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

Transcription

1 Pathology Laboratory Registration number: 212MT is accredited by the Irish National Board (INAB) to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO/IEC 15189:2012 3rd Edition Medical laboratories Particular 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 INAB 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 INAB is a signatory of the European co-operation for (EA) Testing Multilateral Agreement (MLA) and the International Laboratory Cooperation (ILAC) Mutual Recognition Arrangement. Edition 6, 28/10/ MT Page 1 of 15

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 Postal Address: Rock Road (Address of other locations Blackrock as they apply) Co Dublin Telephone: +353 (1) Fax: +353 (1) cranmerc@blackrock-clinic.com Contact Name: Ms Christine Cranmer Facilities: Public testing service Edition 6, 28/10/ MT Page 2 of 15

3 Schedule of THE IRISH NATIONAL ACCREDITATION BOARD (INAB) 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. INAB will on request verify the status and scope. Edition 6, 28/10/ MT Page 3 of 15

4 Blood Transfusion Testing Laboratory INAB Classification number (P9) 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 Equipment/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 Compatability of Manual method using Gel donor units (the Cards investigation of transfusion reactions) Antigen Typing, red blood cells LM-BT-0009 Manual method using Gel 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 6, 28/10/ MT Page 4 of 15

5 Haematology DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1030 Haematology.05 Full Blood Count with automated differential leucocyte count including: White Cell Count Red Cell Count Haemoglobin Haematrocrit Mean Cell Volume MCH MCHC Platelet Count Neutrophilis Lymphocytes Monocytes Eosinophils Basophils Blood Film Examination and differential leucocyte count Erythrocyte Sedimentation Rate Examination for Malarial Parasites LM-HAEM-0017 LM-HAEM-0018 LP-HAEM-0004 LM-HAEM-0011 LM-HAEM-0010 Edition 6, 28/10/ MT Page 5 of 15

6 Haematology DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1030 Haematology Full Blood Count with automated differential leucocyte count including: Prothrombin Time Activated Partial Thromboplastin Time Fibrinogen D Dimer Infectious Mononucleosis Screen Erythrocyte Sedimentation Rate Examination for Malarial Parasites LM-HAEM-0024 LP-HAEM-0012 LM-HAEM-0024 LP-HAEM-0012 LM-HAEM-0023 LP-HAEM-0012 LM-HAEM-0022 LP-HAEM-0011 LM-HAEM-0016 LM-HAEM-0011 LM-HAEM-0010 Edition 6, 28/10/ MT Page 6 of 15

7 Clinical Chemistry DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1061 Clinical Chemistry Alanine Aminotransferase (ALT) Albumin Alkaline Phosphatase (ALP) LM-BIO-0004 Amylase Asparate Aminotransferase (AST) Bilirubin Total Calcium Carbon Dioxide Cholesterol C Reactive Protein Creatine Kinase Creatinine (Enzymatic) Electolytes Na+ K+ Cl-Gamma-Glutamyl Transferase (GGT) LDL-cholesterol Lactate Dehydrogenase (LDH) Magnesium Phosphorus Edition 6, 28/10/ MT Page 7 of 15

8 Clinical Chemistry DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1061 Clinical Chemistry Total Protein Triglyceride Urea Nitrogen LM-BIO-0004 Uric Acid.10 Drugs for therapeutic monitoring.65 Pregnancy test qualitive Urinary/CSF Protein BNP Troponin I Lithium Gentamicin Vancomycin Urine hcg Vitamin B12 Folate Iron Transferrin LM-ENDO-0002 LM-BIO-0004 LM-BIO-0003 LM-ENDO-0002 LM-BIO Ferritin LM-ENDO Protein and peptide tumour markers.20 Hormones CA125 CA153 CEA Free PSA Total PSA FSH Free T4 LH TSH LM-ENDO-0002 LM-ENDO-0002 Edition 6, 28/10/ MT Page 8 of 15

9 Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 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 6, 28/10/ MT Page 9 of 15

10 Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 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 6, 28/10/ MT Page 10 of 15

11 Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 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 6, 28/10/ MT Page 11 of 15

12 Histopathology Laboratory INAB Classification Number (P9) Test/Assay Name Specimen Type SOP 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 6, 28/10/ MT Page 12 of 15

13 MICROBIOLOGY DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 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 Eye Swabs and Canalicular Pus Faeces Specimens for Bacterial Pathogens LM-MICRO-0017 LM-MICRO-0022 LM-MICRO-0025 LM-MICRO-0026 LM-MICRO-0027 LM-MICRO-0028 LM-MICRO-0029 LM-MICRO-0031 Fluids from Normally Sterile Sites LM-MICRO-0032 Intraocular Fluids and Corneal Scrapings LM-MICRO-0035 Edition 6, 28/10/ MT Page 13 of 15

14 MICROBIOLOGY DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1011 Bacteriology Identification of Intravascular Cannulae and Associated Specimens Mouth Swabs Nasal Swabs and Groin Swabs for S. aureus Carriage Sinus Aspirate Skin and Superficial Wound Swabs Swabs and other Specimens for MRSA Rectal Swabs for VRE Throat Swabs Tissues and Biopsies Urine Genital Tract and Associated Specimens Susceptibility Testing Swabs and other Specimens for Carbapenemase Resistant Enterobacteriaceae LM-MICRO-0036 LM-MICRO-0037 LM-MICRO-0038 LM-MICRO-0039 LM-MICRO-0040 LM-MICRO-0042 LM-MICRO-0043 LM-MICRO-0044 LM-MICRO-0045 LM-MICRO-0046 LM-MICRO-0058 LM-MICRO-0060 LM-MICRO-0087 Edition 6, 28/10/ MT Page 14 of 15

15 MICROBIOLOGY DEPARTMENT INAB Classification Number (P9) Test / Assay Name Specimen Type Method Equipment SOP 1011 Bacteriology.06 Legionella Pneumophilia Antigen Detection Streptococcus Pneumonia Urinary Antigen Detection Processing of Faeces for Clostridium Difficile.08 MRSA Confirmation testing with Mastalex 1012 Parasitology Mycology Serology of Infection 1019 Miscellaneous Specimens other than Blood for Parasites Fungal Specimens Microscopic Investigation for Fungi Detection of Measles IgG, Mumps IgG, Rubella IgG Antibodies on the Mini Vidas Joint Fluid for Presence of Crystals by Polarising Microscopy LM-MICRO-0073 LM-MICRO-0074 LM-MICRO-0081 LM-MICRO-0082 LM-MICRO-0070 LM-MICRO-0033 LM-MICRO-0008 LM-MICRO-0075 LM-MICRO-0085 Edition 6, 28/10/ MT Page 15 of 15