Connolly Hospital. Pathology Department, Blanchardstown, Dublin 15. Testing Laboratory Registration number: 220MT
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1 Pathology Department, Blanchardstown, Dublin 15 Testing Laboratory Registration number: 220MT is accredited by the Irish National Board (INAB) to undertake as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO 15189: rd Edition Medical laboratories Particular requirements for quality and competence (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 17:02:2009 Date of last renewal of accreditation: 25:08:2018 Expiry date of this certificate of accreditation: 25:08:2023 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Chairperson: Dr Adrienne Duff Issued on 12 February 2015 Ms. Ita Kinahan Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. The INAB is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 17, 16/11/ MT Page 1 of 14
2 Schedule of (Annex to Certificate) CONNOLLY HOSPITAL Medical Testing Laboratory Blood Transfusion Laboratory Microbiology Laboratory Initial Registration Date 17-February September 2012 Postal Address: (Address of other locations as they apply) Blanchardstown Dublin 15 Telephone: +353 (1) Fax: +353 (1) Contact Name: Ms Linda Martin Facilities: Normally not available for Public Edition 17, 16/11/ MT Page 2 of 14
3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD (INAB) is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial /calibration services. Indeed, any organisation involved in, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO or ISO (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and that is performed on site by individuals and organisations that do not have a permanent calibration/ laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/ service: Conditionally available for public calibration/: Normally not available for public calibration/: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/ more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. INAB will on request verify the status and scope. Edition 17, 16/11/ MT Page 3 of 14
4 Blood Transfusion Laboratory 1020 Immunohaematology Blood grouping, including ABO and Rh(D) ABO and RhD blood grouping Red blood Cells LM-BT-0001 Manual method using DiaMed gels LM-BT-0001 Manual method using tubes 1020 Immunohaematology Antibody screening LM-BT Blood group antibody Plasma Manual IAT method using screen DiaMed gels 1020 Immunohaematology Antibody identification LM-BT-0003 blood Plasma Manual method using group antibodies DiaMed IAT and enzyme gel methods 1020 Immunohaematology Compatability LM-BT Determination of Plasma Manual method using compatibility of donor DiaMed gels units using appropriate techniques including the investigation of transfusion reactions Edition 17, 16/11/ MT Page 4 of 14
5 Blood Transfusion Laboratory 1020 Immunohaematology Red cell phenotyping Antigen typing LM-BT-0006 Red blood cells Manual methods using DiaMed and tube methods 1020 Immunohaematology Direct Antiglobulin Test LM-BT Red blood cells Manual methods using DiaMed gels Note:, Blood Transfusion Department, Blanchardstown, Dublin 15 has been assessed and is competent to comply with Articles 14 and 15 of the EU Directive 2002/98/EC (S.I. No 360 of 2005 and S.I. No 547 of 2006). Edition 17, 16/11/ MT Page 5 of 14
6 Preparation of films for microscopic examination Inoculation of cultures Microscopic examination of Clinical Specimens Detection of bacterial antigens Legionella Specimen Type: Urine Investigation of Urine specimens - Microscopy, culture and sensitivity including using the Sysmex UF1000i Urine Analyser and BioMerieux Vitek MS Binax Now Legionella Kit Binax Now Streptococcus pneumonia Kit LP-MICRO-0007 LP-MICRO-0058 LP-MICRO-0072 LP-MICRO-0091 National Standard Methods, BioMerieux Vitek MS User Manual Sysmex UF1000i User Manual Binax now Legionella Kit Insert Binax now Streptococcus pneumoniae Kit insert Edition 17, 16/11/ MT Page 6 of 14
7 Preparation of films for microscopic examination Inoculation of cultures Microscopic examination of Clinical Specimens Detection of bacterial antigens Specimen Type: Swabs other than genital tract and associated specimens, Pus, Catheter tips, Bile, Fluids, Tissues, Bone, Biopsies, CSFs Investigation of superficial and deep seated wound infections, intravascular cannulae and fluids from normally sterile body sites including using the BioMerieux Vitek MS LP-MICRO-0006 LP-MICRO-0018 LP-MICRO-0019 LP-MICRO-0022 LP-MICRO-0023 LP-MICRO-0024 LP-MICRO-0025 LP-MICRO-0027 National Standard Methods, Edition 17, 16/11/ MT Page 7 of 14
8 Preparation of films for microscopic examination Inoculation of cultures Microscopic examination of Clinical Specimens Detection of bacterial antigens Specimen Type: Faeces Rectal Swabs Investigation of faeces specimens for bacterial pathogens including using the BioMerieux Vitek MS. Investigation of faeces specimens for C.diff toxin including using GeneXpert Dx System LP-MICRO-0012 LP-MICRO-0013 LP-MICRO-0014 LP-MICRO-0090 National Standard Methods, BioMerieux Vitek MS User Manual GeneXpert DX System User Manual Edition 17, 16/11/ MT Page 8 of 14
9 Preparation of films for microscopic examination Inoculation of cultures Microscopic examination of Clinical Specimens Detection of bacterial antigens Specimen Type: Vaginal swabs, Vulval/ Labial swabs, Endocervical/ cervical swabs Penile swabs Urethral swabs Rectal swabs Bartholins gland aspirate Products of conception IUD Investigation of genital tract and associated specimens including using the BioMerieux Vitek MS LP-MICRO-0020 National Standard Methods, BioMerieux Vitek MS User Manual Edition 17, 16/11/ MT Page 9 of 14
10 Preparation of films for microscopic examination Inoculation of cultures Microscopic examination of Clinical Specimens Detection of bacterial antigens Specimen Type: Sputum, Bronchial Lavage Investigation of respiratory specimens for bacterial pathogens other than Mycobacteria including using the BioMerieux Vitek MS LP-MICRO-0017 National Standard Methods, BioMerieux Vitek MS User Manual Edition 17, 16/11/ MT Page 10 of 14
11 .02 Preparation of films for microscopic examination Inoculation of cultures Detection of bacterial antigens Specimen Type: Nasal swabs Throat swabs Perineal/Groin swabs Wound swabs Swabs from other sites as clinically indicated Screening of specimens for Methicillin Resistant Staph aureus (MRSA) including using the BioMerieux Vitek MS LP-MICRO-0010 National Standard Methods, BioMerieux Vitek MS User Manual Edition 17, 16/11/ MT Page 11 of 14
12 .02 Preparation of films for microscopic examination Inoculation of cultures Detection of bacterial antigens Specimen Type: Rectal swabs Swabs from other sites as clinically indicated Screening of specimens for Vancomycin Resistant Enterococci (VRE) including using the BioMerieux Vitek MS LP-MICRO-0011 National Standard Methods, BioMerieux Vitek MS User Manual 1013 Virology Investigation of specimens for LP-MICRO-0090 Non-cultural methods Influenza A, influenza B and GeneXpert DX System User of detection 2009 H1N1 Influenza viral RNA Manual using the Xpert Flu Assay on the GeneXpert Dx System Identification Maldi-TOF LP-MICRO Definitive Vitek 2C identification of LP-MICRO-0083 viruses Edition 17, 16/11/ MT Page 12 of 14
13 Bacterial cultures Antimicrobial resistance using disc diffusion and the BioMerieux Vitek 2 CompactBioMerieux Vitek MS LP-MICRO-0035 LP-MICRO-0036 Guidance Notes, EUCAST Susceptibility Guidelines, Vitek 2 Compact Instrument User Manual BioMerieux Vitek MS User Manual Determination of minimum LP-MICRO-0036 inhibitory concentrations using Etest procedure, BioMerieux gradient strips MICE procedure, Oxoid EUCAST Susceptibility Bacterial cultures Guidelines, Mycology Candida sensitivity tests using LP-MICRO Sensitivity tests to the BioMerieux Vitek 2 Compact antifungal agents LP-MICRO-0015 Immunochromatigraph Kit ic Edition 17, 16/11/ MT Page 13 of 14
14 General Chemistry Pregnancy Tests - qualitative Ulti med Hcg test BTNX Rapid Response Hcg test. Ulti med Hcg Card Kit Insert BTNX Rapid Response Hcg Kit Insert Molecular CRE Gene Xpert LP-MICRO-0083 LP-MICRO-0090 Edition 17, 16/11/ MT Page 14 of 14
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