Schedule of Accreditation

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1 Schedule of Accreditation Organisation Name Mayo University Hospital INAB Reg No 207MT Contact Name Janet Burke Address Castlebar, Mayo Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 09/12/2008 Scope Classification Scope Classification Scope Classification Microbiology and virology Blood Transfusion Science 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 Castlebar, Mayo, F23 H529 INAB Registration No. 207MT Page 1 of 10 Edition 2, 20/01/2018

2 Scope of Accreditation Head Office Blood Transfusion Science Category: A Medical pathology field Blood grouping including ABO, Rh(D) and other antigens by manual s -.02 Blood grouping including ABO, Rh(D) and other antigens by automated s -.03 Blood group antibody screen -.04 Identification of blood /assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard ) ABO, Rh(D) Group Whole Blood BioRad System/ Gel BioVue System/ Column Tube Methodology/ Direct AutoVue Ultra/ BioVue Column Ortho Vision/ BioVue Column Antibody Screen Plasma Automated AutoVue Ultra/ BioVue Column rr Antibody Screen Antibody Identification Manual BioRad System/ Gel INAB Registration No. 207MT Page 2 of 10 Edition 2, 20/01/2018

3 group antibodies -.05 Cross match compatible donor units -.06 Red cell phenotyping Investigation of Whole Blood Transfusion Reactions Red Cell Compatibility by Electronic Issue Red Cell Compatibility ing Red Cell Antigen Phenotyping Plasma Red Cells Manual BioRad System/ Gel Automated AutoVue Ultra/ BioVue Column Vision and AutoVue Ultra/ ilab LIS/ Electronic Issue Automated AutoVue Ultra/ BioVue Column INAB Registration No. 207MT Page 3 of 10 Edition 2, 20/01/2018

4 -.09 Direct antiglobulin test Direct Antiglobulin -.99 Miscellaneous tests Blood Grouping including ABO, Rh(D) and DAT for Newborns Automated AutoVue Ultra/ BioVue Column Manual BioRad System/ Gel Estimation of Feto- Maternal Haemorrhage by the Kleihauer-Betke Whole Blood Manual Slide Staining/ Kleihauer-Betke INAB Registration No. 207MT Page 4 of 10 Edition 2, 20/01/2018

5 Head Office Haematology Medical pathology field -.01 Blood counts.02 Visual examination of blood films.03 Erthrocyte sedimentation rate.05 Automated differential leucocyte counts.06 Automated reticulocyte counts.09 Examination of malarial parasites Category: A /Assay Specimen Type Technique Range of Measurement/Equipment Haematocrit Whole Blood RBC cumulative pulse height detection Haemoglobin MCH MCHC Mean Cell Volume Platelet (Impedance/Optical) Red Cell Count Spectrophotometric (SLS Haemoglobin Method) Calculated from Hb and RBC Calculated from Hb and HCT Calculated from RBC and HCT Sheath Flow DC detection/ Laser Flow Cytometry Sheath Flow DC detection White Cell Count Laser Flow Cytometry Includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, Platelets, White Cell & Red Cell Morphology ESR (Automated) Hematek Modified Wright-Giemsa Staining/ Microscopy Photometric Capillary stopped flow Kinetic Analysis Hematek Stainer, Microscope ALLIFAX- 1 ESR (Manual) Sedimentation of RBCs Manual Westergren Basophil Laser Flow Cytometry Eosinophil Laser Flow Cytometry Lymphocyte Laser Flow Cytometry Monocyte Laser Flow Cytometry Neutrophil Laser Flow Cytometry Reticulocytes Laser Flow Cytometry Sysmex XE-2100 Examination for Malarial Parasites by Thick and Thin Blood Films Malaria Screening (ICT Kit) Staining/ Microscopy Immunochromatographic Microscope Binax NOW Malaria Screening Kit Immunochromatographic CareStart Malaria INAB Registration No. 207MT Page 5 of 10 Edition 2, 20/01/2018

6 .30 s for haemoglobin variants and thalassaemia.41 General haemostasis related tests.57 Screening test for infectious mononucleosis Sickle Screen Activated Partial Thromboplastin Time (APTT) Plasma Solubility Screening for HbS Clotting Assay/ Optical Detection Method Rapydtest Screening Kit Sickledex Kit Sysmex CS-2100 D-Dimer Immunoassay Sysmex CS-2100 Fibrinogen (Clauss) International Normalised Ratio (INR) Prothrombin Time (PT) Infectious Mononucleosis Screen Clotting Assay/ Optical Detection Method Ratio Calculation Clotting Assay/ Optical Detection Method Immunoassay Sysmex CS-2100 Sysmex CS-2100 Sysmex CS-2100 Clearview IM II Kit INAB Registration No. 207MT Page 6 of 10 Edition 2, 20/01/2018

7 Head Office Microbiology and Virology Medical pathology field 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) Category: A /assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard ) Macroscopic Examination and Description Microscopic examination for general bacteriology (including enumeration and description of human cells) Sputum CSF Sputum Bronchoalveolar Lavage Tracheal Aspirate Fluids Bile Urine Wound Swabs Pressure Sores Abscesses Cough swabs HVS Eye Swab Conjunctiva swab Ear Swab Nasal Swabs Mouth Swabs Throat Swab Ulcer Swabs, burn, skin, superficial wound Swab, Exudates, Pus Swabs Surveillance Specimens MRSA Swabs VRE Swabs CRE Swabs Manual Light Microscope/ Microscopic examination with or without fixation and staining with dyes for 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 -.03 Microscopic examination for fungi Microscopic examination for funghi Genital Tract Specimens including penile swab, Vaginal swab, endocervical, IUCD Urethral swab Cannulae CSF Human Tissue Semen Tips Slides (unstained) Light Microscope/ Microscopic examination with or without fixation and staining with dyes as required 1013 Culture of organisms Culture of General CSF Manual Assessment INAB Registration No. 207MT Page 7 of 10 Edition 2, 20/01/2018

8 in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria Bacteria Blood Urines MSU & CSU Faeces Sputum / BAL / Bronchial Washings Pus /Abscess /Post Operative Wound / Deep Seated Infections Abdominal / Peritoneal Fluids Ascitic Fluids Pleural Fluids Bile Pericaridal Fluids Joint Fluids Tissues & Bone Ear, Nose, Throat, Mouth Skin & Superficial Wounds Genital Specimens - HVS, Endocervical, Penile, Urethral, Vulval Tips MRSA Screening - Nasal, Groin & Wound VRE Screening - Rectal CRE Screening - Rectal BacTAlert Blood Culture Monitoring System Sputum Bronchoalveolar Lavage Tracheal Aspirate Fluids Bile Urine Wound Swabs Pressure Sores Abscesses Cough swabs HVS Eye Swab Conjunctiva swab Ear Swab Nasal Swabs Mouth Swabs Throat Swab Ulcer Swabs, burn, skin, superficial wound Swab, Exudates, Pus Swabs Surveillance Specimens MRSA Swabs VRE Swabs CRE Swabs Genital Tract BacT Alert Blood Culture Monitoring System Manual Assessment Light microscope INAB Registration No. 207MT Page 8 of 10 Edition 2, 20/01/2018

9 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.02 Culture of fungi 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.01 Slide agglutination, 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.02 Particle agglutination 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.03 Enzyme immunoassay, 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.04 Immunochromatographic s, 1016 Identification of cultured bacteria and fungi Culture of funghi Staphylococcus Latex Identification of Neisseria gonorrhoeae Specimens including penile swab, Vaginal swab, endocervical, IUCD Urethral swab Cannulae CSF Human Tissue Semen Tips Slides (unstained) Meningitis Latex Urine CSF Serum Streptococcus Grouping for Streptococcus pneumoniae for Neisseria gonorrhoeae for Legionella pneumophilia for Streptococcus pneumoniae Whole Blood Whole Blood Urine Urine CSF Manual Assessment BacT Alert Blood Culture Monitoring System Light microscope Pastorex Staph Plus / Slide Phadebact Monoclonal GC / Particle Pastorex Meningitis Latex Kit/ Particle Prolex Streptococcal Grouping Latex Kit/ Particle Slidex Pneumo Kit/ Particle Pastorex Streptococcus pneumoniae / Latex Gonogen II test kit/ Immunoassay Binax NOW test kit/ Immunochromatography Binax NOW test kit/ Immunochromatography β-lactamase Nitrocefin Disks/ Immunochromatography Identification of cultured bacteria API System / Manual INAB Registration No. 207MT Page 9 of 10 Edition 2, 20/01/2018

10 using non-nucleic acid based techniques -.01 Biochemical s, marked commercial systems 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.03 Identification of fungi by microscopic morphology (Aerobes/Anaerobes) Identification of fungi by microscopic morphology 1016 Identification of Identification of cultured bacteria and fungi bacterial, fungal and using non-nucleic acid mycobacterial isolates based techniques -.04 Identification using MALDI- TOF Spectroscopy 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.03 Yeasts 1024 Preservation of microbial cultures 1029 Miscellaneous -.99 Miscellaneous tests Sensitivity ing Preservation of Isolates Drugs for Therapeutic Monitoring: Gentamicin Drugs for Therapeutic Monitoring: Vancomycin and Tobramycin Serum Plasma Vitek 2XL / Automated Light Microscope VitekMS-MALDI TOF/ Automated EUCAST/ MIC (Manual) ETEST/Disk Diffusion (Manual) Oxoid Discs/Disk Diffusion (Manual) Vitek 2XL / Automated Biochemical ing ETEST/MIC Disk Diffusion (Manual) Vitek 2XL / Automated Biochemical ing Freezer/Manual Roche Cobas C311 / Photometric Roche Cobas C311 / Photometric INAB Registration No. 207MT Page 10 of 10 Edition 2, 20/01/2018