Schedule of Accreditation issued by Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

Issue No: 003 Issue date: 16 September 2020

Department of Microbiology Contact: Governance/Quality Department Pathology Department Tel: +44 (0) 1276 522194 / 1276 522541 / 1276 522175

9734 Wexham Park E-Mail: [email protected] Wexham Website: http://www.nhspathology.fph.nhs.uk Accredited to Slough ISO 15189:2012 SL2 4HL Testing performed at the above address only

DETAIL OF ACCREDITATION

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures activities for the purpose of clinical following current Public Health diagnosis (PHE) Standards for Microbiological Investigations (SMI’s)

Routine samples: Isolation of microorganisms of Manual or automated inoculation, Aspirates clinical significance followed by culture and image Cellular and fluid material contained capture using: on swabs, catheter tips and intrauterine contraceptive devices BD Kiestra TLA (Total Laborator CSF Faeces Automation) Fluids Kiestra SOP MIC-WPH-SOP-57 Genital samples Investigation of superficial wound Pus swabs including surgical swabs Samples from sterile sites MIC-WPH-SOP-45 Semen Tissues Investigation of eye, ear and nose Sputum specimens MIC-WPH-SOP-43

Investigation of deep wounds, tissue, pus, exudate and tips MIC- WPH-SOP-42

Investigation of bile MIC-WPH- SOP-41

Investigation of peritoneal/ascetic fluid, amniotic fluid, pericardial fluid and continuous ambulatory peritoneal dialysis (CAPD) MIC- WPH-SOP-46

Assessment Manager: GD1 Page 1 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Routine samples: (cont’d) Isolation of microorganisms of Manual or automated inoculation, Aspirates clinical significance (cont’d) followed by culture and image Cellular and fluid material contained capture using: on swabs, catheter tips and BD Kiestra TLA (Total Laboratory intrauterine contraceptive devices Automation) CSF Faeces Kiestra SOP MIC-WPH-SOP-57 Fluids Genital samples Respiratory procedures MIC-WPH- Pus SOP-31 Samples from sterile sites Semen Investigation of CSF MIC-WPH- Tissues SOP-13 and MIC-WPH-SOP-14 Sputum Investigation of genital samples MIC-WPH-SOP-44 Gum clinic procedures MIC-WPH- SOP-62

Enteribio for faecal investigation MIC-WPH-SOP-21

Cellular and fluid material contained Screening for: Manual or automated inoculation, on swabs incubation and image capture of chromogenic culture media as above and using:

Methicillin-Resistant MRSA isolation and culture using Staphylococcus aureus (MRSA) chromogenic agar MIC-WPH-SOP- 64

Staphylococcus aureus Staph isolation and culture using chromogenic agar MIC-WPH-SOP- 81

Vancomycin-resistant enterococci Routine screening of VRE using VRE Oxoid brilliance VRE agarMIC- WPH-SOP-79

Assessment Manager:GD1 Page 2 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Faeces Screening for Carbapenemase Manual or automated inoculation, Rectal Swabs Producing Enterobacteriaceae incubation and image capture of (CPE) chromogenic culture media as above and using: Laboratory Detection of Carbapenemase-Producing Bacteria MIC-WPH-SOP-76

Urine Detection, identification and Image capture and recognition quantification of: using Sedimax urine analyser White blood cells Investigation of urines MIC-WPH- Red blood cells SOP-03 Yeasts Bacterial cells

Urine Isolation of microorganisms of Manual or automated inoculation clinical significance followed by culture using Mast Uri System Culture and sensitivity urines MIC-WPH-SOP-03

Blood Isolation of microorganisms of Automated culture using Bactec FX clinical significance liquid culture system BD Bactec FX WPH MIC-WPH- SOP-10 BD Bactec FX RBH MIC-WPH- SOP-11

CSF Isolation of microorganisms of Manual inoculation and media clinical significance culture as above Investigation of CSF MIC-WPH- SOP-13

Cerebrospinal fluid (CSF) Detection, identification and Microscopy and staining quantification (inc. differential) of: Gram White blood cells Red blood cells Bacterial cells Investigation of CSF MIC-WPH- SOP-13

Assessment Manager:GD1 Page 3 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Aspirates Detection, identification and Staining (inc. Gram) and Corneal scrapes quantification of: microscopic examination Eye (specimens from) White blood cells Staining procedures MIC-WPH- Fluids Red blood cells SOP-32 Tissues Bacterial cells Yeast cells and fungal hyphae

Cultures isolated in-house from all Identification of microorganisms of Automated Matrix-assisted laser samples listed above clinical significance desorption/ionisation (MALDI-TOF) using Vitek MS and Vitek 2 MALDI Biotyper MIC-WPH-SOP-29 Vitek 2 MIC-WPH-SOP-39

Bacterial cultures isolated in-house Antimicrobial susceptibility testing of Manual disc diffusion and/or from all samples listed above clinical significant bacteria automated methods using EUCAST sensitivity method and Vitek 2 EUCAST sensitivity method MIC- WPH-SOP-63 Standard operating procedure of Vitek 2 MIC-WPH-SOP-39

Gradient MIC determination by E- test E test for MIC determinationMIC- WPH-SOP61

Identification of ESBL MIC-WPH- SOP-80

Identification of MBL MIC-WPH- SOP-75

Assessment Manager:GD1 Page 4 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Cultures isolated in-house from all Identification of microorganisms of Manual enzymatic, biochemical, samples listed above clinical significance staining and microscopic methods MIC-WPH-SOP-26 MIC-WPH-SOP-27 MIC-WPH-SOP-55 MIC-WPH-SOP-56 MIC-WPH-SOP-66 MIC-WPH-SOP-67 MIC-WPH-SOP-68 MIC-WPH-SOP-69 MIC-WPH-SOP-70 MIC-WPH-SOP-71 MIC-WPH-SOP-72

Clear adhesive tape slides Detection of Enterobious Microscopic examination using in vermicularis larvae and ova house procedure Faecal Parasitology MIC-WPH- SOP-20

Urine Detection of Schistosoma Microscopic examination using in haematobium ova house procedure Concentration of urinary parasites MIC-WPH-SOP-19

Faeces Detection of ova, cysts and Concentration and light microscopic parasites (OCP) examination using Parasep method Faecal Parasitology MIC-WPH- SOP-20

Bile/jejunal/duodenal aspirate Detection of ova, cysts and Microscopic examination including Liver abscess parasites (OCP) wet preparation, using light microscopy Non-faecal parasites MIC-WPH- SOP-82

Assessment Manager:GD1 Page 5 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Sputum Isolation and presumptive Liquid culture using BD BacTec Sterile site (body fluids (CSF, identification of Acid-alcohol fast MGiT 960 followed by Pleural Fluids) bacilli (inc.Mycobacterium spp.) fluorescent/light microscopy Broncho alveolar washings Investigations of specimens of Post mortem specimens mycobacterium MIC-WPH-SOP-34 Bone marrow Staining procedures (Auramine and Bone ZN staining) MIC-WPH-SOP-32 Urine Skin Tissue biopsies

CAPD Detection/Quantification of cells and Light microscopy and staining differentiation polymorphs and (Gram and cell counts) lymphocytes, isolation and MIC-WPH-SOP-46 identification of clinically significant micro organisms

Ascitic fluid Detection/Quantification of cells and Light microscopy and staining differentiation polymorphs and (Gram and cell counts) lymphocytes, isolation and MIC-WPH-SOP-46 identification of clinically significant micro organisms

Faeces Detection of C.difficile toxin A & B Enzyme linked fluorescent assay using BiomerieuxVidas MIC-WPH-SOP-18

Respiratory samples Detection and resistance of: PCR using Cepheid GeneXpert MIC-WPH-SOP-34 Mycobacterium tuberculosis detection

Rifampicin resistance

Assessment Manager:GD1 Page 6 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Respiratory samples Detection of: Polymerase chain reaction using Cepheid GeneXpert VIROL-WPH-SOP-12 MIC-WPH-SOP-22 MIC-WPH-SOP-97 Respiratory syncytial virus (RSV) Influenza A/B C.Difficile Norovirus confirmation MRSA

Bacterial isolates Detection of Carbapenamase Carba-R kit utilising Real-time PCR producing organisms on Cepheid GeneXpert MIC-WPH-SOP-22 MIC-WPH-SOP-97

Faeces Detection of: Automated ELISA using the Launch DS2 MIC-WPH-SOP-17 H.pylori antigen

Rotavirus

Urine Detection of Legionella Manual immunochromatographic pneumophilia serotype 1 antigen method using BinaxNOW Legionella Urinary Antigen card MIC-WPH-SOP-36

Assessment Manager:GD1 Page 7 of 8

Schedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane , Sta ine s -u po n - Thames, TW18 3HR, UK

Frimley Health NHS Foundation Trust

9734 Issue No: 003 Issue date: 16 September 2020 Accredited to ISO 15189:2012

Testing performed at main address only

Materials/Products tested Type of test/Properties Standard specifications/ measured/Range of measurement Equipment/Techniques used

HUMAN TISSUES AND FLUIDS Microbiological examination In-house documented procedures (cont’d) activities for the purpose of clinical following current Public Health diagnosis (cont’d) England (PHE) Standards for Microbiological Investigations (SMI’s)

Urine Detection of S.pneumoniae antigen Manual immunochromatographic method using BinaxNOW streptococcus pneumoniae antigen card MIC-WPH-SOP-37

Faeces Detection of: Using Enteric Bio and Roche 480 light cycler PCR system MIC-WPH- SOP-21 Norovirus G1/G11 Salmonella Sp Shigella Sp Campylobacter jejuni/coli/lari Verocytotoxin e coli Giardia lamblia &Cryptosporidium antigens C.Difficile GDH

END

Assessment Manager:GD1 Page 8 of 8