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

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1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Birmingham Women s and Children s NHS Foundation Trust Microbiology Department Birmingham Children s Hospital Steelhouse Lane Birmingham B4 6NH Contact: Mr Philip Thomason Tel: +44 (0) Fax: +44 (0) philip.thomason@nhs.net Website: Testing performed at the above address only DETAIL OF ACCREDITATION Clinical material on swabs from: Ear Eye Mouth Nose Throat Skin/Wound Genital Fluids: BAL/respiratory fluids CSF PDF Fluids from sterile sites Urine Pus and Exudates Intravascular cannulae and associated specimens diagnosis General isolation of microorganisms relevant Manual inoculation and culture: MICMB/SOP/001 MICMB/SOP/002 MICMB/SOP/004 MICMB/SOP/005 MICMB/SOP/009 MICMB/SOP/011 MICMB/SOP/013 MICMB/SOP/057 MICMB/SOP/010 MICMB/SOP/022 MICMB/SOP/025 MICMB/SOP/023 MICMB/SOP/026 MICUR/SOP/001 MICMB/SOP/016 MICFAE/SOP/007 MICMB/SOP/020 Assessment Manager: DE Page 1 of 7

2 Tissues and Biopsies Clinical material from rectal swabs, and faeces Clinical material on swabs of nose, throat, groin, axilla, umbilical, mouth, wound. Whole blood Bile Duodenal aspirates Jejunal aspirates Clear adhesive tape slide Perianal swab diagnosis General isolation of microorganisms Detection of ESBL, VRE and CRE Detection of MRSA and MSSA General isolation of microorganisms Detection of ova, cysts and parasites (OCP) including: Strongyloides stercoralis larvae, Giardia lamblia trophozoites Cyclospora cayetanesis oocysts Cystoisospora belli oocysts Detection of Cryptosporidium oocysts Detection of Enterobious vermicularis larvae and ova Manual inoculation and culture: relevant MICMB/SOP/017 MICMB/SOP/042 MICMB/SOP/038 MICMB/SOP/044 MICENV/SOP/008 Chromogenic culture for MRSA and MSSA MICENV/SOP/001 Automated culture using BD Bactec 9240 system MICBC/SOP/001 Manual method: concentration (faeces only) and wet prep light microscopy with iodine where applicable Manual auramine stain (fluorescent MICFAE/SOP/007 Direct light microscopy MICFAE/SOP/007 Assessment Manager: DE Page 2 of 7

3 Urine Urine CSF Nail, hair, skin, tissue Cultures isolated in-house from all samples listed above diagnosis Detection of Schistosoma haematobium ova Examination for white and red blood cells, cysteine crystals, epithelial cells, casts (hyaline, cellular, granular, RBC, Tubular epithelial, waxy, WBC), bacteria and yeasts Detection, identification and quantification of: White blood cells Red blood cells Bacterial cells General isolation and characterisation of fungi and yeasts Detection of Clostridium difficile GDH antigen and toxins A & B Identification of clinically significant bacteria relevant Manual method: concentration and wet prep light microscopy with iodine where applicable Manual urine microscopy using a flat-bottomed microtitre tray and light microscopy MICUR/SOP/001 Manual cell count using counting chamber and light microscopy MICMB/SOP/025 Manual Culture method MICENV/SOP/006 Lactophenol cotton blue (light Glutamate dehydrogenase and toxin A/B detection by rapid membrane enzyme immunoassay (Techlab Cdiff Quik Chek Complete) Toxin A/B detection by ELISA (Techlab C.Difficile TOX A/B II) MICFAE/SOP/005 Manual biochemical, enzymatic, agglutination, staining & microscopic methods Assessment Manager: DE Page 3 of 7

4 Cultures isolated in-house from all samples listed above Whole blood. Cultures isolated in-house from all samples listed above. Intravascular cannulae and associated specimens Fluid: BAL Clinical material on swabs of mouth and throat Clinical material on swabs of ear, eye, nose, skin/wound, pus/exudate Fluids: Pus and Exudates, Fluids from sterile sites, PDF, CSF and CSF shunts, respiratory Tissues and Biopsies diagnosis Identification of clinically significant microorganisms Antimicrobial susceptibility testing of clinically significant bacteria Differentiation between gram positive/negative/variable, branching organisms, yeast and fungal hyphae Differentiation between gram positive/negative/variable, branching organisms, yeast, fungal hyphae, presence of pus cell and epithelial cells Presence of Vincent s organisms Differentiation between gram positive/negative/variable, branching organisms, yeast, fungal hyphae and presence of pus cells relevant: Automated Bruker Automated Matrix-assisted laser desorption/ionisation (MALDI-TOF and Sepsityper) MICIDS/SOP/003 Manual disc diffusion and gradient MIC determination by E-test using EUCAST methodology. MICIDS/SOP/037 MICIDS/SOP/034 Assessment Manager: DE Page 4 of 7

5 HUMAN FLUIDS Serology examination activities for the purpose of clinical diagnosis In house documented procedures in conjunction with manufacturer s instructions and package inserts. Automated: DiaSorin Liaison Analyser using Flash chemiluminescence technology (CLIA) MICVIR/SOP/019 Serum/plasma Detection of CMV IgG MICVIR/SOP/012 Detection of CMG IgM MICVIR/SOP/011 In house documented procedures in conjunction with manufacturer s instructions and package inserts. Automated: DiaSorin Liaison Analyser using Flash chemiluminescence technology (CLIA) MICVIR/SOP/019 Detection of Toxoplasma IgM Detection of Toxoplasma IgG Detection of Rubella IgM Detection of Rubella IgG Detection of VZV IgG Detection of EBV VCA IgG Detection of Hepatitis A IgM Detection of Parvovirus IgM Detection of Parvovirus IgG Detection of Measles IgG MICVIR/SOP/013 MICVIR/SOP/014 MICVIR/SOP/008 MICVIR/SOP/007 MICVIR/SOP/015 MICVIR/SOP/016 MICVIR/SOP/017 MICVIR/SOP/009 MICVIR/SOP/010 MICVIR/SOP/018 Assessment Manager: DE Page 5 of 7

6 HUMAN FLUIDS Serum/plasma Serology examination activities for the purpose of clinical diagnosis Detection of antibody to Hep B surface antigen (Anti-HBs) Detection of Hepatitis A IgG Detection of antibody to Hepatitis B core antigen Detection of Hepatitis B surface antigen (Hep B sag) Detection of antibody to Hepatitis C virus Detection of HIV p24 antigen and antibodies to HIV type 1 &/or type 2 (HIV Ag/AB) Detection of antibodies to HTLV 1+2 Detection of antibody to Treponema pallidum (Syphilis) Antibiotic assay, quantitative determination of Gentamycin Antibiotic assay, quantitative determination of Vancomycin In house documented procedures in conjunction with manufacturer s instructions and package inserts. Automated: Abbott Architect Immunoassay i2000sr Analyser using Chemiluminescent microparticle immunoassay (CMIA) MICSER/SOP/003 MICVIR/SOP/003 MICVIR/SOP/006 MIC/VIR/SOP/020 MICVIR/SOP/021 MICVIR/SOP/023 MICVIR/SOP/022 MICVIR/SOP/025 MICVIR/SOP/027 MICVIR/SOP/026 MICVIR/SOP/029 Assessment Manager: DE Page 6 of 7

7 HUMAN FLUIDS Clinical material from vulvo-vaginal swab, endocervical swab, urine, urethral swab (using Gen-probe Aptima collection tube) DNA from clinical material on swabs of nose, throat, groin, axilla, umbilical, mouth, wound. Whole blood EDTA Molecular microbiology examination diagnosis Detection of Chlamydia trachomatis and Neisseria gonorrhoeae rrna Detection of MRSA and MSSA DNA EBV DNA quantification CMV DNA quantification In house documented procedures based on manufacturer s instructions Target amplification nucleic acid probe test for ribosomal RNA of CT/GC detection Automated: Hologic Gen-Probe Panther Kit: Aptima Combo II for CT/GC assay. MICVIR/SOP/001 Rapid detection of MRSA and MSSA using Cepheid Xpert SA Nasal complete and Xpert PCR equipment MICGEN/SOP/045 Automated ELITechGroup Elite InGenius analyser MICVIR/SOP/006 END Assessment Manager: DE Page 7 of 7