What "CLIA waived" means

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate all clinical laboratory testing performed on humans in the U.S. Tests are classified by complexity:

• Waived — simple, low-risk, FDA-cleared for home use or otherwise meeting waived criteria.
• Moderate complexity — non-automated or moderately automated tests requiring some lab training.
• High complexity — multi-step, automated tests requiring substantial lab training.

Waived tests are the simplest and have the most lenient regulatory requirements. Phlebotomists and nurses commonly perform waived POC tests.

Common CLIA-waived tests

The FDA maintains a list of waived tests. As of 2026, common waived tests include:

• POC glucose — fingerstick glucose meters
• Urine dipstick — visual or automated
• Fecal occult blood — guaiac or immunochemical
• Hemoglobin by fingerstick — HemoCue and similar devices
• Rapid strep A — antigen detection
• Rapid influenza A/B — antigen detection
• Urinalysis microscopic — automated urine microscopy systems
• Saliva alcohol — preliminary screening
• Whole blood pregnancy — hCG detection
• Whole blood lactate — POC lactate meters
• Strep B — group B Streptococcus detection
• H. pylori — antibody or antigen detection
• Glycated hemoglobin (HbA1c) — POC analyzers approved for home use
• Prothrombin time (PT/INR) — POC INR devices approved as waived

The PBT exam does not test the entire waived list, but it does test whether the candidate knows that POC glucose, urine dipstick, and rapid strep are waived — and that POC INR is sometimes waived (depending on the device) but is often moderate complexity.

The CLIA certificate requirements

Facilities performing waived testing must hold a CLIA Certificate of Waiver. The application is through CMS or the state agency. The certificate must be:

• Posted in the facility (in some states).
• Renewed every two years (CMS).
• Updated when the menu of tests changes (some states).

The certificate of waiver does not require on-site inspection but is subject to complaint investigations.

The QC requirements for waived tests

Waived tests follow the manufacturer's instructions for QC. The instructions vary by test:

• POC glucose — daily QC with two levels of control.
• Urine dipstick — daily QC with positive and negative controls (or per manufacturer).
• Rapid strep — most rapid tests have built-in positive and negative controls on the device itself; external QC is per manufacturer (typically weekly or monthly).

The exam tests whether the candidate knows that waived tests still require QC, just less than non-waived tests.

Personnel requirements

For waived testing, CLIA does not specify education or training requirements. However:

• Most facilities require documented in-house training for POC operators.
• The lab typically validates the operator's competency before independent practice.
• Competency is reassessed annually for many POC tests.

The exam tests whether the candidate knows that training documentation is required, even for waived tests.

Common exam traps

1. Believing waived tests require no QC. Every waived test has manufacturer's QC instructions; following them is required.

2. Confusing waived with simple. Waived tests are simple relative to non-waived; some still require significant training.

3. Believing any test can be performed under a Certificate of Waiver. Only tests on the FDA waived list can be performed under a Certificate of Waiver. Adding a non-waived test requires a higher-level certificate.

4. Confusing the certificate types. Certificate of Waiver, Certificate of Registration, Certificate of Compliance, Certificate of Accreditation. Each has different requirements.

5. Believing waived testing is unregulated. Waived testing is regulated — just less than non-waived.

How a test becomes waived

The FDA determines whether a test is waived. The criteria include:

• The test is simple to perform.
• The test has a low risk of erroneous result.
• The test is FDA-cleared for home use (or equivalent).

Manufacturers submit tests for waived status through the FDA 510(k) process or a separate waiver application.

When a waived test is performed incorrectly

If a facility performs a waived test incorrectly — wrong procedure, no QC, untrained operator — the consequences can include:

• Certificate revocation — the CLIA Certificate of Waiver can be revoked for noncompliance.
• State sanctions — many states have additional penalties.
• Legal liability — patients harmed by inaccurate POC results can pursue legal action.
• Loss of accreditation — Joint Commission and CAP-accredited facilities face additional consequences.

The exam tests whether the candidate understands that CLIA compliance applies even to waived testing.

The exam's favorite CLIA-waived questions

Question type 1: "Which of the following is a CLIA-waived test?" — Answer options typically include POC glucose, urine dipstick, and rapid strep (waived) and one non-waived option (e.g., blood culture, which is high complexity).

Question type 2: "What is required for a facility performing waived testing?" — Answer: CLIA Certificate of Waiver, manufacturer QC, documented training.

Question type 3: "Who determines whether a test is waived?" — Answer: the FDA.

A practical closing note

CLIA waived testing is the most common form of POC testing in modern facilities. The exam rewards the candidate who knows the list of common waived tests, the QC requirements, and the certificate type. Master these basics and you will navigate CLIA-waived questions with confidence.