Module GLP-11 · Version 1.0
Applying Laboratory Control Rules
A morning QC run flags two control results beyond 2 SD on the same side. Reading a control-rule pattern, telling warning from rejection, matching the pattern to random or systematic error, and sequencing the corrective action ensure patient results are actually reviewed instead of quietly repeated away.
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Who this module is for
Clinical laboratory scientists and students who have covered basic QC statistics (GLP-09) and Levey-Jennings charting (GLP-10) and are learning to apply a defined multirule QC strategy on the bench.
Learning objectives
- Distinguish warning rules from rejection rules and explain why a warning rule alone does not stop reporting
- Match a control rule pattern to whether it primarily detects random error or systematic error
- Select and justify features of a QC strategy, including number of levels, run boundaries, frequency, and risk basis, from a supplied set of options
- Sequence the corrective-action response to an out-of-control result and explain why repeating controls until one passes can conceal a real problem
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. 42 CFR §493.1256, Standard: Control procedures, Subpart K, Quality System for Nonwaived Testing.
Source note · federal regulation
2. Centers for Medicare & Medicaid Services. Individualized Quality Control Plan (IQCP). Official guidance, page modified 2026-02-13.
Source note · federal guidance
3. Centers for Medicare & Medicaid Services. FAQs for IQCP, revised August 2016.
Source note · federal guidance
4. Clinical and Laboratory Standards Institute. C24, Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4th ed., September 29, 2016, corrected edition.
Source note · consensus standard
5. Clinical and Laboratory Standards Institute. EP23, Laboratory Quality Control Based on Risk Management, 2nd ed., August 15, 2023.
Source note · consensus standard
6. College of American Pathologists. Chemistry and Toxicology Checklist, CHM.14600 QC Corrective Action (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
7. Westgard JO, Barry PL, Hunt MR, Groth T. A multi-rule Shewhart chart for quality control in clinical chemistry. Clinical Chemistry. 1981;27(3):493-501.
Source note · peer-reviewed literature
8. Perkins SL, et al. An analysis of multirules for monitoring assay quality control. Laboratory Medicine. 2020;51(1):94-98.
Source note · peer-reviewed literature
9. Westgard JO, Westgard SA. Quality control review: implementing a scientifically based quality control system. Annals of Clinical Biochemistry. 2016;53(1):32-50.
Source note · peer-reviewed literature
10. Westgard QC. Westgard Rules. Educational technical reference.
Source note · professional society guidance
11. Exact manufacturer instructions for use, operator manual, application sheet, package insert, software release notes, and service bulletins for the local measuring system. No particular instrument is named; substitute the actual manufacturer documentation for the measuring system in use.
Source note · manufacturer labeling