Clinical Pathology: General Principles, Lab Management, Clinical Chemistry

• A certificate of waiver is issued to a laboratory that performs ONLY waived testing.

• A certificate of registration is issued to a laboratory to allow the laboratory to conduct nonwaived (i.e., moderate- and/or high-complexity) testing until the laboratory is inspected by the state Department of Health or an accreditation agency to determine its compliance with the Clinical Laboratory Improvement Amendments regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration.

• A certificate of compliance is issued to a laboratory once the state Department of Health conducts an inspection and determines that the laboratory is compliant with all applicable Clinical Laboratory Improvement Amendments requirements. This type of certificate is issued to a laboratory that performs nonwaived (i.e., moderate- and/or high-complexity) testing. This is not needed to add a waived test.

• A certificate of accreditation is issued to a laboratory on the basis of the laboratory’s accreditation by an accreditation organization approved by CMS. This type of certificate is issued to a laboratory that performs nonwaived (i.e., moderate- and/or high-complexity) testing.

• There are six CMS-approved accreditation agencies:

     • AABB

     • American Osteopathic Association

     • American Society for Histocompatibility and Immunogenetics

     • COLA

     • College of American Pathologists

     • The Joint Commission