THE SOUTH CAROLINA SAFE
SURGERY 2015 INITIATIVE- ADJUNCTS AND
BARRIERS TO IMPLEMENTING A STATEWIDE SURGICAL SAFETY CHECKLIST (conversation
with the Harvard and SCHA groups).
In 2010, the South Carolina Hospital Association Leadership
solicited a commitment from the SCHA membership to undertake this process. Dr.
Atul Gawande approached this group because he had prior success internationally
outside the United States in implementation of Surgical Safety Checklists but
had not participated in any partnerships in the U.S. on a statewide scale. Working with Dr. Atul Gawande and the Harvard
University School of Public Health, Joint
Center of Innovation at Brigham and Women's Hospital, SCHA launched an initiative
at implementing the utilization of the Surgical Safety checklist in every
hospital in the state of South Carolina. The team’s estimate was that by institution of
the checklist in all 700,000 surgical procedures being performed annually in
the state of SC, they could potentially save the lives of 500 South
Carolinians. The State of SC previously launched a project with The Joint
Commission to improve the quality and safety of patient care, making this a
natural choice for the Harvard project. The South Carolina Hospital Association
(lead by Lorri Gibbons) already acknowledged that utilization of the Surgical
Safety checklist varied from hospital to hospital. It was apparent that
facilities previously successful in implementation of the checklist were fully
committed to the process via leadership support, financial resources, identification
of clinical staff champions and customization of the process as deemed
necessary to fit the environment. They
also utilized the services of an industrial engineer from Clemson University (Dr.
Ashley Childers) to assist facilities via direct observation with accompanying
recommendations to tailor the needs of the facility. Dr. Gawande’s group
volunteered to assist the program thru provision of any resources that the SCHA
needed to make this succeed, but noted clearly that they understood that for
the program to succeed it had to be developed and supported by their own team
(ie if it was a Harvard program, it would not likely have the same potential
for success in SC).
Ashley Childers and Lori Gibbons conceded that gaining a commitment
from the hospital CEO’s was not too difficult given the attention and planning
by the committee and support by Dr. Gawande’s group. Everyone understood that
this was the right thing to do and this was a state-wide initiative and not an
outside group attempting to pressure them into a specific product or service.
They assured that it was extremely critical that this process be staff driven
using peer to peer pressure (surgeon to surgeon, anesthesia to anesthesia, nurse
to nurse, tech to tech, etc). The
successful sites developed a strongly supported Peer implementation team. They
were very careful to provide up front data education to assure all participants
understood the data being collected. One of the key successes was to allow all
sites to take the WHO checklist and modify any way they wanted. In fact, they
attempted to discourage large hospital corporations from mandating a specific
checklist across all institutions. They were proud that the surgeons requested
the addition of a pause at the end for them to solicit questions from the group
prior to proceeding. This work was supported by face to face observation by Ashley Childers which included a debriefing
afterwards. During this entire process she was in contact with all the
facilities to take away lessons learned and work with each facility as a coach.
During this process they developed a tool based website and webinar to assist
the program move along (http://www.safesurgery2015.org/). They found that some sites were reluctant to do
modify their process because they felt they were ‘already doing the Safety
Checklist’ but in fact what they were performing was solely the Joint
commission time out but did not include the communication pieces (anesthesia
concerns, allergies…). They reminded the staff that this was not designed to be
a checklist of duties or processes but in actuality it was a guide to improve
the conversation regarding patient safety. They focused on NOT referencing that
the program was an indication that they were doing something wrong, but in fact
designed to improve their current process and improve information sharing. Unfortunately,
the use of the name “checklist” probably was a barrier for open-mindedness in
that everyone felt they were already using a “checklist”. Clearly given that
these sentinel events were rare and that most of the staff involved had never
witnessed this occur, the urgency to modify everything that already existed was
not seen in many staff. Another common barrier was the focus on staff on the
readily available data to support modification of their current processes (that
is they did not see that data supported this). One final piece of advice was to
assure that the program supplemented and assisted hospitals in their data
collection.
In
2015, The Harvard Group under the leadership of Sara Singer, Atul Gawande et
al, published their assessment of the effectiveness of implementation of the
Surgical Safety checklist. In their study ‘Implementation of the Surgical Safety Checklist in
South Carolina Hospitals Is Associated with Improvement in Perceived
Perioperative Safety’ they requested
self-surveys from the South Carolina (SC) Hospitals involved in the SAFE
SURGERY 2015: SOUTH CAROLINA (SSSC) initiative. Of the 67 SC Hospitals
targeted by the initiative, 38 hospitals completed pre-implementation surveys
and of those 38, 13 felt they had completed the SSSC program.
The key lesson from
this Harvard study was that while the SSSC tool is useful for improving the
culture of safety, “it was not a fix-all
solution. The work necessary to improve
the culture of surgical safety requires long-term effort that include multiple
interventions targeting the diverse aspect of interaction between health care
providers providing surgical care…“ This is really what needs to be kept in
mind; that these are all simply tools that must be used together and
appropriately to improve safety. In a prior work by this group, Conley et al
reported that to achieve highly successful implementation, hospitals needed to
utilize implementation leaders consisting of surgeons and nurses who could
persuasively covey the purpose and methodology of effectively utilizing the
safety checklist components.
The findings of the study suggested
that implementation affected the perception of health care professionals
differently. Physicians and advanced practicing clinicians (APC) responded more
favorably than surgical nurses/technicians in the post implementation survey to
questions pertaining to the perception of safe surgical practice. Nurses and technicians perceived fewer
improvements than physicians and APC’s.
Surgeons noted a higher completion rate than nurses. Nurses reported
that the SSC helped promote efficiency and avert problems / complications more
frequently than the surgeons/APC’s. What is not clear is if this perception is
a reflection of reality or simply the subjective assessment by MD’s.
That is may simply be a similar
optimistic view expressed by MD’s in Pronovost’s 2013 assessment of the
perception that ICU MD’s and nurses have on the contributions to teamwork made
by staff in the ICU. In his study, 90% of
ICU physicians reported above-adequate teamwork in the nurses but only 54% of
nurses reported above adequate teamwork in the physicians. It is possible that the Surgeons in the
Harvard SC study featured characteristics that contradicted prior study perceptions that Surgeons are
obstacles to Safety Improvement. For example, in 2015 Russ
Sevdalis, Vincent et al sampled 10 hospitals in England to determine barriers
to successfully implementing the WHO surgical Checklist. The study stated that “the most common barrier to checklist implementation, reported by 51% of
the sample was active resistance or passive non-compliance from individuals in
the OR team, most frequently (84%) from senior surgeons and/or
anesthesiologists. This often made it very challenging for the person leading
the checks (often a nurse) to complete them in the intended manner, or without
feeling personally attacked.”
In their
review of the implementation of the WHO Checklist in the United Kingdom, Russ,
Sevdalis, et al concluded that sites successfully implementing the WHO
Checklist did the following (from Box 1):
- Modified the initiative to suit the local context to assure integration into existing programs (enhances buy-in and avoids duplication).
- Tailored education to all stakeholders in manner that is relevant to them. (emphasizing the importance of improvement)
- Identified champions to promote safety in work areas.
- Management led the efforts.
- Developed or enforced a system of accountability for “IMPROPER” behavior or refusal to participate.
- Conducted careful auditing.
In 25% of the samples, it was noted that
if Attending Surgeons or Anesthesiologists led the checks themselves or
actively drove the list, it fostered engagement.
In 20% there was fear that the use of
Tick Boxes associated with limited buy in could create a false sense in
security and complacency leading to reduced vigilance.
Bergs, et al reviewed
45 Qualitative
studies that explored the perspectives of stakeholders * with the
implementation of surgical safety checklists (*nurses, surgeons,
anesthesiologists, residents, implementation leaders, and administrators). In general they found that implementation
of the checklist required change in the workflow of healthcare professionals as
well as in their perception of the checklist and the perception of patient
safety in general. The factors impeding or advancing the required change
concentrated around the checklist, the implementation process and the local
context. Based on the studies, the research team concluded the following:
“the
required safety checks disrupt operating theatre staffs’ routines.
Furthermore, conflicting priorities and different perspectives and motives of
stakeholders complicate checklist implementation. When approaching the
checklist as a simple technical intervention, the expectation of cooperation
between surgeons, anesthetists and nurses is often not addressed, reducing the
checklist to a tick-off exercise.”
Specific factors that discouraged or
favored implementation were as follows:
- The perception of the staff towards the checklist and towards patient safety in general influenced the willingness to use the checklist.Concerns expressed that affected this willingness included:
- Concerns about legal implications- “Nurses were therefore concerned about the legal implications of signing the checklist as they might be held accountable for errors”
- Concerns about patient perception (leading the staff to omit or silently check that were perceived to cause stress to the patients) “specific questions around blood loss and difficult airway would anxiety provoking for certain patients.”
- Concerns about time consumption or efficiency reduction (most common concern).
- Perceived importance of the checklist or its components (varied by profession) “Confirming the team members by name and role was the most missed check. The explanation given for this was that a lack of staff turnover and degree of familiarity with each other made this check appear less important. .”
- Risk perception regarding the actual risks the checklist was presumed to be eliminating.
- Skepticism regarding evidence supporting the implementation of surgical safety checklists.
- Workflow adjustments: individual and team.
Increased burden brought about by redundant system
safety check protocols “the checklist
sometimes entails the repetition by nurses or doctors of one or more safety
checks—as
some are already included in existing procedures—the redundant registration thus creating an administrative
burden. As a result, doctors and nurses might experience the checklist as an
additional, often unnecessary, task. These asynchronous
workflows impacted on a healthcare professional’s ability to halt
their work and
collaboratively meet to communicate at a time-out procedure: Time out was about
to commence and the nurse initiating it asked the anaesthetist “Are you joining us?” The anaesthetist
replies, ‘No, we have things to do’.”
- The checklist itself:
- Checklist content - ambiguous or confusing.
- Execution process did not merge with existing processes- … “duplication with existing processes that already covered several of the items in the surgical checklist.”
- Psychological ownership. Surgeons ”did not necessarily agree with it, albeit this protocol was endorsed by the College of Surgeons.” “ staff should have been involved in adapting and implementing the SSC as a means of
fostering ownership.”
- The implementation process
- Education and training –did staff receive information or training on how to use the SSC?
- Unclear guidelines- uncertain how to use the SSC and who was responsible for leading it.
- Surgeons commitment -Physician’s support and motivation were crucial for implementing the checklist
- The local context
- Executive leadership … “lack of clarity and agreement with protocol specifics, and inadequate executive leadership primarily resulted in reduced ownership and acceptance of the protocol by physicians.”
- Hospital leadership was not seen as involved in either promoting or actively
implementing the SSC.
- Organizational culture –“The same proportion of staff held the perception that the culture within their hospital was that of a general resistance to the introduction of change, whatever form it takes, particularly from more senior members of staff”.
- Communication and teamwork “We often talk about being one team, but it is in itself three teams. The surgeons don’t see themselves as part of the team; they see the others forming the team”.
I had some questions for Dr. Singer
regarding their study and fortunately she was willing to talk with me.
Out
of 67 hospitals, only 38 hospitals were willing to complete the initial
assessment survey. Were these facilities asked why they were reluctant to
complete the survey since this was a statewide initiative?
- SARA SINGER ANSWER: we were very disappointed. Every CEO signed a statement that they would participate. It was as if they snapped their finger and it would happen. Some said they did not want to share it. Others were just struggling to get people to use the checklist and wanted to focus on the checklist and regarded the survey as a potential obstacle. Private sector programs are free to say NO and you don’t know why.
Was
there any follow-up with the remainder of the facilities to see what their
impression at the end of the year was regarding their completion of the
implementation?
- SARA SINGER ANSWER: We are reaching out and communicating with all the hospitals even the ones who did not fill the survey. They felt they have completed the program.
Out
of the 38 hospitals who completed the initial survey only 13 felt they fully
implemented the initiative. Did the 25 hospitals who did not complete the
post-implementation survey reveal their barriers to implementation?
- SARA SINGER ANSWER: They felt like they still had a little ways to go.
I frequently hear “if it ain’t broke, don’t fix it!“. The general consensus espoused by these
surgeons is that the checklists disrupt the flow of care, reducing efficiency
with minimal if any improvements in care. Studies outside the US continue to
reveal mortality reductions following implementation of Surgical Safety
Programs. In Bock’s 2016 sample of
10,741 patients
“the implementation of SSCs was
associated with a 27% reduction of the adjusted risk for all-cause mortality
within 90 days. The risk for all-cause mortality within 30 days remained
unchanged. Adjusted LOS was reduced after implementation of SSCs.”
However, It has
not been as easy to attribute a reduction in adverse events and mortality directly due to implementation of safety
protocols in non-VHA hospitals in the U.S. making it more difficult to convince
American Surgeons to utilize these protocols.
Were you able to show improvement
in quality of care in your study?
SARA
SINGER ANSWER: We have mortality data for all 67 hospitals. We have a
study on its way that shows the when you have checklists imbedded in the
operating room, there is a reduction in mortality. This is over and above the
other hospitals in the state. Unfortunately, the sample size was probably too
low to see a reduction in adverse events.
Physicians
and APC’s perceived more improvements than nurses and Nurses reported that the
SSC helped promote efficiency and avert problems / complications more
frequently than the surgeons/APC’s. Is there any intent to query the responders to assess
exactly what improvements they felt came of the initiative implementation? Is
there any intent to discover the exact measures of OR efficiency and
complications which these staff refer to?
SARA
SINGER ANSWER: We have a
paper looking at the complications that were averted. The biggest was missing
antibiotics, the second was equipment issues, the 3rd was avoidance
of wrong site/wrong side / wrong patient/ wrong procedure/ allergies. Surgeons
frequently do not really know the full extent of the checklist utilization
because they tended to not be participating. Surgeons tend to feel safer in the
room than other staff. We found that teams use the checklist more when the team
is stressed more: the patient has more complex co-morbidities, there are
delays, difficult case, etc. The places where it is not successful there is too
much automaticity. Where it was successful, they put a lot of effort into
designing the process to improve implementation.
In a different paper from
the Harvard Group based on the SC Safety Checklist implantation to be published
in the Journal of the American College of Surgeons in 2016, RELATIONSHIP
BETWEEN OPERATING TEAMWORK, CONTEXTUAL FACTORS AND SAFETY CHECKLIST PERFORMANCE,
Singer et al confided that in the SC study, Surgeon buy-in and surgical
teamwork were critical in promoting checklist use which was instrumental in
ensuring a safe surgical environment. They developed a Surgical Teamwork
Coaching Tool to measure the levels of performance in the following areas:
shared clinical leadership, open communication, active coordination and mutual
respect. Their conclusion was that while surgeon buy-in and clinical leadership
was critical to assure active participation by all team members, not all surgeons
lead effectively. Their recommendation was that surgeons need to improve their
communication to promote the engagement of all OR staff in promoting the safety
of their patients.
In follow-up to the UK Study by Dr.
Russ, Sevdalis et al, I was fortunate to converse via email with Dr. Sevdalis
via email about these topics. He agreed that
their study was performed soon after implementation of the WHO checklist in
England and that while he was not aware of any follow-up study, one would suspect
that there may be more positive views developing over time depending on the
chosen implementation strategies. “These contextual
factors are important and I would say further studies into how we optimise
uptake and implementation of checklists (not just within surgery) ought to
examine them.”
My question to all these groups is the obvious one to me: I believe we understand why surgeons and
Anaesthesia attendings are averse or lackadaisical to the implementation of the
checklists (no data to support it, disrupts flow, takes too long, no benefit)
but has anyone discovered a methodology
to perfect conversion of these dissenters to supporters? And if so how was it
accomplished?
I look forwards to follow this same
process as it unfolds across the State of Louisiana.
Kenneth A. Lipshy, MD, FACS
STEPHANIE RUSS, N SEVDALIS and JOCHEN
BERGS.
Deonne Bailey
<Deonne.Bailey@la.gov>; SreyRam Kuy <SreyRam.Kuy@LA.GOV>; Kenneth
Alexander (kalexander@lhaonline.org); froberts@lhaonline.org; Ashley Childers
(akchilders@ashimprovement.com); Alicia Towne <atowne@scha.org>
(atowne@scha.org); Lorri Gibbons lgibbons@scha.org
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American College of Surgeons. DOI: 10.1016/j.jamcollsurg.2016.07.006
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