Checklists,global health and surgery: a five-year checkup of the WHO Surgical Safety checklist programme

Abstract

The WHO Surgical Safety Checklist has become a high-profile symbol for patient safety efforts in surgery. Since the landmark study by Haynes et al.¹ documenting its success at reducing peri-operative morbidity and mortality in a diversity of settings, others have gone on to show positive effects of the checklist on teamwork, communication, and patient outcomes. The widespread dissemination of the checklist has now allowed for a more global analysis of its role in surgery, and has highlighted two key points: first, the success of the checklist relies on effective and appropriate implementation; and second, the checklist needs to be introduced as part of a broader patient safety movement. Beyond universal challenges with implementation, some questions have been asked about its applicability to low- and middle-income countries. WHO acknowledges that checklist implementation in such settings needs to be well considered; limited availability of resources and less structure around patient safety provides a different context for effective use. Further research needs to be undertaken to better understand what if any modifications need to be made. WHO also hope to better coordinate patient safety efforts with the global surgery movement to maximize the effect of the checklist and improve surgical safety in low- and middle-income countries.

Keywords

Checklist safe surgery patient safety global health surgery

Background

In 2002, the 55th World Health Assembly challenged the World Health Organization (WHO) and its Member States to pay the closest possible attention to the problem of patient safety.² This came on the back of the 2001 Institute of Medicine report, To Err is Human, the 2001 United Kingdom Chief Medical Officer’s Report, An Organization with a Memory and a growing awareness of preventable harm caused within our healthcare systems. Two years later, WHO responded by launching the World Alliance for Patient Safety whose task it was to raise awareness and political commitment to improve safety in healthcare.

The Alliance has set forward several challenges to propel global action in patient safety. The second of these, entitled the Safe Surgery Saves Lives campaign, was initiated in 2007 and aimed to improve the safety of surgical care around the world by defining a core set of standards that can be applied in all WHO Member States. It acknowledged the unacceptably high rate of peri-operative death attributed to surgery and of major complications.³ Several working groups were convened that collectively identified four areas in which large improvements could be made: surgical site infection prevention, safe anaesthesia, safe surgical teams, and measurement of surgical services.

Though only one output of this challenge, the WHO Surgical Safety Checklist has become a high-profile symbol for patient safety efforts in surgery – and in healthcare in general – since its launch in 2008. The concept of checklists in high-reliability organisations is not new.⁴ For example, checklists have been used in the aviation industry since the fall of the Flying Fortress or the Boeing B-17 in 1935. After its infamous crash, the plane once thought doomed went on to fly millions of times, thanks to the introduction of a checklist.

The first widely celebrated use of such tools in healthcare was that used to reduce central line infections.⁵ This concept was then extended to surgery when the Alliance, after a significant consultative process, identified ten objectives for safe surgery.³ It was these ten objectives that formed the backbone of the now well-known 19-item tool. The WHO Surgical Safety Checklist was not the first checklist ever used in surgery; national professional societies and hospitals in some countries had been using them for years. However, it was the first attempt to create a checklist that was applicable in all 154 countries of the WHO.

After development, the WHO Surgical Safety Checklist was tested in eight diverse settings around the world.¹ By undertaking pre- and post-implementation analysis, Haynes et al.¹ showed nearly a 50% reduction in peri-operative mortality, from 1.5% to 0.8%, and a near 40% reduction in inpatient complications, from 11% to 7%.

Other studies have gone on to support this trend.^6–9 Askarian et al. found that surgical complications decreased from 22.9% to 10%.⁹ The Netherlands’ Surgical Patient Safety System found a significant reduction in in-hospital mortality (1.5% to 0.8%) and in overall complications (27.3 to 16.7 per 100) after implementation of a comprehensive surgical checklist.⁸

A further study in the Netherlands showed the checklist was associated with decreased odds of 30-day post-operative mortality,¹⁰ and an American study revealed a reduction in 30-day post-operative morbidity after the checklist was introduced with team training.¹¹ Although some groups have found it to be inconvenient in emergency cases,¹² it has also been shown to be effective in urgent surgery.¹³

Improvements have been broader than just morbidity and mortality. Semel et al. suggested that its use was cost saving.¹⁴ Kearns et al. and Sewell et al. found most users felt the checklist improved communication.^7,12 Studies have also suggested an improvement in safety attitudes,^6,15,16 speaking to the concept that part of its success is attributable to a change in culture and improved communication. Indeed, it is unclear why the checklist has been able to improve patient safety. The original study suggests that it is multifactorial, and that improvement could be because of the checklist itself, the formal pauses, the resultant push for uptake of technology, and teamwork.¹

Five years after WHO launched the first edition of the checklist, its use has become routine practice in many hospitals across the world. This widespread dissemination has allowed for a more global analysis of its role in surgery, and has highlighted two key points: first, the success of the checklist relies on effective and appropriate implementation; and second, the checklist is not the soloist in surgical safety but rather one part of a wider chorus for quality.

Beyond universal challenges with implementation, some questions have been asked about its applicability to low- and middle-income countries (LMIC). This paper reviews the challenges of implementation, reflects on the checklists applicability in LMIC, highlights the role of the checklist in the context of a wider safe surgery movement, and discusses WHO’s role in directing this area of patient safety.

Implementation and compliance

The challenges of implementing the WHO Surgical Safety Checklist have become apparent following its widespread dissemination across diverse countries and healthcare systems. An online survey of all hospitals in Ireland, for example, found that 60% of institutions using the checklist found it difficult to implement.¹⁷ These challenges are understandable – such tools test organizational culture and workflow¹⁸ and challenge professional hierarchies by making all members of the surgical team accountable for safety.

The importance of implementation strategy in the acceptance and success of the checklist was identified early on in this project. When WHO introduced the checklist it released an implementation manual that spoke to the importance of ‘adapting the checklist to local routines and expectations,’ appropriate modification, training, practice, and leadership.¹⁹

A group at Harvard University later reviewed known implementation processes before going on to study checklist use in five hospitals in Washington DC – their paper provides revealing vignettes of successful and unsuccessful centers.²⁰ In brief, they found that active leadership, deliberate enrollment, extensive discussion and training, piloting, multidisciplinary communication, real time coaching, and ongoing feedback were among the main factors that distinguished effective from ineffective implementation strategies. Their study also emphasized the importance of explaining why the checklist should be used and showing indeed how to use it.

Treadwell et al.²¹ reviewed 33 implementation reports and reported similar factors affecting uptake and success, citing the importance of champions and upper management, the ability to modify the checklist to suit local needs, a distribution of responsibility for its implementation and use, and a sense of ownership by end-users. The same group also reviewed barriers to effective implementation. They found papers commonly cited challenges to workflow, limited access to resources required to enact the checklist, confusion as to how to use the checklist, and individual beliefs and attitudes as obstacles to successful implementation.

Synchronous implementation is also important. The checklist requires the collaboration of groups that perform very different roles: nursing staff, anaesthetic staff, and surgeons. Although they operate as a functional team, most of their training, education, administration and leadership occur within their respective specialty units. WHO has observed that facilities that have achieved effective implementation have undertaken synchronous roll out, training, and leadership across all specialty groups. Implementation has fallen down when asynchronous introduction has occurred – nursing staff have been educated, then later surgical staff and anaesthetic team members for example. There has to be a unified approach, with both vertical and horizontal leadership, to facilitate successful implementation by the operative team.

A review of the literature also reveals much discussion about compliance to the use of the checklist. Such themes are inextricably linked to barriers and success factors in implementation, as compliance is one measure of the effectiveness of implementation. Compliance is certainly paramount to the effective running of the checklist. One study found that the positive effect on patient outcomes was significantly reduced when the checklist was not completed in full.¹⁰ The sign out can often be left incomplete,²² while some have found that components that facilitated teamwork and communication are often neglected.²³ Studies in high-income settings suggest compliance is linked to organisational safety culture,²⁴ and is also affected by hierarchical structures and absence of key team members.^20,25,26

Several authors also document that there is also the temptation for the checklist to turn into a check-box exercise, rather than serving as an aide-de-memoir bolstering communication. A New Zealand report showed that several hospitals were physically checking the boxes, signing and dating each section and using this for auditing purposes.²⁷ This unfortunately encourages gaming, detracts from the aide-de-memoir purpose of the checklist, and decreases functional compliance. Furthermore, such self-reporting of compliance does not correlate with observational data and provides little insight into how the checklist is truly adopted.²⁸ Instead, observational techniques should to be employed. Above all, it takes time and a change in safety culture to achieve successful implementation and full compliance. One cannot expect significant changes in outcomes by simply introducing the checklist; Neily et al. found that mortality continued to decrease each quarter after Veteran Health Administraton Hospitals implemented the checklist.²⁹ Indeed, those that have failed to show improvements have likely failed to implement the tool successfully or given enough time to do so.^30,31

Low- and middle-income countries

Several studies have specifically explored implementation of the checklist in LMIC,^6,32–34 where there are higher peri-operative mortality rates³⁵ and where there may be wide variation in infrastructure, personnel, equipment and supplies, regulatory and organizational structures which pose additional challenges to implementation and to patient safety in general. Discussions to date suggest that this area requires specific consideration.

Kwok et al.³³ showed it was possible to implement the checklist in a middle-income country. Their team showed an improvement in adherence to best practices and in patient outcomes in Moldova, but they acknowledged that an insufficient number of pulse oximeters – one of the checklist requirements – was a barrier to compliance with only 15% of operating theatres having access to them before the study. Their results were no doubt aided by the fact their intervention included the provision of pulse oximeters.

Aveling et al. suggested that compliance and fidelity of the checklist was not as good in a sub-Saharan African country hospital in comparison to a UK-based institution.³² They cited that the implementation of the checklist in an LMIC required a bigger change to standard practice in comparison to high-income settings; there was minimal understanding of patient safety, no audit system, and little consequence for non-compliance. They also found that the checklist introduced more new concepts than in the UK, including equipment counts that were not routinely undertaken prior to the checklist introduction.

Thomassen et al.⁴ highlight the need to consider the historical autonomy of clinicians in the operating theatre. The checklist demands a more flattened hierarchy and at times removes the once complete autonomy from the surgeon. Aveling et al.³² identified that this was a more prominent barrier to effective implementation in their sub-Saharan African setting that had a more established hierarchical structure. It meant that some of the communication and teamwork benefits may have been less effective. Others have also reported that a lack of access to resources, such as antibiotics or materials to mark surgical site, impedes the effective use of the checklist.^6,34

Discussion

The introduction and widespread dissemination of the WHO Surgical Safety Checklist has certainly heralded a heightened understanding of and focus on surgical safety. Since the landmark study by Haynes et al.¹ documenting its success at reducing peri-operative morbidity and mortality in a diversity of settings, others have gone on to show positive effects of the checklist on teamwork, communication, and patient outcomes.

When launched, the Patient Safety Alliance aimed to improve the safety of surgical patients across diverse cultural and economic environments. The initial study suggested that this was possible with four low-income countries contributing to the original study,¹ however, the checklist's applicability to LMIC has since been questioned.³² There is certainly great diversity in LMICs and four centres cannot be assumed a representative sample.

WHO acknowledges that checklist implementation in such settings needs to be well considered; limited availability of resources and less structure around patient safety provides a different context for effective use. Further research needs to be undertaken to better understand what if any modifications need to be made to the checklist in LMICs. WHO also hope to better coordinate patient safety efforts with the global surgery movement to maximize the effect of the checklist and improve surgical safety in LMIC. A better understanding of the context of peri-operative mortality and morbidity and the drivers of safety in LMIC is fundamental to improving outcomes.

This need to understand the long-term sustainability of the checklist is something this programme shares with virtually every major effort at improving quality and safety globally. In the US, for example, Dr Carolyn Clancy (former director of the US Agency for Healthcare Research and Quality) recently stated that there were “very few” example of sustained improvement in clinical quality that can be documented with data. The need for a comprehensive and multipronged approach to behavior change and one that is led by clinical leaders seems to be key factor for success.

Certainly, checklists need to be introduced as part of a broader patient safety movement in both LMIC and high-income settings. As Aveling et al.³² succinctly put it: “checklist implementation will be optimized when part of a broader, multi-faceted cultural and organizational programme to strengthen patient safety.” This was recognized in the Keystone Project. The reduction of central line infections was due to more than just a checklist – it was the result of recruiting advocates, keeping teams focused on goals, creating an alliance with higher-level administration, shifting power relations, creating social and reputational incentives for cooperation, creating open channels of communication, and using audit and feedback.²⁴

Over the coming years, WHO plans to bolster its safe surgery activities. With more implementation knowledge available, and with the recent release of the WHO guide to Implementation Research in Health, the Alliance hope to further explore the use of the checklist in LMIC. A revised version of the Implementation Manual is also intended.

The checklist, however, is just one part of a bigger picture. The challenge laid out in 2007 included global monitoring and evaluation of surgical practices and outcomes. Further work also needs to be undertaken strengthening basic human resources and operational capacities of surgical services at the periphery, district, and central hospital levels. Careful consideration of the trauma and emergency care services in a country must also be considered and doing all this in the context of extremely limited national budgets for healthcare in general is also important.

WHO continues to work on the issue of improving surgical care services as a “feature” issue of expanding access to universal healthcare. This issue will shape the future of global health in the near future and ensuring quality of surgical care will be one key axis for action.

Footnotes

Funding

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Conflict of interest

The authors declare no conflict of interest.

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