CLIA and CAP Certification

The Centers for Medicare & Medicaid Services regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

Response Genetics is fully-licensed and accredited by the States of California, Florida, Maryland, Pennsylvania, and Rhode Island; CLIA, and Medicare.

RGI is also accredited for College of American Pathologists (CAP).

• Clinical Laboratory Improvement Act of 1988 Certificate of Compliance CLIA ID#: 05D1066073
• California Department of Health Services Clinical Laboratory License Lab ID#: CLF 335062
• College of American Pathologists (CAP) laboratory accreditation number, LAP #: 7209131

Regulatory Compliance Overview

To ensure quality laboratory testing, genetics laboratories must meet the highest regulatory and compliance standards. RGI meets those standards, guaranteeing our pharmaceutical clients reliable, reproducible results in clinical trials and assays.

RGI meets all state and federal oversight standards for the handling of biohazardous materials (including recombinant DNA), potentially infectious agents, hazardous chemicals and radioactive materials.

GLP Standards

RGI has completed requirements and internal audits associated with Good Laboratory Practice (GLP) regulations.

GLP compliance involves the development and implementation of consistent controls for sample processing, equipment and process validations, training, audits and document control.