A2LA updates CMS-approved clinical laboratory accreditation program

Aug. 13, 2014

The American Association for Laboratory Accreditation (A2LA) has announced an update to its program for the accreditation of clinical laboratories performing waived testing. A2LA is approved by the Centers for Medicare and Medicaid Services (CMS) to accredit clinical laboratories (for all specialties and sub-specialties) to the requirements contained within the Clinical Laboratory Improvement Amendments (CLIA).

On August 7, CMS approved A2LA’s updated approach to accrediting laboratories that perform waived testing. Such testing will now be held to the CLIA-waived testing requirements. A2LA has also chosen to adopt as requirements the guidelines published by the CDC (CS242576-A) related to waived testing. Although A2LA does not accredit laboratories that perform waived testing exclusively, those laboratories that perform non-waived testing in addition to waived testing are eligible for A2LA accreditation.

A2LA has dual recognitions in the clinical testing arena: Recognition by the International Laboratory Accreditation Cooperation for the accreditation of clinical laboratories to ISO 15189:2012 and recognition by CMS for the accreditation of clinical laboratories to the CLIA requirements. This results in a single accreditation that allows A2LA-accredited clinical laboratories increased international business opportunities, improved quality, and a clear competitive advantage.

Applicant clinical laboratories have the opportunity to implement A2LA’s “Platinum Choice” option that allows a clinical laboratory not only to meet CLIA requirements but also to gain accreditation to ISO 15189 with one assessment, using one team of assessors. This option provides domestic recognition for accreditation to the CLIA requirements as well as international recognition of the clinical laboratory’s testing competence and quality via ISO 15189 accreditation. A2LA also offers a separate accreditation program to the CLIA requirements alone and an accreditation program to the ISO 15189:2012 requirements alone as additional options for clinical laboratories. Learn more about A2LA’s programs.

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