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Research ArticleResearch and Reports

Performance Standards for Quality Control Systems

Selom Agboyi and Shashi Mehta
American Society for Clinical Laboratory Science January 2018, 31 (1) 32-36; DOI: https://doi.org/10.29074/ascls.2018000299
Selom Agboyi
SHP-Rutgers University
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Shashi Mehta
SHP-Rutgers University
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    Figure 1.

    Illustration of the concept of total error, which is the combination of systematic error (bias) and random error (2 SD).

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    Figure 2.

    Sigma metric. The graph shows how six-sigma tolerance limits apply to QC in a clinical laboratory. The sigma value of this essay is four, as the mean is at 4 SD from the upper tolerance limit.

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    Table 1.

    QC rules based on sigma metric for two control measurements per run

    SigmaQC RulesNumber of Runs
    ≥613s1
    513s/22s/R4s1
    413s/22s/R4s/41s2
    <413s/22s/R4s/41s/8x4
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American Society for Clinical Laboratory Science: 31 (1)
American Society for Clinical Laboratory Science
Vol. 31, Issue 1
1 Jan 2018
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Performance Standards for Quality Control Systems
Selom Agboyi, Shashi Mehta
American Society for Clinical Laboratory Science Jan 2018, 31 (1) 32-36; DOI: 10.29074/ascls.2018000299

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Performance Standards for Quality Control Systems
Selom Agboyi, Shashi Mehta
American Society for Clinical Laboratory Science Jan 2018, 31 (1) 32-36; DOI: 10.29074/ascls.2018000299
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Jump to section

  • Article
    • LEARNING OBJECTIVES
    • ABSTRACT
    • INTRODUCTION
    • ANALYTICAL SYSTEMS
    • HISTORY OF QC
    • PERFORMANCE STANDARDS
    • EVIDENCE-BASED APPROACH TO QC
    • CONCLUSION
    • References
  • Figures & Data
  • Info & Metrics
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Keywords

  • ΔSEc - critical systematic error
  • CAP - College of American Pathologists
  • CLIA - Clinical Laboratory Improvement Amendments
  • DPM - defects per million
  • EQA - external quality assurance
  • IQC - internal quality control
  • PT - proficiency testing
  • QC - quality control
  • RCPA - Royal College of Pathologists of Australasia
  • SD - standard deviation
  • TE - total error
  • TEa - total error allowable
  • performance standards
  • quality goals
  • evidence-based quality control
  • critical systematic error

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