The AABB CLIA Corner is intended to promote consistency in the approach to the CMS survey process and to assist AABB-accredited laboratories in monitoring operations and ensuring that quality testing is in place. Both AABB and the Centers for Medicare and Medicaid Services (CMS) promote an educational survey process to assist in understanding and achieving quality system concepts.

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, the Clinical Laboratory Improvement Amendments (CLIA) of 1988, and the CLIA regulations at 42 CFR Part 493, to provide guidance to personnel conducting surveys of laboratories.

AABB serves as an accreditation organization (AO) 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 AO in the course of maintaining its accreditation, and by virtue of this accreditation, is “deemed” to meet CLIA requirements. The CLIA requirements pertain to QA 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. AABB meets the criteria as an approved AO (also called “deeming authority”) for the following programs: Blood Bank and Transfusion Services (BB/TS); Immunohematology Reference Laboratory (IRL); Molecular Testing (MT); and the Cellular Therapy (CT). To this end, AABB provides information to educate staff members at AABB-accredited facilities and to provide assistance in the CLIA verification of testing laboratories.

In an effort to categorize the laboratory testing areas in which CMS provides guidance, AABB has divided its educational information into the following areas:

  • Ask the FDA/CMS
  • Competency Assessment
  • Test Complexity
  • Proficiency Testing
  • CLIA Certificates

AABB offers accredited facilities various resources to keep updated and well-informed on the key regulatory issues of the field. These resources are designed to help facilities optimize operations, navigate complex requirements, address challenges, and ensure the highest level of quality and care for donors and patients.