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) CHARLOTTE MAXEKE JOHANNESBURG ACADEMIC HOSPITAL CLINICAL MICROBIOLOGY 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 MICROBIOLOGY 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: 02 January 2011 Certificate Expires: 01 January 2015
2 SCHEDULE OF ACCREDITATION Facility Number: Permanent Address of Laboratory: National Health Laboratory Services (NHLS) Charlotte Maxeke Johannesburg Academic Hospital Microbiology Laboratory Area 454, Room 10 Jubilee Road Parktown 2193 Postal Address: National Health Laboratory Services (NHLS) P O Box 1038 Johannesburg 2000 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Mr C Moodly Tel: (011) Issue No.: 08 Fax: (011) clive.moodly@nhls.ac.za MICROBIOLOGY Urine Wet Preparations / Cell Counts -Microscopy Urine Wet Preparations for Bilharzia & Trichomonas Stool Wet Preparations Stool Cryptosporidium Stain Stool Concentration for Faecal Parasites Blood Malaria Smears: Giemsa Stain, Quick Diff Stain Pus, Fluids include Pleural, Pericardial, Gram Stain Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Culture Pus, Fluids include Pleural, Pericardial, Cell Counts Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, CSF Genital Swabs Wet Preparations Acid Fast Bacilli: Sputum Ziehl Neelsen Stain Sputum Fluorescent Stain Diagnostics Peritoneal Lavages Leucocyte & Erythrocyte Counts Original Date of Accreditation: 01 January 2003 Page 1 of 4
3 MICROBIOLOGY (Continued) Urine, Stool, Pus and Fluids include Aerobic, Anaerobic and Micro-Aerophilic -Media Pleural, Pericardial Peritoneal, Ascetic, Bacterial Cultures Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Pus Swabs, Genitals Swabs, Sputum, Tracheal Aspirates, Bronchial Washing Bronchial Alveolar Lavages, Cerebrospinal Fluid, Blood Culture Blood Cultures Determination of Positive Cultures BacT/Alert 3D Sensitivity: All Specimens Anti-Microbial Testing of Pathogens: -Media Kirby Bauer, ESBL MicroScan Sensitivity Urine Antimicrobial Substances Identification Procedures: Gram Positive Cocci (Aerobic) Catalase DNA agar Aesculin Bile Pyruvate Arabinose PYR 6.5% Salt Broth Optochin Bacitracin Streptex Staphaurex MRS Broth Staph API Strept API Gram Negative Cocci (Aerobic) Oxidase NE API Gram Positive Bacilli (Aerobic) Catalase Aesculin Bile Coryne API Lecithinase Production Camp Test Gram Negative Bacilli (Aerobic) Oxidase (Excluding Haemophilus) Fermentation of Sugars Decarboxylation of Amino Acids Indole Urea Original Date of Accreditation: 01 January 2003 Page 2 of 4
4 MICROBIOLOGY (Continued) H 2S Production Utilization of Citrate Hippurate Test 20E API, NE API Haemophilus X and V Factor Requirement NH API Anaerobic Organisms SPS Sensitivity Antigen Testing: CSF Bacterial Latex CSF Cryptococcal Latex Whole Blood Malaria Antigen Other: Stool Rotavirus Stool Clostridium Difficile Toxin Antibiotic Laboratory Organisms E-test MICs SEROLOGY Serum HIV ELISA Advia Centaur XP / Architect i1000sr Serum Hepatitis Advia Centaur XP Serum Rapid HIV Serum RPR Serum Treponema Pallidum Haemagglutination (TPHA) Serum Treponema Pallidum Antibody (TPAB) Architect i1000sr Serum VDRL Urine, Stool, Pus and Fluids include PAS Stain -Microscopy Pleural, Pericardial, Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal PAS Stain also for: Histoplasma, -Microscopy Aspirates, Bronchial Washing, Bronchial Blastomyces, Mucormycosis Alveolar Lavages, Blood Cultures, Scrapings Cerebrospinal Fluid India Ink Stain -Microscopy Scrapings Hair, Skin, Nail NaOH Wet Preparations, also for: -Microscopy Mucormycosis Original Date of Accreditation: 01 January 2003 Page 3 of 4
5 Bronchial Alveolar Lavages, Pus, Kinyoun Stain -Microscopy Fluids include Pleural, Pericardial, Kinyoun Stain also for: Anaerobic and Ascetic, Pigtail, Knee, Joint, Drain, Aerobic Actinomyces & Nocardia Sputum, Tracheal Aspirates, Bronchial Washings Giemsa Stain for: Histoplasma -Microscopy Culture: Urine, Stool, Pus and Fluids include Fungal Cultures -Media Pleural, Pericardial, Ascetic, Pigtail, Knee, Joint, Drain Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genitals Swabs, Sputum, Cultures also for: Histoplasma Tracheal Aspirates, Bronchial Blastomyces, Anaerobic and Aerobic Washing, Bronchial Alveolar Lavages, Actinomyces, Nocardia & Mucormycosis CSF, Blood Culture, Scrapings Identification Procedures: Moulds Block Mounts LPCB Stain Yeasts Germ Tube -Media Urea 20C Aux Whole Blood Fungitell -Elisa Original Date of Accreditation: 01 January 2003 Page 4 of 4 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM
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