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How are people getting on with the NatSSIPs? PDF version to share NatSSIPs headline booklet.pdf

I would like to open a discussion about how 'lack of written consent' and how this is managed in investigations.

A group of survivors and relatives of people who died in the infected blood scandal are suing a school where they contracted hepatitis and HIV after being given experimental treatment without informed consent. A proposed group action lodged by Collins Solicitors in the high court on Friday alleges that Treloar College, a boarding school in Hampshire that specialised in teaching haemophiliacs, failed in its duty of care to these pupils in the 1970s and 80s. The claim could result in a payout running into millions of pounds, and is based on new testimony given by former staff at the school to the ongoing infected blood inquiry. Gary Webster, 56, a former pupil who was infected with hepatitis C and HIV after being treated with contaminated blood at the school in the early 80s and gave evidence to the inquiry last year, is the lead claimant of the 22 survivors in the group. Speaking to the Guardian, he said: “We were lab rats or guinea pigs. We always thought that we may have been experimented on for research purposes, but we had no proof until the evidence given in the inquiry.” Last year in testimony to the inquiry, the former headteacher of Treloars, Alec Macpherson, confirmed that doctors at the school were “experimenting with the use of factor VIII”, an imported pooled plasma that was later discovered to be contaminated with HIV and hepatitis. He said he and other teaching staff did not question doctors about the trials. He told the inquiry: “We didn’t have any authority or reason to interfere. You can’t – doctors are god, aren’t they?” Macpherson said he consented to the treatment because he trusted the doctors, and he could not recall if parents were informed and consulted. Read full story Source: The Guardian, 23 January 2022

Occupational health professionals should avoid employment and management matters related to unvaccinated NHS staff, new guidance has warned. The Faculty of Occupational Medicine guidance comes as trusts are considering their options of how to approach patient-facing staff who remain unvaccinated, including their potential redeployment or dismissal. However, HSJ understands some occupational health practitioners are concerned they may become entangled in difficult ethical issues, such as the vaccination status of individual employees, or disciplinary processes. Today’s FOM guidance said: “There is no scope for occupational health practitioners to provide an opinion on medical exemptions, whether to confirm or refute them… “Redeployment, dismissal and other employment consequences of vaccine refusal by a worker, within the scope of the proposed regulations, are entirely employment and management matters, and not an area in which occupational health should be involved.” FOM president Steve Nimmo said: “When the programme is implemented, occupational health professionals should be mindful of ethical and consent issues, and be careful not to be associated with any disciplinary process.” Read full story (paywalled) Source: HSJ, 7 January 2022

Patient Safety Learning Press Release 10th December 2020 Today the Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust published its first report on its findings.[1] The report made recommendations for actions to be implemented by the Trust and “immediate and essential actions” for both the Trust and the wider NHS. The Review was formally commissioned in 2017 to assess “the quality of investigations relating to new-born, infant and maternal harm at The Shrewsbury and Telford Hospital NHS Trust”.[2] Initially it was focused on 23 cases but has been significantly expanded as families have subsequently contacted the review team with their concerns about maternity care and treatment at the Trust. The total number of families to be included in the final report is 1,862. These initial findings are drawn from 250 cases reviewed to date. This is another shocking report into avoidable harm. We welcome the publication of these interim findings and the sharing of early actions that have been identified to make improvements to patient safety in NHS maternity services. We commend the ambition for immediate responses and action. Reflecting on the report, there are a number of broad patient safety themes, many of which have been made time and time again in other reports and inquiries. A failure to listen to patients The report outlines serious concerns about how the Trust engaged and involved women both in their care and after harm had occurred. This was particularly notable in the example of the option of having a caesarean section, where there was an impression that the Trust had a culture of wanting to keep the numbers of these low, regardless of patients’ wishes. They commented: “The Review Team observed that women who accessed the Trust’s maternity service appeared to have little or no freedom to express a preference for caesarean section or exercise any choice on their mode of deliver.” It also noted a theme in common with both Paterson Inquiry and Cumberlege Review relating to the Trusts’ poor response to patients raising concerns.[3] The report noted that “there have also been cases where women and their families raised concerns about their care and were dismissed or not listened to at all”. The need for better investigations Concerns about the quality of investigations into patient safety incidents at the Trust is another theme that emerges. The review reflected that in some cases no investigation happened at all, while in others these did take place but “no learning appears to have been identified and the cases were subsequently closed with it deemed that no further action was required”. One of the most valuable sources for learning is the investigation of serious incidents and near misses. If these processes are absent or inadequate, then organisations will be unable to learn lessons and prevent future harm reoccurring. Patient Safety Learning believes it is vital that Trusts have the commitment, resources, and frameworks in place to support investigations and that the investigators themselves have the right skills and training so that these are done well and to a consistently high standard. This has not formed part of the Report’s recommendations and we hope that this is included in their final report. Lack of leadership for patient safety Another key issue highlighted by the report is the failure at a leadership level to identify and tackle the patient safety issues. Related to this one issue it notes is high levels of turnover in the roles of Chief Executive, executive directors and non-executive directors. As part of its wider recommendations, the Report suggests trust boards should identify a non-executive director who has oversight of maternity services. Good leadership plays a key role in shaping an organisations culture. Patient Safety Leadership believes that leaders need to drive patient safety performance, support learning from unsafe care and put in place clear governance processes to enable this. Leaders need to be accountable for patient safety. There are questions we hope will be answered in the final report that relate to whether leaders knew about patients’ safety concerns and the avoidable harm to women and their babies. If they did not know, why not? If they did know but did not act, why not? Informed Consent and shared decision-making The NHS defines informed consent as “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[4] The report highlights concerns around the absence of this, particularly on the issue of where women choose as a place of birth, noting: “In many cases reviewed there appears to have been little or no discussion and limited evidence of joint decision making and informed consent concerning place of birth. There is evidence from interviews with women and their families, that it was not explained to them in case of a complication during childbirth, what the anticipated transfer time to the obstetric-led unit might be.” Again this is another area of common ground with other recent patient safety reports such as the Cumberlege Review.[5] Patient Safety Learning believes it is important that patients are not simply treated as passive participants in the process of their care. Informed consent and shared decision making are vital to respecting the rights of patients, maintaining trust in the patient-clinician relationship, and ensuring safe care. Implementation for action and improved patient safety In its introduction, the report states: “Having listened to families we state that there must be an end to investigations, reviews and reports that do not lead to lasting meaningful change. This is our call to action.” Responding with an official statement in the House of Commons today, Nadine Dorries MP, Minister for Mental Health, Suicide Prevention and Patient Safety, did not outline a timetable for the implementation of this report’s recommendations. In 2020 we have seen significant patient safety reports whose findings have been welcomed by the Department of Health and Social Care but where there has subsequently been no formal response nor clear timetable for the implementation of recommendations, most notably the Paterson Inquiry and Cumberlege Review. Patient Safety Learning believes there is an urgent need to set out a plan for implementing the recommendations of the Ockenden Report and these other patient safety reports. Patients must be listened to and action taken to ensure patient safety. [1] Independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, Ockenden Report: Emerging findings and recommendations form the independent review of maternity services at Shrewsbury and Telford Hospital NHS Trust, 10 December 2020. https://www.ockendenmaternityreview.org.uk/wp-content/uploads/2020/12/ockenden-report.pdf [2] Ibid. [3] The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.serv...; The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf [4] NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/ [5] Patient Safety Learning, Findings of the Cumberlege Review: informed consent, Patient Safety Learning’s the hub, 24 July 2020. https://www.pslhub.org/learn/patient-engagement/consent-and-privacy/consent-issues/findings-of-the-cumberlege-review-informed-consent-july-2020-r2683/

An urgent investigation into blanket orders not to resuscitate care home residents has been launched amid fears some elderly people may still be affected by the “unacceptable” practice. After COVID-19 cases rose slightly in care homes in England in the last week, with 116 residences handling at least one infection, the Care Quality Commission (CQC) said it was developing the scope of its investigation “at pace” and it would cover care homes, primary care and hospitals. In March and April, there were reports that some GPs had applied “do not attempt resuscitation” (DNAR) notices to groups of care home residents that meant people would not be taken to hospital for potentially life-saving care. This was being done without their consent or with little information to allow them to make informed decisions, the CQC said. Cases emerged in care homes in Wales and East Sussex. Care homes said the blanket use of the orders did not appear to be as prevalent ahead of a possible second wave of infections and families were reporting fewer concerns, although that could be because visiting restrictions meant they had less access to the homes and were getting less information. There are also concerns that steps may not have been taken to review DNAR forms added to care home residents’ medical files, and so they could remain in place, without proper consent. The CQC review will examine the use of “do not attempt cardiopulmonary resuscitation” (DNACPR) notices, which only restrict chest compressions and shocks to the heart. Dr Rachel Clarke, a palliative care expert in Oxford, has described the CPR process as “muscular, aggressive, traumatic” and said it often resulted in broken ribs and intubation. The review will also investigate the use of broader do not resuscitate and other anticipatory care orders. “We heard from our members about some pretty horrific examples of [blanket notices] early in the pandemic, but it does not appear to be happening now,” said Vic Rayner, the executive director of the National Care Forum, which represents independent care homes. “DNAR notices should not be applied across settings and must be only used as part of individual care plans.” It will also investigate the use of broader do not resuscitate and other anticipatory care orders. Read full story Source: The Guardian, 12 October 2020

For more than two decades, Derek McMinn harvested the bones of his patients, according to a leaked report – but it was not until last year that anyone challenged the renowned surgeon. The full scale of his alleged collection was apparently kept from the care regulator until just days ago, and thousands of those who went under his knife for hip and knee treatment still have no idea that their joints may have been collected in a pot in the operating theatre, and stored in the 67-year-old’s office or home. Clinicians and managers at the BMI Edgbaston Hospital, where McMinn carried out the majority of his operations, actively took part in the collection of bones and – even after alarms were raised – the hospital did not immediately act to stop the tissue being taken away, according to a leaked internal report seen by The Independent. An investigation found operating theatre staff at the private hospital left dozens of pots containing joints removed from patients femurs during hip surgery in a storage area, in some cases for months. According to the report, there had been warnings about their responsibilities under the Human Tissue Act when an earlier audit between 2010 and 2015 identified the storage of femoral heads, the joints removed in the procedure. The internal report said there was no evidence McMinn had carried out any research or had been approved for any research work – required by the Human Tissue Authority to legally store samples. It said one member of staff told investigators the samples were being collected for research on McMinn’s retirement. Although the Care Quality Commission knew about claims that a small number of bones being kept by McMinn, it is understood that the regulator received a copy of the BMI Healthcare investigation report only last Friday, after The Independent had made initial inquiries about the case. That report suggests a minimum of 5,224 samples had been taken by McMinn. The regulator confirmed to The Independent it had not been aware of the extent of McMinn’s supposed actions. An insider at BMI Healthcare accused the company of “covering up”, adding: “Quite senior staff at the hospital went along with it and just handed the pots over to his staff when they came to collect them.” Read full story Source: The Independent, 30 September 2020