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Working with early adopters To test the PSIRF, NHS Improvement are first working with a small number of early adopters who are using an introductory version of the framework in their organisations. This testing phase will be used to inform the creation of a final version of the PSIRF which is anticipated to be published in Spring 2021. At that point, other providers of NHS funded care in England who are not early adopters will also begin adopting the new framework. All NHS organisations are expected to have transitioned to using the new framework from Autumn 2021. Introductory version of the PSIRF While NHS Improvement are not asking organisations other than the early adopters to transition to the PSIRF, they will help providers outside of the early adopter areas to plan for this change. They have therefore published below the introductory version of the framework that is being tested. Organisations and local systems should review this document and begin to think about what they will need to do to prepare ahead of the full introduction of the PSIRF in 2021. Until instructed to change to the PSIRF (likely from Spring 2021), non-early adopter organisations must continue to use the existing Serious Incident Framework.

I read the recent blog from a fellow nurse, ‘Silent witness’, and I too am frustrated with the current system of ‘datixing’. Reporting is a good thing. We must report incidents; we do report incidents to try to keep our patients and staff safe. Many of us, I think, feel comfortable in reporting incidents. However, the frustration with me is different. Yes, the feedback and the way that the reporter gets ‘missed out’ of inquiries is wrong, but the outcomes and the ‘learning’… that is where my frustration lies. I should point out at this stage of my blog; I am raging. I am so angry and frustrated at this system I could scream. I have been a nurse now for over 20 years. I have probably filed hundreds of Datixes over the years. Some I have received feedback on, some I have not. I want to give you an insight on what I see. Not how it should be, not how you think it should be, this is how I see the system working where I am and how it makes me feel. At present I am angry in what I see. Organisational structure Where I work (in an NHS Trust) we have divisions: Medicine, Women and Children, Surgery, etc. Each one of these divisions has a head of nursing who is responsible for the safety and quality of their area, then, moving down the hierarchy, there are the matrons and then the ward managers – these are the people who would ‘investigate’ the incident that has happened, overseen by the safety and quality team (who are non-clinical). Competition time These divisions have meetings. The frontline staff – nurses, doctors, AHPs and support staff – are not invited to these meetings. From being curious, I have determined what goes on in these meetings by shadowing my manager. In these meetings they discuss how many falls, how many acquired infections, how many serious incidents, pitching against each other to see who has performed best or better than last time. So, by investigating the incidents that happen in your division while attempting to keep your numbers for falls, acquired infections and serious incidents low, by untrained investigators, how can these investigations be rigorous and unbiased? In come the safety team. I’ve never met anyone from our safety team. I don’t know where their office is. I wouldn’t know them if they walked past me in the corridor. I have no idea if they have a clinical background, but what I do know is that they do not have experience in what it is like to work in the department where I work. They don’t know the nuances, the culture, the normal deviance of behaviours or the workarounds that we use to get the work done. Perhaps if they understood... Real life examples I would like to share with you a few events to demonstrate how this safety process is not set up to keep patients safe; it's set up to keep the numbers of serious incidents low in that area. As I mentioned earlier, this is how it looks from my lens. Incident 1 – Tracheostomy and laryngectomy patients Looking after patients with tracheostomies or laryngectomies are sometimes tricky. They are high risk patients and require staff to have specialist training to care for them safely. These patients are cared for on specific wards so that patients are cohorted and cared for by staff who look after them on a regular basis. One of these wards was a surgical ward – the ward where I work. There was an incident on this ward with a patient with a tracheostomy. The patient received significant harm and ended up on the intensive care ward as a result. One of the outcomes from this incident was not to have laryngectomy or tracheostomy patients on this ward. At no point was learning from the incident disseminated to staff about the causes of the incident – just remove this cohort of patients from this ward. I don’t know what we did wrong. If the situation arose again, could we do anything different? We will never know as we don’t care for these patients here now. Incident 2 – Swallowed foreign object An incidental finding on a chest X-ray showed that an elderly lady had swallowed her wedding ring. It was stuck in her throat. This finding was found at 23:00 at night. It was removed at 12:00 midday the following day. A Datix report was filed as a concern was raised about the process of out of hours ENT services at my hospital. The investigation was completed. The response was that the incident was downgraded to low and that this lady was not compromised and that the ring was removed safely. This did not address the system failure. If this was a child in our hospital, what is the provision for removing a foreign object from the throat? Opportunity for changing and improving the current system/process was overlooked. Incident 3 – Dehydration death and downgrade A patient undergoing palliative bladder surgery died of dehydration on a ward less that 24 hours post-operation. The patient was not written up for any fluids, was not on a fluid balance chart and was not correctly monitored. Despite gallant efforts to rehydrate the man over the course of the night, the patient had a cardiac arrest and died. This Datix was graded as catastrophic by the reporter, but down graded to low by investigators. When questioned about this, the response was "his surgery was for comfort, he was going to die anyway". Surely anyone post-operation should have fluids written up and be monitored – otherwise what is the point? Again, system failure has been overlooked and opportunities for future learning quashed. The work we do as clinicians is complex. There needs to be an understanding of what we do and why we do it, or, sometimes, why we don’t do it. Investigating harm from an office about procedures and processes you don’t understand is ludicrous. For my friends and family, I will not recommend this hospital I work in. It’s not a case of we don’t learn from mistakes, it’s a case of we don’t want to learn from our mistakes – it's too much effort. I don’t trust them to do the right thing.

The complaints included in the report are not thematic or related to a specific incident or body. Instead, these new annual Ombudsman Casework Reports will share some of the most significant findings from cases completed over the year, including complaints against: NHS in England Mental Health Care. The report offers valuable lessons about the importance of good complaint handling and how complaints can be used to drive improvements.

The story so far... We investigate an incident to collect facts that will prevent the incident from occurring again (see 'Why investigate?' blog). Facts collected by two or more investigators, with enough time away from the ‘day job’, tend to be of better quality than a single person fitting the investigation in and around their other duties (see 'Who should investigate?' blog). Human factors is a science done by science types who are trained in understanding how the limited ‘cave dweller’ tries to cope with their environment. Human factors types are not likely to have the title ‘Captain’ and have not just landed at Stansted (see 'Human factors' blog). Facts are our friend as they allow us to tell people why an incident occurred and, if those facts are accurate, allow us to do an intervention that will prevent the incident occurring again (see 'Where do facts come from?' blog). Good facts and great remedies allow us then to monitor the success of the intervention. But again, we are getting ahead of ourselves by talking about interventions. Sorry. At this stage it might be worth thinking about what we do with all those facts, how we see patterns in the data, what a good intervention might look like, and how and when we monitor success. As we have seen previously, there are four principal areas where facts come from: the human, the equipment, the environment and the system of working. How the investigation is conducted and by whom, and as we shall see ‘when’, affects these four principal areas of investigation and the three methods of intervention. So, four areas of investigation with facts emerging from many different sources: from inside the witness’s mind, from ward records, from engineering logs, etc. How these facts come together to form a big picture needs to be considered in terms of the intervention. A later blog will explain these interventions (after we discuss data and analysis – yay statistics), but for now it’s worth saying the three interventions are called ‘the three ‘Es’. Luckily the three words all start with the letter E so it makes sense. Engineering – The most effective intervention, as the machine keeps the cave dweller from making mistakes. Enforcement – Where someone polices the method of working or the equipment used, in a given environment. Education – the least effective method, which relies on a training course or a poster. “Don’t operate on the wrong side of a patient”. Well I never, what a useful reminder in a theatre. My favourite was at a rail depot. A poster (1 of 80 in the area) said. “Be alert and check the doors”. Really closing the train doors is a good idea… More in the intervention blogs. The why, the who, the what data collected will affect the quality of the facts. The facts collected determine the intervention chosen. The monitoring of success of the intervention is, perhaps, determined by the original hypothesis of the investigator, very early on in the investigation. We may do a blog on bias in investigations. A word of caution. You don’t always do an intervention. ‘Eek’ I hear screamed from every trust. This is because, as we have discussed, an incident is a rare random event with multiple causes. Sometimes an incident, or series of incidents, have occurred due to the random nature of humans and an emerging pattern of data is thought to have been found. This pattern, and these series of events, are, however, just random. So, very early on in this blog, I introduce the idea that ‘when’ an intervention might occur might be never. An example… Lots of crashes occurred along a three mile stretch of road. Detailed investigations revealed no pattern in any of the crash’s causation. The local authority had over £3 million to spend and was determined to spend it (they rightly want to keep their community safe). Well what intervention would you do given that there is no pattern? There is no consistency in the facts and the only pattern might possibly be in the investigators' minds. Given accidents are rare random events, if you do an intervention will it not make it worse? If it makes it worse, how do you reconcile your ‘no pattern data’? A comment was made by the local authority that suggested a pattern existed and we were not good at investigations and human factors. We reviewed the data again and conducted interviews with those involved (at our own expense). Indeed, there was perhaps a pattern. If you were female (most were), you were travelling north (most were), you were in the early stages of pregnancy (most were) – you appear to be involved in a crash. We noted this at home visits and it’s not recorded in the police data. Upon reporting back, the local authority understood that incidents are indeed rare random events and sometimes data emerges with no explanation. The comment from the authority – “So the only intervention is planned parenthood advice a few days before undertaking any northbound journey?” Indeed, that’s the correct conclusion for the data. No intervention was undertaken, and seven years later no incidents have occurred, and we understand the northbound mummies and babies are doing fine. The local authority remains a client after 18 years. It might be the case that (as my reviewer points out) that “maybe there was a factor there, but it went away without intervention (sleepwalking cattle randomly moved to another field further from the road)”. Hopefully, that should show the connection between the philosophy of data collection, its method of collection and by who, and how it affects the intervention and prevention. Also, the benefits of planned parenthood when travelling northbound. Hopefully, I’ve rounded up the last four blogs. So it’s now time to look at the when; like parenthood, it affects the outcomes too! When to investigate? When to investigate is determined by the facts you want to collect, where those facts come from and whether those facts are time sensitive, and your availability and the accessibility of the location. In broad terms, the ‘when’ is affected by two types of evidence: physical stuff and human witness stuff. Physical evidence Let’s start with a photograph. (Warning the image below contains graphic depictions of an older man in shorts!) Image 1: Older man finds the remains of an aircraft converted to a bar and restaurant. Copyright: User Perspective Ltd. Recovering engineering or physical evidence is less time sensitive than information from witnesses. Ward records can last a long time and engineering logs can as well. If you collect evidence from CCTV – that has a life span of 30 days. Generally, in medicine physical evidence is not time sensitive. However, like the image above, it shows that if you leave evidence for long enough someone will change it. In this case they make it into a restaurant. I eat elsewhere as I was sure a fellow human factor person was looking for the crash site! Human stuff – witnesses Most of the facts you collect come from witnesses, aka humans, aka cave dwellers. As we shall see in the ‘how to interview’ blogs, the facts are contained in the mind and it’s not easy to get them out. As you can see in Image 2 below, the decline in the availability of facts is very severe after 20 minutes. In later blogs we can discuss how to interview witnesses and how to get good quality data. Image 2: The Forgetting curve 1885. Copyright: User Perspective and HM Government (for this version). The important bit now is to think about the basic processes of human memory, which are: Perception – information gets into the mind. Encoding – its related to other facts and ‘digitised’. Storage – we need to keep it somewhere. Retrieval. Unless it can be extracted, it’s not useful. Each of these stages is associated with a decline in the quality of data and its retrieval is based on the ability of (in this case) the interviewer extracting it. As we are talking about when, the important thing is to get to those memories as quickly as possible and, certainly in medicine, to ensure that witnesses don’t get to chat to each other. If you want evidence from humans – get it quickly and ensure they don’t talk to each other. How quickly? It’s called the golden 24 hours in accident investigation – even though the graph from 1885 suggests a lot shorter time span. Incidentally, the person(s) reporting the incident needs acknowledgement a lot quicker than the 24 hours. Your availability and access Ideally you are a human factors person with a ‘go bag’. I’ve several ‘go bags’ that contain equipment needed for each domain (road, rail, security) I work in. The road one has green high vis, the rail has orange. The security one has assorted passes and body armour. This may be different in medicine. You might not be the first person called, and you work shifts, the chances of a call in the middle of the night is most likely rare. In other domains access is aided by blue lights and the possibility of handcuffs. Healthcare is different – remember these blogs are about prevention rather than prosecution. However, the point is that every second counts and the sooner you are there the better the data. Summary The facts you collect, how those facts are collected, and by who and when, affects the conclusions you can draw about the incident. Physical data lasts longer than human memory data but, as the picture of the ‘converted’ aircraft shows – things change. Who and when the facts are collected affects the interventions you can use, and the reliability of testing those interventions you trial / test. Human factors people or psychologists are a vital part of the team. They are only part of the team. You should see a pattern. What evidence (when it’s done and by whom) you collect, affects the intervention and its success. With no data you should not do any interventions. Indeed, without data you may not wish to. Remember it’s about outcomes and not just documented processes. In the words of the philosophers – Metallica – “nothing else matters”. Next time... Human factors part 2, or should we do interventions? Like the Star Wars films, these blogs may appear in the wrong order but the final box set hopefully makes sense! Comments welcome young Skywalker. Read Martin's other blogs Why investigate? Part 1 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

I am an avid fan of the show, Silent Witness; pathologists trying to find out how someone was killed just from the body. The deceased is the only witness to what actually happened. So, by looking at the surroundings is the only way of determining what might have happened. I also love watching 24 Hours in Police Custody. This is where they interview the person directly involved in the incident, the people around the time of the incident and the person who potentially did the crime: questioning, piecing together exactly what happened using statements, CCTV footage, verbal accounts of everyone involved. The art and science of investigation is clear. The experience and knowledge of the investigators is quite remarkable. Investigation in healthcare doesn’t seem to work like this. I am a newly qualified nurse. I have been qualified just over a year now. I reported my first Datix last month. I took over the care of a patient from a colleague. I was coming on to a night shift. My patient looked very unwell. I took his observations. He was scoring a 9 on the NEWS2. I put a medical emergency call out. Everyone came, they got him a bit better. They decided he was not going to do well as he was frail and had many comorbidities, they decided to keep him on the ward and if he deteriorated further, he was for palliation. I was pleased I had a plan for him, but I noticed that he didn’t have any observations taken for over 12 hours previously. So, I reported it as a Datix. I marked it as a serious incident. I was worried when I reported it as I didn’t know what to expect. When would someone from the investigation team come and see me? Would I have to write a statement? When would I get interviewed? Will I get into trouble? I waited. The patient passed away peacefully. I forgot all about the report I had made. Six weeks later I received an email. The investigation had taken place. But I wasn’t included. No one had asked me how I had found the problem, the circumstances around the problem or even asked me to be involved. Why? I’m not trained in investigation, but surely being directly involved in an incident I would be asked what had happened and be included in their investigation? The email I received was to inform me of the outcome. ‘’Lessons learnt - Always follow the policies regarding the observation, statement taken from staff involved, practice educator involved with training.’’ I didn’t give a statement. The member of staff who didn’t do the observations made a statement, but not me. The investigation was also ‘downgraded’. What does it take to be a serious incident? This man had no observations for over 12 hours while unwell in hospital. He deteriorated and it wasn’t recognised. I think this is serious. Have others who have worked in healthcare become immune to the seriousness of incidents? As for the lessons learned; what are these lessons? Telling people to do tasks isn’t good enough. I can’t help thinking that healthcare hasn’t got this process right. Is this the same for other hospitals?

Recommendations from the report There should be a single repository of the whole practice of consultants across England, setting out their practising privileges and other critical consultant performance data, for example, how many times a consultant has performed a particular procedure and how recently. This should be accessible and understandable to the public. It should be mandated for use by managers and healthcare professionals in both the NHS and independent sector It should be standard practice that consultants in both the NHS and the independent sector should write to patients, outlining their condition and treatment, in simple language, and copy this letter to the patient’s GP, rather than writing to the GP and sending a copy to the patient. Differences between how the care of patients in the independent sector is organised and the care of patients in the NHS is organised, should be explained clearly to patients who choose to be treated privately, or whose treatment is provided in the independent sector but funded by the NHS. This should include 219 Recommendations clarification of how consultants are engaged at the private hospital, including the use of practising privileges and indemnity, and the arrangements for emergency provision and intensive care. There should be a short period introduced into the process of patients giving consent for surgical procedures, to allow them time to reflect on their diagnosis and treatment options. We recommend that the GMC monitors this as part of ‘Good Medical Practice’ The CQC, as a matter of urgency, should assure itself that all hospital providers are complying effectively with up-to-date national guidance on MDT meetings, including in breast cancer care, and that patients are not at risk of harm due to non-compliance in this area. Information about the means to escalate a complaint to an independent body is communicated more effectively in both the NHS and independent sector. All private patients should have the right to mandatory independent resolution of their complaint. The University Hospitals Birmingham NHS Foundation Trust board should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen. We recommend that Spire should check that all patients of Paterson have been recalled, and to communicate with any who have not been seen, and that they should check that they have been given an ongoing treatment plan in the same way that has been provided for patients in the NHS. A national framework or protocol, with guidance, is developed about how recall of patients should be managed and communicated. This framework or protocol should specify that the process is centred around the patient’s needs, provide advice on how recall decisions are made, and advise what resource is required and how this might be provided. This should apply to both the independent sector and the NHS. The Government should, as a matter of urgency, reform the current regulation of indemnity products for healthcare professionals, in light of the serious shortcomings identified by the Inquiry, and introduce a nationwide safety net to ensure patients are not disadvantaged. The Government should ensure that the current system of regulation and the collaboration of the regulators serves patient safety as the top priority, given the ineffectiveness of the system identified in this Inquiry. If, when a hospital investigates a healthcare professional’s behaviour, including the use of an HR process, any perceived risk to patient safety should result in the suspension of that healthcare professional. If the healthcare professional also works at another provider, any concerns about them should be communicated to that provider. The Government addresses, as a matter of urgency, this gap in responsibility and liability.