IQCP Requirements Under CLIA, CAP and COLA
Under CLIA, IQCP is the CMS-approved alternative QC option described in SOM Appendix C for 42 CFR 493.1250. It needs a risk assessment, a QC plan signed by the laboratory director, and quality assessment. Accredited labs must follow their accreditor's IQCP requirements, which the CAP and COLA publish separately.
Which IQCP rules apply depends on who inspects you. This page compares CLIA with the public CAP and COLA material.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
CLIA (CMS)
Legal basis: 42 CFR 493.1250 allows an alternative to the analytic QC rules if HHS approves the procedure in CMS State Operations Manual, Appendix C. IQCP is that procedure.
Three required parts: risk assessment, QC plan, quality assessment (CMS IQCP Frequently Asked Questions (Aug 2016)).
The laboratory director must sign, date and approve the QC plan, and that can't be delegated.
The plan can't be less stringent than the manufacturer's QC requirements.
Each CLIA certificate needs its own IQCP.
Periodic review through quality assessment is required; the director sets how often.
Eligible: nonwaived testing in every specialty except pathology.
CAP-accredited labs
CMS says accredited labs follow their accrediting organization's IQCP requirements. Per the CAP's public IQCP FAQ (updated Nov 2024), CAP inspectors look for: - Risk assessment covering all five elements - Written QC plan with control types, acceptance criteria and frequency, never less frequent than the manufacturer's instructions - Director approval before implementation - Ongoing quality assessment - Biennial reapproval - The CAP List of Individualized Quality Control Plans form
The CAP also limits eligibility to tests outside anatomic pathology and cytopathology (with exceptions for tests assignable to other disciplines) that have an internal control process, with microbiology exceptions for media, ID systems and susceptibility testing. Its record retention rule is the life of the IQCP plus two years (five years for transfusion medicine).
COLA-accredited labs
COLA labs follow COLA's accreditation criteria. Publicly, COLA offers an IQCP course that includes a risk assessment template and an IQCP checklist (COLA's IQCP course page). Confirm current IQCP criteria with COLA directly.
State requirements
CMS says more stringent state QC requirements still apply where they exist.
Next, see IQCP eligibility and review frequency.
IQCP Requirements Under CLIA, CAP and COLA checklist
☐ Confirm who inspects you (state agency, CAP, COLA, other)
☐ Read your accreditor's current IQCP requirements
☐ Check state licensure QC rules
☐ Director signature and date on each QC plan
☐ CAP: biennial reapproval and IQCP list form
☐ Records kept per your accreditor's retention rule
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
What are the CLIA IQCP requirements?
A risk assessment, a quality control plan approved by the laboratory director, and quality assessment, as described in SOM Appendix C for 42 CFR 493.1250.
Does the CAP have different IQCP requirements?
Yes. CMS says accredited labs follow their accreditor's requirements. The CAP adds rules such as an internal-control eligibility criterion, biennial reapproval and a required IQCP list form.
How often must a CAP IQCP be reapproved?
At least biennially, per the CAP's IQCP FAQ.
Does COLA accept IQCP?
COLA publishes IQCP education, including a risk assessment template and checklist. Confirm current criteria with COLA.
Do state rules override IQCP?
CMS says more stringent state QC requirements must still be met.
Who must sign the IQCP?
The laboratory director named on the CLIA certificate. CMS says that approval can't be delegated.
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