UKAS Accreditation and Tests

UKAS accreditation

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
BCoR	NOC	Complete	UKAS approval required
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
H3.3 G34W	NOC	Complete	UKAS approval required
H3K36M	NOC	In progress	UKAS approval required
MDM2	NOC	Complete	UKAS approval required
MITF	NOC	Complete	UKAS approval required
PanTRK	NOC	Complete	UKAS approval required
Retinoblastoma	NOC	Complete	UKAS approval required
SMA	NOC	Complete	UKAS approval required
Von Kossa	NOC	Complete	UKAS approval required
BRAF V600E	JR	Complete	UKAS approval required
STAT6	JR	Complete	UKAS approval required
ERG	JR	Complete	UKAS approval required
INI-1	JR	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.