Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust Issue No: 005 Issue date: 01 May 2021 SWLP Department of Blood Sciences Contact: Asam Saeed Epsom and St Helier University Hospitals Tel: +44 (0)208296553 St Helier Hospital E-Mail:[email protected] 8961 Wrythe Lane Surrey Accredited to ISO 15189:2012 SM5 1AA 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 Haematology Department of Blood sciences Asam Saeed • Blood fridges A St Helier Hospital • Biochemistry Wrythe Lane • Special chemistry Carshalton • Neonatal screening SM5 1AA Department of Blood Sciences Asam Saeed • Routine Haematology Epsom General Hospital • Blood Transfusion B Dorking Road • Blood fridges Epsom • Biochemistry KT18 7EG Blood fridge locations aware from the laboratory: Location details Activity Location code Elective Orthopaedic centre • Blood Fridge C Epsom Hospital Ashtead Hospital, The Warren, Ashtead, • Blood fridge E KT21 2SB Assessment Manager: EWS Page 1 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Haematological examination Documented in house methods and activities for the purposes of manufacturers instructions for clinical diagnosis: Quantitative determination of Sysmex XE 5000 using light A, B FBC to include: scatter, impedence count and colormetric technology: Blood BSU.SOP.180 Haemoglobin Platelets White cell count MCV RBC MCH MCHC RDW HCT Neutrophils Lymphocytes Monocytes Eosinophils Basophils Vescube 200 using level sensing: Blood ESR BSU.SOP.089 A, B Manual staining and automate (SP1000i)using MGG stain and light microscopy: Blood films Red cell, white cell and BSU.SOP.174, 195, 170, 202, 212 A platelet morphology and white cell differential Bone Marrow All cell types BSU.SOP.170 and BSU.SOP.046 A Blood Detection & speciation (thin Preparation of thick and thin films, films) of malaria parasites: staining and light microscopy using Giemsa and Fields A and B All plasmodium species known BSU.SOP.221, 360, 363, 364, 365 A to cause human disease Assessment Manager: EWS Page 2 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Haematological examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for clinical diagnosis (cont’d): Manual method using Clearview IM II kit- rapid chromatographic immunoassay: Blood Heterophile antibody BSU.SOP.163 A, B Manual method using Carestart Rapydtests (Pan/Pf) rapid chromatographic immunoassay: Blood Malarial antigens of: BSU.SOP.032 A, B Plasmodium falciparum and pan-detection for: Plasmodium falciparum Plasmodium malariae, Plasmodium ovale & Plasmodium vivax Microgen Bioproducts S-Test kit using insolubility: Blood Sickle cells solubility - HbS BSU.SOP.166 A Haemoglobinopathy testing : Helena Biosciences Acid A electrophoresis gel kit: Documented In-House Methods to meet the requirements of the SCT Programme handbook as defined in the current version of ‘Sickle Cell and Thalassaemmia in pregnancy screening: laboratory QA evidence requirements’ for antenatal and newborn screening Blood HbC BSU.SOP.189 HbD HbS HbE HbG Trinity Biotech G6PDH kit and Jenway spectrophotometer Blood G6PD enzyme BSU.SOP.001 A Assessment Manager: EWS Page 3 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Haematological examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for clinical diagnosis (cont’d): Neonatal Haemoglobinopathy Sebia CapillaryS 2 Neonat fast A analysis by detection of analyser using Capillary haemoglobin variants: Electrophoresis: Documented In- House Methods to meet the requirements of the SCT Programme handbook and Newborn blood spot programme as defined in the current version of ‘Sickle Cell and Thalassaemmia in pregnancy screening: laboratory QA evidence requirements’ for antenatal and newborn screening Dried Blood Spots Hb A BSU.SOP.058, 059, 066, 067, 160, Hb F 161, 162 Hb S Hb C Hb D Hb E Hb O Barts Blood Adult Haemoglobinopathy Sebia CapillaryS 2 Flex piercing A analysis (including Antenatal) analyser using Capillary by detection of haemoglobin electrophoresis: variants: Hb A BSU.SOP.196, 199, 144, 207, 208 Hb A2 Hb S Hb C Hb D Hb E Hb O (Arab) Assessment Manager: EWS Page 4 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Haematological examination Documented in house methods and (cont’d) activities for the purposes of manufacturers instructions for clinical diagnosis (cont’d): Routine Coagulation Screen to CS2100i using clot detection A, B include: unless otherwise stated: Blood PT/INR calculated test BSU.SOP.045/BSU.SOP.630 INR APTT Fibrinogen BSU.SOP.045 D dimer Latex agglutination: BSU.SOP.242 Thrombin time BSU.SOP.056 A Anti thrombin Chromogenic: BSU.SOP.903 A Protein C BSU.SOP.904 A Protein S BSU.SOP.050 A VWF Latex agglutination: BSU.SOP.374 A Xa assay Chromogenic: BSU.SOP.051 A Factor assays BSU.SOP.894 A Lupus screen BSU.SOP.299 A Assessment Manager: EWS Page 5 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Blood Transfusion Procedures documented in (cont’d) examinations to assist in manufacturer’s equipment manuals clinical investigations in conjunction with documented in- house procedures by the following methods: EDTA Packed red cells Blood Group by detection and BioRad IH-1000 analyser and A, B identification of antigens and DiaMed gelstation analyser: antibodies: BSU.SOP.017 A Positive BSU.SOP.007 B Positive O Positive AB Positive A Negative B Negative O Negative AB Negative EDTA Whole Blood/plasma Antibody Screen by detection BioRad IH-1000 analyser and A, B of antibodies to: DiaMed gelstation analyser: BSU.SOP.017 Rh which includes anti-C, BSU.SOP.007 D, C, E, c, e, f, Cw K, k, Kpa , Kpb , Xga Fya , Fyb , Jka, Jkb Lea, Leb S, s, M, N P1 Lua , Lub Blood Automated red cell BioRad IH-1000 analyser and A, B phenotyping:: DiaMed gelstation analyser: C,c BSU.SOP.017 BSU.SOP.007 E,e K Assessment Manager: EWS Page 6 of 13 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK St George’s University Hospitals NHS Foundation Trust 8961 Accredited to Issue No: 005 Issue date: 01 May 2021 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 Blood Transfusion Procedures documented in (cont’d) examinations to assist in manufacturer’s equipment manuals clinical investigations (cont’d) in conjunction with documented in- house procedures by the following methods: EDTA Whole Blood/plasma Antibody identification by Diamed Antibody panels and cards A, B detection of antibodies to: in conjunction with DiaMed incubator and centrifuge Rh which includes anti-C, BSU.SOP.024 D, C, E, c, e, f, Cw K, k, Kpa , Kpb , Xga Fya , Fyb , Jka, Jkb Lea, Leb S, s, M, N P1 Lua , Lub Diamed reagents and cards in conjunction with DiaMed incubator and centrifuge BSU.SOP.024 Red