Color's laboratory has been accredited by the College of American Pathologists (CAP) and has Clinical Laboratory Improvement Amendments (CLIA) certification.
In order to receive CAP accreditation, a laboratory must demonstrate that it operates with the highest standards of quality, accuracy and consistency. The CAP inspection process investigates several components of the laboratory: assay validation data, quality management program, sample tracking procedures, lab personnel qualifications, facilities, safety, and having a lab that is compliant and ready for inspection. The CAP Laboratory Accreditation Process is an internationally recognized program designed to help clinical labs achieve excellence beyond that which is required for regulatory compliance. Because of its comprehensive nature, the Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority to inspect and accredit clinical laboratories. The program is also recognized by the Joint Commission, and can be used to meet many state as well as international certification requirements.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. Centers for Disease Control and Prevention, in partnership with Centers for Medicare and Medicaid Services and the Food and Drug Administration, supports the CLIA program and clinical laboratory quality.
CDC’s responsibilities for the national CLIA program include: Providing analysis, research, and technical assistance; Developing technical standards and laboratory practice guidelines, including standards and guidelines for cytology; Conducting laboratory quality improvement studies; Monitoring proficiency testing practices; Developing and distributing professional information and educational resources; Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC).
CAP #: 8975161
CLIA #: 05D2081492