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Quality indicators (QIs) are crucial for improving laboratory services, especially in pre-analytical and post-analytical phases where most errors occur. Enhanced QIs are needed to address extra-laboratory factors and improve patient care.

Keywords:
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Area of Science:

  • Clinical Laboratory Science
  • Healthcare Quality Improvement
  • Medical Diagnostics

Background:

  • Most laboratory errors occur outside the analytical phase, in the pre- and post-analytical steps.
  • Current quality indicators (QIs) often neglect extra-laboratory factors, hindering comprehensive quality improvement in clinical laboratories.
  • Pre-analytical errors constitute 50-75% of all laboratory errors, frequently categorized under 'identification and sample problems'.

Purpose of the Study:

  • To highlight the critical need for enhanced quality indicators (QIs) in clinical laboratory services.
  • To emphasize the vulnerability of pre- and post-analytical phases to errors and the importance of extra-laboratory factors.
  • To advocate for the development and harmonization of QIs that address the full spectrum of laboratory testing processes.

Main Methods:

  • Review of existing evidence on laboratory errors and quality indicators.
  • Analysis of the limitations of current QI models in addressing pre- and post-analytical phases.
  • Examination of the International Standard for medical laboratory accreditation and patient-centered perspectives.

Main Results:

  • The pre-analytical phase is highly susceptible to errors, accounting for the majority of all laboratory errors.
  • Existing QIs are insufficient, lacking focus on crucial extra-laboratory factors like test request appropriateness and sample transportation quality.
  • The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group model provides a foundation for QI harmonization, but further consensus is required.

Conclusions:

  • There is a significant need for new and improved quality indicators (QIs) to effectively manage pre- and post-analytical laboratory processes.
  • Addressing extra-laboratory factors and standardizing QI development are essential for enhancing overall laboratory quality and patient safety.
  • Further collaborative efforts are necessary to establish a harmonized roadmap for quality indicators in clinical laboratories worldwide.