Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address Mater Private Hospital 191MT Aileen Coughlan Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 22/04/2008 Blood Transfusion Department, Eccles Street, Dublin Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Microbiology and virology Blood Transfusion Science Haematology Immunology Histopathology and cytopathology Chemical pathology Services available to the public¹ ¹ Refer to document on interpreting INAB Scopes of Accreditation Sites from which accredited services are delivered (the detail of the accredited services delivered at each site are on the Scope of Accreditation) Name Address 1 Head Office Blood Transfusion Department, Eccles Street, Dublin, D7 INAB Registration No. 191MT Page 1 of 39 Edition 2, 05/05/2018

2 Scope of Accreditation Head Office Blood Transfusion Science Category: A Medical pathology field - Test 1020 Transfusion science -.01 Blood grouping including ABO, Rh(D) and other antigens by manual s 1020 Transfusion science -.02 Blood grouping including ABO, Rh(D) and other antigens by automated s 1020 Transfusion science -.03 Blood group antibody screen 1020 Transfusion science -.05 Cross match compatible donor units 1020 Transfusion science -.06 Red cell phenotyping Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on ) Blood grouping (ABO RH (D) Typing) & antibody screen Blood grouping (ABO RH (D) Typing), Antibody Screening, Antibody Identification, Direct Coombs Testing, Antigen typing Antibody Identification Compatibility Testing Antigen Typing EDTA Type and Screen samples & serum samples for antibody screen Column agglutination technology Column agglutination technology Range of measurement Std. ref & SOP NA LM-BT-0002 Manual Method of ABO/ Rh D Grouping & Antibody Screening ID Gelstation LM-BT-0023 Automated Method of ABO /Rh D Grouping & Antibody Screening using the ID Gelstation EDTA whole blood IH500 CE N/A LS-BT-0041 Plasma / Serum Plasma EDTA Type and Screen samples Column agglutination technology Column agglutination technology Column agglutination technology ID Gelstation LM-BT-0010 Manual & Automated Methods of Antibody Identification Not Applicable LM-BT-0007 Crossmatching & Issue of Red Cells, Platelets & other Blood Products ID Gelstation LM-BT-0014 Manual & Automated Methods of Antigen Typing INAB Registration No. 191MT Page 2 of 39 Edition 2, 05/05/2018

3 1020 Transfusion science -.09 Direct antiglobulin test Direct Coombs Testing EDTA Type and Screen samples Column agglutination technology ID Gelstation LM-BT-0020 Manual & Automated Methods of Direct Antiglobulin Testing (DAT) INAB Registration No. 191MT Page 3 of 39 Edition 2, 05/05/2018

4 Head Office Chemical Pathology Category: A Medical pathology field - Test 1061 Clinical -.01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Test/assay Specimen Type Technique Equipment/Range of Measurement Albumin Serum Bromocresol green Roche Cobas Albumin Serum dye binding-bcp Siemens Serum/Fluid Bromocresol purple Siemens Alk Phos Serum Roche AMP Buffer Roche Cobas Alk Phos Serum IFCC PNPP Siemens ALT Serum Tris buffer with p5p Roche Cobas ALT Serum IFCC UV with P5P Siemens Method (CE/Non- Std. Ref & CE/In house SOP developed/based on ) INAB Registration No. 191MT Page 4 of 39 Edition 2, 05/05/2018

5 Amylase Serum/Urine Roche liquid stable pnpg7 Roche Cobas Amylase Serum/Fluid CNPG3 Siemens AST Serum Tris buffer without p5p Roche Cobas AST IFCC UV with P5P Siemens Bicarbonate Enzymatic Roche Cobas Bicarbonate Enzymatic Siemens Bilirubin Bilirubin Dichlorophenyl Diazonium Diazo- Caffeine/benzoate CouplingJ-G W/Blank Roche Cobas Siemens INAB Registration No. 191MT Page 5 of 39 Edition 2, 05/05/2018

6 Calcium Serum/Urine NM-BAPTA Roche Cobas Calcium corrected Serum Calculated Siemens Calcium serum Calculation Cresolphthalein complexone Calcium urine Urine Cresolphthalein complexone Roche Cobas Siemens Siemens Chloride Serum / urine ISE indirect Roche Cobas Chloride Serum/Urine Indirect ISE Siemens Cholesterol Total Serum Cholesterol oxidase Roche Cobas INAB Registration No. 191MT Page 6 of 39 Edition 2, 05/05/2018

7 Cholesterol total oxalate Cholestrol HDL & LDL Serum/Fluid Oxalate Siemens Serum Direct HDL & LDL Roche Cobas Direct measure PEG Siemens CK CK-NAC(IFCC) Roche Cobas CK IFCC NAC activated Siemens CKMB CK-NAC(IFCC) Roche Cobas Creatinine & creatinine clearance serum/urine Creatinine /creatinine clearance serum / urine Serum/Urine Serum / urine Alkaline Picrate( Kinetic) Roche Creatinine plus Siemens Roche Cobas CRP Serum Immunoturbidimetric Roche Cobas INAB Registration No. 191MT Page 7 of 39 Edition 2, 05/05/2018

8 Digoxin Immunoassay Roche Cobas Gamma GT Gamme glut3carb4nitro IFCC G-Glutamyl carboxy-nitroanilide Roche Cobas Siemens Globulin calculation Calculated Siemens Calculation Roche Cobas Glucose Serum/CSF/Urine Hexokinase Roche Cobas Glucose Serum/CSF/Fluid Hexokinase UV Siemens Iron Serum FerroZine without deproteinization Roche Cobas LDH Serum L to P IFCC Roche Cobas LDH Serum/Fluid IFCC Lactate - Pyruvate Siemens INAB Registration No. 191MT Page 8 of 39 Edition 2, 05/05/2018

9 Magnesium Serum Xyldyl blue Roche Cobas Magnesium Methylthymol Blue Siemens NT-PRO-BNP Phosphate Phosphate ECLIA Immunoassay Phosphomolybdate UV Phosphomolybdate UV Roche Cobas Roche Cobas Siemens Potassium Serum / urine Indirect ISE Roche Cobas Serum/Urine Indirect ISE Siemens Sodium Serum / urine Indirect ISE Roche Cobas Sodium Serum/Urine Indirect ISE Siemens Triglyceride Serum Lipase Roche Cobas INAB Registration No. 191MT Page 9 of 39 Edition 2, 05/05/2018

10 1061 Clinical -.02 Proteins, quantitative analysis Triglyceride Serum/Fluid Enzymatic w/o glyc.bl., w/o serum blank GPO Siemens Urate Serum Uricase Roche Cobas Urate Uricase Siemens Urea Serum / urine Urease Roche Cobas Urea Serum/Urine Urease with GLDH Siemens C reactive protein Serum PETINA Siemens hs Troponin I(CMIA) hs-troponin T CMIA Abbott Architect LM-ENDO Tests the Abbott Architect ECLIA Immunoassay Roche Cobas Protein CSF Pyrogallol Red Siemens INAB Registration No. 191MT Page 10 of 39 Edition 2, 05/05/2018

11 Protein Urine/Fluid Pyrogallol Red Siemens Protein total Serum Biuret Siemens 1061 Clinical -.06 Blood ph and gas tensions HbA1c Whole Blood HPLC Adams Arkray 8160 LS-BIO-0029 Operation of the Arkray A1C HA-8160 Analyser System LM-BIO-0012 Determination of HBA1C in a Sample 1061 Clinical -.10 Drugs for therapeutic monitoring Digoxin Serum EIA Siemens Gentamicin KIMS Roche Cobas Gentimicin PETINA Siemens INAB Registration No. 191MT Page 11 of 39 Edition 2, 05/05/2018

12 1061 Clinical -.20 Hormones 1061 Clinical -.40 Iron studies Vanc KIMS Roche Cobas Vancomycin PETINA Siemens Free T4 ECLIA Immunoassay Roche Cobas Free T4 (CMIA) CMIA Abbott Architect LM-ENDO Tests the Abbott Architect TSH ECLIA Immunoassay Roche Cobas TSH (CMIA) CMIA Abbott Architect LM-ENDO Tests the Abbott Architect IBCT Ferene Siemens Iron serum Ferene w/o prior protein removal Siemens INAB Registration No. 191MT Page 12 of 39 Edition 2, 05/05/2018

13 1061 Clinical -.50 Protein and peptide tumour markers 1061 Clinical -.60 Glycohaemoglobins Transferrin Ca125 Immunoturbidimetric Roche Cobas ECLIA Immunoassay Roche Cobas Ca125 (CMIA) CMIA Abbott Architect LM-ENDO Tests the Abbott Architect Ca153 CMIA Abbott Architect LM-ENDO Tests the Abbott Architect CEA ECLIA Immunoassay ECLIA Immunoassay Roche Cobas Roche Cobas CEA (CMIA) CMIA Abbott Architect LM-ENDO Tests the Abbott Architect TPSA ECLIA Immunoassay Roche Cobas TPSA (CMIA) CMIA Abbott Architect LM-ENDO Tests the Abbott Architect HbA1c Whole Blood HPLC Adams Arkray 8160 LS-BIO-0029 Operation of the Arkray A1C HA-8160 Analyser System INAB Registration No. 191MT Page 13 of 39 Edition 2, 05/05/2018

14 Head Office Haematology Category: A Medical pathology field - Test 1030 Haematology -.01 Blood counts 1030 Haematology -.02 Visual examination of blood films Test/Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & Measurement/Equipment CE/In house SOP developed/based on ) Full Blood Counts including WBC 1 - RCC 2 - MCV & RDW 3 - HCT 4 - MCHC 5 - Hb 6 - Platelet Visual examination of blood films Whole Blood 1 - Directly measured 2 - Derived from the RCC 3 - Calculated from RCC & MCV 4 - Calculated from RCC & Hb 5 - Photo-optical 555um 6 - Optical flow cytometry May Grunwald Giemsa Modified Wrights Stain Cell Dyn Ruby LM-HAEM Full Blood Counts & Differentials using the Cell Dyn Ruby LS-HAEM Operation and Maintenance of the Cell Dyn Ruby LS-HAEM The Handling of Specimens in the Haematology Department LS-HAEM Operation of Centra CL2 Centrifuge, Spiramix, Waterbath, Angelantoni Fridge LS-HAEM Quality Control in Haematology Manual LM-HAEM May Grumwald Giemsa Staining of Blood Films & Bone Marrow Smears by Manual Method Hematek LM-HAEM Preparation, Microscopic Examination & Reporting of Blood Films LM-HAEM Staining of Blood Films using the Hematek Staining Machine INAB Registration No. 191MT Page 14 of 39 Edition 2, 05/05/2018

15 1030 Haematology -.03 Erthrocyte sedimentation rate 1030 Haematology -.05 Automated differential leucocyte counts 1030 Haematology -.06 Automated reticulocyte counts 1030 Haematology -.09 Examination of Erythrocyte Sedimentation Rate WBC count & differential Reticulocyte Count Blood Film Examination The surface layer of the erythrocytes is detected by means of a change of light intensity at the beginning of the measuring process and after one hour Laser light flow cytometry using MAPPS (multiangle polarized scatter separation technology) New Methylene Blue Thick and Thin Films Fields stain LS-HAEM The Handling of Specimens in the Haematology Department Desaga S2000 LM-HAEM ESR Determination using the Desaga S2000 & Sedivette Back-up LS-HAEM The Handling of Specimens in the Haematology Department Cell Dyn Ruby LM-HAEM Full Blood Counts & Differentials using the Cell Dyn Ruby LS-HAEM Operation and Maintenance of the Cell Dyn Ruby LS-HAEM The Handling of Specimens in the Haematology Department LS-HAEM Operation of Centra CL2 Centrifuge, Spiramix, Waterbath, Angelantoni Fridge LS-HAEM Quality Control in Haematology Cell Dyn Ruby 1 Manual/ Microscopy LM-HAEM Performance of Reticulocytes : Automated & Manual Method LS-HAEM The Handling of Specimens in the Haematology Department Microscopy LM-HAEM INAB Registration No. 191MT Page 15 of 39 Edition 2, 05/05/2018

16 malarial parasites and Giemsa stain Preparation, Microscopic Examination & Reporting of Blood Films 1030 Haematology -.30 Tests for haemoglobin variants and thalassaemia 1030 Haematology -.41 General haemostasis related tests Malaria Rapid Diagnostic Test Sickle Cell Screen General Haemostasis tests inclduging PT, INR, APTT, Fibrinogen quantation, D- dimer, correction studies General Haemostasis tests including PT, INR, APTT, Fibrinogen quantation, D- Dimer, Correction Studies Plasma Immunochromatographic test Haemoglobin solubility test Mechanical clotting system Mechanical Clotting System Manual macroscopic visualisation Manual macroscopic visualisation INAB Registration No. 191MT Page 16 of 39 Edition 2, 05/05/2018 LM-HAEM Identification of Malarial Parasites using a Test Kit * Microscopic Examination of Films LS-HAEM The Handling of Specimens in the Haematology Department LM-HAEM Sickle Cell Disease and Sickle Cell Trait Screening LS-HAEM The Handling of Specimens in the Haematology Department LS-HAEM Operation & Maintenance of MPW-223e Centrifuge, Stuart Waterbath, Angelantoni Fridge Stago compact Max CE LM-HAEM Stago Compact LM-HAEM Operation of the Stago Compact Analyser in the Performance of the PT/INR, APTT, Fibrinogen and D Dimers LS-HAEM The Handling of Specimens in the Haematology Department

17 LS-HAEM Operation & Maintenance of MPW-223e Centrifuge, Stuart Waterbath, Angelantoni Fridge LS-HAEM Quality Control in Haematology 1030 Haematology -.58 Vitamin B12 and folate (serum and red cell) B12, FOLATE, FERRITIN Serum Chemiluminescent Micro Particle Immunoassay Architect i2000 LM-HAEM Ferritin, B12 and Folate Performance on the Abbott Architect LS-HAEM The Handling of Specimens in the Haematology Department LS-HAEM Operation of the Abbott Architect in the Haematology Department INAB Registration No. 191MT Page 17 of 39 Edition 2, 05/05/2018

18 Head Office Histopathology and Cytopathology Category: A Medical pathology field - Test 1051 Histopathology -.01 Processing fixed specimens for Histopathological testing Test/assay Automated Haematoxylin Cover slipping & sorting Cut up Specimen Type Human tissue Equipment/Technique Method (CE/Non- CE/In house developed/based on ) Automated staining slides on Leica disposal of used chemicals and stains. Automated coverslipping of slides using checkin gand labelling and distribution of Manual dissection of Human tissue samples usin gthe G2 speech system in AFOS cut up room AFOS Cut Up Room Balances- Ohous, Range of measurement.. N/A Std. ref & SOP Automated Haematoxylin and Eosin Staining LM-HIST-0009 Staining LM-HIST-0010 Stains & Solutions LS-HIST- LS-HIST-0017 LS-HIST-0037 Disposal of Chemical and Clinical Waste Coverslipping and Sorting LM-HIST-0011 Coverslipping in Histology & Cytology LS-HIST-0010 LS-HIST-0017 LS-HIST-0024 Labeling, Sorting and Checking Slides and Recording Numbers LS- HIST- LM-HIST-0022 Principles of good practice and training manual for Medical Scientists involved in Cut Up LS-HIST-0016 Operation of Balances in INAB Registration No. 191MT Page 18 of 39 Edition 2, 05/05/2018

19 Embedding Microtomy Specimen Reception Automated and Manual Haematoxylin and Eosin Staining Coverslipping Tissue processing Manual of impregnating Human tissue samples with paraffin wax using thetissue Tek TEC 5 Embedding Centre, to create a wax tissue block. Manual and automated use of microtomes for cutting tissue sections onto glass Manual labelling and entering specimens onto LIS. Automated printing of cassettes using the Leica IPC Automated Cassette Printer/Kaltek Dualvision Cassette Writer Automated of xylene, alcohol, paraffin wax infiltration of Human tissue samples usinf the VIP Tissue Processor/ Leica ASP6025 Para Trimmer Tissue Tek TEC 5 Embedding Centre Leica RM 2255 (1-4) RA Lamb Waterbaths Histology Ovens Kaltek Dualvision Cassette Writer Leica IPC Automated Cassette Printer VIP Tissue Processor Leica ASP6025 Tissue Processor... Histology LS-HIST-0044 AFOS Cut Up Room LS-HIST-0050 G2speech LM-HIST-0007 Embedding LS-HIST-0039 Operation of Para Trimmer LS-HIST-0045 Operation of Tissue Tek TEC 5 Embedding Centre Manual and motorized sectioning of processed tissue LM-HIST-0008 Cutting of Paraffin Blocks LS-HIST-0004 Microtomes LS-HIST-0006 RA Lamb Waterbaths LS-HIST-0014 Histology Ovens LS-LIS-0004 Clinisys Laboratory Information Management System in Histology LM-HIST-0001 Specimen Reception, Labeling & Charging LM-HIST-0004 Fixation & Decalcification LS-HIST-0042 Operation of Kaltek Dualvision Cassette Writer LS-HIST-0055 Leica IPC Automated Cassette Printer LM-HIST-0006 Tissue Processing LS-HIST-0032 Operation of VIP Tissue Processor LS-HIST-0054 Leica ASP Histopathology - Cut-up Frozen section Manual weighing, Cryotomy and INAB Registration No. 191MT Page 19 of 39 Edition 2, 05/05/2018

20 .02 Processing fresh specimens for frozen section examination 1051 Histopathology -.03 Histochemistry cryotomy and staining Specimen Reception Alcian Blue Alcian Blue/PAS Chloroacetate esterase cutting of fresh tissue sample in AFOS cut up room. Manual use of Leica Cryostat to section tissue. Manual staining and coverslipping and labelling of Manual entering of specimen details onto LIS, automated printing of cassette using Leica IPC Automated Cassette Printer / Kaltek Dualvision Cassette Writer. Manual accepting, labelling and entering of specimens onto the LIS system. special stain. special stain. special stain Leica Cryostat CM1950 Chemflow Fume Kaltek Dualvision Cassette Writer Leica IPC Automated Cassette Printer Staining LM-HIST-0002 Frozen Sections LM-HIST-0009 Staining LM-HIST- 0011Coverslipping in Histology & Cytology LS-HIST- LS-HIST-0009 Leica Cryostat CM1950 LS-HIST-0044 AFOS Cut Up Room LS-HIST-0016 Balances in Histology LS-HIST-0017 LS-HIST-0042 Kaltek Dualvision Cassette Writer LS-HIST-0055 Leica IPC Automated Cassette Printer N/A N/A LM-HIST-0001 Reception, Labeling & Charging LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, INAB Registration No. 191MT Page 20 of 39 Edition 2, 05/05/2018

21 Congo Red (Amyloid) Diastase - PAS Gram Martius Scarlet Blue (MSB) Masson Fontana Methenamine Silver. special stain. special stain. special stain. special stain. special stain. special stain 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, INAB Registration No. 191MT Page 21 of 39 Edition 2, 05/05/2018

22 Millers Elastic Modified Giemsa Periodic Acid Schiffs (PAS) Perls Prussian Blue. special stain. special stain. special stain. special stain. 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, LM-HIST-0010 Stains & Solutions, LM-HIST-0011 Coverslipping in Histology & Cytology, LS-HIST-0016 Balances in Histology, LS-HIST-0010, LS-HIST-0017, LS-HIST-0024 Labeling, Sorting and Checking Slides and Recording Numbers, LS-HIST- INAB Registration No. 191MT Page 22 of 39 Edition 2, 05/05/2018

23 Reticulin (Gordon & Sweets) special stain. LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, Shikata Orcein special stain. LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, Special stains special stain. CE/Non- LM-HIST-0009 Staining Trichrome (Gomoris) special stain. LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, Trichrome (Masson) special stain. LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, Van Gieson special stain LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, INAB Registration No. 191MT Page 23 of 39 Edition 2, 05/05/2018

24 . Ziehl Neelsen (ZN) special stain. LM-HIST-0010, 0011, 0016, 0010, 0017, 0024, 1051 Histopathology -.09 Immunohistochemistry Actin.Chemflow Fume. Nikon. LS-HIST-0010 LS-HIST-0017 LS-HIST-0024 Labelling, Sorting and Checking Slides and Recording Numbers LS-HIST-0048 Operation of and Immunostaining using Leica Bond III LS-HIST- Actin SM AE1AE3.Chemflow Fume. Nikon. BCL2 BCL6 BEREP4.Chemflow Fume. Nikon. Ca 125. INAB Registration No. 191MT Page 24 of 39 Edition 2, 05/05/2018

25 Calponin Calretinin CAM5.2(Cyto8/18) CD 20 (L26) CD10 CD117 (c-kit) CD138.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon INAB Registration No. 191MT Page 25 of 39 Edition 2, 05/05/2018

26 CD15 (Leu M1) CD23 CD3 CD4 CD30 (Ki1) CD34 CD45 (CLA).Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon INAB Registration No. 191MT Page 26 of 39 Edition 2, 05/05/2018

27 CD5 CD68 (KP1) CD79a CD99 CD8 CDX2 CEA.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon INAB Registration No. 191MT Page 27 of 39 Edition 2, 05/05/2018

28 Chromogranin Cyclin D1 Cyt 903(HMWCK) Cyto 5/6 Cyto 7 Cyto 20 Desmin D240 Dual staining for CYTO 903/Racemase E-Cadherin.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon INAB Registration No. 191MT Page 28 of 39 Edition 2, 05/05/2018

29 EMA ER GATA 3 HMB45 HLO Immunohistochemistry staining s Kappa Lambda immunoslides using. Automated finishing & coverslipping of slides using ST5020 & Leica coverslipper.chemflow Fume. Nikon.Chemflow Fume. Nikon Nikon microscope, chemflow cabinet, immunostainer, Leica multistainer ST05020, Leica coverslipper.chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume LS-HISt LM-HIST-0011 Coverslipping in Histology & Cytology INAB Registration No. 191MT Page 29 of 39 Edition 2, 05/05/2018

30 Melan A MIB1 MLH1 MSH2 MSH6 NSE P16 P53 P63 PAX-8 PMS2 PR Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume INAB Registration No. 191MT Page 30 of 39 Edition 2, 05/05/2018

31 PSA Racemase S-100 SMMS Synaptophysin TTF1 Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume. Nikon.Chemflow Fume INAB Registration No. 191MT Page 31 of 39 Edition 2, 05/05/2018

32 Nikon Vimentin WT1.Chemflow Fume. Nikon Cytopathology -.02 Non gynaecological cytology Non gynaecological cytology, including Smears Cytospin preps and Cell Blocks Automated Staining Papanicolaou Manual Staining MGG Human tissue or fluid Cytospin ThinPrep2000 Leica Multistainer ST5020 and Leica Chemflow Fume CE N/A LM-CYT-002 Specimen Preparation and Fixation LM-CYT-004 Cytology Staining Methods LM-HIST-0011 Coverslipping in Histology & Cytology LS-HIST-0024 Labeling, Sorting and Checking Slides & Recording Numbers INAB Registration No. 191MT Page 32 of 39 Edition 2, 05/05/2018

33 Head Office Immunology Category: A Medical pathology field - Test 1040 Immunology -.01 Quantitative investigation of immunoglobulins G,A,M and D in body fluids 1040 Immunology -.02 Qualitative investigation of immunoglobulins G,A,M and D in body fluids 1040 Immunology -.12 Detection of autoantibodies in body fluids and biopsy material Test/Assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on ) IgG, IgA, IgM Serum Immunoturbidimetric SPAplus Special Protein Analyser Serum Electrophoresis Immunofixation Anti-Nuclear Antibodies Anti-Nuclear Antibody Titre Gastric Parietal Cell Antibodies Range of measurement Std. Ref & SOP LM-IMM-0018 Tests the Spa Plus Special Protein Analyser LS-IMM-0008 Nikon 80i Serum & Urine Agarose Gel Hydrasys 2 Scan LM-IMM-0008 Electrophoresis of Serum and Urines LM-IMM-0012 Immunofixation of Serum and Urine LS-IMM-0013 Hydrasys 2 Serum Indirect Immunofluorescence Indirect Immunofluorescence Indirect Immunofluorescence Euroimmune Hep 20/10 Slides Nikon 80i Euroimmune Hep 20/10 Slides Nikon 80i Euroimmune IIFT Mosaic: Basic Profile 13 B Slides Nikon 80i LM-IMM-0004 Antibody Screening LM-IMM-0010 Performing an Anti-Nuclear antibody/hep 2 Test LS-IMM-0008 Nikon 80i LM-IMM-0004 Antibody Screening LM-IMM-0010 Performing an Anti-Nuclear antibody/hep 2 Test LS-IMM-0008 Nikon 80i LM-IMM-0004 Antibody Screening LS-IMM-0008 Nikon 80i LKM Antibodies Indirect Euroimmune IIFT LM-IMM-0004 INAB Registration No. 191MT Page 33 of 39 Edition 2, 05/05/2018

34 Immunofluorescence Mosaic: Basic Profile 13 B Slides Nikon 80i Antibody Screening LS-IMM-0008 Nikon 80i Mitochondrial Antibodies Indirect Immunofluorescence Euroimmune IIFT Mosaic: Basic Profile 13 B Slides Nikon 80i LM-IMM-0004 Antibody Screening LS-IMM-0008 Nikon 80i Smooth Muscle Antibodies Indirect Immunofluorescence Euroimmune IIFT Mosaic: Basic Profile 13 B Slides Nikon 80i LM-IMM-0004 Antibody Screening LS-IMM-0008 Nikon 80i 1040 Immunology -.14 b2-microglobulin Beta-2 Microglobulin Immunoturbidimetric SPAplus Special Protein Analyser LM-IMM-0018 Tests the Spa Plus Special Protein Analyser LS-IMM-0014 SPAplus Special Protein Analyser 1040 Immunology -.99 Miscellaneous tests Kappa Free Light Chains Immunoturbidimetric SPAplus Special Protein Analyser LM-IMM-0018 Tests the Spa Plus Special Protein Analyser LS-IMM-0014 SPAplus Special Protein Analyser Lambda Free Light Chains Immunoturbidimetric SPAplus Special Protein Analyser LM-IMM-0018 Tests the Spa Plus Special Protein Analyser LS-IMM-0014 SPAplus Special Protein Analyser INAB Registration No. 191MT Page 34 of 39 Edition 2, 05/05/2018

35 Head Office Microbiology and Virology Category: A Medical pathology field - Test 1011 Macroscopic examination and description 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.01 Microscopic examination for general bacteriology purposes (including enumeration and description of human cells) 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.03 Microscopic examination for fungi 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on ) Examination of faecal, sputa samples Cell count for body fluids Examination of urine samples Gram stain Wet preparations Isolation of significant pathogens in clinical samples Range of measurement Faeces, sputum Visual assessment None Body fluids, CSF Microscopy: cell count Nikon microscope Urine Microscopy: cell count Nikon microscope Body fluids, pus, CSF, HVS, Eye Bronchial washing, nail, skin, hair Fluids, CSF, pus, tissue, bone, HVS, Endocervical swab, penile/ urethral swab, IUCD, Ear/ eye/ nose/ throat/ mouth swabs, wound swabs, tips, drains, urine, stool. Microscopy Microscopy Culture Nikon microscope Nikon microscope PolEko Incubator Euroclone CO2 Incubator Oxoid atmospheric generation system Std. ref & SOP 0067 Investigation of Faeces 0066 Investigation of Sputum, Bronchial Washings and associated specimens 0019 Investigation of CSF 0022 Investigation of Urine 0031 Performing a Gram Stain 0036 Investigation of Fungal Specimens 0034, 0023, 0019, 0022, 0063, 0064, 0065, 0067 INAB Registration No. 191MT Page 35 of 39 Edition 2, 05/05/2018

36 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.02 Culture of fungi 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.03 Enzyme immunoassay, 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical s, CE marked commercial systems Screening for MRSA, CRE, VRE Inoculation and incubation of plates Detection of Clostridium difficle in faeces Sputum, Bronchial washing Nose, throat, groin, rectal swabs Bronchial washing, nail, skin, hair Stool Culture Culture Culture Detection of GDH Dectection of C.difficle toxin A and B PolEko Incubator Euroclone CO2 Incubator PolEko Incubator CE marked chromogenic media PolEko Incubator Memmert Incubator Anti-HAV IgG Serum Immunoassay Abbott Architect i2000sr INAB Registration No. 191MT Page 36 of 39 Edition 2, 05/05/ Investigation of Sputum, Bronchial Washings and associated specimens 0034 Investigation of Screening Specimens 0023 Inoculation of Culture Media 0019 Investigation of CSF 0022 Investigation of Urine 0063 Investigation of ENT Specimens 0064 Investigation of Sterile Fluids 0065 Investigation of Swabs, Tissue, IV Cannulae and associated specimens 0067 Investigation of Faeces 0036 Investigation of Fungal Specimens None 0067 Investigation of Faeces LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology

37 Anti-HAV IgM Immunoassay Abbott Architect i2000sr Anti-HBc Immunoassay Abbott Architect i2000sr Anti-HBs Immunoassay Abbott Architect i2000sr Anti-HCV Immunoassay Abbott Architect i2000sr Immunoassay Abbott Architect i2000sr HBsAg Immunoassay Abbott Architect i2000sr Syphillis TP Immunoassay Abbott Architect i2000sr Use of commercial identification Fluids, CSF, pus, tissue, bone, HVS, Culture and sensitivity, biochemical tests, LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology LS-ENDO-0001 Abbott Architect LM-IMM-0015 Tests the Abbott Architect in Immunology Vitek 2 Compact 0058 The INAB Registration No. 191MT Page 37 of 39 Edition 2, 05/05/2018

38 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes systems for bacteria Use of Vitek 2 Compact Determination of MIC Disc diffusion sensitivity testing Endocervical swab, penile/ urethral swab, IUCD, Ear/ eye/ nose/ throat/ mouth swabs, wound swabs, tips, drains, urine, stool. commercial identification systems, automated sensitivity testing, manual sensitivity testing. MIC Strip PolEko Incubator Euroclone CO2 Incubator MIC MIC Strip Oxoid Atmosphere Generation system EUCAST disc diffusion PolEko Incubator Euroclone CO2 Incubator Oxidase Test 0054 Campylobacter Identification 0059 The Catalase Test 0046 API Identification System 0048 Isolate Identification using the RapID System 0061 Use of Vitek Identification and Antimicrobial Susceptibility Testing Cards 0060 Use of Shigella Polyvalent Agglutinating Sera 0045 Use of the Streptex Kit and the PYR Test 0056 Staphylococcus aureus Identification using the Staphaurex Plus Kit 0050 The Wellcolex Colour Salmonella Kit 0052 The E.coli O157 Test 0027 Susceptibility Testing 0027 Susceptibility Testing 0027 Susceptibility Testing INAB Registration No. 191MT Page 38 of 39 Edition 2, 05/05/2018

39 Use of the Vitek 2 Compact Fluids, CSF, pus, tissue, bone, HVS, Endocervical swab, penile/ urethral swab, IUCD, Ear/ eye/ nose/ throat/ mouth swabs, wound swabs, tips, drains, urine, stool. Automated sensitivity testing Automated sensitivity testing Vitek 2 compact 0027 Susceptibility Testing Vitek 2 compact 0027 Susceptibility Testing INAB Registration No. 191MT Page 39 of 39 Edition 2, 05/05/2018