Laboratory locations: 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK 3 Dorset Rise London EC4Y 8EN United Kingdom Contact: lison enson Tel: +44 (0)161 447 6777 E-Mail: lison.benson@spirehealthcare.com Website: www.spirehealthcare.com below s covered by the organisation and their activities details ctivity code ddress Spire Manchester (lood Sciences, Microbiology) 170 arlow Moor Road, Didsbury, Manchester, M20 2F Local contact lison enson Diagnostic testing: Haematology, lood Transfusion, iochemistry, Microbiology ddress Spire Histology Centre Parkway 1 Princess Road Manchester M14 7LU Local contact lison enson Diagnostic testing: Histopathology Site activities performed away from the locations listed above: details ctivity code Spire Manchester Lab lood issue fridge Spire Cheshire lood issue fridge bbey Pines lood issue fridge ssessment Manager: MH 1 of 17
DETIL OF CCREDITTION HUMN ODY FLUIDS Haematology examinations for the purposes of clinical diagnosis lood Full lood Count Haemoglobin White lood Cell Count Red lood Cell Count Platelet Count Haematocrit Mean Cell Volume Mean Cell Haemoglobin Mean Cell Haemoglobin Concentration Neutrophil count Lymphocyte count Monocyte count Eosinophil count asophil count Horiba Pentra 80 using impedance, cytochemistry and absorbance, SPS-HM-SOP0100 Plasma Coagulation screen PT PTT INR IL Elite Pro analyser using viscosity based detection and SPS-HM- SOP0400 lood Estimation of Erythrocyte Sedimentation Rate Manual Westergren Sedatainer method using SPS-HM-SOP0600 lood Detection of sickle cell S test kit and SPS-HM-SOP0400 Serum, plasma Detection of infectious mononucleosis heterophile antibody Monocol card latex agglutination kit and SPS-HM-SOP1100 ssessment Manager: MH Page 2 of 17
HUMN ODY FLUIDS (cont d) iochemistry and Serology examinations for the purposes of clinical Serum, plasma Quantification of the following: Roche Cobas C501 using colorimetric, enzymatic, immunoturbidometry and SPS-C- SOP0100 Urea Creatinine (Jaffe) Sodium Potassium GGT Total protein Cholesterol Triglycerides HDL Phosphates lbumin LP LT mylase ST Total bilirubin Calcium CK Glucose CRP Iron Iron binding capacity unsaturated poliprotein poliprotein Lipoprotein Triglycerides Magnesium Uric cid Salicylate Paracetamol MH Valproate ssessment Manager: MH Page 3 of 17
HUMN ODY FLUIDS (cont d) iochemistry and Serology examinations for the purposes of clinical Serum, plasma Quantification the following: Roche Cobas C601 using electrochemiluminescence immunoassay and SPS-C- SOP0100 Lithium icarbonate LDH Calculated parameters: egfr Globulin djusted Calcium LCL cholesterol ratio Troponin T Oestradiol FSH LH Progesterone Prolactin Qualitative detection of the following: HIV Hep surface antigen Hep C antibody Hep antibody Hep Syphilis antibody Rubella IgG Faeces Detection of occult blood Manual Hemoccult test using SPS- C-SOP0700 Qualitative detection of the following: Trituris 4 ELIS analyser and SPS- VL-SOP0100 Faeces Calprotectin uhlmann kit Elastase ioserve kit Serum, plasma T Quantiferon Qiagen kit Parvovirus 19 IgG Grifols kit Parvovirus 19 IgM Grifols kit ssessment Manager: MH Page 4 of 17
HUMN ODY FLUIDS (cont d) Serology examinations for the purposes of clinical diagnosis (cont d) Serum, plasma Qualitative detection of the following: Chorus ELIS analyser and SPS- VL-SOP0200 EV VC IgG EV VC IgM EV EN CMV IgG CMV IgM Herpes IgG Herpes IgG Toxoplasma IgG Toxoplasma IgM Mycoplasma IgG Mycoplasma IgM Measles IgG Measles IgM Mumps IgM VZV IgG VZV IgM Rubella IgM Helicobacter pylori Ig Coxsackie Coxsackie ssessment Manager: MH Page 5 of 17
HUMN ODY FLUIDS (cont d) lood Transfusion examinations for the purposes of clinical diagnosis lood and plasma lood group detecting O ntibody screen and identification detecting: Rh-D, C, c, e, cw Kell, K, k, kpa, kpd JK-a, JK-b Lewis, LEa, LEb P1 M, N, F, f Lutheran a, b XGa Manual method using Diamed Gel Cards and tube method Coombs nti IgG) and SPS-T-SOP0200 lood and plasma Serological Crossmatching Manual method using Diamed Gel Cards (Coombs anti IgG) and SPS- T-SOP0200 HUMN ODY FLUIDS (cont d) Microbiology examinations for the purposes of clinical diagnosis Documented in-house methods based on related UK Standards for Microbiology Investigations (SMIs) and manufacturer s operating instructions, where. Swabs, tissue, fluids, faeces, tips, urine Isolation and characterisation of microorganisms of clinical significance. Manual inoculation and media culture SPS-MI-SOP0200 SPS-MI-SOP0400 SPS-MI-SOP0500 SPS-MI-SOP0300 Faeces Detection of Clostridium difficile GDH antigen and toxins & Prolab Proflow lateral flow immunoassay SPS-MI-SOP0300 Detection of Helicobacter pylori antigen ssessment Manager: MH Page 6 of 17
HUMN ODY FLUIDS (cont d) Microbiology examinations for the purposes of clinical Documented in-house methods based on related UK Standards for Microbiology Investigations (SMIs) and manufacturer s operating instructions, where. Swabs, Tissue, Fluids Differentiation of different organism types: gram positive/negative/variable, branching organisms, yeasts. Gram Staining and light microscopy SPS-MI-SOP0800 Faeces Detection of Cryptosporidium oocysts Manual staining using auramine and fluorescent microscopy SPS- MI-SOP0800 Faeces, urine, fluids Detection of ova cysts and parasites Manual concentration method using Parasep and SPS-MI- SOP0300 Synovial fluid Detection of uric acid and pyrophosphate crystals Manual method using bi-refringent polarising microscopy and SPS-MI- SOP0800 Urine, fluids Enumeration of white and red blood cells Manual method using Kova slide and SPS-MI-SOP0800 and 0400 Sellotape slide Detection of ova of Enterobius vermicularis Light microscopy and lactophenol blue stain SPS-MI-SOP0700 acterial/fungi/yeasts culture isolates produced by the laboratory Identification of bacteria/fungi/yeasts Manual methods using SPS-MI- SOP0800 Oxidase, chemical reaction Catalase, chemical reaction β lactamase enzyme detection using Remel Nitrocephin X&V factor growth enhancement DNse using Oxoid Methyl Green plates ssessment Manager: MH Page 7 of 17
HUMN ODY FLUIDS (cont d) Microbiology examinations for the purposes of clinical Documented in-house methods based on related UK Standards for Microbiology Investigations (SMIs) and manufacturer s operating instructions, where. acterial/fungi/yeasts culture isolates produced by the laboratory Identification of bacteria/fungi/yeasts Manual methods using SPS-MI- SOP0800 Optochin growth inhibitor using Oxoid discs Urease production using Oxoid urea slopes Strep latex grouping kit (Prolab) agglutination E.coli O157 latex agglutination Prolab Prolex kit Staph latex agglutination Prolab Prolex kit Enteric Serology-Enteric slide agglutinations Vitek 2 Compact identification ntibiotic susceptibility testing Manual disc method using SC breakpoints and guidelines ssessment Manager: MH Page 8 of 17
HUMN TISSUES ND FLUIDS diagnosis Formalin fixed tissues Preparation and examination to identify or exclude morphological abnormalities Macroscopic and Microscopic examination using in-house procedures (listed) in conjunction with manufacturer s instructions for the following methods (where ). Macroanalysis and dissection using SOP SPS-HT-SOP-0200 Tissue processing: utomated method using Leica SP300S and Peloris processors and SOP SPS-HT-SOP-0300 Embedding Manual method using SOP SPS- HT-SOP-0400 Microtomy Manual method using SOP SPS- HT-0500 Formalin fixed, paraffin embedded (FFPE) tissue asophilic and eosinophilic tissue structures Routine Haematoxylin & Eosin (H&E) staining: utomated method using Leica uto-stainer XL and coverslipper CV5030 SPS-HT- SOP0600 Detection of the following: Special stains: Manual methods using SOP SPS- HT-SOP0600 and the following stains Liberated aldehydes Periodic cid Schiff's (+/- diastase) cid and sulphated mucins lcian lue Glycoproteins PS lcian lue ssessment Manager: MH Page 9 of 17
HUMN TISSUES ND FLUIDS (cont d) Detection of the following: Special stains: Manual methods using SOP SPS- HT-SOP0600 and the following stains Helicobacter pylori Modified Giemsa cid fast bacilli Ziehl Neelsen Haemosiderin Perls Prussian lue Fungal Hyphae Grocott Hep Orcein Reticulin Fibres Retic Elastic fibres and collagen Elastic Van Gieson lood and Elastic Tissue HVG myloid Congo Red Collagen and smooth muscle Mason Trichrome Fibrin MS Gram positive and Gramnegative organisms Gram Mast cell granules Toluidine lue ssessment Manager: MH Page 10 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. Smooth muscle Pan-keratin Fibromatosis in reast/ bdomen Mantle zone lymphocytes & interfollicular T lymphocytes Large -cell lymphomas Cell membranes and glycoproteins reast Carcinomas Ovarian Carcinomas Medullary Carcinoma of Thyroid Oesopahgus, Smooth Muscle from bowel and Uterus. Oesopahgus, Smooth Muscle from bowel and Uterus. Mesothelioma, Normal ppendix ctin E1/E3 eta-catenin cl-2 cl-6 erep4 RST-2/GCDFP-15 C125 Calcitonin Caldesmon Calponin Calretnin ssessment Manager: MH Page 11 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. Thymus T Lymphocytes Liver and tonsil. T lymphocytes Germinal centre T lymphocytes; lymphocyte subset T cell Lymphoma Normal, early progenitor lymphoid cells; lymphocytes in germinal centres Hodgkins Lymphoma lymphocytes Follicular Dendritic cell matrix in tonsil. Lymphoma/ Leukaemia s for small cell cell lymphoma CD1a CD3 CD4 CD5 CD8 CD10 CD15 CD20 CD21 CD23 ssessment Manager: MH Page 12 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. Hodgkin lymphoma and naplastic large cell lymphoma Neoplasms of vascular origin Haemopoietic precursor cells; endothelial cells; fibroblasts Lymphoid or myleomonolineage identification. Hodgkin and T-cell lymphomas. Peripheral nerves; NK cells; neuroendocrine differentiation Macrophages lymphocytes Marker of GI origin for adenocarcinomas Normal and neoplastic plasma cells in plasmacytoid lymphomas. CD30 CD31 CD34 CD43 CD45(LC) CD56 CD68 CD79a CDX2 CD138 ssessment Manager: MH Page 13 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. denocarcinomas of Colon/Colon mucosa Neuroendocrine conditions. Proliferating squamous epithelium Simple, glandular & transitional epithelia denocarcinomas and nonkeratinising squamous carcinomas. Tumours of epithelium origin. Epithelia GI epithelia asal cells in the prostate and myoepithelial cells. Mantle cell lymphoma and breast carcinoma Smooth and striated muscle cells CE Chromogranin CK5/6 CK7 CK8/18 CK14 CK19 CK20 CK34 Cyclin D1 Desmin ssessment Manager: MH Page 14 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. denocarcinoma or mestothelioma in Lung, G.I. tract and Ovary Epithelial membrane on glandular tissue. reast carcinomas. Endothelial cells and neoplastic blood cells. Platelets, megakaryocyte and fibroblast. drenal cortical tumours and renal cell carcinomas. Light Chain and heavy chain identification Cell proliferation rate Light and heavy chain identification Detect melanoma quantitatively. Human melanoma black 45 antigen E-Cadherin EM ER Factor VIII Factor XIIIa Inhibin Kappa Ki67 Lambda Melan HM45 ssessment Manager: MH Page 15 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. Colorectal carcinoma Detection of Racemase tumours Ovarian Carcinomas Colon ndenocarcinomas Normal proliferating cells; poorly differentiated squamous cell carcinoma, basal cells; abluminal cells reast carcinomas Prostate specific antigen Hyperplastic prostate or carcinoma of prostate Normal and neoplastic melanocytes; macrophages; adipocytes; nerve fibres Smooth muscle Pancreatic Islet cells MNF116 P504S/MCR P16 P53 P63 PR PS PSP S100 Smooth Muscle Myosin Synaptophysin ssessment Manager: MH Page 16 of 17
HUMN TISSUES ND FLUIDS (cont d) FFPE tissue Detection of the following: Immunohistochemistry utomated methods using the Roche Ventana enchmark XT and XT for the following antibodies: SPS-HT-SOP0700. Follicular carcinomas of the thyroid. Thyroid transcription factor-1 (Thyroid follicular & C cells) Vimentin intermediate filament Ovarian carcinomas and mesotheliomas Thyroglobulin TTF1 Vimentin WT1 END ssessment Manager: MH Page 17 of 17