SCOPE OF ACCREDITATION TO ISO/IEC 17043:2010. AMERICAN PROFICIENCY INSTITUTE 1159 Business Park Drive Traverse City, MI Sue Styles
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1 SCOPE OF ACCREDITATION TO ISO/IEC 17043:2010 AMERICAN PROFICIENCY INSTITUTE 1159 Business Park Drive Traverse City, MI Sue Styles PROFICIENCY TESTING PROVIDER Valid To: December 31, 2022 Certificate Number: In recognition of the successful completion of the A2LA evaluation process, this Proficiency Testing Provider has been found to meet the ISO/IEC 17043:2010, Conformity assessment - General Requirements for Proficiency Testing. Accreditation is granted to this organization to provide proficiency testing samples in the following analyte/matrix combinations: Scheme / Program Chemistry Chemistry Albumin Alkaline Phosphatase Alpha-fetoprotein ALT / SGPT Amylase AST / SGOT Bilirubin, Direct Bilirubin, Total Calcium, Ionized Calcium, Total Chloride Cholesterol, Total CO2 Cortisol Creatine Kinase / CK Creatinine GGT Glucose HDL Cholesterol Iron, Total Lactic Acid LD / LDH LDL Cholesterol (measured) LDL Cholesterol (calculated) / (A2LA Cert. No ) 11/07/2018 Page 1 of 18
2 Chemistry (cont) Chemistry - Endocrinology Lipase Magnesium Osmolality Phosphorus Potassium Sodium Thyroxine / T4 Free T4 Triiodothyronine / T3 Free T3 TIBC (measured) TIBC (iron-based calculation) Total Protein Triglycerides TSH T Uptake UIBC (measured) Urea Nitrogen / BUN Uric Acid Alpha-fetoprotein Cortisol T-Uptake Thyroxine / T4 Free T4 Triiodothyronine / T3 Free T3 TSH Alcohol Acetone / Alcohol Ammonia Ammonia Amniotic Fluid ph ph (nitrazine) ph interpretation B-Ketone Beta-Hydroxybutyrate Blood Gas pco2 ph po2 Blood Gas Plus Calcium, Ionized Chloride Creatinine Glucose Lactate Magnesium, Ionized pco2 ph po2 Potassium Sodium Semi- (A2LA Cert. No ) 11/07/2018 Page 2 of 18
3 / Blood Gas Plus (cont) tco2 (calculated) Urea Nitrogen / BUN (calculated) Blood Lead Lead Blood Oximetry Cardiac Markers Carboxyhemoglobin (calculated), Total Methemoglobin Oxyhemoglobin CK, Total CK-MB BNP D-dimer Myoglobin NT pro-bnp Troponin I Troponin T,,,, Fetal Fibronectin Fetal Fibronectin Fetal ROM Fetal Membrane Rupture Glycohemoglobin HbA1c Glycohemoglobin - whole blood HemoCue Immunoassay HbA1c Glucose CEA DHEA-S Estradiol Estriol (unconjugated) Ferritin Folate FSH Homocysteine LH PAP Prealbumin Progesterone Prolactin PSA, Total Testosterone TIBC (transferrin-based calculation) Transferrin Vitamin B-12 (A2LA Cert. No ) 11/07/2018 Page 3 of 18
4 Immunoassay - Special i-stat Blood Gas & Chemistry i-stat Chemistry Lipid Plus Neonatal Bilirubin 25-OH Vitamin D C-peptide Gastrin Insulin Parathyroid Hormone Calcium, Ionized Chloride CO2 (tco2) Creatinine Glucose Lactate pco2 ph po2 Potassium Sodium Urea Nitrogen / BUN Calcium, Ionized Chloride CO2 (tco2) Creatinine Glucose Lactate Potassium Sodium Urea Nitrogen / BUN Cholesterol, Total Glucose HDL Cholesterol LDL Cholesterol (calculated) Triglycerides Bilirubin, Total / Bilirubin, Direct Procalcitonin Procalcitonin Serum HCG HCG, serum, SHBG & Testosterone Therapeutic Drugs Sex Hormone Binding Globulin Testosterone, Bioavailable Testosterone, Free (calculated) Testosterone, Total Acetaminophen Amikacin Carbamazepine Digoxin (A2LA Cert. No ) 11/07/2018 Page 4 of 18
5 Therapeutic Drugs (cont) Thyroid Antibodies Thyroid - Special Tumor Markers Ethosuximide Gentamicin Lidocaine Lithium Phenobarbital Phenytoin Primidone Procainamide N-acetylprocainamide Quinidine Salicylates Theophylline Tobramycin Valproic Acid Vancomycin Thyroglobulin Antibody (Anti-TG) Thyroid Microsomal Antibody (Anti-TPO) Thyroxine / T4 Free T4 Triiodothyronine / T3 Free T3 TSH T Uptake Beta-2 Microglobulin CA 125 CA 15-3 CA 19-9 CA CEA PSA, Total Free PSA Complexed PSA Thyroglobulin / Whole Blood Glucose Glucose, whole blood Urine Chemistry & Body Fluid Analysis CSF & Body Fluid Chemistry CSF Albumin CSF Chloride CSF Glucose CSF IgG CSF Lactic Acid CSF LD / LDH CSF Sodium CSF Total Protein Body Fluid Albumin Body Fluid Alkaline Phosphatase Body Fluid Amylase (A2LA Cert. No ) 11/07/2018 Page 5 of 18
6 CSF & Body Fluid Chemistry (cont) Body Fluid Bilirubin, Total Body Fluid Calcium Body Fluid Chloride Body Fluid Cholesterol Body Fluid Creatinine Body Fluid Glucose Body Fluid LD / LDH Body Fluid Lipase Body Fluid ph (color comp or ) Body Fluid Potassium Body Fluid Sodium Body Fluid Total Protein Body Fluid Triglycerides Body Fluid Urea Nitrogen Body Fluid Uric Acid / Ethyl Glucuronide Ethyl glucuronide (EtG) Microalbumin Microalbumin Urine Creatinine Urine Adulterants Urine Chemistry Creatinine Nitrite Oxidants ph Specific Gravity Urine Amylase Urine Calcium Urine Chloride Urine Creatinine Urine Glucose Urine Magnesium Urine Microalbumin Urine Osmolality Urine Phosphorus Urine Potassium Urine Sodium Urine Total Protein Urine Urea Urine Uric Acid semi-, semi-,, semi-,, semi-,,, semi-,, semi-, (A2LA Cert. No ) 11/07/2018 Page 6 of 18
7 Urine Drug Screen Hematology QBC Hematology Hematology Acetylmorphine Acetaminophen Alcohol Amphetamines Barbiturates Benzodiazepines Buprenorphine Cannabinoids Carisoprodol Cocaine Metabolites Cotinine EDDP Fentanyl Hydrocodone LSD MDMA Meperidine Methadone Methamphetamines Methaone Opiates Oxycodone Phencyclidine Propoxyphene Tramadol Tricyclic Antidepressants Zolpidem Granulocytes Lymph / Mono RDW / (A2LA Cert. No ) 11/07/2018 Page 7 of 18
8 Hematology - 3S Hematology - 5A Hematology - 5B Hematology - 5C RDW-CV RDW-SD RDW RDW Immature Reticulocyte Fraction (IRF) n RDW-CV RDW-SD Reticulocyte Count / (A2LA Cert. No ) 11/07/2018 Page 8 of 18
9 Hematology - 5C2 Hematology - 5D Hematology-5H Hematology - 5M RDW-CV Immature Reticulocyte Fraction (IRF) n RDW Reticulocyte Count RDW RDW / (A2LA Cert. No ) 11/07/2018 Page 9 of 18
10 Hematology - 5S Immature Reticulocyte Fraction (IRF) n RDW-CV RDW-SD Reticulocyte Count Immature Granulocytes (IG# / IG%) Immature Platelet Fraction (IPF) Reticulocyte (RET He) / Blood Cell ID Blood Cell Identification Advanced Blood Cell ID Blood Cell Identification (educational) Body Fluid Cell Count - C Count Count Body Fluid Cell Count - I Count Nucleated Cell Count Body Fluid Microscopy ID of cells / formed elements Cell Count and Body Fluid Crystals Count Count 2-part differential (Mononuclear/PMN) 5-part differential Body Fluid Crystal ID Fecal Occult Blood Fecal Occult Blood Fetal Fetal (gastric fluid) Flow Cytometry CD3 (T Cells) CD4 (T Helper) CD8 (T Cytotoxic) CD19 (B Cells) CD45 (Leukocytes) CD56 / CD16+56 (NK cells) HemoCue White Blood Cell Count Lamellar Body Count Lamellar Body Count Reticulocyte Count Reticulocyte Count Sedimentation Rate - A Sedimentation Rate Sedimentation Rate - B Sedimentation Rate Sedimentation Rate - C Sedimentation Rate Sedimentation Rate - D Sedimentation Rate Sickle Cell Screen Sickle Cell Screen (A2LA Cert. No ) 11/07/2018 Page 10 of 18
11 Coagulation / Coagulation APTT Fibrinogen INR Prothrombin Time D-dimer - D-dimer D-dimer - D-dimer Heparin Assay Anti-Xa APTT INR Prothrombin Time Thrombin Time i-stat ACT Activated Clotting Time POC Coagulation A INR Prothrombin Time POC Coagulation B INR Prothrombin Time Platelet Function - Aspirin Aspirin-induced inhibition Test Platelet Function - PRU P2Y12 inhibition Test TEG Andrology R-Time (R) (TEG) K-Time (K) (TEG) Maximum Amplitude (MA) (TEG) Angles (TEG) CT (ROTEM) CFT (ROTEM) MCF (ROTEM) Alpha angles (ROTEM) CK R-Time (R) (TEG 6s) CK K-Time (K) (TEG 6s) CK Max Amplitude (MA) (TEG 6s) CK Alpha (a) angles (TEG 6s) CRT Max Amplitude (MA) (TEG 6s) CKH R-Time (R) (TEG 6s) CFF Max Amplitude (MA) (TEG 6s) CFF FLEV (TEG 6s) Antisperm Antibody Antisperm Antibody Post-Vasectomy Sperm Analysis Sperm Count, Sperm Count Sperm Count (A2LA Cert. No ) 11/07/2018 Page 11 of 18
12 / Sperm Morphology Sperm Morphology Sperm Classification Sperm Motility Sperm Motility Sperm Progressive Motility Sperm Viability Sperm Viability Urinalysis, PPM, and Other Tests Urinalysis and HCG Urinalysis - Iris with HCG Specific Gravity Bilirubin Blood or Glucose Ketones Leukocyte Esterase Nitrite ph Protein Urobilinogen Reducing Substance Creatinine Bilirubin, confirmatory Protein, confirmatory HCG Specific Gravity Bilirubin Blood or Glucose Ketones Leukocyte Esterase Nitrite ph Protein Urobilinogen Reducing Substance Bilirubin, confirmatory Protein, confirmatory semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- HCG Urine Crystals Urine Crystal Identification Urine Eosinophils Urine Eosinophils Urine HCG - 5 samples HCG, urine Urine Sediment Urine Sediment (A2LA Cert. No ) 11/07/2018 Page 12 of 18
13 Waived and PPM Package Automated Urine Microscopy - I Specific Gravity Bilirubin Blood or Glucose Ketones Leukocyte Esterase Nitrite ph Protein Urobilinogen Reducing Substance Creatinine Bilirubin, confirmatory Protein, confirmatory HCG Vaginal Wet Preparation Vaginal Wet Preparation (KOH) Urine Sediment Glucose, whole blood Group A Strep Antigen Crystals Non-Squamous Epithelial Cells Bacteria Casts Crystals Epithelial Cells / semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi- semi-, Automated Urine Microscopy - S Fecal Lactoferrin Fecal Lactoferrin Gastric Occult Blood Provider-Performed Microscopy Gastric Occult Blood Gastric ph Fecal Leukocytes Fern Test Nasal Smear Pinworm Preparation Sperm Vaginal Wet Preparation Vaginal Wet Preparation (KOH) Urine Sediment semi- Rapid Urease Urease (A2LA Cert. No ) 11/07/2018 Page 13 of 18
14 Bacteriology / Comprehensive Bacteriology Blood Culture CSF Culture Campylobacter Antigen Ear/Eye Culture Gram Stain Group A Strep Antigen GC/Group B Strep Culture Sputum Culture Stool Culture Throat Culture Urine Colony Count Urine Culture Urine Susceptibility Testing Wound Culture (aerobic & anaerobic) Candida sp. Gardnerella vaginalis Trichomonas vaginalis Affirm VP Bacterial Vaginosis Bacterial Vaginosis Screen (Sialidase) Blood Culture Blood Culture Bordetella pertussis / parapertussis (molecular) Bordetella pertussis Bordetella parapertussis C. difficile Toxin/Antigen C. difficile Antigen C. difficile Toxin Campylobacter Campylobacter sp. (culture) Campylobacter Antigen Chlamydia Antigen Chlamydia Antigen Chlamydia/GC (molecular) Chlamydia trachomatis N. gonorrhoeae Gram Stain Gram Stain Gram Stain Morphology Gram Stain - Direct Smears Gram Stain / Morphology Stain ity Gram Stain - Vaginitis Bacterial Vaginosis (Gram Stain) Nugent Score Group A Strep Antigen Rapid Group A Strep Group B Strep (molecular) Group B Strep Detection GC/Group B Strep Culture Group B Strep Culture N. gonorrhoeae Culture H. pylori Antigen, Stool Helicobacter pylori Antigen Legionella Antigen Legionella Antigen MRSA Culture Methicillin-Resistant Staph aureus MRSA/Staph aureus (molecular) Methicillin-Resistant Staph aureus Staphylococcus aureus (A2LA Cert. No ) 11/07/2018 Page 14 of 18
15 / Mycoplasma pneumoniae M. pneumoniae detection (molecular) Shiga Toxin Shiga Toxin 1 Shiga Toxin 2 Shiga Toxin 1 and/or 2 Strep pneumoniae Antigen S. pneumoniae Antigen Strep Pharyngeal (molecular) Group A Strep Group C/G Strep Throat Culture Throat Culture Urine Culture Urine Colony Count Urine Culture / ID Susceptibility Testing semi- VRE Culture Vancomycin-Resistant Enterococci VRE (molecular) Vancomycin-Resistant Enterococci Mycobacteriology Acid Fast Smears Acid Fast Smears M. tuberculosis (molecular) M. tuberculosis detection Rifampin resistance screen Mycobacteriology Culture Mycobacterial Identification Antimycobacterial Susceptibility Mycology Candida Culture Candida Culture Cryptococcal Antigen Cryptococcal Antigen Dermatophyte Culture Dermatophyte Culture India Ink India Ink KOH Slide KOH Preparation (glass slide) Mycology Culture Mycology Culture Parasitology Blood Parasites Blood Parasite Identification Giardia & Cryptosporidium Antigens Giardia Antigen Cryptosporidium Antigen Parasitology Blood Smear Stool Preparation Fecal Suspension (ID) Modified acid fast stain PVA Slide (ID) Trichomonas (molecular) Trichomonas vaginalis (A2LA Cert. No ) 11/07/2018 Page 15 of 18
16 Virology Scheme / Program / HPV (molecular) Human Papillomavirus HPV Genotypes HSV 1 & 2 (molecular) Herpes Simplex Virus Type 1 Herpes Simplex Virus Type 2 Rotavirus Rotavirus Antigen Virology Package Influenza A or B RSV Antigen Adenovirus Antigen Molecular Multiplex Programs Blood Pathogen Panel GI Panel Respiratory Panel Meningitis Panel Immunology Bacterial Identification Bacterial Resistance Genes Yeast Identification Bacterial Identification Parasite Identification Virus Identification Bacterial Identification Virus Identification Bacterial Identification Virus Identification Yeast Identification ANA Antinuclear Antibody Anti-ssDNA Anti-dsDNA Anti-RNP/Sm Anti-RNP Anti-Sm Anti-SSA/SSB Anti-SSA Anti-SSB Anti-CCP Anti-Cyclic Citrullinated Peptide, semi-, ASO Anti-Streptolysin O,, titer C-Reactive Protein C-Reactive Protein, Diagnostic Allergy IgE, Total IgE, allergen specific, (A2LA Cert. No ) 11/07/2018 Page 16 of 18
17 / High Sensitivity CRP C-Reactive Protein (hs) H. pylori Antibody H. pylori Antibody HSV-2 Antibody HSV-2 Antibody Immunoproteins / C3 & C4 Alpha-1-Antitrypsin Complement C3 Complement C4 Haptoglobin IgA IgG IgM Infectious Mononucleosis Infectious Mononucleosis Lyme Disease Lyme Disease Antibody Mycoplasma Antibody Mycoplasma Antibody Rapid Anti-HIV Anti-HIV 1/2 (screen) HIV-1 p24 Antigen Rheumatoid Factor Rheumatoid Factor,, titer Rubella Rubella,, titer Syphilis Serology Viral Markers Immunohematology Syphilis Screen (RPR / VDRL) Syphilis Confirmation (FTA) Syphilis (titer, serum) Syphilis (titer, CSF) Anti-HIV 1/2 (screen) Anti-HIV 1/2 (confirmation) Anti-HIV 1/2, HIV-1 p24 Antigen Anti-HIV 1 Anti-HIV 2 Anti-HAV (IgG) Anti-HAV (IgM) Anti-HAV (Total) Anti-HBc (IgM) Anti-HBc (Total) Anti-HBs Anti-HCV HBsAg (screen / confirmation) titer titer ABO / Rh ABO Grouping Rh Typing Antibody Elution Antibody Elution Antibody Titer - A Anti-A titer semi-, Antibody Titer - D Anti-D titer semi-, (A2LA Cert. No ) 11/07/2018 Page 17 of 18
18 Automated Blood Bank Automated Blood Bank with Electronic Crossmatch Blood Bank Blood Bank with Electronic Crossmatch ABO Grouping ABO Subgroup typing Antibody Screen Antibody Identification Compatibility Testing Antigen Typing / Identification Rh Typing ABO Grouping ABO Subgroup typing Antibody Screen Antibody Identification Compatibility Testing Antigen Typing / Identification Rh Typing ABO/Rh Type Confirmation - Unit/Recip. Electronic Crossmatch - Automated ABO Grouping ABO Subgroup typing Antibody Screen Antibody Identification Compatibility Testing Antigen Typing / Identification Rh Typing ABO Grouping ABO Subgroup typing Antibody Screen Antibody Identification Compatibility Testing Antigen Typing / Identification Rh Typing ABO/Rh Type Confirmation - Unit/Recip. Electronic Crossmatch / DAT Direct Antiglobulin Testing DAT - Automated Direct Antiglobulin Testing Educational Blood Bank ABO Grouping (educational) ABO Reverse Group (educational) Antibody Screen (educational) Antibody Identification (educational) Antibody Elution (educational) DAT (educational) Rh Typing (educational) Fetal s F Cell Value (flow cytometry) Fetal Screen ( F / rosette) F, quan (Kleihauer- Betke stain) Rh Slide Test Rh Typing (A2LA Cert. No ) 11/07/2018 Page 18 of 18
19 Accredited Proficiency Testing Provider A2LA has accredited AMERICAN PROFICIENCY INSTITUTE Traverse City, MI This accreditation covers the specific proficiency testing schemes listed on the agreed upon Scope of Accreditation. This provider is accredited in accordance with the recognized International Standard ISO/IEC 17043: 2010 Conformity assessment - General requirements for proficiency testing. This accreditation demonstrates technical competence for a defined scope and the operation of a quality management system. Presented this 7 th day of November President and CEO For the Accreditation Council Certificate Number Valid to December 31, 2022 For the proficiency testing schemes to which this accreditation applies, please refer to the provider s Scope of Accreditation.
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