The accreditation agencies that have been given deemed authority by CMS are summarized in Table 1. These agencies have the authority to inspect not only for specific accreditation requirements but also for the CLIA requirements.
Two states are exempt from CLIA regulations: New York and Washington. These states have laws that are equal to or more stringent than CLIA. Thus, those states are only subject to their state requirements (refer to the Exempt State List, attached below).
Some local and state departments of health also perform inspections to verify compliance with additional state and local regulations.
Table 1. Inspection Agencies Deembed by CMS.| CMS- Center for Medicare and Medicaid Services | Confirmation of compliance testing quality required by the CLIA ’88 legislation | Inspection | Mandatory | Dependent on the test complexity classification system established by CLIA ‘88 |
| Food and Drug Administration (FDA) | Oversee the collection, distribution, and safety of blood components | Inspection | Mandatory | Code of Federal Regulation |
| COLA | Laboratory improvement of quality, efficiency, and meeting federal (CLIA) and specific accreditation requirements | Inspection (Survey) | Voluntary | COLA Laboratory Accreditation Manual |
| AABB | Oversee the safety of all aspects of transfusion medicine | Assessments | Voluntary | AABB Standards |
| College of American Pathologists (CAP) | Assist with patient safety by providing oversight and assistance with quality of laboratory medicine | Inspection | Voluntary | Standards for laboratory accreditation |
| Joint Commission (JC) | To direct the laboratory and total organization to zero harm | Inspection (Survey) | Voluntary | Standards for Laboratory Accreditation |
| American Association for Laboratory Accreditation (A2LA) | To provide quality services and acceptance of results | Inspection (Survey) | Voluntary | Uses ISO standards for specialty being reviewed |
| American Society for Histocompatibility and Immunogenetics | To promote the highest standard of laboratory testing to provide optimum patient care | Inspection (Survey) | Voluntary | Standards for Accredited Laboratories American Society for Histocompatibility and Immunogenetics |
| Accreditation Association for Hospitals and Health Systems/Healthcare Facilities Accreditation Programs (AOA/HFAP) | To assist the laboratory in improvement of quality of laboratory testing through peer review, education, and compliance with established conditions and standards | Inspection (Survey) | Voluntary | HFAP Accreditation Requirements for Clinical Laboratories |
