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Equ40-15 Peds Ref RNG Template
Equ40-15 Peds Ref RNG Template
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.
RBC, 106 cells/uL 0 - 3 days 3.3 – 5.0 Ped. Reference Range-2nd Ed (Coulter) Range verified locally
4 – 14 days 3.5 – 5.3 Ped. Reference Range-2nd Ed (Coulter)
15 – 30 days 3.3 – 4.9 Ped. Reference Range-2nd Ed (Coulter)
31 – 60 days 3.1 – 4.1 None Ped. Reference Range-2nd Ed (Coulter)
61 – 730 days 3.4 – 5.2 Ped. Reference Range-2nd Ed (Coulter) Range verified locally
2 – 12 years 3.3 – 4.9 Ped. Reference Range-2nd Ed (Coulter)
13 – 18 years 3.3 – 5.4 Ped. Reference Range-2nd Ed (Coulter)
Critical
Test Age Reference Range Source Comments
Values
MCHC, g/dL 7 – 12 years 31.0 – 37.0 None JHU-Harriet Lane Ref.-6 Ed
th
Critical
Test Age Reference Range Source Comments
Value
XYZ Pediatric Reference Ranges 4 April 2008
Page 4 of 8
Laboratory Header
NEUT, 103 cells/uL 0 – 1 day 5.0 – 21.0 <3.0 JHU-Harriet Lane Ref. -6th Ed
2 – 7 days 1.5 – 10 <1.0 JHU-Harriet Lane Ref.-6th Ed
7 – 14 days 1.0 – 9.5 JHU-Harriet Lane Ref.-6th Ed
14 – 30 days 1.0 – 8.5 JHU-Harriet Lane Ref. -6th Ed
31 – 180 days 1.0 – 8.5 JHU-Harriet Lane Ref. -6th Ed
181 – 730 days 1.5 – 8.5 <0.75 JHU-Harriet Lane Ref.-6th Ed
2 – 6 years 1.5 – 8.0 JHU-Harriet Lane Ref.-6th Ed
7 – 10 years 1.5 – 8.5 JHU-Harriet Lane Ref. -6th Ed
11 – 16 Years 1.8 – 8.0 JHU-Harriet Lane Ref. -6th Ed
MONO, 103 cells/uL 0 - 3 days 0.2 – 2.2 Ped. Reference Range-2nd Ed (Coulter)
4 – 14 days 0.1 – 2.9 Ped. Reference Range-2nd Ed (Coulter)
15 – 30 days 0.2 – 5.0 Ped. Reference Range-2nd Ed (Coulter)
31 – 60 days 0.2 – 2.1 None Ped. Reference Range-2nd Ed (Coulter)
61 – 730 days 0.3 – 1.9 Ped. Reference Range-2nd Ed (Coulter)
2 – 12 years 0.4 – 1.1 Ped. Reference Range-2nd Ed (Coulter)
13 – 18 years 0.4 – 0.9 Ped. Reference Range-2nd Ed (Coulter)
BASO, 103 cells/uL 0 - 3 days 0 – 0.5 Calculated Value/ based on RR’s Above
4 – 60 days 0 – 0.4 Calculated Value/ based on RR’s Above
61 – 730 days 0 – 0.2 None Calculated Value/ based on RR’s Above
2 – 12 years 0 – 0.2 Calculated Value/ based on RR’s Above
13 – 18 years 0 – 0.1 Calculated Value/ based on RR’s Above
CD4ABS, cells/uL 0 – 30 days 400 – 3600 <200 cells/uL Ugandan Range verified locally
XYZ Pediatric Reference Ranges 4 April 2008
Page 5 of 8
Laboratory Header
CD8ABS, cells/uL 0 – 7 days 200 – 1900 JHU-Harriet Lane Ref.-6th Ed Range verified locally
8 – 60 days 400 – 1700 JHU-Harriet Lane Ref. -6th Ed
61 – 270 days 600 – 2200 JHU-Harriet Lane Ref. -6th Ed
271 – 730 days 400 – 2300 None JHU-Harriet Lane Ref.-6th Ed Range verified locally
2 – 5 years 300 – 1600 JHU-Harriet Lane Ref. -6th Ed
6 – 10 years 300 – 1800 JHU-Harriet Lane Ref.-6th Ed
11 – 16 years 200 – 1200 JHU-Harriet Lane Ref. -6th Ed
ALT (SGPT), U/L 0 - 6 day 0 -57 U/L >450 U/L Ugandan Range verified locally
XYZ Pediatric Reference Ranges 4 April 2008
Page 6 of 8
Laboratory Header
Electrolytes
Chloride (CL) 0 – 1 days 97 – 122 mmol/L Roche.Ref.Manual
To be
2 – 28 day 95 – 116 mmol/L determined Roche.Ref.Manual
1 – 12 month 93 – 112 mmol/L Roche.Ref.Manual
1 – 18 years 96 – 111 mmol/L Roche.Ref.Manual