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QUALITY REQUIREMENTS

CLIA Requirements for Analytical Quality

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The tables below contain information on CLIA proficiency testing criteria foracceptable analytical performance, as printed in the Federal RegisterFebruary 28, 1992;57(40):7002­186. These guidelines for acceptableperformance can be used as Analytical Quality Requirements in theWestgard QC Design and Planning process.

(https://www.westgard.com/guide­sample.htm)The Poor Lab's Guide to the Regulations

The tables below contain information on CLIA proficiency testing criteria foracceptable analytical performance, as printed in the Federal Register February 28,1992;57(40):7002­186. These guidelines for acceptable performance can be usedas Analytical Quality Requirements in the Westgard QC Design and Planningprocess.

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1999StockholmConsensusStatement(https://www.westgard.com/stockholm.htm)BiologicalVariationDatabasereference list(https://www.westgard.com/biodatabase3.htm)BiologicalVariationDatabasereferences(https://www.westgard.com/biodatabase2.htm)BiologicalVariation inPatients withDisease(https://www.westgard.com/biodatabasedisease.htm)CLIARequirements

You can skip ahead to specific areas of laboratory tests by clicking on thelisted items:

Routine ChemistryToxicologyHematologyEndocrinologyGeneral Immunology

Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display

the plus/minus character (it should appear right here, ±. If it does not, your browser does not

support this character).

Routine Chemistry

Test or Analyte Acceptable Performance

Alanineaminotransferase

Target value ± 20%

Albumin Target value ± 10%

Alkalinephosphatase

Target value ± 30%

Amylase Target value ± 30%

Aspartateaminotransferase(AST)

Target value ± 20%

Bilirubin, totalTarget value ± 0.4 mg/dL or ± 20%(greater)

Blood gas p02 Target value ± 3 SD

Blood gas pCO2Target value ± 5 mm Hg or ± 8%(greater)

Blood gas pH Target value ± 0.04

Calcium, total Target value ± 1.0 mg/dL

Chloride Target value ± 5%

Cholesterol, total Target value ± 10%

Cholesterol, highdens. lipoprotein

Target value ± 30%

Creatine kinase Target value ± 30%

Creatine kinaseisoenzymes

MB elevated (present or absent) orTarget value ± 3 SD Creatinine

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for AnalyticalQuality(https://www.westgard.com/clia.htm)Clinical QualityRequirements(https://www.westgard.com/clinical.htm)DesirableBiologicalVariationDatabasespecifications(https://www.westgard.com/biodatabase1.htm)EuropeanBiologic Goals(https://www.westgard.com/europe.htm)Final MilanHierarchy(https://www.westgard.com/milan­mandate.htm)Milan 2014ConsensusDraft on QualitySpecifications(https://www.westgard.com/milan­2014­draft1.htm)Minimumanalyticalqualityrequirements(https://www.westgard.com/minimum­requirements.htm)MinimumSpecificationsfrom BiologicalVariationdatabase(https://www.westgard.com/minimum­biodatabase1.htm)OptimalBiologicalVariationdatabasespecifications(https://www.westgard.com/optimal­

Creatinine Target value ± 0.3 mg/dL or ± 15%(greater)

GlucoseTarget value ± 6 mg/dL or ± 10%(greater)

Iron, total Target value ± 20%

Lactatedehydrogenase(LDH)

Target value ± 20%

LDH isoenzymesLDH1/LDH2 (+ or ­) or Target value ±30%

Magnesium Target value ± 25%

Potassium Target value ± 0.5 mmol/L

Sodium Target value ± 4 mmol/L

Total protein Target value ± 10%

Triglycerides Target value ± 25%

Urea NitrogenTarget value ± 2 mg/dL or ± 9%(greater)

Uric acid Target value ± 17%

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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display

the plus/minus character (it should appear right here, ±. If it does not, your browser does not

support this character).

Toxicology

Alcohol, blood Target value ± 25%

Blood leadTarget value ± 10% or ± 4 mcg/dL(greater)

Carbamazepine Target value ± 25%

DigoxinTarget value ± 20% or ± 0.2 ng/mL(greater)

Ethosuximide Target value ± 20%Gentamicin Target value ± 25%

LithiumTarget value ± 0.3 mmol/L or ± 20%(greater)

Phenobarbital Target value ± 20%Phenytoin Target value ± 25%Primidone Target value ± 25%

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biodatabase1htm.htm)QualityRequirementsfor Dogs, Cats,and Horses?(https://www.westgard.com/quality­requirements­for­dogs­cats­and­horses.htm)RCPA(Australasian)QualityRequirements(https://www.westgard.com/rcpa.htm)Rilibak ­GermanGuidelines forQuality(https://www.westgard.com/rilibak.htm)

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IQCP Survey 2015:Labs Speak Out!(https://www.westgard.com/iqcp­survey­comments.htm)

IQCP Survey Results2015

Procainamide (andmetabolite)

Target value ± 25%

Quinidine Target value ± 25%Theophylline Target value ± 25%Tobramycin Target value ± 25%Valproic acid Target value ± 25%

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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display

the plus/minus character (it should appear right here, ±. If it does not, your browser does not

support this character).

HematologyTest or Analyte Acceptable PerformanceCell identification 90% or greater consensus on identificationWhite celldifferentiation

Target ± 3 SD based on percentage ofdifferent types of white cells

Erythrocyte countTarget ± 6%Hematocrit Target ± 6%Hemoglobin Target ± 7%Leukocyte count Target ± 15%Platelet count Target ± 25%Fibrinogen Target ± 20%Partialthromboplastintime

Target ± 15%

Prothrombin time Target ± 15%

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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display

the plus/minus character (it should appear right here, ±. If it does not, your browser does not

support this character).

EndocrinologyTest or Analyte Acceptable PerformanceCortisol Target value ± 25%Free thyroxine Target value ± 3 SDHuman chorionicgonadotropin

Target value ± 3 SD or (positive ornegative)

T3 uptake Target value ± 3 SD by methodTriiodothyronine Target value ± 3 SD

(https://www.westgard.com/iqcp­survey­results.htm)

CMS goes off­off­label(https://www.westgard.com/off­off­label.htm)

Thyroid stimulatinghormone

Target value ± 3 SD

ThyroxineTarget value ± 20% or 1.0 mcg/dL(greater)

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Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display

the plus/minus character (it should appear right here, ±. If it does not, your browser does not

support this character).

General immunologyTest or Analyte Acceptable PerformanceAlpha­1 antitrypsin Target value ± 3 SDAlpha­fetoprotein Target value ± 3 SD

Antinuclear antibodyTarget value ± 2 dilution or (pos.or neg.)

Antistreptolysin OTarget value ± 2 dilution or (pos.or neg.)

Anti­HumanImmunodeficiency virus

Reaction or nonreactive

Complement C3 Target value ± 3 SDComplement C4 Target value ± 3 SDHepatitis (HBsAg, anti­HBc,HBeAg)

Reactive (positive) or nonreactive(negative)

IgA Target value ± 3 SDIgE Target value ± 3 SDIgG Target value ± 25%IgM Target value ± 3 SD

Infectious mononucleosisTarget value ± 2 dilution or (pos.or neg.)

Rheumatoid factorTarget value ± 2 dilution or (pos.or neg.)

RubellaTarget value ± 2 dilution or (pos.or neg.)

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