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Chapter 2 : Quality Assurance and Quality Control in Clinical and Molecular Virology

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Quality Assurance and Quality Control in Clinical and Molecular Virology, Page 1 of 2

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Abstract:

The clinical virology laboratory provides important and often critical information to the health care provider in order to support the diagnosis or monitoring of viral disease for the patient. Testing results will often serve as a guide for optimal treatment of the disease, contribute to infection control and prevention of a hospitalized patient or offer insight into the prognosis for the disease. Therefore, the quality of the virology laboratory testing has to be highly accurate and offered in a timely fashion in order to achieve optimal patient management. A well-structured and ongoing quality assurance (QA) program will provide the framework for maintaining accuracy in all phases of the testing process. These phases include the preanalytical, analytical, and postanalytical stages of the testing. However, no process is perfect, and every QA program should include a surveillance component that continuously identifies and corrects any weakness in the system. This corrective action should also be followed by preventative action in order to eliminate weaknesses and improve the entire QA program.

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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References

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1. Bachner P, Hamlin W. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988—Part II. Clin Lab Med 13:987994.[PubMed]
2. Bachner P, Hamlin W. 1993. Federal regulation of clinical laboratories and the Clinical Laboratory Improvement Amendments of 1988—Part I. Clin Lab Med 13:739752, discussion 737–738.[PubMed]
3. Bankowski MJ,. Molecular microbiology test quality assurance and monitoring. In Persing DH, Tenover FC, van Belkum A, Hayden RT, Ieven M., Miller MB, Nolte FS, Tang Y-W (ed), Molecular Microbiology: Diagnostic Principles and Practice, 3rd ed. ASM Press, Washington, DC, in press.
4. Versalovic J, Carroll KC, Funke G, Jorgensen JH, Landry ML, Warnock DW (ed). American Society for Microbiology. 2011. Manual of Clinical Microbiology, 10th ed. ASM Press, Washington, DC.
5. Fryer JF, Baylis SA, Gottlieb AL, Ferguson M, Vincini GA, Bevan VM, Carman WF, Minor PD. 2008. Development of working reference materials for clinical virology. J Clin Virol 43:367371.[PubMed]
6. Fryer JF, Minor PD. 2009. Standardisation of nucleic acid amplification assays used in clinical diagnostics: a report of the first meeting of the SoGAT Clinical Diagnostics Working Group. J Clin Virol 44:103105.[PubMed]
7. Halling KC, Schrijver I, Persons DL. 2012. Test verification and validation for molecular diagnostic assays. Arch Pathol Lab Med 136:1113.[PubMed]
8. Puppe W, Weigl J, Gröndahl B, Knuf M, Rockahr S, von Bismarck P, Aron G, Niesters HG, Osterhaus AD, Schmitt HJ. 2013. Validation of a multiplex reverse transcriptase PCR ELISA for the detection of 19 respiratory tract pathogens. Infection 41:7791.[PubMed]

Tables

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TABLE 1

Guideline documents from the Clinical and Laboratory Standards Institute (CLSI)

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 2

Cumitech—Cumulative Techniques and Procedures in Clinical Microbiology documents from the American Society for Microbiology (ASM)

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 3

Outline of the clinical virology procedure manual sections including examples and comments

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 4

Molecular virology infectious disease testing quality control sources

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 5

Molecular virology infectious disease testing controls and calibrators

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 6

Corrective action and preventive action (CAPA) checklist for test failures

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2
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TABLE 7

Section outline of the clinical virology test verification/validation protocol

Citation: Bankowski M. 2016. Quality Assurance and Quality Control in Clinical and Molecular Virology, p 27-34. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch2

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