Achieve true lab compliance with My Lab Partner. Your trusted partner for FDA standards and reliable testing.
Welcome to My Lab
Who we serve
Structured, Inspection-Aligned Review
Structured, Inspection-Aligned Review
We work exclusively with:
- Physician Office Laboratories (POLs)
- Urology practices
- OB/GYN practices
- Multi-specialty physician groups
- Independent high-complexity laboratories
- Lab Directors seeking independent compliance assessment
Structured, Inspection-Aligned Review
Structured, Inspection-Aligned Review
Structured, Inspection-Aligned Review
Our compliance risk review mirrors how regulators evaluate laboratories.
We assess:
- Validation and verification alignment to IFU and intended use
- Laboratory-specific performance studies
- Coding and methodology consistency
- Reporting language and clinical defensibility
- Quality systems documentation
- Laboratory Director oversight documentation
Following review, you receive a written summary identifying areas of strength and areas that may require corrective action.
Common Compliance Risk Areas
Structured, Inspection-Aligned Review
Common Compliance Risk Areas
Through advisory work with physician office laboratories — and informed by guidance from nationally recognized healthcare regulatory counsel — we have identified recurring compliance exposure, including:
- Validation or verification that does not fully follow the manufacturer’s Instructions for Use (IFU)
- Reliance on manufacturer-site performance data rather than laboratory-specific validation
- Extension of testing beyond intended use without appropriate supporting studies
- CPT coding or test descriptions not fully aligned with methodology performed
- Misinterpretation of FDA clearance as a substitute for CLIA high-complexity obligations
These issues are rarely intentional.
They are often discovered only during inspection, audit, or payer review.
Regulatory responsibility remains with the laboratory and Laboratory Director.