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

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.