Abstract
Clinical laboratories are expected to provide accurate and sensitive diagnostic tests. In the meantime, clinical laboratories are facing many challenges including rapidly evolving technologies, increasing test needs, and complexity. Like any complicated process, molecular laboratories are not immune from quality problems. Quality control and assurance help to monitor testing performance and provides additional confidence in the quality and reliability of laboratory operations. In addition, clinical laboratory operation, particularly test validation, is one of the heavily regulated areas in clinical practice. In this chapter, we will focus on the common concept of quality control and assurance, regulatory requirements for laboratory operation.
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
References
Genzen JR. Regulation of laboratory-developed tests. Am J Clin Pathol. 2019;152:122–31.
Jennings L, Van Deerlin VM, Gulley ML, College of American Pathologists Molecular Pathology Resource C. Recommended principles and practices for validating clinical molecular pathology tests. Arch Pathol Lab Med. 2009;133:743–55.
Schreier J, Feeney R, Keeling P. Diagnostics reform and harmonization of clinical laboratory testing. J Mol Diagn. 2019;21:737–45.
Roy S, Coldren C, Karunamurthy A, Kip NS, Klee EW, Lincoln SE, Leon A, Pullambhatla M, Temple-Smolkin RL, Voelkerding KV, Wang C, Carter AB. Standards and guidelines for validating next-generation sequencing bioinformatics pipelines: a joint recommendation of the Association for Molecular Pathology and the College of American Pathologists. J Mol Diagn. 2018;20:4–27.
Moncur JT, Bartley AN, Bridge JA, Kamel-Reid S, Lazar AJ, Lindeman NI, Long TA, Merker JD, Rai AJ, Rimm DL, Rothberg PG, Vasalos P, Kim AS. Performance comparison of different analytic methods in proficiency testing for mutations in the BRAF, EGFR, and KRAS genes: a study of the College of American Pathologists Molecular Oncology Committee. Arch Pathol Lab Med. 2019;143:1203–11.
Surrey LF, Oakley FD, Merker JD, Long TA, Vasalos P, Moncur JT, Kim AS. Next-generation sequencing (NGS) methods show superior or equivalent performance to non-NGS methods on BRAF, EGFR, and KRAS proficiency testing samples. Arch Pathol Lab Med. 2019;143:980–4.
Zehnbauer B, Lofton-Day C, Pfeifer J, Shaughnessy E, Goh L. Diagnostic quality assurance pilot: a model to demonstrate comparative laboratory test performance with an oncology companion diagnostic assay. J Mol Diagn. 2017;19:1–3.
Paek SH, Kim BS, Kang KH, Kim HS. False-negative BRAF V600E mutation results on fine-needle aspiration cytology of papillary thyroid carcinoma. World J Surg Oncol. 2017;15:202.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2021 The Author(s), under exclusive license to Springer Nature Switzerland AG
About this chapter
Cite this chapter
Gao, J., Jennings, L.J. (2021). Quality Assurance and Quality Control in Molecular Diagnostic Laboratories. In: Ding, Y., Zhang, L. (eds) Practical Oncologic Molecular Pathology. Practical Anatomic Pathology. Springer, Cham. https://doi.org/10.1007/978-3-030-73227-1_4
Download citation
DOI: https://doi.org/10.1007/978-3-030-73227-1_4
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-73226-4
Online ISBN: 978-3-030-73227-1
eBook Packages: MedicineMedicine (R0)