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 Schedule of Accreditation 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK BCUHB Contact: Dave Lamping Glan Clywd Hospital Tel: +44 (0) ext 2930 Sarn Lane david.lamping@wales.nhs.uk Bodelwyddan Website: LL18 5UJ Testing performed at the above address only Additional site activities performed at main location listed above: Location details Activity Address Glan Clywd Hospital Sarn Lane Bodelwyddan LL18 5UJ Local contact Dave Lamping ext 2930 David.lamping@wales.nhs.uk Nicola Polley (Transfusion Manager) ext 2959 Nicola.Polley@wales.nhs.uk Phlebotomy service Management of three blood fridges: Cancer Centre Enfys ward Top Floor corridor, between Delivery suite/cancer centre Theatres Additional site activities performed away from the main location listed above: Location details Activity Address Abergele Hospital Llanfair Road Abergele LL22 8DP Local contact Nicola Polley (Transfusion Manager) ext 2959 Nicola.Polley@wales.nhs.uk Management of Ward 6 blood fridge Denbigh Infirmary Ruthin Road Denbigh LL16 3ES Nicola Polley (Transfusion Manager) ext 2959 Nicola.Polley@wales.nhs.uk Management of ground floor treatment room blood fridge Assessment Manager: AB2 Page 1 of 12
2 DETAIL OF ACCREDITATION Whole blood EDTA Whole blood EDTA Whole blood EDTA Haematology examination activities Full Blood Counts: - Haemoglobin - White Blood Cell count - Red blood cell 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 Cell count Erythrocyte sedimentation rate (ESR) Detection of normal and abnormal morphologies Sysmex XE5000 using flow cytometry, impedance and spectrophotometry SOP PTH/HAE/005 Automated method using Sysmex Ves-Matic Cube 200 SOP PTH/HAEC/1 Sysmex SP1000 automated staining system using May Grunwald Giemsa method SOP PTH/HAE/006 Manual staining by Clin-tech Speedy Diff kit SOP PTH/HAE/757 Examination by light microscopy Assessment Manager: AB2 Page 2 of 12
3 Haematology examination activities Bone Marrow aspirates Bone Marrow aspirate and stained trephine slides Whole blood Whole blood Whole blood Detection of normal and abnormal morphologies Detection of normal and abnormal morphologies Screening for the detection of Plasmodium falciparum and Plasmodium spp (Including Plasmodium ovale Plasmodium falciparum, Plasmodium malariae Plasmodium vivax) Detection and Identification of Plasmodium species: P.falciparum P.vivax P.ovale P.malariae P knowlesi Detection of the presence of sickling haemoglobins Qualitative detection of infectious mononucleosis heterophile antibodies Sysmex SP1000 automated staining system using May Grunwald Giemsa SOP PTH/HAE/006 Manual staining by Clin-tech Speedy Diff kit SOP PTH/HAE/757 Examination by light microscopy SOP PTH/HAEC/7 Humasis rapid malaria test kit PTH/HAEC/28 Manual staining thin films with Giemsa and thick films with Field s stain. PTH/HAEC/28 SICKLEDEX solubility test kit SOP LP-HAE-HbS Accusay Mono kit rapid immunoassay SOP PTH/HAEC/27 Assessment Manager: AB2 Page 3 of 12
4 Plasma, citrated Plasma, citrated Plasma, citrated Haematology examination activities Coagulation studies: Prothrombin time APTT Fibrinogen INR D-Dimer Factor Assays: Factor II Factor VII Factor VIII Factor IX Factor X Factor XI Factor XII Thrombophilia screening Antithrombin III Protein C activity Free protein S Von willebrand Factor Assay Ristocetin cofactor activity Lupus Anticoagulant Screening Low molecular weight Heparin Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays LP-COAG-CS2100iRoutine Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays PTH/HAEC/5 Sysmex CS 2100 and CS5100 using clotting, chromogenic, immunoturbidimetric and agglutination assays SOP PTH/HAEC/29 SOP PTH/HAEC/5 SOP PTH/HAEC/30 SOP PTH/HAEC/31 Assessment Manager: AB2 Page 4 of 12
5 Blood Blood Blood Blood transfusion examination activities for the purpose of clinical diagnosis Blood Grouping by antigen detection A, B and O groups Rhesus C, c, D, E, e Kell antigen status Red cell antibody screens (detection and identification) of the following Rhesus Kell Duffy Kid Lewis P MNS Lutheran Antigen phenotyping: Rh and Kell Compatibility testing of patients plasma with donor cells Automated testing using Ortho innova, MicroColumns. SOP PTH/TR/809 Automated testing using Ortho innova, MicroColumns. SOP PTH/TR/809 Automated testing using Ortho innova, MicroColumns. SOP PTH/TR/809 Automated testing using Ortho innova SOP PTH/TR/810 Blood Direct antiglobulin test Automated testing using Ortho innova SOP PTH/TR/811 Blood Kleihauer for foetal/maternal bleed estimation Guest Medical, Fetal red cell detection kit PTH/TRC/020 Assessment Manager: AB2 Page 5 of 12
6 Blood Molecular examination activities for the purpose of clinical diagnosis Detection and identification of the following genetic mutations: Factor V Leiden Prothrombin gene P20210 HFE (Haemochromatosis) HLAB27 following: Fluorotype Assay using HAIN thermocycler. SOP PTH/HAEC/33 Cobas 8000 ISE-C702 PTH/BIOC/501 COBAS 8000 workflow PTH/BIOC/601 COBAS traceability PTH/BIOC/528 COBAS 8000 Principles and methods of operation Serum ACE Buhlmann ACE Kinetic enzymatic assay Serum Acetamenophine Cambridge Life Sciences enzymatic end point Serum, urine, plasma, CSF Albumin BCP colorimetric Serum Bile Acid Diazyme Enzymatic rate reaction Serum, urine, plasma, CSF Bilirubin total Gen.3 Diazo Serum, urine, plasma, CSF Calcium Gen.2 photometrical Serum, urine, plasma, CSF Cholesterol Enzymatic, colorimetric Serum, urine, plasma, CSF Bicarbonate absorbance Serum, urine, plasma, CSF Creatinine Photometrical Buffered kinetic Jaffé reaction without deproteinization Serum Direct Bilirubin Wako L type Vanadate oxidation method Assessment Manager: AB2 Page 6 of 12
7 following: Cobas 8000 ISE-C702 Serum, urine, plasma, CSF Glucose UV test Serum, urine, plasma, CSF HDL-Cholesterol Homogeneous enzymatic colorimetric Serum, urine, plasma, CSF Iron Colorimetric Serum, urine, plasma, CSF Lactate colorimetric Serum, urine, plasma, CSF LDL-Cholesterol Homogeneous enzymatic colorimetric Serum, urine, plasma, CSF Magnesium Gen.2 Colorimetric endpoint Serum, urine, plasma, CSF Ammonia enzymatic Serum, urine, plasma, CSF Phosphate Molybdate UV Serum, urine, plasma, CSF Total Protein Colorimetric Urine/CSF Total Protein Turbidimetric Serum, urine, plasma, CSF Triglycerides Enzymatic, colorimetric Serum, urine, plasma, CSF Uric Acid Enzymatic, colorimetric Serum, urine, plasma, CSF Blood Urea Nitrogen Kinetic test with urease and glutamate dehydrogenase Serum, urine, plasma, CSF Alkaline Phosphatase Colorimetric Serum, urine, plasma, CSF Alanine Aminotransferase UV absorbance Serum, urine, plasma, CSF α-amylase Enzymatic colorimetric Serum, urine, plasma, CSF Aspartate Aminotransferase UV absorbance Serum, urine, plasma, CSF Creatine Kinase UV-Test Serum, urine, plasma, CSF γ-glutamyltransferase Enzymatic colorimetric Assessment Manager: AB2 Page 7 of 12
8 following: Cobas 8000 ISE-C702 Serum, urine, plasma, CSF Lactate Dehydrogenase UV-Test Serum, urine, plasma, CSF a1-acid Glycoprotein Immunoturbidimetric Serum, urine, plasma, CSF a1-antitrypsin Immunoturbidimetric Serum, urine, plasma, CSF b2-microglobulin Immunoturbidimetric Serum, urine, plasma, CSF Complement Component C3/C3c Immunoturbidimetric Serum, urine, plasma, CSF Complement Component C4 Immunoturbidimetric Serum, urine, plasma, CSF Ceruloplasmin Immunoturbidimetric Serum, urine, plasma, CSF C-Reactive Protein Particle enhanced immunoturbidimetric assay Serum, urine, plasma, CSF Ferritin Particle enhanced immunoturbidimetric Serum, urine, plasma, CSF Immunoglobulin A Immunoturbidimetric Serum, urine, plasma, CSF Immunoglobulin G Immunoturbidimetric Serum, urine, plasma, CSF Immunoglobulin M Immunoturbidimetric Serum, urine, plasma, CSF Rheumatoid Factors Immunoturbidimetric Serum, urine, plasma, CSF Transferrin Immunoturbidimetric Serum, urine, plasma, CSF Chloride Ion-selective electrodes Serum, urine, plasma, CSF Potassium/Kalium Ion-selective electrodes Serum, urine, plasma, CSF Sodium/Natrium Ion-selective electrodes Serum, urine, plasma, CSF Ethanol Enzymatic method with alcohol dehydrogenase Serum, urine, plasma, CSF Carbamazepine KIMS Assessment Manager: AB2 Page 8 of 12
9 following: Cobas 8000 ISE-C702 Serum, urine, plasma, CSF Digoxin KIMS Serum, urine, plasma, CSF Lithium Colorimetric test Serum, urine, plasma, CSF Phenytoin KIMS Serum, urine, plasma, CSF Salicylate absorbance Serum, urine, plasma, CSF Theophylline KIMS Serum, urine, plasma, CSF Vancomycin absorbance Serum, urine, plasma, CSF b2-microglobulin Immunoturbidimetric Serum, urine, plasma, CSF Gentamicin Homogenous enzyme immunoassay Adjusted Calcium egfr Serum Index Transferrin Saturation Free androgen index following: Calculation Calculation Calculation Calculation Calculation Cobas 8000 ISE-E602 Key SOP: PTH/BIOC/501 COBAS 8000 workflow PTH/BIOC/601 COBAS traceability PTH/BIOC/528 COBAS 8000 Principles and methods of operation Serum, plasma Ferritin ECL / sandwich Serum, plasma Folate III ECL / competition Serum, plasma Vitamin B12 ECL / competition Assessment Manager: AB2 Page 9 of 12
10 following: Cobas 8000 ISE-E602 Serum, plasma Parathyroid hormone - PTH intact ECL / sandwich Serum, plasma Serum, plasma β-crosslaps/serum (β-ctx in serum) N-terminal pro B-type natriuretic peptide ECL / sandwich ECL / sandwich Serum, plasma Troponin T hs (high sensitive) ECL / sandwich Serum, plasma Adrenocorticotropic Hormone ECL / sandwich Serum, plasma Cortisol ECL / competition Serum, plasma Estradiol ECL / competition Serum, plasma Follicle-stimulating hormone ECL / sandwich Serum, plasma Intact human chorionic gonadotropin + β-subunit ECL / sandwich Serum, plasma Luteinizing hormone ECL / sandwich Serum, plasma Macroprolactin ECL / sandwich with PEG precipitation step Serum, plasma Progesterone ECL / competition Serum, plasma Prolactin ECL / sandwich Serum, plasma Human sex hormone-binding globulin ECL / sandwich Serum, plasma Testosterone ECL / competition Serum, plasma Digoxin ECL / competition Serum, plasma Antibodies to thyroid peroxidase ECL / competition Serum, plasma free triiodothyronine ECL / competition Assessment Manager: AB2 Page 10 of 12
11 following: Cobas 8000 ISE-E602 Serum, plasma free thyroxine ECL / competition Serum, plasma Thyrotropin ECL / sandwich Serum, plasma AFP α1-fetoprotein ECL / sandwich Serum, plasma Cancer Antigen 125 ECL / sandwich Serum, plasma Cancer Antigen 15-3 ECL / sandwich Serum, plasma Carbohydrate Antigen 19-9 ECL / sandwich Serum, plasma Carcinoembryonic Antigen ECL / sandwich Serum, plasma Urine Serum, Urine Serum, Urine total (free + complexed) - Prostatespecific antigen Urine Bence Jones confirmation and typing Paraprotein bands identification and clarification Protein abnormalities screening: Decrease/diffuse increase of gamma globulins Decrease in α1 fraction ECL / sandwich Sebia Hydrasys 2 electrophoresis platform and densitometry scanning PTH/BIOC/539 Serum and Urine electrophoresis PTH/BIOC/538 Serum and Urine Immunofixation PTH/BIOC/518 Electrophoresis reporting Assessment Manager: AB2 Page 11 of 12
12 Blood Glycated Haemoglobin (HbA1c) Tosoh G8 PTH/BIOC/514 Tosoh-G8 HbA1c analysis PTH/BIOC/602 traceability data TOSOH CSF Xanthochromia Shimadzu spectrophotometer PTH/BIOC/111-CSF Xanthochromia Faeces Faecal Occult Blood testing Hema screen immobilise guaic and peroxidase reaction PTH/BIOC/516-Faecal Occult Blood analysis Serum, urine Osmolality Advanced instruments 3320 Osmometer Freezing point depression osmometry PTH/BIOC/513-Advanced Instruments Osmometer 3320 operation END Assessment Manager: AB2 Page 12 of 12
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