risk assessment through integrated scoring system.
  • Significant improvements in the quality and safety of laboratory automation were observed.

Cite This Study

Wei et al. (2026) studied this question.

synapsesocial.com/papers/69b79e968166e15b153ac186https://doi.org/10.1002/jcla.70194
View Full Paper
Ask AI
Bookmark
Share

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1An integrative approach to medical laboratory equipment risk management2024 · 8 citations
  2. 2Current State of Laboratory Automation in Clinical Microbiology Laboratory2021 · 72 citations
  3. 3Medical Device Risk Assessment Based on Ordered Weighted Averaging Aggregation Operator2021 · 6 citations
  4. 4Types and Frequency of Errors in the Pre-Analytical Phase in the Clinical Laboratory - Single Center Study from Bosnia and Herzegovina2022 · 2 citations
  5. 5Public health and the role of advancement in laboratory2022 · 1 citations