RSCI Group, Drogheda, Pathology Laboratory, Drogheda Testing Laboratory Registration number: 295MT 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 15189:2012 3rd 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: 25:10:2011 Date of last renewal of accreditation: 25:10:2016 Expiry date of this certificate of accreditation: 25:10:2021 This shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO 15189 and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Mr Tom O Neill Issued on 25 October 2016 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 14, 23/10/2017 295MT Page 1 of 20
Schedue of (Annex to Certificate) OUR LADY OF LOURDES HOSPITAL Drogheda, Co. Louth Pathology Laboratory Blood Transfusion 25-October-2011 Haematology 11-September-2012 Histopathology 11-September-2012 Clinical Chemistry 9-September-2014 Microbiology 9-September-2014 Postal Address: (Address of other locations Drogheda Co. Louth as they apply) Telephone: +353 (41) 9837601 Fax: +353 (41) 9838092 E-mail: sally.byrne@hse.ie Contact Name: Ms. Sally Byrne Facilities: Public testing service Edition 14, 23/10/2017 295MT Page 2 of 20
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 17025 or ISO 15189 (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 14, 23/10/2017 295MT Page 3 of 20
Blood Transfusion Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1020 Immunohaematology 1. Automated method using Blood grouping (ABO & RhD column agglutination technology Blood Grouping (ABO Typing) (CAT) (Ortho BioVue) and RhD Typing) Red blood cells, plasma 2. Manual Method using CAT and tubes (Ortho BioVue).03 Blood Group Antibody screen Antibody Screening, Plasma 1.Automated method using CAT (Ortho BioVue on Autovue Innova) 2. IAT manual method using CAT (Ortho BioVue).04 Identification of blood group antibodies Determination of compatibility of donor units using appropriate techniques including the investigation of transfusion reactions Antibody Identification, Plasma Crossmatch Testing, Plasma Antigen Typing, Red Blood Cells Direct Antiglobulin Testing, Red Blood Cells 1. Manual method using CAT (Ortho BioVue) 2. IAT and Enzyme Method 1. Manual CAT (Ortho BioVue) 2. Manual method using CAT (Ortho BioVue) or tube techniques as per manufacturer s instructions 3. Automated & Manual method using monospecific CAT (Ortho BioVue) or tube techniques Compatibility analysis for the release of compatible blood by electronic means Winpath LIS 5.3.2 EI function Note 1: 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) Note 2: Included also is fridge in Louth County Hospital Edition 14, 23/10/2017 295MT Page 4 of 20
Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested 1030 Haematology Full Blood Count (Whole Blood) Type of test/properties measured Range of measurement White Blood Cell Count Red Blood Cell Count Haemoglobin (Hb) Mean Cell Volume (MCV) Mean Cell Volume haemoglobin (MCH) Mean Cell Volume haemoglobin Concentration (MCHC) Haematocrit (hct) Platelets Nucleated Red Blood Cell s (NRBCs) Standard specifications Equipment/techniques used Automated method using Sysmex XN-1000 and XN-2000 LP-HAEM-0032 Operation and Maintenance of Sysmex XN- 1000 and XN-2000. LP-HAEM-0005 Full Blood Count Testing, Authorisation, Reporting of Results (Critical Values) and Criteria for Blood Films Visual examination of Red blood cell, white blood cell Manual preparation, staining blood film and platelet morphology in and visual examination of peripheral blood and bone blood films..20 Bone marrow aspirate marrow aspirate. morphology LP-HAEM-0006 Preparation, (Whole Blood / Bone Staining and Examination of Marrow aspirate) Blood Films and Bone Marrow Aspirates LP-HAEM-0007 Operation and Maintenance of the WESCOR 7120 Aerospray Stainer LP-HAEM-0008 Operation and Maintenance of the Nikon Eclipse 50i microscope Edition 14, 23/10/2017 295MT Page 5 of 20
Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used.03 Erythrocyte Sedimentation Rate (Whole Blood) Photometrical capillary stopped flow kinetic analysis Automated analysis of whole blood LP-HAEM-0004 Operation and Maintenance of the Alifax Test 1 ESR Analyser Edition 14, 23/10/2017 295MT Page 6 of 20
Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1030 Haematology Neutrophils Automated method using Automated differential Lymphocytes Sysmex XN-1000 and XN- leucoyte counts Monocytes 2000 (whole Blood) Eosinophils Basophils LP-HAEM-0032 Operation and Maintenance of the Sysmex XN 1000 and XN 2000 LP-HAEM-0005 Full Blood Count Testing, Authorisation, Reporting of Results (Critical Values) and Criteria for Blood Films.06 Auotmated reticulocyte counts (Whole Blood) Reticulocyte Count Automated method using Sysmex XN-1000 and XN- 2000 LP-HAEM-0032 Operation and Maintenance of the Sysmex XN 1000 and XN 2000 LP-HAEM-0005 Full Blood Count Testing, Authorisation, Reporting of Results (Critical Values) and Criteria for Blood Films Edition 14, 23/10/2017 295MT Page 7 of 20
Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested.09 Examination for Malarial Parasites Type of test/properties measured Range of measurement Immunochromatographic test for qualitative detection of malarial antigens using Binax NOW Malaria Test Kit and malarial parasitic morphology by thick and thin blood Film Standard specifications Equipment/techniques used Manual serological test for malarial antigens and manual blood film preparation, staining and morphological examination. LP-HAEM-0012 Serological Testing and Blood Film Staining and Examination for Malarial Parasites.30 Tests for haemoglobin S (Whole Blood) Test for fetal maternal haemorrhage (FMH) Acid Elution Test (Whole Blood) Sickledex (HbS) test uses the principle that Sodium Hydrosulphite present in the working solubility buffer reduces haemoglobin. Reduced HbS is insoluble in the buffer and forms a cloudy, turbid suspension. Positive/Negative result Acid elution test whereby fetal haemoglobin (HbF) is more resistant than adult haemoglobin (HbA) to both alkali denaturation and acid elution. Manual method. LP-HAEM-0013 Preparation of Reagent and Performance of Sickledex Test Manual method of film preparation, staining and examination for fetal red cells in maternal circulation. LP-HAEM-0014 Performance of the Kleihauer Test (Acid Elution Test) Edition 14, 23/10/2017 295MT Page 8 of 20
Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested 1030.41 Haematology General haemostasis tests (Plasma) Type of test/properties measured Range of measurement Prothrombin time International normalised ratio Activated Thromboplastin time APTT / Ratio Fibrinogen Clotting assay (clauss method) D-Dimer Standard specifications Equipment/techniques used Automated method using Stago STA-R Evolution LP-HAEM-0016 Operation and Maintenance of the Stago STA-R Evolution LP-HAEM-0022 Coagulation Testing, Authorisation and Reporting of Coagulation Results (Critical Values).55 Iron Stain (Bone Marrow Aspirate) Examination of bone marrow aspirate film for iron using Perl s Prussian Blue staining method Manual staining method. LP-HAEM-0006 Preparation, Staining and Examination of Blood Films and Bone Marrow Aspirates.57 Screening test for infectious mononucleosis (Plasma) Qualitative detection of IMspecific heterophile antibodies Manual method. LP-HAEM-0009 Performing the Clearview IM II Test for Infectious Mononucleosis Edition 14, 23/10/2017 295MT Page 9 of 20
Medical Testing Laboratory Histopathology Laboratory INAB Classification Test/Assay Name Specimen Type SOP 1051 Histopathology Processing fixed specimens for histopathological examination Cut up Tissue processing Embedding Microtomy Automated and Manual Haematoxylin and Eosin Staining Coverslipping Cytology Sample Preparation Human tissue LP-HIST-0001, 0002, 0003, 0004, 0007, 0008, 0010, 0015, 0017, 0031, 0034, 0035, 0036, 0055, 0057 LP-HIST-0016, LP-HIST-0038 LP-HIST-0033 LP-HIST-0034 LM-HIST-0035 LM-HIST-0036 LM-HIST-0037 LM-HIST-0038 LM-HIST-0039 Processing fresh specimens for frozen section examination.03 Histochemistry Manual Automated Cut-up Frozen section cryotomy and staining Special stains List each stain as appropriate for each laboratory. Alican Blue Congo Red Gram-Twort Haematoxylin Van Gieson Masson Fontana Millers Strain Ziehl-Neelsen Alican Blue-Periodic Gordon and Sweet Grocotts Hexamine Silver Haematoxylin and Eosin Martius Scarlet Blue Masson Trichrome Periodic Acid Schiff Perls Prussian Blue Pananicolaou Stain for Cytological Preparations MGG Stain for Cytological Preparations Diastase Periodic Acid Schiff for Glycogen Warthin Starry Human tissue Human tissue LP-HIST-0037 LP-HIST-0015 Edition 14, 23/10/2017 295MT Page 10 of 20
Medical Testing Laboratory Histopathology Laboratory INAB Classification Test/Assay Name Specimen Type SOP Diagnostic Interpretation and reporting of Human tissue specimens.04 Histological interpretation.041 Medical Renal Path.042 Paediatric Pathology.043 Perinatal Pathology.044 Neuropathology.045 Breast screening Pathology (Breastcheck programme) Immunohistochemistry Specialist areas excluded: Medical Renal Pathology Paediatric Pathology Perinatal Pathology Neuropathology Breast screening Pathology (Breast Check designated laboratories only) Specialist areas included: (Added as demonstration of EQA participation is presented) Programmed automated application of reagents Actin Actin BCL2 Calretenin CA125 CD3 CD5 CD10 CD15 CD20 CD30 CD31 CD34 CD45 CD56 CD68 CD79a CD117 CD138 Chromogranin A Cyclin D1 Cytokeratin AE1/3 Cytokeratin CAM 5.2 Cytokeratin MNF116 Human tissue Human tissue LMn-HIST-0001 LP-HIST-0012 LP-HIST-0022 LP-HIST-0024 LP-HIST-0049 Edition 14, 23/10/2017 295MT Page 11 of 20
Medical Testing Laboratory Histopathology Laboratory INAB Classification Test/Assay Name Specimen Type SOP Immunohistochemistry Programmed automated application of reagents Cytokeratin 7 Cytokeratin 20 Cytokeratin 34BE12 CEA Desmin EMA Factor VIII BerEP4 Hmb45 Ki67 Mart1/Tyrosinase PSA P16 P53 Synaptophysin S100 TTF Vimentin Human tissue LP-HIST-0022 LP-HIST-0024 LP-HIST-0049.06 Immunocytochemistry Ventana System iview Detection System Ultra Detection System Optiview Detection System LP-HIST-0024 Edition 14, 23/10/2017 295MT Page 12 of 20
Clinical Chemistry Testing Laboratory INAB Classification Test/Assay Name Specimen Type Equipment SOP Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) LI Heparin Plasma Amylase, Urine Aspartate Aminotransferase (AST), Cholesterol, Calcium, Urine 1061 Clinical Chemistry Glucose Creatinine Creatine Kinase Fluoride EDTA CSF, Urine, Cholesterol HDL, Cholesterol LDL, Iron Magnesium, Phosphate HS Troponin Ferritin Transferrin Ammonia Edition 14, 23/10/2017 295MT Page 13 of 20
Clinical Chemistry Testing Laboratory INAB Classification Test/Assay Name Specimen Type Equipment SOP 1061 Clinical Chemistry Total Protein Urinary Protein Urine CSF Urea Uric Acid Glycated Haemoglobin (HbA1c) EDTA AdamsHA 8180 LP-Bio-0012 Albumin Ci6200i Sodium (Na) Urine Ci6200i Potassium (K) Urine Chloride (Cl) Urine Gamma Glutamyl Transferase (GGT) Lactate Dehydrogenase (LDH) Triglycerides C Reactive protein (CRP) Microalbumin Urine Direct Bilirubin Total Bilirubin Edition 14, 23/10/2017 295MT Page 14 of 20
Clinical Chemistry Testing Laboratory INAB Classification 1061 Clinical Chemistry Test/Assay Name Specimen Type Equipment SOP Vitamin D Ci 16200 Bicarbonate Ci 16200 Lactate Fluoride EDTA Ci 16200 Bile Acid Ci 16200 Edition 14, 23/10/2017 295MT Page 15 of 20
Clinical Chemistry Testing Laboratory INAB Classification 1061.10 Clinical Chemistry Test/Assay Name Specimen Type Equipment SOP Digoxin Gentamicin Lithium Phenytoin Vancomycin Valproic Acid.15 Paracetamol Salicyate.20 B-HCG Cortisol Free T4 Free T3 Progesterone Prolactin TSH FSH LH Oestradiol.45 Vitamin B12 Folate Edition 14, 23/10/2017 295MT Page 16 of 20
Clinical Chemistry Testing Laboratory INAB Classification Test/Assay Name Specimen Type Equipment SOP 1061 CLINICAL AFP CHEMISTRY.50 CA 15-3 CA 19-9 CA 125 CEA PSA total Immunoglobulin A.80 Immunoglobulin M Immunoglobulin G.83 Rheumatoid factor Anti-TPO Antibodies.99 Osmolality Urine 3320 Osmometer LP-Bio-0015 Edition 14, 23/10/2017 295MT Page 17 of 20
Microbiology Testing Laboratory INAB Classification Test/Assay Name Specimen Type Method SOP 1011 Bacteriology.03.04.06.07.08.99 Investigation for pathogens other than parasites Faecal samples Microscopy, Vitek 2 Gene expert Maldi Tof Manual AMS Culture LP-MIC-0008 LP-MIC-0001.03.04.06.07.99 Identification and susceptability testing Genital tract specimens Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0006.04.07.99 MRSA testing Various sample types Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0005.03.04.06.07.99 Investigation of respiratory specimens Respiratory specimens Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0006.03.04.06.07.99 Investigation of cerebrospinal fluid specimens Cerebrospinal fluid Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0002 Edition 14, 23/10/2017 295MT Page 18 of 20
Microbiology Testing Laboratory INAB Classification Test/Assay Name Specimen Type Method SOP 1011 Bacteriology.03.04.06.07.08.99 Investigation of fluids Various fluid types Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0011.03.04.06.07.99 Investigation of Urine Urine samples Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0003.03.04.07.99 Investigation of wounds / abscesses Various wound sites Microscopy, Vitek 2 Maldi Tof Manual AMS Culture LP-MIC-0009 LP-MIC-0010 01.03.04.07.99 Legionella & Pneumococcal Antigen Testing Urine Samples Immunochromatographic LP-MIC-0008 LP-MIC-0005 LP-MIC-0019 1012 Parasitology Detection and identification of parasites Various Manual, Microscopy LP-MIC-0015 Edition 14, 23/10/2017 295MT Page 19 of 20
Microbiology Testing Laboratory INAB Classification 1013 Virology Test/Assay Name Detection of Rotavirus or adenovirus Detection of RSV Syncytical virus fusion protein antigen Specimen Type Faecal specimens Respiratory Samples Urine Method Manual, Immunochromatographic SOP LP-MIC-0008 LP-MIC-0005 LP-MIC-0019 Edition 14, 23/10/2017 295MT Page 20 of 20