Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Transcription

1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Public Health Wales Microbiology and Health Protection 4 th Floor No 2 Capital Quarter Tyndall Street Cardiff CF10 4BQ Contact: Anne Thomas Tel: +44 (0) (ext 5028) anne.thomas5@wales.nhs.uk Website: &pid=25400 Laboratory locations: below s covered by the organisation and their relevant activities details Activity Locatio n code Address Public Health Wales Microbiology Swansea Singleton Hospital Swansea SA2 8QA Contact Julian Rogers Bacteriology, Virology, Molecular testing S Prof. Rachel Chalmers Cryptosporidium reference unit CRU Prof. Edward Guy Toxoplasma Reference Unit TRU Public Health Wales Microbiology North Wales (Bangor Site) Ysbyty Gwynedd Bangor Gwynedd LL57 2PW Steve Murphy Bacteriology B Public Health Wales Microbiology North Wales (Rhyl Site) Ysbyty Glan Clwyd Rhyl Denbighshire LL18 5UJ Steve Murphy Bacteriology, Virology R Public Health Wales Microbiology North Wales (Wrexham Site) Ysbyty Maelor Wrexham Croesnewydd Road Wrexham LL13 7TD Steve Murphy Bacteriology W Assessment Manager: AB2 1 of 30

2 details Activity Locatio n code Public Health Wales Microbiology Carmarthenshire West Wales General Hospital Glangwilli Carmarthen SA31 2AF Andy Keen Bacteriology CM Public Health Wales Microbiology Aberystwyth Bronglais General Hospital Caradog Road Aberystwyth SY23 1ER Caroline Longman Bacteriology A Public Health Wales Microbiology Cardiff University Hospital of Wales Heath Park Cardiff CF14 4XW Lisa Chichester Bacteriology, Virology, Molecular testing Trefor Morris UK Anaerobe Reference Unit ARU Dr Mandy Wootton Specialist Antimicrobial Chemotherapy unit SACU Dr Lewis White Mycology Regional Reference Unit MRRU Dr Sally Corden Molecular Diagnostics unit MDU Public Health Wales Microbiology Cardiff (Wales Centre for Mycobacteria) Llandough Hospital Penlan Road Penarth CF64 2XX Dr Jason Evans Wales Centre for Mycobacteria WCM Site activities performed away from the locations listed above: details Activity code GUM/Integrated Sexual Health Clinic Cardiff Royal Infirmary Newport Road Cardiff CF24 0SZ Lisa Chichester Bacteriology GUM Assessment Manager: AB2 Page 2 of 30

3 DETAIL OF ACCREDITATION Microbiology examination clinical diagnosis In house documented methods incorporating manufacturer s instructions where relevant Faeces, Genital samples, Skin & Superficial wound swabs, Screen swabs: faeces, nose, axilla, groin, perineum, lesions, wounds, indwelling devices, tracheostomy, ear swabs, intravascular cannulae and Associated Specimens, Eye specimens, Mouth swabs, Nose swabs, pernasal swabs and sinus aspirates, Throat/tonsil swabs, Gastric Aspirates and Infection Screen Swabs from Neonates, Investigation of sputum, bronchoalveolar lavage and associated specimens Isolation and characterisation of micro-organisms of clinical significance. Using microscopy, manual gram stain, and manual culture Becton Dickinson workcell automation Kiestra at Rhyl (not for faeces and respiratory samples) MDBSOP 030 MDBSOP 028 MDBSOP 011 MDBSOP 024 MDBSOP 001 MDBSOP 020 MDBSOP 002 MDBSOP 004 MDBSOP 005 MDBSOP 009 MDBSOP 023 MDBSOP 057 A, S,, CM, R MDBSOP 053 MDBSOP 047 Bone joint samples, Sterile fluids, continuous ambulatory peritoneal dialysis (CAPD), Abscesses and Deep Wound infection samples: pus, wound drain fluid, Tissues and Biopsies, CSF Isolation and characterisation of micro-organisms of clinical significance. Using microscopy, manual gram stain, and manual culture Becton Dickinson workcell automation Kiestra at Rhyl A, S,, CM, R, B, W MDSOP 042 MDBSOP 026 MDBSOP 025 MDBSOP 014 MDBSOP 017 Assessment Manager: AB2 Page 3 of 30

4 Microbiology examination clinical diagnosis (cont d) In house documented methods incorporating manufacturer s instructions where relevant Blood Isolation and characterisation of micro-organisms of clinical significance. Using microscopy, manual gram stain, manual culture, biochemical test kits, agglutination test kits and sera as appropriate. A, S,, CM, R, B, W Automated culture using BD BacTec FX MDBSOP 037 Urine, expressed prostatic secretions Isolation and characterisation of micro-organisms of clinical significance. Using microscopy, manual gram stain, and manual culture MDBSOP 041 MDBSOP 003 A (urine only), S,, CM, R Detection, identification and quantification of red cells, white cells and epithelial cells of clinical significance Automated method Menarini Sedimax Beckman Coulter iq200 sprint R S, MDBSOP 041 MDBSOP 003 Detection, identification and quantification of red cells, white cells and epithelial cells of clinical significance Manual microscopy MDBSOP 041 MDBSOP 003 A, S,, CM, R B, W Clinical isolates cultured inhouse Identification of microorganisms of clinical significance. Using manual biochemical tests (all sites) Identification using Maldi-ToF: Bruker Maldi-ToFs at Swansea, Cardiff, and Rhyl. A, S,, CM, R, B, W MDBSOP 100 Assessment Manager: AB2 Page 4 of 30

5 Microbiology examination clinical diagnosis (cont d) In house documented methods incorporating manufacturer s instructions where relevant Clinical isolates cultured inhouse Antibiotic susceptibility testing of micro-organisms of clinical significance. Antibiotic susceptibility testing, based on EUCAST and BSAC guidance, using disc diffusion and gradient strips A, S,, CM, R, B, W MDBSOP 052DD MDBSOP 052 GS Clinical isolates cultured inhouse from blood culture specimens In-house direct susceptibility testing MDBSOP 037 A, S,, CM, R, B, W Clinical isolates cultured inhouse from urine specimens In-house direct susceptibility testing MDBSOP 041 A, S,, CM, R, Sterile fluids including CSF, CSF shunts, CAPD Detection, identification and quantification of red cells and white cells of clinical significance Cell count, light microscopy, manual gram stain, manual differential stain MDBSOP 027 MDBSOP 022 A, S,, CM, R, B, W Faeces Detection of Clostridium difficile toxins A & B and Clostridium difficile GDH Using Alere Quik Chek Complete kit Enzyme Immunoassay A,, CM, R, S MDBSOP 010 Faeces Detection of Clostridium difficile GDH Using Alere C Diff Chek 60 kit on Dynex DS2 analyser S, R Enzyme Immunoassay MDBSOP 010 Assessment Manager: AB2 Page 5 of 30

6 TISSUES/ FLUIDS Microbiology examination clinical diagnosis (cont d) In house documented methods incorporating manufacturer s instructions where relevant Faeces Detection of Clostridium difficile toxins A & B Using Alere Tox A/B Quik Chek Enzyme Immunoassay S, R MDBSOP 010 Faeces Detection of H Pylori antigen Using IDEIA Hp StAR kit on DS2 analyser S Enzyme Immunoassay MDBSOP 056 Gastric washings, BAL, bronchial washings, CSF, sterile body fluids, blood, urine, skin/tissue, laryngeal swab, bone marrow, sputum Detection of mycobacterium species Using microscopy, manual auramine stain, manual modified ZN stain for acid-fast bacilli, MDBSOP 040 A, S,, CM, R Swabs from nose, groin, throat, perineum, lesions, wounds, indwelling devices, tracheostomy, CSU Isolation and identification of MRSA Using manual culture, biochemical test kits, agglutination test kits and sera as appropriate. A, S,, CM, R Identification using Maldi-ToF: Bruker Maldi-ToFs at Swansea, Cardiff, and Rhyl. Becton Dickinson workcell automation Kiestra at Rhyl MDBSOP 029 Synovial fluid Detection of birefringent crystals Microscopic examination of wet preparations using polarising microscopy S ABMBSOP 126 Assessment Manager: AB2 Page 6 of 30

7 TISSUES/ FLUIDS Microbiology examination clinical diagnosis (cont d) In house documented methods incorporating manufacturer s instructions where relevant Genital swabs, throat swabs, rectal, mouth swabs Detection of bacteria of clinical significance for purposes of sexual health screen Microscopy, manual gram stain, wet preparations GUM Skin, hair, nails and tissue Isolation and characterisation of fungi of clinical significance. Using microscopy, manual KOH method, and manual culture A, S,, CM, R MDBSOP 039 Manual Calcofluor method ABERBBA 039 Manual Lactofuchsin red ABMBBA 039 CMBBA 039, A CM, S, R Clinical isolates cultured inhouse Identification of fungi of clinical significance. Using manual biochemical tests and microscopy A, S,, CM, R MDBSOP 039 MDBSOP 053 Assessment Manager: AB2 Page 7 of 30

8 Parasitology examination clinical diagnosis In house documented methods incorporating manufacturer s instructions where relevant Detection and identification of the following: Faeces Ova, cysts and parasites Manual Parasep concentration method and microscopy A, S,, CM, R Manual ZN/Auramine stain for cryptosporidium MDBSOP 031 Bile, duodenal/jejunal aspirate, Strongyloides stercoralis larvae, Giardia lamblia trophozoites. Centrifugation and wet preparation for light microscopy A, S,, CM, R Oocysts of Cryptosporidium species, Cyclospora cayetanesis and Cystoisospora belli Manual ZN/Auramine stain for cryptosporidium MDBSOP 031 Liver/spleen aspirate Entamoeba histolytica, Leishmania species, Echinococcus granulosus Wet preparation for light microscopy MDBSOP 031 A, S,, CM, R Perianal swab Enterobius vermicularis Centrifugation and wet preparation for light microscopy A, S,, CM, R MDBSOP 031 Clear adhesive tape slide Enterobius vermicularis Light microscopy MDBSOP 031 Urine Schistosoma haematobium Centrifugation and wet preparation for light microscopy A, S,, CM, R A, S,, CM, R MDBSOP 031 Assessment Manager: AB2 Page 8 of 30

9 Serology examination clinical diagnosis Blood Detection of -Hepatitis B Surface Antigen (HBsAg) -Hepatitis B Surface Antibody (Anti-HBs) -Hepatitis B Total Core Antibody (Anti-HBc) -Hepatitis B Core IgM (Anti- HBc IgM) -Hepatitis B e Antigen (HBe) -Hepatitis B e Antibody (Anti- HBe) -Hepatitis A IgM -Hepatitis A IgG -Cytomegalovirus IgG -Hepatitis C Antibody (HCV Ab) -HIV Ag/Ab -HTLV 1&2 -Rubella IgM -Rubella IgG -Syphilis (Total Ab) -Toxoplasma IgG -Cytomegalovirus IgM -Epstein Barr Virus Nuclear Antigen IgG (EBNA) -Epstein Barr Virus Viral Capsid Antigen (VCA) IgM -Epstein Barr Virus Viral Capsid Antigen (VCA) IgG Abbott Architect i2000 using Chemiluminescent microparticle (CMIA) technology WVSOP 001 WVSOP 002 WVSOP 003 VSOP 006 ABMVE 006 ABMVSOP 006, S Assessment Manager: AB2 Page 9 of 30

10 Serology examination clinical diagnosis (cont d) Blood Detection of -HBsAg -HBsAb -Anti HBc -Total Core Antibody -Hepatitis C Antibody (HCV Ab) -HIV Ag/Ab Abbott Architect i2000 using Chemiluminescent microparticle (CMIA) technology WVGUID 001 NWRVSOP006 NWWVSOP004 NWBVSOP101 R Blood Detection of -HBsAg -Anti-HBc -Hepatitis Aber IgM -Cytomegalovirus IgG -HIV Ag/Ab Mini-VIDAS using ELFA technique VSOP 004 Blood Detection of -Borrelia burgdorferi (Lymes) IgG -Borrelia burgdorferi (Lymes) IgM -Mumps IgG -VzV IgG -Measles IgG VIDAS-3 using ELFA technique VSOP 005 Blood Detection of -Hepatitis C Antibody (HCV Ab) Using BioRad MONOLISA EIA kit on Dynex DS2 VSOP 107 Assessment Manager: AB2 Page 10 of 30

11 Serology examination clinical diagnosis (cont d) Blood Confirmatory testing of HIV Ag/Ab Manual Alere Determine HIV 1/2 Ag/Ab Combo kit Immunochromatography technique (ICT) VSOP 116 Blood Typing of HIV Ag/Ab Manual Line Assay HIV Ab - FUJIREBIO INNO-LIA HIV l/ll Score kit Enzyme Immunoassay method VSOP 114 Blood Detection of ASO antibody Manual BioMerieux ASL Kit Blood ELISA WBSOP 058 VSOP 039 Manual Siemens Rapitex kit Latex agglutination method NWVSOP 001 R Assessment Manager: AB2 Page 11 of 30

12 Serology examination clinical diagnosis (cont d) Urine Detection of Legionella Urinary Antigen Binax Legionella Urinary Antigen EIA on Dynex DS2 S, WBSOP 033 ABMVSOP 041 VSOP 041 Urine Binax NOW Legionella Urinary Antigen rapid immunochromatographic assay., S, R, B, W VSOP 042 ABMVSOP 042 NWVSOP042 Blood Detection of Helicobacter pylori IgG Quanta Lite Helicobacter pylori EIA kit on Dynex DS2 S, WBSOP 006 ABMVSOP 050 VSOP 051 Blood Detection of Herpes Simplex IgG NovaLisa EIA Herpes Simplex Virus 1 & 2 (HSV) IgG kit on Dynex DS2 VSOP 024 Blood Varicella zoster IgM Siemens Enzygnost Anti-VZ IgM kit on Dynex DS2 VSOP 023 Blood Measles IgG NovaLisa EIA measles virus IgG kit on Dynex DS2 VSOP 024 Blood Measles IgM NovaLisa EIA measles virus IgM kit on Dynex DS2 VSOP 024 Assessment Manager: AB2 Page 12 of 30

13 Serology examination clinical diagnosis (cont d) Blood Mumps IgM NovaLisa EIA mumps virus IgM kit on Dynex DS2 VSOP 024 Blood Detection of Mycoplasma pneumonia antibody particle agglutinations Manual Fujirebio Serodia MYCO ll test Particle agglutination test WVSOP 001 WVSOP 002 WVSOP 003 VSOP 036 Faeces Detection of Norovirus antigen r-biopharm Ridaquick Immunochromatography technique (ICT) R WVSOP 005 WVSOP 001 WVSOP 003 VSOP 211 NWVSOP 211 Assessment Manager: AB2 Page 13 of 30

14 Serology examination clinical diagnosis (cont d) Nasopharyngeal aspirate Detection of respiratory syncytial virus antigen ClearView RSV kit Immunoassay method R NWVSOP011 RSV Directigen EZ kit W Chromatographic immunoassay NWWVSOP401 Blood Detection of Syphilis Rapid Plasma Reagin (RPR) antibody biokit Rapid Plasma Reagin flocculation test. WVSOP 004 ABMVSOP 043 VSOP 043 S Blood Syphilis Treponema Pallidum Haemagglutination (TPHA) biokit Syphagen Indirect haemagglutination test kit. S WVSOP 001 WVSOP 002 WVSOP 003 ABMVSOP 043 VSOP 043 Blood Detection of Varicella zoster IgG Binding Site VaccZyme VZV glycoprotein IgG low level EIA Kit S WVSOP 001 WVSOP 002 WVSOP 003 VSOP 021 ABMVSOP 020 Assessment Manager: AB2 Page 14 of 30

15 Serology examination clinical diagnosis (cont d) Urine Detection of Strep. Pneumoniae urinary antigen Binax NOW Str. pneumoniae Urinary Antigen rapid immunochromatographic assay kit B, R, W NWVSOP402 Blood Parvovirus IgG & IgM Biotrin Parvovirus IgG & IgM Immunofluorescent Antibody MANUAL technique WVSOP 001 WVSOP 002 WVSOP 003 VSOP 019 Detection of the following: Using Dynex DS2 analyser Blood Parvovirus IgM Biotrin Parvovirus B19 IgM Enzyme Immunoassay ELISA WVSOP 001 WVSOP 002 WVSOP 003 VSOP 017 ABMVSOP 017, S Parvovirus IgG Biotrin Parvovirus B19 IgG Enzyme Immunoassay ELISA, S WVSOP 001 WVSOP 002 WVSOP 003 VSOP 017 ABMVSOP 018 Assessment Manager: AB2 Page 15 of 30

16 Serology examination clinical diagnosis (cont d) Blood Detection of Syphilis IgM CAPTIA NMT Syphilis IgM EIA. S WVSOP 001 WVSOP 002 WVSOP 003 ABMVSOP 043 Faeces Qualitative detection of groupspecific proteins, including the major inner capsid protein (VP6), present in Group A rotaviruses. ProSpecT Rotavirus enzyme immunoassay. DS2 at Swansea Manual at Cardiff S WVSOP 001 WVSOP 002 WVSOP 003 VSOP 209 ABMVSOP 209 Assessment Manager: AB2 Page 16 of 30

17 Molecular examination clinical diagnosis Confirmatory testing for: Abbott m2000. Reverse transcription-polymerase chain reaction (RT-PCR) WVSOP 001 WVSOP 002 WVSOP 003 Blood Hepatitis B DNA Abbott RealTime HBV assay VSOP 105 Hepatitis C RNA Abbott RealTime HCV assay VSOP 109 Hepatitis C Genotype Abbott RealTime HCV Genotype II assay. VSOP 108 HIV Viral Load Abbott RealTime HIV assay. VSOP 111 Urine Vulvovaginal swabs Endocervical swabs CT/NG Nucleic Acid Amplification Test PCR using Cobas 4800 WVSOP 001 WVSOP 002 WVSOP 003 VSOP 255 ABMVSOP 300 NWVSOP300, S, R Skin swabs. genital swabs. mouth swabs. eye swabs. swab not specified, blister swab Detection of Herpes Simplex virus In-house PCR assay using ABI Fast analyser WVGUID 005 VSOP 220 Assessment Manager: AB2 Page 17 of 30

18 Molecular examination clinical diagnosis Faeces Detection of Norovirus In-house PCR assay using ABI Fast analyser WVGUID 005 VSOP 214 Whole blood Detection of Cytomegalovirus QPCR using Vela Sentosa SA kit plus Rotorgene Detection of the following: VSOP 060 RT PCR using ABI 7500 FAST. Extraction using Easy Mag or EZ-1 MSOP 016 MDU CSF, Swabs, Respiratory Swabs, Urine, Faeces CSF, Swabs, Respiratory Swabs, urine Culture isolates, swabs and urine Enterovirus DNA MSOP 047 Measles DNA MSOP 055 N. gonorrhoeae MSOP 026 EDTA Whole blood, CSF Meningococcal spp MSOP 027 EDTA Whole blood Pneumococcal spp MSOP 027 Extraction using EZ-1. PCR using Qiagen Rotorgene 6000 CSF, swabs, urine Herpes Simplex MSOP 011 MDU CSF, swabs, urine Varicella zoster MSOP 012 Assessment Manager: AB2 Page 18 of 30

19 Anaerobe reference unit examination activities for the purpose of clinical diagnosis ARU Bacterial colonies Isolation and identification of anaerobic bacteria of clinical significance Identification using Bruker Maldi- ToF and/or manual culture, biochemical test kits, agglutination test kits and sera as appropriate. ARU PCR thermocycler: ABI Veriti Bionumerics Software Applied Maths ARUSOP 003, 004, 006, 011, 012, 013, 014, 017, 021, 026, 046, 096 Bacterial colonies Antibiotic Susceptibility testing of anaerobic bacteria of clinical significance Using manual culture, MIC strips, Antibiotic infused agar plates, Multipoint inoculator ARU ARUSOP 028,029 Bacterial colonies, Faeces C.difficile ribotyping PCR thermocycler: ABI Veriti ARU ABI Capillary Electrophoresis system Gel doc 2000 imaging system. Bionumerics Software ARUSOP 003, 004, 036, 038, 039, 046, 049, 096 Faeces C.difficile Toxin B gene Nucleic Acid Amplification Technique Portrait Analyser: Great Basin Scientific ARU ARUSOP 002 ARUSOP 003 ARUSOP 108 Assessment Manager: AB2 Page 19 of 30

20 Toxoplasma reference unit examination activities for the purpose of clinical diagnosis TRU Serum, Plasma, CSF Sabin-Feldman Toxoplasma Dye Test: Quantitation of total anti-toxoplasma antibody Dye test by visualisation of dye take up by standard tachyzoite preparation in presence of compliment. TRU TRUASOP 006 Serum, Plasma, CSF Toxoplasma IgM In-house manual Enzyme Immunoassay using Anthos Fluido 2 washer and Thermo Scientific Multiskan FC spectrophotometer TRUSOP 008 TRU Serum, Plasma, CSF Detection of Toxoplasma IgM and IgA Using Biomerieux TOXO-ISAGA IgA and IgM immunosorbant agglutination assay kits TRU TRUSOP 012 TRUSOP 011 Serum, Plasma Toxoplasma IgG avidity In-house manual Enzyme Immunoassay using Jencons Millenium hw2 washer and Thermo Scientific Multiskan FC spectrophotometer. TRU TRUSOP 009 Blood (whole EDTA), CSF, Amniotic fluid, Tissues, Bronchoalveolar lavage, Ocular fluid Confirmatory testing for Toxoplasma Rotorgene 6000 In-house real-time PCR TRUSOP 058 TRUSOP 050 TRU Assessment Manager: AB2 Page 20 of 30

21 Cryptosporidium reference unit examination activities for the purpose of clinical diagnosis CRU Stool, DNA Cryptosporidium genotyping, species identification (all species) and subtyping limited to C. parvum and C hominis only Oocyst separation by centrifugation and flotation. DNA extraction using spin columns, Rotor-gene Q 6plex/RG6000 using real-time PCR technology, conventional PCR, gel electrophoresis, and Sanger sequencing. CRU CRUSOP004 CRUSOP005 CRUSOP028 CRUSOP030 CRUSOP034 CRUSOP041 CRUSOP061 Stool Cryptosporidium confirmation Manual immunofluorescent antibody test by microscopy CRU CRUSOP017 Stool Tissue Fluids Respiratory Cryptosporidium specialist detection Manual immunofluorescent antibody test by microscopy DNA extraction using spin columns, conventional PCR, gel electrophoresis, and Sanger sequencing. CRU CRUSOP017 CRUSOP005 CRUSOP028 CRUSOP030 CRUSOP034 Assessment Manager: AB2 Page 21 of 30

22 Cryptosporidium reference unit examination activities for the purpose of clinical diagnosis (cont d) CRU Stool Giardia genotyping DNA extraction using spin columns, Rotor-gene Q 6plex/RG6000 using real-time PCR technology. CRU CRUSOP005 CRUSOP063 Stool Giardia confirmation Using microscopic examination of wet preparations and immunofluorescent antibody test CRU CRUSOP017 Stool Cyclospora confirmation Using microscopic examination of wet preparations and modified ZN stained slides CRU CRUSOP008 CRUSOP017 Assessment Manager: AB2 Page 22 of 30

23 Specialist antimicrobial chemotherapy unit examination activities for the purpose of clinical diagnosis SACU Bruker Maldi-ToF Bacterial colonies Identification of bacterial pathogens MDBSOP 100/101 SACUSOP 051 SACUBA 100 SACUBA 100 F1 SACUBA 100 F2 SACUBA 056 SACU Bacterial colonies Detection of the following in gram negative bacteria: Using manual culture, MIC gradient strips, double ended gradient strips, ROSCO discs, Veriti PCR thermocycler, Proflex PCR thermocycler BioRad Basic Gel electrophoresis tank & powerpack Gel doc 2000 imaging system, Automated disc zone size reader: BIOMIC v3 SACU Carbapenemase SACUSOP 001 SACUSOP 003 SACUSOP 004 SACUSOP 007 SACUSOP 031 SACUSOP 032 SACUSOP 052 SACUSOP 053 SACUSOP 055 SACUSOP 024A SACU Cephalosporinase SACUSOP 001 SACUSOP 004 SACUSOP 006 SACUSOP 018 SACUSOP 013 SACUSOP 052 SACUSOP 053 SACUSOP 055 SACU Assessment Manager: AB2 Page 23 of 30

24 Specialist antimicrobial chemotherapy unit examination activities for the purpose of clinical diagnosis (cont d) SACU Bacterial colonies Panton-Valentine Leucocidin detection in S. aureus Using manual culture, MIC gradient strips, antibiotic infused paper discs, Veriti PCR thermocycler, Proflex PCR thermocycler, BioRad Basic Gel electrophoresis tank & powerpack SACU Gel doc 2000 imaging system SACUSOP 001 SACUSOP 011 SACUSOP 027 SACUSOP 052 SACUSOP 053 SACUSOP 055 Bacterial colonies Glycopeptide resistance detection in enterococci Using manual culture MIC gradient strips, Veriti PCR thermocycler, Proflex PCR thermocycler, BioRad Basic Gel electrophoresis tank & powerpack Gel doc 2000 imaging system SACU SACUSOP 001 SACUSOP 022 SACUSOP 052 SACUSOP 053 SACUSOP 055 Assessment Manager: AB2 Page 24 of 30

25 Specialist antimicrobial chemotherapy unit examination activities for the purpose of clinical diagnosis (cont d) SACU Bacterial colonies Methicillin resistance detection & identification in S. aureus. Using Antimicrobial infused paper disc, Staphaureux reagent, Veriti PCR thermocycler, Proflex PCR thermocycler, BioRad Basic Gel electrophoresis tank & powerpack Gel doc 2000 imaging system. SACU SACUSOP 020 SACUSOP 012 SACUSOP 021 SACUSOP 052 SACUSOP 053 SACUSOP 055 Assessment Manager: AB2 Page 25 of 30

26 Wales Centre for Mycobacteria unit examination clinical diagnosis WCM Sputum, Bronchial lavage, Gastric Aspirates, Faeces, CSF, Endometrial curettings, Sterile fluids, Pus, Swabs from superficial sites, Tissue, Skin, Urine, Blood Isolation and characterisation of mycobacterium spp of clinical significance. Manual microscopy Auramine and ZN manual stain Culture using automated liquid media on the Becton-Dickinson MGIT 960 incubator and manual culture using LJ slopes. WCM WCMSOP 001 WCMSOP 002 WCMSOP 003 WCMSOP 004 WCMSOP 005 WCMSOP 006 WCMSOP 007 WCMSOP 008 WCMSOP 009 WCMSOP 011 WCMSOP 012 WCMSOP 013 WCMSOP 014 WCMSOP 015 WCMSOP 016 WCMSOP 017 WCMSOP 018 WCMSOP 019 WCMSOP 020 WCMSOP 021 WCMSOP 028 WCMSOP 029 WCMSOP 032 WCMSOP 033 WCMSOP 045 Assessment Manager: AB2 Page 26 of 30

27 Wales Centre for Mycobacteria unit examination clinical diagnosis (cont d) WCM Sputum, BALs, CSF, bacterial isolates Direct detection of Mycobacterial DNA SeeGene Anyplex plus MTB/NTM Detection PCR on ABI 7500 WCM Anyplex plus MDR-TB Detection on ABI 7500 WCMSOP 044 Positive Mycobacterial cultures Speciation of positive mycobacterial cultures. Identification of MTBC and MAI using the GeneProbe Accuprobe test. WCM WCMSOP 019 Identification of MTBC isolates using manual LJ culture: WCMSOP 020 Identification of NTM isolates using manual LJ culture: WCMSOP 021 HAIN Common Mycobacterial species test using the ABI Veriti Thermal Cycler and Bee Blot automated hybridisation machine. WCMSOP 045 Assessment Manager: AB2 Page 27 of 30

28 Wales Centre for Mycobacteria unit examination clinical diagnosis (cont d) WCM Positive MTBC cultures Antibiotic susceptibility testing of Mycobacterium tuberculosis isolates against Isoniazid, Rifapmicin, Ethambutol, Ciprofloxacin, Clarithromycin, and Streptomycin Solid media using manual LJ culture WCMSOP 020 WCMSOP 030 WCM Positive MOTT cultures Antibiotic susceptibility testing of Mycobacterium species other than M. tuberculosis against Isoniazid, Rifapmicin, Ethambutol, Ciprofloxacin, Clarithromycin, and Streptomycin Solid media using manual LJ culture WCMSOP 021 WCM Mycology reference unit examination activities for the purpose of clinical diagnosis MRRU Serum, plasma, sputum, BAL Detection of Aspergillus Antigen ELISA method using BioRad Aspergillus Antigen detection kit and plate reader MRRU WMYCSOP 03 Serum, plasma Detection of Aspergillus Antibody IgG ELISA method using BioRad Aspergillus Ab detection kit and plate reader MRRU WMYCSOP 01 Assessment Manager: AB2 Page 28 of 30

29 Mycology reference unit examination activities for the purpose of clinical diagnosis (cont d) MRRU Serum, plasma, BAL Detection of Aspergillus DNA BioMerieux EasyMag extractor Rotogene Q Real-time PCR system MRRU WMYCSOP 02 MSOP045 WMYCSOP 11 WMYCSOP 12 Hair, skin, nail, tissue, BAL/sputum, body fluids (not pleural), body swabs, culture isolates Isolation and characterisation of fungi and yeast of clinical significance Using microscopy and manual culture MRRUSOP 024 MDBSOP 039 WMYCSOP 09 WMYCSOP 08 WMYCSOP 10 MRRU Clinical isolates Identification of fungi and yeast of clinical significance Using manual biochemical test kits (including Auxacolor) MRRU Identification of yeasts using Bruker Maldi-ToF MRRUSOP 025 MRRUSOP 020 MRRUSOP 008 Clinical isolates cultured inhouse Antifungal susceptibility testing of fungi of clinical significance. Antifungal susceptibility testing, based on EUCAST guidance using Yeast Sensititre One Plates MRRU MRRUSOP 007 Assessment Manager: AB2 Page 29 of 30

30 Mycology reference unit examination activities for the purpose of clinical diagnosis (cont d) MRRU Serum, CSF Detection of cryptococcal antigen. Using manual IMMY LF Antigen detection kit MRRU Immunochromatography technique (ICT) WMYCSOP 06 Yeasts Sensitivity testing Using manual TREK yeast sensititre 1 kit MRRU WMYCSOP 07 Bronchoalveolar Lavage, Respiratory swabs PCP (Pneumocystis jirovecii) detection PCR using EasyMag extractor, EZ1 extractor, and ABI 7500 Fast amplification unit MRRU MSOP 041 MSOP 020 Miscellaneous examination clinical diagnosis Urine Detection of urinary hcg Invitech one-step pregnancy test VSOP 074 END Assessment Manager: AB2 Page 30 of 30