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 Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Department of Cellular Pathology Pathology Centre Queen Alexandra Hospital Portsmouth PO6 3LY Contact: Julie Williams Tel: Fax: Julie.williams@porthosp.nhs.uk Website: Testing performed at the above address only Site activities performed away from the locations listed above: Location details Activity Mortuary Department of Cellular Pathology Pathology Centre Queen Alexandra Hospital Portsmouth PO6 3LY Mortuary Services Reception, body storage and release Assessment Manager: GB2 Page 1 of 20

2 DETAIL OF ACCREDITATION HUMAN BODY TISSUE Formalin fixed tissues diagnosis Histopathology Preparation and examination to identify or exclude morphological & cytological abnormalities for the purpose of diagnosis Macroscopic and Microscopic examination using in-house procedures (listed) in conjunction with manufacturer s instructions for the following methods (where relevant) Macroanalysis and dissection Manual method using: LEEC Downdraft Dissecting Bench SOP: HISCMAN001 X-Ray evaluation Evaluation of calcified areas using: Faxitron MX-20 specimen radiography unit and Velopex Extra-X Automatic X-Ray Film Processor SOP: HISPROL008 Decalcification Manual method using: SOP: HISPROL004 Tissue Processing Automated method using: Leica Peloris Tissue Processor SOP: HISPROL114 Leica ASP300/S Processor SOP: HISPROL079 Embedding Manual method using: Leica Embedding Station SOP: HISPROL020 Assessment Manager: GB2 Page 2 of 20

3 Formalin fixed, paraffin embedded (FFPE) tissue FFPE tissue Fresh tissue Frozen tissue FFPE tissue Basophilic and eosinophilic tissue structures Intraoperative analysis: Presence or absence of malignancy Clearance of margins Presence of Thyroid or Parathyroid tissue Special stains Special staining to detect the following: Acid & Neutral Mucins Polysaccharides including glycogen Lipofuscins and elastic fibres Amyloid Differentiates amyloid types Bile pigments Microtomy Manual method using: Shandon Finesse ME microtome Leica RM2255 SOP: HISPROL022 Automated Haematoxylin and Eosin (H&E) staining and coverslipping Automated method using: Leica Autostainer XL Staining Machine SOP: HISPROL025 Dako Coverstainer SOP: HISPROL130 Rapid frozen section Cryotomy and manual Haematoxylin & Eosin (H&E) staining method using: ThermoShandon Cryotome E or Lecia CM1900 Cryostat SOP: HISPROL087 and HISINS115 Manual methods using: SOP: HISPROL137 and the following stains: Alcian Blue Alcian Blue Van Gieson Alcian Blue Periodic Acid Schiff s Alcian Blue Periodic Acid Schiff with or without Diastase Alcian Blue Periodic Acid Schiff s with or without Diastase Aldehyde Fuchsin PPF Congo Red Congo Red with Bleach Fouchet Assessment Manager: GB2 Page 3 of 20

4 FFPE tissue (cont d) Special stains (cont d) Manual methods (cont d) Haematopoietic cells Helicobacter Pylori Gram positive and negative bacteria Argyrophil cell granules Fungi Hyaluronic Acid Melanin Muscle and Connective Tissue Bleaching of melanin pigment Basement Membranes and other polysaccharides Elastic fibres Fibrin connective tissue Lipid Copper associated protein, hepatitis infection / Elastic tissue Haemosiderin Muscle striations (skeletal and cardiac) Reticulin fibres Mast cell granules Giemsa Giemsa (Modified) Gram Grimelius Grocott Hyaluronidase followed by Alcian Blue Masson Fontana Masson Trichrome Acid Permanganate Melanin Bleach Methenamine Silver (Jones Silver) Millers Elastic van Gieson Martius Scarlet Blue Oil Red O Orcein Perls Mallory's Phosphotungstic acid- Haematoxylin (PTAH) Gordon & Sweets' Reticulin Toluidine Blue Assessment Manager: GB2 Page 4 of 20

5 FFPE tissue (cont d) Special stains (cont d) Manual methods (cont d) Connective tissue Calcium salts Acid fast bacilli including Mycobacterium leprae, atypical Mycobacteria Spirochetes, Helicobacter pylori, Bartonella henselae and Bartonella quintana Acid Alcohol fast bacilli (AAFB) including Mycobacterium tuberculosis van Gieson von Kossa Wade Fite Warthin Starry Ziehl Neelsen FFPE tissue Immunohistochemistry Immunohistochemistry to detect the following: α 1 AT Deficiency, Histiocytes, macrophages Liver Diseases, Embryonic cells in normal tissues and germ tumours Leiomyomas, Smooth muscle cells, myoepithelial cells Normal/neoplastic tissue epithelial in origin AA-amyloidosis β CATENIN Protein Follicular lymphoma Automated methods using: Leica Bond System Leica Autostainer XL DAKO Coverstainer SOP: HISPROL101 and the following antibodies: α-1-antitrypsin α-fetoprotein Actin smooth muscle Cytokeratin Multi (AE1/AE3) Amyloid A β-catenin BCL2 Oncoprotein Assessment Manager: GB2 Page 5 of 20

6 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Adenocarcinoma C1q complement component, Renal disease, systemic lupus erythematosus (SLE) C3c fragment of complement, Renal disease Human complement split product C4d, Renal transplant rejection Luminal cells of the fallopian tube, Ovarian carcinoma Medullary thryroid carcinoma / Parafollicular (C-Cells) Smooth muscle, myoepithelial cells, Leiomyoma Myoepithelial cells, smooth muscle, leiomyosarcomas Mesothelial cells, malignant mesothelioma Low molecular weight cytokeratin marker Carcinoembryonic antigen, adenocarcinoma Bile canalicular in liver, carcinoembryonic antigen, liver carcinoma Reed sternberg cells, hodgkins disease Ber-EP4 C1q C3c C4d CA125 Calcitonin Caldesmon Calponin Calretinin CAM 5.2 Carcinoembrionic Antigen Carcinoembrionic Antigen Polyclonal CD15 Assessment Manager: GB2 Page 6 of 20

7 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Mic2 gene products, small blue round tumours Immature B-cells, follicular dendritic cells, lymphoma Mast cells and GIST Plasma cells B-cell marker, lymphoma Mature B-cells, follicular dendritic cells, lymphoma Follicular dendritic cells, lymphoma T-cell marker, lymphoma RS Cells, lymphoma Endothelial cells Endothelial Marker T-helper cells, lymphomas Leukocyte common antigen, lymphoma T-cells, Lymphoma Neural cell adhesion molecule, neuroendocrine cells Macrophages, stimulated T cells, lymphomas B-Cell marker, lymphoma Intestinal epithelial, invasive colorectal carcinoma CD99 CD10 CD117 CD138 CD20 CD21 CD23 CD3 CD30 CD31 CD34 CD4 CD45 CD5 CD56 CD68 PGM1 CD79a CDX2 Assessment Manager: GB2 Page 7 of 20

8 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Neuroendocrine neoplasia Cytomegalovirus (CMV) infected tissue Chromogranin A CMV Squamous, basal epithelia Cytokeratin 14 Epithelial cells, metastatic breast carcinoma in nodes Gastrointestinal epithelia, colonic carcinoma Squamous, basal epithelia, mesothelioma Glandular, transitional epithelia, gynaecological tumours, lung carcinoma Vascular smooth muscle, leiomyomas, leiomyosarcomas, rhabodomyosarcomas Gastro Intestinal Stromal tumours (GIST) Mammary duct epithelia, invasive breast carcinoma Epithelial cells, mesothelial cells Oestrogen Receptor, ER positive breast carcinoma Fibrohistocytic Tumour, dermatofibroma Fibrinogen renal Cytokeratin 19 Cytokeratin 20 Cytokeratin 5 Cytokeratin 7 Desmin DOG-1 E-Cadherin EMA ER Factor XIIIa Fibrinogen Assessment Manager: GB2 Page 8 of 20

9 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Gross Cystic Disease Fluid Protein, breast tumours Mesothelial cells Trophoblastic elements, e.g. in germ cell tumours Differential diagnosis of hepatocellular tumours Human Epidermal growth factor Receptor 2 (HER2) Melanosomes, melanoma High molecular weight cytokeratins Immunoglobulin A, renal nephropathy IgG4 disease Immunoglobulin G, renal glomerular nephritis Immunoglobulin G, renal glomerular nephritis Immunoglobulin M, renal nephropathy Leydig, Sertoli cells Immunoglobulin Kappa light chains, plasma cells, renal disease Proliferation marker GCDFP 15 HBME-1 β-hcg Hepatocyte Using test kit: Leica Bond Oracle HER2 IHC System SOP: HISPROL095 HMB45 HMCK IgA IgG4 IgG Mono IgG Poly IgM Inhibin Kappa Ki67 Assessment Manager: GB2 Page 9 of 20

10 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Immunoglobulin Lambda light chains, plasma cells, renal disease Melanocytes, malignant melanoma Mismatch repair protein, Lynch syndrome Broad range cytokeratin, epithelial cells Mismatch repair protein, Lynch syndrome Mismatch repair protein, Lynch syndrome Neuroendocrine marker, carcinoid tumours Mismatch repair protein, Lynch syndrome Lambda Melan A MLH-1 MNF116 MSH-2 MSH-6 NSE PMS2 Germ cell tumours OCT 3/4 Basal cells in benign prostate, squamous epithelial cells, squamous cell carcinoma HPV, oral SCC, cervical carcinoma Neoplastic prostate glands, prostate carcinoma Tumour suppressor gene p63 P16 p504s p53 Kidney, ovarian and thyroid cancer PAX 8 Placental Alkaline Phosphatase, Molar pregnancies, choriocarcinoma Placental Alkaline Phosphatase Assessment Manager: GB2 Page 10 of 20

11 FFPE tissue (cont d) Immunohistochemistry (cont d) Automated methods (cont d) Polyoma virus, renal transplant rejection Progesterone Receptor, breast cancer Prostatic Acid Phosphatase, prostate Prostate epithelium, prostate specific antigen Melanoma, neuroendocrine Myoepithelial cells in the breast / identification of smooth muscle neoplasm. Neuroendocrine marker Lumen of thyroid follicles, thyroid tumours Thyroid Transcription factor-1, adenocarcinoma of lung and thyroid Mesenchymal Marker, sarcomas Wilms tumour gene product, ovarian serous carcinoma Polyoma Progesterone Receptors Prostate-specific Acid Phosphatase Prostatic Specific Antigen S100 Smooth Muscle Myosin Synaptophysin Thyroglobulin TTF-1 Vimentin WT1 Assessment Manager: GB2 Page 11 of 20

12 Slides prepared in-house from sample types listed above Microscopy (qualitative analysis) Morphological assessment and interpretation/diagnosis In-house procedures: SOP: HISRMAN001 using microscopes: Leica DMLB Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Skin Biopsies (non-ffpe) Skin Immunofluorescence Cryotomy Thermo Shandon Cryotome E or Leica CM1900 Cryostat SOP: HISPROL030 Skin Biopsies (non-ffpe) Detection of Immunoglobulin: Manual FITC Staining SOP : HISPROL030 using FITC antibodies: IgA IgA FITC IgG IgG FITC C3c C3c FITC Assessment Manager: GB2 Page 12 of 20

13 Slides prepared in-house from sample types listed above Renal Biopsies Formalin fixed tissue FFPE tissue FITC Microscopy (qualitative analysis) Morphological assessment and interpretation/diagnosis Renal Biopsies In-house procedures: SOP: HISRMAN001 using microscopes: Leica DMLB Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Sample Preparation In-house procedures: SOP: HISPROL024 using: Zeiss Stemi DV4 Stereo Microscope Tissue Processing In-house procedures: SOP: HISPROL024 using: Leica Peloris or ASP300/S Tissue Processor Embedding Manual method using: Leica Embedding Station SOP: HISPROL020 Microtomy Manual method using: Leica RM2255 SOP: HISPROL022 Assessment Manager: GB2 Page 13 of 20

14 FFPE tissue Basophilic and eosinophilic tissue structures Immunohistochemistry Automated or manual Haematoxylin and Eosin (H&E) staining Automated method using: Leica Autostainer XL Staining Machine SOP: HISPROL025 Dako Coverstainer SOP: HISPROL130 Manual H&E staining using method: HISINS115 FFPE tissue Detection of Immunoglobulin: Automated methods using: Leica Bond System Leica Autostainer XL DAKO Coverstainer SOP: HISPROL101 using antibodies: C3 C3 C1Q C1Q C4d C4d CMV CMV Ig A Ig A Ig G poly Ig G poly Ig M Ig M Polyoma Polyoma Assessment Manager: GB2 Page 14 of 20

15 Slides prepared in-house from sample types listed above Renal Biopsies (non-ffpe) Renal Biopsies (non-ffpe) Microscopy (qualitative analysis) Morphological assessment and interpretation/diagnosis Electron Microscopy: preparation of sample and interpretation of micrograph Preparation of Resin Blocks for Electron Microscopy In-house procedures: SOP: HISRMAN001 using microscopes: Leica DMLB Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Sample Preparation In-house procedures: SOP: HISPROL024 using: Zeiss Stemi DV4 Stereo Microscope Tissue Processing Processing by manual method: SOP: HISPROL041 Embedding Resin block embedding by manual method for referred electron microscopy: SOP: HISPROL041 Assessment Manager: GB2 Page 15 of 20

16 HUMAN BODY TISSUE (Cont d) Resin blocks Resin blocks Electron Micrograph produced by accredited referral laboratory on specimen types specified above Fresh lymph node diagnosis (Cont d) Cutting Semi-thin Sections for Electron Microscopy Staining Semi-thin Sections for determining if Electron Microscopy is required Morphological assessment and interpretation/diagnosis Intraoperative sentinel lymph node testing Breast lymph node (BLN) Metasin Assay detection of marker genes: PBGD MGB CK19 (Cont d) Microtomy Preparation of semi-thin sections by manual method for referred electron microscopy using: Glass Knife manufacture by inhouse procedure: SOP: HISPROL042 Jung Ultracut E SOP: HISPROL043 Staining Manual method using: Toluidine Blue SOP: HISPROL043 using microscopes: Leica DMLB Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Qualitative analysis In-house procedures: SOP: HISRMAN001 Sample Preparation RNA extraction using Qiagen RNeasy kit with in-house procedures: SOP: TCLPROL103 Assessment Manager: GB2 Page 16 of 20

17 Lymph node RNA Body fluid: Urine Joint fluid Serous effusions Endoscopic brushings EUS / EBUS in fluid Fine needle aspirates Needle washings Bronchial washings and lavages CSF Intraocular sample Slides prepared in-house from sample types listed above Cytopathological examination diagnosis Diagnostic Cytopathology Preparation and examination of cellular material in order to identify or exclude morphological and cytological abnormalities Staining to identify or exclude morphological and cytological abnormalities RT-qPCR Semi quantitative reverse transcriptase real time PCR using: Metasin Mastermix [Manufactured in-house using PBGD, CK19 and MGB primers and probes. SOP: TCLPROL107] Cepheid SmartCycler SOP: TCLPROL103 in conjunction with Metasin Interpretation Guide TCLINSL003 in conjunction with manufacturers instructions Preparation/centrifugation In-house procedures: SOP: CYTPROL058 in conjunction with manufacturer s instructions using: Thermo Shandon Cytospin 4 IEC Centra CLS centrifuge Hologic T2000 processor Papanicolaou staining Automated using in-house procedures: SOP: CYTPROL082 in conjunction with manufacturer s instructions using: Leica / Jung Autostainer XL Assessment Manager: GB2 Page 17 of 20

18 Slides prepared in-house from sample types listed above Slides prepared in-house from sample types listed above Joint fluid Cytopathological examination Staining to identify or exclude morphological and cytological abnormalities Microscopy (qualitative analysis) Morphological assessment and interpretation/diagnosis Joint Crystals Preparation and examination to identify Joint Crystals May - Grünwald Giemsa staining Automated using in-house procedures: SOP: CYTPROL082 in conjunction with manufacturer s instructions using: Leica / Jung Autostainer XL In-house procedures: SOP: CYTPROL091 SOP: CYTRMAN001 using microscopes: Leica DMLB Leica DM2500 Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMLS Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Sample preparation: Temporary (wet) & permanent preparations Wet preparation for immediate crystal analysis (polarising microscopy) Permanent preparation for cellular analysis SOP: CYTPROL158 Assessment Manager: GB2 Page 18 of 20

19 Slides prepared in-house from sample types listed above Cervical/vaginal cells Cervical/vaginal cells Cytopathological examination Microscopy (qualitative analysis) Assessment of cellularity and the presence or absence of crystals Crystals are then further identified as urates (gout) or pyrophosphates (pseudogout) Cervical Cytopathology Preparation and screening to identify or exclude cytological abnormalities Polarised light microscopy using inhouse procedures: SOP: CYTPROL091 SOP: CYTPROL158 SOP: CYTRMAN001 using microscopes: Leica DMLB Leica DM2500 Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMLS Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 Liquid based cytology processing Automated method using in-house procedures: SOP CYTPROL137 in conjunction with manufacturer s instructions using: Hologic T5000 processor Hologic T2000 processor Papanicolaou staining Automated method using in-house procedures: SOP: CYTPROL082 in conjunction with manufacturer s instructions using: Leica / Jung Autostainer XL Leica CV5030 coverslipper Assessment Manager: GB2 Page 19 of 20

20 Slides prepared in-house from sample types listed above Cervical/vaginal cells Cytopathological examination Microscopy (qualitative analysis) Morphological assessment and interpretation/diagnosis High-Risk Human Papilloma Virus (HR-HPV) testing Detection of high-risk HPV genotypes In-house procedures: SOP: CYTPROL091 SOP: CYTPROL020 SOP: CYTPROL021 SOP: CYTPROL022 SOP: CYTPROL023 CYTLIST002 using microscopes: Leica DMLB Leica DM2500 Leica DM1000LED Leica DM2000LED Leica DM3000LED Leica DM4000B Leica DMLS Leica DMRB Olympus BX41 Olympus BX50 Olympus BX51 Olympus BX53 Nikon Eclipse E400 Zeiss Axioskop-2 DNA extraction, PCR amplification, hybridisation and detection Automated PCR amplification of target DNA and nucleic acid hybridisation using in-house procedures in conjunction with manufacturer s instructions using: Robas 4800 HPV Kit on the Roche Cobas 4800 SOP: CYTPROL141 SOP: CYTPROL145 END Assessment Manager: GB2 Page 20 of 20