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Best practice guidelines on reference interval harmonization in Canada: Evidence-based recommendations from the CSCC

Mary Kathryn Bohn1, Dana Nyholt2, Cynthia Balion3

  • 1Department of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.

Clinical Biochemistry
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Summary
This summary is machine-generated.

Harmonized reference intervals for 13 routine clinical laboratory tests were established to reduce variations in Canadian healthcare. This standardization aims to improve clinical decision-making and patient care nationwide.

Keywords:
HarmonizationReference intervalsStandardization

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Healthcare Standardization

Background:

  • Variations in clinical laboratory reference intervals lead to inconsistent patient care.
  • Harmonized reference intervals are crucial for standardized quality healthcare.
  • This study addresses the need for evidence-based common reference intervals in Canada.

Purpose of the Study:

  • To recommend evidence-based harmonized reference intervals for routine clinical laboratory tests in Canada.
  • To support the implementation of standardized laboratory practices across hospital and community settings.
  • To improve clinical decision-making and patient care through laboratory harmonization.

Main Methods:

  • Candidate analytes selected based on traceability and external quality assessment.
  • Patient test result data from four Canadian provincial laboratories analyzed.
  • Indirect statistical algorithms used to establish harmonized reference intervals.
  • Verification across nine Canadian laboratories with healthy volunteers.

Main Results:

  • Harmonized reference intervals recommended for 13 routine clinical chemistry analytes.
  • Included analytes: albumin, ALT, ALP, calcium, CO2, chloride, creatinine, LDH, phosphate, potassium, magnesium, total protein, and TSH.
  • Established intervals were compared with existing Canadian and international data and verified in multiple labs.

Conclusions:

  • Evidence-based harmonized reference intervals are recommended for 13 key analytes.
  • These recommendations will support national harmonization of laboratory reference intervals in Canada.
  • Implementation aims to standardize clinical decision-making and enhance patient care across the country.