CLINICAL LABORATORY ACCREDITATION PROGRAMS
American Association for Laboratory Accreditation (A2LA)
5301 Buckeystown Pike, Suite 350
Frederick, MD 21704
With A2LA’s “Deemed Status” by the Centers for Medicare and Medicaid Services (CMS), A2LA now offers three accreditation programs to meet the needs of the clinical laboratory community (see below for more information about each):
• The PLATINUM CHOICE Clinical Accreditation Program;
• The CLIA Accreditation Program; and
• The ISO 15189: 2012 Accreditation Program
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 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 requreiements for waived testing as well as requirements that A2LA has adopted from CDC guidelines.
A2LA offers accreditation to clinical testing laboratories in the following specialties and subspecialties:
• Diagnostic Immunology
• Syphilis Serology
• General Immunology
• Routine Chemistry
• Special Chemistry
• Clinical Cytogenetics
• Flow Cytometry
• General Hematology
• ABO Group
• Antibody Detection (transfusion)
• Antibody Detection (non-transfusion)
• Antibody Identification
• Compatibility Testing
• Rh Type
• Oral Pathology
• Molecular Pathology
ACCREDITATION OFFERINGS AND ASSOCIATED REQUIREMENTS
A2LA offers three options for clinical laboratory accreditation and the requirements for each differ, as indicated below. Please click on each of the options listed for more information about the specific accreditation program and its requirements.
• PLATINUM CHOICE Clinical Accreditation Program – A2LA refers to this program as the “Platinum Choice” since all laboratories applying within this program are assessed against both ISO 15189:2012 and the 42CFR493 standard (the “CLIA requirements”) with one assessment and one team of assessors. Accreditation within this 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.
• CLIA Accreditation Program – Laboratories applying within this program are assessed against the requirements found within 42CFR493 – Centers for Medicare & Medicaid Services, Department of Health and Human Services, Standards and Certification, Laboratory Requirements (the “CLIA requirements”).
• ISO 15189:2012 Accreditation Program – Laboratories applying within this program are assessed against the general criteria contained within ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence.
Click on each of the programs above to learn more about each particular option.
ACCEPTANCE/RECOGNITION OF ACCREDITATION IN THIS FIELD
Interested in learning how A2LA accreditation may be accepted internationally as well as domestically by federal, state and private sector entities? Click on the following links for more information:
• A2LA’s International Recognitions
• A2LA’s Domestic Recognitions
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 Roxanne Robinson, A2LA Vice President/COO, at rrobinson@A2La.org.
• Amanda McDonald
Accreditation Officer II
• Roxanne Robinson
• ISO 15189 Medical FAQ
• Branch System Policy