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 Trust Headquarters A Floor, Tower Building Belfast City Hospital 51, Lisburn Road Belfast County Antrim Northern Ireland BT9 7AB Contact: Leona Grant Tel: +44 (0) Leona.grant@belfasttrust.hscni.net Website: MortuaryServices.htm Laboratory locations: below s covered by the organisation and their relevant activities details Activity code Belfast City Hospital Cellular Pathology Corry Building 51, Lisburn Road Belfast BT12 7AB Mr Desy Smart Histopathology Diagnostic Cytology Cervical Cytology BCH Royal Hospitals Cellular Pathology Institute of Pathology Grosvenor Road Belfast BT12 6BA Mr Desy Smart Histopathology Diagnostic Cytology Royal Hospitals Microbiology Laboratory Kelvin Building Grosvenor Road Belfast BT12 6BA Mr Brendan Kelly Electron microscopy Mic Royal Hospitals Mohs Laboratory Level 5 Dermatology Department Outpatient Centre Falls Road Belfast BT12 6BA Mr Gerry Clarke Intraoperative frozen sections of skin Mohs Assessment Manager: GB 1 of 30

2 details Activity code Northern Ireland Molecular Pathology Laboratory (NI MPL) Centre for Cancer Research and Cell Biology (CCRCB) Queen s University Belfast (QUB) 97, Lisburn Road Belfast BT9 7BL Mr Stephen McQuaid Molecular testing NIMPL Site activities performed away from the locations listed above: details Activity code On-site Mortuary and Body Store Royal Hospitals Grosvenor Road Belfast BT12 6BA Storage of bodies Retrieval of tissue via post mortem Record keeping (body identification and audit trail) Mort FNA Breast Clinic Outpatients, Mammography Suite Belfast City Hospital Slide preparation, Staining by Giemsa method, Screening and provisional reporting BCHbc ROSE Head and Neck Clinic Belfast Royal Hospital Slide preparation, Staining by Giemsa method, ROSE, Rapid onsite evaluation of adequacy HNC Ultrasound ROSE Level 4, Ultra sound department, Belfast Royal Hospital Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given us Ultrasound ROSE Lorimer Suite Ground Floor Belfast City Hospital Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given BCHus Ultrasound ROSE Belfast Royal Hospital, Level 3, Intervention Suite Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given usi Assessment Manager: GB Page 2 of 30

3 details Activity code EUS ROSE Belfast Royal Hospital, Level 3, Endoscopy Day Unit Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given eus EUS ROSE Ground Floor, Tower block, Endoscopy Unit, Belfast City Hospital Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given BCHeus CT ROSE Belfast Royal Hospital, Level 2 and Level 3, X-ray dept and CT dept. EBUS ROSE Ground Floor, Tower Block, Endoscopy Unit, Belfast City Hospital Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given Slide preparation, Staining by Giemsa method. ROSE - adequacy advice given ct BCHebu Assessment Manager: GB Page 3 of 30

4 DETAIL OF ACCREDITATION Cytopathological examination of fluids for the purpose of diagnosis Systemic body fluid samples including fine needle aspirations. Examination of fluids in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Samples centrifuged and processed using Hologic ThinPrep technique T2000 Conventional sample preparation using centrifuge and cytocentrifuge BCH Automated papanicolaou and H&E staining using Leica XL Staining machine Manual giemsa stain LP (TP-81) LP (TP-88) LP (TP-46) Cervical LBC Samples (Thinprep). Preparation of samples in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis/screening Hologic T5000 auto LBC processor LP (TP-114) PD (TP-288) BCH Glass from cervical LBC samples Staining of samples in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis/screening Automated papanicolaou staining using Leica XL Staining machine LP (TP-115) BCH Slides prepared as above Morphological assessment and interpretation/diagnosis Interpretive microscopy using microscopes BCH LP (TP-48) Assessment Manager: GB Page 4 of 30

5 diagnosis Formalin-fixed tissue samples Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Specimen Dissection Cat A LP (TP-76) Cat B LP (TP-77) Cat C LP (TP-78) Cat D LP (TP-79) Cat E LP (TP-80) Examination of Early Miscarriages - LP (TP-159) BCH ( only) Formalin-fixed tissue samples including thrombin clots prepared by systemic cytology service Tissue Processing VIP 6 E2 BCH (Sakura) VIP-6 E2 RGH (Sakura) VIP E300 RGH (Bayer Diagnostics) Contingency LP (TP-55) LP (TP-56) BCH Formalin-fixed tissue samples including thrombin clots prepared by systemic cytology service Embedding using: Thermoshandon embeding centre and Thermoshandon Histo Star Thermoshandon embedding centre BCH LP (TP-57) Bone and calcified tissue Decalcification using phenol BCH TP-69 Assessment Manager: GB Page 5 of 30

6 Fresh/frozen tissue Intraoperative examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Frozen sections using: Leica CM1900 cryostat Leica CM1950 cryostat BCH Leica CM1950 cryostat Mohs Manual H&E staining LP (TP-53) LP (TP-121) Formalin Fixed paraffin wax blocks of processed tissue, including thrombin clots prepared by systemic cytology service Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Microtomy using: Leica RM2135 Leica RM2235 Reichart Jung 2030 Microm HM325 Leica RM2235 Leica RM2135 Leica RM2155 BCH LP (TP-58) Assessment Manager: GB Page 6 of 30

7 (Formalin fixed paraffin embedded) and frozen sections Routine morphological staining for the detection of basophilic and eosinophilic structures H&E staining using: Leica Auto XL Sakura Prisma Thermo Linear BCH Mohs Coverslip Slides using: Tissue Tek Glas BCH Tissue Tek Film X 2 LP (TP-59) (H&E) LP (TP-60) (Maintenance of Staining machines) LP (TP-121) LP (TP-61) (Coverslippers) BCH, BCH, Mohs BCH, Special stains for the detection of: Documented in-house procedures for manual special stains Special Stains Manual - LP (TP-67) Acid mucins Alcian Blue All Mucins Alcian Blue PAS ± Diastase Amyloid Alkaline Congo Red Assessment Manager: GB Page 7 of 30

8 Special stains for the detection of: (cont d) TB bacilli Auramine O Gram positive and negative bacteria Gram with Neutral Red or Twort Counterstain Nissl Substance Cresyl Fast Violet Method Reticulin Gordon and Sweet s Reticulin Stain Fibrosis Haematoxylin and van Gieson Myelin in peripheral nerves Modification of Kultschitsky s Stain Myelin Luxol Fast Blue/Haematoxylin Fibrin deposition, fibrinosis, fibrosis of liver Martius Scarlet Blue Melanin Masson Fontana Fibrosis, differentiation of muscle and collagen Masson Trichrome Fungi Basement membrane (renal) Methenamine Silver Elastin Miller s Elastic Stain Helicobacter Modified May-Grunwald Giemsa Assessment Manager: GB Page 8 of 30

9 Special stains for the detection of: (cont d) Hep B surface antigen Copper-associated protein Orcein Glycogen, basement membranes, and other PASpositive structures Periodic Acid Schiff (PAS + Diastase) Haemosiderin Perls Prussian Blue Mucin Southgate s Mucicarmine Mast cells Toluidine Blue Calcium von Kossa Acid-Alcohol fast bacilii Ziehl Neelsen Frozen sections of rectal tissue Concentration of Acetylcholinesterase for diagnosis of Hirschsprung s disease Manual Acetylcholinesterase stain LP (TP-122) detect the following: staining using Leica Bond III Immunostainer Leica Bond Max Immunostainer and the following antibodies BCH/ Smooth muscle Actin (Smooth muscle) BCH/ Pituitary hormone ACTH Assessment Manager: GB Page 9 of 30

10 detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Muscle dystrophy panel Adhalin For the identification of anaplastic large cell lyphomas ALK protein BCH/ Alpha-1-antitrypsin Alpha-1-antitrypsin Embryonic cell in normal tissues and germ tumours Alpha fetoprotein BCH/ Amyloid marker Amyloid A component Hairy cell leukaemia Annexin-1 Axonal swelling and damage (neuro) APP Dementia profile (neuro) βamyloid Glioma panel (neuro) ATRX Detects syncytiotrophoblasts Beta-hCG Beta-Catenin Beta-Catenin BCH/ Epithelial cells Ber EP4 BCH/ Lymphoma/Carcinoma BCL-2 BCH/ Lymphomas BCL-6 BCH/ Assessment Manager: GB Page 10 of 30

11 detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Autoimmune and immunodeficiency disorders BETA F1 B-cells BOB 1 BCH/ BRAF mutations BRAF Rhabdoid tumours BRG1 Pancreatic tumour/ CA 19-9 BCH/ Ovarian tumour CA 125 BCH/ Gastrointestinal and pulmonary disease Protein involved in smooth muscle and non-muscle contraction Myoepithelial cells in benign and malignant breast lesions Calcitonin Caldesmon H Calponin BCH/ Neuroanatomical marker Calretinin BCH/ Histiocytes/Langerhan cell CD1a BCH/ Pan t-lymphocytes CD2 BCH/ Pan T-cell marker CD3 BCH/ T-cell subset CD4 BCH/ Assessment Manager: GB Page 11 of 30

12 detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Pan T-cell marker CD5 BCH/ T-cell marker CD7 BCH/ T-cell subset CD8 BCH/ Renal carcinoma/lymphoma CD10* RTU BCH/ Renal carcinoma/lymphoma ccd10 (CYTO) BCH/ Renal carcinoma/lymphoma CD11c Hairy cell leukaemia CD13 Hepatocellular carcinoma Breast tumours Renal cell carcinoma Prostate tumour Most Acute myeloid leukaemias A proportion of acute lymphoid leukaemias Reed-Sterberg and other cell types NK cells, activated macrophages and a subset of T cells ccd15 (CYTO) CD15* RTU CD16 BCH/ BCH/ Antigen of B lymphocytes CD20 (B-cell L26) BCH/ Assessment Manager: GB Page 12 of 30

13 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Follicular Dendritic cells CD21 BCH/ Aid in the classification of Lymphoma CD23 BCH/ Reed-Sterberg cells ccd30 Ber H2 (CYTO) BCH/ Reed-Sterberg cells CD30* RTU BCH/ Endothelial marker CD31 BCH/ Stem cell/endothelium Sarcoma CD34* RTU BCH/ Dendritic cell marker CD35 Plasma cells CD38 BCH/ Pan T-cell marker CD43(MT1) BCH/ Pan Leukocyte marker (T&B) CD45 (LCA) Neuroendocrine ccd56 (CYTO) BCH/ Neuroendocrine CD56 * RTU (ROUTINE) BCH/ NK cells, neuroendocrine cells CD57* RTU BCH/ Megakaryocytic leukaemias CD61 Macrophages and mononuclear cells CD68 (KPI) BCH/ Assessment Manager: GB Page 13 of 30

14 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Useful for identification of B- cell lymphomas CD79α BCH/ Ewings sarcoma CD99/MIC 2 BCH/ GIST,RCC,Germ cell tumor CD117 BCH/ Human CD123 CD123 Lymphoma/Plasmacytoma CD138 Antigen in intestinal epithelium CDX2* RTU BCH/ GI carcinoma CEAm Hepatocellular carcinoma CEAp Axonal swelling and damage (neuro) Clusterin Neuroendocrine Chromogranin A* RTU Cytomegalovirus CMV BCH/ Mantle cell lymphoma Cyclin D1 BCH/ Haematopoietic tumours CYMC BCH/ Pan cytokeratin Cytokeratin AE1/AE3 BCH/ Pan cytokeratin Cytokeratin CAM 5.2 BCH/ Assessment Manager: GB Page 14 of 30

15 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies CK in epithelium CK5/6 BCH/ Cytokeratin in epithelium CK7 BCH/ Ck for Carcinoma CK14 Ck for Carcinoma CK19 BCH/ CK in gastro-intestinal cells CK20 BCH/ High MW cytokeratin, complex epithelia Certain types of T-cell lymphomas. Follicular Dendritic tumours. CK 34BE12 CXCL13 BCH/ BCH/ Lymphatic endothelium D2-40 Smooth and striated muscle cells Desmin BCH/ GIST DOG-1 BCH/ Frozen sections of muscle tissue Frozen sections of muscle tissue Frozen sections of muscle tissue Muscular dystrophy panel Dystrophin 1 Muscular dystrophy panel Dystrophin 2 Muscular dystrophy panel Dystrophin 3 Assessment Manager: GB Page 15 of 30

16 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Frozen sections of muscle tissue Muscular dystrophy panel Dysferlin Epstein-Barr virus EBV BCH Distinguish Lobular from Ductal carcinoma E-Cadherin BCH/ Protein in epithelial cells EMA BCH/ Vascular neoplasms ERG Endothelial cells Factor VIII BCH Lymphoma (Hodgkins) Fascin Ewings sarcoma FLI-1 Pituitary hormone FSH Stomach hormone Gastrin Breast and urothelial carcinoma Gata-3 BCH/ Glycoprotein in epithelium GCDFP BCH/ Astrocytes and astrocytic cells in brain GFAP Pancreatic hormone Glucagon Assessment Manager: GB Page 16 of 30

17 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Marker of malignancy Glut 1 Erythroid leukaemias Glycophorin A Hepatocellular carcinoma Glypican 3 BCH/ Cytotoxic T lymphocytes and NK Cells Granzyme B BCH/ Pituitary hormone GH Mesothelial marker HBME-1 Hepatitis B infected tissue Hepatitis B(surface) Hepatitis B infected tissue Hepatitis B(Core) Benign and malignant liver derived tissues Hepatocyte BCH/ Transmembrane glycoprotein HER-2 ORACLE BCH Transmembrane glycoprotein c-erb-2 (her-2) (CYTO) BCH/ HSV infected tissue Herpes Simplex 1 BCH/ HSV infected tissue Herpes Simplex 2 BCH/ For identification of Kaposi s sarcoma HHV8 Muscle myopathies HLA-ABC Assessment Manager: GB Page 17 of 30

18 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Muscle myopathies HLA-DR Melanocytes (Melanoma) HMB45 BCH/ Benign and malignant tumour formation Ovarian clear cell carcinoma marker HMGA2 HNF-1β Glioma marker IDH1 Immunoglobulin A IgA BCH/ Immunoglobulin D IgD BCH/ Immunoglobulin G IgG BCH/ Immunoglobulin G4 IgG4 Immunoglobulin M IgM BCH/ Carcinoma vs Germ cell tumor Inhibin A Tumour marker IMP3 Pancreatic hormone Insulin Malignant Rhabdoid tumours INI-1 Kappa light chains Kappa BCH/ Assessment Manager: GB Page 18 of 30

19 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Lambda light chains-used to identify tumor monoclonality Lambda BCH/ Langerhans cell histiocytosis Langerin BCH Lymphoid LEFI Pituitary hormone LH Mast cells Mast Cell Tryptase Melanocytes (Melanoma) Melan-A BCH/ Frozen sections of muscle tissue Muscular dystrophy panel Merosin Cell proliferation marker MIB-1 (Ki-67) BCH/ Mismatch repair protein MLH1 BCH/ Mismatch repair protein MSH2 BCH/ Mismatch repair protein MSH6 Secretory epithelial/ Mesenchymal tumours Human muc2glycoprotein/ Adenocarcinomas MUC-1 MUC-2 Assessment Manager: GB Page 19 of 30

20 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Soft tissue neoplasms and carcinomas MUC-4 BCH/ Diffuse and infiltrative carcinomas MUC-5AC* RTU Human muc6glycoprotein MUC-6 B cell marker used to aid classification of lymphomas Myeloid cells, histiocytes, granulocytes, macrophages and monocytes MUM1 Muramidase(Lysozyme) Myeloid cell populations Myeloperoxidase BCH/ Rhabdomyosarcoma Myo D1 Rhabdomyosarcoma Myogenin Tumours of muscle origin Myoglobin Myosin heavy chain during muscle fibre development Myosin heavy chain neonatal Lung adenocarcinoma Napsin A BCH/ Neuronal differentiation of neoplasms Neurofilament Protein Assessment Manager: GB Page 20 of 30

21 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Breast hormone Oestrogen Receptor (CYTOLOGY) BCH/ Breast hormone Oestrogen receptor (EP1) * RTU BCH/ B-Cell marker OCT2 BCH/ Germ cell tumours OCT3/4 BCH/ Ovarian cancer/hpv P16 BCH/ P40 BCH Prostate adenocarcinoma P504S BCH/ Cell proliferation marker P53(DO7) BCH/ Hydatidiform mole p57 KIP2 Tumour suppressor gene p63* RTU Pancreatic lipase marker Pancreatic lipase Pancreatic hormone Pancreatic Polypeptide Differential diagnosis of parathyroid tumours Parathyroid Hormone Parvovirus infected tissue Parvovirus Lymphoma marker PD1 Assessment Manager: GB Page 21 of 30

22 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Lymphoma PAX-5 Ovarian, thyroid and renal cell carcinoma marker Enzyme produced by trophoblasts PAX-8 Placental alk phos(plap) BCH/ BCH/ Mismatch repair protein PMS2 BCH/ Breast hormone PgR636 Pituitary hormone Prolactin Used to aid classification metastatic PR carcinoma PSA poly Marker for prostatic carcinoma PSA mono BCH/ Marker for prostatic carcinoma P. Acid Phosphatase BCH/ Renal carcinoma marker RCC BCH/ Germ cell tumours Sall-4 Colorectal carcinomas SATB2 BCH/ Used to aid classification metastatic PR carcinoma S-100* RTU Assessment Manager: GB Page 22 of 30

23 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Adrenal and gonadal development marker SF-1 BCH/ Neurofilament protein (neuro) SMI 32 Pancreatic hormone Somatostatin Mantle cell lymphoma Sox-11 BCH/ Frozen sections of muscle tissue Mantle cell lymphoma Spectrin Demonstration of synaptophysin producing cells Synaptophysin Dementia profile (neuro) Alpha-synuclein BCH/ Immature T cells TdT Precursor of thyroid hormones Thyroglobulin Lymphoid marker TIA-1 BCH/ Soft tissue neoplasms TLE BCH/ Nuclear protein in lung and thyroid Nuclear protein in lung and thyroid TTF-1 (CYTO) TTF-1 * RTU Trypsin levels in pancreas TRYPSIN BCH/ Assessment Manager: GB Page 23 of 30

24 (Formalin fixed paraffin embedded) detect the following: (cont d) staining using Leica Bond III and Bond Max Immunostainers and the following antibodies Pituitary hormone TSH BCH/ Dementia profile (neuro) TAU Toxoplasmosis gondii infected tissue Toxoplasmosis gondii Choroid plexus tumours Transthyretin (TTR) Treponema pallidum infected tissue Treponema pallidum Ab Dementia profile (neuro) Ubiquitin Frozen sections of muscle tissue Muscular dystrophy panel Utrophin Labels brush border in gastrointestinal mucosal epithelium Filaments in mesenchymal cells Villin Vimentin Tumour marker Wilms WT1 BCH Assessment Manager: GB Page 24 of 30

25 detect the following: Manual Immunohistochemical staining the following antibodies Stained on Bond III followed by Luxol Fast Blue Special stain Neurofilament and myelin Anti-Neurofilament Protein LFB Key SOP LP (TP-132) Endothelial cells and myelin Anti-CD34 LFB Key SOP LP (TP-133) Frozen tissue sections Immunofluorescence to detect the following: Type IV Collagen for diagnosis of Alports syndrome Manual indirect immunofluorescence staining for type IV collagen using Wielisa Kit from Eurodiagnostica using antibodies to alpha 1,3,5 chain of type IV collagen; rat and Mouse FITC Key SOP TP-145 (LP ) Detection of AA amyloid Manual indirect immunofluorescence using monoclonal AA antibody Key SOP TP-146 (LP ) Assessment Manager: GB Page 25 of 30

26 Immunofluorescence to detect the following: (cont d) Kappa light chains Manual direct Immunofluorescence to detect Kappa antibodies Key SOP TP-152 Lambda light chains Manual direct Immunofluorescence to detect Lambda antibodies Key SOP TP-152 Frozen sections of transplant renal biopsies Detection of C4d Manual Indirect Immunofluorescence using monoclonal C4d Key SOP TP-147 (LP ) Detection of BK virus Manual Indirect Immunofluorescence using monoclonal BKV Key SOP TP-147 (LP ) Frozen sections of skin Detection of Herpes gestationis factor Manual indirect immunofluorescence using C3 and IgG antibodies Key SOP TP-148 (LP ) Assessment Manager: GB Page 26 of 30

27 Neuropathological examination of tissues for the purpose of diagnosis Fresh muscle biopsy samples Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Leica CM1950 cryostat TP-53 TP-124 TP-128 TP-136 Frozen sections of muscle tissue Special stains for the detection of: Documented in-house procedures for manual special stains Muscle Staining Manual LP (TP-131) Manual H&E TP-67 Lipid Oil Red O Cytochromoxidase enzyme Cytochrome Oxidase Fibre Typing Modified Adenosine Triphosphatase Abnormal mitochondria Modified Gomori s Trichrome NADH enzyme NADH Tetrazolium Reductase Acid Phosphatase Naphthol AS-Bi Phosphate Acid Phosphatase Atrophic Fibres α-naphthyl Acetate Non-Specific Esterase Phosphorylase Phosphorylase Succinase Dehydrogenase enzyme Succinate Dehydrogenase Assessment Manager: GB Page 27 of 30

28 Electron Microscopy examination of tissues for the purpose of diagnosis Tissue samples fixed in glutaraldehyde/formalin Assessment of ultrastructural features Processing and production of EM sections Ultramicrotome Reichurt Jung Ultra Cut E x 2 Mic LP (TP-155) Electron Microscope Philips CM10 Transmission TP-610 Digital camera AMT XR-80M LP (TP-155) Immunopathology examination diagnosis Blood Diagnosis of Erythropoetic protoporphyria Fluorescence microscope DM2000 and camera, Leica DC 300F Key SOPs LP (TP-142) LP (TP-140) Assessment Manager: GB Page 28 of 30

29 Miscellaneous examination of tissues for the purpose of diagnosis Blood Herpes gestationis screening for presence of HGV factor in pregnancy Serum dilutions prepared from Clotted Blood specimens and cryostat sections of normal skin Leica CM1950 Cryostat, centrifuge Eppendorf LP (TP-148) Blood Demonstration of circulating Antibodies - IgA, IgM, IgG, PC Manual Indirect immunofluorescence LP (TP-153) Molecular examination of tissues for the purpose of diagnosis NIMPL Formalin fixed paraffin embedded tissue samples Manual tissue macrodissection and automated DNA Extraction using Roche COBAS DNA Preparation kit, Veriti Thermal Cycler, and Nanodrop 2000 Spectrophotometer Key SOPs LP (TP-162) LP (TP-172) LP (TP-168) DNA extracted from FFPE samples Targeted gene mutation analysis: KRAS (colorectal cancer) NRAS (colorectal cancers Using Roche COBAS & AB3500 Sanger Sequencing KRAS - LP (TP- 792) BRAF/NRAS TP-644 Sanger Sequencer - LP (TP-171) Assessment Manager: GB Page 29 of 30

30 Molecular examination of tissues for the purpose of NIMPL DNA extracted from FFPE samples Targeted gene mutation analysis: BRAF (colorectal cancer, melanoma) Using Roche COBAS LP (TP-644) DNA extracted from FFPE samples Targeted gene mutation analysis: EGFR (NSCLC) Using Roche COBAS LP (TP-689) FFPE tissue HER2 gene amplification status By DDISH on the Ventana XT LP (TP-169) FFPE tissue Targeted gene mutation analysis: ALK (NSCLC) Automated immunohistochemistry using the Ventana XT Ventana Benchmark XT LP (TP-173) FFPE tissue Targeted gene mutation analysis: Gastric Her2 Automated immunohistochemistry and DDISH using the Ventana XT Ventana Benchmark XT- TP-173 FFPE tissue Microsatellite Instability (MSI) Promega Kit MSI kit, Verti Thermal Cycler - Applied Biosystems Genetic Analyser 3500 TP-597 Microsatellite Instability TP-172 Maintenance of AB3500 Gene Analyser END Assessment Manager: GB Page 30 of 30