Submitted Article

The Importance of a Rigorous Root Cause Analysis

(RCA) for Healthcare Sentinel Events

John C. Wocher

Executive Vice President, Kameda Medical Center Consultant, Joint Commission International
Director, International Patient Services,
Kameda Medical Center

“For want of a nail the shoe was lost, for want of a shoe the be or should be impossible for a possible sentinel event
horse was lost, for want of a horse the knight was lost, for want to go unnoticed by the senior medical leadership and the
of a knight the battle was lost, for want of a battle the kingdom
Chief Executive Officer (CEO). This is the time to take
was lost. So a kingdom was lost—all for want of a nail.”
action. The action that needs to be taken initially, in my
-JLA: The Nail (DC Comics, 199) opinion, is to decide if the incident that was reported
*Also attributed to Benjamin Franklin. or discovered met the broad definition of a sentinel
event, and if so, a decision is usually made declaring/
It is unfortunate that we are not immune to unanticipated classifying it to be a sentinel event and requiring a Root
adverse events occurring in hospitals in spite of Cause Analysis to be performed within a defined period
considerable efforts during the past decade to improve after declaration. I think in order to get to a decision,
patient safety. We seemed to have struggled with the CEO or his delegated representative should appoint,
terminology regarding these events, trying to avoid calling in writing, a physician not related to the specialty
them mistakes or accidents. We seem to have preferred involved with the occurrence to conduct a preliminary
terms like occurrences, events, near misses, and incidents investigation to determine if the occurrence should be
as they are less indicative of errors. The most serious ones declared a sentinel event. In the appointing letter, it
today are termed sentinel events. The simple definition should be stated that the purpose of the inquiry is only
of a sentinel event is the unanticipated occurrence in to determine if the occurrence meets the definition and
a healthcare setting of a death or permanent loss of a to provide the rationale for recommending a declaration
major body function. The key word here is unanticipated. or exclusion. The physician should be given five days to
Healthcare delivery is complex and always carries with reach a decision, and submit his or her report in writing.
it some degree of risk. Through the informed consent It should be stressed that this is a primary duty, a priority,
processes, patients are told about the anticipated risks, and no extension of the five-day period will be approved.
benefits, and alternatives associated with their medical If the physician does not recommend classifying it as a
care, and based on these explanations they can decide sentinel event, it is the end point should the CEO concur,
whether to agree to the medical care, decline it, or seek an and can be followed in the normal process of incident
alternative or second opinion. There is a vast amount of reporting analysis. An RCA (Root Cause Analysis) can
evidence collected locally, nationally and internationally still be an option at this point.
on mortality rates, complication rates, and infection rates, If the appointed physician reaches the conclusion that
and these often serve as the basis for informed consent the occurrence met the definition of a sentinel event, and
discussions for procedures and surgeries that are high risk. the CEO concurs, an appointing letter should be prepared
With the huge amount of data collected in hospitals to a team, consisting of the appointed physician, an
and the almost real time reporting of incidents, it would experienced nurse, and an administrator and/or an allied

Japan Hospitals No. 34 / July 2015 3

health provider. These team members should be required much difficulty. Thirdly, these causes must be something
to complete an RCA within a defined period. The Joint that are within our control to correct. This is important,
Commission requirement for completion of an RCA because we cannot control or correct things that are
for a sentinel event is 45 days. A key point is that this beyond our control. These should be identified, but
needs to be done on time with a defined deadline. When they are not root causes, but secondary and contributing
talking with my colleagues in Japanese hospitals, many causes, in my opinion. And lastly, there must be solutions
misunderstand the requirements of an RCA, thinking recommended that could reasonably be implemented.
that it can be completed within a few days by a nurse A successful RCA will contain recommendations for
(typically) by looking at the medical record and asking effective corrective actions that are within management’s
a few questions. There is often a sense of urgency to get control to implement.
it done, and filed as quickly as possible. This is not the Many, many years ago, when I worked in a hospital
intent of an RCA, which is to leave no stone unturned in in the United States, I was responsible for monitoring the
determining the reason(s) for the occurrence. progress of RCAs when sentinel events occurred or when
Many organizations worldwide, including Japan, the hospital felt that the occurrence was a potentially
are familiar with RCA. Hospitals in Japan seem to be compensable event if litigation were to be pursued. I was
less familiar with the requirement when compared to on many teams that conducted the equivalent of RCAs. I
manufacturing or industry. Basically an RCA is effective was assigned to almost all the sentinel events that involved
at identifying what happened, how it happened and a patient’s death. I would like to suggest a model that it is
why something occurred, with the intent of preventing a very effective method for conducting an RCA, although
future occurrences, if preventable. These root causes are there are many other effective models.
underlying reasons that can be easily identified and can be The RCA should always start with a dated appointing
controlled/managed by implementing recommendations letter from the CEO or his delegated representative. While
for improvement, mitigation, or elimination. The reason there is no rigid format, it should contain the following.
a good RCA takes time is that it involves data collection, • Reference to the preliminary inquiry appointing letter,
causal charting in many instances, staff interviews, its recommendations, and concurrence by the CEO.
literature searches, and precise identification of root • The full name of the physician, nurse, other allied
causes (real reasons) that can result in recommendations healthcare professional and or administrator being
and implementation of changes that will minimize appointed, with indication of who is to be the team
or eliminate recurrence. I think the ‘what ‘and ‘how’ leader as teams perform better than individuals, and a
aspects of an RCA are important, of course, but it is the multidisciplinary approach is usually the most effective.
‘why’ that is critical to determine. Only when we get • The complete medical record must be secured, including
to the ‘why’ can we put in place corrective measures all components, by the team leader.
to prevent recurrence. For simple RCAs, many of us • A non-extendable specific date, preferably 45 days or
have heard of the five whys. It is kind of a ‘drill down’ less, for completion of the RCA.
until you get to the real underlying (root) cause(s). A • A mention that this is a primary and priority duty, not a
sentinel event RCA in a hospital is much, much more secondary or collateral duty.
complex and could involve more than a hundred whys The format shall consist of three parts.
as the RCA proceeds.
In looking for root causes, what are we actually looking l Findings of fact (FOF)
for, or in other words, what exactly is a root cause? I think For each finding of fact there must be evidence in the
that root causes have certain characteristics. First, they form of an enclosure(s). This could be a page from
are underlying causes of error that are specific, but not the medical record, a witness statement, a summary of
necessarily the main cause of error. However, there will an interview, etc. Each finding of fact (FOF) shall be
almost always be one or more that are clearly responsible. separate and numbered.
Secondly, they should be reasonably apparent given a
rigorous RCA and these can be identified without too

4 Japan Hospitals No. 34 / July 2015

Examples: Example:
FOF8 – The surgical site (right leg, above the knee) was REC1 – It is recommended that…. See OP6. What can we
not marked prior to surgery as required by hospital policy. recommend to ensure that surgical site marking is ‘failsafe’?
See enclosures (1), (3), and (9). The above example of Findings of fact, Opinions,
FOF16 – The surgeon of record arrived late and said he and Recommendations are, of course, fictitious, but are
was in a hurry to start this case, stating “let’s go people!” provided to stimulate your thoughts on how RCA teams
See enclosures (19), (20) and (21). determine root causes and methods to prevent recurrence.
FOF22 – The left leg was amputated three inches In this hypothetical wrong site surgery example the
above the knee. See enclosures (25), (27) and (31). removal of the wrong leg, resulting in a permanent loss
of a major body function was the sentinel event. (Think
l Opinions (OP) about what recommendations you might consider making
Each opinion (OP) shall be numbered and must be based on this limited hypothetical example – or other
supported by one or more numbered facts. whys you would ask.)
A causal chart may be included but is not required. If
Example: included, it is not a finding of fact, but a supportive document.
OP6 – The surgeon of record arrived at the hospital the Note any difficulties or limitations encountered in
night before this surgery after attending a surgical society completing the RCA.
meeting out of town (FOF21), and said his fatigue had
resulted in his forgetting to mark the site, as was his usual Findings of fact identify causal factors but usually
practice, during his evening rounds. Fatigue is a probable don’t tell us why. This is data collection. These should not
underlying reason (root cause) for failure to mark the be in dispute and need to be backed up by evidence. They
surgical site and was a significant underlying reason (root lead to root causes. Opinions are the important ‘why’
cause) for this wrong site surgery. See FOF16. Question – component. Because these are supported by findings of
Can we control this? We now know why the site was not fact, they become the underlying reasons (root causes).
marked (a root cause). There were three opportunities to The opinions paint a strong image of why something
ensure that correct site surgery was confirmed, and all unanticipated happened. Once we know what happened,
failed in this case to prevent a wrong site surgery. The first how it happened, and why it happened, we are in a good
was the requirement to mark the surgical site by the person position to make recommendations to prevent recurrence.
performing the procedure as well as involving the patient Once the RCA is completed, the CEO approves or
in the marking process. Fatigue is considered to be one disapproves the recommendations and signs the report.
root cause. Second, the failure to use a checklist during By approval, responsibility for implementation of the
the preoperative verification process that documents, approved recommendations and follow up to make sure
among other things, that the correct site was marked and the recommended actions are implemented are assigned.
verified (FOF11, 12, & 13). We still need to ask why. The CEO then briefs the board of governors, at least every
The late arrival of the surgeon and the pressure to begin six months (or more frequently), on the number of sentinel
without completing the required preoperative verification events and the actions as the result of completed RCAs.
process is another root cause (FOF16). We still need to This is also a Joint Commission requirement.
ask why. Next, the failure to conduct a time out procedure I think it is important to give recognition to those who
in the operating room, as required, which has as a required perform RCAs for sentinel events. It is not easy work.
component, verification of the correct surgical site, which The work done by these teams almost always results in
includes site marking, is a serious failure (FOF 14, 16, improvement in care and results in significant safeguards
19). We still need to pursue further and ask why. that protect future patients. I believe this should be noted in
performance evaluations and should be considered when
l Recommendations (REC) promotional opportunities arise. Completion of an RCA is
Each recommendation (REC) shall be numbered and must not a “witch hunt” or looking for bad apples. It does not
be supported by one or more numbered opinions. replace whatever other investigations might be in progress.

Japan Hospitals No. 34 / July 2015 5

It is a document, internal to the healthcare organization mechanisms and procedures have been implemented to
for the purpose of improving care. In supporting a culture prevent a recurrence are most important, if the analysis
of safety, those interviewed or involved need to know that recommends them.
the focus or result is not punitive. I believe that everyone To make sure that I am not misunderstood, I am not
involved in preventable patient harm or death feels terrible advocating, suggesting, or recommending that the RCA
guilt and truly wants whatever caused the occurrence to be be made available to the patient or his family. I am only
clear. They need to know why it happened and how it will suggesting that the patient and or family know that a
be prevented from happening again. It is my opinion that thorough review regarding the unanticipated outcome
that the vast majority of sentinel events are system problems is being accomplished in a timely manner, and I also
and not people problems. Competent people working in a recommend that a general discussion of the conclusions
bad system was a cause of failure in most of the RCAs that reached and the decisions made as a result, be discussed
I completed. There are, unfortunately, exceptions. with them. If a patient or family member feels that
While the results and conclusions contained in the nothing is being done, and they are not being provided
RCA go to the CEO for concurrence and action, there any information, the likelihood of litigation increases. The
is a great opportunity to share findings in a generic or hospital can be reclusive, secretive and reactive, or it can
summarized fashion to the entire staff. If lessons learned be proactive, transparent and cooperative. I recommend
are closely held and only available to senior leadership the latter. It has been my experience that courts act more
and those involved, we miss that chance to share favorably towards the hospital when circumstances show
findings with other departments that might have similar that the hospital took early action to determine the root
circumstances. A time out and surgical site marking cause(s) of the occurrence and implemented corrective
failure in the main operating room, has implications actions to prevent any similar occurrences and cooperated
elsewhere where time out is performed and surgical site with the patient or his family in the process. The hospital’s
marking outside of the operating room is required. The decision must be closely coordinated with its legal counsel.
more staff exposed to improvement opportunities, the If the RCA is not protected as an internal document to the
safer the organization becomes. hospital and is deemed a discoverable document in the
In my experience, the family of a patient who suffered case of litigation, it will surely result in a reluctance to
a sentinel event deserves honesty. They should be told that report these events.
the occurrence was deemed a sentinel event and that the At the time of submission of this article, there is
hospital has an effective mechanism for determining the considerable interest in a proposed change in the Medical
cause. They don’t need the jargon of the sentinel event nor Service Law in Japan that will go into effect in October
RCA, but they need to know that an internal investigation 2015. This law will address requirements for reporting
was convened and will be completed within 45 days. unanticipated deaths to an organization designated by
They need to know that it is not a substitute for other the Ministry of Health, Labour and Welfare for analysis.
investigations that might occur, and the focus it to ensure It may require disclosure to surviving family members
that the cause(s) for this occurrence will undergo analysis whenever an unanticipated death results from medical
and form the basis of corrections, if indicated. They should care. Depending on actual requirements, this can be
also know that as part of the hospital’s culture of safety, very problematic for hospitals. There is always concern
the internal investigation’s focus is not punitive and that regarding disclosure that might lead to presumptions
the report is not provided externally. If the focus were to of guilt or innocence, retributions, sanctions and or
be punitive, or released externally, it would make staff punishment and if without a legal framework to protect
reluctant to be forthcoming about reporting occurrences. against self-incrimination, will certainly make medical
Most hospitals I know do not provide a copy of the report personnel reluctant to report errors. There is the fear that
to the patient or his family, but usually will discuss it the patient’s family may use the investigation results by
with them. Of particular importance is the expression of the hospital and or this third party to pursue litigation. This
remorse/regret for what happened. It is my opinion that change should be followed closely. It is recommended that
an apology is not an admission of guilt. Assurances that an RCA proceed separately from whatever requirements

6 Japan Hospitals No. 34 / July 2015

are established by this new law, as they have separate, but been eighteen times higher than that average of hospitals
complimentary purposes. reporting this information. Between 2010 and 2014 eight
As background in the United States, which has patients died within four months of undergoing surgery
significant malpractice litigation compared to Japan, I’d conducted by one surgeon. It is presumed (because I do
like to cite two instances of the type of protection needed for not know) that these deaths were unanticipated, and would
RCAs. First, The Supreme Court in the state of Delaware have been classified as sentinel events, and an RCA would
“reviewed Office of the Chief Medical Examiner v. Dover have revealed a number of critical root causes that have
Behavioral Health System, 976 A.2d 160 (Del. 2009), only now come to light. How a hospital can be unaware
and a decision was rendered in June 2009. The issue in of an eighteen-fold difference in mortality rates is truly
this case was whether documents created for a health care disturbing. The surgeon in question also falsely reported
facility's internal or peer review of an adverse event are on a diagnostic report for insurance claims that the patient
discoverable by agencies investigating the adverse event. had cancer when in fact the patient did not have cancer.
The Delaware Supreme Court held that documents created It is not surprising that after the hospital completed its
for peer review are privileged and need not be turned interim report in December of 2014 that it “found common
over to investigating agencies if subpoenaed. The case errors across all cases mentioned in in its final report”.iii
addressed public policy favoring unfettered discussion Every sentinel event is an opportunity to determine
between medical providers in reviewing and assessing if we can provide care more safely. An RCA or its
practices within medical facilities” (See above citation). equivalent is one of the very best tools for understanding
The second, more recent case was in the State of New the what, how and why questions that are essential to
Jersey in 2014. The New Jersey Supreme Court on Sept. make recommendations for improvements. There are
29 upheld a hospital's right to maintain the confidentiality many examples of effective methods to evaluate the
of internal review reports written after adverse events, appropriateness and safety of medical care, and I hope
saying confidentiality ensures health care workers will be that when faced with a sentinel event, that an RCA
more forthcoming and candid when errors are made. They will be primary tool that you reach for. And, hopefully
said “Patients who sue a hospital for medical malpractice when you reach for it, that there will be protection from
are not entitled to records documenting the hospital’s discovery should there be malpractice litigation. If not, the
internal examination into what went wrong, the state opportunity to determine root causes will be obstructed by
Supreme Court has ruled, upholding a 2004 law intended fear of recrimination for those reporting these events.
to encourage medical professionals to learn from and
prevent future mistakes.i Almost every state in the United Comments solicited to: john.c.wocher@kameda.jp
States has passed similar legislation protecting internal Opinions expressed are that solely of the author.
reviews of care as privileged and not discoverable. It
is my opinion that if we are to foster learning by our
mistakes and honestly reporting them for internal review,
we need similar protection. It is also noted that generally,
the results of aircraft crashes completed by the National
Transportation Safety Board in the United States are
inadmissible as evidence in a court of law.ii
Also at the time of preparing this article, there were
media reports of a series of patient deaths in a university
hospital in Japan related to laparoscopic liver surgery.
The mortality rate for these surgeries was said to have

i
 http://www.njlawjournal.com/id=1202671725946/Hospitals-
Internal-Error-Reviews-Not-Discoverable-Court-Says#ixzz3W2iITBYj
ii
 http://www.avweb.com/news/avlaw/181884-1.html   Japan Times, 3 March 2015
iii

Japan Hospitals No. 34 / July 2015 7