SAFETY & LEARNING

“The NHS is in critical condition but its vital signs are strong”

Following a nine week rapid review, this was the conclusion of Lord Darzi’s independent investigation into the current state of the NHS. The chapter ‘Quality of care in the NHS’ offers helpful insight into further work needed on safety and learning. For example: 

Maternity and newborn

There has been a reduction in stillbirths and a small decrease in neonatal mortality and serious brain injury. However, maternal deaths have increased since the pandemic. There is huge inequality based on ethnicity and/ or poverty. Increased complexity due to rises in maternal age and multiple morbidities represent a significant challenge. Capacity alone does not appear to constrain improvement as midwife numbers have increased and deliveries per midwife decreased in recent years. “A deeper conversation needs to be had on skills, staffing mix, clinical models, leadership and culture.”

What this means for you

A patient-centric approach is likely to assist with removing inequalities and dealing with increased clinical complexity. Reviewing maternity service skill-mix alongside use of clinical models and care pathways may bring dividends for both staff satisfaction and patient safety. Instilling a culture of openness and transparency where all staff feel able to speak up and are supported in doing so, is central to learning from adverse incidents to prevent future harm.

Mental heath

The ‘Improving Access to Psychological Therapies’ programme has been a success with a recovery rate of c. 50% for those completing a course of talking therapies. This is tempered by increases in admissions since 2019 (82%) and in restrictive interventions for inpatients (particularly children). There has been a steady decline in death by suicide by people with diagnosed mental illness. This reflects sustained efforts to reduce ligature risk and to improve observations. However, there is still further to go to ensure in-patient wards are as safe as possible for those in mental distress.

What this means for you

The role of good record keeping cannot be overstated in the delivery of healthcare, but is particularly crucial in mental health where the continuity of care (evidenced by observations shared with the wider clinical team) is central to prevention of harm to service users and other patients. 

Maternity safety remains a key concern

The Care Quality Commission (CQC) has published its national review of maternity services. A total of 131 hospital maternity locations in England were reviewed between August 2022 and December 2023. The review rated almost 50% as ‘requires improvement’ or ‘inadequate’, with only 4% rated as ‘outstanding’. Many of the issues identified were systemic and included:

• responding to and learning from incidents
  
  • improvements are needed in the way services report, learn and communicate with women following patient safety incidents (PSIs). For example some action plans were weak and/ or ineffective
  • concerns around the potential normalising of harm
• risk assessment and triage
  
  • significant variations across locations, compounded by lack of national targets
  • concerns around patient prioritisation, timeliness of initial assessment, oversight of those waiting, and staff training and competence
• communication with women and families
  
  • not always good enough
  • cultural shift needed – all women should be given the information they need, in a way they can understand it in order to make informed decisions/ consent.

What this means for you

The CQC considered that “a robust focus on safety, embedding a culture that does not accept risk as the norm” should be the starting point for improvement. This will require leading by example and instilling a ‘ward to board’ culture of openness and transparency underpinned by the ‘freedom to speak up’. Effective learning from incidents will also require an effective process to implement, share and review PSI action plans to ensure learning is extracted and improvements made. Healthcare organisations should review their policies and procedures around the duty of candour and PSI investigation. The new flexibility afforded by the new Patient Safety Incident Reporting Framework (PSIRF) should enable investigation resources to be directed to those incidents which have the greatest potential for learning. Triage policies and procedures should be reviewed against the Royal College of Obstetricians and Gynaecologists - Maternity Triage (Good Practice Paper No. 17).

The CQC’s review serves as a timely reminder that understanding the information provided is a key component of informed consent. ‘Understanding’ goes much further than its original context (the law of capacity) as a patient with capacity may require support to understand the material risks of a procedure. The support might be an interpreter or simply the time to ask questions.

DISPUTE RESOLUTION

New Clinical Negligence Claims Agreement 2024

The Clinical Negligence Claims Agreement (CNCA) replaces the Covid-19 Clinical Negligence Protocol (CCNP) established in 2020. The signatories remain the same: NHS Resolution, Action against Medical Accidents and the Society of Clinical Injury Lawyers. The Agreement “reflects the ongoing commitment to fair and efficient resolution of clinical negligence claims, while promoting patient safety and learning.” It builds on the CCNP and aims to further improve case management practices while retaining the emphasis on how parties can avoid the need for litigation by undertaking a stock take prior to commencing litigation. Key features of the CNCA include extended limitation periods for certain cases and early disclosure of relevant documents to help narrow issues and reduce investigation costs.

What’s happened to Lower Damages Fixed Recoverable Costs (LDFRC) in clinical negligence cases?

Prior to the July 2024 general election, the Conservative government signalled its intention to implement the LDFRC regime in October 2024. The central plank of the regime was that only fixed costs (plus a limited number of disbursements) would be recoverable in clinical negligence cases (excluding stillbirth and neonatal claims) with a value up to £25,000. The regime contained various phases which triggered a review of the claim and an opportunity for resolution. For further details see Clinical Law Insight: Summer 2024. However, the requisite legislation was not drafted prior to the dissolution of Parliament. The Ministry of Justice under Labour has given no firm indication so far that the proposals will go forward, although concern has been expressed regarding the cost of clinical negligence claims, most recently in Lord Darzi’s report on the state of the NHS.

Comment

LDFRC was designed to achieve better proportionality of legal costs to the value of the damages claimed. Its stated aim was “speedier justice”. If the proposals are resurrected it will be interesting to see the extent to which this aim is achieved and the stage at which cases settle.

PRIMARY CARE

Patient safety strategy for primary care

NHS England’s (NHSE) patient safety strategy for primary care was launched in September 2024. They identified between 20,000 and 30,000 incidents of avoidable significant harm in general practice each year. These represent 0.7% of the 2.4 million national patient safety incidents (PSIs) per annum. In view of current capacity issue, the strategy seeks to continue to improve patient safety through existing processes and structures as much as possible. The strategy and processes are:

• safety culture – participation in the NHS staff survey
• safety systems – staff to complete patient safety syllabus training
• insight – registration for and use of the ‘Learn from Patient Safety Events’ (LFPSE) incident recording tool and the Patient Safety Incident Response Framework (PSIRF) systems
• involvement – identification of patient safety leads and lay patient safety partners
• improvement – reviewing and testing patient safety improvements in diagnosis, medication, referrals, optometry and dental services.

Integrated Care Boards (ICBs) have been asked to ensure primary care staff have access to Freedom to Speak up (FTSU) guardians who are independent of the provider practice.

NHSE has indicated that it will be developing guidelines on best practice for safety critical processes such as the handling of test results. It also wants primary care IT systems to flag patient safety issues such as missed patient referral follow-ups, safeguarding, diagnosis, and medicine issues.

What this means for you

NHSE will start to implement PSIRF through GP Federations and PCNs with ‘at place’ pilot sites, supported by the fifteen Health Innovation Networks. The networks will be commissioned to work directly with general practice to implement the framework. NHSE has launched a series of online tools - for example, a primary care specific LFPSE, an information helpdesk and a ‘myth buster’ on recording patient safety events.

A retrospective review by Avery et al. in 2020, mentioned by NHSE in its launch information could be a good starting point for primary care organisations to review their patient safety profile. The study found the top three PSI types to be: diagnosis (61%), medication related (26%) and delayed referral (11%).

Health Service Safety Investigations Body (HSSIB) concerns around safety of online consultation tools in general practice

In recent years increasing demand and developments in technology have led to increased use of online consultation tools in general practice. An HSSIB investigation explored the patient safety issues associated with this development. The positive impact of such tools, for example, improved access and management of demand is acknowledged. However, some concerns were raised by both patients and practice staff that when the online tool was used for consultations as opposed to administrative tasks.

HSSIB findings included:

• GPs have not always had specific training in making decisions based on limited clinical information provided through the tool
• the needs of patients and staff may be different in how a tool collects information regarding a medical problem
• variations in how tools have been implemented due to limited oversight and support from ICBs when procuring/ implementing the tools.

HSSIB safety recommendations:

• NHSE to undertake an evaluation of the risks to patient safety from online consultation tools
• NHSE to develop mechanisms for assuring that ICBs support general practices when implementing online consultation to ensure tools best support patient safety.

What this means for you

It is vital that any healthcare professional using an online consultation tool is competent to do so and that will include training on the limitations of the clinical information it can provide and how that impacts decision-making. There is a wider issue regarding any type of ‘remote’ consultation (including telephone and video based-systems). Patient selection/ suitability for those types of consultation is at the heart of patient safety and management of risk. In short, does the patient have the ability to engage and is the process appropriate for the medical condition under consideration?

QUANTUM

Personal Injury Discount Rate (PIDR) review update

The Lord Chancellor commenced the PIDR review on 15 July 2024. In addition to the level of discount rate (currently minus 0.75%) views were canvassed in an earlier call for evidence on whether dual/ multiple rates should be adopted e.g. different rates by duration of award or for different heads of loss. The review must be completed by 11 January 2025. What might we expect?

Comment

PIDR reviews have been completed in Scotland and Northern Ireland where the rate has increased to 0.5%. Therefore, it seems likely that England and Wales will see a positive rate, but the figure would be speculation at this point. A move to a positive discount rate will bring a reduction in the multipliers which are used to calculate awards for future loss and a reduction in overall claim values on a lump sum basis. This may lead to more requests by claimants for periodical payments orders. Watch this space.

REGULATION 

Dash review of the Care Quality Commission (CQC)

The report of Dr Penny Dash’s review of the CQC has been published. It identifies “significant failings…which had led to…a deterioration in the CQC’s ability to identify poor performance and support a drive to improve quality…” Ten conclusions are drawn including:

• Loss of credibility within the health and care sectors due to the loss of sector expertise and wider restructuring, resulting in lost opportunities for improvement.
• Concerns around the single assessment framework (SAF) and its application. For example:
  
  • limited information for providers/ users/ patients as to what ‘good’ care looks like under each of the ratings categories
  • little reference to, or acknowledgement of, the challenges in balancing risk and ensuring high-quality care across an organisation or wider health and care system.
• Lack of clarity regarding how ratings are calculated and concerning use of the outcome of previous inspections (that often took place several years ago) as part of the aggregation methodology used to calculate a current rating.

The following recommendations are made in relation to the concerns mentioned above:

• rebuild expertise and relationships with providers
• review the SAF to make it fit for purpose with clear descriptors and a far greater focus on effectiveness, outcomes and use of resources
• clarify how ratings are calculated and make the results more transparent.

A complementary, but independent report into the SAF and its implementation by Prof. Sir Mike Richards has also been published. It makes similar recommendations to the Dash report, but also recommends that further consideration should be given to the issue of the use of ‘one-word’ ratings to describe an entire organisation with a suggestion that ratings sitting at a lower level down (e.g. location or service level) may make more sense to people using services.

Comment

The CQC has announced that it accepts the “recommendations of both reports, which identify serious organisational failings, and is taking rapid action in response.” This includes modification of the SAF. The five ‘key questions’ (safe, effective, responsive, caring and well-led) will be retained across all sectors, but the 34
‘quality statements’ will be amended for clarity/ removal of duplication. Individual evidence categories will no longer be scored. A second review by Dr Dash covering patient safety will be published early in 2025.

ADVISORY 

New NHS Medical Examiner regime

From 9 September 2024, Medical Examiners (MEs) will review all deaths in any health setting that are not investigated by a coroner. A new medical certificate of cause of death (MCCD) has been introduced. Medical practitioners who attended the deceased in their lifetime are now able to complete an MCCD. Previously, if the medical practitioner had not seen the deceased in the 28 days prior to death nor seen them in person after death, the matter needed to be referred to a coroner.

National Medical Examiner’s guidance has been published by NHS England. The Access to Health Records Act 1990 has been amended to give MEs a statutory right of access to relevant records of deceased patients. Rather like a coroner’s duty to consider whether a Prevention of Future Death’s report should be issued, MEs are required to refer concerns about quality of care to appropriate individuals.

Comment

Healthcare providers should already have systems in place to inform MEs of non-coronial deaths. They should ensure that robust processes are in place to share the deceased’s relevant medical records with the ME, as if these are not made available and the ME cannot establish a cause of death, the ME must notify the coroner. Although quality of care concerns are likely to be less frequent than in the coronial system, healthcare providers should ensure that they are in a position to respond to any issues raised by the ME. In effect, are their patient safety incident policies, procedures and plans flexible enough to capture deaths with a patient safety issue which are not referred to a coroner? Further information on the new ME process can be found in Clinical Law Insight: Summer 2024.

Unannounced inspections of hospital mortuaries

From September 2024 most Human Tissue Authority (HTA) inspections of post mortem licensed premises will take place without notice. The HTA has explained that the change “is being driven by the increased severity of shortfalls…and in some cases a failure to take corrective and preventative action following inspection.”

Comment

The report on phase 2 of the Fuller Inquiry* is due to be published later this year. Its remit is to consider whether hospitals have adequate safeguards for the security and dignity of the deceased. The independent inquiry was launched following the conviction of hospital mortuary maintenance supervisor David Fuller of over 100 offences of sexual abuse of women and girls’ bodies in two hospital mortuaries in Kent and of two unrelated murders.

* The interim report on phase 2 published on 15 October 2024 relates only to the funeral care sector.