Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
NHS Highland
Issue No: 005 Issue date: 22 September 2021
Microbiology Department Contact: Dr David Ashburn Zone 3 Raigmore Hospital Tel: +44 (0) 1463 704108
9612 Old Perth Road Fax: +44 (0) 1463 705648 Inverness E-Mail: [email protected] Accredited to IV2 3UJ ISO 15189:2012 United Kingdom Testing performed at the above address only
DETAIL OF ACCREDITATION
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN BODY FLUIDS AND Microbiological examination In House documented methods TISSUES activities for the purposes of clinical based on PHE UK SMIs Standards diagnosis for Microbiology Investigations
General Bacteriology
Human samples including swabs, General detection and Manual culture and microscopy fluids, tissues. characterisation of micro-organisms including use of Gram stain of clinical significance (MCP011)
Bacterial and Yeast cultures Identification and antimicrobial Identification and susceptibility (isolated in-house) susceptibility testing and testing using SOP MCP066 and determination of minimum inhibitory MCP070 (VITEK 2 automated concentration (MIC) of bacteria and antimicrobial testing system); SOP yeasts MCP082 (Identification of bacterial and yeast isolates using API products); SOP MCP032 and MCP033 (Determination of disc sensitivity and minimum inhibitory concentration (MIC) Sensitivity Procedures using manual methods with EUCAST guidelines)
SOP MCP098 (Detection of ESBL production using SOP MCP098)
Identification and antimicrobial Broth microdilutions of cultured susceptibility testing bacteria using Bioconnections Merlin Micronaut Colistin MIC MBD strips SOP MCP105
Assessment Manager: CM Page 1 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
Blood cultures Detection of microbial growth and Detection of growth in cultures of general isolation and blood and other fluids using characterisation of micro-organisms BACTEC FX – SOP MCP015 of clinical significance
Cannulae and catheter tips General isolation and Manual culture using SOP MCP028 characterisation of micro-organisms of clinical significance
CAPD General isolation and Manual culture and enrichment characterisation of micro-organisms using BACTEC FX: SOPS of clinical significance MCP085, MCP015
Assessment Manager: CM Page 2 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN BODY FLUIDS AND Microbiological examination In House documented methods TISSUES (cont’d) activities for the purposes of clinical based on PHE UK SMIs Standards diagnosis (cont’d) for Microbiology Investigations
General Bacteriology (cont’d)
CSF General isolation and Manual culture and microscopy characterisation of micro-organisms using SOP MCP077, MCP051 of clinical significance
Faeces General isolation and Manual culture methods using characterisation of Salmonella, selective agar and SOP: MCP007 Shigella, Campylobacter & E. coli and MCP008 O157, Vibrio species and other enteric pathogens
Faeces General isolation and Manual culture using selective agar characterisation of Clostridium using SOP MCP037 difficile
Fluids and tissues from normally General isolation and Manual culture using SOP MCP022 sterile sites characterisation of micro-organisms and MCP076 (blood transfusion of clinical significance packs). Fluids from CSF, Ascitic and CAPD Quantification of white and red Manual microscopy using SOPs fluids blood cells and WBC differential MCP051, MCP077, MCP085
Genital swabs Isolation and identification of Group Manual culture using selective agar B Streptococci – SOP MCP005
Respiratory and other specimens AAFB Manual microscopy using phenol auramine SOP: MCP046
Respiratory fluids (including General isolation and Manual culture using sputum, tracheal aspirates, characterisation of micro-organisms SOP:MCP038. bronchial alveolar washings) of clinical significance
Swabs including from eyes, General isolation and Manual culture and microscopy wounds, mouth, nose, throat, ears, characterisation of micro-organisms using SOPs: MCP005, MCP018, genital sites and intrauterine of clinical significance MCP021, MCP023, MCP024, contraceptive devices MCP041, MCP060 (includes Hays criteria for bacterial vaginosis MCP100)
Swabs from rectum and faeces Isolation and identification of Manual culture on chromogenic Vancomycin Resistant agar using SOP MCP026 Enterococcus
Assessment Manager: CM Page 3 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN BODY FLUIDS AND Microbiological examination In House documented methods TISSUES (cont’d) activities for the purposes of clinical based on PHE UK SMIs Standards diagnosis (cont’d) for Microbiology Investigations
General Bacteriology (cont’d)
Swabs from various body sites Isolation of carbapenem resistant Screening for and confirmation of Gram negative rods carbapenem resistant Gram negative rods using SOP MCP006
Swabs including nose, perineum, Isolation of MRSA Manual culture on chromogenic wound sites and urine. agar using SOP MCP042
Urine Quantification of white and red Manual microscopy using SOP: blood cells, bacteria, yeast and MCP051 epithelial cells
Urine General isolation and Manual culture using SOP MCP030 characterisation of micro-organisms of clinical significance
Urine Detection of Legionella Detection of Legionella and pneumophila serogroup 1 antigen Streptococcus pneumoniae urinary and detection of Streptococcus antigen using Immuview urinary pneumoniae antigen antigen test - SOP MCP084
Parasitology
Human samples including faeces Examination activities for the In-house documented procedures and urine as specified purposes of clinical diagnosis based on PHE SMIs
Faeces, Urines, sellotape slides and Examination for the presence of Screening for and identification of rectal swabs parasites (ova, cysts, trophozoites enteric parasites using Midi and worms) of clinical significance Parasep system SOP MCP004
Cryptosporidium and Cyclospora Auramine Phenol Microscopy and oocysts Modified Ziehl Neelsen
Genital swabs Detection of Trichomonas vaginalis Wet preparations using SOP MCP060
Urine Detection of schistosome ova Screening for and identification of urinary tract parasites using SOP MCP004 using concentration and manual microscopy.
Assessment Manager: CM Page 4 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN SAMPLES AND TISSUES Examination activities for the In-house documented procedures (cont’d) purposes of clinical diagnosis based on PHE UK SMIs
Mycology
Human samples including skin Examination activities for the In-house documented procedures scrapings, hair and nail clippings purposes of clinical diagnosis based on PHE SMIs
Skin scrapings, hair and nail General isolation and Detection of pathogenic fungi using clippings characterisation of fungi of clinical SOP MCP052 including direct significance microscopy of KOH digested samples and culture on non- chromogenic selective media.
Antigen detection
Faeces Detection of Clostridium difficile Screening for C difficile GDH and GDH antigen and toxins A & B toxins using SOP ME013 (DS2) and MCP016
Faeces Detection of Rotavirus and Immunochromatographic antigen Adenovirus detection using manufacturers documentation and SOP MCP048
Serology
Serum/ Plasma Anti-streptolysin-O (ASO) Slide agglutination test in conjunction with manufacturer’s documentation and SOP MSP029
Serum/plasma Detection of: Antibody and Antigen detection by chemiluminescent microparticle CMV IgG immunoassay (CMIA) on Abbott CMV IgM Architect in conjunction with, EBV EBNA IgG manufacturer’s documentation and EBV VCA IgG SOPs: EBV VCA IgM Hepatitis A IgM SOPs: ME026 and MSP020 Hepatitis B anti-HBs Hepatitis B core antibody Hepatitis B surface antigen Hepatitis C antibody HIV antibody/antigen combination Rubella IgG Syphilis antibody
Assessment Manager: CM Page 5 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN SAMPLES AND TISSUES Examination activities for the In-house documented procedures (cont’d) purposes of clinical diagnosis based on PHE UK SMIs (cont’d)
Serology (cont’d)
Serum/plasma Detection or confirmation of: Manual or automated ELISA Helicobacter pylori IgG Liaison XL analyser and Diasorin Hepatitis E IgG kits in conjunction with Hepatitis E IgM manufacturer’s documentation and Measles IgG SOPs: Parvovirus B19 IgG Parvovirus B19 IgM ME069 (Liaison)MSP005(H.pylori), VZV IgG MSP037(HEV) MSP038 (Measles), MSP008 (VZV), MSP011(Parvo IgM), MSP017(Parvo IgG)
Serum/plasma/ Lyme Borrelia burgdorferi Manual, semi-automated and automated techniques using manufacturer’s documentation and SOPs:
ME013 (DS2) ME028 (Recom scan) MSP002 (ELISA IgG) MSP015 (Immunoblot) MSP040 (reporting comments)
Borrelia burgdorferi IgG Automated techniques Borrelia burgdorferi IgM (DiasorinLiaison XL analyser (CLIA)
Borrelia burgdorferi IgG Mikrogen CarL immunoblot Borrelia burgdorferi IgM processor)
CSF Borrelia burgdorferi IgG and IgM Automated techniques (Diasorin Liaison XL analyser (CLIA) SOP’s MSP046 ( Carl Immunoblot) MSP048 & ME069 (Liaison) MSP040 (reporting comments)
Assessment Manager: CM Page 6 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
Serum/plasma/ Manual, semi-automated and automated techniques using manufacturer’s documentation and
Toxoplasma IgG avidity t Manual Toxoplasma IgM Western blot Immunoblot (LDBio) LD Bio Western Blot Toxoplasma total antibody Dye Test
Auto Toxoplasma IgG (Diasorin Liaison XL analyser Toxoplasma IgG avidity (CLIA & Mikrogen CarL Immunoblot processor)
Toxoplasma IgM (Diasorin Liaison XL analyser (CLIA) and ISAGA
SOPs: MSP022 (Dye Test) MSP024 (ISAGA ) MSP026 (LDBio WIB) MSP015 (Immunoblot)
MSP046 (CarL) MSP048 & ME069 (Liaison)
MSP040 (reporting comments)
Assessment Manager: CM Page 7 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN SAMPLES AND TISSUES Examination activities for the In-house documented procedures (cont’d) purposes of clinical diagnosis based on PHE UK SMIs (cont’d)
Molecular Biology
Bacterial isolates and fluid from SA / MRSA PCR Real-time PCR using the Cepheid blood culture bottles GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Faeces Norovirus GI and GII Real-time PCR using the Cepheid C. difficile GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Faeces, swabs CPE Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Amniotic fluid, whole blood/buffy Detection of Toxoplasma gondii Extraction by Biomerieux easyMag coat., CSF, ocular fluid, human or Qiacube amplication and tissues detection by ABI 7500 QIAcube whole blood/buffy coat, tissue EasyMag CSF and amniotic and eye fluids SOPs: ME067 ME014, ME015, MMP006
Blood, CSF Detection of Cytomegalovirus Extraction by Biomerieux easyMag or Qiacube amplification and detection by ABI 7500 SOPs: ME067 ME014, ME015, MMP006,ME016
CSF Detection of: Extraction by Biomerieux easyMag or Qiacube amplication and Herpes Simplex Virus 1 & 2 detection by ABI 7500 (SOP Varicella Zoster Virus ME014, ME015), using commercial kits - Launch Fast Track Diagnosis (FTD) SOP MMP019 ME016
CSF, joint fluid, whole blood/buffy Detection of Borrelia burgdorferi Extraction by Biomerieux easyMag coat and human tissue (mainly skin or Qiacubeamplification and biopsies) detection by ABI 7500 SOPs: ME067 ME014, ME015, ,MMP006,
Assessment Manager: CM Page 8 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN SAMPLES AND TISSUES Examination activities for the In-house documented procedures (cont’d) purposes of clinical diagnosis based on PHE UK SMIs (cont’d)
Eye swabs Detection of: Extraction by Biomerieux easyMag amplification and detection by ABI Varicella zoster 7500 Herpes simplex virus 1 & 2, SOPs: ME014, ME015, , , MMP006, Adenovirus
Faeces Norovirus GI and GII Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Lower respiratory tract samples Detection of Pneumocystis jiroveci Extraction by Biomerieux easyMag amplification and detection by ABI 7500 SOPs: ME014, ME015,
Respiratory specimens Influenza A Real-time PCR using the Cepheid Influenza B GeneXpert in conjunction with respiratory syncytial virus manufacturer’s instructions and SOP: MMP011
Respiratory specimens (Sputum) TB PCR Real-time PCR using the Cepheid GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Assessment Manager: CM Page 9 of 10
Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines -u po n - Thames, TW18 3HR, UK
NHS Highland
9612 Issue No: 005 Issue date: 22 September 2021 Accredited to ISO 15189:2012
Testing performed at main address only
Type of test/Properties Standard specifications/ Materials/Products tested measured/Range of measurement Equipment/Techniques used
HUMAN SAMPLES AND TISSUES Examination activities for the In-house documented procedures (cont’d) purposes of clinical diagnosis based on PHE UK SMIs (cont’d)
Nasal swabs, nasopharyngeal Detection of respiratory pathogens; Amplification and detection by aspirates, respiratory swabs, throat • Adenovirus ‘Genmark ePlex’ and in conjunction swabs • Human Bocavirus with manufacturer’s instructions and • Bordetella pertussis SOP;-MMP020 • Chlamydia pneumonia • Coronovirus ( 229E, HKU1, NL63, OC43) • Human Rhinovirus/Enterovirus • Influenza A • Influenza B • Legionella pneumophilia • Human Metapneumovirus • Middle East Respratory Syndrome Coronovirus (MERS) • Mycoplasma pneumoniae • Paraininfluenza 1,2,3,4 • Respratory Syncytial Virus A and B
Vesicle, lesion, skin and ulcer HSV 1, Extraction by Biomerieux easyMag swabs, fluids and crusts, throat HSV 2. or Qiacube amplification ME067 swabs, genital swabs and detection by ABI 7500 (SOPs ME014, ME015 ME 016), using in- house methods (SOPs MMP001, MMP002)
Urines and swabs Detection of Chlamydia trachomatis Real-time PCR using the Cepheid and Neisseria gonorrhoeae GeneXpert in conjunction with manufacturer’s instructions and SOP: MMP011
Urines and swabs Detection of Chlamydia trachomatis SDA using the BD Viper in and Neisseria gonorrhoeae conjunction with manufacturer’s instructions and SOPs: MMP014
END
Assessment Manager: CM Page 10 of 10