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Chapter 8 : Laboratory Design and Operations

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Abstract:

Molecular methods play an increasingly important role in diagnostic microbiologic testing, and this trend will continue with the introduction of new technologies and continued improvement in current assay designs. Individual laboratories considering the implementation of such molecular methods for diagnostic testing face unique challenges in achieving optimal laboratory design and operations that may vary greatly depending on the laboratory setting and the molecular methods employed. Efficient laboratory operation and workflow are closely dependent on optimal design of the laboratory space, and in turn, optimal laboratory design is influenced by the various assay methods and instruments used in the laboratory. Chemical fume hoods and cabinets for storage of hazardous chemicals and flammable liquids should also be incorporated in the overall laboratory design. Efficient clinical laboratory operations providing quality testing services are dependent on several key elements. In addition to the use of dedicated work areas and equipment, regular cleaning and decontamination can also be effective in further reducing the likelihood of amplicon contamination. Specific precautions that should be considered prior to implementation of three molecular diagnostic methods–hybridization-based methods, target amplification-based methods, and target amplification-detection and postamplification analysis methods–have been discussed in the chapter.

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8

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Figures

Image of FIGURE 1
FIGURE 1

Example of a diagnostic molecular microbiology laboratory design facilitating a unidirectional workflow from specimen receipt through various phases of testing. Maximum laboratory flexibility is maintained through the use of an open laboratory design (where possible) with power supply/data poles (■) and movable workbenches throughout the laboratory. The use of pass-through boxes (□) between separate rooms improves laboratory efficiency. Independent negativepressure (NP) and positive-pressure (PP) ventilation systems in the various designated rooms serve to prevent circulation of potential contaminating aerosols from one room to another.

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
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Image of FIGURE 2
FIGURE 2

Value stream mapping can be used to evaluate workflow processes and data flow in a clinical laboratory. Process times are captured to determine the duration of individual process steps. Excess inventories (Δ) capable of causing procedural delays include specimens ready for processing, processed specimens waiting to be analyzed, and test results ready to be reported. Electronic exchange of data (zigzag arrow) can expedite process steps and reduce repetitive and error-prone manual data entry steps. Reprinted with permission of Mayo Foundation for Medical Education and Research.

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
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Image of FIGURE 3
FIGURE 3

Example of a workflow analysis diagram illustrating how laboratory testing capacity can be increased with the use of multiple extraction instruments. Hands-on time is represented by shaded boxes, while hands-off (instrument) time is represented by open boxes.

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
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Image of FIGURE 4
FIGURE 4

Example of a spaghetti diagram showing the multiple sequential steps (dashed lines) involved in a manual sample extraction process in a sample-processing room. This tool can be used to identify suboptimal placement of instruments and work benches as well as workflow inefficiencies within a specific work cell.

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
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References

/content/book/10.1128/9781555816834.ch08
1. Cone, R. W.,, and M. R. Fairfax. 1993. Protocol for ultraviolet irradiation of surfaces to reduce PCR contamination. PCR Methods Appl. 3:S15S17.
2. Fairfax, M. R.,, M. A. Metcalf, and, R. W. Cone. 1991. Slow inactivation of dry PCR templates by UV light. PCR Methods Appl. 1:142143.
3. Garikes, R. W. 2006. Efficient laboratory design. Med. Lab. Observer 38:3336.
4. Hamilton, L. T. 2007. Managing the laboratory technical workforce. Clin. Lab. Med. 27:807821.
5. Joseph, T. P. 2006. Design a lean laboratory layout. Med. Lab. Obs. 38(2):2431.
6. Joseph, T. P. 2006. Design of lean work cells: a lean lab layout (part II). Med. Lab. Obs. 38(8):2432.
7. Kwok, S.,, and R. Higushi. 1989. Avoiding false positives with PCR. Nature (London) 339:237238.
8. Persing, D. H. 1991. Polymerase chain reaction: trenches to benches. J. Clin. Microbiol. 29:12811285.
9. Steward, C. A.,, and N. N. Thompson. 2006. ASCP wage and vacancy survey of medical laboratories. Lab. Med. 37:465469.
10. Wolcott, J.,, A. Schwartz, and, C. Goodman. 2008. Laboratory medicine: a national status report. http://www.futurelabmedicine.org/NationalStatusRptContent.aspx. Accessed 3 October 2008.
11. Zidel, T. G.,, and R. SanLuis. 2008. Principles to improve lab performance. ADVANCE for Administrators of the Laboratory 17:6263.

Tables

Generic image for table
TABLE 1

Recommended considerations for selection and implementation of a new diagnostic molecular microbiology instrument platform

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
Generic image for table
TABLE 2

Recommended schedule for cleaning and decontamination of instruments and work areas

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8
Generic image for table
TABLE 3

Consideration of selected molecular microbiology instrument platforms relative to laboratory design and operation

Citation: Mitchell P, Germer J, Yao J. 2011. Laboratory Design and Operations, p 127-414. In Persing D, Tenover F, Tang Y, Nolte F, Hayden R, van Belkum A (ed), Molecular Microbiology. ASM Press, Washington, DC. doi: 10.1128/9781555816834.ch8

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