Introducing a systematic and sustainable patient safety oversight function in a U.K. arms-length healthcare body

Introduction

The COVID-19 pandemic and the response of health systems was a catalyst for change across the healthcare landscape, accelerating developments in care delivery such as ‘virtual wards’ and remote patient monitoring technologies to meet the challenges of delivering care in a pandemic and tackling elective backlogs.^1,2 These changes offer opportunities for improved patient experience but are challenging as they require new ways of working to reduce the likelihood of error. ³

These innovations occurred in an already evolving patient safety landscape in the United Kingdom. Prior to the start of the pandemic, the National Health Service (NHS) launched its strategy for patient safety. Conceived as a ‘golden thread’ running through healthcare, its vision is to improve patient safety collectively and continuously, generating greater responsiveness to patient needs and system priorities. ⁴ Further developments included formal recognition of the Health Service Safety Investigation Body (HSSIB) as a statutory body to investigate patient safety concerns across England to improve NHS care at a national level, so that its recommendations carry a binding legal duty of implementation. ⁵ HSSIB can issue recommendations to all levels of the healthcare system in England and some of these recommendations can be directed at National Institute for Health and Care Excellence (NICE) such as where updates or clarifications to its evidence-based guidance may assist in reducing overall risk to patient safety. Furthermore, the Independent Medicines and Medical Devices Safety (IMMDS) review ⁶ – a public inquiry into how the health system responds to reports from patients about harmful side effects from medicines and medical devices. with a focus on the use of surgical mesh, prescription of sodium valproate and the hormone pregnancy test Primados, gave a clear message to all public bodies including NICE – that data collection, collaboration and prompt intelligence sharing at a system level needs improvement to promote patient safety.

As an independent arms-length body with responsibility for providing evidence-based health and care guidance, the NICE is a partner in the patient safety system.^7,8 This article considers the organisation's response to the patient safety challenges of the increasingly complex healthcare environment. We illustrate our experience with vignettes from practice and identify learning at organisation and system levels.

The history and role of NICE

Established in 1999, NICE's original role centred on developing clinical guidelines. ⁹ Since then, the institute's role, remit and audiences have expanded. ¹⁰ Today, NICE has a statutory duty in the United Kingdom to improve health and wellbeing by delivering evidence-based guidance, advice and standards to inform quality healthcare decision making. ¹¹

NICE fulfils this role through three interlinked ‘ecosystems’: life sciences, guidelines and information provision. ¹² The life sciences ecosystem evaluates the clinical and cost effectiveness of technologies and assesses new interventional procedures for safety and effectiveness. NICE guidance develops best practice recommendations, advice and quality standards primarily for frontline practitioners but increasingly for patients to support shared decision making and self-care. The information ecosystem provides a wide range of evidence-based information and advice for use in healthcare decision making.^13,14

Developing a focal patient safety structure

Patient safety is integral to NICE's role in producing quality guidance, as it is a core component of quality in healthcare, alongside effectiveness and patient experience.^15–18

At an organisation level, this means reviewing safety signals, or incoming intelligence about safety issues, and responding through NICE's established processes of developing, reviewing, and updating guidance.

Historically, NICE endeavoured to respond effectively to arising safety matters within these existing processes, with an approach to patient safety disseminated implicitly throughout its operational structures but without a centralised oversight team to ensure effective compliance and timely response. ¹⁹ NICE's approach to safety matters at the time was outlined in the evidence it gave to the IMMDS review. ²⁰ Prompted in part by reflection on the evidence it gave to the IMMDS, NICE recognised that its historical approach whilst conducive to patient safety, could be improved. The historical approach at times led to a dispersed organisational response to arising safety signals and the absence of a single organisation lead for safety meant NICE's relationships with other key safety-related partners in the healthcare system was not as effective as they could be. This is important especially when NICE's guidance needed to align in real time with advice from safety regulators such as the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA may issue updated safety advice in relation to medicines and medical devices which has a direct impact on published NICE guidance. The key challenge encountered in defining and establishing the function was to ensure that NICE is working within its defined remit and complemented rather than duplicated the roles of other bodies in the safety system and communicated this effectively both internally and externally. Concerns of some NICE staff included those who see safety assurance as the role of those who have a specific safety regulatory role such as the Care Quality Commission (whose duty is to ensure the safety and quality of care services provided in England) and the MHRA (whose role is regulator of medicines, medical devices and blood components for transfusion in the United Kingdom). Overcoming this challenge requires effective ongoing internal and external engagement strategies to reinforce understanding of how NICE works to interact and complement rather than duplicate the role of these other bodies. ²¹

As the organisation has grown and its role expanded, coupled with a growing emphasis on the importance of effective patient safety measures within the wider health and care system, NICE has recognised the need for a central monitoring and oversight function The intention is for this function, delivered through a cross-organisational oversight group, to provide leadership for NICE's patient safety approach, to establish its role in the wider external system and to respond effectively to issues from an increasingly complex external health and care environment.^22,23

NICE established the safety oversight group to raise safety awareness and co-ordinate cross-organisation activity. ²⁴ This function is led by the roles of Senior Responsible Officer (SRO) for patient safety and Deputy SRO to bring enhanced leadership and visibility to the safety agenda, both within NICE and through engagement with system partners. These roles report to NICE's Chief Medical Officer who represents patient safety on the NICE Executive Team and Board ensuring that patient safety issues can be escalated to a senior level within the organisation where required.

The patient safety oversight group was established through a scoping exercise, led by the SRO supported by a small project team. This exercise included internal engagement through structured interviews with senior leadership teams of all key functions within NICE including programme directors for guideline development, health technology appraisal, implementation support and communications. Methods included purposive sampling, data synthesis from interviews and reporting.

The aim of this exercise was to secure cross-organisational buy-in and to identify the key roles and functions that such a group could provide to the benefit the organisation as a whole. The outcomes of this exercise highlighted which areas of the organisation were more advanced than others in terms of their consideration of safety issues, and areas of the organisation that would benefit more from support to build safety assurance into their processes. Internal interviews also helped to establish what communication methods would be required to promote a safety culture across the organisation, including the need to tailor safety-related messages to specific audiences within the workforce and adapting safety terminology where required to resonate with different teams depending on their level of safety assurance knowledge and maturity.

The exercise also steered the development of the oversight group in terms of how its composition should comprehensively reflect NICE's internal programmes (see Figure 1). The SRO ultimately has the authority to appoint the group's membership and to ensure it has the right skills mix to consider a range of safety issues, for example members include those with experience in clinical care (emergency medicine, paediatrics, haematology), pharmacy, data and analytics, implementation, digital health and medical technology evaluation and communications. The group provides a flexible, adaptive structure, for example by routinely reviewing and updating its membership to reflect the changing organisational structures within NICE. The group represents NICE in developing and maintaining key external relationships with the wider healthcare safety system. Finally, the oversight group is the principle conduit through which safety signals and data coming to NICE from external sources are considered and triaged appropriately for response by the relevant internal teams within NICE. Brought together, these components deliver the vision for patient safety oversight as required by NICE's executive team. We will now turn to examine these components in turn.

OPEN IN VIEWER

Figure 1.

Patient safety oversight group core representation by function.

Adaptive structures and the core role of relationships

The scale and pace of change in the NHS currently requires an adaptive way of working.^25,26 NICE's patient safety function provides ²⁷ a route for raising awareness of safety and, at times, challenging assumptions and the status quo.It has given NICE the means to develop cross-organisation responses with the built in flexibility via the oversight group model to respond to changing needs and structures both within and outside of the organisation (see Vignette 4 example).

Maintaining external relationships is of critical importance to facilitating cross-system communication and collaboration. Such connections are essential for aligning NICE's work with the wider safety system and frontline health and care practice (see Vignette 1).

Vignette 1: NICE and Bristol Medical School – University of Bristol working together to improve governance of new procedures to reduce risk of harm.

An ongoing collaboration between the Patient Safety Oversight Group at NICE and colleagues in the wider system highlights the capacity for improving safety and practice through intelligence sharing. Working with Bristol Medical School colleagues, research findings informed the development of a good practice model to govern the introduction of new interventional procedures in NHS acute trusts. The model has been designed by a multi-disciplinary working group including academic partners and patient representatives and personnel from NICE, with the aim of reducing the variation in governance processes highlighted by Bristol's research and promoting safer introduction of innovation. NICE is now working with the team at Bristol on an audit to measure the uptake of 10 topics with NICE Interventional Procedures guidance special arrangements recommendations. Such a recommendation is made when there is uncertainty about whether a procedure is safe or effective, carries requirements for data collection in practice and an emphasis on informed consent with patients.

In support of its statutory duties, NICE is represented on relevant national groups including the National Quality Board ²⁸ and National Patient Safety Committee and the Digital Safety Advisory Group. ²⁹ Key partners in the healthcare system include the MHRA, Care Quality Commission, the General Medical Council, and others. ³⁰ NICE has a dedicated relationship on patient safety matters with the Maternity and Newborn Safety Investigations Programme and HSSIB (See Vignette 2 for example).

Vignette 2: NICE and HSSIB

An example of essential relationships is that between NICE and the Health Services Safety Investigations Body (HSSIB). HSSIB is tasked with improving patient safety through effective and independent investigations that don’t apportion blame or liability. Their investigations often take into consideration NICE guidance and make safety recommendations to improve the healthcare system. Dialogue between the organisations informs the work. For instance, during discussions on the assessment and management of fever in children under 5 years of age, whilst not mandated to do so, NICE personnel recognised that an amendment to existing guidance (NG143) could improve clarity and promote safer care. The oversight group supported action on this topic, ensuring that the guidance was updated to increase references to signs of sepsis.

Promoting intelligence flows and optimising safety signals

The sources and the quantity of safety signals received by NICE are changing as the wider landscape evolves. ³¹ Safety signals can be directive, such as Coroners’ Prevention of Future Death reports, MHRA alerts or HSSIB investigations. These demand a rapid, specific response and clear structures to ensure they are considered through relevant work programmes. NICE also receives an increasing volume of safety signals that aren’t formal directives but require recognition and recording by appropriate work programmes. These may include issues around medicines availability, provision of patient care raised by members of the public or intelligence received through NICE's engagement activities with key stakeholders such as royal colleges and professional bodies.

With increasing complexity of healthcare innovation, new and unrecognised risks will continue to emerge. The challenge to patient safety presented in this context is whether real world evidence will provide good enough data and whether safety concerns will be reliably identified. NICE is endeavouring to build safety into its evidence generation plans linked to early value assessment (see Vignette 3).

Vignette 3: Managed access and building for safety in early value assessment

Early value assessment (EVA) is a new innovative approach trialled by NICE to assess digital products, devices and diagnostics. By offering a rapid assessment based on clinical effectiveness and value for money, the aim of EVA is for services and patients to be able to benefit sooner. Each new conditional recommendation through EVA will be accompanied by an evidence generation plan. This signals where outcomes through data collection undertaken over a set timeframe should be recorded to fill any gaps in the underlying evidence base, for a complete assessment by NICE. There is no “one size fits all” for the content of these Evidence Generation Plans (EGPs), each being tailored to the products and the nature of the existing evidence base. Each plan is focused on effectiveness. PSOG with its strategic position, is influencing the process to ensure that safety becomes integral to evidence generation with the aim that in future EGPs will include specific safety indicators to monitor.

Perspectives gathered from throughout the health and care system also contextualises safety intelligence and increases understanding of the application of NICE's guidance in practice. As highlighted by the IMMDS review, there is a fundamental need for such dialogue to include the voices and experience of patients. NICE has realised this ambition through supporting shared decision making for treating complications from pelvic mesh surgery (see Vignette 4).

Vignette 4: NICE's response to the IMMDS

The purpose of the IMMDS review was to examine and improve the response of the healthcare system in England to reports of harmful side effects from medicines and medical devices. In response to the review, NICE's SRO for patient safety, supported by the Patient Safety Oversight Group led on the following coordinated actions which were accepted by the U.K. government.

An immediate response to the review by the organisation was provided (a rapid exceptional review of all NICE guidance related to use of mesh for stress-urinary incontinence was undertaken).

SRO contribution to the IMMDS review itself, alongside executive team (ET) members.

ET and Board kept informed by SRO with actions proactively identified for NICE.

Patient Decision Aids were developed in line with international standards and drew on NICE guidance for their evidence base. Importantly they were co-produced with women affected by mesh complications and reviewed by patient and professional groups.

Monitoring of response to these actions by the oversight group was undertaken and progress updates provided to the U.K. Department of Health and Social Care.

Conclusion

Patient safety is integral to NICE's statutory duty to provide evidence-based guidance to support quality healthcare. It is incumbent on all health system organisations to regularly review their own approach to managing patient safety matters and consider how these can be best optimised. Through reflection on changing needs within and surrounding the organisation, along with patient safety and complexity literature, NICE has developed an adaptable, systematic and sustainable model for managing patient safety. In addition to generating learning within NICE, the process also highlighted opportunities for improvement across the patient safety system.

A key consideration is the alignment of information sharing across the healthcare system to ensure intelligence sharing that supports improvement and safety, including the generation of relevant evidence-based guidance and implementation support. Sustained collaboration is critical to align action across the patient safety system. Such communication channels offer for a shared learning and dissemination of best practice.

Optimisation of intelligence sharing and of communication are key steps for population-level patient safety activity. Future development will include developing processes for safety signal management and prioritisation, as well as shared procedures to guide the development, implementation and appraisal of shared responses. Avenues to explore include co-ordinated alerts for safety issues that raise awareness of related evidence-based guidance and what implementation support is available. Opportunities will be sought to link such alerts to changes in dynamic living guideline recommendations or technology evaluation developed by NICE. What is certain is that collaboration must be at the heart of patient safety structures of the future.