Module GLP-15 · Version 1.0
Lot-to-Lot Verification and Corrective Action
A candidate reagent, calibrator, or control lot can pass quality control and still shift patient results. Plan a patient-sample lot comparison, read a difference plot against medical decision points, and run a bounded corrective-action decision when a lot looks different enough to matter.
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Who this module is for
Medical laboratory scientists and technologists who approve reagent, calibrator, or control lot changes on quantitative chemistry or immunoassay methods.
Learning objectives
- Define the material, measurand, concentration range, specimens, comparator lot, and acceptance criteria before testing a new lot
- Separate a true lot bias from a commutability or matrix effect, and read a difference plot against medical decision points
- Investigate a failed lot systematically and choose a defensible disposition: accept, reject, restrict, recalibrate, or escalate
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
11 sources
1. Clinical and Laboratory Standards Institute. User Evaluation of Acceptability of a Reagent Lot Change, 2nd ed. CLSI guideline EP26. Wayne, PA: CLSI; 2022.
Source note · consensus standard
2. Clinical and Laboratory Standards Institute. Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 2nd ed. CLSI guideline EP35 (with November 2025 correction notice). Wayne, PA: CLSI; 2025.
Source note · consensus standard
3. Clinical and Laboratory Standards Institute. Use of Delta Checks in the Medical Laboratory. CLSI guideline EP33. Wayne, PA: CLSI.
Source note · consensus standard
4. 42 CFR § 493.1255, Standard: Calibration and calibration verification procedures. Code of Federal Regulations, Centers for Medicare & Medicaid Services.
Source note · federal regulation
5. 42 CFR § 493.1256, Standard: Control procedures. Code of Federal Regulations, Centers for Medicare & Medicaid Services.
Source note · federal regulation
6. Centers for Medicare & Medicaid Services. CLIA Brochure #9: Calibration and Calibration Verification. CMS; rev. April 2006, referenced within current CMS State Operations Manual Appendix C guidance.
Source note · federal regulation
7. Centers for Medicare & Medicaid Services. Individualized Quality Control Plan (IQCP). CMS CLIA program page.
Source note · federal regulation
8. College of American Pathologists. All Common Checklist, COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
9. College of American Pathologists. All Common Checklist, COM.30500 Reagent Kit Components - Nonwaived Tests (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
10. American Diabetes Association. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S20-S42.
Source note · professional society guidance
11. Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem. 2006;52(4):553-554.
Source note · peer-reviewed literature