CLIA Accreditation and Testing

The following information is found in the Downloads section below:

• A list of approved accreditation organizations with deeming authority under the Clinical Laboratory Improvement Amendments (CLIA); 
• Specialty/subspecialty information for approved accreditation organizations; 
• A list of States with State licensure programs that have exemption from CLIA program requirements; and
• FY 2016 Report to Congress (RTC): Review of Medicare’s Program Oversight of Accrediting Organizations (AOs) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Validation Program (Refer to the Survey and Cert Letter 17-40).

Categorization of Tests

Since November 13, 2003, the Food and Drug Administration (FDA) has had the authority to implement the Clinical Laboratory Improvement Amendments (CLIA) test complexity categorization provisions, which includes, but is not limited to the following:

• Interpreting the CLIA provisions related to complexity categorization;
• Holding public workshops and meetings on CLIA complexity categorization; and,
• Developing and issuing implementing rules and guidance for CLIA complexity categorization.

The FDA CLIA database contains the commercially-marketed in vitro test systems categorized by FDA since January 31, 2000, as well as tests categorized by the Centers for Disease Control and Prevention (CDC) prior to that date.

Certification Boards for Laboratory Directors of High Complexity Testing

The qualification for a laboratory director of high complexity testing at 42 CFR 493.1443(b)(3)(i) is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS. The current approved boards are the following:

1. ABB – American Board of Bioanalysis 
2. ABB public health microbiology certification
3. ABCC – American Board of Clinical Chemistry
4. ABFT – American Board of Forensic Toxicology (limited to individuals with a doctoral degree with Fellow status)* 
5. ABMGG – American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG))
6. ABMLI – American Board of Medical Laboratory Immunology
7. ABMM – American Board of Medical Microbiology
8. ACHI – American College of Histocompatibility and Immunogenetics (formerly known as American Board of Histocompatibility and Immunogenetics (ABHI))
9. NRCC – National Registry of Certified Chemists (limited to individuals with a doctoral degree)*

 * These boards certify non-doctoral individuals also.