Tools,TechnologiesandTrainingforHealthcareLaboratories

(https://www.westgard.com)
MyCart
(https://www.westgard.com/show

HOME(HTTPS://WWW.WESTGARD.COM/)

"WESTGARDRULES"(HTTPS://WWW.WESTGARD.COM/WESTGARDRULES.HTM)

cart/cart.html)|CheckOut
(https://www.westgard.com/show

ESSAYS(HTTPS://WWW.WESTGARD.COM/ESSAYS.HTM)

QCAPPLICATIONS(HTTPS://WWW.WESTGARD.COM/QCAPPLICATIONS.HTM)
cart/cart.html)|Login
(https://www.westgard.com/log

LESSONS(HTTPS://WWW.WESTGARD.COM/LESSONS.HTM)

in/login.html)

CLIA&QUALITY(HTTPS://WWW.WESTGARD.COM/CLIAAQUALITY.HTM)

DOWNLOADS(HTTPS://WWW.WESTGARD.COM/DOWNLOADS.HTML)

STORE(HTTPS://WWW.WESTGARD.COM/STORE.HTML?PRODUCTSUBLAYOUT=0)

RESOURCES(HTTPS://WWW.WESTGARD.COM/RESOURCES.HTM)

ABOUTUS(HTTPS://WWW.WESTGARD.COM/ABOUTUS.HTM)

HOME(HTTPS://WWW.WESTGARD.COM/)
/ CLIA&QUALITY(HTTPS://WWW.WESTGARD.COM/CLIAAQUALITY.HTM)
/
QUALITYREQUIREMENTS(HTTPS://WWW.WESTGARD.COM/QUALITY
REQUIREMENTS.HTM)

in/login.html)

QUALITY REQUIREMENTS

(https://www.westgard.com/sign
up/registers.html)
WHAT'SPOPULAR
(https://www.westgard.com/whats
popular.htm)

CLIA Requirements for Analytical Quality

WHAT'SNEW
(https://www.westgard.com/whats
new.htm)

/ CLIAREQUIREMENTSFORANALYTICALQUALITY

JAMESWESTGARD

(https://www.westgard.com/log

FOUNDER

Blog(http://james.westgard.com/)
AboutUs

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

Member Login

ThetablesbelowcontaininformationonCLIAproficiencytestingcriteriafor
acceptableanalyticalperformance,asprintedintheFederalRegister
(https://www.westgard.com/resources.htm)
February28,199257(40):7002186.Theseguidelinesforacceptable
performancecanbeusedasAnalyticalQualityRequirementsinthe
WestgardQCDesignandPlanningprocess.
ReferenceMaterials
&Resources

Toaccesstheprivate
areaofthissite,
pleaselogin.
Username

CALCULATORS

QCTools
(https://www.westgard.com/qctools.htm)

QCCalculators
(https://www.westgard.com/calculateqc.htm)
MethodValidation
Tools
(https://www.westgard.com/mvtools.htm)
SixSigma
Calculators
(https://www.westgard.com/six
sigma
calculators.htm)
Normalized
OPSpecs
Calculator
(https://www.westgard.com/normalized
opspecs
calculator.htm)
QualityControl
GridCalculator
(https://www.westgard.com/qcsgtool.htm)
ControlLimit
Calculator
(https://www.westgard.com/control
limit
calculator.htm)
(https://www.westgard.com/guidesample.htm)
ThePoorLab'sGuidetotheRegulations
ReportableRange
Calculator:
ThetablesbelowcontaininformationonCLIAproficiencytestingcriteriafor
QuantifyingErrors
acceptableanalyticalperformance,asprintedintheFederalRegisterFebruary28,
(https://www.westgard.com/reportable
199257(40):7002186.Theseguidelinesforacceptableperformancecanbeused
rangecalculator
asAnalyticalQualityRequirementsintheWestgardQCDesignandPlanning
brquantifying
process.
errors.htm)

Password

Rememberme

Login

Forgotlogin?
(https://www.westgard.com/component/comprofiler/l
Register
(https://www.westgard.com/component/comprofiler/r

Other Articles

1999
Stockholm
Consensus
Statement
(https://www.westgard.com/stockholm.htm)
Biological
Variation
Database
referencelist
(https://www.westgard.com/biodatabase3.htm)
Biological
Variation
Database
references
(https://www.westgard.com/biodatabase2.htm)
Biological
Variationin
Patientswith
Disease
(https://www.westgard.com/biodatabasedisease.htm
CLIA
Requirements

Youcanskipaheadtospecificareasoflaboratorytestsbyclickingonthe
ReportableRange
listeditems:
Calculator:
RecordingResults
RoutineChemistry
(https://www.westgard.com/reportable
Toxicology
rangecalculator
Hematology
brrecording
Endocrinology
results.htm)
GeneralImmunology
Dispersion
Calculatorand
Note:AnalyticalQualityRequirementsareaplus/minuspercentage.Somebrowsersmaynotdisplay
CriticalNumberof
theplus/minuscharacter(itshouldappearrighthere,.Ifitdoesnot,yourbrowserdoesnot
TestSamples
supportthischaracter).
(https://www.westgard.com/dispersion
calculatorand
RoutineChemistry
criticalnumberof
TestorAnalyte
AcceptablePerformance
testsamples.htm)
ONLINE STORE

(https://www.westgard.com/store/books
andreference
manuals/basicqc
practices,thirdedition
detail.html)
BasicQCPractices,
ThirdEdition
(https://www.westgard.com/store/books
andreference
manuals/basicqc
practices,thirdedition
detail.html)
$80.00

(https://www.westgard.com/store/books
andreference
manuals/nothingbut
thetruthmanual

Alanine
aminotransferase

Targetvalue20%

Albumin

Targetvalue10%

Alkaline
phosphatase

Targetvalue30%

Amylase

Targetvalue30%

Aspartate
aminotransferase
(AST)

Targetvalue20%

Bilirubin,total

Targetvalue0.4mg/dLor20%
(greater)

Bloodgasp02

Targetvalue3SD

BloodgaspCO2

Targetvalue5mmHgor8%
(greater)

BloodgaspH

Targetvalue0.04

Calcium,total

Targetvalue1.0mg/dL

Chloride

Targetvalue5%

Cholesterol,total

Targetvalue10%

Cholesterol,high
dens.lipoprotein

Targetvalue30%

Creatinekinase

Targetvalue30%

Creatinekinase
isoenzymes

MBelevated(presentorabsent)or
Targetvalue3SDCreatinine

forAnalytical
Quality
(https://www.westgard.com/clia.htm)
ClinicalQuality
Requirements
(https://www.westgard.com/clinical.htm)
Desirable
Biological
Variation
Database
specifications
(https://www.westgard.com/biodatabase1.htm)
European
BiologicGoals
(https://www.westgard.com/europe.htm)
FinalMilan
Hierarchy
(https://www.westgard.com/milan
mandate.htm)
Milan2014
Consensus
DraftonQuality
Specifications
(https://www.westgard.com/milan
2014
draft1.htm)
Minimum
analytical
quality
requirements
(https://www.westgard.com/minimum
requirements.htm)
Minimum
Specifications
fromBiological
Variation
database
(https://www.westgard.com/minimum
biodatabase1.htm)
Optimal
Biological
Variation
database
specifications
(https://www.westgard.com/optimal

detail.html)
NothingbuttheTruth
Manual
(https://www.westgard.com/store/books
andreference
manuals/nothingbut
thetruthmanual
detail.html)
$120.00
PHOTO GALLERY

Creatinine

Targetvalue0.3mg/dLor15%
(greater)

Glucose

Targetvalue6mg/dLor10%
(greater)

Iron,total

Targetvalue20%

Lactate
dehydrogenase
(LDH)

Targetvalue20%

LDHisoenzymes

LDH1/LDH2(+or)orTargetvalue
30%

Magnesium

Targetvalue25%

Potassium

Targetvalue0.5mmol/L

(https://www.westgard.com/index.php?
Sodium
Targetvalue4mmol/L
Totalprotein

Targetvalue10%

Triglycerides
Targetvalue25%
option=com_phocagallery&view=detail&catid=3:westgard
workshops&id=78:ww06attendees&tmpl=component&detail=13&buttons=1)
Targetvalue2mg/dLor9%
UreaNitrogen
(greater)
Uricacid

biodatabase1htm.htm)
Quality
Requirements
forDogs,Cats,
andHorses?
(https://www.westgard.com/quality
requirements
fordogscats
and
horses.htm)
RCPA
(Australasian)
Quality
Requirements
(https://www.westgard.com/rcpa.htm)
Rilibak
German
Guidelinesfor
Quality
(https://www.westgard.com/rilibak.htm)

Targetvalue17%
search...

Backtotop
Note:AnalyticalQualityRequirementsareaplus/minuspercentage.Somebrowsersmaynotdisplay
theplus/minuscharacter(itshouldappearrighthere,.Ifitdoesnot,yourbrowserdoesnot
supportthischaracter).

Alcohol,blood
Bloodlead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin

Toxicology
Targetvalue25%
Targetvalue10%or4mcg/dL
(greater)
Targetvalue25%
Targetvalue20%or0.2ng/mL
(greater)
Targetvalue20%
Targetvalue25%

Lithium

Targetvalue0.3mmol/Lor20%
(greater)

Phenobarbital
Phenytoin
Primidone

Targetvalue20%
Targetvalue25%
Targetvalue25%

What's New
NewCMS/CDC
TrainingGuidefor
IQCP
(https://www.westgard.com/cdc
cmsiqcpguide.htm)
2015IQCPSurvey:
TheViewFrom
Outside
(https://www.westgard.com/iqcp
surveyoutsideus.htm)
IQCPSurvey2015:
LabsSpeakOut!
(https://www.westgard.com/iqcp
survey
comments.htm)
IQCPSurveyResults
2015

Procainamide(and
metabolite)
Quinidine

Targetvalue25%

Theophylline
Tobramycin
Valproicacid

Targetvalue25%
Targetvalue25%
Targetvalue25%

Targetvalue25%

(https://www.westgard.com/iqcp
surveyresults.htm)
CMSgoesoffoff
label
(https://www.westgard.com/off
offlabel.htm)

Backtotop

Note:AnalyticalQualityRequirementsareaplus/minuspercentage.Somebrowsersmaynotdisplay
theplus/minuscharacter(itshouldappearrighthere,.Ifitdoesnot,yourbrowserdoesnot
supportthischaracter).

Hematology
TestorAnalyte AcceptablePerformance
Cellidentification 90%orgreaterconsensusonidentification
Whitecell
Target3SDbasedonpercentageof
differentiation
differenttypesofwhitecells
Erythrocytecount Target6%
Hematocrit
Target6%
Hemoglobin
Target7%
Leukocytecount Target15%
Plateletcount
Target25%
Fibrinogen
Target20%
Partial
thromboplastin Target15%
time
Prothrombintime Target15%
Backtotop
Note:AnalyticalQualityRequirementsareaplus/minuspercentage.Somebrowsersmaynotdisplay
theplus/minuscharacter(itshouldappearrighthere,.Ifitdoesnot,yourbrowserdoesnot
supportthischaracter).

Endocrinology
TestorAnalyte
Cortisol
Freethyroxine
Humanchorionic
gonadotropin
T3uptake
Triiodothyronine

AcceptablePerformance
Targetvalue25%
Targetvalue3SD
Targetvalue3SDor(positiveor
negative)
Targetvalue3SDbymethod
Targetvalue3SD

Thyroidstimulating
hormone

Targetvalue3SD

Thyroxine

Targetvalue20%or1.0mcg/dL
(greater)

Backtotop
Note:AnalyticalQualityRequirementsareaplus/minuspercentage.Somebrowsersmaynotdisplay
theplus/minuscharacter(itshouldappearrighthere,.Ifitdoesnot,yourbrowserdoesnot
supportthischaracter).

Generalimmunology
AcceptablePerformance
Targetvalue3SD
Targetvalue3SD
Targetvalue2dilutionor(pos.
Antinuclearantibody
orneg.)
Targetvalue2dilutionor(pos.
AntistreptolysinO
orneg.)
AntiHuman
Reactionornonreactive
Immunodeficiencyvirus
ComplementC3
Targetvalue3SD
ComplementC4
Targetvalue3SD
Hepatitis(HBsAg,antiHBc, Reactive(positive)ornonreactive
HBeAg)
(negative)
IgA
Targetvalue3SD
TestorAnalyte
Alpha1antitrypsin
Alphafetoprotein

IgE
IgG
IgM
Infectiousmononucleosis
Rheumatoidfactor
Rubella

Backtotop

Targetvalue3SD
Targetvalue25%
Targetvalue3SD
Targetvalue2dilutionor(pos.
orneg.)
Targetvalue2dilutionor(pos.
orneg.)
Targetvalue2dilutionor(pos.
orneg.)

Copyright2009.Allrightsreserved.
WestgardQC7614GrayFoxTrailMadison,Wisconsin53717
Call6088334718orEmailwestgard@westgard.com(mailto:westgard@westgard.com)
"WestgardRules"(https://www.westgard.com/westgardrules.htm)
Questions(https://www.westgard.com/questions.htm)
Interviews(https://www.westgard.com/interviews.htm)
Lessons(https://www.westgard.com/lessons.htm)
CLIA&Quality(https://www.westgard.com/cliaaquality.htm)
Essays(https://www.westgard.com/essays.htm)
Tools(https://www.westgard.com/tools.htm)
QCApplications(https://www.westgard.com/qcapplications.htm)
Photos(https://www.westgard.com/component/phocagallery.html)
ContactWQC(https://www.westgard.com/component/rsform.html)
SiteMap(https://www.westgard.com/component/xmap.html?sitemap=1)