About ISO 15189 Accreditation
Receive CMS and internationally-recognized accreditation for your clinical testing programs with A2LA’s Clinical Testing Lab Accreditation Program.
A2LA is the only accreditation organization (AO) in the world to achieve the Centers for Medicare and Medicaid Services (CMS) Deemed Status for CLIA and International Laboratory Accreditation Cooperation (ILAC) Recognition for ISO 15189.
The A2LA Clinical Accreditation Program accredits clinical laboratories to four comprehensive accreditation programs. Each program advances clinical laboratories within the field and provides lasting solutions to challenges commonly faced by laboratories. Get a quote or contact us to learn more!
Clinical Testing Lab Accreditation Programs
- Platinum Choice Accreditation Program
- CLIA Accreditation Program
- ISO 15189 Accreditation Program
- CLIP Accreditation Program
Platinum Choice Accreditation Program
The Platinum Choice Accreditation Program combines the ISO 15189:2012 or ISO 15189:2022 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. Laboratories accredited to this program will have both standards be assessed during one assessment and receive a CLIA and ISO 15189:2012 or ISO 15189:2022 Certificate of Accreditation.
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 assesses 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 on 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, visit the CMS CLIA Program website.
ISO 15189 Accreditation Program
The ISO 15189 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. The ISO 15189 Accreditation Program currently accredits laboratories to the 2012 and 2022 versions of ISO 15189.
CLIP Accreditation Program
The A2LA CLIP Program was developed 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 Laboratory Medicine Services (CLMS), and this program can rely on non-profit accreditation organizations that maintain CMS deemed status to conduct assessments and provide accreditation. The CLIP requirements 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.
Clinical Testing Lab Accreditation Program Requirements
- Platinum Choice Accreditation Program
- 42 CFR 493 CLIA Requirements
- ISO 15189:2012 or ISO 15189:2022 – Medical Laboratories – Requirements for Quality and Competence
- R701 – General Requirements – Accreditation of Clinical Testing Laboratories Meeting the Platinum Requirements
- A2LA P704 – Platinum Program Policy for Record and Material Retention
- A2LA R702 – Conditions for Accreditation for Clinical Testing Laboratories Meeting the Platinum Requirements
- A2LA P705 – A2LA Metrological Traceability Policy for Platinum Laboratories
- A2LA P703 – Policy on Estimating Uncertainty of Measurement for Platinum Laboratories
- A2LA R703 – General Requirements: Proficiency Testing for Clinical Testing Laboratories Meeting the Platinum Requirements
- A2LA R105 – Requirements When Making Reference to A2LA Accredited Status.
- CLIA Accreditation Program
- 42 CFR 493 CLIA Requirements
- R601 – General Requirements – Accreditation of Clinical Testing Laboratories Meeting the CLIA Requirements
- A2LA P604 – CLIA Program Policy for Record and Material Retention
- A2LA R602 – Conditions for Accreditation for Clinical Testing Laboratories Meeting the CLIA Requirements
- A2LA R603 – General Requirements: Proficiency Testing for Clinical Testing Laboratories Meeting the CLIA Requirements
- A2LA R105 – Requirements When Making Reference to A2LA Accredited Status
- ISO 15189 Accreditation Program
- ISO 15189:2012 or ISO 15189:2022 – Medical Laboratories – Requirements for Quality and Competence
- R101 – General Requirements – Accreditation of Conformity Assessment Bodies
- R102 – Conditions for Accreditation
- R105 – Requirements When Making Reference to A2LA Accredited Status
- P102 – A2LA Policy on Metrological Traceability
- P903 – Policy on Estimating Uncertainty of Measurement for ISO 15189 Testing Labs
- R103 – General Requirements: Proficiency Testing for ISO/IEC 17025 Laboratories
- CLIP Accreditation Program
- Department of Defense Manual 6440.02 Clinical Laboratory Improvement Program Procedures
- R1001 – General Requirements – Accreditation of Clinical Testing Laboratories Meeting the CLIP Requirements
- A2LA P1004 – CLIP Program Policy for Record and Material Retention
- A2LA R1002 – Conditions for Accreditation for Clinical Testing Laboratories Meeting the CLIP Requirements
- A2LA R1003 – General Requirements: Proficiency Testing for Clinical Testing Laboratories Meeting the CLIP Requirements
- A2LA R105 – Requirements When Making Reference to A2LA Accredited Status
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 on CLIA, visit the CMS CLIA Program website.