This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
Lack of time, lack of familiarity with root cause analysis, or suspicion that the reporting may result in negative consequences hinder involvement in the analysis of safety incidents and the search for preventive actions that can improve patient safety.
The aim was develop a tool that enables hospitals and primary care professionals to immediately analyze the causes of incidents and to propose and implement measures intended to prevent their recurrence.
The design of the Web-based tool (BACRA) considered research on the barriers for reporting, review of incident analysis tools, and the experience of eight managers from the field of patient safety. BACRA’s design was improved in successive versions (BACRA v1.1 and BACRA v1.2) based on feedback from 86 middle managers. BACRA v1.1 was used by 13 frontline professionals to analyze incidents of safety; 59 professionals used BACRA v1.2 and assessed the respective usefulness and ease of use of both versions.
BACRA contains seven tabs that guide the user through the process of analyzing a safety incident and proposing preventive actions for similar future incidents. BACRA does not identify the person completing each analysis since the password introduced to hide said analysis only is linked to the information concerning the incident and not to any personal data. The tool was used by 72 professionals from hospitals and primary care centers. BACRA v1.2 was assessed more favorably than BACRA v1.1, both in terms of its usefulness (z=2.2,
BACRA helps to analyze incidents of safety and to propose preventive actions. BACRA guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task. BACRA is useful and easy to use.
Analyzing the causes of unsafe care helps reduce the number of incidents that may cause harm to patients [
Incident reporting systems were introduced into the health care sector in the late 1990s. Similar mechanisms can be found in high-risk sectors, such as the nuclear, railway, and aviation industries. They are essentially mechanisms designed to record critical incidents anonymously [
The Australian Incident Monitoring System, the Sentinel Events Reporting Program, and the New York Patient Occurrence Reporting and Tracking System (NYPORTS) in the United States are three of the first programs designed to learn from incidents [
Incident reporting systems provide a mechanism to identify risks (in this context how and why patients can be harmed) and surface learning opportunities in different organizations, based on their own experience, toward the objective of reducing the frequency of safety incidents [
Incident reporting systems represent a central data collection of incidents with the aim to define fields where action is needed most. These systems are well established, but sometimes they do not succeed in developing an action plan to implement corresponding measures conceived to prevent recurring incidents. The success of IRS requires the involvement of frontline health care providers in the action plan (analyzing causes and proposing solutions related to specific incidents).
In order for IRS to be effective, it is critical to overcome the distrust of professionals who fear the possible consequences of reporting incidents [
Root cause analysis, critical incident analysis, and incident simulations are the most useful techniques for investigating what happened [
Patients who have suffered an adverse event (AE) should receive information about what and how the incident occurred, and about the measures adopted to prevent recurrence [
Senior and middle managers have direct responsibility for incidents that can be analyzed and assessed in the interest of preventing recurrence [
This study’s objective was to develop a tool that helps middle managers and frontline professionals carry out immediate analysis of the causes of incidents related to patient safety whereby they may propose and implement solutions to prevent recurrence. This tool should provide them with the following: a guarantee that the tool adheres to relevant legal regulations; that it engages middle managers and their teams; that it permits appropriate identification of harmful incidents and near misses, probing their immediate and latent causes; and that it conducts a dynamic and agile analysis of these incidents.
Study design of a tool to identify preventive actions for the improvement of patient safety based on the information collected and analyzed from the experiences of previous incidents.
Steps for the design of the incident analysis tool.
To develop the tool, prior research on the barriers for reporting safety incidents, and incident analysis techniques, were considered first [
With this information, a series of criteria were then established with respect to design, navigability, information security and confidentiality, and structure for the analysis of incidents. Based on this, we proposed a feasible projection of what this Web-based tool should deliver in the search for solutions to safety incidents at hospitals and primary care centers.
A review was carried out regarding the tools to conduct an analysis of the causes, consequences, and search for solutions to the incidents, in a broad-based effort to manage risks to patient safety at hospitals and primary care centers. These tools were assessed using criteria established independently by IC, MG, and JJM, with the goal of identifying the characteristics that a new tool should have. From this review, it was determined that the protocol of incident analysis based on the Harvard study [
Different alternatives were considered for the development of the incident analysis tool: creating a mobile app for Android and/or iOS tablets and mobile phones (discarded because the necessary devices were not available at most health care centers), developing an executable program (discarded because of the difficulty of installing unofficial apps at health care centers), developing a portable document format (PDF; discarded due to its limitations for generating dynamic content and questions based on previous responses), and a Web form that permitted a sufficient level of flexibility and was accessible from any computer with an Internet connection. The latter was the option chosen.
From this information, a BACRA beta version was developed, a Web tool based on root cause analysis to search for solutions to incidents of patient safety with leadership from middle managers.
The tool’s beta version was presented to 43 professionals (middle managers of nursing and surgical medicine, intensive care units, blood banks, laboratories, radiology, mental health, pediatrics, surgery, orthopedics, gynecology, medicine, and primary care). Their feedback helped to improve data access and privacy, and their assessments and suggestions were kept in mind to improve the tool, its user friendliness, and its final result in the form of a summarizing table. In this redesign (BACRA v1.1), fields were added in the solutions table and the app was also personalized to register certain specific types of incidents relevant for hospitals or primary care centers.
BACRA v1.1 was presented to 43 other middle managers, who provided ideas for improving its design (BACRA v1.2). This permitted the elimination of unnecessary information and the introduction of small changes to the types and causes of harm addressed, and allowed the improvement of help texts.
In January 2016, once the tool improvement proposals were introduced, BACRA v1.2 became available to users [
BACRA v1.1 was used by 13 frontline professionals to analyze distinct types of incidents, whereas its final version (BACRA v1.2) was used by 59 frontline professionals to analyze incidents both with and without harm to patients. Once the analysis was finished, all users had the opportunity to voluntarily assess the Web-based tool’s utility and ease of use.
The evaluation results of both versions were compared using the nonparametric Mann-Whitney
This study was approved by the Ethics Committee of Clinical Research at the San Juan de Alicante University Hospital, Alicante, Spain.
The professionals interviewed pointed out the following main difficulties related to analysis of reported incidents: the lack of time, coupled with the belief that solutions should be proposed by the services responsible for the area of patient safety; the lack of procedures in primary care for addressing this problem; the difficulty in getting middle managers involved in root cause analysis; the delay in communicating analysis incident results; and the legal consequences for professionals. In their opinion, after identifying the type of incident and whether it had caused harm to patients, the tool should help identify causes and consequences in order to gather the basic knowledge necessary to propose solutions intended to prevent recurrence of similar incidents, including a plan of action.
BACRA v1.2 is structured in seven tabs: (1) general information about the tool, (2) hide/show, (3) what consequences did the incident have, (4) when and how did it occur, (5) why did it occur and root of the incident, (6) how could it have been prevented and solutions and plan of action, and (7) printout of the report. A helpline for users who needed guidance was made available. In
The information tab is always accessible from any point in the analysis (found at the far left, labeled “Info”; see
Before beginning a new analysis, and in order to ensure confidentiality when computers are shared, each user can create a unique password on the “Hide/Show” page (password access; only known to him/her) that will allow access to the analysis in progress for a specific incident. This password is not linked to the person conducting the analysis, but rather to the incident in question. Therefore, the app does not include personalized access whereby the user can consult his/her incidents in progress; instead, this person must generate a new password for each incident they wish to analyze. This way, complete confidentiality of the person conducting the analysis is ensured, protecting the professional and reducing the distrust toward these types of systems. The type of center, either hospital or primary care, must be indicated on the “What Happened?” page. Depending on the choice of center (hospital or primary care), the screen will contain information specific to the type chosen. In addition, the “Solutions” page is dynamically generated with the data introduced in the preceding steps.
Criteria for BACRA to satisfy and analysis of other existing tools.
Criteria | App 1a | App 2b | App 3c | BACRA |
Permits incident analysis by a small group (3-5 persons) | Yes | Yes | Yes | Yes |
Permits incident analysis in less than 20 minutes | No | No | No | Yes |
Uses international taxonomy with help menus in order to correctly interpret the terms | Yes | Yes | Yes | Yes |
Permits analysis of adverse events and near errors at hospitals and primary care | Yes | Yes | Yes | Yes |
Ensures the privacy and confidentiality of the information | Yes | Yes | Yes | Yes |
Offers full guarantees for the legal certainty of the professionals (no data recorded) | No | No | No | Yes |
Permits analyzing immediate and latent causes of incidents | No | No | No | Yes |
Involves middle managers in the search for solutions | Yes | Yes | No | Yes |
Focuses on the search for solutions to prevent recurrence of the same incident | Yes | Yes | No | Yes |
Includes how to implement solutions and how to verify whether the anticipated result is obtained | No | No | No | Yes |
aTPSC Cloud (The Patient Safety Company Cloud).
bSistema de Gestión de Incidentes de Seguridad—Junta de Andalucía.
cSiNASP-Sistema de Notificación y Aprendizaje para la Seguridad del Paciente (Learning and Reporting System for Patient Safety).
BACRA tool flowchart.
(1) Info: information
What BACRA is
What BACRA offers
How to use BACRA
(2) Hide/Show: hide the form so that nobody else can access it (password access)
(3) What Happened: what consequences did the incident have?
Care level selection (hospital or primary care)
Type of harm
Has the incident been reported?
Nature of harm
Related with nosocomial infection
Related to procedures
Related with care
Related with medication
Others
Measures adopted with the patient to remedy the harm and to prevent recurrence of another AE related to the first
Impact (severity and autonomy of the patient)
(4) How: when and how did it occur?
Date and time of the occurrence and its detection
Chronology of the facts
(5) Causes: why did this happen? (root of the incident)
5 Whys technique
Immediate and latent causes
Use of resources and equipment
Organization and culture of safety
Factors attributable to professional action
Intrinsic risk factors for the patient
(6) Solutions: how could it have been avoided? Solutions and plan of action
Risk priority number (RPN)
(7) Print: print report in PDF
Home page and navigation modes.
Screenshot of “Consequence” page: type and nature of harm.
Screenshot of “Causes” page: root of the incident.
Screenshot of “Solutions” page: final result of the analysis.
The tool’s final screen allows the printing of a final report that contains information that is detailed depending on where the report is destined to go. Specifically, two options exist: a report for the head of the unit, containing information drawn exclusively from the “Solutions” page (the final result of the analysis), or a report for the center’s safety committee, containing additional data from the “What Happened?”, “How?”, and “Causes” pages.
BACRA v1.1 was assessed by 12 of 13 professionals who used it (a response rate of 92%) and BACRA v1.2 was assessed by 47 of 59 professionals who used it (a response rate of 80%). Most of these professionals had reported an incident using other reporting systems at their respective health centers (86%, 62/72).
On a scale of zero to five, BACRA v1.2 was rated higher than BACRA v1.1 in both usefulness (v1.1: mean 3.4, SD 1.6; v1.2: mean 4.3, SD 0.9; z=2.2,
BACRA v1.2 was designed to encourage the implementation of preventive measures that impede the repetition of incidents producing harm in patients, as well as incidents that have not yet caused harm but might do so in future due to repetition. This Web-based tool was devised to provide an appropriate response to the difficulties described in the literature, as well as those described by frontline professionals, that have made it difficult to analyze incidents of safety and to seeking solutions. This new instrument promotes health care provider involvement, seeking alternatives to avoid repetition of safety incidents. The data obtained by evaluating the tool justify the changes introduced in v1.2, making it a tool that is useful and easy to use.
BACRA v1.2 is a supplement to an existing IRS to support the frontline health care professional to analyze safety incidents and propose actions to prevent the recurrence of similar incidents. BACRA has been designed to overcome factors limiting reporting and reaching consensus on preventive actions. This tool guarantees anonymity of the analysis and reduces the reluctance of professionals to carry out this task.
The benefits of reporting incidents have been well described, and there is broad consensus that reporting helps improve the management of risks inherent in health care, it strengthens the safety culture, and ultimately increases patient safety [
Other studies have pointed out certain barriers that make it difficult to report new incidents, thus making it difficult to transform information into action. Among other reasons, health care professionals attribute their own reticence to fear of punitive action, scant familiarity with incident analysis techniques, difficulties in achieving appropriate feedback, and lack of time to report [
BACRA guarantees anonymity of the analysis (not only of the reporting) and has been designed to assure that middle managers can become more actively involved in proposing preventive actions to avoid the occurrence of new incidents and thus to save patients from suffering avoidable harm. BACRA is used both to analyze real incidents, which caused harm to patients, and to analyze critical incidents that did not cause harm to patients. This tool provides a framework to identify what has occurred and why, enabling caregivers to determine how to resolve issues and to implant barriers to prevent future failures. The BACRA focus is the implementation of an action plan that defines tasks and responsibilities that follow a clear analytical agenda. The aim of BACRA is to improve patient safety, but it also works to enhance the well-being of frontline professionals by contributing to the creation of a safer clinical context.
BACRA’s Web format is in line with the preferences of electronic systems found in other studies for the analysis of incidents [
Approaches to, and conditions of, incident analysis for patient safety have been studied extensively. These studies have demonstrated the critical importance of leadership, effective dissemination channels, and the capacity for rapid action as crucial to the execution of incident analysis that results in preventive action and that enables caregivers to draw lessons from prior experience [
This Web-based tool employs specific techniques proposed by other analysis methodologies seeking involvement from middle managers that have been deemed beneficial to patient safety [
The causes of most so-called near errors are not usually analyzed, and so they can continue to cause AEs (reaching the patient) in practice. A large number of health care professionals are not familiar with techniques for analyzing safety incidents; their care responsibilities limit the time they have available to carry out such analyses and, in many cases, they are wary of the consequences that could result from being seen involved in the analysis of incidents. BACRA strives to respond to all these limitations by offering a guideline for conducting an analysis focused on reaching a consensus on actions designed to prevent the recurrence of similar incidents.
BACRA should be used as a supplement to an existing IRS, and not as a stand-alone tool. BACRA is a tool designed by and for middle managers and frontline professionals that does not require specific training in patient safety. This new tool proposes a friendly framework to define an action plan and for implementing corresponding countermeasures that involve frontline health care professionals. A combination of top-down and bottom-up approaches helps to engage health care teams as a whole. They know the questions and, in most instances, they have solutions to offer that will implant barriers designed to prevent harmful incidents in future.
This tool’s main limitation is the need for Internet access, which some centers restrict due to security considerations. Response speed problems have also been detected in computers with limited features. To address these limitations in the future, a version of BACRA could be developed that is capable of functioning locally, without access to the Internet.
BACRA is not an incident reporting system and, therefore, should not be used as such. Its focus is centered on identifying preventive actions to avoid the recurrence of incidents that ultimately do harm patients. Sentinel events could require extensive analysis using the root cause technique.
This study was conducted with professionals experienced in incident reporting and thus familiar with basic issues of patient safety. Other users could require more time to become familiar with the tool. This study did not consider certain variables that might influence incident analysis, such as safety culture or perception of the efficacy of proposed solutions. The effectiveness of the proposals to avoid the repetition of similar incidents was not analyzed.
The safety culture at health centers can be determinant when implementing this tool. Learning from one’s errors is not easy due to questions that are both attitudinal and practical in nature. In order to exploit BACRA’s advantages, and learn from the experience toward the end of improving patient safety, it is important to promote a proactive culture of safety that acknowledges the possibility that professionals may commit errors in the course of providing clinical assistance. Effective use of BACRA also requires a commitment to the exercise of responsible behavior that improves patient safety.
By using BACRA at health centers, those responsible for the area of patient safety, in coordination with the middle managers of different care units, can agree on the destination of the results reports that the tool produces. For example, agreement could be reached, under appropriate conditions of confidentiality, to disseminate the proposals of applicable measures for specific types of incidents, thereby fostering shared learning to avoid future risks to patients.
Future research could examine the degree to which BACRA and similar tools are accepted by professionals, both those who use these tools and those who make changes in their clinical practice based on proposals reached consensually following the use of BACRA. The extent that BACRA contributes to strengthening of the culture of safety at centers could also be analyzed, for example, by determining whether application of this tool results in changes to management of the risks inherent to clinical practice.
adverse event
incident reporting system
New York Patient Occurrence Reporting and Tracking System
plan-do-check-act
portable document format
risk priority number
This study was financed by the Spanish Health Research Fund (FIS) and the European Regional Development Fund under grant numbers PI13/0473 and PI13/01220, respectively, as well as the FISABIO (Foundation for the Promotion of Health and Biomedical Research of Valencia Region) project number UGP-14-103.
JJM, LF, IC, and MG conceived the study. EZ, CS, and PP participated in its design. MAV and CF designed BACRA. IC performed the statistical analysis. MG, IC, LF, EZ, CS, and PP coordinated the qualitative research. JJM collected and prepared data to design and improve BACRA. JJM and IC prepared a first version of the original manuscript. All authors read and approved the final manuscript.
None declared.