Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address Midland Regional Hospital Tullamore 221MT Mari Fitzgerald Contact Phone No Website Accreditation Standard ISO Pathology Department, HSE Dublin Mid Leinster, Arden Road, Tullamore, Offaly Date Initially Awarded 07/04/2009 Scope Classification Scope Classification Scope Classification Scope Classification Scope Classification Services available to the public¹ Microbiology and virology Blood Transfusion Science Haematology Histopathology and cytopathology Chemical pathology Yes 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 Quality Office Pathology Department, Midland Regional Hospital Tullamore, Arden Road, Tullamore, Offaly, R35 Y2D1 INAB Registration No. 221MT Page 1 of 15 Edition 1, 27/06/2018

2 Scope of Accreditation Quality Office Blood Transfusion Science Category: A Medical pathology field Transfusion science -.01 Blood grouping including ABO, Rh(D) and other antigens by manual methods /assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based method) Forward Blood Group, Reverse Blood Group Whole Blood in EDTA Manual method using tube and Gels cards 1020 Transfusion Antibody Screen Plasma Manual method using science -.03 Blood group Gel Cards 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 -.99 Miscellaneous tests Antibody Identification Crossmatch testing Antigen typing - Patients and Donor Cells Dicrect coombs testing/monospecific coombs test Donor and Patient Red Cells Patient and Donor Red Cells Manual method using Gel Cards Manual method using Gel Cards Manual method using tube and Gels cards Manual method using Gel Cards CE - based on CE - based on CE - based on CE - based on CE - based on CE - based on Range of measurement - Aggulitination donates a positive reaction - Aggulitination donates a positive reaction - Aggulitination donates a positive reaction - Aggulitination donates a positive reaction - Aggulitination donates a positive reaction - Aggulitination donates a positive reaction Std. ref & SOP Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/003 Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/003 Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/005 Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/004 Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/009 Section of ISO 15189:2012 & BSCH Guidelines, T/BTL/LP/010 INAB Registration No. 221MT Page 2 of 15 Edition 1, 27/06/2018

3 Quality Office Chemical Pathology Category: A Medical pathology field Clinical Chemistry -.01 Analytes in general use in cardiac, liver function, lipid, renal and other profiles and metabolic studies /assay Specimen Type Technique Equipment/Range of Measurement Alanine Aminotransferase (ALT) serum/plasma Photometric Albumin Photometric Albumin/Creatinine Ratio (ACR) Alkaline Phosphatase (ALP) urine Calculation serum/plasma Photometric Amylase serum/plasma/urine Photometric ASOT serum/plasma Immunoturbidimetric Aspartate Aminotransferase (AST) Photometric Bicarbonate Photometric Bilirubin (Direct) Photometric Bilirubin (Total) Photometric BNP plasma C reactive Protein (CRP) serum/plasma Immunoturbidimetric Calcium Photometric Chloride ISE Cholesterol Photometric Corrected Calcium Calculation Creatine Kinase (CK) Creatinine (Enzymatic) Photometric Photometric Creatinine (Jaffe) serum/plasma/urine Photometric Creatinine Clearance Calculation egfr serum/plasma Calculation Method (CE/Non- Std. Ref & CE/In house SOP developed/based method) T/BIO/LP/017 T/BIO/LP/015 T/BIO/LP/007 T/BIO/LP/016 T/BIO/LP/018 T/BIO/LP/019 T/BIO/LP/020 T/BIO/LP/021 T/BIO/LP/027 T/BIO/LP/040 T/BIO/LP/013 T/BIO/LP/026 T/BIO/LP/022 T/BIO/LP/045 T/BIO/LP/023 T/BIO/LP/007 T/BIO/LP/024 T/BIO/LP/049 T/BIO/LP/048 T/BIO/LP/007 T/BIO/LP/007 INAB Registration No. 221MT Page 3 of 15 Edition 1, 27/06/2018

4 1061 Clinical Chemistry -.06 Blood ph and gas tensions 1061 Clinical Chemistry -.07 Other analytes performed on a blood Gamma Glutamyltransferase (GGT) Photometric Glucose serum/plasma/csf Photometric HDL serum/plasma Photometric High Sensitivity Troponin T (HsTnT) Lactate plasma Photometric Lactate DeHydrogenase (LDH) serum/plasma Photometric LDL Photometric Magnesium serum/plasma/urine Photometric Microalbumin urine Immunoturbidimetric Parathyroid Hormone (PTH) plasma Phosphate serum/plasma/urine Photometric Potassium ISE Protein (Urinary/CSF) urine/csf Immunoturbidimetric Sodium serum/plasma/urine ISE Total Protein serum/plasma Photometric Triglyceride Photometric Urea serum/plasma/urine Photometric Uric Acid Photometric pco2 Whole Blood Potentiometric Cobas b221 blood ph Potentiometric Cobas b221 blood PO2 Amperometric Cobas b221 blood Calcium Potentiometric Cobas b221 blood Chloride Potentiometric Cobas b221 blood Glucose Amperometric Cobas b221 blood Lactate Amperometric Cobas b221 blood Potassium Potentiometric Cobas b221 blood T/BIO/LP/029 T/BIO/LP/030 T/BIO/LP/031 T/BIO/LP/060 T/BIO/LP/032 T/BIO/LP/033 T/BIO/LP/034 T/BIO/LP/035 T/BIO/LP/036 T/BIO/LP/058 T/BIO/LP/037 T/BIO/LP/045 T/BIO/LP/043 T/BIO/LP/045 T/BIO/LP/041 T/BIO/LP/042 T/BIO/LP/047 T/BIO/LP/044 INAB Registration No. 221MT Page 4 of 15 Edition 1, 27/06/2018

5 1061 Clinical Chemistry -.10 Drugs for therapeutic monitoring 1061 Clinical Chemistry -.14 Alcohol for non-legal purposes 1061 Clinical Chemistry -.15 Drugs for toxicological purposes 1061 Clinical Chemistry -.50 Protein and peptide tumour markers 1061 Clinical Chemistry -.60 Glycohaemoglobins 1061 Clinical Chemistry -.83 Rheumatoid factor quantitative assays Sodium Potentiometric Cobas b221 blood Standard Bicarbonate Calculation Cobas b221 blood TCO2 Calculation Cobas b221 blood Gentamicin serum/plasma Vancomycin Ethanol Photometric Paracetemol Photometric Salicylate Photometric Alpha Feto Protein (AFP) Cancer antigen 125 (CA 125) Cancer antigen 15.3 (CA 15.3) Cancer antigen 19.9 (CA 19.9) CarcinoEmbryonic Antigen (CEA) Chorionic Gonadotrophin Plus Beta (BHCG) Prostate Specific Antigen (PSA) HbA1c Whole Blood HPLC Ha-8180 Rheumatoid Factor serum/plasma Immunoturbidimetric T/BIO/LP/013 T/BIO/LP/013 T/BIO/LP/028 T/BIO/LP/014 T/BIO/LP/039 T/BIO/LP/051 T/BIO/LP/053 T/BIO/LP/054 T/BIO/LP/050 T/BIO/LP/055 T/BIO/LP/056 T/BIO/LP/057 T/BIO/EQ/017 T/BIO/LP/038 INAB Registration No. 221MT Page 5 of 15 Edition 1, 27/06/2018

6 Quality Office Haematology Category: A Medical pathology field -.01 Blood counts.02 Visual examination of blood films.03 Erthrocyte sedimentation rate.05 differential leucocyte counts.06 reticulocyte counts.09 Examination of malarial parasites.30 s for haemoglobin variants and thalassaemia.41 General haemostasis related tests.57 Screening test for infectious mononucleosis /Assay Specimen Type Technique Range of Method (CE/Non- Std. Ref & Measurement/Equipment CE/In house SOP developed/based method) Full Blood Count Blood Quanitative Flow Cytometry and CN-Free Colourimtric Manual WBC Differential & Blood Film Review ESR White Blood Cell Differential Reticulocyte Count Malaria Parasites Detection Sickle Cell Screening test Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Derived Fib), Fibrinogen ( Clauss Fib), International Normalised Ratio (INR), D-Dimer (D- Dimer) Epson Barr Virus Screening for Infectious Mononucleosis Whole Blood in EDTA Blood Plasma Slide Stainer & Morphological Capillary photometry Quanitative Flow Cytometry Quanitative Flow Cytometry Immunochromatographic Assay and Thick & Thin film Turbidity Solubility Quanitative Turbidimetric, Chromogenic & Immunological Latex Agglutation Advia 2120i T/HAE/EQ/001, T/HAE/EQ/003 & T/HAE/LP/005 Wescor Stainer T/HAE/EQ/015, T/HAE/LP/007 TEST 1 T/HAE/LP/020 Advia 2120i T/HAE/EQ/001, T/HAE/EQ/003 & T/HAE/LP/005 Advia 2120i T/HAE/EQ/001, T/HAE/EQ/003 & T/HAE/LP/005 Manual (CE marked kits) Manual (CE marked kit) T/HAE/LP/017, T/HAE/LP/012, T/HAE/LP/013 T/HAE/LP/009 ACL Top 500 T/HAE/EQ/026, T/HAE/EQ/028, T/HAE/EQ/029 Manual (CE marked kit) T/HAE/LP/010 INAB Registration No. 221MT Page 6 of 15 Edition 1, 27/06/2018

7 Quality Office Histopathology and Cytopathology Category: A Medical pathology field Histopathology -.01 Processing fixed specimens for Histopathological testing 1051 Histopathology -.02 Processing fresh specimens for frozen section examination 1051 Histopathology -.03 Histochemistry /assay and ManualHaematoxylin and Eosin Staining Coverslipping Cut up Embedding Microtomy Tissue processing Cut-up Frozen section cryotomy and staining Aclian Blue/PAS stain Congo Red Diastase PAS stain Specimen Type Paraffin Section of Tissue Stained Glass Slide containing section of human tissue Formalin Fixed tissue Equipment/Technique Method (CE/Non- Range of Std. ref & SOP CE/In house measurement developed/based method) Leica Multistainer/ Manual/ Leica Coverslipper/ Dissection table /Manual Paraffin Leica Embedding Processed Station /Manual tissue Paraffin Block of Tissue Formalin Fixed tissue Fresh Tissue / Formalin Fixed Tissue Leica Microtomes/semi automatic Leica ASP 300S/ Formalin Fixed Paraffin processing Microm Cryostat / Manual Paraffin Semi - Section on Artisan glass slide Manual - Manual- Non CE/Based method Giemsa Manual Non CE/Based method Gram Twort Manual CE / T/HIS/LP/015, T/HIS/EQ/016 T/HIS/LP/002 T/HIS/EQ/005, T/HIS/LP/033 T/HIS/LP/010, T/HIS/LP/038 T/HIS/EQ/003,T/HIS/EQ/004 T/HIS/LP/010 T/HIS/EQ/039 T/HIS/LP/047 CE T/HIS/LP/055 CE T/HIS/LP/046 T/HIS/LP/099 T/HIS/LP/052 INAB Registration No. 221MT Page 7 of 15 Edition 1, 27/06/2018

8 1051 Histopathology -.04 Histological interpretation-medical renal pathology Grocott Methenamine silver Haematoxylin Van Gieson Manual CE T/HIS/LP/062 Non CE/Based method Martius Scarlett Blue Manual Non CE/Based method Masson Fontana Manual Non CE/Based method Massons Trichrome May Grunwald Giemsa PAP (Papanicolou stain) PAS Green Stain PAS Stain Perls Prussian Blue Reticulin Nuclear Fast Red Cytology cytospin Slide / Smears Cytology Thin Prep Slide Leica Multistainer/ Manual/ Leica Multistainer/ Manual/ Paraffin Section on glass slide T/HIS/LP/051 T/HIS/LP/060 T/HIS/LP/058 CE T/HIS/LP/050 CE / CE / Toulidine Blue Manual Non CE/Based method Verhoeff Elastic stain Warthin and Starry Ziehl Neelsen (Breast Check designated Breast screening Pathology Diagnostic Interpretation and reporting of tissue specimens laboratories only) Medical Renal Pathology Neuropathology Paediatric Pathology Perinatal Pathology Formalin fixed paraffin processed human tissue T/HIS/LP/029 T/HIS/LP/030 CE T/HIS/LP/100 CE T/HIS/LP/045 CE T/HIS/LP/048 CE T/HIS/LP/049 T/HIS/LP/057 CE T/HIS/LP/053 CE T/HIS/LP/043 CE T/HIS/LP/034 T/HIS/LP/077 T/HIS/LP/076 Manual T/HIS/LP/070 T/HIS/LP/078 T/HIS/LP/072 T/HIS/LP/075 T/HIS/LP/073 T/HIS/LP/074 INAB Registration No. 221MT Page 8 of 15 Edition 1, 27/06/2018

9 1051 Histopathology -.05 Histological interpretationpaediatric pathology 1051 Histopathology -.09 Immunohistochemistry Specialist areas excluded: Specialist areas included: CD31/AE1-AE3 dual staining CD34/AE1-AE3 dual staining D2-40/AE1-AE3 dual staining HPV staining Kappa Lambda P63/ CK5-6 dual Staining TTF/Napsin Dual Staining D2 40-Podoplanin 34 BE 12, ALK-1, Actin BCL-2, BCL-6, BER EP4 Calretenin, Cam 5.2 CD 15,CD 20,CD 23,CD 30 CD 3,CD 4,CD 5,CD 8,CD 10, CD 31,CD 34,CD 45,CD 56 CD 68,CD 117,CD 138 CDX 2, CEA, Chromogranin CK 5/6,CK 7,CK 19,CK 20 CK AE1/AE3 CMV, Cyclin D1, Desmin DOG-1, BOB-1, TdT, Dual stain CD31 / AE1/3 tissue Paraffin Section on glass slide and Ultraview T/HIS/LP/071 T/HIS/LP/079 INAB Registration No. 221MT Page 9 of 15 Edition 1, 27/06/2018

10 1052 Cytopathology -.02 Non gynaecological cytology 1052 Cytopathology -.04 Cytopathological interpretation Dual Stain CD34/ AE1-3 Dual stain D2-40/ AE1-3 Dual stain P63/CK5-6 Dual Stain TTF/Napsin E-Cadherin, EMA, HSA ER, HMB45,Melan A, MIB-1 Kappa, Lambda, HPV MLH-1, MSH2, MSH6, PMS-2 MOC3, MUM-1, P16 Napsin-A, PLAP, GFAP P40, D2 40- Podoplanin P504S, P53, P57,P63 Pan Cytokeratin AE1/AE3 Progesterone Receptor (PR) Prostate Specific Antigen S100 Antigen, Smooth Muscle Actin Synaptophysin, Thyroglobulin, Thyroglobulin,TTF-1 TTF-1 Vimenti, WT-1, OCT- 2 Vimentin, WT-1, OCT-2 Cytology sample preparation and description Diagnostic Interpretation and reporting of nongynae samples tissue or fluid Stained slide prepared from Tissue or Fluid and Ultraview and Ultraview Otpiview+Ultraview and Ultraview Benchmark Ultra/Ultraview iview Blue Benchmark Ultra/Ultraview Shandon Cytospin/ Thin Prep 2000 T/HIS/LP/004, T/HIS/LP/006, T/HIS/LP/007, T/HIS/LP011, T/HIS/LP/29,T/HIS/LP/30, T/HIS/LP/36, T/HIS/EQ/002, T/HIS/EQ/036 Interpretative / Manual T/HIS/LP/098 INAB Registration No. 221MT Page 10 of 15 Edition 1, 27/06/2018

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12 Quality Office Microbiology and Virology Category: A Medical pathology field 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) 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.02 Microscopic examination for parasites /assay Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based method) Microscopic examination for general bacteriology purposes Blood Cultures Light Microscope Manual - CRE Swab Light Microscope Manual - CSF Light Microscope Manual - Ear Swab Light Microscope Manual - Eye Swab Light Microscope Manual - Fluids Light Microscope Manual - Genital Tract Light Microscope Manual - Intravascular Cannulae Light Microscope Manual - MRSA Swab Light Microscope Manual - Throat and Mouth Swab Light Microscope Manual - Tissues/Biopsies Light Microscope Manual - Urine iq200 - VRE Swab Light Microscope Manual - Wound Swab Light Microscope Manual - Faeces Light Microscope Manual - Range of Std. ref measurement SOP 1012 Preparation of Respiratory Samples Light Microscope Manual - INAB Registration No. 221MT Page 12 of 15 Edition 1, 27/06/2018

13 films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.04 Microscopic examination for mycobacteria 1013 Culture of Microbial Culture organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of general bacteria 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.01 Slide agglutination, 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.02 Particle agglutination Blood BacTAlert 3D/Manual Cultures/Swabs/Fluids/Tissues Culture /Manual S. aureus Isolate - Kit Manual - CE Streptococcus Groups - Kit Manual - CE 1014 Detection of bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.04 Immunochromatographic methods, Clostridium difficile Faeces - Kit Manual - CE 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, CE marked commercial systems Cryptosporidium/Giardia/Ova and Parasites - Kit Manual - CE Helicobacter pylori - Kit Manual - CE Legionella Urine - Kit Manual - CE Rotavirus/Adenovirus Faeces - Kit Manual - CE S. pneumoniae Urine - Kit Manual - CE C. diff Toxin Stool GeneXpert- PCR INAB Registration No. 221MT Page 13 of 15 Edition 1, 27/06/2018

14 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, CE marked commercial systems 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.01 Anaerobes 1018 Detection of antibody response to infection using appropriate CE marked commercial techniques -.07 microparticle immunoassay, using CE marked commercial systems 1024 Preservation of microbial cultures 1029 Miscellaneous -.99 Miscellaneous tests Influenza Swab GeneXpert- PCR Norovirus Stool GeneXpert- PCR Screening samples for CPE by PCR Screening samples for MRSA by PCR Screening samples for VRE by PCR Rectal swab/faeces Cepheid GeneXpert standard test Nasal Groin Swab Cepheid GeneXpert standard test Rectal swab/faeces Cepheid GeneXpert standard test Organism Identification Isolates Vitek 2 Compact/Biochemical Methods Susceptibility ing Vitek 2 Compact/Biochemical Methods HCV Blood Abbot Architect i2000sr: microparticle immunoassay Hepatitis B Core Antibody Hepatitis B Surface Antibodies Hepatitis B Surface Antigen HIV Ag/Ab Combo Preservation of Microbial Cultures Abbot Architect i2000sr: microparticle immunoassay Abbot Architect i2000sr: microparticle immunoassay Abbot Architect i2000sr: microparticle immunoassay Abbot Architect i2000sr: microparticle immunoassay and Manual CE Kits and Manual CE Kits TMIC/LP Isolates T/MIC/R Faecal Occult Blood Faeces KIt Manual - CE Pregnancy Urine KIt Manual - CE INAB Registration No. 221MT Page 14 of 15 Edition 1, 27/06/2018

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