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 Department of Cellular Pathology Forth Valley Royal Hospital Stirling Road Larbert FK5 4WR Contact: Suzanne Ferra Tel: Tel: +44 (0) Fax: +44 (0) Activities performed at other sites;- Locations covered by the organisation and their relevant activities Location details Activity Mortuary As above Body Storage Off Site Block and Slide Storage Central Stores Department Unit 2 Colquhoun Street Stirling FK7 7PX Archival storage of Blocks and Slides Assessment Manager: CM 1 of 14

2 DETAIL OF ACCREDITATION and TISSUES Cervical Cytology examinations to assist in clinical investigations In House documented procedure & manufacturer s instructions using the following equipment Cervical Smears Cervical smear abnormalities Hologic T5000 SOPs-Pathology 2518 and 2552 Hologic T2000 processor SOPs-Pathology and 2547 LEICA XL Autostainer SOPs Pathology and 2548 And using Papanicolou stain Leica CV5030 coverslipper SOPs Pathology-2546 and 2549 Slides/images prepared in house as above Morphological assessment and interpretation/diagnosis Hologic Reviewscope SOPs Pathology-2517 and 2551 Reporting of Cervical Smears (Pathology 33745) Assessment Manager: CM Page 2 of 14

3 Wet fixed Preparations. Body fluids, urine, CSFs, aspirates, washings, brushings, EBUS Air Dried Preparations. Body fluids, CSFs FNA Wet fixed Preparations: breast, thyroid, lymph node etc FNA Air Dried Preparations: breast, thyroid, lymph node etc Slides prepared in house as above Tissue samples Diagnostic Cytology examinations to assist in clinical investigations Detection of abnormal cells Morphological assessment and interpretation/diagnosis Frozen Section Histology Examinations & Touch Preparations to assist in clinical investigations Detection of abnormal cells In House documented procedure & manufacturer s instructions using the following equipment: Processing and Staining using Papanicolou & Modified Giemsa (RAL) Included in: Routine Cytology Stains Pathology Rotina Centrifuge SPS Pathology and 2550 Shandon Cytospin 4 SOPs- Pathology33729 and 2519 Hologic T2000 processor SOPs-Pathology and 2547 LEICA XL Autostainer SOPs Pathology and 2548 Leica CV5030 coverslipper SOPs Pathology-2546 and 2549 Microscopy A General Guide to Reporting of Pathology Specimens Pathology 2899 In House documented procedure & manufacturer s instructions using the following Manual methods using H&E stain and documentation Pathology Procedures for Frozen Sections Leica Cryostats;- CM 1850 and CM1850UV SOPs- Pathology 2523, 2586, and 2524 Assessment Manager: CM Page 3 of 14

4 Tissue samples (cont d) Routine Histopathology examinations to assist in clinical investigations Identification of basophilic and eosinophilic structures In House documented manual methods and manufacturer s instructions Specimen Dissection Manual method using documented procedures in the range Pathology to and 2064 Decalcification of tissue sample included in Pathology 2804 & Pathology 2857 Tissue processing Documented procedure & Leica 200 and 200s- Pathology 2280 Leica 300- Pathology 2440 Leica 300s Pathology 2441 Tissue embedding using SOP Pathjology-2398 Leica EG1150 C & H Embedding centres SOPs Pathology 2332 and 2331 And Leica EG1140 Embedding Centre-SOP Pathology 2395 Tissue sectioning ( Microtomy) Manual method, documented procedure using SOP Pathology 2343 and Leica RM2255 Microtomes SOP Pathology Routine staining (H&E) Documented procedure & LEICA XL Autostainer SOPs Pathology 2582 Leica CV5030 coverslipper SOPs Pathology-2583 Manual method & documented procedure using Histology Staining and Mounting Procedures Pathology 3052 Assessment Manager: CM Page 4 of 14

5 Special staining of Histopathology clinical abnormalities In House documented procedure of manual methods using and Microscopy Tissue samples (cont d) Acid Mucins Alcian Blue Acid and Neutral Mucins Amyloid Argyrophil Cells Bacteria Collagen Collagen/Smooth muscle Elastic Fibres Elastic Fibres, Mast Cell Granules Ferric Iron Fibrin Fungi, Melanin Glycogen, Mucins, Fungi Leprosy bacilli Lipid Mast Cell Granules Melanin pigment Melanin differentiation from DAB staining Melanin pigment removal Mineralised bone Reticulin Fibres Alcian Blue-PAS +/- Diastase Highman s Congo Red Sirius Red Grimelius Silver Gram Stain Masson Trichrome Celestine Blue Haematoxylin Van Gieson Miller s Elastic Van Gieson Stain Millers Elastic H&E Stain Perl s Prussian Blue Martius, Scarlet & Blue (MSB) Grocott Gomori Methanamine Ag. PAS+/- Diastase Wade-Fite Oil Red O Toluidine Blue Masson Fontana (MF) Giemsa (ICC Counterstain) Mallory Bleach Von Kossa Gordon & Sweet s Reticulin Assessment Manager: CM Page 5 of 14

6 Special staining of Histopathology In House documented procedure of manual methods using and Microscopy Tissue samples (cont d) Spirochetes Warthin Starry Tuberculosis bacilli clinical abnormalities Acute Myeloid Leukaemia, Lymph Node, Histiocytic differentiation Adrenal Tumours, Germ Cell Tumours vs Carcinoma, Sex Cord Stromal Tumours Adrenocortical Tumours, Pleura: Adenocarcinoma vs Mesothelioma, adenomatoid tumours, sex cord stromal tumours B Cell Lymphoma, Hodgkin vs Non- Hodgkin Lymphoma B Cell Lymphoma, synovial sarcoma B Cell Lymphomas, Follicular Dendritic cells B Cell Lymphomas, Hodgkin vs Non- Hodgkin Lymphoma, Acute Myeliod Leukemia Ziehl Neelsen CD68 (PGM1) INHIBIN CALRETININ BCL-6 BCL-2 CD23 BOB1 B Cell Lymphomas, Hodgkin vs Non- Hodgkin Lymphomas, Acute Myeloid Leukemia OCT 2. B Cell Lymphomas, Hodgkin vs Non- Hodgkin Lymphomas, Myeloma, Melanoma B Cell Lymphomas, Immunoglobulin Heavy and Light Chain Differentiation MUM1 KAPPA LIGHT CHAIN Assessment Manager: CM Page 6 of 14

7 B Cell Lymphomas, Immunoglobulin Heavy and Light Chain Differentiation B Cell Lymphomas, Lymphoblastic Lymphomas: B Cell vs T cell B Cell Lymphomas, Plasma Cells B Cell vs T Cell B Cell vs T Cell, Lymphoma, T Cell Lymphoma Bladder: Dysplasia vs Reactive, Carcinomas, Cutaneous Neoplasm. Used in identifying the Origin of Certain Carcinomas Breast Carcinoma, Small Cell Carcinoma vs Merckel Cell Carcinoma Breast Carcinomas, Endometrial Carcinomas Breast Carcinomas, Endometrial Carcinomas Breast Lesion, deep fibromatosis Carcinomas, Carcinoma differential diagnosis, Breast Lesion, Breast vs Lung vs Prostate Carcinoma Carcinomas, Lower GI Carcinomas Carcinomas, Squamous differentaion, Breast Myoepithelial cells, Prostate basal cells Cell Proliferation, Bladder Dysplasia vs Reactive Certain Lymphoma LAMBDA LIGHT CHAIN CD20 CD79a PAX5 CD3 CK20 E-CADHERIN OESTROGEN RECEPTOR PROGESTERONE RECEPTOR BETA CATENIN GCDFP-1 CDX2 P63 Ki67 TIA-1 Assessment Manager: CM Page 7 of 14

8 Certain Soft Tissue Sarcoma, Skin: Spindle Cell Tumours, Sex Cord Stromal Tumours, Thymoma Certain soft tissue tumours Certain T Cell Lymphomas Colon vs Ovarian Carcinoma Cytological epithelial differentiation Pleura: Adenocarcinoma vs Mesothelioma, Cytological epithelial differentiation. Pleura: Adenocarcinoma vs Mesothelioma, Cytomegalovirus Differential diagnosis: Carcinoma vs nonepithelial tumour Epithelial differentiation, Certain Soft tissue tumour Epithelial differentiation, Small round blue cell tumours, Specific soft tissue tumour Epstein-Barr Virus CD99 PLAP PgP9.5 CA125 BER-EP4 AUA1 CMV CAM5.2 MNF116 AE1/AE3 EBV-LMP Germ Cell Tumours OCT 4. Germ Cell Tumours vs Somatic Adenocarcinoma, Placental Trophoblastic Cells, Placental Trophoblastic Proliferations GIST: Mutation vs Wild Type, Mastocytosis, Germ Cell Tumours, Kidney: Renal epithelial Tumours, Mast Cells HCG CD117 (ckit) Assessment Manager: CM Page 8 of 14

9 GIST: Mutation vs Wild Type, Spindle Cell Tumours Glial, myoepthelial and Schwann cells Gynaecological Carcinomas, Renal carcinoma, Thyroid carcinoma Hairy Cell Leukemia Hairy Cell Leukemia Hairy Cell Leukemia HCC, germ cell tumours, Melanoma, Wilms tumour Hodgkin vs Non-Hodgkin Lymphoma, Soft tissue tumour, ALCL, Inflammatory myofibroblastic tumour Hodgkin vs Non-Hodgkin Lymphomas, Germ Cell Tumours Hodgkin vs Non-Hodgkin Lymphomas, Skin: Adnexal Tumours, Adenocarcinoma vs Mesothelioma Hodgkin vs Non-Hodgkin Lymphomas, Skin: Adnexal Tumours, Skin: Basal vs Squamous Cell Carcinoma. Carcinomas. Certain Sarcomas Immunoglobulin differentiation Immunoglobulin differentiation Immunoglobulin differentiation DOG1 GFAP PD1 Annexin A1 DBA44 TRAcP GLYCIPAN-3 ALK1 CD30 CD15 EMA IgA IgG IgM Assessment Manager: CM Page 9 of 14

10 Kidney: Renal Epithelial Tumours RCC Liver: Malignant vs Benign HEPATOCYTE 1 Liver: Malignant vs Benign, Pleura: Adenocarcinoma vs Mesothelioma, Carcinomas Liver: Malignant vs Benign, Pleura: Adenocarcinoma vs Mesothelioma, Carcinomas, HCC Liver: Malignant vs Benign, Yolk sac tumours Lymph Node, Follicular Dendritic cells Lymph node, Langerhan s cell histiocytosis, thymoma Lymphoblastic Lymphomas Lymphoblastic Lymphomas: B Cell vs T Cell, T Cell lymphomas Lymphoid differentiation Lymphoma, acute Myeloid Leukemia, Plasma Cells Mantle Cell Lymphoma Medullary Thyroid Carcinoma Melanocytic Lesions Melanocytic Lesions, Neuronal differentiation, Histiocytes, Myoepithelial differentiation Melanocytic Lesions, PEComa, Adrenal tumours CEA (Monoclonal) CEA (Polyclonal) AFP CD21 CD1a TDt CD7 CD45 (LCA) CD43 (MT1) SOX11 CALCITONIN MITF S100 HMB45 Assessment Manager: CM Page 10 of 14

11 Melanotic Tumours, Adrenal Tumours, PEComa Mesenchymal differentiation, RCC, AFX Muscle malignant tumours, Soft tissue neoplasms, Spindle cell tumours, Benign muscle tumours, Myoepithelial cells in breast, basal cells in prostate, myofibroblastic differentiation Neoplastic Plasma cells, Pancreatic Tumours, Spindle Cell tumours, T Cell Lymphomas, Neuroendocrine tumours Neuroendocrine differentiation, Certain Retroperitoneal lesions, Adrenal medullary tumours Neuroendocrine marker Neuronal tissue Neuronal tissue, Neuroendocrine differentiation Ovarian tumours, Barrat s Oesophagus, Bladder Dysplasia vs Reactive, Liver: Malignant vs Benign, Mesothelial Cells: Malignant vs Benign P16 protein Head and Neck carcinoma, Cervical Squamous Carcinoma Papillary Thyroid Carcinoma Certain Cutanous Neoplasm, Pancreas Plasma cell Neoplasm, Lymphoproliferative Neoplasms Plasma Cells, MCL, Melanoma MELAN A VIMENTIN ACTIN (Smooth Muscle) CD56 CHROMGRANIN SYNAPTOPHYSIN NEUROFILAMENT NSE P53 P16 CK19 CD138 (SYNDECAN) CYCD1 Assessment Manager: CM Page 11 of 14

12 Pleura, Adenocarcinoma vs Mesothelioma, Carcinomas, Colon vs Ovarian Carcinoma, squamous tumours, breast myoepthelial cells, prostate basal cells Pleura: Adenocarcinoma vs Mesothelioma, Colon vs Ovarian Carcinoma, Kidney: Renal Epithelial Tumours, Skin: Basal vs Squamous Cell Carcinoma, Carcinomas Pleura: Adenocarcinoma vs Mesothelioma, Lymphatics, Skin: Certain Spindle Cell Tumours, Germ Cell Tumours vs Somatic Adenocarcinoma, Renal Cell Carcinoma vs Haemangioblastoma Pleura: Adenocarcinoma vs Mesothelioma, Ovarian Serous Carcinoma, Small round blue cell tumours, Wilms Tumour Pleura: Adenocarcinoma vs Mesothelioma, Thyroid: Malignant vs Benign Prostate: Malignant vs Benign, Prostate basal cells Prostate: Malignant vs Benign, Prostate Lesions, Colon vs Prostate Adenocarcinoma, PIN, specific renal tumours Prostatic and neoplastic salivary gland epithelium, Prostatic epithelium Skeletal muscle differentiation CK5/6 ERA(MOC31) D2-40 WT1 HBME-1 CK34 (HMWCK) AMACR PSA PSAP MYO D1 Assessment Manager: CM Page 12 of 14

13 Skeletal muscle differentiation Smooth and skeletal muscle differentiation Specific Carcinomas, B Cell Lymphomas, Kidney: Renal Epithelial Tumours, endometrial stromal sarcoma, AFX Specific Spindle Cell Tumours, Certain Epithelioid soft tissue tumours Spindle Cell tumours, Endothelium and endothelial tumours Squamous cell carcinoma T Cell Lymphoma, Histiocytic Lesions T Cell Lymphoma, Mastocytosis T Cell Lymphomas T Cell Lymphomas, Hodgkin vs Non- Hodgkin Lymphoma Thymus, B Cell Lymphomas, Lymphoblastic Lymphomas: B Cell vs T Cell, T Cell Lymphomas, MCL, CLL Thymus, Neuroid Skin Lesions, T Cell Lymphomas, Small round blue cell tumours, Hodgkins vs Non-Hodgkins Lymphoma Thyroid epithelium Used in identifying the Origin of Certain Carcinomas Used in identifying the Origin of Certain Carcinomas, Lung, Thyroid Carcinoma and certain neuroendocrine tumours MYOGENIN DESMIN CD10 CD34 CD31 P40 CD4 CD2 CD8 GRANZYME B CD5 CD57 THYROGLOBULIN CK7 TTF1 Assessment Manager: CM Page 13 of 14

14 Paraffin embedded tissue sections Uterus Trophoblastic Proliferations Immunofluorescence of Histopathology clinical abnormalities IgA IgG IgM C3 Comp Fibrinogen Morphological assessment and interpretation/diagnosis In Situ Hybridisation of Histopathology clinical abnormalities Kappa Lambda EBV Morphological assessment and interpretation/diagnosis P57 Using antibodies to and microscopy;- Olympus Fluorescence Microscope SOPs Pathology 172 and 2320 Olympus Reflected Fluorescence system BX3-URA SOPS Pathology 2326 CoolLED pe 100 Excitation light source SOP- Pathology 2316 Immunofluorescence SOP ;- Pathology Microscopy SOP 2899 Using specific probes and detection kit and Ventana Benchmark XT SOP;- Pathology 3898 Olympus Brightfield Microscope Interpretation of staining pattern Microscopy SOP 2899 END Assessment Manager: CM Page 14 of 14