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INAB Registration No. 208MT
Page 1 of 12
Edition 1, 22/01/2018
Schedule of
Accreditation
Organisation Name
Rotunda Hospital
INAB Reg No
208MT
Contact Name
Susan Luke
Address
Department of Laboratory Medicine, Parnell Square, Dublin 1, Dublin
Contact Phone No
01 8171739
Website
Accreditation Standard
ISO 15189
Date Initially Awarded
09/12/2008
Scope Classification Microbiology and virology
Scope Classification Blood Transfusion Science
Scope Classification Haematology
Scope Classification Histopathology and cytopathology
Scope Classification 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 Department of Laboratory Medicine
Department of Laboratory Medicine-Quality Office, Parnell Square, Dublin, D1
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Scope of Accreditation
Department of Laboratory Medicine
Blood Transfusion Science
Category: A
Medical pathology field - Test
Test/assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)
1020 Transfusion science - .01 Blood grouping including ABO, Rh(D) and other antigens by manual methods
ABO and Rh D grouping of blood
Red Cells Automated AutoVue Innova and Manual method.
Column Agglutination Technology (CAT) Microtitre Plate, Tube Technology
1020 Transfusion science - .03 Blood group antibody screen
Antibody Screening Plasma / Serum Manual method and Automated AutoVue Innova
Column Agglutination Technology (CAT) , Tube Technology
1020 Transfusion science - .04 Identification of blood group antibodies
Antibody Identification Manual / Biorad BioVue
Column Agglutination Technology (CAT)
1020 Transfusion science - .05 Cross match compatible donor units
Compatibility Testing Manual / Biorad BioVue
Column Agglutination Technology (CAT)
1020 Transfusion science - .06 Red cell phenotyping
Red Cell Phenotyping Red Cells Manual BioVue and Tube
Column Agglutination Technology (CAT) , Tube Technology
1020 Transfusion science - .99 Miscellaneous tests
Antibody Titre Plasma / Serum Manual bioVue Column Agglutination Technology (CAT)
Direct Antiglobulin Test
Red Cells Automated AutoVue Innova and Manual method in tubes and BioVue.
Column Agglutination Technology (CAT) , Tube Technology
FMH Estimation Beckman Coulter FC500
Flow Cytometry
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Department of Laboratory Medicine
Chemical Pathology
Category: A
Medical pathology field - Test
Test/assay Specimen Type Technique Equipment/Range of Measurement
1061 Clinical Chemistry - .01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies
Albumin Heparinised plasma Electrochemiluminescence Cobas 6000
Alkaline Phosphatase
Electrochemiluminescence Cobas 6000
ALT Electrochemiluminescence Cobas 6000
AMH Serum Electrochemiluminescence Immunoassay
Cobas 6000
Amylase Heparinised plasma Electrochemiluminescence Cobas 6000
AST Electrochemiluminescence Cobas 6000
Bile Acids Heparinised plasma /serum
Electrochemiluminescence Cobas 6000
CA125 Serum Electrochemiluminescence Immunoassay
Cobas 6000
Calcium Heparinised plasma Electrochemiluminescence Cobas 6000
Chloride Heparinised plasma / urine
Electrochemiluminescence Cobas 6000
Cholesterol Heparinised plasma Electrochemiluminescence Cobas 6000
Creatinine (enzymatic)
Heparinised plasma / urine
Electrochemiluminescence Cobas 6000
CRP Heparinised plasma Electrochemiluminescence Cobas 6000
Ferritin Serum Electrochemiluminescence Immunoassay
Cobas 6000
Folate Electrochemiluminescence Immunoassay
Cobas 6000
Fructosamine Heparinised plasma / serum
Electrochemiluminescence Cobas 6000
FSH Serum Electrochemiluminescence Immunoassay
Cobas 6000
FT4 Electrochemiluminescence Immunoassay
Cobas 6000
Gentamicin Heparinised plasma Electrochemiluminescence Cobas 6000
GGT Electrochemiluminescence Cobas 6000
Glucose Sodium Fluoride Electrochemiluminescence Cobas 6000
Glucose Whole Blood Photometric Hemocue 201 DM
HCG Serum Electrochemiluminescence Immunoassay
Cobas 6000
HDL Heparinised plasma Electrochemiluminescence Cobas 6000
Lactate Sodium Fluoride / CSF
Electrochemiluminescence Immunoassay
Cobas 6000
LDH Heparinised plasma Electrochemiluminescence Cobas 6000
LDL Calculation Cobas 6000
INAB Registration No. 208MT
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LH Serum Electrochemiluminescence Immunoassay
Cobas 6000
Magnesium Heparinised plasma Electrochemiluminescence Cobas 6000
Oestradiol Serum Electrochemiluminescence Immunoassay
Cobas 6000
Phosphate Heparinised plasma Electrochemiluminescence Cobas 6000
Potassium Heparinised plasma / urine
Electrochemiluminescence Cobas 6000
Progesterone Serum Electrochemiluminescence Immunoassay
Cobas 6000
Prolactin Electrochemiluminescence Immunoassay
Cobas 6000
Protein Creatinine Ratio
Urine Calculation Cobas 6000
SHBG Serum Electrochemiluminescence Immunoassay
Cobas 6000
Sodium Heparinised plasma / urine
Electrochemiluminescence Cobas 6000
Testosterone Serum Electrochemiluminescence Immunoassay
Cobas 6000
Total & Direct Bilirubin
Heparinised plasma Electrochemiluminescence Cobas 6000
Total Protein Heparinised Plasma / urine / CSF
Electrochemiluminescence Cobas 6000
TPO Antibody Serum Electrochemiluminescence Immunoassay
Cobas 6000
Triglycerides Heparinised plasma Electrochemiluminescence Cobas 6000
TSH Serum Electrochemiluminescence Immunoassay
Cobas 6000
Urate Heparinised plasma Electrochemiluminescence Cobas 6000
Urea Electrochemiluminescence Cobas 6000
Vitamin B12 Serum Electrochemiluminescence Immunoassay
Cobas 6000
1061 Clinical Chemistry - .05 CO-oximetry
O2Hb Whole Blood Potentiometric Cobas b221/b123
tHb Potentiometric Cobas b221/b123
1061 Clinical Chemistry - .06 Blood pH and gas tensions
Bicarbonate Potentiometric Cobas b221/b123
CoHb Potentiometric Cobas b221/b123
HHb Potentiometric Cobas b221/b123
MetHb Potentiometric Cobas b221/b123
PCO2 Potentiometric Cobas b221/b123
PH Potentiometric Cobas b221/b123
PO2 Potentiometric Cobas b221/b123
SO2 Potentiometric Cobas b221/b123
1061 Clinical Chemistry - .07 Other analytes performed on a blood gas analyser
Bilirubin Potentiometric Cobas b221/b123
Calcium Potentiometric Cobas b221/b123
CL Potentiometric Cobas b221/b123
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Edition 1, 22/01/2018
Glucose Potentiometric Cobas b221/b123
Haematocrit Potentiometric Cobas b221/b123
K Potentiometric Cobas b221/b123
Lactate Potentiometric Cobas b221/b123
Na Potentiometric Cobas b221/b123
1061 Clinical Chemistry - .35 Assays of neonatal specimens
Albumin Heparinised plasma Electrochemiluminescence Cobas 6000
Alkaline Phosphatase
Electrochemiluminescence Cobas 6000
ALT Electrochemiluminescence Cobas 6000
AMH Serum Electrochemiluminescence Immunoassay
Cobas 6000
Amylase Heparinised plasma Electrochemiluminescence Cobas 6000
AST Electrochemiluminescence Cobas 6000
Calcium Electrochemiluminescence Cobas 6000
Chloride Heparinised plasma/urine
Electrochemiluminescence Cobas 6000
Cholesterol Heparinised plasma Electrochemiluminescence Cobas 6000
CK Electrochemiluminescence Cobas 6000
Creatinine (enzymatic)
Heparinised plasma/urine
Electrochemiluminescence Cobas 6000
CRP Heparinised plasma Electrochemiluminescence Cobas 6000
Ferritin Serum Electrochemiluminescence Immunoassay
Cobas 6000
Folate Electrochemiluminescence Immunoassay
Cobas 6000
FSH Electrochemiluminescence Immunoassay
Cobas 6000
FT4 Heparinised plasma/serum
Electrochemiluminescence Cobas 6000
Gentamicin Heparinised plasma Electrochemiluminescence Cobas 6000
GGT Electrochemiluminescence Cobas 6000
Glucose Sodium Fluoride Electrochemiluminescence Cobas 6000
HDL Heparinised plasma Electrochemiluminescence Cobas 6000
Lactate Sodium fluoride / CSF
Electrochemiluminescence Cobas 6000
LDH Heparinised plasma Electrochemiluminescence Cobas 6000
LH Serum Electrochemiluminescence Immunoassay
Cobas 6000
Mg Heparinised plasma Electrochemiluminescence Cobas 6000
Na Heparinised plasma/urine
Electrochemiluminescence Cobas 6000
Oestradiol Serum Electrochemiluminescence Immunoassay
Cobas 6000
Phosphate Heparinised plasma Electrochemiluminescence Cobas 6000
Potassium Heparinised plasma/urine
Electrochemiluminescence Cobas 6000
Progesterone Serum Electrochemiluminescence Immunoassay
Cobas 6000
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Prolactin Electrochemiluminescence Immunoassay
Cobas 6000
Testosterone Electrochemiluminescence Immunoassay
Cobas 6000
Total and Direct Bilirubin
Heparinised plasma Electrochemiluminescence Cobas 6000
Total Protein Heparinised plasma/urine
Electrochemiluminescence Cobas 6000
Triglycerides Heparinised plasma Electrochemiluminescence Cobas 6000
TSH Heparinised plasma / serum
Electrochemiluminescence Cobas 6000
Urate Heparinised plasma Electrochemiluminescence Cobas 6000
Urea Electrochemiluminescence Cobas 6000
Electrochemiluminescence Immunoassay
Cobas 6000
Vitamin B12 Serum Electrochemiluminescence Immunoassay
Cobas 6000
1061 Clinical Chemistry - .50 Protein and peptide tumour markers
CA125 Electrochemiluminescence Immunoassay
Cobas 6000
1061 Clinical Chemistry - .61 Hb A1c
Haemoglobin A1C Whole Blood EDTA HPLC HA-8180
1061 Clinical Chemistry - .99 Miscellaneous tests
Thyroid peroxidase antibody
Serum Electrcheiluminescence Immunoassay
Cobas 6000
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Department of Laboratory Medicine
Haematology
Category: A
Medical pathology field - Test
Test/Assay Specimen Type Technique Range of Measurement/Equipment
1030 Haematology - .01 Blood counts
Full Blood Count including reticulocytes and white cell differential (automated) includes neutrophils, lymphocytes, monocytes, eosinophils and basophils.
EDTA Blood / Na Citrate / Blood / Thromboexact blood
Automated dye cellular staining optical, impedence and flow cytometery methods
Cell Dyn 3200 and Cell Dyn Sapphire
Haemaglobin estimation
Whole Blood Photometric Hemocue 210DM
1030 Haematology - .02 Visual examination of blood films
Blood Film and white cell differential (manual) includes neutrophils, lymphopcytes, monocytes, eosinophils, basophils and red cell morphology.
EDTA Blood Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells
Aerospray stainer / microscopy
1030 Haematology - .05 Automated differential leucocyte counts
Automated differential leucocyte counts
EDTA Blood Automated dye cellular staining optical, impedence and flow cytometery methods
Cell Dyn 3200 and Cell Dyn Sapphire
1030 Haematology - .08 Blood film examinations involving special staining procedures
Manual reticulocyte estimation
Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells
Manual Microscopy
1030 Haematology - .09 Examination of malarial parasites
Malaria Parasites Examination
Blood Film Microscopic examination with or without fixation and staining with dyes for enumeration and description of parasites
Manual Microscopy
Rapid Diagnosis of Malaria
EDTA Blood Immuno -chromatographic using monoclonal antibodies
Manual technique
1030 Haematology - .30 Tests for haemoglobin variants and thalassaemia
Adult and Paediatric Haemoglobinopathy screening
EDTA Blood / Clotted Blood
Capillary Electrophoreseis
Sebia
1030 Haematology - .31 Tests for foetal Hb (Kleihauer)
Kleihauer (tests for foetal Hb)
EDTA Blood Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells
Manual Microscopy
INAB Registration No. 208MT
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1030 Haematology - .40 Limited haemostasis related tests
Lupus Anticoagulant Factor VIII Activated Protein C resistance Anti Thrombin Protein C activity
Sodium Citrate Blood
Colourimetric / absorbance
ACL Top 500
1030 Haematology - .41 General haemostasis related tests
Coagulation Screen: prothrombin time, prothombin time international ration, activated partial thromboplastin time, activated partial thromboplastin ratio, fibrinogen estimation
Colourimetric / absorbance
ACL Top 500
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Department of Laboratory Medicine
Histopathology and Cytopathology
Category: A
Medical pathology field - Test
Test/assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)
1051 Histopathology - .01 Processing fixed specimens for Histopathological testing
Automated Haematoxylin & Eosin
Human tissue DRS stainer
Coverslipping coverslipper, sorbline
Cut-Up microwriter, digital recording system, Kern balance
Embedding embedding centre, heated forceps
Microtomy microtomes, waterbaths, ovens, hotplate
Tissue Processing VIP tissue processor
1051 Histopathology - .02 Processing fresh specimens for frozen section examination
Frozen Sections cryostat
1051 Histopathology - .03 Histochemistry
Special Stains: Pas x 3, Alcian Blue, Grocott, Brown & Brenn, Cold ZN, Perl's Prussian Blue, Masson-Fontana, Von Kossa's, PTAH, Masson Trichrome, Modified Glees, MSB, Verhoeff's Elastic, Miller's Elastic, Verhoeff's Van Gieson, Oil Red O, Celestin Blue Haem Alum, Haematoxylin & Eosin, Rapid H&E, Congo Red, Churukian Schenk, Grimelius silver, Papanicolaou, Grams Twort, Warthin Starry
1051 Histopathology - .06 Histological interpretation-perinatal pathology
Diagnostic interpretation and reporting of human tissue specimens - specialist areas inlcuded: perinatal pathology (confined to histological examination of placental tissue and gravid uteri). Specialist areas excluded: medical
Microscope
INAB Registration No. 208MT
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renal pathology, paediatric pathology, neuropathology & breast screening pathology)
1051 Histopathology - .09 Immunohistochemistry
Dual Stain P16/ki67 Ventana Benchmark & microscope
CE marked
P63 lletzes & cervical biopsies
Ventana Benchmark & micrscope
CE marked
1052 Cytopathology - .02 Non gynaecological cytology
H&E and PAP Non-gynaecological fluids
Thin prep 2000, & viper vortex
1052 Cytopathology - .05 Immunocytochemistry
P57kip, EMA, CLA (CD45), SMA, AE1/3, GFAP, beta-inibin, alphainibin, HCG, HPL, CK7, CK20, vimentin, S100, CD68, CD8, CD20cy, CD79a, CD10, Ki67, P16, P53, Monoclonal CEA & Polyclonal CEA, Calretinin, CD31, CD3, CMV, Parovirus, P63
Human tissue Ventana benchmark, & microscope
INAB Registration No. 208MT
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Edition 1, 22/01/2018
Department of Laboratory Medicine
Microbiology and Virology
Category: A
Medical pathology field - Test
Test/assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method)
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)
Microscopic examination of General Bacteriology
All swabs, bronchial lavage / brushings, endotracheal tubes, other body fluids, pus, pleural fluids, sputum, tissue, urine, blood, CSF, middle ear, effusion, cannual, associated exudates, NICU surveillance, adverse transfusion environmental specimens, semen for culture.
Light microscope Microscopic examination with or without fixation and staining with dyes for 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
Microscopic examination of Fungi
Light microscope Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells.
1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth - .01 Culture of general bacteria
Culture of General Bacteria
BacTAlert 3D System / Microscope
BacTAlert / Manual
1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth - .02 Culture of fungi
Culture of Fungi BacTAlert 3D System / Microscope
BacTAlert / Manual
1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids - .01 Nucleic acid probe hybridization, CE marked commercial systems
Neisseria Gonorrhea, chlamydia, C. Diff toxin, SA/MRSA, Influenza A and B, Group B Streptococcal
Eye / HVS Swabs, urine Stools, blood culture, nasal swabs / aspirate / washings
Cobas 480 GeneXpert
PCR
1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques - .04 Identification using MALDI-TOF Spectroscopy
Identification of Organisms
All swabs, bronchial lavage / brushings, endotracheal tubes, other body fluids, pus, pleural fluids, sputum, tissue, urine, blood, CSF, middle ear, effusion, cannual, associated exudates, NICU surveillance, adverse transfusion environmental specimens, semen for
MaldiTof Spectroscopy
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culture.
1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) - .01 Anaerobes
Aerobes / Anaerobes Vitek 2 Compact Biochemical Testing
Vitek 2 Compact and Manual
MIC / Disk Diffusion
1018 Detection of antibody response to infection using appropriate CE marked commercial techniques - .04 Line immunoassay, using CE marked commercial systems
CMV IgG Serum Abbott Architect Immunoassay
Hepatitis B Core Antibodies Anti-HBc
Abbott Architect Immunoassay
Mini Vidas Immunoassay
Hepatitis B Surface Antigen (HBsAg)
Abbott Architect Immunoassay
Hepatitis C Antibodies Anti-HCV
Abbott Architect Immunoassay
HIV Combo Ab/Ag Abbott Architect Immunoassay
Rubella IgG Abbott Architect Immunoassay
Mini Vidas Immunoassay
Syphilis RPR (rapid plasma reagin)
Abbott Architect Immunoassay
Varicella Zoster IgG Abs
Diaorin Liaison Immunoassay
Mini Vidas Immunoassay
1029 Miscellaneous - .01 Semen analysis (Screening Test)
Semen Analysis Semen Sperminator Equipment
Count, volume, motility.
1029 Miscellaneous - .99 Miscellaneous tests
Pregnancy Testing Urine Surescreen Diagnostic Stick
Chromatography immunoassay