Abstract
Background
Never Events are serious, preventable, and clearly identifiable medical errors with the potential for causing patients significant morbidity and mortality. Despite extensive efforts to eliminate them, Never Events persist.
Aim
To assess whether interdisciplinary clinicians (nurses, surgeons, and anaesthesiologists) and risk managers have different mental models about three aspects of the definition of surgical Never Events: incidence, severity, and preventability.
Methods
Semi-structured interviews were conducted with 25 operating room clinicians and hospital risk managers in Israel from September to December 2019. Verbatim transcripts were analysed using six-phase inductive thematic analysis.
Findings
Mental models of Never Events varied by profession. Surgeons described them as rare and nurses saw them as common. While agreeing on their severity, mental models about preventability were mixed, with surgeons and nurses thinking that training and/or safety standards could prevent them, and anaesthesiologists and risk managers considering them to be unpreventable.
Discussion
The common definition of Surgical Never Events characterises them as severe and preventable events. Different mental models characterise interdisciplinary views about the definition. These differences challenge the utility of a single international consensus definition of Never Events.
Conclusion
Given differences in mental models among clinicians and risk managers, approaches to eliminating Never Events may benefit from identifying and addressing these differences in order to improve teamwork and implementation of safety protocols.
Keywords
Summary of relevance
Problem
Never Events persist despite extensive efforts to eliminate them.
What is already known
Among strategies for eliminating Never Events are efforts to promote patient safety cultures characterised by effective interprofessional teamwork. The literature demonstrates that high functioning healthcare teams have shared knowledge structures – or mental models – regarding patient safety. Nevertheless, less is known about the underlying characteristics of these mental models.
What this paper adds
This study explores mental models of 25 clinicians and risk managers with regard to Surgical Never Events and finds patterns of variability concerning their seriousness, preventability, and incidence – with implications for training and patient safety.
1. Introduction
Never Events were first defined by the National Quality Forum in 2001 as an outcome of voluntary stakeholder consensus process (
Kizer and Stegun, 2005
). They include serious, preventable adverse events with potentially serious consequences for patient morbidity and mortality. Although the definition has varied somewhat and has evolved over time in different countries, these elements are typically present in all definitions (- Kizer K.W.
- Stegun B.S.
Serious reportable adverse events in health care. advances in patient safety: from research to implementation.
in: Henriksen K. Battles J.B. Marks E.S. S E. Lewin D.I. Advances in patient safety: from research to implementation. Volume 4: Programs, Tools, and Products. U.S. Agency for Healthcare Research and Quality,
Rockville2005
Robert et al., 2015
). Such events include, for example, severe bedsores or major medication errors. Surgical Never Events, a subset of Never Events, include performing surgery on the wrong site or the wrong patient, performing the wrong surgical procedure, and unintended retention of a foreign object in a patient's body after surgery, intraoperative, or immediately postoperative death in otherwise healthy patients (- Robert M.C.
- Choi C.J.
- Shapiro F.E.
- Urman R.D.
- Melki S.
Avoidance of serious medical errors in refractive surgery using a custom preoperative checklist.
Journal of Cataract & Refractive Surgery. 2015; 41: 2171-2178https://doi.org/10.1016/j.jcrs.2015.10.060
National Quality Forum 2012
). In Israel, the incidence of retained foreign objects during surgery is 3.2 in every 100,000 surgeries (OECD 2019
). The incidence of wrong site surgeries is unclear but is generally estimated as one in every 100,000 surgeries. These events can lead to physical and emotional suffering and financial burden to patients and can also impact surgeons and the institution who blame themselves for the error (Kumar and Raina, 2017
).Multiple efforts have been undertaken to prevent Surgical Never Events worldwide, including a surgical safety checklist developed by the World Health Organization (
Kumar and Raina, 2017
; World Health Organization 2009
). Other efforts include quality improvement training, root cause analysis, and team huddles. Among organisational strategies for eliminating never events are efforts to promote a patient safety culture (Moppett and Moppett, 2016
) by listening and relating to employee voices (Martin, Chew and Dixon-Woods, 2020
), by encouraging effective interprofessional teamwork, intraoperative communication, and by improving ability to manage disruptions (Mathew, Markey, Murphy and Brien, 2018
). An attribute of the high functioning teams required to implement these approaches is shared mental models in relation to safety (Aveling, et al., 2017). Mental models are individually held knowledge structures around the dimensions of content, similarity, accuracy, and dynamics. Shared mental models can help team members to function collaboratively (McComb and Simpson, 2014
).Two studies have analysed interprofessional mental models in the Operating Room (
Brown et al., 2017
, Aveling et al., 2018
), but neither directly probed clinician views on the fundamental definition of Never Events. Brown et al., 2017
found that variability in mental models hampered communication among members of a cardiac perioperative team at critical care transition points. Schiff et al., 2018
determined that uptake of a training tool for improving teamwork was hampered by variable mental models among members of a surgical gynaecology team. While a study by Göras et al., 2020
notes that mental models are created by shared planning to improve safety, it did not explore the underlying characteristics of varying mental models. Most relevant to the present study, McComb, Lemaster, Henneman and Hinchey, 2017
found that physicians and nurses have significantly different mental models. These are reflected in their divergent views on who is responsible for a number of activities closely related to patient safety, including patient advocacy, identifying errors and near misses, and medication reconciliation. These differences, can affect clinicians' actions during surgical procedures and are related to their knowledge and practice (Flug, Ponce, Osborn and Jokerst, 2018
). Despite the potential significance of different mental models for patient safety, little is known about the mental models of clinicians with regard to the concept of Never Events. This study aims to assess whether interdisciplinary clinicians and risk managers have different mental models about the definition of surgical Never Events, including their seriousness, preventability, and incidence. We also consider possible implications of varying mental models for patient safety training and protocols.2. Methods
2.1 Study design
This qualitative study relied on data from semi-structured, in-person interviews with operating room clinicians and hospital risk managers, based on what was anticipated to be sufficient to reach data saturation. The semi-structured interviews were performed according to a literature-based guide that was developed by the authors and validated by surgery and risk management experts. The guide included open-ended questions specifically intended to explore the participants’ mental model with regard to aspects of the definition of perioperative Surgical Never Events (see Table 1).
Table 1Interview guide.
| Discussion topics | Examples of questions |
|---|---|
| Attitude toward “Never Events” in operating rooms in Israel | How would you define “Never Events” in operating rooms? |
| PROBE: Are there different types of “Never Events” in operating rooms? | |
| PROBE: Preventable vs not preventable | |
| Personal experience with “Never Events” in the operating room | Have you been exposed to a “Never Event” in the operating room? If yes, can you please tell me what happened? |
| PROBE: In your opinion, what were the main causes of the “Never Event” in this case? | |
| PROBE: Do you think the “Never Event” in this case was preventable? | |
| PROBE: Do you have any suggestions for how to avoid a case like that in the future? |
To evaluate the guide, two pilot interviews were conducted, resulting in one question being omitted. The data from the pilot study were added to the final analysis. Field notes were taken during and immediately after each interview in which the interviewers described the participants’ familiarity with components of the Never Events definition and recorded any nonverbal reactions, such as anger or discomfort, during the interview. Conversations were recorded and verbatim transcripts of each interview were produced.
2.2 Participants and sample
The interviewees were selected using a purposive recruitment (
Cheung et al., 2019
) from different general hospitals. Participants were included who had an administrative role, frontline experience, and systemic views of surgical Never Events. Exclusion criteria eliminated participants who were either trainees or staff members without an administrative role. In-person interviews were conducted at participants’ settings from September to December 2019 by one of the study's authors (DA) and were recorded and transcribed verbatim. The interviews lasted 20 min each on average.Overall, 25 participants participated in the study. All were employed at nine Israeli hospitals or at the Israeli Ministry of Health (see Table 2). Although all subjects held administrative positions, 19 of the 25 had also worked (currently or previously) in operating rooms. The risk managers from hospitals and the Ministry of Health had a role in risk assessment in the operating room and policy development accordingly. The hospitals included four large urban trauma centres (>800 beds); three medium-sized (400–800 beds) rural centres, one of which was also a trauma centre; and two small centres (<400 beds), one rural and the one urban, providing only surgical care.
Table 2Characteristics of study participants.
| Characteristic | Respondents number (%) (Total = 25) |
|---|---|
| Age (years) | |
| 35–44 | 3 (12) |
| 45–54 | 10 (40) |
| 55–64 | 10 (40) |
| 65–75 | 2 (8) |
| Sex | |
| Male | 10 (40) |
| Female | 15 (60) |
| Profession | |
| Operating room clinician | 6 (24) |
| Anaesthesiologist | 3 (12) |
| Surgeon | 9 (36) |
| Nurse | 3 (12) |
| Risk manager (physician) Risk manager (nurse) | 4 (16) |
| Administrative role | |
| Yes | 25 (100) |
| No | 0 |
| Experience in profession (years) | |
| 10–19 | 5 (20) |
| 20–29 | 7 (28) |
| 30–39 | 10 (40) |
| 40–50 | 3 (12) |
| Years in current position | |
| 0–4 | 9 (36) |
| 5–9 | 9 (36) |
| 10–14 | 2 (8) |
| 15–19 | 1 (4) |
| 20–25 | 4 (16) |
2.3 Data analysis
The researchers manually entered information from the transcripts into Microsoft Excel, (version 16.0), using the six-phase inductive thematic analysis approach as described by
Braun and Clarke, 2006
: (i) familiarisation with the data, (ii) generating initial codes, (iii) searching for themes, (iv) reviewing themes, (v) defining and naming themes, and (vi) producing the report. Two of the study's authors read and reread the entire data set and systematically, and independently, coded the transcripts. Codes were then grouped into emergent themes after iterative reading and discussion with two different authors. The entire team met several times throughout the analysis process to discuss disagreements and refine and label the themes descriptively and interpretatively (Lindgren, Lundman and Graneheim, 2020
.- Lindgren B.
- Lundman B.
- Graneheim U.H.
Abstraction and interpretation during the qualitative content analysis process.
International Journal of Nursing Studies. 2020; 108103632https://doi.org/10.1016/j.ijnurstu.2020.103632
We followed
Tracy, 2010
criteria for qualitative best practices. Transparency was maintained throughout the process of sorting, choosing and organising data. The rigor of data analysis was achieved through the development of a rational framework to transform and organise raw data into the research report. The first and second authors analysed the data and shared it with the research team to ensure triangulation. Finally, the information was shared continuously with team members during the analysis, with their various professional expertise strengthening the credibility of the analysis.3. Findings
The analysis revealed themes clustering around two main themes: professionals’ perceptions of the formal definition of Never Events; and perceptions around various characteristics of the definition of Never Events.
3.1 Professionals’ perceptions of the definition of Never Events
The participants shared their perceptions of the common definition of Never Events and its concept. Risk managers endorsed the formal definition, whereas most of the operating room clinicians suggested modifying the definition. These clinicians suggested a broader definition to include any event that puts the success of the surgery at risk, but this was based on their own professional role in the surgery. For example, nurses related to their role of being accountable for the patient's safety: “If I want the patient not to fall, I will stand next to him and make sure the stretcher is braked while he is being transferred.” One surgeon viewed inappropriate preparedness for the surgery as a Never Event: “For me, a ‘never event’ is nonsharpened scissors.” and a majority of the anaesthesiologists defined a Never Event as a surgery with an unexpected occurrence of events, including “unexpected death during surgery”, “wrong blood transfusion”, “wrong organ anesthesia”, and “wrong medication administration”.
Risk managers related to the formal regulatory definition of Never Events with a modification to patient's harm—for example, “There is a definition [from] the Ministry of Health”, and “In the Operating Room, there are three types of ‘never events’: error in patient identification, wrong site surgery, [and] surgery to the wrong patient” and suggested adding “Loss of tissue should be included in the definition….It mustn't happen [for] somebody [to go] through a surgery in order to know if he has cancer or not”, and “The issue of patient identification should be a critical aspect in ‘never events’”.
3.2 Perceptions of various characteristics of the definition
3.2.1 Incidence and measurability of Never Events
Perceptions of incidence of Never Events varied among nurses and physicians. Nurses perceived these events as common: “In my opinion, they are very common, especially with regard to their severity” There are patients [who] fall, burns during surgery, and problems with surgical counts, these are common events”. Surgeons perceived the events as rare and related to the implementation of safety standards in the Operating Room: “The events are rare because everybody implemented correct signing, [which] was the major issue in these events…Lack of following work protocols is very simple; it is caused by distraction, working at night, and burnout”, and “[A Never Event is] very rare; it might happen [once] every few years”.
Anaesthesiologists thought that the events were rare but unpredictable and thus hard to measure due to the dynamic work environment in the Operating Room: “An adverse event that surprisingly occurs within our usual routine and is exceptional and unusual”. Another described an unnoticed oesophageal intubation that caused the patient severe harm. A case of unpredictable wrong use of equipment, that we did not [take] notice of, during bronchoscopy that caused the patient harm”.
Risk managers thought that some characteristics of the surgery might increase the incidence of Never Events. These characteristics challenge the measurability of an incident since they consider some errors to be unpredictable. One noted that obstetrics and gynaecology “is [a] high-risk specialty since many surgeries are urgent…also trauma surgeries because the team skips the safety standards due to the urgency”. Another pointed out that, “In general, when the surgery is more complicated, the chance for [a] ‘never event’ is higher because when one needs to give attention to so many details, one starts creating shortcuts and doing things automatically”.
3.2.2 Severity and preventability characterising the definition of Never Events
All participants described their perceptions of two characteristics of the definition of Never Events: severity and preventability (Table 3). There was a consensus among nurses and physicians that severity – or, the potential for serious patient harm – is an essential element of the definition and is related to the complexity of the surgery and the work environment in the Operating Room. An anaesthesiologist further described the importance of the anaesthesiologist's role in quickly decreasing the severity of an emerging event with a rapid response. Moreover, a surgeon stated that a surgical Never Event indicates a serious safety hazard in the operating room that resulted in severe patient harm. Even though there was a consensus regarding the severe outcome of Never Events, a risk manager thought that these events can be graded by their potential severity.
Table 3Perceptions of clinicians and risk managers regarding aspects of the formal “Never Event” definition.
Severity“Never Events” are severe events that cause patient harm
|
PreventabilitySurgical “Never Events” are preventable by increased awareness, training, and following work protocols
|
Preventability refers to the possibility of avoiding Never Events through increased awareness, training, and work protocols. Nurses thought that adhering to safety standards and using tools such as training, awareness, and work protocols can prevent most Never Events. However, they thought that some human errors resulting in Never Events cannot be prevented by safety standards alone.
Two surgeons thought that proper training could help prevent Never Events, whereas other participants said that some events are not preventable due to the inherent risks in some procedures (i.e., the combination of electricity and oxygen can lead to burns). Anaesthesiologists thought that not all Never Events are preventable and described situations of “force majeure”, such as a patient's fall or a surgical burn, which can occur even if standards are upheld.
4. Discussion
Since the first definition of 'Never Events' was advanced by the National Quality Forum in 2001 (
Kizer, 2001
), other health care organisations have adopted what has become a consensus definition (National Patient Safety Agency 2010
; World Health Organization 2009
). This study aimed to assess any variability in mental models among interdisciplinary clinicians and risk managers with regard to key aspects of the definition, including the incidence, seriousness, and preventability of surgical Never Events. The findings suggest that mental models about surgical Never Events varied among professions, particularly with regard to their incidence and preventability, a result with implications for efforts to eliminate them.Focusing on the three key dimensions of Never Events, in our study, surgeons consider the incidence of surgical Never Events to be rare, while nurses say they are common. Interviewees agreed that Never Events are severe, as defined by many international organisations (
Robert et al., 2015
), but had different opinions about whether all are actually preventable. A systemic review of 47 studies by - Robert M.C.
- Choi C.J.
- Shapiro F.E.
- Urman R.D.
- Melki S.
Avoidance of serious medical errors in refractive surgery using a custom preoperative checklist.
Journal of Cataract & Refractive Surgery. 2015; 41: 2171-2178https://doi.org/10.1016/j.jcrs.2015.10.060
Jung, Elfassy, Jüni and Grantcharov, 2019
revealed a variation in the incidence of intraoperative adverse events that is related to their mode of detection. Twenty of the 47 studies reviewed referred to the events based on their severity and level of patient harm, and eight defined the events as unanticipated and preventable. Moreover, the clinicians modified the definition of a Never Event to conform to their specific training and roles in a surgical procedure. This meant that surgeons focused on performing the surgery, anaesthesiologists focused on stabilising patients, and nurses on coordination and patient assistance. In our study, risk managers focused more on potential risks for patient harm, congruent with their role as promoters of patient safety and error preventers (Card, 2016
).The variations we found regarding incidence might also be explained by a dynamic work environment that affects the occurrence of Never Events (
Göras et al., 2020
). Thus, nurses might perceive more of the risks in the operating room that can lead to occurrence of Never Events in their routine work (Haugen et al., 2013
). Regardless of their origin, our findings around mental models have implications for efforts to reduce Never Events.- Haugen A.S.
- Murugesh S.
- Haaverstad R.
- Eide G.E.
- Softeland E.
A survey of surgical team members’ perceptions of near misses and attitudes towards time out protocols.
BMC Surgery. 2013; 13 (doi-org.moh-ez.medlcp.tau.ac.il/)https://doi.org/10.1186/1471-2482-13-46
4.1 Implications for practice
Agreement on the basic attributes of Never Events, particularly among the staff who are central to providing surgical care, would seem to be required for effective – and safe – interprofessional teamwork. All components of communication, trust, respect, mutual acquaintanceship, and more are related to the existence of shared mental models around the required tasks and the environment in which collaboration happens (
Karam, Brault, Van Durme and Macq, 2018
). Studies show that teamwork is essential for the prevention of Never Events (- Karam M.
- Brault I.
- Van Durme T.
- Macq Jean
Comparing interprofessional and interorganizational collaboration in healthcare: a systematic review of the qualitative research.
International Journal of Nursing Studies. 2018; 79: 70-83https://doi.org/10.1016/j.ijnurstu.2017.11.002
Stahel et al., 2022
), from the safe conduct of the surgery itself to the implementation of safety tools, like checklists (Moppett and Moppett, 2016
). Effective teams have a shared understanding of the complexity of a clinical situation, make appropriate decisions, and act efficiently (Mitcell, 2011
).Moreover, tracking the incidence of Never Events and the impact of improvement efforts relies on accurate measurement (
Cohen et al., 2021
), which in turn depends on consistent staff reporting. If some professional groups distinguish (as did the physicians in our study) ‘unexpected consequences’ from errors, or if some groups are conditioned to consider Never Events rare, reporting systems may be compromised. Similarly, measurability of the events, which is influenced by the mental models of various professionals towards adverse events, are in turn conditioned by social norms, awareness, and perception of the event itself (- Cohen A.J.
- Lui H.
- Zheng M.
- Cheema B.
- Patino G.
- Kohn M.A.
- et al.
Rates of serious surgical errors in California and plans to prevent recurrence.
JAMA network open. 2021; 4 (doi-org.moh-ez.medlcp.tau.ac.il/)e217058https://doi.org/10.1001/jamanetworkopen.2021.7058
Haim et al., 2018
).In our study, nurses perceived themselves as playing a key role in identifying risk and promoting safety in the Operating Room. For example, a recent study found that nurses perceive themselves to be key players in raising concerns regarding quality and safety issues (
Martin, Chew and Dixon-Woods, 2020
). Therefore, their advocacy for addressing the existence of divergent mental model and providing solutions may be especially important.Improvement efforts that can help to address variations in mental models include:
- •Enhancing interdisciplinary and collaborative teamwork by evaluating the discrepancies in the team's mental model and planning a specific intervention to encourage their mutual agreement about the most important characteristics of a Never Event;
- •Tailoring a broader definition of Never Events that reflects the multiple roles of interprofessional teams and characteristics of the surgery;
- •Offering a standardised, interprofessional training around the definition and prevention of errors; and
- •Defining a core of information that must be shared by all clinicians participating in the surgery to improve communication and teamwork.
This study has several limitations. First, it was conducted at nine Israeli hospitals or at the Israeli Ministry of Health; therefore, the results may not be generalisable to other settings outside of Israel. Second, the findings represent perceptions of managers and not necessarily that of current frontline staff. Third, our qualitative design means that our respondents may not statistically represent the entire population of healthcare professionals.
5. Conclusion
This study finds that various mental models around surgical Never Events characterise groups of interdisciplinary professionals. Given the likelihood that mental models emerge from a combination of training and practice common to specific healthcare professions, it is likely that the findings reported here can be generalised to interdisciplinary teams charged with preventing adverse events in other healthcare specialties.
Further research would benefit not only from the inclusion of more individuals who hold frontline surgical positions but also from querying a larger group of clinicians via a formal survey. Such a study could explore interprofessional differences as well as assess the impact on mental models of the norms of the participating organisation, including any national or cross-cultural differences.
Finally, follow-up research comparing mental models among clinicians working in environments characterised by different levels of patient safety could further develop the role of mental models in efforts to promote high quality and safe health care.
Author contributions
The paper properly credits the meaningful contributions of co-authors and co-researchers.
Declaration of Competing Interest
To the best of our knowledge, the named authors have no competing interests, financial or otherwise to disclose.
Funding
This study was funded by grant #MOHIG 14-2019 from the Medical Research Fund for Health Services–Jerusalem.
Ethical statement
Ethical approval for the study was obtained from the Medical Research and Ethical Committee of the Israel Ministry of Health, reference number 032-2019, on 27 December 2019. Each participant provided verbal consent to participate and received no compensation for their participation. The anonymity of participants was ensured and the data confidentiality was preserved.
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Article info
Publication history
Published online: October 05, 2022
Accepted:
September 16,
2022
Received in revised form:
September 8,
2022
Received:
July 19,
2022
Publication stage
In Press Corrected ProofIdentification
Copyright
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