Schedule of Accreditation

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1 Schedule of Accreditation Organisation Name St. Luke's Hospital INAB Reg No 205MT Contact Name Alice Melvin Address Highfield Road,, Dublin Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 10/06/2008 Services available to the public¹ Microbiology and virology Blood Transfusion Science Haematology 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 1 Pathology Laboratory, St. Luke's Hospital, Address Highfield Road, Dublin, D6 INAB Registration No. 205MT Page 1 of 7 Edition 1, 08/07/2018

2 Scope of Accreditation Pathology Laboratory, St. Luke's Hospital, Blood Transfusion Science Medical pathology field - Test -.01 Blood grouping including ABO, Rh(D) and other antigens by manual s -.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 ) Antigens by manual s Blood grouping including ABO, Rh(D) Blood group antibody screen Identification of blood group antibodies Cross match compatible donor units Red cell phenotyping (Rhesus) Direct antiglobulin test EDTA EDTA Manual tube Manual tube CE marked antisera CE marked antisera Range of measurement Std. ref & SOP LM-BBT-010 LM-BBT-001 LM-BBT-002 LM-BBT-005 LM-BBT- LM-BBT-003 LM-BBT-009 LM-BBT-008 INAB Registration No. 205MT Page 2 of 7 Edition 1, 08/07/2018

3 Pathology Laboratory, St. Luke's Hospital, Chemical Pathology 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 aminotransferase (ALT) Alkaline Phosphatase Amylase Aspartate amino Transferase (AST) Serum/Plasma Pyruvate to lactate in presence of NADH Para-nitrophenol phosphate CNPG3 substrate to 2 chloro-4 nitrophenol NADH (without P-5'- P) Bilirubin Total Diazo Calcium Arsenazo III Method (CE/Non- Std. Ref & CE/In house SOP ) Calcium (Adjusted) Calculation Calculation Standard Chloride Serum/Plasma ISE (diluted) indirect Creatinine Glucose Hs Troponin I Lactate Dehydrogenase (LDH) Magnesium Phosphate Plasma - Sodium Fluoride Plasma - Lithium Heparin Serum/Plasma Kinetic Alkaline Picrate Hexokinase Chemiluminescent microparticle immunoassay (CMIA) Lactate-pyruvate (NADH) Enzymatic NADP- NADPH Potassium Serum/Plasma ISE (diluted) indirect Sodium Phosphomolybdate ISE (diluted) indirect Urate (Uric Acid) Serum/Plasma Uricase Urea Nitrogen Urease Standard LP-BIO-005 & LP-BIO- INAB Registration No. 205MT Page 3 of 7 Edition 1, 08/07/2018

4 Pathology Laboratory, St. Luke's Hospital, Haematology Medical pathology field - Test.01 Blood counts.02 Visual examination of blood films.03 Erthrocyte sedimentation rate.05 Automated differential leucocyte counts.41 General haemostasis related tests Test/Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & Measurement/Equipment CE/In house SOP ) Full Blood Count EDTA Whole Blood Blood Film Flow cytometry, Cell Dyn 3200 standard LP-HAEMcolorimetry, 005 derivations/calculations Flow cytometry, Cell Dyn Ruby standard LP-HAEMcolorimetry, 019 derivations/calculations Manual light microscopy ESR Sodium Citrate S-Sediplus Enclosed ESR system Full Blood Count EDTA Whole Blood APTT Sodium Citrate Clotting time - Light scatter clot detection D-Dimers Immunoturbidimetric - Detection of D-Dimer cross-linkage Firbinogen PT, INR Hematek Staining machine and Light Microscope S-Sediplus Enclosed ESR System standard standard LP-HAEM- 009 LP-HAEM- 008 Flow cytometry Cell Dyn 3200 standard LP-HAEM- 005 Flow cytometry Cell Dyn Ruby standard LP-HAEM- 019 Clauss - Light scatter clot detection Clotting time - Light scatter clot detection ; calculation Sysmex CA1500 standard LP-HAEM- Sysmex CA1500 standard LP-HAEM- Sysmex CA1500 standard LP-HAEM- Sysmex CA1500 standard LP-HAEM- INAB Registration No. 205MT Page 4 of 7 Edition 1, 08/07/2018

5 Pathology Laboratory, St. Luke's Hospital, Microbiology and Virology Medical pathology field - Test 1011 Macroscopic examination and description 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) Test/assay Macroscopic description of specimens Microscopic examination for general bacteriology purposes (including enumeration and description of human cells) 1013 Culture of Culture of: General organisms in liquid or Bateria agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria 1014 Detection of.01 Slide agglutination, 1014 Detection of.02 Particle agglutination Slide Agglutination: Identification of Salmonella/Shigella species Particle Agglutination: Staphylococcus Specimen Type Equipment/Technique Method (CE/Non- CE/In house ) CSF, sputum, fluids Eye Nasal Ear swab, specimens, Pus exudates, Skin swabs, Wound swabs, CSF, cannulae, Fluids, Blood Packs Eye Nasal Ear swab, specimens, MRSA cultures, Pus exudates, Skin swabs, Wound swabs, CSF, cannulae, Fluids, Blood Packs Faeces Eye Nasal Ear swab, specimens, Manual: Macroscopic examination and description of specimens Manual: Light microscopy for gram stain and primary specimen cell counts Manual: Inoculation of Cultures, Visual monitoring for growth antisera latex agglutination kits: PASTOREX STAPH PLUS INAB Registration No. 205MT Page 5 of 7 Edition 1, 08/07/2018 Range of measurement Std. ref & SOP 004, LP- MIC-008, 010 standard Manual subbing techniques >1000 /cmm, <1000 rounded to the nearest 100, <10 Significant growth graded as +, ++, , LP- MIC-011, 012, LP- MIC-003, 016, LP- MIC-004, 010, LP- MIC-008, 001, 001, LP- MIC-011, 012, LP- MIC-003, 016, LP- MIC-004, 002, LP- MIC-010, 008, LM- MIC-018, 024, LM- MIC-025,

6 1014 Detection of.03 Enzyme immunoassay, 1014 Detection of.04 Immunochromatographic s, 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical s, CE marked commercial systems 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to Particle Agglutination: Streptococcus Enzyme Immunoassay: Clostridium difficile Immunochromatographic s: Urinary Antigens Biochemical Methods: CE marked commercial systems Antimicrobial Sensitivity Testing: Aerobes MRSA cultures, Pus exudates, Skin swabs, Wound swabs, CSF, cannulae, Fluids Eye Nasal Ear swab, specimens, Pus exudates, Skin swabs, Wound swabs, CSF, cannulae, Fluids Faeces Urine Eye Nasal Ear swab, specimens, MRSA cultures, Pus exudates, Skin swabs, Wound swabs, CSF, cannulae, Fluids, Blood Packs latex agglutination kits: PASTOREX STREP kit; TECHLAB C. DIFF QUIK CHEK COMPLETE kit; BinaxNOW Legionella Urinary Antigen Test kit; BinaxNOW Pneumococcal Urinary Antigen Test kit; BinaxNOW Pneumococcal Urinary Antigen Test Manual - including the use of APIs & chromogenic media, identification discs eg. OPT, X + V factor Manual: Disk diffusion, MIC CE & Standard s Eucast Standard Interpreted as Sensitive or Resistant , LM- MIC-009, 012, LM- MIC-017, 024, LP- MIC , LP- MIC-012, INAB Registration No. 205MT Page 6 of 7 Edition 1, 08/07/2018

7 general bacteria (rapidly growing aerobes) -.05 Other categories of organism (as specified ) 003, LP- MIC-016, 004, LP- MIC-002, 010, LP- MIC-008, 010, LP- MIC-031 INAB Registration No. 205MT Page 7 of 7 Edition 1, 08/07/2018