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It has been 15 years since we first posted advice on responding to serious patient safety events (see our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”). Our sample Serious Incident Response Checklist is still a good place to start.
The UK’s National Health Service is in the process of updating its Patient Safety Incident Response Framework (NHS 2020a). Their previous framework was adopted in 2015 (NHS 2015). But, in part because a report showed multiple deficiencies in the way some hospital trusts were dealing with incidents, the need for an update became apparent. That report (CQC 2016) found that interactions with patients and families after deaths or serious incidents were suboptimal and that the incident investigations were not being done in a manner that would promote learning from them. And the issue of accountability was not well handled. NHS is currently piloting the updated version (NHS 2020b) with a set of “early adopters” and expects that the new framework will be adopted by all in autumn 2022.
The revised framework (NHS 2020b) notes that organizational behaviors required in the approach should reflect three main principles:
Like our suggested serious incident response, the NHS framework emphasizes prompt assembly of the team to investigate the incident, proper reporting to regulatory bodies, transparency with disclosure and apology to patient and/or family, ensuring provision of ongoing care for the victim of the incident, and attention to any “second victims”.
One important change in the new revision is moving away from strictly defined serious incidents and using the framework in a manner that focuses on any incident that might lead to organizational learning. Note that the NHS approach replaces the term root cause analysis (RCA) with “systems-based patient safety incident investigation”. The primary focus of the investigation is to promote learning rather than focusing on individual performance.
The new version also adopts Just Culture for a fair and equitable response to patient safety incidents. One really nice feature of the NHS framework is a Just Culture Guide. This takes the investigator or manager through a series of questions to determine whether the behavior of an individual involved in an incident fits one of the 3 main categories in the Just Culture framework. Based on the responses to the questions, recommended actions are suggested. Questions are:
1a. Was there any intention to cause harm?
2a. Are there indications of substance abuse?
2b. Are there indications of physical ill health?
2c. Are there indications of mental ill health?
3a. Are there agreed protocols/accepted practice in place that apply to the action/omission in question?
3b. Were the protocols/accepted practice workable and in routine use?
3c. Did the individual knowingly depart from these protocols?
4a. Are there indications that other individuals from the same peer group, with comparable experience and qualifications, would behave in the same way in similar circumstances?
4b. Was the individual missed out when relevant training was provided to their peer group?
4c. Did more senior members of the team fail to provide supervision that normally should be provided?
5a. Were there any significant mitigating circumstances?
That question 4a is the most important question we usually ask when doing a root cause analysis: “How likely is it that another individual, given the same set of circumstances, might have thought or acted in the same manner?”
The updated framework cautions against hindsight bias or other biases that might interfere with conclusions of an investigation.
The updated version sets expectations for informing and supporting patients, families and carers involved in patient safety incidents. It also sets expectations for informing and supporting staff involved in patient safety incidents.
One stated principle is that all healthcare professionals also have a professional responsibility to be honest with patients when things go wrong. It also says that organizations should seek feedback from patients, families and carers to determine how well they are upholding the principles of openness and transparency. This feedback can come from conversations with staff supporting those affected or be retrospectively sought after an organization concludes its response to an incident. A series of patient videos is provided, demonstrating how patients responded to being in the loop in the incident investigation process.
Consistent with the primary goal of learning from incident investigations, the framework states that organizations must be able to apply knowledge of the science of patient safety and improvement to identify:
The framework includes the following steps:
NHS also has a template to help guide hospitals/trusts in developing their patient safety incident response plan.
The updated NHS is remarkably similar to the our recommendations highlighted in our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”. We developed that sample Serious Incident Response Checklist because many hospitals were still struggling with their root cause analyses of serious adverse events. One of the problems is just getting started promptly. One of the keys to good incident investigation is obtaining all the factual evidence as soon as possible. Particularly when it comes to interviewing witnesses, it is important to remember that memory of the event becomes less clear with passage of time and those memories may even be changed by other events, conversations, etc. It is extremely important that we understand how the participants in the incident perceived the unfolding situation and events as they occurred, rather than reinterpreting them after knowledge that the outcome was adverse.
Therefore, each hospital should have a Serious Incident Response policy and checklist to help guide them in their response to a serious incident.
Obviously, the individual assigned responsibility for each task may vary from organization to organization. But having the task listed on a checklist and and individual designated helps everyone remember what needs to be done.
In the US, the “serious incident” might meet the Joint Commission definition of a Sentinel Event or the state health department definition of a serious reportable event but you should also consider even near-misses as meeting the definition if there was potential for a serious adverse patient outcome. On receiving the incident report, the designated individual (usually a risk manager) should immediately discuss the incident with the medical director, director of nursing and director of quality improvement to decide whether the Serious Incident Investigation Team/RCA Team should be convened. The risk manager (or other designated person) should contact the supervisor of the area where the incident occurred to ensure that all potential witnesses are identified and then schedule a meeting of the Team as soon as possible (usually within one day). In those cases where a witness will be unavailable to be interviewed in person, arrangements can usually be made for that person to be interviewed by phone.
The chart of the patient should be secured and working copies made for use by the Team. When we originally developed our checklist, many facilities had not yet transitioned to electronic medical records. One reason for securing the paper record was to ensure that no changes were made to the original record. The timestamps on electronic medical records largely change the need for that. However, making working copies for the Team to review may still be useful.
Importantly, any equipment or devices involved in the incident should be sequestered. That is to ensure that the equipment is available for the investigation and also to ensure that any potentially faulty equipment is not used for another patient.
We believe that the patient and/or family should be notified early that errors may have occurred and that the incident is being investigated. We’ve long been believers in being very forthright with patients/families and telling them when there were mistakes made in their care. Subsequent research and other experience certainly seems to bear out that such an approach and an apology are important when mistakes or errors did impact on the outcome. The details and the apology, of course, cannot be given until the RCA is complete and all contributing factors known. However, our experience is that patients and families appreciate candor and should be told that an investigation is ongoing and that they will be made aware at some point of at least the general outcome of that investigation. It should be made clear to them that the investigation is being done to help ensure that similar events do not occur in the future. The individual who speaks to the patient or family should usually be the one with the best pre-existing rapport. That is usually the attending physician but may under some circumstances be someone else in the organization. If it is awkward for the attending physician to speak to the family, then the medical director is an appropriate individual to speak to them.
Most of the other items in the check list are self-explanatory (mostly notification to various agencies and bodies of the incident occurrence). Some state Department of Health offices require notification of certain events within 24 hours. Even if that is not a formal requirement, a good general rule is to notify them of any event that is likely to attract press attention. That way the state department is not taken by surprise if an inquiry is made and they are able to respond that they are aware of the incident and the ongoing investigation.
The last item is very important and often overlooked. Caregivers undergo a variety of deep emotions when one of their patients is harmed, particularly when they feel they may have contributed in some way to that adverse outcome. So each organization should have some mechanism for providing needed support and assistance to any physicians, nurses, pharmacists, etc. that may have been directly involved in the incident or had been actively involved in the care of the patient.
Our many columns on root cause analyses reflect the need to use them as learning tools. But we always emphasize that we should not wait for incidents to occur. Doing FMEA’s (failure mode and effects analyses) is an important way to identify potential vulnerabilities before an incident actually occurs. The new NHS framework also encourages organizations to be proactive in a similar manner.
Some of our prior columns on RCA’s, FMEA’s, response to serious incidents, etc:
July 24, 2007 “Serious Incident Response Checklist”
March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them”
April 2010 “RCA: Epidural Solution Infused Intravenously”
March 27, 2012 “Action Plan Strength in RCA’s”
March 2014 “FMEA to Avoid Breastmilk Mixups”
July 14, 2015 “NPSF’s RCA2 Guidelines”
July 12, 2016 “Forget Brexit – Brits Bash the RCA!”
May 23, 2017 “Trolling the RCA”
October 2019 “Human Error in Surgical Adverse Events”
January 2020 “ISMP Canada: Change Management to Prevent Recurrences”
October 2020 “Common Cause Analysis”
Some of our prior columns on Disclosure & Apology:
July 24, 2007 “Serious Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple Patients”
June 22, 2010 “Disclosure and Apology: How to Do It”
September 2010 “Followup to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI: Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error Disclosure by Surgeons”
June 2012 “Oregon Adverse Event Disclosure Guide”
December 17, 2013 “The Second Victim”
July 14, 2015 “NPSF’s RCA2 Guidelines”
June 2016 “Disclosure and Apology: The CANDOR Toolkit”
August 9, 2016 “More on the Second Victim”
January 3, 2017 “What’s Happening to “I’m Sorry”?”
October 2017 “More Support for Disclosure and Apology”
April 2018 “More Support for Communication and Resolution Programs”
August 13, 2019 “Betsy Lehman Center Report on Medical Error”
September 2019 “Leapfrog’s Never Events Policy”
March 9, 2021 “Update: Disclosure and Apology: How to Do It”
November 2021 “When a Radiologist Recognizes He Committed an Error”
Other very valuable resources on disclosure and apology:
Some of our prior columns on “the second victim”:
Our Serious Incident Response Checklist
NHS (National Health Service UK). Patient Safety Incident Response Framework.
NHS (National Health Service UK). Serious Incident framework. March 2015
Care Quality Commission (UK). Learning, candour and accountability. A review of the way NHS trusts review and investigate the deaths of patients in England. December 2016
NHS (National Health Service UK). Patient Safety Incident Response Framework. Introductory Version. NHS 2020
NHS (National Health Service UK). Introductory version of the PSIRF. NHS 2020
NHS (National Health Service UK). A just culture guide. NHS 2020
NHS (National Health Service UK). Patient safety incident response plan 2020/21. Template
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