Quality Management
Programme Sponsor
Applying human factors to improve individual and team performance in biomedical sciences
Applying human factors to improve individual and team performance in biomedical sciences
Quality Management
Abstract
As humans we are fallible and make mistakes both at work and outside it on a regular basis. 1 in 20 hospital admissions has some form of error, and 1 in 20 of those (so 1:400 admissions) has a serious error. Understanding, recognising and applying human factors (HF) in clinical and laboratory practice can help reduce the chances of these and other errors as well as enhancing team working and personal performance HF is gaining ever increasing traction and profile across healthcare, medicine and allied professions. However, unfortunately some colleagues do not think these factors apply to them and, for example, work for many hours without taking a break.
In this short presentation, we will discuss some of the human factors relevant to biomedical scientists. We will highlight the complexities of the science around HF before focusing on sometimes overlooked personal factors that can be utilised to improve both personal performance and enhance team working. We will include the importance and benefits of team briefing, effective communication, maintaining situation awareness and minimising distraction during safety critical tasks. Finally, the importance and value of reducing team authority gradients will be mentioned to help improve both patient safety and empower everyone in our teams.
Learning outcomes
Delegates will:
- Recognise that human error is common and 'normal' in everyday life and medical practice
- Understand how individual and wider team performance can help improve patient care
- Be aware of some of the important factors that can lead to error including poor communication, multitasking and distraction
- Appreciate how shallow authority gradients and an inclusive culture allow colleagues to speak up without fear for any safety concerns.
Speakers
Professor Peter Brennan MB BS, MD, PhD, FRCS, FRCSI, Hon FRCS (Glasg)
The impact of ISO 15189/22367 on risk management in laboratory medicine
The impact of ISO 15189/22367 on risk management in laboratory medicine
Quality Management
Learning outcomes
Delegates will understand:
- Risk Assessment
- Risk Analysis
- Recording Risk and what must be done
- Action planning for risks
- Differentiating between service risk and Organisational risk
Speakers
Dr Mairiead MacLennan
Transforming IVD Regulation in the UK: Implications for Quality, Innovation, and Patient Safety
Transforming IVD Regulation in the UK: Implications for Quality, Innovation, and Patient Safety
Quality Management
Abstract
The UK’s in vitro diagnostic (IVD) regulatory landscape is undergoing a fundamental transformation. Driven by regulatory reform in the EU and in the UK, and shaped by the MHRA’s plans for a modern, risk-based domestic framework, these changes will have far-reaching consequences for laboratories, manufacturers, and most importantly, patients.
This session will provide a practical and forward-looking overview of how evolving IVD regulations impact quality management in clinical laboratories. Attendees will gain insight into how the new requirements for clinical evidence, post-market surveillance, and risk classification are reshaping how labs can assess, adopt, and monitor diagnostic tests. We will explore what these changes mean for procurement decisions, lab validation protocols, and supplier oversight — all central to an effective quality management system.
Critically, we’ll also highlight the opportunities for laboratories to contribute to performance studies and real-world evidence, helping to shape the future of diagnostic innovation. The session will examine the regulatory link between diagnostics and public health, and how robust quality systems can act as a frontline defence in safeguarding patient safety.
If you are responsible for governance, accreditation, procurement, or quality assurance in your lab — this session is essential for understanding how regulation will drive quality outcomes and how your role is central in making that a reality.
Learning outcomes
- Understanding Regulatory Compliance for Medical Devices in Pathology
- Update on regulatory changes for medical devices
- Evaluating the Impact of Policy Changes on Device Safety and Efficacy
- Overview of UKCA
- Things to consider during procurement of devices
Speakers
Stephen Lee
UKAS: Life after transition
UKAS: Life after transition
Quality Management
Abstract
The ISO 15189:2022 transition project is nearing completion. This talk will support laboratory services to continually improve their service to patients and compliance with ISO 15189:2022 post-transition. Trends in nonconformities raised during transition assessments will be shared along with other key learning points.
Speakers
Alyson Bryant
Accreditation - more & different
Accreditation - more & different
Quality Management
Abstract
Delivery of diagnostic services is changing, and UKAS accreditation remains responsive to the changes. This talk will review accreditation options for laboratory services, including discussion of flexible scopes of accreditation, pathology network accreditation, POCT services, and patient-centric sampling.
Learning outcomes
Speakers
Alyson Bryant
Managing in a network service – to harmonise or not
Managing in a network service – to harmonise or not
Quality Management
Abstract
Presenting the experience of merging two Trust's and three pathology labs and harmonising in each discipline. The presentation will be looking at the impact of change on the service and on the staff.
Speakers
Nathan Bourne
20 years of the Human Tissue Act: Evolution, standards, and ethical governance in postmortem practices
20 years of the Human Tissue Act: Evolution, standards, and ethical governance in postmortem practices
Quality Management
Abstract
This presentation explores the fundamental principles of the Human Tissue Act 2004 and how they relate to post mortem tissue being analysed and stored within histopathology departments. It provides guidance on preparing for a Human Tissue Authority (HTA) inspection, and shares good practice of compliance in:
- Traceability between the mortuary and laboratory;
- Governance and quality standards of audit and risk assessment;
- Methods of dignified storage and sensitive disposal of post mortem tissue;
- Reporting incidents to the HTA;
- Improving communication with external stakeholders, such as HM Coroner’s office; and
- Security arrangements for regulated areas.
Learning outcomes
Delegates will gain an:
- Understanding of the history and role of the HTA.
- Understanding of the HTA’s postmortem standards and the involvement of BMS staff in regulatory assessments.
- Understanding of the traceability and governance requirements for the use, storage, and disposal of postmortem tissue.
Speakers
Shane Mongor
Out of the ashes - regaining accreditation
Out of the ashes - regaining accreditation
Quality Management
Abstract
This talk will be jointly delivered by UKAS and an accredited laboratory which lost, and subsequently regained, accreditation. The talk will cover topics including reasons why a laboratory might lose accreditation, the pros and cons of temporarily being unaccredited, and the laboratory's experience of losing and regaining accreditation.
Speakers
Emma Doran
Adrian Donoghue
Opening and Closing Plenary programmes
