Patient safety in the operating room: an intervention study on latent risk factors

Patient safety is one of the greatest imperatives in healthcare today [1]. However, there are many obstacles that must be overcome to make the healthcare system truly safe. This article describes one approach to successful implementation of a patient safety program at the systemic level. A specific strategy for operationalizing a safety program is provided. Through this strategy it is possible to identify and address safety concerns proactively, to develop specific tools and resources that can be used to support an environment of safety and create mechanisms to modify the program in response to patient and staff needs as well as changing priorities. In the contrast between events that are often minor, but salient, and the major, but latent or hidden, systemic weaknesses, most attention has been devoted to the obvious problems. Success here, with individual protocols and techniques, tackles the patient safety problem one issue at a time. This article attempts to attack the deeper-seated underlying problems that, when accurately identified, allow for remedial actions that can impact whole classes of issues simultaneously.

It is increasingly accepted that adverse outcomes are often due to system failures, whereby deficiencies at many different levels create the context in which human error can have a negative impact [2‐4]. Studies also have shown that organizational factors contributing to error and to safety can be grouped into a limited number of general failure classes or Latent Risk Factors (LRFs), including such error-producing conditions such as poor design, maintenance failures, unworkable procedures, shortfalls in training, less than adequate tools and equipment and inadequate staffing [5]. For example, nurse understaffing has been ranked by both the public and physicians as one of the greatest threats to patient safety in US hospitals [6]. The identification of LRFs, that may impact the expected course of care and often compromise patient safety, can support a better understanding of the operating room as a system and the identification of system components that influence patient safety [7]. A proactive systems approach to surgical safety suggests that it is necessary to study all aspects of the system that comprises a surgical operation, ranging from such issues as equipment design and use, to communication and team coordination [8, 9]. Safety experts argue that proactively reducing such latent risk factors, that increase the risk of error by many individuals, will result in delivering safer care more quickly than taking measures directed, often reactively, at specific individuals [2]. Consistent with the objective of minimal patient harm, safety management in health care should be proactive rather than reactive; that is, broad risks should be anticipated and reduced before patients are harmed rather than waiting to identify specific problems and then attacking them. The question is, how can you identify such risks before an incident, rather than waiting for an adverse event or hoping for a report that can uncover a problem?

A proactive error management system, designed to measure and reduce the adverse impact of LRFs within an organization, may provide the answer. Proactive systems work in part by asking people to judge how frequently each of a number of factors such as staffing, supervision, procedures and communication impacts adversely on specific aspects of their work. This type of proactive approach allows the identification of LRFs before they give rise to errors that can compromise patient safety. Such a system may serve not only to reduce error, but also to foster a culture that, by moving away from blaming the individual, encourages reporting, creating a virtuous circle [10]. In the operating room (OR) errors are frequent and often consequential. In reported studies on the incidence of adverse events in hospitals, the largest number occurs in the OR. The proportion of adverse events in the operating room appears to be remarkably stable, comprising approximately 50 % of all adverse events within a hospital [1, 11‐13]. This suggests that the OR is a domain in which improved safety is an urgent and significant challenge. A critical first step in an improvement process involves systematically addressing those factors contributing to adverse events in the OR. Increased awareness of patient safety issues and the resources that are available to both health care practitioners and consumers can help staff ward off patient safety problems before they occur [14].

The study shows that our intervention aimed at Material resources, Training and Staffing resources resulted in demonstrable changes of scores on two of the relevant LOTICS scales. This type of intervention can provide direct benefits to the staff of an OR, because the changes on the working environment were both visible and resulted in improvement in task performance and are therefore likely to be accepted.

The philosophy underlying the development of the LOTICS scale is that interventions should address broad categories of error types (the underlying pathology) rather than individual symptoms. Given this approach, the intervention aimed at improving material resources was based on the concept of standardization. Standardization is a concept well understood by other safety critical industries that value the benefit of lightening the mental burden on staff and users to allow them to concentrate better on the job at hand [30]. In aviation the standardization and disciplined use of procedures, termed SOPs (Standard Operating Procedures) is widely argued to be the most critical factor distinguishing between good and poor outcomes in aviation incidents [31] and could be adapted to the OR to develop protocols that minimize the influence of competing tasks and high workload. Standardization of material and equipment further results in the reduction of costs of operation, in maintenance, repair, storage, and simplified issue procedures. As part of the process in I-OR to standardize and streamline instrumentation and equipment, including locations, old and/or less user-friendly apparatus was replaced, missing items were purchased and manuals with a uniform design were developed. This improvement (at a general level) should and did affect responses to specific test items referring to, amongst others, the availability of equipment, their quality, timely repair and replacement. Moreover, after the intervention PRISMA identified technical factors to be significantly less important as causes of incidents.

Understaffing is one of the greatest threats to patient safety. Staff are often the last layer of defence for any error occurrence and particularly the proportion of professional nursing staff has an effect on patient safety [25, 32, 33]. At the time of the pre-test there were shortages in OR personnel in 14 out of the 60 (23 %) Dutch hospitals investigated [33]. One of the reasons for understaffing in the Netherlands is that working in healthcare is found to be less appealing [34, 35]. To limit turnover and to attract new personnel we need to enhance the attractiveness of the profession. To investigate how this can be achieved we designed and evaluated a number of intervention programs. These programs focused on the enhancement of well-studies work climate characteristics: participation in decision making, job autonomy and social support. Employee perceptions of these characteristics have been linked to various stressors, and a number of individual and organizational outcome variables [36]. In addition to the focus on work climate characteristics more training opportunities were created so that more trainees could be qualified. As expected the interventions turned out to result in higher scores in I-OR compared to C-OR on aspects like the amount of staff to provide good care and the amount of experienced staff.

Staff turnover rate in I-OR decreased from 9.4 % in the year before the intervention to 5.1 % in the year after the intervention. Although we realize that turnover is determined by many factors, including labor market, it is likely that some of this decline can be attributed to the interventions.

Change can be a complex and drawn-out process that depends on a variety of contextual factors. The OR is a highly compartmentalized department structure which brings together members from multiple disciplines whose training and professional goals vary. Lack of communication between operating room personnel is common [37]. Most surgical errors are not attributable to an individual but involve multiple personnel and steps; approximately 43 % of errors are due to poor communication [20]. During the intervention in the OR we actually saw an increase in reported problems with communication. When communication problems do occur, they are found most often between different professional members of a team, such as between anaesthesiologist and surgeon or between nurses and doctors [38].The staff of the I-OR indicated that they needed more information to do their tasks. A tentative explanation for this result could be that having created heightened awareness about safety issues, the staff was more alert to the communication problems they experienced.

The importance of incident reporting is widely recognized [10, 39]. Unfortunately, reporting is grossly incomplete. After the intervention, incident reporting rates in I-OR increased significantly compared with pre intervention rates. We realize that it is difficult to deduce from this result whether the 2.4x change in error reporting reflects a change in report behaviors with actual rates remaining constant or whether the 2.4x change in error reports reflects an increase in error rates despite the intervention. Various studies, however, showed that as an institution improves in the care it delivers and its safety culture more problems may be reported since open reporting is a tenet of safe practice [40]. Increased incident reporting rates may not be indicative of an unsafe organization, but may reflect a shift in organizational culture [41]. In this context it is important to note that the total number of reported incidents more than doubled while the contribution of technical factors to incident causation remained constant.

The propensity to report is probably further strengthened in our study by the implementation of the electronic report system. Various studies showed that an accessible and easy to use reporting system [42], the understanding that the reports will be handled in a non-punitive manner [43], and the notion that the reports are taken seriously and will lead to enhanced learning and systematic changes which will prevent it from recurring [44], positively affects the willingness to report incidents. The empirical findings in this and other studies, taken as a whole, suggest that our result, an increase in incident reporting in I-OR, reflects a change in report behaviors rather than an increase in incident rates.

We believe that this work can contribute to patient safety initiatives and research in two ways: (1) our experience provides detailed insight in the latent risk factors, (2) our findings suggest that the methodology used in the study shows promise as a method for evaluating changes in the quality and safety of care in the operating rooms. Changing culture is a new watchword in patient safety [45]. The willingness of staff to speak up about a patient-safety concern is an important part of safety in the operating room [46]. Therefore there needs to be a culture of openness [47]. We think a first step is this approach is to build a strong foundation of safety awareness among your staff and this may best be done by implementing concrete and visible improvements. We think staff perceptions of safety are a high priority issue within the OR, which will eventually motivate staff to take greater ownership of and responsibility for patient safety.

The change of state of LRFs can be measured using a patient safety questionnaire aimed at these factors. The change of the relevant risk factors (material and staffing resources) concurred with a decrease in perceived and reported error rates in the relevant categories. We conclude that interventions aimed at unfavourable latent risk factors detected by a questionnaire focussed at these factors may contribute to the improvement of patient safety in the OR.

MvB, FB, SA were involved with study development, co-ordination and data collection and writing the article. MvB, SA were involved with data analysis. PH has been involved in drafting the manuscript, and revising it. All authors read and approved the final manuscript.