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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”.
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”:
References:
Our Serious
Incident Response Checklist
NHS
(National Health Service UK). Patient Safety Incident Response Framework.
https://www.england.nhs.uk/patient-safety/incident-response-framework/
NHS
(National Health Service UK). Serious Incident framework. March 2015
https://www.england.nhs.uk/patient-safety/serious-incident-framework/
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
https://www.cqc.org.uk/sites/default/files/20161213-learning-candour-accountability-full-report.pdf
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
https://www.england.nhs.uk/wp-content/uploads/2021/02/NHS_0932_JC_Poster_A3.pdf
NHS (National Health Service UK). Patient safety incident response plan 2020/21. Template
https://www.england.nhs.uk/wp-content/uploads/2020/08/PSIRP_template.docx
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