IQCP for Blood Gas and Unit-Use Cartridge Devices
Unit-use cartridge and blood gas devices can use IQCP to rely on built-in controls between external QC runs. The risk assessment can cover the platform and each analyte together. Blood gas QC is set by 42 CFR 493.1267, and on-board controls may count as external control material if they meet CMS's criteria.
This page is generic. It applies to handheld and benchtop cartridge analyzers from any manufacturer, and we don't claim any affiliation with device makers.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Blood gas default QC
42 CFR 493.1267 requires calibration per the manufacturer, one control sample every 8 hours of testing (with low and high values each day), and a control each time specimens are tested unless the instrument internally verifies calibration at least every 30 minutes. An IQCP can modify the frequency if the data supports it.
On-board controls
CMS says on-board controls (ampules or cartridges) that have a matrix similar to patient specimens, are treated like patient specimens, and go through all elements of the analytic process can meet the requirement for control materials (CMS IQCP Frequently Asked Questions (Aug 2016)). The CAP adds that controls must be a different material or lot from the calibrator, and that electronic simulators and function checks aren't external controls (the CAP's public IQCP FAQ (updated Nov 2024)).
Multi-test cartridges
CMS says one risk assessment can cover a single-use cartridge with several tests: platform risks plus analyte-specific risks.
Typical cartridge risks
Storage temperature and time out of the refrigerator, under- or over-filling, bubbles and clots, sample type and delay, device drops, operator technique, multiple identical handhelds, and transmission errors. Westgard's outside review of a point-of-care IQCP discusses several of these in a POC review.
Frequency and the manufacturer
Whatever interval you choose can't be less stringent than the manufacturer's instructions. See IQCP 30-day QC.
IQCP for Blood Gas and Unit-Use Cartridge Devices checklist
☐ Pull the manufacturer QC and calibration requirements
☐ Map default 493.1267 QC for blood gas
☐ Document what internal or on-board controls cover
☐ Risk table: platform plus each analyte
☐ Cartridge storage and handling controls
☐ External QC frequency backed by data; new lot/shipment QC
☐ Each device and location monitored
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
Can i-STAT-type cartridge devices use IQCP?
Yes, if the test is nonwaived and eligible. Write the IQCP from your own data and the manufacturer's instructions.
What are CLIA blood gas QC requirements?
42 CFR 493.1267: calibration per the manufacturer, a control every 8 hours of testing with low and high values each day, and a control with each run unless calibration is internally verified at least every 30 minutes.
Do on-board liquid controls count as external QC?
CMS says yes if they have a patient-like matrix, are treated like patient specimens and go through the full analytic process.
Does each analyte on a cartridge need its own risk assessment?
No. CMS says one risk assessment can cover the platform plus analyte-specific risks.
Are electronic simulators external controls?
No. The CAP says electronic checks and function checks don't meet the definition of external control material.
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