Schedule of Accreditation
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1 Schedule of Accreditation Organisation Name Coombe Women and Infants University Hospital INAB Reg No 218MT Contact Name Martina Ring Address Dolphins Barn, Cork St, Dublin, Dublin Contact hone No Website Accreditation Standard ISO Date Initially Awarded 17/02/2009 Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Microbiology and virology Blood Transfusion Science Haematology 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 athology Department, Cork Street, Dublin, D8 INAB Registration No. 218MT age 1 of 16 Edition 1, 26/02/2018
2 Scope of Accreditation Head Office Blood Transfusion Science Category: A Medical pathology field - Test 1020 Transfusion ABO and Rh D science -.01 Blood blood grouping grouping including ABO, Rh(D) and other antigens by manual methods 1020 Transfusion ABO and RhD science -.02 Blood blood grouping 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 -.08 Antibody titration 1020 Transfusion science -.99 Miscellaneous tests Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on method) Whole Blood in EDTA Antibody screening lasma Antibody identification Compatibility testing methods using BioRad Gels. method using tubes. Automated method using BioRad IH-1000 IAT method using BioRad gels Automated method using BioRad IH method using BioRad IAT and enzyme gel methods. method using BioRad gels Automated method using BioRad IH-1000 Antigen typing Red blood cells methods using BioRad gels and tubes. Automated method using BioRad IH-1000 Antibody Titration lasma method using BioRad gels Direct Antiglobulin Test FMH by Flow Cytometry Red blood cells Whole Blood in EDTA methods using BioRad gels. Automated method using BioRad IH-1000 Automated method using flow cytometry CE Range of measurement Std. ref & SO TT- ABORHDIAMED- CE Not applicable ATH-TM-G-8 CE Not applicable TT- ABSCRDIAMED- ATH-TM-G-8 CE TT- ABIDDIAMED- CE Not applicable TT-XMDIAMED- ATH-TM-G-8 CE Not applicable TT-HENO- ATH-TM-G-8 CE Not applicable TT-ABTITRE- CE Not applicable TT-DCT- ATH-TM-G-8 CE Not applicable TT-FMH- INAB Registration No. 218MT age 2 of 16 Edition 1, 26/02/2018
3 Head Office Chemical athology Category: A 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 Amino Transferase (ALT) Method (CE/Non- Std. Ref & CE/In house SO developed/based on method) lasma hotometric Olympus AU640 Albumin hotometric Olympus AU640 Alkalinie hosphatase (AL) hotometric Olympus AU640 Ammonia hotometric Olympus AU640 Amylase hotometric Olympus AU640 Aspartated Amino Transferase( AST) hotometric Olympus AU640 Bile Acids lasma/ Serum hotometric Olympus AU640 Bilirublin Direct lasma hotometric Olympus AU640 Bilirublin Total hotometric Olympus AU640 Calcium lasma / Urine Indirect Ion Selective Chloride C-Reactive rotein (CR) C-Reactive rotein (CR) - Highly Sensitive Creatine Kinase (CK) Total Indirect Ion Selective Olympus AU640 Olympus AU640 lasma / Serum Immunoturbidimetric Olympus AU640 Immunoturbidimetric Olympus AU640 Serum hotometric Olympus AU640 Creatinine lasma / Urine hotometric Olympus AU640 Creatinine Clearance Urine Calculation LIS Follicale stimulating Hormone (FSH) Serum Chemiluminescent Immulite Xpi Fructosamine hotometric Olympus AU640 Fructosamine(Corrected) Calculation LIS Gamma Glutamyl Transferase (GGT) lasma hotometric Olympus AU640 Gentamicin hotometric Olympus AU640 ATH-BIO- G-22 INAB Registration No. 218MT age 3 of 16 Edition 1, 26/02/2018
4 1061 Clinical Chemistry -.06 Blood ph and gas tensions Globulin Calculation LIS Glucose lasma / CSF hotometric Olympus AU640 Human Chorionic Gonadotrophin (HCG) Serum Chemiluminescent Immulite Xpi Inorganic hosphate lasma / Urine hotometric Olympus AU640 Lactate Dehydrogenate (LDH) Serum hotometric Olympus AU640 Lipid Index lasma hotometric Olympus AU640 Lutenising Hormone(LH) Serum Chemiluminescent Immulite Xpi Magnesium lasma hotometric Olympus AU640 Oestradiol Serum Chemiluminescent Immulite Xpi otassium lasma / Urine Indirect Ion Selective Olympus AU640 rogesterone Serum Chemiluminescent Immulite Xpi rolactin Chemiluminescent Immulite Xpi rotein ( Urine/CSF) Urine / CSF hotometric Olympus AU640 rotein (24hr) Urine Calculation LIS rotein Total lasma hotometric Olympus AU640 Sodium lasma / Urine Indirect Ion Selective Olympus AU640 T4 Free Serum Chemiluminescent Immulite Xpi Thyroid Stimulating Hormone(TSH) Chemiluminescent Immulite Xpi Urea lasma / Urine hotometric Olympus AU640 Uric Acid (Urate) lasma hotometric Olympus AU640 COHb HHb MetHb O2Hb Total Haemoglobin pco2 Heparinised Whole Blood rapidpoint 500,, Rapidlab 1240 ATH-BIO- G-22 ATH-BIO- G-22 BB-Immulite- ATH-BIO- G-22 ATH-BIO- G-22 ATH-BIO- G-22 ATH-BIO- G Clinical Chemistry -.05 COoximetry ATH-OC- G-1 ATH-OC- G-1 ATH-OC- G-1 ATH-OC- G-1 ATH-OC- G-1 ATH-OC- G-1 INAB Registration No. 218MT age 4 of 16 Edition 1, 26/02/2018
5 ph, Rapidlab 1240 ATH-OC- G-1 po2, Rapidlab 1240 ATH-OC- G Clinical Chemistry -.07 Other analytes performed on a blood gas Calcium ATH-OC- G-1 Chloride ATH-OC- G-1 Glucose Direct s ATH-OC- G-1 Lactate Direct s ATH-OC- G-1 otassium ATH-OC- G-1 Sodium ATH-OC- G-1 INAB Registration No. 218MT age 5 of 16 Edition 1, 26/02/2018
6 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 Automated differential leucocyte counts 1030 Haematology -.06 Automated reticulocyte counts 1030 Haematology -.09 Examination of malarial parasites 1030 Haematology -.31 Tests for foetal Hb (Kleihauer) 1030 Haematology -.41 General haemostasis related tests Test/Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & Measurement/Equipment CE/In house SO developed/based on method) Blood Counts Visual Examination of Blood Films Erythrocyte Sedimentation Rate Automated Differential Leucocyte count Automated Reticulocyte count Examination for Malaria Whole Blood in EDTA eripheral Blood in Sodium Citrate Whole Blood in EDTA eripheral Blood in EDTA Impedance counting, fluorescence analysis by flow cytometry and SLS Haemoglobin measurement on automated cell counter. Eosin & Thiazin Staining, Microscopy. Westergren method Analysis of fluorescence by flow cytometry Analysis of fluorescence by flow cytometry Staining using Field's Stain. Binax NOW RDT. Sysmex XN2000 Wescor Aerospray stainer, Sysmex XN2000 Sysmex XN2000 Kleihauer Acid Elution Immucor Kleihauer Kit, Coagulation Screen (T,ATT, Fibrinogen) Lupus Anticoagulant lasma in Sodium Citrate Mechanical Clotting System Mechanical Clotting System Stago STA-Compact Stago STA-Compact ATH-HAE- G-27 ATH-HAE- G-13, HH- AEROSRAY- ATH-HAE- G-19 ATH-HAE- G-27 ATH-HAE- G-27 ATH-HAE- G-18 ATH-HAE- G-17 ATH-HAE- G-15 ATH-HAE- G-16 INAB Registration No. 218MT age 6 of 16 Edition 1, 26/02/2018
7 Head Office Histopathology and Cytopathology Category: A Medical pathology field - Test 1051 Histopathology -.01 rocessing fixed specimens for Histopathological testing 1051 Histopathology -.02 rocessing fresh specimens for frozen section examination 1051 Histopathology -.03 Histochemistry Test/assay Specimen Type Cut-up, Human Tissue Tissue rocessing, Embedding, Microtomy, Automated and Haematoxylin & Eosin Staining, Mounting/Coverslipping rocessing of; Fresh Specimens, Frozen specimens, Touch reps & Non Gynae Cytology samples and Thin rep Liquid based Cytology Samples. Examination includes: rocessing, Microtomy, Rapid H&E Staining and Oil-Red O special stain. Alcian Blue, Alcian Blue/ as, Congo Red, Gram Twort, Masson Trichrome, Martius Scarlet Blue, Millers Elastin, Oil Red 'O', AS, DAS, erls russian Blue, hosotungstic Acid, Haematoxylin, Ziehl-Neelsen, Van Gieson. Gordon and Sweets' Reticulin Grocott Methenamine Silver 1051 Histopathology - Diagnositc.06 Histological Interpretation and interpretation-perinatal reporting of Human pathology Tissue specimens. Specialist areas included: Gynaecological and erinatal athology Equipment/Technique Tissue rocessing: Thermo Scientific Excelsior AS. Embedding : Sakura Tissue - Tek. Microtomy: Thermo Scientific, Microm HM340E. Cassette /Slide rinting: Thermo Scientific rint Mate & Slide Mate. H&E Staining Ventana HE 600. Coverslipping: Leica CV 5030 & Instrumec. Microscopy: Nikon Eclipse 80i. Leica Cryostat CM1900: Cryotomy Methods., Semi-automated, Semi-automated Method (CE/Non- Range of Std. ref & SO CE/In house measurement developed/based on method) Automated/Semiautomated/ manual methods. Based on Standard methods, Semiautomated based on methods, using CE marked reagents, based on methods. Standard Method Standard Method Microscopy: Leica microscopes Based on Standard Methods INAB Registration No. 218MT age 7 of 16 Edition 1, 26/02/2018
8 (Demonstrations of EQA participation is available) 1051 Histopathology - Immunohistochemistry.09 Staining Methods for : Immunohistochemistry Actin, AE1/AE3, Bcl- 2, BerEp4, Calretinin, CAM5.2, CEA, CD3, CD5, CD10, CD15, CD20, CD23, CD30, CD31, CD34, CD45, CD56, CD68, CD117, CD138, CDX2, Chromogranin A, CINtec lus Ki67/16 Dual Staining, CK5/6, CK7, CK20, Collagen IV, D2-40, Desmin EMA, ER, Factor VIII, α Feto rotein, GFA, HCG, HMB45, hl, Inhibin, Ki67, Ki67/16 Dual Staining, MCM3, MelA, ax8, 16, 40, 53, 57, 63, LA, R, S100, Synaptophysin, Vimentin, WT1 CMV. KI67/16 Dual Staining Cell Block from Liquid Based Cytology Immunohistochemistry:Ventana Benchmark Ultra & Ventana Benchmark LT Automated, Semi automated Toxoplasmosis Human Tissue Ventana Ultra and Benchmark LT Automated, Semiautomated. Based on s Ventana Ultra, Ventana LT Standard Method INAB Registration No. 218MT age 8 of 16 Edition 1, 26/02/2018
9 1051 Histopathology -.11 Chromogenic / bright-field in situ hybridisation 1052 Cytopathology -.01 Gynaecological (cervical) 1052 Cytopathology -.04 Cytopathological interpretation 1052 Cytopathology -.05 Immunocytochemistry 1052 Cytopathology -.07 Chromogenic / bright-field in situ hybridisation Human apiloma Virus (HV) in-situ Hybridistion- Molecular HV 111 Family robe B & C Molecular C17 robe: Silver in-situ Hybridisation Cytology sample preparation and description apanicolaou Staining and coverslipping Scanning of stained slide preparation Screening of stained slides Slide reparation Diagnostic interpretation and reporting of cervical samples, Diagnostic interpretation and reporting of non-gynae samples CINtec lus Ki67/16 Dual Staining Molecular HV 111 Family 16 robe C Human apiloma Virus (HV) in-situ Hybridisation- Molecular HV 111 Family robe C Human Tissue, Immunohistochemistry: Cell Ventana BenchMark Ultra & LT Blocks/Cytology smears from Liquid Based Cytology samples Human Tissues and Smears unstained liquid based cytology, cell blocks Unstained Liquid Based Cytology Immunohistochemistry: Ventana BenchMark Ultra & LT Automated Standard method Standard method Sakura DRS stainer Stained slide Semi-automated scanning Thinrep Imager Liquid Based Cytology Unstained Liquid Based Cytology, Cell Blocks Unstained Liquid Based Cytology, Cell Blocks, Fluids Slides from Liquid Based Cytology Samples Unstained Liquid based Cytology slides Unstained Liquid based Cytology, smears semi-automated scanning review Scope Automated T5 Semi-automated T2 Immunohistochemistry: Ventana BenchMark Ultra & LT Automated, Semi automated Automated/semi automated Standard method Ventana Ultra, Ventana LT Ventana Ultra Ventana LT CC- SAKURADRS2000-, CC- TISSUETEKGLC550-, CC- STAINCHECK- CC-IMAGER- CC- CXSMRSCREEN-, CC- REORTCODES-I, CC-ATHREF- CC- REVIEWSCOEO-, CC- CXSMRSCREEN-, CC- REORTCODES-I CC-SAMREG-, ATH-CYTO-G-1 CC-T2, CC- REBLOODSMR- INAB Registration No. 218MT age 9 of 16 Edition 1, 26/02/2018
10 Head Office Microbiology and Virology Category: A Medical pathology field - Test 1011 Macroscopic examination and description 1012 reparation 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 reparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.02 Microscopic examination for parasites Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on method) Range of measurement Std. ref & SO CSF CSF macroscopic MM-CSF- Semen analysis semen Swab Faeces Culture manual Blood Culture Blood MM- CSF CSF MM-CSF- ETT secretions Upper Respiratory Tract Secretions Swab Ear swab MM-EAR- swab, pus or Eye Swab Nasal Culture Oral Swab erineal/episiotomy Wound Culture Abscess, pus and Fluids urinalysis urine Blood Culture Blood MM- CSF CSF MM-CSF- Swab Ear swab MM-EAR- Eye Swab Nasal Culture INAB Registration No. 218MT age 10 of 16 Edition 1, 26/02/2018
11 1012 reparation 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 swab, pus or Oral Swab erineal/episiotomy Wound Culture Umbilical swab MM-UMB- Upper Respiratory Tract Secretions Abscess, pus and Fluids urinalysis urine Blood Culture Blood MM- CSF CSF MM-CSF- Swab Eye Swab swab, pus or Nasal Culture Oral Swab erineal/episiotomy Wound Culture Upper Respiratory Tract Secretions Abscess, pus and Fluids m urinalysis urine Bacterial Culture Blood BacTalet for monitoring of BloodCulture Bottle, CSF Bacterial Culture ETT secretions Upper Respiratory Tract Secretions Swab Bacterial Culture manual MM- MM-CSF- MM-UMB- MM-EAR- INAB Registration No. 218MT age 11 of 16 Edition 1, 26/02/2018
12 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.02 Culture of fungi swab, pus or change Faeces Culture Bacterial Culture urinalysis urine Bacterial Culture Blood BacTalet for monitoring of BloodCulture Bottle, CSF Bacterial Culture ETT secretions Swab manual MM- MM-CSF- MM-UMB- MM-EAR- INAB Registration No. 218MT age 12 of 16 Edition 1, 26/02/2018
13 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 article agglutination swab, pus or urinalysis Faeces Culture Bacterial Culture Bacterial Culture Staphurex positive or CSF Staphurex positive or ETT secretions Staphurex urinalysis Blood Culture Streptex kit positive or CSF Streptex kit positive or ETT secretions Streptex kit Swab Staphurex positive or Staphurex INAB Registration No. 218MT age 13 of 16 Edition 1, 26/02/2018 MM- MM-CSF- MM- MM-CSF- MM-UMB- Staphurex positive or MM-EAR-
14 swab, pus or urinalysis Staphurex Staphurex Staphurex Staphurex Streptex kit positive or Streptex kit Streptex kit positive or Streptex kit Streptex kit Streptex kit Streptex kit Staphurex Streptex kit 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, CE marked commercial systems Bacterial Culture result issued by CSF result issued by ETT secretions Swab result issued by swab, pus or urinalysis result issued by 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.03 Identification of fungi by microscopic morphology Blood Culture Yeasts or 1017 Measurement of antimicrobial activity and application of Bacterial Culture result issued by MM-UMB- MM-EAR- MM- MM-CSF- MM-UMB- MM-EAR- MM- MM- INAB Registration No. 218MT age 14 of 16 Edition 1, 26/02/2018
15 clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.03 Yeasts CSF result issued by Disk sensitivity ETT secretions MIC-Etest MIC- Swab result issued by swab, pus or result issued by urinalysis MM-CSF- MM-UMB- MM-EAR- Blood Culture MM- CSF result issued by Disk sensitivity ETT secretions MIC-Etest MIC- Swab result issued by swab, pus or result issued by urinalysis MM-CSF- MM-UMB- MM-EAR- INAB Registration No. 218MT age 15 of 16 Edition 1, 26/02/2018
16 1024 reservation of microbial cultures 1029 Miscellaneous -.01 Semen analysis (Screening Test) 1029 Miscellaneous -.99 Miscellaneous tests Bacterial Culture Semen analysis semen Urinary hcg urine Alere Kit Urine Chemistry Bayer 10S and Uristix MM-EAR- MM- MM-CSF- MM-UMB- INAB Registration No. 218MT age 16 of 16 Edition 1, 26/02/2018
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