paml and testing partners update reference ranges … · paml is the managing partner for an...
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PAML is the managing partner for an integrated
network of laboratories providing services to
physicians and hospitals throughout the northwest.
The PAML network is standardized for many aspects
of laboratory practice, including reference intervals
for a core group of chemistry and hematology
analytes. All testing sites utilize the same reference
intervals, established by network wide studies.
As instrumentation and analytical methods are
upgraded and new partners are added into the
network, it becomes necessary to reassess
reference ranges and update them to meet current
standards.
PAML and its testing partners recently completed
a network-wide reference range study. Seventeen
network testing sites using a variety of analytical
instrument platforms participated in the study.
Lawrence M. Killingsworth, Ph.D., DABCC, FACB, Chief Science & Technical Offi cer - Carmen L. Wiley, Ph.D., DABCC, FACB, Director, Chemistry and ImmunologyWilliam A. Dittman, Jr., M.D., Director, Hematology - Michael G. Rush, MT(ASCP), Network Coordinator
PAML and Testing Partners Update Reference Ranges Across the Network
Reference Ranges Update
The study followed guidelines published by the Clinical
Laboratory Standards Institute (CLSI). Each site
recruited healthy adult volunteers, obtained consent for
the study, gathered personal health information on a
standard questionnaire, collected blood specimens and
assayed all the core analytes.
Health questionnaires on each subject were reviewed
to ensure that the subjects met the CLSI criteria for
healthy individuals. Seven hundred forty three healthy
subjects were included in the study. Sophisticated
data analysis was done, using both parametric and
non-parametric statistical tools, to determine the
ranges. Department Directors then reviewed the
data to establish the central 95% range and establish
reference intervals based on the data.
Network Reference Intervals Analyte units Old Range n NEW RANGE
Albumin g/dL 3.5 to 5.0 735 3.5 - 5.0
Alkaline Phosphatase U/L 38 to 110 735 35 - 115ALT U/L 5 to 50 734 10 - 65AST U/L 5 to 40 735 10 - 45Bilirubin, Total mg/dL 0.1 to 1.5 735 0.1 - 1.5BUN mg/dL 7 to 23 742 8 - 25Calcium mg/dL 8.5 to 10.5 742 8.5 - 10.2Chloride mmol/L 98 to 109 743 99 - 109
CK - Female U/L 20 to 200 371 30 - 240CK - Male U/L 25 to 287 316 55 - 400
Creatinine - Female (IDMS) mg/dL 0.40 to 1.00 (PAML) 408 0.50 - 1.00Creatinine - Male (IDMS) mg/dL 0.50 to 1.30 (PAML) 333 0.70 - 1.30
Ferritin - Female ng/mL 6 to 250 318 6 - 170Ferritin - Male ng/mL 20 - 350 261 11 - 450
GGT U/L 5 to 65 684 5 - 75
Iron - Female ug/dL 30 to 150 344 30 - 180Iron - Male ug/dL 35 to 190 288 45 - 190
LD U/L 100 to 200 640 115 - 225Magnesium mg/dL 1.5 to 2.4 689 1.7 - 2.4Phosphorus mg/dL 2.5 to 4.8 689 2.3 - 4.8Potassium mmol/L 3.5 to 5.0 743 3.5 - 5.0Protein, Total (Serum) g/dL 6.3 to 8.0 442 6.2 to 8.2Protein, Total (Plasma) g/dL 6.3 to 8.0 253 6.1 - 8.4PSA ng/mL 0.00 to 4.00 203 0.00 - 4.00Sodium mmol/L 135 to 145 743 135 - 145T4, Total ug/dL 5.0 to 12.0 549 4.7 - 11.3
TIBC - Female ug/dL 250 to 450 345 260 - 490TIBC - Male ug/dL 230 to 430 287 250 - 450
TSH uIU/mL 0.40 to 5.00 662 0.45 - 5.10
Uric Acid - Female mg/dL 2.0 to 6.7 370 2.2 - 7.1Uric Acid - Male mg/dL 3.1 to 8.1 315 3.2 - 8.6
Data reviewed and reference intervals proposed by Lawrence M. Killingsworth, Ph.D., DABCC, FACB and Carmen L. Wiley, Ph.D., DABCC, FACB
Indicates no change from old range.
Network Reference Intervals Analyte units Old Range n NEW RANGE
WBC K/uL 4.0 to 11.0 662 3.8 - 11.0
RBC - Female M/uL 3.80 to 5.20 370 3.70 - 5.10
RBC - Male M/uL 4.30 to 5.70 291 4.20 - 5.70
Hemoglobin - Female g/dL 11.6 to 15.5 371 11.3 - 15.5
Hemoglobin - Male g/dL 13.7 to 16.7 291 13.2 - 17.0
Hematocrit - Female % 35.0 to 46.0 371 34.0 - 46.0
Hematocrit - Male % 40.0 to 50.0 291 39.0 - 50.0
MCV (not currently standardized)
fL80.0 to 100.0 (PSHMC)
662 80.0 - 100.0
MCH (not currently standardized)
pg27.0 to 34.0 (PSHMC)
662 27.0 - 34.0
MCV (not currently standardized)
g/dL32.0 to 35.5 (PSHMC)
662 32.0 - 35.5
RDW (not currently standardized)
%11.0 to 15.0 (PSHMC)
629 11.0 - 15.5
Platelet Count K/uL 150 to 400 662 150 - 400
Neutrophils (Automated) % 40.0 to 80.0 658 40.0 - 75.0
Neutrophils (Automated) K/uL 2.0 to 7.3 658 1.9 - 7.4
Lymphocytes (Automated) % 15.0 to 45.0 658 15.0 - 48.0
Lymphocytes (Automated) K/uL 1.0 to 3.4 658 1.0 - 3.9
Data reviewed and reference intervals proposed by William A. Dittman, Jr., M.D.
Indicates no change from old range.
A suffi cient number of subjects was included for rigorous statistical analysis of the data, giving a high level of confi dence in the results.
The large number of subjects also allowedestablishment of some appropriate gender-relatedranges.
These standardized reference ranges will allow physicians and other caregivers throughout the region to use the same reference ranges, regardless of where testing is performed.
This study enabled PAML and its network testing partners to update current ranges and establish new network-wide reference ranges applicable for current analytical methodology at all testing sites. The ranges were adopted on June 12th, 2012.
Chemistry
Hematology
101012Reference Ranges_PACLAB_RR_0002