UKAS accreditation
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 ISO15189:2022 [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 ISO15189:2022, the process and benefits it brings, please visit:
For more general information please visit:
United Kingdom Accreditation Service (UKAS)
UKAS accredited tests
The schedule of processes and tests that are currently accredited by UKAS can be found via the following links:
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.
| Platforms in development | Area of use | In-house Validation Status | Comment |
|---|---|---|---|
| Automated Microtome | Histopathology JR site only | In progress | ETS to be submitted to UKAS Mar 2026 |
| Bond Prime Immunohistochemistry Staining Platforms | Histopathology JR site only | In progress | ETS submitted for UKAS review in April 2026 |
|
AI Supported digital Pathology
|
Histopathology JR site only | Complete | ETS to be submitted to UKAS May 2026 |
The department now has a flexible scope of accreditation for Immunohistochemistry tests. Once the in-house validation status is ‘complete’, stringent quality assurance steps have been carried out and Flexible Scope sign off will be sought. Until this is complete, this test remains unaccredited but ‘in progress’. Once accredited it will be transferred to the Flexible Scope Accredited list.
| Antibodies in development | Area of use | In-house Validation Status | Comment |
|---|---|---|---|
| BRG-1 | JR | Complete | Final Governance Sign off required |
| Claudin 18.2 | JR | Complete | Final Governance Sign off required |
| CYP11B2 | JR | Complete | Final Governance Sign off required |
| H3 K36M | NOC | Complete | Final Governance Sign off required |
| HSV Type 1 | JR | Complete | Final Governance Sign off required |
| INSM1 | JR | Complete | Final Governance Sign off required |
For any tests which the department is unable to follow the normal validation steps, the continued use of a test will be clearly identified as NOT ACCREDITED to relevant service users and will not form part of the routine range of tests used to reach a primary diagnosis.
- Currently there are no tests in this category.
