The Operating Theatre Journal

Author:

Mr Nigel Roberts, MSc, BA (Hons), PGR student,

Theatre Lead, University Hospitals of Derby and Burton

Acknowledgements:

Professor Stephen Wordsworth,

University of Derby

Professor Denis Anthony,

University of Derby

Keywords: Never events, Surgery safety checklist, Airline industry, Barriers, Non-technical skills, Education, Local champions, Wrong site surgery, Retained foreign object post procedure, Wrong implant/prosthesis

Background:

A review of the literature on the safer surgical checklist to understand why never events are still occurring in the operating theatres across the National Health Service as well as globally.

Aim:

Our aim is to understand the barriers that are affecting the effective use and implementation of the surgical safety checklist to understand what further work, research, and education is required to either limit or stop never events from occurring intra-operatively.

Methods:

Six databases were searched, with a date range of 2009 – 2021.

Databases:

CINAHL n = 23, Cochrane library n = 2, Embase n – 81, Researchgate n = 60, Scopus n = 53 and additional sources from websites n = 28.

From the initial search, a total of 261 papers were found across six databases. The records were screened, and duplicates removed, this left a total of 53 papers to be assessed for eligibility. This was further reduced by 11 as the literature was either not accessible or relevant to the topic. From other sources such as websites and organisations a further 28 papers were deemed to be appropriate to be included in the study.

The above has been reviewed and presented in a synthesised framework in appendix one, pages 22 – 26.

Search:

Papers published in English, peer reviewed, and academic journals restricted to 2009-2021.

# (surgical checklist) AND (patient safety) AND operating theatre OR surgery Or operating room

The search was carried out between 26^th July 2021 and the 10^th August 2021.

Appendix 2, page 27, details a PRISMA diagram of the search.

Exclusion criteria:

Animals, not written for a theatre environment, the abstract or title was deemed not relevant and not published in English

Discussion:

Examining the literature on the safer surgery checklist, a combination of seventy articles, journals and websites were reviewed. The main themes identified were ones of barriers, culture, training, non-technical skills, local champions, and surgical safety checklist per speciality.

Background:

All operating theatres encounter a complex working environment, daily time pressures, high workloads, and have the potential for catastrophic results if errors occur. The checklists that are used across the world today are based upon three principles, simplicity, widespread applicability, and measurability (WHO, 2008).

Objectives:

The main objective of this narrative review is to present a transparent process whereby: –

• We systematically searched databases to identify studies on the safer surgical checklist
• We describe the sources of the studies and any impact on patient care
• We show the re-occurring themes from across twelve years of studies

Research question:

Why are never events still occurring intra-operatively in our operating theatres?

Outcome:

Surgical safety checklist background

Recognition of theatres being a hazardous environment was made by Thomas et al (2000) and De Vires et al (2008) when it was estimated that nearly half of the adverse events that occur, are preventable. The ethos of a checklist is to help identify mistakes before any harm is caused to patients. Helmreich (2000) reported that checklists are commonly used as a method of both error and safety management to reduce risk. Haynes et al (2009) demonstrated that the use of a simple checklist can reduce the risk of morbidity, mortality and surgical site infection associated with surgery. Checklists not only reinforce communication (McConnell et al, 2012) but also improve communication (Gillespie et al, 2010 & Low et al, 2012) amongst all the multidisciplinary team.

In 2009, the World Health Organisation (WHO) launched guidelines for safe surgery saves life (WHO, 2009) in six languages (Haynes et al, 2009), across 132 countries (Gillespie et al, 2018) with the aim of preventing unnecessary death and improving outcomes for surgical patients (Viswanath et al, 2017), consequently, nineteen items were compiled into the three steps, for the original WHO safer surgery checklist (SSC). However, later in December 2010 following feedback from the initial implementation, a further two steps were added, these were the team brief and debrief. (Shah, 2011)

In January 2009 (Braham et al, 2014), the National Health Service (NHS) authorised the use of the checklist, and the National Patient Safety Agency (NPSA) (2008) stated that all NHS trusts must adopt this very simple and effective intervention. From February 2010 the NPSA checklist became a mandatory requirement for all operations in NHS England (NPSA, 2010). It was mandated by the NHS Commissioning Board Special Health Authority (Braham et al, 2014).

Learning from the airline industry

However, checklists are not new, the NHS has adopted this methodology from other sectors that use checklists daily, mainly the airline industry as the operating theatres have similar comparisons of time pressure, high workloads, and a potential for catastrophic errors, as previously stated. The first checklist was introduced into aviation after an accident on the 30^th October 1935 when the United States army corps was looking for its next generation of long range bombers. The plane took off, climbed up to 300 feet, staled and crashed. This was due to the pilot forgetting to release a new locking mechanism (Gawande, 2007). Later in the 1970s, aviation introduced its first cockpit resource management (CRM) programme into its training (Helmreich, 2000), initially it was only available to captains. However, a decade later, CRM was extended to all flight crew members and engineers.

Early adoption of the surgical safety checklist

When the checklist was introduced in 2009, the World Health Organisation (WHO) indicated that the checklist is not intended to be comprehensive, additions and modifications were encouraged (WHO, 2009). This was supported by Harden (2013) as it was suggested that checklists are not one size fits all, they must be customised to fit local practice. Verdassdonk et al (2009) had previously suggested that if the checklist is modified, it may influence its efficiency but, if it is too long or difficult, it may have a negative effect or no effect at all. McConnell et al (2012) found similar findings as they suggested the checklist should remain succinct and concise, otherwise checklist fatigue may occur. Thimbleby (2013) stated that checklists need to be tailored for different procedures. However, Pugel et al (2015), suggested that adopting a checklist to fit local practice may promote ownership and could improve compliance. Raman et al (2016) suggested that checklists need to be tailored to the specific task being performed. The use of stock questions decreases the likelihood of ensuring all theatre personnel are attentive. This was supported by both Raman et al (2016) and Barbanti-Brodano et al (2020) as they suggested specialised checklists reduce adverse events.

Second time out

Song et al (2013) suggested a second time out, a second checklist that is conducted three to four hours after the start of surgery to assess patient safety. The second checklist will promote communication between the surgical, anaesthetic and theatre staff whilst addressing concerns that may impact on prolonged operations. Song et al (2015) later reported that this initiative received positive feedback from all surgeons. A few years later, Schwab (2017) stated that we are now living in a new era, the fourth industrial revolution and Westman et al (2020), suggested that future studies should consider the use of checklists for robotic surgeries and artificial intelligence. Whilst conducting the literature review on the surgical safety checklist, it became apparent that there is still more research needed to understand the potential benefits of a second time out. The current papers were limited from the databases searched, and given that surgeries are complex, and multiple procedures are lasting longer than four hours, this is an area that needs to be explored further to ascertain, what, if anything, the benefits a second time out could have on patient outcomes, both immediately following surgery and thirty days post op.

Barriers to the implementation of the surgical safety checklist

What are the barriers to the SSC, and are we getting any closer to removing them altogether, as Fourcade et al (2012) and Levy et al (2012) earlier research, suggested that despite the awareness of the safer surgical checklist, most hospitals were struggling with effective implementation? Mahajan (2011) early research suggested that some barriers to implementation included anxiety; timing; duplication; relevance and misuse. Hurtado et al (2012) study concluded that knowledge of when to use the checklist was a definitive barrier to effective implementation. Levy et al (2012) American study also concluded that there was a lack of understanding and familiarity of the checklist amongst staff. Later in 2014, Treadwell et al, reported that the perceived barriers fell in to four categories; confusion; pragmatic challenge; access to resources and individual beliefs and attitudes. A year later, in 2015, Treadwell et al, still noted that there were barriers, but in fact identified five main categories; staff perception, workflow; design and content of the checklist; implementation and local context. Gillespie et al (2018) in their Australian study stated that the most significant barriers to using the SSC were workflow, knowledge, contents, and clinical leadership.

To successfully implement the safer surgical checklist Collins et al (2014) suggested that key stakeholders are identified, a change in culture and a shared vision for safety and active communication were all required. This theory was supported as both Bergs et al (2015) and Gillespie et al (2018) suggested that there is evidence identifying both contextual and organisational challenges in relation to checklist adoption.

To lead the change and to implement the SSC Vats et al (2010) suggested that the use of local champions will help in achieving complete adoption of the checklist. This theory was previously supported by Reinertsen et al (2007), Paull et al (2009) and Sewell et al (2013). Mahajan (2011) found that for successful implementation, three essential elements were required. They were developing local champions, organisational leadership, and training. Conley et al (2011) stated that a local champion can lead implementation by educating and supporting team members, as this will also help reduce the perceived barriers as previously mentioned. O’Connor et al (2013) study in Ireland found that by having a designated local champion it helped to remove any barriers and ensured the SSC was used. Oppikofer and Schwappach, (2017) suggested that hospital leadership is essential as acceptance comes from the participation of the users.

Other challenges associated with the use of the SSC whilst undertaking this literature review was one of time. An early study in France by Fourcade et al (2102) concluded the SSC was considered a waste of time as it took staff too long to complete, when their workload is already busy. There was also a perception of no actual added patient benefit. A study in Canada by Urbach et al (2014) found that the SSC added steps, that caused unnecessary delays in an already busy operating theatres schedule. Treadwell et al (2014) similarly reported that staff felt the checklist decreased efficiency in the operating room. In 2016, Tian et al study reported that the WHO checklist was still relevant and important but concluded that adequate time must be provided for checklist completion as this will lead to both ‘buy in’ from staff and ultimately improve patient safety. Barimani et al (2020) concluded that a major barrier to adoption of the SSC was the lack of a streamlined and cohesive approach in implementation.

In the current climate, where the NHS and other health care organisations from around the world, are faced with high demands on an already stretched service, we must consider the staff, and potentially how fatigued they are all feeling following Covid-19, and the pressures placed on NHS trusts by the government to tackle a growing backlog of patients that require not only surgical intervention, but also other NHS services. The current waiting lists are at a fourteen-year high, and there is an estimated 4.7m people waiting for treatment to begin (O’Dowd, 2021).

What is a never event?

The next question to ask is, so why are never events still occurring, if the SSC is in daily use? The literature would suggest that there are still six areas that require further research, education, and training. NHS England (2021) defines a never events as:

Serious incidents that are entirely preventable because guidance of safety recommendations providing strong systematic barriers are available at a national level and should have been implemented by all healthcare providers

Healthcare is complex and hence riddled with the potential for errors due to human factors (IOM, 2001). Surgery is one example of where clinicians are faced with high levels of uncertainty in their daily work, which may impact on the quality and safety of care patients receive (Tucker and Spears, 2006).

Slips and lapses are generally the result of fatigue, stress and emotional or sensory distraction (Systems approach, 2012). Over the years, much effort has been made to train surgeons and theatre staff in technical skills, but the aspects of non-technical skills, namely teamwork, leadership, situational awareness, decision making, task management and communication have long been neglected (Oppikofer and Schwappach, 2017). These traits were stated back in 2011 by Panesar et al as they also suggested that the non-technical traits such as better teamwork, and communication in the operating theatres reduces risk, improves staff well-being and mental health, reduces staff turnover, and reduces delays and glitches in the surgical process which is key to a safe working environment.

Speaking up and being encouraged to do so is not easy as Oppikofer and Schwappach (2017) suggested that nurses for example may not speak up to a surgeon if they notice a problem due to fear of being ridiculed for perhaps being incorrect, or the fear of being blamed by a superior. Encouragement of speaking up and creating a climate allowing all members to speak without the risk of being punished is therefore a true act of medical leadership. During surgery, all team members must be empowered to stop the surgery if they sense or discover a breach in patient safety.

After the publication of the first global survey on the use of the SSC by Haynes et al 2009, it was clear that this tool, adopted from the aviation industry would have an increasing impact on patient safety. High Quality Care For All (2008) proposed that a never event policy be introduced for the NHS in England from April 2009. The NPSA co-produced a set of criteria for defining “never events” and agreed a core list of eight “never events”, alongside a policy framework.

Regarding the surgical intra operative never events, only two were defined in 2009, they were wrong site surgery and retained instrument post operation. A new list of never events for 2011/12 increased to twenty-five. This included the other current surgical intra-operative never event, classed as wrong implant/prostheses. Retained instrument post operation was changed to retained foreign object post-operation. (DOH 2011).

At the time of writing this paper there were a total of 223 NHS trusts in England and 157 trusts have operating theatres. (NHS England, facilities data, Q3 2019-20). This equates to 3,282 operating theatres where a never event may occur.

A question to consider is has the NHS created a stigma instead of learning from ones’ mistake? Never events highlight weak areas within an organisation’s safety process and patient safety. Therefore, they are integral for the improvement and development of the NHS system. (Sampson, 2018). By creating a list of never events, not only is the NHS suggesting that other equally harmful events are not as serious as they have not made it onto the list, but it can also attach a stigma to these events and creates a culture of blame as opposed to a culture of learning and openness (MDU, 2016). From April 2016, patient safety was now part of NHS Improvement and for transparency about patient safety incident reporting, from April 2014, the NHS published never event data (NHS England, 2016). Sampson (2018) summed up healthcare mistakes by stating that at any point during patient treatment, a mistake can occur, these often come down to human error, we should learn from our mistakes, but sometimes they are unavoidable, and therefore should be seen as a learning curve as opposed to a disastrous event for the trust. Figure 1 on page ** details the amount of intra operative never events that have occurred between April 2012 and March 2020

Figure 1 – Never event final data, April 2012 – March 2020 (excluding wrong tooth removed)

The three intra-operative never events, wrong site surgery, retained foreign object post procedure and wrong implant/prostheses will be briefly summed up.

Wrong site surgery (WSS)

From April 2012 – February 2021, 942 cases were reported to NHS England. (NB. The total figure excludes wrong tooth removal). World-wide, approximately 2,700 patients are harmed by WSS each year with communication breakdowns reported as the main cause of such errors. (Collins et al, 2014). Wrong site surgery (WSS) is potentially devastating, and it is still a concern in orthopaedic surgery, despite major initiatives to address this issue such as “operate through your initials” campaign by the Canadian Orthopaedic Association (Wright et al 2009 , the “sign your site” initiative by the AAOS (2009), the “SMaX” imitative (NASS, 2001) and the Royal College of surgeons and NPSA guidance (2009).

The Care Quality Commission (CQC) review in 2018, ‘Opening the door to change’ suggested that WSS occurs due to:

1. Corporate culture and insufficient emphasis on adherence to SOPs.
2. Task overload and time pressure.
3. Distractions.
4. Absence of cross-checking or team co-ordination.
5. Complacency and over confidence.
6. Doing checklist as ‘tickbox’.
7. Changing team e.g., a new surgeon taking over shift or different surgeons from the one taking consent.
8. Missing patient notes.
9. Similar sounding first names.

Since February 2021, wrong tooth extraction was no longer considered a never event. (BDA, 2021 and NHS Improvement, 2021) NHS improvement came to this decision due to the systemic barriers to prevent the removal of wrong teeth are considered not to be strong enough to prevent these from occurring e.g., lack of standardisation in types of tooth notation and difficulties with site marking (NHS Improvement, 2021). Is this correct or just a way of reducing reporting? Is wrong tooth removal as harmful or as dangerous as potentially life-threatening events such as maternal death or surgery on the wrong side of the brain? (Sampson, 2018).

Retained foreign object post procedure

Data between 1^st April 2015 to 31^st March 2020 reveals that 389 claims were settled, with damages paid, for retained foreign objects post-surgery. These were classed as never events. This cost the NHS £12,472,347 (NHS Resolution, March 2021). The most common retained foreign object post procedure was instruments (46%) followed by swabs (44%). From April 2012 – February 2021 a total of 860 incidents were reported to NHS England (NHS England, 2021). Studies by Wang et al (2007), Zejnullahu et al (2017) and Zarenhad et al (2017) all stated that patients may re-present with the following symptoms following a retained foreign object (swab) frequent infections; palpable mass; obstruction; abscess and pain. Zejnullahu et al (2017) study concluded by stating that the key to preventing the incidence of retained surgical bodes is excellent communication with the surgical team, between the surgeons, nurses, and anaesthetists.

A study by Steelman et al (2018) in the USA reported a total of 319 incidents involving retained sponges between 2012-2017. These were most frequently retained in the abdomen or pelvis (50.2%) and the vagina (23.9%). NHS England during the same time reported 341 swabs or similar items. Steelman et al (2018) concluded that the contributing factors which led to retained foreign objects included human factors, leadership, communication, and the environment. Interesting to note that Gawande (2003) stated that in most cases where sponges were left behind, the number of sponges before closing was always declared correct, suggesting that counting alone is not sufficient. In addition, Stawicki et al (2013) suggested that studies have showed that body mass index, intraoperative complications and unexpected events are associated with an increased risk for retained foreign bodies after surgical procedures.

Wrong implant/prosthesis

The data from April 2012 – March 2020 shows that ophthalmic lens was the largest wrong implant (n=166), followed by hip prosthesis (n=93) and then knee prosthesis (n=90). In 2015, NHS England published the National Safety Standards for Invasive Procedures (NATSSIPS). One of the standards relates to prosthesis verification and details the expected checks to be carried by the theatre team, The checks include, type, design, style or material, side, manufacturer, expiry date, sterility, and compatibility of multiple components. It is important to note, regarding both hip and knee arthroplasty, that there are an estimated 80,000 prosthesis and implant combinations that could be used during surgery (HSIB, 2018).

Conclusion:

To conclude, Barimani (2020) found no evidence to suggest that any patient harm has occurred by using the SSC. However, for checklists to work, be successful and to reduce harm, non-technical skills such as leadership, basic cognition, situational awareness, operative briefing, and communication all need to be taught and understood by all users. There is still much work needed to address the myth of having the time to perform the checklist, but this can be overcome by having local champions to help reduce the perceived associated barriers of using the safe surgery checklist. Having tailored speciality specific checklists that are reviewed every two years to ensure that are still meeting the needs of both the patient and the end users may also increase staff buy-in. There is still much more research needed to understand if these contributing factors result in patient harm, as well as understanding if a further second time out would be of benefit.

Funding:

None

Acknowledgments:

None

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Appendix one – Synthesised framework on the safer surgical checklist

Appendix 2 – PRISMA flow diagram – Surgical Checklist