Quality Management

Ron B. Schifman; George Cembrowski; Donna Wolk

doi:10.1128/9781555817695.ch20

Chapter 20 : Quality Management

Authors: Ron B. Schifman, George Cembrowski, Donna Wolk

Content Type: Reference

Publication Year: 2004

Category: Clinical Microbiology

Book DOI: 10.1128/9781555817695

Chapter DOI: 10.1128/9781555817695.ch20

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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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Figure 20.1a

Examples of interlaboratory quality control reports.

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Figure 20.1a

Examples of interlaboratory quality control reports.

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Figure 20.1b

Examples of interlaboratory quality control reports.

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Figure 20.1b

Examples of interlaboratory quality control reports.

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Figure 20.2

Levey-Jennings charts.

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Figure 20.2

Levey-Jennings charts.

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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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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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Figure 20.4

Flow chart illustrating proficiency test review.

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Figure 20.4

Flow chart illustrating proficiency test review.

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APPENDIX 20.1a

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APPENDIX 20.1a

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APPENDIX 20.1b

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APPENDIX 20.1b

References

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Tables

Quality Management

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Table 20.1

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

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

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Table 20.1

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

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

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Table 20.2

Method evaluation and implementation

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Table 20.2

Method evaluation and implementation

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Table 20.3

Quality control rules

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Table 20.3

Quality control rules

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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

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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

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Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

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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

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Table 20.7

Document categories

10.1128/9781555817695/tab20-7_thmb.gif

10.1128/9781555817695/tab20-7.gif

Table 20.7

Document categories