Improving peri-operative patient care: the surgical safety checklist.

“What is needed, however, isn’t just that people working together be nice to each other. It is discipline”

In 2004, the World Health Organization launched the World Alliance for Patient Safety, an initiative to ‘facilitate patient safety and policy’, which was triggered by increasing evidence that lapses in patient safety were causing significant harm.[2] Since then, the alliance has identified challenges to patient safety and launched a series of campaigns to improve patient care. The second of these initiatives, launched in 2007-08, was the “Safe Surgery Saves Lives” campaign. This campaign focused on measures to decrease peri-operative morbidity and mortality and a key feature was the development of a surgical safety checklist to be administered at various time-points during the surgical process as a combined effort by members from the surgical, anesthesia and nursing teams.[3] The objective of the checklist is to ensure preparation and planning for the surgery, document problems (patient, procedure and equipment-related) and improve team-work and communication.[3]

The earliest evidence that the checklist was effective as a patient safety tool came from Haynes who conducted a global multi-centric 7000-plus patient study and found that the implementation of the checklist significantly improved peri-operative morbidity and mortality.[4] Since then, several studies have re-iterated these findings and a recent systematic review of 33 studies looking at the impact of surgical checklists concluded that ‘surgical safety checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating room staff’.[5]

In this issue of the journal, Oak SN et al. have explored the impact of the WHO surgical safety checklist on patient safety in pediatric surgery over a 2 year period. The authors found that the use of the checklist helped to identify several errors which could potentially have caused significant patient harm.[6]

Critics of checklists believe that most of the data we have today regarding their effectiveness is from non-randomized studies and that these tools promote a false sense of security, expend resources for training of staff, are time-consuming, reduce operating room efficiency and may contribute to increased patient anxiety.[5] However, a recent cluster randomized trial has shown that the use of the surgical safety checklist led to a significant decrease in surgical complications and a non-significant but important reduction in hospital length of stay and mortality.[7] In resource-constrained settings such as the one where Oak and colleagues have done the study, this could translate into considerable cost savings.

The actual impact of safety checklists is difficult to measure. The incidence of hard outcomes like peri-operative mortality is low (around 1.5% in the Western world) and it would take very large and probably multi-centric studies to demonstrate a significant change.[4] With increasing awareness about the checklist, a randomized study design, even with the cluster technique, is prone to contamination. The presence of an ongoing audit is likely to change the behavior of personnel involved and elicit falsely promising results. Also, the introduction of measures like the checklist is usually associated with improvements in other peri-operative processes and the resultant favorable impact on outcomes may be due to a multi-factorial change and not necessarily due to the checklist itself.[5]

While acknowledging these limitations, Oak and colleagues need to be commended for carrying out this study and for proving that adopting and applying the checklist into routine practice is definitely feasible and potentially beneficial. The impact of their study is particularly significant because it has been carried out in a potentially vulnerable patient population. In India, the culture of briefings among members of the operating team is an alien concept and communication between team members is usually far from optimum. Most surgical set-ups in India do not have circulating nurses who can be entrusted with applying the checklist. In this setting, Oak and colleagues have shown us that it is possible to successfully implement the checklist and consequently improve patient safety.

The study has some shortcomings. A large proportion of the mistakes detected by the checklist dealt with issues of patient identity, and site and side of surgery — however, no major peri-operative errors were detected during the study spanning 2 years and 3000 patients. It is difficult to judge whether the lapses detected by the use of the checklist actually averted these major errors and resulted in better patient outcomes. The authors could have considered using a control group (for example, a before-after implementation study) to get baseline information on the incidence of major peri-operative errors in their population (such as wrong patient, wrong site and wrong side surgery) and assess the actual impact of the use of the checklist. It would also have been interesting to have data on the time needed to implement the checklist and its effect, if any, on operating room efficiency.

Having said this, studies like this can and should pave the way for more institutes in India to adopt the use of the checklist and generate data to add to the existing body of evidence on the use of checklists and their impact on patient safety.