Module GLP-17 · Version 1.0
Calibration Verification, Acceptance Criteria, and Implementation
A hospital core lab changes its glucose reagent lot and must show the method still reports accurately across its reportable range before the new lot goes live. Select challenge materials, apply documented acceptance limits, read recovery and residuals, and convert a completed study into a go-live decision.
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Who this module is for
Clinical laboratory scientists and technologists preparing for or performing calibration verification, and laboratory supervisors reviewing implementation readiness.
Learning objectives
- Distinguish calibration verification from calibration, linearity, analytical measurement range (AMR), and reportable range
- Select low, mid, high, and clinically relevant challenge materials with matrix and commutability awareness
- Apply predefined acceptance criteria, investigate a failed point, and document implementation readiness
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
15 sources
1. Centers for Medicare & Medicaid Services. State Operations Manual, Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (CLIA), advance copy released 2024-12-06, current version.
Source note · federal regulation
2. 42 CFR 493.1255, Standard: Calibration and calibration verification procedures (via Cornell Legal Information Institute, current).
Source note · federal regulation
3. Centers for Medicare & Medicaid Services. CLIA Brochure: Calibration and Calibration Verification.
Source note · federal regulation
4. Centers for Medicare & Medicaid Services. Revised Final Rule - CLIA Proficiency Testing: Analytes and Acceptable Performance (CMS-3355-F), QSO-24-15, reissued 2024-07-08.
Source note · federal regulation
5. CLSI. EP06, Evaluation of Linearity of Quantitative Measurement Procedures, 2nd edition.
Source note · consensus standard
6. CLSI. EP15-A3, User Verification of Precision and Estimation of Bias.
Source note · consensus standard
7. CLSI. EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, with EP17-Ed2-IG implementation guide.
Source note · consensus standard
8. College of American Pathologists. Chemistry and Toxicology Checklist, CHM.13600 AMR Verification (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
9. College of American Pathologists. Chemistry and Toxicology Checklist, CHM.13400 Recalibration/Calibration Verification Criteria (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
10. College of American Pathologists. Chemistry and Toxicology Checklist, CHM.13100 Calibration and Calibration Verification Materials (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
11. Vesper HW, Miller WG, Myers GL. Reference Materials and Commutability. Clinical Biochemistry Reviews. 2007;28(4):139-147. PMID 18392124; PMCID PMC2282402.
Source note · peer-reviewed literature
12. Miller WG, et al. IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design. Clinical Chemistry. 2018. PMID 29348163; PMCID PMC5832613.
Source note · professional society guidance
13. Roche Diagnostics. cobas GLUC3 Glucose HK Gen.3 assay, FDA 510(k) clearance summary K191899.
Source note · manufacturer labeling
14. Roche Diagnostics. Accu-Chek Inform II Linearity Test Kit package insert, catalog 05871166.
Source note · manufacturer labeling
15. American Diabetes Association. Standards of Care in Diabetes - 2026: Section 2, Diagnosis and Classification of Diabetes. Diabetes Care.
Source note · professional society guidance