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 operating as North East Essex and Suffolk Pathology Service (NEESPS) Cellular Pathology Contact: Lynn Partridge Ipswich Hospital Tel: +44 (0) Heath Road Ipswich Suffolk IP4 5PD Testing performed at the above address only HUMAN BODY TISSUE Tissue samples Formalin fixed tissue Tissue (FFPE) Fresh tissue DETAIL OF ACCREDITATION Basophilic and eosinophilic structures Specimen dissection: Cut-up Manual - Routine Specimens SOP HCM 343 and SOP H52 Decalcification in formic acid or EDTA using SOP H73 Tissue processing Leica ASP300 AND Sakura VIP 6 Tissue processors Using SOP HCM56 Tissue embedding Sakura Tissue Tec 5 Embedding centres using SOP H69 Microtomy Sections cut using Microm H325 Leica RM2245, RM2235, and PFM Medical 3005 E and SOP H65 Thermo Shandon Gemini stainer and Clearvue Coverslipper H&E Staining and coverslipping using SOP HO4 Cryotomy Leica CM1860UV Cryostat and using SOP HCM 335 Assessment Manager: VB Page 1 of 13

2 (cont d) Documented in-house procedures for manual Tinctorial Histochemical Special Stains Acid mucins Alcian blue SOP H.01 Elastic fibres Elastic Van Gieson (Millers) SOP H.20 Gram +ve and ve bacteria Gram SOP H.09 Connective tissue, fibrin Mauritius Scarlett Blue (MSB) SOP H.21 Melanin Masson Fontana SOP H.22 Hepatitis B surface antigen Victoria Blue SOP H.31 Iron Perls Prussian Blue SOP H.23 Mast cells Toluidine Blue SOP H.27 Leprosy Bacilli Wade Fite SOP H.28 Collagen,muscle,RBCs Weigerts Haematoxylin van Gieson SOP H.13 Documented in-house procedures for Automated Tinctorial Histochemical Special Stains using the Ventana Benchmark Special Stain Machine. Acid and Neutral Mucopolysaccharides Alcian Blue/Periodic Acid Schiff SOP H.02 Amyloid Congo Red SOP H.03 Helicobacter pylori Giemsa SOP H.06 Assessment Manager: VB Page 2 of 13

3 (cont d) Documented in-house procedures for Automated Tinctorial Histochemical Special Stains using the Ventana Benchmark Special Stain Machine Reticulin fibres Reticulin stain. SOP H.08 Fungi and Pneumocystis jiroveci Grocott Hexamine silver SOP H.12 Fungi, glycogen, mucins Periodic acid Schiff reaction (PAS) SOP H.18 Tubercle bacilli Ziehl Neelsen SOP H.29 Immunohistochemistry Identification of Smooth muscle cells, myofibroblasts and myoepithelial cells Identification of normal and abnormal epithelial cells Determination of human alpha-1- fetoprotein Determination of the presence of p80 protein found in human tissues. Used as an aid in the identification of Androgen Receptor positivity Identification of HCG containing cells. Identification of cells expressing bcl-2 Actin (Smooth muscle) AE1/3 AFP ALK Androgen receptor b.hcg BCL2 Assessment Manager: VB Page 3 of 13

4 (cont d) Used for the detection of the bcl6 protein Identification of most epithelial cells, used as a discriminant in the differential of adenocarcinoma versus malignant mesothelioma Human thyroid C-cells, and other calcitonin-containing cells. Characterisation of neoplasms, especially those of lung, endometrial and ovarian Reacts with human calretinin and intracellular calcium binding protein. Marker for mesotheliomas Identification of cytokeratin 7 and cytokeratin 8 present on secretory epithelia but not on stratified squamous epithelia. Used to aid in the identification of cells and tumours of epithelial origin. Used as an aid in the identification of lymphoblastic lymphoma/leukemia and Langerhans cell histiocytosis Identification of the CD3 protein expressed by T-cell lymphocytes. BCL6 BerEp4 Calcitonin CA125 Calretinin CAM5.2 CD1A CD3 Assessment Manager: VB Page 4 of 13

5 HUMAN BODY TISSUE lymphocytes and lymphomas lymphocytes and lymphomas lymphocytes and lymphomas lymphomas and renal carcinomas. Identification of CD11c molecules Identification of lacto-n-fucopentose III. Normally found in granulocytes and granulocyte precursors, monocytes, a subset of tissue macrophages, and activated T- lymphocytes. lymphocytes and lymphomas Identification of follicular dendritic cells and mature B cells. Useful for the identification of structural alterations in the meshwork of follicular dendritic cells, which are frequently found in malignant lymphomas. lymphocytes and lymphomas CD4 CD5 CD8 CD10 CD11C CD15 (LeuM1) CD20 (L26) CD21 CD23 Assessment Manager: VB Page 5 of 13

6 (cont d) Classification of lymphomas. Identification of endothelial cells. Used to identify lymphocytes. Identification of the presence of human CD56 molecules, used to aid with the classification of tumours Identification of the presence of human CD57 molecules, used to aid with the classification of tumours Used to identify macrophages. lymphocytes Identification of cells expressing CD99. Identification of cells expressing the transmembrane tyrosine kinase receptor CD117/c-kit Detection of the CD138 protein in human tissue Identification of cells expressing CEA glycoproteins Identification of secretory granules of endocrine cells. CD30 CD31 CD45 (LCA) CD56 CD57 CD68 CD79a CD99 CD117 CD138 CEA Chromogranin A Assessment Manager: VB Page 6 of 13

7 (cont d) Used to aid the of low differentiated squamous cell carcinoma and adenocarcinoma and between epithelioid mesothelioma and lung carcinoma Identification of glandular and transitional cells, normal and neoplastic. Used in the classification of tumours, particularly useful for identification of basal like carcinomas of breast. Identification of epithelial cells and classification of epithelial cell tumours. Identification of normal and abnormal gastric and intestinal epithelium, urothelium and Merkel cells Used to identify Cytomegalovirus Used to aid in the identification of mantle cell lymphoma, and breast carcinoma Use of this antibody is indicated,, as an aid in the identification of lymphatic invasion of a variety of tumors and between epitheloid and mesothelioma and lung adenocarcinoma CK5/6 CK7 CK14 CK8/18 CK20 CMV Cyclin D1 D2-40 (Podoplanin) Assessment Manager: VB Page 7 of 13

8 (cont d) Identification of myocytic cells Used to identify DOG-1 presence, to aid with the classification of tumours. To identify cells positive for E- cadherin. Normal and abnormal epithelial and mesothelial cells. Used to identify and evaluate oestrogen receptors. Study of Angiogenesis in neoplasms and for the identification of epithelioid hemangioendothelioma Used for differentiating skin lesions particularly dermal lesions. Identification of Gross Cystic Disease Fluid Protein-15 molecules Identification of erythroid cells at almost all stages of differentiation and is a useful tool for the identification of erythroleukaemia Detection of HER2 antigen in sections Identification of hepatocytes and hepatocellular tumours Desmin Dog-1 E Cadherin EMA ER Factor VIII Factor XIIIa GCDFP 15 Glycophorin A HER 2 Hepatocyte Assessment Manager: VB Page 8 of 13

9 Identification of melanocytes and classification of melanomas and melanocytic lesions Subclassification of neoplastic tissue as carcinoma or epithelial in origin Proliferating cells A highly sensitive breast cancer marker, this antibody is used as an aid to classify tumours. Identification of histiocytosis belonging to either the malignant variety or the haemophagocytic syndromes. Used for the identification of Melanoma. Sub classification of neoplastic tissue as carcinoma or epithelial in origin Used as an aid to the classification of lymphomas. Identification of neurons of the central and peripheral nervous system, and for the identification of tumours with neuronal differentiation HMB45 HMC KI67 Mammoglobulin MAC387 Melan A MNF116 MUM1 Neurofilament Assessment Manager: VB Page 9 of 13

10 Identification of normal and neoplastic cells of neuronal and neuroendocrine origin Detection of the p16ink4a protein Used in the detection of p40 protein in human tissue, particularly useful for classification of lung carcinomas. Identification of wild type and mutant p53 Identification of the p63 protein. Used to aid differentiation of benign and malignant prostatic or breast lesions, and in the differentiation of lung squamous cell carcinoma and lung adenocarcinoma. Identification of neuroendocrine cells and associated tumours Identification of cells expressing placental alkaline phosphatase (PLAP) and PLAP-like alkaline phosphatase, also named germ cell AP (GCAP) Identification of human prostate specific antigen. Used to identify and evaluate progesterone receptors. NSE P16 P40 P53 P63 PGP9.5 PLAP PSA PR Assessment Manager: VB Page 10 of 13

11 Used to identify cells expressing the parathyroid hormone. Used to assist in distinguishing morphologically difficult tissue as benign, atypical or cancerous. Identification of normal and neoplastic cells expressing S100 protein. Identification of cells containing Synaptophysin molecules. Thyroglobulin containing cells TTF-1 found in lung and thyroid (thyroid follicular cells) Used as an aid to the classification of lymphomas. Identification of cells containing Vimentin 55 kda intermediate filament (IF) protein Epithelial cells and smooth muscle in fallopian tube. Wilms tumour Parathyroid Racemase (p504s) S100 Synaptophysin Thyroglobulin TTF-1 TDT Vimentin WT-1 Assessment Manager: VB Page 11 of 13

12 Slides prepared in-house from sample types listed above In Situ Hybridisation Used to detect cytoplasmic mrna for kappa immunoglobulin light chain Used to detect cytoplasmic mrna for lambda immunoglobulin light chain Used to identify Epstein Barr Virus. Morphological assessment and interpretation/ Kappa Lambda EBV Interpretive Microscopy Using SOP H53 Histopathology Reporting, including BCS and BSS cases. Assessment Manager: VB Page 12 of 13

13 HUMAN BODY TISSUE Non gynaecological cytology samples including: Serous fluids - Ascitic, pleural and pericardial. Respiratory samples, including Bronchial washings, brushings and sputum. EBUS samples. Cereprospinal fluid samples. Cyst fluids, - ovarian cyst fluids, breast cyst Synovial fluid Urine samples Semen for cell morphology. Fine needle aspirates, - soft tissue, thyroid, lymph node, salivary gland, breast and head and neck samples. Cytopathological examination Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Diagnostic cytology (non-gynae) inhouse documented manual procedures for preparation using SOPs: C22, C13, C10, C21, C25, C14, C09, C17 Papanicolaou Stain using SOP HCM 393 Thermo Shandon 24/4 and Vision Biosystems Autostainer Rst. MGG staining, SOP HCM 392 Slides prepared in-house from sample types listed above Morphological assessment and interpretation/ Interpretive Microscopy Screening and Reporting using: C29 END Assessment Manager: VB Page 13 of 13