Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-Upon-Thames TW18 3HR

Transcription

1 Schedule of ccreditation United Kingdom ccreditation Service 2 Pine Trees, Chertsey Lane, Staines-Upon-Thames TW18 3HR Issue No: 007 Issue date: 20 pril 2018 ccredited to Medical Microbiology Ninewells Hospital Ninewells venue Dundee DD1 9SY Contact: Nick Parsons Tel: +44 (0) nick.parsons@nhs.net Laboratory locations: below s covered by the organisation and their relevant activities details ctivity code ddress Microbiology Department Ninewells Hospital Ninewells venue Dundee DD1 9SY Local contact Nick Parsons Tel: +44 (0) nick.parsons@nhs.net Bacteriology Mycology Enteric Parasitology Virology Serology Molecular Microbiology ddress Sexual and Reproductive Health Clinic Ninewells Hospital Ninewells venue Dundee DD1 9SY Local contact s above Plate inoculation and microscopy B ssessment Manager: CM Page 1 of 9

2 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 DETIL OF CCREDITTION HUMN BODY FLUIDS ND TISSUES clinical diagnosis based on PHE UK SMIs General Bacteriology Human samples including swabs, fluids, tissues. Detection and characterisation of micro-organisms Use of Gram stain and SOP: NB029 Microscopy and Identification Human samples including swabs, fluids, tissues. Detection and characterisation of micro-organisms Use of Gram stain and SOP: NB029 Microscopy and Identification B Swabs from eyes, wounds, mouth, nose, throat, ears, genital sites and intrauterine contraceptive devices Manual culture using SOPs: NB002 Exudates Manual NB036 Genital Swabs NB039 cute Bench CSF Detection of cryptococcus Use of India Ink stain and SOP: NB039 cute Bench Inoculated plates from Site B Processing of inoculated plates using SOPs: NB010 Sexual and Reproductive Health Clinic NB036 Genital Swabs Respiratory fluids (sputum, bronchial washings) Manual culture using SOP: NB003 Respiratory Specimens Swabs from nose, perineum and wound sites Isolation of MRS Manual culture on chromogenic agar using SOP: NB040 MRS Screens Swabs from rectum and faeces Isolation of Vancomycin Resistant Enterococcus Manual culture on chromogenic agar using SOP: ssessment Manager: CM Page 2 of 9

3 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on PHE UK SMIs General Bacteriology (cont d) Swabs from various body sites Isolation of carbapenem resistant Gram negative rods Screening for and confirmation of carbapenem resistant Gram negative rods using SOPs: NB030 Carbapenem Resistance Confirmation in GNR NB072 Use and Maintenance of the Cepheid GeneXpert Intravenous catheters Manual culture using SOPs: NB039 cute Bench Fluids and tissues from normally sterile sites Manual culture using SOPs: NB038 Orthopaedic Specimens NB039 cute Bench Fluids from CSF and CPD fluids Quantification of white and red blood cells and WBC differential Manual microscopy using SOPs: NB029 Microscopy and Identification NB039 cute Bench Urine Quantification of white and red blood cells, bacteria and epithelial cells Manual microscopy using SOP: NB007 Urine Manual Urine Manual culture using SOP: NB007 Urine Manual Urine Detection of Legionella pneumophila serotype 1 antigen Detection of legionella urinary antigen using SOPs: NV153 BINX NOW Legionella Urinary ntigen NV230 Uni-Gold Legionella Urinary ntigen PLUS ssessment Manager: CM Page 3 of 9

4 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on PHE UK SMIs General Bacteriology (cont d) Faeces characterisation of Salmonella, Shigella, Campylobacter & E. coli O157 and other enteric pathogens Manual culture methods using selective agar and SOP: Faeces Detection of Clostridium difficile GDH antigen and toxins & B Screening for C diff GDH and toxins using SOP: in conjunction with manufacturer s instructions using DS2analyser (GDH) and VIDS (Toxin) Faeces Detection of Helicobacter pylori Screening for H pylori faecal antigen using SOP: NB073 Helicobacter pylori ntigen in conjunction with the manufacturer s instructions for mplified IDEI HpStR on DS2 analyser. Blood cultures Detection of microbial growth and general isolation and Detection of growth in cultures of blood using SOPs: NB001 Blood Cultures in conjunction with manufacturer s instructions for automated system BacT/lert. Bacterial and Yeast cultures (isolated in-house) Identification and antimicrobial susceptibility testing and determination of minimum inhibitory concentration (MIC) of bacteria and yeasts Identification and susceptibility testing using VITEK 2 automated antimicrobial testing system SOPs: NB027 Sensitivity Testing NB012 Etest MIC NB013 ESBLTesting NB029 Microscopy and Identification NB030 Carbapenem Resistance ssessment Manager: CM Page 4 of 9

5 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on PHE UK SMIs Parasitology Human samples including faeces and urine as specified Examination activities for the purposes diagnosis based on PHE SMIs Faeces Examination for the presence of parasites (ova, cysts, trophozoites and worms) of clinical Screening for and identification of enteric parasites using SOP: using concentration where required and manual microscopy. Urine Detection of schistosome ova Screening for and identification of urinary tract parasites using SOP: NB007 Urine Manual using concentration where required and manual microscopy. Mycology Human samples including skin scrapings, hair and nail clippings Examination activities for the purposes diagnosis based on PHE SMIs Skin scrapings, hair and nail clippings characterisation of fungi of clinical Detection of pathogenic fungi using SOP: NB006 Mycology manual and direct microscopy of KOH digested samples and culture on non-chromogenic selective media. ssessment Manager: CM Page 5 of 9

6 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on manufacturer s instructions Serology Detection of: Hepatitis IgM Hepatitis total antibody Hepatitis B anti-hbs Hepatitis B core antibody Hepatitis B surface antigen Hepatitis C antibody HIV antibody/antigen combination Rubella IgG Syphilis antibody Serology using the Centaur DVI (Siemens) in conjunction with the manufacturer s instructions & SOPs: NV032 Reporting of HBsg Positives from NC Patients in Tayside NV033 Hepatitis B Testing and Reporting NV037 Hepatitis Testing and Reporting NV040 Rubella IgG Testing NV115 HIV Minimum Testing lgorithm NV121 Serological Diagnosis of Syphilis NV136 Handling of HIV Requests in Children <18 months of age NV197 Preparation of Dried Blood Spots NV218 Dried Blood Spot HIV, HCV, and HBsg Testing NV241 Procedure for Samples processed on Centaur Detection or confirmation of: CMV IgM EBV EBN IgG EBV VC IgG EBV VC IgM Measles IgG Parvovirus B19 IgG Parvovirus B19 IgM VZV IgG DiaSorin Liaison XL analyser in conjunction with the manufacturer s instructions & SOPs: NV040 Rubella IgG Testing NV103 Hep C Confirmation Reporting Protocol NV111 Biotrin Parvovirus ELIS NV122 Rubella IgM (RBM) Serology NV215 EBV Testing on the Liaison NV217 CMV IgM testing on the Liaison NV227 VZV IgG testing on the Liaison NV252 Measles IgG on the Liaison NV262 Use and Maintenance of the Liaison XL ssessment Manager: CM Page 6 of 9

7 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on manufacturer s instructions Serology (cont d) Detection or confirmation of: CMV IgG Hepatitis B core antibody Hepatitis B core IgM Hepatitis B e antibody Hepatitis B e antigen Hepatitis B surface antigen Hepatitis C antibody HIV antibody/antigen combination Mumps IgG Rubella IgM Toxoplasma IgM Toxoplasma total antibody Serology using the BioMerieux VIDS analyser in conjunction with the manufacturer s instructions and SOPs: NV017 Toxoplasma Total ntibody and IgM NV032 Reporting of HBsg Positives from NC Patients in Tayside NV033 Hepatitis B Testing and Reporting NV041 VIDS HBsg Confirmation Protocol NV042 Mumps and CMV Vidas Protocol NV115 HIV Minimum Testing lgorithm NV122 Rubella IgM Serology NV136 Handling of HIV Requests in Children <18 months of age NV258 Use and Maintenance of the VIDS 3 analyser Dried Blood Spots Detection of: Hepatitis B Hepatitis C HIV Serology using SOPs: NV197 Preparation of Dried Blood Spots NV198 Modified Ortho HCV ELIS for Dried Blood Spot Testing NV218 Dried Blood Spot HIV, HCV, and HBsg Testing Serum Confirmation of HIV Serology using SOP NV250 Geenius HIV 1 and 2 Confirmatory ssay Detection of: Lyme IgG Serology using SOP: NV246 Immunetics C6 Lyme ELIS ssessment Manager: CM Page 7 of 9

8 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on manufacturer s instructions Serology (cont d) Syphilis confirmation using specific Reagin antibody tests, Biokit RPR Reditest, Fujirebio Serodia TPP kit, and Lab21 Syphilis IgM kit. Serology using SOPs: NV013 Serodia Syphilis TPP NV014 Biokit Syphilis RPR Reditest NV121 Serological Diagnosis of Syphilis NV233 Lab21 Syphilis IgM EI and instructions in the manufacturers kit inserts. HUMN BODY FLUIDS ND TISSUES (cont d) based on manufacturer s instructions Molecular Biology Respiratory specimens TB PCR Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer s instructions and SOPs:NB004 TB Manual NB072 Use and Maintenance of the Cepheid GeneXpert Blood, Urine Quantitative detection of: BK Virus EBV CMV Real-time PCR using BioMerieux Easymag and BI 7500 thermocyclers and SOPs: NV203 Preparation of BK Standard and DN control for PCR NV204 Preparation of CMV Standard and DN Control for PCR NV225 Non-respiratory IH PCR NV235 Quantitative IH PCR ssessment Manager: CM Page 8 of 9

9 Schedule of ccreditation United Kingdom ccreditation Service ccredited to Issue No: 007 Issue date: 20 pril 2018 HUMN BODY FLUIDS ND TISSUES (cont d) based on manufacturer s instructions Bloods, CSF, Faeces, Fluids, Respiratory aspirates, Swabs (various sites), Urines Molecular Biology Detection of: denovirus Respiratory BK Virus CMV Coronavirus (x4) EBV Enterovirus Hepatitis B Hepatitis C HIV HSV Influenza and B Influenza Subtyping Measles Metapneumovirus Mumps Mycoplasma pneumoniae Norovirus Parainfluenza (x4) Parechovirus Rhinovirus RSV VZV Real-time PCR using BioMerieux Easymag and BI 7500 thermocyclers and SOPs: NV115 HIV Minimum Testing lgorithm NV171 IH Respiratory PCR NV186 Preparation of Norovirus RN Control for PCR NV203 Preparation of BK Standard and DN control for PCR NV204 Preparation of CMV Standard and DN Control for PCR NV205 Preparation of DN Control for HSV, VZV and denovirus PCR NV213 Influenza Subtyping PCR NV225 Non-respiratory IH PCR NV234 Preparation of EBV Standard and EBV Control NV237 Preparation of Nucleic cid for Parecho-Entero virus PCR Controls Bacterial isolates and fluid from blood culture bottles MSS / MRS PCR Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer s instructions and SOP: NB040 MRS Screens NB072 Use and Maintenance of the Cepheid GeneXpert Urines and swabs Neisseria gonorrhoeae PCR Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer s instructions and SOP: NB072Use and Maintenance of the Cepheid GeneXpert END ssessment Manager: CM Page 9 of 9