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 SOP HSS3 – Silver Bielschowskys
Amyloid SOP HSS4 – Congo Red (Higmans)
Neurones SOP HSS5 - Cresyl Violet Acetate
Elastin fibres SOP HSS6 – Elastic Van Gieson
Gram positive or negative SOP HSS9 – Gram stain bacteria
Formalin fixed paraffin Special stains (cont’d) Documented in-house procedure A embedded tissue (FFPE by manual staining Tissue) unless otherwise stated: (cont’d) Detection of:
Fungi SOP HSS8 – Grocott Hexamine Silver technique
Basophilic and eosinophilic SOP HSS11 – Haematoxylin and structures Eosin
Myelin and other CNS SOP HSS12 – Modified Luxol Fast structures Blue
Myelin & CNS structures; SOP HSS32 - Luxol Fast Blue / basophilic & eosinophilic Haematoxylin and Eosin structures
Assessment Manager: MP Page 7 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 (cont’d) Documented in-house procedure A embedded tissue (FFPE by manual staining Tissue) unless otherwise stated: (cont’d) Detection of:
Connective tissue SOP HSS16 – Masson Trichrome Technique
Fibrin SOP HSS17 – MSB technique
Glycogen and other SOP HSS20 – Periodic Acid Schiff periodase-reactive carbohydrates
Ferric iron salts SOP HSS21 – Perls Prussian Blue
Reticulin SOP HSS23 - Reticulin method (Gordon & Sweets)
Myelin SOP HSS24 – Solochrome Cyanine
Metachromatic substances SOP HSS25 – Toluidine Blue (Wolman 1971)
Connective tissue SOP HSS29 – Van Gieson
TB SOP HSS26 – Ziehl Neelsen stain
Assessment Manager: MP Page 8 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
Muscle biopsy frozen Muscle Biopsy service Preparation of sample sections HSM1 – receipt and preparation of A muscle tissue HMS3 – Frozen Section Protocol – Muscle biopsies
Enzyme histochemistry using:
Demonstration of lipofushin SOP HSM12 - Acid Phosphatase
Fibre typing SOP HSM13 by– Myofibrillar ATPase
Mitochondrial complexes SOP HSM11 – Cytochrome oxidase
Mitochondrial complexes SOP HSM8 by Muscle Tinctorial using Gomori Trichrome
Basophilic and eosinophilic SOP HSM5 - Haematoxylin and structures Eosin
Special stain techniques for Documented in-house procedure detection of: by manual staining
Myodenylate activity SOP HSM15 – Myodenylate deaminase
Lipids SOP HSM7 – Oil Red O
NADH SOP HSM9 - NADH
Phosphorylase activity SOP HSM16 – Phosphorylase
PAS +ve substances SOP HSM6 – Periodic Acid Schiff
Phosphofructokinase SOP HSM14 - Phosphofructokinase
SDH activity SOP HSM10 – Succinic dehydrogenase
Cytochrome oxidase / SDH COX / SDH (SOP HSM17) actvity
Assessment Manager: MP Page 9 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 Immunohistochemistry AND TISSUES
Formalin fixed paraffin Examination of tissues to Automated immunohistochemical A embedded tissue (FFPE identify or exclude staining methods using Ventana Tissue and muscle) unless morphological and cytological Benchmark Ultra otherwise stated: abnormalities for the purposes SOP HS177 of clinical diagnosis
Neuro protein Alpha synuclein
Pituitary hormone ACTH
Alzheimer Precursor Protein APP
Neuro protein β-Amyloid (BAM)
Gliomas ATRX
Epithelial cells – metastic CAM disease
CD1a positive cells CD1a
Leukaemia antigen, clear cell CD10 renal carcinomas
Reed Sternberg cells, CD30 hodgkins
Vascular neoplasm CD31
Vascular epithelium CD34
Neuroectodermal cells, CD56 neurones, astrocytes
B cells CD79a
Plasma cell differentiation CD138
GI carcinoma marker CDX2
Epithelial malignancy CEA
Neuroendocrine tumours Chromogranin
Squamous cell differentiation CK 5/6
Assessment Manager: MP Page 10 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
Immunochemistry
Formalin fixed paraffin Examination of tissues to Automated immunohistochemical A embedded tissue (FFPE identify or exclude staining methods using Ventana Tissue and muscle) unless morphological and cytological Benchmark Ultra otherwise stated: abnormalities for the purposes SOP HS177 of clinical diagnosis
Glandular and transitional CK7 epithelial cells
Gastric and intestinal epithelial CK20 cells
Ewings sarcoma Ewing’s (CD99)
Epithelial cells EMA
Estrogen receptor ER
Pituitary hormone FSH
Astrocytic protein GFAP
Pituitary hormone GH
Germ cell tumours HCG
Melanocytes HMB45
Isocitrate dehydrogenase 1 IDH1
Atypical teratoid rhabdoid INI 1a tumours
Proliferating cells Ki67
Lymphoid LCA
Pituitary hormone LH
Diffuse midline gliomas H3K27M
Melanocytes Melan A
Epithelial Cells MNF116
Myelin Basic Protein MBP
Assessment Manager: MP Page 11 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
Immunochemistry
Formalin fixed paraffin Examination of tissues to Automated immunohistochemical A embedded tissue (FFPE identify or exclude staining methods using Ventana Tissue and muscle) unless morphological and cytological Benchmark Ultra otherwise stated: abnormalities for the purposes SOP HS177 of clinical diagnosis
Neuronal nuclei protein NeuN
Axons NFP
Germ cell tumours PLAP
Progesterone receptor PR
Pituitary hormone Prolactin
Prostate neoplasm PSA
Tumour suppression P53
Neuroendocrine marker Synaptophysin
Melanoma, glial cells S100
Muscle derived actin Smooth Muscle Actin
Solitary fibrous tumour STAT6
Tangles in neurones TAU
Thyroid Thyroglobulin
Pituitary hormone TSH
Lung and thyroid TTF-1
Inclusions in Ubiquitin neurodegenerative disease
T cells in mantle zone CD3
T cells CD4 & CD8
Macrophages CD68
B cells-lymphoma L26
Assessment Manager: MP Page 12 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
Formalin fixed paraffin Examination of tissues to Automated immunohistochemical A embedded tissue (FFPE identify or exclude staining methods using Ventana Tissue and frozen muscle) morphological and cytological Benchmark Ultra unless otherwise stated: abnormalities for the purposes SOP HS177 of clinical diagnosis
Smooth and striated muscle Desmin
Mesenchymal cells Vimentin
Formalin fixed paraffin Examination of tissues to Automated immunohistochemical A embedded tissue (FFPE identify or exclude staining methods using Ventana frozen muscle only) unless morphological and cytological Benchmark Ultra otherwise stated: abnormalities for the purposes SOP HS177 of clinical diagnosis
Membrane attack complex C5b-9
Localisation of muscle protein Dysferlin
Localisation of muscle protein Dystrophin 1
Localisation of muscle protein Dystrophin 2
Localisation of muscle protein Dystrophin 3
Localisation of muscle protein Emerin
B cells HLA-1
Compliment protein HLA-DR
Inclusion bodies P62
Limb Girdle Muscular Alpha-Sarcoglycan Dystrophy Beta-Sarcoglycan Delta-Sarcoglycan Gamma-Sarcoglycan
Neuronal marker Utrophin
Muscle membrane integrity Spectrin
Assessment Manager: MP Page 13 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 Cytology AND TISSUES
CSF Examination of tissues to SOP HSCY1 by manual staining A identify or exclude method using Tinctorial stain with morphological and cytological haematoxylin and eosin abnormalities for the purposes of diagnosis FFPE
Electron Microscopy Service Preparation of sample A
SOP HSEM1 Preparation and processing of specimens
SOP HSEM2 Making glass knives for cutting EM specimens
SOP HSEM3 Ultramicrotomy sample preparation for Transmission electron microscopy
Ultrastructural examination
Muscle biopsy specimens, Examination of tissues to SOP HSEM5 Electron microscopy A Peripheral Nerve biopsy identify or exclude specimens and Tumour ultrastructural morphological biopsy specimens abnormalities for the purpose of diagnosis.
END
Assessment Manager: MP Page 14 of 14