The Leeds Teaching Hospitals NHS Trust

Pathology

Quality Assurance

Laboratory accreditation provides assurance that the laboratory is working to international standards and providing results that are of the highest possible quality.

The LTHT Microbiology department is accredited to ISO15189:2012, customer number 8157. The full scope of the tests that are accredited can be viewed on the UKAS website by following the link. The department strives to continuously update its repertoire and for this reason some tests may not be currently included on the scope of accreditation. Tests are validated or verified for use before bringing into use and where ever possible a suitable Quality assurance scheme is in place. Current tests offered that are outside scope including their status for accreditation defined in table below (data as of January 2020):

      

Test Name

Status of Accreditation

   

Confirmation of Giardia/Crypto EIA positives

Not accredited

Faecal Calprotectin

Not accredited

TB genotyping only

Not accredited

Speciation of Neisseria meningitidis PCR (detection is in scope)

Not accredited

NAAT testing for Chlamydia and Gonorrhoea in swabs from non-genital site

Not accredited

C trachomatis IgG

Not accredited - extension to scope application submitted

Quantitative bloodborne viral loads (Hep B, HIV, Hep C PCR)

Not accredited - extension to scope application submitted

TB Quantiferon

Not accredited - extension to scope application submitted

Mycoplasma genitalium NAAT testing                                                    

Not accredited - extension to scope application submitted

Hepatitis E Serology                                                     

Change to platform, for removal, extension to scope application submitted                                                                        

Molecular Respiratory Virus Testing

Not accredited - extension to scope application submitted

16s PCR

Change to platform, for removal, extension to scope application submitted

Whipples PCR

Change to platform, for removal, extension to scope application submitted

Detection and  identification of Mycobacterum species (including M.tuberculosis)

Change to platform, for removal, extension to scope application submitted

Cepheid TB and drug resistance

Not accredited - to apply

Cepheid Norovirus testing

Not accredited - to apply

COVID-19 Testing

Not accredited - extension to scope application submitted for testing on Panther Hologic TMA assay and Cepheid Gene Xpert

Extended respiratory panel on Biofire

Not accredited - to apply

The Public Health Laboratory including the C difficile Ribotyping Network hosted by LTHT Microbiology is accredited to ISO15189:2012, customer number 10883. The full scope of the tests that are accredited can be viewed on the UKAS website by following the link.

The Department has an extensive Quality Management system and Governance procedures in place to control all the processes within the laboratory.

We participate in a number of internal and external quality assurance schemes from NEQAS, QCMD, Labquality and Instand to ensure the quality of our results.

If you require any further information on specific tests please contact the Quality Manager, Ms Hannah Armitage ( hannah.armitage@nhs.net )