Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name IB Reg No Contact Name Address The Adelaide & Meath Hospital 330MT Ann Leonard Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 24/02/2015 Incorporating The National Children's Hospital, Medical Testing Laboratory, Tallaght, Dublin Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Services available to the public¹ Microbiology and virology Blood Transfusion Science Haematology Histopathology and cytopathology Chemical pathology No ¹ Refer to document on interpreting IB 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 Adelaide and Meath Hospital Incorporating The National Children's Hospital, Tallaght Hospital, Dublin, D24 IB Registration No. 330MT Page 1 of 37 Edition 1, 20/07/2018

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 methods 1020 Transfusion science -.02 Blood grouping including ABO, Rh(D) and other antigens by automated methods 1020 Transfusion science -.03 Blood group antibody screen 1020 Transfusion science -.04 Identification of blood group antibodies 1020 Transfusion science -.05 Cross match compatible donor units 1020 Transfusion science -.06 Red cell phenotyping 1020 Transfusion science -.09 Direct antiglobulin test Test/assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard method) Blood Grouping (ABO & Rh Typing) Confirming ABO and Rh(D) group of donor units Blood Grouping (ABO & Rh Typing) Confirming ABO and Rh(D) group of donor units Red Blood Cells (EDTA) Antibody Screening Plasma (EDTA) Antibody Identification Compatibility Testing Patient Plasma (EDTA) Donor Red Blood Cells : Biovue Tube : Biovue : Biovue on Autovue analyser : Biovue on Autovue analyser : Biovue on Autovue analyser : Biovue Tube : Biovue Tube : Biovue on Autovue analyser : Biovue Tube Antigen Typing Red Blood Cells : Biovue/Tubes Biovue (Rh & K) BioRad (Rh & K) Direct Coombs Test Red Blood Cells (EDTA) : BioRad Tube Range of measurement Std. ref & SOP Standard Method N/A BT-T-EP-001 BT-T-EP-002 Standard Method N/A BT-LP-0114 Standard Method Standard Method Standard Method N/A N/A N/A BT-LP-0103 BT-LP-0114 BT-LP-0103 Standard Method N/A BT-T-EP-010 BT-T-EP-012 Standard Method N/A BT-LP-0111 Standard Method N/A BT-LP-0103 Standard Method N/A BT-T-EP-005 BT-T-EP-006 Standard Method N/A BT-LP-0122 BT-T-EP-041 BT-T-EP-040 Standard Method N/A BT-T-EP-030 BT-T-EP-032 IB Registration No. 330MT Page 2 of 37 Edition 1, 20/07/2018

3 Head Office Chemical Pathology Category: D Medical pathology field - Test 1061 Clinical Chemistry -.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 Alanine Aminotransferase (ALT) Albumin Albumin/creatine ratio Alkaline Phosphatase Plasma/Serum According to IFCC (w/o P5P activation) Colorimetric/Bromocresol Green Urine Immunoturbidometric Calculated Plasma/Serum Colorimetric acc to IFCC Ammonia Plasma (EDTA) Enzymatic with GLDH Amylase Aspartate Aminotransferase ( AST) Plasma/Serum/Urine Enzymatic/Colorimetric acc. to IFCC Plasma/Serum According to IFCC (w/o P5P activation) Bicarbonate Enzymatic Bilirubin Direct Bilrubin Total Colorimetric/Sulfanilic acid Diazonium colorimetric method Calcium Plasma/Serum/Urine Colorimatric/NM-Bapta Calcium adjusted Plasma/Serum Calculated Calcium Creatine ratio Urine Calculated Chloride Plasma/Serum Ion Selective electrode (ISE) Cholesterol Enzymatic/Colorimetric Creatine Kinase (CK) UV ADP,G6P method Creatinine Plasma/Serum/Urine Enzymatic Creatinine Clearance Plasma/Serum Calculated egfr (MDRD) Plasma/Serum/Urine Calculated Method (/Non- Std. Ref & /In house SOP developed/based on standard method) Gamma- Plasma/Serum Enzymatic Colorimetric IB Registration No. 330MT Page 3 of 37 Edition 1, 20/07/2018

4 1061 Clinical Chemistry -.02 Proteins, quantitative analysis glutamyltransferase (GGT) Glucose Plasma/NaF/Koxalate/ CSF method standardised to IFCC Hexokinase enzymatic method HDL-Cholesterol Plasma/Serum Homogeneous enzymatic colorimatric method with Mg++ and dextran sulphate Lactate Lactate Dehydrogenase (LDH) Plasma/NaF/Koxalate/ CSF Plasma/Serum Colorimetric LOD/POD L-Lactate-Pyruvate UV assay acc IFCC ver.2 LDL Cholesterol Calculated Lipoprotein (a) (Lp(a)) Magnesium N- terminal pro B type natriuretic peptide (NT-pro BNP) Osmolality Phosphate (inorganic) Potassium Immunoturbidometric coloimetric end point assay with xylidyl blue,diazonium salt Plasma/Serum/Urine Freezing point depression UV Molybdate method Ion Selective electrode (ISE) Protein CSF/Urine Turbidometric method with benzethonium chloride Protein/Creatinine Ratio Sodium Urine Turbidometric/Kinetic Jaffe Plasma/Serum/Urine Ion Selective electrode (ISE) Total Protein Plasma/Serum Colorimetric assay with divalent copper ions at alkaline ph Triglycerides Troponin T hs (high sensitive) Urea Enzymatic Colorimetric method Plasma/Serum/Urine Kinetic with urease and GLDH Uric Acid Plasma/Serum Enzymatic Colorimetric method Alpha 1 Antitrypsin Caeruloplasmin Complement C3c Complement C4 Immunoturbidometric assay Immunoturbidometric assay Immunoturbidometric assay Immunoturbidometric assay IB Registration No. 330MT Page 4 of 37 Edition 1, 20/07/2018

5 1061 Clinical Chemistry -.10 Drugs for therapeutic monitoring 1061 Clinical Chemistry -.14 Alcohol for non-legal purposes 1061 Clinical Chemistry -.15 Drugs for toxicological purposes 1061 Clinical Chemistry -.20 Hormones C-Reactive Protein (CRP) C-Reactive Protein (CRP)-high Sensitive (CRPHS) Immunoglobulin A (IgA) Immunoglobulin E Total (IgE) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Amikacin-Analytical stage Carbamazepine Particle enhanced immunoturbidometric assay Particle enhanced immunoturbidometric assay Immunoturbidometric assay Electro-chemiluinescence Immunoturbidometric assay Immunoturbidometric assay Kinetic interaction of microparticles in solution (KIMS) Homogeneous microparticle agglutination /KIMS Cyclosporine Blood ( EDTA) Digoxin Plasma/Serum Lithium Serum Colorimetric assay with substituted porphyrin at alkaline ph Methotrexate Plasma/Serum Homogeneous enzyme Phenobarbital Phenytoin Kinetic interaction of microparticles (KIMS) Kinetic interaction of microparticles (KIMS) Tacrolimus Blood ( EDTA) Theophylline Plasma/Serum Kinetic interaction of microparticles (KIMS) Tobramycin- Analytical stage Valproic Acid Ethanol Paracetamol Salicylate Cortisol C-Peptide Homogeneous EIA Homogeneous enzyme Alcohol dehydrogenase enzymatic method Colorimetric method with arylacylamidase Spectrophotometric using salicylate hydroxylase IB Registration No. 330MT Page 5 of 37 Edition 1, 20/07/2018 Follicle-stimulating Electro-

6 1061 Clinical Chemistry -.30 Sweat electrolytes 1061 Clinical Chemistry -.40 Iron studies 1061 Clinical Chemistry -.50 Protein and peptide tumour markers hormone (FSH) Free Thyroxine (FT4) Free triiodothyronine (FT3) Insulin Intact human chorionic gonadotropin + the B-subunit (HCG+B) Luteinizing hormone (LH) Oestradiol Parathyroid Hormone-intact EDTA plasma chemiluminescence Progesterone Plasma/Serum Prolactin Testosterone Tyrotropin (TSH) Chloride Sweat Coulometric Elitech Chlorocheck 3400 Iron Plasma/Serum Colorimatric assay with ascorbate and Ferrozine Total iron binding capacity (TIBC) Transferrin saturation Unsaturated iron binding capacity (UIBC) Alpha1- fetoprotein (AFP) Cancer antigen 125 (C125) Cancer antigen 15-3 (C15-3) Calculated Calculated Direct with ferrozine 501 Cancer antigen 19- Electro- IB Registration No. 330MT Page 6 of 37 Edition 1, 20/07/2018

7 1061 Clinical Chemistry -.60 Glycohaemoglobins 1061 Clinical Chemistry -.99 Miscellaneous tests 9 (C19-9) chemiluminescence Carcinoembryonic antigen (A) Total Prostatespecific antigen (PSA) Haemoglobin A1c Blood HPLC Adams A1c HA8180 Faecal occult blood Faeces Latex agglutination Eiken OC-Sensor Rio Antibodies to thyroid peroxidase (Anti TPO) Plasma/Serum Conductivity Sweat Conduction Wescor Homocysteine Plasma/Serum Enzymatic assay IB Registration No. 330MT Page 7 of 37 Edition 1, 20/07/2018

8 Head Office Haematology Category: A Medical pathology field - Test 1030 Haematology -.01 Blood counts 1030 Haematology -.02 Visual examination of blood films 1030 Haematology -.03 Erthrocyte sedimentation rate 1030 Haematology -.05 differential leucocyte counts 1030 Haematology -.06 reticulocyte counts 1030 Haematology -.09 malarial parasites 1030 Haematology -.30 Tests for haemoglobin variants and thalassaemia 1030 Haematology -.41 General haemostasis related tests 1030 Haematology -.55 Iron studies 1030 Haematology -.57 Screening test for infectious mononucleosis 1030 Haematology -.58 Vitamin B12 and folate (serum and red cell) Test/Assay Specimen Type Technique Range of Method (/Non- Std. Ref & Measurement/Equipment /In house SOP developed/based on standard method) Full blood Count EDTA Various Sysmex XE2100 Various HAEM-LP- 0050A Visual examination of blood films Erthrocyte sedimentation rate differential leucocyte counts reticulocyte counts malarial parasites Sickle cell solubility PT, APTT, Fibringoen, D Dimer Microscopy Leica Microscopes Microscopy HAEM-LP Sedimentation Vesmatic 30 Sedimentation HAEM-LP Flow cytometry Sysmex XE2100 Flow cytometry HAEM-LP- 0050A Flow cytometry Sysmex XE2100 Flow cytometry HAEM-LP- 0050A Microscopy Leica Microscopes Microscopy HAEM-LP- 0054A & HAEM-LP- 0054B Turbidimetric Turbidimetric HAEM-LP Sodium Citrate Turbidimetric Sysmex CS2100 Turbidimetric HAEM-LP Ferrtin Serum CLIA Abbott Architect CLIA HAEM-LP Screening test for infectious mononucleosis Vitamin B12 and folate (serum and red cell) EDTA/Serum Immunoassay Immunoassay HAEM-LP Serum & EDTA CLIA Abbott Architect CLIA HAEM-LP IB Registration No. 330MT Page 8 of 37 Edition 1, 20/07/2018

9 Head Office Histopathology and Cytopathology Category: A Medical pathology field - Test 1051 Histopathology -.01 Processing fixed Histopathological testing 1051 Histopathology -.02 Processing fresh frozen section examination 1051 Histopathology -.03 Histochemistry Test/assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard method) Haematoxylin and Eosin staining Coverslipping Human tissue Leica Autostainer XL Coverslipper CTM6 Microm Cut-up Microtomy Tissue embedding Tissue Processing Microtome HM340E Microm Thermo Scientific Embedding Console Sakura Tissue Tek TEC Sakura Tissue-Tek Xpress x50 Tissue Processor Leica ASP6250 Cut-up Milestone Presto Chill Frozen section cryotomy and staining Alcian Blue Alcian Blue - PAS/DPAS Human tissue/body fluid Cryostat HM550 Microm Thermo Scientific Giemsa Gordon and Sweet's Reticulin Gram Twort Hales Colloidal Iron Highman's Congo Red Long Ziehl Nielson Luxol Fast Blue Martius Scarlet Blue Masson Fontana Range of measurement Std. ref & SOP CP-LP-0056 CP-LP-0065 CP-LP-0198 CP-LP-0035 CP-LP-0061 CP-LP-0052 CP-LP-0050 CP-LP-0198 CP-LP-0035 CP-LP-0043 CP-LI-0075 CP-LI-0076 CP-LI-0080 CP-LI-0082 CP-LI-0083 CP-LI-0086 CP-LI-0087 CP-LI-0088 CP-LI- CP-LI-0090 CP-LI-0091 IB Registration No. 330MT Page 9 of 37 Edition 1, 20/07/2018

10 1051 Histopathology -.05 Histological interpretationpaediatric pathology 1051 Histopathology -.09 Immunohistochemistry Masson's Trichrome Sigma Aldrich Kit HT15-1KT Melanin Bleach Miller Elastic Oil Red O PAS/DPAS Perl's Prussian Blue Phosphotungstic Acid Haematoxylin Rubeanic Acid Schmorl's Reaction Shikata Orcein Southgate's Mucicarmine Special Stains Toluidine Blue Van Gieson Von Kossa Ziehl Nielsen General Histological interpretation including Paediatric pathology AE1,AE3 ALK Alphafetoprotein AMACR b-catenin BCL-2 BCL-6 Human tissue Microscope BX50 Olympus CP-LI-0092 CP-LI-0093 CP-LI-0094 CP-LI-0096 CP-LI-0097 CP-LI-0098 CP-LI-0099 CP-LI-0100 CP-LI-0101 CP-LI-0102 CP-LI-0103 CP-LP-0112 CP-LI-0104 CP-LI-0105 CP-LI-0106 CP-LI-0107 CP-MF CP-LP-0202 Ber-Ep4 IB Registration No. 330MT Page 10 of 37 Edition 1, 20/07/2018

11 Calcitonin Calretinin Cam5.2 CD10 CD117 CD138 CD15 CD2 CD20 CD21 CD23 CD3 CD30 CD31 CD31CH (CD31 Chromogranin cocktail) CD34 CD4 CD43 CD45 CD5 IB Registration No. 330MT Page 11 of 37 Edition 1, 20/07/2018

12 CD56 CD57 CD61 CD68 CD79a CD8 CD99 CDX2 AM AP Chromogranin A CK19 CK5,6 CMV C-MYC Cyclin D1 D2-40 D2-40 / Melan A Cocktail DESKR (Desmin AE1,3) Cocktail Desmin IB Registration No. 330MT Page 12 of 37 Edition 1, 20/07/2018

13 DOG1 EBV E-cadherin EMA GATA -3 GFAP Glycophorin A Glypican 3 Granzyme B HBME HCG HepPar1 HLO HMB45 HSV I HSV II IgG4 Inhibin a Ki67 / MIB1 KLC(plasma cells) IB Registration No. 330MT Page 13 of 37 Edition 1, 20/07/2018

14 KLCP/LLCP Cocktail KR20 KR7 KR903 LLC (plasma cells) Melan A MIB1/MelanA Cocktail MLH1 MNF MPO MSA MSH2 MSH6 MUM1 MYF4 Napsin NF OCT3/4 OR p16 IB Registration No. 330MT Page 14 of 37 Edition 1, 20/07/2018

15 p53 p57kip2 p63 p63 / AMACR Cocktail p63 / KR7 Cocktail P63/Napsin cocktail PAX5 PAX8 PD1 PLAP PMS2 PPSA PR PSA PSAP RCC S100 SMA Synaptophysin TdT IB Registration No. 330MT Page 15 of 37 Edition 1, 20/07/2018

16 Thyroglobulin TTF1 TTF1 / CK5,6 Cocktail Vimentin WT Histopathology -.10 Fluorescence in situ hybridisation Lsi IGH SG/CCND1 SO (t11:14) Vysis VP2000 Processor CP-LP-0155 LSI BCL6 Dual colour Breakapart Vysis VP2000 Processor CP-LP-0155 Lsi IGH SG/BCL2 SO Vysis VP2000 Processor Cp-LP-0155 Lsi IGH/MYC:P8 Vysis VP2000 Processor CP-LP-0155 Lsi MALT1 Dual Clour Breakapart Vysis VP2000 Processor CP-LP-0155 Lsi MYC Breakapart Vysis VP2000 Processor CP-LP Histopathology -.11 Chromogenic / bright-field in situ hybridisation INFORM EBER (Epstein-Barr Virus Early R) ISH 1052 Cytopathology -.02 Non gynaecological cytology Cytology sample preparation and description Body fluid Cytospin 4 Thermo Shandon Electron Corporation. Leica Autostainer XL CP-LP Cytopathology -.04 Cytopathological interpretation Diagnostic Interpretation and Reporting of Non- Gynae samples Microscope BX50 Olympus CP-MF Cytopathology -.05 Immunocytochemistry AE1,AE3 ALK Alphafetoprotein AMACR b-catenin BCL-2 IB Registration No. 330MT Page 16 of 37 Edition 1, 20/07/2018

17 BCL-6 Ber-Ep4 Calcitonin Calretinin Cam5.2 CD10 CD117 CD138 CD15 CD2 CD20 CD21 CD23 CD3 CD30 CD31 CD31CH (CD31 Chromogranin cocktail) CD34 CD4 CD43 IB Registration No. 330MT Page 17 of 37 Edition 1, 20/07/2018

18 CD45 CD5 CD56 CD57 CD61 CD68 CD79a CD8 CD99 CDX2 AM AP Chromogranin A CK19 CK5,6 CMV C-MYC Cyclin D1 D2-40 D2-40 / MELAN A Cocktail IB Registration No. 330MT Page 18 of 37 Edition 1, 20/07/2018

19 DESKR (Desmin AE1,3) Cocktail Desmin DOG1 EBV E-cadherin EMA GATA 3 GFAP Glycophorin A Glypican 3 Granzyme B HBME HCG HepPar1 HLO HMB45 HSV I HSV II IgG4 Inhibin a IB Registration No. 330MT Page 19 of 37 Edition 1, 20/07/2018

20 Ki67 / MIB1 KLC(plasma cells) KLCP/LLCP Cocktail KR20 KR7 KR903 LLC (plasma cells) Melan A MIB1/MelanA Cocktail MLH1 MNF MPO MSA MSH2 MSH6 MUM1 MYF4 Napsin NF OCT3/4 IB Registration No. 330MT Page 20 of 37 Edition 1, 20/07/2018

21 OR p16 p53 p57 p63 p63 / AMACR Cocktail p63 / KR7 Cocktail P63/Napsin cocktail PAX5 PAX8 PD1 PLAP PMS2 PPSA PR PSA PSAP RCC S100 SMA IB Registration No. 330MT Page 21 of 37 Edition 1, 20/07/2018

22 Synaptophysin TdT Thyroglobulin TTF1 TTF1 / CK5,6 Cocktail Vimentin WT1 IB Registration No. 330MT Page 22 of 37 Edition 1, 20/07/2018

23 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) Test/assay Specimen Type Equipment/Technique Method (/Non- /In house developed/based on standard method) material from normally sterile sites examination of a transfusion reaction Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Culture and sensitivity Blood cultures for micro-organisms other than mycobacterium species CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices Blood packs red cell concentrates, platelets other blood components Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Blood cultures IB Registration No. 330MT Page 23 of 37 Edition 1, 20/07/2018 Range of measurement Std. ref & SOP 0001/Micro- LP /Micro- LP-0011 micro-lp- 0021/Micro- LP-0022 micro-lp- 0019/Micro- LP /Micro- LP-0191 not applicable Micr-LP /Micro- LP-0109 UK standards for microbiology investigation, Public health england 0191/Micro- LP-

24 material from normally sterile sites CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices 0001/Micro- LP /Micro- LP-0011 micro-lp- 0019/Micro- LP /Micro- LP UK standards for microbiology investigation, Public health england /Micro- LP-0191 Identification of bacterial and fungal isolates Cultures of bacteria and fungi 0191 micro-lp- 0076/Micro- LP /Micro- LP /Micro- LP genital tract and specimens High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab UK standards for microbiology investigation, Public health england /Micro- LP-0191 Investigation of skin scraping for Gram negative Diplococci Skin scrapings 0003 UK standards for microbiology investigation, Public health england skin swabs and superficial wound Wound swabs, swabs from other superfical sites 0018 IB Registration No. 330MT Page 24 of 37 Edition 1, 20/07/2018

25 swabs 0058 UK standards for microbiology investigation, Public health england /Micro- LP-0191 Investigation of urine samples -Microscopy and culture and sensitivitiy Urine, CSU. MSU, Clean catch urine, Subra pubic aspirate, bag urine 0058 enumeration and identification of bacteria and fungi from air sampling and settle plates Settle plates Air sampling plates 0030 HICPAC, Guidelines 2003 Hospital infection society guidelines 2001 examination of a transfusion reaction Blood packs red cell concentrates, platelets other blood components 0058 procedure for the intravascular cannulae and specimens Hickman, Vascath, portacath, Femoral line, central line, arterial line,subclavian line, Jugular line UK standards for microbiology investigation, Public health england ESBL, CRE and VRE Rectal swab Faeces swabs from other sites as clinically indicated UK standards for microbiology investigation, Public health england /Micro- LP-0191 procedure for the screening for MRSA Nasal, groin Wound other sites as clinically indicated UK standards for microbiology investigation, Public health england /Micro- LP-0191 IB Registration No. 330MT Page 25 of 37 Edition 1, 20/07/2018

26 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.02 Microscopic examination for parasites 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 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.04 Microscopic examination for mycobacteria 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Identification of parasites from samples other than blood genital tract and specimens enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction Microscopy,culture and the use of the MGIT 960 including limited mycobacteria identification Culture and sensitivity Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Faeces, Urine, Bronchoalveolar lavages, Sellotape slide, Doudenal/jejunal aspirates, aspirates from spleen/liver High vaginal swab, low vaginal swab, Vulval swab, labial swab, Penile swab Settle plates Air sampling plates Isolates of fungi from Blood packs, red cell concentrates, platelets and other blood components Sputum,Bronchoalveolar lavage, pleural fluids, Urine, Cough swabs, CSF, Tissue, pus, other body fluids Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth / Aerospray stainer not applicable 0012 UK standards for microbiology investigation, Public health england /Micro- LP UK standards for microbiology investigation, Public health england Not applicabel /Micro- LP UK standards for microbiology investigation, Public health england /Micro- LP /Micro- LP /Micro- LP-0007 UK standards for microbiology investigation, Public health England IB Registration No. 330MT Page 26 of 37 Edition 1, 20/07/2018

27 /Micro- LP-0191 Blood cultures for micro-organisms other than mycobacterium species Blood cultures Bac T alert 0025/Micro- LP-0109 material from normally sterile sites CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices 0001/Micro- LP /Micro- LP-0011 micro-lp- 0021/Micro- LP-0022 micro-lp- 0019/Micro- LP-0020 genital tract and specimens High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Not applicabel 0016 skin swabs and superficial wound swabs Wound swabs, swabs from other superfical sites 0018 Investigation of urine samples -Microscopy and culture and sensitivitiy Urine, CSU. MSU, Clean catch urine, Subra pubic aspirate, bag urine 0013 UK standards for microbiology investigation, Public health England enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction Settle plates Air sampling plates Blood packs red cell concentrates, platelets other blood components faeces for bacterial pathogen Faeces UK standards for microbiology investigation, Public health england /Micro- LP-0191 procedure for the intravascular Hickman, Vascath, portacath, Femoral line, central line, arterial 0034 IB Registration No. 330MT Page 27 of 37 Edition 1, 20/07/2018

28 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.02 Culture of fungi cannulae and specimens ESBL, CRE and VRE procedure for the screening for MRSA Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Culture and sensitivity material from normally sterile sites genital tract and specimens enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction Sputum, Bronchoalveolar lavages and line,subclavian line, Jugular line Rectal swab Faeces swabs from other sites as clinically indicated Nasal, groin Wound other sites as clinically indicated Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Settle plates Air sampling plates Blood packs red cell concentrates, platelets other blood components Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages not applicable /Micro- LP /Micro- LP /Micro- LP /Micro- LP /Micro- LP-0011 micro-lp- 0021/Micro- LP-0022 micro-lp- 0019/Micro- LP not applicable 0012 IB Registration No. 330MT Page 28 of 37 Edition 1, 20/07/2018

29 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.03 Culture of mycobacteria 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.01 Slide agglutination, 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.02 Particle agglutination bacterial pathogens other than mycobacteria Microscopy,culture and the use of the MGIT 960 including limited mycobacteria identification Culture and sensitivity Sputum,Bronchoalveolar lavage, pleural fluids, Urine, Cough swabs, CSF, Tissue, pus, other body fluids Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Isolates of salmonellan and shigella faeces for bacterial pathogen Culture and sensitivity Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites genital tract and specimens skin swabs and superficial wound swabs Investigation of urine samples -Microscopy and culture and sensitivitiy procedure for the intravascular cannulae and specimens procedure for the screening for MRSA Isolates of staphylococcus aureus from Nasal, Ear, Eye (including cannicular pus) and mouth Isolates of staphylococcus aureus from blood cultures Isolates of staphylococcus aureus from normally sterile sites Isolates of staphylococcus aureus igh vaginal swab, low vaginal swab, Vulval swab, labial swab, Penile swab Isolates of staphylococcus aureus from skin swabs and superficial wound swabs Isolates of staphylococcus aureus from Urine samples, CSU, MSU, clean catch, supra pubic aspirate, DST urine, bag urine Isolates of staphylococcus aureus from intravascular cannulae and specimens Isolates of staphylococcus aureus / MGIT 960 IB Registration No. 330MT Page 29 of 37 Edition 1, 20/07/ /Micro- LP Micro-LI- 0017C Ce 0064 Ce 0064 Ce 0064 Ce 0064 Ce Not applicable Micor-LP Ce 0064 Ce 0064 Ce 0064

30 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.03 Enzyme, 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.04 Immunochromatographic methods, 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, marked commercial systems 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, marked commercial systems Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Detection of Clostridium difficile toxins A and B Detection of legionella pneumophilia and streptococcus pneumoniae urinary antigens Microscopy,culture and the use of the MGIT 960 including limited mycobacteria identification procedure for the detection of helicobacter stool antigen Molecular detection of salmonella, shigella, Verotoxigenic E. coli, cryptosporidium, Giardia and Clostridium difficile Culture and sensitivity Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites Identification of bacterial and fungal isolates Isolates of staphylococcus aureus from Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Ce 0064 Faeces / Enteric bio IB Registration No. 330MT Page 30 of 37 Edition 1, 20/07/ urine Sputum,Bronchoalveolar lavage, pleural fluids, Urine, Cough swabs, CSF, Tissue, pus, other body fluids 0166 Faeces 0169 Coris, Bioconcept Kit insert Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Blood cultures CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices Cultures of bacteria and fungi Enteric Bio automated vitek 2 automated

31 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.03 Identification of fungi by microscopic morphology genital tract and specimens skin swabs and superficial wound swabs enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction Faeces faeces for bacterial pathogen procedure for the intravascular cannulae and specimens ESBL, CRE and VRE procedure for the screening for MRSA Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Culture and sensitivity High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Wound swabs, swabs from other superfical sites Settle plates Air sampling plates Blood packs red cell concentrates, platelets other blood components Hickman, Vascath, portacath, Femoral line, central line, arterial line,subclavian line, Jugular line Rectal swab Faeces swabs from other sites as clinically indicated Nasal, groin Wound other sites as clinically indicated automated 0076/Micro- LP /Micro- LP-0082 Micro-Lp- 0084/Micro- LP automated vitek 2 Sputum, endotrachal / aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth not applicable 0152 IB Registration No. 330MT Page 31 of 37 Edition 1, 20/07/2018

32 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.04 Identification using MALDI-TOF Spectroscopy Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites Identification of bacterial and fungal isolates skin swabs and superficial wound swabs enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction procedure for the intravascular cannulae and specimens Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Culture and sensitivity Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites Identification of bacterial and fungal isolates Blood cultures manual CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices Cultures of bacteria and fungi Fungi isolated from Wound swabs, swabs from other superfical sites Settle plates Air sampleing plates Blood packs red cell concentrates, platelets other blood components Hickman, Vascath, portacath, Femoral line, central line, arterial line,subclavian line, Jugular line Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Blood cultures CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices Cultures of bacteria and fungi automated Vitek MS Vitek MS automated vitek MS Vitek MS not applicable IB Registration No. 330MT Page 32 of 37 Edition 1, 20/07/2018

33 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.03 Yeasts genital tract and specimens skin swabs and superficial wound swabs Investigation of urine samples -Microscopy and culture and sensitivitiy enumeration and identification of bacteria and fungi from air sampling and settle plates examination of a transfusion reaction Faeces faeces for bacterial pathogen procedure for the intravascular cannulae and specimens ESBL, CRE and VRE procedure for the screening for MRSA Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Antibiotic susceptibility testing disc diffusion, vitek 2 Determination of MIC using gradient diffusion Culture and sensitivity High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Wound swabs, swabs from other superfical sites Urine, CSU. MSU, Clean catch urine, Subra pubic aspirate, bag urine Settle plates Air sampling plates Blood packs red cell concentrates, platelets other blood components Hickman, Vascath, portacath, Femoral line, central line, arterial line,subclavian line, Jugular line Rectal swab Faeces swabs from other sites as clinically indicated Nasal, groin Wound other sites as clinically indicated Vitek MS automated Vitek MS Vitek MS IB Registration No. 330MT Page 33 of 37 Edition 1, 20/07/ automated Vitek MS Vitek MS / vitek 2 Vitek MS Vitek MS Sputum, endotrachal aspirate, pleural fluids, Vitek MS cough swabs, Bronchoalveolar lavages Cultures of yeast Cultures of yeast isolated from Nasal (inculuding per nasal), /automated /automated vitek 2 not applicable 0191

34 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.05 Other categories of organism (as specified ) Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites genital tract and specimens skin swabs and superficial wound swabs Investigation of urine samples -Microscopy and culture and sensitivitiy procedure for the intravascular cannulae and specimens Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Antibiotic susceptibility testing disc diffusion, vitek 2 Determination of MIC using gradinet diffusion Throat, Ear, Eye (including cannicular pus) and mouth Cultures of yeast isolated from Blood cultures isolates of yeast from CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices /automated Cultires of yeast isolated from High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Cultures of yeast Urine, CSU, MSU, Clean catch urine, Subra pubic aspirate, bag urine Cultures of Yeast automated / vitek 2 Isolates of yeast from / Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages Cultures of aerobic bacteria /automated Not applicable Micor-LP- not applicable Performance standards for AST using EUCAST and CLSI user manual UK standards for microbiology investigation, Public health england Culture and sensitivity Cultures of aerobic bacteria isolated from /automated vitek 2 IB Registration No. 330MT Page 34 of 37 Edition 1, 20/07/2018

35 Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Blood cultures for micro-organisms other than mycobacterium species Cultures of aerobic bacteria isolated from blood cultures automated material from normally sterile sites isolates of aerobic bacteria CSF, fluids,tissue, Biopsies, Bone marrow, CAPD, Prosthetic devices /automated genital tract and specimens Cultures of aerobic bacteria isolated from High vaginal swab, low vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Not applicabel Micor-LP- skin swabs and superficial wound swabs Cultures of aerobic bacteria automated Investigation of urine samples -Microscopy and culture and sensitivitiy Cultures of aerobic bacteria isolated from Urine, CSU, MSU, Clean catch urine, Subra pubic aspirate, bag urine / faeces for bacterial pathogen Isolates of salmonella, shigella, vibrio, Yersina procedure for the intravascular cannulae and specimens Cultures of aerobic bacteria vitek 2 standard method ESBL, CRE and VRE Cultures of aerobic bacteria isolated from Rectal swab,faeces and swabs from other sites as clinically indicated procedure for the screening for MRSA Cultures of aerobic bacteria Sputum, Bronchoalveolar lavages and bacterial pathogens other than mycobacteria Isolates of aerobic / bacteria from Sputum, endotrachal aspirate, pleural fluids, cough swabs, Bronchoalveolar lavages not applicable 1023 Characterisation of subtypes within species C. diphtheriae toxin testing Bacterial isolates PCR detection of tox 0130 IB Registration No. 330MT Page 35 of 37 Edition 1, 20/07/2018

36 of bacteria, fungi or virus using appropriate techniques -.02 Molecular / nucleic acid analysis methods [specifying the particular techniques] 1024 Preservation of microbial cultures 1025 Measurement of antimicrobial levels by immunological methods 1029 Miscellaneous -.99 Miscellaneous tests Blood cultures for micro-organisms other than mycobacterium species material from normally sterile sites faeces for bacterial pathogen ESBL, CRE and VRE procedure for the screening for MRSA Antibiotic assays on the Abbott architect Receipt and reporting of amikacin and tobramycin assays Culture and sensitivity Blood cultures for micro-organisms other than mycobacterium species Identification of bacterial and fungal isolates genital tract and (DT) gene Blood cultures Bacterial isolates from CSF Isolates of salmonella, shigella, vibrio, Yersina Isolates of CRE, VRE and ESBLs Isolates of MRSA Serum,plasma Nasal (inculuding per nasal), Throat, Ear, Eye (including cannicular pus) and mouth Architect i1000 Blood cultures Cultures of bacteria and fungi Cultures of aerobic bacteria isolated from High vaginal swab, low Vancomycin: 3.0µg/ml to µg/ml Gentamicin: 0.3 µg/ml to 10.0 µg/ml Not applicable to microbiology Measurement carried put in clinical chemistry 0027/Micro- LP UK standards for microbiology investigation, Public health england (oxidase) 0049 (urease) 0040 (oxidase) 0065 IB Registration No. 330MT Page 36 of 37 Edition 1, 20/07/2018

37 specimens Investigation of urine samples -Microscopy and culture and sensitivitiy vaginal swab, Vulval swab, labial swab, endocervical swab, Penile swab Urine, CSU, MSU, Clean catch urine, Subra pubic aspirate, bag urine, DST urine / Vitek MS faeces for bacterial pathogen Faeces 0040 (oxidase) 0040 (oxidase) 0049 (urease) IB Registration No. 330MT Page 37 of 37 Edition 1, 20/07/2018