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.)


Copyright 1996. All rights reserved.

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