RSCI Group St. Luke's Hospital

Transcription

1 RSCI Group St. Luke's Hospital Pathology Laboratory, Rathgar, Dublin 6 Testing Laboratory Registration number: 205MT 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 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: 08:07:2013 Expiry date of this certificate of accreditation: 08:07:2018 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: Dr Adrienne Duff Issued on 15 September 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 15, 11/10/17 205MT Page 1 of 15

2 Schedule of (Annex to Certificate) ST. LUKE'S HOSPITAL Pathology Laboratory, Rathgar, Dublin 6 Blood Transfusion Chemistry/Haematology/Microbiology Initial Registration Date : 10-June Sept Postal Address: (Address of other locations as they apply) Pathology Laboratory, Rathgar, Dublin 6 Telephone: +353 (1) Fax: +353 (1) Alice.Melvin@slh.ie Contact Name: Ms Alice Melvin Facilities: Normally not available for Public Testing Edition 15, 11/10/ MT Page 2 of 15

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 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 a site laboratory a mobile laboratory or 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 15, 11/10/ MT Page 3 of 15

4 MICROBIOLOGY DEPARTMENT MICROBIOLOGY INAB Classification Number (P9) 1011 Bacteriology Test/Assay Name Specimen Type Method Equipment SOP.01 Preparation of films for microscopic examination CSF, Fluids Manual, microscopy LP-MIC-010, LP-MIC Bacteriology.03 Microscopic Examination of clinical specimens, CSF, Fluids Manual, microscopy, cell count LP-MIC-011, LP-MIC-010, LP-MIC-008 Edition 15, 11/10/ MT Page 4 of 15

5 MICROBIOLOGY DEPARTMENT 1011 Bacteriology.02 Inoculation of Cultures, Faeces, Eye Swab, Nasal Swab, Mouth/Throat Swab, Ear swab, Genital tract swabs, Sputum and associated specimens, MRSA cultures, Pus, exudates, Skin swabs, Wound swabs, CSF, Intravascular, Fluids Manual Culture LP-MIC-001, LP-MIC-011, LP-MIC-012, LP-MIC-015, LP-MIC-014, LP-MIC-003, LP-MIC-013, LP-MIC-016, LP-MIC-004, LP-MIC-002, LP-MIC-005, LP-MIC-010, LP-MIC-006, LP-MIC-007, LP-MIC-008, LM-MIC-025 Edition 15, 11/10/ MT Page 5 of 15

6 MICROBIOLOGY DEPARTMENT 1011 Bacteriology Bacteriology.05 Identification of organisms including antibiotic sensitivity testing Identification of organisms excluding antibiotic sensitivity testing, Faeces, Eye Swab, Nasal Swab, Mouth/Throat Swab, Ear swab, Genital tract swabs, Sputum and associated specimens, MRSA culture, Pus, exudates, Skin swabs, Wound swabs, CSF, Intravascular, Fluids, Faeces, Eye Swab, Nasal Swab, Mouth/Throat Swab, Ear swab, Genital tract swabs, Sputum and associated specimens, MRSA culture, Pus, exudates, Skin swabs, Wound swabs, CSF, Intravascular, Fluids Manual, gram, identification test methods including biochemical tests. Antibiotic susceptibility testing (EUCAST) Manual, gram, identification test methods including biochemical tests, LM-MIC-001, LM-MIC-002, LM-MIC-003, LM-MIC-004, LM-MIC-005, LM-MIC-006, LM-MIC-007, LM-MIC-008, LM-MIC-009, LM-MIC-010, LM-MIC-012, LM-MIC-014, LM-MIC-017, LM-MIC-021, LM-MIC-022, LM-MIC-023, LM-MIC-024, LM-MIC-025, LM-MIC-026, LM-MIC-027, LP-MIC-031 LM-MIC-001, LM-MIC-002, LM-MIC-003, LM-MIC-004, LM-MIC-005, LM-MIC-006, LM-MIC-007, LM-MIC-008, LM-MIC-009, LM-MIC-012, LM-MIC-017, LM-MIC-021, LM-MIC-022, LM-MIC-023, LM-MIC-024, LM-MIC-025, LM-MIC-026, LP-MIC-031 Edition 15, 11/10/ MT Page 6 of 15

7 MICROBIOLOGY DEPARTMENT 1011 Serology of Infection Serology of Infection Serology of Infection.06 Legionella Urinary Antigen Testing Detection of bacterial antigens Streptococcus Pneumoniae Urinary Antigen Testing Detection of bacterial antigens Testing for Toxins Detection of bacterial antigens Faeces Manual kit BinaxNOW Legionella Urinary Antigen Test - an immunochrom ato-graphic membrane assay Manual kit BinaxNOW Streptococcus Pneumoniae Urinary Antigen Test - an immunochrom ato-graphic membrane assay Manual kit ImmunoCard Toxins A&B a rapid qualitative enzyme LM-MIC-016 LM-MIC-015 LM-MIC-013 Edition 15, 11/10/ MT Page 7 of 15

8 MICROBIOLOGY DEPARTMENT INAB Classification Number (P9) 1011 Bacteriology Serology of Infection.06 Test / Assay Name Specimen Type Method Equipment SOP Identification of organisms excluding antibiotic sensitivity testing Legionella Urinary Antigen Testing Detection of bacterial antigens.06 Testing for Toxins Detection of bacterial antigens, Faeces, Eye Swab, Nasal Swab, Mouth/Throat Swab, Ear swab, Genital tract swabs, Sputum and associated specimens, MRSA culture, Pus, exudates, Skin swabs, Wound swabs, CSF, Intravascular, Fluids Faeces Manual, gram, identification test methods including biochemical tests, Manual kit BinaxNOW Legionella Urinary Antigen Test - an immunochromato-graphic membrane assay Manual kit ImmunoCard Toxins A&B a rapid qualitative enzyme LM-MIC-001, LM- MIC-002, LM-MIC- 003, LM-MIC-004, LM-MIC-005, LM- MIC-006, LM-MIC- 007, LM-MIC-008, LM-MIC-009, LM- MIC-012, LM-MIC- 017, LM-MIC-021, LM-MIC-022, LM- MIC-023, LM-MIC- 024, LM-MIC-025, LM-MIC-026, LP-MIC- 031 LM-MIC-016 LM-MIC-013 Edition 15, 11/10/ MT Page 8 of 15

9 BLOOD TRANSFUSION DEPARTMENT INAB Classification Number (P9) 1020 Immunohaematology.01 Blood Grouping including ABO, RH(D) Test / Assay Name Specimen Type Method Equipment SOP EDTA Ortho BioVue Antibody Screening EDTA Ortho BioVue Antibody Identification EDTA Ortho BioVue Compatibility Testing EDTA Ortho BioVue Rhesus Phenotyping EDTA Ortho BioVue Direct Coombs Testing EDTA Ortho BioVue Antigen Typing EDTA Ortho BioVue Manual Cassette Method & Manual tube method Manual Cassette Method Manual Cassette Method Manual Cassette Method Manual tube Method Manual Cassette Method Manual Cassette Method LM-BBT-001 ABO & Rh (D) Typing (Method) LM-BBT-002 ABO & Rh (D) Typing (Tube Method) LM-BBT-005 Antibody Screening LM-BBT-006 Identification of Red Cell Antibodies LM-BBT-003 LM-BBT-009 Rhesus Phenotyping LM-BBT-008 Direct Test LM-BBT-010 Antigen Typing Note: St Luke s Hospital Rathgar 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 15, 11/10/ MT Page 9 of 15

10 HAEMATOLOGY DEPARTMENT INAB Classification Number (P9) 1030 Haematology Test / Assay Name Specimen Type Method Equipment SOP Automated Differential Leucocyte counts Neutrophils, Lymphocytes, Monocytes, Eosinophils Basophils. Blood Counts MCV, MCH, MCHC, RDW, MPV EDTA Whole Blood Sample EDTA Whole Blood Sample Flow cytometry Flow cytometry, colorimetry, derivations/ calculations Cell Dyn Ruby/3200 Cell Dyn Ruby/3200 LP-HAEM-005 LP-HAEM-019 LP-HAEM-005 LP-HAEM Visual examination of blood films Blood Film examination of red cell, white cell and platelet morphology White Cell Differential (Manual) includes Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils EDTA Whole Blood Sample Manual microscopy Hematek Staining Machine and Manual microscopy LP-HAEM Erythrocyte Sedimentation Rate (ESR) ESR Sample (Sodium Citrate) S-Sediplus (R) Enclosed ESR System S-Sediplus (R) Enclosed ESR System LP-HAEM Prothrombin Time (PT) Sodium Citrate Plasma Clotting time - Light scatter clot detection Sysmex CA-1500 LP-HAEM-006 International Normalised Ratio (INR) Sodium Citrate Plasma Calculation Sysmex CA-1500 LP-HAEM-006 Edition 15, 11/10/ MT Page 10 of 15

11 HAEMATOLOGY DEPARTMENT INAB Classification Number (P9) 1030 Haematology.41 Test / Assay Name Specimen Type Method Equipment SOP Activated Partial Thromboplastin Time (APTT) Fibrinogen Sodium Citrate Plasma Sodium Citrate Plasma Clotting time - Light scatter clot detection Clauss - Light scatter clot detection Sysmex CA-1500 Sysmex CA-1500 LP-HAEM-006 LP-HAEM-006 D-Dimer Sodium Citrate Plasma Immunoturbidimetric- Detection of D-Dimer cross-linkage Sysmex CA-1500 LP-HAEM-006 Edition 15, 11/10/ MT Page 11 of 15

12 BIOCHEMISTRY DEPARTMENT INAB Classification Number (P9) Test/Assay Name Specimen Type Method 1061 General Chemistry.01 Alkaline Phosphatase (ALP) Alanine (ALT) Amylase amino Transferase (AST) Bilirubin Total Diazo Para-nitrophenol phosphate Pyruvate to lactate in presence of NADH CNPG3 substrate to 2 chloro-4 nitrophenol NADH (without P- 5 -P) Calcium Arsenazo III Equipment Calcium adjusted Calculation Manual Chloride/ Urinary Chloride Cholesterol Total Creatinine Clearance ISE (Diluted) indirect Enzymatic Cholesterol esters to cholesterol Calculation: U x V /P X 1440 N/A SOP Edition 15, 11/10/ MT Page 12 of 15

13 BIOCHEMISTRY DEPARTMENT Creatinine/ Urinary Creatinine Estimated Glomerular Filtration Rate Gamma Transferase (GGT) Glucose Lactate Dehydrogenase (LDH) Lactate Magnesium Plasma - Sodium Fluoride/EDTA Plasma - Sodium Fluoride/EDTA Kinetic Alkaline Picrate Calculation derived from Creatinine Test using 4V-MDRD Formula. L-gamma-glutamyl- 3 carboxy-4 nitroanilile substrate Hexokinase Lactate pyruvate (NADH) Lactic Acid Pyruvate (lactate oxidase) Enzymatic NADP - NADPH Phosphate Phosphomolybdate Potassium/ Urinary Potassium Sodium/ Urinary Sodium Triglycerides ISE (Diluted) Indirect ISE (Diluted) Indirect Glycerolphosphate oxidase N/A Edition 15, 11/10/ MT Page 13 of 15

14 BIOCHEMISTRY DEPARTMENT 1061 General Chemistry.02 Proteins-quantitative 1061 General Chemistry.20 Hormones Hs-Troponin I Plasma - Lithium Heparin Urate (Uric Acid) Uricase Urea Nitrogen Urease Protein/ Ratio Calculation & Calculation Albumin Green C-Reactive Protein (CRP) Globulin Protein (total) Biuret Urinary Protein (total) Chloride T4 (Free) Thyroid Stimulating Hormone (TSH) Turbidimetric latex Calculation: Total Protein-Albumin =Globulin i2000sr N/A i2000sr LP-BIO-005 LP-BIO-006 LP-BIO-005 LP-BIO-006 Edition 15, 11/10/ MT Page 14 of 15

15 BIOCHEMISTRY DEPARTMENT 1061 General Chemistry.50 Protein and peptide tumour markers 1061 Alpha Feto Protein (AFP) -Human Chorionic Gonadotropin ( -HCG) CA 15-3 Carcinoembryonic Antigen (CEA) PSA (Total) i2000sr i2000sr i2000sr i2000sr i2000sr LP-BIO-005 LP-BIO-006 LP-BIO-005 LP-BIO-006 LP-BIO-005 LP-BIO-006 LP-BIO-005 LP-BIO-006 LP-BIO-005 LP-BIO-006 General Chemistry.65 Pregnancy Test sample Alere Anti-hCG Monoclonal Antibody Manual LP-BIO-014 Pregnancy Tests qualitative Edition 15, 11/10/ MT Page 15 of 15