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In the Netherlands, the odds ratio for death within 30days of surgery ranged
from 0.44 for full implementation, to 1.09 for partial implementation, and up to 1.16
with noncompliance [45].
In July 2010, the Ontario (Canada) Ministry of Health and Long-Term Care mandated adherence to the SSC.Among the 101 hospitals in the study, there was no
signicant difference in risk of death during the hospital stay or within 30days after
discharge. There were also no differences in surgical complications, emergency
department visits, or hospital readmissions in 3-month periods before and after
implementation [46].
On reection, the approach to implementation in Ontario may have contributed
to the disappointing ndings [47]. While almost all hospitals in Ontario reported
some sort of educational intervention, it was unclear what these interventions
entailed or the degree of support they received. Self-reported compliance across
centers was greater than 92% during the study period. However, as has been demonstrated in many studies since, hospitals are motivated to report high levels of
compliance in administrative auditing processes. These inated numbers are often
not reected in independent observations, especially when compliance is nancially
rewarded or when it is a requirement for hospital accreditation [46].
In Ontario, it was observed that most hospitals did not modify the SSC for their
local needs, raising concerns about whether the surgical teams were meaningfully
engaged in implementation. Buy-in remains a critical piece of effective implementation, as people tend to embrace interventions they have a hand in designing [48].
Perhaps most importantly, one of the great lessons in these large scale interventions
is that effective implementation takes time, and the 3-month follow-up period might
not have been adequate to demonstrate meaningful change [49].
M. Kochis et al.
Implementation Matters
Building on early studies examining the impact of SSC effectiveness, a wave of
research grounded in implementation science and quality improvement principles
have explored the elements of successful implementation. Contrasting the former
investigations’ quantitative methods characterizing mortality or complication rates,
these later investigations often relied on qualitative methods, employing practices
from organizational psychology and medical sociology examining the human experience. In this eld where the nuances of local circumstances are critical, case studies are particularly illustrative.
Behavioral Change
A follow-up study to the initial eight-site pilot trial with an intensive implementation strategy showed that checklist rollout was associated with a statistically signicant increase in safety attitudes as measured by a validated questionnaire; the degree
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of improvement in safety scores correlated with a reduction in complication rate.
Overall, 80% of respondents indicated the SSC was easy to use, 79% felt the program prevented errors, and 93% would want the checklist used if they were a patient
[50]. Subsequent studies in many contexts delved deeper into exploring how checklist implementation impacted the culture and attitudes of the surgical teams and
perceptions of surgical safety.
Case Study: South Carolina In the South Carolina experience, a state-wide
implementation of the SSC was achieved through a partnership between the South
Carolina Hospital Association and Ariadne Labs, a health systems research platform including many of the original developers of the WHO SSC at Harvard.
These organizations co-developed a program of recommended practices to support and facilitate checklist implementation (Table2.1). This process, although
less intensive than the implementation of the initial WHO pilot, was performed
over multiple years with signicant nancial and leadership investment. By
design, it ensured a degree of rigor and commitment from the surgical teams
involved in the checklist rollout.
As part of this process, surveys were performed that measured perceptions of
perioperative safety practices. These surveys found that the process of checklist
implementation was associated with improved perceptions of mutual respect,
clinical leadership, and team coordination and communication; however,
Table 2.1 Barriers and Facilitators to Successful Checklist Implementation
Domain Barriers Facilitators
Checklist
design
Culture
Workow
Execution
Outcomes
Adapted from [22, 39, 51, 52]
− Impractical layout
− Confusing wording or content
− Poor relevance
− Ambiguity how to use (who, when)
− Resistance to change
− Skepticism about evidence
− Anxiety of unfamiliarity
− Staff hierarchy
− “Going through the motions”
− Noncompliance
− Increasing workload
− Repetition, wasted time, delays
− Unsuitable timing of checks
− Poor planning
− Limited access to necessary resources
(marking pens, antibiotics)
− Unintended negative effects
− Patient perceptions/anxiety
− Straightforward format
− Modication/adaptation
− Organizational priority
− Demonstrable leadership
− Local champions
− Senior clinician buy-in
− Support from hospital
management
− Integration with existing
processes
− Education/training on safety
and improvement
− Involving entire OR team
− Starting small
− Evident progress and execution
of plans
− Regular audits
− Feedback on local data
− Accountability for
noncompliance
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differences in perceptions based on professional role signied room for improvement [53].
These measures of improved perceptions of surgical safety and team culture
were aligned with safety outcomes. Among the 14 hospitals that enrolled in the SSC
program, there was a 22% decrease in 30-day mortality, but there was no such difference among control hospitals [54].
M. Kochis et al.
Best Practices forImplementation
The efcacy of a checklist depends on successful implementation, which is thoughtful
and deliberate. While there are several frameworks available to teams, the Explore,
Prepare, Implement, and Sustain (EPIS) framework is easy to understand and use across
the pre-implementation, implementation, and post-implementation phases [55]. As a
rst step, teams should Explore their surgical context, its members, and their needs.
Next, teams should Prepare a customized SSC by leveraging teams’ experiences and
contextual knowledge, so it aligns with their workow and patient populations. The
third step, Implement, entails the team introducing their customized SSC to the OR and
working to engrain the new SSC into their processes. The last step of the EPIS framework, Sustain, involves teams evaluating their SSC’s use and impact on their OR and
nding ways to ensure teams’ performance does not wane. This framework can also be
applied to re-implementation if previous efforts have stalled [56].
The aspects of implementation described below reect the robust theoretical
frameworks relevant to effective implementation of the SSC.The ndings and recommendations are based on studies with various methodologies ranging from a
scoping review to a realist synthesis, which is an approach designed to consider
what works for whom, under what circumstance, and why [57]. These insights will
be just as relevant to other checklist interventions.
Pre-Implementation: Explore andPrepare
For the pre-implementation phase, which encompasses the Explore and Prepare
steps, best practices include grounding the work within a theoretical framework,
understanding barriers and facilitators, and analyzing the local safety culture [58].
Grounded inTheory
Two organizational behavior theories relevant to the SSC include the Normalization
Process Theory and Response Regulation Theory. The former examines the cognitive
and physical steps involved in embedding a practice into routine work patterns, while
the latter describes how leaders use various methods to steer attitudes and behaviors [57].
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Understanding theLocal Context
In a systematic review of 33 studies, Treadwell etal. [39] summarized barriers
into four categories: confusion regarding how to properly use the checklist, pragmatic challenges to efcient workow, access to resources, and beliefs and attitudes of participating staff—particularly surgeons [39]. This latter nding was
borne out in a qualitative study in the UK, which found the single most cited barrier to checklist implementation was active resistance or passive noncompliance
among OR team members, with the vast majority being senior surgeons and/or
anesthesiologists.
Even so, the study found the majority of reported barriers pertained to the checklist itself, either in terms of layout (e.g., no space to write answers) or content (e.g.,
confusing wording like “are there any unexpected steps?” since by denition they
are not anticipated) [52]. Anticipating, identifying, and addressing barriers and optimizing facilitators is a key aspect of achieving initial success in SSC rollout as well
as sustaining checklist use (Table2.1).
To reference a real-world example, a strength of the aforementioned VHA checklist
lies in the researchers’ 2-month period dedicated to gathering information on safety
barriers and understanding the local culture before implementing the team intervention [29].
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Implementation
Here, strategies include customizing the SSC, empowering leaders, and providing
support, awareness, and training. Gillespie and Marshall also found that active
involvement of physicians and their adaptation of the checklist to their specic circumstances are critical aspects of this stage of implementation [57].
Customization
From the beginning, the WHO has encouraged teams to tailor the SSC based on
their contextual needs. Modication of the SSC is associated with successful uptake,
as a UK study found modication to be the most commonly cited implementation
facilitator [52]. Making changes addresses surgical teams’ needs inlocal contexts
and helps create a sense of ownership. Additions should not introduce unnecessary
burdens, and eliminations should not compromise opportunities for all team members to speak up; all changes should promote tool usage and teamwork [3]. In general, modications may involve adding elements that the current checklist overlooks
(e.g., surgical implants), or aspects of the procedure (e.g., robotic surgery) or patient
(e.g., neonates) where additional processes need to be considered [3, 59].
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M. Kochis et al.
As an example, adaptation of the checklist to ambulatory surgeries, where morbidity and especially mortality are so low, shifted the focus to reducing pain and
preventing postoperative nausea/vomiting [60]. Checklists have been applied to
many surgical subspecialties including Neurosurgery, Orthopedics, Cardiac Surgery,
Urology, and Otolaryngology [61], each with their own adaptations. In Pediatric
surgery, for example, a well-regarded practice is encouraging parental involvement
in checklist activities [62].
However, adaptation should be viewed with caution due to potential downsides. First
is diminished effectiveness, which can occur through either loss of important elements
or addition of items that are irrelevant to regular use or make the tool too onerous, leading to disengagement or inefciency. Second, modications complicate comparability
and aggregation which are necessary for benchmarking and research purposes. Such
was a concern among researchers in Switzerland, who discovered signicant variations
in content, timing, and role denitions in checklists across the country [63].
Multi-Level Leadership
A study of SSC implementation at ve hospitals in Washington State found leaders
to be a strong factor for implementation success, since they can explain the reasoning behind checklist use and demonstrate how it is used in real life. When there was
a lack of understanding on why or how the SSC works, it led to staff frustration,
disinterest, and eventual abandonment [64]. Furthermore, the tone among highlevel hospital or departmental decision-makers can have a profound inuence on
users’ buy-in and acceptance of the SSC.As John Kotter, a thought leader on organizational change, once said, “Unless you win support for your ideas, from people
at all levels of your organization, big ideas never seem to take hold or have the
impact you want” [65]. Indeed, engagement of institutional stakeholders like hospital CEOs, and not just physicians and nurses, was believed to be a key element of
the success of the South Carolina program [66].
Implementation Support
Finally, the last theme–providing support, awareness, and training–can again be
illustrated through the South Carolina implementation (Table2.1). Here, implementation success was associated with the completion of low- and high-touch activities:
while inexpensive webinars and coaching phone calls were easy to implement and
supported the process, more intensive activities like in-person meetings and teamwork skills trainings resulted in greater engagement and effectiveness [66]. It is
likely that a combination of these approaches can address issues of feasibility and
cost as well as efcacy.
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Post-Implementation: Sustain
After evaluation, strategies that audit and improve the ongoing use of the SSC are
critical so that its value can be sustained or augmented, and it can continue to address
the changing needs of surgical teams. The key themes in this phase include ongoing
monitoring in which data on the use of the checklist are documented, and feedback in
which that data are shared with users for the sake of reinforcing positive behaviors or
correcting problematic behaviors. While successful pre- and during- intervention initiatives are necessary for a checklist to achieve its best effect, demonstration of the
benets to the involved parties can enhance utilization and ensure that the outcomes
are sustained in the long term. Locally collected data, observations, and anecdotes
which are personally relevant are persuasive and should be fed back and discussed
with teams frequently [52]. The Proctor framework introduces eight standard outcomes used to evaluate successful implementation of an intervention [67]; assessment
of these outcomes helped demonstrate sustained nationwide checklist implementation
in Benin [68].
After providing surgical teams with the knowledge and resources needed to
implement the SSC, it is important to realize that change does not happen immediately. There is no standard implementation timeline, since acceptance of an intervention is idiosyncratic and multifactorial. The South Carolina program, for
example, spanned 8years, with additional hospitals joining the community as success became evident [66]. This underscores the notion that the act of translating
knowledge into action should not be taken for granted.
Next Steps
SSC inLow andMiddle-Income Countries
It is a common misperception that checklists’ benet is seen exclusively or primarily in low-resource settings. In reality, early studies demonstrated that the checklist
could be effective in both high- and low-resource settings, the latter ranging from an
under-resourced hospital in Moldova [41] to a large multi-specialty hospital in India
[40]. However, low-resource settings face several barriers which hamper the efcacy of the SSC.
Slow Progress
The WHO sought nationwide implementation of the SSC in 15 African countries in
2011 by convening a group of one representative hospital from each country. By
October 2012, 10 of the 15 hospitals reported successful implementation of the
checklist, but none of them implemented it in all of their ORs, and no national
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efforts were underway [69]. While efforts since then have been limited, there have
been some successes. For instance, the health ministries of Madagascar, Benin, and
Guinea partnered with the non-prot Mercy Ships, which runs the world’s largest
civilian hospital ship [70]. Furthermore, several studies have examined successful
implementation initiatives, identifying barriers and establishing best practices
[68, 71].
Although SSC use does not rely on technology and is designed to be used in all
settings, the competing demands, diminished infrastructure, and cultural barriers in
low resource settings have resulted in poor adoption and sustainment of the SSC in
these contexts. Ten years after introduction of the SSC, signicant variability exists
in terms of use of SSC, with decreased overall use in low Human Development
Index (HDI) countries compared to those with very high HDI [72].
The Clean Cut Program
Developed by local surgical leaders both within and external to Lifebox, a nonprot organization focused on improving worldwide surgical care (lifebox.org),
Clean Cut is an adaptive, multimodal checklist-based program that targets six areas:
appropriate skin and hand antisepsis, maintenance of a sterile eld, instrument sterilization, appropriate prophylactic antibiotic administration, routine gauze counting, and routine use of the SSC.Following program implementation in ve hospitals
in Ethiopia from August 2016 to October 2018, compliance with the six items
increased, and the risk of infections decreased [73]. This program is currently being
scaled throughout Ethiopia, and teams have begun to implement in several other
African countries.
M. Kochis et al.
Beyond theWHO SSC
In many settings, it has been over a decade since the SSC’s rst implementation,
with new users inheriting SSCs from a prior implementation period [3, 59]. In light
of changing needs, organizations should periodically review and update their checklists, not only because it refreshes the items on their SSCs, but also because it galvanizes the team and recognizes new perspectives. Such a review should be
comprehensive and systematic. While this process may seem daunting, there are
various systems for changing teams’ checklists and revitalizing their use. For example, in assessing SSC use at Singapore General Hospital, a team from Ariadne Labs
developed a three-part evaluation plan involving assessing (1) quality of care via a
review of surgical safety events, (2) safety culture through a validated survey and
informal feedback, and (3) checklist performance through direct observations and a
survey of staff. This allowed them to revise and re-implement the checklist in
Singapore while also setting forth a framework for other organizations [56].
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Technology Tools
The potential opportunities provided by visual displays, real data integration, and
clinical decision support may result in further checklist evolution. One study used
checklists displayed via an app on smart glasses. As compared to standard
approaches such as a poster on the wall, the smart glasses group had improved
completion rate and decreased time spent performing the checklists [74]. Another
innovation involves a Digital Checklist Box, which projects the timeout information
onto the patient’s drapes and allows surgeons to navigate the interface with hand
gestures [75].
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