CLIA and ISO 15189 Accreditation with One Assessment
A2LA is proud to announce 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 over 35 years of accreditation experience, with accreditation programs spanning six international standards and eighteen program areas. A2LA’s commitment to quality, integrity, and technical competence in ensuring patient health and welfare is complemented by the addition of the CLIA requirements to the Association’s accreditation offerings.
With this achievement, A2LA becomes the only U.S. accreditation body with dual recognitions in the clinical testing arena: Recognition by the International Laboratory Accreditation Cooperation (www.ILAC.org) 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 and a clear competitive advantage.
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. The CLIA and ISO 15189:2012 requirements work together to enhance overall quality and ensure patient health and welfare.
“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, something that other accreditation bodies are simply unable to offer,” states Larnell Simpson, Director of Marketing and Medical Affairs for A2LA.
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.
A2LA is the first CLIA accreditation organization to be recognized by CMS since 1995. For more information about A2LA’s exciting and innovative accreditation programs for clinical laboratories, please visit the A2LA website.
Tags: Accreditation, CLIA
Date Published: April 7, 2014
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