IQCP Example: Walking One Test System Through the Process
A typical IQCP example covers one nonwaived test system. It gathers the manufacturer's instructions and in-house data, lists risks by the five components, writes a QC plan with control type, frequency and acceptance criteria, gets the director's signed approval, and sets quality assessment monitors to confirm the plan works.
This is our own illustrative walkthrough for a hypothetical unit-use cartridge analyzer with built-in internal controls. It isn't a plan for any real device. For official worked examples, see the CDC/CMS workbook and the ASM templates.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
Step 1: Gather information
Package insert and operator manual, the manufacturer's QC requirements, verification study, several weeks of daily external QC and internal-control results, PT history, maintenance logs, staff list and competency records.
Step 2: Risk assessment (excerpt)
Component Possible failure Control / evidence Specimen Delayed testing after collection Time-to-test limit in procedure; staff trained; competency record Test system Internal analytic failure Internal control on each cartridge; device locks out results on failure Reagent Cartridges stored outside temperature range Storage temperature log; out-of-range action in procedure Environment Room temperature outside operating range Room temperature log; device warning Personnel Untrained operator Operator lockout; training and competency records
Step 3: Quality control plan (excerpt)
External controls at two levels at the interval the in-house data supports, never less often than the manufacturer requires. Also on each new lot and shipment, after major maintenance or software updates, and when results don't fit the clinical picture. The internal control is reviewed on every test. The director signs and dates the plan before use.
Step 4: Quality assessment (excerpt)
Monthly review of QC and internal-control failures, errors, complaints and corrective actions. PT reviewed each event. The IQCP is reassessed when failures or changes occur.
Official examples
Developing an IQCP - A Step-By-Step Guide (CDC/CMS workbook): a full worked scenario with worksheets
ASM's IQCP protocol templates for microbiology and molecular testing: media, ID, AST and cartridge molecular examples
Westgard's outside review of a point-of-care IQCP: a reviewed POC example showing the gaps reviewers found
Adapt any example to your own data; CMS says each CLIA lab needs its own IQCP. Use our IQCP template to structure yours.
IQCP Example checklist
☐ Pick one test system and define its scope
☐ Collect manufacturer and in-house data
☐ Build the five-component risk table
☐ Write the QC plan from the risks
☐ Director signs and dates
☐ Start quality assessment monitors
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
Where can I find an official IQCP example?
The CDC/CMS workbook 'Developing an IQCP - A Step-By-Step Guide' includes a worked example. ASM publishes microbiology and molecular examples.
Can I copy an IQCP example for my lab?
You can use the format, but CMS requires each CLIA lab to have its own IQCP supported by its own data.
Does an IQCP example have to use a risk matrix?
No. CMS says a risk acceptability matrix isn't required.
How long is a typical IQCP?
CMS sets no length or format. It needs to contain the required parts and supporting data.
Does the example's QC frequency apply to my lab?
No. Your frequency must come from your own risk assessment and data, and can't be less stringent than your manufacturer's instructions.
Official sources and further reading
Developing an IQCP - A Step-By-Step Guide (CDC/CMS workbook)
ASM's IQCP protocol templates for microbiology and molecular testing
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