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 Pathology Department Russells Hall Hospital Dudley DY1 2HQ United Kingdom Contact: Vikki Banton Tel: +44 (0) Fax: +44 (0) Website: Laboratory locations: below s covered by the organisation their relevant activities details ctivity code ddress Microbiology Department Russells Hall Hospital Local contact s above General Bacteriology Virology Serology Molecular microbiology ndrology Site activities performed away from the locations listed above: details ctivity code GUM clinic North Block Russells Hall Hospital Local contact s above Slide plate preparation B ssessment Manager: JP 1 of 9

2 DETIL OF CCREDITTION Microbiology examination In house documented procedures based on related UK Stards for Microbiology Investigations (SMI s) incorporating the manufacturer s instructions where relevant Joint fluids CSF scitic fluid CPD fluids Manual inoculation followed by culture using SOPs: SOP/M/B/0021 SOP/M/B/0024 SOP/M/B/0025 Swabs from eyes, ears, nose, throat, wounds, ulcer, iv. line sites, iv. tips Manual inoculation followed by culture using SOPs: SOP/M/B/0022 SOP/M/B/0023 HVS, endo cervical, urethral penile swabs General isolation & characterisation of microorganisms Manual inoculation of culture plates slides using SOPs: SOP/M/B/0005 SOP/M/B/0017 B Directly inoculated selective plates slides Culture using SOPs: SOP/M/B/0007 SOP/M/G/0042 SOP/M/G/0011 Respiratory fluids (sputum, pleural fluids bronchial washings) Manual inoculation followed by culture using SOPs: SOP/M/B/0003 Whole blood Fluids utomated culture SOP/M/B/0001 BCTEC FX ssessment Manager: JP Page 2 of 9

3 Microbiology examination In house documented procedures based on related UK Stards for Microbiology Investigations (SMI s) incorporating the manufacturer s instructions where relevant Urine Quantification of white red blood cells, bacteria epithelial cells utomated urine analysis using SOP/M/B/0026 IRIS iq200 Sprint Cellular fluid material contained on swabs Isolation of MRS Manual culture using chromogenic culture media Using: SOP/M/B/0022 Faeces Manual inoculation followed by culture using SOPs: SOP/M/B/0008 Joint fluids CSF scitic fluid CPD fluids Detection, identification quantification of: White blood cells Red blood cells Bacterial cells Yeast cells Staining microscopic examination (Gram differential) SOP/M/G/0011 SOP /M/0134 Prolab staining machine nd manual methods Cultures isolated in-house from all samples listed above Identification of microorganisms Manual Biochemical ID utomated biochemical method using SOP/M/G/0033 SOP/M/G/0011 nd VITEK 2 ssessment Manager: JP Page 3 of 9

4 Microbiology examination In house documented procedures based on related UK Stards for Microbiology Investigations (SMI s) incorporating the manufacturer s instructions where relevant Cultures isolated in-house from all samples listed above ntimicrobial susceptibility testing ly significant bacteria Manual /or automated antimicrobial susceptibility testing using the latest EUCST methodology SOP/M/G/0033 VITEK 2 nd SOP/M/G/0032 Gradient MIC determination by E- test Urine General isolation characterisation of microorganisms identification antimicrobial susceptibility testing Sensitivity testing biochemical identification tests SOP/M/G/0011 SOP/M/B/0018 MST Urisystem SOP/M/G/0033 VITEK system Urine Detection of Legionella pneumonophila serotype 1 antigen Streptococcus pneumonia antigen Immunochromatographic membrane assay SOP/M/G/0023 Binax NOW kits Faeces Detection of C. difficile GDH antigen C. difficile toxins & B utomated EI SOP/M/G/0034 Dynex DS2 ssessment Manager: JP Page 4 of 9

5 Virological examination Faeces Detection of Rotavirus, denovirus Norovirus antigen Immunochromatographic assay SOP/M/B/0008 Coris Combi strips Proflow Norovirus kit Naso-pharyngeal aspirate Detection of RSV antigen Immunochromatographic assay SOP/M/G/0024 nd Binax Now RSV test Serological examination Plasma Microbial serology for the detection of: HIV 1 & 2 antibody Hepatitis IgM Hepatitis IgG Hepatitis B surface antigen Hepatitis B surface antigen antibody Hepatitis B core antibody Hepatitis B markers Hepatitis C antibody Rubella IgM Rubella IgG EBV IgG EBV IgM CMV IgG CMV IgM Toxoplasma IgG Toxoplasma IgM Syphilis antibodies Chemiluminescent EI SOP/M/S/0016 nd bbott rchitect i2000sr ssessment Manager: JP Page 5 of 9

6 Serological examination Therapeutic drug monitoring: Plasma Gentamicin Vancomycin Chemiluminescent EI SOP/M/S/0016 nd bbott rchitect i2000sr Procalcitonin utomated EI SOP/M/S/0012 VIDS 3 system Microbial serology for the detection of: Borrelia burgdorferi IgG Borrelia burgdorferi IgM Hepatitis C antibody Hepatitis B surface antigen VZ IgG HIV1/2 antibody utomated EI SOP/M/S/0012 VIDS 3 system Microbial serology for the detection of: VZ IgG Measles IgG Mumps IgG Helicobacter pylori antibody Parvovirus IgG Parvovirus IgM utomated EI SOP/M/S/0034 Dynex DS2 ssessment Manager: JP Page 6 of 9

7 Serological examination Detection of ntistreptolysin O antibody Semi quantitative latex agglutination method SOP/M/S/0004 Biokit Rheumajet SO kit Confirmatory testing for syphilis by detection of Treponema pallidum antibodies Passive particle agglutination assay SOP/M/S/0006 Fujirebo TPP kit Rapid plasma regain (RPR) Rapid plasma regain flocculation assay SOP/M/S/0007 Biokit Rheumajet RPR kit Detection of HIV 1/2 antibody p24 antigen Qualitative Immunochromatographic assay SOP/M/S/0015 lere HIV Combo kit HIV 1 2 antigen confirmation Qualitative Immunochromatographic assay SOP/M/S/0022 BioRad Geenius kit ssessment Manager: JP Page 7 of 9

8 Molecular diagnostic examination activities for the purpose of Swabs in manufacturers sample collection tube vaginal swab urine Nucleic acid detection of: Chlamydia trachomatis Neisseria gonorrhoea utomated Nucleic cid mplification technique SOP/M/M/0001 nd Roche COBS 4800 EDT plasma HIV RN Quantification utomated nucleic acid amplification assay SOP/M/M/0002 NucliSENS EasyQ HIV 1 Human Body fluids ndrology examinations to assist Semen Basic infertility assessment comprising: Volume ph Sperm concentration Motility Morphology Vitality Microscopy Manual method, in-house documented procedure based on WHO Laboratory Manual for the Examination processing of human semen 5th Edition SOP/M//0001 Volume using pipette ph using ph paper Sperm concentration using Improved Neubauer counting chamber Motility assessment using microscopical examination Morphology using diff-quick stain Vitality using eosin-nigrosin stain ssessment Manager: JP Page 8 of 9

9 Human Body fluids ndrology examinations to assist Semen Post vasectomy semen analysis Presence of sperm Motility assessment Microscopy Manual method, in-house documented procedure based on the British ndrology Society guidelines for the assessment of post vasectomy semen samples (2002) SOP/M//0002 nd using Leja Slides for microscopical examination Miscellaneous Urine Human Chorionic Gonadotrophin (HCG) Qualitative immunochromatographic assay SOP/M/G/0001 nd Quadratech Check4 Pregnancy-M kit END ssessment Manager: JP Page 9 of 9