Quality accreditation at the Caris lab

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The Caris Life Sciences laboratory has the highest level of quality accreditation of all tumour profiling services globally. It has received accreditation from several national bodies in the United States, where it is based, as well as international accreditation.

ISO: International Standards Association

Caris Life Sciences Molecular Profiling is the only tumour profiling laboratory service in the United States to have received ISO15189 accreditation. This accreditation is given only to laboratories that meet the most stringent quality control requirements.

ISO 15189:2012 Certificate of Accreditation

College of American Pathologists (CAP)

The College of American Pathologists (CAP) is an internationally recognised association of certified pathologists. It provides a peer-inspector accreditation program, both nationally and internationally. Accreditation involves both assessment using endorsed laboratory standards and peer based inspections. Once accredited laboratories are checked to ensure their ongoing compliance with standards every two years. The Caris Life Sciences laboratories have been CAP accredited since 2014.

CAP Certificate of Accreditation

US Government Centres for Medicare and Medicaid Services: Clinical Laboratory Improvement Amendments (CLIA)

The United States Centres for Medicare and Medicaid Services regulates all human laboratory testing in the US through the Clinical Laboratories Improvements Amendment (CLIA). It ensures quality laboratory testing. The Caris Laboratories are CLIA accredited.

CLIA Certificate of Accreditation 

New York State Department of Health: Clinical Laboratory Evaluation Program (CLEP)

The New York State Department of Health evaluates and provides accreditation to laboratories receiving tissue samples from patients in New York State through its Clinical Laboratory Evaluation Program (CLEP). Its quality evaluation assesses the qualifications of staff working in the laboratory and the proficiency with which the laboratory performs tests, through on-site inspection. The Caris Life Sciences laboratories have received New York State Department of Health accreditation in 2014. There are over 120 dedicated pathologists, geneticists and laboratory staff in our laboratory.

CLEP Certificate of Accreditation

 

Other State accreditations
The Caris Life Sciences laboratory has also received accreditation in the following States:

 

References

  1. Eden PR. Quality control in clinical laboratory samples. Medical Laboratory Observer. 2015 [cited January 2017]. [Full text]
  2. International Organisation for Standardisation. About ISO. Undated [cited 26 February 2017]. Available from: [URL link]
  3. College of American Pathologists. Laboratory Accreditation Program. 2017 [cited 26 February 2017]. Available from: [URL link]
  4. College of American Pathologists. Accredited Laboratory Detail. 2017 [cited 26 February 2017]. Available from: [URL link]
  5. Centres for Medicare and Medicaid. Survey and Certification: General Information. 2013 [cited 26 February 2017]. Available from: [URL link]
  6. CLIA Laboratory Demographic Information Report. 2017 [cited 26 February 2017]. Available from: [URL link]
  7. New York State Department of Health. Clinical Laboratory Evaluation Program. Undated [cited 26 February 2017]. Available from: [URL link]
  8. New York State Department of Health. Search Approved Clinical Laboratories. 2017 [cited 26 February 2017]. Available from:  [URL link]
  9. New York State Department of Health. Clinical Laboratory Standards of Practice. 2017 [cited 26 February 2017]. Available from:  [URL link]
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