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 EAST LONDON LABORATORY Facility Accreditation Number: M0458 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, CYTOLOGY, 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: 02 July 2014 Certificate Expires: 01 July 2018
2 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0458 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) East London Laboratory Main Amalinda Drive East London 5201 Postal Address: Private Bag X9018 East London 5200 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Ms D Birkholtz Tel: (043) Issue No.: 06 Fax: (043) Date of Issue: 06 August Diane.Birkholtz@nhls.ac.za Expiry Date: 01 July 2018 Chemistry Discipline / Sample Type Type of Tests Serum Acetaminophen (Paracetamol) DXC 600 Body Fluids, CSF Adenosine Deaminase (ADA) DXC 800 Equipment / Method Serum Alanine Aminotransferase (ALT) DXC 800 / DXC 600 Serum Albumin DXC 800 / DXC 600 Serum Alkaline Phosphatase (ALP) DXC 800 / DXC 600 Serum Amylase DXC 800 Serum Aspartate Aminotransferase (AST) DXC 800 / DXC 600 Serum Beta Human Chorionic Gonadotrophin (βhcg) Quantitative DXI Serum Bicarbonate (CO2) DXC 800 Serum Bilirubin, Direct DXC 800 / DXC 600 Serum Bilirubin, Total DXC 800 / DXC 600 Serum Calcium DXC 800 / DXC 600 Serum Carbamazepine (Tegretol) DXC 800 Serum Chloride DXC 800 / DXC 600 Serum Cholesterol (HDL) DXC 800 Serum Cholesterol (LDL) Calculated Serum Cholesterol (Total) DXC 800 Serum Cholinesterase DXC 600 Serum C-Reactive Protein (CRP) DXC 800 / DXC 600 Serum Creatine Kinase (CK) DXC 800 / DXC 600 Serum, Urine Creatinine DXC 800 / DXC 600 Serum Ferritin DXI Serum Gamma Glutamyl Transferase (GGT) DXC 800 / DXC 600 Serum, CSF, Plasma, Body Fluids Glucose DXC 800 / DXC 600 Page 1 of 5
3 Serum HbA1c DXC 600 Serum Iron Studies DXC 800 Serum Lactate DXC 600 Serum, Body Fluids Lactate Dehydrogenase (LDH) DXC 800 / DXC 600 Serum Magnesium DXC 800 / DXC 600 Serum Phenobarbital DXC 600 Serum Phosphate DXC 800 / DXC 600 Serum Potassium DXC 800 / DXC 600 Serum, Body Fluids, CSF, Urine Protein DXC 800 / DXC 600 Serum Sodium DXC 800/ DXC 600 Serum Triglycerides DXX 800 Serum, Body Fluids Urate DXC 800 / DXC 600 Serum Urea DXC 800 / DXC 600 Endocrinology Serum Alpha Feto-protein (AFP) DXI Serum, Urine Beta Human Chorionic Gonadotrophin (βhcg) Serum Carcinoembryonic Antigen (CEA) DXI Serum Digoxin DXC 600 Serum Free Thyroxine (F-T4) DXI Serum Free Triiodothyronine (F-T3) DXI Serum Folate DXI Serum Phenytoin (Epanutin) DXC 800 Serum Prostate Specific Antigen (PSA) DXI Serum Rheumatoid Factor DXC 800 Serum Salicylate DXC 600 Serum Theophylline DXC 600 Serum Thyroid Stimulating Hormone (TSH) DXI Serum Transferrin DXC 800 Whole Blood Troponin I DXI 600 Serum Troponin T Cobas h232 Serum Valproic Acid (Epilim) DXC 800 Serum Vitamin B12 DXI Haematology Whole Blood CD4 (Panleucogated CD4 Quantitation) MPL FC5000 Whole Blood D-Dimer Qualitative and Semi-Quantitative Cardiac Reader Whole Blood Differential Cell Count Advia 2120i / Manual Method / Sysmex XS 1000i Whole Blood Erythrocyte Sedimentation Rate (ESR) Whole Blood Full Blood Count (FBC) Advia 2120i / Sysmex XS 1000i Whole Blood Malaria Antigen Whole Blood Malaria Smear Whole Blood Platelet Count Advia 2120i / Sysmex XS 1000i Page 2 of 5
4 Microbiology URT & LRT-Sputum, Endotracheal Aspirate, Gastric Aspirate, Bronchoscopy, Tracheal Aspirate -Kirby Bauer / Blood Cultures BacTalert / - Kirby Bauer / CSF Cell Count Indian Ink -Kirby Bauer / Sterile Fluids: Pleural, Ascitic, Synovial, Abdominal, Peritoneal, Eye, Pericardial, Catheter Tips Wet Preparation -Kirby Bauer / Urine including Midstream Cell Count using 'Fastread' Slide, Parasite Examination -Kirby Bauer / Pus Swabs including Wounds, Burns, Bedsores, Ulcers, Ears, Nose, Throat, Eye, Mouth, Genital, Pus Aspirates, Tissues, Devises and Fine Needle Aspirate Wet Preparation -Kirby Bauer / Page 3 of 5
5 Stool and Rectal Swabs Wet Preparation -Kirby Bauer / Stool, Rectal Swab Rotavirus Molecular Biology Sputum PCR GeneXpert Infinity Serology Serum Anti Nuclear Antibodies Serum Antistreptolysin O titre (ASOT) DXC 800 Serum Anti Hepatitis B Core IgM Antibody (Anti-HBc IgM) Architect Serum Anti Hepatitis B Surface Antibody (Anti-HBs) Architect Serum, CSF Cryptococcal Antigen Serum Hepatitis A Architect Serum Hepatitis B Surface Antigen (HBsAg) Architect Serum Hepatitis C Architect Serum HIV Architect / Elisa / DXI Serum Rapid Plasma Reagin (Syphilis) Flocculation Test Serum Treponema Pallidum Antibody (TPAB) Architect Plasma Viral Load Ampliprer / Taqman Roche Cytology Gynae: Cervical Smears Non Gynae: Pleural Fluid, Peritoneal Fluid, Pericardial Fluid, Hydrocele Fluid, Synovial Fluid, Sputum, Urine, CSF, Fine Needle Aspirate, Brushes, Wipes, Washings Specimen Prep: Staining Mounting Screening Specimen Prep: Staining Mounting Screening & Leica Stainer & Leica Stainer Centrifuge Cytospin Page 4 of 5
6 Original Date of Accreditation: 02 July 2010 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Field Manager Page 5 of 5
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