Quality

Our Cellular Pathology Service across all sites is fully accredited by UKAS in conformance with ISO 15189:2022. Our UKAS Medical Laboratory Reference Number is 8648. The department participates in regular exhaustive assessments to maintain its accreditation status. The department is licensed by the Human Tissue Authority (HTA). The department is committed to deliver a quality service to our users and continual improvement. A quality management system is utilised to ensure all documents, processes, quality records and clinical material are controlled to DLM (Division of Laboratory Medicine) policy. Processes and systems are regularly audited to identify non-conformities and quality improvements.

External Quality Assurance (EQA)

The department participates in the following external quality assurance schemes:

UKNEQAS for Cellular Pathology Technique

• Tissue Diagnostics – submission of H&E and corresponding block from each processor that is registered as an asset.
• Specialist Techniques – submission of stained slides which includes
  • Special Stains on sections provided by UKNEQAS,
  • Renal Biopsy Pathology,
  • Bone Marrow Pathology,
  • Mega slides
  • and Frozen Sections.

UKNEQAS for Immunocytochemistry and In Situ Hybridisation

• General Pathology – Both Sites
• Breast Pathology (Hormonal Receptors) – Wythenshawe Only
• Breast Pathology (HER-2) – Wythenshawe Only
• Breast Pathology Low Her-2- Wythenshawe Only
• Lymphoid Pathology – Both Sites
• Alimentary Tract Pathology – Both Sites
• ISH – Breast Pathology (DDISH only). – Wythenshawe Only
• MMR – ORC Only
• ALK NSCLC – Both Sites
• PD-L1 – Both Sites
• PDL1 clone 22C3 (pilot) ORC only
• PD-L1 breast SP142– Wythenshawe Only
• ROS-1 – ORC Only
• KI67– Wythenshawe Only
• Head and Neck Advance Staining for P16 (Pilot) – ORC Only
• Electron Microscopy- ORC only

Data protection

The department complies with trust, DLM and departmental policies relating to the handling, use and protection of personal information (DLM-QUAL-PRO-022 Management of Data and Information).

• We only ask for information that we need to allow interpretation of results
• We protect the information and ensure only those staff who need to see the information can access it
• We share the information only when we need to for patient care, for example sending the information to another laboratory for testing
• We don’t store information for any longer than is absolutely necessary

Uncertainty of measurement

In clinical laboratory testing there are potential uncertainties that can affect test results, such as poor specimen collection or transport, patient related factors or other interfering factors. The laboratory examination process itself is subject to some degree of variability and our department regularly monitors this by the use of internal quality control and participation in external quality assurance schemes.

In accordance with the RCPath guidance, an assessment of the uncertainty of measurement will be carried out for any measurement that is included in the diagnostic report if it is deemed to have actual or potential “direct clinical impact.”

Where weights and measurements are part of an overall description and do not impart prognostic or predictive value, an assessment will not be carried out.

Patient consent

It is the responsibility of the requesting clinician to ensure that any objections or restrictions expressed by a patient to the use of their tissue are clearly recorded on the request card.

It is vital to ensure that all early pregnancy tissue specimens for histological investigation have the appropriate fully completed PS1consent form enclosed with the histology request card.

(Last reviewed August 2025)