clia requirements for analytical quality - westgard
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CLIA Requirements for Analytical Quality - WestgardTRANSCRIPT
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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.
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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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Routine ChemistryToxicologyHematologyEndocrinologyGeneral Immunology
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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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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
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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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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
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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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