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Process and risk analysis to reduce errors in clinical laboratories.

Chiara Signori1, Ferruccio Ceriotti, Alberto Sanna

  • 1Diagnostica e Ricerca, San Raffaele SpA, Milan, Italy. signori.chiara@hsr.it

Clinical Chemistry and Laboratory Medicine
|June 21, 2007
PubMed
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Monitoring laboratory quality indicators helps reduce errors and improve outcomes. Standardized risk analysis enables effective benchmarking in clinical laboratories, enhancing overall performance.

Area of Science:

  • Laboratory Medicine
  • Quality Improvement
  • Risk Management

Background:

  • Defining monitoring indicators is crucial for assessing laboratory trends and improving quality.
  • Continuous observation of indicators aids in error reduction and enhances laboratory outcomes.
  • Standardized risk evaluation and indicator sets facilitate clinical laboratory benchmarking.

Purpose of the Study:

  • To adapt and apply non-healthcare risk analysis methodologies to laboratory medicine.
  • To evaluate risks and enable benchmarking among participating clinical laboratories.

Main Methods:

  • Five Italian hospital laboratories collaborated on the project.
  • Methodologies from aeronautical and transport industries were adapted for laboratory medicine.

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  • Process and risk analysis were conducted, with expert input for adaptation.

    • Main Results:

    • A list of non-conformities representing risks of errors was formulated.
    • The risk level associated with each non-conformity was quantified.
    • Graphical representation identified risk areas specific to each participating laboratory.

    Conclusions:

    • The applied techniques successfully identified and quantified risks in laboratory processes.
    • Risk quantification and graphical representation aid in understanding laboratory-specific risk profiles.
    • This approach supports targeted quality improvement and benchmarking in clinical laboratories.