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Chapter 20 : Quality Management

Authors: Ron B. Schifman, George Cembrowski, Donna Wolk
Content Type: Reference
Publication Year: 2004

Category: Clinical Microbiology

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Abstract:

This chapter enables understanding the three phases of the total testing process; factors affecting quality of test ordering, specimen collection, and patient satisfaction; basic statistical processes involved in monitoring analytical performance; factors affecting test turnaround time; the role of corrected and incomplete reports in quality management and understanding systems for document control. Developing an effective quality management program is challenging because the goal of the program (good outcomes) is often difficult to quantify and may involve processes that are not directly under the laboratory manager's control. Quality management of analytical phase of the testing process is the most standardized and regulated and has therefore received the most attention. Setting up a hot line through which clients can report potential problems or errors and make inquiries may help large laboratories consolidate customer support services. Quality management of the analytical phase involves reducing inaccuracy and imprecision (variability) of test methods as much as possible. The primary quality characteristic that is monitored during the analytical process is the deviation of an analytical measurement from expected. Errors can be classified as systematic (resulting in a shift) or random (resulting in increased imprecision). Inadequate laboratory test turnaround time is one of the most common complaints that comes to the laboratory manager. Clinical laboratories process and handle an enormous amount of information each day. These processes require an organized approach for controlling and organizing this information and making it readily accessible to busy laboratory staff and laboratory inspectors.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Quality Management
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Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.fig20-1
Figure 20.1a

Examples of interlaboratory quality control reports.

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Image of Figure 20.1a
Figure 20.1a

Examples of interlaboratory quality control reports.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Figure 20.1b

Examples of interlaboratory quality control reports.

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10.1128/9781555817695/fig20-1a.gif
Image of Figure 20.1b
Figure 20.1b

Examples of interlaboratory quality control reports.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Figure 20.2

Levey-Jennings charts.

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Image of Figure 20.2
Figure 20.2

Levey-Jennings charts.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Figure 20.3

Flow chart showing implementation of the 2-2SD / 1-3 SD control procedure. Courtesy Tammy Hofer, BSc (MT), MBA.

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Image of Figure 20.3
Figure 20.3

Flow chart showing implementation of the 2-2SD / 1-3 SD control procedure. Courtesy Tammy Hofer, BSc (MT), MBA.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Figure 20.4

Flow chart illustrating proficiency test review.

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Image of Figure 20.4
Figure 20.4

Flow chart illustrating proficiency test review.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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APPENDIX 20.1a
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APPENDIX 20.1a

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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APPENDIX 20.1b
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APPENDIX 20.1b

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
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Tables

Quality Management
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Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-1
Table 20.1

CAP Q-Tracks and Q-Probes quality assurance program, 2004

CAP (http://www.cap.org).

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Table 20.1

CAP Q-Tracks and Q-Probes quality assurance program, 2004

CAP (http://www.cap.org).

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-2
Table 20.2

Method evaluation and implementation

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Table 20.2

Method evaluation and implementation

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-3
Table 20.3

Quality control rules

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Table 20.3

Quality control rules

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-4
Table 20.4

Comparison of MAEs, derived from physiological variation to typical instrument imprecisions

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Table 20.4

Comparison of MAEs, derived from physiological variation to typical instrument imprecisions

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-5
Table 20.5a

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.5a

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-5b
Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

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Generic image for table
Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-6
Table 20.6

Stages in the testing cycle where turnaround time may be measured

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Table 20.6

Stages in the testing cycle where turnaround time may be measured

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20
/content/10.1128/9781555817695.chap20.tab20-7
Table 20.7

Document categories

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Table 20.7

Document categories

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20

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