Laboratory Compliance Risk Mitigation for Physician Office Laboratories

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OUR ROLE

Our role is simple:
To ensure your laboratory’s testing practices align with CLIA, CAP, and state regulatory expectations—independent of manufacturer claims or FDA clearance status.

Why This Matters

FDA-cleared assays are valuable tools—but FDA clearance does not replace laboratory responsibilities under CLIA.

In our experience, laboratories are often placed at risk due to:

Reliance on manufacturer validation studies rather than lab-specific studies

Validation not performed according to the IFU or intended use
CPT coding that does not f

FDA-cleared assays are valuable tools—but FDA clearance does not replace laboratory responsibilities under CLIA.

In our experience, laboratories are often placed at risk due to:

Reliance on manufacturer validation studies rather than lab-specific studies

Validation not performed according to the IFU or intended use
CPT coding that does not fully align with the test performed
Incomplete documentation supporting reporting and medical necessity
Misunderstanding of how FDA clearance interacts with CLIA high-complexity requirements.

These gaps are rarely intentional—and frequently uncovered only during audits or payer reviews.

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Who We Serve

We work exclusively with:

Physician Office Laboratories (POLs)
Urology, OB/GYN, and multi-specialty practices
Independent labs performing high-complexity testing
Laboratories adding quantitative or molecular assays
Lab Directors seeking independent review prior to running clinical samples

Our Approach

CPT Coding Accuracy

We use a structured, inspection-aligned review process that mirrors how regulators evaluate laboratories.

Our compliance risk assessments focus on:

Validation & verification alignment to IFU and intended use
Laboratory-specific study documentation
Test utilization and coding alignment
Reporting language and clinical defensibility
Quality system

We use a structured, inspection-aligned review process that mirrors how regulators evaluate laboratories.

Our compliance risk assessments focus on:

Validation & verification alignment to IFU and intended use
Laboratory-specific study documentation
Test utilization and coding alignment
Reporting language and clinical defensibility
Quality system completeness and oversight
Laboratory Director responsibility and documentation.

You receive a clear, written risk summary with prioritized next steps.

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Expert Validation

CPT Coding Accuracy

We focus on conducting lab-specific validation studies that align with the intended use of our assays. This approach minimizes risks associated with relying solely on manufacturer validation.

CPT Coding Accuracy

Our team ensures that CPT coding is thoroughly aligned with the tests performed, reducing the likelihood of billing discrepancies. This attention to detail is essential for maintaining compliance and financial integrity.