Toby Cartwright: Normal Values -- Pediatrics

NAVIGATE: Pediatric Normal Values

Flow Cytometry

Hematology

Chemistry

XYZ Laboratory Pediatric Reference Ranges

In accordance with CLIA Approved Guideline C28-A [7] the XYZ Research Laboratory will adopt the pediatric reference ranges contained in the tables on pages 2-7. 

“The NCCLS Approved Guideline C28-A [7] describes different ways for a laboratory to validate the "transference" of established reference intervals to the individual laboratory:

1. Divine judgment. The acceptability of the transfer may be subjectively assessed on the basis of consistency between the "demographics and geographics" of the study population(s) and the demographics of the laboratory's test population(s). The laboratory simply reviews the information submitted and subjectively verifies that the reference intervals are applicable to the adopting laboratory's patient population and test methods. To do this, all the information about the original study should be requested and made available to the adopting laboratory. This includes the demographics of the reference sample group, the selection process, pre-analytical conditions of the study such as subject preparation and specimen collection and handling techniques, the analytical system used, and the statistical method used to establish the intervals. Sometimes it is useful to request the original reference values and to re-analyze them to verify the original statistical analysis. Most cases for transference involve adoption of intervals from another laboratory using the same analytical system or intervals established by the method manufacturer.

US CLIA regulations permit the Medical Director of a laboratory to make this assessment and judgment.

While transference requires only the appropriate signature, the approach depends on a careful investigation of published recommendations, access to appropriate information, and significance laboratory and medical experience to assure the comparability of conditions.

Provision of reference intervals for sub-populations, particularly the pediatrics year-by-year intervals, often requires this approach because of the difficulty in obtaining sufficient specimens to experimentally establish or verify reference intervals.”

The adoption of these ranges is based on sound clinical judgment and consultation with local medical professionals, including pediatricians.  The reference ranges are judged to be representative of the XYZ population demographics and geographical conditions. These ranges will be monitored and verified over time when appropriate data becomes available.

Flow Cytometry--Pediatric Reference Ranges

Pediatric Hematology

Chemistry--Pediatric Reference Ranges