Quality and Accreditation

CLIA certification

CLIA #49D0016288. The Clinical Laboratory Improvement Amendments (CLIA) program of the U.S. Centers for Medicare & Medicaid Services governs quality standards for clinical laboratory testing on human specimens for the diagnosis, prevention, or treatment of disease. High-complexity certification applies to laboratories performing sophisticated testing that requires specialized personnel and quality controls.

CAP accreditation

The laboratory holds accreditation under the College of American Pathologists Laboratory Accreditation Program, a peer-reviewed program examining laboratory operations, personnel qualifications, procedures, quality control, and results reporting.

Quality management

The laboratory maintains a quality-management system encompassing standard operating procedures, validation records, competency assessment, corrective and preventive action, proficiency testing, internal audit, and continuous improvement, aligned with CLIA and CAP requirements. Findings from internal audit and proficiency testing inform ongoing improvement.

Personnel qualifications

• Medical Director Douglas Grider, M.D. maintains clinical responsibility for reporting, interpretation, and clinical consultation.
• Scientific Director Carla V. Finkielstein, Ph.D. oversees scientific direction, method oversight, and research integration.
• General Supervisor Sarah Stern assures regulatory compliance and operational oversight, in alignment with CLIA, CAP, and institutional EHS requirements.

Continuous improvement

Findings from audits, proficiency testing, and post-implementation monitoring are reviewed and acted upon through documented corrective and preventive action processes. Change control governs modifications to validated assays and standard operating procedures.