Schedule of Accreditation
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1 Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address MedLab Pathology Ltd 296MT Elaine Donegan Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 06/12/2011 Unit 3 Sandyford Business Centre, Sandyford Business Park, Dublin Elaine.Donegan@medlabpathology.ie Scope Classification Scope Classification Scope Classification Scope Classification Services available to the public¹ Microbiology and virology Haematology Histopathology and cytopathology Chemical pathology Yes 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 Unit 3 Sandyford Business Centre, Sandyford Business Park, Dublin, D18 INAB Registration No. 296MT Page 1 of 12 Edition 1, 23/10/2018
2 Scope of Accreditation 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/ Specimen Type Technique Equipment/Range of Measurement Alanine Transferase Albumin Albumin/Globulin Ratio Alkaline Phosphatase Amylase Aspartate Transferase Bicarbonate Serum/Plasma L-lactate and NAD+/IFCC Bromcresol Green/Colourimetric Colourimetric/ p- nitrophenol Enzymatic colourimetric / IFCC NADH oxidation/ L-malate (IFCC) without pyridoxal phosphate Phosphoenolpyruvate (PEP) Bilirubin Total Azobilirubin/Colourmetric Calcium Schwarzenbach with o- cresolphthalein complexone Chloride ISE, Indirect Cholesterol Enzymatic/Colourimetric method INAB Registration No. 296MT Page 2 of 12 Edition 1, 23/10/2018 Method (CE/Non-CE/In house developed/based on standard method) Std. Ref & SOP L-lactate and NAD+/IFCC 14 Bromcresol Green/Colourimetric Colourimetric/ p- nitrophenol Enzymatic colourimetric / IFCC NADH oxidation/ L-malate (IFCC) without pyridoxal phosphate Phosphoenolpyruvate (PEP) Azobilirubin/Colourmetric Schwarzenbach with o- cresolphthalein complexone ISE, Indirect Enzymatic/Colourimetric method
3 Corrected Calcium C-Reactive Protein C-Reactive Protein - High Sensitivity Particle-enhanced immuno-turbidimetric Particle-enhanced immuno-turbidimetric Creatine Kinase D-6-phosphogluconate + NADPH + H +/UV Test Creatinine (Jaffe) Enzymatic Creatinine Estimated GDFR (MDRD) Free T3 Free T4 Gamma Glutamate Transferase Alkaline Picrate Enzymatic Enzymatic colourimetric 6000 Globulin Glucose HDL Cholesterol Serum/Plasma Lactate Dehydrogenase LDL Cholesterol Serum/Fluoride Oxalate Enzymatic reference method with hexokinase Homogeneous enzymatic colourimetric Pyruvate + NADH + H +/UV Homogeneous enzymatic colourimetric c311 (MLP110044) Lithium Serum Colometric Particle-enhanced immuno-turbidimetric Particle-enhanced immuno-turbidimetric D-6-phosphogluconate + NADPH + H +/UV Test Alkaline Picrate Enzymatic Enzymatic colourimetric Enzymatic reference method with hexokinase Homogeneous enzymatic colourimetric Pyruvate + NADH + H +/UV Homogeneous enzymatic colourimetric Colometric Magnesium Serum/Plasma Colourimetric method with Colourimetric method with CC17 7 1, INAB Registration No. 296MT Page 3 of 12 Edition 1, 23/10/2018
4 1061 Clinical Chemistry -.20 Hormones Chlorophosphonazo III Phosphate Molybdate UV Potassium ISE, Indirect Sodium ISE, Indirect Thyroid Stimulating Hormone Thyroxine (T4) Total Protein Colourimetric Triglyceride Enzymatic/Colourimetric test Troponin T hs Plasma Electrochemilumin escence Immuno (ECLIA) Urea Serum/Plasma Kinetic test with urease and glutamate dehydrogenase Uric Acid Anti-Mullerian Hormone (AMH) Serum/Plasma/Capillary Blood Enzymatic colourimetric test Beta-HCG Serum/Plasma Estradiol Follicular Stimulating Hormone Luteinizing Hormone Progesterone 6000 (MLP110144) Chlorophosphonazo III 20 Molybdate UV ISE, Indirect ISE, Indirect Colourimetric Enzymatic/Colourimetric test Electrochemilumin escence Immuno (ECLIA) Kinetic test with urease and glutamate dehydrogenase Enzymatic colourimetric test INAB Registration No. 296MT Page 4 of 12 Edition 1, 23/10/2018
5 Prolactin Testosterone 1061 Clinical Ferritin Chemistry -.40 Iron studies 1061 Clinical Chemistry -.45 Vitamin B12 and folate 1061 Clinical Chemistry -.47 Vitamin s 1061 Clinical Chemistry -.50 Protein and peptide tumour markers Iron Colourimetric Total Iron Binding Capacity Transferrin Transferrin Saturation Unsaturated Iron Binding Capacity Folate Vitamin B12 Vitamin D Total Prostate Specific Antigen 1061 Clinical Haemoglobin Chemistry -.60 A1C (IFCC) Glycohaemoglobins 1061 Clinical Chemistry -.71 Faecal Immunochemical test 1061 Clinical Chemistry -.83 Rheumatoid factor quantitative Faecal Immunochemical Testing (FIT) Rheumatoid Factor Whole Blood Immunoturbidimetric Direct determination with FerroZine Turbidimetric Inhibition Immuno (TINIA) c311 (MLP110044) Faeces Latex aggluination Diana QC Sensor (MLP110113) & (MLP110114) Serum/Plasma Immunoturbidimetric INAB Registration No. 296MT Page 5 of 12 Edition 1, 23/10/2018 Colourimetric Immunoturbidimetric Direct determination with FerroZine Turbidimetric Inhibition Immuno (TINIA) Latex aggluination Immunoturbidimetric ,
6 s INAB Registration No. 296MT Page 6 of 12 Edition 1, 23/10/2018
7 Head Office Haematology Category: A Medical pathology field - Test 1030 Haematology -.01 Blood counts 1030 Haematology -.02 Visual examination of blood films Test/Assay Full Blood Counts (Including Red Cell Count, Haemoglobin, Haematocrit, Mean Cell Volume, Mean Cell Haemoglobin, Mean Cell HB CONC, White Cell Count, Total, Neutrophils (Absolute), Neutrophils (%), Lymphocytes (Absolute), Lymphocytes (%), Monocytes (Absolute), Monocytes (%), Eosinophils (Absolute), Eosinophils (%), Basophils (Absolute), Basophils (%), Platelets Count, RDW, MPV Blood Film Morphology Specimen Type Technique Range of Method (CE/Non-CE/In Measurement/Equipment house developed/based on standard method) Whole Blood Fluorescent Flow Sysmex XE-2100 (Flow Cytometry/Hydrodynamic Cytometer) (MLP110020) Focusing, DC-Sheath & Sysmex XS-1000i Flow Cytometry, (MLP110143) Haemoglobin method, /Derived, Haemoglobin Method Fluorescent Flow Sysmex XE-2100 (Flow Cytometry/Hydrodynamic Cytometer) (MLP110020) Focusing, DC-Sheath & Sysmex XS-1000i Flow Cytometry, (MLP110143) Haemoglobin method, /Derived, Haemoglobin Method Fluorescent Flow Sysmex XE-2100 (Flow Cytometry/Hydrodynamic Cytometer) (MLP110020) Focusing, DC-Sheath & Sysmex XS-1000i Flow Cytometry, (MLP110143) Haemoglobin method, /Derived, Haemoglobin Method Romanowsky Romanowsky (Microscope) (MLP110056) (Microscope) (MLP110056) Std. Ref & SOP Fluorescent Flow HM-1, Cytometry/Hydrodynamic HM-2, Focusing, DC-Sheath HM-19 Flow Cytometry, Haemoglobin method, /Derived, Haemoglobin Method Fluorescent Flow HM-1, Cytometry/Hydrodynamic HM-2, Focusing, DC-Sheath HM-19 Flow Cytometry, Haemoglobin method, /Derived, Haemoglobin Method Fluorescent Flow HM-1, Cytometry/Hydrodynamic HM-2, Focusing, DC-Sheath HM-19 Flow Cytometry, Haemoglobin method, /Derived, Haemoglobin Method Romanowsky Romanowsky HM-1, HM-6 HM-1, HM-6 Romanowsky Romanowsky HM-1, INAB Registration No. 296MT Page 7 of 12 Edition 1, 23/10/2018
8 1030 Erythrocyte Haematology -.03 Sedimentation Rate Erthrocyte sedimentation rate 1030 Haematology -.09 Examination of malarial parasites 1030 Haematology -.41 General haemostasis related tests Examination for Malaria Parasites ACTIVATED CITRATE, PARTIAL PLASMA THROMBOPLASTIN TIME FIBRINOGEN (CLAUSS) Sedivette Sedivette Sedivette Procedures for the investigation of malaria parasites Procedures for the investigation of malaria parasites Procedures for the investigation of malaria parasites (Microscope) (MLP110056) Sarstedt Sedivette ESR Rack (MLP110042) Sarstedt Sedivette ESR Rack (MLP110042) Sarstedt Sedivette ESR Rack (MLP110042) (Microscope) (MLP110056) (Microscope) (MLP110056) (Microscope) (MLP110056) Sedivette Sedivette Sedivette Procedures for the investigation of malaria parasites Procedures for the investigation of malaria parasites Procedures for the investigation of malaria parasites HM-6 HM-1, HM-8 HM-1, HM-8 HM-1, HM-8 HM-18 HM-18 HM-18 CLOTTING METHOD SYSMEX CA660 CLOTTING METHOD HM-26 CLOTTING METHOD SYSMEX CA660 CLOTTING METHOD HM-27 INR CLOTTING METHOD SYSMEX CA660 CLOTTING METHOD HM-25 PROTHROMBIN TIME CLOTTING METHOD SYSMEX CA660 CLOTTING METHOD HM-25 INAB Registration No. 296MT Page 8 of 12 Edition 1, 23/10/2018
9 Head Office Histopathology and Cytopathology Category: A Medical pathology field - Test 1052 Cytopathology -.01 Gynaecological (cervical) Test/ Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Gynaecological Thin Prep Hologic Panther High Risk HPV using Hologic Panther; thin prep LBC sample mrna (messenger Ribonucleic Acid) * Not used for Primary Screening High Risk HPV Stained LBC Slide Unstained ThinPrep LBC for (PAP) Staining Thinprep LBC Range of measurement Std. ref & SOP MB-12, MB-13 Roche 4800 Analyser High Risk HPV MB-9, MB-10 Roche 4800 Analyser High Risk HPV MB-9, MB-10 Roche 4800 Analyser High Risk HPV MB-9, MB-10 Roche 4800 Analyser High Risk HPV MB-9, MB-10 Microscope Microscope Microscope Microscope Hologic T5000 Hologic T5000 Hologic T5000 Hologic T5000 Leica staining machine and coverslipper Leica staining machine and coverslipper Stained LBC Slide Stained LBC Slide Stained LBC Slide Stained LBC Slide Unstained for (PAP) Staining Unstained for (PAP) Staining CY-2, CY-3, CY-6, CY-11 CY-2, CY-3, CY-6, CY-11 CY-2, CY-3, CY-6, CY-11 CY-2, CY-3, CY-6, CY-11 CY-39 CY-39 CY-39 CY-39 CY-9 CY-9 INAB Registration No. 296MT Page 9 of 12 Edition 1, 23/10/2018
10 Leica staining machine and coverslipper Unstained for (PAP) Staining CY-9 Leica staining machine and coverslipper Unstained for (PAP) Staining CY-9 INAB Registration No. 296MT Page 10 of 12 Edition 1, 23/10/2018
11 Head Office Microbiology and Virology Category: A Medical pathology field - Test 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, CE marked commercial systems 1018 Detection of antibody response to infection using appropriate CE marked commercial techniques -.07 Chemiluminescent microparticle immuno, using CE marked commercial systems Test/ Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method) Chlamydia Trachomatis (CT) Neisseria Gonorrhoeae (NG) Anti-Hepatitis B Core (HBcAb) Anti-Hepatitis C Virus (HCVAb) Hepatitis B Surface Antibody (HBsAb) Hepatitis B Surface Antigen (HBsAg) HIV Combi (HIV) Rubella IgG (Rubella IgG) Syphilis Urine/Swab 4800 (MLP & MLP110097) Serum/Plasma/CAPILLARY BLOOD Serum/Plasma Serum/Plasma/CAPILLARY BLOOD Serum/Plasma Serum/Plasma/CAPILLARY BLOOD 4800 (MLP & MLP110097) e411 e411 e411 e411 e411 e411 e411 Real time PCR amplification Real time PCR amplification Range of Std. ref & measurement SOP LOD </= 0.8 U/ml MB-11 MB-11 2, SR COI 2, SR IU/L 2, SR COI 2, SR-1 LOD </= 2 IU/ml IU/ml 2, SR-5 2, SR-6 LOD <0.7 COI 2, SR-10 INAB Registration No. 296MT Page 11 of 12 Edition 1, 23/10/2018
12 INAB Registration No. 296MT Page 12 of 12 Edition 1, 23/10/2018
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