Original Article |
Corresponding author: Rositsa Dimova ( rositsa.dimova@mu-plovdiv.bg ) © 2024 Rositsa Dimova, Ralitsa Raycheva, Pavlina Pavlova.
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation:
Dimova R, Raycheva R, Pavlova P (2024) Application of the bow-tie analysis to improve patient safety – a lesson learned from clinical practice. Folia Medica 66(4): 549-554. https://doi.org/10.3897/folmed.66.e129251
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Abstract
Aim: This study aimed to assess the risk management of drug safety in an operating theater setting within a hospital-based treatment facility.
Materials and methods: This is a case study detailing a single patient. The bow-tie model was modified for analyzing medication errors in anesthesiology practice and implemented in the operating room of the university hospital. The diagram was created using well-established methods. The data was gathered using an online portal (www.rsps.bg) designed to evaluate hospital safety culture and report incidents.
Results: The Striped Bow Tie® methodology-built model illustrated the primary reasons for the medication error. The risk score was estimated to be 12 based on the specified parameters. The severity is rated on a 4-point scale ranging from catastrophic (4), critical (3), marginal (2), to negligible (1). The likelihood is assessed on a 5-point scale from frequent (5), probable (4), occasional (3), moderate (2), to unlikely (1). Preventive methods were suggested to minimize the risk, avert the incident, and manage the process.
Conclusion: The bow-tie approach is suitable and simple to apply in hospital anesthesia practice and serves as an essential instrument for analyzing medication safety risks. The analysis demonstrated systemic errors that led to the incident, including unrealized potential for continuing medical education and transforming the hospital into a place where clinicians can constantly learn by reporting adverse events and medical errors.
bow-tie method, patient safety culture, medication error
The World Health Organization is drafting a Global Action Plan for Patient Safety for the years 2021–2030.[
The different approaches outlined in the specialized literature, such as Brainstorming, Checklists, Event Tree Analysis (ETA), Swiss cheese model, Failure Mode and Effect Analysis (FMEA) are used to discover common causes of errors.[
This study aims to assess the risk management about drug safety in the operating room of a hospital treatment facility.
The study is a descriptive, epidemiological case report. It was conducted in a 400-bed university hospital affiliated to the Medical University of Plovdiv. The goal of the present study was achieved by gathering essential data through a web-based self-reported anonymous survey on hospital patient safety culture using the cross-culturally validated and adapted Bulgarian version of the HSOPSC questionnaire.[
One of the 10 reported and discussed topics is the subject of the current study. Experts later assessed the input utilizing the brainstorming technique. The authors have organized one-day creative group-thinking session in June 2022 with methodologists and researchers as well as with an internal physician, a surgeon, an anesthesiologist, and a surgical nurse. Following the Brainstorming technique’ principles and rules, the subsequent iterative process of consultation and revision resulted in redefining the reasons concerning patient safety and medication error.
The bow-tie risk analysis methodology was applied in a 400-bed university hospital specializing in active-care services. The bow-tie approach was implemented in the clinical context of the operating room. The tool examines the working circumstances of healthcare workers and identifies necessary preventive measures to reduce errors or lessen their impact. The method is frequently used in the system approach to identify and analyze errors in management and their causes. In contrast to the system approach, the individual method focuses on personal errors and seeks to assign blame for negligence, inattention, incompetence, etc.
The diagram was generated using MS Excel. The diagram illustrates the incident (top event) in its center, with layers or prevention on the left and layers of mitigation on the right. Potential consequences of undesirable outcomes are also listed on the right side of the bow tie diagram. The initial stage is to identify the hazards associated with the working environment, psychological climate, equipment, staff qualifications, and organization that may lead to the incident. The next steps include evaluating the likelihood and impact of the event happening.[
Severity × Likelihood = Risk
Anesthesia induction preparations commenced in the operating room at 4:00 PM. Besides the anesthesiologist, surgeons, a surgical and anesthesiologist nurse and students were present in the hall, approximately 16 people in total. The anesthesiologist advised the intravenous administration of the induction anesthetic thiopental at a dose of 250 mg. The young, inexperienced nurse anesthetist mistakenly heard the muscle relaxant tracrium 50 mg due to the abnormally noisy environment. Within 90 seconds of receiving the muscle relaxant, the patient’s respiratory muscles were paralyzed, leading to the suppression of spontaneous breathing with the patient remaining conscious. No complications occurred for the patient after appropriate and prompt interventions were taken.
An extensive investigation was conducted to brainstorm the most critical safety issues in the surgery room. Following the discussion, 12 incidences were identified: 11 near misses and one prescription error, which had the greatest potential for causing harm. A team of medical specialists thoroughly examined the primary causes associated with the medication error during surgery.
The medication error occurred due to insufficient communication between the anesthesiologist and the anesthesiologist nurse. Multiple factors played a role in this situation: the operation taking place late when the team was fatigued, the distracting noise in the environment, and the nurse anesthesiologist’s lack of experience in recognizing the typical sequence of induction medication and confirming any changes in appointments.
The innovative Striped Bow Tie® methodology was used to depict the sources and causes of the risk, particular preventive measures, and existing controlling systems to reduce harm to the patient in the reported instance (Fig.
The experts participating in the analysis drew attention to the fact that any anesthesia should be administered following the priority concept outlined in the medical standard “Anesthesia and Intensive Care” to ensure the safety of every patient. According to the algorithms for the introduction and maintenance of anesthesia, the medication tracrium can be given before starting anesthesia induction only in specific situations by skilled anesthesiologists, with the necessary equipment for intubation and breathing available.
The risk level was estimated using the following formula:
Severity × Likelihood = Risk
The reduction in the relative risk (RR) was assessed following the implementation of the mandatory preventative measures based on Lyon B and Popov G’s model (Table
Bow-tie analysis can be performed to qualitatively or semi-quantitatively demonstrate the effectiveness of controls, countermeasures, and risk mitigation strategies.[
A risk matrix for assessment of the degree of risk according to the criteria of severity and likelihood of the event
<-Severity of injury orIllness consequence-> | ||||
Likelihood of occurrence or Exposure for select unit of time or activity | Negligible (1) | Marginal (2) | Critical (3) | Catastrophic (4) |
Frequent (5) | 5 | 10 | 15 | 20 |
Probable (4) | 4 | 8 | 12 | 16 |
Occasional (3) | 3 | 6 | 9 | 12 |
Moderate (2) | 2 | 4 | 6 | 8 |
Unlikely (1) | 1 | 2 | 3 | 4 |
Very high risk: 12 or greater; High risk: 7–11; Moderate risk: 4–6; Low risk: ≤ 3 |
This study has some limitations. We relied on the anonymously self-reported adverse events, errors and near misses by the healthcare professionals on the web-based platform (www.rsps.bg). This single case study and its results of the risk analysis only apply to this particular case study and operational theater and cannot be generalized. However, the method is applicable to other operational and clinical settings.
This study may contribute to nursing education in focus, particularly to continuous medical education (CME) related to patient medication safety in the operating room. We consider the reporting and description of the errors as well as the proposed measures to prevent them as valuable features of the study as shown in the bow-tie diagram. We also believe that such studies can be useful in encouraging the healthcare professionals to report patient safety incidents in order to learn from them and improve patient safety culture.
The bow-tie analysis was implemented for the first time in the anesthesiology practice in our setting. The method serves as an exceptional risk communication tool and is suitable for use in hospital medical practice. Nevertheless, more profound findings can be derived from further observations. It could be successfully used to conduct a risk assessment of drug safety in the surgery room. The current study emphasized some concerns related to patient safety culture in operating theaters and provided solutions for them. Some untapped opportunities for enhancing the safety culture in medical staff’s continuing education include implementing specialized qualification courses to enhance practical skills, attending seminars and training sessions to improve workplace communication, and transforming the hospital into a learning organization that consistently learns from reported adverse events, near misses, and medical errors.
The authors have no support to report.
This study is part of an intra-university project No. 11/2016, titled “Introduction of a web-based platform for registering and evaluating the level of hospital culture to ensure patient safety in medical facilities and conducting a representative study for the country.”
The authors have declared that no competing interests exist.