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.
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.
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