CLIA REQUIREMENTS FOR 


ANALYTICAL QUALITY


This table contains information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC planning process.


Routine Chemistry

Test or Analyte

Acceptable Performance

Alanine aminotransferase

Target value ±; 20%

Albumin

Target value ±; 10%

Alkaline phosphatase

Target value ±; 30%

Amylase

Target value ±; 30%

Aspartate aminotransferase (AST)

Target value ±; 20%

Bilirubin, total

Target value ±; 0.4 mg/dL or ±; 20% (greater)

Blood gas p02

Target value ±; 3 SD

Blood gas pCO2

Target 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, high dens. lipoprotein

Target value ±; 30%

Creatine kinase

Target value ±; 30%

Creatine kinase isoenzymes

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

Creatinine

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

Glucose

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

Iron, total

Target value ±; 20%

Lactate dehydrogenase (LDH)

Target value ±; 20%

LDH isoenzymes

LDH1/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 Nitrogen

Target value ±; 2 mg/dL or ±; 9% (greater)

Uric acid

Target value ±; 17%


 
 

Toxicology

Theophylline

Target value ±; 25%

Tobramycin

Target value ±; 25%

Procainamide (and metabolite)

Target value ±; 25%

Quinidine

Target value ±; 25%

Valproic acid

Target value ±; 25%


Hematology

Test or Analyte

Acceptable Performance

Cell identification

90% or greater consensus on identification

White cell differentiation

Target ±; 3 SD based on percentage of different types of white cells

Erythrocyte count

Target ±; 6%

Hematocrit

Target ±; 6%

Hemoglobin

Target ±; 7%

Leukocyte count

Target ±; 15%

Platelet count

Target ±; 25%

Fibrinogen

Target ±; 20%

Partial thromboplastin time

Target ±; 15%

Prothrombin time

Target ±; 15%


Endocrinology

Test or Analyte

Acceptable Performance

Cortisol

Target value ±; 25%

Free thyroxine

Target value ±; 3 SD

Human chorionic gonadotropin

Target value ±; 3 SD or (positive or negative)

T3 uptake

Target value ±; 3 SD by method

Triiodothyronine

Target value ±; 3 SD

Thyroid stimulating hormone

Target value ±; 3 SD

Thyroxine

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


General immunology

Test or Analyte

Acceptable Performance

Alpha-1 antitrypsin

Target value ±; 3 SD

Alpha-fetoprotein

Target value ±; 3 SD

Antinuclear antibody

Target value ±; 2 dilution or (pos. or neg.)

Antistreptolysin O

Target value ±; 2 dilution or (pos. or neg.)

Anti-Human Immunodeficiency virus

Reaction or nonreactive

Complement C3

Target value ±; 3 SD

Complement C4

Target value ±; 3 SD

Hepatitis (HBsAg, anti-HBc, HBeAg)

Reactive (positive) or nonreactive (negative)

IgA

Target value ±; 3 SD

IgE

Target value ±; 3 SD

IgG

Target value ±; 25%

IgM

Target value ±; 3 SD

Infectious mononucleosis

Target value ±; 2 dilution or (pos. or neg.)

Rheumatoid factor

Target value ±; 2 dilution or (pos. or neg.)

Rubella

Target value ±; 2 dilution or (pos. or neg.)


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WesTgard® Quality Corporation, P.O. Box 2026, Ogunquit ME 03907
Call 207-646-1553 or e-mail
westgard@westgard.com