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
- 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 (email@example.com); firstname.lastname@example.org; Ashley Childers (email@example.com); Alicia Towne <firstname.lastname@example.org> (email@example.com); Lorri Gibbons firstname.lastname@example.org
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