Oxford University Hospitals NHS Foundation Trust
Cellular Pathology

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UKAS Accreditation and Tests

UKAS accreditation

UKAS

This symbol shows that our laboratories have passed full accreditation against ISO standard 15189:2012.

Laboratories based at the John Radcliffe Hospital under registration number 8415 and the specialised bone laboratory based at the Nuffield Orthopaedic Centre under registration number 8683.

Accreditation provides formal recognition that the Cellular Pathology Clinical Services Unit [CSU] at OUH is competent to perform Cytology, Histology and Post Mortem services [which are detailed in the scope of accreditation] in a reliable, credible and accurate manner.

The CSU undergoes inspection for conformance with internationally recognised standards of ISO15189:2012 [medical laboratory accrediation].

As an accredited service our users can have confidence in the quality of the results, their traceability, comparability, validity and commutability.

For more information on accreditation to ISO15189:2012, the process and benefits it brings, please see:

www.ukas.com

UKAS accredited tests

Cellular Pathology at the John Radcliffe and Nuffield Orthopaedic Centre sites have compliance with ISO15189:2012 reviewed annually.

The schedule of processes and tests that are currently accredited by UKAS can be found via the following links:

John Radcliffe Cellular Pathology Service schedule of processes and tests (pdf) - www.ukas.com

Nuffield Orthopaedic Centre Pathology Service schedule of processes and tests (pdf) - www.ukas.com

New / amended tests* undergo validation and quality assurance processes in order to be eligible for inclusion in the accredited schedule.

The validity of results are assessed though correlation with external sources; primarily this is through participation in national external quality assurance schemes (EQA).

If there is no relevant EQA scheme, the department ensures the results are accurate and valid by a combination of internal quality assurance tools and appropriate relevant external source such as:

  • control material (known positives and negatives) with every run
  • cross referencing to external images / information
  • correlating results in panels
  • comparing results with other laboratories
  • requesting bespoke reviews by an EQA body
  • double reporting or team reviews of results.

*This is approach is also used for research antibodies (i.e. not CE/IVD marked) which have been recommended for use by a professional body (such as the RCPath), NICE or within a peer reviewed paper.

'Non-accredited' tests

As a dynamic department, that continually seeks to improve for the benefit of patients, there are a number of tests and processes that are being developed or amended between accreditation visits.

This can arise due to:

  • new tests becoming available
  • recommendations for use by a professional body (such as the RCPath), NICE or within a peer reviewed paper
  • service development projects.

Until they have been ratified by the UKAS team, it must be made clear that these new / amended tests / processes are not accredited by UKAS (see list in table below).

To ensure that tests are introduced in a safe way, with sound, scientific reasoning, the department follows prescribed procedures of acceptance testing, validation and verification of any new, or amended process.

Test provided Area of use In-house validation status Comment
Adenovirus JR In progress Awaiting UKAS approval
ALK D5F3 JR Complete Awaiting UKAS approval
BAP-1 JR Complete Awaiting UKAS approval
BRAF VE1 JR In progress Awaiting UKAS approval
Calreticulin (CALR) JR Complete Awaiting UKAS approval
Cathepsin K JR In progress Awaiting UKAS approval
CD14 JR Complete Awaiting UKAS approval
CD56 NOC Complete UKAS approval required
CD79a NOC Complete UKAS approval required
CK5/6 NOC Complete UKAS approval required
ERG NOC Complete UKAS approval required
Fumarate hydratase JR Complete Awaiting UKAS approval
H3.3 G34W NOC Complete UKAS approval required
LM02 JR Complete Awaiting UKAS approval
MDM2 NOC Complete UKAS approval required
Napsin A JR Complete Awaiting UKAS approval
NKX3.1 JR Complete Awaiting UKAS approval
P40 JR Complete Awaiting UKAS approval
Parafibromin JR Complete Awaiting UKAS approval
PAX8 MRQ-50 JR Complete Awaiting UKAS approval
PD-L1 JR Complete Awaiting UKAS approval
PHOX2B JR Complete Awaiting UKAS approval
PSMA JR Complete Awaiting UKAS approval
Renin JR In progress Awaiting UKAS approval
ROS1 JR Complete Awaiting UKAS approval
SDHB JR Complete Awaiting UKAS approval
SOX10 JR/NOC Complete Awaiting UKAS approval
TFE3 JR Complete Awaiting UKAS approval
THSD7A JR Complete Awaiting UKAS approval
Von Kossa NOC Complete UKAS approval required

For tests which the department is unable to follow the normal validation steps (see above), the continued use of a test will be clearly identified to relevant service users.