Quality Assurance & Licensing
Genome-Based Diagnostics (GbDx) provides highly sensitive, enhanced detection of clinically relevant medical conditions and clinically relevant pathogens. We perform our medical testing under a strict quality controlled testing environment conforming to tissue culture room standards. We follow exemplary laboratory practices regarding personnel qualifications and experience, facility and equipment maintenance, and protocol validation as defined by federal regulations governing laboratory testing for human health in the United States (Clinical Laboratory Improvement Amendment, 1998, 2002). For more information on laboratory standards, please see the Centers for Medicare/Medicare Services website – https://www.cms.gov/CLIA/.
Our Laboratory Director is a CLIA-qualified High Complexity Laboratory Director with over 20 years of experience as a CLIA-qualified Laboratory Director. All personnel are formally trained on standard operating procedures, laboratory safety, and quality assurance procedures regarding sample handling, processing, and reporting.
Proficiency testing verifies laboratory personnel and equipment competency using an independent externally verified set of samples with known results. Genome-Based Diagnostics is actively enrolled in the American Proficiency Institute's testing program. For more information on our proficiency testing program, please see the API's website - https://api-pt.com/.
For questions, please contact the lab at (760)487-8235 or email info
