Module GLP-14 · Version 1.0
Proficiency Testing and Alternate Assessment
A routine chemistry bench walks through one proficiency testing (PT) event, from enrollment through an unacceptable sodium result, then covers when alternate assessment substitutes for PT and how to investigate and document unacceptable performance without treating it as random error.
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Who this module is for
Clinical laboratory scientists and medical laboratory technicians performing nonwaived testing, and laboratory supervisors who manage PT enrollment, alternate assessment, and investigation records.
Learning objectives
- Distinguish regulated PT, unregulated PT, and alternate assessment, and identify which applies to a given test
- Process challenge specimens through the laboratory's routine personnel, methods, and reporting pathway without prohibited referral or interlaboratory communication
- Investigate unacceptable PT or alternate-assessment performance through clerical, specimen, method, calibration, QC, and competency evidence rather than defaulting to random error
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. 42 CFR § 493.2, Definitions.
Source note · federal regulation
2. Centers for Medicare & Medicaid Services. 42 CFR § 493.801, Condition: Enrollment and testing of samples.
Source note · federal regulation
3. Centers for Medicare & Medicaid Services. 42 CFR § 493.803, Successful participation.
Source note · federal regulation
4. Centers for Medicare & Medicaid Services. 42 CFR § 493.807, Condition: Reinstatement of laboratories performing nonwaived testing.
Source note · federal regulation
5. Centers for Medicare & Medicaid Services. 42 CFR § 493.1236, Standard: Evaluation of proficiency testing performance.
Source note · federal regulation
6. Centers for Medicare & Medicaid Services. Proficiency Testing Programs.
Source note · federal guidance
7. Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments: Proficiency Testing and PT Referral, October 2024.
Source note · federal guidance
8. Centers for Medicare & Medicaid Services. State Operations Manual, Appendix C: Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services, Transmittal 233, September 12, 2025.
Source note · federal guidance
9. Clinical and Laboratory Standards Institute. QMS24, Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality, 3rd ed., reaffirmed May 2021.
Source note · consensus standard
10. College of American Pathologists. All Common Checklist, COM.01500 Alternative Performance Assessment (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard