Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of COLA as a CLIA Accreditation Organization

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This notice announces the continued approval of COLA (formerly the Commission on Office Laboratory Accreditation) as an accreditation organization for laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by CLIA law and regulations. Consequently, laboratories that voluntarily become accredited by COLA in lieu of direct Federal oversight and continue to meet COLA requirements would meet the CLIA condition level requirements for laboratories and, therefore, are not subject to routine inspection by State survey agencies to determine their compliance with CLIA requirements. They are, however, subject to Federal validation and complaint investigation surveys.