As more physicians explore whether to bring diagnostic testing in-house, understanding the difference between CLIA-waived and moderately complex testing is critical. Whether you’re operating a physician office lab (POL), an urgent care center, a pharmacy, or a health system, offering CLIA-waived testing can improve patient care and create new revenue streams with fewer regulatory hurdles than more advanced testing categories.

In this guide, we’ll explore what defines CLIA-waived testing, outline how practices can incorporate these tests, and discuss the benefits of eventually transitioning to moderate complexity testing.

RELATED ARTICLE: Transitioning from CLIA-Waived to Moderate-Complexity Testing

What Is CLIA-Waived Testing?

CLIA-waived tests are diagnostic analyses that have been designated by the Centers for Medicare & Medicaid Services (CMS) as “waived” under the Clinical Laboratory Improvement Amendments (CLIA) regulations. These tests are considered simple to perform and carry a low risk of incorrect results when conducted properly.

Key Characteristics of CLIA-Waived Tests:

• Minimal complexity: Tests require little to no interpretation and are largely automated or use simple-to-read indicators.
• Low regulatory burden: Laboratories only need a CLIA Certificate of Waiver to legally perform these tests.
• Point-of-care friendly: Tests are often used in outpatient or near-patient settings such as physician offices, retail clinics, and pharmacies.

Common CLIA-Waived Test Examples:

• Blood glucose testing
• Fecal occult blood tests (FOBT)
• Urinalysis (dipstick)
• Rapid strep and flu tests
• Pregnancy tests (urine)

For a complete and up-to-date CLIA list of waived tests, visit the FDA’s CLIA Test Categorization database.

How to Start Offering CLIA-Waived Testing in Your Practice

If you’re a physician or healthcare provider interested in adding waived testing to your practice, the good news is that it’s a relatively straightforward process:

• Apply for a CLIA Certificate of Waiver: This certificate allows your practice to legally conduct waived tests. Applications can be submitted through CMS or your state’s designated agency.
• Purchase FDA-approved waived tests: Only tests that appear on the FDA’s waived list may be performed under a Certificate of Waiver.
• Follow manufacturer instructions: Strict adherence to testing instructions is required to maintain CLIA compliance.
• Train staff: While waived tests are simple, staff should be properly trained to ensure reliable results and documentation.

CLIA-Waived vs. Moderate Complexity Testing

Understanding the distinction between waived and moderate complexity testing can help your practice grow strategically. Here’s how they compare:

Why Expand to Moderate Complexity Testing?

Once your practice is comfortable with CLIA-waived testing, you may consider transitioning to moderate complexity testing to enhance diagnostic capabilities and improve your overall revenue performance.

“Our program for moderately complex labs not only makes adding this testing easy, but it is also a cost-effective way to grow your practice efficiently,”
—Neil Gerber, Director of Business Development for Lighthouse

Benefits of Moderate Complexity Testing Include:

• Expanded test menu and in-house capabilities
• Improved diagnostic precision
• Reduced turnaround times for results
• Increased reimbursement potential
• Opportunities for staff development and advanced training

Considerations Before Expanding Beyond Waived Testing

However, Gerber notes that transitioning to moderate complexity testing requires thoughtful planning to ensure your practice is ready to make the leap. Key factors include:

• Volume and demand: Ensure your patient base can support the cost of expansion.
• Regulatory compliance: You’ll need to meet stricter CLIA requirements and may be subject to inspections.
• Staffing: You may need to hire certified lab professionals or retrain existing staff.
• Infrastructure: Additional space and equipment may be required.
• Financial planning: A cost-benefit analysis and revenue forecasting are critical to long-term success.

How Lighthouse Can Help Add CLIA-Waived Tests

At Lighthouse Lab Services, we specialize in supporting labs at every stage, from waived testing startups to moderate complexity expansion. Our experts provide:

• Assistance obtaining your CLIA Certificate of Waiver or Compliance
• Guidance on selecting and implementing appropriate tests
• Development of standard operating procedures (SOPs)
• Staff training programs tailored to your practice
• Ongoing quality management and regulatory support

Whether you’re starting small or ready to scale, we’re here to ensure your lab remains compliant, efficient, and profitable.

Get Started with CLIA-Waived Testing Today

Adding CLIA-waived testing to your practice is a low-risk, high-reward opportunity to improve patient care and streamline diagnostics. With the right support and strategy, it can also serve as the first step toward broader in-house lab capabilities.

Interested in launching or expanding your lab? Contact Lighthouse Lab Services today for a complimentary consultation to learn how we can help you build and grow a successful diagnostic testing program.

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