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) MICROBIOLOGY REFERENCE UNIT 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 MOLECULAR BIOLOGY 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: 01 June 2012 Certificate Expires: 31 May 2016

2 SCHEDULE OF ACCREDITATION Facility Number: Permanent Address of Laboratory: National Health Laboratory Service (NHLS) National Institute for Communicable Diseases (NICD) Microbiology 1 Modderfontein Road Sandringham Johannesburg 2138 Postal Address: Private Bag X4 Sandringham 2138 Signatories: Signatories as authorised by the Head of Laboratory Contact Person: Mr H P Julius Tel: (011) Issue No.: 06 Fax: (011) henryj@nicd.ac.za MOLECULAR BIOLOGY Sexually Transmitted Infections Reference Centre Urine, Genital Swabs (Penile, Naats Testing for N. gonorrhoeae, DNA Extraction, Amplification, Detection Vaginal, Urethral, Endocervical) C. trachomatis, T. vaginalis, M. genitalium Method use: Real Time PCR, Amptima Combo 2, Amptima CT, Amptima NG Genital Ulcers Naats Testing for HSV 1&2, H. ducreyi, DNA Extraction, Amplification, Detection T. pallidum Real Time PCR Genital Swabs, Ulcers Naats Testing for LGV DNA Extraction, Amplification, Detection, In-house Real Time PCR MICROBIOLOGY Sexually Transmitted Infections Reference Centre (STIRC) Genital Swabs (Penile, Vaginal, Microbiological Detection for N. gonorrhoeae, Culture and Identification Urethral, Endocervical) C. trachomatis, T. vaginalis Bacterial Isolates MIC (Antimicrobial Susceptibility Testing) E-test, Agar Dilution Method Blood, Sera Serological Testing for HSV-2, Syphilis, HSV-2 (EIA Elisa) Chlamydia, HIV Rapid Tests Syphilis (RPR, TPPA) Chlamydia (Microimmunofluorescence Test) HIV Rapid Tests Original Date of Accreditation: 26 June 2008 Page 1 of 5

3 MICROBIOLOGY (Continued) Special Bacterial Pathogens Reference Laboratory (SBPRL) Environmental Specimens Culture Isolation of B. antracis Manual Method Serum Detection of Anti-FI antibody (Yersinia pestis) EIA Competitive Blocking Enzyme Linked Immunosorbent Assay for Antibody Detection Suspected Bacillus Anthracis Culture Penicillin Sensitivity Test for Bacillus anthracis Antibiotic Susceptibility Test Phage for Bacillus anthracis Serum Leptospira IgM Panbio Elisa Respiratory Meningeal Pathogens Research Unit (RMPRU) Isolates on Dorset Transport Identification and Susceptibility Antimicrobial Susceptibility Testing Medium of Streptococcus (Discs and MICs), Serotyping pneumoniae Isolated from Normally (Quellung) Sterile Sites (Mostly Blood Culture and CSF) Isolates on Dorset Transport Identification and Susceptibility Antimicrobial Susceptibility Testing Medium of Neisseriam Meningitidis (MICs), Serogrouping (Slide Agglutination) Isolates on Dorset Transport Identification and Susceptibility Antimicrobial Susceptibility Testing Medium for Haemophilus influenzae (Discs and MICs), Serotyping (Slide Agglutination) CSF or Blood Culture Identification Antigen Detection (Culture Negative, Latex and / or Gram Stain Microscopy Positive for Haemophilus Influenzae, Streptococcus Pneumoniae and Neisseria Meningitidis) MOLECULAR BIOLOGY Respiratory Meningeal Pathogens Research Unit Isolates on Dorset Transport Identification PCR for Identification Medium of Streptococcus pneumoniae Isolated from Normally Sterile Sites (Mostly Blood Culture and CSF) Isolates on Dorset Transport Identification PCR for Serogrouping and Identification Medium of Neisseriam Meningitidis Original Date of Accreditation: 26 June 2008 Page 2 of 5

4 MOLECULAR BIOLOGY (Continued) Respiratory Meningeal Pathogens Research Unit Isolates on Dorset Transport Identification PCR for Identification and Serotyping Medium for Haemophilus influenzae CSF or Blood Culture Identification PCR for Identification (Culture Negative, Latex and/or Gram Stain Microscopy Positive for Haemophilus Influenzae, Streptococcus Pneumoniae and Neisseria Meningitidis) Mycology Reference Unit Isolates on Dorset Transport Identification of Cryptococcus Species API, Niger Seed Agar and Medium of Cryptococcus from L Canavanine Glycine Bromothymol Sterile Sites (Mostly Blood Culture Blue Medium Used for Cryptococcus and CSF) Identification Molecular Identification of Fungi Identification PCR and Sequencing for Identification MICROBIOLOGY Enteric Disease Reference Unit (EDRU) CED Bacteriology Isolate: Salmonella Identification API 20E / Vitek Isolates on Dorset transport medium Serotyping Slide Agglutination Using Commercial Salmonella sp Isolated Antisera Antimicrobial Susceptibilities Testing Agar Plates Using Etests Strips and Antimicrobial Discs Isolate: Shigella Identification API 20E / Vitek Isolates on Dorset Transport Serotyping Slide Agglutination Using Commercial Medium of Shigella sp Isolated Antisera Antimicrobial Susceptibilities Testing Agar Plates Using Etests Strips and Antimicrobial Discs Isolate: Diarrhoeagenic E.Coli Identification API 20E / Vitek Isolates on Dorset Transport Serotyping Tube / Microtitre Plate Agglutination Medium of Diarrhoeagenic E. Coli Test Using Commercial Antisera Isolated Stool, Rectal Swabs Environmental Isolates (Soil, Water, Food) Original Date of Accreditation: 26 June 2008 Page 3 of 5

5 MOLECULAR BIOLOGY (Continued) Enteric Disease Reference Unit Isolate: Vibrio cholerae Identification API 20E / Vitek Isolates on Dorset Transport Serotyping Slide Agglutination Using Commercial Medium of Vibrio Cholera Isolated Antisera Body Sites Isolate: Salmonella DNA Fingerprinting of Strains via PFGE Biorad CHEF-DRIII Electrophoresis Isolates on Dorset transport medium Analysis System Salmonella sp Isolated DNA Fingerprinting of Salmonella Typhi DNA Thermal Cycler and an Agarose Body Strains via MLVA Gel Electrophoresis Unit Sites Isolate: Shigella DNA Fingerprinting of Strains via PFGE Biorad CHEF-DRIII Electrophoresis Isolates on Dorset Transport Analysis System Medium of Shigella sp Isolated Isolate: Diarrhoeagenic E.Coli Virulence Gene Identification Via Multiplex DNA Thermal Cycler and an Agarose Isolates on Dorset Transport PCR Gel Electrophoresis Unit Medium of Diarrhoeagenic E. Coli DNA Fingerprinting of Strains Via PFGE Biorad CHEF-DRIII Electrophoresis Isolated Analysis System Stool, Rectal Swabs Environmental Isolates (Soil, Water, Food) Isolate: Vibrio cholerae PCR for Cholera Toxin DNA Thermal Cycler and Isolates on Dorset Transport Electrophoresis Units Medium 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 Original Date of Accreditation: 26 June 2008 Page 4 of 5

6 MOLECULAR BIOLOGY Continued 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 Conventional PCR of Antibiotic Resistant Genes Thermal Cycler Isolates on Blood Agar/McConkey Plates and Typing Antimicrobial Susceptibility Testing Microscan and Vitek Original Date of Accreditation: 26 June 2008 Page 5 of 5 ISSUED BY THE SOUTH AFRICAN NATIONAL ACCREDITATION SYSTEM