Analyte Index With Grading Ranges
Analyte Index With Grading Ranges
“Fixed” grading limits use either a constant concentration (type C limits) or a constant percentage of the target value (type P limits) to define a range of acceptable performance above and below the target value.
The target value for qualitative or semi-quantitative results is the most frequently reported (consensus) value(s) of all valid results.
The target value for quantitative results is the mean of all results after removal of outliers. In contrast to fixed limits, limits based on standard deviations (SDs) can lead to different grading ranges for the same analyte, even when different peer groups have the same means.
The limits required by CMS consist of all three types discussed above; fixed concentration (type C), fixed percentage (type P), and SD (type S):
All three types of CMS grading limits are used. Not all analytes listed have CMS limits.
Proficiency testing is not required by CMS or other agencies for analytes/procedures which have no CMS-mandated grading limits. Such analytes/procedures are identified in the Analytes Index as well as on the reporting forms.
Results for these CMS-unscored analytes are not included in computing participants’ overall CMS subspecialty scores. Therefore these scores do not appear on CMS Cumulative Summary reports; they appear only on graded reports (which do not go to CMS).
In the interest of uniformity, the limits used for CMS-unscored analytes are derived from those used for CMS-scored analytes which are similar.
A listing of the limits used for all analytes/procedures, both CMS-scored (regulated analytes) and CMS-unscored, follows.
CMS and CDC have proposed the inclusion of new analytes as regulated. Where the new proposed ranges differ from our historic ranges, we have adopted the new proposed ranges so laboratories will be prepared for analyte regulation if or when it occurs.
CMS regulated analytes for CLIA purposes are in bold |
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*CAP Accepted Analytes |
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For qualitative/semi-quantitative procedures exluding Immunohematology evaluation is based |
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on 80% Participant or Referee Consensus of the intended results. |
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QUANTITATIVE ANALYTES |
2025 GRADING LIMITS |
CHEMISTRY |
|
Albumin, Serum |
8% |
Albumin, Fluids |
12% or 0.3 g/dL |
Alkaline Phosphatase |
20% |
Alpha-fetoprotein (AFP) |
20% |
Alanine Aminotransferase (ALT/SGPT) |
15% or 6 U/L |
Ammonia, Serum |
20% or 5 μmol/L |
Amylase, Serum |
20% |
Amylase, Fluids |
30% |
Amylase, Urine |
30% |
Apolipoprotein A1 |
30% or 5 mg/dL |
Apolipoprotein B |
25% or 5 mg/dL |
Aspartate Aminotransferase (AST/SGOT) |
15% or 6 U/L |
Beta-2-microglobulin |
30% or 0.06 mg/L |
Bilirubin, Direct |
20% or 0.4 mg/dL |
Bilirubin, Neonatal |
20% or 0.4 mg/dL |
Bilirubin, Total |
20% or 0.4 mg/dL |
BNP |
30% |
Calcium, Serum |
1.0 mg/dL |
Calcium, Ionized |
0.25 mmol/L |
Calcium, Urine |
1.0 mg/dL |
Carbon Dioxide (CO2) |
20% |
Chloride, Serum |
5% |
Chloride, Fluids |
5% |
Chloride, Urine |
25% |
Cholesterol, Fluids |
10% or 15 mg/dL |
Cholesterol, HDL |
20% or 6 mg/dL |
Cholesterol, LDL - Calc |
20% or 20 mg/dL |
Cholesterol, LDL - Direct |
20% |
Cholesterol, Total |
10% |
CK-MB |
25% or 3 ng/mL |
Creatine Kinase, Total (CK) |
20% |
Creatinine, Fluids |
15% or 3 mg/dL |
Creatinine, Serum |
10% or 0.2 mg/dL |
Creatinine, Urine |
15% or 3 mg/dL |
Ferritin |
20% |
Gamma-Glutamyl Transferase (GGT) |
15% or 5 U/L |
Glucose, Fluids |
10% or 6 mg/dL |
Glucose, Serum |
8% or 6 mg/dL |
Glucose, Urine |
10% or 6 mg/dL |
Glucose, Whole Blood - Waived |
16% or 6 mg/dL |
Glycohemoglobin (Hemoglobin A1C) |
8% |
Iron |
15% |
Lactate, Fluids |
30% or 0.3 mmol/L |
Lactate, Serum / Whole Blood |
30% or 0.3 mmol/L |
Lactate Dehydrogenase, Total (LDH) |
15% |
LDH, Fluids |
20% |
Lipase |
30% |
Lipoprotein (a) |
30% or 5 mg/dL |
Magnesium, Serum |
15% |
Magnesium, Ionized |
25% |
Magnesium, Urine |
25% |
Microalbumin, Urine |
25% or 10 mg/L |
Myoglobin, Urine |
30% |
NT-proBNP |
30% |
Osmolality, Urine |
10% or 9 mOsm/kg |
pCO2, Blood Gas |
8% or 5.0 mm Hg |
pH, Blood Gas |
0.04 |
pH, Fluids |
1 |
Phosphorus, Serum |
10% or 0.3 mg/dL |
Phosphorus, Urine |
15% or 3 mg/dL |
pO2, Blood Gas |
15% or 15 mm Hg |
Potassium, Serum |
0.3 mmol/L |
Potassium, Urine |
15% or 3 mmol/L |
Prealbumin |
30% |
Protein, Total (Serum) |
8% |
Protein, Total (Fluids) |
25% or 1 mg/L |
Protein, Total (Urine) |
44% or 1 mg/dL |
Prostate Specific Antigen (PSA), Total |
20% or 0.2 ng/mL |
Sodium, Serum |
4 mmol/L |
Sodium, Fluids |
4% or 4 mmol/L |
Sodium, Urine |
25% or 4 mmol/L |
Specific Gravity, Urine |
0.01 |
Total Iron Binding Capacity (TIBC) - Calc |
20% |
Total Iron Binding Capacity (TIBC) - Direct |
20% |
Triglycerides |
15% |
Troponin I |
30% or 0.9 ng/mL |
Troponin I, HS |
30% |
Troponin T |
30% or 0.2 ng/mL |
Troponin T, HS |
30% |
Unsaturated Iron Binding Capacity (UIBC) |
20% |
Urea Nitrogen, Serum |
9% or 2 mg/dL |
Urea Nitrogen, Urine |
20% |
Uric Acid, Serum |
10% |
Uric Acid, Fluids |
17% or 0.3 mg/dL |
Uric Acid, Urine |
25% |
ENDOCRINOLOGY |
|
Anti-Müllerian Hormone |
20% or 0.2 ng/mL |
Beta Hydroxybutyrate |
25% or 1 mg/dL |
CA 125 |
20% |
CA 15-3 |
2SD or 2 U/mL |
CA 19-9 |
2SD or 1.5 U/mL |
CA 27.29 |
2SD or 3 U/mL |
Carcinoembryonic Antigen (CEA) |
15% or 1 ng/mL |
Cortisol |
20% |
C-Peptide |
30% or 0.5 ng/mL |
*DHEA-S |
15% or 6.0 μg/dL |
*Estradiol |
30% |
Ferritin |
(See Chemistry) |
Folate |
30% or 1 ng/mL |
*Follicle Stimulating Hormone (FSH) |
18% or 2 U/L |
*Human Chorionic Gonadotropin (hCG), Serum |
18% or 3 mU/mL |
Homocysteine |
20% or 2.5 μmol/L |
Insulin |
30% or 1.5 μU/mL |
*Luteinizing Hormone (LH) |
20% |
Parathyroid Hormone (PTH), Intact |
30% |
*Progesterone |
25% |
*Prolactin |
20% |
Prostate Specific Antigen (PSA), Free |
20% or 0.2 ng/mL |
Prostate Specific Antigen (PSA), Total |
(See Chemistry) |
Prostatic Acid Phosphatase (PAP) |
30% or 0.2 ng/mL |
Sex Hormone Binding Globulin (SHBG) |
30% or 0.3 nmol/L |
T3 (Triiodothyronine), Free |
25% or 0.3 ng/mL |
T3 (Triiodothyronine), Total |
30% |
T3 Uptake |
18% |
T4 (Thyroxine), Total |
20% or 1.0 μg/dL |
T4 (Thyroxine), Free |
15% or 0.3 ng/dL |
Testosterone, Bioavailable |
30% or 0.2 ng/dL |
Testosterone, Free |
30% or 3 pg/mL |
*Testosterone, Total |
30% or 20 ng/dL |
Thyroglobulin |
2SD or 1 ng/mL |
Thyroglobulin Antibody |
2SD |
Thyroid Peroxidase Antibody (TPO) |
2SD |
*Thyroid Stimulating Hormone (TSH) |
20% or 0.2 mU/L |
Transferrin |
7% or 10 mg/dL |
Vitamin B12 |
25% or 30 pg/mL |
Vitamin D, 25-OH |
25% or 10 ng/mL |
TOXICOLOGY |
|
Acetaminophen |
15% or 3 μg/mL |
Alcohol (Ethanol) |
20% |
Carbamazepine |
20% or 1 μg/mL |
Digoxin |
15% or 0.2 ng/mL |
Gentamicin |
25% |
Lead, Blood - Waived |
10% or 2 μg/mL |
Lithium |
15% or 0.3 mmol/L |
Phenobarbital |
15% or 2 μg/mL |
Phenytoin |
15% or 2 μg/mL |
Salicylates |
15% or 2 μg/mL |
Theophylline |
20% |
Valproic Acid |
20% |
Vancomycin |
15% or 2 μg/mL |
COAGULATION |
|
Activated Partial Thromboplastin Time (APTT) |
15% |
Fibrinogen |
20% |
INR |
15% |
Prothrombin Time |
15% |
HEMATOLOGY |
|
Erythrocyte (RBC) Count |
4% |
Erythrocyte Sedimentation Rate (ESR) |
3SD |
Hematocrit |
4% |
Hemoglobin |
4% |
Leukocyte (WBC) Count |
10% |
Platelet Count |
25% |
Reticulocyte Count |
30% or 2SD |
WBC Differential |
3SD |
IMMUNOHEMATOLOGY |
|
ABO Group |
95% Participant or 100% Referee Consensus |
Antibody Identification |
95% Participant or 95% Referee Consensus |
Compatibility Testing |
95% Participant or 100% Referee Consensus |
Rh Factor (D Type) |
95% Participant or 100% Referee Consensus |
Unexpected Antibody Detection |
95% Participant or 100% Referee Consensus |
IMMUNOLOGY |
|
Alpha-fetoprotein (AFP) |
(See Chemistry) |
Antinuclear Antibody (ANA) titer |
± 2 dilutions |
Beta-2-microglobulin |
(See Chemistry) |
Complement C3 |
15% |
Complement C4 |
20% or 5 mg/dL |
C-Reactive Protein (CRP) |
30% or 1 mg/dL |
C-Reactive Protein, high sensitivity (hsCRP) |
30% or 1 mg/L |
Ferritin |
(See Chemistry) |
IgA |
20% |
IgE |
20% |
IgG |
20% |
IgM |
20% |
Rheumatoid Factor (RF) |
30% or 15 U/L |
Rheumatoid Factor (RF) titer |
± 2 dilutions |
Syphilis titer |
± 1 dilutions |
ANDROLOGY |
|
*Sperm Count |
30% or 7 million/mL |
Sperm Morphology, % |
5 percentage units or 3SD |
Sperm Motility |
25% or 12 percentage units |
Sperm Motility, Forward Progression % |
25% or 12 percentage units |
*Sperm Viability |
20% or 10 percentage units |