In this section
Cellular Pathology (Histology and Cytology) is fully accredited by UKAS in conformance with ISO 15189:2012. Our UKAS Medical Laboratory Reference Number is 9083. The department participates in regular extensive assessments to maintain its accreditation status.
The department is licensed by the Human Tissue Authority (HTA) under licence number 12253.
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 department participates in the following external quality assurance schemes:
UKNEQAS for Cellular Pathology Technique:
- General Cellular Pathology (Tissue Diagnostics Scheme and Specialist Techniques Scheme – from 2021)
- Frozen Sections/Mega Blocks
UKNEQAS for Immunocytochemistry and In Situ Hybridisation:
- Module 1 – General Pathology – 2 antibodies
- Module 2 – Breast Pathology (Hormonal Receptors) – 1 antibody
- Module 3 – Breast Pathology (HER-2) – 1 antibody
- Module 4 – Lymphoid Pathology – 2 antibodies
- Module 7a – Alimentary Tract Pathology (GIST) – 2 antibodies
- ISH – Breast Pathology (DDISH only, scoring and technical).
- ALK,
- PD-L1
- PD-L1 breast SP142
- KI67
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 April 2023)