IQCP for Point-of-Care Testing
An IQCP for point-of-care testing covers a nonwaived POC device used across units or sites. It must address many operators, varied environments and multiple identical devices. CMS allows one risk assessment for identical devices if it covers each location's risks, but each location needs its own QC plan and quality assessment.
POC programs are where IQCP is used most, and where it's easiest to under-document. Waived POC tests don't need an IQCP at all.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Scope first
Only nonwaived POC testing is eligible. Waived POC tests follow the manufacturer's instructions. Build your device and site inventory before writing anything.
Multiple devices and locations
CMS says identical test systems at several locations can share one risk assessment if it considers each location's risks, but each location needs a QC plan and QA for the system (CMS IQCP Frequently Asked Questions (Aug 2016)). The CAP adds that each device and each location must be monitored in some way (the CAP's public IQCP FAQ (updated Nov 2024)).
POC-specific risks to cover
Westgard's outside review of a point-of-care IQCP found that a sample POC IQCP based largely on manufacturer guidance missed environment and personnel risks, didn't verify performance across multiple identical devices, lacked local historical data, and left a manufacturer minimum requirement out of its QC plan. Building from those themes, check:
Preanalytic: right patient, right order, collection technique, contamination
Analytic: dropped devices, cartridge or strip handling, fill errors, operator lockout
Postanalytic: result transmission, interference recognition, inconsistent results
Environment: storage and testing temperature and humidity across units
Personnel: many operators, competency, turnover
Reagent/QC material: storage and handling of controls and calibration-verification material
POC program records
Device inventory, operator list and competency, QC by device, temperature logs by location, PT, and QA monitors by unit.
Pair this with our point-of-care testing checklist and unit-use cartridge IQCP.
IQCP for Point-of-Care Testing checklist
☐ Inventory nonwaived POC devices and locations
☐ Risk assessment covers each location
☐ QC plan and QA for each location
☐ Each device monitored
☐ Operator training and competency current
☐ Manufacturer minimum requirements all in the QC plan
☐ Director signature and date
CDC resources on CLIA
CDC's overview of the CLIA program: CDC explains that CLIA applies to every U.S. site that tests human specimens to assess health or to diagnose, prevent, or treat disease. It also explains that CDC supports the program alongside CMS and FDA.
CDC on CLIA test complexity categories: CDC explains how FDA scores tests as moderate or high complexity using seven criteria. It also notes that lab-developed or modified tests default to high complexity, and that moderate and high complexity standards differ only in personnel requirements.
CDC's free CLIA educational materials: CDC offers brochures and booklets on waived testing, PPM, and IQCP.
Frequently asked questions
Do waived POC tests need an IQCP?
No. CMS says waived tests follow the manufacturer's instructions.
Can one IQCP cover POC devices on many units?
CMS allows one risk assessment for identical devices if it considers each location's risks, but each location needs a QC plan and QA.
Does every POC device need QC under IQCP?
The CAP says each device and each location must be monitored in some way.
What do POC IQCPs commonly miss?
A published review found environment and personnel risks, multiple-device verification, local historical data and some manufacturer requirements were missing from a sample POC IQCP.
Who approves a POC IQCP?
The laboratory director on the CLIA certificate, without delegation, per CMS.
Official sources and further reading
Related IQCP guides
Talk to an IQCP consultant
Sound Lab Consultants helps labs nationwide build, review and maintain IQCPs from their own data and the official CMS and CDC guidance.
Sound Lab Consultants, PO Box 2135, Chandler, AZ 85244