Module GLP-21 · Version 1.0
Inspection Readiness, Common Deficiencies, and Competency
How a CLIA survey or CAP inspection actually samples the operating quality system, what the six required CLIA competency-assessment procedures cover and how often they run, and how to trace evidence and draft a systemic deficiency response when a record is missing.
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Who this module is for
Testing personnel, technical consultants and supervisors, laboratory directors, and quality staff preparing for CLIA survey or CAP inspection in a moderate- or high-complexity laboratory.
Learning objectives
- Distinguish training, competency assessment, performance evaluation, and continuing education
- Assemble traceable evidence from policy through record and observed practice
- Identify common deficiency patterns and design a systemic, not just corrective, remediation
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
9 sources
1. Centers for Medicare & Medicaid Services. "Clinical Laboratory Improvement Amendments (CLIA): Assessing Personnel Competency." Revised May 2025.
Source note · federal regulation
2. Centers for Medicare & Medicaid Services. QSO-25-10-CLIA, revised 2025-06-23 (State Operations Manual guidance on 42 CFR 493.1235, 493.1236, 493.1413, 493.1451 competency and PT-review requirements, and POC/AOC corrective-action expectations).
Source note · federal regulation
3. Centers for Medicare & Medicaid Services. State Operations Manual, Appendix C, Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services.
Source note · federal regulation
4. Centers for Medicare & Medicaid Services. Form CMS-2567, "Statement of Deficiencies and Plan of Correction," with current form instructions.
Source note · federal regulation
5. Centers for Medicare & Medicaid Services. QSO-25-19-All, "Release of CMS-2567: Statement of Deficiencies and Plan of Correction," 2025.
Source note · federal regulation
6. College of American Pathologists. "Inspection Tools and Training." CAP.org, accessed 2026-08-16.
Source note · accreditation standard
7. College of American Pathologists. "2025 Edition Accreditation Checklist Summary" (Laboratory General and All Common checklist revision summary).
Source note · accreditation standard
8. Clinical and Laboratory Standards Institute. QMS03, Training and Competence Assessment, 4th edition (QMS03-Ed4), published 2016-12-30, reaffirmed 2021.
Source note · consensus standard
9. 42 CFR Part 493, Subpart M (Personnel for Nonwaived Testing), sections 493.1235, 493.1236, 493.1413, 493.1451, as reproduced and paraphrased in CMS QSO-25-10 and the CMS competency brochure.
Source note · federal regulation