Quality Management
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point-of-Care Testing
Quality Management
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point-of-Care Testing
1pm – 1.30pm BST, 25 September 2023 ‐ 30 mins
Quality Management
Abstract
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.
Speakers
The human factors in change processes
Quality Management
The human factors in change processes
1.30pm – 2pm BST, 25 September 2023 ‐ 30 mins
Quality Management
Speakers
Quality in IT procurement
Quality Management
Quality in IT procurement
2pm – 2.30pm BST, 25 September 2023 ‐ 30 mins
Quality Management
Learning outcomes
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
Speakers
Regulation of in vitro diagnostic medical devices in the UK
Quality Management
Regulation of in vitro diagnostic medical devices in the UK
2.30pm – 3pm BST, 25 September 2023 ‐ 30 mins
Quality Management
Abstract
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.
Learning outcomes
Delegates attending this presentation will understand:
- What are in vitro diagnostic medical devices (IVDs) and how they will be regulated in the UK.
- The potential impacts of regulations on UK pathology.
- The exemption for health institutions.
Speakers
Stephen Lee
Director, Diagnostics Regulation, Association of British HealthTech Industries
Development & Introduction of ISO 15189:2022
Quality Management
Development & Introduction of ISO 15189:2022
3.45pm – 4.05pm BST, 25 September 2023 ‐ 20 mins
Quality Management
Abstract
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.
Learning outcomes
This lecture will provide context as to the intent behind the new version of ISO15189. It will cover how and why the standard has been written in the current format
As one of the drafting team there will be the opportunity to ask questions on the new standard and get a response from someone at the heart of this version.
Speakers
Dr David Ricketts DBMS CSci FIBMS
Head of Laboratory Process Improvement, Health Services Laboratories LLP
The IBMS's view of ISO 15189:2022
Quality Management
The IBMS's view of ISO 15189:2022
4.05pm – 4.25pm BST, 25 September 2023 ‐ 20 mins
Quality Management
Speakers
Introduction to the UKAS ISO 15189:2022 transition
Quality Management
Introduction to the UKAS ISO 15189:2022 transition
4.25pm – 4.45pm BST, 25 September 2023 ‐ 20 mins
Quality Management
Abstract
This session provides an overview of the key changes to the ISO 15189 standard and explains the UKAS transition process including deadlines and actions to be taken by accredited organisations.
The same session is being run on Monday, Tuesday and Thursday to ensure as many delegates as possible are able to attend.
Speakers
Implementation of the Patient Safety Incident Response Framework (PSIRF): an NHS trust perspective
Quality Management
Implementation of the Patient Safety Incident Response Framework (PSIRF): an NHS trust perspective
9am – 9.30am BST, 28 September 2023 ‐ 30 mins
Quality Management
Learning outcomes
This presentation will give delegates:
- An overview of the PSIRF and the differences between this and the Serious Incident Framework
- The learning from implementation in an acute and community provider
- A case example of a Patient Safety Incident Investigation (PSII) in practice
- The governance of improvement plans and the monitoring and assurance of these
Abstract
The presentation gives an overview of the NHS Patient Safety Incident Response Framework, it’s principles and requirements. There is also a brief summary of the Systems Engineering Initiative for Patient Safety (SEIPS) and how this is different to previous models of investigation. The presentation then focusses on how PSIRF has been implemented at Northumbria Healthcare, an acute and community provider in the North East of England, with a focus on the phased implementation approach used by the PSIRF leads. The speaker will also cover the challenges in the implementation to date and the successes experienced so far.
Speakers
Rachel Carter
Director of Patient Safety, Patient Safety Specialist , Northumbria Healthcare NHS Foundation Trust
Rudeness costs lives
Quality Management
Rudeness costs lives
9.30am – 10am BST, 28 September 2023 ‐ 30 mins
Quality Management
Abstract
Many reports have demonstrated the correlation between good team working and better outcomes. This talk explores the value of civility and the cost to our patients of rudeness in the workplace.
Learning outcomes
Delegates attending this presentation will understand from the perspective of quality management:
- The importance of teamwork and civility
- Impact on patient care due to incivility
Speakers
Nathan Bourne
Pathology Governance & Quality Manager, University Hospitals Dorset NHS Foundation Trust
Development & Introduction of ISO 15189:2022
Quality Management
Development & Introduction of ISO 15189:2022
10.30am – 10.50am BST, 28 September 2023 ‐ 20 mins
Quality Management
Abstract
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.
Learning outcomes
This lecture will provide context as to the intent behind the new version of ISO15189. It will cover how and why the standard has been written in the current format
As one of the drafting team there will be the opportunity to ask questions on the new standard and get a response from someone at the heart of this version.
Speakers
Dr David Ricketts DBMS CSci FIBMS
Head of Laboratory Process Improvement, Health Services Laboratories LLP
The IBMS's view of ISO 15189:2022
Quality Management
The IBMS's view of ISO 15189:2022
10.50am – 11.10am BST, 28 September 2023 ‐ 20 mins
Quality Management
Speakers
Introduction to the UKAS ISO 15189:2022 transition
Quality Management
Introduction to the UKAS ISO 15189:2022 transition
11.10am – 11.30am BST, 28 September 2023 ‐ 20 mins
Quality Management
Abstract
This session provides an overview of the key changes to the ISO 15189 standard and explains the UKAS transition process including deadlines and actions to be taken by accredited organisations.
The same session is being run on Monday, Tuesday and Thursday to ensure as many delegates as possible are able to attend.
Speakers
ISO 15189:2022 Q&A
Quality Management
ISO 15189:2022 Q&A
11.30am – 12pm BST, 28 September 2023 ‐ 30 mins
Quality Management
Validation and Verification Workshop
Quality Management
Validation and Verification Workshop
12.45pm – 1.45pm BST, 28 September 2023 ‐ 1 hour
Quality Management
Learning outcomes
This lunchtime workshop will:
- Provide definitions of validation and verification
- Discuss the processes of validation & verification to comply with ISO15189
- Enable delegates to troubleshoot difficulties in validation and verification
Speakers
Competences for Managers
Quality Management
Competences for Managers
2pm – 2.30pm BST, 28 September 2023 ‐ 30 mins
Quality Management
Learning outcomes
Delegates attending this presentation will:
- Understand what competence is
- Understand the requirements of ISO15189:2022
- Be able provide examples of competence for managers
Speakers
Managing the Human Tissue Authority inspection and selected case studies
Quality Management
Managing the Human Tissue Authority inspection and selected case studies
2.30pm – 3pm BST, 28 September 2023 ‐ 30 mins
Quality Management
Abstract
I wish to offer a practical guide to working with the Human Tissue Authority.
I will provide examples of what to do and how to do it when issues arise
I will take you through the paperwork involved
I will describe how best to approach HTA reportable incidents
I will take you through how to prepare for the HTA inspection
This will be a very hands on guide and strongly welcome participation from the audience.
Learning outcomes
Through the discussion of relevant situations and cases delegates attending this presentation will:
- How to approach the HTA and the Inspection
- Understand managing reportable incidents.
Speakers
Quality in IT Procurement
Quality Management
Quality in IT Procurement
3pm – 3.30pm BST, 28 September 2023 ‐ 30 mins
Quality Management
Learning outcomes
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
Speakers
Jonathan Boxshall
Pathology Quality Manager, Northumbria Healthcare NHS Foundation Trust