Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name Cavan General Hospital Trading As INAB Reg No 231MT Contact Name Brian O'Malley Address Lisdarn, Cavan Contact Phone No Website Accreditation Standard ISO Date Initially Awarded 09/06/2009 Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Microbiology and virology Blood Transfusion Science Haematology Histopathology and cytopathology 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 Cavan General Hospital Pathology Laboratory, Cavan, H12 Y7W1 INAB Registration No. 231MT Page 1 of 18 Edition 2, 01/10/2018

2 Scope of Accreditation Cavan General Hospital Blood Transfusion Science Category: A Medical pathology field - Test 1020 Transfusion science -.01 Blood grouping including ABO, Rh(D) and other antigens by manual methods 1020 Transfusion science -.03 Blood group antibody screen 1020 Transfusion science -.04 Identification of blood group antibodies 1020 Transfusion science -.05 Cross match compatible donor units 1020 Transfusion science -.06 Red cell phenotyping 1020 Transfusion science -.09 Direct antiglobulin test 1020 Transfusion science -.99 Miscellaneous tests Test/assay Specimen Type Equipment/Technique Method (CE/Non-CE/In house developed/based on standard method) Blood Grouping including ABO, Rh(D) Blood Group Antibody Screen Identification of Blood Group Antibodies Range of measurement Std. ref & SOP Whole Blood Ortho Vision LM-BT-0014 Ortho Vision LM-BT-0014 Ortho Vision LM-BT-0014 Crossmatch Testing Ortho Vision LM-BT-0014 Phenotyping Ortho Vision LM-BT-0014 Direct Antiglobulin Test Ortho Vision LM-BT-0014 Kleihauer Test Manual Method LM-BT-0007 Note: Cavan General Hospital 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) INAB Registration No. 231MT Page 2 of 18 Edition 2, 01/10/2018

3 Cavan General Hospital Chemical Pathology Category: A Medical pathology field - Test.01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies Test/assay Specimen Type Technique Equipment/Range of Measurement Alanine Aminotransferase (ALT) Serum TRIS Buffer without PLP Method (CE/Non- Std. Ref & CE/In house SOP developed/based on standard method) Albumin HCG Albumin/Creatinine Ratio Alkaline Phosphatase (ALP) Amylase Asparate Aminotransferase (AST) Urine Calculated Serum AMP Buffer not IFCC TRIS Buffer without PLP TRIS Buffer without PLP BNP EDTA Calcium Serum Arsenazo III Urine Arsenazo III Chloride (Cl) Serum Ion-Selective Electrode Diluted (Indirect) Urine Ion-Selective Electrode Diluted (Indirect) Cholesterol Serum Choesterol esterase/oxydase Corrected Calcium Calculated Creatine Kinase NAC Creatinine Enzymatic Creatinine Clearance Urine Enzymatic Serum/Urine Calculated Direct Bilirubin Serum UV Method egfr Calculated Ethanol ADH Globulins Calculated Glucose Sodium Fluoride Hexofinase + G6PD HDL Cholesterol Serum Accelerator Selective Detergent High Sensitivity INAB Registration No. 231MT Page 3 of 18 Edition 2, 01/10/2018

4 .02 Proteins, quantitative analysis.10 Drugs for therapeutic monitoring.15 Drugs for toxicological purposes.20 Hormones Troponin Iron Ferene Lactate Dehydrogenase (LDH) LDL Cholesterol Lactate to Pyruvate (NADH) Measured Light Selective Detergent Magnesium Arsenazo III Microalbumin Urine Immunoturbidimetric Paracetemol Serum Spectrophotimetric Phosphate Potassium (K) Urine Phosphomolybdate UV Ion-Selective Electrode Diluted (Indirect) Ion-Selective Electrode Diluted (Indirect) Protein Biuret Salicylate Serum Enzymatic/Colorimetric Sodium (Na) Urine Ion-Selective Electrode Diluted (Indirect) Ion-Selective Electrode Diluted (Indirect) Total Bilirubin Serum Diazo Total Protein Biuret Triglycerides Glycerol Phosphate Oxidase Urea Kinetic Urease Uric Acid Endpoint Uricase C Reactive Protein (CRP) Gentamicin Immunoturbidimetric Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) Litium Spectrophotimetric Tobramycin Vancomycin Ferritin Follicle Stimulating Hormone (FSH Particle-enhanced Turbidimetric Inhibition Immunoassay (PETINIA) Fluorescence Polarisation Immunoassay Free T4 INAB Registration No. 231MT Page 4 of 18 Edition 2, 01/10/2018

5 .40 Iron studies.45 Vitamin B12 and folate.47 Vitamin assays.50 Protein and peptide tumour markers.60 Glycohaemoglobins.65 Pregnancy tests qualitative.80 Quantitative Gamma Glutamyl Transferase (GGT) Luteinising Hormone (LH) Oestradiol Progesterone Thyroid Stimulating Hormone (TSH) Folate Free PSA Vitamin B12 Vitamin D Alpha Fetoprotein (AFP) Ca 15.3 Ca 19.9 CA-125 Carcino-embryonic Antigen Free T3 Total Prostate Specific Antigen (PSA) L-Gamma-glutamyl-3- carboxy-4-nitroanilide Substrate HBA1C Whole Blood Adams A1C HA- 8180V Beta Human Chorionic Gonadotrophin (Beta HCG) Serum HPLC SDFSDFSD CDSSSDCSD LM-BIO-0003 Adams A1C HA- 8180V CE Marked LM-BIO-0003 IgA Immunoturbidimetric INAB Registration No. 231MT Page 5 of 18 Edition 2, 01/10/2018

6 investigation of immunoglobulins G, A, M and in body fluids.83 Rheumatoid factor quantitative assays IgG Immunoturbidimetric IgM Immunoturbidimetric Rheumatoid Factor (RF) Immunoturbidimetric INAB Registration No. 231MT Page 6 of 18 Edition 2, 01/10/2018

7 Cavan General Hospital Haematology Category: A Medical pathology field - Test.01 Blood counts.02 Visual examination of blood films.03 Erthrocyte sedimentation rate.05 Automated differential leucocyte counts.06 Automated reticulocyte counts.08 Blood film examinations involving special staining procedures.09 Examination of malarial parasites.30 Tests for haemoglobin variants and thalassaemia.40 Limited haemostasis related tests.57 Screening test for Test/Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & Measurement/Equipment CE/In house SOP developed/based on standard method) Blood Count EDTA Sysmex XN-2000 WBC x 10(3)/uL RBC x 10(6)/uL HgB 0-26g/dl HCT: 0-75% PLT x 10(3)/uL NRBC# 0-20 x 10(3)/uL Visual Examination of Blood Films Erythrocyte Sedimentation Rate Blood Count Differential Sodium Citrate LM-HAEM Manual Method LM-HAEM Westergren Method/Sediplus S100 Westergren Method/Sediplus S2000 LM-HAEM LM-HAEM EDTA Sysmex XN-2000 LM-HAEM Reticulocyte Count Sysmex XN-2000 RET# x 10(6)/uL Blood Film Preparation Examination for Malarial Parasites LM-HAEM EDTA SP20 Stainer SP20 Stainer CE Marked LM-HAEM EDTA Manual/Test Kit LM-HAEM Sicke Cell Screen Manual/Test Kit LM-HAEM Activated Partial Thromboplasin Time (APTT) D-Dimer Fibrinogen Prothombin Time (PT) Infectious Mononucleosis Sodium Citrate Automated/Sysmex CS-2100i Automated/Sysmex CS-2100i Automated/Sysmex CS-2100i Automated/Sysmex CS-2100i Up to 180 seconds LM-COAG mg/L LM-COAG g/L LM-COAG Up to 180 seconds LM-COAG Plasma Manual/Test Kit LM-HAEM INAB Registration No. 231MT Page 7 of 18 Edition 2, 01/10/2018

8 infectious mononucleosis Serum Manual/Test Kit LM-HAEM Whole Blood Manual/Test Kit LM-HAEM INAB Registration No. 231MT Page 8 of 18 Edition 2, 01/10/2018

9 Cavan General Hospital Histopathology and Cytopathology Category: A Medical pathology field - Test 1051 Histopathology -.01 Processing fixed specimens for Histopathological testing 1051 Histopathology -.03 Histochemistry Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Automated Haematoxylin & Eosin Staining Coverslipping Automated/Artisan Automated/Tissue Tek Cut-Up Manual Decalcification Manual Embedding Labelling, Sorting & Checking of Slides Manual Haematoxylin & Eosin Staining Automated/Tissue Tek Embedding Centre Manual Manual Microtomy Manual/Microtome Routine H&E Screening Specimen Reception & Labelling Tissue Processing Automated/Tissue Tek Prisma Manual Automated/Tissue Tek VIP Alcian Blue Automated/Artisan Alcian Blue/PAS Automated/Artisan Congo Red for Amyloid Diffquik Automated/Artisan Automated/Tissue Tek Prisma Elasin Stain Automated/Artisan Gram Stain Automated/Gram Stainer Grocott Stain Automated/Artisan HVG Automated/Artisan Martius Scarlet Blue Manual Masson Fonatana Manual Range of measurement Std. ref & SOP LM-HIST-0009 LM-HIST-0003 LM-HIST-0002 LM-HIST-0005 LM-HIST-0010 LM-HIST-0006 LM-HIST-0001 LM-HIST-0004 INAB Registration No. 231MT Page 9 of 18 Edition 2, 01/10/2018

10 1051 Histopathology -.06 Histological interpretationperinatal pathology 1051 Histopathology -.09 Immunohistochemistry Masson's Trichrome Stain Automated/Artisan PAS for Fungi Automated/Artisan PAS for Glycogen Automated/Artisan Perls Stain for Iron Automated/Artisan Reticulin Stain Automated/Artisan Ziehl Neelsen Stain Automated/Artisan Diagnosic Interpretation and Reporting Perinatal Pathology (Confined to histological Examination of Placental Tissue and Gravid Uterie Actin ALK 1 AMACR Apha Feto Protein BCL06 BCL-2 Beta Catenin CA125 Calcitonin Calcretinin CD10 CD138 (Syndecan CD15 CD20 CD23 CD3 CD30 CD34 Manual/Microscope Manual/Microscope LM-HIST-0003 LM-HIST-0003 INAB Registration No. 231MT Page 10 of 18 Edition 2, 01/10/2018

11 CD5 CD65 CDX2 CEA Chromogranin CK20 CK7 C-Kit (CD117) CMV Cyclin D1 Desmin Ecadherin EMA ER Factor 8 HCG HEP PAR HER 2 HMB45 Inhibin Kl 67 LCA MELA/MART 1 NSE P16 P53 P63 PAN K INAB Registration No. 231MT Page 11 of 18 Edition 2, 01/10/2018

12 1051 Histopathology -.11 Chromogenic / bright-field in situ hybridisation 1052 Cytopathology -.02 Non gynaecological cytology 1052 Cytopathology -.04 Cytopathological interpretation 1052 Cytopathology -.05 Immunocytochemistry PAX 8 PLAP Podoplanin PR RCC S100 Somatostatin Synaptophysin Thyroglobulin TTF Vimentin Eber Probe Kappa Lambda Sample preparation & description Diagnosic Interpretation and Reporting BCL-6 Fluid Ber EP4 Fluid CA125 Fluid Calcitonin Fluid Calretinin Fluid CD15 Fluid LM-CYT LP-HIST-0032 INAB Registration No. 231MT Page 12 of 18 Edition 2, 01/10/2018

13 CD20 Fluid CD23 Fluid CD3 Fluid CD30 Fluid CD68 Fluid CK 5/6 Fluid CK20 Fluid CK7 Fluid ER Fluid K167 Fluid MELA/MART 1 Fluid PAN K Fluid PR Fluid RCC Fluid INAB Registration No. 231MT Page 13 of 18 Edition 2, 01/10/2018

14 S100 Fluid Somatostatin Fluid Thyroglobulin Fluid TTF Fluid INAB Registration No. 231MT Page 14 of 18 Edition 2, 01/10/2018

15 Cavan General Hospital Microbiology and Virology Category: A Medical pathology field - Test 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) Test/assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Microscopic examination of General bacteriology Blood, Wound Swab, Sputum, Bronchoalveolar Lavage, HVS, Eye Swab, Ear Swab, MRSA Swab, VRE Swab, CRE Swab, Throat Swab, Bile, Genital Tract Specimens, Urine, Fluids, Faeces, Sinus Aspirate, Nasal Swabs, Mouth Swabs, Pressure Sores, Abscesses, Intravascular Cannulae, CSF, CSF Shunts, Tissues/Biopsies, Ulcer Swabs, Surveillance Specimens, Adverse Transfusion, Environmental Specimens Microscopic examination with or without fixation and staining with dyes for enumeration and description of human cells/light Microscope CE Marked Range of measurement Std. ref & SOP LM , , 0028, , 0058, 0075, 0078, 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 Bactec FX Culture Intrument/Microscopy CE Marked LM , , 0028, 0030, 0075, Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.03 Enzyme immunoassay, HIV Blood Enzyme Immunoassay/Test Kit CE Marked LM RSV β-lactamase Nasopharyngeal Aspirate Blood, Wound Swab, Sputum, Enzyme Immunoassay/Test Kit CE Marked LM Enzyme Immunoassay/Test Kit CE Marked LM- INAB Registration No. 231MT Page 15 of 18 Edition 2, 01/10/2018

16 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.04 Immunochromatographic methods, 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, CE marked commercial systems 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques - Bronchoalveolar Lavage, HVS, Eye Swab, Ear Swab, MRSA Swab, VRE Swab, CRE Swab, Throat Swab, Bile, Genital Tract Specimens, Urine, Fluids, Faeces, Sinus Aspirate, Nasal Swabs, Mouth Swabs, Pressure Sores, Abscesses, Intravascular Cannulae, CSF, CSF Shunts, Tissues/Biopsies, Ulcer Swabs, Surveillance Specimens, Adverse Transfusion, Environmental Specimens Adenovirus Faeces Immunochromatographic/Test Kit Cryptosporidium Immunochromatographic/Test Kit Legionella Urine Immunochromatographic/Test Kit Rotavirus Faeces Immunochromatographic/Test Kit S. pneumoniae Urine Immunochromatographic/Latex Kit Immunochromatographic/Test Kit INAB Registration No. 231MT Page 16 of 18 Edition 2, 01/10/ CE Marked LM CE Marked LM CE Marked LM CE Marked LM CE Marked LM CE Marked LM C. diff Gene Faeces PCR/BD Max CE Marked LM Enteric Bacterial Pathogens Aerobes/Anaerobes Blood, Wound Swab, Sputum, Bronchoalveolar Lavage, HVS, Nucleic-Acid Amplification/BD Max MIC/Disk Diffusion/Pheonix 100 CE Marked LM CE Marked LM LM-

17 .03 Identification of fungi by microscopic morphology 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.04 Identification using MALDI-TOF Spectroscopy 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes 1024 Preservation of microbial cultures 1029 Miscellaneous -.99 Miscellaneous tests Eye Swab, Ear Swab, MRSA Swab, VRE Swab, CRE Swab, Throat Swab, Bile, Genital Tract Specimens, Urine, Fluids, Faeces, Sinus Aspirate, Nasal Swabs, Mouth Swabs, Pressure Sores, Abscesses, Intravascular Cannulae, CSF, CSF Shunts, Tissues/Biopsies, Ulcer Swabs, Surveillance Specimens, Adverse Transfusion, Environmental Specimens 0057 Spectroscopy/MALDI-TOF CE Marked LM , , 0028, 0030, 0034, 0039, 0040, 0075, 0078, 0081 Biochemical Testing/Pheonix 100 CE Marked LM LM MIC/Disk Diffusion/Manual CE Marked LM LM Isolates Freezer/Manual CE Marked LP Faecal Occult Blood Faeces Test Kit/Manual CE Marked LM Microscopy Urine Particle Counter/Sedimax CE Marked LM Pregnancy Test Test Kit/Manual CE Marked LM INAB Registration No. 231MT Page 17 of 18 Edition 2, 01/10/2018

18 INAB Registration No. 231MT Page 18 of 18 Edition 2, 01/10/2018