CERTIFICATE OF ACCREDITATION

Transcription

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) NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES (NICD) Practice No.: PR MICROBIOLOGY REFERENCE UNIT Facility Accreditation Number: M0029G 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 MOLECULAR BIOLOGY 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: 01 June 2012 Certificate Expires: 31 May 2016

2 ANNEXURE A SCHEDULE OF ACCREDITATION Permanent Address of Laboratory: National Health Laboratory Service (NHLS) National Institute for Communicable Diseases (NICD), Microbiology Reference Unit 1 Modderfontein Road, Sandringham Signatories: Signatories as authorised by the Head of Laboratory Johannesburg 2138 Postal Address: Private Bag X4 Contact Person: Mr H P Julius Sandringham 2138 Tel: (011) Issue No.: 07 Fax: (011) Date of Issue: 23 October henryj@nicd.ac.za Expiry Date: 31 May 2016 Discipline / Sample Type Molecular Biology Sexually Transmitted Infections Reference Centre (STIRC) Urine, Genital Swabs (Penile, Vaginal, Urethral, Endocervical) Type of Tests Naats Testing for N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium Equipment / Method DNA Extraction, Amplification, DetectionMethod use: Real Time PCR, Amptima Combo 2, Amptima CT, Amptima NG Genital Ulcers Naats Testing for HSV 1&2, H. ducreyi, T. pallidum DNA Extraction, Amplification, Detection Real Time PCR Genital Swabs, Ulcers Naats Testing for LGV DNA Extraction, Amplification, Detection, Inhouse Real Time PCR Microbiology Sexually Transmitted Infections Reference Centre (STIRC) Genital Swabs (Penile, Vaginal, Urethral, Endocervical) Microbiological Detection for N. gonorrhoeae Culture and Identification Bacterial Isolates MIC (Antimicrobial Susceptibility Testing) E-test, Agar Dilution Method Blood, Sera Serological Testing for HSV-2, Syphilis, Chlamydia, HIV Rapid Tests HSV-2 (EIA Elisa) Syphilis (RPR, TPPA) Chlamydia (Microimmunofluorescence Test) HIV Rapid Tests Page 1 of 5

3 Special Bacterial Pathogens Reference Laboratory (SBPRL) Environmental Specimens Culture Isolation of B. antracis Manual Method Serum Detection of Anti-FI antibody (Yersina Pestis) EIA Competitive Blocking Enzyme Linked Immunosorbent Assay for Antibody Detection Suspected Bacillus Anthracis Penicillin sensitivity test for Bacillus anthracis Antibiotic Susceptibility Test Culture Phage for Bacillus anthracis Serum Leptospira IgM Panbio Elisa Respiratory Meningeal Pathogens Research Unit (RMPRU) of Streptococcus pneumoniae Isolated from of Neisseriam Meningitidis Isolated from for Haemophilus influenzae Isolated from Molecular Biology Respiratory Meningeal Pathogens Research Unit (RMPRU) of Streptococcus pneumoniae Isolated from of Neisseria Meningitidis Isolated from for Haemophilus influenzae Isolated from CSF or Blood Culture (Culture Negative, Latex and/or Gram Stain Microscopy Positive for Haemophilus Influenzae, Streptococcus Pneumoniae and Neisseria Meningitidis) PCR for Identification PCR for Serogrouping and Identification PCR for Serogrouping and Identification PCR for Identification Antimicrobial Susceptibility Testing (Discs and MICs), (Quellung) Antimicrobial Susceptibility Testing (MICs), Serogrouping (Slide Agglutination) Antimicrobial Susceptibility Testing (Discs and MICs), (Slide Agglutination) Page 2 of 5

4 Mycology Reference Unit of Candida Species isolated from Blood Culture Molecular Identification of Fungi Microbiology Enteric Disease Reference Unit (EDRU) CED Bacteriology PCR and Sequencing for Identification Chromogenic Agar and Vitel / API for Identification Antifungal Susceptibility Testing MICs Broth Dilution and E- tests) ABI Sequencer Isolate: Salmonella Identification API 20E / Vitek Isolates on Dorset transport medium Salmonella sp Isolated Antimicrobial Susceptibility Testing Slide Agglutination Using Commercial Antisera Agar Plates Using Etests Strips and Antimicrobial Discs Isolate: Shigella Identification API 20E / Vitek of Shigella sp Isolated Antimicrobial Susceptibility Testing Slide Agglutination Using Commercial Antisera Agar Plates Using Etests Strips and Antimicrobial Discs Isolate: Diarrhoeagenic E.Coli Identification API 20E / Vitek of Diarrhoeagenic E. Coli Isolated Stool, Rectal Swabs Environmental Isolates (Soil, Water, Food) Tube / Microtitre Plate Agglutination Test Using Commercial Antisera Isolate: Vibrio cholerae Identification API 20E / Vitek of Vibrio Cholera Isolated Slide Agglutination Using Commercial Antisera Page 3 of 5

5 Isolate: Salmonella Isolates on Dorset transport mediumsalmonella sp Isolated DNA Fingerprinting of Strains via PFGE Analysis DNA Fingerprinting of Salmonella Typhi Strains via MLVA Biorad CHEF-DRIII Electrophoresis System DNA Thermal Cycler and and Agarose Gel Electrophoresis Unit Isolate: Shigella of Shigella sp Isolated DNA Fingerprinting of Strains via PFGE Analysis Biorad CHEF-DRIII Electrophoresis System Isolate: Diarrhoeagenic E.Coli of Diarrhoeagenic E. Coli Isolated Stool, Rectal Swabs Environmental Isolates (Soil, Water, Food) Virulence Gene Identification via Multiplex PCR DNA Thermal Cycler and and Agarose Gel Electrophoresis Unit DNA Fingerprinting of Strains via PFGE Analysis Biorad CHEF-DRIII Electrophoresis System Isolate: Vibrio cholerae PCR for Cholera Toxin DNA Thermal Cycler and and Agarose Gel Electrophoresis Unit of Vibrio Cholera Isolated Parasitology Reference Unit Stool Stool Parasite Identification Formalin-ethyl Acetate Concentration, Modified Ziehl-Neelsen Acid Fast Stain, Light Microscopy Blood Blood Parasite Identification Parasite Concentration, Giemsa Stain, Antigen Detection, Light Microscopy Sputum Pneumocystis Detection Parasite Concentration, IFA Stain, Fluorescence Microscopy Page 4 of 5

6 Parasitology Molecular Biology Blood, Respiratory Samples, Stools, Urines, Tissue Conventional PCR / Realtime PCR Eppendorf Mastercycler / AB 7500 Realtime System Antimicrobial Resistance Reference Laboratory Isolates on Blood Agar Plates Real Time PCR of Antibiotic Resistant Gene Real Time PCR Machine Isolates on Blood Agar Plates Isolates on Blood Agar/McConkey Plates Conventional PCR of Antibiotic Resistant Genes and Typing Identification and Antimicrobial Susceptibility Testing Thermal Cycler Microscan-Vitek and Maldi- TOF Original Date of Accreditation: 26 June 2008 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM Field Manager Page 5 of 5