Blackrock Clinic. Pathology Laboratory. Medical Testing Laboratory Registration number: 212MT

Transcription

1 Pathology Laboratory Registration number: 212MT is accredited by the Irish National Board () to undertake testing as detailed in the Schedule bearing the Registration detailed above, in compliance with the International Standard ISO 15189:2012 3rd Edition Medical laboratories Requirements for quality and competence (This Certificate must be read in conjunction with the Annexed Schedule of ) Date of award of accreditation: 17:02:2009 Date of last renewal of accreditation: 31:10:2013 Expiry date of this certificate of accreditation: 31:10:2018 This shall remain in force until further notice subject to continuing compliance with accreditation criteria, ISO/IEC and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Mr Tom O Neill Issued on 28 October 2014 Organisations are subject to annual surveillance and are re-assessed every five years. The renewal date on this Certificate confirms the latest date of renewal of accreditation. To confirm the validity of this Certificate, please contact the Irish National Board. The is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 9, 21/12/ MT Page 1 of 19

2 Schedule of (Annex to Certificate) BLACKROCK CLINIC Co Dublin Blood Transfusion Testing Laboratory Initial Registration Date : 17- February Haematology: 28 - October Clinical Chemistry: 28 - October 2014 Microbiology: 28 - October 2014 Histopathology: 28 - October 2014 Postal Address: Rock Road, Blackrock, Co Dublin (Address of other locations Smurfit Building, Beaumont Campus, Dublin 9 as they apply) Telephone: +353 (1) Fax: +353 (1) eoin.orourke@blackrock-clinic.com Contact Name: Mr. Eoin O Rourke Facilities: Public testing service Edition 9, 21/12/ MT Page 2 of 19

3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD () is the Irish body for the accreditation of organisations including laboratories. Laboratory accreditation is available to testing and calibration facilities operated by manufacturing organisations, government departments, educational institutions and commercial testing/calibration services. Indeed, any organisation involved in testing, measurement or calibration in any area of technology can seek accreditation for the work it is undertaking. Each accredited laboratory has been assessed by skilled specialist assessors and found to meet criteria which are in compliance with ISO/IEC or ISO/IEC (medical laboratories). Frequent audits, together with periodic inter-laboratory test programmes, ensure that these standards of operation are maintained. Testing and Calibration Categories: : Permanent laboratory calibration and testing where the laboratory is erected on a fixed location for a period expected to be greater than three years. Category B: Category C: Category D: Site calibration and testing that is performed by staff sent out on site by a permanent laboratory that is accredited by the Irish National Board. Site calibration and testing that is performed in a site/mobile laboratory or by staff sent out by such a laboratory, the operation of which is the responsibility of a permanent laboratory accredited by the Irish National Board. Site calibration and testing that is performed on site by individuals and organisations that do not have a permanent calibration/testing laboratory. Testing may be performed using (a) (b) (c) (d) portable test equipment a site laboratory a mobile laboratory or equipment from a mobile or site laboratory Standard Specification or Test Procedure Used: The standard specification or test procedure that is accredited is the issue that is current on the date of the most recent visit, unless otherwise stated. Glossary of Terms Facilities: Public calibration/testing service: Conditionally available for public calibration/testing: Normally not available for public calibration/testing: Commercial operations which actively seek work from others. Established for another primary purpose but, more commonly than not, is available for outside work. Unavailable for public calibration/testing more often than not. Laboratory users wishing to obtain assurance that calibration or test results are reliable and carried out to the Irish National Board criteria should insist on receiving an accredited calibration certificate or test report. Users should contact the laboratory directly to ensure that this scope of accreditation is current. will on request verify the status and scope. Edition 9, 21/12/ MT Page 3 of 19

4 Blood Transfusion Testing Laboratory Classification number Materials/products tested 1020 Immunohaematology Blood Grouping including ABO, Rh(D) Type of test/properties measured Range of measurement Blood grouping (ABO & RhD) Typing). Red Blood Cells. Standard specifications /techniques used LM-BT-0016 Manual Method,Gel Cards 1020 Immunohaematology.03 Blood Group Antibody Antibody Screening, Plasma LM-BT-0016 screen Manual method using Gel Cards 1020 Immunohaematology.04 Identification of blood Antibody Identification, Plasma LM-BT-0005 group antibodies Manual method using Gel IAT and enzyme cards 1020 Immunohaematology.05 Determination of Crossmatch Testing, plasma LM-BT-0010 Compatibility of donor Manual method using Gel units (the Cards investigation of transfusion reactions) LM-BT-0009 Manual method using Gel Antigen Typing, red blood cells Cards Direct Antiglobulin test, red LM-BT-0011 blood cells Manual method using Gel Cards Note: Blood Bank has been assessed and is competent to comply with articles 14 and 15 of the EU Directive 2002/98/EC (S.I.No. 360 of 2005 and S.I. No. 547 of 2006) Edition 9, 21/12/ MT Page 4 of 19

5 Haematology DEPARTMENT Classification 1030 Haematology Full Blood Count with automated differential leucocyte count including: EDTA Blood Automated.05 White Cell Count EDTA Blood Automated Red Cell Count EDTA Blood Automated Haemoglobin EDTA Blood Automated Haematrocrit EDTA Blood Automated Mean Cell Volume EDTA Blood Automated MCH EDTA Blood Automated MCHC EDTA Blood Automated Platelet Count EDTA Blood Automated LM-HAEM-0025 LP-HAEM-0013 Edition 9, 21/12/ MT Page 5 of 19

6 Haematology DEPARTMENT Classification 1030 Haematology Neutrophils EDTA Blood Automated LM-HAEM-0025 LP-HAEM Lymphocytes EDTA Blood Automated Monocytes EDTA Blood Automated Eosinophils EDTA Blood Automated.03 Basophils EDTA Blood Automated Blood Film Examination and differential leucocyte count Erythrocyte Sedimentation Rate EDTA Blood Sodium Citrate/EDTA Manual Microscopy Automated Sedimentation Microscope Diesse Vesmatic LM-HAEM-0017 LM-HAEM-0018 LP-HAEM-0004 LM-HAEM Examination for Malarial Parasites Infectious Mononucleosis Screen Prothrombin Time Activated Partial Thromboplastin Time EDTA Blood EDTA Blood Serum/Plasma Sodium Citrate Sodium Citrate Manual Microscopy Immuno- Chromatographic Kit Microscope LM-HAEM-0010 Manual Immunoassay N/A LM-HAEM-0016 Photo optical detection Photo optical detection Fibrinogen Sodium Citrate Photo optical detection D Dimer Sodium Citrate Enzyme Linked Fluorescence ACL Top ACL Top ACL Top Mini Vidas LM-HAEM-0024 LP-HAEM-0012 LM-HAEM-0023 LP-HAEM-0012 LM-HAEM-0022 LP-HAEM-0011 Edition 9, 21/12/ MT Page 6 of 19

7 Clinical Chemistry DEPARTMENT Classification 1061 Clinical Chemistry Alanine Plasma NADH (with P-5 -P) Aminotransferase (ALT) Albumin Plasma Bromocresol purple Alkaline Para-nitrophenyl Plasma Phosphatase (ALP) Phosphate CNPG3 Substrate Amylase Plasma Enzymatic LM-BIO-0004 Asparate Aminotransferase (AST) Plasma Enzymatic Bilirubin Total Plasma Diazonium salt Calcium Plasma/urine Arsenazo III Carbon Dioxide Plasma PEP Carboxylase Enzymatic Cholesterol Plasma Enzymatic C Reactive Protein Plasma Immunoturbidimetric Creatine Kinase Plasma Enzymatic Creatinine (Enzymatic) Electolytes Na+ K+ Cl-Gamma-Glutamyl Plasma/urine Plasma/Urine Enzymatic Ion selective electrode (indirect) Transferase (GGT) Plasma Enzymatic LDL-cholesterol Plasma Enzymatic Lactate Dehydrogenase (LDH) Plasma Enzymatic Magnesium Plasma Enzymatic Phosphorus Plasma Colorimetric Phosomolybdate Edition 9, 21/12/ MT Page 7 of 19

8 Clinical Chemistry DEPARTMENT Classification 1061 Clinical Chemistry Plasma Colorimetric LM-BIO-0004 Total Protein Triglyceride Plasma Enzymatic Urea Nitrogen Plasma Urease Uric Acid Plasma Uricase BNP High Sensitivity Troponin I.10 Urinary/CSF Protein Urine/CSF Turbidimetric Assay Benzethonium chloride Gentamicin Vancomycin Plasma Plasma Serum Colorimetric Architect i2000sr LM-ENDO-0002 LM-BIO-0004 Plasma/Serum Plasma/Serum Particle Enhanced Turbidimetric Assay Particle Enhanced Turbidimetric Assay Architect i2000sr Architect i2000sr.45 Vitamin B12 Folate.40 Iron Transferrin Plasma/Serum Architect i2000sr Plasma/Serum Ferene Abbott Plasma/Serum Immunoturbidimetric LM-ENDO-0002 LM-BIO Ferritin Plasma/Serum Architect i2000sr.50 Protein and Architect peptide tumour i2000sr markers CA125 CA153 CEA Free PSA Total PSA Plasma/Serum Plasma/Serum Plasma/Serum Serum Serum LM-ENDO-0002 LM-ENDO-0002 Edition 9, 21/12/ MT Page 8 of 19

9 Clinical Chemistry DEPARTMENT Classification 1061 Clinical Chemistry.20 Hormones FSH Free T4 LH TSH Plasma/Serum Plasma/Serum Plasma/Serum Plasma/Serum Architect i2000sr LM-ENDO-0002 Glucose Plasma/CSF Hexokinase LM-BIO-0004 HDL-cholesterol Plasma Accelerator Selective Detergent LM-BIO-0004 Edition 9, 21/12/ MT Page 9 of 19

10 Histopathology Laboratory Classification Test/Assay Name Specimen Type 1051 Histopathology Processing fixed specimens for histopathological examination Cut up Tissue processing Embedding Microtomy Automated and Manual Haematoxylin and Eosin Staining Coverslipping Human tissue LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0002 LM-HIST-0003 LM-HIST-0004 LM-HIST-0005 LM-HIST-0006 LF-HIST-0011 LF-HIST-0012 LF-HIST-0013 LF-HIST-0021 LF-HIST-0029 LF-HIST-0055 LF-HIST-0061 WI-HIST-0003 WI-HIST-0005 WI-HIST-0006 WI-HIST-0008 WI-HIST-0009 WI-HIST-0010 WI-HIST-0017 WI-HIST-0018 WI-HIST-0019 Edition 9, 21/12/ MT Page 10 of 19

11 Histopathology Laboratory Classification Test/Assay Name Specimen Type 1051 Histopathology Processing fresh specimens for frozen section examination Cut-up Frozen section cryotomy and staining Human tissue LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0001 LM-HIST-0002 LM-HIST-0003 LM-HIST-0004 LM-HIST-0005 LM-HIST-0006 LF-HIST-0011 LF-HIST-0012 LF-HIST-0013 LF-HIST-0021 LF-HIST-0022 LF-HIST-0029 LF-HIST-0054 LF-HIST-0055 LF-HIST-0061 WI-HIST-0003 WI-HIST-0005 WI-HIST-0007 WI-HIST-0017 WI-HIST-0018 WI-HIST-0019 LP-HIST-0005 LP-HIST-0007 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0008 LF-HIST-0053 WI-HIST-0001 WI-HIST-0004 WI-HIST-0014 WI-HIST-0015 WI-HIST-0023 Edition 9, 21/12/ MT Page 11 of 19

12 Histopathology Laboratory Classification Test/Assay Name Specimen Type 1051 Histopathology LP-HIST-0047 Special stains automated:.03 Histochemistry H&E (Tissue) Papanicolaou Stain H&E (Cytology) Giemsa Stain Periodic Acid-Schiff s (PAS) counterstain LM-HIST-0007 Special stains manual: Alcian Blue Stain Giemsa Stain for Helicobacter Pylori Giemsa Stain for bacteria Grocott Stain Haematoxylin-Van Gieson Stain Highman s Congo Red Stain Masson Trichrome Stain Masson Fontana Stain Mauritus Scarlet Blue Stain Miller s Elastin Stain Periodic Acid-Schiff (PAS) Stain Perl s Prussian Blue Stain Reticulin Stain Von Kossa Stain Ziehl Neelsen (Kinyouin) Stain Human tissue Coverslipping automated Coverslipping manual Slide issue LP-HIST-0047 LP-HIST-0008 LP-HIST-0005 Diagnostic Interpretation and reporting of Human tissue specimens.04 Histological interpretation Specialist areas excluded: Medical Renal Pathology Paediatric Pathology Perinatal Pathology Neuropathology Breast screening Pathology Human tissue LP-HIST-0003 LP-HIST-0006 LP-HIST-0009 LP-HIST-0016 Edition 9, 21/12/ MT Page 12 of 19

13 Histopathology Laboratory Classification Test/Assay Name Specimen Type 1052 Cytopathology Cytology sample preparation and description Human tissue or fluid Non-gynaecological cytology Diagnostic Interpretation and reporting of non-gynae samples Registration and labelling Gross description Thin Prep Direct smears Cell blocks Processing Embedding Microtomy Storage Disposal Human tissue or fluid LP-HIST-0001 LP-HIST-0004 LP-HIST-0008 LP-HIST-0013 LP-HIST-0014 LP-HIST-0016 LM-HIST-0005 LM-HIST-0006 LM-HIST-0010 LF-HIST-0029 LF-HIST-0055 WI-HIST-0017 WI-HIST-0019 Edition 9, 21/12/ MT Page 13 of 19

14 MICROBIOLOGY DEPARTMENT Classificatio n 1011 Bacteriology Identification of Organisms Abscesses, Post- Operative wounds and Deep Seated Infections Bronchoalveolar Lavage and Associated Specimens Cerebrospinal Fluid Continuous Ambulatory Peritoneal Dialysis Fluid Ear Swabs and Associated Specimens Bacterial isolate Wound swabs Pus Fluid Tissue Biopsies BAL, Respiratory Specimens Cerebrospinal Fluid CAPD Fluid Ear swabs Biochemical tests LM-MICRO-0017 LM-MICRO-0022 LM-MICRO-0025 LM-MICRO-0026 LM-MICRO-0027 LM-MICRO-0028 Eye Swabs and Canalicular Pus Faeces Specimens for Bacterial Pathogens Eye swabs Conjunctival swabs Faeces Colonic aspirates LM-MICRO-0029 LM-MICRO-0031 Fluids from Normally Sterile Sites Intraocular Fluids and Corneal Scrapings Fluids Aqueous/Vitreous fluids Corneal Scrapings LM-MICRO-0032 LM-MICRO-0035 Edition 9, 21/12/ MT Page 14 of 19

15 MICROBIOLOGY DEPARTMENT Classification 1011 Bacteriology Identification of Intravascular Cannulae and Associated Specimens Mouth Swabs Nasal Swabs and Groin Swabs for S. aureus Carriage Sinus Aspirate Tips Mouth swabs Nasal swabs Groin swabs Aspirates Fluids Culture, Identification & Culture, Identification & LM-MICRO-0036 LM-MICRO-0037 LM-MICRO-0038 LM-MICRO-0039 Skin and Superficial Wound Swabs Skin Culture, Identification & LM-MICRO-0040 Swabs and other Specimens for MRSA Nasal swab Groin swab Axilla swab Throat swab Culture, Identification & N/A LM-MICRO-0042 Rectal Swabs for VRE Throat Swabs Rectal swabs Throat swabs Culture, Identification & LM-MICRO-0043 LM-MICRO-0044 Tissues and Biopsies Tissues Biopsies Artificial devices LM-MICRO-0045 Edition 9, 21/12/ MT Page 15 of 19

16 MICROBIOLOGY DEPARTMENT Classification 1011 Bacteriology Urine Genital Tract and Associated Specimens Urine Supra-pubic aspirate High Vaginal Swabs Endocervical Swabs Cervical swabs Urethral swabs Rectal swabs Pharyngeal swabs LM-MICRO-0046 LM-MICRO-0058 Zone measurements Testing Bacterial isolates Broth MIC LM-MICRO-0060 Swabs and other Specimens for Carbapenemase Resistant Enterobacteriaceae Rectal swabs Minimum inhibitory concentration strip diffusion Culture, Identification & LM-MICRO-0087 Edition 9, 21/12/ MT Page 16 of 19

17 MICROBIOLOGY DEPARTMENT Classification 1011 Bacteriology Parasitology Mycology Legionella Pneumophilia Antigen Detection Streptococcus Pneumonia Urinary Antigen Detection Processing of Faeces for Clostridium Difficile MRSA Confirmation testing with Mastalex Specimens other than Blood for Parasites Fungal Specimens Urine Urine Faeces Bacterial isolate Faeces, Worms, Sellotape slides, Duodena/Jejunal aspirates, Urine, Liver and Spleen aspirates, Sputum, Bile, CSF Skin, Hair, Nail, Tissue Qualitative detection of Legionella pneumophila serogroup 1 antigen using the BINAX Legionella Urinary Antigen EIA Kit Qualitative detection of Streptococcus pneumoniae antigen using the BINAX Streptococcus pneumoniae Urinary Antigen EIA Kit Qualitative detection of GDH and Toxin using TechLab C.Diff Quik Chek Complete Kit Qualitative detection of Penicillin Binding Protein 2 using MASTALEX MRSA Kit Microscopy Microscopy & Culture N/A N/A N/A N/A N/A N/A LM-MICRO-0073 LM-MICRO-0074 LM-MICRO-0081 LM-MICRO-0082 LM-MICRO-0070 LM-MICRO-0033 Edition 9, 21/12/ MT Page 17 of 19

18 MICROBIOLOGY DEPARTMENT Classification 1014 Mycology Microscopic Investigation for Fungi Skin, Hair, Nail, Tissue Microscopy N/A LM-MICRO Serology of Infection 1016 Serology of Infection Detection of Measles IgG, Mumps IgG, Rubella IgG Antibodies on the Mini Vidas HIV Ag/Ab Syphilis Hep B SAg Anti-HBs Hep C Serum Serum Quantitative serology testing using Mini Vidas Mini Vidas Architect i2000sr LM-MICRO-0075 LP-HAEM-0011 LM-ENDO Miscellaneous Joint Fluid for Presence of Crystals by Polarising Microscopy Joint Fluids Microscopy N/A LM-MICRO-0085 Edition 9, 21/12/ MT Page 18 of 19

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