Appendix B

CLIA 88 has publisheded acceptable performance criteria for analytes that are graded in proficiency surveys. Some analytes have different performance criteria at different medical decision levels. When two criteria are given, which ever one is greater should be used. CLIA allowable error is calculated by multiplying CLIA acceptable performance criteria by the medical decision level. Fraser has independently published what he believes allowable error should be based on medical significance.

Routine Chemistry	CLIA Acceptable Performance	Medical Decision Level	CLIA Allowable Error	Medically Allowable Error
Albumin	+/-10%	3.5 g/dL	0.35 g/dL	0.24 g/dL
Bilirubin	+/-20% or 0.4 mg/dL	1.0 mg/dL	0.40 mg/dL	0.54 mg/dL
		20 mg/dL	4.00 mg/dL	10.8 mg/dL
Calcium	+/-1.0 mg/dL	7.0 mg/dL	1.00 mg/dL	0.37 mg/dL
		10.8 mg/dL	1.00 mg/dL	0.48 mg/dL
		13.0 mg/dL	1.00 mg/dL	0.57 mg/dL
Chloride	+/-5%	90 meq/L	4.50 meq/L	2.97 meq/L
		110 meq/L	5.50 meq/L	3.63 meq/L
Cholesterol	+/-10%	200 mg/dL	20.00 mg/dL	29.8 mg/dL
Creatinine	+/-0.3 mg/dL or +/-15%	1.0 mg/dL	0.30 mg/dL	0.11 mg/dL
		3.0 mg/dL	0.45 mg/dL	0.36 mg/dL
Glucose	+/-6mg/dL or +/-10%	50 mg/dL	6.00 mg/dL	5.35 mg/dL
		120 mg/dL	12.00 mg/dL	12.7 mg/dL
		200 mg/dL	20.00 mg/dL	21.4 mg/dL
Iron	+/-20%	150 mg/dL	30.00 mg/dL	109.4 mg/dL
Magnesium	+/-25%	2.0 mg/dL	0.50 mg/dL	0.11 mg/dL
Phosphate		4.5 mg/dL		0.86 mg/dL
Potassium	+/-0.5 meq/L	3.0 meq/L	0.50 meq/L	0.33meq/L
		6.0 meq/L	0.50 meq/L	0.66 meq/L
Protein, total	+/-10%	7.0 g/dL	0.70 g/dL	0.51 g/dL
Sodium	+/-4meq/L	130 meq/L	4.00 meq/L	1.78 meq/L
		150 meq/L	4.00 meq/L	2.06 meq/L
Triglycerides	+/-25%	160 mg/dL	40.00 mg/dL	97.0 mg/dL
Urea nitrogen	+/-2 mg/dL or +/- 9%	27 mg/dL	2.40 mg/dL	8.2 mg/dL
Uric acid	+/-17%	6.0 mg/dL	1.0 mg/dL	1.25 mg/dL

Enzymes	CLIA Acceptable Performance	Medical Decision Level (U/L)	CLIA Allowable Error (U/L)	Medically Allowable Error (U/L)
Acid ptase		2		0.40
ALP	+/- 30%	150	45	30.0
ALT	+/- 20%	50	10	34.0
Amylase	+/- 30%	100	30	21.3
AST	+/- 20%	30	6	10.7
		70	14	24.3
CK	+/- 30%	200	60	200.0
GGT		100		51.4
LD	+/- 20%	250	50	50.0

Hormones	CLIA Acceptable Performance	Medical Decision Level	CLIA Allowable Error	Medically Allowable Error
FSH		10 U/L		1.3 U/L
		95 U/L		12.5 U/L
hCG	+/- 3 SD	25 IU/L	3 SD
LH		6 U/L		1.9 U/L
		55 U/L		18.0 U/L
Prolactin		15 ug/L		4.0 ug/L
		200 ug/L		58.0 ug/L
Testosterone		90 ng/dL		20.5 ng/L
		1000 ng/dL		226.0 ng/L
Free T4	+/- 3 SD	2.3 ng/dL	3 SD	0.4 ng/dL
T3 Uptake	+/- 3 SD	25%	3 SD	0.0 %
T3	+/- 3 SD	100 ng/dL	3 SD	21.5 ng/dL
		200 ng/dL	3 SD	43.0 ng/dL
TSH	+/- 3 SD	0.3 mIU/L	3 SD	0.1 mIU/L
		5.0 mIU/L	3 SD	2.0 mIU/L
Thyroxine	+/-1 ug/dL or +/- 20%	3 ug/dL	1.0 ug/dL	0.5 ug/dL
		13 ug/dL	2.6 ug/dL	2.3 ug/dL

Toxicology	CLIA Acceptable Performance	Medical Decision Level	CLIA Allowable Error	Medically Allowable Error
Alcohol, blood	+/- 25%	0.10 g/dL	0.025 g/dL
Blood lead	+/- 4 ug/dL or +/- 10%	10 ug/dL	4.0 ug/dL
		40 ug/dL	4.0 ug/dL
Carbamazepine	+/- 25 %	8 mg/dL	2.0 mg/dL	2.2 mg/dL
		12 mg/dL	3.0 mg/dL	3.5 mg/dL
Digoxin	+/- 0.2 ng/mL or +/- 20%	0.8 ug/L	0.2 ug/L	0.2 ug/L
		2.0 ug/L	0.4 ug/L	0.5 ug/L
Ethosuximide	+/- 20%	40 mg/L	8.0 mg/L	8.0 mg/L
		100 mg/L	20.0 mg/L	20.0 mg/L
Gentamicin	+/-25%	10 mg/L	2.5mg/L
Lithium	0.3 mmol/L or +/- 20%	0.5 mmol/L	0.3 mmol/L	0.2 mmol/L
		1.5 mmol/L	0.3 mmol/L	0.7 mmol/L
Phenobarbital	+/- 20%	15 mg/L	3.0 mg/L	5.2 mg/L
		40 mg/L	8.0 mg/L	14.4 mg/L
Phenytoin	+/- 25%	10 mg/L	2.5 mg/L	3.2 mg/L
		20 mg/L	5.0 mg/L	6.0 mg/L
Primidone	+/- 25%	5 mg/L	1.2 mg/L	2.2 mg/L
		12 mg/L	3.0 mg/L	5.4 mg/L
Procainamide	+/- 25%	4 mg/L	1.0 mg/L
		20 mg/L	5.0 mg/L
Quinidine	+/- 25%	7 mg/L	1.8 mg/L
Theophylline	+/- 25%	10 mg/L	2.5 mg/L	3.3 mg/L
		20 mg/L	5.0 mg/L	6.6 mg/L
Valproic acid	+/- 25%	100 mg/L	25mg/L	30.0 mg/L

Immunology	CLIA Acceptable Performance	Medical Decision Level	CLIA Allowable Error	Medically Allowable Error
Alpha -1 antitrypsin	+/- 3 SD		3 SD
AFP	+/- 3 SD		3 SD
ANA	+/- 2 titers or P/N		2 titers or P/N
ASO	+/- 2 titers or P/N		2 titers or P/N
Anti-HIV	Reactive/ Nonreactive		Reactive/ Nonreactive
CEA		5 ng/mL		1.7 ng/mL
C3	+/- 3 SD		3 SD
C4	+/- 3 SD		3 SD
HBsAg			Reactive/ Nonreactive
anti-HBc	Reactive/ Nonreactive		Reactive/ Nonreactive
IgA	+/- 3 SD	500 mg/dL	3 SD	107 mg/dL
IgE	+/- 3 SD	200 IU/mL	3 SD
IgG	+/- 25%	2000 mg/dL	3 SD	252 mg/dL
IgM	+/- 3 SD	300 mg/dL	3 SD	66 mg/dL
Infectious mono	+/- 2 titers or P/N		2 titers or P/N
Rheumatoid factor	+/- 2 titers or P/N		2 titers or P/N
Rubella	+/- 2 titers or P/N or Immune/ nonimmune		2 titers or P/N
Transferrin		375 mg/dL		44.6 mg/dL

Hematology	CLIA Acceptable Performance	Medical Decision Level	CLIA Allowable Error	Medically Allowable Error
Hemoglobin	+/- 7%	16 g/dL	1.12 g/dL	1.00 g/dL
Hematocrit	+/- 6%	50%	3.00%	3.20%
RBC	+/- 6%	5.5*10⁶/uL	0.33*10⁶/uL	0.55*10⁶/uL
Platelet count	+/- 25%	500,000/uL	125,000	102,000
MCV		100 fl		5.10 fl
MCH		33 pg		1.25 pg
MCHC		37%		1.10%
WBC	+/- 15%	11,400/uL	1700/uL	2950/uL
Neutrophils	+/- 3 SD	8300 cells/uL	3 SD	2200/uL
Lymphocytes	+/- 3 SD	3600 cells/uL	3 SD	975/uL
Monocytes	+/- 3 SD	99 cells, uL	3 SD	297/uL
Granulocytes	+/- 3 SD	500 cells/uL	3 SD	250/uL
Fibrinogen	+/- 20%	400 mg/dL	80 mg/dL
Protime	+/- 15%	15 sec	2.25 sec
APTT	+/- 15%	35 sec	5.25 sec




Introduction Initial Questions Linearity Precision Interference Recovery Method Comparison Lower Limit of Detection Carryover Reference Ranges Periodic Reevaluation Second Instrument of Similar Make Appendix A Appendix B