University Hospital Waterford

Transcription

1 Pathology Department, Dunmore Road, Waterford Medical Testing Laboratory Registration number: 170MT 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: 13:12:2005 Date of last renewal of accreditation: 16:07:2015 Expiry date of this certificate of accreditation: 16:07:20 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 Issued on 16th July 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 31, 30/06/ MT Page 1 of 36

2 Schedule of (Annex to Certificate) Insert accreditation symbol here UNIVERSITY HOSPITAL WATERFORD Medical Testing Laboratory Department: Initial Registration Date : 13-December-2005 Microbiology Department Blood Transfusion Department Haematology Department Biochemistry Department Histopathology Department Postal Address: Dunmore Road (Address of other locations Waterford as they apply) Telephone: +353 (51) Dec April Sept Sept Dec-2010 Fax: +353 (51) Contact Name: Facilities: Ms. Carmel Cullen Public testing service Edition 31, 30/06/ MT Page 2 of 36

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 (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 31, 30/06/ MT Page 3 of 36

4 Blood Transfusion Testing Laboratory INAB Classification number (P9) Materials/products tested 1020 Immunohaematology Blood grouping including ABO, Rh(D) Type of test/properties measured Range of measurement Blood grouping including ABO & Rh(D) Red cells Standard specifications Equipment/techniques used PPC-PATH-BT-003 (ABO & Rh(D) Grouping by test tubes and DiaMed Gel System).03 Blood Group antibody screen.04 Identification of blood group antibodies.05 Determination of compatibility of donor units using appropriate techniques including the investigation of transfusion reactions 1020 Immunohaematology.06 Red cell phenotyping Antibody Screening- Plasma Antibody Identification Plasma Compatibility testing Plasma Red Cell Phenotyping Red Cells WRH-BT-LP-020 ( Method in Test Tube) PPC-PATH-BT-004 ( & Automated Methods by DiaMed Gel System) PPC-PATH-BT-010 ( & Automated Methods by DiaMed Gel System) WRH-BT-LP-50 ( Method by DiaMed Gel System) WRH-BT-LP-051 ( Method by Test Tube) PPC-PATH-BT-007- Rh & Kell Phenotyping ( & Automated methods by DiaMed Gel System) PPC-PATH-BT-008- Extended Phenotyping ( Method by Test Tube) Edition 31, 30/06/ MT Page 4 of 36

5 Blood Transfusion Testing Laboratory INAB Classification number (P9) Materials/products tested Immunohaematology Miscellaneous tests Type of test/properties measured Range of measurement DCT- Direct Coombs testing Red Cells Standard specifications Equipment/techniques used PPC-PATH-BT-009 Polyspecific & Monospecific DCT Testing ( & Automated Methods by DiaMed Gel System and test tubes) Note: Blood Transfusion Department, Dunmore Road, Waterford 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 31, 30/06/ MT Page 5 of 36

6 Microbiology Testing Laboratory INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1010 Microbiology Investigation of specimens of Sputum, bronchoalveolar lavage and associated specimens Investigation of Blood cultures Investigation of fluids from sterile sites Investigation of faeces specimens for bacterial pathogens Investigation of Urine specimens Investigation of Ear, Nose, Throat, and related specimens Sputum Bronchoalveolar lavage Bronchial aspirate Bronchial washings Cough swab Nasopharyngeal swab/ aspirate Pleural fluid Blood Joint fluid Amniotic fluid Ascitic fluid Bursa fluid Pericardial fluid Peritoneal fluid Synovial fluid CAPD fluid Hydrocele fluid Faeces Rectal swab Urine Throat swab Nasal swab Ear swab Mouth/tongue swab Antrum washout Middle ear effusion Endotracheal tube Microscopy, culture and sensitivity BacT Alert Blood culture system microscopy, culture and sensitivity Microscopy, culture and sensitivity Microscopy, culture and sensitivity Microscopy, culture and sensitivity Microscopy, culture and sensitivity BacT Alert 3D system, Semiautomated TM-A-MT001 TM-A-MB001 TM-A-MB003 MT-A-MF001 TM-A-MU001 PPC-PATH-MIC-22 TM-A-MW001 Edition 31, 30/06/ MT Page 6 of 36

7 Microbiology Testing Laboratory INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1010 Microbiology Investigation of superficial wound swabs and intravascular cannulae Investigation of abscesses, postoperative wounds and deep seated wound infections Investigation of eye swabs, contact lens and fluid, intraocular fluids and corneal scrapings Wound swab Skin swab Infected cyst swab Ulcer swab Line/catheter tips Exit site swab Deep seated wound swabs Pus Abscess swab Bile Drain fluids Eye swab Conjuntival swab Corneal ulcer swab Orbital cellulitis swab Eyelid swab Lacrimal swab/stone Contact lens/fluid Corneal screppings Intraocular fluid Aqueous humour Vitreous humour Canalicular pus Microscopy, culture and sensitivity Microscopy, culture and sensitivity Microscopy, culture and sensitivity TM-A-MW002 TM-A-MW003 TM-A-MW004 Investigation of tissues, biopsies, bone and prosthetic devices specimens Biopsy specimens Prosthetic devices Products of conception Microscopy, culture and sensitivity TM-A-MW006 Edition 31, 30/06/ MT Page 7 of 36

8 Microbiology Testing Laboratory INAB Classification Number (P9) 1010 Microbiology Microbiology Test / Assay Name Specimen Type Method Equipment SOP Investigation of Infection Screen Swabs from Neonates Investigation of Genital Tract and associated specimens Investigation of specimens for Mycobacterium species Throat/oral swab Ear swab Eye swab Nasal swab Umbilical swab Axilla swab Groin swab Perineal swab High vaginal swab Low vaginal swab Vulval/labial swab Endocervical/ cervical swab Bartholins cyst swab Penile swab Subprepuce/Meatus swab Urethral swab Genital ulcer swab Rectal swab Bartholins gland aspirate Fallopian tube aspirate Pouch of Douglas aspirate Tubo-ovarian abscess Intra-uterine device Sputum Bronchoalveolar lavage Bronchial aspirate Bronchial washings Early morning urine CSF Blood Bone marrow Pleural/pericardial fluid Pus Gastric lavage CAPD fluid Swabs Microscopy, culture and sensitivity Microscopy, culture and sensitivity MB/BacT Alert system Microscopy, culture, nucleic acid amplification MB/Bact Alert, GeneXpert TM-A-MW007 TM-A-MV001 TM-A-MT002 Edition 31, 30/06/ MT Page 8 of 36

9 Microbiology Testing Laboratory INAB Classification Number (P9) 1010 Microbiology 1013 Test / Assay Name Specimen Type Method Equipment SOP Screening of specimens for Methicillin resistant Staphylococcus aureus MRSA Nasal swab Throat swab Perineal swab Urine Sputum Wound swab Culture and sensitivity TM-A-MM Screening for Vanomycin-resistant Enterococci Rectal swab Perineal swab Faeces Urine Wound swab Culture and sensitivity TM-A-MM Microbiology Screening of specimens, and management of isolates for carbapenem resistance in Enterobacteriaceae Rectal swab Faeces Wound swab Urine Tip Isolates Culture and sensitivity, nucleic acid amplification, GeneXpert TM-A-MM Investigation of CSF CSF Microscopy, culture and sensitivity, nucleic acid amplification, Biofire filmarray TM-A-MB002 Edition 31, 30/06/ MT Page 9 of 36

10 Microbiology Testing Laboratory INAB Classification Number (P9) 1010 Microbiology Test / Assay Name Specimen Type Method Equipment SOP Antimicrobial Resistance Testing Determination of Minimum Inhibitory Concentration Bacterial cultures Bacterial cultures Zone measurements Minimum inhibitory concentration using gradient MIC strips Biomic Biomic TM-A-MG001 TM-A-MG Antifungal susceptibility testing Fungal isolates Minimum inhibitory concentration using Yeast One TM-A-MG Microbiology Investigation of specimens other than blood for parasites Faeces Duodenal/jejunal aspirates Sellotape slide Urine Liver/spleen aspirates Sputum Bronchoalveolar lavage Microscopy TM-A-MF Microbiology Investigation of specimens for superficial mycoses Hair Nail Skin Microscopy, culture and sensitivity TM-A-MW Clinical Chemistry.71 Faecal occult blood Faeces Test cards- Guaiac PPC-PATH-MIC-4 Edition 31, 30/06/ MT Page 10 of 36

11 Microbiology Testing Laboratory INAB Classification Number (P9) 1010 Microbiology Test / Assay Name Specimen Type Method Equipment SOP Detection of Legionella and Pneumococcal urinary antigens Investigation of faeces for viral agents Detection of Respiratory Syncytial Virus (RSV) Detection of Helicobacter pylori antigen in faecal specimens Molecular screening of faecal specimens for Salmonella, Shigella, Campylobacter, Verotoxigenic E.coli, Cryptosporidium and Giardia Urine Faeces Rectal swab Nasopharyngeal Aspirate specimens Faeces Faeces Immunochromatographic membrane assay Immunochromatographic membrane assay Immunochromatographic membrane assay Immunochromatographic membrane assay Nucleic acid amplification Epmotion 5070, Roche Lightcycler 480 TM-A-MU001 TM-A-MF004 TM-A-MT004 PPC-PATH-MIC-26 TM-A-MF Microbiology Molecular detection of Norovirus Molecular Detection of Influenza A, Pandemic (H1N1) 2009 and Influenza B Molecular detection of Chlamydia trachomatis and Neisseria gonorrhoea Faeces Nasopharyngeal aspirate/washes/s wab Endocervical/ vaginal swab Urethral swab Urine Nucleic acid amplification Nucleic acid amplification Nucleic acid amplification MagNa Pure, Roche lightcycler 480, GeneXpert GeneXpert Abbott m2000 system TM-A-MF006 TM-A-MS030 PPC-PATH-MIC-33 Confirmatory assay for the molecular detection of Neisseria gonorrhoea PCR Extract Nucleic acid amplification Roche lightcycler 1.5 TM-A-MV Microbiology Molecular detection of Legionella species Investigation of faeces specimens for toxigenic Clostridium difficile Respiratory specimens Faeces Nucleic acid amplification Nucleic acid amplification Magna Pure, Roche lightcycler 480 Epmotion 5070, Roche Lightcycler 480, GeneXpert PPC-PATH-MIC-10 TM-A-MF005 Edition 31, 30/06/ MT Page 11 of 36

12 Microbiology Testing Laboratory INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1010 Microbiology Detection of HIV Ag/Ab Enzyme immunoassay VIDAS TM-A-MS008 Detection of VZV IgG Enzyme immunoassay Detection of Rubella IgG Detection of Hepatitis A IgM Detection of Hepatitis BsAg Detection of Hepatitis BsAg antibody Detection of Measles antibodies IgG Detection of Mumps IgG antibodies Detection of Hepatitis C antibody Detection of antibody to Hepatitis B core antigen Enzyme immunoassay Enzyme immunoassay Enzyme immunoassay VIDAS VIDAS VIDAS VIDAS TM-A-MS009 TM-A-MS010 TM-A-MS011 TM-A-MS012 Enzyme immunoassay VIDAS TM-A-MS0013 Enzyme immunoassay Enzyme immunoassay Enzyme immunoassay Chemiluminescent microparticle immunoassay VIDAS VIDAS VIDAS Abbott Architect TM-A-MS027 TM-A-MS028 TM-A-MS033 TM-A-MS018 Detection of Hepatitis BsAg Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS Microbiology Detection of Hepatitis C antibody Detection of Hepatitis A IgG Chemiluminescent microparticle immunoassay Chemiluminescent microparticle immunoassay Abbott Architect Abbott Architect TM-A-MS021 TM-A-MS022 Detection of HIV Ag/Ab Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS023 Detection of CMV IgG Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS034 Detection of CMV IgM Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS035 Edition 31, 30/06/ MT Page 12 of 36

13 Microbiology Testing Laboratory INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP Detection of EBV EBNA IgG Chemiluminescent microparticle immunoassay Abbott Architect PPC-PATH-MIC-11 Detection of EBV VCA IgM Chemiluminescent microparticle immunoassay Abbott Architect PPC-PATH-MIC-12 Detection of EBV VCA IgG Chemiluminescent microparticle immunoassay Abbott Architect PPC-PATH-MIC Microbiology Detection of Rubella IgG Detection of Hepatitis A IgM Detection Hepatitis B surface antigen antibody (Anti-HBs) Chemiluminescent microparticle immunoassay Chemiluminescent microparticle immunoassay Chemiluminescent microparticle immunoassay Abbott Architect Abbott Architect Abbott Architect TM-A-MS024 TM-A-MS025 TM-A-MS026 Detection of Hepatitis C virus antigen Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS029 Detection of Toxoplasma IgG Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS031 Detection of Toxoplasma IgM Chemiluminescent microparticle immunoassay Abbott Architect TM-A-MS032 Edition 31, 30/06/ MT Page 13 of 36

14 Haematology Testing Laboratory INAB Classification Number (P9) 1030 Haematology Blood Counts.04 Automated Differential Leucocyte Counts.06 Automated Reticulocyte Counts 1030 Haematology.02 Test/Assay Name Specimen Type Method Equipment SOP White Cell Count (WBC) Red Cell Count (RBC) Blood Blood Fluorescence Flow Cytometry Hydrodynamic Focussing Direct Current (DC) detection Haemoglobin (Hb) Blood Sodium Lauryl Sulphate (SLS) Haemoglobin Haematocrit (HCT) Mean Cell Volume (MCV) Blood Blood Cumulative Pulse Measurement Calculated MCH Blood Calculated MCHC Blood Calculated Platelet Count Blood Hydrodynamic Focussing Direct Current (DC) detection Automated Blood Fluorescence Neutrophil Count Automated Lymphocyte Count Automated Monocyte Count Automated Eosinophil Count Automated Basophil Count Automated Reticulocyte Count Blood Blood Blood Blood Blood Flow Cytometry Fluorescence Flow Cytometry Fluorescence Flow Cytometry Fluorescence Flow Cytometry Fluorescence Flow Cytometry Fluorescence Flow Cytometry Neutrophils Blood Staining/ Microscopy XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 XN 10/XN 20 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-101 WRH-HAE-LP-102 WRH-HAE-LP-403 Microscopic examination of Edition 31, 30/06/ MT Page 14 of 36

15 Haematology Testing Laboratory Visual Examination of Blood Films Lymphocytes Blood Staining/ Microscopy Monocytes Blood Staining/ Microscopy Eosinophils Blood Staining/ Microscopy Blood Films Basophils Blood Staining/ Microscopy Red Cell Morphology Blood Staining/ Microscopy Edition 31, 30/06/ MT Page 15 of 36

16 Haematology Testing Laboratory INAB Classification Number (P9) 1030 Haematology.09 Examination for Malarial Parasites Test/Assay Name Malaria blood film Examination Specimen Type Method Equipment SOP Blood Staining/Microscopy WRH-HAE-LP- 404 Malaria blood film Examination Optimal Screening test Blood Immunochromatographic Test WRH-HAE-LP- 211 Opimal malaia Kit Binax NOW Screening test Blood Immunochromatographic Test WRH-HAE-LP- 212 Binax NOW malaria kit.30 Tests for haemoglobin variants and thalassaemia Haemoglobin S Detection Solubility Screening test for HbS Blood Solubility Screening test for HbS (WRH-HAE-LP- 204) Detection of Hb S(WRH-HAE-LP Tests for Foetal HB Kleihauer Test (Screening only) Blood Staining and microscopy WRH-PATH-LP- 203 Detection of Foetal Maternal Haemorrhage Edition 31, 30/06/ MT Page 16 of 36

17 Haematology Testing Laboratory INAB Classification Number (P9) Test/Assay Name.57 Screening test for Infectious Mononucleosis Heterophile Antibody.41 General Haemostasis Related Tests Glycohaemoglobins Prothrombin Time (PT) International Normalised Ratio (INR) Activated Partial Thromboplastin Time (APTT) Specimen Type Method Equipment SOP Blood Clotting CS-5100 CS-2500 Blood Clotting CS-5100 CS-2500 Blood Clotting CS-5100 CS-2500 Fibrinogen Blood Clotting CS-5100 CS-2500 D-Dimer Blood CS-5100 CS-2500 HbA1c Blood HPLC Tosoh G8 WRH-HAE-LP-205 WRH-HAE-LP-001 WRH-HAE-LP-002 WRH-HAE-LP-001 WRH-HAE-LP-002 WRH-HAE-LP-001 WRH-HAE-LP-002 WRH-HAE-LP-001 WRH-HAE-LP-002 WRH-HAE-LP-001 WRH-HAE-LP-002 WRH-HAE-LP-206 Edition 31, 30/06/ MT Page 17 of 36

18 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 General Chemistry Test/Assay Name Alainine Amino Transferase (ALT) Specimen Type Method Equipment SOP Serum Colorimetric.02 Albumin Serum Immunoturbidim etric.99 Alpha 1 Antitrypsin (A1AT) Alkaline Phosphate (ALP).20 Alpha Fetoprotein (AFP) Serum Immunoturbidim etric Serum Colorimetric Serum Electrochemilu minescence Amylase Serum Colorimetric.85 Anti Thyroglobulin.85 Anti Thyroid Peroxidase Serum Serum Electrochemi Luminescence Electrochemi Luminescence WRH-BIO-LP- G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas WRH-BIO-LP G003 Cobas Edition 31, 30/06/ MT Page 18 of 36

19 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 General Chemistry Test/Assay Name Asparate Amino Transferase (AST) Specimen Type Method Equipment SOP Serum Colorimetric Cobas.06 Base Excess Blood Calculated b221 Bicarbonate Serum 2 Point Rate Bilirubin - Direct Serum Diazo Bilirubin - Total Serum Colorimetric WRH-BIO-LP-M012 Operation of the b221 Cobas Cobas Cobas Cobas Cobas Edition 31, 30/06/ MT Page of 36

20 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 GENERAL CHEMISTRY.05 Test/Assay Name Specimen Type Method Equipment SOP Carboxyhaemoglobin Blood Cooximetry Roche Cobas b221 WRH-BIO-LP-M012 Operation of the Roche COBSAS Chloride Serum Ion Selective Electrode Roche Cobas Cobas Cholesterol Serum Enzymatic Colorimetric Roche Cobas Cobas.20 Cortisol Serum Electrochemilu minescence Roche Cobas Cobas Creatine Kinase (CK) Serum UK Test Roche Cobas Cobas Creatinine Serum CRP (C Reactive Protein) 1061 GENERAL CHEMISTRY.20 Follicile Stimulating Hormone (FSH) Gamma Glutamyl Transferase (GGT) Serum Serum Serum.10 Gentamicin Serum Jaffe Rate Method Particle Enhanced Immuno Turbidimetric Assay Electrochemilu minescence Enzymatic colorimetric Homogenous Enzyme Roche Cobas Roche Cobas Roche Cobas Roche Cobas Roche Cobas Glucose Plasma UV Test Roche Cobas.99 Haptoglobin Serum Turbidimetric Roche Cobas Cobas Cobas Cobas Cobas Cobas Cobas Cobas Edition 31, 30/06/ MT Page 20 of 36

21 Biochemistry Testing Laboratory.20 HCG - Beta Serum.06 HC03 Heparinise d Blood Electrochemilu minescence Calculated Roche Cobas Roche Cobas b221 Cobas WRH-BIO-LP-M012 Operation of the b221 Edition 31, 30/06/ MT Page 21 of 36

22 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 GENERAL CHEMISTRY Test/Assay Name High Density Lipoprotein (HDL) Specimen Type Serum Method Equipment SOP Homogeneous Enzymatic Colorimetric Cobas.40 Iron Serum Colorimetric Lactate Dehydrogenase (LDH) Serum/Fluid Enzymatic Colorimetric.20 LH Serum Electrochemilu minescence Low Density Lipoprotein (LDL) Serum Calculated.20 Macroprolactin Serum PEG pptte Magnesium Serum Colorimetric.20 Oestradiol Serum Electrochemilu minescence.99 Osmolality Serum / Urine Freezing Point Depression Advanced Instruments Model 3320 Osmometer.10 Paracetamol Serum 2 Point End.06 pco2 Heparin Blood Potentiometric b ph Heparin Blood Potentiometric b po2 Heparin Blood Potentiometric b Phenobarbitone Serum Kinetic Interaction of Microparticles in solution Cobas Cobas Cobas Cobas Cobas Cobas Cobas WRH-BIO-LP M004 Osmolality Cobas WRH-BIO-LP M012 Operation of the b221 WRH-BIO-LP M012 Operation of the b221 WRH-BIO-LP M012 Operation of the b221 Cobas Edition 31, 30/06/ MT Page 22 of 36

23 Biochemistry Testing Laboratory 1061 GENERAL CHEMISTRY.10 Phosphate - inorganic Phenytoin Serum Particle Enhanced turbidimetric Inhibition Serum Molybdate UV Potassium Serum ISE Cobas Cobas Cobas.20 Progesterone Serum Electrochemilu minescence.20 Prolactin Serum Electrochemilu minescence Cobas Cobas.02 Protein-Total Serum / Fluid Colorimetric Cobas.20 PSA - Total Serum Electrochemilu minescence.20 PTH Plasma Electrochemilu minescence Cobas Cobas.10 Salicylate Serum Colorimetric Sodium Serum ISE Cobas Cobas Edition 31, 30/06/ MT Page 23 of 36

24 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 GENERAL CHEMISTRY.06 Test/Assay Name Standard Bicarbonate Specime n Type Method Equipment SOP Blood Calculated b221 WRH-BIO-LP M012 Operation of the b Sweat Test Sweat Chloride Wescor Sweat Check 3120 Sweat Conductivity.06 Total CO2 Blood Calculated b Testosterone Serum.10 Theophylline Serum.20 T3 - Free Serum.20 T4 - Free Serum Triglycerides Serum.20 Thyroid Stimulating Hormone (TSH) Serum Electrochemilu minescence Particle Enhanced Turbidimetric Inhibition Method Electrochemilu minescence Electrochemilu minescence Enzymatic Colorimetric Test Electrochemilu minescence WRH-BIO-LP- M007 Sweat Testing WRH-BIO-LP M012 Operation of the b221 Cobas Cobas Cobas Cobas Cobas Cobas Edition 31, 30/06/ MT Page 24 of 36

25 Biochemistry Testing Laboratory INAB Classification Number (P9) 1061 GENERAL CHEMISTRY.40 Test/Assay Name Transferrin Specimen Type Serum Method Equipment SOP Immunoturbidometric Cobas.40 Transferrin Saturation Serum Calculated Urea Serum Kinetic Uric Acid Serum Enzymatic Colorimetric.10 Valproate Serum Homogeneous Enzyme.10 Vancomycin Serum Electrochemilu minescence.10 Amikacin Serum KIMS - Kinetic interaction of microparticles in solution.10 Tobramycin Serum Homogeneous Enzyme OH Vitamin D Serum ECLIA- Electrochemilum inescence.20 CA9 Serum ECLIA- Electrochemilum inescence Management of Cobas Management of Cobas Management of Cobas Management of Cobas Cobas Cobas Cobas Cobas Cobas WRH-BIO-LP-G003 WRH-BIO-LP-G003 WRH-BIO-LP-G003 WRH-BIO-LP-G003 Edition 31, 30/06/ MT Page 25 of 36

26 Biochemistry Testing Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type Method Equipment SOP 1061 GENERAL CHEMISTRY.81 Electrophoresis Serum/Urine Capillary/ Urine: Agarose Gel Sebia Minicap Sebia Hydrasys 2 WRH-BIO-LP-P008 Serum Protein Electrophoresis on the Minicap WRH-BIO-LP-P009 Urine Electrophoresis.81 Immunofixation Serum/Urine Agarose Gel / Immunofixation.80 Immunoglobin IgA.80 Immunoglobulin IgG.80 Immunoglobulin IgM.82 Total Immunoglobulin IgE (Allergy Screen).83 Rheumatoid Factor Serum Serum Serum Serum Serum Immunoturbidimetric Immunoturbidimetric Immunoturbidimetric Electrochemilu minescence Immunoturbidimetric Assay Sebia Hydrasys 2 WRH-BIO-LP-P003 Protein Immunofixation WRH-BIO-LP-G003 Cobas WRH-BIO-LP-G003 Cobas WRH-BIO-LP-G003 Cobas WRH-BIO-LP-G003 Cobas WRH-BIO-LP-G003 Cobas 1040 IMMUNOLOGY.88 Beta-2 Microglobulin (B2M) Serum Immunoturbidometric Cobas.86 C3 Serum Immunoturbidometric Cobas.86 C4 Serum Immunoturbidim etric Cobas Edition 31, 30/06/ MT Page 26 of 36

27 Biochemistry Testing Laboratory.50 CA 125 Serum Electrochemilu minescence Cobas.50 CA 153 Serum Electrochemilu minescence Cobas.50 CEA Serum Electrochemilu minescence Cobas.10 Digoxin Serum Electrochemilu minescence Cobas.60 Haemoglobin A1C EDTA Blood HPLC Menarini HA Lithium Serum Colorimetric.45 Vitamin B12 Serum.45 Folate Serum.40 Ferritin Serum Corrected Calcium Serum egfr Serum Electrochemilumines cence competition principle Electrochemilumines cence competition principle Electrochemillumines cence Sandwich Principle Calculated Calculated TM-A-MT003 Nat.Std. method, HPA UK Cobas Cobas Cobas Cobas Cobas Cobas Edition 31, 30/06/ MT Page 27 of 36

28 Histopathology Testing Laboratory INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 1051 HISTOPATHOLOGY Processing fixed specimens for Histopathological testing Cut-up Processing Specimens for Examination description, dissection and block selection, Gross Imaging system Sample Vacuum impregnation Automated Processors WRH-HIS-LP- 001, 002, 017 WRH-HIS-LP- 007 Embedding Processed Sample tissue orientation in wax Embedding Centres WRH-HIS-LP- 003 Microtomy Automated Haematoxyli n & Eosin Staining / Coverslipping Paraffin Embedded Sample section on Cutting and selection of representative tissue sections Automated application of reagents and coverslip Standard microtomy equipment Automated Haematoxylin & Eosin Stainer/ Coverslipper WRH-HIS-LP- 004 WRH-HIS-LP HISTOPATHOLOGY.02 Processing fresh specimens for frozen section examination Immediate Frozen section diagnosis Frozen Sample Gross Descriptions, Cryostat Microtomy, Programmed Automated Application of Staining Reagents, Microscopic Examination Cryostat, Automated Haematoxylin & Eosin Stainer WRH-HIS-LP- 300 Edition 31, 30/06/ MT Page 28 of 36

29 INAB Classification Number (P9) 1051 HISTOPATHOLOGY.03 Histochemistry Test/Assay Name Specimen Type Method Equipment SOP Alcian Blue Section Application of Reagents Alcian Blue/PAS Section Application of Reagents Giemsa Section Application of Reagents WRH-HIS-LP-006 WRH-HIS-LP-006 WRH-HIS-LP-006 Gordon and Sweets Silver Impregnation Section Application of Reagents Gram Stain Section Programmed application of Reagents Grocott s Methenamine Silver Highmans Congo Red Section Section Application of Reagents Application of Reagents WRH-HIS-LP-006 WRH-HIS-LP-006 WRH-HIS-LP-006 WRH-HIS-LP-006 Martius Scarlet Blue (MSB) Section Application of Reagents WRH-HIS-LP-006 Massons Trichrome Section Application of Reagents WRH-HIS-LP-006 Millers Elastin Section Application of Reagents PAS Section Application of Reagents PAS-D Section Application of Reagents WRH-HIS-LP-006 WRH-HIS-LP-006 WRH-HIS-LP-006 Perls Prussian Blue Section Application of Reagents WRH-HIS-LP-006 Weigerts Van Gieson Section Application of Reagents WRH-HIS-LP-006 Shikata Orcein Section Application of Reagents Ziehl Neelsen Section Application of Reagents WRH-HIS-LP-006 WRH-HIS-LP-006 Edition 31, 30/06/ MT Page 29 of 36

30 INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 1051 HISTOPATHOLOGY.040 Histological Interpretation Diagnostic Pathology (including placental and products of conception pathology). Human Gross Descriptions, Dissections and Block Selection Microscopic Examination Digital Slide Imager PPC-PATH-HIS-6 PPC-PATH-HIS HISTOPATHOLOGY Alk Prot (CD246) Ag/Ab reaction.05 Immunohisto - chemistry Bcl-2 Ag/Ab reaction Bcl-6 Ag/Ab reaction BerEp4 Ag/Ab reaction BOB-1 Ag/Ab reaction Ca125 Ag/Ab reaction Calretinin Ag/Ab reaction CAM 5.2 Ag/Ab reaction CD1A Ag/Ab reaction Edition 31, 30/06/ MT Page 30 of 36

31 Histopathology Testing Laboratory Permanent Laboratory: INAB Classification Number (P9) 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Test/ Assay Name CD3 CD4 CD5 CD8 CD10 CD15 CD20 CD21 CD23 CD30 CD31 CD34 CD56 CD68 CD79A CD117 CD138 CDX-2 CEA Specimen Type Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Section on Method Equipment SOP Edition 31, 30/06/ MT Page 31 of 36

32 Histopathology Testing Laboratory Permanent Laboratory: INAB Classification Number (P9) 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Test/ Assay Name Chromogranin A CK5/6 CK7 CK14 CK CK20 CKAE1/3 CKHMW Cyclin D1 Desmin DOG-1 D2-40 E-Cadherin EMA Specimen Type Method Equipment SOP Edition 31, 30/06/ MT Page 32 of 36

33 Histopathology Testing Laboratory INAB Classification Number (P9) 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Test/ Assay Name ER Factor 8 Factor 13 GATA 3 Glyco-A Hepatocyte Her-2 HMB-45 Inhibin Ki-67 LCA Mammaglobin Mel-A Specimen Type Method Equipment SOP Edition 31, 30/06/ MT Page 33 of 36

34 Histopathology Testing Laboratory INAB Classification Number (P9) 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Test/ Assay Name MNF116 MPO MSI Markers (MSH2, MSH6, PMS2, MLH1) MUM-1 Napsin A NSE OCT4 P16 P40 P53 P57 P63 P504s (AMACR) Pax-5 Pax-8 Specimen Type Method Equipment SOP Edition 31, 30/06/ MT Page 34 of 36

35 Histopathology Testing Laboratory INAB Classification Number (P9) 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Test/ Assay Name PLAP Plasma Cells PR PSA PSAP S100 SMA Synaptophysin TdT Thyroglobulin TTF-1 Vimentin WT-1 Specimen Type Method Equipment SOP Edition 31, 30/06/ MT Page 35 of 36

36 Histopathology Testing Laboratory INAB Classification Number (P9) Test/ Assay Name Specimen Type Method Equipment SOP 1051 HISTOPATHOLOGY.05 Immunohisto - chemistry Kappa Lambda EBER ISH reaction Dual staining Prostate Cocktail (C4BE12 & P63) 1052 CYTOPATHOLOGY.02 Non-gynae cytology Exfoliative cytology (FNA excluded) Cytology sample preparation & description (PAP) Diagnostic interpretation & reporting Exfoliative fluids Cytocentrifu ge WRH-HIS-LP IMMUNOLOGY.12 Detection of autoantibodies in body fluids and biopsy material Skin Biopsy Direct Immunofluorescence Fresh Sample Cryostat Microtomy, Application of Reagents Cryostat WRH-HIS-LP MISCELLANEOUS Semen analysis (Screening Test) Semen analysis Fertility & Postvasectomy Semen Centrifuge Microscope PPC-PATH-HIS-12 PPC-PATH-HIS-13 PPC-PATH-HIS-14 Edition 31, 30/06/ MT Page 36 of 36