Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name Trading As INAB Reg No Contact Name Address Louth/Meath Hospital Group Our Lady's Hospital Navan 215MT Ray O'Hare Contact Phone No Website Pathology Laboratory, Our Ladys Hospital, Navan, Meath Accreditation Standard ISO Date Initially Awarded 17/02/2009 Scope Classification Scope Classification Scope Classification Scope Classification Microbiology and virology Blood Transfusion Science Haematology Chemical pathology 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 Blood Bank, Pathology Laboratory, Navan, Meath INAB Registration No. 215MT Page 1 of 11 Edition 2, 17/10/2018

2 Scope of Accreditation Head Office Blood Transfusion Science Category: A Medical pathology field - Test -.01 Blood grouping including ABO, Rh(D) and other antigens by manual methods -.03 Blood group antibody screen -.04 Identification of blood group antibodies -.05 Cross match compatible donor units -.06 Red cell phenotyping -.09 Direct antiglobulin test Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Blood Grouping (ABO & RhD Typing) Whole Blood Tube Technology Standard method - manual agglutination in tubes using CE marked Antibody Screening Plasma Gel Technology Standard method - manual Indirect Antiglobulin Test using CE marked Gel Cards Antibody Identification Cross-Match Testing Gel Technology Standard method - manual Indirect Antiglobulin Test using CE marked Gel Cards & Enzyme Gel Cards. Gel Technology Standard method - manual Indirect Antiglobulin Test using CE marked Gel Cards Antigen Typing Red Blood Cells Gel Technology Standard method - manual test using CE marked Gel Cards Direct Antiglobulin Test Gel Technology Standard method - manual Direct Antiglobulin Test using CE marked Gel Cards Range of measurement Not applicable Not applicable Not applicable Not aplicable Not applicable Not applicable Std. ref & SOP LM-BT-0002 ABO & RhD Typing using Tube Technology including Rack Set-up LM-BT-0004 Antibody Screening using Gel Technology LM-BT-0006 Identification of Red Cell Antibodies LM-BT-0015 Crossmatching using Gel Technology LM-BT-0013 Antigen Testing using Gel Cards LM-BT-0017 Direct Antiglobulin Test using Gel Technology INAB Registration No. 215MT Page 2 of 11 Edition 2, 17/10/2018

3 Head Office Chemical Pathology Category: A Medical pathology field - Test 1061 Clinical Chemistry -.01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Test/assay Specimen Type Technique Equipment/Range of Measurement Alanine Amino Transferase (ALT) Albumin Alkaline Phosphatase (ALP) Amylase Aspartate Aminotransferase (AST) Bilirubin - total Calcium Cholesterol - HDL Serum/Plasma Method (CE/Non-CE/In house developed/based on standard method) Quantitative determination by standard enzymatic method of Alanine Amino Transferase using NADH without P-5'-P (CE marked using Bromocresol Green (CE marked Para-nitrophenyl Phosphate (CE marked using CNPG3 substrate (CE marked NADH without P-5'-P (CE marked Quantitiation determination by a using Diazo dye (CE marked using Arsenzo III dye (CE marked Std. Ref & SOP INAB Registration No. 215MT Page 3 of 11 Edition 2, 17/10/2018

4 Cholesterol - LDL C-Reactive Protein (CRP) Creatine Kinase Creatinine Gamma Glutamyl Transferase Glucose Lactate Dehydrogenase (LDH) Magnesium Microalbumin Urine using accelerator selective detergent (CE marked using liquid selective detergent (CE marked standard immunoturbidometric method (CE marked Quantitative determination by N-acetyl-L-cysteine -NAC (CE marked standard Kinetic Alkaline Picrate method (CE marked L-Gamma-glutamyl-3-carboxy-4- nitroanilide substrate (CE marked Hexokinase/G-6-P-D (CE marked NADH (CE marked standard enzymatic method (CE marked standard turbidometric/immunoturbidometric method (CE marked INAB Registration No. 215MT Page 4 of 11 Edition 2, 17/10/2018

5 1061 Clinical Chemistry -.10 Drugs for therapeutic monitoring Phosphate Serum/Plasma Potassium (K) Sodium (Na) Total Protein Triglycerides Troponin-I (High sensitivity) Urea Uric Acid system with ISE allowing system with ISE allowing immunoassay Digoxin Serum standard photometic method using Phosphomolybdate (CE marked standard method using Ion Selective Electrode (ISE) utilizing potentiometry (CE marked reagent ) standard method using Ion Selective Electrode (ISE) utilizing potentiometry (CE marked reagent ) standard photometic method using Biuret (CE marked Glycerol Phosphate Oxidase (CE marked standard chemiluminescent microparticle immunoassay using CE marked Urease (CE marked Uricase (CE marked standard particle-enhanced turbidometric inhibition immunoassay using CE marked INAB Registration No. 215MT Page 5 of 11 Edition 2, 17/10/2018

6 Gentamicin Serum standard particle-enhanced turbidimetric inhibition immunoassay using CE marked Lithium Serum standard colorimetric method using CE marked 1061 Clinical Chemistry -.15 Drugs for toxicological purposes Vancomycin Paracetamol standard particle-enhanced turbidimetric inhibition immunoassay using CE marked standard enzymatic/colorimetric method using CE marked 1061 Clinical Chemistry -.20 Hormones Follicle Stimulating Hormone Free T4 Luteinising Hormone Oestradiol Progesterone INAB Registration No. 215MT Page 6 of 11 Edition 2, 17/10/2018

7 Prolactin Testosterone Thyroid Stimulating Hormone Total T3 β-hcg Qualitative and quantitative determination by a 1061 Clinical Chemistry -.40 Iron studies Ferritin Iron immunoassay standard spectrophotometric method using FERENE (CE marked Transferrin standard immunoturbidimetric method (CE marked 1061 Clinical Chemistry -.45 Vitamin B12 and folate Vitamin B12 immunoassay INAB Registration No. 215MT Page 7 of 11 Edition 2, 17/10/2018

8 Head Office Haematology Category: A Medical pathology field - Test Test/Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & SOP Measurement/Equipment CE/In house developed/based on standard method).01 Blood counts White Blood Cell Count, Red Blood Cell Count, Haemoglobin, Mean Cell Volume, Mean Cell Haemoglobin, Mean Cell Haemoglobin Concentration, Haematocrit, Platelets. Blood Flow Cytometry & Photometric Sysmex XN2000 CE Operation/ of the Sysmex XN2000 [LP-HAEM-0024]..02 Visual examination of blood films.03 Erthrocyte sedimentation rate.05 Automated differential leucocyte counts Red Blood Cell, White Blood Cell, Platelet. Erythrocyte Sedimentation Rate. Photometrical capillary stopped flow kinetic analysis. Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils. Staining/Microscopy. Microscope Based on standard method Photometrical capillary stopped flow kinetic analysis. Preparation, Staining and Examination of Blood Films [LP-HAEM-0008]. Alifax CE Operation and of the Alifax Test 1 ESR and Performance of ESR Testing [LP-HAEM- 0005]. Optical Flow Cytometry. Sysmex XN2000 CE Operation/ of the Sysmex XN2000 [LP-HAEM-0024]..06 Automated reticulocyte counts.09 Examination of malarial parasites Reticulocytes. malarial antigens and malarial parasitic morphology Optical Flow Cytometry, Fluorescence. Immunochromatographic test for the qualitative detection of malarial antigens and malarial parasitic morphology Sysmex XN2000 CE Reticulocyte Testing on the Sysmex XN2000 [LP-HAEM-0019]. NOW BINAX CE Serological Testing and Blood Film Staining for Malarial Parasites [LP-HAEM-0011]..30 Tests for haemoglobin HbS - Qualitative Solubility Test. Qualitative Solubility Test HbS Solubility Kit CE Haemoglobin S - Solubility Screen [LP-HAEM-0010]. INAB Registration No. 215MT Page 8 of 11 Edition 2, 17/10/2018

9 variants and thalassaemia.41 General haemostasis related tests.57 Screening test for infectious mononucleosis D-Dimer. Immunoturbidoimetric HaemosIL D-Dimer HS ACL TOP 300 Prothrombin Time, Activated Thromboplastin Time, Fibrinogen, Qualitative Detection of the Infectious Mononucleosis heterophile antibodies. Immunoassay Clotting Chromogenic and Immunoturbidoimetric CE of the ACL TOP 300 ETS [LP-HAEM-0023]. ACL Top 300 CE Operation and of the ACL TOP 300 ETS [LP-HAEM-0023]. Qualitative detection Clearview IM CE Infectious Mononucleosis Testing [LP-HAEM-0006]. INAB Registration No. 215MT Page 9 of 11 Edition 2, 17/10/2018

10 Head Office Microbiology and Virology Category: A Medical pathology field - Test 1012 Preparation of films 01 on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.01 Microscopic examination for general bacteriology purposes (including enumeration and description of human cells) 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Microscopic examination for general bacteriology purposes (including enumeration and description of human cells).01 Culture of general bacteria.02 Fungi VRE Swab, CRE Swab, MRSA Swab, Wound Swab, Ulcer Swab, Abscess Swab, Urine, VRE Swab, CRE Swab, MRSA Swab, Wound Swab, Ulcer Swab, Abscess Swab, Urine, Light Microscope Sedimax Automated Sediment Urinary Light Microscope Incubators Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells Visual monitoring for growth Range of measurement Std. ref & SOP LP-MIC-0003 LP-MIC-0007 LP-MIC-0009 LP-MIC LP-MIC-0038 LP-MIC-0050 LP-MIC-0054 LP-MIC-0055 LP-MIC-0003 LP-MIC-0007 LP-MIC-0009 LP-MIC-0017 LP-MIC-0020 LP-MIC LP-MIC LP-MIC Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.01 Slide agglutination,.02 Staphaurex Plus Kit.02 Streptococcal Grouping Latex Kit.04 PBP2 Kit Test Kit Particle Agglutination Immunochromatographic methods, LP-MIC Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, CE marked commercial systems.01 Biochemical methods, CE marked commercial systems VRE Swab, CRE Swab, MRSA Swab, Wound Swab, Ulcer Swab, Abscess Swab, Urine Phoenix API Biochemical Strips Light microscope Biochemical methods Microscopy LP-MIC-0003 LP-MIC-0007 LP-MIC-0009 LP-MIC-0018 LP-MIC-0020 LP-MIC LP-MIC-0036 LP-MIC-0045 LP-MIC-0047 LP-MIC Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes.01 Antimicrobial Susceptibility Testing Minimum Inhibitory Concentration Phoenix NA NA Broth MIC Disc Diffusion Gradient MICs LP-MIC-0003 LP-MIC-0007 LP-MIC-0009 LP-MIC-0018 LP-MIC-0020 LP-MIC LP-MIC-0036 LP-MIC-0042 LP-MIC-0044 LP-MIC-0045 LP-MIC-0047 LP-MIC-0050 INAB Registration No. 215MT Page 10 of 11 Edition 2, 17/10/2018

11 1024 Preservation of microbial cultures Microorganism Storage Isolates Internal Quality Control Organisms Freezer Isolates Internal Quality Control Organisms LP-BIO-0031 LP-MIC-0039 LP-MIC-0041 INAB Registration No. 215MT Page 11 of 11 Edition 2, 17/10/2018