AABB Receives Deemed Status Under CLIA

April 16, 2024

The Centers for Medicare and Medicaid Services (CMS) renewed AABB’s "deemed status" for the following subspecialties under the Clinical Laboratory Improvement Amendments of 1988 (CLIA):  

  • Blood banks and transfusion services.
  • Immunohematology reference laboratories.
  • Cellular therapy services.
  • Molecular testing for red cell, platelet and neutrophil antigens.

CMS granted AABB deemed status for six years, effective April 12.

In the U.S., clinical testing laboratories are regulated by CMS. Survey protocols and interpretive guidelines are established pursuant to pertinent sections of the Social Security Act, the Public Health Service Act, CLIA and the CLIA regulations at 42 CFR Part 493, which provide guidance to personnel conducting surveys of laboratories.

AABB serves as an accreditation organization for its accredited facilities that subscribe to this service. Under the CLIA Certificate of Accreditation provisions, a laboratory is not routinely subject to direct federal oversight by CMS. Instead, the laboratory receives an inspection by the accreditation organization in the course of maintaining its accreditation and, by virtue of this accreditation, is “deemed” to meet CLIA requirements. The CLIA requirements pertain to quality assurance and quality control programs, records, equipment, personnel, proficiency testing and other areas to assure accurate and reliable laboratory examinations and procedures; AABB requirements meet or exceed those CLIA requirements.

If a laboratory performs any nonwaived testing, the laboratory may have either a Certificate of Compliance or Certificate of Accreditation. All laboratories with either of these certificate types must meet all nonwaived testing requirements and are subject to biennial surveys. These surveys can be conducted by AABB as a CMS-approved accreditation organization.

Additional Information and guidance regarding meeting both AABB Standards and CLIA regulations can be found on AABB’s website on the AABB CLIA Corner web page. Individuals with questions may contact accreditation@aabb.org.