Midland Regional Hospital Portlaoise Pathology Laboratory, Portlaoise, Co. Laois Medical Testing Laboratory Registration number: 203MT is accredited by the Irish National Accreditation Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 15189:2007 2nd Edition “Medical laboratories – Particular requirements for quality and competence” (This Certificate must be read in conjunction with the Annexed Schedule of Accreditation) Date of award of accreditation: 28:10:2008 Date of last renewal of accreditation: 17:05:2013 Expiry date of this certificate of accreditation: 17:05:2018 This Accreditation shall remain in force until further notice subject to continuing compliance with INAB accreditation criteria, ISO/IEC 15189 and any further requirements specified by the Irish National Accreditation Board. Manager: Chairperson: Dr Adrienne Duff Mr Tom O’Neill Issued on 17 May 2013 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 Accreditation Board. The INAB is a signatory of the European co-operation for Accreditation (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement. Edition 7, 22/04/2014 203MT Page 1 of 9 Wilton Park House, Wilton Place, Dublin 2, Ireland Tel +353 1 607 3003 Fax +353 1 607 3109 E-mail [email protected] Web www.inab.ie Schedule of Accreditation (Annex to Accreditation Certificate) Permanent Laboratory: Category A MIDLAND REGIONAL HOSPITAL PORTLAOISE Co Laois Medical Testing Laboratory Initial Registration Date : 28-October-2008 Blood Transfusion Testing Laboratory Haematology Testing 19-October-2010 Laboratory Biochemistry Testing 06-November-2012 Laboratory Postal Address: Pathology Laboratory (Address of other Midland Regional Hospital locations as the apply) Portlaoise Co Laois Telephone: +353 (57) 8696269 Fax: +353 (57) 8696275 E-mail: [email protected] Contact Name: Ms Elizabeth Ryan Facilities: Public testing service Edition 7, 22/04/2014 203MT Page 2 of 12 Wilton Park House, Wilton Place, Dublin 2, Ireland Tel +353 1 607 3003 Fax +353 1 607 3109 E-mail [email protected] Web www.inab.ie Schedule of Accreditation Permanent Laboratory: Category A 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/IEC 17025 or ISO/IEC 15189 (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: Category A: 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: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Accreditation Board. Category C: 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 Accreditation Board. Category D: 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) portable test equipment (b) a site laboratory (c) a mobile laboratory or (d) 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: Commercial operations which actively seek work from others. Conditionally available for public calibration/testing: Established for another primary purpose but, more commonly than not, is available for outside work. Normally not available for public calibration/testing: 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 Accreditation 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 7, 22/04/2014 203MT Page 3 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Blood Transfusion Testing Laboratory INAB Classification number (P9) Materials/products tested 1020 .01 Type of test/properties measured Range of measurement Immunohaematology Standard specifications Equipment/techniques used Red Blood Cells P/BT/SOP/002 Plasma / Serum Manual (Tube and Gel card) Blood grouping including ABO Rh (D) 1020 Immunohaematology Plasma / Serum P/BT/SOP/002 Manual Gel method .03 Blood group antibody screen 1020 Immunohaematology .04 Identification of blood Plasma / Serum P/BT/SOP/004 Manual Gel method group antibodies 1020 .05 Immunohaematology Plasma / Serum and red blood P/BT/SOP/003 cells P/BT/SOP/002 Determination of P/BT/SOP/004 compatibility of donor P/BT/SOP/007 units using appropriate Manual Gel method techniques including the investigation of transfusion reactions Edition 7, 22/04/2014 203MT Page 4 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A 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 Red blood cells P/BT/SOP/004 Immunohaematology Manual Gel and Tube .06 Red cell phenotyping 1020 Immunohaematology methods Red blood cells P/BT/SOP/006 Manual Gel method .99 Direct Coombs Test Note: Midland Regional Hospital Portlaoise Blood Bank 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 7, 22/04/2014 203MT Page 5 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1030 Full Blood Count including P/HAEM/SOP/001 Haematology White Cell Count .01 Blood Counts Red Cell Count Haemaglobin Mean Cell Volume Platelet Count 1030 Haematology Visual examination of Blood P/HAEM/SOP/005 Films including White Cell .02 Blood films Differential and cell morphology 1030 Haematology Erythrocyte Sedimentation Rate P/HAEM/SOP/003 (semi automated) .03 1030 Erythrocyte Erythrocyte Sedimentation Rate Sedimentation Rate (Manual) in blood Haematology Automated Differential P/HAEM/SOP/001 Leucocyte Counts including .05 Automated Differential Neutrophils, Lymphocytes, Leucocyte Counts Monocytes, Eosinophils and Basophils 1030 Haematology .06 Automated Reticulocyte Automated Reticulocyte Counts P/HAEM/SOP/001 Counts Edition 7, 22/04/2014 203MT Page 6 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1030 Blood film examination for P/HAEM/SOP/009 Haematology malarial parasites .09 Examination for Malarial Parasites Edition 7, 22/04/2014 203MT Page 7 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Haematology Testing Laboratory INAB Classification number (P9) Materials/products tested Type of test/properties measured Range of measurement Standard specifications Equipment/techniques used 1030 Sickle Cell screen (Qualitative P/HAEM/SOP/010 Haematology Solubility Test) in EDTA and .30 Tests for Blood Haemoglobin Variants 1030 Haematology Kleihauer Test, Manual (Visual P/HAEM/SOP/011 examination of blood films) .31 Tests for foetal Hb 1030 Haematology Prothrombin Time Internationalised Normalised .41 General haemostasis Ratio related tests Activated Partial P/COAG/SOP/004 Thromboplastin Time P/COAG/SOP/004 Fibrinogen D dimer P/COAG/SOP/005 In EDTA, Blood and Citrate Plasma P/COAG/SOP/006 P/COAG/SOP/007 1030 Haematology Screening test for Infectious P/HAEM/SOP/014 Mononucleosis Qualitative test .57 Screening test for infectious mononucleosis 1012 Parasitology Detection of parasitic antigens P/HAEM/SOP/009 Qualitative antigen test for .04 Detection of parasitic malaria antigens Edition 7, 22/04/2014 203MT Page 8 of 12 Scope of Accreditation Permanent Laboratory: Midland Regional Hospital Portlaoise Category A Medical Testing Laboratory BIOCHEMISTRY DEPARTMENT INAB Classification Number (P9) 1061 General Chemistry .01 Analytes in general use Test/Assay Name Specimen Type Method Equipment SOP Alkaline Phosphatase (ALP) Serum, Heparin Plasma Colourimetric Roche Modular P P BIO SOP 023 Alanine Amino-transferase (ALT) Serum, Heparin Plasma IFCC w/o pyridoxal phosphate Roche Modular P P BIO SOP 024 Aspartate Aminotransferase (AST) Serum, Heparin Plasma IFCC w/o pyridoxal phosphate Roche Modular P P BIO SOP 026 Creatine Kinase (CK) Serum, Heparin Plasma UV Roche Modular P P BIO SOP 031 Total Bilirubin (TB) (TBil) Serum, Heparin Plasma Colourimetric Roche Modular P P BIO SOP 058 Direct Bilirubin(DB) Serum, Heparin Plasma Diazonium Roche Modular P P BIO SOP 027 Gammaglutamyltransferase (GGT) Serum, Heparin Plasma IFCC enzymatic colourimetric Roche Modular P P BIO SOP 038 Cholesterol (Chol) Serum, Heparin Plasma Enzymatic colourimetric Triglyceride (Trig) (Tg) Serum, Heparin Plasma Enzymatic colourimetric Roche Modular P Roche Modular P Low Density Lipid (LDL) Serum, Heparin Plasma Enzymatic colourimetric Roche Modular P P BIO SOP 044 High Density Lipid (HDL) Serum, Heparin Plasma Enzymatic colourimetic Roche Modular P P BIO SOP 040 Lactate Dehydrogenase (LDH) Serum, Heparin Plasma Photometric Roche Modular P P BIO SOP 043 Uric Acid (UA) Serum, Heparin Plasma Urine Enzymatic Roche Modular P P BIO SOP 055 Serum, Heparin Plasma, Urine ISE indirect Roche Modular I P BIO SOP 041 Potassium (K) Serum, Heparin Plasma,Urine ISE indirect Roche Modular I P BIO SOP 041 Chloride (Cl) Serum, Heparin Plasma,Urine ISE indirect Roche Modular I P BIO SOP 041 Amylase (AMY) Serum, Heparin Plasma IFCC Roche ModularP P BIO SOP 025 Calcium (Ca) Serum, Heparin Plasma, Urine Colourimetric Roche Modular P P BIO SOP 057 Sodium (Na) Edition 7, 22/04/2014 203MT Page 9 of 12 P BIO SOP 030 P BIO SOP 051 Scope of Accreditation Permanent Laboratory: Midland Regional Hospital Portlaoise Category A Medical Testing Laboratory BIOCHEMISTRY DEPARTMENT INAB Classification Number (P9) 1061 General Chemistry .01 Analytes in general use Test/Assay Name Specimen Type Method Equipmen t SOP Magnesium (Mg) Serum, Heparin Plasma, Urine Colourimetric Roche Modular P P BIO SOP 045 Inorganic Phosphate (i Phos) (Phos) Serum, Heparin Plasma, Urine Ammonium Molybate Roche Modular P P BIO SOP 047 Urea Serum, Heparin Plasma Kinetic UV Urease Roche Modular P P BIO SOP 054 Enzymatic colourimetric Roche Modular P P BIO SOP 042 UV Hexokinase Roche Modular P P BIO SOP 037 Enzymatic Colourimetric Roche Modular P P BIO SOP 033 Cobas E411 P BIO SOP 049 P BIO SOP 046 Lactate (Lact) Glucose (Glu) Creatinine (Creat) 1061 General Chemistry .02 Quantitative analysis of proteins Sodium Fluroide Plasma Sodium Fluroide Plasma, Heparin Plasma Serum, CSF Serum, Heparin Plasma, Urine Troponin T hs STAT (Trop) Serum, Heparin Plasma Immunoassay Nt-proBNP (BNP) Serum, Heparin Plasma Immonoassay Osmolality Serum, Urine Freezing point Albumin (ALB) Serum, Heparin Plasma Colourimetric Bromocresol Green Cobas E411 Fiske OneTen Micorosmo mete Roche Modular P C Reactive Protein (CRP) Serum, Heparin Plasma Immunoturbidimetri c Roche Modular P P BIO SOP 034 Total Protein (TP) Serum, Heparin Plasma Colourimetric Biuret reaction Roche Modular P P BIO SOP 050 CSF/Urine Protein CSF, Urine Benzethonium Chloride Roche Modular P P BIO SOP 052 Urine Immunoturbidimetri c Roche Modular P P BIO SOP 021 Microalbumin (Malb) Edition 7, 22/04/2014 203MT P BIO SOP 008 P BIO SOP 020 Page 10 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Medical Testing Laboratory BIOCHEMISTRY DEPARTMENT INAB Classification Number (P9) Test/Assay Name Specimen Type Method Equipment SOP 1061 General Chemistry .14 Alcohol for non-legal purposes Ethanol Serum, Heparin Plasma Enzymatic Roche Modular P P BIO SOP 035 Acetaminophen (Acet) Serum, Heparin Plasma Colourimetric Roche Modular P P BIO SOP 022 Salicylate (Sal) Serum, Heparin Plasma Colourimetric Roche Modular P P BIO SOP 048 Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Barbiturates (Bar) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Benzodiapenes (BZO) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Cocaine (Coc) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Methadone (MTD) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Opiates (Opi) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Marijuana (THC) Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 Urine Fluorescent Immunoassay Triage Meter Plus P BIO SOP 011 1061 General Chemistry .15 Drugs for Toxicological purposes 1061 General Chemistry .15 Drugs for Toxicological Purposes Amphetamines (Amp) Methamphetamines (Met Amp) Tricyclic Antidepressants (TCA) Edition 7, 22/04/2014 203MT Page 11 of 12 Scope of Accreditation Midland Regional Hospital Portlaoise Permanent Laboratory: Category A Medical Testing Laboratory BIOCHEMISTRY DEPARTMENT INAB Classification Number (P9) Test/Assay Name Specimen Type Method Equipment SOP 1061 General Chemistry .20 Hormones Total human Chorionic Gonadotropin (hCG) Serum, Heparin plasma Immunoassay Cobas E411 P BIO SOP 039 1061 General Chemistry .40 Iron Studies Iron (Fe) Serum, Heparin plasma Colourimetric Roche Modular P P BIO SOP 036 Unconjugated Iron Binding Capacity (UIBC) Serum, Heparin plasma Photometric Roche Modular P P BIO SOP 053 1061 General Chemistry .06 Blood pH and gas tensions pH Whole Blood Potentiometric Roche Omni S2 P BIO SOP 007 p02 Whole Blood Clarke measurement of current Roche Omni S2 P BIO SOP 007 pCO2 Whole Blood Potentiometric Roche Omni S2 P BIO SOP 007 Edition 7, 22/04/2014 203MT Page 12 of 12
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