American Association for Laboratory Accreditation

CLIA Accreditation Program

A2LA is proud to announce its "Deemed Status" by the Centers for Medicare & Medicaid Services (CMS) for the accreditation of clinical testing laboratories to the requirements of 42CFR493 under the Clinical Laboratory Improvement Amendments (CLIA). A2LA's CLIA Accreditation Program provides accreditation to clinical laboratories performing moderate or high complexity testing as defined in 42CFR493. Laboratories that provide only waived or Provider Performed Microscopy (PPM) are not eligible for accreditation through A2LA; however, if a laboratory performs moderate or high complexity testing along with waived testing and/or PPM, A2LA will accredit the laboratory for all of this testing and microscopy.

On August 7, 2014, CMS approved A2LA's new approach toward assessing and accrediting clinical laboratories that perform waived testing. Such testing will be held to the CLIA requirements for waived testing as well as requirements that A2LA has adopted from CDC guidelines.

A2LA offers accreditation to clinical testing laboratories in the following specialities and subspecialties:

  • 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
  • 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 applying within this program are assessed against the requirements of 42CFR493 under the Clinical Laboratory Improvement Amendments (CLIA).

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

Acceptance/Recognition of Accreditation in this Field

In light of A2LA's "Deemed Status" by CMS, the A2LA CLIA Accreditation Program is fully recognized and accepted by CMS for the purposes of complying with the Clinical Laboratory Improvement Amendments (CLIA).

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, 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: