Naas General Hospital

Transcription

1 Pathology Laboratory, Naas, Co. Kildare Registration number: 259MT 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 15189:212 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: 13:4:21 Date of last renewal of accreditation: 13:4:215 Expiry date of this certificate of accreditation: 13:4:22 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: Chairperson: Dr. Adrienne Duff Mr. Tom O Neill Issued on 2 April 216 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 17, 4/4/ MT Page 1 of 15

2 Schedule of (Annex to Certificate) NAAS GENERAL HOSPITAL Initial Registration Date : 13-April - 21 Postal Address: Transfusion Laboratory 13-Apr-21 (Address of other locations Haematology Laboratory 31-May-211 as they apply) Biochemistry Laboratory 25-Oct-211 Microbiology Laboratory 25-Oct-211 Naas Co Kildare Telephone: +353 (45) Fax: +353 (45) helen.dolan@hse.ie Contact Name: Ms. Helen Dolan Facilities: Public testing service Edition 17, 4/4/ 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 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 1725 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 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 17, 4/4/ MT Page 3 of 15

4 INAB Classification number (P9) Materials/products tested 12.1 Immunohaematology grouping including ABO, Rh(D).3 Group antibody screen Identification of blood group antibodies Type of test/properties measured Range of measurement Whole Plasma Plasma Standard specifications Equipment/techniques used method in gel cassettes. method in tubes. Automated method in gel cassettes. NGH/BB/SOP/4 method in gel cassettes. method in tubes. Automated method in gel. NGH/BB/SOP/6 method in gel. method in tubes NGH/BB/SOP/7.5 Determination of compatibility of donor units using appropriate techniques including the investigation of transfusion reactions Plasma method in gel. method in tubes. NGH/BB/SOP/1 Note: has been assessed and is competent to comply with Articles 14 and 15 of the EU Directive 22/98/EC (S.I.No. 36 of 25 and S.I. No. 547 of 26) Edition 17, 4/4/ MT Page 4 of 15

5 INAB Classification number (P9) Materials/products tested 12.6 Immunohaematology Red cell phenotyping Type of test/properties measured Range of measurement Red cells Standard specifications Equipment/techniques used method in gel. method in tubes NGH/BB/SOP/9.99 Miscellaneous Tests Direct Antiglobulin Test (DAT) for detection of sensitized cells Red Cells method in gel. method in tubes Automated method in gel. NGH/BB/SOP/8 Note: has been assessed and is competent to comply with Articles 14 and 15 of the EU Directive 22/98/EC (S.I.No. 36 of 25 and S.I. No. 547 of 26) Edition 17, 4/4/ MT Page 5 of 15

6 Haematology Department INAB Classification 13 HAEMATOLOGY.1 BLOOD COUNTS 13 HAEMATOLOGY.3 Erythrocyte Sedimentation Rate Test/Assay Name White Cell Count Red Cell Count Haemoglobin Haematocrit Mean Cell Volume MCH MCHC Platelet Count Erythrocyte Sedimentation Rate (Automated) Specimen Type Method Equipment SOP Flow Cytometry Light Scatter Flow Cytometry Impedence Absorption Spectrophotometry Calculated from Red Cell Count and MCV Flow Cytometry Calculated from Haemoglobin and Red Cell Count Calculated from Haemoglobin, MCV and Red Cell Count Flow Cytometry Optical Sedimentation of RBCs ALIFAX Test - 1 NGH/HAEM/SOP/21 Scope of Edition 17, 4/4/ MT Page 6 of 15

7 Haematology Department INAB Classification Test/Assay Name Specimen Type Method Equipment SOP Includes: Neutrophils Film Staining/Microscopy Hematek Stainer Nikon Microscopes NGH/HAEM/SOP/2 13 HAEMATOLOGY Lymphocytes Monocytes Film Staining/Microscopy Hematek Stainer Nikon Microscopes NGH/HAEM/SOP/2 Visual examination of blood films Eosinophils Basophils Precursor cells Platelets Film Staining/Microscopy Hematek Stainer Nikon Microscopes NGH/HAEM/SOP/2 Red Cell Morphology Film Staining/Microscopy Hematek Stainer Nikon Microscopes NGH/HAEM/SOP/2 Neutrophil Count Flow Cytometry Light Scatter 13 HAEMATOLOGY.5 Automated differential leucocyte counts Lymphocyte Count Flow Cytometry Light Scatter Monocyte Count Flow Cytometry Light Scatter Eosinophil Count Flow Cytometry Light Scatter Basophil Count Flow Cytometry Light Scatter.6 Automated reticulocyte counts Reticulocyte Count Fluorescence Flow Cytometry Edition 17, 4/4/ MT Page 7 of 15

8 Haematology Department INAB Classification Test/Assay Name Specimen Type Method Equipment SOP 13 HAEMATOLOGY Prothrombin Time (PT) Photo-Optical Technology Sysmex CS- 21i NGH/HAEM/SOP/6.41 General haemostasis related tests International Normalised Ratio (INR) Calculation using PT result, mean normal PT and ISI Sysmex CS- 21i NGH/HAEM/SOP/6 Activated Partial Thromboplastin Time (APTT) Photo-Optical Technology Sysmex CS- 21i NGH/HAEM/SOP/6 Fibrinogen (Clauss) Photo-Optical Technology Sysmex CS- 21i NGH/HAEM/SOP/6 D-Dimer Photo-Optical Technology Sysmex CS- 21i NGH/HAEM/SOP/6 13 HAEMATOLOGY Malaria Film Examination Staining/ Microscopy NGH/HAEM/SOP/25 Binax Now Screening Test Immuochromatograhi c Test NGH/HAEM/SOP/25 Edition 17, 4/4/ MT Page 8 of 15

9 Biochemistry Department INAB Classification Test /Assay name Specimen type Method Equipment SOP 161 GENERAL CHEMISTRY.1 Analytes in general use in cardiac, liver function, lipid, renal & other profiles & metabolic studies Acetaminophen Colorimetric assay Alanine Aminotransferase (ALT) TRIS buffer without pyridoxal phosphate activation, acc. to IFCC Albumin BCG Colorimetric assay Alkaline Phosphatase (ALP) AMP buffer IFCC Colorimetric assay NGH/BIO/SOP/21 NGH/BIO/SOP/22 NGH/BIO/SOP/23 NGH/BIO/SOP/24 Amylase Aspartate Aminotransferase (AST) Calcium Calcium corrected Calculated Chloride Indirect ISE Cholesterol Creatine Kinase (CK) Creatinine egfr Calculated C-Reactive Protein (CRP) Free Thyroxine (FT4) Gamma Glutamyltransferase (GGT) Glucose Enzymatic colorimetric assay acc. to IFCC G7 substrate TRIS buffer without pyridoxal phosphate activation - IFCC 5-nitro-5 -methyl-bapta (NM-BAPTA) Enzymatic colorimetric assay CK N-acetylcysteine - IFCC Compensated Kinetic Jaffe Particle enhanced immunoturbidimetric assay Competition principle Electrochemiluminescence immunoassay Enzymatic colorimetric assay IFCC - Carboxynitroanilide Enzymatic reference method with Hexokinase NGH/BIO/SOP/25 NGH/BIO/SOP/26 NGH/BIO/SOP/27 NGH/BIO/SOP/2 NGH/BIO/SOP/28 NGH/BIO/SOP/29 NGH/BIO/SOP/32 NGH/BIO/SOP/31 NGH/BIO/SOP/2 NGH/BIO/SOP/3 NGH/BIO/SOP/53 NGH/BIO/SOP/34 NGH/BIO/SOP/35 Edition 17, 4/4/ MT Page 9 of 15

10 Biochemistry Department INAB Classification Test /Assay name Specimen type Method Equipment SOP 161 GENERAL CHEMISTRY.1 Analytes in general use in cardiac, liver function, lipid, renal & other profiles & metabolic studies High Density Lipoprotein (HDL) Lactate Dehydrogenase (LDH) Calculated Low Density Lipoprotein (cldl) Homogeneous enzymatic colorimetric assay L-Lactate to Pyruvate IFCC. N-methylglucamine Calculated NGH/BIO/SOP/36 NGH/BIO/SOP/37 NGH/BIO/SOP/49 Magnesium Colorimetric endpoint method Xylidyl Blue NGH/BIO/SOP/39 Microalbumin Phosphate Potassium Immunoturbidimetric assay Phosphomolybdate UV Indirect ISE Salicylate Enzymatic method Sodium Indirect ISE NGH/BIO/SOP/51 NGH/BIO/SOP/4 NGH/BIO/SOP/41 NGH/BIO/SOP/42 NGH/BIO/SOP/43 Thyroid Stimulating Hormone (TSH) Sandwich Principle Electrochemiluminescence Immunoassay NGH/BIO/SOP/54 Total Bilirubin Colorimetric Diazo method Creatinine EDTA/ Enzymatic Method Total Protein Troponin T hs Plasma Colorimetric Biuret assay Turbidimetric method Sandwich Principle Electrochemiluminescence Immunoassay Triglyceride Enzymatic Colorimetric NGH/BIO/SOP/72 NGH/BIO/SOP/31 NGH/BIO/SOP/45 NGH/BIO/SOP/5 NGH/BIO/SOP/57 NGH/BIO/SOP/46 Edition 17, 4/4/ MT Page 1 of 15

11 Biochemistry Department INAB Classification 161 GENERAL CHEMISTRY.1 Analytes in general use in cardiac, liver function, lipid, renal & other profiles & metabolic studies Test /Assay name Urea Uric Acid Specimen type Method Equipment SOP Kinetic urease NGH/BIO/SOP/47 Enzymatic Colorimetric test Endpoint uricase.1 CSF Glucose CSF mmol/l CSF Total Protein CSF mg/dl.1 NT-PRO BNP Plasma 5-35 mg/ml 161 GENERAL CHEMISTRY.1 Drugs for Therapeutic monitoring 161 GENERAL CHEMISTRY.14 Alcohol for nonlegal purposes 161 GENERAL CHEMISTRY.5 Protein and peptide tumour markers Hexokinase Turbidimetric Electrochemilumi nescence NGH/BIO/SOP/48 NGH/BIO/SOP/35 NGH/BIO/SOP/52 NGH/BIO/SOP/44 Lithium Serum Colorimetric assay NGH/BIO/SOP/38 Ethanol Prostate Specific Antigen (PSA).6 Glycated Haemoglobins HbA1c EDTA/ General Chemistry Enzymatic method with alcohol dehydrogenase Sandwich Principle Electrochemiluminescence Immunoassay Reverse phase cation exchange chromatography hcg Beta.1-1 iu/l Gentmicin Serum Kinetic interaction of microparticles (Enzyme immunoassay ) Adams Arkay HA- 818V Electrochemilumi nescence C311 NGH/BIO/SOP/33 NGH/BIO/SOP/55 NGH/BIO/SOP/59 NGH/BIO/SOP/58 NGH/MIC/SOP/21.1 Drugs for therapeutic monitoring Vancomycin Serum Enzyme Immunoassay C311 NGH/MIC/SOP/21 Edition 17, 4/4/ MT Page 11 of 15

12 Microbiology Department INAB Classification Test/ Assay Name Specimen Type Method Equipment SOP 111 BACTERIOLOGY.1.3 CSF CULTURE CSF Microscopy NGH/MIC/SOP/ FLUID CULTURES Amniotic Fluid Ascitic Fluid Bursa Fluid Pericardial Fluid Peritoneal Fluid Pleural Fluid Synovial Fluid Microscopy 2 Edition 17, 4/4/ MT Page 12 of 15

13 Microbiology Department INAB Classification Test/Assay Name Specimen Type Method Equipment SOP Faeces Culture Faeces NGH/MIC/SOP/1 111 BACTERIOLOGY.1.3 Cervical Culture Ear Culture Cervical Swab Ear Swab Middle Ear Effusion Microscopy Eye Culture High Vaginal Culture Eye Swab Canalicular Pus High Vaginal Swab (HVS) Vaginal Discharge Vulval Swab Labial Swab Microscopy Low Vaginal Culture Mouth Culture MRSA Screen Low Vaginal Swab Mouth Swab Nasal, Throat, Axilla, Groin, Perineum and other sites depending on clinical information MicroscopyC ulture/ Microscopy if requested 1 NGH/MIC/SOP/3 Nasal Culture Nasal Swab Edition 17, 4/4/ MT Page 13 of 15

14 Microbiology Department INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 111 BACTERIOLOGY.1.3 Penile Culture Penile Swab Microscopy 1 Throat Culture Throat Swab Urethral Culture Sputum and Associated Specimens culture Urethral Swab Bronchoalveolar Lavage, Sputum and Associated Specimens Microscopy Microscopy if required 1 NGH/MIC/SOP/1 3 Tip Culture Intravascular cannulae & associated specimens Culture Wound Culture Clostridium difficile culture removed Antimicrobial susceptibility testing CLSI method Identification &Antimicrobial susceptibility testing on the BD Phoenix BAG CATCH CSU MSU SUPRA PUBIC Exudates Pus Swabs Faeces Bacterial cultures Bacterial cultures MicroscopyC ulture/ Microscopy if required latex id/ eliza toxin id CLSI Eucast Automated NGH/MIC/SOP/ 1 NGH/MIC/SOP/1 2 NGH/MIC/SOP/8 NGH/MIC/SOP/8 1 Edition 17, 4/4/ MT Page 14 of 15

15 Microbiology Department INAB Classification Number (P9) 112 PARASITOLOGY Test/ Assay Name Specimen Type Method Ova, Cysts & Parasites Pneumococcal Antigen Test Legionella Antigen Test Equipment SOP Faeces Microscopy NGH/MIC/SOP/11 Qualitative Pos/Neg Qualitative Pos/Neg Immunochrom atographic membrane assay Immunochrom atographic membrane assay NGH/MIC/SOP/3 NGH/MIC/SOP/3 Edition 17, 4/4/ MT Page 15 of 15