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Belfast Health and Social Care Trust Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Belfast Health and Social Care Trust Issue No: 002 Issue date: 17 January 2020 Department of Haematology and Contact: Frances McCauley Transfusion Tel: +44 (0)289 5047 908 Belfast Health and Social Care Trust Fax: +44 (0)289 0745 435 Royal Group of Hospitals E-Mail: [email protected] 8703 Grosvenor Road Website: Kelvin Building www.belfasttrust.hscni.net/services/Laboratory- Accredited to MortuaryServices.htm ISO 15189:2012 Belfast BT12 6BA United Kingdom 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 Belfast City Hospital Haematology BCH Lisburn Road Coagulation Belfast Blood Transfusion BT9 7AB United Kingdom Belfast Royal Victoria Hospital Haematology RVH 7 Mulhouse Road Coagulation Belfast Blood Transfusion BT12 5DL United Kingdom Royal Belfast Hospital for Sick Children Haematology RBHSC 180-184 Falls Road Blood Transfusion Belfast BT12 6BE United Kingdom Mater Infirmorum Hospital Haematology MIH 45-51 Crumlin Road Blood Transfusion BT14 6AB United Kingdom Assessment Manager: GM4 Page 1 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Site activities performed away from the locations listed above: Location details Activity Theatre Reception Blood storage & issue only Belfast City Hospital Fridge monitored by Haematology Lisburn Road Belfast BT9 7AB United Kingdom Cardiac Theatre Reception Blood storage & issue only Belfast Royal Victoria Hospital Fridge monitored by Haematology 7 Mulhouse Road Belfast BT12 5DL Theatres Level 3 A Block Blood storage & issue only Belfast Royal Victoria Hospital Fridge monitored by Haematology 7 Mulhouse Road Belfast BT12 5DL 3B RICU Level 3 Blood storage & issue only Belfast Royal Victoria Hospital Fridge monitored by Haematology 7 Mulhouse Road Belfast BT12 5DL ICU Blood storage & issue only Royal Belfast Hospital for Sick Children Fridge monitored by Haematology 180-184 Falls Road Belfast BT12 6BE Theatres Blood storage & issue only Royal Belfast Hospital for Sick Children Fridge monitored by Haematology 180-184 Falls Road Belfast BT12 6BE Royal Jubilee Maternity Hospital (RMH) Blood storage & issue only Delivery Suite Fridge monitored by Haematology 274 Grosvenor Road Belfast BT12 6BA Assessment Manager: GM4 Page 2 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 Accredited to ISO 15189:2012 Testing performed by the Organisation at the locations specified Location details Activity Musgrave Park Hospital (MPH) Theatre Blood storage & issue only Reception Fridge monitored by Haematology Stockmans Lane Belfast BT9 7JB Ulster Independent Clinic (UIC) Theatre Blood storage & issue only Reception Level 1 Fridge monitored by Haematology 245 Stranmillis Road Belfast BT9 5JH Kingsbridge Private Hospital (KPH) Theatre Blood storage & issue only Reception Level 2 Fridge monitored by Haematology 815 Lisburn Road Belfast BT9 7GX Lagan Valley Hospital (LVH) Theatre Blood storage & issue only Hillsborough Road Fridge monitored by Haematology Lisburn BT28 1JP Downe Hospital (DH) Level 1 Ward 2 Blood storage & issue only 2 Struell Wells Road Fridge monitored by Haematology Downpatrick BT30 6RL MIH Resus (Casualty) Blood storage & issue only Mater Infirmorum Hospital Fridge monitored by Haematology 45-51 Crumlin Road BT14 6AB United Kingdom MIH Theatre Recovery Blood storage & issue only Mater Infirmorum Hospital Fridge monitored by Haematology 45-51 Crumlin Road BT14 6AB United Kingdom Assessment Manager: GM4 Page 3 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 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 Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Blood Transfusion Procedures documented in examinations to assist in manufacturer’s equipment manuals clinical investigations in conjunction with documented in- house procedures by the following methods: Whole Blood unless stated Blood Group /antigens: Ortho Clinical Diagnostics (OCD) BCH, ABO Forward/Reverse and Ortho Autovue - column MIH and RhD Group agglutination technology RVH Manual: SOP H-249 Automated: SOP H-296 Antibody screening/detection Ortho Autovue - column BCH, agglutination technology. MIH and Manual: SOP H-262 RVH Automated: SOP H-296 Antibody Identification Ortho Autovue - column BCH, Rh –C,D,E,c,e, Cw agglutination technology. MIH and Kell –K, Kpa Manual: SOP H-45 RVH Duffy –Fya, Fyb Automated: SOP H-44 MNSs- M, N, S, s Kidd –JKa, Jkb Rhesus/ K Phenotype Ortho Autovue column BCH, agglutination technology MIH and Manual Genotype SOP H-272 RVH Automated: Phenotype SOP H-242 Genotype SOP H-252 Assessment Manager: GM4 Page 4 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 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 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: Whole Blood unless stated Direct Coombs for detection of Ortho Autovue - column BCH, red cell sensitisation. agglutination technology MIH and Manual: SOP H-263 RVH Automated: SOP H-264 & H-265 Donor Red Cells Cross-match to determine Ortho Biovue column agglutination BCH, compatibility technology - IAT MIH and Automated H-293 RVH Manual H-261 Feto-Maternal Haemorrhage Kleihauer elution technique RVH only SOP H-295 RhD Negative screen for Ortho Autovue - column RVH only atypical antibodies in the agglutination technology presence of passively Manual: SOP H-312 acquired Anti-D Automated: SOP H-312 Newborn Test to determine Ortho Biovue column agglutination RVH the cell group of infants under technology 4 months old and IgG Automated: SOP H-265 sensitisation Cord Group to determine Ortho Biovue column agglutination RVH forward group of infants born technology to RhD neg. mothers Automated: SOP H-281 Assessment Manager: GM4 Page 5 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 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 Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematological examinations Procedures documented in (cont’d) for the purpose of clinical manufacturer’s equipment manuals diagnosis in conjunction with documented in- house procedures by the following methods: Whole Blood in EDTA unless Complete Blood Count (CBC) Sysmex XE-2100 BCH, stated for the following parameters: SOP H-595 MIH, RVH and Haemoglobin Estimation SLS Hb detection method (light RBHSC absorbance) Haematocrit RBC cumulative pulse height detection method White Cell Count (WCC) Flow cytometry method using semi- conductor laser Red cell Count (RCC) Hydrodynamic focusing Mean Cell Volume (MCV) Calculations using Sysmex analysers Mean Cell Haemoglobin Calculations using Sysmex Concentration (MCHC) analysers Mean Cell Haemoglobin Calculations using Sysmex (MCH) analysers Platelets Hydrodynamic focusing Neutrophil Count Flow cytometry method using semi- conductor laser Lymphocyte Count Flow cytometry method using semi- conductor laser Eosinophil Count Flow cytometry method using semi- conductor laser Basophil Count Flow cytometry method using semi- conductor laser Monocyte Count Flow cytometry method using semi- conductor laser Assessment Manager: GM4 Page 6 of 17 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Belfast Health and Social Care Trust 8703 Issue No: 002 Issue date: 17 January 2020 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 Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematological examinations Procedures documented in (cont’d) for the purpose of clinical manufacturer’s equipment manuals diagnosis (cont’d) in conjunction
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