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Review Article| Volume 38, ISSUE 3, P515-526, September 2018

Accreditation and Quality Assurance for Clinical Liquid Chromatography–Mass Spectrometry Laboratories

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      References

        • Clinical and Laboratory Standards Institute (CLSI)
        Liquid chromatography-mass spectrometry methods; approved guideline (C62-A).
        Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2014
      1. Centers for Medicare and Medicaid Services (CMS). Clinical laboratory improvement amendments (CLIA). Available at: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/

        • Clinical and Laboratory Standards Institute (CLSI)
        Quality management system: a model for laboratory services (QMS 01).
        4th edition. Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2011
        • Clinical and Laboratory Standards Institute (CLSI)
        Quality management system: continual improvement (QMS 06).
        3rd edition. Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2011
        • Clinical and Laboratory Standards Institute (CLSI)
        Development and use of quality indicators for process improvement and monitoring of laboratory quality (QMS 12).
        Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2010
        • Clinical and Laboratory Standards Institute (CLSI)
        Laboratory quality control based on risk management (EP23).
        Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2011
        • Clinical and Laboratory Standards Institute (CLSI)
        Mass spectrometry in the clinical laboratory: general principles and guidance (C50-A).
        Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2007
      2. U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: bioanalytical method validation. 2001. Available at: https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf. Accessed April, 2018.

      3. European Medical Agency. Guideline on bioanalytical method validation. 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf. Accessed April, 2018.

        • Scientific Working Group for Forensic Toxicology
        Scientific Working Group for Forensic Toxicology (SWGTOX) standard practices for method validation in forensic toxicology.
        J Anal Toxicol. 2013; 37: 452-474
        • Clinical and Laboratory Standards Institute (CLSI)
        Statistical quality control for quantitative measurement procedures: principles and definitions (C24).
        4th edition. Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2016
        • Clinical and Laboratory Standards Institute (CLSI)
        Metrological traceability and its implementation (EP32).
        Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2006
        • Clinical and Laboratory Standards Institute (CLSI)
        Using proficiency testing and alternative assessment to improve medical laboratory quality (QMS24).
        3rd edition. Clinical and Laboratory Standards Institute (CLSI), Wayne (PA)2016
        • College of American Pathologists (CAP)
        CAP accreditation program: chemistry and toxicology checklist.
        College of American Pathologists, Northfield (IL)2016 (Available at:) (Accessed April, 2018)
      4. U.S Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Discussion paper on laboratory developed test, January 2017. Available at: https://www.fda.gov/downloads/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/laboratorydevelopedtests/ucm536965.pdf. Accessed April, 2018.