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

Transcription

1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Charing Cross Hospital Rm 2L20, Pathology Quality Office Fulham Palace Road London W6 8RF Contact: Sarah Horton Tel: +44 (0) Website: Laboratory locations: below s covered by the organisation and their relevant activities details Activity code Address St. Mary s Hospital Praed Street Paddington London W2 1NY Local contact Sarah Horton (as above) Histopathology Cytology (screening & diagnostic) M-Cyto Hammersmith Hospital Du Cane Road East Acton London W12 0HS Sarah Horton (as above) Histopathology Diagnostic Cytology Molecular Diagnostics Minimal Residual Disease Immunophenotyping H-Cyto H-MDL H-MRD H-Immunop Charing Cross Hospital Fulham Palace Road Hammersmith London W6 8RF Sarah Horton (as above) Histopathology Electron Microscopy X-EM Chelsea and Westminster 369 Fulham Road London SW10 9NH Sarah Horton (as above) Frozen section histology C-Histo Site activities performed away from the locations listed above: details Activity code MOHS Chelsea and Westminster MOHS frozen section histology C-MOHS Endobronchial ultrasound (EBUS) Clinic Endoscopic ultrasound (EUS) FNA material/slide preparation & cellularity assessment FNA material/slide preparation & cellularity assessment M-FNA H-FNA Assessment Manager: DE 1 of 56

2 DETAIL OF ACCREDITATION AND FLUIDS diagnosis Tissues: biopsy, excision and resection. Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Tissue dissection: Gynaecological - CEL-CP-035-IMP Respiratory - CEL-CP-037-IMP Haematopathology - CEL-CP-047-IMP Hepatopancreaticobiliary - CEL-CP-051-H Biopsies - CEL-CP-056-H Kidney Transplantectomy - CEL-CP-057- H Pancreas Transplantectomy - CEL-CP- 058-H Thyroid and Parathyroid - CEL-CP-061- IMP Temporal Artery - CEL-CP-063-IMP Skin - CEL-CP-027-IMP Head & Neck - CEL-CP-028-IMP Salivary gland - CEL-CP-029-IMP Assessment Manager: DE Page 2 of 56

3 Tissues: biopsy, excision and resection Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Tissue dissection (cont d): Breast - CEL-CP-031-IMP Amputation - CEL-CP-033-IMP Osteoarticular - CEL-CP-034-IMP Central and peripheral nervous system tumours - CEL-CP-040-X Nerve - CEL-CP-041-X Bladder - CEL-CP-042-IMP Kidney - CEL-CP-043-IMP Penis - CEL-CP-044-IMP Prostate - CEL-CP-045-IMP Testis - CEL-CP-046-IMP Upper GI - CEL-CP-012-M Amputation - CEL-CP-033-IMP Colorectal - CEL-CP-019-M Liver - CEL-CP-020-IMP Assessment Manager: DE Page 3 of 56

4 Tissues: biopsy, excision and resection Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Tissue dissection (cont d): Placenta - CEL-CP-022-M Bowel Cancer Screening - CEL-CP-065- XM Gallbladder and Appendices - CEL-CP- 066-M Specimen Transfer by Approved BMS - CEL-LP-109-M Decalcification: Decalcification - CEL-LP-296-H Decalcification - CEL-LP-240-X Fresh tissue Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Frozen sections - Bright OTF 5000 Cryostat and Thermo Cryotome FSE: Preparing Tissue for Frozen Section, Cryotomy and Diagnosis - CEL-LP-328-H Assessment Manager: DE Page 4 of 56

5 Fresh tissue Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Frozen sections - Leica CM1900 Cryostat: Frozen Section Technique-CEL-LP-243-X Frozen sections - Thermo Cryotome SME Frozen Section - CEL-LP-116-M Frozen sections - Thermo Cryotome SME Mohs - CEL-LP-459-C C-MOHS Frozen Section - CEL-LP-449-C C-Histo (FFPE), Fresh tissue, Frozen Tissue, Cell blocks Tissue processing - Tissue-Tek 5 model 5E-F2: Use of Vacuum Infiltration Processors (VIP) - CEL-LP-422-H Vacuum Infiltration Processors - CEL-LP- 332-X Vacuum Impregnated Processor - CEL- LP-117-M Tissue processing - Tissue-Tek 6, model QRG VIP 6E2: Vacuum Impregnated Processor - CEL- LP-117-M Assessment Manager: DE Page 5 of 56

6 (FFPE), Fresh tissue, Frozen Tissue, Cell blocks Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Embedding - Tissue-Tek Sakura: Embedding - CEL-LP-095-M Embedding - CEL-LP-252-X Embedding - Thermo Scientific Histostar Embedding - CEL-LP-346-H Microtomy - Thermo HM340E, Microm HM325, Leica RM2235 Section Cutting - CEL-LP-293-X Microtomy - Leica RM2235 Section Cutting - CEL-LP-347-H Microtomy - Microm HM335E, Thermo Finesse Section Cutting - CEL-LP-094-M Automated coverslipping - Leica CV5030 Use of Leica CV5030 Coverslipper - CEL- LP-420-H Assessment Manager: DE Page 6 of 56

7 Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Automated coverslipping - Leica CV5030, Leica CV5000: Autostainer (H&E) and Coverslipper - CEL-LP-307-X Automated coverslipping - Sakura Tissue- Tek Film: Use and Maintenance of Film Coverslipping Machine - CEL-LP-114-M Manual coverslipping: Hand Coverslipping - CEL-LP-421-H Special staining of Histopathology examinations to assist in detection of clinical abnormalities: Automated routine staining - Leica ST5020: Basophilic and eosinophilic structures Use of Leica ST5020 Staining Machine - CEL-LP-414-H Automated routine staining - Leica autostainer XL, Vision Biosystems Autostainer RSt, Autostainer (H&E) and Coverslipper - CEL-LP-307-X Assessment Manager: DE Page 7 of 56

8 Special staining of Histopathology examinations to assist in detection of clinical abnormalities: Automated routine staining - Tissue-Tek DRS 2000 Automated Staining Machines - CEL-LP- 118-M Automated routine staining - Thermo Scientific Linistat Linear Stainer: Mohs - CEL-LP-459-C C-MOHS Manual techniques: Acid and neutral mucins Alcian Blue Periodic Acid Schiff - CEL-LP- 371-H Alcian Blue Diastase Periodic Acid Schiff - CEL-LP-445-H Alcian Blue PAS - CEL-LP-186-X Alcian Blue PAS - CEL-LP-065-M Acid mucins Alcian Blue - CEL-LP-373-H Alcian Blue - CEL-LP-064-M Alcian Blue including Hyaluronidase digestion - CEL-LP-185-X Assessment Manager: DE Page 8 of 56

9 Special staining of Histopathology examinations to assist in detection of clinical abnormalities (cont d) Manual techniques (cont d): Amyloid Congo Red - CEL-LP-375-H Collagen/mallory bodies/giant mitochondria Neutral mucins/polysaccharides/f ungi/basement membranes/glycogen Congo Red - CEL-LP-111-M Alkaline Congo Red - CEL-LP-187-X Cab - CEL-LP-069-M Diastase Periodic Acid Schiff - CEL-LP- 377-H Periodic Acid Schiff - CEL-LP-401-H Periodic Acid Schiff - CEL-LP-434-X Microorganisms/parasites /leucocyte granules/chromaffin granules Periodic Acid Schiffs - CEL-LP-052-M Giemsa - CEL-LP-199-X Assessment Manager: DE Page 9 of 56

10 Fresh tissue. Special staining of Histopathology examinations to assist in detection of clinical abnormalities (cont d) Manual techniques (cont d): Elastic fibres & connective tissue Elastic Picro Sirius - CEL-LP-378-H Elastic Van Gieson - CEL-LP-194-X Elastic Van Gieson -CEL-LP-071-M Basophilic and eosinophilic structures Frozen Section Haematoxylin and Eosin - CEL-LP-382-H H&E Frozen sections - CEL-LP-204-X Haematoxylin and Eosin - CEL-LP-389-H Haematoxylin and Eosin - CEL-LP-438-X Haematoxylin and Eosin - CEL-LP-081-M Haematopoietic cells Giemsa - CEL-LP-383-H Gram +/- organisms Gram - CEL-LP-386-H Gram - CEL-LP-193-X Gram - CEL-LP-077-M Assessment Manager: DE Page 10 of 56

11 Special staining of Histopathology examinations to assist in detection of clinical abnormalities (cont d) Manual techniques (cont d): Fungi Grocott - CEL-LP-388-H Grocott - CEL-LP-195-X Grocott - CEL-LP-080-M Basement membranes Jones Hexamine Silver - CEL-LP-391-H Lipofuscin Long ZN - CEL-LP-392-X Myelin sheaths/nissl substance/neurones Fibrin/connective tissue/muscle Fibrin/connective tissue/muscle Luxol Fast Blue - CEL-LP-159-X Martius Scarlet Blue - CEL-LP-393-H Martius Scarlet Blue - CEL-LP-203-X Masson Trichrome - CEL-LP-207-X Haematoxylin Van Gieson - CEL-LP-082- M Argentaffin/melanin Masson Fontana - CEL-LP-206-X Melanin Melanin Bleach - CEL-LP-396-H Helicobacter Pylori Modified Giemsa - CEL-LP-556-M Assessment Manager: DE Page 11 of 56

12 Fresh tissue Special staining of Histopathology examinations to assist in detection of clinical abnormalities (cont d) Manual techniques (cont d): Hepatitis B surface antigen/copper associated protein Orcein (Shikata) - CEL-LP-050-M Haemosiderin/Iron Perls' - CEL-LP-402-H Reticulin fibres Perls - CEL-LP-215-X Perls - CEL-LP-053-M Reticulin (Gordon & Sweet's) - CEL-LP- 403-H Reticulin (Gordon & Sweet's) - CEL-LP- 219-X Retic (Gordon & Sweet's) - CEL-LP-058- M Mast cell granules Toluidine Blue - CEL-LP-409-X Assessment Manager: DE Page 12 of 56

13 Fresh tissue. Special staining of Histopathology examinations to assist in detection of clinical abnormalities (cont d) Manual techniques (cont d): Calcium salts Von Kossa - CEL-LP-231-X Mycobacterium leprae Wade Fite - CEL-LP-230-X Spirochetes/ helicobacter Warthin and Starry - CEL-LP-229-X Mycobacterium spp. including tuberculosis Ziehl Neelsen - CEL-LP-413-H Ziehl Neelson - CEL-LP-198-X Ziehl Neelsen - CEL-LP-062-M Assessment Manager: DE Page 13 of 56

14 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions: Automated immunocytochemistry - Bond Max, Bond III: Automated Immunocytochemistry for the Bond - CEL-LP-357-H Using antibodies for: Fetal liver cells, liver disease a-fetoprotein Anaplastic large cell lymphoma ALK-1 Corticotrophs. Pituitary tumours. ACTH AA-amyloidosis Amyloid A Androgen receptor Androgen receptor Epithelial cells AUA1 Mantle cell lymphoma bcl-1/cyclin D1 B and T cells in the mantle and marginal zone B and T cells in the mantle and marginal zone B and T cells in the mantle and marginal zone bcl-2 bcl-2 alt bcl-3 Assessment Manager: DE Page 14 of 56

15 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions (cont d): Automated immunocytochemistry - Bond Max, Bond III Nuclei of germinal B cells bcl-6 Epithelial cells BerEP4 Epithelial cells and fibroblasts beta-catenin B cells BOB-1 C1 complement C1q (Paraffin) C3c complement C3 C4c complement C4c (Paraffin) Peritubular and glomerular capillaries Luminal surface of epithelial cells of the fallopian tube, endometrium and endocervix. Tumour cells in GI and pancreas carcinomas C4d CA-125 Ca19.9 C-cells Calcitonin Smooth muscle Caldesmon Assessment Manager: DE Page 15 of 56

16 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Mesothelial cells Calretinin Epithelial cells (low molecular weight) Pre B and T cells, some T cells, germinal centre cells Dendritic cells, monocytes, macrophages, neutrophils and some B cells Monocytes and dermal dendritic cells Granulocytes and Reed- Sternburg cells B cells and follicular dendritic cells Langerhans cell, dendritic cells and thymocytes Cam5.2 CD10 CD11c CD14 CD15 CD19 CD1a Vascular endothelial cells CD105 (Endoglin) Plasmacytoid dendtritic cells CD123 Assessment Manager: DE Page 16 of 56

17 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions (cont d): Automated immunocytochemistry - Bond Max, Bond III Plasma cells CD138 Endothelial cells, Megakaryocytes, Monocytes, Platelets, Neutrophils Endothelial cells, Smooth muscle actin Monocytes and macrophages CD141 Thrombomod CD146 Mel-Cam CD163 Pan T cells CD2 Pan B cells CD20 Follicular dendritic and mature B cells B cells and EBV transformed B lymphoblasts Marker for hairy cell leukemia and systemic mastocytosis CD21 CD23 CD25 Pan T cells CD3 Reed-Sternburg cells CD30 Assessment Manager: DE Page 17 of 56

18 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions (cont d): Automated immunocytochemistry - Bond Max, Bond III Endothelial cells CD31 Myelomonocytic lineage cells CD33 Endothelial cells CD34 Neutophils, Monocytes, B cells, natural killer cells, red blood cells Immature T and B cells, thymocytes, plasma cells T helper cells, monocytes, macrophages and dendritic cells Platelets, megakaryocytes, endothelial cells T cells, monocytes, granulocytes and some B cells CD35 CD38 CD4 CD42b CD43 MT1 Monocytes CD44 T and B cells CD45 (LCA) T cells and some B cells CD5 Assessment Manager: DE Page 18 of 56

19 diagnosis Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Neurons, glia, skeletal muscle and NK cells CD56 (N-CAM) NK cells CD57 (Leu7) Macrophages, myeloid and histiocytic cells Monocytes and macrophages CD68 (KP1) CD68 (PGM1) T cells and NK cells CD7 B cells CD79a Cytotoxic T cells CD8 Intestinal epithelium CDX2 Elithelial cells CEA (poly) Neuroendocrine cells Chromogranin A Mast cells and GIST C-kit CD117 Overexpression in hematopoitic tumours C-Myc Basement membranes Collagen IV Epithelial cells Cytokeratin AE1/AE3 Assessment Manager: DE Page 19 of 56

20 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III High molecular weight cytokeratin - basal cells Cytokeratin 34BE12 Basal cells of squamous and glandular epithelium Cytokeratin 5 Epithelial cells Cytokeratin 8/18 Basal cells of squamous and some glandular epithelium Basal cells of complex epithelia Cytokeratin 14 Cytokeratin 17 Simple epithelium Cytokeratin 18 Epithelial cells Cytokeratin 19 Gastric and intestinal epithelium, urothelium and Merkel cells Glandular and transitional epithelium Cytokeratin 20 Cytokeratin 7 Epithelial cells Cytokeratin MNF116 Cytomegalovirus Cytomegalovirus Lymphatic endothelium D2-40 Assessment Manager: DE Page 20 of 56

21 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Hairy cell Leukaemia DBA 44 Smooth, skeletal and cardiac muscle Desmin GIST DOG-1 Epithelial tissue E-cadherin Epithelial cells EMA Endothelial cells Factor VIII Dermatofibroma Factor XIIIa FSH in pituitary lesions FSH T cells Fox P3 Neutrophils and vascular endothelium Gastrin producing cells in the stomach Galectin 3 Gastrin Bladder carcinoma Gata-3 Apocrine epithelia of skin and breast GCDFP-15 (BRST2) Assessment Manager: DE Page 21 of 56

22 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Astrocytes, Schwann cells, glial cells, satellite cells GFAP (GA5) Glucagon secreting cells Glucagon Cytotoxic T cells and NK cells Granzyme B GH in pituitary lesions Growth Hormone Helicobacter pylori in stomach H. pylori Mesothelial cells HBME-1 (Meso) Trophoblasts HCG Adult and fetal liver Hepatocyte/HepPar1 HSV I Herpes simplex I HSV II Herpes simplex II Latent nuclear antigen protein Antigen presenting cells, B cells and some activated T cells HHV8 HLA-DR Assessment Manager: DE Page 22 of 56

23 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Glioma / oligodendroglioma IDH-1 Surface IgA alpha - Myeloma IgA (BMT) Surface IgA alpha IgA (renals) Surface IgD delta chains IgD Surface IgG gamma IgG (BMT) Surface IgG gamma IgG (renals) IgG4 positive plasma cells IgG4 Surface IgM mu chains IgM (BMT) Surface IgM mu chains IgM (renals) Ovarian granulosa cells, testicular sertoli and leydig cells Beta cells of the islets of Langerans in pancreas Surface immunoglobulin on B cells Inhibin Insulin Kappa (Lymphoma) Assessment Manager: DE Page 23 of 56

24 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Plasma cells Kappa (PC) Proliferating cells Ki67 (K2) Surface immunoglobulin on B cells Surface immunoglobulin on B cells Lambda (PC) Lambda (Lymphoma) Basement membranes Laminin Langerhans cells Langerin Pre B and T cells Lef-1 LH in pituitary lesions Luteinizing Hormone Mast cells Mast Cell Tryptase Melanocytes, junctional and blue nevus cells Mel Sp Ag (HMB45) Melanocytes/ melanomas Melan A Mesothelial cells Mesothelin Assessment Manager: DE Page 24 of 56

25 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Some lymphocytes, cortical thymocytes, granulosa cells of the ovary, Langerhans islet cells, sertoli cells Mic-2 Glioma / oligodendroglioma MGMT Identification of mismatch repair protein MLH-1 (ES05) Identification of mismatch repair protein MSH2 (25D12) Identification of mismatch repair protein MSH6 Apical surfaces of epithelial cells in breast, GI, respiratory and GU tracts MUC-1 Goblet cells of the small intestine and colon, bronchus and salivary glands MUC-2 Assessment Manager: DE Page 25 of 56

26 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Gastric and tracheobronchial mucosa, primary ovarian mucinous carcinoma MUC-5AC Antrum body and pyloric glands MUC-6 Germinal centre B cells, plasma cells and activated T cells MUM1 Precursors of granulocytes in BMT Myeloperoxidase Skeletal and cardiac muscle Myoglobin Rhabdomyosarcoma Myo D1 Type II pneumocytes and lung adenocarcinoma Neurones, Neuronal processes, peripheral nerves and ganglion cells Neutrophils and neutrophil precursor Napsin A Neurofilaments Neut. Elastase Assessment Manager: DE Page 26 of 56

27 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Neuroendocrine cells NSE B cells OCT-2 Embryonic stem and germ cells OCT-3/4 HPV P16 (RTU) Tumour suppressor protein P53 (D07) Basal cells P63 Prostate adenocarcinoma P504S (AMACR) Chief cells in the parathyroid gland Parathyroid hormone Parvovirus Parvovirus B cells Pax-5 Thyroid, renal cell carcinomas Activated T cells, B cells and myeloid cells Cytotoxic T cells and NK cells Pax-8 PD1 Perforin Assessment Manager: DE Page 27 of 56

28 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Megakaryocytes PGP3 (CD61) Neuroendocrine cells PGP9.5 Syncytiotrophoblasts Plac. Lactogen (PL) Germ cell tumours PLAP Identification of mismatch repair protein Prolactin in pituitary lesions Glandular epithelium in prostate Glandular epithelium in prostate Tumour suppressor protein Red cells and their precursors PMS 2 Prolactin Pros acid phos (PAP) Prostate specific antigen (PSA) PTEN Ret40f/Glycophorin C Melanocytes, Langerhans cells, histiocytes, Scwann cells, apidocytes S-100 Assessment Manager: DE Page 28 of 56

29 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III Enterochromaffin cells of the GI tract Serotonin Skin, pancreatic, colon, uterus and epithelial cells. It is also produced by fibroblasts Smad4 Smooth muscle cells, myofibroblasts and myoepithelial cells Smooth Muscle Actin Pancreatic islets, delta cells in the antrum and duodenum Somatostatin Mantle cell lymphoma SOX-11 SV-40 SV-40 (Bk virus) Neuroendocrine cells Synaptophysin T cells TCR-Beta F1 Primitive T and B cells, thymocytes Tdt Thyroid follicular cells Thyroglobulin Treponema Pallidum Treponema Pallidum Assessment Manager: DE Page 29 of 56

30 Cytospins Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Automated immunocytochemistry - Bond Max, Bond III TSH in pituitary lesions TSH Follicular epithelial cells of the thyroid, type II pneumocytes and Clara cells of the lung TTF-1 Hairy cell Leukaemia TRAP T cells and thymocytes UCHL1 (CD45R0) Fibroblasts, endothelial cells, smooth muscle and melanocytes Vimentin Assessment Manager: DE Page 30 of 56

31 Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions: Automated immunocytochemistry - Ventana: Automated Immunocytochemistry for the Ventana - CEL-LP-647-H Using antibodies for: Estrogen receptor ER Progesterone receptor PR Cerb B2 in breast and GI HER2 HPV 6/11 HPV 6/11 HPV 16+ HPV 16+ Renal Cell Carcinoma Renal Cell Carcinoma Trophoblastic disease P57 frozen tissue sections Identification of antigens at a subcellular level by means of fluorescent antibodies Manual immunofluorescence: Renal IF Staining - CEL-LP-356-H Using antibodies for: Renal frozen sections C1q complement C1q C3c complement C3c IgA alpha chain IgA Assessment Manager: DE Page 31 of 56

32 frozen tissue sections Identification of antigens at a subcellular level by means of fluorescent antibodies Manual immunofluorescence: Renal frozen sections (cont d) IgG gamma chain IgG IgM mu chain IgM Light chain deposition Kappa Light chain deposition Lambda Direct Skin Immunofluorescence - CEL- LP-176-X Using antibodies for: Skin frozen sections Bullous diseases, pemphigoid, LE - C3c complement C3c Bullous diseases, pemphigoid, LE - Fibrinogen Fibrinogen Bullous diseases, pemphigoid, LE - IgA alpha chain IgA Bullous diseases, pemphigoid, LE - IgG gamma chain IgG Bullous diseases, pemphigoid, LE - IgM mu chain IgM Assessment Manager: DE Page 32 of 56

33 Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions: Manual immunocytochemistry: Antigen Retrieval - CEL-LP-174-X Immunocytochemistry - By hand - CEL- LP-172-X Using antibodies for: Complement activation C5b9 T helper cells, monocytes, macrophages and dendritic cells CD 4 Cytotoxic T cells CD 8 Pan B cells CD20 Glycogen storage CD68/PGM1 Transmembrane protein Caveolin 3 Caveolin 3 Collagen Type VI Coll VI Muscle Desmin Mid rod domain (between amino acids 1181 and 1388) of dystrophin Dys 1 Dystrophin (C-terminus) Dys 2 Assessment Manager: DE Page 33 of 56

34 Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions Manual immunocytochemistry Amino terminal domain (between amino acids 321 and 494) of dystrophin Dys 3 Sarcolemma of muscle fibres Dysferlin Emery-Dreifuss muscular dystrophy Emerin Inflammation HLA class 1 Congenital muscular dystrophies Congenital muscular dystrophies Congenital muscular dystrophies Human myosin developmental type heavy chain Laminin a2 (C-ter, 80 Kda) Laminin b1 Laminin a300kd Myosin development Assessment Manager: DE Page 34 of 56

35 Identification of cellular or tissue constituents (antigens) by means of antigen antibody interactions (cont d): Manual immunocytochemistry (cont d): Muscle fibre types Myosin neonatal Myosin fast Myosin slow Muscle integrity Myotilin NK cells NCAM Nitric oxide pathway nnos Muscle degeneration P62 Muscle disorders and dystrophies Muscle membrane integrity Sarcoglycan a Sarcoglycan b Sarcoglycan g Sarcoglycan d Spectrin Utrophin Assessment Manager: DE Page 35 of 56

36 instructions where relevant for preparation, staining and Interpretive/diagnostic microscopy - Olympus: BH2, BX41, BX45, BX50, BX51, BX40CY, BX 51XT, BX50F4 & BX51TF. Leitz: Laborlux K, Nikon: Eclipse 80i, Eclipse Ci-S, E600 & E400. Leica MZ8: Reporting - CEL-CP-032-IMP,, Assessment Manager: DE Page 36 of 56

37 HUMAN BODY FLUIDS/TISSUES/CELLUL AR MATERIAL Cytopathology (Gynae) examination activities for the purposes of clinical diagnosis instructions where relevant for preparation, staining and Liquid based cytology samples taken as part of the cervical screening programme Morphology assessment of gynaecological Cervical ThinPrep Liquid Based Specimens to identify or exclude cytological abnormalities Sample preparation: Processing of Gynae Cytology Specimens - CEL-LP-014-M M-Cyto Espostis method for Gynae LBC samples - CEL-LP-031-M M-Cyto Sample processing T5000 Operating Procedure and Maintenance - CEL-LP-530-M M-Cyto Processing of Gynae/Non-Gynae using Thin Prep (T2000) Machine - CEL-LP- 026-M M-Cyto Automated routine staining - Leica Autostainer XL: Papanicolaou Staining Method - CEL-LP- 002-M M-Cyto Automated coverslipping - Sakura Tissue- Tek SCA: Automated and Manual coverslipping and Maintenance - CEL-LP-001-HM M-Cyto Screening and rapid review - Olympus BX 40's and BX 45's: Primary Screening of LBC - CEL-LP-009-M M-Cyto Assessment Manager: DE Page 37 of 56

38 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d) Cytopathology (Gynae) examination activities for the purposes of clinical instructions where relevant for preparation, staining and Liquid based cytology samples taken as part of the cervical screening programme Morphology assessment of gynaecological Cervical ThinPrep Liquid Based Specimens to identify or exclude cytological abnormalities Screening and rapid review (cont d): Protocol for Rapid Review and Checking of screened LBC - CEL-LP-006-M M-Cyto Interpretive/diagnostic microscopy - Olympus BX 45's and BX 51: Gynae Cytology Abnormal Reporting - CEL-CP-001-M M-Cyto Assessment Manager: DE Page 38 of 56

39 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d) Cytopathology (Non- Gynae) examination activities for the purposes of clinical diagnosis instructions where relevant for preparation, staining and Body fluids Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Sample preparation - Thermo Cytospin 4, Thermo multifuge 3L: Use of Shandon Cytospin - CEL-LP-023- M M-Cyto Use of General Centrifuge - CEL-LP-034- M M-Cyto In the preparation of: Preparation of CSF - CEL-LP-016-M M-Cyto Preparation of Serous and Miscellaneous Fluids - CEL-LP-017-M M-Cyto Preparation of Urine - CEL-LP-018-M M-Cyto Preparation of Sputum - CEL-LP-019-M M-Cyto Preparation of Synovial Fluid - CEL-LP- 022-M M-Cyto Preparation of Fine Needle Aspirations - CEL-LP-028-M M-Cyto Processing Cytology Clot Specimens - CEL-LP-024-M M-Cyto Assessment Manager: DE Page 39 of 56

40 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d)) Cytopathology (Non- Gynae) examination activities for the purposes of clinical diagnosis (cont d) instructions where relevant for preparation, staining and Body fluids Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Sample preparation - Thermo Cytospin 2, Shandon Heraeus Megafuge 40R: Cytospin - Laboratory Equipment (General Use & Maintenance) - CEL-LP- 365-H H-Cyto Centrifuge - Laboratory Equipment (General Use & Maintenance) - CEL-LP- 415-H H-Cyto In the preparation of: Bronchoalveolar (BAL & Wash) - Specimen Preparation - CEL-LP-362-H H-Cyto Cerebrospinal Fluid (CSF) - Specimen Preparation - CEL-LP-363-H H-Cyto Serous & Miscellaneous Fluid - Specimen Preparation - CEL-LP-364-H H-Cyto Urine - Specimen Preparation - CEL-LP- 367-H H-Cyto Sputum - Specimen Preparation - CEL- LP-368-H H-Cyto Synovial Fluid - Preparation - CEL-LP- 369-H H-Cyto Fine Needle Aspiration Cytology - CEL- LP-282-H H-Cyto Assessment Manager: DE Page 40 of 56

41 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d) Cytopathology (Non- Gynae) examination activities for the purposes of clinical diagnosis (cont d) instructions where relevant for preparation, staining and reporting Body fluids Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Sample preparation Cell Block & Clot- Processing of Cytology Specimens - CEL-LP-442-H H-Cyto Sample preparation - Hologic T2000 Processing of Gynae/Non -Gynae using Thin Prep (T2000) Machine - CEL-LP- 026-M M-Cyto T2000 LBC Processor - Laboratory Equipment (General Use & Maintenance) - CEL-LP-419-H H-Cyto In the preparation of: Preparation of Bronchoalveolar (BAL) Specimens - CEL-LP-020-M M-Cyto Preparation of Anal & Vaginal LBC - CEL- LP-682-H H-Cyto Assessment Manager: DE Page 41 of 56

42 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d) Cytopathology (Non- Gynae) examination activities for the purposes of clinical diagnosis (cont d) instructions where relevant for preparation, staining and reporting Body fluids Examination of cellular material in order to identify or exclude morphological and cytological abnormalities Automated routine staining - Leica Autostainer XL, Leica ST5020: Papanicolaou Staining Method - CEL-LP- 002-M M-Cyto Papanicolaou & May Grünwald Giemsa Staining Methods - Cytology - CEL-LP- 281-H H-Cyto Auto Stainer Leica ST Laboratory Equipment (General Use & Maintenance) - CEL-LP-418-H H-Cyto Demonstration of: Cells (nuclei and cytoplasm) and microorganisms Manual techniques: RAL Staining Methods for Non- Gynae - CEL-LP-030-M M-Cyto Rapid Diff Quick - Staining Methods for Non-Gynae - CEL-LP-030-M M-Cyto M-FNA May Grünwald Giemsa - Staining Methods for Non-Gynae - CEL-LP-030-M M-Cyto Ziehl-Neelsen - Staining Methods for Non-Gynae - CEL-LP-030-M M-Cyto May Grünwald Giemsa - Staining Methods - Cytology - CEL-LP-281-H H-Cyto Assessment Manager: DE Page 42 of 56

43 HUMAN BODY FLUIDS/TISSUES/ CELLULAR MATERIAL (cont d) Cytopathology (Non- Gynae) examination activities for the purposes of clinical diagnosis (cont d) instructions where relevant for preparation, staining and reporting Body fluids Examination of cellular material in order to identify or exclude morphological and cytological abnormalities (cont d) Demonstration of: Cells (nuclei and cytoplasm) and microorganisms (cont d) Manual techniques (cont d) RAL Staining Methods - Cytology - CEL-LP-281-H H-Cyto H-FNA Automated coverslipping - Sakura Tissue- Tek SCA, Leica CV5030: Automated and Manual coverslipping and Maintenance - CEL-LP-001-HM M-Cyto, H-Cyto Interpretive/diagnostic microscopy - Olympus BX41, BX 45 BX50, BX51's: Reporting - CEL-CP-032-IMP M-Cyto, H-Cyto Assessment Manager: DE Page 43 of 56

44 HUMAN BODY FLUIDS Immunophenotyping examination procedures for the purposes of clinical diagnosis Documented in house methods and manufacturer s instructions for flow cytometry using BD FacsCanto Bone marrow (EDTA), peripheral blood (EDTA), bone marrow (lithium heparin), bone marrow (preservative-free heparin plus tissue culture medium), CSF, pleural effusions, ascetic fluid, fine needle aspirates (FNA), endobronchial ultrasound (EBUS), bronchoalveolar lavage (BAL), whole lymph nodes/tissue samples, rare fluids (e.g. vitreous fluids) Examination of haematopoetic cells in order to identify the lineage and stage of maturation of the abnormal proliferating cells in the diagnosis and management of AML, ALL, LPD, MPD, CLL, MDS, MM, Non-Hodgkin lymphoma and PNH Manual sample preparation, sample set up, mixing of antibody cocktails Immunophenotyping for Haematological Malignancies - CEL-LP-510-H H- Immunop Acute leukaemia screening Using antibodies for: CYT MPO, CD79a, CD34, CD19, CD7, smcd3, CYCD3, CD45 H- Immunop Classification of acute leukaemia CD117, CD58, CD66c, CD10, CD38, CD20, NUC TDT, CYT U, CD22, CD9, smig LAMBDA, smlg KAPPA, CD1a, CD42a/CD61, CD64, CD99, CD8, CD11b, CD300e, HLA-DR, CD14, CD71, CD235a, CD36, CD105, CD56, CD123, CD64, CD3, CD4, CD5, CD15 H- Immunop Chronic lymphoproliferative screening CD8, smlglambda, smlgkappa, CD56, CD5, CD19, TCRGammadelta, smcd3, CD38, CD20, CD4, CD45 H- Immunop Classification of chronic lympoproliferative disorders FMC7, CD10, CD23, CD79b, CD22, CD19, CD43, CD25, CD200, CD81, CD103, CD305, CD11c, CD27, CD49d, CD7, CD57, CD3, CD138, CD16, CYT Kappa, CYT Lambda, CD2, CD28, TCRAlphabeta, CD27, CD38 H- Immunop Assessment Manager: DE Page 44 of 56

45 HUMAN BODY FLUIDS (cont d) Immunophenotyping examination procedures for the purposes of clinical Documented in house methods and manufacturer s instructions for flow cytometry using BD FacsCanto Bone marrow (EDTA), peripheral blood (EDTA), bone marrow (lithium heparin), bone marrow (preservative-free heparin plus tissue culture medium), CSF, pleural effusions, ascetic fluid, fine needle aspirates (FNA), endobronchial ultrasound (EBUS), bronchoalveolar lavage (BAL), whole lymph nodes/tissue samples, rare fluids (e.g. vitreous fluids) Examination of haematopoetic cells in order to identify the lineage and stage of maturation of the abnormal proliferating cells in the diagnosis and management of AML, ALL, LPD, MPD, CLL, MDS, MM, Non-Hodgkin lymphoma and PNH Manual sample preparation, sample set up, mixing of antibody cocktails PNH Analysis: Testing for the presence of PNH clones in Red blood cell and White blood cell populations: Detection of Paroxysmal Nocturnal Haemoglobinuria by Flow Cytometry - CEL-LP-507-H H- Immunop Using antibodies for: Red blood cells CD59 and CD235a H- Immunop White blood cells FLAER, CD14, CD33, CD64, CD45, CD15, CD24 H- Immunop Assessment Manager: DE Page 45 of 56

46 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL Molecular Diagnostics: DNA and RNA profiling for detection of abnormal sequences for clinical diagnosis Documented in house methods and manufacturer s instructions for molecular diagnostics Whole blood (EDTA), bone marrow (EDTA), blood (lithium heparin), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, Stem cell apheresis in DMSO, lyophilised cells, saliva, FFPE tissue rolls, fresh frozen tissue Extraction & storage of DNA & RNA DNA & RNA Extraction - Qia Symphony, Eppendorf Micro-centrifuge - CEL-LP- 654-H H-MDL DNA Extraction from FFPE Tissue - CEL- LP-549-H H-MDL Nucleic Acid Extraction using QIAvac 24 Plus - CEL-LP-668-H H-MDL Molecular DNA extraction-qiagen Manual method - CEL-LP-484-H H-MDL, H-MRD Fresh Frozen (FF) Tissue Processing - CEL-LP-664-H H-MDL DNA and/or RNA from - Whole blood (EDTA), bone marrow (EDTA), blood (lithium heparin), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, Stem cell apheresis in DMSO, lyophilised cells Translocation detection for? CML and ALL patients Sample preparation - Qiagen Tissue Lyser: Sample preparation - CEL-LP-492-H H-MRD cdna Synthesis - Heating Block, Eppendorf Micro-centrifuge Assessment Manager: DE Page 46 of 56

47 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular Diagnostics: DNA and RNA profiling for detection of abnormal sequences for clinical Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Whole blood (EDTA), bone marrow (EDTA), blood (lithium heparin), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, Stem cell apheresis in DMSO, lyophilised cells cdna Synthesis - CEL-LP-494-H H-MRD Followed by either: Multiplex PCR for new patients - QIAxcel - CEL-LP-491-H & CEL-LP-505-H H-MRD QPCR - Applied Biosystems 7900HT RT- PCR Machine, StepOne RT-PCR Machine, Micro Amp Fast Optical 96-well reaction plate: For either: a) BCR-ABL1 rare transcript RT-qPCR - CEL-LP-665-H H-MRD b) BCR-ABL e1a2 RQ PCR analysis - CEL-LP-665-H H-MRD Translocation detection for? AML patients Sample preparation - Qiagen Tissue Lyser: Sample preparation - CEL-LP-492-H H-MRD cdna Synthesis - Heating Block, Eppendorf Micro-centrifuge cdna Synthesis - CEL-LP-494-H H-MRD Assessment Manager: DE Page 47 of 56

48 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular Diagnostics: DNA and RNA profiling for detection of abnormal sequences for clinical Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Whole blood (EDTA), bone marrow (EDTA), blood (lithium heparin), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, Stem cell apheresis in DMSO, lyophilised cells BCR-ABL1 TKD Mutation Analysis using SeqScape - CEL-LP-643-H H-MRD CML - BCR-ABL TK domain sequencing - G storm thermo cycler machine, Applied Biosystems 3500xL DX CEL-LP-503-H H-MRD AML RT-qPCR analysis - CEL-LP-672-H H-MRD BCR-ABL1 TK Domain Mutation Analysis Sample preparation - Qiagen Tissue Lyser: Sample preparation - CEL-LP-492-H H-MRD BCR-ABL1 TK Domain Mutation Analysis (cont d) cdna Synthesis - Heating Block, Eppendorf Micro-centrifuge cdna Synthesis - CEL-LP-494-H H-MRD BCR-ABL1 TKD Mutation Analysis using SeqScape - CEL-LP-643-H H-MRD CML - BCR-ABL TK domain sequencing - G storm thermo cycler machine, Applied Biosystems 3500xL DX CEL-LP-503-H H-MRD Interpretation/Reporting: Reporting and communicating MRD results - CEL-LP-501-H H-MRD Assessment Manager: DE Page 48 of 56

49 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular Diagnostics: DNA and RNA profiling for detection of abnormal sequences for clinical Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Whole blood (EDTA), bone marrow (EDTA), blood (lithium heparin), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, Stem cell apheresis in DMSO, lyophilised cells Clonality assessment of suspected T or B Cell lymphoproliferative disorders DNA & RNA Extraction - Qia Symphony, Eppendorf Micro-centrifuge: CEL-LP-654-H H-MDL MDL- Lymphoprep Cell Isolation - CEL- LP-474-H H-MDL Assessment Manager: DE Page 49 of 56

50 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular Diagnostics: DNA and RNA profiling for detection of abnormal sequences for clinical Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, lyophilised cells Testing and analysis - G-storm PCR thermocycler, Life Technologies Genetic analyser AB3500 and data analysis using GeneMapper: Commercial kits (InVivoScribe) fragment analysis - MDL - IGH/TCR Clonality - CEL-LP-475-H H-MDL AML prognostic markers: Testing and analysis - G-storm PCR thermocycler, Life Technologies Genetic analyser AB3130 & AB3500 and data analysis using GeneMapper: FLT3 NPM1 FLT3 & NPM1 Mutation Analysis - CEL- LP-468-H H-MDL DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), buccal swabs Post BMT Transplant monitoring: T Cell Separation - RoboSep: Chimerism MDL - T-cell Separation using Immunomagnetic Cell Isolation - CEL-LP- 478-H H-MDL Followed by: Manual DNA extraction: Molecular DNA extraction-qiagen Manual method - CEL-LP-484-H H-MDL Assessment Manager: DE Page 50 of 56

51 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular genetic examination for the diagnosis including response to therapy, for a range of somatic disorders Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), buccal swabs Chimerism (cont d) Testing and analysis - G-storm PCR thermocycler, Testing using Promega PowerPlex 16 commercial kit. Life Technologies Genetic analyser AB3130 & AB3500 and data analysis using ChimerMarker: MDL - Chimerism Assessment DNA Fragment Size Analysis using Capillary Electrophoresis and PCR - CEL-LP-473- H H-MDL DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), Lymphocyte cell pellets in PBS, lyophilised cells SNP analysis: Factor V (FVL) Testing and analysis - QFPCR using Step 1 Plus: Factor V and Prothrombin Testing Using Xpert FII & FV Cartridges - CEL-LP- 655-H H-MDL TSPO MDL - Translocator protein (TSPO) genotyping using taqman fast-pcr - CEL-LP-485-H H-MDL APO E Apolipoprotein-E Mutation Detection using Taqman FAST-PCR Genotyping - CEL-LP-533-H H-MDL Assessment Manager: DE Page 51 of 56

52 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular genetic examination for the diagnosis, carrier and predictive testing for inherited disorders Documented in house methods and manufacturer s instructions for molecular diagnostics DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), buccal swabs Testing and analysis - G-storm PCR thermocycler, Life Technologies Next Generation sequencing using PGM platform: Diamond Blackfan Anaemia DBA mutation analysis with the NGS custom DBA Panel - CEL-LP-635-H H-MDL DBA NGS Analysis Using Ion Reporter - CEL-LP-644-H H-MDL Testing and analysis - G-storm PCR thermocycler, Sanger sequencing and/or MLPA for confirmation of findings: Confirmation of DBA mutations using Sanger sequencing - CEL-LP-651-H H-MDL Genetic Mutation Analysis using SeqScape - CEL-LP-642-H H-MDL Hemoglobinopathies: Testing and analysis - G-storm PCR thermocycler, Life Technologies Genetic analyser AB3130 & AB3500 and data analysis using SeqScape HBB genetic testing for Beta Thalassaemia Sequencing of the beta-globin gene using the 3500xL genetic analyser - CEL-LP- 488-H H-MDL Alpha Thalassaemia Genetic Mutation Analysis using SeqScape - CEL-LP-642-H H-MDL UGT1A1 MDL - UGT1A1 PCR - CEL-LP-476-H H-MDL Assessment Manager: DE Page 52 of 56

53 HUMAN BODY FLUIDS / TISSUES / CELLULAR MATERIAL (cont d) Molecular genetic examination for the diagnosis, carrier and predictive testing for inherited disorders (cont d) Documented in house methods and manufacturer s instructions for molecular diagnostics (cont d) DNA and/or RNA from - Peripheral blood (EDTA), bone marrow (EDTA), blood (lithium heparin), blood (Sodium citrate), bone marrow (lithium heparin), buccal swabs Testing and analysis - G-storm PCR thermocycler, GAP PCR and QIAxecl Alpha Thalassaemia Alpha Thalassaemia Mutations - CEL-LP- 542-H H-MDL Use of the QIAxcel - CEL-LP-505-H H-MDL XMN1 Xmn1 Polymorphism Analysis - CEL-LP- 551-H H-MDL G6PD genetic testing Testing and analysis - G-storm PCR thermocycler, Life Technologies Genetic analyser AB3130 & AB3500 and data analysis using SeqScape Sequencing of Glucose-6-Phosphate Dehydrogenase - CEL-LP-548-H H-MDL MDL- Glucose-6-Phosphate Dehydrogenase Mutation - CEL-LP-465-H H-MDL Genetic Mutation Analysis using SeqScape - CEL-LP-642-H H-MDL Interpretation/Reporting: Molecular Reporting Principles - CEL-LP- 466-H H-MDL Assessment Manager: DE Page 53 of 56

54 S / CELLULAR MATERIAL (cont d) Electronmicroscopic diagnosis Glutaraldehyde fixed nerve, Glutaraldehyde fixed renal biopsies, Glutaraldehyde fixed duodenal biopsies, Glutaraldehyde fixed muscle biopsies, wax reprocessed blocks and slides Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Tissue dissection & Sample preparation: Specimen dissection - CEL-LP-564-X X-EM Processing paraffin wax blocks for TEM - CEL-LP-583-X X-EM Reprocessing paraffin wax section for TEM - CEL-LP-584-X X-EM Followed by either: Manual sample processing: Routine Processing to Spurr Epoxy Resin - CEL-LP-576-X X-EM OR Automated sample processing - Leica EM TP, Lynx: Automatic processing with the Leica processor - CEL-LP-587-X X-EM Automatic Processing of tissue for Transmission Electron Microscopy using the Lynx Processor - CEL-LP-578-X X-EM Assessment Manager: DE Page 54 of 56

55 S / CELLULAR MATERIAL (cont d) Electronmicroscopic Resin embedded cells/tissue biopsies Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Section cutting - Reichert-Jung Ultracut, Ultracut E, Reichert OMU3: Preparation of resin embedded tissue blocks for ultramicrotomy - CEL-LP-589-X X-EM Preparation of glass knives for ultramicrotomy - CEL-LP-590-X X-EM Preparation of semi-thin (thick) survey sections for light microscopy - CEL-LP- 591-X X-EM Preparation of ultra-thin (thin) sections for Transmission Electron Microscopy - CEL- LP-592-X X-EM Manual staining: Semi-thin sections of resin embedded cells/tissue biopsies Toludine blue stain for overview staining Staining semi-thin (thick) survey sections for examination by light microscopy - CEL-LP-593-X X-EM Ultra-thin sections of resin embedded cells/tissue biopsies Staining ultra-thin (thin) sections with heavy metals for Transmission Electron Microscopy - CEL-LP-594-X X-EM Assessment Manager: DE Page 55 of 56

56 S / CELLULAR MATERIAL (cont d) Electronmicroscopic Ultra-thin sections of resin embedded cells/tissue biopsies Electronmicroscopy & digital image capture - Hitachi S7650 Transmission Electron Microscope, AMT 2K digital camera: Operation & Maintenance of the Hitachi S7650 Transmission Electron Microscope - CEL-LP-599-X X-EM Digital Imaging on the Transmission Electron Microscope - CEL-LP-602-X X-EM Interpretation/Reporting: Handling and reporting surgical tissues - CEL-LP-628-X X-EM END Assessment Manager: DE Page 56 of 56