Quality

Cellular Pathology (Histology and Cytology) is fully accredited by UKAS in conformance with ISO 15189:2022. Our UKAS Medical Laboratory Reference Number is 8648. The department participates in regular extensive assessments to maintain its accreditation status.

The department is committed to delivering a quality service to our users and operates within a framework of 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 departments participate in the UKNEQAS for Cellular Pathology Technique (CPT) Scheme which was formed in 1991 following the merger of a group of regional schemes and is now the result of many years of development and evolution in the field of Cellular Pathology External Quality Assessment (EQA). UKNEQAS for CPT is an established international scheme with a first-class reputation and participant base that provides external quality assurance to both public and private institutions within the UK and overseas.

Currently UKNEQAS for CPT offers 6 assessment cycles per year in many modules, one of which is Diagnostic Cytopathology (NG).

Additionally, following a pilot scheme in UKNEQAS CPT Diagnostic Cytopathology Cell Block Scheme, the department has successfully subscribed to this scheme in 2023. There are 6 cycles per year and coincide with the slide scheme.

Data protection

The departments comply 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

Measurement uncertainty

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.

The laboratory has undertaken a specimen pathway risk assessment to ensure all factors that may contribute to measurement uncertainty that cannot be statistically defined are captured and controlled as far as possible.

Information for users relating to measurement uncertainty is available on request.

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 samples are clearly recorded on the request card.

For samples submitted from external locations, it is the responsibility of the referring Trust to ensure consent for testing is in place, please be aware that evidence of consent may be required prior to sample testing.

(Last reviewed February 2025)