Module GLP-20 · Version 1.0
CLIA, Accreditors, and Laboratory Personnel Requirements
A working map of who governs U.S. clinical laboratory testing: CLIA statute and 42 CFR Part 493, CMS interpretive guidance, deemed accreditors such as CAP, state law, and local policy. Covers waived, moderate, and high-complexity test classification, the five CLIA certificate types, and the personnel qualification pathways for director, supervisor, and testing-personnel roles, with an emphasis on locating and verifying the current primary-source text rather than memorizing it.
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Who this module is for
Laboratory professionals, laboratory managers, and hiring supervisors in U.S. clinical laboratories who need to identify which authority governs a requirement and confirm personnel qualifications before appointment.
Learning objectives
- Distinguish statute/regulation, CMS interpretive guidance, deemed accreditor requirements, state law, and laboratory policy as separate layers of authority
- Classify waived, moderate, provider-performed microscopy (PPM), and high-complexity testing at a high level and match each to its CLIA certificate type
- Locate the current personnel qualification and responsibility requirement for a given role and testing complexity, and identify what must be verified fresh rather than assumed
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
19 sources
1. Centers for Medicare & Medicaid Services. "Clinical Laboratory Improvement Amendments (CLIA)." CMS.gov, program overview page. https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments
Source note · federal regulation
2. 42 CFR Part 493, Subparts A-C (General Provisions; Certificate of Waiver; Registration Certificate, PPM Certificate, and Certificate of Compliance). Electronic Code of Federal Regulations, current. https://www.law.cornell.edu/cfr/text/42/part-493/subpart-B
Source note · federal regulation
3. Centers for Medicare & Medicaid Services. "CLIA Certification - How to Obtain a CLIA Certificate" (types of certificates). CMS.gov. https://www.cms.gov/CLIA/downloads/HowObtainCLIACertificate.pdf
Source note · federal regulation
4. Centers for Disease Control and Prevention. "Test Complexities." Laboratory Quality, CLIA program. https://www.cdc.gov/clia/php/test-complexities/index.html
Source note · federal regulation
5. U.S. Food and Drug Administration. "CLIA Categorizations." IVD Regulatory Assistance. https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations
Source note · federal regulation
6. Centers for Medicare & Medicaid Services. "CLIA Accreditation and Testing" (list of CMS-approved accreditation organizations). CMS.gov. https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/accreditation-exemptions
Source note · federal regulation
7. 42 CFR 493.1443, Standard: Laboratory director qualifications (high complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90041, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1443
Source note · federal regulation
8. 42 CFR 493.1405, Standard: Laboratory director qualifications (moderate complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90039, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1405
Source note · federal regulation
9. 42 CFR 493.1449, Standard: Technical supervisor qualifications (high complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90041, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1449
Source note · federal regulation
10. 42 CFR 493.1461, Standard: General supervisor qualifications (high complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90043, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1461
Source note · federal regulation
11. 42 CFR 493.1489, Standard: Testing personnel qualifications (high complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90044, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1489
Source note · federal regulation
12. 42 CFR 493.1409, Condition: Laboratories performing moderate complexity testing; technical consultant. Electronic Code of Federal Regulations. https://www.law.cornell.edu/cfr/text/42/493.1409
Source note · federal regulation
13. 42 CFR 493.1417, Standard: Clinical consultant qualifications (moderate complexity testing). Electronic Code of Federal Regulations, as amended 88 FR 90040, Dec. 28, 2023. https://www.law.cornell.edu/cfr/text/42/493.1417
Source note · federal regulation
14. 42 CFR 493.15(e)(1), Condition: Laboratories performing waived tests. Electronic Code of Federal Regulations. https://www.govinfo.gov/content/pkg/CFR-2021-title42-vol5/pdf/CFR-2021-title42-vol5-sec493-15.pdf
Source note · federal regulation
15. Centers for Disease Control and Prevention. "Ready? Set? Test! Patient Testing Is Important. Get the Right Results." Updated April 2024. https://www.cdc.gov/lab-quality/docs/waived-tests/readysettest_2024_final.pdf
Source note · professional society guidance
16. Washington State Department of Health. "Medical Test Sites (MTS) - Licensing Information." https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/medical-test-sites-mts/licensing-information
Source note · federal regulation
17. New York Codes, Rules and Regulations, 10 NYCRR 58-1.1, "Permit" (Clinical Laboratory Evaluation Program). https://regs.health.ny.gov/content/section-58-11-permit
Source note · federal regulation
18. College of American Pathologists. Laboratory General Checklist, GEN.55505 Competency Assessment Frequency - Nonwaived Testing (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
19. College of American Pathologists. Laboratory General Checklist, GEN.55500 Competency Assessment Elements - Nonwaived Testing (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard