N.D.D.H. Pathology provides a complex, specialist diagnostic service and we pride ourselves on compliance with a number of organisations which we must achieve and maintain standards both in the way our services are run and the technical quality assurance of the results and reports we issue.
The laboratory has been assessed by and is compliant with standards required by the Human Tissue Authority (HTA) and (Medicines and Healthcare Products Regulatory Authority (MHRA). The pathology service has also been granted accreditation by the United Kingdom Accreditation Service (UKAS) to ISO 15189 (2012); Medical Laboratories – Requirements for Quality and Competence.
Our schedule of accredited tests can be found on the UKAS website. Enter our UKAS number (9100) into the search box to access the schedule. However, this schedule should be viewed in tandem with the list of non-accredited tests, available here.
Tests may not be currently accredited due to a number of reasons for example, when a new test becomes available for use (e.g. Covid-19) or a change in analytical equipment. Our repertoire of accredited tests is regularly updated following annual accreditation visits by UKAS and we are continuously working towards gaining accreditation status for those tests not currently accredited.
The pathology department has established a selection of Key Performance Indicators (KPIs) to monitor and evaluate performance throughout critical aspects of pre-examination, examination and post-examination processes. Primarily, we monitor these KPIs to evaluate the laboratory’s contribution to patient care. The process of monitoring our KPIs is planned, which includes establishing the objectives, methodology, interpretation, limits, action plan and duration of measurement. We review the KPIs annually as part of the Pathology Annual Management Review process to ensure their continued appropriateness.
Protection of Personal Information
The Pathology Department regards the lawful and correct treatment of patients’ personal information as vital to successful operations and to maintaining the confidence of users of the service. Our policy is that we will treat personal information lawfully and correctly and therefore we fully endorse and adhere to the principles of data protection described in the Data Protection Act 2018.
There is a system of regular reviews of quality through scheduled audits. All grades of pathology staff are encouraged to participate in the audit process, which usually involves examining all the stages of processing a patients specimen – from start to finish, as well Quality Management System specific audits such as document control compliance and equipment records for example.
Non-compliances found as a result of the audit process are investigated and the responsibility for remedial action determined. Remedial action is implemented against an agreed timescale and monitoring the effectiveness of the action taken. Non-compliances will we investigated for a root cause and where appropriate, action will be taken to remove the root cause, therefore preventing a recurrence.