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 Lewisham and Greenwich Hospital NHS Trust Queen Elizabeth Hospital Stadium Road Woolwich SE18 4QH United Kingdom Contact: Breege Nicholson Tel: +44 (0) ext Website: Testing performed at the above address only Human Tissues and fluids DETAIL OF ACCREDITATION Genital swabs, HVS, endocervical, urethra, penile Swabs from eyes, wounds, nose, throat, ears, genital sites, skin, Intravenous cannulae & associated specimens, respiratory specimens, cough swab, fluids from various sites, pus, tissues, biopsy material General isolation of microorganisms Manual culture onto selected culture media SOP MB-RP-001, MB-RP-009, MB- RP-006, MB-CP-007, MB-CP-004 Swabs from nose, perineum and wound sites Isolation and identification of Methicillin Resistant Staphylococcus aureus (MRSA) Manual culture on chromogenic Oxoid Brillance MRSA Agar SOP MB-RP-007 Wound sites Blood General isolation and characterisation of micro-organisms Detection of microbial growth and isolation of micro-organisms of clinical significance Detection of CO2 production by microorganisms Oxoid pre-poured media using MB- RP-009, EUCAST susceptibility testing By fluorescence detection using BACTEC Fx automated system followed by manual culture onto selected media SOP MB-BP-001 SOP MB-BP-001 by manual microscopy & examination of Gram stained preparation & subculture. Assessment Manager: VB Page 1 of 9

2 Quantification of white and red blood cells, bacteria and epithelial cells in urine Isolation, identification, and antimicrobial susceptibility testing of bacteria Manual microscopy using microtitre tray and inverted microscope Automated digital camera microscopy using Menarini Sedimax SOP MB-UP-001 Culture on selected media and susceptibility testing using breakpoint methodology using Mast Urisystem SOP MB-UP-006 HVS, endocervix, urethra, penile Detection of Trichomonas vaginalis Fluorescence microscopy using Acridine Orange stain SOP MB-RP-003 Throat swab General identification of microorganisms Detection of human chrionic gonadorophin Isolation of Corynebacterium species including C. diphtheriae Manual culture onto selected media SOP MB-UP-003 Alere hcg cassette SOP MB-UP-003 SOP MB-RP-006 in conjunction with manufacturer s instructions using Oxoid pre-poured media: Hoyles Tellurite medium Per-nasal swab Bordetella species/whooping cough Manual culture onto Bordetella selective medium SOP MB-RP-006 Intra-uterine device Detection of Actinomyces spp Manual culture onto Actinomyces Selective Agar SOP MB-RP-004 Faeces General isolation and characterisation of Salmonella, Shigella, Campylobacter & E. coli 0157, Vibrio sp, Yersinia sp Manual culture onto selected chromogenic and other media SOP MB-FP-008 Assessment Manager: VB Page 2 of 9

3 Faeces Nose, throat, perineum, wound sites Nose, throat, perineum, urine, wound sites Rectal and urine Ear,nose,umbillicus Rectal, perineum, urine Detection of Clostridium difficile Glutamate Dehydrogenase Detection of Clostridium difficile toxins A & B Detection of Adenovirus and Rotavirus antigen Detection of Norovirus antigen Detection of Vancomycin resistant enterococci (VRE) Detection of Multi-resistant Acinetobacter Isolation of Ciprofloxacin and gentamicin resistance screening of Enterobacteriaceae Isolation of ESBL/AmpC producing Enterobacteriaceae Isolation of Carbapenemase producing Enterobacteriaceae ELISA using Premier C. GDH kit on DS2 analyser SOP MB-FP-001 Meridan Immunocard Toxins A & B SOP MB-FP-002 APACOR Rapydtest Rota-Adeno kit SOP MB-FP-007 Meridan Immunocard Stat Norovirus SOP MB-FP-005 Manual culture onto Oxoid ChromID VRE agar SOP MB-RP-010 SOP MB-RP-015 in conjunction with manufacturer s instructions and Oxoid Brilliance UTI agar and Columbia agar with blood plus a gentamicin disc Manual culture onto selected media SOP MB-RP-016 Manual culture onto selected media SOP MB-RP-011 Manual culture onto selected media SOP MB-RP-012 Bacterial or fungal cultures isolated in-house General identification of microorganisms By matrix assisted laser desorption ionisation using Bruker MALDI-ToF SOP MB-IP-001 Assessment Manager: VB Page 3 of 9

4 Bacterial cultures isolated in-house Blood cultures, fluids, tissues and cultures isolated in-house Bacterial cultures isolated in-house General identification of microorganisms Differentiation between Gram positive and negative bacteria Bacterial identification and antimicrobial susceptibility testing Antimicrobial Susceptibility Testing Antimicrobial susceptibility testing General kit based biochemical identification methods: SOP MBB002 API system SOP MB-IP-012 Pro-Lab Xtra Latex SOP MB-IP-013 Tube Coagulase SOP MB-IP-008 Prolex Strep Group SOP MB-IP-006 Remel Oxidase SOP MB-IP-007 Remel Spot Indole SOP MB-IP-009 Catalase Test SOP MB-IP-010 Nitrocefin Test SOP MB-IP-017 Tributyrin Test SOP MB-IP-004 ID AmpC / ESBL SOP MB-IP-019 KPC and MBL ID Manual microscopy using Gram stain SOP MB-IP-005 By biochemical methods and MIC testing using BD Phoenix and EUCAST guideleines Sop MB-IP-016 Gradient MIC using Oxoid MIC Evaluator SOP MIB-IP-011 Manual disc diffusion using antimicrobial discs and EUCAST guidelines SOP MB-IP-014 Detection of Schistosoma sp Microscopic examination of centrifuged sample SOP MB-FP-009 Faeces Sellotape slide Examination for the presence of parasites (ova, cysts, trophozoites and worms) By concentration using Parasep system and manual microscopy SOP MB-FP-009 Assessment Manager: VB Page 4 of 9

5 Faeces Identification of Cryptosporidium sp Pro-Lab Phenol auramine stain (screening) and Modified Ziehl- Neelsen stain (confirmation) and microscopy SOP MB-FP-009 Joint fluid CSF (Cerebro-spinal fluid), ascitic and other body fluids CSF Lower respiratory tract specimens, sterile site body, fluids pus, urine Mycobacterial cultures isolated inhouse Lower respiratory tract specimens, sterile site body, fluids pus, urine Skin scrapings, hair and nail clippings Detection and identification of birefringent crystals Examination for white and red blood cells, bacteria and yeasts Presumptive identification of Cryptococcus species Detection of acid fast bacilli Culture of Mycobacteria sp Isolation and identification of Dermatophytes and fungi of clinical significance Polarising microscopy SOP MB-CP-005 SOP MB-CP-003 Manual microscopy using fast read counting chamber SOP MB-CP-003 & MB-CP-005 Remel Oxoid Indian ink stain and Microscopy OP MB-CP-003 Phenol auramine, Kinyoun and Malachite Green stains and manual microscopy SOP MB-CF-006 By fluorescence detection using BACTEC MGIT 960 and Lowenstein-Jensen medium SOP MB-CP-006 Manual culture Culture onto selected media followed by microscopy MB-BP-004 Upper respiratory tract specimens Moraxella catarrhalis Tributryin test SOP MB-IP-017 Hydrolysis of tributyrin using Rosco Diagnostics Assessment Manager: VB Page 5 of 9

6 Serological examination activities for the In-house documented procedures Serum/plasma (unless stated) Detection of Anti-Streptolysin O Slide agglutination using Biokit Rheumajet ASO Latex SOP MV- GP-009 Detection of: By chemiluminescence using Abbott Architect with reference to: Hepatitis C antibody Hepatitis B envelope antibody Hepatitis B envelope antigen MV-AP-045 MV-AP-013 MV-AP-039 Hepatatis B Surface Antibody MV-AP- 043 Hepatis B Surface Antigen MV-AP- 047 Hepatitis A IgM & IgG Rubella IgG CMV IgG MV-AP-042 & MV-AP-044 MV-AP-041 MV-AP Detection of: CMV IgM Hepatitis B Surface Antigen Hepatitis B Core IgM Hepatitis B Core total Hepatitis B Envelope Antigen Hepatitis B Envelope Antibody Rubella IgM Mumps IgG By ELFA using BioMerieux VIDAS with reference to: MV-AP-023 MV-AP-028 MV-AP-021 MV-AP-018 MV-AP-022 MV-AP-022) MV-AP-025 MV-AP-019 Assessment Manager: VB Page 6 of 9

7 Serology activities for the purpose of clinical diagnosis (cont d) incorporating manufacturers Serum/plasma (unless stated) Toxoplasma IgG MV-AP-024 Serum and Blood (unless otherwise specified) Detection of Varicella-Zoster IgG By ELISA suing Binding site VZV and Dynex DS2 SOP MV-AP-010 Faeces Detection of Helicobacter antigen. By ELISA using Premier HpSA Plus and using Dynex DS2 analyser SOP MB-FP-010 Blood/serum (unless otherwise specified) Detection of Parvovirus B19 IgG & IgM Detection of Measles IgG Detection of EBV EBNA IgG Detection of EBV VCA IgM Detection of Hepatitis C antibody Detection of Hepatitis D antibody (Delta virus) Detection of HIV 1 &2 antibody HIV 1&2 antigen-antibody HIV 1&2 antibody By ElisaUSING using Novalisa kit and Dynex DS2 analyser SOP MV-AP-008, BioMerieux VIDAS, ELFA MV-AP- 059 Abbott Architect, chemiluminescence, MV-AP-040 BioMerieux VIDAS, ELFA, MV-AP- 020 BioMerieux VIDAS, ELFA, MV-AP- 026 By ELISA using DiaSorin ETI-AB- DEL-TAK2 and Dynex DS2 analyser SOP MV-AP-007 Abbott Architect, chemiluminescence, MV-AP-004 BioMerieux VIDAS, ELFA, MV-AP- 012 Bio- Rad Genie Fast SOP MV-GP-006 Assessment Manager: VB Page 7 of 9

8 Blood/serum (unless otherwise specified) Serum Serology activities for the purpose of clinical diagnosis (cont d) RSV antigen Detection of Legionella pneumophilia serogroup 1 antigen Detection of Pneumococcal soluble antigen Detection of Syphilis (Total) antibody Detection of Syphilis TPPA Detection of Syphilis RPR Molecular diagnostics incorporating manufacturers Binax NOW RSV kit SOP MB-CP-014 Binax NOW kit SOP MB-CP-008 Binax NOW kit SOP MB-CP-011 Abbott Architect, chemiluminescence, MV-AP-058 By agglutination using Serodia SOP MV-GP-010 By microparticle flocculation using, BIOKIT RPR Reditest. SOP MV-GP-007 Endocervix, urethral, rectal swabs,urine Detection of Chlamydia trachomatis and Neisseria gonorrhoeae RNA amplification chemiluminescence logic Gen- Probe panther MV-MP-015 CSF Detection of Enteroviruses, Varicella, HSV Bu PCR using Cepheid Smart Cycler, Progenie RealCycler ENHEVA Multiplex PCR and Diasorin Arrow nucleic acid extraction system SOP MV-MP-013 Cepheid Smart Cycler Progenie RealCycler and Diasorin Arrow nucleic acid extraction system with reference to: Assessment Manager: VB Page 8 of 9

9 Serology activities for the purpose of clinical diagnosis (cont d) Molecular diagnostics incorporating manufacturers Bacterial cultures Staphylococcal Panton Valentine Leucocidin SOP MV-MP-013 and 023 Genital swabs Syphilis antigen (DNA) SOPs MV-MP-006, MV-MP-021 and SOP MV-MP-013 Rectal swabs LGV SOP MV-MP-013 and MV-MP-019 Genital, skin, eye swabs, vesicle fluid Blood Sputum and positive cultures Faeces Detection of Herpes simplex 1 and 2 Detection of Hepatitis B DNA quantitative Hepatitis C RNA quantitative HIV RNA viral load Detection of Mycobacterium tuberculosis complex and rifampicin resistance Detection of Clostridium difficile toxin gene Detection of Norovirus SOP MV-MP-007 SOP MV-VMP-003, using PCR and Realtime viral load, Abbott M2000 analyser Abbott M2000, PCR, MVMP-018 Realtime HIV Viral load, Abbott M2000 analyser using SOP MV- MP-002 By PCR using Cepheid GeneXpert MTB RIF (PCR) SOP MIR011 By PCR using Meridian Illumigene Clostridium difficile SOP MB-FP-004 By PCR using Cepheid Smartnorovirus and Cepheid Smart Cycler SOP MB-FP-006 END Assessment Manager: VB Page 9 of 9

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