1. Human error

The human error problem can be viewed in two ways: the person approach and the system approach. The person approach focuses on the errors of individuals, blaming them for recklessness, negligence or failure to perform their duties. In the system approach, errors are seen as consequences rather than causes, having their origins not so much in the perversity of human nature as in systemic factors. When an AE occurs, the important issue is not who made the mistake, but how and why the defenses failed¹¹.

1.a- Defenses, barriers, and safeguards

Defenses, barriers, and safeguards occupy a key position in the system approach. In an ideal world each defensive layer would be intact. In reality, they are more like slices of Swiss cheese. The presence of holes in any one “slice” would not normally cause an adverse outcome; however, the AE occur when the holes in many layers momentarily line up to permit a trajectory of accident opportunity¹². Thus, an AE in surgery is the result of a combination of several factors, with the intervention of more than one member of the healthcare team and multiple failures in the safety barriers of the healthcare process. Therefore, if we focused on the individual’s error, we would divert the attention from those circumstances and systemic factors that contributed to the development of the AE.

1.b- What is a “Never Event”?

The National Quality Forum defines a “Never Event” as an identifiable and preventable medical error that has serious consequences for the patient and indicates a real problem in the safety and quality of a healthcare facility. Never events in surgical or procedural events include surgery performed on the wrong body part or on the wrong patient, wrong procedure, unintended retention of a foreign object in a patient after surgery or other invasive procedure, and intraoperative or perioperative death in an ASA Class I patient¹³. At the institutional level, this type of event adds a serious economic burden as a consequence of its medical-legal implications and has a negative impact on the reputation of the surgeon and the institution. Therefore, a better understanding of why these events occur and the efforts focused on reducing their frequency are important for the safety of patients, physicians and institutions.

2. Importance of a patient safety team

Every healthcare organization should have a multidisciplinary team to promote a culture of quality and safety and be the driving force behind the comprehensive approach to AE. This team is responsible for the systematic review of Never Events, objective analysis of facts, review of medical records, interviews with the professionals involved, development of improvement strategies, implementation of these strategies, monitoring the changes implemented after the analysis of an AE, institutional communication of the measures adopted, measurement of results and periodic review of the existing barriers. Other objectives include education and training of staff in quality and patient safety, and promotion of positive leadership based on ethical values, transparent management, integrity and good practices.

2.a- An Incident reporting systems

Effective risk management depends on creating a culture of reporting patient safety incidents. This allows the identification of predisposing factors and the implementation of early and proactive strategies rather than reactive strategies once the AE has occurred. Reporting systems should be confidential, voluntary, and non-punitive. The potential reporters must feel confidentiality is ensured and that the reporting system is safe, without censorship or disciplinary measures against the person who reports the incident. Communicators should perceive that their reports lead to investigation and corrective actions when possible. Safety culture will be easier to build and sustain when employees feel comfortable reporting AEs and believe the reporting process system is positive.

2.b- Immediate action in case of an AE

If an AE occurs, especially if there are serious consequences for the patient, the immediate response should focus on 3 elements: the patient, the professionals and the scene of the event. An adequate response to a serious AE is characterized by an immediate approach, transparency in management, effective apology and assumption of responsibility. This paper is not focused on the immediate management of the AE at the patient level, the process of disclosing the AE to the patient and family members, how to approach second victims, how to proceed when legal actions are initiated, or the process of external communication of AEs. Instead, our objective is to provide a guide for the analysis and development of strategies for improvement in case of AEs in surgery. Once the patient’s needs have been met and immediate precautions have been implemented to prevent further harm, it is necessary for the patient safety team to conduct a thorough analysis of the AE to determine the factors that may have contributed to the occurrence of the incident and, thus, design strategies to reduce the likelihood of recurrence of similar events. This often requires the use of specific tools as the RCA3.

3. Root-Cause Analysis

Thorough analysis of the situations and predisposing factors leading to AEs with the root-cause analysis helps the healthcare team to reflect on AEs using a systemic approach rather than an individual approach to blame someone. The steps involved in RCA are presented below, using as an example a case of retained foreign object in surgery.

3. a- Data gathering about the event

To understand the events that led to the AE, it is essential to collect all the information by reviewing the medical record and the operative report, and with interviews of those involved, to produce a summary of the event. Early recording of this information helps to ensure that staff members’ recall of the event is recent and accurate.

Summary of a case: A 48-year-old woman was admitted for a scheduled cytoreductive surgery for ovarian cancer. The patient underwent hysterectomy and bilateral oophorectomy, peritonectomy, omentectomy, bilateral pelvic and lumbo-aortic lymphadenectomy, and anterior resection of the rectum due to perforation of the anterior aspect of the rectum during excision of metastases. A low colorectal anastomosis was performed with a protective ileostomy due to the site of the anastomosis. In addition, a perforation of the diaphragm was observed during peritonectomy of the diaphragmatic dome.

A right pleural drainage tube was inserted and hemostatic material was placed over the hepatic dome. Fever developed on postoperative day 3. A CT scan of the chest, abdomen and pelvis was ordered. There was a heterogeneous image with air bubbles at the right subdiaphragmatic level and scarce oral contrast material within the subcutaneous cellular tissue thickness at the ostomy site. The subdiaphragmatic image was interpreted as secondary to the hemostatic material placed intraoperatively. Surgical revision of the ostomy was decided because the patient was hemodynamically stable and fever had ceased after modifying the antibiotic therapy. On postoperative day 6, the patient had fever again. After ruling out other possible sources, surgical exploration was decided. The ostomy was adequately fixed, and there were no periostomal collections or leakage. The image described in the CT scan corresponded to a partially organized hematoma with hemostatic material inside that was then removed. After exploring the rest of the cavity, a gauze with a marker was observed at the intercavo-aortic level.

3. b- Creation of a flow diagram with the information

This is not always necessary, but it helps to summarize and evaluate the facts in a schematic way (Fig. 1).

FIGURE 1 Flow diagram of the information 

3. c- Ishikawa diagram

A fishbone diagram, also known as Ishikawa diagram or cause and effect diagram, is a tool used to visualize and prioritize all the potential causes of a problem to discover the root causes. The fishbone diagram helps to group these causes and provides a structure in which to display them. When applied correctly, it ensures the actual cause of the problem is addressed. The first step to solve any problem, and the key to a successful Ishikawa diagram, is to correctly define the problem. When a problem is clearly defined, it is easier to identify the causes that affect the metric directly. In the case previously presented, the problem is the retained foreign object. Then, one must decide what areas of the problem or process are key to determining the actual cause. In our case, we considered 6 areas: Patient, Equipment/Resources, Management/Leadership, Policies and Procedures, Human Factor and Setting/ Environment. Then, one must go through each area and try to determine all the individual influences within each category that can affect our result. Some causes may have multiple sub-causes, which may cause the diagram to expand. The Ishikawa diagram of the case problem is presented below (Fig. 2):

FIGURE 2 Ishakawa diagram of retained foreign object in surgery 

In the case reported, the predisposing factors identified included prolonged surgery, intervention of two surgical teams, multivisceral resection, additional procedures due to intraoperative intercurrent events, change of scrub persons and circulating nurses during the procedure, and placement of metal clips in the area of the retained foreign object, which contributed to confusing the radiopaque mark in the CT scan. The use of one checklist that does not consider simultaneous or successive procedures with the same patient and human factors are other factors identified. The probable root cause was the use of a checklist that does not contemplate surgeries with two different surgical teams (poorly defined policy and procedure) and the lack of safety culture (human factor).

4. Corrective actions proposed

Once the evaluation of the events that led to the development of the AE has been completed, the existing barriers should be analyzed and additional barriers should be designed to reduce the probability of a new event. The corrective actions proposed in the case reported are detailed in Table 1.

TABLE 1 Corrective actions proposed 

4.a- Which option(s) choose?

It is clear from the RCA that an AE is not the consequence of a single failure, but of a series of events that, when combined, predispose to the occurrence of the event. However, it is not always possible to implement all the new safety measures, either due to costs, availability or impossibility of implementation in the existing structure of the institution. Measures should address the main predisposing factors, with a strategic and efficient approach. The implementation either of one or another strategy, or the combination of multiple strategies, involves a cost-benefit analysis and will depend on the resources available in the institution. It will also depend on the type of process analyzed and the level of safety it requires. It is essential to understand that surgery is a process that requires high levels of safety and, therefore, needs multiple redundant barriers¹⁴. In the case presented we adopted the following measures:

- We modified the surgical checklist procedure, including in the process how to act in cases of simultaneous or successive surgeries with the patient.

- Review of counting process:

- An interdisciplinary project was started to improve adherence to the checklist.

- Education of staff on prevention measures and safety culture.

4.b- Implementation of selected corrective actions and analysis of results

The new safety measures will not work unless the authorities and staff implement them. Therefore, communicating the new strategies to your stakeholders is an indispensable step. Surgeons have the responsibility to participate in the implementation, administration, outcome measurement and management of these changes related with safety and quality of care. It is not only necessary to implement barriers, but also evaluate the effect of specific interventions, monitor adherence to the process, assess its impact on healthcare, provide feedback to operating room professionals about compliance with policies and procedures. This will be proactive in detecting possible failures to promote a change before another AE occurs^15,16. This can be achieved by using a control panel with a set of indicators which can be monitored and evaluated regularly to provide valuable information on the performance of the sector analyzed, allowing for comparisons over time that would otherwise be impossible to make¹⁷. We must be sure that the information used for the indicators is reliable to obtain accurate results and thus take actions to improve the quality and safety of care. This stage is also useful to modify the recommendations we have made, if necessary.

5. Communication of the AE

The communication of AEs should be as objective as possible, avoiding value judgments and, especially, derogatory comments about other professionals or comments favoring one’s own interests. Morbidity and mortality meetings are useful for sharing the report of AEs and near misses, to raise awareness of their occurrence and facilitate crosssectional communication of the findings of the analysis and present new safety measures or barriers.

6. Safety culture

Hospitals usually tend to focus on technical issues such as surgeon skills and operating room equipment to improve their surgical outcomes. However, a “safety culture” can be just as important in providing quality care¹⁹. The analysis shows that lack of a safety culture plays a fundamental role in the development of AEs. Those minimizing the potential hazard of an AE will not comply with the policies and procedures designed to prevent such events. Therefore, consolidating a work culture focused on safety and quality is a mainstay for change, and is the responsibility of all the members of the surgical team^19,20. Promoting safe operating rooms can improve the functioning and performance of the team and contribute to achieving positive outcomes for patients, surgeons and the institution where they work²¹. Surgeons-in-training are an essential part of the surgical team. Although ultimately responsible, the surgeon in charge gradually transfers to the resident most of his or her participation in the surgical case. Because of their increasing responsibility in patient care, the development of educational programs aimed at promoting teamwork and adherence to patient safety protocols provides the opportunity to teach residents from the beginning of their training program about the different risk factors associated with AEs, their medical-legal implications, effective prevention strategies, and the importance of respecting the policies and procedures of the institution where they are being trained^22,23.