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Clinical Decision-Making Suffers from Inequivalent Measurement Results and Inadequate Reference Intervals.
Marith van Schrojenstein Lantman1,2, Miranda van Berkel2, Philip Kuijper3
1Stichting Kwaliteitsbewaking Medische Laboratoria (SKML), Nijmegen, the Netherlands.
Clinical Chemistry
|September 17, 2024
Summary
Reference intervals (RIs) used in laboratories often conflict with analytical bias, leading to misinterpretations. Harmonizing RIs ensures consistent patient diagnosis across healthcare facilities.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Biomedical Analysis
Background:
- Clinical decision-making requires interpreting measurement results against valid limits.
- Reference intervals (RIs) are crucial for distinguishing normal from abnormal results.
- This study assesses RI suitability considering analytical bias for creatinine, hemoglobin, and ferritin in Dutch laboratories.
Purpose of the Study:
- To evaluate the suitability of routinely used reference intervals (RIs) in Dutch laboratories.
- To assess the impact of analytical bias on the interpretation of laboratory results.
- To determine the benefit of harmonized RIs for consistent clinical decision-making.
Main Methods:
- Collected external quality assessment (EQA) data from SKML.
- Gathered routinely used RIs for a standard demographic (55-year-old female).
- Established harmonized RIs using routine patient data and compared them with routine RIs, analyzing analytical bias.
Main Results:
- Laboratories reported diverse RIs inconsistent with analytical bias and measurement procedures.
- Assay performance within bias limits does not ensure correct RI usage.
- Potential for structural misinterpretation of patient diagnoses exists due to inappropriate RIs.
Conclusions:
- Inconsistent RIs create unnecessary between-laboratory variations in clinical decisions.
- Harmonized RIs promote uniform result interpretation across healthcare facilities.
- Harmonized RIs are implementable with acceptable bias or after measurand standardization.
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