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National guidance for the investigation of any patient safety incidents identified as either a Serious Incident (SI) or No Surprises/Sensitive Issue relating to the provision of digital health care services in Wales

HSIB has made three safety recommendations as a result of this report - two to NHS England and NHS Improvement, and one to the Centre for Perioperative Care. NHS England and NHS Improvement It is recommended that NHS England and NHS Improvement revises the Never Events list to remove events, such as those presented in this national learning report, that do not have strong and systemic safety barriers. It is recommended that NHS England and NHS Improvement develops and commissions programmes of work to find strong and systemic safety barriers for specific incidents where barriers are felt to be possible but are not currently available. Centre for Perioperative Care It is recommended that the Centre for Perioperative Care reviews and revises the National Safety Standards for Invasive Procedures (NatSSIPs) policy to increase standardisation of safety critical steps that are common across all procedures.

In the two weeks before his death Robbie was seen seven times by five different GPs. The child was seen by three different GPs four times in the last three days when he was so weak and dehydrated he was bedbound and unable to stand unassisted. Only one GP read the medical records, six days before death, and was aware of the suspicion of Addison's disease, the need for the ACTH test and the instruction to immediately admit the child back to hospital if he became unwell. The GP informed the Powells that he would refer Robbie back to hospital immediately that day but did not inform them that Addison's disease had been suspected. The referral letter was not typed until after Robbie had already died and was backdated to the day following the consultation. In a statement after Robbie's death this GP stated: "An Addisonian crisis is precipitated by an intercurrent illness and the stress it induces." Dyfed-Powys Police investigated Robbie's death between 1994 and 1996 but asserted, supported by the Crown prosecution Service in Wales, that there was no evidence of crimes committed by the GPs who, incidentally, were retained by this police force as police surgeons. Following a complaint by Will Powell (Robbie's father) in 1998 against the Deputy Chief Constable of Dyfed-Powys Police, regarding the inadequacies of the criminal investigation, a second criminal investigation was agreed, which commenced in January 1999. As with the first criminal investigation, there was a gross failure to adequately investigate the criminality of the doctors. This resulted in Will Powell making a formal complaint against the Chief Constable of Dyfed-Powys Police in late 1999. This complaint against the Chief Constable resulted in Dyfed-Powys Police appointing an outside police force to review Robbie's case in 2000. Detective Chief Inspector Robert Poole [DCI Poole] from West Midlands Police was appointed. DCI Poole’s investigation report, entitled 'Operation Radiance', which was based on the documents provided to Dyfed Powys Police in March 1994, by Will Powell and his solicitor, was submitted to CPS York in March 2002. This report put forward 35 suggested criminal charges against five GPs and their medical secretary. The listed charges were: gross negligence manslaughter forgery attempting to pervert the course of justice conspiracy to pervert the course of justice. DCI Poole's investigation also resulted in a disciplinary inquiry by Avon & Somerset Constabulary into Will Powell's allegations of misconduct against Dyfed-Powys Police officers with regards to their two inept criminal investigations between 1994 and 2000. Dyfed-Powys Police was found to have been 'institutionally incompetent' but no police officer was made accountable. In April 2003, Will Powell met representatives from the CPS in London, who accepted there was sufficient evidence to prosecute two GPs and their secretary for forgery and perverting the course of justice. However, they would not prosecuted because of (1) the passage of time, which was caused by a decade of cover ups between 1990 and the appointment of DCI Poole in 2000, (2) Dyfed Powys Police had provided the GPs with a letter of immunity, and (3) the available evidence had been initially overlooked by the police and the CPS, between 1994 and 2000, for a variety of reasons. Following a 2013 adjournment debate, in the House of Commons, the Director of Public Prosecutions subsequently agreed, in October 2014, that there would be an independent review of the decisions made by Crown Prosecution Service, in 2003, not to prosecute, when there was sufficient evidence to do so. The reviewing Queen's Counsels have been provided with a report, written by myself ( a healthcare IT professional, former head of IT in an NHS trust and clinician) on major anomalies in Robbie's Morriston Hospital computerised records, which were erased during the first criminal investigation between 1994 and 1996. The review has not been concluded six years on. The letter below (and also attached) from the English and Welsh Ombudsman was sent on 10 November 2020 sets out the case for a Public Inquiry.

Nasogastric (NG) tubes placed incorrectly, going undetected and delivering food, liquid or medication into the lungs is a well-recognised never event in the NHS. Despite safety alerts and various safety initiatives, the investigation identified that this type of never event continues to happen and that there are not strong ‘systemic’ barriers to prevent NG tubes being accidentally placed into the lungs. Data from national reporting systems shows that there were 14 incidents of misplaced NG tubes from April to September this year. The report acknowledges that measures carried out to tackle COVID-19 have also added to the challenges of inserting and confirming placement of NG tubes. The report concludes with five safety recommendations focusing on agreeing standards and specifications relating to procurement and design of devices, researching new technologies and standardising competency-based training for national implementation. The report also sets out eight safety observations and three safety actions taken by the Trust following Fabian’s case. Safety recommendations It is recommended that Health Education England coordinates the development and publication of a national standardised competency based training programme for nasogastric tube placement and confirmation by pH testing. The model may include simulation, observed practical assessment and ongoing competency assessment. The competency-based training programme would need to be defined, developed, and tested using a human factors approach prior to any widespread implementation. The competency based training programme will lead to a recognised accreditation which will be transferable across the NHS care providers in England. It is recommended that NHS England and NHS Improvement works with the Department of Health and Social Care and others, to identify the process by which the NHS can identify and commission necessary research to support improvements in patient safety. This would include research to confirm nasogastric tube placement. It is recommended that NHS Supply Chain and the British Standards Institution work together (engaging other system leaders as appropriate, such as the Medicines and Healthcare products Regulatory Agency and NHS England and NHS Improvement), to develop and publish an agreed standard to minimise the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. The standard should consider product design, regulatory standards, procurement practices and human factors engineering to provide a consistent approach that can be embedded within NHS Supply Chain product specifications. It is recommended that NHS Supply Chain develops essential specifications to support the clinicallyled procurement of devices to include devices to confirm nasogastric tube placement, for example, pH testing strips. The essential specifications should set out a range of factors critical to inform the selection by NHS Supply Chain of a product including, but not limited to: clinical output requirements; design and ergonomics; human factors and intended use; and limitations on use and usability. Critically, these specifications should ideally be established in partnership across the healthcare system with clinicians, healthcare professionals and safety leads, while maximising best practice. It is recommended that the British Society of Gastrointestinal and Abdominal Radiologists, working with Health Education England and the Society and College of Radiographers, develops and publishes a national standardised competency-based training programme for X-ray interpretation to confirm nasogastric tube placement. The competency based training programme will include the referral process for X-ray to confirm nasogastric tube position and the subsequent reviewing, recording and communication of the clinical evaluation of the X-ray findings prior to initiation of feed. The standards must meet the Ionising Radiation (Medical Exposure) Regulations IR(ME)R requirements. The competency-based training programme will lead to a recognised accreditation for those qualified to clinically evaluate and record their findings, for example doctors, radiographers and advanced care practitioners. The accreditation certificate will be transferable across NHS care providers in England.

Immediate and essential actions 1) Enhanced safety Essential action - Safety in maternity units across England must be strengthened by increasing partnerships between Trusts and within local networks. Neighbouring Trusts must work collaboratively to ensure that local investigations into Serious Incidents (SIs) have regional and Local Maternity System (LMS) oversight. 2) Listening to women and families Essential action - Maternity services must ensure that women and their families are listened to with their voices heard. 3) Staff training and working together Essential action - Staff who work together must train together. 4) Managing complex pregnancy Essential action - There must be robust pathways in place for managing women with complex pregnancies Through the development of links with the tertiary level Maternal Medicine Centre there must be agreement reached on the criteria for those cases to be discussed and /or referred to a maternal medicine specialist centre. 5) Risk assessment throughout pregnancy Essential action - Staff must ensure that women undergo a risk assessment at each contact throughout the pregnancy pathway, 6) Monitoring fetal wellbeing Essential action - All maternity services must appoint a dedicated Lead Midwife and Lead Obstetrician both with demonstrated expertise to focus on and champion best practice in fetal monitoring. 7) Informed consent Essential action - All Trusts must ensure women have ready access to accurate information to enable their informed choice of intended place of birth and mode of birth, including maternal choice for caesarean delivery.

Mrs Trellis of North Wales writes: Q: Why is there no mention in your blogs about "motivation, personality, team building, and alike"? A: Well that’s not human factors. That’s another branch of psychology called occupational psychology. These people are trained – BSc then MSc and then often four years of supervised work. Usefully for the medical profession they are registered by the Health and Care Professional Council (HCPC). If you are interested in these matters, ensure they have at least the postgraduate qualifications. The most important bit is that they abide by a code of ethics. Ignore the "I do team talks and motivational stuff" go for MSc in the subject. If they say I’m a Human Factors person who does team talks, then sigh. It’s like a GP saying they also will have a go at dentistry/carpentry/service your car. Q: How do I select a Human Factors person? A: Do they have a doctorate (DPhil preferred!) in the domain and, as it's research, have they published in peer reviewed journals, or has their work been reviewed by other PhD types? They should have a minimum of an MSc and tell you they abide by a code of ethics. As this is still a new area of science go for a postgraduate qualification in the core areas of engineering or cognitive psychology from a university you recognise. There are international protocols about how humans should be treated, and they should be able to say they meet them (NHS Research Ethics Committee is cool). The organisation should have an ethics committee and that should contain lay members and professorial level scientists. Q: Do I need a research ethics committee to do an investigation? A: If its collecting novel data and people are put in a place where their wellbeing (psychological and physiological) may be affected – then YES. The NHS has a network of ethics committees and you will have one (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/). I was recently asked to take part in a questionnaire study about ‘cover ups’ in hospitals. Question one was about whistleblowing and I needed to give my name. I asked about ethics permission and I was told its not needed and they (the university) would not grant it anyway. I asked if reliving a traumatic event caused me some anxiety would they offer me support? The answer was “it’s just a research project looking at deaths – why would you need that”. Your duty as a researcher is to protect the person giving the answers. Q: There is someone into my hospital who tells me they can help with Human Factors, how do I know they are fit and proper? A: Well that’s what the Disclosure and Barring System (DBS) is about. Ask that they have a minimum of an enhanced DBS check or alternatively, with Human Factor types, security clearance (SC & DV). With DBS the nature of their originating organisation often determines the frequency required by them to renew it (sometimes just once). Check that their organisation stores and handles data safely and securely. This is not GDPR. Ask how they store it and if they meet a recognised standard. Financial health is important and such ‘numbers stuff’ is on companies house. Look for three years of accounts. Many look for five but companies have to start somewhere. Q: Is healthcare all about process and not about outcomes? A: True, but it does not have to be. It is easy to solve the problem. Q: Are non-technical skills (NTS) and neuro linguistic programming (NLP) real science? A: NTS is a system that claims you can measure ‘attentiveness’ and ‘conciseness', and, in investigations, these factors are the cause of accidents. In humans there are ‘hidden’ cognitive processes so NTS people say, for example, ‘situational awareness’ and ‘attention to detail’, which are overtly manifested as behavioural markers. NLP makes claims about modelling exceptional people and being a cure for the common cold. Neither have any scientific validation, sound theoretical stance or pretty much any sort of evidence to support the concepts. In essence they are pseudoscience A useful link to Professor Wiki again (https://en.wikipedia.org/wiki/Neuro-linguistic_programming) Those proposing this pseudoscience also say there are overt NTS behavioural markers, that to the trained observer (you need normally need to pay and go on a course), can easily be measured. What a behavioural marker looks like that shows higher or lower attention to detail we are never informed. All these markers are, of course, they claim a-cultural, universal, and innate. There are some ideas that really stretch credibility – even to the untrained, including that during certain hours of the day you can’t see below your knee, which if true would mean any invading army only needs to sneak in just below knee height. One proponent said you can do this pseudoscience after a fatality – but when questioned how you communicate with the dead, they became vague as to the precise methodology. Q: I’ve hired someone who works in ‘other high risk or high-performance industries’ and if it works aboard ship/chemical plant/airside it's fine for medicine. Comments? A: Well no. Sadly Human Factors is not widespread in healthcare and healthcare is totally unique. Despite my experience in rail, aviation, marine, road and security, I have found healthcare to be very different. Human Factors types have not had much involvement in medicine (sorry). Each discipline in medicine is vastly different to each other. My first time in the Emergency Department was a shock, and I thought, naively, I could generalise that knowledge to paramedics and vans with flashing lights. Even comparison between theatres (in the same trust) where I thought I knew what each team did was foolhardy. Each discipline is unique and whoever works with you needs to spend a lot of time understanding what happens (see part 4 of my blog). Orthopaedics is very unique; strangely I like doing work there. A big thank you to many Royal colleges and every scrub nurse and operating department practitioner, oh and anaesthetist – whose battle with even the room is amazing. Q: We have investigated an event like this before. Why do we need to do it again? A: In the 600 investigations I’ve done, not one is the same. Indeed, I’ve not known the cause at the beginning of any investigation. We described that there are over 1000 variables (blog part 1) that come together, in one moment of time, and it's often four or more coming together to cause the incident in a domain like transport. As my American colleagues say – “Do the Math” – all incidents are unique. Q: Should we only investigate major incidents (multiple deaths) and not be distracted by all the rest? A: Sigh. How do you know if they are major unless you investigate? If you don’t investigate, how do you stop them from happening again, and how disrespectful to the family of the person who was injured or died. An example of good and bad outcomes: Good example of best practice We believe the fatality occurred because the high viz uniform is not effective during rain, the lighting caused glare on the windscreen that meant there was not much light hitting the retina of the person trying to detect your late partner. So, the evidence suggested your partner was not detected by them. I’m sorry for your loss but this is the new uniform, and this is how we have reduced the lighting to stop glare. Simply this will not happen again, no other family will suffer such a loss. Bad example Alternatively – Meh – others have died in the same way and well your loss is in the ‘all the rest’ pile. Do we want the latter in our society? Q: All this investigation work tells us nothing we did not know before the incident occurred. Comment? A: You are doing the investigation wrongly. It’s a worry, if you knew it was going to occur again then you are not dealing with an accident, but you are looking at a crime scene. Remember an accident is a rare random event (see blog part 1) that’s not foreseeable. Q: How many of the 600 odd cases did you not find the cause? A: One – still a total mystery as to its cause. A vehicle after 60 miles of perfect driving where a driver diverts across three lanes of the motorway and hits the only vehicle parked on the hard shoulder for nearly 30 miles. If anyone has a thought – please share. Q: There are courses on Human Factors methods like hierarchical task analysis (you mention Task Analysis in your blogs) and Control charts, aka Shewhart charts. Is that what we need? A: Your training in medicine is what to focus on. Let Human Factors people do Human Factors stuff. Keeping up to date in your chosen field and looking after patients is enough. No society should expect you to become an expert in everything. Q: Our 40-stage model of investigation process …. Is the way forward? Rest withheld A Process is not outcomes. Start with a blank sheet of paper. Collect data. Its fine to allocate tasks to the investigation team members – but in healthcare – its just you, and perhaps a friend. When I say friend – someone from the ward below – or someone who still makes eye contact after the last one! Q: Why should I report – nothing happens for months and when it does nothing changes; I’ve reported the same type of incident three times in 2 years. I’ve not been interviewed, or a statement taken. A: I always use an analogy in industries where reporting is critical. The analogy refers to any relationship where information needs to be two way. The analogy: imagine you come home each night and say to your partner – “I love you”, and there is no response. How long will you say that to them? An example from security. It's important that all members of a security team report to the control room what they see, then to the police. Our extensive research showed that people stopped reporting when they had no feedback. Simple remedy – give feedback. In counter terrorism work the feedback sometimes can’t be that detailed, but what we found is – thanks that’s useful – is often enough. The feedback needs to be within 24 hours (see the When to investigate blog) and it needs to be personal. Hopefully if you are on a train, see something, say it, you should get the immediate feedback – it's sorted. Happy days testing that audio on the rail network! Encouraging reporting is the next step. If it's quiet and you are getting nothing – raise the issues with everyone, immediately. My colleague had a super way of getting security teams to communicate during a major event. The ‘broadcast all’ button on their radio was hit and all got a message – it’s a bit quiet. Long story but reports started coming in within seconds, the team (about 200 of them) became chatty and two of those reports were useful. Yes, feedback was given aided by tea and biscuits. Q: My report is downgraded – although the person died. How can that be? A: Let’s look at the NHS Improvement's Serious Incident Framework guidance and think of an event that did not happen – a near miss. The guide says of near misses: “It may be appropriate for a ‘near miss’ to be a classed as a serious incident because the outcome of an incident does not always reflect the potential severity of harm that could be caused should the incident (or a similar incident) occur again. Deciding whether or not a ‘near miss’ should be classified as a serious incident should therefore be based on an assessment of risk that considers: The likelihood of the incident occurring again if current systems/process remain unchanged; and The potential for harm to staff, patients, and the organisation should the incident occur again“ It's clear it's not the severity but the potential severity and the potential to occur again. I do wonder if investigation teams understand that we investigate to stop it occurring again. It's not about getting to the bottom of the pile of reports or getting ready for court. It's about prevention. As Metallica say "Nothing else matters" and NHS improvement are correct. (see blog part 1). Q: Do you think only those with medical training should investigate incidents (see Who should investigate blog)? A: It’s a team effort. There now appears to be some universities doing investigation training. This appears to be about creating a process of investigating. I would ask them how many investigations they have done, the outcomes, and evidence that the proposed process gets to the proximate cause. Q: Why is a postgraduate qualification is suggested in this area. A: Well, It’s a new area of science – that’s what a post doc or MSc is about. Its research – it being a new area of science – so a research qualification is ideal. Ethics forms a major area of postgraduate training in psychology Ethics is vital in medicine and its cornerstone is informed consent. Well if I go to my GP, I would like to know they have a Dr title. This is in the area of medicine. Having spent many hours talking about science, ethics, forensics, and psychology in assorted village halls and drafty council offices on behalf of HM Government. l’ll be delighted to address any club or institute about these matters. All I can ask the tea is strong, the cake light and fluffy. Q: As an experienced investigator, I think I’ve been taught very little about investigations, Human Factors, philosophy, logic, statistics and cognitive psychology. Where do I learn or even should I? A: I know truly little about medicine. I spent thirty years learning the list above. I think those with an expertise in medicine should do medicine. The beauty comes when we work together, each asking questions with the Socratic method (blog part 6). If you really want to know more, a degree in psychology or engineering/computer science is good. Avoid a standalone MSc from a university you have never heard of. A PhD or posh DPhil from one of the few universities that offer it, is a must. Training by a police force as a Senior Investigating Officer is cool. There are some organisations offering investigation training – ask how many have you done, who commissioned you and how have you become an expert in this? My editor adds “and how long did they spend in the witness box answering questions.” Q: We have now got walkie talkies to communicate. Are they a good idea? A: Oh dear – technology mediated communications needs a lot of thought and training. In the military and in the police, you are trained to use a radio – I’ve done the police course twice due to me forgetting the radio was live when describing someone on a beach! What you are communicating, if you know and trust the person, how the information is displayed (vertically ships/horizontally submarines), even if there is a 20 millisecond delay in the comms – all affect reliability and, importantly, trust. Q: What is the single most important “bit of science/philosophy in investigations?” A: Occam’s Razor. Thanks to our new MSc student – why do new people make us oldies look dim. I’ll cover that in my next blog. Willian of Occam (1287 – 1347) kind of set the scene – which for followers of these blogs updates us from the normal Greek learning (500 BC) we talk about. In a few years together we can chat about the 1930s! Q: So, in blog part 6 you set a challenge about a train station and incidents – what’s the answer? A: The passenger information system was underneath a glass canopy, and this is where all the incidents occurred. Hence, I say everyone knew the train times and would not be running. As you get older you may often need to get closer to text to read it. You also have issues with glare and contrast. All fine for being older – but put a change in platform surface at the same point as arms are raised to stop the glare in the eyes through the glass canopy – well you see why those fell. Information sign moved slightly, and no incidents. A big thanks to my science editors, Profs Alex and Graham, and soon to be PhDs Lara and Emma. Thanks to the hub editor (Sam) who I know groans when another blog arrives to have the bad jokes removed. Yes, dear reader, they start off far worse than the ones you read... Oh, look our doormat is festooned with another letter from a Mrs Trellis – she writes... Read Martin's other blogs Why investigate? Part 1. A series of blogs from Dr Martin Langham Why investigate? Part 2: Where do facts come from (mummy)? Who should investigate? Part 3 Human factors – the scientific study of man in her built environment. Part 4 When to investigate? Part 5. How or Why. Part 6

Implementation challenges The investigation highlighted the main implementation challenges. This includes: National consistency in drug libraries – smart infusion pumps have an inbuilt dose error reduction system (DERS) which requires the use of a drug library. The investigation found that drug libraries were developed ‘locally’ and that there is no agreed national drug library for use in NHS. They also found that there is no national guidelines or standards on how to implement the libraries. Significant changes in processes – introducing the technology requires significant changes to prescribing and administration processes in trusts. The investigation found that procedure and guidance documents often needed updating, and variations in medication practice were ‘locally managed’ and were rarely shared within and between hospitals. Provision of specialist IT support and infrastructure – substantial IT infrastructure is needed to support the integration of smart pump technology. Software is needed to upload the drug library to smart pumps, download data logs (including any errors detected) and monitor the status of each smart pump. The investigation highlighted that maintaining the required IT infrastructure required specialist staff roles and often a new skill set. The investigation found that the implementation of smart pump functionality would benefit from the use of risk management practices, as requirements are complex and similar to the introduction of a new IT system. Existing NHS Clinical risk standards could provide a basis for both manufacturers and trusts to work together to manage risks.