Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust
Issue No: 007 Issue date: 17 September 2021
Haematology and Blood Transfusion Contact: Rebecca Sedman Department Tel: +44 (0) 191 333 2628 University Hospital of North Durham E-Mail: [email protected] 8770 North Road Website: cddft.nhs.uk Accredited to Durham ISO 15189:2012 DH1 5TW 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 and Blood Transfusion UHND Haematology and Blood Joanne Lawson Transfusion Department, Pathology Tel: +44 (0)191 333 2628 University Hospital of North Durham Email: [email protected]
Address Local contact Haematology and Blood Transfusion DMH Haematology and Blood Nicola McKeagueTel: +44 Transfusion Department (0)1325 743686 Darlington Memorial Hospital Hollyhurst Road Email: Darlington [email protected] DH3 6HX
Site activities performed away from the locations listed above:
Location details Activity
Address Local Contact Shotley Bridge Hospital Joanne Lawson Management of Ward 4 blood fridge Shotley Bridge Tel: +44 (0)191 333 2628 Consett Email: [email protected] DH8 0NB
Address Local Contact Bishop Auckland Hospital Nicola McKeague Management of laboratory-based blood fridge Cockton Hill Road Tel: +44 (0)1325 743686 Specimen reception DL14 6AD Email [email protected]
Assessment Manager: GS2 Page 1 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Blood Transfusion Manufacturer’s instructions and examination activities for the documented In-house methods purpose of clinical diagnosis using:
Whole Blood: EDTA samples Blood Grouping Automated Bio-Rad IH1000 blood transfusion analysers
• A B O SOP: LP/PA/TR 9 • Rhesus D status Manual methods using DiaMed-ID Micro Typing system UHND, LP/PA/TR16 DMH
Whole Blood: EDTA samples Antibody Screening Automated Bio-Rad IH1000 blood transfusion analysers
Antibodies of the following SOP: LP/PA/TR 9 systems: • Rh- C,D,E,c,e, Manual methods using DiaMed-ID • Kell- K,k, Micro Typing system UHND, • Duffy- Fya, Fyb LP/PA/TR16 DMH • MNSs- M,N,S,s • Kidd- Jka, Jkb
Antibody Screening Automated Bio-Rad IH1000 blood transfusion analysers
Antibodies of the following SOP: LP/PA/TR 9 UHND, systems: DMH Manual methods using DiaMed-ID • Rh- Cw Micro Typing system • Kell- Kpa • Lutheran- Lua, LP/PA/TR16 • Lewis- Lea, Leb • P- P1
Whole Blood: EDTA samples Antigen phenotyping
C, c, E, e, K, Fya, Fyb, Jka, Manual methods using DiaMed-ID DMH Jkb, M, N, S, s Micro Typing system
LP/PA/TR57
Assessment Manager: GS2 Page 2 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Manufacturer’s instructions and examination activities for the documented In-house methods purpose of clinical diagnosis using:
Antigen phenotyping (cont’d) Whole Blood: EDTA samples C, c, E, e, K, Fya, Fyb, Jka, Manual methods using DiaMed-ID UHND Jkb, M, N, S, s, Lea, Leb, P1, Micro Typing system Kpa, Lua, Cw LP/PA/TR57
c, C, e ,E, and K Manual methods using DiaMed-ID UHND, Micro Typing system and DiaClon DMH Rh-subgroups + K cards
LP/PA/TR57
• Diaclon Anti-Jka/Jkb, Manual methods using DiaMed-ID UHND, • Diaclon Anti-M/N, Micro Typing system DMH • Diaclon Anti-Fya/Fyb & ID Anti-Fya/Fyb test serum LP/PA/TR57 for phenotyping Fya, Fyb antigens, • Diaclon Anti-S/s & ID Anti- S/s test serum, • Biorad Seraclone Anti-s (MNS4) antisera, • Biorad Seraclone Anti- Fya (FY1) antisera, • Biorad Seraclone Anti- Fyb (FY2) antisera
• Diaclon Anti-Lea/Leb, Manual methods using DiaMed-ID UHND • Biorad Seraclone Anti- Micro Typing system Kpa (KEL3) antisera, • Biorad Seraclone Anti- LP/PA/TR57 Lua (LU1) antisera, • Biorad Seraclone Anti-Cw (RH8) antisera
Whole Blood: EDTA samples Kleihauer test for estimation of Clin Tech Shepherds Stain kit and UHND, foeto-maternal haemorrhage Eosin stain DMH SOP: LPPATR3
Assessment Manager: GS2 Page 3 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Manufacturer’s instructions and examination activities for the documented In-house methods purpose of clinical diagnosis using:
Whole Blood: EDTA samples Direct anti-globulin test, SOP LPPATR 9 monospecific and polyspecific
Manual methods using DiaMed-ID Micro Typing system
SOP LPPATR51
Whole Blood: EDTA samples Crossmatch
SOP LPPATR58
Coagulation examination Manufacturer’s instructions and activities for the purpose of documented In-house methods clinical diagnosis using:
Plasma (sodium citrate) Blood Coagulation ACL TOP 550 CTS
• PT Optical clot detection UHND, • APTT DMH • Clauss-Fibrinogen Key SOPs LP/PA/HA/CO3 LP/PA/HA/CO2 Actin FS LP/PA/HA/CO3
Assessment Manager: GS2 Page 4 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Coagulation examination Manufacturer’s instructions and activities for the purpose of documented In-house methods clinical diagnosis using:
Plasma (sodium citrate) Blood Coagulation ACL TOP 550 CTS
• Activated Protein C Optical clot detection UHND Resistance • Antithrombin Key SOPs • Anti Xa Assay LP/PA/HA/CO3 • Free Protein S LP/PA/HA/CO2 • Heparin monitoring LP/PA/HA/CO7 • Lupus anticoagulant LP/PA/HA/CO6 • Protein C Chromogenic LP/PA/HA/CO9 LP/PA/HA/CO11 • Reptilase Clotting Time LP/PA/HA/CO8 • Thrombin Time Blood LP/PA/HA/CO5 • Thrombophilia Screen LP/PA/HA/CO22 Blood LP/PA/HA/CO10 • Factor VIIIc
INR Optical clot detection UHND, DMH SOP LP/PA/HA/CO26
D-Dimer Latex agglutination UHND, DMH SOP LP/PA/HA/CO32
Derived fibrinogen Algorithm on ACL TOP 550 CTS SOP LP/PA/HA/CO1
Assessment Manager: GS2 Page 5 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Haematology examination Manufacturer’s instructions and activities for the purpose of documented In-house methods clinical diagnosis using:
Whole Blood (EDTA) Screening test for Glucose 6 Trinity Biotech kit, visual qualitative UHND phosphate dehydrogenase fluorescence deficiency SOP LP/PA/HA37
Urine Identification of urinary Manual iron stain UHND haemosiderin SOP LP/PA/HA60
Bone marrow aspirate slides Reporting of normal and Manual MGG stain UHND, abnormal morphologies DMH
Automated stain using SP10
Manual iron stain UHND, DMH SOP LP/PA/HA60 LP/PA/HA/59 LP/PA/HA/63
Whole blood, Detection of infectious Clearview IM II test UHND, Plasma (citrate or EDTA), mononucleosis heterophile chromatographic immunoassay kit DMH Serum. antibodies SOP LP/P/HA/4
Whole blood (EDTA) Identification of normal and Sysmex SP10 UHND, abnormal morphologies DMH. including WBC differential Manual MGG UHND count
Manual microscopy UHND, DMH Key SOPs LP/PA/HA7 LP/PA/HA21 LP/PA/HA61
Assessment Manager: GS2 Page 6 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Haematology examination Manufacturer’s instructions and activities for the purpose of documented In-house methods clinical diagnosis using:
Whole Blood EDTA Malaria screening for: Thick and thin films UHND, P. falciparum DMH P. vivax Fields stain and manual P. ovale microscopy P. malariae Binax Now immunochromatographic test
Key SOPs LP/PA/HA/13 LP/PA/HA1
Whole blood EDTA ESR Vitech Interliner UHND, DMH Key SOPs LP/PA/HA17 LP/PA/HA22
ESR Manual method – Westergreen UHND tube method on half hour tikme with 1-hour conversion algorithm, on board
Measurement of Launch Diagnostics Dynex DS2 analyser (ELISA)
Serum Anticardiolipin IgG/IgM LP/PA/HA129 UHND antibodies
Intrinsic Factor Antibodies LP/PA/HA130 UHND
Assessment Manager: GS2 Page 7 of 8
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
County Durham and Darlington NHS Foundation Trust 8770 Accredited to Issue No: 007 Issue date: 17 September 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 Haematology examination Manufacturer’s instructions and activities for the purpose of documented In-house methods clinical diagnosis using:
Whole blood (EDTA) Full Blood count: Sysmex XN9000 UHND, • Haemoglobin DMH • Platelets Key SOPs • Red Blood Cells LP/PA/HA5 • Haematocrit LP/PA/HA14 • MCV • MCH • MCHC • Red cell distribution width • White Cell Differential • Neutrophils • Lymphocytes • Monocytes • Eosinophils • Basophils
Whole blood (EDTA) Reticulocytes Sysmex XN9000 UHND, DMH Key SOPs LP/PA/HA45 LP/PA/HA67
Documented -in-house methods to meet the requirements of the SCT screening programme as defined in the July 2018 NHS Sickle Cell and Thalassaemia Screening Programme: laboratory quality assurance evidence requirement
Whole blood Haemoglobinopathy screen to confirm or exclude presence of haemoglobin variant and / or thalassaemia with testing undertaken by UKAS laboratory 8543
Whole Blood (EDTA) Detection of haemoglobin S Clintech Solubility test kit UHND (Hb-S), SOP LP/PA/HA19
END
Assessment Manager: GS2 Page 8 of 8