Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the College of American Pathologists as a CLIA Accreditation Organization

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This notice announces the continuance of the approval of the College of American Pathologists (CAP) as an accreditation organization for laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). We found that the accreditation process of this organization provides reasonable assurance that the laboratories accredited by it meet the conditions required by CLIA statute and regulations. Consequently, laboratories that voluntarily become accredited by CAP in lieu of direct Federal oversight and continue to meet CAP 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. However, they are subject to Federal validation and complaint investigation surveys.