Patient Safety Tip of the Week
May 23, 2017 Trolling the RCA
Hard to believe it’s
been almost a year since we had to defend the root cause analysis (see our July
12, 2016 Patient Safety Tip of the Week “Forget
Brexit – Brits Bash the RCA!”).
But now we’re at it again!!
The May 2017 issue
of BMJ Quality and Safety has several articles questioning whether RCA’s are
good or bad for patient safety (Kellogg 2017) (Trbovich
2017) (Peerally 2017). One of the articles (Peerally
2017) is actually the
article published online ahead of print that triggered our 2016 column
mentioned above but these articles provide the opportunity to again discuss
what’s good and what’s bad about RCA’s in healthcare.
The RCA is not dead.
We’ve always had a strong conviction that the RCA (root cause analysis)
is probably the most important learning tool that an organization with a good
culture of safety has at its disposal. We encourage organizations to do RCA’s
not just on events with bad patient outcomes but on any event that had the
potential to induce harm (near-misses). The
key problems with RCA’s are:
- They are not done well in many (or even most) cases
- The interventions chosen as solutions are all too often weak and not
sustainable
- We fail to disseminate the lessons learned beyond the walls of our
organizations (and sometimes even within our organizations)
That last problem is
a major failure in our healthcare system. How many times do we need to see a
problem uncovered in one hospital occur in other hospitals simply because our
system does not promote sharing of problems and solutions?
The new study was a review of RCA’s from a major academic
medical center (Kellogg
2017). Researchers reviewed 302 RCA’s over an 8-year period, 106 of which
proposed solutions. The average number of solutions proposed per RCA was 4.7. But
a large proportion of solutions offered were what we would deem “weak”
interventions (eg. training 20%, process change
19.6%, policy reinforcement 15.2%). Moreover, multiple
event types were repeated during the study period despite repeated RCA’s.
Kellogg and colleagues, of course, are correct that many or
most RCA’s fail to implement strong interventions as solutions. That echoes a
criticism in the second article (Peerally 2017),
one with which we strongly agree, that solutions and action plans are poorly designed or implemented. In our March 27, 2012 Patient Safety Tip of the Week
“Action
Plan Strength in RCA’s” we noted prior studies in the VA system (Hughes
2006) which analyzed action items from RCA’s and found that 30% were not
implemented and another 25% were only partially implemented. Stronger action
items were more likely to be implemented. Actions that were assigned to
specific departments or people were more likely to be implemented than those
assigned to general areas. And they found that the patient safety manager plays
a critical role in RCA action implementation.
In our March 27,
2012 Patient Safety Tip of the Week “Action
Plan Strength in RCA’s” we emphasized the importance of tracking whether
recommended action steps were implemented following an RCA, whether they were
effective, and whether there were any unintended consequences. All too often
action steps never get implemented at all or consist solely of “weak” action
steps and organizations are then surprised when a similar adverse event occurs
in the future. Moreover, even the most well intentioned and well planned action
steps sometimes lead to consequences that were never anticipated. We
typically see weak actions like education and training or policy changes as the
sole actions undertaken rather than strong actions like constraints and forcing
functions. We discussed strength of actions in our March 27, 2012 Patient Safety Tip of the Week “Action
Plan Strength in RCA’s”. In that column we included an analogy to the
effectiveness of signs and tools used to try to get drivers to slow down
in construction zones on highways. We put them together in pictures with RCA
action items and now incorporate them in our webinar presentations on doing
good RCA’s. Click
here to see them. Remember: images are more likely to be remembered than
words!
One of the biggest issues we see in hospitals related to
RCA’s is failure to follow up and close
the feedback loop. In fact, probably the majority of hospitals lack formal
procedures for ensuring the corrective actions recommended in an RCA are actually
carried out (or barriers to their implementation identified and alternative
steps taken). In our March 30, 2010 Patient Safety Tip of the Week “Publicly
Released RCA’s: Everyone Learns from Them” we discussed an incident at a
hospital in which a similar incident had occurred several years prior. After
the first incident an extensive root cause analysis was done and multiple recommendations
were made, including key recommendations that should have prevented the second
incident. But all those recommendations had never been fully implemented.
Importantly, the recommendations were communicated back to those individuals
deemed to be in the “need to know” but not widely disseminated to middle for
front line management nor to front line staff.
We recommend you keep a list or table of such identified
action items from all your RCA’s to discuss at your monthly patient safety
committee or performance improvement committee meetings. Action items should
remain on that list until they have been implemented or completed. Only that
sort of rigorous discipline will ensure that you did what you said you were
going to do, i.e. that you “closed the
loop”. And don’t forget you need to monitor your implemented actions for
unanticipated and unintended
consequences. For example, you might take the strong action of removing a
drug from a particular setting, only to realize later that there were circumstances
where that drug was needed in that setting.
Take a look at the cases discussed in some of our recent
columns. Though these were not technically the RCA’s performed by the
hospitals, their plans of correction (POC’s) did include the actions taken. And
those actions were relatively weak. In our April 25, 2017 Patient Safety Tip of the Week “Dialysis
and Alarm Fatigue” the
actions taken by the hospital were primarily education and policy changes, both
of which are “weak” interventions. They missed the opportunity to implement
stronger interventions. One would have been to redesign the alarm system to
focus the responder’s eyes to the site indicated by the alarm. A second would
have been to add a hard stop to the alarm. The best interventions are forcing functions. We’d suggest that
these alarm systems program in a “hard”
stop for this particular alarm that requires the responder to verify that
he/she has inspected the access site. That verification should then become part
of the medical record.
As above, constraints
and forcing functions are the strongest of actions. In our May 20, 2014
Patient Safety Tip of the Week “Ophthalmology:
Blue Dye Mixup” and September 2014 What's New in
the Patient Safety World column “Another
Blue Dye Eye Mixup” we discussed unfortunate
cases where methylene blue was used during cataract surgery rather than trypan
blue. It is very clear there is a
huge system issue here. The system
actually put those healthcare workers and the patient in a vulnerable position
that allowed the mistake to happen. It is very much akin to the
concentrated potassium chloride issue of the past in which nurses accidentally
administered fatal doses of concentrated KCl to
patients. There was little reason for nurses to have access to vials of
concentrated KCl yet we placed them on nursing units
and it was simply a matter of time until someone unwittingly drew up a syringeful and administered a fatal dose. Our eventual
system fix was to remove vials of concentrated KCl
from floor stock on nursing units. If you are a facility that only does eye
cases, you probably have no need for methylene blue and therefore should not stock it at all. In other
facilities where you may have a legitimate need for methylene blue (for
example, it is used to help identify leaks in some surgeries or to help
identify tissue in need of debridement in others) you clearly need to store the two blue dyes separately. If
you have a dedicated “eye” room and can store all the medications and materials
for eye surgery there (or in an automated dispensing cabinet dedicated to
ophthalmology) make sure that methylene blue is not in those areas.
But sometimes it is
difficult to implement a strong intervention following an RCA. In our May 2,
2017 Patient Safety Tip of the Week “Anatomy
of a Wrong Procedure” the
major problem was a poor culture of safety. In their recent editorial Trbovich and Shojania (Trbovich
2017) put at the top of their hierarchy of effectiveness “culture change” as one of the “strong”
actions. Of course, it is undoubtedly the strongest of all actions. You’ve often heard us use the phrase “culture
trumps ________” (fill in the blank with words like policy, procedure,
strategy, tactics, vision, etc). In fact, “Culture
trumps…Everything!”. But, unfortunately, changing the
culture is a long-term process, tough to implement and difficult to measure. So
while it’s something that desperately needs work, very few RCA’s include it as
an action. One possible stronger action to take in
that case, and we would consider it an action of only intermediate strength,
would have been to cancel any elective case in which copies of the consent and
H&P are not available several days prior to the scheduled procedure and
then ensure those documents are available in the OR at the time the procedure
is actually done. But even those are weak actions because there is no guarantee
that people will use them. The case also illustrates that use of a stronger
action (implementation of the WHO Surgical Safety Checklist) failed because of
poor implementation and verification of its use.
But that gets us
back to our most significant point. Hospitals often fail to include strong
actions because they don’t know what those strong actions are. Our inability
to disseminate lessons learned at other facilities and their solutions is,
in our minds, the single biggest barrier to improving patient safety. Peerally and colleagues also lament a lack of dissemination
of lessons learned and lack of aggregation of similar events. Ironically, the
example Peerally and
colleagues used to illustrate lessons not learned was implantation of incorrect
intraocular lenses. In several of our columns (most recently in our May 17, 2016 Patient Safety Tip of the Week “Patient
Safety Issues in Cataract Surgery”) we’ve described that very issue as the one that led us over 20 years
ago to develop one of the earliest surgical timeout protocols that subsequently
served as a model for subsequent state and national timeout protocols! In those
columns we describe how cases of incorrect intraocular lens (IOL) implantation
occurred singly (or occasionally multiply) in many hospitals yet those cases
and their contributing factors were never shared widely. The same concept, of
course, was seen with cases of fatal overdoses from inadvertent injection of
concentrated potassium chloride. Those typically occurred as single isolated
events in many hospitals and it was only years later that the widespread
occurrence of this unfortunate incident was appreciated and steps taken to
remove concentrated potassium chloride from floor stocks.
Even in
organizations capable of wider dissemination of lessons learned there is a
tendency to wait until several cases have been aggregated before sharing those
lessons. But some isolated solitary cases also need to be shared because the
circumstances leading to those cases is very likely replicated at multiple
other venues. Such an example is that ophthalmological incident with the
inadvertent use of methylene blue dye instead of trypan blue (see our prior columns of May 20, 2014 “Ophthalmology:
Blue Dye Mixup” and September 2014 “Another
Blue Dye Eye Mixup”). When we discussed the first
case, we said “we can’t believe this is the first time this has happened”.
Then, shortly thereafter a second case was reported. In fact, the second case
anteceded the first. Perhaps with better dissemination of lessons learned the
subsequent case might have been avoided.
In reality, such
failure to share is a societal problem. The various legal and public
relations consequences of sharing lessons and aggregating similar cases have
been among the biggest barriers to implementation of sound patient safety
practices. PSO’s (Patient Safety Organizations) have the potential to help
disseminate lessons learned and solutions but to date have had a limited impact
since their work is shared only with their individual member organizations.
See our July 12,
2016 Patient Safety Tip of the Week “Forget
Brexit – Brits Bash the RCA!”
for discussion of several of the other points raised by Peerally
et al. such as the problem of “many hands”, political hijacking of the RCA
process, challenges of getting unbiased information, timeline issues, conduct
of and participation in an RCA, having the right expertise available, figuring
how to fit patients and families into the RCA process, and more.
In their recent
editorial Trbovich and Shojania
(Trbovich
2017) warn that jumping to corrective actions on the basis of a single
case can be problematic. That’s one reason we also recommend periodically
reviewing all your RCA’s to cull out recurrent themes. It’s often such collective reviews that make you realize
the increased importance of root causes that were identified in individual
RCA’s.
One of the most important things in making your
organization’s use of RCA’s is to have a culture that understands the focus is
to uncover system issues that can be fixed to prevent subsequent similar
events. That means people should not fear reporting events or speaking openly
in RCA interviews. James Bagian does a nice job in an
AHRQ interview on RCA’s (AHRQ
2016) explaining that you have to educate people that, when they report in
the safety system, they will be held harmless but that doesn't mean people get
a free pass. If there was a “blameworthy act”, the case would be placed on an
administrative route where the facts of the event have to be
"rediscovered" by the administrative system, which could culminate in
punitive action. But if it was not blameworthy, under no circumstances would
there ever be punitive action.
In our July 12, 2016
Patient Safety Tip of the Week “Forget
Brexit – Brits Bash the RCA!”
we noted that perhaps the toughest nut to crack is the complicated issue
of blame. The beauty of the RCA is that it stresses identification and
remediation of system defects that are generally more amenable than human
behaviors. And it is clear that system defects may put individuals at risk of
committing human errors that then result in adverse patient outcomes. One key
tenet of the National Patient Safety Foundation’s RCA2 Guidelines (NPSF
2015) is that it only addresses system issues and should not address or
focus on individual performance (see our July 14, 2015 Patient Safety Tip of the Week “NPSF’s
RCA2 Guidelines”). In fact, NPSF recommends that all organizations
should define “blameworthy” events and actions that fall outside the purview of
the safety system and define how and under what circumstances they will be
handled separately. Of course, we would emphasize that system issues that lead
to or facilitate improper individual performance must be addressed under the RCA2
process. For example, workarounds are (often) improper individual actions that
almost always have a system issue that led to their use. Another example is “normalization of deviance” where the
culture of the system led to acceptance of a certain deviation from proper
practice as being “normal” and allowed that deviation to be performed by many
individuals.
Peerally and colleagues
acknowledge that a “no-blame” approach is not always possible or appropriate
and may impede thorough incident investigation and we often see failure to
place blame when placing blame may be appropriate. They note that most of us
have adopted the “Just Culture” approach but that tools such as algorithms and
decision tools (eg. the “culpability tree”) have
flaws of their own. Also, don’t forget that in parallel to your RCA process you
need to ensure your organization has a means to address the “second victim” or
healthcare workers involved in such incidents (see also our December 17,
2013 Patient Safety Tips of the Week “The
Second Victim” and August 9,
2016 “More
on the Second Victim”.)
Alternatives to the RCA are available. Gupta and Lyndon (Gupta
2017) recently reviewed many of the issues raised in the Peerally article and in the RCA2 documents (see
our July 14, 2015 Patient Safety Tip of
the Week “NPSF’s
RCA2 Guidelines”) and note several other review tools and techniques
that can be applied effectively in certain situations, often with less time and
effort. The FMEA (Failure Mode and Effects Analysis) is also a great tool to
identify system issues that may lead to patient safety events. But a FMEA is
time consuming and most organizations can do only one or two in a year. They
also deal with a lot of theoretical issues or “what ifs” that staff may
consider to be unlikely to occur. On the other hand, the RCA is typically done after
an actual event or near miss that grabs everyone’s attention and hammers home
that we need to make changes to avoid another event. The best case, however, is
seeing the RCA from someone else’s facility and saying “Wow! That could happen
here!” and implementing changes at your facility before you have an untoward
event.
See our Patient
Safety Tips of the Week for July 14, 2015 “NPSF’s
RCA2 Guidelines” and July 12, 2016 “Forget
Brexit – Brits Bash the RCA!”
for many other recommendations to include in your RCA process.
So our message to all the detractors of RCA’s…stop trolling
the RCA! The RCA is a great learning tool. The problem is doing it right and
what you do with it. Instead, help fix the barriers that prevent the sharing of
lessons learned and the solutions that utilize strong actions to help prevent
patient safety incidents in all healthcare settings.
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!”
References:
Kellogg KM, Hettinger Z, Shah M, et al. Our current approach
to root cause analysis: is it contributing to our failure to improve patient
safety? BMJ Qual Saf 2017;
26(5): 381-387
http://qualitysafety.bmj.com/content/26/5/381
Trbovich P, Shojania
KG. Root-cause analysis: swatting at mosquitoes versus draining the swamp. BMJ Qual Saf 2017; 26(5): 350-353
http://qualitysafety.bmj.com/content/26/5/350
Peerally MF, Carr
S, Waring J, Dixon-Woods M. The problem with root cause analysis. BMJ Qual Saf 2017; 26(5): 417-422
http://qualitysafety.bmj.com/content/26/5/417
Hughes D. Root Cause Analysis: Bridging the Gap Between Ideas and Execution. VA NCPS Topics in Patient
Safety TIPS 2006; 6(5): 1,4 Nov/Dec 2006
http://www.patientsafety.va.gov/docs/TIPS/TIPS_NovDec06.pdf#page=1
Weak vs. Strong Responses to an RCA (Power Point
presentation).
http://patientsafetysolutions.com/docs/RCA_strong_vs_weak_responses.ppt
AHRQ. Perspectives on Safety. In Conversation With... James P. Bagian, MD, PE.
Root Cause Analysis: What Have We Learned? AHRQ PSNet
2016; Published December 2016
https://psnet.ahrq.gov/perspectives/perspective/211/in-conversation-with--james-p-bagian-md-pe
NPSF (National Patient Safety Foundation) RCA2. Improving
Root Cause Analyses and Actions to Prevent Harm. NPSF 2015
http://c.ymcdn.com/sites/www.npsf.org/resource/resmgr/PDF/RCA2_first-online-pub_061615.pdf
Gupta K, Lyndon A. Perspectives on Safety. Annual
Perspective 2016. Rethinking Root Cause Analysis. AHRQ PSNet
2017; January 2017
https://psnet.ahrq.gov/perspectives/perspective/216/rethinking-root-cause-analysis
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