It is important to note that this book is meant to explain and clarify requirements that are set forth under the Clinical Laboratory Improvement Amendments (CLIA). Laboratories seeking a Certificate of Compliance will be inspected directly by Centers for Medicare and Medicaid Services (CMS) surveyors or by the laboratory's state agency. Laboratories seeking a Certificate of Accreditation (COA) will be inspected by an accrediting agency approved by CMS. If a laboratory passes inspection and is issued a COA, they are considered to have obtained “laboratory accreditation” and are an accredited laboratory. If a laboratory successfully obtains a Certificate of Compliance (COC), however, they are not considered an accredited laboratory. Accrediting agencies are responsible for determining if laboratories seeking a COA are in compliance with CLIA requirements. Since these agencies are assessing laboratories on behalf of CMS, they must be approved by CMS for this purpose.