CLIA Certification and Accreditation, ISO 15189 Accreditation, and Proficiency Testing

Abstract Clinical laboratories can ensure the quality of testing and result reporting through laboratory certification and accreditation. The Centers for Medicare & Medicaid Services (CMS), which administers the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program, can issue a certificate of accreditation based on the laboratory's meeting certification requirements for a CMS‐approved accreditation organization. While the CLIA certificate of accreditation is one way of meeting the required quality standards for U.S. laboratories, meeting an International Organization for Standardization (ISO) accreditation standard is another option for international laboratories or U.S. laboratories aspiring to higher levels of quality. ISO 15189 provides an overview of the quality management system standards and includes additional quality and competence criteria in medical laboratories. Proficiency testing (PT) is an essential part of a laboratory's quality system, and clinical laboratories use PT to verify test accuracy and reliability.