SCOPE OF ACCREDITATION TO ISO/IEC 17043:2010
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1 SCOPE OF ACCREDITATION TO ISO/IEC 17043:2010 BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA Regulatory Phone (Elizabeth Platt): US Product Info/Sales: Phone: (800) , Option #1 Nearest Worldwide Office: PROFICIENCY TESTING PROVIDER Valid To: February 29, 2020 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 provider to provide proficiency testing samples in the following programs: PROGRAM NAME FREQUENCY ANALYTES MEASURED 1 CATEGORY B: BIOLOGICIAL AND CLINICAL PROPERTIES Blood Gas One distribution of 12 These liquid proficiency samples are prepared from a buffered aqueous solution with no added constituents of human or animal origin. 1. Calcium, Ionized 2. Chloride 3. Glucose 4. Lactate (Lactic Acid) 5. Magnesium 6. pco2 7. ph 8. po2 9. Potassium 10. Sodium Blood Typing Three distributions of 3 samples + 1 donor sample every 4 months. These liquid proficiency samples are a suspension of red blood cells in a preservative diluent with added preservatives. Parameters: 1. ABO Group 2. Antibody Screen 3. Rh(D) (A2LA Cert. No ) Revised 09/19/2017 Page 1 of 9
2 Blood Typing 4. Antibody Identification 5. DAT (Direct Antiglobulin Test) 6. Compatibility (Cross-match) Cardiac Markers One distribution of 12 These liquid frozen proficiency samples are prepared from human serum, plasma and proteins with added chemicals and preservatives. 1. Brain Natriuretic Peptide (BNP) 2. CK-MB 3. D-dimer 4. hs-crp 5. Myoglobin 6. N-terminal pro BrainNatriuretic Peptide (NT-ProBNP) 7. Troponin I 8. Troponin T 9. Homocysteine Clinical Chemistry (Monthly) One distribution of 12 every month prepared from human serum with added chemicals, purified biochemicals (tissue extracts of human and animal origin) and stabilizers. 1. Acid Phosphatase (Total) 2. Alanine Aminotransferase (ALT/SGPT) 3. Albumin 4. Alkaline Phosphatase (ALP) 5. Amylase (Pancreatic) 6. Amylase (Total) 7. Aspartate Aminotransferase (AST/SGOT) 8. Carbon Dioxide (CO2) 9. Bilirubin (Direct) 10. Bilirubin (Total) 11. Calcium (Ionized) 12. Calcium (Total) 13. Chloride 14. Cholesterol (HDL) 15. Cholesterol (LDL) 16. Cholesterol (Total) 17. Cholinesterase 18. Copper 19. Cortisol 20. Creatine Kinase (CK) (A2LA Cert. No ) Revised 09/19/2017 Page 2 of 9
3 Clinical Chemistry (Monthly) 21. Creatinine 22. Gamma Glutamyl Transferase (GGT) 23. Glucose 24. Iron 25. Iron Binding Capacity, Total (TIBC) 26. Iron Binding Capacity, Unsaturated (UIBC) 27. Lactate (Lactic Acid) 28. Lactate Dehydrogenase (LDH) 29. Lipase 30. Lithium 31. Magnesium 32. Osmolality 33. Phosphorus 34. Potassium 35. Protein (Total) 36. Sodium 37. Thyroid Stimulating Hormone (TSH) 38. Thyroxine (T4), Free 39. Thyroxine (T4), Total 40. Triglycerides 41. Triiodothyronine (T3), Free 42. Triiodothyronine (T3), Total 43. Urea 44. Urea Nitrogen 45. Uric Acid 46. Zinc Coagulation One distribution of 12 prepared from human plasma with added chemicals and stabilizers. 1. Activated Partial Thromboplastin Time (APTT) 2. Antithrombin III (ATIII) 3. Fibrinogen 4. International Normalized Ratio (INR) 5. Prothrombin Time (PT) 6. Protein C 7. Protein S 8. Thrombin Time (TT) 9. D-dimer Ethanol/Ammonia One distribution of 12 These liquid proficiency samples are prepared from human serum and purified chemicals with added preservatives and stabilizers. (A2LA Cert. No ) Revised 09/19/2017 Page 3 of 9
4 Ethanol/Ammonia 1. Ethanol 2. Ammonia Hematology Four distribution of 3 These liquid proficiency samples are prepared from human erythrocytes, mammalian leukocytes and platelets with preservatives. 1. Hematocrit (HCT) 2. Hemoglobin (Total) 3. Mean Corpuscular Hemoglobin (MCH) 4. Mean Corpuscular Hemoglobin Concentration (MCHC) 5. Mean Corpuscular Volume (MCV) 6. Mean Platelet Volume (MPV) 7. Platelets (PLT) 8. Red Blood Cell Distribution Width (RDW) 9. Red Blood Cell Distribution Width Standard Deviation (RDW-SD) 10. Red Blood Cells (RBC) 11. White Blood Cells (WBC) Hemoglobin One distribution of 12 every month prepared from human whole blood with added stabilizers and preservatives. 1. Hemoglobin A1C 2. Hemoglobin A2 3. Hemoglobin (Total Glycated) HIV/Hepatitis One distribution of 12 These liquid samples are prepared with human source material with added constituents of animal origin and preservatives. 1. Anti HAV 2. HAV IgG 3. HAV IgM 4. Anti HBc 5. HBc IgM 6. Anti HBe 7. Anti HBs 8. Anti HCV 9. Anti HIV Anti HIV-2 (A2LA Cert. No ) Revised 09/19/2017 Page 4 of 9
5 HIV/Hepatitis 11. Anti HIV 1/2 12. Anti HTLV HBe Ag 14. HBs Ag 15. HIV-1 Ag Immunoassay (Monthly) One distribution of 12 prepared from human serum with added constituents of human and animal origin, chemicals and therapeutic drugs Deoxycortisol α -OH-Progesterone OH Vitamin D 4. β-2 Microglobulin 5. ACTH 6. Aldosterone 7. Alphafetoprotein (AFP) 8. Androstenedione 9. Angiotensin Converting Enzyme (ACE) 10. C-Peptide 11. CA CA CA CA Carbamazepine 16. Carcinoembryonic Antigen (CEA) 17. Cortisol 18. DHEA 19. DHEA Sulfate 20. Digoxin 21. Estradiol 22. Estriol, Free (UE3) 23. Ferritin 24. Folate 25. Follicle Stimulating Hormone (FSH) 26. Gastrin 27. Human Chorionic Gonadotropin (hcg) 28. Human Growth Hormone (hgh) 29. Immunoglobulin E (IgE) 30. Insulin 31. Intact PTH 32. Luteinizing Hormone (LH) 33. Neuron Specific Enolase (NSE) 34. Phenobarbital 35. Phenytoin 36. Plasma Renin Activity 37. Progesterone 38. Prolactin 39. Prostate Specific Antigen (PSA), Free 40. PSA- Free/Total (Ratio) (A2LA Cert. No ) Revised 09/19/2017 Page 5 of 9
6 Immunoassay (Monthly) 41. Prostate Specific Antigen (PSA), Total 42. Renin (Direct) 43. S100 Protein 44. Sex Hormone Binding Globulin (SHBG) 45. T-Uptake 46. T3 Uptake 47. Testosterone 48. Theophylline 49. Thyroid Stimulating Hormone (TSH) 50. Thyroxine (T4), Free 51. Thyroxine (T4), Total 52. Thyroxine Binding Globulin (TBG) 53. Transferrin 54. Triiodothyronine (T3), Free 55. Triiodothyronine (T3), Total 56. Valproic Acid 57. Vitamin B Thyroglobulin (Tg) Lipids One distribution of 12 These liquid proficiency samples are prepared from human serum with added constituents of human origin, preservatives and stabilizers. 1. Apolipoprotein A1 2. Apolipoprotein B 3. Cholesterol, HDL 4. Cholesterol, LDL 5. Cholesterol, Total 6. Triglycerides 7. Lipoprotein(a) Serum Proteins One distribution of 12 prepared from human serum with added constituents of animal origin, chemicals 1. α -1-Acid Glycoprotein 2. α-1 Antitrypsin 3. α-2 Macroglobulin 4. β-2 Microglobulin 5. Albumin 6. Antistreptolysin O (ASO) 7. C-Reactive Protein (CRP) 8. Ceruloplasmin 9. Complement C3 10. Complement C4 11. Haptoglobin 12. Immunoglobulin A (IgA) 13. Immunoglobulin E (IgE) 14. Immunoglobulin G (IgG) (A2LA Cert. No ) Revised 09/19/2017 Page 6 of 9
7 Serum Proteins 15. Immunoglobulin M (IgM) 16. Kappa Light Chain 17. Lambda Light Chain 18. Prealbumin 19. Protein (Total) 20. Rheumatoid Factor 21. Transferrin Syphilis One distribution of 12 These liquid samples are prepared from human source material with added preservatives. 1. Non-Treponemal Antibodies 2. Treponema pallidum lgm 3. Treponema pallidum IgG 4. Treponema pallidum Antibodies Therapeutic Drug Monitoring One distribution of 12 every month prepared from defibrinated human plasma with added chemicals and therapeutic drugs. 1. Acetaminophen 2. Amikacin 3. Amitriptyline 4. Caffeine 5. Carbamazepine 6. Cyclosporine 7. Digoxin 8. Ethosuximide 9. Gentamicin 10. Lithium 11. Methotrexate 12. Nortriptyline 13. Phenobarbital 14. Phenytoin 15. Primidone 16. Salicylate 17. Theophylline 18. Tobramycin 19. Tricyclic Antidepressants (TCA) Screen 20. Valproic Acid 21. Vancomycin ToRCH/EBV/MuMZ One distribution of 12 These liquid samples are prepared from human source material with added preservatives. 1. Cytomegalovirus (CMV) IgG 2. Cytomegalovirus (CMV) IgM 3. Epstein-Barr Virus (EBNA) IgG 4. Epstein-Barr Virus (VCA) IgG (A2LA Cert. No ) Revised 09/19/2017 Page 7 of 9
8 ToRCH/EBV/MuMZ 5. Epstein-Barr Virus (VCA) IgM 6. Herpes Simplex Virus (HSV-1) IgG 7. Herpes Simplex Virus (HSV-2) IgG 8. Herpes Simplex Virus (HSV1/2) IgG 9. Measles Virus (Rubeola) IgG 10. Mumps Virus IgG 11. Rubella Virus IgG 12. Rubella Virus IgM 13. Toxoplasma gondii (Toxo) IgG 14. Toxoplasma gondii (Toxo) IgM 15. Varicella Zoster Virus (VZV) IgG Urinalysis One distribution of 12 These liquid samples are prepared with human erythrocytes, constituents of animal origin, chemicals, and preservatives. 1. Albumin 2. Albumin-to-Creatinine Ratio 3. Bilirubin 4. Blood (Hemoglobin) 5. Creatinine 6. Glucose 7. Human Chorionic Gonadotropin (hcg) 8. Ketones 9. Leukocytes 10. Nitrite 11. ph 12. Protein (Total) 13. Protein-to-Creatinine Ratio 14. Specific Gravity 15. Urobilinogen Urine Chemistry One distribution of 12 prepared from human urine with added chemicals, hormones and stabilizers Hydroxyindoleacetic Acid (5-HIAA) 2. Aldosterone 3. Calcium (Total) 4. Chloride 5. Cortisol (Free) 6. Creatinine 7. Dopamine 8. Epinephrine 9. Glucose 10. Homovanillic Acid (HVA) 11. Hydroxyproline (Total) (A2LA Cert. No ) Revised 09/19/2017 Page 8 of 9
9 Urine Chemistry 12. Magnesium 13. Metanephrine 14. Microalbumin 15. Norepinephrine 16. Normetanephrine 17. Osmolality 18. Phosphorus 19. Potassium 20. Protein Total 21. Sodium 22. Urea Nitrogen 23. Uric Acid 24. Vanillylmandelic Acid (VMA) 1 Analytes/parameters in each program are targeted per defined specifications. Assigned values and associated uncertainties are known values with results determined by finished product testing of proficiency program. (A2LA Cert. No ) Revised 09/19/2017 Page 9 of 9
10 Accredited Proficiency Testing Provider A2LA has accredited BIO-RAD LABORATORIES Irvine, CA 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 23 rd day of February President and CEO For the Accreditation Council Certificate Number Valid to February 29, 2020 Revised November 16, 2016 For the proficiency testing schemes to which this accreditation applies, please refer to the provider s Scope of Accreditation.
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