IQCP Quality Assessment and Review: Keeping the Plan Working
IQCP quality assessment is the ongoing check that your QC plan works. It reviews QC failures, errors in every testing phase, PT results and complaints, then decides whether to revise the risk assessment or QC plan. CMS requires periodic review but leaves frequency to the director; the CAP requires biennial reapproval.
Quality assessment is the third required part of an IQCP and the one labs most often let lapse.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
What to monitor
CMS describes the QA plan as monitors that find problems through continuous monitoring, investigation and problem solving, so the QC plan can be adjusted as the data warrants (CMS IQCP Frequently Asked Questions (Aug 2016)). The CAP lists what ongoing assessment must include (the CAP's public IQCP FAQ (updated Nov 2024)):
Errors in the different phases of testing
QC failures and corrective action
Complaints from clinicians and other providers
Whether the IQCP needs to be reassessed and revised
The CAP also says QC and maintenance/function-check data must still be reviewed at least monthly. The Developing an IQCP - A Step-By-Step Guide (CDC/CMS workbook) example uses monthly reviews of temperature logs and QC logs.
How often to review
CMS: periodic review is required; the laboratory director sets the frequency.
CAP: director (or designee) reapproval at least biennially.
Event-driven: reassess after QC or PT failures, new reagent formulations, new staff or locations, or test system changes.
Records to keep
Under CLIA, keep QC and QA records per the record retention rules under 42 CFR 493.1105. The CAP requires keeping risk assessment data and the QC plan for the life of the IQCP plus two years (five years for transfusion medicine), and ongoing monitoring records for two years.
Revising or discontinuing an IQCP
If monitoring shows the plan isn't controlling risk, revise it (often by tightening QC frequency) and get director approval. To stop using IQCP, go back to default CLIA QC for that test, document the date and reason, and update your IQCP list. CMS notes that problems from weak risk decisions usually surface, and get cited, in QC, QA and PT.
Related: QC corrective action documentation.
IQCP Quality Assessment and Review checklist
☐ QA monitors defined for each IQCP
☐ Monthly QC and maintenance review documented
☐ Errors, complaints and PT tracked per test system
☐ Review frequency set by director
☐ CAP: biennial reapproval scheduled
☐ Revision and discontinuation steps written
☐ Records kept per retention rules
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
How often must an IQCP be reviewed?
CMS requires periodic review and leaves frequency to the laboratory director. The CAP requires reapproval at least biennially.
What does IQCP quality assessment include?
Monitoring errors across testing phases, QC failures and corrective actions, complaints, and whether the plan needs revision.
Is there an IQCP annual review form?
CMS doesn't require one. The CAP provides an example ongoing-assessment form in its e-LAB Solutions Suite.
How long do I keep IQCP records?
CAP labs keep risk assessment data and the QC plan for the life of the IQCP plus two years, and monitoring records for two years. Follow CLIA retention rules as well.
How do I stop using an IQCP?
Return the test to default CLIA QC, document the date and reason, and update your IQCP list and procedures.
Who can do the periodic review?
The CAP allows reapproval by the laboratory director or a designee. CMS says initial QC plan 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