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 Officer - Carmen L. Wiley, Ph.D., DABCC, FACB, Director, Chemistry and Immunology William 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.

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Page 1: PAML and Testing Partners Update Reference Ranges … · PAML is the managing partner for an integrated network of laboratories providing services to physicians and hospitals throughout

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.

Page 2: PAML and Testing Partners Update Reference Ranges … · PAML is the managing partner for an integrated network of laboratories providing services to physicians and hospitals throughout

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