Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition

Clinical and Laboratory Standards Institute. (2010). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition.

Type

Standard

Intellectual base

Reference work

Year

2010

Link

https://clsi.org/shop/standards/ep28/

Cited from

data_science

Cited by

3 citations across 3 artifacts.

Each citation links to the sentence it supports in the citing article.

Primes

• Baseline Deviation
  • In clinical laboratory reporting, every result arrives paired with a reference range and a high/low/critical flag, so the clinician never looks up "normal hemoglobin."

    This sourceStandard for establishing population reference intervals and high/low/critical flagging, including partitioning by demographic to avoid inappropriate-population references.

    Supported in partVerified against the work's full text

    Confirms reference intervals for clinical laboratory tests exist to interpret results, but says nothing of per-result high/low/critical flagging or clinicians not looking up normal values.

    “This document provides guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests. It is designed to help laboratories establish accurate and reliable reference ranges, which are essential for interpreting test results and ensuring high-quality patient care.”

    Read by an automated reader; not a human review. How support was checked

Mechanisms

• Clinical Reference Range
  • The guard is clinical context: read the range as a prompt for judgment, against the right population partition, never as a verdict.

    This sourceTreats reference intervals as aids to clinical interpretation whose applicability must be established for the relevant population and partition.

• Reference Range Flag
  • The Reference Range Flag's first act is selecting the right range — pulling the age-appropriate, assay-appropriate reference interval

    This sourceRequires reference-interval work to account for subject partitions such as age and analytical-method differences rather than applying one undifferentiated range.

Verification

Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.

Does it back the claim? Read against the text for 1 of 3 citations: 1 supported in part. Each verdict is shown under its citation below, with what in the work backs the sentence.

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