Module GLP-19 · Version 1.0
Root Cause, CAPA, Risk, and Continuous Improvement
A framework for investigating a laboratory nonconforming event, distinguishing a correction from a corrective action, choosing higher-leverage controls over training alone, and defining a measurable effectiveness check, worked through a hemolyzed-potassium release.
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Who this module is for
Laboratory testing personnel, technical supervisors, and quality staff who investigate nonconforming events and write corrective and preventive actions, following GLP-18.
Learning objectives
- Distinguish proximate cause, contributing factor, root or system cause, correction, corrective action, preventive control, and improvement in a stated event
- Apply proportionate root-cause tools (Five Whys, fishbone, barrier analysis, FMEA) to identify the system conditions that allowed an event and that failed to detect it
- Write a corrective or preventive action with an owner, a deadline, a measurable effectiveness check, a target, and a follow-up period, choosing the highest-leverage control that fits the risk
How completion works
Mark every required section done and answer every knowledge check in those sections correctly. The final save completes the module automatically.
Sources
12 sources
1. Centers for Medicare & Medicaid Services. State Operations Manual Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (42 CFR Part 493, including 493.1282 Corrective actions and 493.1289 Quality assessment).
Source note · federal regulation
2. Clinical and Laboratory Standards Institute. CLSI QMS11, Nonconforming Event Management, 2nd edition. Published August 25, 2015; reaffirmed without content revision September 2019.
Source note · consensus standard
3. Clinical and Laboratory Standards Institute. CLSI QMS12, Developing and Using Quality Indicators for Laboratory Improvement, 2nd edition. Published March 28, 2019; reaffirmed without content revision October 2024.
Source note · consensus standard
4. Clinical and Laboratory Standards Institute. CLSI EP23, Laboratory Quality Control Based on Risk Management, 2nd edition. Published August 15, 2023.
Source note · consensus standard
5. College of American Pathologists. Laboratory General Checklist, GEN.20310 Investigation of Non-conforming Events (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
6. College of American Pathologists. Laboratory General Checklist, GEN.20208 Identification of Non-conforming Events (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
7. College of American Pathologists. Laboratory General Checklist, GEN.20318 Corrective and Preventive Action (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
8. Reason J. Human error: models and management. BMJ. 2000;320(7237):768-770. doi:10.1136/bmj.320.7237.768.
Source note · peer-reviewed literature
9. AHRQ Patient Safety Network. Safety I, Safety II, and the New Views of Safety (primer summarizing Hollnagel's resilience-engineering framework, work-as-imagined vs. work-as-done).
Source note · professional society guidance
10. Agency for Healthcare Research and Quality. Using Root Cause Analysis to Improve Quality and Performance (Five Whys, fishbone) and Barrier Identification and Mitigation Tool.
Source note · professional society guidance
11. National Institute for Occupational Safety and Health (CDC). Hierarchy of Controls.
Source note · professional society guidance
12. Institute for Healthcare Improvement. Model for Improvement (three questions and Plan-Do-Study-Act cycle).
Source note · professional society guidance