Expanding the national list of “never events”

Expanding the list of “never events” will be done according to, and consistent with, the criteria outlined earlier.

There are a number of sources for suggested additional “never events” including the list used by the National Quality Forum in the United States of America, lists used locally by NHS organisations in England, and suggestions from clinical and other experts with the Department and the National Patient Safety Agency.

The Department has used all of these to propose a revised “never event” list comprising 22 events in total, including those already on the list but in some cases suggesting amendments. These are not final and we are seeking comments on the types of incidents listed, their definitions and suitability as “never events”, and whether there are other events suitable for inclusion that we have missed.

Do you agree that the list of events and the definitions that we have produced below should be used for the new “never event” list and that they are consistent with the “never event” criteria outlined earlier?

Do you agree with the inclusion of the events listed below but have suggestions for amending the scope and/or definition of the events?

Do you have any additional suggestions for events and/or definitions to be included on the “never event” list?

In 1. Expanding the list

44 Responses to Expanding the national list of “never events”

  1. Siobhan Teasdale says:

    Do you agree that the list of events and the definitions that we have produced below should be used for the new “never event” list and that they are consistent with the “never event” criteria outlined earlier?

    Yes but the ‘Midazolam’ one needs some definitions around it in view of the large amounts required in ICU patients sometimes.

  2. M Luckmann says:

    No to quite a few of the old and new criteria.

    In general the endpoint “serious injury” is ill defined and open to biased interpretation

    NG tubes in sedated/anaesthetised patients: no sufficiently foolproof way to detect tip position, as all methods can result in errors even if checked carefully

    PPH – still most common single individual factor in perinatal morbidity and mortality. It cannot be reliably prevented and fully controlled under all circumstances, as eg. required blood products (platelets) and a full range or pro-coagulants are not readily available in remote healthcare settings. Reducing a small risk further would require considerable investments to increase ubiquitous and immediate availability of blood product/drugs needed and access to an overall insufficient number of ICU/HDU resources (UK: 6/100,000 vs. EU 12-15/100,000 population). The investments would withdraw resources from other areas of healthcare.

    Oxygen desaturation under anaesthetic. the term General Anaesthetic needs to be clearly defined. Does it apply to out-of-hospital settings, during transfers? A lot of situations do not allow for accurate measurement (SpO2) or clinical observation (cyanosis) of saturation levels, e.g. shock/vasoconstriction, profound anaemia, CO intox, movement/vibration artifacts etc so monitoring may be impossible. Hence desaturation can go undetected. Overall, an unsuitable indicator of unacceptably poor quality of care.

    Intravascular air embolism. Air aspiration during central venous cannulation, particularly in shock/ hypovolaemia and awake/breathing patients are very rare but accepted complications, not indicators of extreme sub-standard care.

    Opioid overdose. There is no accepted strict dose regime for strong opioids, and no accepted/recommend dose limit for opioids. A lethal overdose can happen in a wide variety of clinical situations, e.g. long-term opioids for chronic or cancer pain with pain improving rapidly because of other parallel treatment or spontaneous improvement of condition or patient taking undeclared other centrally suppressing substances. Not a suitable indicator of extreme sub-standard care.

    Very similar to the above said for opioids. Why Midazolam only, what about other injectable (or enteral) benzodiazepines or centrally depressing agents in general.

    The cost penalty: financial punishment should not financially destabilise a provider leading to service reductions or disruptions, where patients suffer in the end.

  3. Gary Cheung, Quality & Risk Manager says:

    Echoing M Luckmann – There is a risk that extending the never event regime to some of the proposed new categories could adversely affect existing, well established preventive structures. For example, the SHOT/SABRE system has been highly effective in reducing ABO incompatible transfusion (and it is logical to seek to extend best practice to other areas of transplant medicine), but depends on the delicate, long fought for “no/low blame culture” that ensures a high level of good quality widespread and objective reporting of events and near misses. In general, large financial penalties have the effect of legalising the risk management approach and can bring pressure to be selective about event reporting, particularly where there is uncertainty about the degree of “imputability” or the definition of “serious injury”. Furthermore, there is a fundamental difference between the NPSA instruction (to rate incident severity according to actual harm) vs. the approaches favoured by the Competent Authorities (potential harm) that can also result in pressure to downgrade severity assessment . If the severity assessment were to be included in any filtering of incidents reported to NPSA with regard to assessment of which incidents qualify as punishable never events this effect could be magnified.
    Now that the NPSA knows it will be transferring its responsibilities to other bodies it ought to be considering how the mandatory reporting process will be transferred so that it meets the requirements of the different bodies, regimes and schemes and so that the good relationships between healthcare providers and regulators are not damaged.
    Whilst the threat of financial penalties has the potential to make more resource available for preventive measures (e.g. blood traceability systems) it should be recognised that transplantation can be a complex area in which ABO/HLA incompatibility is not completely black and white. The definitions need to be absolutely clear.

  4. Simon Bramhall says:

    Please do not forget organ donation. Despite the best efforts of the transplant community we are still thwarted in maximising solid organ donation (and in particular organ donation from brainstem dead patients) by a combination of poor clinical practice on ICUs and family refusal. There is a great opportunity with ‘Never Events’ to put pressure on ICU staf and Hospitals to identify and refer all possible organ donors in a timely fashion. A timely referral would allow appropriately trained individuals to approach families and discuss organ donation and should improve family consent rates.

  5. Graham Brushett says:

    The GMC issued new guidance this year entitled:
    “Treatment and care towards the end of life: good practice in decision making”
    The following points explain the responsibilities of doctors in relation to organ donation:

    81 If a patient is close to death and their views cannot be determined, you should be prepared to explore with those close to them whether they had expressed any views about organ or tissue donation, if donation is likely to be a possibility.

    82 You should follow any national procedures for identifying potential organ donors and, in appropriate cases, for notifying the local transplant coordinator. You must take account of the requirements in relevant legislation and in any supporting codes of practice, in any discussions that you have with the patient or those close to them. You should make clear that any decision about whether the patient would be a suitable candidate for donation would be made by the transplant coordinator or team, and not by you and the team providing treatment.

    In the light of this guidance I believe the ‘Never events’ list should be extended to include organ donation. It is, in my view, a ‘serious untoward incident’ for an acute trust not to refer a dying patient for organ donation if that was their living wish as expressed by signing the organ donor register. If the patient has been diagnosed as brain stem dead and has no medical contraindications that would prevent donation, the patient’s end of life choice to be a donor must be honoured. There is no second chance to put this right after the event. Therefore the failure to refer a suitable donor to the Specialist Nurses for Organ Donation should be added to the ‘Never Events’ list.

    This is not only in the best interest of the dying or deceased patient, but also the 10,000 people waiting for a life transforming transplant procedure. The shortage of viable organs leads to the AVOIDABLE deaths of at least three patients a day waiting for a transplant. A stronger commitment to donor referral would go some way to reducing this unnecessary loss of life.

  6. Caroline Miriam Batchelor says:

    The list could be furrther expanded to include:
    Serious harm/death caused through delayed results of investigations:
    Serious harm/death caused by hospital falls:
    Serious harm/death caused by the developement of pressure lesions:
    Serious harm/death caused through cancelled; delayed operations without a clinical indication.
    Serious harm/death caused due to post operative haemorrhage (tonsillectomies) ENT:
    Serious harm/death caused due to poor nutritional screening and assessment:
    Serious harm/death caused due to dehydration.

  7. Tina Naldrett says:

    in NHS Devon we have been utilising the broad concept of the never event to be creative with our teams and get them to run Foresight activity, creating a culture of prevention in relation to patient safety and quality. These “Never events” have had a community and community hospital focus and have been informed by quality agendas as well as safety ones. Many of the national never events have had an acuity/secondary care focus and it would be supportive to see more with a primary care focus. This is a welcome way of working and is well owned by teams who identify near misses and respond with a never event explored using RCA methodologies

  8. Paul Murphy says:

    I note with interest that consideration is being given to the inclusion of an aspect of organ transplantation into the proposed expanded list of ‘never events’. Whilst I would fully support the proposition that a patient should never receive an inadvertently mis-matched organ transplant, I am firmly of the opinion that similar consideration should be given to situations where no consideration has been given to a deceased person’s wishes to donate organs for the purposes of transplantation after their death.

    It is still the case that hospital staff fail to check the Organ Donor Register in all circumstances where organ donation is possible. This means that individuals who have registered in life a sincere wish to donate organs for the purposes of transplantation after death are being denied this wish through the distraction, neglect or indifference of the clinical staff caring for them during their final illness. I believe that this has a number of unwelcome consequences
    a. the wishes of the deceased are being ignored – a parallel might be a failure to honour a legally sound last will and testament. It was clear from the consultation carried out by the Organ Donation Taskforce that the public were outraged that their wishes might be summarily disregarded by hospital staff in this way
    b. the family of the potential donor are being denied the solace and comfort that donation frequently affords – they view their loved one as a hero, and this should not lightly be denied to them
    c. potential recipients are being denied the opportunity for a life-transforming / saving transplant, whilst at the same time the healthcare economy is being unnecessarily committed to the additional costs of maintaining patients with end stage organ failure. For example, the added costs of kidney dialysis over and above those of kidney transplantation are approximately £250 000 over the average life time of a kidney transplant.

    The direct consequence of failure to increase organ donation rates is unnecessary and therefore premature death of potential transplant recipients, and it is estimated that three people die each day waiting for an organ transplant, and yet potential donors continue to not be identified and referred from our acute hospitals. This is most surely a never event, representing harm for both the potential donor and recipients.

    The Organ Donation Taskforce was clear – and the international evidence from both Spain and the United States strongly supports this – that it is vital that we identify and introduce a metric that encourages hospitals to put in place the systems to ensure effective and timely referral of ALL potential donors, to make donation ‘core business’ to use the terminology of the Taskforce. I understand that the Organ Donation policy unit within the Department of Health has proposed that failure to recognise that circumstances where an individual who dies in hospital with a potential to donate and who is on the Organ Donor Register but does not donate should be considered to be never events. I would support this proposal in the strongest possible terms, since it would mean that acute hospitals would have to put the systems in place to check the register on all occasions, and even in those circumstances where the individual was not on the Organ Donor Register the possibility of donation would be being considered and the medical suitability for donation checked with donor transplant coordination (since the Register is checked via the Donor Transplant Coordinator). Effectively then, this would mean that all potential donors are referred and a discussion regarding donation potential initiated between critical care and donor coordination.

    The ‘never event’ initiative represents a prime opportunity to establish the effective identification and referral of all potential organ donors. I recommend that the benefits of such a system of referral be assessed very carefully, and it would certainly receive my full personal support.

  9. Denis Wilkins says:

    The list seems reasonable to me. Death from haemorrhage after elective caesarean haemorrrhage is outside of my field of expertise.
    Organ Donation: I chair an Organ Donation Committee and for many years before retirement worked as a kidney transplant surgeon. I have followed the ups and downs of cadaveric organ donation and we seem to have reached the limits of the approach by persuasion of hearts and minds. I generally dislike rules and regulation, but in this case am in agreement with the suggestion that failure to approach a next of kin in the circumstances of potential organ retrieval is a serious untoward event and should, therefore, be classed as a ‘never’ event.

  10. Huw Twamley says:

    The organ donation register is a clear indication of a person’s wishes to donate organs when they die. Failure to check the register and refer for consideration of organ donation contravenes guidance concerning end of life issues. In addition to this, there are patients dying on the transplant waiting list due to NHS organisations failing to identify suitable donors. Simple systems have already been shown to be effective in trusts throughout the country in addressing this problem.
    If misplaced NG tubes can be on the list, then why can’t an event that is resulting in daily deaths be added.

  11. Keith Rigg says:

    I am commenting on behalf of the British Transplantation Society.
    We would like to propose a new ‘never event’ that a person who is on the Organ Donor Register and who does not have an absolute contra-indication for organ donation and who dies without having been referred for consideration of organ donation.
    Under the Human Tissue Act 2004 the wishes of the deceased in life are paramount and this is of particular importance in organ donation. There are various ways that an individual may express their wish to be a potential organ donor in life, but this is usually by registering on the Organ Donor Register and/or discussing it with their family. It is therefore important that health care professionals caring for patients who are potential organ donors should refer these patients, unless there is an absolute contraindication. The referral of potential organ donors is also part of best practice in end of life care, as laid down in the End of Life Strategy. There is data from the Potential Donor Audit to show that not all potential donors are currently being referred and this will have some impact on the 10000 people awaiting a transplant in the UK and the 1000 people who die per year whilst waiting.
    We believe that this meet all the criteria for the establishment of a ‘never-event’ and are happy to provide further information if you require.

  12. Dr Martin Walker says:

    I am an Intensivist and a Clinical Lead in Organ Donation. My view on the addition of the referral of potential brain stem dead organ donors on the Organ Donor Register to a specialist nurse as a never event is that it is a laudable aim, but is based on some incorrect premises that result in this event not yet satisfying the criteria for a never event.

    Crucially the proposal as circulated to many of us involved and posted here does not clarify the consideration of donors after cardiac death or donors after brain death. Currently only donors after brain death could be considered for this never event and I understand that is the aim of the proposal, although this is not made very clear. Likewise the proposal is only applicable to patients admitted to a critical care unit

    The spirit of the never events is preventing events that cause harm or death to an individual patient rather than to a third party remote to the event in time and place. Not following patients’ wishes does cause them harm, even if they have unfortunately died despite active treatment, but the risk to patients on transplant waiting lists introduces a third party, which is not within the spirit of these events. There is evidence of occurrence in the past, but the exact extent of occurrence is uncertain due to inaccuracies in the data source (The Potential Donor Audit or PDA run by NHSBT). NHSBT themselves acknowledge these inaccuracies. There are enormous problems defining the type of patient being considered and at present the definition of a potential donor is made in retrospect by a specialist nurse inputting data in to the audit not contemporaneously following discussion with a clinician, this results in several situations where patients are currently described as being probably brain stem dead when that isn’t the case. However there are still cases who have brain stem death tests performed and are not referred to a specialist nurse. If a patient is brain stem dead there are several reasons why non-referral may occur, including families volunteering their refusal of donation, extreme cardiovascular instability, Coroner issues, medical contraindications, bed pressures and age. Getting this issue wrong risks alienating critical care staff, causing severe capacity issues with prolonged ICU stays and causing conflicts of interest between the care of a potential donor and a live patient. The national guidance is therefore not adequate on how this event can be avoided as the definitions are not fully clarified or recorded. This also results in it not being easily defined, identified or continually measured.

    In communications to interested parties NHSBT staff have acknowledged the inaccuracies of the PDA and asked us to expose the problems. Well many of us involved as Clinical Leads have done so since its first version was designed. Unfortunately the suggested changes have not been made nor have the relevant analyses exploring the problem been performed. If organ donation rates and numbers of transplanted organs are to continue to rise we need the support of accurate and comprehensive data of why donation doesn’t proceed and why organs are not accepted. Armed with that information we will be able to define missed cases accurately. As yet the PDA does not fulfil this role and detailed analysis of other NHSBT databases and sources of information is required. After that the criteria for never events may be fulfilled, but they certainly are not at present. Only then should we consider making non-referral a never event with a concise and reproducible definition of what a potential donor is. Even better is to use this information and define an “ideal” donor to use for the never event.

  13. Kay Hawkins says:

    I am writing as a Paediatric Intensivist and as the Clinical Lead for Organ Donation at my Trust. I would like to see as a new “never event” – A person who is on the Organ Donor Register and who does not have an absolute contraindictaion for organ donation and who dies without being referred for consdieration of organ donation.
    Every year in the UK 1000 people die waiting for a life saving transplant. People on the Organ Donor Register have expressed their wish to donate organs in the even of their death, to give the gift of life. Their wishes should be fulfilled, and the potential for organ (and tissue) donation explored. I believe this new “never event” meets the criteria for inclusion on the list.

  14. Linda Stewart says:

    Re: Keith Riggs commenting on behalf of the British Transplant Society about making the death of a patient who is on the ODR without referral for donation a Never Event. Most (if not all) of us in ITU believe this is appropriate after a diagnosis of brainstem death has been made. However, in his statement, not only does he not directly mention that this should apply only to Donation after Brainstem Death, but there is no indication that he is only referring to ITU patients. Does he think everyone on the ODR who is dying(either in hospital or not) should be stabilised to allow donation? Without even getting into the ethical and legal aspects of this, where are all the extra ITU beds required for such an undertaking going to come from? The Intensive Care Community is working really hard towards improving the number of donors. This has involved a great deal of time and effort on the part of the SN-ODs and CLODs. This proposal has the ability to undermine all that hard work. The suggestion from Simon Bramhall that we need “to put pressure on ITU staff” is insulting and shows a complete lack of understanding of the whole donation process. The Potential Donor Audit (I assume the medium that Keith is using to identify missed donors) is fundementally flawed. It vastly overestimates the number of missed donors, the majority of whom are not appropriate for referral, because it does not ask the “right” questions. It requires urgent revision to reflect the true status in intensive care units throughout the country. This has been pointed out to NHSBT and the British Transplant Society time and time again, although to date they have refused to take action. The suggestion from what I’m reading here, is that ITU’s are all to blame for the organ shortage. Those of us who work in donation know that this is far from being the case. What about surgeons not being able to agree on basic criteria for accepting or refusing organs, not making the decision to accept /refuse organs in a timely manner, and on some occasions not being available to retrieve organs when referred (an incident which has occurred recently in my own hospital and led to a “missed donor”). Can I suggest 2 new Never Events of my own :
    1) All organs to be placed within 4 Hours of patient review by a SN-OD. These patients are all potentially unstable. We know after BSD cardiac arrest can and does occur with full haemodynamic support , therefore provarication on this matter cannot be allowed to conitnue.
    2) No patient should be turned down as a donor because of lack of a retrieval team.

    I am a CLOD and Lead Clinician in Neuro Intensive Care.

  15. p smith says:

    Clear potential for or has caused severe harm or death – I assume this includes the many PCTs now refusing treatments for:
    examples and not full – refusal to agree to cataract surgery, patient falling as unable to see; refusal of referrals for assessment of airway obstruction resulting in harm from sleep apneoa (children and adults); refusal in ‘routine’ orthopeadic procedures such as hip replacement resulting in patient being unable to undertake daily care, severe pain, falling and fracturing hip; refusal of tonsillectomy assessment in relation to recurrent infections and airway obstruction; refusal of consultant to consultant referral resulting in preventable significant morbitity and potential death; refusal to agree with clinical decision that follow up required in secondary care resulting in potential sub optimal care of chronic condition requiring expertise; severe anaemia caused by refusal of PCT allowing assessment and treatment for menorrhagia. The list of situations published by PCTs is very long and should be referred to as many on the list, if not undertaken, could and possible would result in CLEAR POTENTIAL FOR HARM/DEATH.
    failing to enable patient to feed after assessments because no one available to aide patient

  16. Martin Ward Platt says:

    I am a paediatrician & specialist in neonatal medicine, as well as the risk management lead for the maternity service.

    The criteria:
    • The incident has clear potential for or has caused severe harm/death.
    - “potential” is too slippery a criterion, and depends on the fertility of people’s imagination. The incident MUST have a track record for severe harm or death.

    • There is evidence of occurrence in the past (i.e. it is a known source of risk).
    - Fine – this excludes the problem with the word “potential” above. I would use this criterion alone, but say ‘There is evidence of the occurrence of severe harm or death in the past.’

    • There is existing national guidance and/or national safety recommendations on how the event can be prevented and support for implementation.
    - You need more than ‘national guidance’ or even ‘recommendations’, some of which are just consensus statements. There must be solid observational or trial evidence that a preventative strategy actually works.

    • The event is largely preventable if the guidance is implemented.
    - this comes down to the need for hard evidence as stated above.

    • Occurrence can be easily defined, identified and continually measured.
    - Absolutely. No room for woolliness or ambiguity.

    The present events:
    • Misplaced naso or orogastric tube not detected prior to use.
    - The problem with this, highlighted by others, is that there is no certain strategy for preventing it. The problem is even greater in neonates, where the use of tube feeding is extensive and stomach pH is particularly unreliable.

    My suggestions for additional events:
    • Implanting the wrong embryo in a fertility service
    • Giving a baby to the wrong mother in a maternity service.

    Proposed events:
    I agree with “Death or serious injury arising from the inadvertent administration of ABO/HLA- incompatible blood or blood products or transplant of ABO/HLA incompatible organs”, but blood and organ transplants should be two separate categories of ‘never’ event as they are controlled by rather different systems. In fact, the “death or serious injury” should be taken out of the definition: wrong blood or wrong organ should just never happen, regardless of the consequences.

    “Death or serious injury as a result of a healthcare professional’s prescribing, preparing or administration of insulin in overdose, or his or her failure to prescribe or administer insulin when clinically indicated in a healthcare setting.” This is problematic because the ‘clinical indicated’ bit is highly controversial, especially in relation to glucose control in non-diabetic patients in intensive care, coronary care, and neonatal intensive care settings; and the fact that indications could extend to the management of hyperkalaemia. Furthermore there is no evidence based, foolproof system by which errors in insulin prescription or administration can be prevented. The most important safeguard is in fact patient monitoring, but only intermittent measurement is currently available in most clinical settings, and until continuous monitoring systems are both widely available, and proven to reduce harm, this avenue cannot be recommended.

    “Death or serious injury associated with the use of wrongly prepared high risk injectable medication, including dose, when the error occurs in the healthcare facility preparing and administering the medication”. This fails the test of having hard evidence for an effective preventative strategy. It is well known in the risk management literature that the preparation of any medication can be a complex act and that a wide variety of factors contribute to errors, so this category of events does not lend itself to being ‘never’ on the proposed criteria.

    “Death or occurrence of kernicterus associated with failure to identify and treat hyperbilirubinemia in neonates”. This is not well thought through. First, kernicterus is not uncommon as a pathological finding at autopsy in very preterm babies dying predominantly of other causes, such as septicaemia. Second, levels of bilirubin well below the currently recommended action levels can lead to kernicterus even when a baby is not yet recognised to be unwell: the only two clinical instances in our service in the last 20 years (and in a cohort of around 100,000 babies) both occurred in mildly preterm babies who rapidly developed systemic infection in association with very modest levels of jaundice, and it is hard to see how any strategy could have prevented either of these. Third, much severe jaundice now occurs in the community as a result of the much earlier discharge of babies from maternity facilities, and babies will at most be seen just once a day by the community midwives, so detection of severe jaundice is likely to take longer than if the baby was on a postnatal ward. Furthermore there is very little relevant evidence for so-called ‘action levels’ in relation to neonatal jaundice. Most of the data are derived from babies with rhesus D haemolytic disease from more than 40 years ago, but rhesus disease is now almost unknown, most term babies with jaundice do not have any underlying pathology, and there is hardly any evidence relevant to the very preterm population we now routinely manage. Any guidance that increases the rate of invasive treatment such as exchange transfusion risks substituting the very real hazards of exchange transfusion – which ironically include air embolism, but also encompass infection and haemorrhage – for the much rarer risk of kernicterus. Kernicterus is very rare, but it will never be ‘never’.

    “Death or serious injury arising from overdose with opioid medicines where the dose of opioid given was inappropriate to the patient’s condition and needs.” This is too woolly to be a useful definition, and fails several of the proposed criteria.

    “Death or serious injury arising from overdose of midazolam injection.” You can’t say “all care settings” if the guidance relates only to adults. There appeared to be no children involved in the reported errors, and importantly, no deaths in any age group. I can’t see what makes midazolam different from many other drugs that are potentially dangerous in overdose, and unlike many others (but like many opioids), there is at least an antidote. As with opioids, the suggestion fails the criteria for ‘never’ events.

  17. Peter Ware says:

    As a non-medical Organ Donation Committee member, I would have strong reservations about extending the list in the way proposed, mainly on the ground of existing ethical safeguards, and the avoidance of ‘disciplinarising’ the organ donation area. We need to change the culture, and this is not the way to do it.

  18. Stephen Drage says:

    I do not agree with the proposed inclusion of non referral of potential organ donors as a ‘never event’ . I am a Clinical Lead for Organ Donation and also a lead for patient safety in my Trust. The reasons for my objection have been eloquently put by Martin Walker. As it is proposed this move may be counterproductive and harm relations with critical care staff and reduce the credibility of other ‘never events’.

  19. Keith Rigg says:

    I wanted to clarify my previous comment and of course I was only referring to those patients dying in a hospital environment with a diagnosis of brainstem death. This will nearly always be within critical care although the Potential Donor audit is now recording the potential donor pathway in Emergency Departments. Apolgies for any confusion caused in my previous comment.

  20. Dr Anthony Warley says:

    The regrettable part of this very important debate is the premise that it is only the threat of financial punishment that will result in the hoped for improvements in donor referral rates. More so, probably, than in any other country, the medical profession in the UK are increasingly hidebound by rules and strictures that frequently override professional consideration and opinion. In this instance we are being threatened rather than encouraged to spread good practice.

    Whilst believing absolutely that we should all strive for non-referral of suitable donors to indeed be a ‘Never Event’ in each of our hospitals, I consider the threat of financial penalty in such circumstances another erosion of professional decision-making which we should not support.

    Approaching a family for donation as a professional who believes in donation is one thing. Approaching a family as a representative of an organisation that must avoid financial penalty is quite another.

    Furthermore at a practical level, and has been pointed out by several others, the proposal is not completely clear.

  21. Richard Nelson says:

    Can I start out by saying that I am both an intensivist and a Clinical Lead for Organ Donation. While I support the idea that reference to the wishes of the deceased, or soon to be deceased, concerning organ donation should always occur, I am not sure that this opinion is shared by the entire critical care community under all possible circumstances. As such I do not consider that this can be construed a “Never Event”. The current list of never events is not-contentious, so there is near universal engagement in working to eradicate them, but I fear that putting organ donation into that category might risk alienating the very people with whom we wish to engage. I have colleagues who resent immensely being told what to do, but who are incredibly pro-active in cases of possible organ donation. There may come a day, and I hope it will be soon, when the overwhelming majority in critical care will be willing to commit to this standard, but I think we need a year or two of increasing acitivity and better feedback on failed donations before we can expect some colleagues to do anything other than bristle. So I’m for it in principle, but against it in practice as I fear it will do more harm than good at this stage.
    Richard Nelson: CLOD Countess of Chester NHS Foundation Trust

  22. Richard Nelson says:

    Can I suggest that one worthwhile target would be the avoidance of death or cardiac arrest during transfer of a critically ill patient between hospitals when the transfer is being made for non-clinical (insufficient beds) reasons. As fatal events in the ambulance are rare, and patients may undergo catastrophic deterioration during an ill-advised transfer without actually dying, perhaps the definition might be extended to a short (4 hours?) period after arrival in the recipient hospital. Such a recommendation should be balanced by another that death of a patient identified as suitable for critical care should not occur before admission to the critical care unit unless the death is a result of a planned withdrawal of life-sustaining care, otherwise the temptation would be to keep patients for too long in a site off intensive care rather than transfer.

  23. Christine Usher says:

    Consider adding “serious harm caused due to treatmetn of the wrong individual” – this could be harm to the person who was treated or to the person who should have been treated. There should be a threshold of harm caused to exclude trivial cases, like outting a sticking plaster on the wrong person, and there probably needs to be something that allows fro the presumably rare case when a person deliberately misleads the health professional about their identity.

  24. Dr Karl-Heinz Blenk says:

    I would strongly advocate to include the failure to refere a potential solid organ donor to the organ donation coordinator among “never events” when the name of the patient concerned is on the organ donor register!
    Such an ommission clearly meets the “Never event” criteria:

    It undoubtledy causes harm insofar as it:
    - denies the donation patient his/her will
    - denies the recipient a life saving/health improving procedure
    - denies the society the finanial benefit of a cost effective intervention

    There is clear evicence of occurence in both the past and and the presence.

    There are clear recommendations from both NHSBT and the “Map of Medicine” clinical pathways how to avoid the event.

    Implementation of these giudelines can easily prevent an omission to make a phone call to the organ donation coordinator

    The occurence can easily be defined because the Specialist Nurse Organ Donation (SNOD) will review all cases in which treat ment on ITU has been withdrawn. It will be very clear from the notes if
    - an absolute contraindication was present

    and the SNOD will know/be able to extablish if:
    - a referral has been made
    - the patient was on the organ donation register

    If the ommission to refere an elegible patient, who is on the organ donation register to the organ donation coordinator therefore meets the criteria for a “never event” the only arguments against inclusion I can extract form other postings are:
    - potential alienation of ICU staff
    - potential alienation of relatives

    Even ii either of this was a byproduct of the elevation of non referral to the status of a “never event”, alienating some colleagues and some relatives, who for whatever reason object to the wishes of the patient concerned, seems infinitely preferable to alienating the potential donor on the ODR or the potential recipients.

    Dr Karl-Heinz Blenk
    James Paget University Hospital Foundation Trust

  25. Cheryl says:

    ABO compatible.
    I am a transfusion practitioner and have spend a long time teaching nurses/medical staff/ midwifes- and anyone else involved in the blood transfusion process the importance of following the basic steps involved to get the process right, as set out by the NPSA. Everyone that I teach agrees that the process of getting the right blood in the tube, with the right patient details and the right request card is easy but still mistakes happen. The Lab staff at the Hospital where I am based frequently comes across patients whom have totally changed blood group??? (as we know this doesn’t generally happen- so it’s a case of wrong blood in tube or wrong patient details) and so these patients could potentially be given an ABO incompatible transfusion- it would appear to me that despite NPSA guidelines the message is still not getting though- this issue needs to be brought to the forefront of the medical world and action needs to be taken. I believe that staff involved in such an incident, whom have received training in the past 12 months, should be heavily penalised and adding this issue to the “never events” list would help to do this. With everyone involved in the transfusion chain from the bleeding to the infusion, I can not understand how these such events do still happen and I do not believe it is down to in complacent staff, or lack of training- more staff members who think they are infallible and can cut corners- we as an organisation should get the message across cutting corners does cost lives and this is not acceptable.

  26. Kate Pendry says:

    Continuing the blood transfusion theme, I would like to suggest as a never event: death due to delay in provision of blood in an acute situation. This topic is covered in the NPSA RRR017 published October 2010 – the details would need to be thought through very carefully for example what is the definition of delay, should this cover just red cells or other blood components as well. It is also difficult to estimate the impact of delay in blood / blood components on the eventual outcome for the patient given that the patients are in a life threatening situation already
    Consultant haematologist with interest in transfusion

  27. Mr Liaqat Chowoo says:

    I am a consultant urologist.
    From time to time I come across a patient who attended A&E with testicular pain and was discharged with a provisional clinical diagonosis of epidedymorchits etc
    After a day or two he is readmitted and confirmed to have a dead testicle secondary to Torsion of testis.
    In the modern world of advanced imaging, I belive this should not happen and should be labelled a “never event”
    Colour Dopler sonography picks up torsion with very high levels of sensitivity.
    If middle grade doctors in A&E or Surgery are trained to do this investigation, losing a testicle secondary to torsion can be mostly avoided.

  28. David Wood says:

    I am an Intensivist and CLOD and have become concerned that the attempting to use the financial penalty based approach of never events will undermine and negate many of the gains that have been made in Organ donation through the current initiatives.

    Donation is an act of giving.

    All clinical staff can appreciate this simple concept and generally accept that meeting / supporting a patients wishes in this matter is good practise. The focus of our campaign has to be that consideration of Donation is a normal part of our care for the dying, this simple message will do more to encourage the laggards than any whip.

    I wholeheartedly agree with Linda Stewarts comments that improving the consistency of response from the Transplant Surgeons would send a much stronger positive message.

  29. Hadrian Ball says:

    I am medical director of Norfolk and Waveney Mental Health NHS Foundation Trust. I am very concerned about the proposed new event status for death or serious disability arising from restraint in a mental health care setting. I was heavily involved in the events leading to, and in, the public inquiry into the death of patient David Bennet (2003). I have also published an article on aspects of the cause of death during restraint.
    A never event is an event that should not happen if an environment is being properly managed and acceptable standards of care are being applied. Unless there has been a significant addition to the knowledge base recently of which I am unaware, our understanding of the mechanisim of death during restraint is very incomplete. It seems illogical, therefore, to expect a provider to prevent an event, the cause of which is unknown. Additionally, there would be a major implication for the immediate availability of medical (ie by a doctor) cover so that an alternative to manual restraint (tranquilisation – which in itself is associated with dangers) can be provided. For reasons I make clear in my 2005 article (Death in Restraint – Psychiatric Bulletin) the community nature of modern mental health services renders this virtually impossible in some parts of the country. It appears that all of the known and uncertain risks associated with the manual restraint of patients are to be carried in their entirety by provider units.

  30. Angus Vincent says:

    On behalf of Newcastle upon Tyne Hospitals Donation Committee. We support the application of “Never Event” to the situation as described in Chris Rudge’s recent clarification, namely failure to refer a brain dead patient on ITU, on the ODR with no absolute contraindication to donation. Additional points raised by our group did highlight the potential difficulty of who reports this event should it occur – it has the potential to strain relations should it be seen that a SN-OD reported a unit for failing in such a situation. However, as for other never events, it should be accepted as a professional duty for teams to report.

  31. Dr Giles Morgan says:

    Adding failure to identify potential non-heart beating organ donors to a list of “never events” does nothing to encourage a culture change regarding organ donation. “Never events” are supposed to protect the primary target of medical and nursing care, not an unidentified third party who might benefit some way down the line. There must be better ways of ensuring that potential donors are identified without recourse to this sort of occult and rather vulgar coercion.

  32. Further to the publication of the consultation/discussion document Expanding the list of “never events” the Thermostatic Mixing Valve Association is responding with a proposal to DoH for an additional “never event” to be included to cover Death or serious injury arising from scalding. This additional “never event” meets all of the listed criteria in that:
    • It has clear potential to cause severe harm/death – In healthcare properties, hot water is circulated at ~60oC. Healthy adult skin requires 30 seconds of exposure to water at 54°C – 55°C before third-degree burning occurs, but only 5 seconds at 60°C and less than one second at 70°C. However, the skin of children and the elderly is even more sensitive to extreme temperatures
    • There is evidence of occurrence in the past – Every year around 20 deaths occur from scalding and around 600 serious scald injuries are suffered
    • There is existing national guidance on prevention – NHS Model Engineering Specification D08 (Thermostatic Mixing Valves – healthcare premises); Hospital Technical Memorandum HTM04-01 (The control of Legionella, hygiene,“safe” hot water, cold water and drinking water system); Hospital Technical Memorandum HTM64 (Sanitary assemblies), Health Guidance Note (“safe” hot water and surface temperatures). Building Regulations-Part G3 (Prevention of Scalding) .
    • The event is largely preventable if the guidance is implemented – Adherence to the relevant guidelines alongside suitable patient handling and care guidelines will serve to minimise the likelihood of scalding accidents for both patients and staff
    • Occurrence can be easily defined, identified and continually measured – scalding incidents are easily defined and identified and can be easily measured and recorded as such
    The storage and distribution of high temperature hot water in healthcare premises is used to combat the proliferation of legionella and as such there is a need to control the temperature at point of use so that it is discharged at a safe temperature for hand washing and bathing. Thermostatic Mixing Valves are used to manage the water discharge temperature at a safe and controlled level but there will also be a need for good patient care processes to be in place to also check drawn water temperature before introducing patients into the water. It is this combination of appropriate technology (Thermostatic Mixing Valves) with good practice (patient care) which will minimise the risk of scalding in healthcare properties. This is particularly relevant to the more vulnerable patients (children, older people, or the infirm).
    Unfortunately, despite the wealth of guidance available, scalding incidents still occur and therefore including scalding as a “never event” would help to highlight their happening and would ultimately be another tool to help eradicate them in the future.
    Including scalding as a “never event” will help to prevent this type of tragedy and the associated suffering to patients and their families.

  33. NHS Swindon says:

    1. We agree with the expanded list of events and the associated definitions and also that they should be used in a revised “never event” list. They all appear to be consistent with the “never event” criteria.

    2. We suggest that consideration should be given to “Death or serious disability as a result of a healthcare professional failing to make a record of contact within a patient’s notes”.

    3. With regard to cost recovery, in our opinion is that it should not disadvantage smaller providers and consideration should be given to the formulation of an economic model which assures equity.

    4. Incentives to promote better and safer practices should continue via a more rigorous CQUIN framework. This would allow commissioners to allocate incentive monies that fit with the quality profiles of their local providers.

  34. Dale Gardiner says:

    As an investigator in my Trust of a recent never event I am struck by two points:

    1. Preventing a never event is an unemotional state – if you follow the designated technical process the never event will not happen (or as close to will not happen as is humanly possible)

    2. Once a never event does occur it is a very emotional state for those involved – no one sets off to work with a plan to commit a never event. Additionally the investigation and financial sanctions are punitive.

    As a Clinical Lead for Organ Donation I can not see how the first point can be applied successfully to deceased solid organ donation and I can not see how the second point will support and improve donation activity.

    Dealing with the dead and dying is not a technical process – there is no simple how to guide. It is about people and it is never unemotional. The previous comments by others reflect the controversial and divisive feelings people have toward classifying failure to consult the organ donor register as a never event. Never events should not be controversial and divisive. Never events should have no areas of grey but be black and white. Yet grey is the predominant colour when one considers the ethics of dying.

    When a never event does occur it is a very emotional state for those involved, especially when the investigation and punitive sanctions are raised. In practice who will discover a never event on organ donation has occurred? It will be the specialist nurse for organ donation. Who will be the most likely to have committed the never event – it will be the consultant intensive care doctor. A prime objective for embedding specialist nurses onto intensive cares is to foster the relationship between intensive care staff and the specialist nurse. A never event around organ donation will be disastrous for this relationship and detrimental to future donation activity.

    As both a clinical lead for organ donation and an investigator of never events, I can not support an expansion of never events into areas of organ donation.

  35. Helen Goodwin says:

    I am responding on behalf of East Kent Hospitals University NHS Foundation Trust and the Trust Patient Safety Board. In principle, there are no issues to expanding the list however; the endpoint “serious injury” is ill defined and open to biased interpretation. In order to define an incident as a “never event” such ambiguity must be clarified. This is more evident in the proposed never events involving medication. Specifically, the one open to interpretation relates to insulin.

    Whilst it is easy to define an insulin overdose, the failure to administer insulin is less clear cut, and assumes knowledge that the patient is diabetic. This is not always the case in an A&E setting, where individuals may present but be unable to give a history and may have no next of kin present. Standard practice would be to do a blood glucose on all majors but unfortunately there is sometimes a delay. There are other major concerns with this proposal, which while appearing reasonable superficially, has implementation issues which put the Trust at risk through failures of other parties. Our own safety monitoring has identified that trigger root cause is usually a prescribing or transcription error by doctors in training. It is impracticable to restrict the prescribing rights of all new doctors to the Trust until the Trust has quality assurance of their training and application of the multiple domains relevant to safe insulin prescribing. Indeed recently it took three months and four tests to retrain a doctor identified as having specific weaknesses in these domains as we do implement such testing on new F1s. We have learnt that other Trusts no longer undertake such quality assurance, on the grounds that this is now an expected domain for delivery by UK Medical Schools to meet GMC requirements. However our own experience has shown that over 10% of the 2009 UK graduates do not process safe insulin prescribing skills.

    Further with the PCT and local providers we have had to address two incidents within the last 3 months where MARs charts forwarded by care homes were misinterpreted to indicate patients were on 100 Units/insulin in 24 hours and 300 Units/insulin in 24 hours. While both incidents were detected before patient harm, it was the practice of other providers that produced medication records able to be misinterpreted and again both doctors involved were senior enough trainees that it could have been assumed they would have been familiar with dosing of insulin due to prior training elsewhere.

    We also note that this proposed metric is actually two separate never events, as the failure to prescribe/administer insulin leading to death or serious injury is a failure of clinical management and incident of omission rather than commission. In effect it is a failure to prevent serious ketoacidosis or hyperglycaemic states. Why choose in particular diabetes mellitus associated omission/diagnosis events? There are plenty of other chronic diseases where problems can arise with omission/failure to diagnose. Is this metric going to produce desired effect? How common is this event? None of the sources provide this data. If it’s going to be a never event we need to be clear if it only relates to previously diagnosed insulin dependent diabetics only.

    Our considerations have also identified the issue of wrong insulin is so common that preventing the never event aspect has a greater element of chance and may not reflect usual excellent safe practice in a Trust. We have had acutely confused patients self administering their own undeclared insulin at inappropriate dose for example.

    Daily administration of oral methotrexate for non-cancer treatment or provision of oral methotrexate for non-cancer treatment with the instruction to take daily – should be changed to read “Death or serious injury resulting from daily prescription/supply or administration of oral methotrexate for non-cancer treatment or provision of oral methotrexate for non-cancer treatment with the instruction to take daily in all health settings.” Our own experience at moment would be otherwise we would generate one or even more reportable events in a year when we have had no harm episodes as to date our multiple redundant safety practices have worked internally to prevent harmful dosing.

    Death or serious injury arising from overdose with opioid medicines where the dose of opioid given was inappropriate to the patient’s condition and needs – Difficult as may have subjective element even in well regulated medical practice. It is also difficult because of variation in individual metabolism, drug interaction etc. It is not an appropriate never event. Indeed may lead to under treatment of severe cancer pain etc.

    A comment from the Medical Director, a paediatrician, on the proposed Kernicterus never event, is “these babies can develop significant jaundice after discharge from hospital and the symptoms may not be apparent until much later”. Echoing the feedback from other neonatologists, the issue of NG tube detection in neonates is problematic and making this a “never event” may not be feasible.

    Other possible “never events” could include a newborn discharged to the wrong person, or abduction of a newborn from the hospital.

  36. Tod Guest says:

    Written on behalf, and with the full support, of the Consultants in Intensive Care, at The Royal Cornwall Hospital.

    We wholeheartedly support the aims of improving successful organ donation rates to enhance both the lives of the thousands of patients on the transplant list and the end of life care for potential organ donors registered with NHSBT.

    Of 315 hospitals listed in England, Wales and Scotland, ours ranks 34th with 16 donors over the last 3 years (of the 33 ranking higher, at least 26 are Neurosurgical service providers – we are not).

    However we feel compelled to make the following comments.

    We have discussed and considered the proposal to make non-referral of all potential organ donors to the SN-OD a never-event, and strongly hold the belief that this is an inappropriate and potentially damaging use of this system.
    We agree with many of the arguments outlined in previous comments opposing the proposal, in particular those of Martin Walker and Linda Stewart.
    The suggestion that more pressure should be put on clinical staff (through financial penalisation of the trust) to increase donation rates is in our opinion, likely to alienate the very people who can make a real positive difference to organ donation. Furthermore, we are concerned by the language and inferences in some of the comments on the DOH forum which suggest that the practice and attitudes of frontline critical care staff are, on occasion dismissive, disinterested and laissez-faire towards organ donation and provision of high quality end-of-life care for our patients.

    We have major concerns that this proposal would:-
    • Result in potential clinical conflict of interest between providing the best care for all our ICU patients and avoiding the never event, in direct opposition to our primary duty of care as stated in Good Medical Practice.
    • Force the Trust executives to put pressure on clinicians to avoid the costly never event, compounding the strained clinical engagement process.
    • Distort the ethical decision making processes central to end of life care of some critical care patients.

    As has been previously mentioned, there have been concerns raised by many regarding the validity of some data in the NHSBT PDA. This has been borne out in our experience through our regular M&M meetings with our CL-OD. We therefore do not feel that it is fair or reasonable to use the data as it stands to underpin the Never Event proposal.

    Being a geographically relatively remote hospital (Birmingham, our current provider for organ retrieval is 250 miles by road) the time from referral to a SN-OD to being able to take the donor to theatre is generally at least 12 hours. In our experience this has resulted in relatives having agreed to organ donation, subsequently withdrawing their agreement due to being unable to cope with the drawn out dying process of their loved one. Being pressurized into this process when we would have normally chosen not to enter into it will not result in more relatives gaining solace from the knowledge of their loved ones heroic act of giving, but risk creating a negative reputation for the process in the eyes of the general population. We would welcome further development of transplant team response times in this regard.

    In summary, although being ardent supporters of improving organ donation processes and rates, we do not support the proposal to include non-referral of potential organ donors as a never event. Before this can be considered a reasonable suggestion, we believe that the processes in place for organ retrieval must be better structured, with greater transparency regarding decisions to transplant organs or not from those referred. We would welcome progress in resolving known issues with the PDA, and suggest that NHSBT need to look at their own performance indicators before applying punitive processes to those striving for excellence at the clinical sharp end.

  37. On behalf of Director of Nursing says:

    Barnet & Chase Farm Hospitals NHS Trust collective response – we are in agreement with expanding the list. We believe it is a positive step to improving patient safety across the NHS.

  38. Carole Berryman says:

    Do you agree that the list of events and the definitions that we have produced below should be used for the new “never event” list and that they are consistent with the “never event” criteria outlined earlier?
    YES for all providers.
    NHS cost recovery will, of course, be different from the legal costs of such an occurrence, but providers will be liable for both. Where long term damage is involved, with very high future care costs, then compensation will be proportionately higher. Any small care provider has to insure against these events and the risk of litigation, so presumably care providers will take out a similar policy to cover never events and the financial consequences – legal or in terms of commissioning. Never events result in very poor outcomes, and do nothing to contribute to efficiency or productivity gains, so the providers should rightly carry the risk, and be incentivised to minimise it at every opportunity.

    Do you agree with the inclusion of the events listed below but have suggestions for amending the scope and/or definition of the events?
    The contracting arrangements will have to align with data capture and “SIRI” reporting systems. One concern might arise where providers cover up the event – or at least the “near misses” – so reducing financial penalties or censure, especially where high medico-legal costs may align with commissioner penalties. This will not help openness, and learning from mistakes or near misses. It helps if routine coding systems can be used consistently to flag these events clearly and accurately, as well as the mandatory reporting systems being used to monitor these events.
    This must be implemented in a totally transparent and consistent way. For this reason the definition of never events must be absolutely clear. Given the expanded list, special care must be taken to define the never events very clearly, especially where a spectrum of events is possible – like in the proposal for never events relating to insulin administration, where there may be room for different clinical interpretations as to when insulin is absolutely indicated or not.
    Please can the list be more explicit when defining wrong site surgery? Does this include the correct vertebral level during spinal surgery? There is no national guidance on finding the correct level for spinal surgery so does this preclude it? Does wrong site include vertebral levels or not? Does it include dental – removing the wrong tooth?
    Would an overdose of insulin which caused death or serious injury include where it was given to the patient who was not prescribed it?

  39. Simon Harrison-Boyle: Patient Safety Manager says:

    United Bristol Healthcare Foundation Trust response to NPSA ‘Expanding the List of Never Events’ proposal Document (October 2010)

    • Do you agree that the list of events and the definitions that we have produced below should be used for the new “never event” list and that they are consistent with the “never event” criteria outlined earlier?

    The Trust agrees with the concept of ‘Never Events’ and its future development. Patients can rightly expect that lessons are being learnt and the NHS should not cause serious avoidable harm. The focus on high priority areas of potential harm is therefore helpful.

    The Trust concludes that there needs to be a clearer clarification of the term ‘Serious Injury’ as this is seen to be required to avoid subjectively different interpretations by commissioners and providers. Guidance is suggested as being available from the DoH Serious Incident Framework.

    All of these events have catastrophic potential but the Trust staff may not be clear whether the actual harm caused is considered a ‘serious injury’ and how that relates to ‘near misses’ where no harm has occurred at all.

    The Trust requires clarity concerning incidents where a ‘Never Event’ has occurred in a situation where the Trust had demonstrated that compliance with Safety Alerts and best practice recommendations has been adhered to. It is not clear if the process and definitions of Never Events are flexible enough to take this into account.

    The Trust welcomes the clarification to exclude needles from the ‘retained instrument’ Never Event.

    • Do you agree with the inclusion of the events listed below but have suggestions for amending the scope and/or definition of the events?

    Definition of ‘Serious Harm’ may be subjective when relating to an incident involving insulin and opioid use, especially concerning patients who are receiving other complex care. Clarification is requested concerning the term ‘clinically indicated’ with specific reference to blood glucose monitoring.

    The Trust states that there needs to be an acknowledgement that an overdose of an opioid should be immediately apparent, rather than made as a result of a medical opinion. The Trust proposes the removal of this proposed Never Event as it is not clear what constitutes an overdose and there is no clarity as to how it would be measured.

    The methotrexate event may be open to confusion as it states it explicitly excludes administration on a weekly basis.

    The inclusion of the Health & Safety category of patient falls from windows is a positive addition as this is cited in the Corporate Manslaughter act as a healthcare example where this type of incident in healthcare could be a test case

    The event concerning air embolism is a potential cause of debate due to the route cause relating to a stated failure in healthcare provision possibly not being apparent or accurate. This also applies to the provision of medical gases, where there may not be clarity concerning actual events e.g. during a Cardio Pulmonary Resuscitation (CPR) procedure.

    The inclusion of a Never Event’ relating to serious harm caused by injectable medication, may require a debate about every incident causing harm from injections, to decide if it meets the criteria, and inevitably some of these will be borderline. The Trust requests the wording to be made clearer to describe the proposed intention.

    The Trust states that there should be a clear explanation concerning the titration of anaesthesia in sick patients. There needs to be clarity that if there is an anaesthetic death at induction the involvement of a wrongly prepared or administered i/v medicine is clearly responsible for the death rather than any other factor. This also applies to critical oxygen saturation levels in a patient undergoing general anaesthesia.

    The Trust requests clarity concerning incidents involving midazolam being given to a patient who subsequently died at that time and whether this link is automatically a never event without acknowledgement of the patients broader clinical circumstances?

    A number of events proposed relate to complex procedures where the patient’s outcome and the incident itself are not necessarily related. There may also be difficulty in establishing a link between the two. Using phrases such as ‘associated with’ encourages interpretation and therefore reduces the level of objectivity and clarity of decision.

    It is suggested by the Trust that the serious impact on an individual, relating to a Proposed Never Event involving restraint, does not specify if the actual impact was caused by the restraint procedure itself, or the situation where restraint is being used.

    The Trust requests that the NPSA provides a mechanism for Trusts to access advice online to assist with incidents that occur ‘out of hours’.

    • Do you have any additional suggestions for events and/or definitions to be included on the “never event” list?

    No comment

    • Do you agree with cost recovery for all providers, given that some incidents relate to short term, low cost interventions and others relate to long-term care where cost recovery could be many thousands of pounds? This could disproportionately affect small providers.

    The Trust agrees that this is appropriate as by definition, Never Events are rare.

    • Do you have alternative suggestions for the contractual framework?

    No comment

  40. Jonathan Howell says:

    The definition of “never events” does not seem precise enough particularly when some of the events should be largely preventable but will still happen. Whilst “never events” is a catchy slogan it will be undermined if it does not apply in all cases

  41. Hilde Storkes says:

    The Medicines Safety Group at NHS Sheffield has looked at the proposal for the extension of the list. We have commented specifically under some of the new proposals. Overall, we have 1 reservation about the expansion of the list. There is a danger in the more “never events” there are that the impact of the list will be reduced; that it will discourage reporting; and will lead to more administrative and managerial input that may not ultimately benefit patients over the current mechanisms that are in place.

  42. Jonathan Howell says:

    West Midlands Specialised Commissioning Team – (also stated elsewhere as a coment from out mental health commissioners) Never events and any penalties should be included in the operating framework.

  43. Chair Great Western Hospitals NHS Foundation Trust Organ Donation Committee says:

    On behalf of the Great Western Hospitals NHS Foundation Trust :Organ Donation Committee we would like as a committee to give our support to a new never event. That a person who is deemed to be brain stem dead,is on a ventilator in ICU and on the the OD register with no absolute contra-indications to donation and dies without having been refered for consideration of organ donation..

  44. Lorraine Cook & Mark Doran says:

    We have reviewed the Expanded List of Never events and are supportive of it.
    Two areas suggested for inclusion as Never Events are:
    Carrying out a surgical procedure without valid consent or carrying out a procedure different to that for which valid consent has been given

    A similar clause would include those patients unable to give consent, but where a procedure was agreed as per the requirements of the MCA but a different procedure was carried out.

    The exception would be where the procedure or carrying out a different procedure is lifesaving as currently set out in the national requirement for consent.

    This would be a never event irrespective of degree of harm.

    Death or serious injury caused by procedure, treatment or medication given to the patient for whom it was not intended.