A2LA's CLIA accreditation program for clinical laboratories achieves CMS approval

April 2, 2014

The American Association for Laboratory Accreditation (A2LA) has announced approval by the Centers for Medicare and Medicaid Services (CMS) to accredit clinical laboratories worldwide to the Clinical Laboratory Improvement Amendments (CLIA) requirements. A2LA has more than 35 years of accreditation experience, with accreditation programs spanning six international standards and eighteen program areas. A2LA representatives say the association’s commitment to quality, integrity, and technical competence in ensuring patient health and welfare is complemented by the addition of the CLIA requirements to its accreditation offerings. A2LA now 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.

Applicant clinical laboratories now have the opportunity to implement A2LA’s “Platinum Choice” option that allows a clinical laboratory not only to fully meet CLIA requirements but also to gain accreditation to ISO 15189 with one assessment, using one team of assessors. The ”Platinum Choice” 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.

“We are not offering laboratories an exercise on the ISO process; we are offering laboratories a single assessment accepted by our domestic and international peers,” says Larnell Simpson, A2LA Director of Marketing and Medical Affairs. 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 accreditation programs for clinical laboratories.

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