American Association for Laboratory Accreditation

AABB/A2LA Clinical Accreditation Program

A2LA has formed a partnership with AABB to offer a combined accreditation program for clinical laboratories, blood banks, and transfusion services. This accreditation program combines three assessment criteria into one assessment: AABB accreditation requirements, ISO 15189:2012 accreditation requirements and the clinical laboratory accreditation program (CLIA) requirements. This partnership saves an organization valuable personnel time by allowing them to undergo an assessment to all of their accreditation criteria in one activity. The benefits of this program include:

  • Three assessments in one - AABB, ISO 15189:2012, and CLIA Requirements - reducing laboratory staff time.
  • An ISO standard that is not prescriptive and can be implemented based on a laboratory's work culture and processes.
  • Internationally-recognized accreditation through ILAC (A2LA) and ISQua (AABB).
  • Value-added assessments by quality-focused technical experts in the areas they are assessing.
  • Partners in accreditation that will provide an educational experience for laboratories navigating the accreditation landscape.
  • Accreditation organizations with independently-earned CMS Deemed Status.
  • Over 100 years of combined experience in helping facilities improve quality.

AABB shares its core values with A2LA, values upon which both organizations were based, including: continuous improvement and improved patient safety and outcomes backed by over 100 years of combined experience. Like A2LA, AABB is a not-for-profit association, headquartered in the United States but providing services internationally.

A2LA offers accreditation to clinical testing laboratories in the following specialties and sub-specialties:

  • Histocompatibility
  • Microbiology
    • Bacteriology
    • Mycobacteriology
    • Mycology
    • Parasitology
    • Virology
  • Diagnostic Immunology
    • Syphilis Serology
    • General Immunology
  • Chemistry
    • Routine Chemistry
    • Special Chemistry
    • Urinalysis
    • Endocrinology
    • Toxicology
  • Clinical Cytogenetics
  • Flow Cytometry
  • Hematology
    • General Hematology
    • Coagulation
    • Immunohematology
  • Immunohematology
  • ABO Group
    • Antibody Detection (transfusion)
    • Antibody Detection (non-transfusion)
    • Antibody Identification
    • Compatibility Testing
    • Rh Type
  • Pathology
    • Histopathology
    • Oral Pathology
    • Cytology
    • Molecular Pathology
  • Radiobioassay

Accreditation Requirements

Clinical laboratories, blood banks and transfusion services applying for accreditation within the AABB/A2LA Accreditation Program are assessed against the general criteria contained within ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence and/or the requirements outlined within 42CFR493 under the Clinical Laboratory Improvement Amendments (CLIA) in addition to the AABB requirements with one assessment and one team of assessors.

Please click here to begin the process of applying within the AABB/A2LA Accreditation Program.

Acceptance/Recognition of Accreditation in this Field

In light of A2LA's "Deemed Status" by CMS, the AABB/A2LA Accreditation Program is fully recognized and accepted by CMS for the purpose of complying with the Clinical Laboratory Improvement Amendments (CLIA) when the CLIA assessment criteria are selected for accreditation.

A2LA accreditation to the ISO 15189 standard is recognized worldwide by virtue of the Mutual Recognitions Arrangements that A2LA has signed with our counterparts around the world. We invite you to click on the following links for more information:

Advisory Committee

A2LA has developed a Medical Testing Advisory Committee (MedTAC) to assist the Association by providing technical input on policy creation and decisions related to the clinical testing laboratory accreditation program. If you wish to participate on the MedTAC, we invite you to contact Amanda McDonald, A2LA Senior Accreditation Officer, at amcdonald@A2LA.org.

Additional Resources

To assist clinical laboratories in achieving and maintaining the necessary certifications and recognitions, A2LA has compiled the following documents for reference: