Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
NHS Ayrshire and Arran
Issue No: 002 Issue date: 26 July 2019
Department of Haematology Contact: Mr David Drysdale Crosshouse University Hospital Tel: +44 (0) 1563 827413
8695 Kilmarnock E-Mail: [email protected] Accredited to KA2 0BE Website: www.nhsaaa.net 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 A Department of Haematology Mr David Drysdale Blood Transfusion Crosshouse University Hospital Blood and blood product issue Kilmarnock Immunology KA2 0BE
Address Local contact Haematology B Department of Haematology Mr David Drysdale Blood Transfusion University Hospital Blood and blood product issue Ayr KA6 6DX
Site activities performed away from the locations listed above:
Location details Activity Location code
Theatre Complex- Crosshouse As Above Blood Fridges A Issue fridge - Main Lab
Theatres- Ayr Hospital As above Blood Fridge B Issue fridge - Main Lab
Arran War Memorial Hospital – In patient As Above Blood fridge C ward Issue Fridge Lamlash Isle of Arran KA27 8LF
Girvan Community Hospital – In patient ward As above Blood fridge D Issue fridge Bridgemill Girvan KA26 9HQ
Assessment Manager: KS Page 1 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 Accredited to ISO 15189:2012
Testing performed by the Organisation at the locations specified
Location details Activity Location code
East Ayrshire Community Hospital- Corridor As above Blood fridges E next to dining room Ayr Road Cumnock KA18 1EF
Ayrshire Maternity Unit As above Blood Fridge F Crosshouse Hospital See above address
Assessment Manager: KS Page 2 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 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 Haematological examination Documented in house methods and activities for the purposes of manufacturer’s instructions for: clinical diagnosis:
Quantitative determination of: Sysmex XN 9100 A and XN3100 B:
Using Flow Cytometry Method: EDTA whole blood Hb LPH HAE001 A+B WBC Platelets RBC HCT MCV MCH MCHC Neutrophils Lymphocytes Monocytes Basophils Nucleated RBC
Pleural/ascitic fluids Cell count LPH HAE014 A EDTA Whole Blood Reticulocyte count LPH HAE010 A
Sysmex CS-2500 using Turbidimetric technology: EDTA whole blood APTT LPH COA018 A+B PT LPH COA018 A+B Fibrinogen LPH COA018 A+B D Dimer LPH COA022 A+B Factor VIII LPH COA019 A+B Factor IX LPH COA019 A+B INR LPH COA018/004 A+B Protamine Sulphate correction LPH COA023 A+B
Starstedt S2000 using Westergren and photometric technology: EDTA whole blood ESR LPH HAE009 A
Gel Plate using Radial immunodiffusion Method: EDTA whole blood Beta 2 Microglobulin LPI IMM022 A
Assessment Manager: KS Page 3 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 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 examination Documented in house methods and (cont’d) activities for the purposes of manufacturer’s instructions for: clinical diagnosis: (cont’d)
Quantitative determination of: Manual blood film reporting. Using microscopy: EDTA whole blood Blood cells LPH HAE008 A+B
Staining using May Grunwald and Giemsa stains and microscopy: Bone Marrow Bone Marrow cells LPH HAE022/023 A+B
Thermo cytospin 4 and microscopy: CSF CSF Cells LPH HAE034 A
Iron Stain and microscopy: Urine Urinary Iron LPH HAE016 A+B
Abnormal Haemoglobinopathy Helena Electrophoresis kit and tank Screen and further using Electrophoresis principles identification to include: and Menarini HA 8160 using HPLC: Blood HbS LPH SPH005 and LPH SPH022 A HbC HbD HbG HbE HbO
Siemens Centaur XP Using chemiluminescence: EDTA whole blood Ferritin LPH SPH001 A Vitamin B12 LPH SPH001 A Folate LPH SPH001 A
Qualitative determination of: Carestart rapid test immunochromatographic assay: EDTA whole blood Malaria parasites LPH HAE007 A+B • P.falciparum • P.vivax • P.ovale • P.malariae
Assessment Manager: KS Page 4 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 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 FLUID Haematological examination Documented in house methods: (cont’d) activities for the purposes of clinical diagnosis (cont’d): Sickledex kit (STRECK) using turbidometric technology: Blood Sickle cell screen- HbS LPH SPH004 A
Microgen IM kit using agglutination: A+B Blood Detection of infectious LPH SPH002 mononucleosis Heterophile antibody
Siemens Gel plate using radial immunodiffusion: Blood Haptoglobin LPH SPH011 A
Immunological examination Documented in house methods and activities for the purposes of manufacturer’s instructions for: clinical diagnosis
Qualitative determination of: Immunoconcepts kit using indirect fluorescence and microscopy: Blood Anti-nuclear Antibodies LPI IMM003 A Crithidia DS DNA LPI IMM004 A
NOVA LITE kit using indirect fluorescence and microscopy: Blood Liver autoantibodies LPI IMM008 A Smooth Muscle antibodies LPI IMM008
Microgen RA screening kit using Latex agglutination: Blood Rheumatoid factor LPI IMM011 A
Unicap using fluorescence/photometric technology Blood Specific IgE to the following: LPI IMM007 A Grass Cat Dog House dust mite Egg
Assessment Manager: KS Page 5 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 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 Immunological examination Documented in house methods and (cont’d) activities for the purposes of manufacturer’s instructions for: clinical diagnosis (cont’d):
Unicap using fluorescence/photometric technology Blood (cont’d) Specific IgE to the following: LPI IMM007 A (cont’d) Milk Aspergillus fumigatus Alternaria alternate Horse dander Cow dander Guinea pig epithelium Budgie droppings Budgie feathers Sheep epithelium Rabbit epithelium Hamster epithelium Fish (cod) Wheat Peanut Soya bean Tomato
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:
EDTA Packed red cells Blood Group by detection and Column Technology: Biorad Gel A+B identification of antigens: Station automation. Manual BioVue system Agglutination and A Rh (D) Positive photometric: AB Rh (D) Positive B Rh (D) Positive A Rh (D) Negative AB Rh (D) Negative B Rh (D) Negative O Rh (D) positive O Rh (D) negative
Assessment Manager: KS Page 6 of 7
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Ayrshire and Arran
8695 Issue No: 002 Issue date: 26 July 2019 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:
EDTA Whole Blood Antibody Screen by detection LPH BTD003 A+B of antibodies to: LPH BTD005
D, E, C, c, e, Cw K, k, Kpa , Kpb , Fya , Fyb , Jka, Jkb Lea, Leb S, s, M, N Lua , Lub
EDTA Plasma Antibody Titration LPH BTD006 A
EDTA Compatibility testing of LPH BTS063 A+B Plasma patient’s plasma with donor LPH BTS012 cells
EDTA packed red cell Direct Antiglobulin Test (DAT) LPH BTD004 A+B
EDTA Whole packed red cell Red cell phenotyping to Biorad Column Technology: A+B include:
D, E, C, c, e, Cw LPH BTD012 K Fya , Fyb , Jka, Jkb Lea, Leb S, s, M, N
END
Assessment Manager: KS Page 7 of 7