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 Microbiology Dept. Calderdale Royal Hospital Salterhebble Halifax HX3 0PW United Kingdom Contact: John Hardy Tel: +44 (0) Website: cht.nhs.uk Testing performed at the above address only DETAIL OF ACCREDITATION TISSUES Swabs (Skin surface wound, eye throat, ear, mouth, genital, nose, pernasal). Tissue samples samples/biopsies Sputum Bronchoalveolar lavage IV cannulae Corneal scrapes Wound drain fluids Sterile site fluids CSF General Microbiology Isolation and characterisation of microorganisms of clinical significance instructions where relevant Manual inoculation and media culture SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP Assessment Manager: LD1 Page 1 of 7

2 TISSUES Blood Swabs (Nose. Groin, lesions), urine General Microbiology Culture and detection of microorganisms of clinical significance Screening for Methicillin-Resistant Staphylococcus aureus (MRSA) Becton Dickinson BDFx liquid culture/fluorescent growth detection, and manual inoculation and culture SOP Manual inoculation and culture on chromogenic medium SOP Breast milk Sterility check Manual inoculation and media culture SOP Isolation of bacterial pathogens Campylobacter spp. Shigella spp. Salmonella sp. Escherichia coli O157 Vibrio spp. Yersinia spp. Manual inoculation and media culture SOP Urine Isolation of bacterial and fungal species of clinical significance Manual culture methods SOP Assessment Manager: LD1 Page 2 of 7

3 TISSUES Cultures isolated in-house from all samples listed above General Microbiology Identification of microorganisms of clinical significance Identification of microorganisms of clinical significance and Antibiotic susceptibility testing of isolated bacterial pathogens Manual; biochemical/ monoclonal antibody/ latex-antigen detection methods SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP SOP Automated; Becton Dickenson Maldi-TOF Biotyper using calculation of a similarity of a mass spectrometry based pattern profile of an unknown organism SOP Automated BD Phoenix ID: Biochemical Reactions to provide a profile which is compared to a database. Sensitivity: MIC using EUCAST SOP BD Phoenix Assessment Manager: LD1 Page 3 of 7

4 TISSUES Cultures isolated in-house from all samples listed above Urine CSF General Microbiology Antibiotic susceptibility testing of isolated bacterial pathogens Detection and quantification of red cells, white cells, bacteria, epithelial cells, urinary casts and yeast cells Detection and quantification of red cells, white cells Manual and/or automated antimicrobial susceptibility testing using EUCAST methodology. Disc diffusion & gradient MIC determination SOP IRIS IQ Sprint: automated Urine Microscopy system and particle recognition SOP Manual microscopy using counting chamber. SOP Detection of Cryptosporidia Fluorescent microscopy using Auramine O stain SOP Identification of faecal ova, cysts and parasites Detection of Clostridium difficile antigen Detection of C.difficile toxin A and B Detection of Helicobacter stool antigen Concentration method using centrifugation and light microscopy of concentrate SOP Techlab C.Diff Quik Chek manual enzyme immunoassay and Techlab C.DIFF CHECK -60 plate EIA on DS2 SOP (See Molecular section for confirmatory testing) Alere DS2 automated immunoassay using Oxoidamplified IDEIA Hp StAR kit. SOP Assessment Manager: LD1 Page 4 of 7

5 TISSUES Plasma (Lithium Heparin) Urine General Microbiology Detection of interferon-gamma following stimulation of T-cells in vitro, as an indicator of Tuberculosis specific antigen- cell mediated response) Quantification of Anti Streptolysion O titres Detection of Legionella and Pneumococcal urinary antigen Quantiferon Gold Plus (4 tubes) kit on DS2 plate analyser SOP Latex agglutination using Rheumajet ASO Kit SOP Manual immunochromatographic assay using Binax Now Legionella urinary antigen card and Binax Now Streptococcus pneumoniae urinary antigen card SOP Urine Pregnancy testing (HCG detection) Manual immunochromatographic assay using Surestep One step Pregnancy test SOP Lower respiratory tract samples, swabs, tissue, urine Endocervical swabs, male urethral swabs, female and male urine specimens. Lesion, eye, rectal and throat swabs Genital swabs and Urine Male urethral swabs, urine, eye,rectal and throat swabs Isolation/identification of Mycobacteria species Molecular testing DNA detection: Chlamydia, Neisseria gonorrhoeae and Herpes simplex DNA detection: Trichomonas vaginalis Detection of: Neisseria gonorrhoeae DNA Influenza A + B RNA Clostridium difficile toxin DNA Auramine flourescent staining, microscopy Becton Dickinson MGIT Fluorometric growth detection. SOP Becton Dickinson VIPER Strand Displacement Amplification (SDA) SOP Becton Dickinson BD MAX system. Automated extraction, purification and amplification of DNA/RNA SOP Assessment Manager: LD1 Page 5 of 7

6 TISSUES Skin scarping Hair cuttings Nail clippings Mycology Isolation and identification of fungi of clinical significance Serology/Virology HIV Antibody/Antigen detection Hepatits B surface antigen Syphilis antibody Rubella IgG antibody Hepatitis C antibody Hepatitis core antibody Hepatitis B surface antibody Culture, macroscopic examination and fluorescent microscopy SOP Siemens Centaur XPT Random access immunoassay analyser SOP , SOP Hepatitis A Total Antibody Hepatitis A IgM Toxoplasma Total antibody SOP Cytomegalovirus IgG SOP Cytomegalovirus IgM Borrelia IgG and IgM SOP Procalcitonin SOP Measles IgG SOP Rubella IgG SOP Varicella zoster IgG SOP Biomerieux Vidas immunoassay analyser SOP SOP Chlamydia trachomatis IgG VZV IgG Measles IgG Calprotectin Helicobacter pylori antigen Diasorin Liason XL Automated Chemiluminescence analyser SOP Assessment Manager: LD1 Page 6 of 7

7 TISSUES Serology/Virology Norovirus Antigen Rotavirus Antigen Immunocard STAT by Meridian bioscience (rapid immunoassay) SOP SOP END Assessment Manager: LD1 Page 7 of 7