IQCP for New Tests, New Instruments and Multiple Sites
For a new test, a lab can collect data and build the IQCP before reporting results, or report under default CLIA QC until the director approves the plan. Adding identical devices or sites means updating the risk assessment and getting director approval. Each CLIA number needs its own IQCP and data.
Expansion is when IQCPs drift out of date. Here's how CMS and the CAP say to handle it.
Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · General information, not legal advice.
New tests and instruments
CMS gives two paths (CMS IQCP Frequently Asked Questions (Aug 2016)): build the QC plan from data before reporting, or report right away under default CLIA QC until the director approves the plan. CMS encourages more frequent QC at first. The CAP gives an example of a seven-day initial study and weekly QC, extended later as data builds (the CAP's public IQCP FAQ (updated Nov 2024)).
Adding devices, tests or sites
The CAP lists the steps: review the risk assessment for new risks across the five components and three phases, evaluate lab-specific data, get director approval, keep the records, set up QA, and update the IQCP list.
Multi-site systems
CMS says each CLIA certificate needs its own IQCP and supporting data. Systems can share formats and common manufacturer information, but each location's risks must be evaluated and each director approves their own plan. Within one CLIA or CAP number, one risk assessment can cover several sites if it accounts for their differences.
Different models
Separate IQCP per make and model, per CMS.
IQCP for New Tests, New Instruments and Multiple Sites checklist
☐ Choose a path: build first, or default QC until approval
☐ Run QC more often during initial implementation
☐ Update the risk assessment for each added device or site
☐ Director approves each change
☐ Separate IQCP per CLIA number and per model
☐ Update the IQCP list (CAP)
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 start a new test under IQCP immediately?
Only if the IQCP is complete and approved. Otherwise CMS says to follow default CLIA QC until it is.
How much data do I need for a new test?
CMS leaves it to the director. The CAP suggests starting with a short interval and extending it as data accumulates.
Can I add a replacement analyzer to my IQCP?
Yes, if it's identical, after you update the risk assessment and the director approves the change, per the CAP.
Can a health system use one IQCP for all its labs?
No. CMS says each CLIA certificate needs its own IQCP, though common formats may be shared.
Do different analyzer models need separate IQCPs?
Yes, per CMS.
Official sources and further reading
Related IQCP guides
IQCP Risk Assessment: Five Components and How to Document Them
IQCP Quality Assessment and Review: Keeping the Plan Working
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