Mark Hughes

Following the conviction of Valdo Calocane in January 2024 for the killings of Ian Coates, Grace O’Malley-Kumar and Barnaby Webber, the Secretary of State for Health and Social Care commissioned the Care Quality Commission (CQC) to carry out a rapid review of Nottinghamshire Healthcare NHS Foundation Trust (NHFT) under section 48 of the Health and Social Care Act 2008. The first part of this review, published in March 2024, set out the CQC’s findings of their assessment of patient safety and quality of care provide by NHFT, and progress made at Rampton Hospital since their last inspection in July 2023. This second report provides a rapid review of available evidence related to the care of Valdo Calocane. Throughout the 2 years he was under the care of Nottinghamshire Healthcare NHS Foundation Trust (NHFT), the CQC states that it is clear from Valdo Calocane (VC’s) records that he was acutely unwell. VC showed symptoms of psychosis, including presenting as guarded, and having little understanding or acceptance of his condition throughout his care under NHFT. Problems with him not taking his medicine were also recorded from early on. Their review found: If the decision had been made to treat VC under section 3 of the Mental Health Act (MHA) 1983, during his fourth admission to hospital, further options would have been available for his care and treatment in the community There was a series of errors, omissions and misjudgements, all of which were compounded by the symptoms of VC’s illness. A core part of the CQC's review was to consider whether the evidence we gathered from VC’s care records indicated wider patient safety concerns or systemic issues in Nottingham. The CQC noted that while they did not find any widespread patterns with 10 other cases that we reviewed as a benchmark, many of the issues we have identified are consistent with the problems we found in our wider review of the quality of care and safety of services at NHFT. Recommendations The CQC recommended that NHFT must: Review treatment plans on a regular basis to ensure that treatment prescribed is in line with national guidelines, including from NICE (National Institute for Health and Care Excellence), specifically when it relates to treatment of schizophrenia and medicines optimisation. Ensure clinical supervision of decisions to detain people under section 2 or section 3 the Mental Health Act (MHA) 1983 and regularly carry out audits of records for people detained under these sections, which are reported to the NHFT board. Ensure that regular auditing of medicines monitoring takes place within community mental health teams to identify any themes, trends and required learning. Ensure that, in line with national guidance and best practice, staff are aware of the importance of involving and engaging patients’ families and carers and that they do so in all aspects of care and treatment, including at the point of discharge, with patient consent. The trust should ensure that where patients do not give consent, this is reviewed on a regular basis in line with best practice and on all the available information available to the multidisciplinary team. Have a robust policy and processes for discharge that consider the circumstances surrounding discharge and whether discharge is appropriate. For community mental health services for working age adults, the CQC recommended that NHFT must: Ensure regular medicines monitoring takes place within the community and address any issues quickly where problems are identified. Ensure all practicable efforts are made to engage patients who have disengaged from the early intervention in psychosis service. This includes referring people who find it difficult to engage with services to a team that provides assertive and intensive support. Ensure there is a standard operating procedure in place for early intervention in psychosis and community teams to follow when a patient does not attend for appointments and follow-up actions are defined for care co-ordinators. The CQC also recommended that NHS England: Appoints a named individual to take ownership for the delivery of these recommendations. Ensures that providers’ boards fully understand their role in the oversight of the needs of patients who have a serious mental illness and who find it difficult to engage with services. This includes developing local services in partnership with others to provide intensive support in order to prevent this cohort of patients from falling through the gaps. Ensures every provider and commissioner in England undertakes a review of the model of care in place for patients with complex psychosis who typical services struggle to engage and who present with high risk. Within the next 12 months, provides evidence-based guidance setting out the national standards for high-quality, safe care for people with complex psychosis and paranoid schizophrenia. Within 3 months of the publication of the national standards for high-quality, safe care for people with complex psychosis and paranoid schizophrenia, ensures every provider and commissioner develops and delivers an action plan to achieve these. Through the providers’ boards, ensures delivery of the actions within 12 months of the standards being published. (Together with the Royal College of Psychiatrists: reviews and strengthens the guidance to clinicians relating to medicines management in a community setting and reviews how legislation is used in the community to deliver medication for those patients who have a serious mental illness and where it is known they are non-compliant with medication regimes.

On the 3 July 2023, Susan Pollitt was admitted to the Royal Oldham Hospital following a collapse at her home. She was treated for a number of medical issues including acute kidney injury. During her admission, she developed ascites—a condition in which fluid collects in spaces within the abdomen. The Consultants involved in her care decided an ascitic drain was not required at that time. Subsequently on the 11 July, a junior doctor reviewed Mrs Pollitt and decided that an ascitic drain should be placed. The Physician Associate who undertook the procedure was not aware of the local guidance on the insertion of ascitic drains or that the drain should remain in place for no longer than six hours. Mrs Pollitt’s drain remained in place for 21 hours before being removed. She subsequently developed bacterial peritonitis and died on 16 July. Further to the details in the summary above, the Coroner noted that in this case: The junior doctor who reviewed Mrs Pollitt decided that an ascitic drain should be placed. However, the Court found that this procedure was not clinically indicated at that time. The Physician Associate who undertook the procedure also directed that the drain be clamped due to a concern that the loss of fluid could cause a drop in blood pressure. This was unwarranted given the moderate level of fluid which had been drained and the Court heard that the Physician Associate did not appreciate that clamping a drain increased the risk of infection. The situation was compounded by Mrs Pollitt’s placement on a respiratory ward rather than a gastroenterology ward since there was a lack of understanding and awareness across all the staff on the respiratory ward including the medical team as to the management of ascitic drains. The Coroner set out their matters of concern as follows: There is no regulatory body with oversight of Physician Associates. It is understood that this is currently the subject of a consultation by the General Medical Council. The Physicians Associate Managed Voluntary Register held by the Faculty of Physician Associates (FPA) is voluntary. Whilst employers are encouraged to check the register there is no duty to do so, nor is it clear how the FPA would be made aware of any concerns relating to an individual Physician Associate. There is no national framework as to how Physician Associates should be trained, supervised and deemed competent. This is placing both patients, Physician Associates and their employers at risk. The court heard that since the death of Mrs Pollitt the Northern Care Alliance have put in place a local trust framework. Unlike all other clinical roles there is no national guidance save for very recent guidance issued by the British Medical Association (March 2024). There remains limited understanding and awareness of the role of a Physician Associate both amongst medical colleagues, patients and their families. The lack of a distinct uniform and the title “Physician” gives rise to confusion as to whether the practitioner is a doctor. In June 2022 the Physicians Associate had been signed off as competent for the insertion of ascetic drains. This sign off was completed by a liver nurse specialist using a competency form which was provided by the FPA. Whilst the competency form assessed the technical aspect of placing the drain, it did not include competency around the wider aspects of care such as taking consent, risk factors and after care.

This report examines waiting times, access to assessments, treatment, and post-diagnostic support for people with dementia in memory assessment services. This is drawn from data collection carried out in Memory Assessment services at the end of 2023, relating to patients who had appointments for assessment from the beginning of the year, plus information about how the service is provided. The results indicate that there is still a great deal of variation between services in key results such as average waiting time for patients, the proportion of patients diagnosed with dementia, and the provision of post diagnostic support and therapy. Key findings Report recommendations Memory Assessment Services should ensure provision and consistent recording of high-quality memory assessment, including brief assessment of: eyesight and hearing, alcohol consumption and falls. They should offer post-diagnostic follow up and support through provision or facilitated access to a dementia advisor, Cognitive Stimulation Therapy, carer psychoeducation courses, and medication review as required. Trusts should ensure monitoring at an appropriate senior level of the recommendations set out in the Dementia Care Pathway Implementation Guidance and work together within regions, involving people with lived experience and their carers, to identify barriers to access, including demographic factors and deprivation. Integrated Care Boards should review results of their services with reference to responsibilities to meet the recommendations set out in the Dementia Care Pathway Implementation Guidance, including: Commissioning to meet current and anticipated need. Recommended waiting times in line with the Guidance. Criteria to ensure equitable access to services. Diagnostic criteria and components of routine in-clinic assessment, as set out in the Guidance. Equitable access to post diagnostic support, including standard provision of Cognitive Stimulation Therapy to people diagnosed as living with mild to moderate dementia. NHS England/ Dementia Evidence Toolkit. NHS England, at national and regional levels, should support Integrated Care Boards and Trusts to work jointly to address variations highlighted by the audit data in access to and provision within memory assessment services, with the expectation that in all parts of the country people using services receive equitable provision, including: appropriate referral and assessment, including appropriate use of neuroimaging, timely diagnosis within recommended timeframes, access to evidence-based treatment (e.g. Cognitive Stimulation Therapy), post-diagnostic support and follow up, as recommended in the NICE guideline. This work should be informed by the Dementia Care Pathway Implementation Guidance and the Memory Services National Accreditation Programme Standards for Accreditation.

The Centers for Medicare and Medicaid Services (CMS) this month have confirmed they will add seven new measures to their hospital inpatient quality reporting programme starting from 2025. In this short blog, Patient Safety Learning comments on the inclusion of a new Patient Safety Structural Measure (PSSM) as part of this. The CMS is a federal agency within the United States Department of Health and Human Services. It pays acute care hospitals and long-term care hospitals under two systems, the Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). The law requires the CMS to update payment rates annually and as part of this it also sets quality measures and efficiency measures for hospitals in the United States of America. This month the CMS has confirmed it will adopt seven new quality measures for the fiscal year 2025.[1] One of these new measures is the Patient Safety Structural Measure (PSSM), which will begin at the start of 2025. Patient Safety Structural Measure This is an attestation-based measure that assesses whether hospitals demonstrate having a structure and culture that prioritises patient safety. It is informed by Safer Together: The National Action Plan to Advance Patient Safety as well as scientific evidence from existing patient safety literature, and detailed input from patient safety experts, advocates, and patients.[2] The Patient Safety Structural Measure includes five domains, each containing multiple statements that aim to capture the most salient structural and cultural elements of patient safety: Leadership commitment to eliminating preventable harm Strategic planning and organizational policy Culture of safety and learning health system Accountability and transparency Patient and family engagement Hospitals will attest to whether they engage in specific evidence-based best practices within each of these domains to achieve a score from zero to five out of five points.[3] You can find a detailed breakdown of the five domains here. Patient Safety Learning perspective At Patient Safety Learning we welcome the CMS’s decision to adopt this new Patient Safety Structural Measure. We believe that this attestation-based model aligns with our organisational view that it is essential that we apply standards of good practice for patient safety in the way that we do for other safety issues. In December last year we set out our strong support for this proposal in our response to the public consultation on this.[4] The approach in the Patient Safety Structural Measure has a similar basis to our Patient Safety Standards, enabling organisations to self-assess their current patient safety performance, identifying both strengths and weaknesses.[5] The outputs can form the basis for a comprehensive patient safety strategy, as well as the foundations for evidence-based improvement programmes. Likewise, organisations are assessed in our Patient Safety Standards against each of the seven foundations, which significantly align and overlap with the five domains set out in the Patient Safety Structural Measure. In our consultation feedback, we set out in more detail our views on each of the five domains included in the Measure. References Centers for Medicare and Medicaid Services, FY2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule – CMS-1808-F, 1 August 2024. Institute for Healthcare Improvement, Safer together: A national action plan to advance patient safety, 14 September 2020. Centers for Medicare and Medicaid Services, Rules - Medicare, Medicaid, and Children's Health Insurance Programs: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates, etc, 1 August 2024. Patient Safety Learning, Feedback on the CMS list of Measures Under Consideration: Patient Safety Structure Measure (#MUC2023-188), 21 December 2023. Patient Safety Learning, Why Standards?, 8 August 2024.

Mahamoud Hussain Ali fell in the street and was taken by ambulance to Homerton University Hospital. He discharged himself but was later readmitted after another fall on the same day. Subsequently, he was detained under section 2 of the Mental Health Act 1983 and transferred to Lea Ward, Mile End Mental Health Hospital. He was placed in isolation and assigned to be under observation every 15 minutes. On the 21 August 2020 at around 18:00 he was found unresponsive on the floor of his room. Following this he was taken to Royal London Hospital and died on 26 August 2020 at the Royal London Hospital. Looking into this case, the Coroner has stated that staff at East London Foundation Trust had falsified observation records. The report also notes that investigations commissioned by Trust following Mr Ali’s death uncovered 11 further “fatal incidents” where records may have been fabricated. The Coroner set out their matters of concern as follows: Although Mr Ali was meant to be under 15-minute observations, a registered mental health nurse on Lea Ward gave evidence that on 21 August 2020 at around 1740 she saw that the observations board had not been completed for 1700, 1715 and 1730. She then completed it as if she had conducted those observations, recording that Mr Ali was asleep. Evidence has been provided by the Trust that since Mr Ali’s death on 26 August 2020, there have been 11 fatal incidents where observation records may have been filled in when observations have not been conducted. One of these, in May 2023, was in Lea Ward, the same ward where Mr Ali was detained. Whilst the date and name of the hospital and/or ward connected with each of these deaths have been provided to me, evidence has not been given by the Trust as to the specific circumstances of each death, nor the subsequent individual investigation and findings and any consequential action taken. Nor has this issue been addressed in the Trust’s Action Plan as part of its internal investigation. The Trust has stated that the majority of the 11 deaths pre-date the work that it has been doing to improve practice around observations that has been progressing since Autumn 2022. The Coroner has been provided with evidence that in October 2023, the Trust wrote to staff about ‘Falsification of Observation Records’, stating: “We commenced a Trust wide QI project in September 2022 in response to prevention of future death (PFDs) notices from the coroners. The PFDs highlighted concerns about the quality and consistency of engagement and observation practice. This work has engaged all Directorates in enhancing our appreciation and understanding of the importance and impact of therapeutic engagement and observation. Directorates have been doing work using QI methodology to look at how we can improve standards to ensure consistency and quality in undertaking these…” Further, that “Despite this work, we have seen an increase in occasions where observation records have not been completed but records falsified to reflect that they had been done.” Given the above, the Coroner is concerned that action undertaken thus far by the Trust has not been sufficient to ensure that observations are being conducted and/or recorded as required which in my opinion gives rise to a concern that future deaths will occur.

Researchers have traditionally focused diagnostic safety efforts on identifying errors and their causes with the goal of reducing diagnostic error rates. More recently, complementary approaches to diagnostic errors have focused on improving diagnostic performance drawn from the safety sciences. These approaches have been called Safety-II and Safety-III, which apply resilience engineering and system safety principles, respectively. This review explores the safety science paradigms and their implications for analysing diagnostic errors, highlighting their distinct yet complementary perspectives.

This investigation by the Health Services Safety Investigations Body (HSSIB) explores the patient safety risks associated with the use of online consultation tools in general practice. The investigation focussed on the use of these tools for ‘asynchronous’ consultation where the patient and healthcare professional are not in the same room, and the patient does not receive a response in real time. Findings of this report included: Where actual and potential harm to patients has been contributed to by the use of online consultation tools, these incidents are not always reported. There is underreporting of patient safety incidents in general practice. Harm can result to patients where they are unable to use an online consultation tool due to their personal circumstances. This may also result in inequitable access to care if patients are not aware of or unable to use other access routes. General practitioners have not always had specific training to undertake online consultations, resulting in some having concerns about the making of decisions based on the limited clinical information provided through an online tool. The design and configuration of an online consultation tool may mean it is not always able to safely deliver the task(s) it is being used for, nor address and meet the needs of its users (patients, carers and staff). The explicit needs of users are not always identified and incorporated into the design and configuration of online consultation tools. The needs of patients and staff may be different in respect to how a tool collects information about a patient’s medical problem. General practices engaged with during the investigation have had limited oversight and support from their former clinical commissioning groups and current integrated care boards when procuring and implementing online consultation tools. This has contributed to variation in how tools have been implemented. Limited patient engagement and education can lead to misinterpretation about how to access care. The investigation found examples in different parts of the country where patients believed they could no longer access general practice care if they could not use the online route. In this report HSSIB recommends that: NHS England undertakes an evaluation of the risks to patient safety of online consultation tools in general practice, taking into account the findings of this investigation, recent research, and the experiences of general practices. This is to identify and implement actions to support the safe delivery of care using online consultation tools in line with best practice. NHS England develops mechanisms for assuring that integrated care boards support general practices when implementing online consultation. This is to ensure online consultation tools are procured and implemented in ways that best support patient safety.

In this report, the National Guardian’s Office analyses questions relating to speaking up that were asked in the 2023 NHS Staff Survey. It highlights that while workers’ confidence in speaking up about anything which concerns them showed signs of improvement, the survey revealed a five-year low in the number of respondents who feel secure raising concerns about unsafe clinical practice. The report sets out that looking at the national picture, there has been minimal change in the perceptions of workers about Freedom to Speak Up. Its key findings include: Clinical practice questions are showing signs of decline or remain unchanged with ‘I would feel secure raising concerns about unsafe clinical practice’ now being at a five-year low. 71.3% of respondents said they felt safe to speak up about unsafe clinical practice and 56.8 per cent thought that their organisation would address such concerns. Questions about any concerns have stabilised and are starting to show improvements. 62.3% of respondents said they felt safe to speak up about anything and 50.1% thought that their organisation would address such concerns. This figure (50.1%) is the highest in the three years this question has been asked. In ambulance services, the Freedom to Speak Up sub-score has markedly improved from 5.83 in 2022 to 5.96 in 2023. Acute specialists are showing early warning signs of a declining speak up culture with the Freedom to Speak Up sub-score at the lowest since 2021 when the measure was introduced. There are signs of reducing confidence in speaking up for workers at Integrated Care Boards with 26 out of the 37 organisations that participated in both 2022 and 2023 surveys Freedom to Speak Up sub-scores deteriorating. Medical and dental worker confidence in raising clinical safety concerns has declined by around six (5.7) percentage points since 2021. The Freedom to Speak Up sub-score for the ‘general management’ occupational group has worsened for the past two years. This is despite workers indicating that they feel more supported by their immediate managers. The Freedom to Speak Up sub-score for workers with a long-lasting condition or illness (6.08) is markedly lower than for those workers who do not have a long-lasting condition or illness (6.60). Related reading National Guardian’s Office: Fear and futility - What does the Staff Survey tell us about speaking up in the NHS (8 June 2023) We are not getting safer: Patient safety and the NHS staff survey results (Patient Safety Learning, 26 March 2024)

The role of the Patient Safety Commissioner for England is to promote patient safety in relation to medicines and medical devices and to promote patients’ voices. This annual report summarises the work of the Patient Safety Commissioner, their strategy and plans for 2024/25.

In May 2024, National Institute for Health and Care Research (NIHR) Evidence held a webinar on care for adults in mental health crisis. The webinar shared research findings on what works in community crisis care, how acute day units compare to crisis resolution teams and whether peer-supported self-management can reduce acute readmissions. This Collection summarises the 3 research projects presented at the webinar. It includes video clips from the speakers and incorporates quotes from the day. The information will be useful for anyone involved in commissioning or delivering mental health crisis services.

The National Guardian’s Office (NGO) leads, trains and supports a network of Freedom to Speak Up (FTSU) Guardians in England. It also conducts speaking up reviews to identify learning and support improvement of the speaking up culture of the healthcare sector. This is their updated strategy to support cultural change in healthcare to improve worker experience and patient safety. The National Guardian’s Office (NGO) has set out its six strategic goals to achieve the National Guardian’s vision—to improve existing services as well as making step changes to drive further change across the system. These are: Continuing to improve resources and offer to Freedom to Speak Up (FTSU) guardians. Developing additional support and guidance for organisational leaders. Using the National Guardian’s independent voice to champion Freedom to Speak Up and challenge the healthcare system by raising awareness of issues which affect workers’ confidence to speak up. Using the insight gathered by the National Guardian’s Office to drive recommendations to improve speak up measures and culture, for example through Speak Up Reviews, and challenging organisations to do better. Improving partnership working with key organisations to deliver change. Improving the organisational maturity and internal infrastructure of the National Guardian’s Office to support these ambitions.