Waived vs Non-Waived Laboratory Tests
Understanding the Difference Between Waived and Non-Waived Tests
Clinical laboratories perform a wide range of tests, each with specific regulatory requirements. One of the most important distinctions under CLIA is whether a test is classified as waived or non-waived. Understanding this difference is critical for compliance, staffing, quality oversight, and inspection readiness.
What Are Waived Tests?
Waived tests are considered simple laboratory examinations with a low risk for error. These tests are approved by the FDA for home use or have been determined to be so straightforward that the likelihood of incorrect results is minimal when performed according to manufacturer instructions.
Common examples include:
• Urine pregnancy tests
• Blood glucose testing by fingerstick
• Urinalysis dipsticks
• Rapid strep tests (when FDA-approved as waived)
While waived tests have fewer regulatory requirements, they are not unregulated. Laboratories must still:
• Hold a valid CLIA Certificate of Waiver
• Follow manufacturer instructions exactly
• Maintain basic documentation
• Ensure staff are appropriately trained
A common misconception is that waived testing does not require oversight. In reality, improper performance or documentation can still lead to deficiencies during inspections.
What Are Non-Waived Tests?
Non-waived tests include moderate-complexity and high-complexity testing. These tests require a higher level of technical skill, interpretation, and quality control due to increased risk if errors occur.
Examples include:
• Automated chemistry and hematology testing
• Molecular and PCR testing
• Manual differentials
• Blood bank testing
Non-waived testing carries significantly more regulatory requirements, including:
• Detailed quality control and quality assurance programs
• Competency assessment and personnel qualifications
• Method validation or verification
• Proficiency testing participation
• Comprehensive documentation and review
Laboratories performing non-waived testing must maintain appropriate CLIA certification and ensure compliance with all applicable standards.
