Events during September 2023

ISO15189:2012 had reached its periodic review date and there was international consensus that it needed revision. The new version was published on 6th December 2022 and there are some key changes which include an emphasis on a patient-focused approach and to promote the welfare of patients - i.e. putting the patient at the heart of the service. There is also more emphasis on a risk based approach to the Quality Management system. In addition ISO 22870 (POCT) has been incorporated into ISO 15189:2022.

This presentation will review POCT definitions, highlight key considerations for currently accredited POCT services and also for organisations considering applying for accreditation to include (or extend) POCT in their scope.

POCT is referenced implicitly throughout ISO 15189:2022 and with additional distinct requirements as an Annex A.

The presentation will discuss generic POCT services, and highlight considerations on both current POCT services and also emphasise considerations for planning new POCT services, and that overall, when compared with ISO 22870:2016, things have not changed as much as one would think. Principles are similar, and POCT could even be considered as another specialty within pathology, regardless of where it is or managed from.

The human factors in change processes

This lecture will provide context and understanding of the processes and practices used within Northumbria Healthcare for ensuring Quality is underpinned throughout the procurement process within Pathology IT. Including:

Governance
Lessons learned from previous projects
Learning from others
Contract Development
Frameworks and Technical Standards

The safety and performance of diagnostic devices used in pathology (equipment, software, reagents etc) is assured through regulation. The UK is developing a new set of regulations that will completely change how the safety and performance of diagnostic devices can be demonstrated. Regulations will have an impact on procurement and availability and will affect how new products can be developed in pathology facilities.

ISO15189:2022 has undergone a major revision and was release in December 2022. David was one of the core drafting team responsible for the latest version and will discuss how the document was developed and agreed by the international community, why the changes were made and the purpose of the new standard.

Areas covered in this lecture will include the change in the format of the standard, why Point of Care testing is now part of the main assessment, if applicable and the increased empathies on risk and patient welfare.ISO15189 was revised and released in December.

ISO 15189:2022 Q&A

Gynae pathology

Skin

A brief overview of two interesting case studies in uropathology covering the normal histology of the kidney and prostate, the common tumour types/pathologies and the potential challenges or differential diagnoses that may need to be considered.

Upper GI tract