Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
Issue No: 006 Issue date: 05 August 2021
Frimley Health NHS Foundation Contact: Governance / Quality Department Trust Tel: +44 (0) 1276 522194 / 1276 522541 / 1276 522175 Frimley Park Hospital, 8086 E-Mail: [email protected] Frimley Website: www.nhspathology.fph.nhs.uk Accredited to Camberley ISO 15189:2012 GU16 7UJ 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 Histology RBH Cellular Pathology Department Amanda Babington Immunocytochemistry Tel: +44 (0) 118322 8201 Frozen Section for intraoperative Royal Berkshire Hospital diagnosis. E-Mail: London Road Interpretive microscopy Amanda.babington@Roy Non-Gynae Cytology Reading alberkshire.nhs.uk RG1 5AN
Address Local contact Histology WPH Department of Histopathology Stephen Brown Immunocytochemistry Tel: +44 (0) 300 615 Frozen Section for intraoperative Wexham Park Hospital 3458 diagnosis. Slough E-Mail: Interpretive microscopy Non-Gynae Cytology (cell block or clot Berkshire [email protected] processing and staining) SL2 4HL
Local contact Address Harvi Atwal OSNA (one-step nucleic acid HH Tel: +44 (0) 118 322 amplification) Heatherwood Hospital 7738 High St Ascot E-Mail: SL5 8AA Harvinder.Atwal@royalbe rkshire.nhs.uk
Assessment Manager: DE 1 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 Locatio n code
One stop breast FNA clinic Local contact Non-Gynae cytology specimen collection A Outpatients 2 Department Amanda BabingtonTel: Royal Berkshire NHS Foundation Trust +44 (0) 118 322 8201 Hospital E-Mail: London Road Amanda.babington@Roy Reading alberkshire.nhs.uk RG1 5AN
Assessment Manager: DE Page 2 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination In-house documented procedures RBH FLUIDS activities for the purposes of using manual methods or analysers clinical diagnosis as specified, in conjunction with manufacturers’ instructions:
Tissue samples: Fixed, fresh The examination of tissues to Macroscopic and Microscopic RBH and frozen, including Bone exclude or identify examination Marrow trephines. morphological and cytological Non-gynae cytology cell abnormalities for the purpose Supported by documented in house blocks of clinical diagnosis methods incorporating manufacturer’s instructions where relevant:
Formalin-fixed tissue samples Tissue Dissection
HIS-RBH-SOP-001 Histology cut- RBH up HIS-RBH-SOP-002 Dissection of small spec HIS-RBH-SOP-003 Dissection of large spec Thermofisher Printmate
HIS-WPH-SOP-0077 Medical Specimen Dissection
Formalin-fixed tissue samples Decalcification RBH HIS-RBH-SOP-019 Decalcifier TDE TM 30
Formalin-fixed tissue samples Tissue Processing including Non-gynae cytology cell blocks HIS-RBH-SOP-006 RBH Tissue Processing Thermofisher Excelsior, STP 420 Sakura VIP 6AI WPH HIS-WPH-SOP-0100 Sakura VIP tissue processors.
Assessment Manager: DE Page 3 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination In-house documented procedures FLUIDS activities for the purposes of using manual methods or analysers (cont’d) clinical diagnosis cont’d) as specified, in conjunction with manufacturers’ instructions:
Tissue Embedding RBH Formalin-fixed tissue samples HIS-RBH-SOP-005 Embedding including Non-gynae cytology Thermofisher Histostars cell blocks WPH HIS-WPH-SOP-0100 Sakura TEC 5 and 6 Embedding centre
Formalin Fixed paraffin wax Tissue Sectioning blocks of processed tissue, including Non-gynae cytology HIS-RBH-SOP-007 RBH cell blocks Section Cutting Leica RM2235, Sakura Accu-cut SRM200 & Microm HM325 WPH MicrotomesHIS-WPH-SOP-0204 Leica RM2235
Fresh/frozen tissue Frozen sections (cryotomy)
HIS-RBH-SOP-011 Cryomicrotomy RBH and Intraoperative Frozen Sections. Thermo Cryostar NX50
HIS-WPH-SOP-0300 WPH Leica CM1950 cryostats.
Assessment Manager: DE Page 4 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination In-house documented procedures FLUIDS activities for the purposes of using manual methods or analysers (cont’d) clinical diagnosis cont’d) as specified, in conjunction with manufacturers’ instructions:
Formalin-fixed paraffin Demonstration of basophilic Automated Haematoxylin and RBH, embedded tissue slides and eosinophilic structures Eosin Staining Roche HE600 Coverstainer Fresh/frozen tissue HIS-RBH-SOP-026; RBH Frozen section Haematoxylin and Eosin Staining procedures: HIS-RBH-SOP-011
MYREVA Automated stainer HIS-RBH-SOP-038
HIS-WPH-SOP-0217 HIS-WPH-SOP-0400 Sakura Prisma and Sakura DRS WPH 2000 automated staining machines
Demonstration of: Special Tinctorial Histochemical RBH Formalin-fixed paraffin Staining Methods embedded tissue slides (cont’d) Documented in house procedures for manual specials stains SOP H9
Acid mucins Alcian Blue Technique RBH Mucicarmine Technique
Acid and Neutral mucins Alcian Blue – Periodic Acid-Schiff ± RBH Diastase
Amyloid - Primary Congo Red with Potassium RBH Permanganate
Amyloid – Secondary Congo Red (Highman) RBH
Amyloid deposits Sirius Red
Assessment Manager: DE Page 5 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 Special Tinctorial Histochemical HUMAN BODY TISSUE AND Histopathological Staining Methods FLUIDS examination activities for the (cont’d) (cont’d) purposes of clinical diagnosis cont’d)
Formalin-fixed paraffin Basement membranes Jones Methenamine (Hexamine) RBH embedded tissue slides Silver method. (cont’d)
Bacteria Gram Stain. RBH
Bile Pigments Fouchet Technique RBH
Bone marrow cell Giemsa Stain. RBH differentiation
Calcium Von Kossa Technique RBH
Colloidal Iron Dialyzed Iron stain. RBH
Elastin Van Gieson Verhoeff’s Stain. RBH
Fibrin MSB Stain. RBH
Fungi or Pneumocystis Grocott Methenamine (Hexamine) RBH Silver Method.
Glycogen PAS ± Diastase. RBH
Haemosiderin Perl’s Prussian Blue Stain. RBH
Hepatitis B Antigen Orcein (Shikata) Stain. RBH
Helicobacter Toluidine Blue. RBH
Helicobacter – modified Giemsa RBH
Frozen tissue Lipids Oil Red O RBH
Mast Cells Toluidine Blue. RBH
Assessment Manager: DE Page 6 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Special Tinctorial Histochemical FLUIDS activities for the purposes of Staining Methods (cont’d) clinical diagnosis cont’d) (cont’d)
Frozen tissue (cont’d) Melanin Masson Fontana Silver Overnight RBH Masson Fontana Heated Method Melanin Bleach Method.
M Leprae Wade-Fite Method. RBH
M Tuberculosis Ziehl-Neelsen RBH
Formalin-fixed paraffin embedded tissue slides (cont’d)
Reticulin Fibres Gordon and Sweet Stain. RBH
Smooth muscle/Collagen Haematoxylin and Van Gieson RBH
Spirochaetes Warthin Starry Method RBH
Demonstration of: Demonstration of: WPH Special Tinctorial Histochemical Staining Methods
Documented in house procedures for manual specials stains HIS-WPH-SOP-0400
Mast Cells Toluidine Blue WPH
Acid mucins Alcian Blue WPH
Neutral Mucins PAS & Diastase WPH
Acid & Neutral mucins LP-CP-Alcian Blue / Periodic Acid WPH Schiff
H. pylori Alcian Yellow WPH
Assessment Manager: DE Page 7 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Special Tinctorial Histochemical FLUIDS activities for the purposes of Staining Methods (cont’d) clinical diagnosis cont’d) (cont’d)
Formalin-fixed paraffin Elastic fibres Millers Elastic van Gieson WPH embedded tissue slides (cont’d)
Gram +/- organisms Gram WPH
Fungi Grocott WPH
Haemosiderin Iron (Perls Prussian Blue) WPH
Melanin Masson Fontana WPH
Melanin Bleach Melanin Bleach WPH
Connective tissue Masson Trichrome RBH WPH
Fibrin Martius Scarlet Blue (MSB) WPH
Hepatitis B & copper Orcien (Shikata) WPH associated Protein
PAS +ve substances e.g. Periodic acid Schiff WPH Glycogen
Reticulin fibres Reticulin (Gordon & Sweet) WPH
Metachromatic substances Toluidine Blue WPH
Calcium Von Kossa WPH
Tubercle bacilli (TB) Ziehl Neelsen WPH
Amyloid Congo Red WPH
Assessment Manager: DE Page 8 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination In-house documented procedures FLUIDS activities for the purposes of using manual methods or analysers (cont’d) clinical diagnosis cont’d) as specified, in conjunction with manufacturers’ instructions:
Formalin-fixed paraffin Immunohistochemistry for the Automated Immunohistochemistry RBH, embedded tissue slides detection of: Documented in house procedures WPH (cont’d): in conjunction with manufacturer’s instructions for Roche Ventana Benchmark Ultra: HIS-RBH SOP-012
HIS-WPH-SOP-501 – using the following antibodies.
Squamous epithelium, 34Be12 (HMWCK) RBH follicular epithelia in thyroid, WPH epithelia and mesothelium in small and large bowel
Amyloid A AAC (Amyloid C Component) WPH
Smooth Muscle, soft tissue Actin (SMA) RBH, tumour such as WPH leiomyosarcomas
Germinal Centre macrophages A-1-AT RBH - tonsil
Embryonic Cells in normal AFP RBH, tissue and germ tumours. WPH
Pan Cytokeratin AE1/AE3 WPH
Prostate tumour marker AMACR WPH
Assessment Manager: DE Page 9 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Anaplastic lymphoma kinase ALK-1 RBH embedded tissue slides large cell lymphoma. (cont’d)
Hairy Cell Leukaemia Annexin A1 RBH
Colorectal Cancers and Beta-Catenin RBH adenomas
Follicular and diffused large BCL-2 RBH, cell lymphomas from reactive WPH lymph nodes
Diffuse large B cell BCL-6 RBH, lymphomas and Burkitt's WPH lymphoma and Reed Sternberg cells in Hodgkin’s disease
Epithelial Cells of the Colon. BerEP4 RBH, WPH
B cells, plasma cells BOB-1 RBH
Luminal cells of fallopian CA125 RBH, tubes, Ovarian epithelial WPH malignancies
Smooth muscle tumours Caldesmon RBH
Sclerosing lesions breast Calponin RBH carcinoma
Classification of mesothelial Calretinin RBH, cells and malignant WPH mesothelioma of the epithelial type
Assessment Manager: DE Page 10 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Parafollicular cells of the Calcitonin RBH, embedded tissue slides thyroid (cont’d)
Carcinomas from malignant CAM 5.2 RBH tumours of non epithelial origin
Langerhans cells in skin CD1a RBH
Normal and neoplastic T cells CD3 RBH from thymocytes to mature T WPH cells
Inducer T cells both normal CD4 RBH and neoplastic
T cell lymphomas and mantle CD5 RBH, cell lymphoma WPH
T cells cytotoxic / suppressor CD8 RBH
All germinal centre cells – CD10 RBH, tonsil WPH Renal cell carcinoma
Granulocytes, Reed-Sternberg CD15 RBH, cells. WPH
B cells CD20 RBH, WPH
Follicular dendritic cells CD21 RBH
Small B cell lymphocytic CD23 RBH lymphoma. WPH
Assessment Manager: DE Page 11 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Reed Sternberg cells in CD30 RBH, embedded tissue slides Hodgkin’s lymphoma, WPH (cont’d) anaplastic large cell lymphoma and plasma cells
Endothelial cells. Benign and CD31 RBH malignant vascular disorders
Leucocyte differentiation CD34 RBH, WPH
T and B cell lymphomas CD43 RBH
All Leucocytes CD45 (LCA) RBH, WPH
Neural / neuroendocrine tissue CD56 RBH, and natural killer cells WPH
Mononuclear cells, natural CD57 RBH killer and neuroectodermal cells
Macrophages CD68 RBH WPH
B cells all stages CD79a RBH, WPH
T- Lymphocytes, granulosa CD99 RBH cells ovary, pancreatic islet cells, CNS ependymal cells and Sertoli’s, Ewing’s sarcoma
KIT protein in gastro-intestinal CD117 (C-Kit) RBH, stromal tumours WPH
Plasma cells CD138 RBH, WPH
Assessment Manager: DE Page 12 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Loss of differentiation in CDX2 RBH, embedded tissue slides colorectal cancers WPH (cont’d)
Adenocarcinoma CEA RBH WPH
Neuroendocrine cells Chromogranin A RBH, WPH
Glandular and stratified CK (AE/AE3) RBH squamous epithelium WPH
Myoepithelial cells of the CK5/6 RBH, prostate / breast. Squamous WPH cell carcinoma
Adenocarcinomas of breast, CK7 RBH, lung, endometrium, ovary, WPH thyroid and carcinomas of bladder and renal cell
Epithelial cells CK8/18 RBH CK18 WPH
Squamous epithelium CK14 WPH
Adenocarcinomas of colon, CK19 RBH stomach, pancreas, biliary WPH tract, liver and breast
Columnar cell epithelium CK20 RBH, WPH
Epithelial cells CK MNF116 WPH
Cytomegalovirus infected cells CMV RBH
Assessment Manager: DE Page 13 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Mantle cell lymphomas and Cyclin D1 RBH embedded tissue slides breast WPH (cont’d)
Endothelial Cells D2-40 WPH
Hairy cell leukaemia DBA44 RBH,
Smooth and striated muscle Desmin RBH, tumours WPH
Gastro-intestinal stromal DOG-1 RBH, tumours WPH
Epstein Barr virus infected EBI-3 WPH cells
Adenocarcinoma from E-Cadherin RBH, mesothelioma and ductal vs WPH lobular cancer of the breast
Variety of normal and EMA RBH, neoplastic epithelia WPH
Oestrogen receptors breast ER RBH carcinoma WPH
Endothelial cells Factor VIII RBH WPH
Endothelial cells and Factor VIIIa RBH neoplastic blood cells. Used for differentiation between dermatofibroma and sarcoma
Luminal epithelial cells in GATA3 RBH, mammary glands WPH
Breast Carcinoma GCDFP RBH
Assessment Manager: DE Page 14 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d) Formalin-fixed paraffin Astrocytes, Schwann cells. RBH embedded tissue slides GFAP (cont’d)
Hepatocellular carcinoma, Glypican -3 RBH hepatoblastoma, melanoma, testicular germ cell tumours and Wilms tumour
Placental secreting HCG RBH, trophoblasts. WPH
Melanoma cells HMB-45 RBH, WPH
Choriocarcinoma and HPL RBH trophoblastic tumour of testis
Normal and neoplastic Hepatocyte WPH hepatocytes
Renal/Fallopian tube Ca PAX-8 RBH WPH
Leydig and Sertoli cells testis Inhibin RBH, WPH
B cells and plasma cells Kappa RBH, WPH
B cells and plasma cells Lambda RBH, WPH
Myeloid leukaemia Lysozyme RBH
Assessment Manager: DE Page 15 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Melanomas and MART-Melan-A RBH embedded tissue slides angiomyolipomas (cont’d)
Melanoma Melan A (red or brown) RBH, WPH
Mesotheliomas, epithelial Mesothelin RBH ovarian cancers and some MSLN squamous cell carcinomas
Proliferating cells in germinal MIB-1 (Ki67) RBH, B cells WPH
Mismatch repair deficiency MSH2, MSH6, MLH1 AND PMS2 WPH (MMR panel) screening in antibodies colorectal carcinoma
Neoplastic differentiation of MOC-31 RBH lung adenocarcinoma and mesothelioma
Expressed in plasma cells MUM-1 RBH, germinal centre B cells WPH activated T cells and Reed Sternberg cells
Normal and neoplastic skeletal Myo D1 RBH and cardiac muscle cells
Rhabdomyosarcomas, Wilms Myogenin RBH, tumour WPH
Normal and neoplastic skeletal Myoglobin RBH and cardiac muscle cells
Myeloid Cells Myeloperoxidase RBH WPH
Assessment Manager: DE Page 16 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Central and peripheral NSE RBH, embedded tissue slides neuroendocrine cells WPH (cont’d)
Seminoma / germ cell tumour OCT-4 RBH
Renal Cell, Thyroid and PAX8 WPH Ovarian Carcinomas
Neurons and neuroendocrine PGP 9.5 RBH cells
Placental trophoblasts PLAP RBH, WPH
Breast carcinoma Progesterone RBH, WPH
Prostatic carcinoma P504S (AMACR) RBH WPH
Prostate secretory and ductal PSA RBH, epithelium WPH
Glandular prostatic epithelium PSAP RBH
Malignant change in cervical P16 RBH epithelium, HPV WPH
Cell proliferation P53 RBH, WPH
Prostate basal cells, glandular P63 RBH, epithelium WPH
Assessment Manager: DE Page 17 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination Automated Immunohistochemistry FLUIDS (cont’d) activities for the purposes of using Roche Ventana Benchmark clinical diagnosis (cont’d) Ultra (cont’d)
Formalin-fixed paraffin Renal tumours RCC RBH embedded tissue slides (cont’d)
Schwann cells, adipocytes, S100 RBH, cartilage WPH
Islets of Langerhans cells Synaptophysin RBH, WPH
Leukaemias, acute TdT RBH, lymphoblastic
Lymphomas in lung and TTF-1 RBH, thyroid. WPH
Mesothelioma Thrombomodulin RBH
Thyroid follicular epithelial Thyroglobulin RBH, cells WPH
Cells of mesenchymal origin Vimentin RBH, WPH
Mesenchymal cells, Wilms WT1 RBH, tumour, Serous ovarian WPH adenocarcinoma
Myosin SMM RBH, WPH
Assessment Manager: DE Page 18 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 Automated using Roche Ventana HUMAN BODY TISSUE AND Histopathological examination Benchmark Special Stainer FLUIDS (cont’d) activities for the purposes of HIS-WPH-SOP-0400; clinical diagnosis (cont’d) HIS-WPH-SOP-0401
Acidic mucins Alcian Blue WPH
Heliobacter Alcian Yellow WPH
Amyloid Congo Red WPH
Acidic mucins, neutral mucins, Diastase/PAS WPH PAS positive substances
Haemopoietic cells Giesma WPH
Acid Fast Bacilli Gram
Fungi Grocott WPH
Haemosiderin, Ferric iron, Perls Prussian Blue WPH Asbestos, Ferringinous bodies
Connective Tissue Reticulin WPH
Frozen tissue sections from Diagnosis of skin blistering Automated Immunofluorescence in RBH skin biopsies disorders conjunction with manufacturer’s instructions for Ventana Benchmark Ultra Fluorescent microscope Leica DM200 + FL 290963SOP H12 ICC SOP H11 Frozen sections and Cryotomy
incorporating the following antibodies.
IgA IgG IgM C3
Assessment Manager: DE Page 19 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 TISSUE AND Histopathological examination In-house documented procedures FLUIDS (cont’d) activities for the purposes of using manual methods or analysers clinical diagnosis (cont’d) as specified, in conjunction with manufacturers’ instructions:
Sentinel lymph node tissue Detection of Cytokeratin 19 Documented in-house procedures RBH (CK19) mRNA OSNA HH HIS-RBHHWD-SOP-018
In conjunction with manufacturer’s instructions for Sysmex RD210, Eppendorf minispin. RP10 Homogeniser. OSNA (One Step Nucleic Acid Amplification)
Stained tissue slides Morphological assessment Microscopic examination: RBH and interpretation / diagnosis Assorted range of diagnostic bright- field microscopes WPH
SOP OFF 12 HIS-WPH-SOP-0703
HUMAN BODY FLUIDS Cytopathological (Non-Gynae) In-house documented procedures examination activities for the using manual methods or analysers purposes of clinical diagnosis as specified, in conjunction with manufacturers’ instructions:
Body fluids Examination of body fluid/fine Documented in-house procedures RBH Fine Needle Aspirations needle aspirate samples to HIS-RBH-SOP-067 Hydrocele and renal cyst fluid exclude or identify Non Gynae Cytology Cerebro-spinal fluid (CSF) morphological and cytological Sputum abnormalities for the purpose In conjunction with manufacturer’s Bronchio-alveolar lavage of clinical diagnosis instructions for Cytopsin, Bronchial washings megafuge, Hologic Thinprep 2000 Hematospermia (not hydrocele fluid or CSF), Roche EBUS specimens HE600 Tissue-Tek Prisma Staining Synovial fluid Machine & G2 Glass Coverslipper
Demonstration of Tinctorial stains HIS-RBH-SOP-067 RBH Cells (nuclei and cytoplasm) Papanicolaou stain and micro organisms May Grunwald stain Microscopy
Assessment Manager: DE Page 20 of 21
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK
Frimley Health NHS Foundation Trust
8086 Issue No: 006 Issue date: 05 August 2021 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 Cytopathological (Non-Gynae) In-house documented procedures (cont’d) examination activities for the using manual methods or analysers purposes of clinical diagnosis as specified, in conjunction with (cont’d) manufacturers’ instructions:
Preparation of cell blocks for HIS-RBH-SOP-067 RBH histology processing and Non Gynae Cytology staining
Cyst fluid Examination of cellular FNA slide preparation and manual RBH Nipple discharge material in order to identify or staining with Gurr Diff Quik May Body fluids exclude morphological and Grunwald Giemsa kit Fine Needle Aspirations cytological abnormalities Documented in-house procedures SOP C5 Breast Clinic HIS-RBH-SOP-067 Non Gynae Cytology
Stained cytology slides Morphological assessment Microscopic examination: RBH and interpretation / diagnosis Assorted range of diagnostic bright- field microscopes HIS-RBH-SOP-062Medical Reporting Stained cytology slides Morphological assessment Microscopic examination: WPH and interpretation / diagnosis Assorted range of diagnostic bright- field microscopes Documented in-house procedure HIS-WPH-SOP-0703
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