MedLab Pathology Ltd Unit 3, Sandyford Business Centre, Sandyford Business Park, Dublin 18 Registration number: 296MT is accredited by the Irish National Board () to undertake testing as detailed in the Schedule bearing the Registration Number detailed above, in compliance with the International Standard ISO 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: 06:12:2011 Date of last renewal of accreditation: 28:10:2016 Expiry date of this certificate of accreditation: 28:10:2021 This shall remain in force until further notice subject to continuing compliance with accreditation criteria, ISO 15189 and any further requirements specified by the Irish National Board. Manager: Dr Adrienne Duff Chairperson: Issued on 28/10/2016 Mr. Tom O Neill 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 13, 29/05/2018 296MT Page 1 of 10
Schedule of (Annex to Certificate) MEDLAB PATHOLOGY LTD Initial Registration Date : 6-December-2011 Postal Address: (Address of other locations as they apply) Unit 3, Sandyford Business Centre Sandyford Business Park, Sandyford, Dublin 18 Telephone: +353 (1) 2933690 Fax: +353 (1) 2933671 E-mail: info@medlabpathology.ie Contact Name: Lisa Clarke Facilities: Public testing service Edition 13, 29/05/2018 296MT Page 2 of 10
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 17025 or ISO 15189 (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 13, 29/05/2018 296MT Page 3 of 10
CYTOPATHOLOGY TESTING LABORATORY Test/Assay Name 1052.01 Cytopathology Gynaecological (Cervical) Thin Prep Thin Prep LBC Sample Sample processing on Hologic T5000 SOP-CY-39 Gynaecological (Cervical) Thin Prep Unstained ThinPrep LBC Sample for Papanicolaou (PAP) staining Operation and Mianenabce of lecia Staining Machine & Coverslipping SOP-CY-9 Screening & Reporting Gynaecological (Cervical) Gynaecological (Cervical) Thin Prep Thin Prep Thin Prep Papanicolaou Stained LBC Slide Sample High Risk HPV using the Roche 4800 Analyser DNA High Risk HPV using Hologic Panther; thin prep LBC sample Mrna Messenger Ribonucleic acid Provate cervical smears Cytology Internal Quality Audit Operation and mainteneace of Olympus BX-45 Microscope Molecular analysis of high risk HPV using the Roche 4800 Analyser. MB-10 PPV Reporting Hologic Panther: MB-12, MB- 13 SOP-CY-2- SOP-CY-3- SOP-CY-6- SOP-CY-11 SOP-MB-9 Gynaecological (Cervical) *Not used for primary screening Edition 13, 29/05/2018 296MT Page 4 of 10
CHEMISTRY DEPARTMENT 1061 General Chemistry Test/Assay Name SODIUM ISE,Indirect POTASSIUM ISE,Indirect CHLORIDE ISE,Indirect BICARBONATE Phosphoenolpyruvate (PEP) Kinetic test with urease and UREA glutamate dehydrogenase. CREATININE(JAFFE) Alkaline Picrate ESTIMATED GFR(MDRD) BILIRUBIN TOTAL Azobilirubin/Colourmetric ALKALINE PHOSPHATASE Colourimetric/p-nitrophenol NADH oxidation/l-malate( ASPARTATE IFCC) without pyridoxal TRANSFERASE phosphate ALANINE TRANSFERASE GAMMA GLUTAMATE TRANSFERASE LACTATE DEHYDROGENASE TOTAL PROTEIN ALBUMIN GLOBULIN ALBUMIN/GOBULIN RATIO CALCIUM CORRECTED CALCIUM PHOSPHATE MAGNESIUM URIC ACID L-lactate and NAD+/IFCC Enzymatic colourimetric assay Pyruvate + NADH + H+/UV assay Colourimetric Bromcresol Green/Colourimetric Schwarzenbach with o- cresolphthalein complexone. Molybdate UV Colourimetric method with Chlorophosphonazo III Enzymatic colourimetric test CC-48, CC-5 CC-48, CC-5 CC-48,CC-5 CC-48,CC-6 CC-48, CC-8 CC-48, CC-9 CC-48,CC-9 CC-48, CC-10 CC-48, CC-12 CC-48,CC-13 CC-48, CC-14 CC-48, CC-17 CC-48, CC-16 CC-48, CC-18 CC-48,CC-7 CC-48,CC-7 CC-48,CC-7 CC-48, CC-19 CC-48, CC-19 CC-48, CC-21 CC-48, CC-20 CC-48, CC-23 Edition 13, 29/05/2018 296MT Page 5 of 10
CHEMISTRY DEPARTMENT Test/Assay Name AMYLASE C-REACTIVE PROTEIN C-REACTIVE PROTEIN - HIGH SENSITIVITY CREATINE KINASE TRIGLYCERIDE CHOLESTEROL HDL CHOLESTEROL LDL CHOLESTEROL GLUCOSE IRON UNSATURATED IRON BINDING CAPACITY TOTAL IRON BINDING CAPACITY Troponin T hs Enzymatic Creatinine TRANSFERRIN TRANSFERRIN SATURATION Enzymatic colourimetric assay/ifcc Particle enhanced immuno-turbidimetric assay Particle enhanced immuno-turbidimetric assay D-6-phosphogluconate + NADPH + H+/UV Test Enzymatic colourimetric test Enzymatic/Colourimetric method Homogeneous enzymatic colourimetric assay. Homogeneous enzymatic colourimetric assay. Serum/ Fluoride Enzymatic reference oxalate method with hexokinase Colourimetric assay Plasma Direct determination with FerroZine Electrochemilumin escence Immunoassay (ECLIA) Enzymatic Immunoturbidimetric assay Roche Cobas c311 (MLP110044 )& 6000 (MLP110144) (MLP110o79) CC-48, CC-54 CC-48, CC-41 CC-48, CC-42 CC-48, CC-15 CC-48, CC-25 CC-48, CC-28 CC-48, CC-27 CC-48, CC-28 CC-1, CC-48, CC-22 CC-48, CC-24 CC-48, CC-44 CC-48, CC-44 CC-49, EN-32 CC-48, CC-9 CC-48, CC-40 CC-48, CC-24 Edition 13, 29/05/2018 296MT Page 6 of 10
CHEMISTRY DEPARTMENT 1061 General Chemistry Test/Assay Name RHEUMATOID FACTOR Immunoturbidimetric assay HAEMOGLOBIN A1C (IFCC) FREE T3 FREE T4 THYROID STIMULATING HORMONE ESTRADIOL FOLLICULAR STIMULATING HORMONE βeta-hcg LUTEINIZING HORMONE PROGESTERONE PROLACTIN TESTOSTERONE Anti-Mullerian Hormone (AMH) WHOLE / Capillary Blood Turbidimetric inhibition immunoassay (TINIA) Roche Cobas c311 (MLP110044 )& Roche Cobas 6000 CC-48, CC-43 CC-1, CC-48, CC-39 CC-49, EN-2 CC-49, EN-3 CC-49, EN-1 CC-49, EN-15 CC-49, EN-16 CC-49, EN-17 CC-49 EN-18 CC-49, EN-19 CC-49, EN-20 CC-49, EN-21 CC-49, CC-58 Edition 13, 29/05/2018 296MT Page 7 of 10
CHEMISTRY DEPARTMENT 1061 General Chemistry Test/Assay Name TOTAL PROSTATE SPECIFIC ANTIGEN FERRITIN FOLATE VITAMIN B12 THYROXINE (T4) SERUM LITHIUM Colometric SERUM/PLASMA VITAMIN D FAECAL IMMUNOCHEMICAL TESTING (FIT) FAECES Latex aggluination Diana QC Sensor (MLP110113) & (MLP110114) CC-49, EN-27 CC-49, EN-4 CC-49, EN-6 CC-49, EN-5 CC-49, EN-31 CC-48, CC-59 CC-49, CC-61 CC-55 Edition 13, 29/05/2018 296MT Page 8 of 10
HAEMATOLOGY DEPARTMENT 1030 Haematology.01 Test/Assay Name FULL COUNTS (INCLUDING RED CELL COUNT, HAEMOGLOBIN, HAEMATOCRIT, MEAN CELL VOLUME, MEAN CELL HAEMOGLOBIN, MEAN CELL HB CONC, WHITE CELL COUNT,TOTAL, NEUTROPHILS (ABSOLUTE), NEUTROPHILS (%),LYMPHOCYTES(ABSOLUTE), LYMPHOCYTES(%),MONOCYTES(ABSOLUTE), MONOCYTES(%),EOSINOPHILS(ABSOLUTE), EOSINOPHILS(%),BASOPHILS(ABSOLUTE), BASOPHILS(%),PLATELETS COUNT, RDW, MPV WHOLE Fluorescent Flow Cytometry/Hydrodynam ic Focusing, DC-Sheath Flow Cytometry, Sulfolyzer (SLS)- Haemoglobin method, /Derived, Sulfolyzer (SLS)- Haemoglobin method Sysmex XE- 2100(Flow Cytometer) (MLP110020) & Sysmex XS-1000i (MLP110143) HM-1, HM-2, HM-19.03 ERYTHROCYTE SEDIMENTATION RATE.02 FILM MORPHOLOGY.09 EXAMINATION FOR MALARIA PARASITES WHOLE WHOLE WHOLE Sedivette Romanowsky Procedures for the investigation of malaria parasites Sarstedt Sedivette ESR rack (MLP110042) Olympus BX45(Microscope) (MLP110056) Olympus BX45(Microscope) (MLP110056) HM-1, HM-8 HM-1, HM-6 HM-18 Edition 13, 29/05/2018 296MT Page 9 of 10
MICROBIOLOGY DEPARTMENT 1018 Detection of antibody response to infection using appropriate CE marked commercial techniques 1015 Detection and/or identifiaction of bacterial, parasite, fungal and viral nucleic acids Test/Assay Name Anti-Hepatitis B Core (HBcAb) Hepatitis B Surface Antibody (HBsAb) Hepatitis B Surface Antigen (HBsAg) Anti-Hepatitis C Virus (HCVAb) Syphilis HIV Combi (HIV) Rubella IgG (Rubella IgG) Chlamydia trachomatis (CT) Neisseria gonorrhoeae (NG) /CAPILLARY /CAPILLARY /CAPILLARY /CAPILLARY /CAPILLARY Urine/Swab Urine/Swab ce ce ce ce ce ce ce Real time PCR amplification Real time PCR amplification ) Roche Cobas 4800 MLP110096 & MLP110097 Roche Cobas 4800 MLP110096 & MLP110097 SR-8 SR-3 SR-1 SR-4 SR-10 SR-5 CC-49, SR-6 MB-11 MB-11 Edition 13, 29/05/2018 296MT Page 10 of 10