Clinical Testing Accreditation

Receive CMS and internationally-recognized accreditation for your clinical testing programs.

A2LA is the only accreditation organization (AO) in the world to achieve the Centers for Medicare and Medicaid Services (CMS) Deemed Status and International Laboratory Accreditation Cooperation (ILAC) Recognition for ISO 15189.

A2LA offers the clinical industry four comprehensive accreditation programs, described below. Each program advances clinical laboratory accreditation and provides lasting solutions to challenges commonly faced by laboratories.

Clinical Accreditation Programs

 

Platinum Choice Accreditation Program

The Platinum Choice Accreditation Program combines the ISO 15189:2012 Requirements for Quality and Competence with the CFR493 CLIA Requirements. This program delivers the prescriptive technical requirements established in the CLIA requirements with the core quality management system and testing requirements of ISO 15189, resulting in the world's first all-inclusive clinical accreditation package.

 

CLIA Accreditation Program

The A2LA CLIA Accreditation Program, which received CMS Deemed Status in 2014, is your assurance of reliable results. A2LA assigns assessors who are familiar with the latest technologies, are a match with clients’ technical capabilities and who make every assessment based on requirements – not personal opinion. If a deficiency cannot be cited to a CLIA requirement clause, state requirement, or the laboratory's own policies or procedures, it isn't a finding.

 

ISO 15189:2012 Accreditation Program

The A2LA ISO 15189:2012 Accreditation Program, launched in 2007, is recognized by the International Laboratory Accreditation Cooperation, meaning that A2LA was evaluated much the same way as our customers are evaluated as a testing laboratory to achieve accreditation. This standard provides requirements for technical competency in performing pre-analytical, analytical and post analytical functions, as well as quality management system requirements. Laboratories attaining A2LA Accreditation to this standard operate a testing laboratory based on continuous improvement and choose this standard to aid in supporting their team in operating at a high-level.

 

AABB / A2LA Clinical Accreditation Program

The AABB / A2LA Clinical Accreditation Program is a combined accreditation program for clinical laboratories, blood banks, and transfusion services. The value-added program combines up to three assessment criteria—ISO 15189:2012, CLIA requirements, and the American Association of Blood Banks (AABB) requirements—into one assessment catered to your laboratory’s business needs. Using just one assessment team of experts, this program reduces the time and expense of laboratory staff undergoing ongoing surveys.

 

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