9845 Medical Multiple
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Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board Issue No: 006 Issue date: 19 April 2021 Ysbyty Gwynedd Contact: Bernadette Astbury Penrhosgarnedd, Bangor Tel: +44 (0) 1978 291 100 9845 Gwynedd E-Mail: [email protected] LL57 2PW Website: http://www.bcu.wales.nhs.uk/ Accredited to 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 Address Local contact Haematology Wrexham Maelor Hospital Tony Coates Biochemistry WMH Croesnewydd Road 03000 858100 Blood Transfusion Wrexham Andrology LL13 7TD Management of five blood fridges: United Kingdom • Laboratory blood fridge • Theatre blood fridge • Haemosafe remote issue fridge in theatres • A & E blood fridge • Office blood fridge in Pathology laboratory Address Local contact Haematology YG Ysbyty Gwynedd Biochemistry Penrhosgarnedd Mr Trefor Roberts Toxicology Bangor 01248 384651 Immunology Gwynedd Blood Transfusion LL57 2PW Management of three lab-based blood fridges Local contact Haematology YGC Address Dave Lamping Biochemistry Glan Clywd Hospital 01745 448790 ext Blood Transfusion Sarn Lane 2930 Bodelwyddan Management of three blood fridges: LL18 5UJ Luke Hughes • Cancer Centre Enfys ward 01745 448790 ext • Top Floor corridor, between 2959 Delivery suite/Cancer centre • Theatres Assessment Manager: GM5 Page 1 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only Location details Activity Location code Renal and Diabetic Unit Tony Coates HbA1c analysis RDU Gladstone Centre 03000 858100 Maelor Hospital Croesnewydd Road Wrexham LL13 7TD United Kingdom Site activities performed away from the locations listed above: Location details Activity Llandudno General Hospital Local contact Management of blood fridge: Ground floor, Rear of Hospital Road Joe Leung Aberconwy Ward Llandudno Conwy LL30 1LB Abergele Hospital Local contact Management of Ward 6 blood fridge Llanfair Road Luke Hughes Abergele 01745 448790 ext 2959 LL22 8DP Denbigh Infirmary Local contact Management of ground floor treatment room blood fridge Ruthin Road Luke Hughes Denbigh 01745 448790 ext 2959 LL16 3ES Assessment Manager: GM5 Page 2 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only DETAIL OF ACCREDITATION Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematology examination In-house documented procedures activities for the purpose of based on equipment manuals as clinical diagnosis relevant Whole blood EDTA Plasma viscosity Benson viscometer WMH SOP PTH/HAEE/611 Whole blood EDTA Detection of normal and abnormal morphologies Manual staining by Clin-tech Speedy Diff kit SOP PTH/HAEE/56 SOP PTH/HAEW/96 SOP PTH/HAE/757 WMH YG YGC Examination by light microscopy SOP PTH/HAEE/53 SOP PTH/HAEW/105 SOP PTH/HAEC/57 WMH YG YGC Bone Marrow aspirates Detection of normal and abnormal morphologies Manual staining by Clin-tech Speedy Diff kit SOP PTH/HAEE/56 SOP PTH/HAEW/96 SOP PTH/HAE/757 WMH Manual Perls stain YG SOP PTH/HAE/102 YGC SOP PTH/HAEW/107 WMH YG Assessment Manager: GM5 Page 3 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematology examination In-house documented procedures (cont’d) activities for the purpose of based on equipment manuals as clinical diagnosis (cont’d) relevant Bone Marrow aspirate and Detection of normal and Examination by light microscopy stained trephine slides abnormal morphologies SOP PTH/HAEE/0110 WMH SOP PTH/HAEE/53 WMH SOP PTH/HAEW/105 YG SOP PTH/HAEC/57 YGC CSF Detection of spinal infiltration Using Cytopsin Shandon Cytospin YG (residual cells) 2 and Sysmex SP1000 automated staining system using May Grunwald – Giemsa SOP PTH/HAEW/98 SOP PTH/HAEW/102 Whole blood Screening for the detection of Humasis rapid malaria test kit Plasmodium spp (Including Plasmodium ovale SOP WMH Plasmodium falciparum, PTH/HAE/102 YG Plasmodium malariae YGC Plasmodium vivax) Preliminary screening for Manual thin film staining using WMH malaria parasites Giemsa with Sorensens Buffer – pH 7.2, SOP PTH/HAEE/602 SOP PTH/HAEE/53 Preparation of thick films to be stained and reported at other sites as below. Whole blood Detection and identification of Manual thin film staining using Plasmodium species: Giemsa with Sorensens Buffer – • P.falciparum pH 7.2, and thick films with Field’s • P.vivax Stain. • P.ovale Reporting of thick and thin films • P.malariae from across the network • P knowlesi SOP PTH/HAEW/95 YG SOP PTH/HAE/764 YGC Assessment Manager: GM5 Page 4 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematology examination In-house documented procedures (cont’d) activities for the purpose of based on equipment manuals as clinical diagnosis (cont’d) relevant Whole blood Detection of the presence of SICKLEDEX solubility test kit sickling haemoglobins SOP PTH/HAEE/10 SOP PTH/HAEW/117 WMH YG Whole blood Detection of infectious Accusay Mono kit rapid mononucleosis heterophile immunoassay antibodies SOP PTH/HAE/104 WMH YG YGC Whole blood G6PD screen G6PD Trinity Biotech using red cell enzyme rate reaction SOP PTH/HAEW/116 YG • • • Factor II SOP PTH/HAEW/63 YG • Factor V • Factor VII • Factor X • Factor XI • Factor XII Assessment Manager: GM5 Page 5 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Haematology examination In-house documented procedures (cont’d) activities for the purpose of based on equipment manuals as clinical diagnosis (cont’d) relevant Whole blood Haemoglobinopathy SEBIA Capillarys 2 using capillary WMH screening: electrophoresis Detection of Haemoglobin variants Hb A Hb A2 SOP PTH/HAEE/604 Hb F Hb S Hb C Hb D Punjab Hb E Whole blood EDTA Erythrocyte sedimentation rate Starrsed Auto-Compact analyser (ESR) (Westergren method) SOP PTH/HAEC/798 YG YGC Plasma, citrated Platelet Function Testing Platelet Aggregometry: Helena YG Biosciences AggRam using Turbidimetry SOP PTH/HAEW/59 Assessment Manager: GM5 Page 6 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed at main address only Materials/Products tested Type of test/Properties Standard specifications/ Location measured/Range of Equipment/Techniques used Code measurement HUMAN BODY FLUIDS Blood transfusion examination In-house documented procedures (cont’d) activities for the purpose of based on equipment manuals as clinical diagnosis relevant Blood Blood Grouping by antigen Automated testing using detection OrthoVision, MicroColumns. • A, B and O groups • Rhesus C, c, D, E,e SOP PTH/TRE/007 WMH • Kell antigen status YG YGC Red cell antibody screens Automated testing using (detection and identification) of OrthoVision, MicroColumns. the following • Rhesus Key SOPs • Kell PTH/TR/845 WMH • Duffy PTH/TR/846 YG • Kid YGC • Lewis • P • MNS • Lutheran Blood Antigen phenotyping: Automated testing using • Rhesus OrthoVision, MicroColumns. • Kell PTH/TR/848 YG YGC WMH Blood Compatibility testing of Automated testing using patient’s plasma with donor OrthoVision, MicroColumns. cells SOP PTH/TR/847 WMH YG YGC Blood Direct antiglobulin test Automated testing using OrthoVision, MicroColumns. SOP PTH/TR/849 WMH YG YGC Assessment Manager: GM5 Page 7 of 29 Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK Betsi Cadwaladr University Health Board 9845 Issue No: 006 Issue date: 19 April 2021 Accredited to ISO 15189:2012 Testing performed