Schedule of Accreditation - draft issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

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1 - draft 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Royal Bournemouth & Christchurch Hospitals NHS Foundation Cellular Pathology Department Royal Bournemouth Hospital Castle Lane East Bournemouth BH7 7DW United Kingdom Contact: Alex Grainey Tel: +44 (0) Alexandra.Grainey@rbch.nhs.uk Website: Laboratory locations: Testing performed at the above address only Locations covered by the organisation and their relevant activities Location details Activity Address: Cellular Pathology Department Royal Bournemouth Hospital Castle Lane East Bournemouth BH7 7DW Local contact: Alex Grainey Tel: +44 (0) Routine Histopathology Special Stains Frozen section service Non-Gynae cytology Site activities performed away from the locations listed above: Location details Activity Poole Hospital Department of Cellular Sciences Poole Hospital Longfleet Road Poole BH15 2JB FNA Clinic Royal Bournemouth Hospital Histology Frozen section preparation BMS Specimen cut up Rapid On site assessment FNA adequacy checks Assessment Manager: EWS Page 1 of 12

2 DETAIL OF ACCREDITATION Tissue: biopsy, excision, resection and post-mortem specimens Formalin Fixed Paraffin wax blocks of processed tissue. Tissue for frozen sections FFPE slides (Formalin fixed paraffin embedded) and frozen sections prepared in house as above clinical diagnosis Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Routine morphological staining for the detection of: Basophilic and eosinophilic structures Specimen dissection [B-CP-I-00001, B-CP- I-00002, B-CP-I-00003, B-CP-I-00004] Cassette printers Printmates Tissue processing using Bayer VIP Tissue processors [B-CP ] Decalcification using SOP [B-CP-I-0004] Tissue Embedding Using Tissue Tek embedding stations [B- CP-I-0006] Tissue Sectioning Using Shandon Finesse ME + Microtomes, [B-CP-I-00007] Cryotomy Intra-operative Frozen sections Using Shandon and Brights Cryostats[B-CP- I-00009] Routine morphological staining Sakura Prisma stainer / coverslipper using Haematoxylin and Eosin [B-CP-P-00001] Rapid H&E stain for frozen section [B-CP-I-00010] Staining, labelling and checking-out [B-CP-I ] Assessment Manager: EWS Page 2 of 12

3 clinical diagnosis Special stains for the detection of: Documented in-house procedures for Tissue-tek DRS 2000 slide stainer for special stains Frozen Sections Lipids Fat Stains on Frozen Sections Oil Red O Method [B-CP-P-00030] FFPE slides Acid Mucopolysaccharides Alcian Blue (ph 2.5) Technique (Lison 1954) [B-CP-P-00016] Acid and Neutral Mucopolysaccharides Amyloid Alcian Blue - Periodic Acid/Schiff (ABPAS) Technique [B-CP-P-00005] Congo Red (ph 10) for Amyloid [B-CP-P-00012] Sirus Red for Amyloid [B-CP-P-00013] Elastic fibres and connective tissue Helicobacter/Microorganisms Gram positive and negative microogranisms Basophilic and eosinophilic structures, cellular tissue and architecture Connective tissue, fibrin and basement mebranes Melanin, Argentaffin cells and Lipofuscin pigment Connective tissue, muscle Elastic fibres Haematoxylin Van Gieson [B-CP-P-00002] Giemsa Stain for Helicobacter pylori [B-CP-P-00006] Gram Stain for Micro-organisms [B-CP-P-00021] Haematoxylin & Eosin (H&E) [B-CP-P ] Martius Scarlet Blue [B-CP-P-00011] Masson-Fontana Method [B-CP-P-00025] Masson s Trichrome [B-CP-P-00037] Miller s Elastic Stain [B-CP-P-00010] Assessment Manager: EWS Page 3 of 12

4 clinical diagnosis Neutral Mucopolysaccharides, glycogen, A1AT deficiency, basement membrane disruption and fungus Haemosiderin and ferric iron Muscle striations, prickle cells, fibrin, neuroglia Reticulin fibres (collagen III) Copper-associated protein and Hepatitis B-surface antigen affected cells Copper Copper Tubercle bacilli (acid and alcohol fast bacilli) Lipofuscin in Bile Calcium phosphates and carbonates Basement membrane Fungi (Aspergillus) and Pneumocystis Viral inclusions Periodic Acid/Schiff (PAS) Technique [B-CP-P-00003] Diastase (Amylase) - Periodic Acid/Schiff (PAS+D) Technique [B-CP-P-00004] Perls' Prussian Blue Reaction for Ferric Iron [B-CP-P-00008] Phosphotungstic Acid-Haematoxylin Method [B-CP-P-00028] Reticulin - Gordon and Sweets' Method [B-CP-P-00007] Orcein Shikata s Method [B-CP-P-00009] Modified DMAB Rhodanine [B-CP-P-00031] Rubeanic Acid (Dithio-Oxamide) [B-CP-P-00032] Ziehl-Neelsen Method [B-CP-P-00035] Fouchet s Method for Bile Pigment [B-CP-P-00019] Von Kossa Silver Method [B-CP-P-00034] Alizarin Red S for Calcium Deposits [B-CP-P-00015] Periodic Acid/Methenamine Silver [B-CP-P-00014] Grocott s Hexamine Silver Method [B-CP-P-00022] Phloxine-Tartrazine Method [B-CP-P-00029] Assessment Manager: EWS Page 4 of 12

5 clinical diagnosis Lipids liquid or semi-liquid at 60 o C Muscle fibres, prickle cells Myelinayed nerve fibres Uric acid crystals Neuroendocrine cell granules Acid mucins Helicobacter Pylori Leprosy atypical mycobacteria Haemopoetic tissues, parasites B-carboline Spirochetes, Legionella pneumophila Sudan Black B [B-CP-P-00033] Heidenhains Iron Haematoxylin [B-CP-P-00023] Luxol fast Blue [B-CP-P-00024] Methenamine Silver for Uric Acid Crystals [B-CP-P-00026] Pasquale s method [B-CP-P-00027] Hale s Dialysed Iron Prussian Blue Technique [B-CP-P-00038] Cresyl Fast Violet [B-CP-P-00039] Wade Fite Method [B-CP-P-00036] Giemsa Morphological [B-CP-P-00020] Alkaline Diazo Reaction for Argentaffin Substances [B-CP-P-00017] Dieterle s Method for Spirochaetes & Legionella [B-CP-P-00018] FFPE slides Detection of the following: Ventana Benchmark XT Macrophages, neutrophils, A1AT accumulation Embryonic cell in normal tissues and germ tumours Large cell lymphoma HGPIN, prostate adenocarninoma Alpha 1 Antitrypsin Alpha Fetoprotein ALK AMACR (racemase) Assessment Manager: EWS Page 5 of 12

6 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT Expressed in variety tumours e.g. Mantle cell lymphoma Diffuse lymph-proliferative disease and neoplastic cells of follicular lymphomas. B cells of mantle zone, interfollicular T cells. Follicular centre B cells Epithelial cell types Parafollicular cells in thyroid and medullary thyroid carcinomas. Calcitonin producing cells of thyroid. Smooth Muscle Cells Reacts with human calretinin and intracellular calcium binding protein. Marker for mesotheliomas Low molecular weight cytokeratin marker Dendritic cells and thymocytes, Langerhans cells in the skin T cells T cells, B cells in the mantle zone Follicular dendritic cells, CALLA Granulocytes, Reed-Sternberg in Hodgkins disease BCL-1 (Cyclin D1) Bcl-2 oncoprotein Bcl-6 Ber Ep4 Calcitonin Caldesmon Calretinin CAM CD1a CD3 CD5 CD10 CD15 Assessment Manager: EWS Page 6 of 12

7 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT B cells CD20 Mature B cells, Follicular dendritic cells B cells, Follicular dendritic cells Reed-Sternberg cells in Hodgkins lymphoma, plasma cells Vascular endothelial cells Vascular endothelial cells Platelet surface membrane glycoprotein Macrophages, myeloid elements Macrophages, monocytes and myeloid cells B cell marker T lymphocytes, corticol thymocytes, granulosa cells of ovary, pancreatic islet cells, CNS and sertoli cells GIST Plasma cells CEA glycoproteins in adenocarcinoma Tissues of neuroendocrine origin CD21 CD23 CD30 CD31 CD34 CD42b CD68 CD68 (KP-1) CD79a CD99 CD117 CD138 CEA Chromogranin Assessment Manager: EWS Page 7 of 12

8 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT Cytomegalovirus Basal cells, filamentous keratins form glandular to stratified squamous, prostate adenocarcinoma, myoepithelia cells in breast Epithelial tissue from glandular to stratified squamous broad range cytokeratin marker Stratified squamous epithelium, basal cells, mesotheliomas Normal and neoplastic ductal, glandular and transitional epithelia CMV Cytokeratin (HMWCK/34βE12) Cytokeratin (MNF116) Cytokeratin 5/6 Cytokeratin 7 Epithelial cells Cytokeratin 8 Epithelial cells Cytokeratin 19 Normal and neoplastic epithelial cells of colonic lineage Striated and smooth muscle cells Epstein Barr virus Cell adhesion molecule Normal and neoplastic epithelium V.W factor in endothelial cells Histiocytic cells Cytokeratin 20 Desmin EBV E-Cadherin EMA Factor VIII Factor XIIIa Assessment Manager: EWS Page 8 of 12

9 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT Erythrocyte membrane gylcoprotein Placental trophoblasts Her 2 expression Normal and neoplastic hepatocytes Melanoma, melanocyte differentiation Human Papilloma virus Surface immunoglobulin IgA alpha chain Surface immunoglobulin IgG alpha chain Surface immunoglobulin IgM alpha chain B cells and plasma cells Glycophorin C HCG Her2 (4B5) Hepatocyte HMB45 HPV IgA IgG IgM Kappa Proliferating Cells Ki 67 B cells and plasma cells B cells, T cells, monocytes, macrophages, eosinophils Melanoma marker Germinal centre B cells, plasma cells and activated T cells Skeletal and cardiac muscle cells Lambda LCA (CD45) Melan-A MUM-1 Myoglobin Assessment Manager: EWS Page 9 of 12

10 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT Neural cell adhesion marker Neural, neuroendocrine and endocrine marker Neutrophils Peripheral nerves, neuroendocrine tumours Nuclei of cells containing a high level of oestrogen Tumour suppression marker, HPV driven tumour eg Squamous cell carcinoma Tumour suppressor gene, Neoplastic cells in epithelium Basal cell marker, Squamous epithelium Germ cell tumours Pneumocystis jirovecii Nuclei of cells showing expression of Progesterone Prostate secretory and ductal epithelium Schwann cells, nerve processes, S100 +ve neoplasms eg Melanoma Smooth muscle cells, myoepithelial cells N-CAM (CD56) Neuralfilament Neutrophil elastase NSE Oestrogen Receptors P16 P53 P63 PLAP P. jirovecii Progesterone Receptors PSA-P PSA-M S100 Smooth Muscle Actin (SMA) Assessment Manager: EWS Page 10 of 12

11 clinical diagnosis FFPE slides Detection of the following: Ventana Benchmark XT Slides prepared in house as above Smooth muscle cells, myoepithelial cells Neuroendocrine cells Thyroglobulin containing cells TTF-1 found in epithelial cells of lung and thyroid (thyroid follicular cells) Cells of mesenchymal origin Epithelial cells and smooth muscle in fallopian tube. Wilms tumour Morphological assessment and interpretation / diagnosis Smooth Muscle Myosin (SMM) Synaptophysin Thyroglobulin TTF-1 Vimentin WT-1 Interpretive/diagnostic microscopy Guidelines for producing reports for the Histopathologist and Secretarial staff [B-CP-I-00025] Assessment Manager: EWS Page 11 of 12

12 NG Specimens including: Serous Cavity Effusions Washings/Brushings Smears CSF Urines Fluids FNA Respiratory (excluding FNA) Sputum Skin scraping Slides prepared in house as above Cytopathology (Non-Gynae) examination activities for the purposes of clinical diagnosis Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Demonstration of : Cells (nuclei and cytoplasm) and micro organisms Cytologcial assessment and interpretation / diagnosis manual methods or equipment in conjunction Diagnostic cytology (non-gynae) in-house documented manual procedures for preparation, screening and reporting Specimen reception cytopathology [B-CP-I-01001] Sample Preparation Cytopathology [B-CP-I-01003] Attending clinics Cytopathology [B-CP-I-01004] Staining, coverslipping and labelling Cytopathology [B-CP-I-01005] Giemsa (Hema Gurr) Papanicalaou Reporting and result entry Cytopathology [B-CP-I-01006] END Assessment Manager: EWS Page 12 of 12

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