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Quality indicators to detect pre-analytical errors in laboratory testing.

M Plebani1, L Sciacovelli1, A Aita1

  • 1Department of Laboratory Medicine, University-Hospital, Padova, Italy.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|September 10, 2013
PubMed
Summary
This summary is machine-generated.

Developing reliable quality indicators (QIs) is essential for assessing laboratory service quality. These indicators must address pre-analytical factors, including test requests and sample collection, to minimize errors.

Keywords:
Clinical laboratoryHarmonizationPatient safetyQualityQuality indicatorsTotal testing process

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Area of Science:

  • Clinical Laboratory Science
  • Quality Management in Healthcare
  • Medical Diagnostics

Background:

  • Accurate laboratory results depend on robust quality indicators (QIs).
  • Pre-analytical errors significantly impact patient care, yet receive insufficient attention.
  • The ISO 15189:2012 standard emphasizes evaluating the entire pre-analytical phase, including the 'pre-pre-analytical' steps.

Purpose of the Study:

  • To highlight the critical need for comprehensive quality indicators (QIs) in the pre-analytical phase.
  • To propose a model for QIs that encompasses all pre-analytical steps, from test ordering to sample collection.
  • To facilitate the harmonization of pre-analytical QIs for consistent quality assessment.

Main Methods:

  • Reviewing existing literature and standards (e.g., ISO 15189:2012) on laboratory quality management.
  • Analyzing the scope of pre-analytical errors, including those in test requesting and sample handling.
  • Developing a QI model based on the framework by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group.

Main Results:

  • A comprehensive model for pre-analytical quality indicators has been developed.
  • The model incorporates errors related to test requests, request forms, sample identification, and sample collection.
  • It provides objective criteria for harmonizing QIs across different laboratories.

Conclusions:

  • Reliable QIs are crucial for quantifying laboratory service quality.
  • Addressing the entire pre-analytical phase, including test ordering, is vital for reducing errors.
  • The proposed QI model offers a standardized framework for improving pre-analytical quality in clinical laboratories.