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The letter attached is from Professor Catherine Ross, Chief Scientific Officer for Scottish Government, with an update on the work relating to ‘Healthcare Science in Scotland’ and the theme of ‘quality, safety and, assurance’ as set out in Healthcare Science in Scotland: Defining Our Strategic Approach.    The Scottish Government has commissioned the Professional Standards Authority (PSA) to carry out a Right Touch Assurance (RTA) assessment of the Healthcare Science workforce. This work will examine the potential risk of harm to patients, particularly as many roles in Healthcare Science are not currently subject to statutory regulation. The assessment aims to inform future decisions about whether additional regulation may be needed to strengthen quality, safety and assurance across the profession. Stakeholder engagement will form a key part of the process, with opportunities to contribute evidence and views. A final report is expected by Spring 2027, after which the Scottish Government will consider next steps.

Surgical implants, such as joint replacements, are used for many serious conditions. Innovation continues to supply new implants, including outputs of the soft robotics revolution. However, they carry risk of complications with potentially devastating consequences. This opinion paper provides the reflections of two surgical technologists on present challenges to safety, efficacy and broad implementation of medical implants. They highlight lack of familiarity with implant surgery in healthcare services, with concomitant risk. First-in-human application of new implants is not sufficiently standardised and regulated. IDEAL-D is a structured framework for medical devices (Idea, Development, Exploration, Assessment, Long-term study). Once CE-marked and approved for mainstream use, there are problems with the implementation. ‘Early adopter’ surgeons and centres face cultural inertia, lack of funding support and issues around training, especially learning curves. Patient selection may not be well-defined, and complications inaccurately reported, affecting implant dissemination detrimentally. The Cumberlege report showed how harmful this can be. There is need to standardise early clinical studies. Implementation of implantable devices requires changes to whole-team training, funding and post-implementation reporting. The IDEAL-D framework represents an important step, but other system-wide changes are required if implants are to achieve their intended clinical impact.

The Professional Standards Authority for Health and Social Care (PSA) has launched its Strategic Plan for 2026-29, setting out how it will encourage a more preventative approach to regulation through delivery of its statutory duties to help meet the challenges of today’s rapidly changing health and social care landscape. At its heart, the plan reaffirms the PSA’s unwavering commitment to protecting the public. It recognises that regulation can best support safe, effective care when it is targeted, proportionate and preventative, and when it works as part of a wider safety and quality system. PSA's strategic plan identifies five strategic themes around their work: oversight prevention reform governance collaboration. The plan contains three strategic aims: delivering highly effective oversight of regulation and registration driving continuous improvement across regulators and Accredited Registers working with others to make the overall system more cohesive, supportive and preventative. It also sets out how the PSA will support governments to maximise the benefits of a more modern and flexible legislative framework while remaining agile in prioritising work that delivers the greatest benefit for patients, service users and the public across England, Northern Ireland, Scotland and Wales.

A study supported by the NIHR North West London PSRC examined the implementation of the Scan4Safety programme at an NHS demonstrator site to understand the hospital experience of adopting barcoding technologies and standards to improve patient safety and quality of care. Researchers found that using standardised data to identify patients, products, places and procedures, Scan4Safety helps build a robust information infrastructure across both internal and external hospital supply chains, with the potential to deliver significant value to patients, clinicians and the NHS. Related reading on the hub: Using barcode scanning technology to improve blood group testing in unborn babies Patient barcode scanning in NHS hospitals: safety, snags and workarounds. A nurse’s perspective

This guidance sets out the relevant principles of good practice if you are involved in any criminal or regulatory proceedings, and want to know whether you should report this to the General Medical Council. 

Patient safety has become a central component of quality of care. One of the best known and most widely used security tools in all work settings is the checklists. The checklist is a tool that helps to not forget any step during the performance of a procedure, to do tasks with an established order, to control the fulfilment of a series of requirements or to collect data in a systematic way for its subsequent analysis. It is an aid to improve the efficiency of teamwork, promote communication, decrease variability, standardise care and improve patient safety. This article discusses the barriers in establishing checklists and the practical applications in paediatrics.

By setting out 6 core standards, this guidance describes what NHS providers should have in place for the safe, effective and reliable implementation of Martha’s Rule. Standard 1: Reliable implementation and equitable access to all components of Martha’s Rule Intent To ensure that all 3 components of Martha’s Rule – patient wellness question, access to escalation and rapid clinical review – are implemented in line with guidance. All 3 components are operational and consistently accessible to patients, families, carers and staff in both adult and children’s inpatient settings in England. The patient wellness question is asked in line with adult, children and young people implementation guidance to ensure it is always asked in the same way (including response options) and the patient or family member’s direct response is recorded and actioned appropriately. Rapid reviews are carried out in line with guidance: reviewers are independent, appropriately skilled and can undertake or facilitate the review. Patients, families, carers and staff can reliably activate escalation and access rapid review. Self-assessment question Would patients, families, carers and staff be confident that all 3 components of Martha’s Rule are reliably available and implemented as intended? Standard 2: Rapid review conducted by independent, appropriately skilled clinicians Intent To ensure that when Martha’s Rule is activated, a rapid review is conducted or facilitated by an independent clinician with the appropriate skills. Rapid reviews are triggered promptly and involve a clinician not directly responsible for the patient’s ongoing care. The reviewing clinician has the appropriate skills to assess deterioration and either undertakes the review or facilitates timely access to the right clinician. The review focuses on the concerns raised and considers the patient’s condition in the round. All concerns raised by patients, families, carers and staff are listened to and acted on appropriately. Outcomes and any actions are communicated clearly to those who raised the concern, including patients and families. Self-assessment question If Martha’s Rule were activated today, would there be confidence that an independent clinician could review the patient and provide clear feedback to those involved? Standard 3: Meaningful involvement of patients, families, carers and staff in the patient wellness question and rapid review Intent To ensure that patients, families, carers and staff are meaningfully involved in the patient wellness question and the rapid review process, so concerns are accurately captured and acted on. Patients and families are made aware of the patient wellness question and understand its purpose and how their responses are used, whether within or outside an early warning system. Patients are always involved in the patient wellness question, other than in exceptional circumstances, for example when sedated. Older children who can engage are supported to answer the patient wellness question for themselves. Families or carers support patients with a learning disability or dementia or who are a very young child to answer the patient wellness question or provide relevant information. A staff member can advocate for such a patient who has no support. Where patients cannot engage directly, supportive tools such as soft signs of deterioration, observations or communication aids are used. During rapid review, patients, families, carers or staff who raised the concern are actively listened to, and their perspectives and responses are recorded and used to inform decisions about the patient’s care. Feedback from both the patient wellness question and rapid review is provided in a way that patients, families, carers and staff can understand and use. Staff understand their role in monitoring and escalating deterioration and how the patient wellness question will support their understanding of a patient’s condition over time. Self-assessment question Would patients, families, carers and staff report that their perspectives are actively sought, captured and used in both the patient wellness question and rapid review? Standard 4: Equitable access, awareness and understanding of Martha’s Rule Intent To ensure that patients, families, carers and staff are aware of Martha’s Rule and can access it fairly and consistently. All relevant groups are aware of Martha’s Rule and understand its purpose and how to access it. Martha’s Rule is promoted to all patients, families and carers, to ensure access is equitable across different needs, circumstances and clinical settings. Communication aids are readily available to support those whose first language is not English, who have low health literacy or who have a disability that limits access. Staff support patients and families to access Martha’s Rule. No patient, family member, carer or staff member is disadvantaged by language, disability, role, background, confidence or access to digital devices. Self-assessment question Would all relevant groups have equal opportunity to know about and access Martha’s Rule? Standard 5: Staff education, knowledge and understanding of Martha’s Rule Intent To ensure that all staff understand Martha’s Rule and their role in supporting it, have the confidence to recognise deterioration, involve patients, families and carers, and are able to activate and respond to the review process as appropriate. All staff understand the purpose and intent of all 3 components, including locum, agency and transient staff. Staff have the knowledge and the confidence to recognise changes in wellness and support patient, family and carer involvement. Staff know how to facilitate or activate escalation and rapid review. Staff understand how to involve patients who cannot self-report directly and older children appropriately. Staff feel empowered, supported and able to act when they have a concern or when concerns are raised with them. Self-assessment question Would staff feel confident that they understand Martha’s Rule, their role in the patient wellness question and escalation, and how to involve patients, families and carers appropriately? Standard 6: Embedding Martha’s Rule in governance and quality management systems Intent To ensure that Martha’s Rule is integrated into the organisation’s broader approach to patient safety, deteriorating patient management and quality improvement. Martha’s Rule is reflected in governance structures, quality management systems and strategies for patient deterioration. Martha’s Rule continues to be aligned with other patient safety initiatives around deterioration such as NEWS, NPEWS, NEWTT2 and MEWS. Responsibilities for oversight and review are clear. Martha’s Rule is embedded as a routine part of patient care, not a separate process. Data is submitted nationally and used locally to generate insight and continually improve patient outcomes, experiences and care. Feedback and learning from activations of Martha’s Rule is used to inform governance, quality management and staff training. Self-assessment question Would organisational leadership and governance structures be able to describe how Martha’s Rule contributes to patient safety and insight generation, and how improvements are identified and acted on?

The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals for the approach to recognising CE marked medical devices in Great Britain. The MHRA welcomes the views from anyone who will be impacted by the proposals, including medical device manufacturers and distributors, trade associations, regulatory experts, approved bodies, healthcare professionals including clinicians and those involved in procurement of medical devices, devolved administrations and patient representative organisations. MHRA are inviting views on the following proposals: Extending the current transitional arrangements for devices that comply with the Medical Device Directive (MDD) to align with the EU timelines for devices to transition from MDD to EU Medical Devices Regulation. Indefinitely recognising devices that comply with the EU Medical Device Regulation (EU MDR) and EU in vitro Diagnostic Medical Devices Regulation (EU IVDR). Introduction of an international reliance route for devices classified higher in Great Britain than in the EU. This consultation closes at 11:59pm on 10 April 2026.

The paper from Carl Macrae explores why safety recommendations in healthcare often fail to produce meaningful or sustained safety improvements. It identifies common problems in how recommendations are created, used, and managed, and proposes principles to improve their effectiveness. Eight problems with safety recommendations The Abundance Problem If safety recommendations are produced in large quantities and from many different sources, they can overwhelm recipients’ capacity to respond constructively and effectively. The Rigour Problem If safety recommendations are based on weak evidence and superficial, unsystematic or flawed analysis, they can misdirect improvement effort and attention to inconsequential issues. The Specificity Problem If safety recommendations make proposals that are under-specified and do not precisely articulate risks to be addressed, or are over-specified and target localised minutiae, they can cause scattered or myopic improvement efforts. The Integration Problem If safety recommendations are developed in isolation and without regard to connections with other recommendations, safety issues or ongoing work, they can deter or distract from systemic improvement activity. The Improvement Problem If safety recommendations present definitive solutions or corrective actions, they can preclude recipients from engaging in the collaborative, exploratory and locally adaptive work of learning. The Management Problem If safety recommendations are used as a tool for directing and managing action, they can degrade or marginalise local management capabilities and impede development of robust safety infrastructure. The Compliance Problem If safety recommendations issue mandatory or directive instructions, they can generate superficial compliance-oriented behaviour and box-ticking responses without addressing underlying risks. The Accountability Problem If safety recommendations are not supported by robust processes for allocating and monitoring accountabilities for improvement, they can dilute responsibility for effecting material change. Eight guiding principles Strategic Prioritisation: Recommendations are strategically selected and prioritised to target the most compelling and important risks. Careful consideration is given to any ongoing safety improvement activities, existing guidance or prior recommendations. Recommendations are prepared in a form that is actionable and accounts for recipients’ capacity and capabilities. Analytical Rigour: Recommendations are based on robust evidence and grounded in systematic investigation and analysis. Recommendations target meaningful risks and propose credible routes to safety improvement. The evidentiary basis and logic underlying specific recommendations can be clearly explained. Calibrated Specificity: Recommendations clearly articulate and describe the specific safety risks that are being targeted and which the recommendation seeks to address. The level of detail provided by recommendations is appropriate to the form and scale of action expected to be taken. Systemic Integration: Recommendations account for existing safety improvement activities and any related or planned recommendations. System-level safety priorities are considered with reference to activities of other bodies and organisations. Recommendations are aligned to, or integrated with, those from other organisations to support systemic improvement. Enabling Improvement: Recommendations encourage rigorous reflection and analysis and enable adaptive learning. Recipients are encouraged to rigorously explore, understand and address the risks targeted by recommendations. Safety innovation and collaborative learning are supported. Capability Enhancement: Recommendations build and enhance local safety management and governance processes. Recommendations are designed to support and strengthen the safety governance capabilities and capacity of recipients, developing safety competencies. Meaningful Engagement: Recommendations aim to generate genuine engagement with the challenge of addressing the safety risks being targeted. Thoughtful, reflective, rigorous and locally adaptive responses are supported and encouraged. Opportunities for narrow or superficial compliance are minimised. Active Accountability: Recommendations assign clear responsibilities for monitoring implementation and achieving safety improvement. Recommendations are monitored and managed through robust and transparent processes for tracking progress and meaningful change and safety improvement.

Fitness to Practise is the process by which the Nursing and Midwifery Council (NMC) investigate concerns about the professionals on their Register and take action if it is required to protect the public. Fitness to Practise affects relatively few of our professionals but it can have significant consequences and is therefore subject to particular scrutiny. This publication provides new insights about: Why some cases about similar concerns receive more serious sanctions than others. What types of behaviours constitute dishonesty. Why some concerns raised by employers concluded at the initial stages, indicating that some concerns can be safely and fairly resolved locally. What was found Continuing rise in new concerns NMC have seen a 13% increase in the new concerns they received in the last year. The number of professionals on their Register increased by 3%. Members of the public continue to be the biggest source of concerns, but referrals from employers are increasing and returning to pre-pandemic levels. The number of Fitness to Practise concerns received each year involves less than 1% of the professionals on their Register. Concerns raised by employers Between 01 April 2024 and 31 March 2025, 15% of concerns which were closed after an initial assessment and did not progress beyond screening for regulatory investigation were raised by employers. The NMC want to work more closely with employers to support the right decisions about the concerns they can manage locally, and when a fair and appropriate referral is required. Making unnecessary Fitness to Practise referrals causes additional stress and worry for those involved. It also causes delays in the progression of other Fitness to Practise cases. The analysis of a sample of employers’ concerns found that just over half of employers in the sample had not used the employer advice line before making the referral, and that employers had been unable to complete local investigations for a quarter of the concerns because professionals had not engaged with the process. Outcomes at hearing stage Factors which result in the most serious sanctions include conduct which puts people risk of harm, a lack of insight into failings, a pattern of misconduct over time, and abuse of a position of trust. Dishonesty is one of the concerns most likely to result in a more serious sanction. The analysis reveals the types of behaviours that constitute dishonesty and some of the reasons expressed by professionals for this behaviour. A culture of learning It is important that professionals experience working environments and workplace cultures that enable them to speak up and report mistakes so that learning can be shared. This also prevents repetition of that mistake and enables the nurse, midwife or nursing associate to rectify errors immediately without fear of blame, bullying or harassment.

The Professional Standards Authority for Health and Social Care (PSA) twice-yearly bulletin provides a valuable overview of the volume of learning points the PSA send and the themes identified. The PSA checks all final fitness practise decisions across the 10 health and social care regulators they oversee. This means they can highlight issues and identify themes. PSA regularly provide these to the regulators by way of learning points.  This can assist regulators in improving their decision-making processes. The learning points PSA identify will also be considered by their performance review team and explored in more detail as part of PSA's annual reviews on how the regulators are meeting their Standards of Good Regulation. PSA Learning Points Bulletin Issue 4 (March 2026) PSA Learning Points Bulletin Issue 3 (September 2025) PSA Learning Points Bulletin Issue 2 (February 2025) PSA Learning Points Bulletin Issue 1 (July 2024)

In the first report of its type to be published, this report explains more about the Professional Standards Authority's role under Section 29 of the NHS Reform and Health Care Professions Act, including details about why and how they decide to appeal a regulator’s panel decision.  Using key data, comparative statistics, case studies and thematic insights, this report can be used by regulators for training their fitness to practise teams and panellists.

The General Medical Council (GMC) may decide to investigate a concern about a doctor, physician associate (PA) or anaesthesia associate (AA) registered with them. Their website contains information about the support available as we know this can be a difficult and stressful time. It also explains their investigation processes and the actions they may take. Fitness to practise explained How we investigate concerns about doctors Doctors under investigation - Find out what support is available for doctors. And find out how the GMC investigation process works. Physician associates or anaesthesia associates under investigation - Find out what support is available for PAs or AAs. And find out how the GMC investigation process works. Hearings and decisions - Find the latest results of hearings and decisions by GMC and the Investigation Committee. Help for witnesses - Guide for witnesses helping the GMC with an investigation. It sets out how you can help, what to expect and the support available.

In her first newsletter of 2026, Judy Walker discusses how After Action Review Conductors need to strike a balance between standardisation and authenticity through practicing self-awareness, setting adaptable ground rules and closing effectively

The US Agency for Healthcare Research and Quality (AHRQ) has established the AHRQ Surveys on Patient Safety Culture® (SOPS®) Ambulatory Surgery Center Database as a central repository for survey data from ambulatory surgery centres (ASCs) that have administered the AHRQ patient safety culture survey instrument and choose to submit their survey data to the AHRQ SOPS Ambulatory Surgery Centre Database. The database serves as an important resource for patient safety culture improvement. Participation is free and open to all SOPS ASC Survey users, provided the questionnaires are administered in a manner consistent with SOPS guidance and survey data are submitted according to SOPS specifications. The SOPS ASC Database contains data voluntarily submitted by participating ASCs and is not representative of all U.S. ASCs.

Commissioned by NHS England Specialised Commissioning team in July 2024, this operational review of NHS adult gender dysphoria clinics (GDCs) in England was led by Dr David Levy, with the support of a panel of clinicians and other key stakeholders. The aim was to determine whether the operation and delivery of the GDCs meet the requirements of the non-surgical interventions service specification and consider the safety and effectiveness of the GDC service. The report sets out its key findings as follows: Access A majority of these clinics have exceptionally long waiting times for NHS services, with patients often waiting for many years to be assessed. This can be distressing for patients, place undue pressure on staff and contribute to patient safety risks. As the GDCs maintain separate waiting lists, the true size of the waiting list is unclear, as some patients may be referred to 1 or more GDC through self-referral or GP referral. The current referral process means the majority of GDCs need to manage relationships with GPs and other services outside their region or ICB area. This places additional demands on resources. Quality (including safety) The absence of any patient outcomes data, alongside limited and inconsistent quality data reporting, and minimal clinical audit makes it impossible to properly understand patient outcomes and the safety of these services. These gaps place these clinics outside standard NHS quality assurance expectations. In addition, existing patient demographic data and clinic feedback indicate that there has been a shift in patient demographics in recent years to a younger cohort with reported additional conditions. Yet, this has not always been met with corresponding changes in how some clinics identify and address patients’ potential additional biopsychosocial needs. Productivity There is currently a wide variation in service provision across the country. This includes differences in the number of appointments per GDC clinician and consultation length. These variations need to be considered both in terms of improving access and ensuring high-quality services and patient safety. Additional financial resources have been made available to each GDC to expand its staffing in recent years. However, workforce data has not always reflected an expansion in staff numbers in some GDCs. Culture, leadership and governance Some clinics undertake little or no quality improvement work or knowledge-sharing between services. The senior clinical leadership approach at some clinics also limits staff’s clinical curiosity and the opportunities to identify ways to improve patient outcomes. The review also found that oversight by some trust boards and by NHS England regional specialised commissioning teams has not consistently identified these concerns, sought any mitigating actions or supported improvements. This contributes to concerns that these services carry a high level of risk. Commissioners and host organisation oversight, governance and supportive leadership need to be strengthened to manage this risk. This will be critical to delivering improvements. Next steps Based on these findings, the review panel has set out twenty recommendations to improve patient care which are included in this report. The report calls for a wider healthcare response from national and local commissioning teams, adult gender dysphoria clinics, NHS trusts, ICBs, primary care, and other healthcare constituents. This joint approach will be driven by the proposed National Quality Improvement Programme for Adult Gender Services and a new National GDC Oversight Board.