IQCP Eligibility: When You Can Use It and When You Need It
IQCP is voluntary and applies only to nonwaived testing. Every CLIA specialty except pathology is eligible. Waived tests follow the manufacturer's instructions instead. You need an IQCP only when you want to run QC differently from the default CLIA requirements, for example relying on internal controls instead of daily external QC.
Eligibility questions are among the most common IQCP searches. Here's what CMS and the CAP actually say.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Who can use IQCP
Nonwaived tests only. CMS says IQCP was developed for nonwaived testing (CMS IQCP Frequently Asked Questions (Aug 2016)). The CDC's Individualized Quality Control Plan resources page says it applies to existing and new test systems.
All specialties except pathology. Immunohematology is eligible, but the §493.1271 requirements still apply.
LDTs and molecular tests in eligible specialties may use IQCP, per CMS.
Who can't, or doesn't need to
Waived tests: follow the manufacturer's instructions. CMS says no IQCP is needed even if you run two levels daily.
Mixed kits: CMS says only the nonwaived part (for example, serum hCG on a serum/urine kit) is eligible.
PPM labs: IQCP is available but CMS notes it may not be practical.
Not allowed under IQCP at the CAP: IQCP covers QC only; it can't reduce calibration, AMR verification or instrument comparisons (the CAP's public IQCP FAQ (updated Nov 2024)).
When an IQCP is effectively required
IQCP is voluntary, but if you run less QC than the default CLIA rules (42 CFR 493.1256), you need one. CMS says a surveyor would cite the QC rule you didn't follow, and you can correct by either following default QC or implementing IQCP. The CAP adds microbiology cases where an IQCP is needed to use reduced QC, even when you're following manufacturer or CLSI guidance.
CAP eligibility rule
CAP-accredited labs: eligible tests must be outside anatomic pathology and cytopathology and must have an internal control process (electronic, procedural or built-in). Microbiology media, ID systems and susceptibility testing are exceptions. The CAP says MALDI-TOF doesn't currently meet its criteria.
Waived lab moving up? See CLIA waiver requirements and upgrading to moderate/high complexity.
IQCP Eligibility checklist
☐ Confirm test complexity (waived vs nonwaived)
☐ Confirm specialty isn't pathology
☐ Check accreditor-specific eligibility (CAP internal-control rule)
☐ Decide: default CLIA QC or IQCP
☐ If running less QC than default, have an IQCP in place first
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 IQCP be used for waived tests?
No. CMS says IQCP was developed for nonwaived testing; waived tests follow the manufacturer's instructions.
Which specialties can't use IQCP?
Pathology. All other CLIA specialties and subspecialties are eligible.
Is IQCP required?
No, it's voluntary. But if you run less QC than default CLIA rules, you need an IQCP to support it.
Can IQCP reduce calibration frequency?
No. The CAP says IQCP applies to QC only, not calibration, AMR verification or instrument comparison.
Can LDTs use IQCP?
Yes. CMS says IQCP may be used for LDTs and molecular tests in eligible specialties.
Is MALDI-TOF eligible for IQCP?
Not under the CAP's current criteria, because it lacks an internal control process.
Official sources and further reading
Related IQCP guides
IQCP for Microbiology: Media, Identification Systems and AST
IQCP for Molecular Testing: Cartridge PCR, LDTs and Exclusions
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