Clinical Laboratory Up to high standards.

Licensure & Accreditation

The Clinical Laboratory Improvement Amendments of 1988, CLIA ‘88, established quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue, to diagnose, prevent, or treat disease or assessment of health. These regulations cover all aspects of testing, including general laboratory requirements, quality monitors, pre-analytics, analytic performance, post-analytics, and personnel requirements. To summarize, CLIA establishes the rules and guidelines that laboratories must follow to ensure they are providing accurate laboratory results. Federal agencies and state Departments of Health then work together to support the CLIA amendments and enforce compliance. States requiring additional clinical laboratory certification/registration include CA, MD, NY, PA, and RI.

Our clinical laboratories are routinely inspected by both their home state Department of Health and the College of American Pathologists (CAP). They participate in the proficiency testing programs administered by both CAP and the American Proficiency Institute to maintain licensing in multiple states. They are accredited by CAP, an internationally recognized program designed to advance Laboratory Services’ quality. Through the use of rigorous checklists designed to improve the overall quality practice of the management and operation of a clinical laboratory in combination with routine peer-led inspections, a laboratory can gain accreditation by meeting or exceeding CAP standards. CAP standards are recognized to be the highest standards of excellence. Our laboratories have continually maintained exemplary ratings by these agencies.