Module GLP-30 · Version 1.0
POCT Oversight, Compliance, and Quality
Point-of-care testing (POCT) puts laboratory-quality results in the hands of staff who are not laboratorians, on devices scattered across a facility. A governance model keeps that testing under one quality system: who owns test selection and validation, how operators are authorized and monitored, what quality indicators reveal about a decentralized program, and how the laboratory contains a system-wide device problem instead of chasing it site by site.
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Who this module is for
Medical laboratory scientists, POCT coordinators, and laboratory supervisors overseeing decentralized testing programs.
Learning objectives
- Distinguish central-laboratory responsibility from unit or operator-level tasks in a POCT program
- Map the POCT lifecycle from test request and validation through connectivity, monitoring, and retirement
- Use risk, connectivity, competency, QC, EQA/PT, and quality-indicator data to monitor decentralized testing and choose a defensible containment action for a system-wide device issue
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
16 sources
1. 42 CFR Part 493, Subpart B, §§493.15, 493.35, 493.37 (Laboratories performing waived tests)
Source note · federal regulation
2. 42 CFR §493.1236, Standard: Evaluation of proficiency testing performance
Source note · federal regulation
3. 42 CFR §493.1256, Standard: Control procedures
Source note · federal regulation
4. 42 CFR §493.1451(b)(8)-(9), Standard: Technical supervisor responsibilities (competency assessment)
Source note · federal regulation
5. 42 CFR §493.1461, Standard: General supervisor qualifications, as amended by CMS-3326-F, effective 12/28/2024
Source note · federal regulation
6. Centers for Medicare & Medicaid Services. FAQs for IQCP (Individualized Quality Control Plan)
Source note · federal regulation
7. College of American Pathologists. Laboratory General Checklist, GEN.54000 Organizational Chart (Phase II). CAP Accreditation Program, 12.09.2025 edition. College of American Pathologists. Laboratory General Checklist, GEN.20100 QMS Extent of Coverage (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
8. College of American Pathologists. Laboratory General Checklist, GEN.20208 Identification of Non-conforming Events (Phase II). CAP Accreditation Program, 12.09.2025 edition. College of American Pathologists. All Common Checklist, COM.04050 Error Detection and Correction (Phase II). CAP Accreditation Program, 12.09.2025 edition.
Source note · accreditation standard
9. ISO/TS 22583:2024, Requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment, 2nd edition
Source note · consensus standard
10. Clinical and Laboratory Standards Institute. POCT01, Point-of-Care Connectivity
Source note · consensus standard
11. Clinical and Laboratory Standards Institute. POCT12-A3, Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline (reaffirmed 2018)
Source note · consensus standard
12. Clinical and Laboratory Standards Institute. GP47, Management of Critical- and Significant-Risk Results
Source note · consensus standard
13. U.S. Food and Drug Administration. EXTRANEAL (icodextrin) peritoneal dialysis solution, prescribing information, 2024 revision
Source note · manufacturer labeling
14. American Diabetes Association. "7. Diabetes Technology: Standards of Care in Diabetes-2026." Diabetes Care
Source note · professional society guidance
15. "Utilizing connectivity and data management system for effective quality management and regulatory compliance in point of care testing." PMC7649638
Source note · peer-reviewed literature
16. "Identifying sources of error and selecting quality indicators for point of care testing." PMC8042172
Source note · peer-reviewed literature