Module GLP-18 · Version 1.0
Managing a Nonconforming Laboratory Event
A workflow for recognizing, containing, documenting, and closing a nonconforming laboratory event, built around a potassium quality-control failure that reached patient results, with the boundary between immediate correction and systemic corrective action kept explicit throughout.
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Who this module is for
Clinical laboratory staff and trainees who need a consistent, risk-based way to respond to a deviation, complaint, or unexpected result, working from GLP-01 and basic quality-system concepts.
Learning objectives
- Distinguish nonconforming event, complaint, incident, near miss, error, and adverse outcome
- Take immediate containment and patient-result protection actions
- Document event facts, scope, disposition, communication, and ownership before root-cause work
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
10 sources
1. CLSI. QMS11, Nonconforming Event Management in the Laboratory, 2nd ed. Clinical and Laboratory Standards Institute; published 2015-08-25, reaffirmed without content revision September 2019.
Source note · consensus standard
2. 42 CFR § 493.1291, Standard: Test report (CLIA), Subpart K. Current e-CFR text.
Source note · federal regulation
3. 42 CFR § 493.1289, Standard: Analytic systems quality assessment (CLIA), Subpart K; interpretive guidance, CMS Quarterly Provider Update.
Source note · federal regulation
4. 42 CFR § 493.1105, Standard: Retention requirements (CLIA), Subpart J. Current text.
Source note · federal regulation
5. 42 CFR § 493.801, Condition: Enrollment and testing of samples (proficiency testing referral prohibition), Subpart H. Current text.
Source note · federal regulation
6. 42 CFR § 493.1840, Suspension, limitation, or revocation of any type of CLIA certificate, Subpart R. Current text.
Source note · federal regulation
7. US Department of Health and Human Services, Office for Civil Rights. Breach Notification Rule, 45 CFR §§ 164.400-164.414.
Source note · federal regulation
8. Agency for Healthcare Research and Quality (AHRQ), Patient Safety Network (PSNet). "Adverse Events, Near Misses, and Errors" and "Patient Safety 101" primers.
Source note · federal guidance
9. CLSI Harmonized Terminology Database, quality-related term entries.
Source note · consensus standard
10. 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