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.: PR KING EDWARD VIII HOSPITAL LABORATORY Facility Accreditation Number: M0533 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 AND MICROBIOLOGY 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: 18 December 2017 Certificate Expires: 17 December 2021
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0533 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) King Edward VIII Hospital, Pathology Laboratory Building Gate2, Cnr Umbilo & Rick Turner Road Signatories: Signatories as authorised by the Head of Laboratory Congela Durban 4013 Postal Address: Private Bag X02 Contact Person: Dr E Y Samuel Congela 4013 Tel: (031) Issue No.: 05 Fax: (031) Date of Issue: 30 October Elizabeth.samuel@nhls.ac.za Expiry Date: 17 December 2021 Discipline / Sample Type Type of Tests Equipment / Method Chemistry Serum Acetaminophen Dimension EXL with LM / Serum Alanine Aminotransferase (ALT) Dimension EXL with LM / Dimention EXL 200 Serum Albumin Dimension EXL with LM / Serum Alkaline Phosphatase (ALP) Dimension EXL with LM / Plasma Ammonium Dimension EXL with LM / Serum, Urine Amylase Dimension EXL with LM / Serum Aspartate Aminotransferase (AST) Dimension EXL with LM / Serum Bicarbonate (CO2) Total Dimension EXL with LM / Serum Bilirubin, Direct Dimension EXL with LM / Serum Bilirubin, Total Dimension EXL with LM / Serum, Urine Calcium (Total) Dimension EXL with LM / Serum Carbamazepine Dimension EXL with LM / Page 1 of 4
3 Urine Cannabis Dimension EXL with LM / CSF, Serum, Urine Chloride Dimension EXL with LM / Serum Cholesterol (HDL) Dimension EXL with LM / Serum Cholesterol (Total) Dimension EXL with LM / Serum C-Reactive Protein (CRP) Dimension EXL with LM / Serum Creatine Kinase (CK) Dimension EXL with LM / Plasma Creatine Kinase MB (CKMB) Centaur Serum, Urine Creatinine Dimension EXL with LM / Serum Gamma Glutamyl Transferase (GGT) Dimension EXL with LM / CSF, Plasma, Urine Glucose Dimension EXL with LM / Serum Iron Dimension EXL with LM / Plasma Lactate Dimension EXL with LM / Serum Lactate Dehydrogenase (LDH) Dimension EXL with LM / Serum Lithium Dimension EXL with LM / Serum, Urine Magnesium Dimension EXL with LM / Serum Paracetamol Dimension EXL with LM / Serum, Urine Phosphate - Inorganic Dimension EXL with LM / Serum, Urine Potassium Dimension EXL with LM / CSF, Urine Protein (Micro) Dimension EXL with LM / Serum Protein (Total) Dimension EXL with LM / Serum, Urine Sodium Dimension EXL with LM / Serum Triglycerides Dimension EXL with LM / Serum, Urine Urate Dimension EXL with LM / Serum, Urine Urea Dimension EXL with LM / Page 2 of 4
4 Endocrinology Urine Beta Human Chorionic Gonadotrophin (βhcg) Beta clear Serum Digoxin Dimension EXL with LM / Serum Gentamycin Dimension EXL with LM / Serum Phenobarbital Dimension EXL with LM / Serum Phenytoin Dimension EXL with LM / Serum Procalcitonin (PCT) Centaur Serum Salicylate Dimension EXL with LM / Serum Theophylline Dimension EXL with LM / Serum Transferrin Dimension EXL with LM / Plasma Troponin I Centaur Serum Valproic Acid Dimension EXL with LM / Dimensio EXL 200 Haematology Plasma Activated Partial Thromboplastin Time (APTT) CS2100i Whole Blood CD4 Aquious Whole Blood Coombs Test Plasma Cryptococcal Antigen Plasma D-Dimer CS2100i Stained Slides Differential Count Whole Blood Erythrocyte Sedimentation Rate (ESR) / Mix Rate 20 Whole Blood Full Blood Count and Differential Count LH750 Plasma International Normalised Ration (INR) CS2100i Whole Blood Malaria Antigen Binax Now Kit Whole Blood Malaria Thick & Thin Plasma Prothrombin Time (PT) CS2100i Whole Blood Reticulocytes LH750 Microbiology aspirates, Abscess / Pus Culture Page 3 of 4
5 Aspirates, Abscess / Pus Sensitivity / Vitek aspirates, Abscess / Pus Microscopy: Gram Stain Sputum Acid Fast Bacilli (AFB) Sputum and Extra Pulmonary Samples MDR TB GeneXpert CSF, Serum Cryptococcal Antigen Stool Parasitology Blood Culture Serology Microscopy: Gram Stain Culture Sensitivity / Bact- Alert 3D / Vitek Serum Hepatitis B Surface Antigen, Rapid Serum HIV Rapid Original Date of Accreditation: 18 December 2013 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 4 of 4
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