Mullingar Midland Regional Hospital

Transcription

1 Pathology Laboratory, Mullingar, Co Westmeath Testing Laboratory Registration number: 195MT 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/IEC 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: 10:06:2008 Date of last renewal of accreditation: 22:05:2013 Expiry date of this certificate of accreditation: 22:05:2018 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: Dr Adrienne Duff Chairperson: Issued on 15 April 2015 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 26, 7/4/ MT Page 1 of 16

2 Schedule of (Annex to Certificate) MULLINGAR MIDLAND REGIONAL HOSPITAL Co Westmeath Blood Transfusion Clinical Chemistry/Haematology Initial Registration Date : 10-June April Postal Address: (Address of other locations Microbiology 16-February-2016 Mullingar Co Westmeath as they apply) Telephone: +353 (44) Fax: +353 (44) jill.gillen@hse.ie Contact Name: Ms Jill Gillen Facilities: Edition 26, 7/4/ MT Page 2 of 16

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/IEC or ISO/IEC (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 26, 7/4/ MT Page 3 of 16

4 1020 Immunohaematology.01 Blood Grouping (ABO & Red Blood cells and plasma Manual method RhD Typing). - Tube LP-M/BT/5 Manual Method Gel card LP-M/BT/8 Automated method Gel Card LP-M/BT/7.03 Blood Group antibody Plasma Manual method,gel card screen LP-M/BT/10 &12 Automated method Gel Card. LP-M/BT/7.04 Identification of blood Plasma Manual Method, Gel card group antibodies LP-M/BT/12 Antibody Titration Plasma (titration method) Automated method Gel card. LP-M/BT/103 Edition 26, 7/4/ MT Page 4 of 16

5 Immunohaematology Determination of compatability of donor units using appropriate techniques including the investigation of transfusion reactions.06 Red Cell phenotyping.99 Direct Antiglobulin testing Tests for Foetal Hb Plasma Red blood cells Red Blood Cells Kleihauer test Red Blood Cells Manual - Gel Card LP-M/BT/21 Manual method Tube & Gel Card LP-M/BT/14 Automated method - Gel card LP-M/BT/7 Manual method, Gel Card LP-M/BT/30 LP-M/BT/8 Automated method - Gel Card LP-M/BT/7 LP-M/BT/29 Note: 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 26, 7/4/ MT Page 5 of 16

6 Haematology Blood counts.02 Visual Examination of blood films Blood counts - White Bld Count Red Bld Count Platelets Reticulocyte count Haemoglobin Blood Automated on Advia 2120 Analyser by: - Flow Cytometry Flow Cytometry Flow Cytometry Flow Cytometry Colourimetric method LP-M/H/1 Manual method, Miscroscopy/Staining LP-M/H/4.03 Erythrocyte Sedimentation Rate Flexible scope notes 3&4 apply Blood Automated on Vesmatic 30 by Sedimentation & Photometry, LP-M/H/3.05 Automated differential leucocyte counts flexible scope note 4 Includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils Automated on Advia 2120 Analyser by Flow Cytometry methods, LP-M/H/1.09 Exam for malarial parasites Blood Manual Method by "CARESTART" Serological test kit & Microscopy, LP- M/H/5 Edition 26, 7/4/ MT Page 6 of 16

7 Haematology Tests for Haemoglobin variants and thalassaemia.40 Limited haemostasis related tests Sickle cell screen, whole blood Haemostasis screening tests and anticoagulant monitoring. Prothrombin Time & International Normalised Ratio (INR) Activated Partial thromboplastin time, D-Dimer & Fibrinogen Manual Method by Sickle Cell kit. LP-M/H/6 Automated on the Stago Star - LP-M/C/1.57 Screening test for infectious mononucleosis. Blood / Serum Manual Method by immunoassay, LP-M/H/2 Edition 26, 7/4/ MT Page 7 of 16

8 Biochemistry Analytes in general use. Analysis of serum/plasma Aspartate amino-transferase Creatinine Kinase Alkaline Phosphatase Alanine aminotransferase Total bilirubin Direct bilirubin Gamma-Glutamyltransferase Cholesterol Creatinine (enzymatic) Triglyceride Low Density Lipid High Density Lipid Lactate Dehydrogenase Troponin I Brain natriuretic peptide Automated on Beckmann Coulter AU 680 IFCC, LP-M/B/7 IFCC,LP-M/B/12 IFCC, LP-M/B/3 IFCC, LP-M/B/4 DPD, LP-M/B/8 DPD, LP-M/B/16 IFCC, LP-M/B/20 CHO-POD LP-M/B/11 ENZ LP-M/B/54 GPO-POD LP-M/B/34 ENZ LP-M/B/26 ENZ LP-M/B/22 IFCC LP-M/B/25 LP-M/CC/1 (IA) LP-M/CC/7 (IA) 1061 Biochemistry Automated on Beckmann Coulter AU Analytes in general Sodium, Potassium, Chloride ISE Indirect, LP-M/B/23 use Amylase IFCC-EPS, LP-M/B/6 Calcium ocpc, LP-M/B/9 Creatinine kinetic jaffe, LP-M/B/14 Magnesium Colourmetric, LP-M/B/29 Phosphate Molybdate LP-M/B/32 Urea LP-M/B/40; Kinetic Uric Acid LP-M/B/37; PAP Edition 26, 7/4/ MT Page 8 of 16

9 Plasma/CSF Plasma Serum/Plasma/CSF Lactate Ammonia Glucose LP-M/B/24; ENZ LP-M/B/5; ENZ LP-M/B/21Hexokinase 1061 Biochemistry Automated on Beckman Coulter AU Quantitative analysis Albumin LP-M/B/2; BCG of proteins; C-Reactive Protein LP-M/B/15, Immunotur Serum/Plasma Total Protein LP-M/B/36; Biuret Urine Urine/CSF.10 Drugs for therapeutic monitoring Alcohol for non-legal.14 purposes Urinary Albumin Urinary/CSF protein Analysis of serum/plasma Carbamazepine Gentamycin Phenobarbitone Phenytoin Theophylline Valproic Digoxin Lithium Serum/Plasma Ethanol LP-M/B/28, Immunotur LP-M/B/38, PRM Automated on Beckmann Coulter AU680 LP-M/B/10; IA LP-M/B/19, IA LP-M/B/30,IA LP-M/B/31, IA LP-M/B/35, IA LP-M/B/41, IA LP-M/E/3, IA LP-M/CC/6, Spectrophotometric Automated on Beckmann Coulter AU680 LP-M/B/17;kinetic Edition 26, 7/4/ MT Page 9 of 16

10 .15 Drugs for toxicological purposes Analysis of serum Acetaminophen Salicylate Automated on Beckmann Coulter AU680 LP-M/B/1 LP-M/CC/ General Chemistry Automated on Beckmann.20 Hormones Analysis of serum Coulter DxI800 Free Thyroxine(FT4) Immunoassay, LP-M/E/21 Thyroid Stimulating Hormone Immunoassay, LP-M/E/16 Free Triidothyronine (FT3) Immunoassay, LP-M/E/12, Follicle Stimulating Hormone Immunoassay, LP-M/E/8, Luteinising hormone Immunoassay, LP-M/E/10, Progesterone Immunoassay, LP-M/E/13, Prolactin Immunoassay, LP-M/B/14, Oestradiol Immunoassay, LP-M/E/24, Total human chorionic Immunoassay, LP-M/B/15, gonadotropin Cortisol Immunoassay, LP-M/E/2 Testosterone Immunoassay, LP-M/E/22 PTH Immunoassay, LP-M/CC/9.40 Iron Studies Ferritin in serum Iron in serum Transferrin in serum Automated on Beckmann Coulter DxI800 Immunoassay, LP-M/E/5 LP-M/B/18; TPTZ LP/M/B/57 Immunotur Edition 26, 7/4/ MT Page 10 of 16

11 General Chemistry Vitamin B12 & folate Vitamin assays Flexible scope notes 1, Analysis of serum Vitamin D in serum Automated on Beckmann Coulter DxI800 Immunoassay, LP-M/E/17&6 LP-M/CC/8 Immunoassay Protein and peptide tumour markers Prostate Specific Antigen in serum Immunoassay, LP-M/E/11, Glycohaemoglobin Whole blood HbA1c Menarini HA-8180 LP-M/CC/ Analysis of serum.83 Quantitative Analysis of Rheumatoid factor 1070 Genetic Testing Haemochromatosis Testing /HFE Genotyping Immunoturbidimetric method, LP-M/B/47 Realtime PCR LP-M/E/25 Edition 26, 7/4/ MT Page 11 of 16

12 Immunology Quantitative investigation of immunoglobulins G, A, M in body fluids 2 3 & 4 apply..02 Qualitative investigation of immunoglobulins G, A, M in body fluids Analysis of serum Serum Protein Electrophoresis Urine Protein Electrophoresis Immunofixation, Immunotyping -Qualitative investigation of immunoglobulins G, A, M, D,E & kappa & lambda light chains in serum & urine BN Prospec / Nethelometry LP-M/I/28 Semi-Automated on Sebia Minicap & Hydrasys LC Analyser -Electrophoresis, Immunotyping and Immunofixation, LP-M/I/2 & LP-M/I/3, LP-M/I/27 Ceruloplasmin Alpha 1 antitrypsin Haptoglobin B2 Microglobulin BN Prospec / Nephelometry LP-M/I/28 Edition 26, 7/4/ MT Page 12 of 16

13 Immunology Total IgE Flexible scope note 1, 2, 3& 4 apply Analysis of serum Automated on the Phadia Immunocap 250 Analyser - Enzyme Immunoassay LP-M/I/30, LP-M/I/ Immunology Allergen-specific IgE Analysis of serum Phadia Immunocap 250 -Enzyme Immunoassay LP-M/I/30 & LP-M/I/ Immunology C3 BN Prospec / Nephelometry Investigation of C4 LP-M/I/28.06 complement Analysis of serum.12 Detection of autoantibodies in body fluids and biopsy material flexible scope notes 1, 2, 3 & 4 apply. Analysis of serum Anti-nuclear Abs Anti-Smooth Muscle Abs Anti Mitochondrial Abs Gastric Parietal cell Abs Double stranded DNA Abs Endomysial Abs Semi-Automated & Manual methods -Indirect Immunofluorescence, LP-M/I/20, LP-M/I/26 Manual method by -Indirect Immunofluorescence, LP-M/I/21, LP-M/I/22, tissue Transglutaminase Abs Automated on the Phadia Immunocap 250 Analyser - Enzyme Immunoassay Edition 26, 7/4/ MT Page 13 of 16

14 Detection of TPO antibodies LP-M/I/29 & LP-M/I/32 Phadia automatic analyser LP-M/I/24 Edition 26, 7/4/ MT Page 14 of 16

15 Microbiology Laboratory INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 1010 Macroscopic examination and description Microscopic examination of CSF & Sputum CSF/Sputum Macroscopic examination and description Microscope SP-M/M/12, Preparation of films on glass slides, microscopic examination and staining as required Detection of microbial, parasite, viral or fungal antigens Microscopic examination of General bacteriology Parasites Fungi C.Difficile H.Pylori Cryptospiridium Giardia Rotavirus Adenovirus Respiratory Syncytial virus Staphlococcus L pneumophilia S pneumoniae Urine MSU/CSU/Bag/ Suprapubic Faeces Fluid / Aspirates All swab types Tips Skin and wounds Sputum CSF Bronchial lavage Hair, skin, nail clippings Faeces Urine Aspirate Microbial cultures from liquid or solid media Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells Immunochromat ographic Slide agglutination Light fluorescent microscope Bactek FX CE marked Kit based methods SP-M/M/1, 10, 11, 2, 3, 5, 6, 9, 14, 19, 22, 18, 13, 4, 6, 18,5, 24, 9, 12, 7, 15, 10, 20 SP-M/M/1, 10, 11, 2, 3, 5, 6, 9, 14, 19, 22, 18, 13, 4, 6, 18,5, 24, 9, 12, 7, 15, 10, 20 IDP-M/M/5 LP-M/M/24 LP-M/M/39 LP-M/M/ Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids using.03 Chlamydia trachomatis Neisseira gonorrhoea Urine / swab Realtime PCR Cobas 4800 LP-M/M/42 Edition 26, 7/4/ MT Page 15 of 16

16 Microbiology Laboratory INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 1016 Identification of cultured bacteria and fungi using nonnucleic acid based techniques Culture of General bacteria Fungi As per 1012 Microbial cultures from liquid or solid media Biochemical kits MALDITOF Microscopic Morphology Vitek 2 compact API NH MaldiTof SP-M/M/1, 10, 11, 2, 3, 5, 6, 9, 14, 19, 22, 18, 13, 4, 6, 18,5, 24, 9, 12, 7, 15, 10, 20 IDP-M/M/5 IDP- M/M/24 LP- M/M/15 The laboratory has been awarded flexible scope in the P9 categories as noted in the scope document and in accordance with the laboratories approved and documented procedures. Note 1 - Range may be extended for the test Note 2 New parameters / tests may be added Note 3 New matrices may be added Note 4 Changes to equipment / kits where the underlying methodology does not change as per PS11. For further details please refer to the laboratories Master list of Flexible scope changes, available directly from the laboratory. Edition 26, 7/4/ MT Page 16 of 16