Integration of the ISO 15189 quality management system in the undergraduate internship teaching of medical laboratory technology
Clinical Snapshot
PICO Framework
| P — Population | 60 undergraduate medical laboratory technology students commencing clinical clerkship at Second People's Hospital of Hunan Province |
| I — Intervention | Simulated laboratory teaching based on ISO 15189 standard including quality management system construction and full-process simulated accreditation practice |
| C — Comparator | Traditional clinical clerkship teaching methods |
| O — Outcomes | Comprehensive assessment scores (pre-, intra-, and post-examination quality control knowledge), problem-solving ability in quality management, understanding of quality management systems, quality improvement awareness, and teaching satisfaction |
Bottom Line
This randomised controlled trial suggests that ISO 15189-based simulated laboratory teaching significantly improves quality management competencies in medical laboratory technology students compared to traditional methods. However, the study has important methodological limitations including unclear randomisation procedures, lack of baseline comparisons, and absence of effect size reporting. While the intervention appears promising for enhancing laboratory quality education, the evidence quality is moderate due to these methodological concerns. The approach could be valuable for Australian medical laboratory science programs seeking to align with NATA accreditation standards, but implementation should include robust evaluation with better methodological rigour. Further research with improved study design and reporting is needed to confirm these findings.
Key Findings
P Value: P < 0.01 for all primary outcomes
Effect Size: Not reported - only statistical significance provided
Primary Outcome: Significantly higher comprehensive assessment scores in intervention group across all quality control domains
Nnt Or Sensitivity: Not applicable for educational intervention
Confidence Interval: Not reported
Clinical Application
Requires development of ISO 15189-based simulation materials and trained educators, but feasible in established laboratory medicine programs Highly relevant to Australian medical laboratory science programs. Could align with NATA ISO 15189 accreditation requirements and support AIMS professional development standards Undergraduate medical laboratory technology students in clinical training programs
Abstract
BACKGROUND: The International Organization for Standardization (ISO) 15189 standard is essential for quality management in clinical laboratories, yet its integration into undergraduate medical laboratory technology education remains limited. This study aimed to evaluate the impact of a simulated laboratory teaching model based on the ISO 15189 standard on the quality management competencies of undergraduate interns and to compare it with traditional teaching methods. METHODS: A parallel-group, randomized controlled trial was conducted in the Department of Clinical Laboratory at the Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province). A total of 60 undergraduate medical laboratory technology students scheduled to commence their clinical clerkship between July 2023 and May 2025 were enrolled and randomly allocated to an intervention group (n = 30) or a control group (n = 30). The intervention group received simulated laboratory teaching based on the ISO 15189 standard, including the construction of a quality management system and full-process simulated accreditation practice. The control group received traditional clinical clerkship teaching. Primary outcome measures were comprehensive assessment scores at the end of the internship (covering pre-examination, intra-examination, and post-examination quality control knowledge) and problem-solving ability scores in quality management roles. Secondary outcome measures included understanding of the quality management system, quality improvement awareness, and teaching satisfaction. RESULTS: Compared with the control group, the intervention group showed significantly higher scores in pre-examination quality control, intra-examination quality control, post-examination quality control, understanding of the quality management system, quality improvement awareness, and problem-solving ability in quality management roles (P < .01). Teaching feedback questionnaires also indicated higher satisfaction with the teaching model in the intervention group. CONCLUSION: For undergraduate medical laboratory technology interns, the simulated laboratory teaching model based on the ISO 15189 standard is significantly more effective than traditional teaching methods in enhancing their knowledge, skills, and competency in quality management.
References
- 1.Ma, N., Deng, X., Luo, T., Hu, X., Tang, X., & Zou, G. (2026). Integration of the ISO 15189 quality management system in the undergraduate internship teaching of medical laboratory technology. Medicine, Article 0000000000048228. https://doi.org/10.1097/MD.0000000000048228
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