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 3SD (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 |
CAP Accepted |
Program Analyte |
SD |
Grading Limits Concentration |
% |
NR |
NR = CAP acceptance not required |
||||
|
Adulterated Urine |
|
|
|
|
|
Creatinine, Urine |
|
3 mg/dL |
15 |
|
|
Nitrite, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
pH, Urine |
|
0.5 (+/- 1pad) |
|
|
|
Specific Gravity, Urine |
|
0.01 |
|
|
Interpretation |
correct/incorrect |
||||
|
Afinion Glycohemoglobin |
|
|
|
|
|
|
Hemoglobin A1c, Afinion (HbA1c) |
|
8 |
|
|
Ammonia |
|
|
|
|
|
Ammonia, Serum |
|
10 umol/L |
5 |
|
|
Blood Gases |
|
|
|
|
|
Calcium, Ionized |
|
0.25 mmol/L |
|
|
Chloride |
|
|
5 |
||
Glucose |
|
6 mg/dL |
10 |
||
|
Lactate (Lactic Acid), Whole Blood |
|
0.3 mmol/L |
25 |
|
CMS |
pCO2 |
|
5.0 mm Hg |
8 |
|
CMS |
pH, Blood Gas |
|
0.04 |
|
|
CMS |
pO2 |
3SD |
|
|
|
Potassium |
|
0.5 mmol/L |
|
||
Sodium |
|
4 mmol/L |
|
||
|
Blood Lead – Waived |
|
|
|
|
|
Lead, Blood |
|
2 ug/dL |
10 |
|
|
BNP/D-Dimer |
|
|
|
|
|
BNP |
30 |
|||
|
NT-proBNP |
30 |
|||
D-Dimer, Quant, ng/mL |
2SD |
30 ng/mL |
|
||
|
|
D-Dimer, Quant, ugFEU/mL |
2SD |
0.3 ugFEU/mL |
|
|
Cardiac Markers |
|
|
||
|
|
BNP |
30 |
||
CMS |
CK-2/CKMB |
3SD |
|
|
|
|
|
Myoglobin, Quantitative |
15 ng/mL |
30 |
|
|
|
NT-proBNP |
30 |
||
|
|
Troponin I |
0.9 ng/mL |
30 |
|
|
|
Troponin T |
0.2 ng/mL |
30 |
|
|
Chemistry Module |
|
|
||
CMS |
Albumin |
|
10 |
||
CMS |
Alkaline Phosphatase |
|
30 |
||
CMS |
Alpha-fetoprotein (AFP) |
3SD |
|||
CMS |
ALT/SGPT |
|
|
20 |
|
CMS |
Amylase |
|
|
30 |
|
CMS |
AST/SGOT |
|
|
20 |
|
|
Bicarbonate (CO2) |
|
20 |
||
Bilirubin, Direct |
0.4 mg/dL |
20 |
|||
CMS |
Bilirubin, Total |
|
0.4 mg/dL |
20 |
|
CMS |
Calcium |
|
1.0 mg/dL |
|
|
CMS |
Chloride |
|
|
5 |
|
CMS |
Cholesterol, Total |
|
|
10 |
|
CMS |
Cholesterol, HDL |
30 |
|||
Cholesterol, LDL - Calc |
|
20 |
|||
Cholesterol, LDL - Direct |
|
20 |
|||
CMS |
Cortisol |
|
|
25 |
|
CMS |
Creatine Kinase, Total (CK or CPK) |
|
|
30 |
|
CMS |
Creatinine |
|
0.3 mg/dL |
15 |
|
Gamma-Glutamyl Transferase (GGT) |
5 IU/L |
15 |
|||
CMS |
Glucose |
|
6 mg/dL |
10 |
|
CMS |
Iron |
|
|
20 |
|
CMS |
Lactate Dehydrogenase, Total (LD/LDH) |
20 |
|||
Lactic Acid, Serum |
|
0.3 mmol/L |
25 |
||
Lipase |
|
|
30 |
||
CMS |
Magnesium, mg/dL |
|
|
25 |
|
|
Phosphorus |
|
0.3 mg/dL |
10 |
|
CMS |
Potassium |
|
0.5 mmol/L |
|
|
CMS |
Protein, Total |
|
|
10 |
|
CMS |
Sodium |
|
4 mmol/L |
|
|
CMS |
T3 Uptake |
3SD |
|||
T3 (Triiodothyronine), Free |
0.3 ng/mL |
25 |
|||
CMS |
T3 (Triiodothyronine), Total |
3SD |
|||
CMS |
T4 (Thyroxin), Free |
3SD |
|||
CMS |
T4 (Thyroxin), Total |
1.0 ug/dL |
20 |
||
Iron Binding Capacity, Total (TIBC) - Calc |
|
|
20 |
||
Iron Binding Capacity, Total (TIBC) - Direct |
|
|
20 |
||
CMS |
Triglycerides |
|
|
25 |
|
CMS |
CAP |
Thyroid Stimulating Hormone (TSH) |
3SD |
|
|
UIBC (Unsaturated Iron Binding Capacity) |
20 |
||||
CMS |
Urea Nitrogen, Blood |
|
2 mg/dL |
9 |
|
CMS |
Uric Acid |
|
|
17 |
|
|
Comprehensive Metabolic panel |
|
|
|
|
CMS |
Albumin |
|
|
10 |
|
CMS |
Alkaline Phosphatase |
|
|
30 |
|
CMS |
ALT/SGPT |
|
|
20 |
|
CMS |
AST/SGOT |
|
|
20 |
|
|
Bicarbonate (CO2) |
|
20 |
||
Bilirubin, Direct |
0.4 mg/dL |
20 |
|||
CMS |
Bilirubin, Total |
|
0.4 mg/dL |
20 |
|
CMS |
Calcium |
|
1.0 mg/dL |
|
|
CMS |
Chloride |
|
|
5 |
|
CMS |
Creatinine |
|
0.3 mg/dL |
15 |
|
CMS |
Glucose |
|
6 mg/dL |
10 |
|
CMS |
Iron |
|
|
20 |
|
|
Lactic Acid, Serum |
|
0.3 mmol/L |
25 |
|
|
Phosphorus |
|
0.3 mg/dL |
10 |
|
CMS |
Potassium |
|
0.5 mmol/L |
|
|
CMS |
Protein, Total |
|
|
10 |
|
CMS |
Sodium |
|
4 mmol/L |
|
|
Iron Binding Capacity, Total (TIBC) - Calc |
|
|
20 |
||
Iron Binding Capacity, Total (TIBC) - Direct |
|
|
20 |
||
UIBC (Unsaturated Iron Binding Capacity) |
20 |
||||
CMS |
Urea Nitrogen, Blood |
|
2 mg/dL |
9 |
|
CMS |
Uric Acid |
|
|
17 |
|
Endocrinology 1 |
|||||
|
CAP |
DHEA-S |
|
6.0 ug/dL |
15 |
|
CAP |
Estradiol |
|
30 |
|
|
Ferritin |
|
20 |
||
|
Folate |
|
1.0 ng/mL |
30 |
|
|
CAP |
Follicle Stimulating Hormone (FSH) |
|
2 mIU/mL |
18 |
|
Homocysteine |
|
2.5 umol/L |
20 |
|
|
CAP |
Luteinizing Hormone (LH) |
|
20 |
|
|
Pre-albumin |
|
|
25 |
|
|
CAP |
Progesterone |
|
25 |
|
|
CAP |
Prolactin |
|
20 |
|
|
CAP |
Testosterone,Total |
|
20 ng/mL |
30 |
|
Transferrin |
|
10 mg/dL |
7 |
|
|
Vitamin B12 |
|
30 pg/mL |
25 |
|
Endocrinology 2 |
|||||
|
|
C-Peptide |
|
1.0 ng/mL |
25 |
|
Insulin |
|
1.5 uIU/mL |
25 |
|
|
PTH (Parathyroid Hormone) |
|
30 |
||
|
Vitamin D |
2SD |
2 ng/mL |
||
Ethyl Glucuronide – Add-On |
|||||
Ethyl glucuronide |
|||||
|
Fertility Testing |
|
|
|
|
|
CAP |
DHEA-S |
|
6.0 ug/dL |
15 |
|
CAP |
Estradiol |
|
30 |
|
|
CAP |
Follicle Stimulating Hormone (FSH) |
|
2 mIU/mL |
18 |
|
CAP |
Luteinizing Hormone (LH) |
|
20 |
|
|
CAP |
Progesterone |
|
25 |
|
|
|||||
Fluids Chemistry |
|||||
Albumin, Fluids |
10 |
||||
|
Amylase, Fluids |
|
30 |
||
|
Chloride, Fluids |
|
5 |
||
Cholesterol, Fluids |
10 |
||||
|
Creatinine, Fluids |
|
3 mg/dL |
15 |
|
|
Glucose, Fluids |
|
6 mg/dL |
10 |
|
Lactic Acid, Fluids |
0.3 mmol/L |
25 |
|||
Lactate Dehydrogenase (LD or LDH), Fluids |
20 |
||||
pH, Fluids |
0.5 |
||||
|
Protein, Total, Fluids |
|
1 mg/L |
25 |
|
|
Sodium, Fluids |
|
4 mmol/L |
4 |
|
|
Uric Acid, Fluids |
|
0.3 mg/dL |
17 |
|
|
Glycohemoglobin |
|
|
|
|
|
|
Glycohemoglobin, 2 vial |
|
8 |
|
|
Glycohemoglobin, 5 vial |
|
8 |
||
|
High Sensitivity C-Reactive Protein (hs-CRP) |
|
|
|
|
|
C-Reactive Protein, high sensitivity (hsCRP) |
1 mg/dL |
30 |
||
|
Iron Binding Capacity |
|
|
|
|
|
Iron, Binding Capacity, Total (TIBC) |
|
20 |
||
|
Iron, Binding Capacity, Unsaturated (UIBC) |
|
20 |
||
|
Transferrin |
|
10 mg/dL |
7 |
|
|
i-STAT Chemistry |
|
|
|
|
|
|
Bicarbonate (CO2) |
|
20 |
|
|
|
Calcium, Ionized |
|
|
|
CMS |
|
Chloride |
|
|
5 |
CMS |
|
Creatinine |
|
0.3 mg/dL |
15 |
CMS |
|
Glucose |
|
10 |
|
CMS |
|
Hematocrit |
|
6 |
|
CMS |
|
Hemoglobin |
|
7 |
|
CMS |
|
Potassium |
|
|
|
CMS |
|
Sodium |
|
|
|
CMS |
|
Urea Nitrogen, Blood |
|
9 |
|
|
i-STAT Chemistry - Waived |
|
|
|
|
|
Bicarbonate (CO2) |
|
4 mEq/L |
20 |
|
|
Calcium, Ionized |
|
0.25 mmol/L |
|
|
Chloride |
|
|
5 |
||
Creatinine |
|
0.3 mg/dL |
15 |
||
Glucose |
|
6 mg/dL |
10 |
||
Hematocrit |
|
|
6 |
||
Hemoglobin |
|
|
7 |
||
Potassium |
|
0.5 mmol/L |
|
||
Sodium |
|
4 mmol/L |
|
||
Urea Nitrogen, Blood |
|
2 mg/dL |
9 |
||
Lipid Panel/Glucose – Waived |
|||||
Cholesterol, HDL |
30 |
||||
Cholesterol, LDL (Calc) |
|
20 |
|||
Cholesterol, HDL |
|
30 |
|||
Glucose |
|
6 mg/dL |
10 |
||
Triglycerides |
|
25 |
|||
|
Lipid Profile |
|
|
|
|
|
Apolipoproteins, A1 |
|
25 mg/dL |
30 |
|
|
Apolipoproteins, B |
|
20 mg/dL |
25 |
|
CMS |
Cholesterol, HDL |
|
30 |
||
Cholesterol, LDL (Direct) |
|
20 |
|||
Cholesterol, LDL (Calc) |
|
20 |
|||
CMS |
Cholesterol, Total |
|
10 |
||
|
Lipoprotein (a) |
|
10 mg/dL |
30 |
|
|
Neonatal/Direct Bilirubin |
|
|
|
|
Bilirubin, Direct |
|
0.4 mg/dL |
20 |
||
CMS |
Bilirubin, Neonatal |
|
0.4 mg/dL |
20 |
|
CMS |
|
Bilirubin, Total |
|
0.4 mg/dL |
20 |
PSA |
|||||
|
Prostate-specific Antigen (PSA), Total |
|
0.2 ng/mL |
20 |
|
|
Serum Alcohol/Ketones |
|
|
|
|
|
Acetone |
|
pos/neg, +/- 1 pad |
||
CMS |
Alcohol (Ethanol) |
|
25 |
||
|
|
Beta Hydroxybutyrate (qualitative) |
|
0.1 mmol/L |
20 |
Serum HCG |
|||||
CMS |
CAP |
Serum hCG - qualitative |
|
pos/neg |
|
CMS |
CAP |
Serum hCG – quantitative |
3SD |
||
|
SHBG & Testosterone |
|
|
|
|
|
|
Sex Hormone Binding Globulin (SHBG) |
10 nmol/L |
30 |
|
|
|
Testosterone, Bioavailable |
0.2 ng/mL |
30 |
|
|
|
Testosterone, Free |
0.2 ng/mL |
30 |
|
Testosterone, Total |
20 ng/mL |
30 |
|||
|
Therapeutic Drug Monitoring |
|
|
|
|
|
Acetaminophen |
|
3 ug/mL |
15 |
|
CMS |
Carbamazepine |
|
25 |
||
CMS |
Digoxin |
|
0.2 ng/mL |
15 |
|
CMS |
Gentamicin |
|
25 |
||
CMS |
Lithium |
|
0.3 mmol/L |
20 |
|
CMS |
Phenobarbital |
|
20 |
||
CMS |
Phenytoin |
|
25 |
||
Salicylates-ug/dL |
|
2.0 ug/dL |
15 |
||
CMS |
Theophylline |
|
25 |
||
CMS |
Tobramycin |
|
25 |
||
CMS |
Valproic Acid |
|
25 |
||
|
Vancomycin |
|
2.0 ug/mL |
15 |
|
Thyroid Antibodies |
|||||
Thyroglobulin Antibody |
2SD |
||||
Thyroid Peroxidase Antibody (TPO) |
2SD |
||||
Thyroid Profile |
|||||
CMS |
Alpha-fetoprotein (AFP) |
3SD |
|||
CMS |
Cortisol |
25 |
|||
CMS |
T3 Uptake |
3SD |
|||
T3 (Triiodothyronine), Free |
0.3 ng/mL |
25 |
|||
CMS |
T3 (Triiodothyronine), Total |
3SD |
|||
CMS |
T4 (Thyroxin), Free |
3SD |
|||
CMS |
T4 (Thyroxin), Total |
1.0 ug/dL |
20 |
||
CMS |
Thyroid Stimulating Hormone (TSH) |
3SD |
|||
Total Protein |
|||||
CMS |
Protein, Total |
|
|
10 |
|
|
Tumor Markers |
|
|
|
|
|
|
Beta-2-microglobulin |
0.06 mg/L |
30 |
|
|
CA 125 |
20 |
|||
|
CA 15-3 |
2SD |
2 IU/mL |
||
|
CA 19-9 |
2SD |
1.5 IU/mL |
||
|
CA 27.29 |
2SD |
3 IU/mL |
||
|
Carcinoembryonic Antigen (CEA) |
1.0 ng/mL |
15 |
||
Prostate-specific Antigen (PSA), Total |
0.2 ng/ml |
20 |
|||
|
|
Prostate-specific Antigen (PSA), Free |
0.9 ng/mL |
30 |
|
|
|
Prostatic Acid Phosphatase (PAP) |
0.2 ng/mL |
20 |
|
|
|
Thyroglobulin |
2SD |
1 ng/mL |
|
|
Urine Chemistry |
|
|
|
|
|
Amylase, Urine |
|
|
30 |
|
|
Calcium, Urine |
|
1.0 mg/dL |
|
|
|
Chloride, Urine |
|
|
5 |
|
|
Glucose, Urine |
|
6 mg/dL |
10 |
|
|
Magnesium, Urine |
|
|
25 |
|
|
Osmolality, Urine |
|
9 mOsm/kg |
10 |
|
|
Phosphorus, Urine |
|
3mg/dL |
15 |
|
|
Potassium, Urine |
|
3mmol/L |
15 |
|
|
Protein, Total, Urine |
|
1 mg/L |
25 |
|
|
Sodium, Urine |
|
4 mmol/L |
4 |
|
|
Urea Nitrogen, Urine |
|
|
9 |
|
|
Uric Acid, Urine |
|
0.3 mg/dL |
17 |
|
|
Urine Drug Screen |
|
|
|
|
|
Acetaminophen |
|
pos/neg |
|
|
|
|
Alcohol (Ethanol) |
|
pos/neg |
|
Amphetamines |
|
pos/neg |
|||
|
Amphetamines/Methamphetamines |
|
pos/neg |
|
|
|
Barbiturates |
|
pos/neg |
|
|
|
Benzodiazepines |
|
pos/neg |
|
|
|
Buprenorphine |
|
pos/neg |
|
|
|
Cannabinoids / Marijuana |
|
pos/neg |
|
|
Carisoprodol |
pos/neg |
||||
|
Cocaine Metabolites |
|
pos/neg |
|
|
|
Cotinine |
|
pos/neg |
|
|
|
Ecstasy (MDMA) |
|
pos/neg |
|
|
Fentanyl |
pos/neg |
||||
Hydrocodone |
pos/neg |
||||
|
LSD (Lysergic Acid Diethylamide) |
|
pos/neg |
|
|
6-MAM |
pos/neg |
||||
|
EDDP |
|
pos/neg |
|
|
|
Methadone |
|
pos/neg |
|
|
|
Meperidine |
|
pos/neg |
|
|
|
Methamphetamines |
|
pos/neg |
|
|
|
Methaqualone |
|
pos/neg |
|
|
|
Opiates |
|
pos/neg |
|
|
|
Oxycodone |
|
pos/neg |
|
|
|
Phencyclidine (PCP) |
|
pos/neg |
|
|
|
Propoxyphene |
|
pos/neg |
|
|
Tramadol |
pos/neg |
||||
|
Tricyclic Antidepressants (TCA) |
|
pos/neg |
|
|
Zolpidem |
pos/neg |
||||
|
Waived Chemistry Panel |
|
|
|
|
|
|
Albumin |
|
|
10 |
|
|
Alkaline Phosphatase |
|
|
30 |
|
|
ALT/SGPT |
|
|
20 |
|
|
AST/SGOT |
|
|
20 |
|
|
Bicarbonate (CO2) |
|
4 mEq/L |
20 |
|
|
Bilirubin, Total |
|
0.4 mg/dL |
20 |
|
|
Calcium |
|
1.0 mg/dL |
|
|
|
Chloride |
|
|
5 |
|
Cholesterol, HDL |
|
|
30 |
|
|
Cholesterol, Total |
|
10 |
||
|
|
Creatine Kinase, Total (CK or CPK) |
|
|
30 |
|
|
Creatinine |
|
0.3 mg/dL |
15 |
|
|
Gamma-Glutamyl Transferase (GGT) |
|
5 IU/L |
15 |
|
Glucose |
|
6 mg/dL |
10 |
|
Phosphorus |
0.3 mg/dL |
10 |
|||
|
|
Potassium |
|
0.5 mmol/L |
|
|
|
Protein, Total |
|
|
10 |
|
|
Sodium |
|
4 mmol/L |
|
|
|
Triglycerides |
|
|
25 |
|
|
Urea Nitrogen, Blood |
|
2 mg/dL |
9 |
|
|
Uric Acid |
|
|
17 |
Whole Blood Glucose |
|||||
Glucose, Whole Blood |
6 mg/dL |
10 |
|||
PPM & URINALYSIS |
|||||
|
Fecal Occult Blood |
|
|
|
|
|
Occult Blood, Fecal (FOB) |
|
pos/neg |
|
|
Gastric Occult Blood |
|
|
|||
|
Occult Blood, Gastric |
|
pos/neg |
|
|
|
KOH Slides |
|
|
|
|
|
|
KOH Preparation |
|
pos/neg |
|
|
Provider Performed Microscopy (PPM) |
|
|
|
|
Fecal Leukocytes |
pos/neg |
||||
|
Fern Testing |
|
pos/neg |
|
|
|
Nasal Eosinophils |
|
pos/neg |
|
|
|
Pinworm Preparation |
|
pos/neg |
|
|
|
Scabies |
pos/neg |
|
||
|
Sperm, Qualitative (Digital Image) |
|
pos/neg |
|
|
Vaginal KOH Preparations |
pos/neg |
||||
|
Vaginal Wet Mount Preparations |
|
correct/incorrect |
|
|
|
Urinalysis Dipstick |
|
|
|
|
|
Bilirubin, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Creatinine, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Glucose, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Hemoglobin/Blood, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Ketones |
|
pos/neg, +/- 1 pad |
|
|
Leukocyte Esterase |
|
pos/neg, +/- 1 pad |
|||
|
Nitrite |
|
pos/neg, +/- 1 pad |
|
|
|
pH, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Protein, Total, Urine |
|
pos/neg, +/- 1 pad |
|
|
Specific Gravity, Urine |
|
+/- 0.01 |
|||
|
Urobilinogen |
|
pos/neg, +/- 1 pad |
|
|
|
Urinalysis Module |
|
|
|
|
|
Bilirubin, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Creatinine, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Glucose, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Hemoglobin/Blood, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Ketones |
|
pos/neg, +/- 1 pad |
|
|
Leukocyte Esterase |
|
pos/neg, +/- 1 pad |
|||
|
Nitrite |
|
pos/neg, +/- 1 pad |
|
|
|
pH, Urine |
|
pos/neg, +/- 1 pad |
|
|
|
Protein, Total, Urine |
|
pos/neg, +/- 1 pad |
|
|
Specific Gravity, Urine |
|
0.01 |
|||
|
Urine Sediment (Microscopic ID) |
|
correct/incorrect |
|
|
|
Urobilinogen |
|
pos/neg, +/- 1 pad |
|
|
Urine hCG |
|||||
CAP |
Pregnancy, Urine |
pos/neg |
|||
|
Urine Microalbumin/Creatinine |
|
|
|
|
|
Creatinine, Urine |
|
3 mg/dL |
15 |
|
|
Creatinine, Urine, Semiquantitative |
|
pos/neg |
|
|
|
Microalbumin, Quantitative |
|
10 mg/L |
25 |
|
|
Microalbumin, Semiquantitative & qualitative |
|
pos/neg |
|
|
Urine Pregnancy – 2 vial |
|||||
CAP |
Pregnancy, Urine |
pos/neg |
|||
Urine Sediment |
|||||
Urine Sediment (Microscopic ID) |
correct/incorrect |
||||
Waived Packages |
|||||
Basic Waived and PPM Package |
|||||
Fecal Occult Blood |
pos/neg |
||||
PPM |
pos/neg |
||||
Strep Antigen Detection |
pos/neg |
||||
Urinalysis |
correct/incorrect |
||||
Urine Sediment |
correct/incorrect |
||||
Urine hCG |
pos/neg |
||||
Whole Blood Glucose |
6 mg/dL |
10 |
|||
Waived and PPM Package |
|||||
Fecal Occult Blood |
pos/neg |
||||
PPM |
pos/neg |
||||
Strep Antigen Detection |
pos/neg |
||||
Urinalysis |
correct/incorrect |
||||
Urine Sediment |
correct/incorrect |
||||
Urine hCG |
pos/neg |
||||
Whole Blood Glucose |
6 mg/dL |
10 |
|||
Hematocrit |
6 |
||||
Hemoglobin |
7 |
||||
Coagulation |
|||||
|
Activated Clotting Time (ACT), 2 vial |
|
|
|
|
|
Activated Clotting Time |
|
|
20 |
|
|
CoaguChek XS Plus Prothrombin Time |
|
|
|
|
|
|
INR |
|
|
15 |
CMS |
Prothrombin Time |
|
|
15 |
|
|
CoaguChek XS Plus Prothrombin Time Waived |
|
|
|
|
|
|
INR |
|
|
15 |
Prothrombin Time |
|
|
15 |
||
|
Coagulation Module |
|
|
|
|
CMS |
Activated Partial Thrombin Time (APTT) |
|
|
15 |
|
CMS |
Fibrinogen |
|
|
20 |
|
|
INR |
|
|
15 |
|
CMS |
Prothrombin Time |
|
|
15 |
|
i-STAT Prothrombin Time |
|||||
INR |
|
|
15 |
||
CMS |
Prothrombin Time |
|
|
15 |
|
Roche CoaguChek XS INR – Waived |
|||||
INR |
|
|
20 |
||
Hematology |
|||||
|
Blood Cell Identification |
|
|
|
|
CMS |
Blood Cell Identification |
|
correct/incorrect |
|
|
|
Blood Cell Identification (Add-On) |
|
|
|
|
Blood Cell Identification |
|
correct/incorrect |
|
||
Hematology Module |
|||||
CMS |
Blood Cell Identification |
|
correct/incorrect |
||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Platelet Count |
|
|
25 |
|
Hematology with 3-part Diff |
|
|
|
||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
Hematology - Sysmex 3-part Diff |
|
|
|
||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
Hematology with 5-part Diff |
|||||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
|
Hematology with 5-part Diff – Abbott Cell-Dyn |
|
|
|
|
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
Hematology with 5-part Diff AcT 5 and Pentra |
|
|
|
||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
Hematology with 5 or 6-part Diff - Sysmex |
|
|
|
||
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
|
Hematology with 5-part Diff - DxH 500 Series |
|
|
|
|
CMS |
Erythrocyte (RBC) Count |
|
|
6 |
|
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
CMS |
Leukocyte (WBC) Differential, Auto |
3SD |
|
|
|
CMS |
Platelet Count |
|
|
25 |
|
|
Hemoglobin/Glucose – HemoCue |
|
|
|
|
|
|
Glucose |
|
6 mg/dL |
10 |
|
|
Hemoglobin |
|
7 |
|
Hemoglobin/Hematocrit/WBC |
|||||
CMS |
Hematocrit |
|
|
6 |
|
CMS |
Hemoglobin |
|
|
7 |
|
CMS |
Leukocyte (WBC) Count |
|
|
15 |
|
Hemoglobin & Hematocrit – Waived |
|
|
|
||
|
Hematocrit |
|
|
6 |
|
|
Hemoglobin |
|
|
7 |
|
Reticulocyte Count |
|
|
|
||
|
Reticulocytes |
2SD |
30 |
||
Rapid Sedimentation Rate (ESR |
|
||||
|
Erythrocyte Sedimentation Rate (ESR) |
3SD |
|
||
Sedimentation Rate (ESR) |
|
||||
|
Erythrocyte Sedimentation Rate (ESR) |
3SD |
|
||
|
Sickle Cell Screen |
|
|
|
|
|
Sickle Cell Screen |
|
pos/neg |
|
|
Immunohematology |
|||||
|
ABO & Rh Factor (D Type) |
|
|
|
|
CMS |
ABO Typing |
|
correct/incorrect grouping |
|
|
CMS |
D (Rh) Typing |
|
pos/neg |
|
|
Blood Bank 1 |
|||||
CMS |
ABO Typing |
|
correct/incorrect grouping |
||
CMS |
D (Rh) Typing |
|
pos/neg |
||
CMS |
Unexpected Antibody Detection |
|
detected/ undetected |
||
Blood Bank 2 |
|
|
|
||
CMS |
ABO Typing |
|
correct/incorrect grouping |
|
|
CMS |
Compatibility Testing (Crossmatch) |
|
compatible/incompatible |
|
|
CMS |
D (Rh) Typing |
|
pos/neg |
|
|
CMS |
Unexpected Antibody Detection |
|
detected/ undetected |
|
|
CMS |
Unexpected Antibody Identification |
|
correct/incorrect |
|
|
|
D (Rh) Typing Only |
|
|
||
CMS |
D (Rh) Typing |
|
pos/neg |
||
Direct Antiglobulin Test (DAT) |
|
|
|||
|
Direct Antiglobulin |
|
pos/neg |
||
Immunology/Serology |
|||||
ANA Panel |
|
|
|||
CMS |
Antinuclear Antibody (ANA) Screen |
|
pos/neg |
|
|
Anti-dsDNA |
pos/neg |
||||
Anti-ssDNA |
pos/neg |
||||
Anti-RNP |
pos/neg |
||||
Anti-Sm |
pos/neg |
||||
Anti-RNP/Sm |
pos/neg |
||||
Anti-SSA |
pos/neg |
||||
Anti-SSB |
pos/neg |
||||
Anti-SSA/SSB |
pos/neg |
||||
Florescence Pattern |
correct/incorrect |
||||
|
C-Reactive Protein (CRP) |
|
|
|
|
|
C-Reactive Protein (CRP), Qualitative |
|
pos/neg |
|
|
|
C-Reactive Protein (CRP), Quantitative |
3SD |
0.5 mg/dL |
30 |
|
Diagnostic Allergy |
|||||
Allergen Specific IgE |
|||||
Total Ige |
3SD |
||||
|
H. Pylori Antibody Detection |
|
|
|
|
|
Helicobacter Pylori Antibody |
|
pos/neg |
|
|
|
High Sensitivity C-Reactive Protein (hs-CRP) |
|
|
|
|
|
C-Reactive Protein, high sensitivity (hsCRP) |
1 mg/L |
30 |
||
HIV Markers |
|
|
|
||
CMS |
HIV, Anti-HIV 1 (confirmation) |
|
pos/neg |
|
|
CMS |
HIV, Anti-HIV 1 or 1/2 (screening) |
|
pos/neg |
|
|
|
HIV, p24 Antigen |
|
pos/neg |
|
|
HIV Markers – Waived |
|
|
|
||
|
HIV, Waived |
|
pos/neg |
|
|
|
HIV, p24 Antigen, Waived |
|
pos/neg |
|
|
|
Immunology Module |
|
|
|
|
CMS |
Antistreptolysin O (ASO) |
|
pos/neg |
||
CMS |
Infectious Mononucleosis |
|
pos/neg |
||
CMS |
Rheumatoid Factor (RF), Qualitative |
|
pos/neg |
||
CMS |
|
Rheumatoid Factor (RF), Quantitative, titer |
|
+/- 2 dilution |
|
|
|
Rheumatoid Factor (RF), Quantitative |
|
2 U/L |
30 |
Immunoproteins |
|
|
|
||
CMS |
Complement C3 |
3SD |
|
|
|
CMS |
Complement C4 |
3SD |
|
|
|
CMS |
IgA |
3SD |
|
|
|
CMS |
IgE |
3SD |
|
|
|
CMS |
IgG |
|
|
25 |
|
CMS |
IgM |
3SD |
|
|
|
Infectious Mononucleosis |
|
|
|
||
CMS |
Infectious Mononucleosis |
|
pos/neg |
|
|
Infectious Mononucleosis – Waived |
|
|
|
||
|
Infectious Mononucleosis |
|
pos/neg |
|
|
Infectious Mono/Rheumatoid Factor |
|||||
CMS |
Infectious Mononucleosis |
|
pos/neg |
|
|
CMS |
Rheumatoid Factor (RF), Qualitative |
|
pos/neg |
|
|
Mycoplasma Antibody |
|||||
Mycoplasma Antibody |
pos/neg |
||||
|
Oral Fluid HIV Antibodies |
|
|
|
|
CMS |
|
HIV, Oral Fluids (confirmation) |
|
pos/neg |
|
CMS |
HIV, Oral Fluids (screening) |
|
pos/neg |
|
|
Rheumatoid Factor |
|
|
|
||
CMS |
Rheumatoid Factor (RF), Qualitative |
|
pos/neg |
||
CMS |
Rheumatoid Factor (RF), Quantitative, titer |
|
+/- 2 dilution |
||
CMS |
Rheumatoid Factor (RF), Quantitative |
|
2 U/L |
30 |
|
Rheumatology Module |
|||||
CMS |
Rheumatoid Factor (RF), Qualitative |
|
pos/neg |
||
CMS |
Rheumatoid Factor (RF), Quantitative, titer |
|
+/- 2 dilution |
||
CMS |
Rheumatoid Factor (RF), Quantitative, u/mL |
|
2 U/L |
30 |
|
|
C-Reactive Protein (CRP), Qualitative |
|
pos/neg |
||
Rubella |
|
|
|
||
CMS |
Rubella, IgG |
|
pos/neg |
|
|
SARS-CoV-2 Serology |
|||||
SARS CoV-2 Antibody |
pos/neg |
||||
Specific Allergen Testing |
|||||
Allergen Specific IgE |
correct/incorrect |
||||
Syphilis Serology |
|
|
|
||
CMS |
Syphilis, Qualitative |
|
pos/neg |
|
|
CMS |
Syphilis, Quantitative |
|
+/- 1 dil |
|
|
|
ToRCH |
|
|
|
|
|
|
Cytomegalovirus |
|
pos/neg |
|
|
|
Herpes Simplex Virus, Type I, IgG |
|
pos/neg |
|
|
|
Herpes Simplex Virus, Type I, IgM |
|
pos/neg |
|
|
|
Herpes Simplex Virus, Type I/II, IgG |
|
pos/neg |
|
|
|
Herpes Simplex Virus, Type I/II, IgM |
|
pos/neg |
|
|
|
Rubella, IgM |
|
pos/neg |
|
|
|
Toxoplasma |
|
pos/neg |
|
Viral Markers |
|
|
|
||
Hepatitis, Anti-HAV, IgM |
|
pos/neg |
|
||
Hepatitis, Anti-HAV, Total |
pos/neg |
||||
CMS |
Hepatitis, Anti-HBc, IgM |
|
pos/neg |
|
|
CMS |
Hepatitis, Anti-HBc, Total |
|
pos/neg |
|
|
Hepatitis, Anti-HBs |
|
pos/neg |
|
||
Hepatitis, Anti-HCV |
|
pos/neg |
|
||
CMS |
Hepatitis, HBeAg |
|
pos/neg |
|
|
CMS |
Hepatitis, HBsAg |
|
pos/neg |
|
|
CMS |
HIV, Anti-HIV 1 or 1/2 (screening) |
|
pos/neg |
|
|
Microbiology |
|||||
|
Acid Fast Smears |
|
|
|
|
CMS |
Acid-Fast Bacteria/Smears |
|
pos/neg |
|
|
Bacteriology 1 |
|
|
|
||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
|
|
CMS |
Gram Stain Identification |
correct/incorrect |
|||
Gram Stain Organism Morphology |
correct/incorrect |
||||
CMS |
Organism Identification, Stool Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Blood Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, CSF Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Genital Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Throat Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Urine Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Wound Culture |
|
correct/incorrect |
|
|
Bacteriology 2 |
|
|
|||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
|
|
CMS |
Gram Stain Identification |
|
pos/neg |
|
|
|
Gram Stain Organism Morphology |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Genital Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Throat Culture |
|
correct/incorrect |
|
|
CMS |
Organism Identification, Urine Culture |
correct/incorrect |
|||
Strep Group A, Antigen Screen |
|
pos/neg |
|||
C. Dificile/Rotavirus Antigen Detection |
|||||
CMS |
C. dificile antigen detection |
pos/neg |
|||
CMS |
Rotavirus antigen detection |
pos/neg |
|||
|
Chlamydia/GC/Strep Group B Antigen Screen |
|
|
|
|
CMS |
Chlamydia Antigen Screen |
|
pos/neg |
|
|
CMS |
GC, Antigen Screen |
|
pos/neg |
|
|
CMS |
Strep Group B, Antigen Screen |
|
pos/neg |
|
|
|
Genital Culture |
|
|
|
|
CMS |
Organism Identification, Genital Culture |
|
correct/incorrect |
|
|
CMS |
Gram Stain Identification |
|
pos/neg |
||
|
Gram Stain Organism Morphology |
|
correct/incorrect |
||
Genital/Urine Culture |
|||||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
||
CMS |
Organism Identification, Genital Culture |
|
correct/incorrect |
||
CMS |
Organism Identification, Urine Culture |
correct/incorrect |
|||
CMS |
Gram Stain Identification |
|
pos/neg |
||
|
Gram Stain Organism Morphology |
|
correct/incorrect |
||
Gram Stain |
|
|
|
||
CMS |
Gram Stain Identification |
|
pos/neg |
|
|
|
Gram Stain Organism Morphology |
|
correct/incorrect |
|
|
Legionella Antigen Detection |
|||||
CMS |
Legionella Antigen Detection |
pos/neg |
|||
|
MRSA Culture |
|
|
|
|
CMS |
|
MRSA Culture |
|
Present/Absent |
|
OSOM Bacterial Vaginosis – Waived |
|
||||
|
Bacteroides |
|
pos/neg |
||
CMS |
Gardnerella |
|
pos/neg |
||
Mobiluncus |
pos/neg |
||||
|
Prevotells |
|
pos/neg |
||
|
Shiga Toxin |
|
|
|
|
|
|
Shiga Toxin |
|
pos/neg |
|
|
Strep A Antigen Detection |
|
|
|
|
CMS |
Strep Group A, Antigen |
|
pos/neg |
|
|
Strep A Antigen Detection – Waived |
|
|
|
||
|
Strep Group A, Antigen |
|
pos/neg |
|
|
Streptococcus pneumoniae Antigen Detection |
|||||
CMS |
Streptococcus pneumoniae Antigen Detection |
pos/neg |
|||
|
Supplemental Blood Culture |
|
|
|
|
|
|
Organism Identification, Blood Culture |
|
correct/incorrect |
|
Throat Culture |
|
|
|
||
CMS |
Organism Identification, Throat Culture |
|
correct/incorrect |
|
|
Trichomonas vaginalis, waived |
|||||
Trichomonas vaginalis |
pos/neg |
||||
|
Urine Colony Count |
|
|
|
|
|
Colony Count, Urine |
|
correct/incorrect |
|
|
Urine Presumptive ID |
correct/incorrect |
||||
Urine Culture |
|
|
|
||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
||
CMS |
Gram Stain Identification |
|
pos/neg |
||
|
Gram Stain Organism Morphology |
|
correct/incorrect |
||
CMS |
Organism Identification, Urine Culture |
|
correct/incorrect |
||
Urine/Throat Culture |
|
|
|
||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
|
|
Colony Count, Urine |
|
correct/incorrect |
|
||
CMS |
Gram Stain Identification |
|
pos/neg |
||
Gram Stain Organism Morphology |
|
correct/incorrect |
|
||
CMS |
Organism Identification, Urine Culture |
|
correct/incorrect |
|
|
Urine Presumptive ID/Throat Culture |
|
|
|
||
CMS |
Antimicrobial Susceptibility |
|
correct/incorrect |
|
|
CMS |
Gram Stain Identification |
|
pos/neg |
||
Gram Stain Organism Morphology |
|
correct/incorrect |
|
||
CMS |
Urine Presumptive ID |
|
correct/incorrect |
|
|
Rapid Urease (CLO) |
|
|
|
||
Urease |
pos/neg |
||||
Vaginosis Screen |
|
|
|||
|
Candida |
|
pos/neg |
|
|
CMS |
Gardnerella |
|
pos/neg |
|
|
|
Trichomonas |
|
pos/neg |
|
|
CMS |
BV Detection |
pos/neg |
|||
Mycology |
|||||
Dermatophyte Culture |
|||||
CMS |
Dermatophyte culture |
correct/incorrect |
|||
|
KOH Preparation |
|
|
|
|
|
|
KOH Preparation |
|
pos/neg |
|
Parasitology |
|||||
Cryptosporidium/Giardia Antigen Detection |
|||||
CMS |
Cryptosporidium Immunoassay |
|
pos/neg |
|
|
CMS |
Giardia Immunoassay |
pos/neg |
|||
Parasitology |
|
|
|
||
CMS |
Parasitology |
|
correct/incorrect |
|
|
PVA Slides (Add On) |
|||||
Parasitology |
correct/incorrect |
||||
Trichomonas vaginalis, waived |
|||||
Trichomonas vaginalis |
pos/neg |
||||
Virology |
|||||
Respiratory Antigen Detection |
|
|
|
||
CMS |
Influenza, Type A, Antigen Screen |
|
pos/neg |
|
|
CMS |
Influenza, Type B, Antigen Screen |
|
pos/neg |
|
|
CMS |
|
Respiratory Syncytial Virus (RSV) Antigen |
|
pos/neg |
|
Respiratory Antigen Detection - Waived |
|
|
|
||
|
Influenza, Type A, Antigen Screen, Waived |
|
pos/neg |
|
|
|
Influenza, Type B, Antigen Screen, Waived |
|
pos/neg |
|
|
|
|
Respiratory Syncytial Virus (RSV) Antigen, Wv |
|
pos/neg |
|
SARS CoV-2 Antigen Detection |
|||||
SARS CoV-2 Antigen |
pos/neg |
||||
SARS CoV-2 Molecular Detection |
|||||
SARS CoV-2 Molecular Detection |
pos/neg |
||||
Embryology/Andrology |
|||||
Antisperm Antibody |
|
|
|||
|
NR |
Antisperm Antibody |
|
pos/neg |
|
|
Embryo Grading |
|
|
|
|
|
NR |
Embryo Grading |
|
correct/incorrect |
|
|
Fetal Fibronectin (fFN) |
|
|
|
|
|
NR |
Fetal Fibronectin (fFN) |
|
pos/neg |
|
|
Fetal Membrane Rupture Test |
|
|
|
|
|
NR |
Fetal Membrane Rupture (PAMG-1) |
|
pos/neg |
|
|
IVF Embryo Culture Media |
|
|
|
|
|
NR |
IVF, Human Sperm Cell Survivial, Media Acceptability |
|
acceptable (yes/no) |
|
|
NR |
IVF, Mouse Embryo, Media Acceptability |
|
acceptable (yes/no) |
|
Preimplantation Genetic Testing- Aneuploidy |
|||||
Sex Status |
correct/incorrect |
||||
Euploid or Aneuploid Status |
correct/incorrect |
||||
Chromosome addition or deletion |
correct/incorrect |
||||
|
Sperm Count |
|
|
|
|
|
Sperm Count, Qualitative |
|
pos/neg |
|
|
|
CAP |
Sperm Count, Quantitative |
|
7 million/mL |
30 |
Sperm Count, Qualitative/Post-vasectomy |
|||||
CAP |
Sperm Count, Qualitative |
|
pos/neg |
||
|
Sperm Morphology |
|
|
|
|
|
NR |
Sperm Morphology, % |
3SD |
5 percentage units |
|
|
NR |
Sperm Morphology, Cell ID |
|
correct/incorrect |
|
|
Sperm Motility |
|
|
|
|
|
NR |
Sperm Motility |
|
12 percentage units |
25 |
|
NR |
Sperm Motility, Forward Progression % |
|
12 percentage units |
25 |
|
NR |
Sperm Motility, Forward Prog, semi-quant. |
|
correct/incorrect |
|
|
Sperm Viability |
|
|
|
|
|
CAP |
Sperm Viability |
|
10 percentage units |
20 |
Specialty |
|||||
|
WB Glucose, Basic-EQAS (Multi-site) |
|
|
|
|
|
Glucose, Whole Blood |
|
6 mg/dL |
10 |
|