Ireland East Hospital Group The National Maternity Hospital Pathology Department, Holles Street, Dublin 2 Registration number: 240MT 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 3 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: 15:09:2009 Date of last renewal of accreditation: 21:10:2014 Expiry date of this certificate of accreditation: 21:10:2019 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 Issued on 20 October 2015 Chairperson: 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 13, 22/01/2018 240MT Page 1 of 23
Schedule of (Annex to Certificate) Initial Registration Date : 15-September-2009 Transfusion Department 31-May -2011 Anatomic Pathology Division 13 - September - 2011 Microbiology Department 13-September-2013 Haematology Department Postal Address: (Address of other locations as they apply) 19-February-2013 The National Maternity Hospital Pathology Department Holles Street Dublin 2 Clinical Chemistry Department Telephone: +353 (1) 6373547 Fax: +353 (1) 6373410 E-mail: mculliton@nmh.ie Contact Name: Marie Culliton Facilities: Public testing service Edition 13, 22/01/2018 240MT Page 2 of 23
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 13, 22/01/2018 240MT Page 3 of 23
BLOOD TRANSFUSIONDEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1020 ImmunoHaematology grouping including ABO/Rh Testing ABO and Rh D grouping of blood ABO and Rh D grouping of blood Red Cells/ Red Cells & Automated Diamed Gel station 1H 1000 N/A LP-BTR- GELTEST PP-CS-BT-16 LP-BTR- ABORHT Group Antibody Screen Antibody Identification of blood Group Antibodies.05 Determination of compatibility of donor units using appropriate techniques including the investigation of transfusion reactions Antibody screening Antibody Screening Antibody Identification Compatibility testing Red Cells & Automated method in GelCard Method using DiamedGel Cards Semi-automated method using DiamedGel Cards Method using DiamedGel Cards Diamed Gel station IH 1000 NA Diamed Gel station NA LP-BTR- GELTEST PP-CS-BT-16 LP-BTR- ABORHT LP-BTR- ABINVEST LP-BTR- XMATCH Edition 13, 22/01/2018 240MT Page 4 of 23
BLOOD TRANSFUSIONDEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1020 ImmunoHaematology.06 Red Cell Phenotyping Antigen Typing Red Cells Method using DiamedGel Cards tubes N/A LP-BTR-AT.99 Miscellaneous Tests Antibody Titre Direct Coombs Test Direct Coombs Test Red Cells Red Cells Automated method in GelCard N/A Diamed Gel station 1H 1000 N/A PP-CS-BT-5 LP-BTR- GELTEST PP-CS-BT-16 LP-BTR- ABORHT Note: The National Maternity Hospital, Transfusion Department, Holles Street, Dublin 2 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 13, 22/01/2018 240MT Page 5 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY Culture Bactec Culture instrument Microscopy Culture BacT Alert PP-CS-MIC-2 CSF Culture CSF Microscopy PP-CS-MIC-12 Fluid Cultures Amniotic Fluid Ascitic Fluid Bursa Fluid Pericardial Fluid Peritoneal Fluid Synovial Fluid Microscopy PP-CS-MIC-38 Edition 13, 22/01/2018 240MT Page 6 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY Faeces Culture Rota/ Adeno Faeces Faeces Culture / Immuno Chemotography PP-CS-MIC-21 PP-CS-MIC-21 Rota/ Adeno Faeces Immunochemotograpgy PP-CS-MIC-23 Cervical Culture Cervical Swab Microscopy PP-CS-MIC-23 Ear Culture Eye Culture Genital Culture Mouth Culture Ear Swab Ear Swab IUD Eye Swab Canalicular Pus High Vaginal Swab (HVS) Vaginal Discharge Vulval Swab Labial Swab Endocervical Swab Penile Swab Low Vaginal Swab Urethral Swab Mouth Swab Microscopy / Microscopy / Culture / / Microscopy PP-CS-MIC-15 PP-CS-MIC-16 PP-CS-MIC-72 PP-CS-MIC-20 PP-CS-MIC-72 PP-CS-MIC-23 PP-CS-MIC-4 PP-CS-MIC-72 Edition 13, 22/01/2018 240MT Page 7 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY MRSA Screen Nasal, Throat, Axilla, Groin, Perineum, Umbilical and other sites depending on clinical information Culture / PP-CS-MIC-29 PP-CS-MIC-72 Nasal Culture Nasal Swab Nasal Secretions Microscopy PP-CS-MIC-30 Throat Culture Throat Swab Microscopy PP-CS-MIC-40 PP-CS-MIC-72 Screening of Paediatric Rectal Swabs for the Carriage for VRE, ESBLs and Gentamicin Resistant Gram-negative bacilli Faeces Rectal Swab PP-CS-MIC-8 PP-CS-MIC-70 Edition 13, 22/01/2018 240MT Page 8 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY Sputum Culture Aspirate, Endotracheal Tube Aspirate, Sputum Culture / Microscopy PP-CS-MIC-37 Tip Culture CVP or Hickman lines Cannula Tips Endotracheal Tube Tip PP-CS-MIC-25 PP-CS-MIC-19 Urine Culture BAG CATCH CSU MSU SUPRA PUBIC Microscopy PP-CS-MIC-42 Wound Culture Exudates Pus Swabs Microscopy if required PP-CS-MIC-44 Edition 13, 22/01/2018 240MT Page 9 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY Processing and Microbiological Examination of Abscesses and Deep Seated Infections Abscess sample Microscopy if required PP-CS-MIC-1 Examination of Buttock and Groin Swabs Buttock and Groin Swabs PP-CS-MIC-5 Examination of PM Screening Swabs PM Screening Swabs PP-CS-MIC-6 Edition 13, 22/01/2018 240MT Page 10 of 23
MICROBIOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1011 BACTERIOLOGY Examination of Expressed Breast Milk, Breast Swabs and Nipple Swabs Expressed Breast Milk, Breast Swabs and Nipple Swabs Microscopy if required PP-CS-MIC-17 Placental Swab Placental Swab PP-CS-MIC-33 Semen Semen PP-CS-MIC-35.99 1014 Skin Swab HCG Limited identification of fungal isolates Skin Swab Urine Body fluids, excretions, materials, swabs and environmental and infection control swabs Clearview HCG kit Microscopy Culture Rapid Response PP-CS-MIC-36 PP-CS-MIC-50 PP-CS-MIC-34 PP-CS-MIC-18 PP-CS-MIC-72 Edition 13, 22/01/2018 240MT Page 11 of 23
MICROBIOLOGY DEPARTMENT INAB Classification 1011 BACTERIOLOGY Test/ Assay Name Preparation of films for microscopic examination Specimen Type Method Equipment SOP Preparation of films for microscopic examination Microscopy PP-CS-MIC-34 Performance of Sellotape Test PP-CS-MIC-24 Gram Stain PP-CS-MIC-43 Wet Preparation Inoculation of cultures. body fluids, excretions, materials and swabs. PP-CS-MIC-28 Inoculation of culture media Edition 13, 22/01/2018 240MT Page 12 of 23
MICROBIOLOGY DEPARTMENT INAB Classification 1011 BACTERIOLOGY Test/ Assay Name Identification of organisms including antibiotic sensitivity testing: Automated and manual methods of identification and susceptibility testing Specimen Type Method Equipment SOP body fluids, excretions, materials and swabs. VITEK 2 Automated and WI-CS-MIC-8 Modified Hodge Test PP-CS-MIC-48 Susceptibility Testing PP-CS-MIC-57 Use of identification kits in Microbiology PP-CS-MIC-75.05 Identification of organisms excluding antibiotic sensitivity testing body fluids, excretions, materials, swabs and environmental and infection control swabs Culture Automated and PP-CS-MIC-18 Examination of environmental and infection control swabs PP-CS-MIC-9 Identification of anaerobes Edition 13, 22/01/2018 240MT Page 13 of 23
ANATOMIC PATHOLOGY DEPARTMENT INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 1051 HISTOPATHOLOGY Processing fixed specimens for histopathological examination Cut up Tissue processing Embedding Microtomy Automated and Haematoxylin and Eosin Staining Coverslipping Semi-Automated & Automated Immunohistochemical Tissue Staining Human tissue LP-AP-TISSUEPROC PP-CS-AP-44 LP-AP-EMBEDDING LP-AP-Microtomy HM325 LP-AP- AUTOMICROTOMY LP-AP- AUTOSTAIN LP-AP-IHCPREP PP-CS-AP-45 Special stains: Processing fresh specimens for frozen section examination Histochemistry Gram Stain Oil Red O PAS PAS-D Perls Prussian Blue H+E Human Tissue LP-AP-GRAM LP-AP-OILREDO LP-AP-PAS LP-AP-PAS LP-AP-PERLS LP-AP- H+E Edition 13, 22/01/2018 240MT Page 14 of 23
ANATOMIC PATHOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type SOP 1051 HISTOPATHOLOGY Histological interpretation Diagnostic Interpretation and reporting of Human tissue specimens Specialist areas excluded: Medical Renal Pathology Paediatric Pathology Neuropathology Breast screening Pathology Specialist areas included: Perinatal Pathology (confined to Placental examination & Products of conception) Human tissue PP-CS-AP-13 PP-CS-AP-10 PP-CS-AP-33 PP-CS-AP-11 PP-CS-AP-34 PP-CS-AP-37 PP-CS-AP-11 PP-CS-AP-12 PP-CS-AP-24 PP-CS-AP-35 PP-CS-AP-32 PP-CS-AP-9 PP-CS-AP-14 PP-CS-AP-2 PP-CS-AP-28 PP-CS- AP-47.05 Immunohistochemistry Desmin Vimentin Actin (SMA) EMA GFAP CD 3 CD 10 CD 20 CD 31 CD 34 CD 45 (CLA) CD61 CD68 CD138 AE1/AE3 Cytokeratin CAM5.2 CK7 CK20 Ki-67 PP-CS-AP-45 Edition 13, 22/01/2018 240MT Page 15 of 23
ANATOMIC PATHOLOGY DEPARTMENT 1051 HISTOPATHOLOGY.05 Immunohistochemistry P16 P53 P57 S100 HMB45 CMV Parvovirus Oestrogen Receptor Progesterone Receptor HPL HCGp PLAP Inhibin CA 125 Calretinin CEA WT1 D240 Factor VIII Chromogranin A Synaptophysin CD 56 Ki67/p16 dual stain CD3/CD138 dual stain PROXEXC BCL 2 CK 5/6 Pax 8 Edition 13, 22/01/2018 240MT Page 16 of 23
ANATOMIC PATHOLOGY DEPARTMENT INAB Classification Number (P9).05 Immunohistochemistry Test/Assay Name Specimen Type Immunohistochemistry staining methods Human tissue PP-CS-AP-45 SOP Edition 13, 22/01/2018 240MT Page 17 of 23
HAEMATOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP White Cell Count RF/DC detection method Flow Cytometry XP-300 33 39 Red Cell Count Haemaglobin RF/DC detection method Flow Cytometry SLShaemoglobin method XP-300 XP-300 33 39 33 39 1030 Haematology Counts Haematocrit Mean Cell Volume Calculated from RBC and MCV Indirect measurement (mean of RBC vol) XP-300 XP-300 33 39 33 39 MCH MCHC Calculation derived from HGB, RBC & MCV Calculation derived from HGB, HCT XP-300 XP-300 33 39 33 39 Platelet Count RF/DC detection method Flow Cytometry (FC) XP-300 33 39 Edition 13, 22/01/2018 240MT Page 18 of 23
HAEMATOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1030 Haematology Visual Examination of Films.05 Automated Differential Leucocyte Counts Includes Neutrophils Lymphocytes Monocytes Eosinophils, Basophils Red Cell Morphology Platelet Morphology Staining/Microscopy Hematek Stainer Staining/Microscopy Hematek Stainer Staining/Microscopy Hematek Stainer Staining/Microscopy Hematek Stainer Staining/Microscopy Hematek Stainer 17 20 17 20 17 20 17 20 17 20 Neutrophil Count Flow Cytometry 33 Lymphocyte Count Flow Cytometry 33 Monocyte Count Flow Cytometry 33.06 Automated Reticulocyte Counts Eosinophil Count Flow Cytometry 33 Edition 13, 22/01/2018 240MT Page 19 of 23
HAEMATOLOGY DEPARTMENT.06 Automated Reticulocyte Counts Basophil Count NRBC s Flow Cytometry Flow Cytometry Sysmex Xe 33 33 Flow Cytometry Sysmex Xe 33 Edition 13, 22/01/2018 240MT Page 20 of 23
HAEMATOLOGY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1030 Haematology.40 Limited Haemostasis Related Tests Prothrombin Time (PT) Citrate Transmitted, Light Detection Method Sysmex CS- 2100i CA-660 34 38.41 General Haemostasis Related Tests International Normalised Ratio (INR) Activated Partial Thromboplastin Time (APTT) Fibrinogen (Clauss) Citrate Citrate Citrate Ratio Calculation Transmitted, Light Detection Method Transmitted, Light Detection Method Sysmex CS- 2100i CA-660 Sysmex CS- 2100i CA-660 Sysmex CS- 2100i CA-660 34 38 34 38 34 38.30 Tests for Haemoglobin Variants and Thalassaemia.31 Tests for Foetal HB Sickle Screen (Sickledex) Estimation of Foetal Maternal Haemorrhage- Kleihauer Test Qualitative Solubility Test Semi-Quantative Acid Elution/Microscopy 13 19.09 Malaria Screen Immunodiagnostic test 7 Edition 13, 22/01/2018 240MT Page 21 of 23
BIOCHEMISTRY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1061 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Albumin Alk. Phosphatase Amylase Aspartate Transaminase Alanine Transaminase Bilirubin-Direct Bilirubin-Total Calcium Chloride CK Creatinine Glucose ( & CSF) LDH Magnesium Potassium Inorganic Phosphate Sodium Total Protein Triglyceride Urate Urea Bile Acids Calcium Chloride Creatinine Inorganic Phosphate Potassium Protein Sodium Osmolality Urine Urine Colourimetric, turbidimetric, latex agglutination, homogenous EIA and indirect ISE Colourimetric, turbidimetric, latex agglutination, homogenous EIA and indirect ISE Advanced Micro- Osmometer 3320 Beckman Coulter AU680 Chemistry Analyser Beckman Coulter AU680 Chemistry Analyser Osmometer 3320 PP-CS-BIO-1 Routine Operation of the AU680 Clinical Chemistry Analyser PP-CS-BIO-1 Routine Operation of the AU680 Clinical Chemistry Analyser PP-CS-BIO-34 Operation of the Advanced Micro- Osmometer 3320 Edition 13, 22/01/2018 240MT Page 22 of 23
BIOCHEMISTRY DEPARTMENT INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 1061 Proteins, quantitative analysis CRP Fructosamine CSF Protein analysis & CSF Colourimetric & Immunoturbidimetric Beckman Coulter AU680 Chemistry Analyser PP-CS-BIO-1 Routine Operation of the AU680 Clinical Chemistry Analyser HCG Immunoassay Roche Cobas e411 PP-CS-BIO-33 Operation of The Roche Cobas e411.10 Drugs for therapeutic monitoring.32 Maternal markers for foetal wellbeing Oestradiol Ca 125 AMH Free T4 TSH Gentamicin Serum Immunoassay Enzyme Immunoassay Roche Cobas e411 Beckman Coulter AU680 Chemistry Analyser PP-CS-BIO-33 Operation of The Roache Cobas e411 PP-CS-BIO-1 Routine Operation of the AU680 Clinical Chemistry Analyser Free BHCG PAPP-A Serum Immunofluorometric assays based on the use of europium chelate labels with detection by time resolved fluorometry DELFIA Xpress Analyser PP-CS-BIO- 28: Routine Operation of the DELFIA Xpress Analyser Edition 13, 22/01/2018 240MT Page 23 of 23