8642 Medical Multiple 007
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Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust Issue No: 007 Issue date: 13 August 2020 Lower Lane Contact: Wallis Hayes Fazakerley Tel: +44 (0) 151 529 5495/5499 8642 Liverpool Fax: +44 (0) 151 529 5498 Merseyside E-Mail: [email protected] Accredited to L9 7LJ Website: thewaltoncentre.nhs.uk ISO 15189:2012 Testing performed by the Organisation at the locations specified below Locations covered by the organisation and their relevant activities Laboratory locations: Location details Activity Location code Address Local contact The Neurosciences Laboratories Wallis Hayes Neurobiochemistry A The Walton Centre Neuroimmunology Lower Lane Neuropathology Fazakerley Liverpool L9 7LJ United Kingdom Address Local contact Theatre Suite Hot Lab Wallis Hayes Stereotactic biopsies B The Walton Centre Lower Lane Fazakerley Liverpool L9 7LJ United Kingdom Assessment Manager: MP Page 1 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement Biochemistry HUMAN BODY FLUIDS Biochemical examination In house documented procedures activities for the purposes of based on equipment manuals and clinical diagnosis: standard methods as specified below: Serum Quantification of anti-epileptic By liquid chromatography tandem A drug levels: mass spectrometry using Waters Aquity TQD with reference to SOPs BSM9 & BSM10 and: Lamotrigine SOP BSM8 Total phenytoin SOP BSM8 Free phenytoin SOP BSM4 Carbamazepine SOP BSM8 Carbamazepine epoxide SOP BSM8 Phenobarbital SOP BSM8 Valproate SOP BSM8 Midazolam SOP BSM17 Pregabalin SOP BSM12 Levetiracetam SOP BSM11 Topiramate SOP BSM13 Quantification of: Roche Cobas c311 A SOP BSR20 Serum & CSF Total protein Serum, plasma & CSF Glucose Serum Albumin CSF Lactate Assessment Manager: MP Page 2 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement Biochemistry (cont’d) HUMAN BODY FLUIDS Biochemical examination In house documented procedures activities for the purposes of based on equipment manuals and clinical diagnosis: (cont’d) standard methods as specified below: Quantification of: Siemens BN Prospec A SOP BSR4 CSF Albumin Serum & CSF IgG Serum IgA Serum IgM Fluid & serum Beta trace protein Siemens BN Prospec A SOP BSR22 Serum Gel electrophoresis using Helena A SAS-1plus & SAS-2 equipment with reference to SOPs BSP5 & BSP7 and the following: Detection of normal and SOP BSP2 abnormal protein electrophoretic patterns Detection of kappa & lambda SOP BSP4 light chains Fluid & serum Quanitification of Beta-2- Gel electrophoresis and A transferrin immunochemical detection using Helena SAS-1plus SOP BSP1 CSF & serum Detection of oligoclonal bands Isoelectric focusing using A Pharmacia Biotech and immunoblotting SOP BSP3 CSF CSF cell count and differential Manual microscopy using Leica A DM2000 microscope SOP BSR11 Assessment Manager: MP Page 3 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Biochemical examination In house documented procedures activities for the purposes of based on equipment manuals and clinical diagnosis: (cont’d) standard methods as specified below: CSF Detection of bliirubin By spectrophotometry using A Analytik Jena SPECORD 210 Plus UV-Visible Spectrophotometer SOP BSR2 Immunology HUMAN BODY FLUIDS Immunological examination In house documented procedures activities for the purposes of based on equipment manuals and clinical diagnosis: standard methods as specified below: Quantification of: Radioimmunoassay using Wizard A Gamma Counter with reference to: Serum Antibodies to voltage gated SOP IS17 potassium channels Serum Antibodies to voltage gated SOP IS16 calcium channels Serum Antibodies to acetyl choline SOP IS6 receptor Serum Antibodies to muscle specific SOP IS28 kinase Immunohistochemistry screen A followed by recombinant immunoblot with reference to: CSF & Serum Paraneoplastic antibodies: PNS14 kit Hu, Yo, Ri, CV2, amphiphysin, SOPs IS14, IS2 & IS3 Ma1, Ma2, Tr, SOX-1, GAD65, Zic4, Titin, Recoverin, Protein Kinase C Gamma Serum Antibodies to Amphiphysin, Ravo SPS Blot kit GAD65 SOP IS18 & IS14 CSF Antibodies to Amphiphysin, PNS14 kit GAD65 SOP IS18 & IS14 Assessment Manager: MP Page 4 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement Immunology HUMAN BODY FLUIDS Immunological examination In house documented procedures activities for the purposes of based on equipment manuals and clinical diagnosis: standard methods as specified below: ELISA using Biochrom EZ Read A LED Microplate reader Serum Detection and quantification of: In-house ELISA method Glycolipid antibodies (GM1, SOPs IS20, IS29 & IS39 GQ1b, GT1b, GD1a) Serum Qualitative detection of: Antibodies to myelin Buhlman anti-MAG ELISA kit associated glycoprotein SOP IS24 & IS39 Quantification of: Immunofluorescence using the A EUROStar III plus Euroimmune microscope with reference to: Serum & CSF NMDA Receptor Antibodies SOP IS32 Serum & CSF Antibodies to LGI1 and SOP IS35 CASPR2 Serum Antibodies to IgLON5 SOP IS36 Serum & CSF Antibodies to AMPA1, AMPA2 SOP IS37 & GABA-B Assessment Manager: MP Page 5 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement Neuropathology Fixed, fresh and frozen Examination of tissues to Macroscopic and Microscopic A tissue; neuropathology tissue identify or exclude examination using in house samples (brain biopsies, morphological and cytological documented procedures based on skull bone, spinal biopsies, abnormalities for the purposes equipment manuals and standard temporal artery, nerve & of diagnosis methods as specified below: muscle) Specimen dissection & tissue processing Documented in-house procedure HSB6 and HSB43 in conjunction with manufacturers instructions using Leica ASP300 and Leica ASP6025 Tissue Embedding Documented in-house procedure HSB10 in conjunction with manufacturers instructions using Leica EG1160b Tissue Sectioning Documented in-house procedure HSB12 to HSB17 Intraoperative Quick Nuclei and other cellular SOP HSIN3 by manual H&E stain A Smears/Frozen Sections components Metachromatic substances SOP HSIN3 by manual Toluidine A Blue stain Serial Stereotactic Nuclei and other cellular SOP HSIN6 – Serial stereotactic B Preparations components preparation and reporting H&E Stain Assessment Manager: MP Page 6 of 14 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK The Walton Centre NHS Foundation Trust 8642 Issue No: 007 Issue date: 13 August 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement Neuropathology Fixed, fresh and frozen Examination of tissues to Macroscopic and Microscopic A tissue; neuropathology tissue identify or exclude examination using in house samples (brain biopsies, morphological and cytological documented procedures based on skull bone, spinal biopsies, abnormalities for the purposes equipment manuals and standard temporal artery, nerve & of diagnosis methods as specified below: muscle) Formalin fixed paraffin Special stains Documented in-house procedure A embedded tissue (FFPE by manual staining Tissue) unless otherwise stated: Detection of: Acid mucins SOP HSS1 – Alcian Blue Acid and neutral mucins SOP HSS2 – Alcin Blue / PAS Technique Axons