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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 Facility Number: M0197 ANNEXURE A SCHEDULE OF ACCREDITATION Facility Number: M0197 Permanent Address of Laboratory: Signatories: Signatories as authorised by the Head of Laboratory National Health Laboratory Service (NHLS) Charlotte Maxeke JHB Academic Hospital, Microbiology Laboratory Area 454, Room 10 Cnr York and Jubilee Road Parktown 2193 Postal Address: Contact Person: P O Box 1038 Miss S Naidoo Johannesburg 2000 Tel: (011) 489-8421 Fax: E-mail: [email protected] Discipline / Sample Type Issue No.: 12 Date of Issue: 20 December 2016 Expiry Date: 01 January 2019 Type of Tests Equipment / Method Microbiology Microscopy: Urine Wet Preparations for Bilharzia & Trichomonas Manual Method Stool Cryptosporidium Stain Manual Method Stool Concentration for Faecal Parasites Manual Method Blood Malaria Smears: Manual Method Giemsa Stain, Quick Diff Stain Whole Blood Malaria Antigen Manual Method Pus, Fluids include Pleural, Pericardial, Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Culture Gram Stain Manual Method Genital Swabs Acid Fast Bacilli Manual Method Sputum Ziehl Neelsen Stain Manual Method Sputum Fluorescent Stain Manual Method Page 1 of 4 Facility Number: M0197 Urine, Stool, Pus and Fluids include Pleural, Pericardial Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Culture Aerobic, Anaerobic and Micro-aerophillic Manual Method-Media Urine, Stool, Pus and Fluids include Pleural, Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Culture Bacterial Cultures Manual Method-Media Blood Cultures Determination of Positive Cultures BacT/Alert 3D Anti-Microbial Testing of Pathogens: Manual Method-Media Sensitivity: All Specimens Kirby Bauer, ESBL Sputum Sensitivity Vitek 2XL TB GeneXpert Identification Procedures: Gram Positive Cocci (Aerobic) Catalase DNA Agar Manual Method Aesculin Bile Manual Method Pyruvate Manual Method Arabinose Manual Method 6.5% Salt Broth Manual Method Optochin Manual Method Bacitracin Manual Method Streptex Manual Method Staphaurex Manual Method Identification and Sensitivity Vitek 2XL Gram Negative Cocci (Aerobic) Oxidase Page 2 of 4 Manual Method NH API Manual Method Identification Vitek 2XL Gram Positive Bacilli (Aerobic) Catalase Gram Negative Bacilli (Aerobic) (Excluding Haemophilus) Manual Method Manual Method Aesculin Bile Manual Method Identification Vitek 2XL Oxidase Manual Method Fermentation of Sugars Manual Method Facility Number: M0197 Decarboxylation of Amino Acids Manual Method Indole Manual Method Urea Manual Method H2S Production Manual Method Utilization of Citrate Manual Method 20E API, NE API Manual Method Identification and Sensitivity Vitek 2XL X and V Factor Requirement Manual Method NH API Manual Method Identification Vitek 2XL CSF Bacterial Latex Manual Method CSF Cryptococcal Latex Manual Method Stool Clostridium Difficile Toxin Manual Method Sputum TB GeneXpert E-Test MIC's Manual Method Urine, Stool, Pus and Fluids include Pleural, Pericardial, Peritoneal, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, Blood Cultures, Tissue PAS Stain Manual MethodMicroscopy Urine, Stool, Pus and Fluids include Pleural, Pericardial, Ascetic, Pigtail, Knee, Joint, Drain, Throat Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washing, Bronchial Alveolar Lavages, CSF, Blood Culture, Scrapings PAS Stain also for: Histoplasma, Blastomyces, Mucormycosis Manual MethodMicroscopy CSF India Ink Stain Manual MethodMicroscopy Bronchial Alveolar Lavages, Pus, Fluids include Pleural, Pericardial, Ascetic, Pigtail, Knee, Joint, Drain, Sputum, Tracheal Aspirates, Bronchial Washings, Tissue Kinyoun Stain Manual MethodMicroscopy Haemophilus Antigen Testing: Other: Antibiotic Laboratory Organisms Mycology Microscopy: Page 3 of 4 Facility Number: M0197 Bronchial Alveolar Lavages, Pus, Fluids include Pleural, Pericardial, Ascetic, pigtail, Knee, Joint, Drain, Sputum, Tracheal Aspirates, Bronchial Washings, Tissue Kinyoun Stain also for: Anaerobic and Aerobic Actinomyces & Nocardia Manual MethodMicroscopy Culture: Urine, Stool, Pus and Fluids Fungal Cultures include Pleural, Pericardial, Ascetic, Pigtail, Knee, Joint, Drain Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Cultures, Scrapings, Tissue Manual Method-Media Urine, Stool, Pus and Fluids Cultures also for: Histoplasma Blastomyces, Manual Method-Media include Pleural, Pericardial, Anaerobic and Aerobic Actinomyces, Nocardia Ascetic, Pigtail, Knee, Joint, & Mucormycosis Drain Throat Swabs, Nose Swabs, Ear Swabs, Pus Swabs, Genital Swabs, Sputum, Tracheal Aspirates, Bronchial Washings, Bronchial Alveolar Lavages, CSF, Blood Cultures, Scrapings Identification Procedures: Yeast Germ Tube Manual Method-Media Urea Manual Method 20C Aux Manual Method Identification and Sensitivity Vitek 2XL Original Date of Accreditation: 01 January 2003 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM __________________________________ Accreditation Manager Page 4 of 4
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