Before any new test is used to produce patient results, CLIA requires you to verify that it performs accurately, precisely, and consistently in your lab and under your own conditions.

Verification of performance specifications is one of the most critical and commonly overlooked CLIA requirements. Failing to verify a new test before clinical use is a serious citation and a risk to patient safety.

In this article, we’ll explain what’s required, where labs go wrong, and how to implement a standardized, inspection-proof process.

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Verification means confirming that a commercially available, FDA-cleared or approved test performs as expected in your lab.

You must verify the following characteristics:

• Accuracy: How close the test results are to the true value

• Precision: How reproducible results are across runs and techs

• Reportable Range: The span of values the test can accurately measure

• Reference Intervals: Normal values for your patient population (if established internally)

• Analytical Sensitivity and Specificity: Especially for qualitative tests (e.g., PCR, antigen tests)

This verification must be done before using the test clinically, and must be documented.

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🚨 Why Labs Get Cited

• No verification is performed because tests are used “out of the box” without proper procedure.

• Only partial characteristics are verified (e.g., accuracy but not precision)

• No written protocol or acceptance criteria

• Data exists but is not signed, dated, or stored properly

• Staff can’t find the verification documents during inspection

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✅ How to Build a Solid Verification Process

1. Use a Standardized Verification Protocol

Create or adopt a lab-wide template that includes:

• Purpose of the verification

• Characteristics being verified

• Sample types and number

• Control materials used

• Acceptance criteria

• Reviewer sign-off

This ensures consistency and sets expectations for data requirements.

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2. Run the Right Studies

Use known patient samples, split samples, or commercial controls. Evaluate:

• Accuracy: Compare to known or peer-reviewed results

• Precision: Perform repeated measurements (within-run and between-run)

• Reportable Range: Test high and low extremes

• Reference Intervals: Validate or adopt manufacturer values

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3. Document, Review, and Store It

In order for data to count it must be:

• Signed and dated by the verifier and lab director

• Stored in an accessible, labeled, and version-controlled location

• Tied to the instrument or platform used

Use digital folders, file naming conventions, or a tool like StaffReady to manage this efficiently.

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🧠 Why It Matters for Patient Care

Verification ensures that the data your clinicians rely on is trustworthy, and they know it’s trustworthy because it was tested, reviewed, and validated under your conditions, not just in a manufacturer’s lab.

Skipping this step introduces risk for:

• Misdiagnosis or delayed treatment

• Repeated or unnecessary testing

• Regulatory citations that can delay onboarding of other tests

🔁 Common Questions

Q: Do I need to verify waived tests?
No, however some labs may choose to, especially when patient outcomes or insurance billing is involved.

Q: What if the manufacturer already did validation?
You still need to verify it in your lab, using your instruments and your sample types.

Q: Does this apply to LDTs or modified FDA tests?
No it does not. Those tests require full validation, not just verification.