Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address Claymon Laboratories trading as Biomnis Ireland 159MT Brid Muimneach Contact Phone No Website Three Rock Road, Sandyford Business Estate, Dublin 18, Dublin, Dublin Accreditation Standard ISO Date Initially Awarded 1/02/2005 Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Microbiology and virology Haematology Immunology Chemical pathology Genetics 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 Three Rock Road, Sandyford Business Estate, Dublin, D18 INAB Registration No. 159MT Page 1 of 15 Edition 1, 12/10/2017

2 Scope of Accreditation Head Office Chemical Pathology Category: A Medical pathology field - Test.01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Test/assay Specimen Type Technique Equipment Alanine Amino Transferase (ALT) **1, 2, Albumin **1, 2, Albumin / Globulin ratio **1, 2, Albumin/ Creatinine Ratio **1, 2, Alkaline Phosphatase (ALP) **1, 2, Alpha 1-AntiTrypsin Amylase **1, 2, Aspartate Aminotransferase (AST) **1, 2, Calcium **1, 2, Carbon Dioxide (Co₂ ) **1, 2, Ceruloplasmin Chloride (Cl) **1, 2, Cholesterol **1, 2, Corrected Calcium **1, 2, Creatinine **1, 2, Gamma Glutamyl Transferase (GGT) **1, 2, Heparin Serum, plasma (EDTA, Na-heparin, citrate) Serum,Heparin (Na or Li) Serum, plasma (EDTA, Li-heparin) Heparin, Urine TRIS buffer without PLP BCG Calculation Calculation AMP buffer not IFCC Immunoturbidimetry G3 Substrate TRIS buffer without PLP Arsenazo III PEP Carboxylase Immunoturbidimetry Ion-selective electrode diluted (Indirect) Cholesterol esterase/oxydase Calculation Kinetic Jaffe Urine Jaffe AU60 (Na or Li) L-Gamma-glutamyl- 3-carboxy-- nitroanilide Substrate INAB Registration No. 159MT Page 2 of 15 Edition 1, 12/10/2017

3 Globulins **1, 2, Calculated Glucose **1, 2, Sodium Fluoride Hexokinase + G6PD.02 Proteins, quantitative analysis.10 Drugs for therapeutic monitoring HDL **1, 2, High Sensitivity C Reactive protein (hscrp) **1, 2, Heparin (Na or Li) Homocysteine **1, 2, Li Hep, Heparin Accelerator Selective Detergent Immunoturbidimetric Enzyme Immunoassay Iron **1, 2, Serum Ferene Lactate DeHydrogenase (LDH) **1, 2, LDL **1, 2, (Na or Li) Heparin Lactate to Pyruvate (NADH) Measured, Liquid Selective Detergent Lipase **1, 2, Serum Quinone Dye Lipoprotein a (Lp(a)) **1, 2, Magnesium **1, 2, Heparin Immunoturbidimetric Arsenazo III Microalbumin **1, 2, Urine Immunoturbidimetric Phosphate **1, 2, Potassium (K) **1, 2, Sodium (Na) **1, 2, Phosphomolybdate UV Ion-selective electrode diluted (Indirect) Ion-selective electrode diluted (Indirect) Total Bile Acids **1, 2, Enzymatic / Colorimetric Total Bilirubin **1, 2, Total Protein **1, 2, Triglycerides **1, 2, Heparin (Na or Li) Diazo Biuret Glycerol Phosphate Oxidase Urea **1, 2, Kinetic Urease Uric Acid **1, 2, Endpoint Uricase Urinary Total Protein Urine Benzethonium Chloride Sex hormone Binding Globulin **1, 2, Amikacin **1, 2, Digoxin **1, 2, Gentamicin **1, 2, Serum,, Heparin (Li), EDTA Serum,, Heparin (Li), EDTA Chemilumininescent Particle-enhanced turbidimetric immunoassay (PETIA) Particle-enhanced turbidimetric immunoassay (PETIA) Particle-enhanced turbidimetric inhibition immunoassay INAB Registration No. 159MT Page 3 of 15 Edition 1, 12/10/2017

4 (PETINIA).1 Alcohol for non-legal purposes.15 Drugs for toxicological purposes.20 Hormones Tacrolimus **1, 2, Whole Blood Chemilumininescent (CLIA) Tobramycin **1, 2, Valproic Acid **1, 2, Vancomycin **1, 2,, EDTA Heparin Particle-enhanced turbidimetric inhibition immunoassay (PETINIA) Fluorescence Polarisation Immunoassay Fluorescence Polarisation Immunoassay Ethanol **1, 2, Urine DRI AU60 6-Acetyl Morphine **1, 2, DIA AU60 Amphetamine **1, 2, Oral Fluid DIA AU60 Amphetamine/Ecstasy **1, 2, Benzodiazepines **1, 2, Urine DIA AU60 Oral Fluid DIA AU60 Urine DIA AU60 Cannabis **1, 2, Oral Fluid DIA AU60 Cannabis Metabolites **1, 2, Urine DIA AU60 Cocaine **1, 2, Oral Fluid DIA AU60 Urine DIA AU60 EDDP **1, 2, DIA AU60 Methadone **1, 2, Oral Fluid DIA AU60 Opiates **1, 2, DIA AU60 Cortisol **1, 2, C-Peptide **1, 2, Dehydroepiandrosterone Sulphate (DHEAS) **1, 2, Follicle Stimulating Hormone (FSH) **1, 2, Free Thyroxin (FT) **1, 2, Urine DIA AU60 Heparin, EDTA, Citrate Heparin INAB Registration No. 159MT Page of 15 Edition 1, 12/10/2017

5 .0 Iron studies.5 Vitamin B12 and folate.7 Vitamin assays Free TrilodiThyronine (FT3) **1, 2, Insulin **1, 2, Luteinising Hormone (LH) **1, 2, Oestradiol **1, 2, Parathyroid Hormone (PTH) **1, 2, Progesterone **1, 2, Prolactin **1, 2, Testosterone **1, 2, Thyrotropine (Thyroid Stimulating Hormone, TSH) **1, 2, Serum, EDTA Heparin (Li) Heparin (Li, Na) Heparin Urinary Cortisol Urine microparticle immunoassay Coefficient of saturation **1, 2, Ferritin **1, 2, TIBC **1, 2, Transferrin **1, 2, Unsaturated Iron Binding Capacity (UIBC) **1, 2, Folate **1, 2, Vitamin B12 **1, 2, 250H Vitamin D **1, 2, Heparin (Li) Heparin (Li) Calculation Heparin (Li) Calculation Immunoturbidimetric Ferene Serum, EDTA, EDTA, Citrate INAB Registration No. 159MT Page 5 of 15 Edition 1, 12/10/2017

6 .50 Protein and peptide tumour markers.61 Hb A1c.65 Pregnancy tests qualitative.80 Quantitative investigation of immunoglobulins G, A, M and in body fluids.81 Qualitative investigation of immunoglobulins G, A, M and in body fluids.82 Total lge.83 Rheumatoid factor quantitative assays.8 Anti-thyroid microsomal antibodies.85 Anti-thyroglobulin antibodies AlphaFetoProtein (AFP) **1, 2, CarcinoEmbryonic Antigen (A) **1, 2, Carcinomic Antigen 125 (CA 125) **1, 2, Carcinomic Antigen 153 (CA 153) **1, 2, Carcinomic Antigen 199 (CA 199) **1, 2, Total prostate Specific Antigen (total PSA) **1, 2, Glycated Haemoglobin (HbA1c) **1, 2, Beta Human Chorionic Gonadotrophin (Beta HCG) **1, 2, ImmunoGlobulin A (IgA) **1, 2, ImmunoGlobulin G (IgG) **1, 2, ImmunoGlobulin M (IgM) **1, 2, Quantitative investigation of immunoglobulins G, A, M. in body fluids **1, 2, Qualitative investigation of immunoglobulins G, A, M in body fluids **1, 2, Immunoglobulin E (Total IgE) **1, 2, Rheumatoid Factor (RF) **1, 2, Anti-Thyroid Peroxidase (Anti-TPO) **1, 2, Anti-Thyroglobulin (Anti- Tg) **1, 2, Heparin (Li, Na) Serum Whole blood Enzymatic Heparin Serum Heparin Serum Heparin (li, Na) Heparin (Li) Immunoturbidimetric Immunoturbidimetric Immunoturbidimetric Capillary Electrophoresis Immunofixation Sebia Minicap Sebia Hydrasys Immunoturbidimetric Immunoturbidimetric INAB Registration No. 159MT Page 6 of 15 Edition 1, 12/10/2017

7 .86 C3 and C.88 b2-microglobulin.99 Miscellaneous tests C3 **1, 2, C **1, 2, B 2 Microglobulin **1, 2, Heparin Immunoturbidimetric Immunoturbidimetric Enzyme Immunoassay ph **1, 2, Urine DRI AU60 The laboratory has been awarded flexible scope in the P9 categories as noted in the scope document and in accordance with the laboratories approved and documented procedures. Note 1 - Range may be extended for the test Note 2 New parameters / tests may be added Note 3 New matrices may be added Note Changes to equipment / kits where the underlying methodology does not change For further details please refer to the laboratories Master list of Flexible scope changes, available directly from the laboratory. INAB Registration No. 159MT Page 7 of 15 Edition 1, 12/10/2017

8 Head Office Genetics Category: A Medical pathology field - Test 1076 Molecular pathology -.01 Assay for somatic variants in DNA sequence(s) Test/assay Specimen Type Technique Equipment Identification of the C282Y and H63D in the HFE human gene EDTA Whole blood Real time PCR Maxwell 16 / Applied Biosystem7500 INAB Registration No. 159MT Page 8 of 15 Edition 1, 12/10/2017

9 Head Office Haematology Category: A Medical pathology field - Test 1030 Haematology -.01 Blood counts Test/assay Specimen Type Technique Equipment Haematocrit **1, EDTA Whole Blood Calculated from the RBC & MCV Haemoglobin **1, MCH **1, MCHC **1, Mean Cell Volume **1, Red Cell Count **1, White Cell Count **1, 1030 Haematology -.02 Blood Film & White Visual examination of blood Cell Differential. films Includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils Leucocytes ** 1030 Haematology -.03 Erthrocyte sedimentation rate 1030 Haematology -.05 Automated differential leucocyte counts 1030 Haematology -.09 Examination of malarial Erythrocyte Sedimentation Rate (ESR) **1, Basophil Count **1, Eosinophil Count **1, Lymphocyte Count **1, Monocyte Count **1, Neutrophil Count **1, Platelet Count **1, Examination for Malarial parasites ** CyanmethHb colorimetric method Calculation derived from HGB, RBC & MCV FC laser optics. Utilizing RBC channel/mie group Indirect Measurement (mean of the RBC Vol) FC laser optics. Mie's theory Flow Cytometry (FC) Staining/ Microscopy Manual Photo-Metric Kinetic Technology Indirect Measurement of WBC by algorigrams/ cluster analysis Indirect Measurement of WBC by algorigrams/ cluster analysis Indirect Measurement of WBC by algorigrams/ cluster analysis Indirect Measurement of WBC by algorigrams/ cluster analysis Indirect Measurement of WBC by algorigrams/ cluster analysis FC laser optics. Utilizing RBC channel/mie map. Micro Test 1 Staining/ Microscopy Manual INAB Registration No. 159MT Page 9 of 15 Edition 1, 12/10/2017

10 parasites 1030 Haematology -.1 General haemostasis related tests Activated Partial Thromboplastin Time (APTT) **1, Fibrinogen **1, Prothrombin Time (PT) **1, Photo Optical Technology Photo Optical Technology Photo Optical Technology Sysmex CA50 Sysmex CA50 Sysmex CA50 The laboratory has been awarded flexible scope in the P9 categories as noted in the scope document and in accordance with the laboratories approved and documented procedures. Note 1 - Range may be extended for the test Note 2 New parameters / tests may be added Note 3 New matrices may be added Note Changes to equipment / kits where the underlying methodology does not change For further details please refer to the laboratories Master list of Flexible scope changes, available directly from the laboratory. INAB Registration No. 159MT Page 10 of 15 Edition 1, 12/10/2017

11 Head Office Immunology Category: A Medical pathology field - Test 100 Immunology -.0 Allergen - specific lge 100 Immunology -.12 Detection of autoantibodies in body fluids and biopsy material Test/assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard method) Specific IGE **1, 2, 3, Anti Cardiolipin IgG Antibodies Anti Cardiolipin IgM Antibodies Anti NP Antibodies Anti Cyclic Citrullinated Peptide (CCP) Antibodies **1, 2, 3, Anti Double Stranded DNA Antibodies **1, 2, 3, Anti Gliadin IgA Antibodies Anti Gliadin IgG Antibodies Anti Glomerular Basement Membrane (GBM) Antibodies Anti JO-1 Antibodies Anti LA Antibodies Anti Mitochondrial Antibodies Anti Myeloperoxidase (MPO) Antibodies Anti PR3 Antibodies Anti RO Antibodies Anti SCL-70 Antibodies, EDTA Serum,, EDTA, Citrate Serum, 250 / FluroEnzyme (FEIA) (ELIA) (ELIA) (ELIA) / Immunoassay (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) INAB Registration No. 159MT Page 11 of 15 Edition 1, 12/10/2017

12 Anti Sm Antibodies Anti Tissue Transglutaminase IgA Antibodies Anti U1RNP Antibodies Anti β2 - Glycoprotein I IgG Antibodies **1, 2, 3, Anti β2 - Glycoprotein I IgM Antibodies **1, 2, 3, Antinuclear Antibodies Calprotectin **1, 2, 3, Serum, EDTA, Citrate Serum, Faeces (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) (ELIA) The laboratory has been awarded flexible scope in the P9 categories as noted in the scope document and in accordance with the laboratories approved and documented procedures. Note 1 - Range may be extended for the test Note 2 New parameters / tests may be added Note 3 New matrices may be added Note Changes to equipment / kits where the underlying methodology does not change For further details please refer to the laboratories Master list of Flexible scope changes, available directly from the laboratory. INAB Registration No. 159MT Page 12 of 15 Edition 1, 12/10/2017

13 Head Office Microbiology and Virology Category: A Medical pathology field - Test 1012 Preparation of films 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) 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.02 Microscopic examination for parasites 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.03 Microscopic examination for fungi 101 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.0 Immunochromatographic methods, 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, marked commercial systems 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.05 Other categories of organism (as specified ) Test/assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard method) Gram Stain **2, 3, Swabs, CSF, tissue, fluid, pus, sputum, urine. Gram Stain; Light Microscope Microscopy **3, Urine Light/fluorescent microscope Parasitology **2, 3, Faeces, urine, sellotape tests Mycology **2, 3, Clostridium difficile toxin **2, 3, Hair, nail, skin scrapings Light Microscope Light/fluorescent microscope Faeces Kit GDH **2, 3, Kit Helicobacter pylori stool antigen **2, 3, Organism Identification **2, 3, Susceptibility Testing Swabs, CSF, tissue, fluid, pus, sputum, faeces, urine, tips, IUCD. Kit Vitek 2 Compact, ID Kits Vitek 2 Compact/ManualDisk diffusion/minimum Inhibitory Concentration INAB Registration No. 159MT Page 13 of 15 Edition 1, 12/10/2017

14 1018 Detection of antibody response to infection using appropriate marked commercial techniques -.02 Enzyme immunoassay, using marked commercial systems 1029 Miscellaneous -.99 Miscellaneous tests Anti-Human T- lymphocytes Virus I+II (HTLV I+II) **1, 2, 3, Serum,, Potassium EDTA / Anti-Streptolysin-O Serum Cytomegalovirus IgG Cytomegalovirus IgM Hepatitis B Core Antibody Hepatitis B Surface Antibody (Anti-Hbs) Hepatitis B Surface Antigen (Hbs Ag) **1, 2, 3, Hepatitis C Antibody Hepatitis C Antigen HIV Ab/Ag Combo Quantiferon TB Gold Rubella IgG **1, 2, 3, Rubella IgM **1, 2, 3, Syphilis (Treponema pallidum) Antibody Urine Dipstick **1, 2, 3, Heparin (Li) Heparin (Na) Heparin Li Hep, Heparin / / / / / / / / INAB Registration No. 159MT Page 1 of 15 Edition 1, 12/10/2017 Blood Dynex DS2 Heparin Heparin (li, Na) / / / Urine Colorimetric The laboratory has been awarded flexible scope in the P9 categories as noted in the scope document and in accordance with the laboratories approved and documented procedures. Note 1 - Range may be extended for the test Note 2 New parameters / tests may be added Note 3 New matrices may be added Note Changes to equipment / kits where the underlying methodology does not change

15 For further details please refer to the laboratories Master list of Flexible scope changes, available directly from the laboratory. INAB Registration No. 159MT Page 15 of 15 Edition 1, 12/10/2017