Our Lady's Hospital Navan Ireland East Hospital Group

Transcription

1 Ireland East Hospital Group Department of Pathology, Navan, Co. Meath Testing Laboratory Registration number: 215MT is accredited by the Irish National Board (INAB) to undertake testing 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: 24:01:2014 Expiry date of this certificate of accreditation: 24:01:2019 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO and any further requirements specified by the Irish National Board. Manager: Chairperson: Dr Adrienne Duff Issued on 05 April 2016 Mr Tom O Neill 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 6, 23/10/ MT Page 1 of 9

2 Schedule of (Annex to Certificate) OUR LADY'S HOSPITAL NAVAN Department of Pathology Initial Registration Date : 17-February-2009 Blood Transfusion 19 April Clinical Chemistry 19 April Haematology Postal Address: (Address of other locations Navan Co Meath as they apply) Telephone: +353 (46) Fax: +353 (46) ray.ohare@hse.ie Contact Name: Mr Ray O'Hare Facilities: Public testing service Edition 6, 23/10/ MT Page 2 of 9

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 testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, 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 testing 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 testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing 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 testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing 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/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: 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/testing 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 6, 23/10/ MT Page 3 of 9

4 Blood Transfusion Testing Laboratory Immunohaematology Whole blood Blood grouping (ABO & RhD Typing). LM-BT-0002 Manual Method in tubes.03 Plasma Antibody Screening.04 Plasma Antibody Identification LM-BT-0004 IAT manual method using gel cards LM-BT-0006 Manual method using Gel IAT and enzyme 1020 Immunohaematology LM-BT Plasma Crossmatch Testing Manual Method of Crossmatching in gel.05 Red Blood Cells Antigen Typing.05 Red Blood Cells Direct Antiglobulin Testing LM-BT-0013 Manual Method of Antigen Typing in Gel Cards LM-BT-0017 Manual Method of Direct Antiglobulin Testing by monospecific gel cards. Note: 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 6, 23/10/ MT Page 4 of 9

5 Haematology Testing Laboratory Red Blood Cell LP-HAEM Visual Examination of White Blood Cell Blood Films Platelet, Staining/Microscopy LP-HAEM Erythrocyte Erythrocyte Sedimentation Rate Sedimentation Rate Photometrical capillary stopped flow kinetic analysis White Blood Cell Count LP-HAEM-0024 sysmex XN Full Blood Count Red Blood Cell Count Haemoglobin Mean Cell Volume Mean Cell Haemoglobin Mean Cell Maemoglobin concentration Haematocrit, Platelets Fluorescence Flow Cytometry (WBC, PLT) Impedence (RBC, PLT) Optical (PLT) Phometric SLS (Hgb) Edition 6, 23/10/ MT Page 5 of 9

6 Haematology Testing Laboratory.09 Examination of Malarial Parasites Immunochromatographic test for the qualitative detection of malarial antigens and malarial parasitic morphology LP-HAEM-0011 HbS - Qualitative Solubility Test LP-HAEM Tests for Haemoglobin Variants and Thalassemia LP-HAEM Screening Test for Qualitative Detection of the Infectious Infectious Mononucleosis Mononucleosis heterphile antibodies. Immunoassay Plasma Prothrombin Time, Activated LP-HAEM-0023 Thromboplastin Time,.41 General Haemostatasis Fibrinogen, D-Dimer Related Tests Neutrophils, Lymphocytes, LP-HAEM 0024 (Sysmex XN.05 Automated Differential Monocytes, Eosinophils, 2000) Leucocyte Counts Basophils, Fluroescence Flow Cytometry Reticulocytes LP-HAEM 0024 (Sysmex XN.06 Automated Reticulocyte Fluroescence Flow Cytometry 2000) Counts Edition 6, 23/10/ MT Page 6 of 9

7 Clinical Chemistry Testing Laboratory.01 / Plasma Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Alanine Amino Transferase (ALT) Albumin, Alkaline Phosphatase (ALP) Amylase Aspartate Aminotransferase (AST) Bilirubin - total Calcium Cholesterol - HDL Cholesterol - LDL Creatinine Creatine Kinase C Reactive Protein (CRP) Gamma Glutamyl Transferase Glucose Lactate Dehydrogenase (LDH) Magnesium Microalbumin Potassium (K) Phosphate, Sodium (Na), Total Protein, Trigcerides, hstroponin I, Urea, Uric Acid Edition 6, 23/10/ MT Page 7 of 9

8 Clinical Chemistry Testing Laboratory.10 Drugs for therapeutic monitoring Digoxin Gentamicin Lithium Vancomycin Paracetamol.15 Drugs for toxicological purposes Ɓ-HCG.20 Hormones Follicular Stimulating Hormone Free T4 Luteinising Hormone Oestradiol Progesterone Prolactin Total T3 Thyroid Stimulating Hormone Testosterone Ferritin 0 Iron Studies Transferrin Iron Vitamin B12 Vitamin B12 and Folate.45 Folate Edition 6, 23/10/ MT Page 8 of 9

9 Clinical Chemistry Testing Laboratory PSA - total Protein and Peptide Markers Rheumatoid Factor Edition 6, 23/10/ MT Page 9 of 9