22/11/2018 CLIA Requirements for Analytical Quality - Westgard

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The tables below contain information on CLIA proficiency testing criteria for area of this site, please
Reference Materials
acceptable analytical performance, as printed in the Federal Register February log in.
& Resources
28, 1992;57(40):7002-186. These guidelines for acceptable performance can be
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1999 Stockholm
Normalized Consensus
OPSpecs Statement
Calculator (/stockholm.htm)
(/normalized- 2016 State of
opspecs- the Art
calculator.htm) Hematology
Performance
Quality Control Specifications
Grid Calculator (/rcpa.htm)
sample.htm)
(/qcsgtool.htm) A selection of
The Poor Lab's Guide to the Regulations
SEKK-DMax
Control Limit
The tables below contain information on CLIA proficiency testing criteria for specifications
Calculator
acceptable analytical performance, as printed in the Federal Register February 28, (/sekk-
(/control-limit-
1992;57(40):7002-186. These guidelines for acceptable performance can be used as dmax.htm)
calculator.htm)
Analytical Quality Requirements in the Westgard QC Design and Planning Belgium EQA
Reportable Range process. performance
Calculator: specifications
Quantifying Errors You can skip ahead to specific areas of laboratory tests by clicking on the (/belgium-eqa-
(/reportable-range- listed items: goals.htm)
calculator-br- Biological
Routine Chemistry Variation
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22/11/2018 quantifying- Toxicology CLIA Requirements for Analytical Quality - Westgard Database
errors.htm) Hematology reference list
Endocrinology (/biodatabase3.htm)
Reportable Range General Immunology Biological
Calculator:
Variation
Recording Results
Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display Database
(/reportable-range-
the plus/minus character (it should appear right here, ±. If it does not, your browser does not support references
calculator-br-
this character). (/biodatabase2.htm)
recording-
Biological
results.htm)
Routine Chemistry Variation in
Dispersion Patients with
Test or Analyte Acceptable Performance Disease
Calculator and
Critical Number of Alanine (/biodatabasedisease.htm)
Target value ± 20%
Test Samples aminotransferase CLIA
(/dispersion- Requirements
Albumin Target value ± 10%
calculator-and- for Analytical
Alkaline Quality
critical-number-of- Target value ± 30%
phosphatase (/clia.htm)
test-samples.htm)
Amylase Target value ± 30% Clinical Quality
Requirements
ONLINE STORE Aspartate
(/clinical.htm)
aminotransferase Target value ± 20%
Consolidated
(AST)
Comparison of
(/store/books- Target value ± 0.4 mg/dL or ± 20% Hematology
Bilirubin, total
(greater) Performance
Blood gas p02 Target value ± 3 SD Specifications
and-reference- (/hematology-
manuals/basic-qc- Target value ± 5 mm Hg or ± 8%
Blood gas pCO2 goals.htm)
practices,-third-edition- (greater)
Desirable
detail.html) Blood gas pH Target value ± 0.04 Biological
Basic QC Practices, Variation
Calcium, total Target value ± 1.0 mg/dL
Fourth Edition Database
(/store/books-and- Chloride Target value ± 5%
specifications
reference- Cholesterol, total Target value ± 10% (/biodatabase1.htm)
manuals/basic-qc- European
Cholesterol, high
practices,-third-edition- Target value ± 30% Biologic Goals
dens. lipoprotein
detail.html) (/europe.htm)
$80.00 Creatine kinase Target value ± 30%
Final Milan
Creatine kinase MB elevated (present or absent) or Hierarchy
isoenzymes Target value ± 3 SD Creatinine (/milan-
Target value ± 0.3 mg/dL or ± 15% mandate.htm)
Creatinine French EQA
(/store/books-and- (greater)
reference-manuals/six- performance
Target value ± 6 mg/dL or ± 10%
sigma-risk-analysis- Glucose specifications
(greater)
detail.html) (/french-eqa-
Six Sigma Risk Analysis Iron, total Target value ± 20% goals.htm)
(/store/books-and- Lactate Milan 2014
reference-manuals/six- dehydrogenase Target value ± 20% Consensus
sigma-risk-analysis- Draft on Quality
(LDH)
detail.html) Specifications
LDH1/LDH2 (+ or -) or Target value ± (/milan-2014-
$90.00 LDH isoenzymes
30% draft1.htm)
Magnesium Target value ± 25% Minimum
PHOTO GALLERY
analytical
Potassium Target value ± 0.5 mmol/L
quality
Sodium Target value ± 4 mmol/L requirements
Total protein Target value ± 10% (/minimum-
(/index.php? requirements.htm)
Triglycerides Target value ± 25%
Minimum
Target value ± 2 mg/dL or ± 9% Specifications
Urea Nitrogen
(greater)
option=com_phocagallery&view=detail&catid=3:westgard- from Biological
workshops&id=52:6wkshp02&tmpl=component&detail=13&buttons=1)
Uric acid Target value ± 17% Variation
database
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biodatabase1.htm)
Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display
Optimal
Biological
the plus/minus character (it should appear right here, ±. If it does not, your browser does not support
Variation
this character).
database
specifications
(/optimal-
Toxicology
biodatabase1htm.htm)
Alcohol, blood Target value ± 25%
Quality
Target value ± 10% or ± 4 mcg/dL Requirements
Blood lead
(greater) for Dogs, Cats,
Carbamazepine Target value ± 25% and Horses?
(/quality-
https://www.westgard.com/clia.htm#chem 2/4
22/11/2018 CLIA Requirements for Analytical
Target value ± 20% Quality - Westgard
or ± 0.2 ng/mL requirements-
Digoxin
(greater) for-dogs-cats-
Ethosuximide Target value ± 20% and-
Gentamicin Target value ± 25% horses.htm)
Target value ± 0.3 mmol/L or ± 20% RCPA
Lithium Allowable Limits
(greater)
Phenobarbital Target value ± 20% of Performance
Phenytoin Target value ± 25% for Biochemistry
Primidone Target value ± 25% (/rcpa-
biochemistry.htm)
Procainamide (and
Target value ± 25% Rilibak -
metabolite)
German
Quinidine Target value ± 25%
Guidelines for
Theophylline Target value ± 25%
Quality
Tobramycin Target value ± 25%
(/rilibak.htm)
Valproic acid Target value ± 25%
Spanish
Minimum
Back to top Consensus
Performance
Note: Analytical Quality Requirements are a plus/minus percentage. Some browsers may not display
Specifications
the plus/minus character (it should appear right here, ±. If it does not, your browser does not support
(/minimum-
this character). consensus-
specifications.htm)
Hematology The New Era of
Test or Analyte Acceptable Performance Biological
Cell identification 90% or greater consensus on identification Variation:
White cell Target ± 3 SD based on percentage of EUBIVAS
differentiation different types of white cells (/eubivas.htm)
Erythrocyte count Target ± 6%
Hematocrit Target ± 6%
Hemoglobin Target ± 7%  search...
Leukocyte count Target ± 15%
Platelet count Target ± 25%
Fibrinogen Target ± 20%
What's New
Partial The 17 Signs of a
thromboplastin Target ± 15% Struggling (Losing)
time Laboratory (/17-signs-
Prothrombin time Target ± 15% losing-lab.htm)

Affiliated Hospital of
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Qingdao University -
Sigma Verification of
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Performance (/sigma-
the plus/minus character (it should appear right here, ±. If it does not, your browser does not support
vp-qingdao-
this character).
university.htm)

Endocrinology Cookie Policy for

Test or Analyte Acceptable Performance Westgard QC
Cortisol Target value ± 25% (/cookie-policy.htm)
Free thyroxine Target value ± 3 SD Privacy Policy
Human chorionic Target value ± 3 SD or (positive or (/privacy-policy.htm)
gonadotropin negative)
T3 uptake Target value ± 3 SD by method 20 Questions on
Triiodothyronine Target value ± 3 SD Hematology QC
(/questions-qc-
Thyroid stimulating
Target value ± 3 SD hematology.htm)
hormone
Target value ± 20% or 1.0 mcg/dL
Thyroxine
(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 immunology
Test or Analyte Acceptable Performance
Alpha-1 antitrypsin Target value ± 3 SD
Alpha-fetoprotein Target value ± 3 SD
Target value ± 2 dilution or (pos.
Antinuclear antibody
or neg.)
Target value ± 2 dilution or (pos.
Antistreptolysin O
or neg.)
Anti-Human
Reaction or nonreactive
Immunodeficiency virus
Complement C3 Target value ± 3 SD
https://www.westgard.com/clia.htm#chem 3/4
22/11/2018 Complement C4 CLIA Requirements
Target for Analytical
value ± 3 SDQuality - Westgard

Hepatitis (HBsAg, anti-HBc, Reactive (positive) or nonreactive

HBeAg) (negative)
IgA Target value ± 3 SD
IgE Target value ± 3 SD
IgG Target value ± 25%
IgM Target value ± 3 SD
Target value ± 2 dilution or (pos.
Infectious mononucleosis
or neg.)
Target value ± 2 dilution or (pos.
Rheumatoid factor
or neg.)
Target value ± 2 dilution or (pos.
Rubella
or neg.)

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