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Equ51-07 Ref RNG RQMT Chem
Equ51-07 Ref RNG RQMT Chem
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect
your lab’s specific processes and/or specific protocol requirements. Users are encouraged to ensure
compliance with local laws and study protocol policies when considering the application of this document.
If you have any questions contact SMILE.
Subject Page 1 of 1
Revision
History
The REFERENCE RANGE (OR REFERENCE INTERVAL) is the range of test values
expected for a designated population where 95% of the individuals are presumed to be
healthy (or normal).
If Then
≥ 90% of samples are The reference range is
within the reference verified.
range
< 90% of samples are Re-evaluate the range being
within the reference verified.
range Re-evaluate the healthy
volunteer qualifications.
Collect and evaluate 20
additional samples.
≥ 90% of the additional The reference range is
samples are within the verified.
reference range
< 90% of the additional Proceed with step II below
samples are within the (Establishment of Reference
reference range Ranges)
IV. References
A. GCLP Guideline, Standard for Performance Specifications.
B. Clinical and Laboratory Standards Institute (CLSI).Defining, Establishing, and
Verifying reference Intervals in the Clinical Laboratory Proposed Guideline-
Third Edition, March 2008. CLSI document C28-P3 (ISBN 1-56238-663-8).
Clinical and Laboratory Standards Institutes, 940 West Valley Road, Suite
100, Wayne, Pennsylvania 19098-1898 USA.
C. EP Evaluator Release 8, David G. Rhoads Associates Inc.,
www.dgrhoads.com.
D. James O. Westgard, Online Validation Training, Westgard QC, Inc.
www.westgard.com, Module 14: Verifying Reference Intervals.