8227 Medical Single

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust

Issue No: 008 Issue date: 30 June 2020

Haematology Department Contact: Mrs Elizabeth Worsam Bristol Royal Infirmary Tel: +44 (0) 117 3422575 8227 Marlborough Street E-Mail: [email protected]

Accredited to Bristol Website: www.uhbwnhs.uk ISO 15189:2012 BS2 8HW

Testing performed at the above address only

Site activities performed away from the locations listed above:

Location details Activity Location code

Blood issue fridge Storage of blood and blood products N/A Bristol Children’s Hospital Upper Maudlin Street Bristol BS2 8BJ

Blood issue fridge Storage of blood and blood products N/A St Michael’s Maternity Hospital Southwell Street Bristol BS2 8EG

Blood issue fridge Storage of blood and blood products N/A South Bristol Community Hospital Hengrove Promenade Bristol BS14 0DE

Blood issue fridge Storage of blood and blood products N/A Cardiac ICU Bristol Royal Infirmary Upper Maudlin Street Bristol BS2 8BJ

Blood issue fridge Storage of blood and blood products N/A Blood Transfusion Laboratory Bristol Royal Infirmary Upper Maudlin Street Bristol BS2 8BJ

Assessment Manager: SGB Page 1 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Sta ine s -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Location details Activity Location code

Blood issue fridge Storage of blood and blood products N/A Bristol Haematology and Oncology Centre Upper Maudlin Street Bristol BS2 8BJ

Blood issue fridge Storage of blood and blood products N/A Heygroves Theatre Bristol Royal Infirmary Upper Maudlin Street Bristol BS2 8BJ

Assessment Manager: SGB Page 2 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

DETAIL OF ACCREDITATION

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Haematology examinations for the In-house documented procedures based on purposes of clinical diagnosis equipment manuals as relevant

Blood Full Blood Count Using Sysmex XN-10 and Sysmex XN- • Haemoglobin 20 by impedance spectrophotometry • White Blood Cell Count fluorescent flow cytometry. • Red Blood Count LP-HAEM-XNDaily • Platelet Count LP-HAEM-XNWeekly • Haematocrit LP-HAEM-XNQC • Mean Cell Volume LP-HAEM-XNFBC • Mean Cell Haemoglobin LP-HAEM-XNReagent • Mean Cell Haemoglobin LP-HAEM-XNAlarm Concentration • Neutrophil count • Lymphocyte count • Monocyte count • Eosinophil count • Basophil count • Reticulocyte count • Nucleated Red Cells

Erythrocyte Sedimentation Rate 1) Manual technique using DispetteESR system, Westergren method LP-HAEM-ESR LI-HAEM-ESR

2) Diesse Vescube, Westergren method LP-HAEM-ESRVescube

Blood G6PDH quantitative assay Using the Trinity Biotech G6PD Assay kit and Cecil Spectrophotometer. LP-HAEM-G6PD, LI-HAEM-G6PDH

Blood Peripheral Blood Film Assessment Using Sysmex SP10 for automatic blood smear and stain Sysmex SP10 for staining (after manual smear) Examined by light microscopy LP-HAEM-ManualFilm LP-HAEM-SP-10

Assessment Manager: SGB Page 3 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Haematology examinations for the In-house documented procedures based on (cont’d) purposes of clinical diagnosis (cont’d) equipment manuals as relevant (cont’d)

Blood Malaria screen for Using Giemsa/Fields Staining for thick and P. falciparum thin smearsand manual microscope P. vivax LP-HAEM-MALFILMS, LP-HAEM- P. ovale MALFILMEX P. malariae P. knowlesi

Blood Rapid Screen Malaria pLDH and Malaria Antigen test using Care Start HRP2 antigens RapydTest LP-HAEM-CSMALRDT

Blood Haemoglobinopathy Using Biorad HPLC Variant 2 HbA2 LP-HAEM-HREPORTING HbF LP-HAEM-BIORADQC&SMPLS Abnormal Hb

Blood Sickle solubility test for presence of Streck Sickledex using SOP LP-HAEM- sickle haemoglobin (HbS) SICKLEDEX

Blood HbA1c quantification Menarini Hb9210 by HPLC using LP-HAEM-HBA Coagulation examinations for the purpose of clinical diagnosis

Blood Plasma APTT Using Sysmex CS2500 analyser, PT coagulation and chromogenic methods Fibrinogen using SOPs INR LP-COAG-Xa Low Molecular Weight Heparin LP-COAG-CS2500 Unfractionated Heparin Thrombin Clotting Time

D-Dimer LP-COAG-D-Dimer

Thrombophilia testing Using Sysmex CS2500 analyser, coagulation, chromogenic, immunoassay and aggregation assays. LP-COAG-CS2500

• Antithrombin • Protein C • Free protein S LP-COAG-Thrombo • Activated protein C resistance • Lupus Anticoagulant Assay LP-COAG-LUPUS

Assessment Manager: SGB Page 4 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Coagulation examinations for the In-house documented procedures based on AND TISSUES (cont’d) purpose of clinical diagnosis (cont’d) equipment manuals as relevant (cont’d)

Von Willebrand Factor Antigen LP-COAG-VWAG LP-COAG-RI

Ristocetin Factor and CoFactor LP-COAG-Factor Assays Assays: II; V; VII; VIII; IX; X; XI and XII LP-COAG-Factor XIII XIII

Specialist Integrated Haematological In-house documented procedures based on Malignancies Diagnostics Services equipment manuals as relevant (SIHMDS) investigations for the purposes of clinical diagnosis

Bone Marrow aspirate Immunophenotyping of the following Becton Dickinson FACS Canto 10 and LSR Peripheral Blood markers/antigens to diagnose and Fortessa laser flow cytometry and: Cerebrospinal fluids monitor the following disorders: SOP LP-FLOW-CANTO and Effusions/other fluids LP-FLOW-FORTESSA. Tissues and fine needle Acute Leukaemia LP-FLOW-Acquisition aspirates Mastocytosis LP-FLOW-IS Myelodysplastic/myeloproliferative LP-FLOW-ACUTE neoplasms LP-FLOW-MDS Mature Lymphoid Disorders LP-FLOW-BLPD B cell and T cell Lymphoproliferative LP-FLOW-TLPD Disorders LP-FLOW-Plasma Cell Lymphoma LP-FLOW-CSF Myeloma/Plasma cell neoplasms LP-FLOW-Non-Haem LP-Flow-Nuclear

CD1a CD2 CD3 CD4 CD5 CD7 CD8 CD9 CD10 CD11b CD11c CD13 CD14

Assessment Manager: SGB Page 5 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Specialist Integrated Haematological In-house documented procedures based on AND TISSUES (cont’d) Malignancies Diagnostics Services equipment manuals as relevant (SIHMDS) investigations for the purposes of clinical diagnosis

Assessment Manager: SGB Page 6 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

Assessment Manager: SGB Page 7 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

Peripheral Blood Immunophenotyping of the following BD FACS Canto 10 Flow Cytometer markers/antigens to diagnose and BD LSR Fortessa Flow Cytometer and monitor the following disorders LP-FLOW-CANTO Paroxysmal Nocturnal LP-FLOW-Fortessa Haemoglobinuria LP-FLOW-Acquisition LP-FLOW-PNH FLAER GPA CD59 CD24 CD14 CD16 CD45 CD64

Blood CD34+ stem cell absolute count BD FACS Canto Flow Cytometer Using the following antisera: BD LSR Fortessa Flow Cytometer and CD34 CD45 LP-FLOW-CANTO LP-FLOW-Fortessa LP-FLOW-Acquisition LP-FLOW-CD34

Becton Dickinson FACS Canto 10 and LSR Fortessa laser flow cytometry and: SOP LP-FLOW-CANTO and LP-FLOW-FORTESSA. LP-FLOW-Acquisition Blood Measurement of Platelet glycoprotein LP-FLOW-PLATELET GP CD41 CD42a CD61 CD36 CD45

Assessment Manager: SGB Page 8 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Blood Transfusion investigations for In-house documented procedures based on AND TISSUES (cont’d) the purposes of clinical diagnosis equipment manuals as relevant

Blood Cross match Manual column agglutination in Bio RadID cards LP-BTR-COMPATIBILITY LP-BTR-GROUPCONF LP-BTR-MANGROUP LP-BTR-RBCISSUE LP-BTR-EISSUE

Blood Blood Groups

Antibody panels Bio Rad IH1000 column agglutination Antigens of the following systems: LP-BTR-IH1000 Rh – C,D,E,c,e, Cw LP-BTR-ABP Kell – K, K, Kpa LP-BTR-GELSTATION Duffy –Fya, Fyb LP-BTR-ANTENATAL MNSs M, N, S, s LP-BTR-MANGROUP Kidd – JKa, Jkb Lutheran – Lua Lewis – Lea, Leb P – P1

Blood Measurement of foetal Hb in maternal SOP LP-BTR-KLE using the Kleihauer blood for FMH determination technique with acid elution and the Clin- Tech Shepard’s stain kit.

Blood Phenotyping Manual technique Using Bio Rad Cards Rhesus and K phenotyping LP-BTR-RhKPHENO Rh – C, D, E, c, e Kell - K

Blood Direct antiglobulin test for detection of Using the Tube Technique and Cell Washer antibody bound red cells LP-BTR-DCT

Assessment Manager: SGB Page 9 of 10

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK

University Hospitals Bristol and Weston NHS Foundation Trust 8227 Issue No: 008 Issue date: 30 June 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN BODY FLUIDS Immunology examinations for the In-house documented procedures based on AND TISSUES (cont’d) purpose of clinical diagnosis equipment manuals as relevant Serum In-house documented procedures based on equipment manuals as relevant

Using DS2 automated ELISA processor and reader with the following kits Detection of: • Anti-PR3 autoantibodies Quanta Lite by Inova Diagnostics using SOP • Anti-MPO autoantibodies LP-IMM-PR3, SOP LP-IMM-MPO and LP- • Intrinsic Factor antibodies IMM-Intrinsic Factor

Detection of Cardiolipin antibody Organtec kit using SOP LP-IMM-ACA

Detection of DNA antibody Diastat kit using SOP LP-IMM-DNA

Detection of Anti CCP antibody Inova kit using SOP LP-IMM-CCP

Extractable Nuclear Antigen (ENA) Ogantec kit using SOPs LP-IMM-ENA and screening test and ENA antibody LP-IMM-ENT confirmation

Detection of heterophile antibodies to Monogen kit using SOP LP-IMM-SHA Infectious mononucleosis (Glandular fever) (Paul Burnell)

Detection of Rheumatoid factor - Manual assay using Biokit kit and screening test SOP LP-IMM-RAL

Autoimmune testing Automated film preparation using an ASP processor (SOP LP-IMM-ASP-1200) followed by staining with FITC reagent and fluorescent microscopy using the following SOPs

ANCA LP-IMM-ANCA Anti-nuclear Ab (ANA) LP-IMM-HP2 Anti smooth muscle Ab LP-IMM-AIP Anti gastric parietal cell Ab LP-IMM-AIP Anti mitochondrial Ab LP-IMM-AIP Anti liver/kidney microsomal Ab LP-IMM-AIP

END

Assessment Manager: SGB Page 10 of 10