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Patient Safety Tip of the Week
February 20, 2024
What is a
“Safety Case”?
We were recently asked what we thought about “safety cases”.
We said “we love them – our mantra is Stories…Not
Statistics”. Well, that’s not what they were asking about. Turns out they were
talking about the “safety case” that is largely a European concept.
A recent BMJ Quality & Safety article (Liberati
2024) defines the Safety Case as “a regulatory technique that requires organizations
to demonstrate to regulators that they have systematically identified hazards
in their systems and reduced risks to being as low as reasonably practicable.
It is used in several high-risk sectors, but only in a very limited way in
healthcare.” Examples of the regulators that might consider Safety Cases are
those in the nuclear or petrochemical industries.
Sujan et al. (Sujan
2015) note that the purpose of a safety case is to “provide a structured
argument, supported by a body of evidence that provides a compelling,
comprehensible and valid case that a system is acceptably safe for a given
application in a given context.” It basically has a risk-based argument and
corresponding evidence that shows all risks associated with a particular system
have been identified, appropriate risk controls are in place, and appropriate
monitoring is in place and on-going.
A program with eight collaborating sites in the NHS in the
UK tested the Safety Case concept in healthcare (Sujan
2015, Liberati
2024). A few examples of the Safety Cases in that program are:
·
Improve the medication management pathway for
patients with Parkinson’s disease between primary and secondary care.
·
Improve safety and effectiveness of the transfer
of care between daytime and out-of-hours.
·
Improve the quality and safety of shared care of
renal patients receiving surgical intervention. clinical teams.
We’d probably consider the Safety Case to be a FMEA+. It
takes it a few steps further than simply identifying all the potential risks
involved in a process. It includes documentation of the interventions you put
in place to mitigate those risks and appropriate monitoring to demonstrate that
those interventions are accomplishing their intent.
There are certainly a multitude of topics we could choose
for a Safety Case in healthcare. We are currently giving an adult learning
course at Dartmouth on “Why Accidents Happen”. One of the discussions was on
MRI accidents. We are gobsmacked by the similarities
between the cases we described in our Patient Safety Tips of the Week for
October 24, 2012 “Serious MRI Accident at
Unregulated MRI Center” and November 21, 2023 “Another Terrifying MRI
Accident” and the 2001 Michael Columbini
case so thoroughly discussed by Tobias Gilk and Robert Latino in Patient Safety & Quality Healthcare (Gilk 2011) and video. So, if we were a regulator, we’d like to see a Safety Case
performed by anyone planning to do or already doing MRI
scanning.
We’d be asking questions about
risks, what policies, procedures and actions you’ve implemented
to address those risks, and how you are monitoring compliance with those actions.
The gamut of risks involved in MR imaging is far beyond the scope of today’s
column. Many of the questions to consider about risks can be found in the ACR
Manual on MR Safety and ACR
Accreditation Toolkit for Validation Site Surveys. Though it’s not an actual
ACR document, the MRI Safety Program Assessment Checklist from Tobias Gilk (Gilk
2021) is probably the best list of questions you should be asking. So, we’ll
just discuss a few examples that should be included in an MR Safety Case.
One of the biggest risks involves
non-MR personnel entering the MR suite. Your Safety Case would need to demonstrate
how you provide training about MR safety to anybody who might enter the MR
suite and how you prevent access by anybody unaccompanied
by MR staff. You probably provide your MR safety training in
different levels based upon the likelihood they might enter the MR suite.
Obviously, full training would be required for all your clinical staff, plus
maintenance, cleaning and janitorial staff, and any
clerical or administrative staff who are likely to interact with the MRI unit. How
do you document both the initial training and annual inservice
training? But, even then, there are specific considerations. For example, if
you sometimes utilize temporary nurses, how do you ensure they have been
trained prior to working in your facility? And, ever since our first columns on
MR safety, we’ve stressed the importance of regular training for outside personnel
who might be required to enter an MR suite (such as police, firemen, prison
guards, etc.). It’s particularly difficult to ensure that new hires in those
latter categories get training. And what if your local fire department is a
fully volunteer fire department that has frequent turnover? By the way, Stephanie
Holowka has a nice Power Point presentation on MRI for First Responders (Holowka
2021).
Given that it would be impossible
to train everybody who might enter the MR suite, how do you prevent access to
the suite unaccompanied by MR personnel? Could someone from your billing department
walk into the MR unit during a lunch break and inadvertently stick her head
into Zone IV looking for someone to deliver a document to? Could a non-English-speaking
visitor wander past your signage and enter the unit? Are your barriers to
access more than simply signage? Are you using physical barriers?
What about the “little things” that
might not be directly related to the MR unit? A latent factor in the Columbini accident was that there was no oxygen available
from the wall outlet in Zone IV. You have checklists you use for screening
patients and others for the presence of ferromagnetic materials, but do you
have a checklist that requires MR personnel to check daily the status of that
oxygen supply or the functional status or your metal detectors or that you have
a non-expired MR-safe fire extinguisher present?
Oversight and leadership issues
need to be addressed in your Safety Case. Our November 21, 2023 Patient
Safety Tip of the Week “Another Terrifying MRI
Accident” discussed multiple issues regarding the leadership
overseeing MR safety at that facility, including their own training and keeping
up-to-date. But an issue often neglected is dispersion
of responsibility. We still see today many instances where a hospital owns the
MRI machine and contracts with a physician group to run it, or where a
physician group owns an MRI machine and rents space for it in a hospital. Your
policies need to make it clear as to the responsibilities of each party. Which
party ensures that oxygen is available (and in a form that will not lead to
projectile accidents)? Who is ensuring that all the education and training noted
above gets done? And it gets even more complicated if you are a small rural
hospital that contracts with a mobile MRI unit that parks outside your
hospital.
Several of the MRI accidents noted earlier included examples
of delayed quenching of the magnet because MR techs felt they needed higher ups
to approve quenching. Do you have policies that make it clear an MR tech can
initiate quenching in certain emergency situations (eg.
fire, person pinned in or against a unit) or that a person with authority to
initiate a quench is immediately available at all times?
After you’ve identified potential risks and taken steps to
mitigate those risks, how are you monitoring their effectiveness. Obviously,
you can check personnel records for proof of MR safety training. You could
check daily logs that someone has checked on the status of your metal detector
alarms or the wall outlet oxygen supply. You might have to get more creative
regarding the access issues. Inexpensive security cameras today can record
events triggered by motion and are programmed to only identify those that
included a person. You couldn’t be expected to review every event recorded (you’d
probably have hundreds of these each day at an MRI unit)
but you can do random sampling that would help you identify instances where
someone unauthorized had access without MR staff accompanying them.
We can’t do your Safety Case for you.
But you get the picture. Constructing a good Safety Case is an incredibly
complex task. It’s easier to see how a nuclear regulatory agency could require
a Safety Case for each of a handful of nuclear reactors in a small country. But
we have thousands of MRI units inside and outside of our hospitals. Wouldn’t it
be nice if we had a program similar to the one described by our European
colleagues (Sujan
2015, Liberati
2024) where one hospital or facility could do a Safety Case for MR safety and
share it as a template for others to follow in doing a Safety Case of their own?
Some of our prior
columns on patient safety issues related to MRI:
·
February 19, 2008 “MRI Safety”
·
March 17, 2009 “More on MRI Safety”
·
October 2008 “Preventing Infection in MRI”
·
March 2009 “Risk of Burns during MRI
Scans from Transdermal Drug Patches”
·
January
25, 2011 “Procedural
Sedation in Children”
·
February
1, 2011 “MRI
Safety Audit”
·
October
25, 2011 “Renewed
Focus on MRI Safety”
·
August
2012 “Newest
MRI Hazard: Ingested Magnets”
·
October
22, 2013 “How
Safe Is Your Radiology Suite?”
·
October
21, 2014 “The
Fire Department and Your Hospital”
·
August
25, 2015 “Checklist
for Intrahospital Transport”
·
August
2016 “Guideline Update for
Pediatric Sedation”
·
October
2016 “MRI Safety: There’s an App
for That!”
·
January
17, 2017 “Pediatric MRI Safety”
·
August
8, 2017 “Sedation for Pediatric MRI
Rising”
·
March
2018 “MRI Death a Reminder of
Dangers”
·
March
2018 “Cardiac Devices Safe During
MRI But Spinners!?”
·
November
2018 “OMG! Not My iPhone!”
·
April 2,
2019 “Unexpected Events During MRI”
·
September
2019 “New MRI Hazard: Magnetic
Eyelashes”
·
October
15, 2019 “Lots More on MRI Safety”
·
November
5, 2019 “A Near-Fatal MRI Incident”
·
November
2019 “ECRI Institute’s Top 10
Health Technology Hazards for 2020”
·
January
7, 2020 “Even More Concerns About MRI
Safety”
·
March
2020 “Airway Emergencies in the
MRI Suite”
·
October
2020 “New Warnings on Implants and
MRI”
·
January
2021 “New MRI Risk: Face Masks”
·
June 1,
2021 “Stronger Magnets, More MRI
Safety Concerns”
·
November
2021 “Yet Another Risk During MRI”
·
January
2022 “MRI Safety Issues”
·
July 26,
2022 “More Risks in the Radiology
Suite”
·
October 24, 2012 “Serious MRI Accident at
Unregulated MRI Center”
·
November 21, 2023 “Another Terrifying MRI
Accident”
·
January 2024 “Guns
and MRI Don’t Mix”
References:
Liberati EG, Martin GP, Lamé G, et al What can Safety Cases
offer for patient safety? A multisite case study. BMJ
Quality & Safety 2024; February 13, 2024 Published
Online First: 21 September 2023
https://qualitysafety.bmj.com/content/early/2024/02/13/bmjqs-2023-016042
Sujan M, Spurgeon P, Cooke M, et al. The development of
safety cases for healthcare services: Practical experiences, opportunities
and challenges. Reliability Engineering & System Safety 2015; 140: 200-207
https://www.sciencedirect.com/science/article/pii/S095183201500099X
Gilk T, Latino RJ. MRI Safety 10
Years Later. What can we learn from the accident that killed Michael Colombini?
Patient Safety & Quality Healthcare 2011; October 14, 2011
https://www.psqh.com/analysis/mri-safety-10-years-later/
Colombini MRI Case: Root Cause
Analysis - Tobias Gilk & Reliability Center (video). 2011
https://www.youtube.com/watch?v=0nA-UceHMqc
ACR Manual on MR Safety
https://www.acr.org/-/media/ACR/Files/Radiology-Safety/MR-Safety/Manual-on-MR-Safety.pdf
ACR Accreditation Toolkit for Validation Site Surveys
Gilk T. ACR MRI Safety Program
Assessment Checklist: Reviewer Guidance
https://www.facebook.com/groups/MRIsafety/permalink/10158326473843239/
Holowka
S. MRI for First Responders (PowerPoint). 2021
https://www.facebook.com/groups/MRIsafety/permalink/10157939061958239/
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