Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
NHS Lothian
Issue No: 006 Issue date: 18 February 2020
Pathology Contact: Nadine Wilkinson Royal Infirmary of Edinburgh Address: Laboratory Medicine Nine Bio Quarter 51 Little France Crescent 8698 Edinburgh 9 Little France Road Edinburgh, EH16 4UX Accredited to EH16 4UX Tel: +44 (0)131 242 6809 ISO 15189:2012 E-mail: [email protected]
Testing performed by the Organisation at the locations specified below
Locations covered by the organisation and their relevant activities
Laboratory locations:
Location details Activity Location code
Address Local Contact Routine Histopathology A NHS Lothian- Royal Infirmary Anne Wright Special Stains of Edinburgh- Pathology Department of Pathology Immunocytochemistry Royal Infirmary of Edinburgh Royal Infirmary of Edinburgh Frozen Section Histology 51 Little France Crescent 51, Little France Crescent Cytology ( Cervical and Edinburgh EH16 4SA Diagnostic) Tel: 0131 242 7130 E-mail: [email protected]
Address Local Contact Neuropathology B Western General Scott Maxwell Immunofluorescence Stain NHS Lothian-Western General Department of Pathology CSF and Urine Cytology Hospital Western General Hospital Breast FNA Cytology Pathology Porterfield Road Frozen Section Crewe Road South Edinburgh Edinburgh Tel: 0131 537 1959 EH4 2XU E-mail:[email protected]
Address Local Contact Body store C St John's Hospital Anne Wright NHS Lothian Department of Pathology Howden Road West Royal Infirmary of Edinburgh Livingston 51, Little France Crescent West Lothian Edinburgh EH16 4SA EH54 6PP Tel: 0131 242 7130 E-mail: [email protected] (site not manned on day to day basis)
Assessment Manager: CM Page 1 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Site activities performed away from the locations listed above:
Location details Activity Location code
Address Local Contact Body store D Mortuary RIE Alison M Anderson NHS Lothian- Royal Infirmary Department of Pathology of Edinburgh- Pathology Royal Infirmary of Edinburgh Royal Infirmary of Edinburgh 51, Little France Crescent 51 Little France Crescent Edinburgh EH16 4SA Edinburgh Tel: 0131 242 7179 EH16 4SA E-mail: [email protected]. nhs.uk
Address Local Contact Body store E Western General Anne Wright NHS Lothian-Western General Department of Pathology Hospital Royal Infirmary of Edinburgh Mortuary 51, Little France Crescent Crewe Road South Edinburgh EH16 4SA Edinburgh Tel: 0131 242 7130 EH4 2XU E-mail: [email protected]
Address Local Contact Frozen Section F Mohs Dermatology Clinic Anne Wright 3rd Floor Department of Pathology Lauriston Building Royal Infirmary of Edinburgh 39 Lauriston Place 51, Little France Crescent EDINBRUGH Edinburgh EH16 4SA EH3 9EN Tel: 0131 242 7130 E-mail: [email protected]
Assessment Manager: CM Page 2 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
DETAIL OF ACCREDITATION
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Cervical Cytology In House documented procedure & TISSUES examinations to assist in manufacturer’s instructions clinical investigations using the following equipment
Cervical Smears Cervical smear abnormalities Hologic T5000 AL – A SOP-EXT-60 Hologic T2000 – SOP-CYT-21, CYT-44, CYT-46 Prisma staining machine – SOP-CYT-69 Prisma coverslipper – SOP-PATH-171 Hologic Imaging System – SOP-EXT-108, CYT-51 CYT-66, CYT-37
Diagnostic Cytology examinations to assist in clinical investigations
Wet Fixed Preparations – Processing and Staining of May Grunwald Giemsa (MGG A Body fluids, urine, CSFs, Diagnostic Specimens for Manual method using documented aspirates, washings, detection of abnormal cells procedure brushings, EUS/EBUS FNA, SOP-CYT-68, CYT-57 FNA
Air Dried Preparations - Papanicolau-Manual method using Body fluids, CSFs documented procedure SOP- CYT-57, CYT-68, CYT-69
FNA Wet Fixed Preparations RAL 55-Rapid Giemsa Breast, Thyroid, Lymph Manual method using documented nodes procedure SOP- CYT-57, CYT-68, CYT-69
FNA Air Dried Preparations - Rapid Papanicolau Breast, Thyroid, Lymph Documented procedure & nodes manufacturers instructions using Hologic T2000 sample processor – CYT-57
Assessment Manager: CM Page 3 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Diagnostic Cytology In House manual methods and TISSUES (cont’d) examinations to assist in manufacturer’s instructions clinical investigations (cont’d) documented
Air Dried Preparations- Oil Red O A Paediatric BAL, Stool Manual method using documented procedure SOP- CYT-57, CYT-68, CYT-69
FNA Stainer B SOP-CYT-69
Neuropathology examinations to assist in clinical investigations
Muscle Detection of abnormal cells SOP_PATH-W-26 B ATPases PH 9.4, 4.6,4.3 Cytochrome C oxidase NADH Phosphofructokinase+ adolase Phosphorylase Acid Phosphatase Myoadenylate deaminase reaction Succinic dehydrogenase H&E Periodic acid schiffs Gomoris trichrome Sudan black 4
Skin Immunofluorescence Skin and blood serum Immunofluorescence Stain SOP_PATH-W-24 FITC Ig_A, G, M, C3 Novalite Monkey Oesohagus IFA kit Direct ImP staining method Blood and serum Specimen for indirect IMF Blood indirect staining protocol
Assessment Manager: CM Page 4 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Neuropathology examinations In House manual methods and TISSUES (cont’d) to assist in clinical manufacturer’s instructions investigations (cont’d) documented
CSF Cerebrospinal fluids H&E B SOP-CYT-68
Frozen Section Histology examinations to assist in clinical investigations
Tissue samples Detection of abnormal cells Using the Leica Cryostats and A,B, F SOPs;- in SOP- PATH- 165,167,187, 211 PATH-W-23, 26,32, ICC-R36 And SOP- EXT-266, PATH-41, PATH- 167,PATH-200
Routine Histopathology examinations to assist in clinical investigations
Tissue samples Detection of abnormal cells Specimen Dissection A Manual method using documented procedures in the range PATH- 165,176,185,186,187,205,206 210,PATH-W-43,PATH-W-32
Tissue processing Documented procedure & manufacturer’s instructions using Leica Peloris, Leica ASP300 & Thermo Shandon Excelsior PATH- 190, PATH-R-34
Tissue embedding Manual method using documented procedure Sakura embedding centres PATH-29
Assessment Manager: CM Page 5 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Routine Histopathology In House manual methods and TISSUES (cont’d) examinations to assist in manufacturer’s instructions clinical investigations (cont’d) documented
Tissue samples (cont’d) Detection of abnormal cells Tissue sectioning A (cont’d) Manual method using documented procedure- Leica Microtomes PATH-167,172,175
Routine staining (H&E Documented procedure & manufacturer’s instructions using Sakura Prisma stainer and Leica Autostainer CV5030 coverslipper, PATH-R-48, PATH-R-31, PATH-R- 32,PATH-171
Special staining of Histopathology examinations to assist in detection of clinical abnormalities
Tissue samples Using series SOPs and Microscopy A PATH-R-37,38,39
Acid and Neutral Mucins Alcian Blue paS
Acid Fast Tubercle Bacilli Zeihl Neelsen
Acid Mucins/Mast Cells Azure A Metachromatic Technique
Amyloid Congo Red (Highmans) Modified Congo Red (ResinSections) Sirius Red
Argentaffin Cells/Carcinoid Alkaline Diazo Tumour
Basement Membranes Jones Methenamine Sliver
Basophil/Eosinophol/ Giemsa Neutorphil granules
Assessment Manager: CM Page 6 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Special staining of In House manual methods and TISSUES (cont’d) Histopathology examinations manufacturer’s instructions to assist in detection of clinical documented abnormalities (cont’d)
Tissue samples (cont’d) Calcium Von Kossa A
Connective tissue / Collagen / Masson Trichrome Muscle Picro Sirius Red Van Gieson
Connective tissue / Collagen / Martius Scarlet Blue (MSB) Muscle / Fibrin
DNA Feulgen
Elastic Fibres Elastic Haematoxylin & Eosin Elastic Stain
Fungi Grocott Gomori Methenamine Silver
Using series SOPs and Microscopy-PATH-R-37,38,39
General Architecture Paragon Stain (Resin Sections) A
Glycogen/Neutral Periodic Acid Schiffs (PAS) +/- Mucins/Fungi Diastase
Gram +ve & Gram –ve Gram Stain Organisms
Haemosiderin Perls Prussian Blue
Helicobacter/Micro-organisms Modified Giemsa
Hepatitis B affected Cells Shikata’s Orcein /Copper associated protein
Lipid Oil Red O
Assessment Manager: CM Page 7 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Special staining of In House manual methods and TISSUES (cont’d) Histopathology examinations manufacturer’s instructions to assist in detection of clinical documented abnormalities (cont’d)
Tissue samples (cont’d) Mast Cells Toluidine Blue A
Melanin / Argentaffin / Masson Fontana Chromaffin / some Lipofuscin
Mucin Lisons Alcian Blue
Mycobacterium Leprae Wade-Fite
Nuclei Celestin Blue-Haematoxylin
pH1 Sulphated Acid Alcian Blue (pH1 & pH2.5) Mucins/pH2.5 Acid Mucins
Reticulin Fibres Gordon & Sweet’s Reticulin
Spirochetes Warthin Starry
Immunocytochemistry of Histopathology examinations to assist in detection of clinical abnormalities
Tissue samples & Cell In house documented procedures A blocks & manufacturer’s instructions using Leica Bond III system – SOP ICC-R-36,R8,28,29,34
Embryonic cells in normal Using antibodies to and tissues and germ tumours microscopy;-
ACTH producing corticotrophs a-1-Fetoprotein in pituitary
Smooth muscle cells, ACTH myoepithelial cells
Anaplastic Large Cell Actin, smooth muscle Lymphoma's (ALCL's)
Assessment Manager: CM Page 8 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell blocks B cells, lymphomas Bcl-2 (Dako) A (cont’d) Bcl-6 Protein
B cells, plasma cells Bob-1 (C20
Complement C4d in allograft C-4d rejection
Ovarian epithelial CA125 malignancies, seminal vesical carcimoma, anaplastic lymphoma
Parafollicular cells in thyroid Calcitonin and medullary thyroid Caldesmon carcinomas
Smooth muscle cells Calponin (cell marque) Calretinin Marker for mesotheliomas CCD43 (Qbend10)
Mature B cells, follicular CD10 (CALLA) dentritic cells, CALLA
Various - mast cells, stem CD117 (c-kit) cells, Cajal cells, melanocytes, basal cells (skin) and mammary duct epithelium
Plasma cells CD138 (Syndecan-1)
Assessment Manager: CM Page 9 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell Granulocytes, Reed-Sternberg CD15 (Leu-M1) A blocks (cont’d) cells
Monocytes CD163
Langerhans cells CD1aCD2(LFA-2)
T cells CD3
B cell CD20 (CD20cy)
Mature B cells, Follicular CD21 dentritic cell
B cells, some T cell CD23
Reed-Sternberg cells, plasma CD30 (Ki-1) cells
Endothelial cells CD31 Dako
Myeloid cells CD33
Erythrocytes, leukocytes, CD35 glomerular podocytes and follicular dendritic cells
T cells (helper & mature) CD4 (poly/mono)
T and B cell Lymphoma's CD43 (Qbend10)
Leucocytes CD45(LCA)
Assessment Manager: CM Page 10 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell Mature T cells, T cell CD5 A blocks (cont’d) lymphomas
Natural killer cells, CD56(N-CAM) and neuroendocrine tissues
Platelets, megakaryocytes, CD57 macrophages, endothelila cells
Macrophages, monocytes, CD61 myeloid cells
T cells. Natural killer cells, CD68 (Routine PG M1) thymocytes
B cells CD7
T cells CD79a
Tumours including Ewings CD8 Saracoma, & T cell lymphoma CD99 (MIC2) Intestinal epithelial cells, CDX2 colorectal + other adenocarcinomas
CEA glycoproteins CEA
Tissues of neuroendocrine Chromagranin A origin
Basal cells, filamentous CK, HMW (34BE12) keratins form glandular to stratified squamous, prostate adenocarcinoma
Expressed in variety tumours Cyclin D1
Pan cytokeratin (broad range) Cytokeratin , MNF116
Assessment Manager: CM Page 11 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell blocks Epithelial cells Cytokeratin 14 A (cont’d) Epithelial cells including ductal Cytokeratin 19 and glandular epithelia
Adenocarcinomas, columnar Cytokeratin 20 epithelial cells
Stratified squamous Cytokeratin 5/6 epithelium, basal cells, mesotheliomas
Normal and neoplastic Cytokeratin 7 epithelia
Pan cytokeratin (broad range) Cytokeratin AE1/AE3
Epithilial cells Cytokeratin, Cam 5.2
Cytomegalovirus Cytomegalovirus
Lymphatic vessels D2-40
Striated and smooth muscle Desmin cells
Gastro Intestinal Stromal DOG-1 tumours (GIST)
Epstein Barr Encoded RNA EBER ISH expressing cells
Epstein-Barr Virus EBV, LMP1
Normal duct epithelial cells, E-Cadherin ductal carcinoma
Assessment Manager: CM Page 12 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell Normal and neoplastic EMA (Dako E29) A blocks (cont’d) epithelium
Epithilial cells, most EP4 adenocarcinomas
Nuclei of cells containing a Estrogen Receptor high level of oestrogen
V.W factor in endothelial cells Factor XIIIa
Folicle Stimulationg Hormone FSH (Novacastra)
G Cell hyperplasia Gastrin
Breast carcinoma's GCDFP-15
Schwann cells, enteric glial GFAP cells, astrocytomas, ependymomas
Glucagonomas Glucagon
Erythrocytes Glycophorin A and Glycophorin C
T cell lymphoma's GMP-17 (TIA-1)
Cytotoxic T Lymphocytes, Granzyme B Natural Killer cells
Growth Hormone Growth Hormone
Hairy cell leukaemia's Hairy Cell Leukaemia
Placental trophpblasts hCG
Assessment Manager: CM Page 13 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell B cells, monocytes, HLA-DR A blocks (cont’d) macrophages, myeloid/erythroid precursors, activated T cells and some epithilial cells
Melanoma, melanocyte HMB45 differentiation
Herpes Simplex Virus type I HSV1
Herpes Simplex Virus type II HSV2
Sex chord stromal tumours Inhibinin, alpha
Insulin Insulin
Proliferating Cells Ki67/p16-MIB-1(Ki67) Dako
B cells and plasma cells Kappa
B cell follicles Lambda
Non Small Cell Lung Lung ALK Carcinoma's (NSCLC)
Lutenising Hormone Lutinising Hormone
Melanoma marker Melan A
Granulocytes and monocytes MPO
Urothelium MUC-4
Lympho-haemopoietic MUM1 tumours
Rhabdomyosarcoma MyoD1 and Myogenin
Assessment Manager: CM Page 14 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell Smooth muscle cells Myosin (Skeletal Fast) A blocks (cont’d) myoepithelial cells Myosin Heavy Chain (Smooth muscle)
Epithilial and endothilial cells Neuroblastoma(NB84)
Neuro, endocrine and neuro- NFP endocrine tumours
Peripheral nerves, NSE neuroendocrine tumours
B Cell lymphomas, germinal Oct 2 centre derived lymphomas
Germ cell tumours, OCT 3/4 seminomas
Various tumours P16 Protein
Squamous and Basal Cell P40 Carcinoma's
Breast, colon, lung and P53 (DO-7) urothelial carcinoma's
Prostate basal cells, P63 profliferative cells, glandular epithelium
Non-small cell lung P63/CK7 carcinonoma differentiation
B Cells PAX-5
Assessment Manager: CM Page 15 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell Neurones and neuro- PGP9.5 A blocks (cont’d) endocrine cells
Germ cell tumours, Placental Alkaline Phosphatase seminomas
Nuclei of cells showing Progesterone expression of Progesterone
Prolactin Prolactin
Metastatic prostatic tumours Prostatic Acid Phosphatase
Prostate secretory and ductal PSA poly epithelium
Prostate adenocarcinoma Racemace (P504s)
High Grade PIN S-100 Schwann cells, nerve processes, S100 +ve neoplasms
Somatostatin Somatostatin Simian Virus 40 SV40
Neuroendocrine cells Synaptophysin
Leukaemias, acute TdT lymphocytic lymphomas
Thyroglobulin containing cells Thyroglobulin
Thyroid stimulating hormone TSH
Assessment Manager: CM Page 16 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and Immunocytochemistry of In house documented procedures TISSUES (cont’d) Histopathology examinations & manufacturer’s instructions using to assist in detection of clinical Leica Bond III system – abnormalities (cont’d) SOP ICC-R-36,R8,28,29,34
Tissue samples & Cell TTF-1 found in lung and TTF-1 A blocks (cont’d) thyroid (thyroid follicular cells)
Small cell differention in Lung TTF-1/CK5/6 cancer
Small cell differentiation in Vimentin Lung Cancer
Cells of mesenchymal origin Wilm’s Tumour (WT1) Epithelial cells and smooth muscle in fallopian tube
Formalin-fixed, paraffin- Breast and gastric carcinomas HER – 2 using monoclonal anti- embedded human breast expressing HER-2 HER2 clone and gastric cancer tissue
Tissue samples & Cell Immunocytochemistry in Flexible scope of the Leica Bond III A blocks Histopathology examinations system with ER1, ER2 enzyme to assist in detection of clinical retrieval or no retrieval using abnormalities polymer refine detection DAB and Bond polymer refined red detection using SOP:QUAL-106, and spreadsheet L:drive/Laboratory Specialities/Pathology/ICC Lab/ Antibodies.
Lung bx Metastatic non-small cell lung PD-L1 via DAKO Autostainer A cancer (NSCLC) system using SOP: ICC-R79
Assessment Manager: CM Page 17 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and FISH analysis to assist in In House manual methods and TISSUES (cont’d) detection of clinical manufacturer’s instructions abnormalities documented
FFPE tissue samples and ALK1 rearrangement for FISH Analysis A cell blocks therapy stratification in NSCLC Manual staining procedures: ICC- R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
DDIT3 rearrangement for FISH Analysis sarcoma classification (mxyoid Manual staining procedures: ICC- liposarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
EWSR1 rearrangement for FISH Analysis sarcoma classification Manual staining procedures: ICC- (Ewing’s sarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46 FOXO1 rearrangement for FISH Analysis sarcoma classification Manual staining procedures: ICC- (alveolar rhabdomyosarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
FUS rearrangement for FISH Analysis sarcoma classification Manual staining procedures: ICC- (myxoid/fibromyxoid sarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
HER2 amplification for therapy FISH Analysis stratification in breast and Manual staining procedures gastric cancer (gastric): ICC-R41 Leica Bond automated staining procedures (breast): ICC-R39 Fluorescence Microscopy Interpretation and scoring: ICC-R46
MDM2 amplification for FISH Analysis sarcoma classification (well Manual staining procedures: ICC- differentiated liposarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
Assessment Manager: CM Page 18 of 19
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Lothian
8698 Issue No: 006 Issue date: 18 February 2020 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement
HUMAN BODY FLUIDS and FISH analysis to assist in In House manual methods and TISSUES (cont’d) detection of clinical manufacturer’s instructions abnormalities (cont’d) documented
FFPE tissue samples and SS18 rearrangement for FISH Analysis A cell blocks sarcoma classification Manual staining procedures: ICC- (synovial sarcoma) R41 Fluorescence Microscopy Interpretation and scoring: ICC-R46
END
Assessment Manager: CM Page 19 of 19