Schedule of Accreditation issued by 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 Tel: +44 (0) 151 529 5495/5499

8642 Fax: +44 (0) 151 529 5498 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