The Mater Private Hospital

Transcription

1 The Mater Private Hospital Pathology Laboratory, Eccles Street, Dublin 7 Medical Testing Laboratory Registration number: 191MT 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/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: 22:04:2008 Date of last renewal of accreditation: 11:03:2013 Expiry date of this certificate of accreditation: 11:03:2018 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: Chairperson: Dr Adrienne Duff Issued on 27 February 2015 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 12, 13/07/ MT Page 1 of 19

2 Schedule of (Annex to Certificate) THE MATER PRIVATE HOSPITAL Medical Testing Laboratory Initial Registration Date : Haematology/ clinical chemistry: Microbiology: 22-April November September-2013 Postal Address: (Address of other locations Eccles Street Dublin 7 as they apply) Telephone: +353 (1) Fax: +353 (1) tosullivan@materprivate.ie Contact : Ms Therese O' Sullivan Facilities: Public testing service Edition 12, 13/07/ 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 12, 13/07/ MT Page 3 of 19

4 Transfusion Testing Laboratory 1020 Immunohaematology Test / Assay SOP.01 Grouping including ABO, Rh(D) grouping (ABO RH (D) Typing) Red Cells LM-BT Testing using the Gel Station LM-BT-0002 Methods.03 Group Antibody Screening Antibody Screening Plasma LM-BT-006 & methods of antibody screening..04 Identification of Group Antibodies Antibody Identification Plasma LM-BT 010 & methods of antibody identification.05 Determination of Compatibility of Donor Units using Appropriate Techniques.06 Red Cell Phenotyping Compatibility Testing Plasma LM-BT-0007 Methods of Crossmatching Antigen Typing Red Cells LM-BT-0014 & Methods of antigen typing.99 Miscellaneous Tests Direct Coombs Testing Red Cells LM-BT & Methods of Direct Antiglobulin Testing (DAT) Note: The Mater Private Hospital Dublin, 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 12, 13/07/ MT Page 4 of 19

5 Clinical Chemistry Testing Laboratory Test / Assay Method Equipmen t SOP 1061 Clinical Chemistry.01 Analytes in General Use in Function, Lipid, Renal and other Profiles and Metabolic Studies Albumin Serum/ Fluid Bromocresol purple Alk Phos Serum IFCC PNPP ALT Serum IFCC UV with P5P Amylase Serum/ Fluid CNPG3 AST Serum IFCC UV with P5P Bilirubin Serum Diazo- Caffeine/ benzoate Coupling J-G W/Blank Calcium serum Serum Cresolphthalein complexone Calcium urine Urine Cresolphthalein complexone Calcium Serum Calculated corrected Chloride Serum/ Indirect ISE Urine Cholesterol Serum/ Fluid Oxalate total oxalate Cholestrol Serum HDL & LDL Bicarbonate Serum Enzymatic Direct measure PEG CK Serum IFCC NAC activated Creatinine/c reatinine clearance serum/ urine Serum/Urine Alkaline Picrate (Kinetic) Gamma GT Serum IFCC G-Glutamyl carboxynitroanilide Siemen s Dimens ion RXL LM-BIO-009 Individual Biochemistry Assays Performed on the Dimension RxL Clinical Chemistry Analyser and the Method for Analysing Patient Samples Edition 12, 13/07/ MT Page 5 of 19

6 Clinical Chemistry Testing Laboratory Test / Assay Method Equipmen t SOP 1061 Clinical Chemistry Glucose Serum/CSF/ Hexokinase UV Fluid Globulin Serum Calculated calculation Magnesium Serum Methylthymol Blue Phosphate Serum Phosphomolybdat e UV Potassium Serum/Urine Indirect ISE Sodium Serum/Urine Indirect ISE Triglyceride Serum/Fluid Enzymatic w/o glyc.bl., w/o serum blank GPO Urate Serum Uricase Urea Serum/Urine Urease with GLDH Albumin Serum dye binding-bcp.02 Proteins, quantitative analysis LDH Serum/Fluid IFCC Lactate - Pyruvate Troponin I (CMIA).2 Hormones Free T4 (CMIA) TSH (CMIA).5 Protein and Peptide Tumour Markers TPSA (CMIA) CEA (CMIA) Ca153 Serum CMIA Abbott Architect LM-ENDO-0008 Individual Tests Performed on the Abbott Architect.06 Glycohaemoglobins Ca125 (CMIA) HbA1c HPLC Adams Arkray 8160 LS-BIO-0029 LM-BIO-0012 Determination of HBA1C in a Patient Sample Edition 12, 13/07/ MT Page 6 of 19

7 Haematology Testing Laboratory Test / Assay 1030 Haematology.01 Counts Full Counts including the following parameters RCC Hb RDW HCT MCV MCHC Platelet Directly measured Photo-optical 555um Derived from the RCC Calculated from RCC & MCV Derived from the RCC Calculated from RCC & Hb Optical flow cytometry Cell Dyn Ruby LM-HAEM-0044 Full Counts & Differentials using the Cell Dyn Ruby.05 differential leucocyte counts WBC count & differential Laser light flow cytometry using MAPPS (multi-angle polarized scatter separation technology) Edition 12, 13/07/ MT Page 7 of 19

8 Haematology Testing Laboratory 1030 Haematology.02 Visual Examination of Flood Films Test / Assay Visual examination of blood films Modified Wrights Stain May Grunwald Giemsa : Hematek LM-HAEM-0028 Preparation, Microscopic Examination & Reporting of Films LM-HAEM-0043 Full Counts & Differentials using the Cell Dyn Ruby LM-HAEM-0032 May Grumwald Giemsa Staining of Films & Bone Marrow Smears by Method.03 Erythrocyte Sedimentation Rate Erythrocyte Sedimentati on Rate The surface layer of the erythrocytes is detected by means of a change of light intensity at the beginning of the measuring process and after one hour Desaga S2000 LM-HAEM-0042 ESR Determination using the Desaga S2000 & Sedivette Backup.06 Reticulocyte Count Reticulocyte Count New Methylene Blue Cell Dyn Ruby 1 / Microscopy LM-HAEM-0036 Performance of Reticulocytes : & Method.09 Examination for Malarial Parasites Malaria Rapid Diagnostic Test Immunochromatograp hic test macroscopic visualisation LM-HAEM-0009 Identification of Malarial Parasites using Edition 12, 13/07/ MT Page 8 of 19

9 Haematology Testing Laboratory 1030 Haematology Test / Assay Film Examination Thick and Thin Films Fields stain and Giemsa stain Microscopy a Test Kit * Microscopic Examination of Films LM-HAEM-0028 Preparation, Microscopic Examination & Reporting of Films.30 Tests of Haemoglobin Variants and Thalassaemia Sickle Cell Screen Haemoglobin solubility test method macroscopic visualisation LM-HAEM-0022 Sickle Cell Disease and Sickle Cell Trait Screening LS-HAEM General Haemostasis Related Tests General Haemostasis tests including PT, INR, APTT, Fibrinogen quantation, D-Dimer, Correction Studies Plasma Mechanical Clotting System Stago Compact LM-HAEM-0041 Operation of the Stago Compact Analyser in the Performance of the Pt/Inr, Aptt, Fibrinogen and D Dimers LM-HAEM-0038 Determination of PT, APTT & Fibrinogen using the Thrombotrack.58 Vitamin B12 and Folate (Serum and Red Cell) B12, FOLATE, FERRITIN Serum Chemiluminescent Micro Particle Immunoassay Architect i2000 LM-HAEM-0045 Ferritin, B12 and Folate Performance on the Abbott Architect Edition 12, 13/07/ MT Page 9 of 19

10 Microbiology Testing Laboratory Classificatio n Number (P9) Test / Assay 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) Gram stain Examination of urine samples Cell count for body fluids Body fluids, pus, CSF, HVS, Eye Urine Body fluids, CSF Microscopy LM-MICRO-0031 Performing a Gram Stain Microscopy: cell count Microscopy: cell count LM-MICRO-0022 Urine LM-MICRO-0019 CSF LM-MICRO-0064 Sterile Fluids.02 Microscopic examination for fungi Wet preparations Bronchial washing, nail, skin, hair Microscopy LM-MICRO-0036 Fungal s 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth.01 Culture Screening for Culture LM-MICRO-0034 Nose, throat, for general MRSA, CRE, groin, rectal bacterial VRE Screening swabs s Isolation of significant pathogens in clinical samples Fluids, CSF, pus,, bone, HVS, Endocervical swab, penile/ urethral swab, IUCD, Ear/ eye/ nose/ throat/ mouth swabs, wound swabs, tips, drains, urine, stool. LM-MICRO-0023 Inoculation of Culture Media LM-MICRO-0019 CSF LM-MICRO-0022 Urine LM-MICRO-0063 ENT s Edition 12, 13/07/ MT Page 10 of 19

11 Microbiology Testing Laboratory Classificatio n Number (P9) Test / Assay LM-MICRO-0064 Sterile Fluids.02 Culture of fungi Isolation of significant pathogens in clinical samples Inoculation and incubation of plates Sputum, Bronchial washing Bronchial washing, nail, skin, hair LM-MICRO-0065 Swabs, Tissue, IV Cannulae and associated specimens LM-MICRO-0067 Faeces Samples Culture LM-MICRO-0066 Sputum, Bronchial Washings and associated specimens Culture LM-MICRO-0036 Fungal s 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques..03 Enzyme Immunoassa y Stool LM-MICRO-0067 Faeces Samples Detection of Clostridium difficle in faeces Detection of GDH Dectection of C.difficle toxin A and B 1016 Identification of cultured bacteria and fungi using non-nucleic acid based.01 Biochemical method, CE marked commercial systems Use of commercial identification systems for bacteria Use of Vitek 2 Fluids, CSF, pus,, bone, HVS, Endocervical swab, penile/ urethral swab, IUCD, Culture and sensitivity, biochemical tests, commercial identification systems, LM-MICRO-0058 The Oxidase Test LM-MICRO-0054 Campylobacter Identification Edition 12, 13/07/ MT Page 11 of 19

12 Microbiology Testing Laboratory Classificatio n Number (P9) Test / Assay Compact Ear/ eye/ nose/ throat/ mouth swabs, wound swabs, tips, drains, urine, stool. automated sensitivity testing, manual sensitivity testing. Vitek 2 Compact LM-MICRO-0059 The Catalase test LM-MICRO-0046 API Identification System LM-MICRO-0048 Isolate Identification using the RapID system LM-MICRO-0061 Use of Vitek Identification and Antimicrobial Susceptibility Testing Cards LM-MICRO-0060 Use of Shigella Polyvalent agglutinating sera LM-MICRO-0045 Use of the Streptex kit and the PYR test LM-MICRO-0056 Staphylococcus aureus identification using the Staphaurex plus kit LM-MICRO-0050 The Wellcolex colour Salmonella kit LM-MICRO-0052 The E.coli O157 Test Edition 12, 13/07/ MT Page 12 of 19

13 Immunology Testing Laboratory 1040 Immunology.01 Quantitative investigation of immunoglobulins G, A and M in body fluids Test / Assay Specim en IgG, IgA, IgM Serum Immunoturbidimetric SPAplus Special Protein Analyser LM-IMM-0018 Individual Tests Performed on the Spa Plus Special Protein Analyser LS-IMM-0014 Operation of the SPAplus Special Protein Analyser.02 Qualitative investigation of immunoglobulins G, A and M in Electrophoresis Serum Electrophoresis Immunofixation Serum & Urine Agarose Gel Hydrasys 2 Scan LM-IMM-0008 Electrophoresis of Serum and Urines LM-IMM-0012 Immunofixation of Serum and Urine 0.14 b2 - microglobulin 0.99 Miscellaneous Tests Beta-2 Microglobulin Kappa Free Light Chains Lambda Free Light Chains Serum Immunoturbidimetric SPAplus Special Protein Analyser LM-IMM-0018 Individual Tests Performed on the Spa Plus Special Protein Analyser 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques (Test carried out in Immunology).03 Enzyme Immunoassay HBsAg Serum Immunoassay Abbott Anti-HCV Syphillis Architect i2000sr LM-IMM-0015 Individual Tests Performed on the Abbott Architect in Immunology Edition 12, 13/07/ MT Page 13 of 19

14 Histopathology Testing Laboratory 1051 Histopathology.01 Processing fixed specimens for histopathologic al examination.01 Processing fixed specimens for histopathologic al examination Test / Assay Reception and Haematoxylin and Eosin Staining Coverslipping Cut up Tissue processing labeling and entering specimens onto LIS. printing of cassettes using the IPC Cassette Printer/Kalte k Dualvision Cassette Writer dissection of samples using the G2 speech system in AFOS cut up room method of xylene, alcohol, paraffin wax infiltration of samples using the VIP Tissue Processor/ ASP6025 Kaltek Dualvision Cassette Writer IPC Cassette Printer AFOS Cut Up Room Balances- Ohous, Denver VIP Tissue Processor ASP6025 Tissue Processor LM-HIST-0004 Fixation & Decalcification LM-HIST-0022 Principles of good practice and training manual for Medical Scientists involved in Cut Up LS-HIST-0044 AFOS Cut Up Room LM-HIST-0006 Tissue Processing Edition 12, 13/07/ MT Page 14 of 19

15 Histopathology Testing Laboratory 1051 Histopathology.01 Processing fixed specimens for histopathologic al examination Test / Assay Embedding Microtomy Haematoxylin method of impregnating samples with paraffin wax using the Tissue Tek TEC 5 Embedding Centre, to create a wax block. and automated use of microtomes for cutting sections onto glass slides. staining and coverslipping of slides Para Trimmer Tissue Tek TEC 5 Embedding Centre RM 2255 (1-4) RA Lamb Waterbaths Histology Ovens Multistainer ST5020 and Coverslippe r CV5030 Chemflow Fume Cabinet LM-HIST-0007 Embedding LS-HIST-0039 Operation of Para Trimmer LS-HIST-0045 Operation of Tissue Tek TEC 5 Embedding Centre /motorized sectioning of processed LM-HIST-0008 Cutting of Paraffin Blocks Haematoxylin and Eosin Staining LM-HIST-0009 Staining Cover slipping & sorting coverslipping of slides using Multistainer ST5020 and CV5030. Multistainer ST5020 and CV5030 Nikon Microscope Coverslipping and Sorting LM-HIST-0011 Coverslipping in Histology & Cytology LS-HIST-0010 Edition 12, 13/07/ MT Page 15 of 19

16 Histopathology Testing Laboratory 1051 Histopathology.02 Processing fresh specimens for frozen section examination Test / Assay Reception Cut-up Frozen section cryotomy and staining accepting, labeling and entering of specimens onto the LIS system. weighing, cutting of fresh sample in AFOS cut up room Multistainer ST5020 and Coverslipper CV5030 LM-HIST-0001 Reception, Labeling & Charging Cryotomy and Staining LM-HIST-0002 Frozen Sections LM-HIST-0009 Staining LM-HIST-0011 Coverslipping in Histology & Cytology.03 Histochemistry Special stains Perls Prussian Blue Reticulin (Gordon & Sweets) Trichrome (Masson) Trichrome (Gomoris) Van Gieson Shikata Orcein Periodic Acid Schiffs (PAS) staining of special stain slides. 'finishing special' and coverslippin g using Multistainer ST5020 and Coverslippe r CV5030. Nikon Microscope Multistainer ST5020 and Coverslipper CV5030 Chemflow Fume Cabinet Balances- Ohous, Denver LM-HIST-0009 Staining LM-HIST-0011 Coverslipping in Histology & Cytology Edition 12, 13/07/ MT Page 16 of 19

17 Histopathology Testing Laboratory Test / Assay 1051 Histopathology Diastase - PAS Alcian Blue/PAS Alcian Blue Congo Red (Amyloid) Martius Scarlet Blue (MSB) Millers Elastic checking labeling and sorting of slides. Methenamine Silver Masson Fontana Ziehl Neelsen (ZN) Gram Modified Giemsa Chloroacetate esterase.05 Immuno histochemistry Immunohistoc hemistry staining methods Actin Actin SM AE1AE3 BCL2 BCL6 BEREP4 Ca 125 Calponin Calretinin CAM5.2 Tissue staining of immuno slides using the Bond III. Finishing and coverslippin g of slides using Multistainer ST5020 and Coverslippe r CV5030. Nikon Microscope Chemflow Fume Cabinet Bond III Immunostaine r Multistainer ST5020 and Coverslipper CV5030 LM-HIST-0011 Coverslipping in Histology & Cytology LS-HIST-0048 Operation of and Immunostaining using Bond III Edition 12, 13/07/ MT Page 17 of 19

18 Histopathology Testing Laboratory Test / Assay 1051 Histopathology (Cyto8/18) CD3 CD4 CD5 CD8 CD10 CD15 (Leu M1) CD 20 (L26) CD23 CD30 (Ki1) CD34 CD45 (CLA) CD68 (KP1) CD79a CD99 CD117 (c-kit) CD138 CDX2 CEA Chromogranin Cyclin D1 Cyto 5/6 Cyto 7 Cyto 20 Cyt 903 (HMWCK) Desmin D240 Dual staining for CYTO 903/ Racemase E- Cadherin EMA ER HMB45 HLO Kappa Lambda checking and sorting of slides. Edition 12, 13/07/ MT Page 18 of 19

19 Histopathology Testing Laboratory Test / Assay 1051 Histopathology Melan A MIB1 MLH1 MSH2 MSH6 NSE P16 P53 P63 PAX-8 PMS2 PR PSA Racemase SMMS Synaptophysin S-100 TTF1 Vimentin WT1 Edition 12, 13/07/ MT Page 19 of 19