Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

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1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Haematology Department Contact: Ian Diton Eastbourne Hospital Tel: +44 (0) ex 4127 Kings Drive Eastbourne Website: East Sussex BN21 2UD Testing performed at the above address only HUMAN BODY FLUIDS DETAIL OF ACCREDITATION Haematology examination activities for the purposes of clinical diagnosis Haematology Full blood counts and automated differential: Haemoglobin (Hb) Total white cell count (WBC) Red cell count (RBC) Platelet count (PLT) MCV MCH MCHC Nucleated Red Cell Count (NRBC) Neutrophil count Lymphocyte count Monocyte count Eosinophil count Haematocrit (HCT) Red Cell Distribution Width (RDW) Reticulocyte Count (RET) Erythrocyte Sedimentation Rate (ESR) Examination of Peripheral blood film, detection of normal and abnormal morphologies, white blood cell differential based on manufacturer s operating instructions, where relevant, to support clinical diagnosis Sysmex XN2000 and XN1000 analyser. SLS-HGB method- Absorbance at 555nm, Fluorescence flow cytometry, Hydrodynamic focussing DC detection (impedance method), and calculated red cell parameters HAJ-184 StarrSed Autocompact Blood Sedimentation Instrument based on Westergren method. HAJ-100 Thin film slide preparation and manual staining with Wright s stain and examination by light microscopy HAJ-170, HAJ176 Assessment Manager: PW Page 1 of 8

2 Bone Marrow aspirate Bone Marrow aspirate Plasma Plasma Haematology examination activities for the purposes of clinical diagnosis (cont d) Examination of bone marrow films, detection of normal and abnormal morphology Examination of Bone Marrow Films for assessment of iron storage Detection of Malarial antigens of: P. falciparum Pan-detection for P.falciparum, P.malariae, P.ovale & P.vivax Thin blood Film detection and identification of malarial parasites P.falciparum, P.vivax, P.ovale, P.malariae and P.knowlesi Thick blood Film detection of malarial parasites (P. falciparum, P. vivax, P. ovale, P.malariae and P.knowlesi Infectious Mononucleosis (Paul Bunnell/ PB): qualitative detection of heterophile antibodies Manual staining with Wrights and Giemsa stains and examination by light microscopy. HAJ-188, HAJ-SOP-15 Manual staining Perls stain and examination by light microscopy. HAJ-188, HAJ-SOP-15 CareStart Malaria HRP2/pLDH Combo Immunoassay HAJ-156 Thin film slide preparation and manual staining with Giemsa stain and examination by light microscopy HAJ-156 Thick film slide preparation and manual staining with Field s A&B stain and examination by light microscopy HAJ-156 Clearview IM II Test card using mobilised/immobilised bovine erythrocyte glycoprotein. HAJ-161 Assessment Manager: PW Page 2 of 8

3 Haematology examination activities for the purposes of clinical diagnosis (cont d) Citrated plasma Coagulation Sysmex CS2500 using in house documented procedures based on standard methods and incorporating manufacturers instructions as relevant: Prothrombin Time (PT) Sysmex clotting detection method change in optical density of sample/reagent mixture over time. INR HAJ-198 INR Activated Partial Thromboplastin Time (APT) Calculated from mean normal PT and ISI value. HAJ-198 Sysmex clotting detection method change in optical density of sample/reagent mixture over time. HAJ-199 Fibrinogen (FIB) Sysmex clotting detection method change in optical density of sample/reagent mixture over time. Result calculated from reference curve. HAJ-200 D-dimer (DD) Immuno-turbidometric assay using reagents containing monoclonal antibody specific to D-dimer. Result calculated from reference curve. HAJ-201 Blood (whole) Sickle Solubility test Streck Sickledex Reduced HbS solubility HAJ-162 Assessment Manager: PW Page 3 of 8

4 Blood Transfusion examination activities for the purpose of clinical diagnosis Blood Transfusion Blood Grouping: ABO blood groups Rh D antigen: Red cell phenotyping: D,C,E,c,e,Cw,K,k,Fya,Fyb, Jka,Jkb,Lea,Leb,P1,M,N,S,s, Lua, Lub Red cell antibody detection: Anti- D,C,E,c,e,Cw,K,k,Fya,Fyb, Jka,Jkb,Kpa,Kpb,Lea,Leb,P1,M,N,S,s, Lua, Lub based on manufacturers instructions Automated method Using Diamed GelCards and using Diamed Gelstation SOP BTE-11 Manual method Using Diamed GelCards and centrifugation SOP BTE-12 Manual method Using tube and centrifugation SOP BTE-13 Manual method Using Diamed GelCards and centrifugation SOP BTJ-114 Automated method Using Diamed GelCards and using Diamed Gelstation SOP BTE-11 Manual method Using Diamed GelCards and centrifugation SOP BTE-12 Direct Antiglobulin Test (DAT) Manual method Using Diamed GelCards and centrifugation BTJ-115 Assessment Manager: PW Page 4 of 8

5 Blood (whole) Blood (whole) Blood Transfusion examination activities for the purpose of clinical diagnosis (cont d) Compatibility Testing: Serological Crossmatch- serological compatibility test between donor red cell antigens and patient plasma Detection and estimation of Foetal Maternal Haemorrhage (Kleihauer test) Immunology examination activities for the purpose of clinical diagnosis Automated Method based on Diamed manufacturer s instructions for column technology and Diamed Gelstation BTE-16, BTJ-114 Manual Method based on Diamed manufacturer s instructions for column technology and centrifugation. BTE-19, BTJ-114 Source Bioscience Foetal Cell Detection Kit. Acid elution and microscopic examination. BTJ-112 based on manufacturers instructions Serum Auto Immunity In house documented procedures based on standard methods and incorporating immunoassay manufacturers instructions and Werfen DS2 automated ELISA analyser (Test specific kits listed below) IME-7, IME-4 Anti-tissue transglutaminase antibody (ATTGA) Anti-nuclear antibody screen (ANAS) Anti-cyclic citrullinated peptide antibody (ACCPA) Inova Diagnostics QUANTA Lite R h-ttg IgA ELISA Inova Diagnostics QUANTA Lite ANA ELISA Inova Diagnostics QUANTA Lite CCP3 IgG ELISA Assessment Manager: PW Page 5 of 8

6 Immunology examination activities for the purpose of clinical diagnosis (cont d) Serum (cont d) Auto Immunity (cont d) Werfen DS2 automated ELISA analyser and test specific kits Anti-cardiolipin screen (CARDS) Anti-intrinsic factor antibody (AIFA) Organtec Anticardiolipin Screen Inova Diagnostics QUANT Lite Intrinsic Factor ELISA Serum Allergy (IgE) Screening: In house documented procedures based on standard methods and incorporating Phadia immunoassay manufacturers instructions and Thermofisher Immunocap 100 analyser (Individual allergen kit references listed) IME-9, IME-4 Anti-cardiolipin IgG (CARDG) & IgM (CARDM) confirmation Total IgE (IGE) Cat dander (CAT) Dog dander (DOG) Horse dander (HORSE) Mixed feathers (FEATHE) (Goose, chicken, duck, turkey) House dust mite (D1) Latex (LATEX) Organtec Anticardiolipin IgG/IgM ImmunoCAP Total IgE Anti-IgE ImmunoCAP allergen e1, Cat dander ImmunoCAP allergen e5, Dog dander ImmunoCAP allergen e3, Horse dander ImmunoCAP allergen ex71, Feathers ImmunoCAP allergen d1, House dust mite ImmunoCAP allergen k82, Latex Aspergillus fumigatus (M3) ImmunoCAP allergen m3, Aspergillus fumigatus Grass mix (GX1) (Bermuda, Rye, Johnson, Brame, Velvet, Bahia) ImmunoCAP allergen gx1, Grass pollen Assessment Manager: PW Page 6 of 8

7 Immunology examination activities (cont d) (Cont d) Serum Allergy (IgE) Screening (cont d): Thermofisher Immunocap 100 analyser and allergen kits (Cont d) Mould mix (MX1) (Penicillium chrysogenum, Cladosporium herbarum, Aspergillus fumigatus, Alternaria alternata) Tree mix (TX8) (Box elder, Silver birch, Hazel, Oak, Maple leaf, sycamore) Chocolate (CHOC) Nut mix (FX1) (Peanut, Hazelnut, Brazil nut, Coconut, Almond) Peanut (F13PN) Hazelnut (F17HN) Brazil nut (F18BN) Coconut (F36COC) Almond (F20ALM) Cashew nut (CASHEW) Food mix (FX5) (Soybean, Egg white, Cod, Wheat, Milk) Soybean (F14SB) Egg white (F1E) Fish (Cod) (F3F) Wheat (F4W) Milk (F2M) ImmunoCAP allergen mx1, Moulds ImmunoCAP allergen tx8, Tree pollen ImmunoCAP allergen f93, Cacao ImmunoCAP allergen fx1, Food ImmunoCAP allergen f13, Peanut ImmunoCAP allergen f17, Hazelnut ImmunoCAP allergen f18, Brazil nut ImmunoCAP allergen f36, Coconut ImmunoCAP allergen f20, Almond ImmunoCAP allergen f202, Cashew nut ImmunoCAP allergen fx5, Food ImmunoCAP allergen f14, Soybean ImmunoCAP allergen f1, Egg white ImmunoCAP allergen f3, Fish(cod) ImmunoCAP allergen f4, Wheat ImmunoCAP allergen f2, Milk Assessment Manager: PW Page 7 of 8

8 Immunology examination activities (cont d) Serum (cont d) Allergy (IgE) Screening (cont d): Thermofisher Immunocap 100 analyser and allergen kits Fish mix (FX2) (Cod, Salmon, Shrimp, Tuna, Blue Mussel) Salmon (F41SAL) Shrimp (F24SH) Fruit mix (FX15) (Orange, Apple, Banana, Peach) Orange (F33OR) Apple (F49AP) Banana (F92BAN) Peach (F95PEA) Tomato (TOMATO) ImmunoCAP allergen fx2, Food ImmunoCAP allergen f41, Salmon ImmunoCAP allergen f24, Shrimp ImmunoCAP allergen fx15, Fruits ImmunoCAP allergen f33, Orange ImmunoCAP allergen f49, Apple ImmunoCAP allergen f92, Banana ImmunoCAP allergen f95, Peach ImmunoCAP allergen f25, Tomato Strawberry (STRAWB) ImmunoCAP allergen f44, Strawberry Gluten (GLUTEN) Walnut (WALNUT) Honeybee venom (BEEV) ImmunoCAP allergen f79, Gluten ImmunoCAP allergen f256, Walnut ImmunoCAP allergen i1, Honeybee venom Bumblebee venom (BBEEV) ImmunoCAP allergen i205, Bumblebee Wasp venom (WASPV) ImmunoCAP allergen i3, Common wasp venom (yellow jacket) END Assessment Manager: PW Page 8 of 8