What makes the Caris lab so special? Quality control at the Caris Life Sciences laboratory

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What is quality control?

Quality control refers to the sets of procedures laboratories use to eliminate errors from laboratory tests and ensure test results are precise.

What is quality accreditation?

Laboratories that demonstrate certain standards of quality in their testing procedures can receive accreditation nationally and/or internationally. Organisations that provide accreditation include peak bodies (e.g. national associations of pathologists) or independent organisations.

ISO (International Standards Organisation) is the largest quality control accreditation organisation globally. It involves experts in the relevant professional disciplines, to develop standards of quality control needed to ensure the production of precise test results, and assess laboratories’ adherence to these standards. Accreditation by ISO International Standards, is recognised internationally. Amongst the 21,000 internationally recognised standards for goods and services, ISO15189 details standards for medical laboratories and their testing procedures.

Quality accreditation at the Caris lab

The Caris Lifesciences 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

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:

Quality control procedures in the Caris Life Sciences laboratory

The Caris Life Sciences laboratory has put in place the most stringent quality controls of any tumour profiling laboratory in the world. This includes quality controls mandated by quality accreditation bodies (discussed above) and self-imposed non-mandatory quality controls which far exceeds those required to attain the mandated regulatory standards, in order to provide the most accurate test results possible.

Mandatory quality controls

Certain quality control procedures are mandated by the organisations that provide accreditation for medical laboratories, including those organisations that have accredited the Caris Life Sciences laboratories. These mandatory standards include:

  • A Quality Management System which documents:
    • Staff qualifications and ongoing training requirements
    • Provision and maintenance of facilities and resources for performing laboratory tests;
    • Protocols to ensure the quality of samples received for testing;
    • Selection of instruments and reagents used to perform tests;
    • Periodic quality assessments performed;
    • Mechanisms to monitor the performance of tests and verify test results before they are sent to patients;
    • Procedures to ensure timely and accurate reporting of results;
    • Participation in periodic quality assurance testing; and
    • Procedures for corrective action when areas of non-conformance with standards are identified.
  • Staff that are suitably qualified and trained.
  • Laboratory facilities that are suitably designed for the tests performed.
  • Suitable laboratory equipment which is periodically checked and maintained.
  • Safety management procedures.
  • Operating procedures outlining standards of practice for performing each test.
  • Pre-examination procedures, for ensuring the quality of samples received.
  • Examination and test verification procedures, for ensuring suitable tests are selected.
  • Calibration procedures.
  • Records retention procedures.
  • Confidentiality standards.
  • Participation in proficiency testing.
  • Complaint resolution procedures.

Non-mandatory quality controls

In addition, Caris voluntarily implements additional quality controls. These include:

    • Use of a multi technology platform;
    • Ongoing staff proficiency testing for all cancer biomarkers;
    • Use of laboratory developed tests, where commercially available tests do not meet the patient’s testing requirements;
    • Validation of every antibody lot tested for specificity and sensitivity. Antibodies that do not meet the high standard set by Caris are returned;

    • Tissue micro-array controls on every slide for a side-by-side confirmation of staining performance to ensure consistent staining results. These are included on every immunohistochemistry slide to provide highly accurate confirmation of positive and negative results;

  • Manual microdissection of all slides used to enrich tumour concentration of the sample;
  • Regular internal and external inspections; and
  • Ongoing monitoring of test performance and thresholds of individual staff members.

The laboratory also has a committee available to discuss unexpected results with the ordering physician.

References

  1. Eden PR. Quality control in clinical laboratory samples. Medical Laboratory Observer. 2015. January. [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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