Abstract
It is essential for molecular pathology laboratories to be in a state of inspection readiness at all times. Thorough and complete documentation of each step conducted by the laboratory allows for inspectors to follow a specimen through all phases of testing. Assays must be validated by the performing laboratory before testing can begin on patient samples, and a comprehensive procedure must be available to testing personnel. A well-developed quality management plan ensures laboratory quality is monitored and corrective actions taken if thresholds set by laboratories are exceeded.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Further Reading
Association for Molecular Pathology Clinical Practice Committee. Molecular diagnostics assay validation. Bethesda: Association for Molecular Pathology Clinical Practice Committee; 2009.
Buckingham L. Quality assurance and quality control in the molecular laboratory. In: Buckingham L, Flaws ML, editors. Molecular diagnostics fundamentals, methods, and clinical applications. Philadelphia: F.A. Davis; 2007. p. 403–25.
Burd EM. Validation of laboratory-developed molecular assays for infectious diseases. Clin Microbiol Rev. 2010;23:550–76.
Centers for Medicare and Medicaid Services, Centers for Disease Control and Prevention. 42 C.F.R. Part 493. Medicare, Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule; 2003. p. 3640–714.
College of American Pathology. All common checklist. http://www.cap.org. Accessed 11 July 2011.
College of American Pathology. Laboratory general checklist. http://www.cap.org. Accessed 11 July 2011.
College of American Pathology. Microbiology checklist. http://www.cap.org. Accessed 11 July 2011.
College of American Pathology. Molecular pathology checklist. http://www.cap.org. Accessed 11 July 2011.
Ferreira-Gonzalez A, Wilkinson DS, Bluth MH. Establishing a molecular diagnostic laboratory. In: McPherson RA, Pincus MR, Henry JB, editors. Henry’s clinical diagnosis and management by laboratory methods. Philadelphia: Elsevier Saunders; 2011. p. 1314–29.
Mifflin TE. Setting up a PCR laboratory. In: Dieffenbach CW, Dveksler GS, editors. PCR primer: a laboratory manual. New York: Cold Spring Harbor Laboratory Press; 2003. p. 5–14.
Morshed MG, Lee MK, Jorgensen D, Isaac-Renton JL. Molecular methods used in clinical laboratory: prospects and pitfalls. FEMS Immunol Med Microbiol. 2007;49:184–91.
National Committee for Clinical and Laboratory Standards. Assessment of laboratory tests when proficiency testing is not available; approved guidelines. NCCLS document GP29-A2. Wayne: NCCLS; 2008.
National Committee for Clinical and Laboratory Standards. Collection, transport, preparation, and storage of specimens for molecular diagnostic methods; approved guidelines. NCCLS document MM13-A. Wayne: NCCLS; 2005.
National Committee for Clinical and Laboratory Standards. Establishing molecular testing in clinical laboratory environments; approved guideline. NCCLS document MM19-A. Wayne: NCCLS; 2011.
National Committee for Clinical and Laboratory Standards. Quality management system: continual improvement; approved guideline. 3rd ed. NCCLS document GP22-A3. Wayne: NCCLS; 2011.
Seaton BL. Verification of molecular assays. In: Coleman WB, Tsongalis GJ, editors. Molecular diagnostics: for the clinical laboratorian. New York: Humana Press; 2006. p. 237–41.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media New York
About this entry
Cite this entry
Post, K.M., Cheng, L. (2013). Laboratory Management: Quality Assurance and Inspection. In: Cheng, L., Zhang, D., Eble, J. (eds) Molecular Genetic Pathology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-4800-6_46
Download citation
DOI: https://doi.org/10.1007/978-1-4614-4800-6_46
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-1-4614-4799-3
Online ISBN: 978-1-4614-4800-6
eBook Packages: MedicineReference Module Medicine