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) Practice No.: ADDINGTON PATHOLOGY LABORATORY Facility Accreditation Number: M0503 is a South African National Accreditation System accredited facility provided that all 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, HAEMATOLOGY, MICROBIOLOGY, MOLECULAR BIOLOGY AND SEROLOGY The facility is accredited in accordance with the recognised International Standard ISO 15189:2012 The accreditation demonstrates technical competency for a defined scope and the operation of a quality management system While this certificate remains valid, the accredited facility named above is authorised to use the relevant accreditation symbol to issue facility reports and/or certificates Mr R Josias Chief Executive Officer Effective Date: 29 November 2012 Certificate Expires: 28 November 2016
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0503 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Addington Pathology Laboratory, 2nd Floor, Addington Hospital 16 Erskine Terrace, South Beach Durban 4000 Postal Address: P O Box 977 Durban 4000 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms R Bridgemohan Tel: (031) Issue No.: 02 Fax: (031) Date of Issue: 03 August Roshini.bridgemohan@nhls.ac.za Expiry Date: 28 November 2016 Chemistry Discipline / Sample Type Type of Tests Serum Acetaminophen Serum Alanine Aminotransferase (ALT) Equipment / Method, Peritoneal, Albumin Serum Alkaline Phosphatase (ALP) Serum, Urine, Pleural, Ascitic, Peritoneal, Amylase Serum Aspartate Aminotransferase (AST) Serum Bicarbonate (CO2) Total Serum Bilirubin, Direct Serum Bilirubin, Total Serum Calcium Serum Carbamazepine Serum, CSF, Pleural, Ascitic, Peritoneal, Chloride Serum Cholesterol (HDL) Serum Cholesterol (Total) Serum Complement C3 Serum Complement C4 Serum C-Reactive Protein (CRP) Page 1 of 4
3 Serum Creatine Kinase (CK) Serum, Urine Creatinine Serum Ferritin Centaur XP Serum Fructosamine Serum Gamma Glutamyl Transferase (GGT) Serum, CSF, Pleural, Ascitic, Peritoneal, Glucose Serum HbA1c Serum HIV (Rapid) Kit Serum Iron Plasma Lactate, Pericardial, Peritoneal, Joint, Vitreous Lactate Dehydrogenase (LDH) Serum Magnesium Stool Occult Blood Kit Serum Phosphate, Pericardial, Peritoneal, Joint, Vitreous CSF, Urine, Pleural, Ascitic, Peritoneal Dialysis, Pericardial, Peritoneal, Joint, Serum, CSF, Pleural, Ascitic, Peritoneal,, Pericardial, Peritoneal, Joint, Vitreous Potassium Protein (Micro) Protein (Total) Sodium Serum Triglycerides Whole Blood Troponin T (Qualitative) Cardiac Reader / Cobas h232 Plasma Urate, Pericardial, Peritoneal, Joint, Vitreous Urea Blood Gas: Whole Blood, Syringe Blood Analyser Gem Prem 3500 Page 2 of 4
4 Endocrinology Urine Beta Human Chorionic Gonadotrophin (βhcg) (Qualitative) Manual Method-Kit Serum Digoxin Serum Free Thyroxine (F-T4) Centaur XP Serum Phenytoin Serum Prostate Specific Antigen (PSA) Centaur XP Serum Salicylate Serum Thyroid Stimulating Hormone (TSH) Centaur XP Serum Transferrin Serum Troponin I Centaur XP Serum Valproic Acid Haematology Plasma Activated Partial Thromboplastin Time (APTT) CA560 / CS2100i Plasma D-Dimer CS2100i Whole Blood Differential Count Manual Method Whole Blood Direct Antiglobulin Test Manual Method-Kit Whole Blood Erythrocyte Sedimentation Rate (ESR) Manual Method Plasma Fibrinogen CA560 / CS2100i Whole Blood Full Blood Count and Differential Count Sysmex XT 2000i / Coulter LH75 Plasma International Normalised Ratio (INR) CA560 / CS2100i Whole Blood Malaria Antigens Kit Whole Blood Malaria Smears Manual Method Whole Blood Reticulocyte Count Sysmex XT 2000i / Coulter LH75 Microbiology Urine Urine Dipstick Kit CSF, Urine, Stool, Sputum, Swabs, Pleural, Ascitic, Peritoneal,, Tissue/Bone, Catheter Tip, Gastric Aspirates, Eye/Corneal Scrapping Culture Sensitivity Microscopy: Gram Stain Cell Count Manual Method / Vitek Manual Method Blood Culture Microscopy: Gram Stain Culture Sensitivity Manual Method Manual Method / BacTAlert 3D / Vitek Sputum Concentrated Auramine for Acid Fast Bacteria (AFB) Manual Method / Acid Fast Aerospray Page 3 of 4
5 Sputum TB PCR GeneXpert Stool Parasites Manual Method Stool Rota / Adenovirus Kit CSF, Serum Cryptococcal Antigen Lateral Flow Assay Kit Serology Serum Hepatitis B Surface Antigen, Rapid Kit Molecular Biology Plasma, EDTA Viral Load m2000rt / m2000sp Original Date of Accreditation: 29 November 2012 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Field Manager Page 4 of 4
CERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION LANCET KENYA LIMITED UPPERHILL NAIROBI LABORATORY Co. Reg. No.: C168507 Facility Accreditation Number: is a South African National Accreditation System accredited laboratory
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
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
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
CERTIFICATE OF ACCREDITATION LANCET LABORATORIES Registration No: 4120108883 Facility Accreditation Number: MED 006 is a SADCAS accredited Medical Laboratory provided that all SADCAS conditions are complied
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
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
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
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
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
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),
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CERTIFICATE OF ACCREDITATION
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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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