Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
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1 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Haematology Department Royal Infirmary Marlborough Street BS2 8HW Contact: Mrs Elizabeth Worsam Tel: +44 (0) Website: Testing performed at the above address only Site activities performed away from the locations listed above: Location details Activity Location code issue fridge Children s Hospital issue fridge St Michael s Maternity Hospital Southwell Street BS2 8EG issue fridge South Community Hospital Hengrove Promenade BS14 0DE issue fridge Cardiac ICU Royal Infirmary issue fridge Transfusion Laboratory Royal Infirmary Assessment Manager: MH1 Page 1 of 9
2 Location details Activity Location code issue fridge Haematology and Oncology Centre, issue fridge Heygroves Theatre Royal Infirmary Assessment Manager: MH1 Page 2 of 9
3 DETAIL OF ACCREDITATION purposes of clinical diagnosis Full Count Haemoglobin White Cell Count Red Count Platelet Count Haematocrit Mean Cell Volume Mean Cell Haemoglobin Mean Cell Haemoglobin Concentration Neutrophil count Lymphocyte count Monocyte count Eosinophil count Basophil count Reticulocyte count Nucleated Red Cells Erythrocyte Sedimentation Rate equipment manuals as relevant Using Sysmex XE-2100 by flow cytometry and impedance. 1) Manual technique using DispetteESR system, Westergren method LP-HAEM-ESR LI-HAEM-ESR 2) Diesse Vescube, Westergren method LP-HAEM-ESRVescube plasma Plasma viscosity Benson Viscometer, capillary method. LP-HAEM-PV Detection of abnormal Haemoglobin C, D, E Using Helena Biosciences iso-electric focussing Gels for Hb. LP-HAEM-IEF G6PDH quantitative assay Using the Trinity Biotech G6PD Assay kit and Cecil Spectrophotometer. LP-HAEM-G6PD, LI-HAEM-G6PDH Assessment Manager: MH1 Page 3 of 9
4 (cont d) purposes of clinical diagnosis (cont d) film assessment (peripheral) Using Sysmex SP1000i blood film maker and May Grunwald-Giemsa staining. Examined by light microscopy SOP LP-HAEM-SP1000i, LP-HAEM- ManualFilm Malaria screen for P. falciparum P. vivax P. ovale P. malariae P. knowlesi Rapid Screen Malaria pldh and HRP2 antigens Haemoglobinopathy HbA2 HbF Abnormal Hb Sickle solubility test for presence of sickle haemoglobin (HbS) Using Giemsa/Fields Staining for thick and thin smearsand manual microscope LP-HAEM-MALFILMS, LP-HAEM- MALFILMEX Malaria Antigen test using Care Start RapydTest LP-HAEM-CSMALRDT Using Biorad HPLC Variant 2 LP-HAEM-HREPORTING LP-HAEM-BIORADQC&SMPLS Streck Sickledex using SOP LP-HAEM- SICKLEDEX HbA1c quantification Menarini Hb9210 by HPLC using LP-HAEM-HBA Coagulation examinations for the purpose of clinical diagnosis Plasma APTT PT Fibrinogen INR Low Molecular Weight Heparin Unfractionated Heparin Thrombin Clotting Time Using Sysmex CS2100i, coagulation and chromogenic methods using SOPs LP-COAG-Xa Assessment Manager: MH1 Page 4 of 9
5 (cont d) Coagulation examinations for the purposes of clinical diagnosis (cont d) D-Dimer Thrombophilia testing LP-COAG-D-Dimer Using Sysmex CS2100i, coagulation, chromogenic, immunoassay and aggregation assays. Antithrombin Protein C Free protein S Activated protein C resistance Lupus Anticoagulant Assay LP-COAG-Thrombo LP-COAG-LUPUS Platelet rich plasma AND TISSUES Bone Marrow aspirate Peripheral Cerebrospinal fluids Effusions/other fluids Tissues and fine needle aspirates as defined below Von Willebrand Factor Antigen Ristocetin Factor and CoFactor Assays: II; V; VII; VIII; IX; X; XI and XII XIII Platelet aggregation studies detecting platelet aggregation reported as percentage aggregation purposes of clinical diagnosis Immunophenotyping LP-COAG-VWAG LP-COAG-RICOF LP-COAG-Factor Assays LP-COAG-Factor XIII Using PAP-8E aggregometer and light transmission aggregometry LP-COAG-Platelet Aggregation Becton Dickinson FACS Canto II flow cytometer and Becton Dickinson LSR Fortessa flow cytometer using SOP LP- FLOW-CANTO and LP-FLOW-FORTESSA. Measurements using monoclonal antibodies and other fluorescent labels and Laser flow cytometry CD34 enumeration LP-FLOW-CD34 Measurement of Platelet glycoprotein LP-FLOW-PLATELET GP Measurement of foetal Hb in maternal blood for FMH determination- Kleihauer LP-FLOW-FMH Assessment Manager: MH1 Page 5 of 9
6 AND TISSUES and bone marrow Bone marrow and blood Formalin fixed paraffin embedded tissues (FFPE) purposes of clinical diagnosis (cont d) Haematology Molecular examinations Genetic studies for detection of gene mutation JAK2 V617F Factor 5 Leiden Prothrombin gene mutation FLT3, NPM1 IgV H mutation status KIT and PDGFR mutations Polymerase chain reactions, and where applicable, sequencing of RNA and DNA products. Extraction by Promega Maxwell followed by real-time PCR and melting curve analysis using a LightCycler 1.5 Thermocycler using SOPs: LP-MOL-Maxbld and LP-MOL- LJAK2, LP-MOL-LFVL or LP-MOL-LPT. Extraction by Promega Maxwell followed by PCR using a Biometra, Peqlab or BIOER Thermocycler and gel electrophoresis using the Agilent Tapestation using SOPs:LP- MOL-Maxbld and LP-MOL-FLT3, LP-MOL- NPM1, LP-MOL-IGV or LP-MOL-gist followed by LP-MOL-Tapestation and LP- MOL-seq if applicable Bone marrow or blood Quantitative BCRABL Manual RNA extraction using the 5Prime RNA extraction kit followed by cdna generation using the Biometra Thermocycler followed by Real-time quantitative PCR using a LightCycler 1.5 using SOP LP-MOL- BCQ, bone marrow or FFPE Haematology Molecular examinations for the purposes of clinical diagnosis TCR and IgH Clonality Extraction by Promega Maxwell followed by PCR using a Biometra, Peqlab or BIOER Thermocycler and gel electrophoresis using the Agilent Tapestation, using SOPs LP- MOL-IGH or LP-MOL TCRgclonality Assessment Manager: MH1 Page 6 of 9
7 AND TISSUES purposes of clinical diagnosis Detection of (8;21), t(15;17), Inv (16) Manual RNA extraction using the 5Prime RNA extraction kit followed by cdna generation using the Biometra Thermocycler followed by nested PCR using a Biometra, Peqlab or BIOER Thermocycler and gel electrophoresis using the Agilent Tapestation, using SOPs: LP-MOL-RNA extract, LP-MOL-RTPCRmann and LP- MOL-NESTEDAML Tissue biopsy K-RAS Extraction by Promega Maxwell followed by DNA quantification using a Nanodrop Lite spectrophotometer followed by Real-time PCR and High Resolution Melting curve analysis using a LightCycler 480 followed by PCR using Biometra, Peqlab or BIOER Thermocycler and pyrosequencing on a Qiagen Q24 pyrosequencer if necessary using SOPs LP-MOL-KRAS-HRM followed by LP-MOL-K-RAS if necessary Transfusion Cross match Manual column agglutination in Diamed ID cards LP-BTR-COMPATIBILITY LP-BTR-GROUPCONF LP-BTR-MANGROUP LP-BTR-RBCISSUE LP-BTR-EISSUE Groups Antibody panels Antigens of the following systems: Rh C,D,E,c,e, Cw Kell K, K, Kpa Duffy Fya, Fyb MNSs M, N, S, s Kidd JKa, Jkb Lutheran Lua Lewis Lea, Leb P P1 Using Diamed H100 and Gel-station, column agglutination LP-BTR-IH1000 LP-BTR-ABP LP-BTR-GELSTATION LP-BTR-ANTENATAL LP-BTR-MANGROUP Assessment Manager: MH1 Page 7 of 9
8 Transfusion (cont d) Documented in-house procedures based on equipment manuals as relevant Serum Measurement of foetal Hb in maternal blood for FMH determination Phenotyping Rhesus and K phenotyping Rh C, D, E, c, e Kell - K Direct antiglobulin test for detection of antibody bound red cells Immunology examinations for the purpose of clinical diagnosis Detection of: Anti-PR3 autoantibodies Anti-MPO autoantibodies Intrinsic Factor antibodies Detection of Cardiolipin antibody Detection of DNA antibody SOP LP-BTR-KLE using the Kleihauer technique with acid elution and the Clin- Tech Shepard s stain kit. Manual technique Using Diamed Cards LP-BTR-RhKPHENO Using the Tube Technique and Cell Washer LP-BTR-DCT equipment manuals as relevant Using DS2 automated ELISA processor and reader with the following kits Quanta Lite by Inova Diagnostics using SOP LP-IMM-PR3, SOP LP-IMM-MPO and LP- IMM-Intrinsic Factor Organtec kit using SOP LP-IMM-ACA Diastat kit using SOP LP-IMM-DNA Assessment Manager: MH1 Page 8 of 9
9 (cont d) Immunology examinations for the purpose of clinical diagnosis (cont d) equipment manuals as relevant Serum (cont d) Detection of Anti CCP antibody Inova kit using SOP LP-IMM-CCP Extractable Nuclear Antigen (ENA) screening test and ENA antibody confirmation Detection of heterophile antibodies to Infectious mononucleosis (Glandular fever) (Paul Burnell) Detection of Rheumatoid factor - screening test Detection of Rheumatoid particle Autoimmune testing ANCA Anti-nuclear Ab (ANA) Anti smooth muscle Ab Anti gastric parietal cell Ab Anti mitochondrial Ab Anti liver/kidney microsomal Ab Ogantec kit using SOPs LP-IMM-ENA and LP-IMM-ENT Monogen kit using SOP LP-IMM-SHA Biokit kit using SOP LP-IMM-RAL Fujirebio kit using SOP LP-IMM-RAPA agglutination test 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 LP-IMM-ANCA LP-IMM-HP2 LP-IMM-AIP LP-IMM-AIP LP-IMM-AIP LP-IMM-AIP END Assessment Manager: MH1 Page 9 of 9
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
ccredited to Laboratory locations: Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK University Hospital NHS Foundation Trust General
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