CERTIFICATE OF ACCREDITATION
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1 CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1), (2) and (3) of the said Act, I hereby certify that:- NATIONAL HEALTH LABORATORY SERVICE (NHLS) GROOTE SCHUUR HOSPITAL CHEMISTRY LABORATORY Practice No.: PR Facility Accreditation Number: is a South African National Accreditation System accredited laboratory provided that all SANAS conditions and requirements are complied with This certificate is valid as per the scope as stated in the accompanying schedule of accreditation, Annexure A, bearing the above accreditation number for MEDICAL TESTING LABORATORY CHEMISTRY, ENDOCRINOLOGY, IMMUNOLOGY, MOLECULAR BIOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2007 The accreditation demonstrates technical competency for a defined scope and the operation of a laboratory quality management system While this certificate remains valid, the Accredited Facility named above is authorised to use the relevant SANAS accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 27 November 2014 Certificate Expires: 30 June 2018
2 SCHEDULE OF ACCREDITATION Facility Number: Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Groote Schuur Hospital Chemical Pathology Laboratory C 17, Groote Schuur Hospital Observatory 7925 Postal Address: Groote Schuur Hospital Chemical Pathology Laboratory Observatory 7935 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms L Johnson Tel: (021) Issue No.: 09 Fax: (021) leigh.johnson@nhls.ac.za CHEMISTRY Acetylcholine Receptor Antibody (ARA) Manual Method-RIA, Pleural Fluid, Peritoneal Fluid, CSF Adenosine Deaminase Integra 400 Plus Alanine Aminotransferase (ALT) Cobas 6000, CSF Albumin Cobas 6000 Urine Albumin (Micro) Cobas 6000 Alkaline Phosphatase (ALP) Cobas 6000 Plasma Ammonia Integra 400 Plus, Ascitic Fluid Amylase Cobas 6000 Apolipoprotein A Integra 400 Plus Apolipoprotein B Integra 400 Plus Aspartate Aminotransferase (AST) Cobas 6000 Bicarbonate (CO2) Integra Bilirubin, Direct Cobas 6000 Bilirubin, Total Cobas 6000, Urine Calcium (Total) Cobas 6000 / Integra 400 Plus, Urine, CSF Chloride Cobas 6000, Pericardial Fluid, Pleural Fluid Cholesterol Cobas 6000 Cholesterol (HDL) Cobas 6000 Complement C3 Integra 400 Plus Complement C4 Integra 400 Plus C-Reactive Protein (CRP) Cobas 6000 Creatine Kinase (CK) Cobas 6000 Creatine Kinase MB (CKMB) Cobas 6000, Urine, Dialysate Fluid, Ascetic Fluid Creatinine Cobas 6000 / Integra 400 Plus Ferritin Cobas 6000 Gamma Glutamyl Transferase (GGT) Cobas 6000, CSF Glucose Cobas 6000 Haptoglobin Integra 400 Plus / Cobas 6000 Whole Blood HbA1c Integra 400 Plus Original Date of Accreditation: 01 July 2006 Page 1 of 4
3 CHEMISTRY (Continued) Iron Cobas 6000 Plasma Lactate Integra 400 Plus Lactate Dehydrogenase (LDH) Cobas 6000 Lipase Cobas 6000 Lithium Integra 400 Plus, Urine, Body Fluid Magnesium Cobas 6000, Urine Osmolality Osmometer 3320 Paracetamol Integra 400 Plus, Urine Phosphate Cobas 6000, Urine, Body Fluid Potassium Cobas 6000 / Integra 400 Plus, Urine, CSF Protein (Total) Cobas 6000 Rheumatoid Factor (RF) Integra 400 Plus, Urine Sodium Cobas 6000, Pleural Fluid, Pericardial Fluid, Triglyceride Cobas 6000 Ascitic Fluid Whole Blood Troponin T Cobas 6000, Urine Urate Cobas 6000, Urine, Ascitic Fluid Urea Cobas 6000 / Integra 400 Plus Electrophoresis CSF Electrophoresis Sebia Hydrasys Immunofixation Sebia Minicap Lipoprotein Electrophoresis Sebia Hydrasys Protein Electrophoresis Sebia Minicap Urine Protein Electrophoresis Sebia Hydrasys Urine Immunofixation Sebia Hydrasys ENDOCRINOLOGY 17-hydroxyprogesterone (17-OH Progesterone) Manual Method-RIA Aldosterone Manual Method-RIA Alpha Feto-protein (AFP) Cobas 6000 Alpha-1-Antitrypsin Integra 400 Plus Beta Human Chorionic Gonadotrophin (ßHCG) Cobas 6000 CA 125 Cobas 6000 CA 19.9 Cobas 6000 Carcinoembryonic Antigen (CEA) Cobas 6000 Cortisol Cobas 6000 Dehydroepiandrosterone Sulphate (DHEAS) Cobas 6000 Estradiol (E2) Cobas 6000, Whole Blood Folate Cobas 6000 Follicle Stimulating Hormone (FSH) Cobas 6000 Free Thyroxine (F-T4) Cobas 6000 Free Triiodothyronine (F-T3) Cobas 6000 Insulin Cobas 6000 Lipoprotein (a) Integra 400 Plus Luteinising Hormone (LH) Cobas 6000 Methotrexate TDX Parathyroid Hormone (PTH) Cobas 6000 Procalcitonin ( PCT) Cobas 6000 Progesterone Cobas 6000 Prolactin Cobas 6000 Prostate Specific Antigen (PSA) Free Cobas 6000 Prostate Specific Antigen (PSA) Total Cobas 6000 Original Date of Accreditation: 01 July 2006 Page 2 of 4
4 ENDOCRINOLOGY (Continued) Renin Manual Method-RIA Sex Hormone Binding Globulin (SHBG) Cobas 6000 Testosterone Cobas 6000 Thyroid Stimulating Hormone (TSH) Cobas 6000 Transferrin Cobas 6000 Vitamin B12 Cobas 6000 MOLECULAR BIOLOGY Inherited Metabolic Disorders Alpha 1 Anti-trypsin Deficiency Cystic Fibrosis Mutations Epithelial Sodium Channel Mutations Galactosemia Mutations Glutaryl-Co-enzyme A Dehydrogenase Deficiency Mitochondrial DNA Mutations Spinal Muscular Atrophy Mutations Thiopurine Methyl Transferase Mutations Gene Sequencing for Rare Diseases (CXT, LPL, MCAD, ApoE, HPRT) Original Date of Accreditation: 01 July 2006 Page 3 of 4
5 IMMUNOLOGY / ALLERGOLOGY Anti-Cyclic Citrullinated Peptide Antibody ImmunoCAP (accp) Anti-Tissue Transglutaminase IgA Antibodies ImmunoCAP (Coel) Anti-Tissue Transglutaminase IgG Antibodies ImmunoCAP (Coel) Anti-Deamidated Gliadin IgA Antibodies(Coel) ImmunoCAP Anti-Deamidated Gliadin IgG Antibodies(Coel) ImmunoCAP Aspergillus Fumigatus (IgG) Antibodies ImmunoCAP Antinuclear Antibodies (ANA) CTD Screen ImmunoCAP B2-Glycoprotein Antibodies IgG (B2GP1) ImmunoCAP B2-Glycoprotein Antibodies IgM (B2GP1) ImmunoCAP Cardiolipin Antibodies IgG (ACLA) ImmunoCAP Cardiolipin Antibodies IgM (ACLA) ImmunoCAP Centromere Antibodies (CENP) ImmunoCAP Double Stranded DNA (dsdna) ImmunoCAP Glomerular Basement Membrane Antibodies ImmunoCAP (GBM) Immunoglobulin E (IgE) - Total ImmunoCAP Immunoglobulin G (IgG)-Avian Precipitins ImmunoCAP Jo-1 Antibodies ImmunoCAP Neutrophil Cytoplasmic Antibodies (ANCA-MPO ImmunoCAP and PR3) RAST (Specific IgE) ImmunoCAP RNP70 and Sm Antibodies ImmunoCAP Ro and la Antibodies ImmunoCAP SCL-70 Antibodies ImmunoCAP SEROLOGY Immunoglobulin A (IgA) Integra 400 Plus Immunoglobulin M (IgM) Integra 400 Plus Immunoglobulin G (IgG) Integra 400 Plus Original Date of Accreditation: 01 July 2006 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
CERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION In terms of section 22(2) (b) of the Accreditation for Conformity Assessment, Calibration and Good Laboratory Practice Act, 2006 (Act 19 of 2006), read with sections 23(1),
CERTIFICATE OF ACCREDITATION
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CERTIFICATE OF ACCREDITATION
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Analyte Specimen Demographic Reference Range Units
Acetone Negative titer Alanine aminotransferase (ALT/SGPT) 10-49 U/L Albumin 3.2-4.8 g/dl Alcohol < 10 Alpha-fetoprotein (AFP) < 1.3-8.1 ng/ml Alkaline phosphatase 0 7 days 7 30 days 1 3 3 6 6 12 1 3 3
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Alanine Aminotransferase (ALT, SGPT) 3-9 years 9-18 years 1-9 years 9-18 years 10-30 U/L 10-30 U/L 10-20 U/L Albumin 0-6 days 6 days - 37 months 37 months - 7 years 7-20 years 2.6-3.6 g/dl 3.4-4.2 g/dl
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Alanine Aminotransferase (ALT, SGPT) 3-9 years 9-18 years 1-9 years 9-18 years 10-25 U/L 10-35 U/L 10-30 U/L 10-25 U/L 10-30 U/L 10-35 U/L 10-25 U/L 10-35 U/L 10-25 U/L 10-20 U/L 10-35 U/L Albumin 0-6
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AFP All All < 15 ug/l Albumin All 0-3M 25-40 g/l Albumin All 3-12M 32-45 g/l Albumin All 1-70Y 34-48 g/l Albumin All >70Y 32-46 g/l Alk Phos All 0-10Y 80-350 U/L Alk Phos M 10-14Y 45-400 U/L Alk Phos F
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