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.

The aA2LA Clinical Accreditation Program accredits clinical laboratories to five comprehensive accreditation programs. Each program advances clinical laboratories within the field and provided 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 42 CFR 493 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 was launched in 2014 when A2LA received deemed status from the Centers for Medicare and Medicaid Services (CMS). The A2LA CLIA Accreditation Program assess your laboratory’s competence with the 42 CFR 493 requirements, and a Certificate of Accreditation provided under A2LA can be granted for laboratories performing moderate or high complexity testing.

A2LA is approved under our deemed status to grant accreditation under the following specialties and subspecialties recognized by CMS:

  • Histocompatibility
  • Microbiology
    • Bacteriology
    • Mycobacteriology
    • Mycology
    • Parasitology
    • Virology
  • Diagnostic Immunology
    • Syphilis Serology
    • General Immunology
  • Chemistry
    • Routine Chemistry
    • Urinalysis
    • Endocrinology
    • Toxicology
  • Hematology
  • Immunohematology
    • ABO/Rh Group
    • Antibody Transfusion
    • Antibody Non-Transfusion
    • Antibody Identification
    • Compatibility Testing
  • Pathology
    • Histopathology
    • Oral Pathology
    • Cytology
  • Radiobioassay
  • Cytogenetics


The A2LA CLIA Program is your assurance of reliable results. During the accreditation process, A2LA assigns assessors who are not only familiar with the latest technologies but are a match with clients’ technical capabilities. Every assessment is based of the requirements and not personal opinion. If a deficiency is unable to be cited to a CLIA requirement, state requirement, A2LA requirement, or the laboratory’s own policies or procedures, it is not a finding.

For more information on CLIA, please visit the CMS CLIA Program website.

 

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.

 

CLIP Accreditation Program

The A2LA CLIP Program was develop for A2LA to grant accreditation to CLIP requirements as A2LA maintains CMS deemed status recognition. The CLIP accreditation program is overseen by the DoD Center for Clinical Laboratory Medicine (CCLM), and this program can rely on non-profit accreditation organizations that maintain CMS deemed status to conduct assessments and provide accreditation. The CLIP requires are similar to the CLIA requirements, but some of the requirements have been modified.

The CLIP specific requirements can be seen in the DoD Instructions 6440.2.

 

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Clinical Labs: Subscribe to New CMS Communications Update

The Centers for Medicare & Medicaid Services (CMS) launched a communications update to help laboratories comply with Clinical Laboratory Improvement Amendments (CLIA).

 

Subscribers will receive:

  • Important updates and information
  • Resources to help laboratory professionals navigate the survey and certification process
  • Announcements of the release of new regulatory and policy documents

 

Go to the CMS GovDelivery Subscriber page, enter your email address, and click “CLIA Communications”.

 

For more information, visit the CMS CLIA Program website.

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