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 Calderdale and Huddersfield NHS Foundation Trust Calderdale Royal Hospital Salterhebble Halifax HX3 0PW United Kingdom Contact: Dr Richard Knights Tel: +44 (0) Testing performed at the above address only Additional site activity performed away from the laboratory: Location details Activities On-site Body Store Storage of bodies Record keeping (body identification and audit trail) Site activities performed away from the location listed above: Location details Activities Off Site Body Store: Huddersfield Royal Infirmary Acre Street Huddersfield HD3 3EA Storage of bodies Record keeping (body identification and audit trail) Storage Archive: Acre Mill Huddersfield HD3 3EB Block, slide and record storage Assessment Manager: LD1 Page 1 of 11

2 DETAIL OF ACCREDITATION FLUIDS purpose of diagnosis Bronchoscopy samples Cereprospinal fluid samples Fine needle aspirates Serous fluids Sputum samples Urine samples Cytopathology Papanicolaou (PAP) staining for nuclear and cytoplasmic detail Reading and interpretation of slides from processed tissues and fluids Centrifuge Cytospin Microscope Non-gynae specimen process Staining: Automated - Sakura Tissue-Tek Prisma staining machine and coverslipper: SOP Manual back up - SOP Interpretive Microscopy: SOP Non-gynae specimen process SOP Non-gynae specimen process SOP Breast FNA SOP Thyroid cancers SOP Bronchial and lung cancers SOP Kidney tumours SOP Bladder tumours SOP Lymphnodes Assessment Manager: LD1 Page 2 of 11

3 Tissue samples Histopathology Specimen dissection: SOP Cut up SOP Biomedical Scientist Cut up SOP Advanced practitioner cut up Tissue processing: Leica ASP 6025 tissue processors for fatty tissue and routine histology tissue. Thermo Scientific Excelsior tissue processor for diagnostic biopsies and cell blocks. Leica EG 1150 tissue embedder. SOP Tissue processing Embedding: SOP Embedding Decalcification: SOP Decalcification Microtomy: Leica RM 2245 microtome x2 Leica RM 2235 microtome x3 Thermo Scientific Finnesse E+ microtome SOP Microtomy Frozen sections for urgent diagnostic histopathology : Thermo Scientific Cryotome FSE SOP Frozen sections Assessment Manager: LD1 Page 3 of 11

4 Tissue samples (cont d) H&E staining for tissue architecture and nuclear detail Papanicolaou (PAP) staining for nuclear and cytoplasmic detail Haematoxylin and Eosin staining Papanicolaou (PAP) staining: Sakura Tissue-Tek Prisma staining machine and coverslipper: SOP stainer/coverslipper for automated H&E and PAP staining Manual SOP Special stains for back up manual H&E and PAP staining Tissue samples Special staining for the identification of: Mucins Carbohydrates Elastic fibres Helicobacter Gram +ve and ve organisms Fungi Basement membranes SOP Rapid H&E on frozen sections only Special staining: Manual methods according to UKNEQAS CPT best methods and Bancroft, J.D. & Gamble, M. (2003) Theory and practice of histological techniques, 5th edition, Edinburgh. Churchill Livingstone. SOP Special stains Alcian blue AB/PAS Diastase- PAS Elastic Van Gieson Giemsa Gram-Twort Grocott Hexamine Silver Assessment Manager: LD1 Page 4 of 11

5 Tissue samples (cont d) Special staining for the identification of (cont d): Amyloid Collagen Highmans Congo Red HVG Lipofuchsin Connective tissues Melanin Connective tissues to remove melanin pigment Mast cells Hepatitis B Mucins, fungi and carbohydrates Ferric iron Reticulin fibres Mineralised bone and calcium deposits Leprosy bacilli TB bacilli Long ZN M.S.B. for connective tissues Masson Fontana Masson Trichrome Melanin Bleach Methylene blue Shikata Orcein P.A.S. Perl's Prussian Blue Gordon and Sweets Reticulin Von Kossa Wade + Fite Z N Assessment Manager: LD1 Page 5 of 11

6 Tissue samples and cell blocks Immunochemistry for the identification of: Cytokeratins in epithelial cells Immunochemistry: Roche Ventana Benchmark Ultraautomated method SOP immunohistochemistry Using antibodies to: 34BE12 Cytokeratins in epithelial cells Protein present in lymphocytes Antigen in epithelium Antigen in fallopian tube epithelium Antigen present in colon cancer AE1/3 BCL-2 BEREP4 CA125 CA19.9 Protein in mesothelial cells CALRETININ Cytokeratins in epithelial cells CAM 5.2 Antigen on T lymphocytes Antigen on some lymphoid cells Antigen on B lymphocytes Reed-Sternberg cells Endothelial cells Endothelial cells Nerve and neuroendocrine cells CD3 CD10 CD20 CD30 CD31 CD34 CD56 Assessment Manager: LD1 Page 6 of 11

7 Tissue samples and cell blocks (cont d) Immunochemistry for the identification of (cont d): Macrophages and mononuclear cells Antigen in intestinal epithelium Protein in gastro-intestinal cells Granules in neuroendocrine cells Using antibodies to: CD68 CDX2 CEA CHROMOGRANIN Cytokeratin in epithelium CK 5/6 Cytokeratin in specific epithelium Cytokeratin in gastro-intestinal cells Smooth and striated muscle cells Protein in epithelial cells Protein in epithelial cells Nuclear receptor Glycoprotein in specific epithelium Activated/neoplastic melanocytes Helicobacter pylori bacterium Hormone in testicular cells CK7 CK20 DESMIN E-CADHERIN EMA ER GCDFP HMB45 H PYLORI INHIBIN Nuclear protein in proliferating cells KI67 (MIB 1) Lymphocytes LCA (CD45) Assessment Manager: LD1 Page 7 of 11

8 Tissue samples and cell blocks (cont d) Immunochemistry for the identification of (cont d): Cytokeratin in epithelial cells Nuclear protein in epithelial cells Antigen in melanocytes Enzyme produced by trophoblasts Nuclear receptor Protein in prostatic epithelium Using antibodies to: MNF116 P63 PANMEL PLAP PR PSA Protein in nerve cells Smooth muscle cells Smooth muscle cells Cells within the muscularis propria Granules in neuroendocrine cells Nuclear protein in lung and thyroid Filament in mesenchymal cells Protein in specific tissues Oncoprotein in breast cancer S100 SMA SMM SMOOTHELIN SYNAPTOPHYSIN TTF-1 VIMENTIN WT1 SOP Her 2 testing Using antibodies to: HER2 Assessment Manager: LD1 Page 8 of 11

9 Tissue samples and cell blocks (cont d) Tissue samples Immunofluorescence for the identification of: Immunoglobulin A in skin Immunoglobulin G in skin Immunoglobulin M in skin Complement C3 in skin Fibrinogen in skin Reading and interpretation of slides from processed tissues and fluids Immunofluorescence Roche Ventana Benchmark Ultra Fluorescent microscope SOP Immunofluorescence Using antibodies to: IgA IgG IgM Complement Fibrinogen Interpretive Microscopy: SOP Breast palpable lesion SOP Breast impalpable lesion SOP Breast FNA SOP Breast cores SOP Colorectal cancers SOP Colorectal poly and dysplasia SOP Gastrectomy for stomach tumours SOP Oesophagectomy for oesophageal tumours SOP kidney tumours SOP Bladder tumours SOP Prostate tumours SOP Testicular tumours SOP Routine hysterectomy SOP Hysterectomy for endometrial cancer SOP Hysterectomy for smooth muscle tumours SOP Cervical biopsies Assessment Manager: LD1 Page 9 of 11

10 Tissue samples (cont d) Reading and interpretation of slides from processed tissues and fluids (cont d) Interpretive Microscopy: SOP Ovarian tumours SOP Bronchial and lung biopsies for cancer SOP Lymphnodes SOP Malignant melanomas SOP ER and PR scoring SOP Skin tumours SOP Thyroid cancers SOP Hepatitis C liver biopsies SOP Bowel cancer screening specimens SOP Her 2 testing SOP Reporting of frozen sections Assessment Manager: LD1 Page 10 of 11

11 Semen Examination activities for the purpose of clinical diagnosis Andrology Post vasectomy analysis for presence (motile/non-motile) or absence of spermatazoa Infertility testing for the following properties: Appearance ph Liquefaction Viscosity Agglutination Spermatozoa Concentration Spermatozoa Motility Spermatozoa Viability Spermatozoa Morphology Round cell count Light microscopy Manual method according to WHO (2010) guidelines 5th Edition and British Andrology Society guidelines for the assessment of post vasectomy semen samples (2002) Light microscopy using counting chamber Manual method according to WHO (2010) guidelines 5th Edition SOP Infertility tests END Assessment Manager: LD1 Page 11 of 11

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