SAFETY & LEARNING

Learning from the Infected Blood Inquiry

The Infected Blood Inquiry has published its final report. It spans seven volumes and runs to 2,555 pages. The report considers the treatment of thousands of patients who received blood products or transfusions, who were infected subsequently with or are at increased risk of contracting HIV and/or Hepatitis B, C or D and/or vCJD. It is estimated that more than 3,000 deaths are attributable to infected blood, blood products and tissue. The report identifies some of the causes which led to “death, illness and suffering” and draws out lessons to be learned.

Causes

For example:

• Treating patients, including children (and in some cases conducting research on them) without in many cases providing information on risks and benefits and/or alternative treatments i.e. without informed consent.
• Taking a decision in July 1983 not to suspend the continued importation of commercially based blood products and failing to keep it under review.
• Failures of record keeping to enable each unit of blood to be traced from donation to use in treatment.
• Failing to carry out any lookback at the time universal screening of donations for Hepatitis C was introduced.
• A lack of openness, transparency and candour.

Lessons to be learned

As Inquiry Chair, Sir Brian Langstaff states, “first and paramount consideration should always be (patient) safety.” Lessons include:

• Risk needs to be better understood
• what is to be avoided is confusing certainty with whether there is a real risk calling for a response – which should be prompt.
• Questioning the status quo
• everyone has a responsibility for patient safety
• all must be aware of “sacred cows” in medicine / clinical practice.
• Consent and communication
• communication means listening
• there can be no proper consent without adequate communication
• communication should not be withheld or delayed because the message conveyed may be difficult.
• Candour
• candour is essential in the relationship between clinicians and patients.

Comment

Many of the themes highlighted in the report are as relevant today as they were several decades ago when the tragic events began to take place. Although the sheer size of the report may seem daunting, the sections on identification of the causes and lessons to be learned contain much to assist anyone with responsibility for risk in today’s NHS. Appropriate and effective policies to manage risk, obtain informed consent, good record keeping, review / lookback regarding decision-making and process, communication and openness and transparency (candour) are the building blocks of patient safety and good governance.

Update on Martha’s Rule

NHS England have confirmed that 143 sites have signed up to the initial roll out of Martha’s Rule (initial target 100 sites). Martha’s Rule provides staff, patients, families, carers and advocates 24/7 access to rapid review from a critical care outreach team should they have concerns about a patient’s condition. Evaluation of how the system works at the 143 sites will take place over the course of this year and will inform proposals for the Rule to be rolled out across all acute hospitals (subject to future government funding).

The GMC, NMC and CQC have issued a joint statement supporting the implementation of Martha’s Rule. They “welcome the way that Martha’s Rule emphasises effective teamwork, mutual respect, and open communication. The emphasis on professionals working together encourages active listening, promotes person-centred care and supports a culture of learning and improvement”.

NHS Resolution Maternal (and Perinatal) Incentive Scheme (MIS), Year 6

New guidance has been published by NHS Resolution. This year, they have introduced an audit/compliance tool to complement the MIS document. The tool is not mandatory and is for trust internal use only. It will allow trusts to track progress with the actions and record when supporting evidence has been approved and where it is saved.

NHS Resolution has also created a Future NHS MIS Workspace which will provide access to shared resources and updates.

What this means for you

The ten safety actions that trusts need to meet to obtain the incentive (recovery of their contribution to the MIS fund) have been updated. These safety actions support the national maternity ambition to reduce the number of stillbirths, neonatal and maternal deaths and brain injuries from the 2010 rate by 50% before the end of 2025. Applications must be submitted by 12 noon 3 March 2025.

New guidance on supervision of Medical Associate Professionals

The BMA has published new guidance on the supervision of Medical Associate Professionals (MAPs), which include Physician Associates. MAPs must always work under the supervision of doctors. The guidance clarifies who can be a supervisor and their responsibilities and deals with a number of safety issues. It covers doctors working in both the NHS and private sectors. Key recommendations include:

• The MAP should have an immediately available named supervisor who is a Consultant, autonomously practising Specialty and Associate Specialist (SAS) doctor or a GP.
• Tasks considered suitable for delegation to MAPs are limited to those in the traffic light tables in the BMAs Safe Scope of Practice for MAPs.
• Supervisors should have allocated time to discuss patients with MAPs and, if necessary, to review them personally.
• Supervisors should have appropriate indemnity in place to supervise MAPs.
• Supervisors must have a clear understanding of the scope parameters, competencies and level of supervision required for MAPs generally and for the specific work MAPs undertake under their supervision.

What this means for you

Indemnity cover for NHS work is state-backed via the Clinical Negligence Schemes for Trusts and General Practice (CNST/CNSGP). In relation to private work, supervisors should notify their Medical Defence Organisation or insurer that they are undertaking such supervision. Although MAPs remain accountable for their actions a supervisor will retain responsibility for overall management of the patient. Therefore, it is crucial that supervisors ensure that MAPs are working within their competency at all times and that they have access to appropriate training. Making time to discuss (and if necessary review) patients may be a challenge where staff resource is scarce, but its importance cannot be overstated. 

DISPUTE RESOLUTION

Introduction of Lower Damages Fixed Recoverable Costs (LDFRC) in clinical negligence cases

The Conservative Government responded to the consultation on disbursements in LDFRC cases and signaled its intention to implement the new regime in October 2024. Only fixed costs will be recoverable in clinical negligence cases with a value up to £25,000. The consultation sought to determine whether certain disbursements should be included in the fixed costs or recoverable in addition. It has been agreed that the following will be separately recoverable:

• Expert report fees (includes expert’s associated costs dealing with the report) and ATE insurance premiums covering the report’s cost).
• Court fees for an application for pre-action disclosure.
• Inquest costs and disbursements only to the extent that they would be in clinical negligence claims not subject to LDFRC.
• Court fees for issue of proceedings/application for or extending a stay of proceedings, where limitation is due to expire imminently.
• Only where the Claimant is a protected party or a child – counsel’s fees and court fees for a Part 8 approval hearing.

Comment

LDFRC is designed to achieve better proportionality of legal costs to the value of the damages claimed. Once in force it will be interesting to see the stage at which cases settle and the extent to which the aim of “speedier justice” is achieved. Further information on the structure of the regime can be found in Clinical Law Insight, Autumn 2023.

Update to NHS Resolution’s Early Notification Scheme

NHS Resolution is committed to improving engagement with families who are potentially impacted by the scheme. The Early Notification (EN) Scheme is designed to investigate eligibility for financial compensation in certain circumstances where a baby may have suffered a brain injury at birth. For babies born on or after 1 October 2023 and where the scheme entry criteria are met, NHS Resolution will now seek permission from the family before commencing a legal investigation under the scheme.

As part of the transition to the updated process, an updated trust report form was launched in July 2023 which includes family language preference and translation needs, to support improved communication with families. More recently NHS Resolution has launched an animation designed to explain to families what the EN scheme does. This was produced in collaboration with their Maternity Voices Advisory Group and a group of parents via Peeps-HIE (a charity dedicated to supporting those affected by HIE – hypoxic ischaemic encephalopathy – a mechanism of neonatal brain injury).

Proposed Rule changes will enable courts to order parties to engage in Alternative Dispute Resolution

A Civil Procedure Rules Committee (CPRC) consultation proposes changes to the Civil Procedure Rules (CPR) to codify the decision in Churchill v Merthyr Tydfil BC (2023). In Churchill, the Court of Appeal determined that a court could order parties to engage in Alternative Dispute Resolution (ADR), so long as it did not restrict their ability to proceed to a judicial hearing. The proposals included extending the CPR ‘overriding principle’ to include in the definition of dealing with a case “justly and at proportionate cost” includes, so far as practicable, using and promoting methods of ADR. In addition, failure to comply with an order for ADR or unreasonable failure to participate in ADR proposed by another party should form part of ‘conduct’ when courts decide whether to make an order for costs.

What this means for you

Compulsory mediation is already required in the small claims track. We anticipated a further expansion post Churchill, so the consultation is no surprise - judges are managing cases more actively. Parties should consider dispute resolution at all stages of a claim in whatever form – for example mediation and early neutral evaluation. Mediation is a key strategic pillar, which can be undertaken at any point, to rebuild relationships between the parties and resolve claims cost-effectively. Further information on the Churchill decision can be found in Clinical Law Insight, Spring 2024.

INQUESTS

New system for investigating deaths and new rules on medical certification

From 9 September 2024, all deaths in any health setting that are not investigated by a coroner will be reviewed by NHS medical examiners (MEs). A new medical certificate of cause of death (MCCD) will also be introduced. From 9 September medical practitioners will be able to complete an MCCD if they attended the deceased in their lifetime. In contrast the current rules require referral of the case to a coroner for review if the medical practitioner had not seen the patient within the 28 days prior to death or had not seen in person the patient after death.

Comment

The concept of MEs was first proposed in response to the murders committed by Dr Harold Shipman. Independent scrutiny of all non-coronial deaths should provide safeguards for the public and the appropriate direction of deaths to the coroner. In addition the ME system should provide a better service for the bereaved and give them an opportunity to raise concerns with a doctor not involved in the deceased’s care.

The role of bereaved people in coroners’ inquests and investigations

In 2023 almost 200,000 deaths were reported to the coroner and almost 40,000 inquests were concluded. Academics from the Voicing Loss project interviewed 89 bereaved people and 82 coronial professionals. The results of the study shed light not only on the experiences of the bereaved, but on the scope for policy and practice reforms to support their inclusion in the coronial process. Some bereaved respondents felt the coronial process had helped them and offered some catharsis, but more of them spoke of being negatively impacted, recounting anxiety, uncertainty and the psychological toll. Respondents concerns included issues with:

• Process: Difficulty navigating a complicated legal process of which they had little/ no prior knowledge, while in the early stages of grief.
• Participation: Many respondents encountered barriers to participation and found many aspects of the process alienating and disempowering.
• Outcomes: Some found it helpful that the inquests gave them answers, others learned nothing new. Many were deeply frustrated and disappointed by coroners’ limited capacity to help prevent future deaths.

A number of proposals for change are made focusing on three main areas of concern.

1. Multiple tensions and ambiguities within the coroner’s role and remit, resulting in a mismatch between bereaved people’s expectations of the coronial process and what it tends to deliver.
   
   Proposal: Measures should be put in place to bring greater clarity to the purpose, structure and operation of the coroner service. For example the introduction of decision-making guidelines for coroners and a requirement for them to give reasons at each decision-making stage as part of the written inquest record.
2. The aspiration to place bereaved people at the heart of the coronial process is vague, overly broad and in some respects unrealistic.
   
   Proposal: Ensuring that humanity is central to the process, supporting the bereaved as participants and developing provision for  beyond the coroner service. For example, restorative dialogue between them and clinicians involved in the death.
3. Identification of principles for good practice which support the overarching aim of placing humanity at the heart of the coronial process.
   
   Proposal: The principles address information and communication throughout the process; quality of interactions at hearing; and respecting and reflecting the personhood of the deceased.

Comment

The researchers acknowledge the tension between the increasing demands on the coroner service, the challenge presented by under resourcing and calls for structural reform such as creation of a national coroner service and mechanisms for oversight of Prevention of Future Death reporting. The impact of the new medical examiner system remains to be seen. Clearly the system has significant potential to take pressure off the coroner service by reducing the number deaths referred. It will be interesting to review the statistics after its first year of operation.

ADVISORY

A reminder of the consequences of ‘failing to provide safe care’

Following a Care Quality Commission prosecution for breaches of regulation 12 Health and Social Care Act 2002‘failure to provide safe care or treatment’, a Foundation Trust has been ordered to pay fines totaling £200,000 (plus £15,170 for legal costs and victim surcharge). Tragically, a Child and adolescent mental health services patient took her own life in hospital in 2019, in a way which was almost identical to two previous attempts. In 2020, Patient X was involved in a self-inflicted incident on a ward and tragically died several days later. They had tried to harm themselves in a similar way days before. In both cases the trust had failed to mitigate the risk of harm. The trust pleaded guilty to both charges.

What this means for you

Trusts providing mental health services are particularly vulnerable to repeat incidents of self-harm/ suicide attempts. Learning from and acting on previous incidents and keeping the patient’s care plan under close review are a vital part of providing safe care and minimising the risk of tragic outcomes.