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) CHARLOTTE MAXEKE JOHANNESBURG ACADEMIC HOSPITAL Practice No.: PR 5200296 CLINICAL MICROBIOLOGY LABORATORY Facility Accreditation Number: M0197 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 MICROBIOLOGY AND MYCOLOGY 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: 21 May 2015 Certificate Expires: 01 January 2019
ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0197 Permanent Address of Laboratory: National Health Laboratory Service (NHLS) Charlotte Maxeke JHB Academic Hospital, Microbiology Laboratory Area 454, Room 10 Signatories: Signatories as authorised by the Head of Laboratory Cnr York and Jubilee Road Parktown 2193 Postal Address: P O Box 1038 Contact Person: Miss S Naidoo Johannesburg 2000 Tel: (011) 489-8421 Issue No.: 13 Fax: Date of Issue: 14 December 2017 E-mail: sudeshi.naidoo@nhls.ac.za Expiry Date: 01 January 2019 Discipline / Sample Type Type of Tests Equipment / Method Microbiology : Urine Iris Urine Wet Preparations for Bilharzia & Trichomonas Stool Cryptosporidium Stain Stool Concentration for Faecal Parasites Blood Malaria Smears: Giemsa Stain, Quick Diff Stain Whole Blood Malaria Antigen Pericardial, Peritoneal, Drain, Ear Swabs, Pus Swabs, Lavages, CSF, Blood Culture Gram Stain Sputum Ziehl Neelsen Stain Sputum Fluorescent Stain Page 1 of 4
include Pleural, Pericardial Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, CSF, Blood Culture include Pleural, Peritoneal, Drain, Ear Swabs, Pus Swabs, Lavages, CSF, Blood Culture Aerobic, Anaerobic and Micro-aerophillic Bacterial Cultures -Media -Media Blood Cultures Determination of Positive Cultures BacT/Alert 3D : All Specimens Anti-Microbial Testing of Pathogens: -Media Kirby Bauer, ESBL Sputum TB GeneXpert Procedures: Gram Positive Cocci (Aerobic) Catalase DNA Agar Aesculin Bile Pyruvate Arabinose Vitek 2XL / 6.5% Salt Broth Optochin Bacitracin Streptex Staphaurex Gram Negative Cocci (Aerobic) Oxidase NH API Gram Positive Bacilli (Aerobic) Catalase Gram Negative Bacilli (Aerobic) (Excluding Haemophilus) Aesculin Bile Oxidase Vitek 2XL / Page 2 of 4
Indole 20E API, NE API Vitek 2XL / Haemophilus X and V Factor Requirement Antigen Testing: NH API Vitek 2XL / Manual Method CSF Bacterial Latex CSF Cryptococcal Lateral Flow Assay Other: Stool Clostridium Difficile Toxin Antibiotic Laboratory Organisms E-Test MIC's Mycology : Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Lavages, Blood Cultures, Tissue Drain, Throat Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washing, Bronchial Alveolar Lavages, CSF, Blood Culture, Scrapings PAS Stain PAS Stain also for: Histoplasma, Blastomyces, Mucormycosis - - CSF India Ink Stain - Pericardial, Ascetic, Pigtail, Knee, Joint, Drain, Sputum, Washings, Tissue Kinyoun Stain - Page 3 of 4
Pericardial, Ascetic, pigtail, Knee, Joint, Drain, Sputum, Washings, Tissue Kinyoun Stain also for: Anaerobic and Aerobic Actinomyces & Nocardia - Culture: Drain Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Lavages, CSF, Blood Cultures, Scrapings, Tissue Drain Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Lavages, CSF, Blood Cultures, Scrapings Procedures: Fungal Cultures Cultures also for: Histoplasma Blastomyces, Anaerobic and Aerobic Actinomyces, Nocardia & Mucormycosis -Media -Media Yeast Germ Tube -Media Serology Urea 20C Aux Vitek 2XL / Serum Rapid Plasma Reagin (RPR) Serum Treponema Pallidum Antibody (TPAB) Serum, CSF Treponema Pallidum Heamagglutination (TPHA) CSF VDRL Original Date of Accreditation: 01 January 2003 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Accreditation Manager Page 4 of 4