Module GLP-13 · Version 1.0
Building an Individualized Quality Control Plan
Work through how a laboratory builds an IQCP: a risk assessment across specimen, environment, reagent, test system, and personnel; a written quality control plan with layered controls; and an ongoing quality assessment process with a defined change trigger, using a reagent-lot failure to make the reasoning concrete.
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Who this module is for
Laboratory scientists and technologists studying for advanced quality-system responsibilities, and quality staff drafting or reviewing an individualized quality control plan under CLIA.
Learning objectives
- Distinguish an individualized quality control plan from simply running less external control
- Identify failure modes across specimen, environment, reagent, test system, and testing personnel using a structured risk worksheet
- Select layered controls and define an ongoing quality assessment process with measurable review triggers
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. Centers for Medicare & Medicaid Services, HHS. 42 CFR § 493.1250, Condition: Analytic systems. 2025 annual CFR edition, codified through 2025-10-01.
Source note · federal regulation
2. Centers for Medicare & Medicaid Services, HHS. 42 CFR § 493.1256, Standard: Control procedures. 2025 annual CFR edition, codified through 2025-10-01.
Source note · federal regulation
3. Centers for Medicare & Medicaid Services, HHS. 42 CFR § 493.1289, Standard: Analytic systems quality assessment. 2025 annual CFR edition, codified through 2025-10-01.
Source note · federal regulation
4. Centers for Medicare & Medicaid Services. Individualized Quality Control Plan (IQCP). Page modified 2026-02-13.
Source note · federal guidance
5. Centers for Medicare & Medicaid Services. FAQs for IQCP. Revised August 2016.
Source note · federal guidance
6. Centers for Medicare & Medicaid Services and U.S. Department of Health and Human Services. Developing an IQCP: A Step-by-Step Guide. 2015-05-15.
Source note · federal guidance
7. Centers for Medicare & Medicaid Services. CLIA Individualized Quality Control Plan: Considerations When Deciding to Develop an IQCP. November 2014.
Source note · federal guidance
8. Centers for Medicare & Medicaid Services. CLIA Individualized Quality Control Plan: What Is an IQCP? November 2014.
Source note · federal guidance
9. Clinical and Laboratory Standards Institute. EP23, Laboratory Quality Control Based on Risk Management, 2nd ed., 2023.
Source note · consensus standard
10. College of American Pathologists. All Common Checklist, COM.50200 List of Individualized Quality Control Plans (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard