Abstract
In the clinical microbiology laboratory advances in nucleic acid detection, quantification, and sequence analysis have led to considerable improvements in the diagnosis, management, and monitoring of infectious diseases. Molecular diagnostic methods are routinely used to make clinical decisions based on when and how to treat a patient as well as monitor the effectiveness of a therapeutic regime and identify any potential drug resistant strains that may impact on the long term patient treatment program. Therefore, confidence in the reliability of the result provided by the laboratory service to the clinician is essential for patient treatment. Hence, suitable quality assurance and quality control measures are important to ensure that the laboratory methods and service meet the necessary regulatory requirements both at the national and international level. In essence, the modern clinical microbiology laboratory ensures the appropriateness of its services through a quality management system that monitors all aspects of the laboratory service pre- and post-analytical—from patient sample receipt to reporting of results, from checking and upholding staff competency within the laboratory to identifying areas for quality improvements within the service offered. For most European based clinical microbiology laboratories this means following the common International Standard Organization (ISO9001) framework and ISO15189 which sets out the quality management requirements for the medical laboratory (BS EN ISO 15189 (2003) Medical laboratories—particular requirements for quality and competence. British Standards Institute, Bristol, UK). In the United States clinical laboratories performing human diagnostic tests are regulated by the Centers for Medicare and Medicaid Services (CMS) following the requirements within the Clinical Laboratory Improvement Amendments document 1988 (CLIA-88). This chapter focuses on the key quality assurance and quality control requirements within the modern microbiology laboratory providing molecular diagnostics.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
BS EN ISO 15189 (2003) Medical laboratories—particular requirements for quality and competence. British Standards Institute, Bristol, UK
Boone DJ, Hansen HJ, Hearn TL, Lewis DS, Dudley D (1982) Laboratory evaluation and assistance efforts: mailed, onsite and blind proficiency testing surveys conducted by the Centers for Disease Control. Am J Public Health 72:1364–1368
Bartlett RC, Mazens-Sullivan M, Tetreault JZ, Lobel S, Nivard J (1994) Evolving approaches to management of quality in clinical microbiology. Clin Microbiol Rev 7:55–87
Nutting PA, Main DS, Fischer PM, Stull TM, Pontious M, Seifert M, Boone DJ, Holcomb S (1996) Problems in laboratory testing in primary case. JAMA 275:635–639
Warford A (2000) Quality assurance in clinical virology. In: Richman DD, Whitley RJ, Hayden FG (eds) Clinical virology manual, 3rd edn. ASM Press, Washington, DC, pp 3–10
Niesters HGM (2002) Clinical virology in real time. J Clin Virol 25:S3–S12
Pasloske BL, Walkerpeach CR, Obermoeller RD, Winkler M, DuBois DB (1998) Armored RNA technology for production of ribonuclease-resistant viral RNA controls and standards. J Clin Microbiol 36(12):3590–3594, PMCID: PMC105245
van Doornum GJJ, Schutten M, Voermans J, Guldemeester GJJ, Niesters HGM (2007) Development and implementation of real-time nucleic acid amplification for the detection of enterovirus infections in comparison to rapid culture of various clinical specimens. J Med Virol 79:1868–1876
Libeer JC (2001) Role of external quality assurance schemes in assessing and improving quality in medical laboratories. Clin Chim Acta 309(2):173–177
Sunderman FW Sr (1992) The history of proficiency testing/quality control. Clin Chem 38(7):1205–1209
Belk WP, Sunderman FW (1947) A survey of the accuracy of chemical analyses in clinical laboratories. Am J Clin Pathol 17(11):853–861
Noordhoek GT, Kolk AH, Bjune G, Catty D, Dale JW, Fine PE, Godfrey-Faussett P, Cho SN, Shinnick T, Svenson SB (1994) Sensitivity and specificity of PCR for detection of Mycobacterium tuberculosis: a blind comparison study among seven laboratories. J Clin Microbiol 32(2):277–284
Valentine-Thon E (2002) Quality control in nucleic acid testing/where do we stand? J Clin Virol 25:S13–S21
Health Care Financing Administration (HCFA), Department of Health and Human Services (1992) Clinical Laboratory Improvement Amendments of 1988; final rule. Fed Regist. Feb 28:7146
ISO/IEC 17043: 2010(E). Conformity assessment—general requirements for proficiency testing. International Organisation for Standardization, Geneva, Switzerland
MM14-A. Proficiency testing (external quality assessment) for molecular methods; approved guideline to MM14-A2. Clinical and Laboratory Standards Institute, PA, USA
Sciacovelli L, Secchiero S, Zardo L, Plebani M (2001) External Quality Assessment Schemes: need for recognised requirements. Clin Chim Acta 309:183–199
Forbes BA (2003) Introducing a molecular test into the clinical microbiology laboratory: development, evaluation, and validation. Arch Pathol Lab Med 127(9):1106–1111
Pandit A, MacKay WG, Steel C, van Loon AM, Schuurman R (2008) HIV-1 drug resistance genotyping quality assessment: results of the ENVA7 Genotyping Proficiency Programme. J Clin Virol 43(4):401–406
Aberle SW, Puchhammer-Stöckl E (2002) Diagnosis of herpesvirus infections of the central nervous system. J Clin Virol 25:S79–S85
Staines HJ, Garcia-Fernandez L, Pogothata R, Wallace PS, MacKay WG, van Loon AM (2009) Monitoring performance of nucleic acid-based diagnostic measurement system users by EQA. Accred Qual Assur 14(5):243–252
College of American Pathologists (2007) Laboratory improvement: Laboratory Accreditation Program Checklists. CAP, Chicago
Bedson P, Sargent M (1996) The development and application of guidance on equipment qualification of analytical instruments. Accred Qual Assur 1:265–274
Thejls H, Gnarpe J, Gnarpe H, Larsson PG, Platz-Christensen JJ, Ostergaard L, Victor A (1994) Expanded gold standard in the diagnosis of Chlamydia trachomatis in a low prevalence population: diagnostic efficacy of tissue culture, direct immunofluorescence, enzyme immunoassay, PCR and serology. Genitourin Med 70(5):300–303
Green JM (1996) A practical guide to analytical method validation. Anal Chem News Features 68:305A–309A
Toney DM (2007) Validation of molecular methods in a Public Health Laboratory. In: APHL annual meeting, 5 June 2007
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer Science+Business Media, LLC
About this protocol
Cite this protocol
Wallace, P.S., MacKay, W.G. (2013). Quality in the Molecular Microbiology Laboratory. In: Wilks, M. (eds) PCR Detection of Microbial Pathogens. Methods in Molecular Biology, vol 943. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-60327-353-4_3
Download citation
DOI: https://doi.org/10.1007/978-1-60327-353-4_3
Published:
Publisher Name: Humana Press, Totowa, NJ
Print ISBN: 978-1-60327-352-7
Online ISBN: 978-1-60327-353-4
eBook Packages: Springer Protocols