Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address West North West Hospitals Group Galway University Hospital Dept Haematology 239MT Mary Kilcooley Contact Phone No 091 544419 Email Website Haematology Laboratory, Galway University Hospital,, Newcastle Road, Galway mary.kilcooley@hse.ie http://www.saolta.ie Accreditation Standard ISO 15189 Date Initially Awarded 15/09/2009 Scope Classification Haematology Services available to the public¹ ¹ Refer to document on interpreting INAB Scopes of Accreditation Sites from which accredited services are delivered (the detail of the accredited services delivered at each site are on the Scope of Accreditation) Name Address 1 Head Office Haematology Laboratory, Newcastle Road, Galway, H91 YR71 INAB Registration No. 239MT Page 1 of 7 Edition 1, 07/11/2017
Scope of Accreditation Head Office Haematology Category: A Medical pathology field - Test.01 Blood counts Test/Assay Specimen Type Technique Basophil Count Blood Eosinophil Count Haematocrit Haemoglobin Lymphocyte Count MCH Calculated from RBC and MCV CyanmethHB colorimetric method Calculation derived from HGB, RBC & MCV Range of Method (CE/Non- Std. Ref & SOP Measurement/Equipment CE/In house developed/based on standard method) MCHC FC laser optics. Utilizing INAB Registration No. 239MT Page 2 of 7 Edition 1, 07/11/2017
.02 Visual examination of blood films Mean Cell Volume Monocyte Count Neutrophil Count Platelet Count Red Cell Count Reticulocytes White Cell Count Includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils Red Cell Morphology RBC channel Indirect measurement (mean of RBC vol) FC laser optics. Utilizing RBC channel / Mie Map FC Laser Optic. Mie's theory Staining with Oxazine 750 and Optical FC Peroxidase/Basophil Flow Cytometry (FC) Staining / Microscopy Staining / Microscopy Haematek Slide Stainer Various microscopes Haematek Slide Stainer Various microscopes Based on FBC/SOP/017 Reading Blood Films and Performing Differentials FBC/SOP/017 Reading Blood Films and Performing Differentials INAB Registration No. 239MT Page 3 of 7 Edition 1, 07/11/2017
.03 Erthrocyte sedimentation rate.05 Automated differential leucocyte counts.06 Automated reticulocyte counts.08 Blood film examinations involving special staining procedures.09 Examination of malarial parasites.20 Bone marrow ESR Automated Basophil Count Eosinophil Count Lymphocyte Count Monocyte Count Neutrophil Count Reticulocyte Count Iron Stain (Marrow and Urinary Haem Leucocyte Acid Phosphatase Leucocyte Alkaline Phosphatase Mixed Esterase Stain Photo optical based on Westergren method Staning with Oxazine 750 and Optical FC FBC/SOP/016 Criteria for referring Blood Films to Clinical Haematologist for Morphology DIESSE Analyser ESR/SOP/001 Automated Erythrocyte Sedimentation Rate (ESR) DIESSE Analyser Advia 120/2120 FBC/SOP/012 Criteria Advia 120/2120 FBC/SOP/012 Criteria Advia 120/2120 FBC/SOP/012 Criteria Advia 120/2120 FBC/SOP/012 Criteria Advia 120/2120 FBC/SOP/012 Criteria Advia 120/2120 FBC/SOP/011 Advia 2120: Reticulocyte Counting Staining / Microscopy Manual SHaem/SOP/007 Iron Stain Staining / Microscopy Manual SHaem/SOP/010 TRAP Acid Phosphatase Stain Staining / Microscopy Manual SHaem/SOP/011 Alkaline Phosphatase Procedure Staining / Microscopy Manual SHaem/SOP/009 Mixed Esterase Stain Sudan Black B Staining / Microscopy Manual SHaem/SOP/008 Sudan Black B Staining Blood Film Examination Malaria Screening Test Bone Marrow Examination Staining / Microscopy Manual Based on Immunochromatographic Test SHaem/SOP/004 Malaria Screening Manual SHaem/SOP/004 Malaria Screening Bone Marrow Staining / Microscopy Manual Based on SHaem/SOP/005 Bone Marrow INAB Registration No. 239MT Page 4 of 7 Edition 1, 07/11/2017
examination.25 Progenitor cell transplantation procedures.30 Tests for haemoglobin variants and thalassaemia.31 Tests for foetal Hb (Kleihauer).36 Screening tests for G6Pd.40 Limited haemostasis related tests CD34 Quantitation Blood / Bone Marrow Sickle Screen (Sickledex) Kleihaur Test Glucose 6 Phosphate Dehydrogenase (G6PD) Screen Activated Protein C Resistance Anti Factor Xa level (LMWH) Antithrombin FII Coagulation FIX Coagulation Free Protein S FV Coagulation FVII Coagulation FVIII Coagulation FX Coagulation FXI Coagulation FXII Coagulation Blood Flow Cytometry Qualitative Solubility Test Semi-Quantitative Acid Elution/Microscopy Qualitative Visual Flourescence Ratio 1-5 0.14-1.3 IU/ml 0-130% 6-150% 2.5-132% 0-165% 6-136% 6-145% 2.5-123% 6-145% 5.5-133% 6-144% BD FACSCanto II Flow SHaem/SOP/040 Stem Cell SOP Manual SHaem/SOP/015 Sickledex Screen Manual SHaem/SOP/001 Kleihaur Betke Test Manual SHaem/SOP/002 G6PD Assay CS2100i SCoag/SOP/022 CS2100i SCoag/SOP/024 Anti- Xa Assay CS2100i SCoag/SOP/022 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/022 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 CS2100i SCoag/SOP/023 INAB Registration No. 239MT Page 5 of 7 Edition 1, 07/11/2017
.41 General haemostasis related tests.45 Tests of platelet function.55 Iron studies.58 Vitamin B12 and folate (serum and red cell).62 Plasma viscosity.70 Immunophenotyping Lupus Anticoagulant Protein C Von Willebrand Factor Antigen Von Willebrand Ristocetin Cofactor (RiCof) Assay Activated Partial Thromboplastin Time (APTT) Blood Interpretative Pos/Neg 0-150% 10-150% Coagulation technique D-Dimer Blood Derived Fibrinogen Fibrinogen (Clauss) International Normalised Ratio (INR) Prothrombin Time (PT) Derived Calculation from PT CS2100i SCoag/SOP/026 Lupus Anticoagulant Assay CS2100i SCoag/SOP/022 CS2100i SCoag/SOP/028 Von Willebrand Factor Antigen Assay 11 IU/ml - 150 IU/ml depending on Lot number of calibrator / CS2100i INAB Registration No. 239MT Page 6 of 7 Edition 1, 07/11/2017 SCoag/SOP/029 VW Ristocetin Cofactor (RiCof) Assay CS5100 RCoag/SOP/026 Activated Partial Thromboplastin Time (APTT) Assay CS5100 RCoag/SOP/027 D-Dimer CS5100 RCoag/SOP/025 Prothrombin Time/ Derived Fibrinogen Assay CS5100 RCoag/SOP/028 Clauss Fibrinogen Ratio Calculation CS5100 RCoag/SOP/025 Prothrombin Time/ Derived Fibrinogen Assay Thrombin Time Coagulation technique 15-27 seconds / CS2100i Platelet Aggregation Studies Blood Optical Impedance Platelet Aggregation Profiler Ferritin Blood Immunoassay Red Cell Folate Serum Folate Vitamin B12 Immunoassay Immunoassay Immunoassay CS5100 RCoag/SOP/025 Prothrombin Time/ Derived Fibrinogen Assay Based on Rcoag/SOP/031 Thrombin Time SCoag/SOP/002 Platelet Aggregation Abbot Architect i400sr Haematinics/SOP/005 Architect Ferritin Assay Abbot Architect i400sr Haematinics/SOP/003 Architect Red Cell Folate Abbot Architect i400sr Haematinics/SOP/002 Architect Serum Folate Abbot Architect i400sr Haematinics/SOP/004 Architect B12 Assay Plasma Viscosity Capillary Viscometer Capillary Viscometer Based on Acute Leukaemia Panel Blood / Bone Marrow Flow Cytometry BD FACSCanto II Flow SHaem/SOP/003 Plasma Viscosity SHaem/SOP/038 Flowcytometry Acute Chronic and Intracellular Panels CSF by Flow Cerebrospinal Immunophenotyping LOD = 20 events / SHaem/SOP/048
Cytometry Fluid BDFACSCanto Flow CSF Panel Lymphoproliferative Panel Blood / Bone Marrow Flow Cytometry BD FACSCanto II Flow SHaem/SOP/038 Flowcytometry Acute Chronic and Intracellular Panels MRD/CLL Panel Flow Cytometry BD FACSCanto II Flow SHaem/SOP/047 Detection of MRD in Chronic Lymphocytic Leukaemia PNH-Screen Blood Flow Cytometry BD FACSCanto II Flow SHaem/SOP/046 PNH Screen.99 Miscellaneous tests Meth-Haemoglobin Visible Absorption Spectroscopy Radiometer ABL90 series Blood Gas Analyser SHaem/SOP/017 Methhaemoglobin Procedure INAB Registration No. 239MT Page 7 of 7 Edition 1, 07/11/2017