QualTek Molecular Laboratories
CAP Accredited / CLIA Certified Laboratory
QualTek Clinical Laboratories located in Goleta, California is a CAP/CLIA laboratory that is licensed by the federal government, State of California and the College of American Pathologists. QualTek Clinical Laboratories is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to be qualified to perform high complexity clinical laboratory testing.
The responsibilities, qualifications and the training of staff at QualTek, and staffing levels, are documented and sufficient to perform the tasks required. QualTek maintains quality standards for proficiency testing (PT), patient test management, quality control, personnel qualifications and quality assurance. Board certified pathologists at QualTek Clinical Laboratories are available to provide scientific leadership and guidance in all areas of the laboratory to ensure the accuracy, reliability and timeliness of test results for this study. All procedures performed in our CLIA laboratory have been approved by our AP/CP board certified Medical Director. As a standard requirement, all staff members are required to follow these SOP procedures.
Some of the tests reported may have been developed and the performance characteristics determined by QualTek Laboratories. They have not been cleared or approved by the U.S. Food and Drug Administration (FDA). However, the FDA has determined that such clearance or approval is not necessary. Pursuant to the requirements of CLIA, this laboratory has established and verified the accuracy and precision of all tests and additional information is available upon request.