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 Pathology Department Nuffield Warwickshire Hospital The Chase Leamington Spa Warwick CV32 6RW Contact: Richard Heckford Tel: +44 (0) Fax: +44 (0) Website: below Laboratory locations: s covered by the organisation and their relevant activities details ctivity code ddress Pathology Department Nuffield Warwickshire Hospital The Chase Leamington Spa Warwick CV32 6RW Local contact Richard Heckford Haematology Blood Transfusion Coagulation Chemistry Immunology Histopathology Gynaecological Cytology Diagnostic Cytology Microbiology Specimen Reception ddress Pathology Department Leicester Hospital Scraptoft Lane Leicester LE5 1HY s above Haematology Chemistry Specimen Receipt Blood Issue Fridge B ddress Pathology Department Derby Hospital Rykneld Road Derby DE23 4SN s above Haematology Specimen Receipt Blood Issue Fridge C Site activities performed away from the locations listed above: ssessment Manager: RB2 1 of 27

2 details ctivity code Theatres Nuffield Warwickshire Hospital The Chase Leamington Spa Warwick CV32 6RW Local contact Richard Heckford Blood Issue Fridge No testing occurs at this location C Theatres Leicester Nuffield Hospital Scraptoft Lane Leicester LE5 1HY Local contact Richard Heckford Blood Issue Fridge No testing occurs at this location D Theatres Derby Nuffield Hospital Rykneld Road Derby DE23 4SN Local contact Richard Heckford Blood Issue Fridge No testing occurs at this location E ssessment Manager: RB2 Page 2 of 27

3 DETIL OF CCREDITTION HUMN BODY FLUIDS as specified below: Haematology examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Blood Blood Full Blood Count (Hb, RBC, WBC, Hct, MCV, MCH, MCHC, RDW Platelets, Neutrophils, lymphocytes, monocytes, Eosinophils, Basophils) SOP PTH F2 H 4.07Operation of Sysmex XT1800 nalyser and photometry, impedence and light scatter. Blood ssessment for cell typing and morphology including enumeration of reticulocytes Manual SOP W-PTH F2 H 3.31 Blood film preparation, examination of blood films and counting by microscopy and staining with brilliant cresyl blue. Blood ssessment for cell typing and morphology including white blood cell differential for enumeration of cell types. SOP W PTH F2 H3.35 Blood film preparation and manual staining with Leishman stain. Blood ESR SOP W-PTH F Erythrocyte Sedimentation Rate Westergren Method Blood PT INR PTT SOPs PTH F2 H4.01 and 02 using the Sysmex C560 Coagulometer and optical density change, B Blood Detection of infectious Mononucleosis SOP W PTH F2 H3.38 Latex gglutination test -Oxoid Kit Blood Detection of Haemoglobin S SOP W PTH F2 H3.39 Clinitek Kit Blood Determination of plasma viscosity SOP W- PTH F2 H4.24 using Benson Viscometer ssessment Manager: RB2 Page 3 of 27

4 HUMN BODY FLUIDS as specified below: Haematology examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Blood Blood Full Blood Count (Hb, RBC, WBC, Hct, MCV, MCH, MCHC, RDW Platelets, Neutrophils, lymphocytes, monocytes, Eosinophils, Basophils) SOP PTH F2 H 4.04 Sysmex XS1000i Set up, Start up and Maintenance QC, FBC nd photometry, impedence and light scatter B Blood ssessment for cell typing and morphology including white blood cell differential for enumeration of cell types. SOP LR PTH D1 H4.11 F01 Blood film preparation and automated staining using Haematek stainer and Haemaclor Romanowsky stain Whole Blood Full Blood Count (MCV, Hb, RBC, WBC, Hct, MCV, MCH, MCHC, RDW Platelets, Neutrophils, Lymphocytes, mixed white cells SOP PTH D1.2 POCT 4.04 Sysmex Pochi using Hydrodynamic focusing Direct Current detection and cumulative pulse height detection C ssessment Manager: RB2 Page 4 of 27

5 HUMN BODY FLUIDS as specified below (cont d): Blood Transfusion examination activities for the purposes of clinical diagnosis (cont d) In house documented procedures standard methods as specified below Blood Blood Grouping/Phenotyping BO Rhesus Rh- C,c,D,E,e SOP PTH F2 BT3.39 Use of the Gelstation nalyser using corresponding antisera or gel card Duffy System Fy a, Fy b Kell Sytem K, K(Cellano) MNS M, N, S, s or SOP PTH F2 BT3,51 Manual Blood Transfusion Procedures using Diamed centrifuge, incubator, card centrifuge. Using corresponding antisera or gel card ntibody (screening) investigations: Blood BO nti- nti-1 nti-b SOP PTH F2 BT3.39 Use of the Gelstation nalyser Or Rhesus-Rh nti-c,cw,c,d,ee Duffy System nti-fya,fyb Kell System nti-k, k(cellano) Lewis System nti-lea, Leb Lutheran System nti-lua, Lub MNS nti-m,n,s,s P System nti-p1 SOP PTH F2 BT3. 51 Manual Blood Transfusion Procedures using Diamed centrifuge, incubator, card centrifuge Using manufacturer's 3 cell panel and Manufacturer's 3 cell panel with enzyme added ssessment Manager: RB2 Page 5 of 27

6 HUMN BODY FLUIDS as specified below (cont d): Blood Transfusion examination activities for the purposes of clinical diagnosis (cont d) In house documented procedures standard methods as specified below ntibody confirmation BO nti- nti-1 nti-b Rhesus-Rh nti-c,cw,c,d,ee Duffy System nti-fy a,fy b Kell System nti-k, k(cellano) Lewis System nti-le a, Le b Lutheran System nti-lu a, Lu b MNS nti-m,n,s,s P System nti-p1 SOP PTH F2 BT3.39 Use of the Gelstation nalyser or SOP PTH F2 BT3. 51 Manual Blood Transfusion Procedures using Diamed centrifuge, incubator, card centrifuge Using manufacturer's 11 cell panel and Manufacturer's 11 cell panel with enzyme added Crossmatching (compatibility testing of patient s plasma with donor red cells) SOP PTH F2 BT3.39 Use of the Gelstation nalyser or SOP PTH F2 BT3.51 Manual Blood Transfusion Procedures ssessment Manager: RB2 Page 6 of 27

7 HUMN BODY FLUIDS as specified below (cont d): Clinical Biochemistry examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Plasma/Serum Serum/Urine Serum/CSF Urea lbumin, LT, LP, ST, Total Bilirubin, Creatine Kinase (CK), CRP, Cholesterol, Total GGT, HDL-Cholesterol, Mg, Total protein, Triglyceride, LDH lpha 1 ntitrypsin C3 C4 Ceruloplasmin Ig IgG IgM Rheumatoid Factor UIBC Iron Corrected Calcium LDL-Cholesterol EGFR Total Binding Iron Capacity mylase Calcium Creatinine Sodium Potassium Inorganic Phosphate Uric acid Glucose SOP PTH F2 BC 4.03, PTH F2 BC4.05 using the Roche C6000/C501 nalyser and photometry, ISE, colorimetery, spectroscopy and turbidimetry. By calculation ssessment Manager: RB2 Page 7 of 27

8 HUMN BODY FLUIDS as specified below (cont d): Clinical Biochemistry examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Serum Urine/CSF Determination of C15-3 C19-9 C125 CE Testosterone SHBG LH Progesterone FSH Prolactin HCG Estradiol Cortisol Serum Folate Ferritin nti-ccp Vitamin B12 Total Vitamin D FT3 FT4 TSH PS Total PS Free Microalbumin: Creatine Ratio Protein: Creatinine Ratio Protein SOP PTH F2 BC3.51 using the Roche C6000/e601 nalyser and Electrochemiluminescence By Calculation Blood Detection of Hb1c SOP W PTH F2 BC3.14 Hb1C via Sebia Capillary Flex 2 Electrophoresis ssessment Manager: RB2 Page 8 of 27

9 HUMN BODY FLUIDS as specified below (cont d): Clinical Biochemistry examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Serum Determination of LT lbumin LP mylase ST Bilirubin, Total Calcium Cholesterol CRP Creatinine GGT Glucose HDL Cholesterol Creatinine Kinase Sodium Potassium Chloride Phosphate Triglyceride Urea Uric cid Corrected Calcium SOP PTH F2 BC 4.03 Daily Startup of Roche Cobas c311 By Calculation B Plasma Detection of: ph po2 pco2 TCO2 SOP PTH D1.2 POCT 4.03 using the bbott I-Stat and Blood Gas Cartridge ssessment Manager: RB2 Page 9 of 27

10 HUMN BODY FLUIDS as specified below (cont d): Clinical Immunology examination activities for the purposes of clinical diagnosis In house documented procedures standard methods as specified below: Serum Protein electrophoresis and immunotyping SOP WPTH F2 BC Protein Electrophoresis by capillary method using Sebia Flex2 Serum N SOP Path D1 IM 4.02 Running assays on the EUROIMMUN I-2P nalyser - Immunofluorescence NC ntibodies utoantibody Profile Endomysial ntibodies nti EN Profile Serum nti Intrinsic factor antibodies SOP Path D1 IM 4.02 Running assays on the EUROIMMUN I 2P nalyser ELIS nti Tissue Transglutaminase ntibodies nti Proteinase 3 nticardiolipin IgG and IgM ntigliadin IgG and IgM nti ds-dn ntibodies to Nuclear ntigens Serum Detection of ntineuronal ntibodies SOP Path F2 IM 3.17 EUROBLOT - Immunoblot ntibodies to Nuclear ntigens ssessment Manager: RB2 Page 10 of 27

11 HUMN BODY FLUIDS as specified below (cont d): Microbiological examination activities for the purposes of clinical diagnosis In house documented procedures standard methods, incorporating SMIs, as specified below spirates Cellular & fluid material contained on swabs, Fluids Pus Samples from sterile sites Tissue Isolation of clinically significant bacteria and fungi Manual culture using: SOPs W-PTH F2 MB ; 3.013; Urine Isolation of clinically significant bacteria and fungi Manual culture using: SOP-W-PTH F2 MB 3.01 Blood Isolation of clinically significant bacteria and fungi utomated culture using: BacT lert W-PTH F2 MB3.04 Joint Fluids/scitic Fluids Detection and quantification of red and white cells Manual culture and microscopy using SOP W-PTH F2 MB 3.13 Joint Fluids Examination for crystals Microscopy using polarising microscope and SOP W-PTH F2 MB 3.74 Cellular and fluid material contained on nose, throat & groin/perineum swabs Screening for: Methicillin-Resistant Staphylococcus aureus (MRS) Manual culture using: MRS Screening: Cellular and fluid material contained on nose, throat & groin/perineum swabs Screening for: Methicillin-Susceptible Staphylococcus aureus (MSS) Manual culture using MSS Screening: W-PTH F2 MB3.97 ssessment Manager: RB2 Page 11 of 27

12 HUMN BODY FLUIDS (cont d) Microbiological activities for the purposes of clinical diagnosis (cont d) In house documented procedures standard methods, incorporating SMIs, as specified below Bacterial & yeast isolates cultured in-house from the above ntimicrobial sensitivity testing BSC disc diffusion & gradient minimum inhibitory concentration determination using: W-PTH F2 MB3.39 Susceptibility Testing (BSC Guidelines) Bacterial & yeast isolates cultured in-house from the above Identification of ß-haemolytic streptococci groups -D, F and G. W-PTH F2 MB 3.30 Streptococcal grouping Bacterial & yeast isolates cultured in-house from the above Detection of Staphylococcus aureus W-PTH F2 MB 3.97Staph Latex test Prolab Test Kit Faeces C. difficile GDH ntigen C. difficile toxins & B SOP W-PTH F2 MB 3.43 lere Quickcheck Test Kit - Immunochromatographic Bacterial & fungal isolates cultured in-house from the above Identification of bacteria and fungi Manual biochemical/enzymatic & staining using gram stain /microscopic methods W-PTH F2 MB3.05 Bacterial & fungal isolates cultured in-house from the above Identification of bacteria and fungi Manual biochemical identification using PI 10s strips W-PTH F2 MB3.05 Faeces Isolation of bacterial enteric pathogens: Escherichia coli O157 Salmonella sp. Shigella spp. Vibrio spp. Campylobacter spp. Manual Culture using: SOP W-PTH F2 MB 3.14 Faeces Detection of Carbapenamase Resistant Organisms (CROs) Manual Culture using Chromogenic/Selective agar and SOP-W PTH F2 MB3.92 ssessment Manager: RB2 Page 12 of 27

13 HUMN BODY FLUIDS (cont d) Microbiological activities for the purposes of clinical diagnosis (cont d) In house documented procedures standard methods as specified below Faeces Detection of Faecal Calprotectin SOP W-PTH F2 MB 3.94 using Quantum Blue Calprotectin Kit Faeces Detection of Haemoglobin SOP W-PTH F2 MB 3.40 using Hema Screen Test Kit Faeces Detection of ova, cysts & parasites (OCP) SOP W-PTH F2 MB Ova Cysts and Parasite Detection - Unstained and iodine stained direct microscopic examination Parasep concentration and microscopic examination. Faeces Detection of Cryptosporidium oocysts SOP W-PTH F2 MB Ova Cysts and Parasite Detection and W-PTH F2 MB 3.37 Cold Ziehl Neelsen stain Clear adhesive tape slide Detection of Enterobious vermicularis larvae and ova SOP W-PTH F2 MB Ova Cysts and Parasite Detection - Microscopic examination Skin, hair, nails Isolation of clinically significant fungi SOP W-PTH F2 MB 3.71 Manual culture and microscopy; stained using Calcufluor ssessment Manager: RB2 Page 13 of 27

14 HUMN BODY FLUIDS (cont d) Serology activities for the purposes of clinical diagnosis (cont d) In house documented procedures standard methods as specified below Serum Detection of: Hep Total ntibodies IgG IgM Hep B Surface ntibody Hep B Surface ntigen Hep B core antibody (Total) Hep Be antibody Hep Be antigen Hep C antibody HIV I/II Combi SOP W-PTH E2 VR 3.12, W- PTH E2 VR 3.13, W-PTH E2 VR3.1 using Roche Cobas 6000 Cervical Smear (PreservCyt Solution) Detection of HPV SOP PTH F2 VR4.16 HPV Extraction and sample preparation using the Roche Cobas C4800 ssessment Manager: RB2 Page 14 of 27

15 HUMN BODY TISSUE ND FLUIDS Histopathological Examination activities for the purposes of clinical diagnosis. Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers instructions where relevant: Fixed and fresh tissue, excisional and incisional biopsies and surgical resection specimens Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Tissue Dissection using SOPs W-PTH F2 HS3 04a Specimen Cut-up BMS; W-PTH F2 HS3.04 Specimen Cut-up ssist; W- PTH F2 HS3.04 Specimen Cut-up Category Tissue processing using SOP: W-PTH F2 HS3.06 and Leica SP300S processor Embedding SOP: W-PTH F2 HS3.07 Tissue embedding and Leica EG1150H, Leica EG1150C Microtomy SOP: W-PTH F2 HS3.08 Leica RM2135 and 2125 RTS Sectioning microtome ssessment Manager: RB2 Page 15 of 27

16 HUMN BODY TISSUE ND FLUIDS Histopathological Examination activities for the purposes of clinical diagnosis. Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers instructions where relevant: Fixed and fresh tissue, excisional and incisional biopsies and surgical resection specimens Routine staining for identification of basophilic and eosinophilic structures Routine FFPE H & E staining Haematoxylin and Eosin stain utomated: Leica utostainer XL SOP: W-PTH D1 HS4.72 Leica XL Staining machine. Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides. Examination of tissues in order to identify or exclude morphological and cytological abnormalities for the purpose of diagnosis Macroscopic and Microscopic examination: Manual tinctorial stains cid Mucins lcian Blue - W-PTH F2 HS3.39 myloid Elastin Helicobacter Congo Red Stain - W-PTH F2 HS3.43 Millers Elastic Van Geison (EVG)- W-PTH F2 HS3.52 Modified Giemsa - W-PTH F2 HS3.59 Elastin/collagen/muscle/ RBC Gram Stain - W-PTH F2 HS3.46 Fungi Grocott - W-PTH F2 HS3.55 Melanin Muscle, red blood cells, fibrin, connective tissue Masson Fontana W-PTH F2 HS3.51 Masson Trichrome - W-PTH F2 HS3.60 Fibrin MSB - W-PTH F2 HS3.42 ssessment Manager: RB2 Page 16 of 27

17 HUMN BODY TISSUE ND FLUIDS Histopathological Examination activities for the purposes of clinical diagnosis. Macroscopic and Microscopic examination: Documented in house methods incorporating manufacturers instructions where relevant: Manual Tinctorial Stains Copper Orcein - W-PTH F2 HS3.49 Mucins / glycogen Mucins/Glycogen lcian Blue Periodic cid Schiff (BPS) - W-PTH F2 HS3.54 Diastase lcian Blue Periodic cid Schiff (DBPS) - W-PTH F2 HS3.62 Mucins/Glycogen Diastase Periodic cid Schiff (DPS) - W-PTH F2 HS3.45 Carbohydrates Fungi Ferric Iron Periodic cid Schiff Reaction (PS) W-PTH F2 HS3.44 Periodic cid Schiff (PSF) - W- PTH F2 HS3.63 Perl s Iron Stain - W-PTH F2 HS3.41 Reticulin Silver Stain - W-PTH F2 HS3.40 Mast Cells Collagen Toluidine Blue - W-PTH F2 HS3.61 Weigert s Van Gieson - W-PTH F2 HS3.38 M. leprae Wade Fite (Modified ZN) - W- PTH F2 HS3.64 cid Fast Bacilli ZN Method - W-PTH F2 HS3.47 ssessment Manager: RB2 Page 17 of 27

18 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Cytokeratin classification of tumours of epithelial origin E1/E3 Follicular lymphoma. Various B and T cell lymphoproliferative diseases Bcl2 Classification of B cell lymphomas, follicual lymphomas and Burkitts lymphoma Bcl6 Identification of epithelial cells BEREP4 Identification of B-cells in germinal centres, differentiation of lymphomas BOB-1 Mucin-like glycoproteins variety of tumours, classification of adenocarcinomas. C125 Smooth muscle cells Normal and neoplastic mesothelial cells CLRETININ Tumour marker gastrointestinal, lung, breast CK18/8 ID of Burkitts lymphoma, follicular lymphoma, LL and renal carcinoma (clear cell) CD10 Ewing s sarcoma marker CD117 ssessment Manager: RB2 Page 18 of 27

19 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Transmembrane tyrosine kinase receptors CD138 Hodgkin s disease CD15 CD1a positive cells in normal and neoplastic tissue CD1a B cells and identification of neoplasms of B cell derivation CD20 Follicular dendritic cells and mature B cells, lymphoma CD21 B cell activator proteins CD23 Classification of T-Cell neoplasms CD3 Normal B lymphocytes and malignant lymphomas CD30 ctivated T and B cells CD31 naplastic large cell Lymphoma, Reed-Sternberg cells, Hodgkin s CD34 Thymocytes and T helper cells identifying anaplastic T-Cell lymphoma T Lymphocytes, myeloid lineage cells CD4 CD43 ssessment Manager: RB2 Page 19 of 27

20 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer T and B lymphocytes CD45 (LC) ID of B and T cell malignancies CD5 Identification of NK cells, neural / neuroendocrine tissue, carcinoid CD56 T Cells, oligodendromas and neuroendocrine tumours CD57 Detection of activated platelets, neutrophils and basophils CD68 Mononuclear phagocytes CD79 Cytotoxic suppressor T Cells CD8 B cells and B Cell neoplasms CD99 ID of adenocarcinomas and carcinoids of the GI tract CE Terminally differentiated plasma cells CDX2 Prognostic indicator for breast cancer CHROMOGRNIN Identification of epithelial tumours, and may be useful in identifying cholangiocellular carcinomas CK19 ssessment Manager: RB2 Page 20 of 27

21 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Normal and abnormal gastric and intestinal epithelium, urothelium and Merkel cells CK20 Differentiation between squamous cell carcinoma and adenocarcinoma CK5 (CK5/6) Glandular and transitional epithelial cells CK7 Identification of mantle cell lymphomas CYCLIN D1 Identification of lymphatic invasion D2-40 Labels smooth and striated muscle cells as well as mesothelial cells, identification of rhabdomyosarcomas, leiomyomas and mesotheliomas DESMIN Differential diagnosis of gasterointestinal stromal tumours DOG 1 E-cadherin-positive cells in normal and neoplastic tissues E-CD Labels epithelial cells in a wide variety of tissues and is a useful tool for the identification of neoplastic epithelia EM ssessment Manager: RB2 Page 21 of 27

22 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Labels estrogen receptor α- positive cells and is useful in the assessment of estrogen receptor status in human breast carcinomas ER Expressed in mammary gland and several exocrine tissues GCDFP15 Classification of melanomas and melanocytic lesions and also aid in distinguishing metastatic amelanotic melanomas from other poorly differentiated tumours of uncertain origin HMB45 Marker for differentiation of high grade invasive urothelial carcinoma from prostate cancer HMWCK lpha Inhibin Expression INHIBIN Labels plasma cells and related lymphoid cells containing kappa light chains KPP Ki-67 antigen in normal and neoplastic cells e.g soft-tissue sarcoma, prostatic adenocarcinoma, and breast carcinoma KI67 ssessment Manager: RB2 Page 22 of 27

23 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Labels plasma cells and related lymphoid cells containing lambda light chains LMBD Labels melanocytes and iidentification of melanomas, and, if melanoma is ruled out, for adrenocortical carcinomas MELN Differential identification of colorectal carcinoma MLH1 Epithelial tissues from simple glandular to stratified squamous epithelium and identification of normal and neoplastic cells of epithelial origin MNF116 Differential identification of colorectal carcinomas MSH2 Differential identification of colorectal carcinomas MSH6 Labels the MUM1 protein, which is expressed in a subset of B cells in the light zone of the germinal centre plasma cells, activated T cells, and a wide spectrum of related haematolymphoid neoplasms MUM-1 ssessment Manager: RB2 Page 23 of 27

24 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Labels both normal and neoplastic cells of neuronal and neuroendocrine origin NSE Lymphoid restricted immunoglobulin octamer binding antibody OCT2 Tumour suppressor gene P16 Identification of p53 in normal and neoplastic tissue P53 basal epithelial cell proliferation regulator, identification of prostate adenocarcinoma as an aid in the differentiation between benign prostate lesions and prostate adenocarcinoma P63 B-cell-specific activator protein ID of pro-, pre-, and mature B cells and in the classification of lymphomas PX5 Prostate needle cores differentiation between HGPIN and adenocarcinoma PIN 4 identification of seminomas and desmoplastic small round cell tumors and identification of germ cell tumours PLP ssessment Manager: RB2 Page 24 of 27

25 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Differential identification of colorectal carcinomas PMS2 Labels progesterone receptor in human breast carcinomas PR Prostatic epithelium and is a useful tool for the identification of benign and malignant cells of prostatic origin PS Identification of S100-positive neoplasms, such as malignant melanoma, Langerhans' histiocytosis, chondroblastoma and schwannoma S100 Smooth muscle cells, myofibroblasts and myoepithelial cells, and leiomyosarcomas and pleomorphic adenomas SM Classification of breast tumours SMM Identification of neuroendocrine neoplasms, including neoplasms of epithelial type, ID of nervous system neoplasms with neuronal differentiation and ID of adrenocortical neoplasm SYNPTOPHYSIN ssessment Manager: RB2 Page 25 of 27

26 HUMN BODY TISSUE ND FLUIDS (cont d) Immunochemistry examination for the purposes of clinical diagnosis Microscopic examination supported by automated staining with positive and negative controls: Formalin Fixed Paraffin Embedded Tissue (FFPE) sections on glass slides utomated equipment Leica Bond Max SOP: W-PTH D1 HS4.76 Bond-Max Immunohistochemistry Stainer Thyroid transcription factor-1 in normal and malignant cells TTF-1 Cells of mesenchymal origin in normal and neoplastic tissues, and is of value in tumour diagnosis VIMENTIN Classification of Will s tumour, malignant mesothelioma and serous ovarian adenocarcinoma WT1 Slides prepared in house from the sample types listed above. Morphological assessment and interpretation/diagnosis Microscopy (qualitative analysis) In house procedures: W-PTH-F2 HS3.04 HUMN BODY TISSUE ND FLUIDS (cont d) Diagnostic Cytology examination activities for the purposes of clinical diagnosis In-House documented procedures standard methods as specified below: Fluids and Fine needle aspirates (FNS) Sample preparation using W- PTH F2 CY3.24 Systemic Cytology Preparation Procedures W-PTH F2 HS3.24 Non-Gynae Cytology Preparation Procedures Using Cytospin, Hologic T2000 ssessment Manager: RB2 Page 26 of 27

27 HUMN BODY TISSUE ND FLUIDS (cont d) Diagnostic Cytology examination activities for the purposes of clinical diagnosis In-House documented procedures standard methods as specified below: ir dried slides, fixed slides and Thinprep slides Staining for the purposes of Cell Differentiation SOP W PTH F2 CY3.07 and CY3.25 utomated staining: Leica utostainer XL for Papanicolaou and May Grunwald Giemsa stains Slides prepared in house from the sample types listed above. Morphological assessment and interpretation/diagnosis Microscopy (qualitative analysis) In house procedures: W-PTH G1 CY HUMN BODY TISSUE ND FLUIDS (cont d) Gynaecological Cytology examination activities for the purposes of clinical diagnosis Macroscopic and Microscopic examination: In-House documented procedures based on equipment manuals and standard methods as specified below: Cervical/vaginal cells (Liquid based Cytology/LBC Sample) Preparation and screening to identify or exclude cytological abnormalities for the purpose of diagnosis Specimen processing using Thinprep methodology and Hologic T2000 processor SOP W PTH F2 CY1.05 ir dried slides, fixed slides and Thinprep slides Staining for the purposes of Cell Differentiation SOP W PTH F2 CY3.07 utomated staining: Leica utostainer XL for Papanicolaou stain Slides prepared in house from the samples listed above Morphological assessment and interpretation/diagnosis Microscopy (qualitative analysis) In-house procedures: SOP W PTH F2 CY3.09 and W PTH F2 CY3.10 END ssessment Manager: RB2 Page 27 of 27