Establishing the Reportable Interval for Routine Clinical Laboratory Tests: A Data-Driven Strategy Leveraging...

Area of Science:

• Clinical Laboratory Science
• Medical Informatics
• Biostatistics

Background:

• Establishing reportable intervals in clinical laboratory testing is crucial for accurate results.
• Lack of clear guidelines for reportable intervals can lead to reporting errors and patient risk.
• A data-driven strategy is needed to define these critical testing parameters.

Purpose of the Study:

• To develop and validate a data-driven strategy for establishing reportable intervals in clinical laboratory testing.
• To address the limitations of current methods for defining result ranges.
• To enhance the reliability and safety of laboratory diagnostics.

Main Methods:

• Integrated statistical analysis, expert review, and outlier calculations using over 124 million laboratory test records.
• Applied the Dixon test to identify outliers and determine non-outlier result values for 916 distinct tests.
• Validated findings with clinical pathology experts and aligned intervals with LOINC and UCUM standards.

Main Results:

• Established reportable intervals for 135 routine laboratory tests (493 LOINC codes).
• Demonstrated efficacy on a 23 million record dataset, identifying over 1% of results as implausible.
• Validated the strategy's ability to detect potentially erroneous laboratory results.

Conclusions:

• A data-driven strategy using large EMR datasets effectively establishes laboratory reportable intervals.
• Implementation improves autoverification, data reliability, and reduces patient care errors.
• Continuous refinement and reporting of out-of-interval results enhance laboratory management and patient safety.