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 United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK North Tyneside General Hospital Rake Lane North Shields Tyne & Wear NE29 8NH Contact: Ian Taylor Tel: +44 (0) Fax: +44 (0) ian.taylor@ncht.nhs.uk Website: Laboratory locations: Location details Activity Address: Pathology Department North Tyneside General Hospital Rake Lane North Shields NE29 8NH Local contact: Mr Ian Taylor Mrs Carmen Ward Routine Histopathology Special Stains Immunocytochemistry Frozen Section Histology Cytology -Diagnostic Mortuary Services and Body Store Site activities performed away from the locations listed above: Location details Activity Mortuary Hexham General Hospital Corbridge Road Hexham Northumberland NE45 1QJ Mr Ian Taylor Mrs Carmen Ward Mortuary Services and Storage of bodies Body Store Northumbria Specialist Emergency Care Hospital Northumbria Way Cramlington Northumberland NE23 6NZ Mr Ian Taylor Mrs Carmen Ward Storage of bodies Body Store Wansbeck General Hospital Woodhorn Lane Ashington Northumberland NE63 9JJ Mr Ian Taylor Mrs Carmen Ward Storage of bodies Assessment Manager: JCR Page 1 of 11

2 DETAIL OF ACCREDITATION HUMAN BODY FLUIDS AND TISSUES purpose of diagnosis Macroscopic and Microscopic examination: instructions where relevant Tissue samples Histopathology Specimen Dissection Manual method using documented procedures in the range LP-HIS- SUH-N-072 to 097 Tissue processing Documented procedure & Leica ASP, Leica Peloris (LP-HIS-SUH-N-098 & 117) Tissue embedding Manual method using documented procedure LP-HIS-SUH-N-018 Tissue sectioning Manual method using documented procedure LP-HIS-SUH-N-019 & LI- HIS-MGT-N-004 Decalcification using documented procedure LP-HIS-SUH-N-031 Frozen Section procedures Using the Leica Cryostat (LP-HIS-SUH-N-001) Assessment Manager: JCR Page 2 of 11

3 Tissue samples (cont d) Frozen sections prepared as above Fixed Tissue samples Routine staining for identification of basophilic and eosinophilic structures Special staining to identify the following Elastic Fibres &Collagen Blood cells Reticulin Gram positive and Gram negative bacteria Fungi Glycoaminoglycans, Acid & neutral mucins Melanin Collagen Helicobacter pylori Manual rapid Haematoxylin & Eosin using (LP-HIS-SUH-N-003 & 096) Leica Autostainer XL LP-HIS-SUH-N-022 In House documented procedure of manual methods and Microscopy and automated staining using Leica Autostainer XL LP-HIS-SUH-N-022 Elastic Haematoxylin and Eosin LP-HIS-SUH-N-103 May Grunwald Giemsa LP-HIS-SUH-N-052 Gordon and Sweets Reticulin LP-HIS-SUH-N-048 Gram LP-HIS-SUH-N-045 Grocott - GomoriMethenamine Silver LP-HIS-SUH-N-047 Alcian Blue PAS & Diastase AB PAS LP-HIS-SUH-N-040 Masson Fontana LP-HIS-SUH-N-050 Masson Trichrome LP-HIS-SUH-N-051 Modified Giemsa LP-HIS-SUH-N-049 Assessment Manager: JCR Page 3 of 11

4 Special staining to identify the following (cont d) Fibrin Adipose cells Fungi Glycogen Mucins Iron Hepatitis B surface antigen, copper associated protein Amyloid Mast cells Collagen & Muscle Calcium Spirochaetes Acid fast tubercle bacteria Martius, Scarlet & Blue stain (MSB) LP-HIS-SUH-N-053 Oil Red O LP-HIS-SUH-N-066 PAS & Diastase PAS LP-HIS-SUH-N-043 Perls Prussian Blue LP-HIS-SUH-N-057 OrceinLP-HIS-SUH-N-055 Sirius Red LP-HIS-SUH-N-059 Toluidine Blue LP-HIS-SUH-N-061 Van Gieson LP-HIS-SUH-N-062 Von Kossa LP-HIS-SUH-N-113 Warthin Starry LP-HIS-SUH-N-067 Ziehl Neilson LP-HIS-SUH-N-063 Assessment Manager: JCR Page 4 of 11

5 Immunocytochemistry for the identification of: Embryonic cell in normal tissues and germ tumours Embryonic cells in normal tissues and germ tumours B cells, folicular lymphomas B cells, lymphomas Epithelial cell types Tumour cells in gastrointestinal carcinomas Ovarian epithelial malignancies, seminal vesicalcarcimoma, anaplastic lymphoma Parafollicular cells in thyroid and medullary thyroid carcinomas Marker for mesotheliomas Mature T cells, T cell lymphomas Mature B cells, follicular dentritic cells, CALLA Granulocytes, Reed-Sternberg cells T cells In house documented procedures & Leica Bond System LP-HIS-ICC-N Using antibodies to and microscopy;- a-1-antitrypsin a-1-fetoprotein Bcl-2 Bcl-6 Ber EP4 CA 19-9 CA125 Calcitonin Calretinin CD5 CD10 CD15 CD3 Assessment Manager: JCR Page 5 of 11

6 Immunocytochemistry for the identification of: (cont d) B cells B cells, some T cell Reed-Sternberg cells, plasma cells Endothelial cells Endothelial cells T cells. Natural killer cells, thymocytes T cells Gastrointestinal stromal tumours Primary & metastatic tumours of gastrointestinal tract, carcinoids CEA glycoproteins Tissues of neuroendocrine origin Basal cells, filamentous keratins form glandular to stratified squamous, prostate adenocarcinoma Mantle cell lymphomas Pan cytokeratin (broad range) instructions where relevant (cont d ) In house documented procedures & Leica Bond System LP-HIS-ICC-N Using antibodies to and microscopy:- (cont d) CD20 CD23 CD30 CD31 CD34 CD68 (Routine PG M1) CD79a CD117 CDX2 CEA Chromagranin A CK, HMW (34bE12) Cyclin D1 MNF116 Assessment Manager: JCR Page 6 of 11

7 Immunocytochemistry for the identification of: (cont d) instructions where relevant (cont d ) In house documented procedures & Leica Bond System LP-HIS-ICC-N Using antibodies to and microscopy:- (cont d) Epithelial tumours Cytokeratin 8/18 Epithelial cells Cytokeratin 14 Epithelial cells including ductal and glandular epithelia Adenocarcinomas, columnar epithelial cells Stratified squamous epithelium, basal cells, mesotheliomas Cytokeratin 19 Cytokeratin 20 Cytokeratin 5 Normal and neoplastic epithelia Cytokeratin 7 Striated and smooth muscle cells Gastrointestinal stromal tumours Estrogen Receptor Von Willebrand factor in endothelial cells Breast carcinoma's Placental trophoblasts Her2 protein, breast cancer Mesothelial cells Melanoma, melanocyte differentiation Desmin DOG1 ER (6F11) Factor VIII GCDFP-15 HCG HER2 HMBE1 HMB45 Assessment Manager: JCR Page 7 of 11

8 Immunocytochemistry for the identification of: (cont d) Hepatic tissue, hepatocellular carcinoma Herpes simplex virus Cell proliferation marker Melanoma marker Lympho-haemopoietic tumours Smooth muscle cells Lung adenocarcinoma Peripheral nerves, neuroendocrine tumours Prostate adenocarcinoma Breast, colon, lung and urothelial carcinomas Germ cell tumours, seminomas Nuclei of cells showing expression of Progesterone Prostate carcinoma Prostate adenocarcinoma Renal cell carcinoma marker D2-40 In house documented procedures & Leica Bond System LP-HIS-ICC-N Using antibodies to and microscopy:- (cont d) HSA HSV Ki67 Melan A MUM1 Myosin Heavy Chain Napsin NSE P504 P53 (DO-7) PLAP PR (PgR636) Prostatic acid phosphatase Prostate specific antigen RCC Assessment Manager: JCR Page 8 of 11

9 Immunocytochemistry for the identification of: (cont d) High Grade PIN Schwann cells, nerve processes, S100 +ve neoplasms Neuroendocrine cells Thyroglobulin containing cells TTF-1 found in lung and thyroid (thyroid follicular cells) Cells of mesenchymal origin Epithelial cells and smooth muscle in fallopian tube Cells of mesenchymal origin, mesotheliomas In house documented procedures & Leica Bond System LP-HIS-ICC-N Using antibodies to and microscopy:- (cont d) S-100 Synaptophysin Thyroglobulin TTF-1 (8G7G31) Vimentin WT1 Assessment Manager: JCR Page 9 of 11

10 Wet Fixed Preparations Body fluids, urine, CSFs, aspirates, washings, brushings Air Dried Preparations Body fluids, CSFs FNA Wet Fixed Preparations Breast, Thyroid, Lymph nodes FNA Air Dried Preparations - Breast, Thyroid, Lymph nodes Blocks prepared from centrifuge deposits of cellular material from fluids. Cytopathology Processing and Staining of Diagnostic Specimens for detection of abnormal cells Manual Methods using documented procedures in the range: SOP (LP-HIS-CYT-N-001 to 021) Documented procedure & manufacturer s instructions using the following equipment and staining using Papanicolou and Diff Quick Hologic T2000 Processor (LP-HIS-CYT-N-006) Sigma 6-15 centrifuge (LP-HIS-CYT-N-019) Leica Autostainer XL staining machine (LP-HIS-SUH-N-022) Leica CV 5030 coverslipper (LP-HIS-SUH-N-107) Shandon Cytospin (LP-HIS-CYT-N-015) Manual rapid Haematoxylin & Eosin using (LP-HIS-SUH-N-003 & 096) Leica Autostainer XL LP-HIS-SUH-N-022 Assessment Manager: JCR Page 10 of 11

11 Slides prepared in house as above Histopathology and Cytopathology Morphological assessment and interpretation/diagnosis instructions where relevant (cont d ) Microscopy With reference to: LP-HIS-SUH-N-027 LP-HIS-ICC-N-006 LP-HIS-CYT-N-017 END Assessment Manager: JCR Page 11 of 11