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 Christie Hospital Manchester M20 4BX Contact: Neil Wrathall Tel: +44 (0) Fax: +44 (0) Website: Testing performed at the above address only DETAIL OF ACCREDITATION HUMAN BODY TISSUE Tissues: biopsy, excision and resection from anatomical sites as listed below: Urology Skin, lung, GI, Plastics, Thyroid Head & Neck Haematolymphoid, Gynae Sarcomas Formalin Fixed Paraffin wax blocks of processed tissue. (FFPE slides) diagnosis Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Specimen dissection: Steelline downdraft benches Tissue processing Peloris and Pathcentre tissue processors, LI-Hist-CPP-SOP Tissue Embedding Using Leica Embedding Centre, LI- Hist-CPP-SOP Tissue sectioning Using Microtomes LI-Hist-CPP- SOP Assessment Manager: GS2 Page 1 of 13

2 Frozen sections FFPE slides (Formalin fixed paraffin embedded) and frozen sections Routine morphological staining For the detection of: Basophilic and eosinophilic structures Special stains for the detection of: Cryotomy Frozen sections Using Leica CM 3050S cryostat. LI- Hist-CPP-SOP Routine morphological staining Leica XP stainer, Leica CV5030 coverslipper and LI-Hist-CPP-SOP Haematoxylin and eosin (H&E) staining LI-Hist-Christie-SOP Documented in-house procedures for manual special stains FFPE slides Acid mucins Alcain Blue (AB) LI-Hist-Christie-SOP Acid and neutral mucins Amyloid Glycogen Helicobacter Haematopoietic cells Bacteria Fungi AB/Periodic Acid Schiff (PAS) Congo Red LI-Hist-Christie-SOP Diastase Digestion / PAS LI-Hist-Christie-SOP Giemsa - Modified LI-Hist-Christie-SOP Giemsa LI-Hist-Christie-SOP Gram Stain LI-Hist-Christie-SOP Grocott LI-Hist-Christie-SOP Assessment Manager: GS2 Page 2 of 13

3 Special stains for the detection of: (cont d) Hyaluronic acid Hyaluronidase / AB LI-Hist-Christie-SOP Fibrin Melanin Connective tissue Basement membranes Martius Scarlet Blue LI-Hist-Christie-SOP Masson Fontana LI-Hist-Christie-SOP Masson's Trichrome LI-Hist-Christie-SOP Methanamine Silver for Basement Membrane LI-Hist-Christie-SOP Elastic fibres Miller's Elastic Stain (EVG ) LI-Hist-Christie-SOP Glycogen Ferric Iron and haemosiderin Reticulin fibres Neutral mucin Mast cells Connective tissue Mycobacterium leprae Periodic Acid Schiff (PAS)LI-Hist- Christie-SOP Perl's Prussian Blue LI-Hist-Christie-SOP Reticulin LI-Hist-Christie-SOP Southgate's Mucicarmine LI-Hist-Christie-SOP Toluidine Blue LI-Hist-Christie-SOP Van Gieson Stain LI-Hist-Christie-SOP Wade Fite LI-Hist-Christie-SOP Assessment Manager: GS2 Page 3 of 13

4 Special stains for the detection of: (cont d) Acid fast bacilli Ziehl - Neelsen LI-Hist-Christie- SOP following: Cytokeratin Cytokeratin AFP glycoprotein Anaplastic lymphoma kinase Anaplastic lymphoma kinase Prostate adenocarcinoma Associated with cell adhesion T cell receptor Breast and ovarian cancer Diffuse lymph-proliferative disease and neoplastic cells of follicular lymphomas. Adenoca/mesothelioma Reed-sternberg cells Range of B cell Lymphocytes Melanoma and other cancers Renal cell carcinoma 34BE12 AE1/AE3 AFP ALK D5F3 Alk-1 AMACR B Catenin BF1 BAP-1 BCL-2 BCL-6 BER EP4 Ber H2 BOB-1 BRAF V600E CAIX Assessment Manager: GS2 Page 4 of 13

5 following: Tumour marker Smooth muscle Smooth muscle cells Mesotheliomas Calcitonin Caldesmon Calponin Calretinin Cytokeratin Cam 5.2 Renal cell carcinoma Langerhans and dendritic cells T cell marker T cells (helper+mature) Mature T cells, T cell lymphomas T Cell, NK cells Mature B cells, follicular dentritic cells, CALLA Granulocytes Reed-Sternberg cells Haematological malignancies Reed-sternberg cells B cells, some T cells Cathepsin K CD1a CD2 CD3 CD4 CD5 CD7 CD8 CD10 CD11c CD15 CD19 CD21 Assessment Manager: GS2 Page 5 of 13

6 following: B Cells, Reed-Sternberg cells Histiocytic/dendritic cell neoplasms Plasma cells and activated T-cells Platelet activation marker Natural killer cells, neuroendocrine tissues Reactive urothelium and Lymphocytes Neuroectodermal tumours Hodgkin s and T cell marker B lymphocytes Plasma cells Adenocarcinoma and carcinoid (intestinal epithelium) CEA glycoproteins in adenocarcinoma CD22 CD23 CD25 CD35 CD38 CD42b CD43 CD44 CD56 CD57 CD79a CD123 CD138 CD163 CDX2 CEA Assessment Manager: GS2 Page 6 of 13

7 Carcinoid tumours Stratified squamous epithelium, basal cells, mesotheliomas Normal and neoplastic epithelia Squamous cell tumours Epithelial tumours GI carcinomas AML/GISTS/small cell lung ca Carcinomas Cytomegalovirus Basement membranes Expressed in variety tumours e.g. Mantle cell lymphoma Mesothelioma/rhabdomyosarcoma Hairy cell leukaemia GIST E-cadherin positive cells Neoplastic epithelia Chromogranin CK5/6 CK7 CK14 CK19 CK20 CKit Claudin CMV Collagen Type IV c-myc Cyclin D1 D33 DBA-44 DOG-1 E-Cadherin EMA Assessment Manager: GS2 Page 7 of 13

8 Breast carcinomas PNET Prostate and breast tumours Gastrin producing cells Bladder cancers, breast cancer Breast/prostate carcinomas Salivary gland neoplasms Pancreatic cells, intestine, stomach Hepatocellular carcinomas Leukaemia s Mesothelioma Germ cell tumours Hepatocellular tumours Kaposi s sarcoma Melanomas Endometrial and prostate cancer ERG Fli-1 FOXA-1 Gastrin GATA-3 GCDF-15 GFAP Glucagon Glycophorin A Glypican-3 GPIIIa Granzyme HBME-1 hcg Hepa HHV8 HMB45 HNF1B Assessment Manager: GS2 Page 8 of 13

9 Rhabdoid tumours Adrenalcortical v renal cell tumours Insulin producing cells Malignant vascular disorders B cells and plasma cells B cells and plasma cells Dendritic cells B cells, T cells, monocytes, macrophages Reed-sternberg cells Granulocytes, monocytes and histiocytes Mast cells Sarcomas IgA IgD IgM INI-1 Inhibin Insulin JC70A Kappa L26 Lambda Langerin LCA Leu M1 LMP(EBV) Lysozyme Mast Cell Tryptase MDM2 Assessment Manager: GS2 Page 9 of 13

10 Melanomas Soft tissue sarcomas Lung and thyroid tumours Neoplasms of epithelial origin Melanoma Pancreatic tumours Melan A MIB-1 Mic-2 MNF116 MPTF MUC-4 MUM 1 Lymphoid v myeloid disorders myod1 positive cells rhabdomyosarcomas cross striated muscle in tumours neuronal differentiation prostate epithelial cells melanoma Myeloperoxidase Myo D1 Myogenin Myosin Neurofilament NKX3.1 NK1C3 classification of lymphomas OCT 2 testicular germ cell tumours OCT 3/4 Marker for Pulmonary Carcinoids Cervical intraepithelial neoplasia OTP p16 Assessment Manager: GS2 Page 10 of 13

11 Lung, bladder, prostate carcinomas Many neoplasia s Differential marker for prostate classification of lymphomas renal cell/ovarian carcinomas classification of lymphomas urothelial carcinoma macrophages neuroendocrine tumours melanomas germ cell tumours prostate specific prostatic carcinoma breast/prostate/thyroid cancers parathyroid p40 p53 p63 Pax-5 Pax-8 PD1 PDL1 PGM-1 PGP9.5 PHH-3 PLAP PSA PSAP PTEN PTH classification of lymphomas Q Bend 10 retinoblastoma retinoblastoma RB358 Retinoblastoma Assessment Manager: GS2 Page 11 of 13

12 ovarian and lung cancer melanoma rhabdomyosarcoma adrenocortical ca/ovarian tumours leiomyomas/adenomas testicular germ cell tumours ROS1 S100 Saromeric Actin SF1 Smooth Muscle Actin (SMA) SOX2 melanomas/peripheral nerve sheath SOX 10 Diagnostic marker for haemangiopericytomas neuroendocrine tumours classification of lymphomas vascular tumours thyroid carcinomas classification of lymphomas renal cell carcinoma lung and thyroid tumours melanoma Transitional cell carcinoma Bladder/prostate/renal cancers STAT-6 Synaptophysin Tdt Thrombomodulin Thyroglobulin TIA-1 TFE-3 TTF-1 Tyrosinase Uroplakin III Uroplakin II Assessment Manager: GS2 Page 12 of 13

13 Sarcomas/melanomas/lymphomas Wilms tumour Vimentin WT1 protein FFPE slides breast and gastric Breast receptors Angrogen Breast receptors Oestrogen receptors EGFR ER Herceptin marker of breast cancer Her 2 Progesterone marker PR Cytopathology examination diagnosis Peritoneal fluid Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Cell block preparation for peritoneal fluid from Gynae cases: END Diagnostic cytology in-house documented manual procedures for VWR CompactStar CS4. LI-Hist-CPP-SOP Peloris and Pathcentre tissue processors, LI-Hist-CPP-SOP Leica Embedding Centre, LI-Hist- CPP-SOP Microtomes LI-Hist-CPP-SOP Assessment Manager: GS2 Page 13 of 13