Schedule of Accreditation

Transcription

1 Schedule of Accreditation Organisation Name INAB Reg No Contact Name Address Saolta University Health Care Group Galway University Hospital Microbiology 223MT Anne Coleman Contact Phone No (091) Website Accreditation Standard ISO Division of Clinical Microbiology, Newcastle Rd, Galway Date Initially Awarded 07/04/2009 Scope Classification Microbiology and virology 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 Head Office Galway University Hospital, Newcastle Road, Galway INAB Registration No. 223MT Page 1 of 13 Edition 1, 09/03/2018

2 Scope of Accreditation Head Office Microbiology and Virology Medical pathology field - Test 1011 Macroscopic examination and description 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.01 Microscopic general bacteriology purposes (including enumeration and description of human cells) Category: A Test/ Specimen Type Equipment/Technique Method (CE/Non- CE/In house developed/based on standard method) Macroscopic examination and description Microscopic general bacteriology purposes Sputum Faeces Blood cultures Swabs Wound exudates CSFs Fluids/Aspirates Genital tract and associated specimens Corneal lens/scrapings Bronchoalveolar Lavage Bronchial washings Pus Tissue/Biopsy Urine Fluids NA Light/ fluorescent microscope NA Microscopic 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 parasites 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.03 Microscopic fungi 1012 Preparation of films on glass slides followed by microscopic examination with or without fixation and staining with dyes as required -.04 Microscopic mycobacteria 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.01 Culture of Microscopic general bacteriology purposes Culture of general bacteria Fluids/Aspirates Faeces Blood Sellotape slides Urine Hair/nail/skin clippings Bronchoalveolar Lavage Bronchial washings Fluids/Aspirates Pus Tissue/Biopsy Sputum Blood cultures Blood cultures Swabs Wound exudates CSFs Fluids/Aspirates Genital tract and Light microscope Light/ fluorescent microscope Light/ fluorescent microscope Incubators Bactec FX Blood Culture System Microscopic parasites Microscopic fungi Microscopic mycobacteria Investigation of Blood cultures, urines, CSFs, faeces INAB Registration No. 223MT Page 2 of 13 Edition 1, 09/03/2018

3 general bacteria 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.02 Culture of fungi 1013 Culture of organisms in liquid or agar based culture media with visual or instrument monitoring for growth -.03 Culture of mycobacteria 1014 bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.01 Slide agglutination, Culture of fungi Culture of mycobacteria associated specimens Corneal lens/scrapings Bronchoalveolar Lavage Bronchial washings Pus Tissue/Biopsy Urine Fluids Faeces Sputum Swabs including screening swabs for VRE, CPE, MRSA and ESBL Tips IUD Hair/nail/skin clippings Skin scrapings Blood cultures Sputum Bronchoalveolar Lavage Bronchial washings Tissue/Biopsy Pus Incubators Bactec FX Blood Culture System Incubators Bactec MGIT 960 -Investigation of genital tract and associated Specimens -Culture of diagnostic specimens -Screening for multidrug resistant organisms Investigation of Dermatological Specimens for Superficial Mycoses Culture of mycobacteria Slide agglutination NA Serotyping of: - E. coli 026 and Bordatella isolates - Salmonella species -Typhoidal Salmonella -Listeria monocytogenes -Shigella species 1014 bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.02 Particle agglutination 1014 bacterial, parasite, viral or fungal antigens using Particle agglutination NA Identification of E. coli O157 using the Oxoid Dryspot E. coli O157 kit Enzyme immuno NA Identification of S. aureus by latex agglutination. NA Serological identification of beta haemolytic strep belonging to Lancefield groups A, B,C,D, F and G CSF NA Cryptococcal antigen in CSF Plasma/Serum Confirmation of the presence of Hepatitis B virus INAB Registration No. 223MT Page 3 of 13 Edition 1, 09/03/2018

4 specific antibodies and appropriate techniques -.03 Enzyme immuno, 1014 bacterial, parasite, viral or fungal antigens using specific antibodies and appropriate techniques -.04 Immunochromatographic methods, Immunochromatographic methods Serum Biomerieux Vidas Plate Reader and Washer Surface Antigen in plasma, using the HBsAg confirmatory Hepatitis B virus Surface Antigen in plasma, using the HBsAg Hepatitis C virus Antigen in human serum and plasma, Architect HCV Ag Hepatitis B virus e antigen, in human serum and plasma, using the Biomerieux VIDAS HBe/Anti-HBe C6 antigen using the Immunetics C6 Lyme ELISA kit Faeces Timer Helicobacter antigen in stool specimens using Coris Bioconcept Pylori-Strip Mycobacterial isolates Timer Investigation of faeces specimens for Rota and Adenovirus using Coris Bioconcept Combi strip Timer Identification of M. tuberculosis Complex using Becton Dickinson (BD) MGIT TBc identification test Urine NA Legionella Urinary Antigen detection using the Binax NOW kit INAB Registration No. 223MT Page 4 of 13 Edition 1, 09/03/2018

5 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.03 Nucleic acid amplification tests, CE marked commercial systems GeneXpert Carba-R GeneXpert GC RT- PCR GeneXpert MRSA/SA Blood culture Blood culture Aliquots Nucleic acid Faeces amplification tests, CE marked commercial systems Nasopharyngeal swabs Nose/Throat swab Roche Diagnostics Ltd Light cycler 480II Eppendorf Epmotion 5070 Roche Diagnostics Ltd Light cycler 480II Eppendorf Epmotion 5070 RTPCR System AB7500 the blakpc, blandm, blavim, blaoxa- 48, and blaimp-1 gene sequences associated with carbapenem-nonsusceptibility in gram-negative bacteria detection and of Neisseria gonorrhoeae DNA from bacterial isolates. detection and of Staph aureus and MRSA DNA from blood culture aliquots. Norovirus genogroup I and II RNA using the Cepheid GeneXpert Kit Identification and characterisation of Clostridium difficle using the Cepheid GeneXpert Kit Dectection of Salmonella enterica spp., Shigella spp., Campylobacter jejuni/coli/lari, Stx1/Stx2, Cryptosporidium and Giardia DNA using the Enteric Bio Real Time PCR Gastro Panel 2 kit from Serosep. C. difficile DNA using the Enteric Bio Real Time C. difficile PCR Kit from Serosep. Influenza A+B and RSV A+B viral RNA using the Cepheid GeneXpert Kit Influenza A, Influenza B and RSV RNA using the Fast-track INAB Registration No. 223MT Page 5 of 13 Edition 1, 09/03/2018

6 Flu/RSV 1015 Detection and/or identification of bacterial, parasite, fungal and viral nucleic acids -.04 Nucleic acid amplification tests, in house developed s S. pneumoniae from EDTA blood using in house Real Time PCR Plasma/Serum Respiratory specimens and Mycobacterial isolates Specimens of urine and endocervical, vaginal, and male urethral swab specimens collected multi-collect Specimen Collection Kit Swabs Nucleic acid Respiratory amplification tests, CE specimens marked commercial systems Nucleic acid amplification tests, inhouse developed ABBOTT m2000sp and ABBOTT m2000rt SYSTEMS ABBOTT m2000sp and ABBOTT m2000rt SYSTEMS ABBOTT m2000sp and ABBOTT m2000rt SYSTEMS EDTA blood samples Qiagen EZ1 Advanced XL AB AB AB7500 Qiagen EZ1 - AB7500 Qiagen EZ1 Detection and quantitation of HCV RNA using the Abbott RealTime HCV. Detection and quantitation of HIV RNA using the Abbott Real Time PCR HIV-1 M. Tuberculosis complex and Rifampicin resistance using the MTB/RIF Ultra GeneXpert Kit Chlamydia trachomatis and Neisseria gonorrhoeae DNA RealTime CT/NG Chlamydia trachomatis and Neisseria gonorrhoeae DNA using the Cepheid GeneXpert Kit S. pneumoniae from EDTA blood Pneumocyctis jirovecii DNA in respiratory specimens using the AB7500 RT PCR for the identification of Salmonella tartrate positive isolates RT PCR Assays for the blactx-m group 1, group 2 & group 9 and blakpc, blages, blaimi, blaoxa-48, blandm, bla VIM, blaimp, blaoxa- 23, blaoxa-51, blaoxa-24, blaoxa-58, CIT, DHA, ACC, ACT, INAB Registration No. 223MT Page 6 of 13 Edition 1, 09/03/2018

7 CSF CSF Fluids Tissues Swabs CSF VTMS Faeces Nasal swabs Throat swabs - AB7500 Qiagen EZ1 - AB7500 Qiagen EZ1 - AB7500 Qiagen EZ1 - AB7500 Qiagen EZ1 Real-Time PCR System AB7500 Biomerieux NucliSENS easymag nucleic acid extraction system - AB Biomerieux NucliSENS easymag nucleic acid extraction system FOX gene DNA in Gram-Negative isolates. RT PCR for the Enterovirus RNA in CSF specimens RT PCR for the CoA gene in S.aureus -RT PCR for the Group A Streptococcal DNA -RT PCR for the MecA gene in S.aureus -RT PCR for the S.pneumoniae DNA and determination of penicillin susceptibility RT PCR asssays for the Haemophilus influenzae, Neisseria meningitidis DNA RT PCR for the Herpes Simplex Virus 1 and 2 DNA RT PCR Taqman for the VZV Norovirus Genogroup I & II RNA using RT PCR Influenza A, Influenza A (H3), Influenza A (Swine), Influenza B, RSV A, RSV B and Influenza B using Multiplex Virus RNA using a multiplex RT PCR RT-PCR Assay for the colistin Bacterial Isolates AB7500 colistin INAB Registration No. 223MT Page 7 of 13 Edition 1, 09/03/2018

8 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.01 Biochemical methods, CE marked commercial systems 1016 Identification of cultured bacteria and fungi using non-nucleic acid based techniques -.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 plasmid mediated resistance RT-PCR Assay for the Plasmodium species from Blood Biochemical methods, CE marked commercial systems Identification of fungi by microscopic morphology Identification using MALDI-TOF spectroscopy Measurement of antimicrobial activity and application of clinical interpretive criteria for general bacteria Use of ciprofloxacin, erythromycin and tetracycline E- tests/mic and discs for susceptibility of Campylobacter species. EDTA Blood samples Qiagen EZ1 Advanced XL AB7500 Fungal isolates Fungal isolates Bacterial, fungal and Mycobacterial isolates Biomerieux Vitek Compact instrument Biomerieux Vitek Compact instrument Light/ fluorescent microscope Bruker MALDI TOF instrument The BIOMIC V3 Microbiology plate reading System from Giles Scientific Trek Diagnostic Sensititre instrument plasmid mediated resistance Plasmodium species from Blood Biochemical differentiation of Salmonella subspecies Identification of bacterial and yeast isolates using the Vitek compact, Biomerieux APIs and other biochemical identification kits Investigation of Dermatological Specimens for Superficial Mycoses Identification of organisms using the MALDI TOF Biotyper Antimicrobial resistance testing of bacterial isolates using Disk diffusion and Minimum inhibitory concentration (MIC) testing with MIC strips and broth dilution on the Trek Diagnostic Sensititre instrument using EUCAST and CLSI interpretive guidelines Biomic Vision Digital Imaging Antibiotic Zone Reader Antimicrobial resistance testing of bacterial isolates using Disk diffusion and Minimum inhibitory concentration (MIC) testing with MIC strips and broth dilution on the Trek Diagnostic Sensititre instrument INAB Registration No. 223MT Page 8 of 13 Edition 1, 09/03/2018

9 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.02 Mycobacteria 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.03 Yeasts 1017 Measurement of antimicrobial activity and application of clinical interpretive criteria to general bacteria (rapidly growing aerobes) -.05 Other categories of organism (as specified ) 1018 antibody response to infection using appropriate CE marked commercial techniques -.01 Particle agglutination, using CE marked commercial systems Measurement of antimicrobial activity and application of clinical interpretive criteria of Mycobacterial isolates Measurement of antimicrobial activity and application of clinical interpretive criteria of yeasts Inoclic - a new inoculum standardization device Particle agglutination, using CE marked commercial systems Mycobacterial isolates Yeast isolates Becton Dickinson BACTEC 960 MGIT Biomerieux Vitek Compact instrument The BIOMIC V3 Microbiology plate reading System from Giles Scientific using EUCAST and CLSI interpretive guidelines Antimicrobial resistance testing of Mycobacterial isolates on the BACTEC MGIT Antimicrobial resistance testing of Yeast isolates using MIC test strips and the Vitek compact Antimicrobial resistance testing of bacterial isolates using Disk diffusion and Minimum inhibitory concentration (MIC) testing with MIC strips using EUCAST and CLSI interpretive guidelines Plasma/Serum NA antibodies to Treponema pallidum in human serum or plasma, using the Serodia- TP-PA particle agglutination test. Serum NA Semi quantitative anticardiolipin antibodies using the BD RPR card antigen flocculation test 1018 antibody response to infection using appropriate CE marked commercial techniques -.02 Enzyme immuno, using CE marked commercial systems Enzyme immuno, using CE marked commercial systems NA Semi-quantitative antistreptolysin-o antibodies, in human serum, using the Biokit rheumajet ASO Latex agglutination test Plasma/Serum Biomerieux Vidas Hepatitis B virus Core Antibody using the Biomerieux VIDAS Anti-HBc Total II INAB Registration No. 223MT Page 9 of 13 Edition 1, 09/03/2018

10 Biomerieux Vidas Plate reader and washer Plate reader and washer HIV p24 antigen, HIV-1 antibody and HIV-2 antibody in human serum and plasma Parvovirus IgM antibodies using the Biotrin Parvovirus IgM IgM antibody to Mumps virus using the Microimmune Mumps IgM capture EIA Serum Biomerieux Vidas anti- EBV EBNA IgG in human serum using the VIDAS EBV EBNA IgG Biomerieux Vidas Biomerieux Vidas anti- EBV VCA IgG and anti-ebv EA IgG in human serum using the VIDAS EBV VCA/EA IgG Enzyme Linked Fluorescent Assay anti- EBV VCA IgM in human serum using the VIDAS EBV VCA IgM Enzyme Linked Fluorescent Assay Biomerieux Vidas Biomerieux Vidas Biomerieux Vidas Hepatitis C antibody using the Biomerieux VIDAS Mumps IgG antibodies using the VIDAS Mumps IgG Quantitative IgG antibody to Rubella virus using the VIDAS RUB IgG II INAB Registration No. 223MT Page 10 of 13 Edition 1, 09/03/2018

11 1018 antibody response to infection using appropriate CE marked commercial techniques -.07 Chemiluminescent microparticle immuno, using CE marked commercial systems Chemiluminescent microparticle immuno, using CE marked commercial systems Plasma/Serum antibody to Hepatitis Be virus in human serum and plasma using the Abbott Architect Anti HBe antibody to Hepatitis C virus in plasma using the Anti HCV antibody to Treponema pallidum, in human serum and plasma, Architect Syphilis TP Cytomegalovirus IgG antibodies in plasma, using the CMV IgG Cytomegalovirus IgM antibodies Architect CMV IgM EBNA IgG antibodies, EBV VCA IgG antibodies and EBV VCA IgM antibodies using the Abbott Architect EBV Assays Hepatitis B Core Antibody, in human serum and plasma, Architect Anti-HBc II HIV INAB Registration No. 223MT Page 11 of 13 Edition 1, 09/03/2018

12 p24 antigen, HIV-1 antibody and HIV-2 antibody in human serum and plasma Architect HIV Ag/Ab combo IgG antibody to Hepatitis A virus in plasma, using the HAVAb-IgG IgM antibody to Hepatitis A virus, in plasma using the HAVAb-IgM Rubella virus IgM Architect Rubella IgM Toxoplasma gondii IgG antibodies in plasma, using the Toxoplasma IgG Toxoplasma gondii IgM antibodies, Architect Toxoplasma IgM Hepatitis B core IgM using the anti HBc IgM Quantitative Hepatitis B virus Surface Antibody in human serum and plasma, using the Abbott Architect Anti-HBs INAB Registration No. 223MT Page 12 of 13 Edition 1, 09/03/2018

13 1023 Characterisation of subtypes within species of bacteria, fungi or virus using appropriate techniques -.01 Phage typing 1023 Characterisation of subtypes within species of bacteria, fungi or virus using appropriate techniques -.02 Molecular / nucleic acid analysis methods [specifying the particular techniques] Architect Quantitative Rubella virus IgG Architect Rubella IgG Hepatitis Be Antigen using the HBeAg Assay Serum VIRCLIA Varicella zoster IgG antibodies using the Vircell Varicella- Zoster Virclia IgG Monotest Phage typing Salmonella isolates Multipipettor Phage typing of Salmonella Typhimurium /S.Enteritidis Molecular/nucleic acid analysis methods Salmonella Shigella and Listeria isolates RTPCR System AB7500 fast Qiagen EZ1 CHEF Mapper GeneAmp PCR System 9700 Molecular subtyping of S. Typhimurium by MLVA -Molecular subtyping of nontyphoidal Salmonella serotypes, Shigella sonnei and Listeria monocytogenes by Pulsed Field Gel Electrophoresis (PFGE) and RT PCR procedures for Salmonella and Shigella species 1024 Preservation of microbial cultures Preservation of microbial cultures Microbial cultures Referigerators Freezers Preservation of microbial cultures on agar plates and slope and in Protect beads INAB Registration No. 223MT Page 13 of 13 Edition 1, 09/03/2018