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9059 Medical Multiple 005 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories Issue No: 008 Issue date: 17 September 2021 Shropshire House Contact: Dorothy Kasibante Shropshire Place/Queens Yard Tel: +44 (0)207 034 4616 9059 Capper Street Fax: +44 (0)207 487 2721 London E-Mail: [email protected] Accredited to WC1E 6JA Website: hcalaboratories.co.uk ISO 15189:2012 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 Shropshire House Local contact Microbiology A Shropshire Place/Queens Yard Dorothy Kasibante Serology Capper Street Risk & Compliance Clinical Immunology London Manager Biochemistry WC1E 6JA Haematology Mr Charles Percy - CEO Blood Transfusion Administration Tel: +44 (0)207 486 5091 Referrals Molecular Specimen Reception Cytopathology (inc. gynaecological & diagnostic) Histopathology (inc. routine & special staining, Decalcification & frozen sections) London Bridge Hospital Laboratory Local contact Sample Reception B London bridge Hospital As above Biochemistry Tooley Street Haematology London Blood Transfusion SE1 2PR EBUS and Slide production, staining & mounting of fine needle aspirates for diagnostic cytology LOC laboratory Local contact Biochemistry C 59/97 Harley Street As above Haematology London W1G 6AF Sydney Street Lab Local contact Biochemistry D 102 Sydney Street, As above Haematology Chelsea, SW3 6NJ Assessment Manager: HL Page 1 of 52 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories 9059 Issue No: 008 Issue date: 17 September 2021 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Site activities performed away from the main laboratory location listed above: Location details Local Contact Activity Outpatient Phlebotomy Rooms Dorothy Kasibante Venesection 111 Harley Street Risk & Compliance Manager London W1G 6AW Mr Charles Percy - CEO Tel: +44 (0)207 486 5091 The Harley Street Clinic As above EBUS Clinics 16 Devonshire Street London Portland Hospital As above Blood fridge storage only 205 - 209 Great Portland Street Fridge managed by Laboratory London W1W 5AH Princess Grace Hospital As above Blood fridge storage only 42-52 Nottingham Place Fridge managed by Laboratory London Slide production, staining & mounting of W1U 5NY fine needle aspirates for diagnostic cytology. Lister Hospital As above Blood fridge storage only Chelsea Bridge Road Fridge managed by Laboratory London Slide production, staining & mounting of SW1W 8RH fine needle aspirates for diagnostic cytology. Wellington Hospital North and South As above Blood fridge storage only Buildings Fridge managed by Laboratory Wellington Place EBUS and Slide production, staining & London mounting of fine needle aspirates for NW8 9LE diagnostic cytology. Harley Street Clinic As above Blood fridge storage only 35 Weymouth Street Fridge managed by Laboratory London W1G 8BJ 10th Floor (H0) Cancer Centre As Above Blood fridge storage only Fridge managed by Laboratory Guy’s Hospital Rapid Frozen Section Great Maze Pond London SE1 9RT The Shard Medical Centre As above Slide production, staining & mounting of The Shard fine needle aspirates for diagnostic 32 ST Thomas Street cytology. London, SE1 9BS Platinum Medical Centre: 5-17 Lodge As above Slide production, staining & mounting of Road, St John’s Wood, London NW8 7JA fine needle aspirates for diagnostic cytology. Assessment Manager: HL Page 2 of 52 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories 9059 Issue No: 008 Issue date: 17 September 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 measurement Equipment/Techniques used Code HUMAN BODY FLUIDS Haematology examinations for the Procedures documented in purpose of clinical diagnosis manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood Full Blood Count Sysmex XN20, XN10 A XN10, XN20 B, C XN20 D and SOP: Haem/050 Basophils Light scatter and Fluorescent Eosinophils Flow Cytometry Lymphocytes Monocytes Neutophils Immature Granulocytes (IG) Reticulocytes Fluorescent Flow Cytometry WBC Haematocrit Impedance, Calculations and histogram analysis. Calculated using the RBC pulse height detection method Haemoglobin RBC lysis by SLS, photometry at 55nm MCH Impedance, Calculations and histogram analysis. Calculated using patients’ HGB and RBC values MCHC Impedance, Calculations and histogram analysis. Calculated using patients’ HGB and HCT values MCV Impedance, Calculations and histogram analysis. Calculated using patients’ HCT and RBC values MPV Impedance, fluorescent flow cytometry and machine calculated Platelets Impedance and fluorescent flow cytometry Assessment Manager: HL Page 3 of 52 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories 9059 Issue No: 008 Issue date: 17 September 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 measurement Equipment/Techniques used Code HUMAN BODY FLUIDS Haematology examinations for the Procedures documented in cont’d purpose of clinical diagnosis manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood Sysmex XN10 XN20 and SOP: Haem/050 cont’d Platelets optical platelet count A,B,C,D PLT-F A RBC Impedance with Hydro- A,B,C,D dynamic focusing RDW Impedance, Calculations and histogram analysis Blood Morphology and identification Blood film stained by using A Sysmex SP-50 Slide Maker and Stainer (MGG stain) or backup Haematek staining machine (Mod Wrights stain) Read by Light microscopy SOP’s: HAEM/006, HAEM/IOP/004 Bone Marrow Morphology of Bone Marrow Bone Marrow films stained by A using Sysmex SP-50 Slide Maker and Stainer (MGG stain) or backup Haematek staining machine (Mod Wrights stain) and read by Light microscopy SOP’s: HAEM/015, HAEM/IOP/004 Blood ESR STARRSED RS ESR A, B ANALYSER Westergren Reference Method SOP’s: HAEM/IOP/017, LB/IOP/017 Assessment Manager: HL Page 4 of 52 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories 9059 Issue No: 008 Issue date: 17 September 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 measurement Equipment/Techniques used Code HUMAN BODY FLUIDS Haematological examinations for the Procedures documented in (cont’d) purpose of clinical diagnosis (cont’d) manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: Blood G6PD Screen Trinity BiotechG6PDH A Deficiency Kit Visual Fluorescence Screening of G6PD SOP: HAEM/009 Blood Glycated Hb (HbA1c) TOSOH G8 A HPLC SOP: HAEM/IOP/046, HAEM/IOP/020 Blood Glandular Fever Screen Unipath - Clear view IM Kit A Immunoassay SOP: HAEM/008 Blood Haemoglobinopathy Screen: TOSOH G-8 A measurement of HbA2, HbF, HbS Cation Exchange HPLC quantitation SOP: HAEM/IOP/046, HAEM/IOP/020 EDTA Whole Blood Kleihauer estimation of Kleihauer Stain and light Foetal/Maternal haemorrhage (FMH) microscopy following alkali A denaturation to detect foetal cells and calculation of bleed. SOP: HAEM/007 EDTA Whole Blood Detection & speciation (thin films) of Preparation of thick and thin A malaria parasites: films, manual May Grunwald- Giemsa staining and light Plasmodium falciparum Plasmodium microscopy malariae Plasmodium ovale SOP: HAEM/012 Plasmodium vivax Plasmodium Knowlesi Assessment Manager: HL Page 5 of 52 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK HCA International Limited, operating as HCA Laboratories 9059 Issue No: 008 Issue date: 17 September 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 measurement Equipment/Techniques used Code HUMAN BODY FLUIDS Haematological examinations for the Procedures documented in (cont’d) purpose of clinical diagnosis (cont’d) manufacturer’s equipment manuals in conjunction with documented in- house procedures by the following methods: EDTA Whole Blood Detection of HRP2 and pLDH CareStart Malaria A antigens for the identification of Malaria Antigen Test Malaria parasites Malaria HRP2/pLDH Combo Test SOP: HAEM/042 Citrate Plasma International Normalised Ratio STAGO STA-R MAX2 A, B Calculated using the Patients PT and Reagent ISI Technoclone Ak-Calibrant
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