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Chapter 5 : Laboratory Design

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Laboratory Design, Page 1 of 2

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Abstract:

Planning and executing the design of a clinical laboratory is a unique and challenging task. This process not only involves coordinating how clinical samples will be received and tested, but also how efficiency can be maximized, safety ensured, and flexibility maintained. The design of a modern-day clinical virology laboratory can be especially challenging, given the continued application of traditional viral cell culture in some laboratories and the increasing use of molecular techniques (e.g., real-time PCR) for the diagnosis of viral infections. If there is one truth regarding laboratory design, it is that there is no “one size fits all” approach. Before a laboratory can begin to discuss the ideal approach for virologic testing at its institution, a number of important issues must be considered. These issues include the space that is (or will be) available, the number of laboratory staff that will occupy the space, the testing that will be performed, and the patient population from whom samples will be collected and submitted for testing. Furthermore, important decisions need to be made by laboratory and institutional leadership regarding whether testing should be performed in a centralized (i.e., consolidated) laboratory, a decentralized (i.e., specialized) laboratory, or a combination of the two. Another important consideration, driven by the increasing development of rapid, sample-to-answer molecular devices, centers around whether testing should be performed “near the patient” or at the “point of care.” Addressing each of these important issues is outside the scope of this chapter. However, key components of laboratory design, especially as they pertain to clinical virology, will be discussed to provide laboratory professionals with a foundation and guide to help ensure that test results are accurate, laboratory staff are safe, and future growth can be accommodated.

Citation: Binnicker M. 2016. Laboratory Design, p 51-55. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch5
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Figures

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FIGURE 1

The phases of laboratory design.

Citation: Binnicker M. 2016. Laboratory Design, p 51-55. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch5
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Image of FIGURE 2
FIGURE 2

Laboratory design schematic for performing both molecular testing and routine viral cell culture. Sample processing is often performed inside a biosafety cabinet (BSC). For molecular testing, reagent and master mix preparation is ideally performed in a separate walled-in room that has positive pressure in relation to the remainder of the laboratory (1). Nucleic acid extraction may be performed in a unique or shared space as long as strict unidirectional workflow is followed. Test setup, which includes loading the master mix and nucleic acid extract into the test cartridge, is then completed in a separate area (2). Finally, PCR is performed in a third walled-in space that has negative air pressure (3). No material (e.g., laboratory coats, gloves, work books, equipment) in the PCR analysis room should be removed from this space without proper decontamination. For viral cell culture testing, work should be performed in a biosafety level 2 (BSL2) or BSL3 facility using an appropriate BSC. The airflow should maintain negative pressure in relation to the remainder of the laboratory.

Citation: Binnicker M. 2016. Laboratory Design, p 51-55. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch5
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Image of FIGURE 3
FIGURE 3

Laboratory design schematic for performing both molecular testing and routine viral cell culture in a common area. For molecular testing, reagent and master mix preparation as well as nucleic acid extraction should be performed in a separate area, preferably in a different room (1). Test setup (2) and PCR amplification/analysis (3) may be performed in a common space, but testing should follow a strict unidirectional workflow. BSC, biosafety cabinet.

Citation: Binnicker M. 2016. Laboratory Design, p 51-55. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch5
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References

/content/book/10.1128/9781555819156.ch05
1. College of American Pathologists. Commission on Laboratory Accreditation. 2013. Laboratory general checklist. College of American Pathologists, Northfield, IL.
2. Clinical and Laboratory Standards Institute (CLSI). 2007. Laboratory design; approved guideline, 2nd ed. CLSI document QMS04-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
3. College of American Pathologists. Commission on Laboratory Accreditation. 2013. Microbiology checklist. College of American Pathologists, Northfield, IL.
4. Kurec AS, Lifshitz MS,. 2011. General concepts and administrative issues, p. 711. In McPherson RA, Pincus MR(ed), Henry's clinical diagnosis and management by laboratory methods, 22nd ed. Elsevier Saunders, Philadelphia, PA.
5. World Health Organization (WHO). 2008. Guidelines on establishment of virology laboratory in developing countries. World Health Organization Regional Office for Southeast Asia, New Delhi, India.
6. Dieffenbach CW, Dveksler GS. 1993. Setting up a PCR laboratory. PCR Methods Appl 3:S2S7[CrossRef].[PubMed]
7. Mifflin TE,. 2003. Setting up a PCR laboratory, p. 514. In Dieffenbach CW, Dveksler GS (ed), PCR primer, 2nd ed. Cold Spring Harbor Laboratory Press, Cold Spring Harbor, NY.
8. Viana RV, Wallis CL,. 2011. Good clinical laboratory practice (GLCP) for molecular based tests used in diagnostic laboratories, p. 2952. In Akyar I (ed), Wide spectra of quality control. Intech, Rijeka, Croatia.
9. Public Health England. 2013. UK standards for microbiology investigations; Good laboratory practice when performing molecular amplification assays. Standards Institute, Microbiology Services, Public Health England, London, United Kingdom.
10. Warford A,. 2000. Quality assurance in clinical virology, p. 9. In Specter S, Hodinka RL, Young SA (ed), Clinical virology manual, 3rd ed. ASM Press, Washington, DC.
11. Gomah ME, Turley JP, Lu H, Jones D. 2010. Modeling complex workflow in molecular diagnostics: design specifications of laboratory software for support of personalized medicine. J Mol Diagn 12:5157[CrossRef].[PubMed]
12. Mitchell PS, Mandrekar JN, Yao JD. 2014. Adoption of lean principles in a high-volume molecular diagnostic microbiology laboratory. J Clin Microbiol 52:26892693[CrossRef].[PubMed]

Tables

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TABLE 1

Biosafety level requirements in the clinical virology laboratory

Citation: Binnicker M. 2016. Laboratory Design, p 51-55. In Loeffelholz M, Hodinka R, Young S, Pinsky B (ed), Clinical Virology Manual, Fifth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555819156.ch5

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