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

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 with documented in- house procedures by the following methods:

Whole Blood in EDTA unless Complete Blood Count (CBC) Sysmex XE-2100 cont’d BCH, stated (cont’d) for the following parameters: MIH, (cont’d) RVH and RBHSC Nucleated Red Cell count Flow cytometry method using semi- conductor laser

Reticulocyte count Flow cytometry method using semi- conductor laser

Blood Film: Leucocyte differential count Manual microscopic analysis BCH, SOP H-631, H-628 MIH, RVH and RBHSC

HbA1c BioRad Variant II Turbo RVH and MIH

Adams A1c HA8180T Reverse BCH phase ion exchange chromatography H-1604, 2082

Malarial antigens of: Immunochromatographic Assay by RVH BinaxNow Kit. Plasmodium falciparum SOP H-603 and pan-detection for: Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale & Plasmodium vivax

Plasmodium falciparum Giemsa R66 formulation Stain by RVH Plasmodium malariae Gurr and Microscopic Examination Plasmodium ovale SOP H-603 Plasmodium vivax Plasmodium knowlesi

CSF Haematological cell type Manual cell count & Cytospin RBHSC Examination SOP H-637 and H-636

Assessment Manager: GM4 Page 7 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 Haemostasis and thrombosis Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis in conjunction with documented in- house procedures by the following methods:

Sysmex CS2100i Photo-optical clot detection

Citrated plasma unless stated Prothrombin Time / INR SOP H-556 BCH, MIH and RVH

Activated Partial SOP H-556 BCH, Thromboplastin Time (APTT) MIH and RVH

Fibrinogen SOP H-556 BCH, MIH and RVH

D-Dimer SOP H-540 RVH and MIH

APTT Mixing Studies SOP H-556 BCH and RVH

ADAMTS13 ELISA RVH SOP H-2216 Molecular haemostasis

Whole Blood unless stated Screening for the following Applied Biosystems 2700 Thermal mutations: Cycler / 3300 DNA Sequencer

F8 Gene: Coding Sequence SOP H-564 BCH

F8 Gene: Intron 1 Inversion SOP H-574 BCH

F8 Gene: Intron 22 Inversion SOP H-511 BCH

F9 Gene: Coding Sequence SOP H-561 BCH

VWF Gene: Screen for Type 2 SOP H-619 BCH VWD Mutations

Mutations Associated with SOP H-550 BCH VWD

Assessment Manager: GM4 Page 8 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 Molecular haemostasis Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis (cont’d) in conjunction with documented in- house procedures by the following methods:

Whole Blood unless Screening for the following Applied Biosystems 2700 Thermal stated (cont’d) mutations: (cont’d) Cycler / 3300 DNA Sequencer

F7 Gene: Coding Sequence SOP H-437 BCH

F11 Gene: Coding Sequence SOP H-620 BCH

F10 Gene: Coding Sequence SOP H-620 BCH

VWF Gene: Screen for Type SOP H-622 BCH 2N VWD Mutations

DNA from whole blood unless Molecular red cells stated examinations for the purpose of clinical diagnosis MagNapure Compact SOP H-625

Haemoglobin variants ABI2700 PCR instrument, ABI DNA BCH sequencer SOP H-539

Beta Thalassaemia gene ABI2700 PCR instrument, ABI DNA BCH mutations sequencer SOP H-544

Alpha Thalassaemia common ABI2700 PCR instrument BCH mutations 3.7,4.2 SOP H-555

Alpha Variants/Alpha ABI2700 PCR instrument, ABI DNA BCH Thalassaemia - point sequencer mutations SOP H-611

JAK2 exon 12 screen Roche Lightcycler 480 BCH PCR analysis SOP H-558

MPL exon 10 screen Roche Lightcycler BCH PCR analysis SOP H-572

Assessment Manager: GM4 Page 9 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 Molecular red cells Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis (cont’d) in conjunction with documented in- house procedures by the following methods:

DNA from whole blood JAK2 V617F screen ABI2700 PCR instrument, ABI DNA BCH sequencer SOP H-569

Whole Blood Haemachromatosis (HFE) MagNapure & LC480 LightCycler BCH gene mutations PCR analysis H63D, S65C, C282Y SOP H-625 & H-566

Haemato-oncology examinations for the purpose of clinical diagnosis

Bone Marrow Iron deposits/stores and Cytochemical stain Perls Prussian BCH presence of ringed Blue sideroblasts SOP H-2078

Peripheral Blood Paroximal nocturnal FACScanto II, Becton Dickinson BCH haemoglobinuria (PNH) clone Lyse Wash Assistant, Sysmex XE2100 Flow Cytometry and use of fluorescence labelled antibodies to identify target cells SOP H-893

CSF Malignant white cells FACScanto II BCH Manual microscopic analysis and flow cytometry SOP H-875 & SOP H-883

Peripheral Blood, Bone CD 34 Emumeration FACScanto II Flow Cytometry BCH Marrow, PBSC Harvests SOP H-881

Urine Haemosiderin Cytochemical stain - Perls Prussian BCH Blue Manual microscopic analysis

Assessment Manager: GM4 Page 10 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 Haemato-oncology Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis (cont’d) in conjunction with documented in- house procedures by the following methods:

Lymph Node, Spleen Malignant cells FACScanto II, Becton Dickinson BCH Lyse Wash Assistant, Sysmex XE2100 Immunophenotypic examinations Manual microscopic analysis and flow cytometry SOP H-874, H-882, H-883

Plural Fluid, Ascitic Fluid, Malignant cells FACScanto II, Becton Dickinson BCH Peritoneal Fluid Lyse Wash Assistant, Sysmex XE2100 Immunophenotypic examinations Manual microscopic analysis and flow cytometry SOP H-874 & H-883

Peripheral Blood, Bone Absolute Lymphocyte Counts FACScanto II BCH Marrow Measured by Flow Cytometry SOP H-2076

Cellular Fluid Malignant cells FACScanto II, Becton Dickinson BCH Lyse Wash Assistant, Sysmex XE2100

Immunophenotypic examinations Manual microscopic analysis and flow cytometry SOP H-882 & H-883

Peripheral Blood Hereditary spherocytosis EMA binding assay BCH FACScanto II Flow cytometry SOP H-2077

Peripheral Blood Platelet Glycoproteins FACScanto II BCH Measured by Flow Cytometry SOP H-895

Assessment Manager: GM4 Page 11 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 Special red cells 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:

Peripheral blood unless G6PD Unicam Spectrophotometer BCH Stated Spectrophotometer SOP H-525

Haemoglobin variants Iso-electric focussing Flat Bed BCH screen SOP H-519

Plasma Haemoglobin Unicam Spectrophotometer BCH SOP H-492

Erythropoietin Quantitative method by R&D BCH Systems EPO ELISA Kit SOP H-496

Sickle Cell Screen for HbS Qualitative test using Sickledex kit RVH SOP H-546 and BCH

HbF and HbA2 Adams A1c HA8180T BCH High Pressure Liquid Chromatography SOP H-2070

Pyruvate Kinase Assay Unicam Spectrophotometer BCH SOP H-529

Assessment Manager: GM4 Page 12 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

Citrated plasma unless stated Prothrombin Time Stago Compact Max Clotting method BCH SOP H-633

Prothrombin Time Correction Clotting method BCH time SOP H-621

APTT Clotting method BCH and SOP H-585 RVH

APTT correction time Clotting method BCH and RVH SOP H-623

Fibrinogen Clotting method BCH and RVH SOP H-614

D-dimer Immuno-turbidimetric assay BCH SOP H-671

INR Clotting method BCH and SOP H-633 RVH

Factor II Clotting method BCH SOP H-470

Factor V Clotting method BCH SOP H-473

Factor VII Clotting method BCH SOP H-462

Factor VIII clotting Clotting method BCH and SOP H-626 RVH

Chromogenic Factor VIII Chromogenic Assay BCH and SOP H-629 RVH

Factor IX Clotting method BCH SOP H-674

Assessment Manager: GM4 Page 13 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 Haemostasis and thrombosis Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis (cont’d) in conjunction with documented in- house procedures by the following methods:

Citrated plasma unless stated Factor X Stago Compact Max (cont’d) Clotting method BCH and SOP H-467 RVH

Factor XI Clotting method BCH SOP H-508

Factor XII Clotting method BCH SOP H-504

Factor XIII Spectrophotometer BCH Chromogenic Assay SOP H-689

Factor IX inhibitor status Stago Compact Max BCH Clotting method SOP H-445

Factor VIII inhibitor Clotting method BCH SOP H-445

Von Willebrand Factor Antigen Immuno-turbidimetric assay BCH SOP H-659

Von Willebrand Factor Activity Immuno-turbidimetric assay BCH Latex SOP H-667

Activated Protein C Stago Compact Max, IL APC BCH Resistance Resistance kit Clotting method SOP H-455

Antithrombin Antigen Immuno-turbidimetric assay BCH SOP H-2449

Immunologocal Fibrinogen Binda RID fib - Radial BCH Immunodiffusion SOP H-664

Assessment Manager: GM4 Page 14 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

Citrated plasma unless stated Fondaparinux Stago Compact Max (cont’d) Chromogenic Assay BCH SOP H-656

Protein S Activity Clotting method BCH SOP H-513

Serum Heparin associated antibody GTI-PF4 ELISA Kit BCH ELISA technique SOP H-575

Citrated plasma unless stated Incubated APTT Stago Compact Max BCH Clotting method SOP H-527

Unfractionated Heparin assay Chromogenic Assay BCH SOP H-656

Lupus Anticoagulant Screen Clotting method BCH SOP H-680

LA Sensitive APTT / Clotting method BCH Correction SOP H-685

Citrated plasma unless stated Plasminogen Stago Compact Max BCH Chromogenic Assay SOP H-451

Plasminogen Activator Inhibit Chromogenic Assay BCH SOP H-451

Protein C Antigen ELISA technique BCH SOP H-2372

Reptilase Time Stago Compact Max Clotting method SOP H-589

Assessment Manager: GM4 Page 15 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

Citrated plasma Thrombin Clotting Time Stago Compact Max Clotting method BCH SOP H-609 Molecular haemato-oncology examinations for the purpose of clinical diagnosis

Whole Blood FactorVLeiden & PT 20210 MagNapure & LC480 LightCycler BCH (FVL & PT20) PCR SOP H-625 & H-598

Bone Marrow, Peripheral DNA/RNA extraction Blood, Tissue, Body Fluids Qiagen DNeasy Tissue kit Qiagen RNeasy PlusMini Kit

Extracted RNA BCR-ABL High Capacity cDNA Reverse BCH transcription kit from Applied Biosystems SOP H-2149

Extracted DNA Immunoglobulin Gene AB Thermocycler GeneAmp2700 BCH Rearrangements PCR analysis SOP H-596 & H-618

Bone Marrow, Peripheral T-Cell Receptor Gene Horizon electrophoresis gel BCH Blood, Tissue, Body Fluids Rearrangements apparatus (Life technologies) SOP H-618, H-507, H-596 & H-582

Bone Marrow, Peripheral t(14;18) Translocation Horizon electrophoresis gel BCH Blood, Tissue, Body Fluids apparatus (Life technologies) Qiagen DNeasy Tissue Kit SOP H-618, H-507, H-596 & H- 591 AB Thermocycler GeneAmp2700

Assessment Manager: GM4 Page 16 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 Molecular haemato-oncology Procedures documented in (cont’d) examinations for the purpose manufacturer’s equipment manuals of clinical diagnosis (cont’d) in conjunction with documented in- house procedures by the following methods:

Bone Marrow, Peripheral t(11;14) Translocation Horizon electrophoresis gel BCH Blood, Tissue, Body Fluids apparatus (Life technologies) Qiagen DNeasy Tissue Kit, SOP H-618, H-507, H-596 & H- 506 AB Thermocycler GeneAmp2700

END

Assessment Manager: GM4 Page 17 of 17