American Association for Laboratory Accreditation

"The Platinum Choice" Clinical

Accreditation Program

CLIA and ISO 15189:2012

A2LA is proud to announce its "Platinum Choice" Clinical Accreditation Program as a result of our approval 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) and our long-standing international recognition to accredit clinical laboratories to the requirements of ISO 15189. A2LA's Platinum Choice Clinical Accreditation Program combines the quality management strengths of the ISO 15189 Standard with the technically-detailed 42CFR493 requirements, commonly referred to as the CLIA requirements. For this reason, this program is called THE PLATINUM CHOICE and laboratories who achieve accreditation in this program are assured of having met the most complete and comprehensive standards and requirements for clinical testing laboratories.

Accreditation within A2LA's Platinum Choice program sets a clinical laboratory apart from its competitors and counterparts as it is the only program in the world that offers domestically-recognized accreditation to the CLIA requirements as well as internationally-recognized accreditation to ISO 15189:2012. A2LA's Platinum Choice Clinical Accreditation Program raises the bar in laboratory quality by elevating expectations and attestations of competence beyond the minimum requirements established by law.

A2LA provides accreditation to any clinical laboratory 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
  • 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 for accreditation within A2LA's Platinum Choice Clinical Accreditation Program are assessed against the general criteria contained within ISO 15189:2012 Medical Laboratories - Requirements for Quality and Competence, as well as the requirements outlined within 42CFR493 under the Clinical Laboratory Improvement Amendmends (CLIA), with one assessment and one team of assessors.

Please click here to begin the process of applying within the Platinum Choice Clinical Accreditation Program.

Acceptance/Recognition of Accreditation in this Field

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

A2LA accreditation to the ISO 15189 standard is recognized worldwide by virture 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, since A2LA's Platinum Choice Clinical Accreditation Program is the only program in the world that offers not only domestically-recognized accreditation to the CLIA standard but also internationally-recognized accreditation to ISO 15189.

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: