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Chapter 21 : Quality Management

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Quality Management, Page 1 of 2

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Abstract:

The “total testing process” is a concept that provides a comprehensive working model for evaluating the components of the laboratory’s quality management plan as an interdependent component of the organization’s total quality improvement program. This chapter explains the three phases of the total testing process. The first phase, the preanalytical phase, involves all the various processes and resources that precede the measuring step. The second phase, the analytical phase, involves managing the reliability of instruments and reagents used for measuring patient specimens and obtaining test results. The last phase, postanalytical, involves reporting, interpretation, and clinical use of test results. The chapter discusses the factors affecting quality of test ordering, specimen collection, and patient satisfaction. Special attention must be given to the collection of specimens for microbiological examinations. In some cases, specimen quality can be evaluated by smear examinations before cultures are performed, and specimens may be deferred from testing if judged to be of poor quality. The only direct experience patients have with the laboratory is during phlebotomy. Patient satisfaction with this experience is an important preanalytical quality measurement. The chapter talks about basic statistical processes involved in monitoring analytical performance. Factors affecting test turnaround time are explained. The chapter also discusses the role of corrected and incomplete reports in quality management, and systems for document control. A document control policy should state the intent and direction the laboratory takes to document and record the structure it uses for creating, revising, approving, distributing, storing, retrieving, and destroying documents.

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21

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Figure 21.1a

Examples of interlaboratory quality control reports. (A) The SDI (a peer-based measure of bias) and CVR (a peer-based estimator of precision) are combined as an , coordinate within three performance zones: acceptable, acceptable to marginal, and marginal. (B) Reports provide monthly and cumulative statistics for the laboratory and between-laboratory comparisons with a peer group. Report includes mean, standard deviation, coefficient of variation, CVR, SDI, number of data points, and number of laboratories. CVR, coefficient of variation ratio, a ratio of laboratory imprecision to peer group imprecision. A value less than 1 indicates better than average imprecision; a value greater than 1 indicates more than average imprecision compared to the peer group. doi:10.1128/9781555817282.ch21.f1a

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.1b
Figure 21.1b

Examples of interlaboratory quality control reports. (A) The SDI (a peer-based measure of bias) and CVR (a peer-based estimator of precision) are combined as an , coordinate within three performance zones: acceptable, acceptable to marginal, and marginal. (B) Reports provide monthly and cumulative statistics for the laboratory and between-laboratory comparisons with a peer group. Report includes mean, standard deviation, coefficient of variation, CVR, SDI, number of data points, and number of laboratories. CVR, coefficient of variation ratio, a ratio of laboratory imprecision to peer group imprecision. A value less than 1 indicates better than average imprecision; a value greater than 1 indicates more than average imprecision compared to the peer group. doi:10.1128/9781555817282.ch21.f1b

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.2
Figure 21.2

Quality control charts. doi:10.1128/9781555817282.ch21.f2

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.3
Figure 21.3

Flow chart showing implementation of the 2-2SD/1-3SD control procedure. Courtesy of Tammy Hofer. doi:10.1128/9781555817282.ch21.f3

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.4
Figure 21.4

Flow chart illustrating proficiency test review, from reference with permission. doi:10.1128/9781555817282.ch21.f4

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Tables

Generic image for table
Table 21.1

CAP Q-Tracks and Q-Probes quality assurance program, 2011

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

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.2

Method evaluation and implementation

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.3

Common quality control rules

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.4

Comparison of MAEs derived from physiological variation to typical instrument imprecisions

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.5

Control rules that can be used for various MAE/imprecision ratios

Adapted with permission from reference .

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6a

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6b

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6c

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.7

Stages in the testing cycle where turnaround time may be measured

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.8

CLSI quality system essentials

See reference .

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21

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