mid cheshire hospitals nhs foundation trust

Assessment Manager: MP 1 of 4

Schedule of Accreditation issued by

United Kingdom Accreditation Service

2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK

8064

Accredited to

ISO 15189:2012

Mid Cheshire Hospitals NHS Foundation Trust

Issue No: 003 Issue date: 11 April 2016

Microbiology Department

Macclesfield Hospital

Victoria Road

Macclesfield

SK10 3BL

United Kingdom

Contact: Kevin Wright

Tel: +44 (0)1625661812

E-Mail:[email protected]

Website: www.mcht.nhs.uk

Testing performed by the Organisation at the locations specified below

Locations covered by the organisation and their relevant activities

Laboratory locations:

Location details Activity

Address

Microbiology Department Macclesfield Hospital Victoria Road Macclesfield SK10 3BL United Kingdom

Local contact

Kevin Wright Tel: +44 (0)1625661812 E-mail:[email protected] Website: www.mcht.nhs.uk

General Bacteriology Serology Mycology Parasitology Post Vasectomy Semen Analysis

8064

Accredited to

ISO 15189:2012


United Kingdom Accreditation Service 2 P ine Trees , Cher t sey Lane, S ta i nes -upon-Thames , TW 18 3HR, UK



Testing performed by the Organisation at the locations specified

Assessment Manager: MP of 4

DETAIL OF ACCREDITATION

Materials/Products tested

Type of test/Properties

measured/Range of measurement

Standard specifications/ Equipment/Techniques

used

HUMAN BODY FLUIDS Microbiology examination

activities for the purposes of clinical diagnosis

General Bacteriology In-house documented procedures based on

PHE SMIs

Swabs from eyes, wounds, nose, throat, ears, genital sites, respiratory fluids (sputum, bronchial washings)

General isolation and characterisation of micro-organisms of clinical significance and antimicrobial susceptibility testing and determination of minimum inhibitory concentration (MIC)

Manual culture using SOPs MW060 Wound Processing MW059 ENT processing MG003 Genital swabs Manual culture using SOP MR006 Manual disk diffusion using SOP MW071 and SOP MW077 for MIC determination using E-Tests Automated susceptibility testing using Vitek 2 Compact using SOP ME028

Swabs from nose, perineum and wound sites

Isolation of MRSA

Manual culture on chromogenic agar using SOP MW010

Fluids from CSF, ascetic and peritoneal fluids

Quantification of white and red blood cells and bacteria

SOP MW060 by manual microscopy

Urine

Quantification of white and red blood cells, bacteria and epithelial cells

SOPMU004 in conjunction with equipment manual using IQ200 Urinanalyser and by manual microscopy using SOP MU003

Urine

General isolation and characterisation of micro-organisms of clinical significance

SOP MU005 in conjunction with manufacturers instructions using Mast Urisystem

Nasopharyngeal aspirates

Detection of RSV fusion protein antigen

SOP MW074 with manufacturers instructions using Binax NOW kit

Urine

Detection of Legionella pneumophila serotype 1 antigen

SOP MU002 in conjunction with manufacturers instructions using Binax NOW kit

8064

Accredited to

ISO 15189:2012











used

HUMAN BODY FLUIDS (cont’d)

Microbiology examination activities for the purposes of clinical diagnosis (cont’d)

General Bacteriology (cont’d) In-house documented procedures based on PHE SMIs

Faeces

General isolation and characterisation of Salmonella, Shigella, Campylobacter & E. coli O157

Manual culture methods using selective agar and SOP MF015

Faeces

Detection of Clostridium difficile GDH antigen and toxins A & B

SOP MF016 in conjunction with manufacturers instructions using C. diff Check 60 (ELISA) on DS2 analyser and Quik Chek complete (immunochromatography)

Faeces Detection of Helicobacter

pylori

SOP MF016 in conjunction with manufacturers instructions for IDEIA HpStaR kit on DS2 analyser

Whole blood

Detection of microbial growth and general isolation and characterisation of micro-organisms of clinical significance

SOP MB001 in conjunction with manufacturers instructions for BacTALERT 3D automated system

Parasitology In-house documented procedures based on

PHE SMIs Faeces Examination for the presence

of parasites (ova, cysts, trophozoites and worms) of clinical significance

SOP MF010 by concentration using Parasep system and manual microscopy

Mycology

In-house documented procedures based on PHE SMIs

Skin scrapings and nail clippings

General isolation and characterisation of fungi of clinical significance

Manual method using SOP MF004 by direct microscopy of KOH digested samples and culture on non-chromogenic selective media

8064

Accredited to

ISO 15189:2012











used

HUMAN BODY FLUIDS (cont’d)

Andrology examination activities for the purposes of clinical diagnosis

In-house documented procedures based on PHE SMIs

Semen (post vasectomy) Detection of spermatazoa

Manual microscopy using documented in-house procedure MF011 and based on BAS (2002) guidelines

Serology examination

activities for the purposes of clinical diagnosis

In house documented procedures based on manufacturers instructions

Serum/plasma (unless stated)

Detection of Hepatitis A IgM Detection of Hepatitis B Surface Antigen Detection of Hepatitis B Core Antibody Detection of Hepatitis B Surface Antibody

SOP MS014 in conjunction with manufacturers instructions using Beckman Coulter DxI

Detection of Hepatitis C

antibody

Detection of Rubella IgG Detection of HIV-1 p24 antigen

& antibody to HIV-1 (gp m & o) & HIV-2

Detection of Syphilis antibody SOP xxxx in conjunction with manufacturers

instructions using Beckman Coulter AU680 Human samples including swabs, fluids, tissues as specified

Detection of Varicella-Zoster antibody Detection of HIV p24 antigen & antibody to HIV 1 & 2

Immunoassay using documented in-house procedure MS016 in conjunction with manufacturers instructions using VIDAS 3

END

mid cheshire hospitals nhs foundation trust

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