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A new spreadsheet tool, SPAE, simplifies patient-based quality control (PBQC) for clinical laboratories. This accessible informatics solution aids in monitoring analytical performance and enhances familiarity with PBQC methods.

Keywords:
analytical errorbiaslaboratory errorlaboratory informaticspatient-based quality controlpatient-based real-time quality controlquality control

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Area of Science:

  • Clinical chemistry and laboratory science
  • Quality control in healthcare
  • Medical informatics

Background:

  • Conventional internal quality control (QC) methods are standard in laboratories.
  • Patient-based quality control (PBQC) offers an alternative by utilizing patient data for analytical performance monitoring.
  • Widespread adoption of PBQC is hindered by a lack of user-friendly informatics tools and familiarity.

Purpose of the Study:

  • To develop and evaluate a novel informatics tool for implementing patient-based quality control (PBQC) in routine laboratory settings.
  • To create an accessible and automated spreadsheet-based solution that addresses the barriers to PBQC adoption.
  • To provide a tool that facilitates both routine QC monitoring and educational purposes for laboratory professionals.

Main Methods:

  • Development of a Microsoft Excel-based spreadsheet tool named SPAE (Spreadsheet for PBQC Analysis and Evaluation).
  • Incorporation of IFCC-recommended features including automated data visualization, Box-Cox transformation, and winsorization for extreme value treatment.
  • Implementation of user-selectable parameters such as block size, false positive rate, and bias detection thresholds.

Main Results:

  • The SPAE tool automates the calculation of winsorization limits, transformed data, and key performance metrics like false positive rates and the number of results affected before error detection (NPed).
  • Validation of the SPAE tool's performance against an independent Python-based model confirmed its reliability.
  • The tool provides a verified PBQC model suitable for routine laboratory monitoring.

Conclusions:

  • The SPAE spreadsheet is a user-friendly desktop application designed to reduce the complexity of implementing PBQC.
  • It serves as a valuable educational resource for familiarizing laboratory personnel with PBQC principles.
  • The tool supports independent verification and promotes wider adoption of PBQC in laboratory quality management systems.