Impact of an Original Methodological Tool on the Identification of Corrective and Preventive Actions After Root Cause Analysis of Adverse Events in Health Care Facilities: Results of a Randomized Controlled Trial

Abstract

The aim of the study was to assess the effectiveness of a new methodological tool for the identification of corrective and preventive actions (CAPAs) after root cause analysis of health care-related adverse events.Methods: From January to June 2010, we conducted a randomized controlled trial involving risk managers from 111 health care facilities of the Aquitaine Regional Center for Quality and Safety in Health Care (France). Fifty-six risk managers, randomly assigned to two groups (intervention and control), identified CAPAs in response to two sequentially presented adverse event scenarios. For the baseline measure, both groups used their usual adverse event management tools to identify CAPAs in each scenario. For the experimental measure, the control group continued using their usual tools, whereas the intervention group used a new tool involving a systemic approach for CAPA identification. The main outcome measure was the number of CAPAs the participants identified that matched a criterion standard established by eight experts.Results: Baseline mean number of identified CAPAs did not differ between the two groups (P = 0.83). For the experimental measure, significantly more CAPAs (P = 0.001) were identified by the intervention group (mean [SD] = 4.6 [1.7]) than by the control group (mean [SD] = 2.8 [1.2]). Conclusions:For the two scenarios tested, more relevant CAPAs were identified with the new tool than with usual tools. Further research is needed to assess the effectiveness of the new tool for other types of adverse events and its impact on patient safety.

Review of alternatives to root cause analysis: developing a robust system for incident report analysis

“…Third, tools should demonstrate improved clinical processes or outcomes. RCAs have been critiqued on the strength and implementation percentage of their actions 28 32–36 56 116. Better outcomes can include a decrease in the observed-to-expected mortality ratio as in the SWARM study 27 28 106…”

What Is Ethically Informed Risk Management?

“…This oversight leads to predictable and-given the alternatives-frankly unethical failures of the risk management process, especially with regard to patient safety risks. 49,50,51,52,53,54,55,56,57,58 Because health care organizations are complex adaptive systems characterized by what Plsek and Greenhalgh refer to as "individual agents with freedom to act in ways that are not always totally predictable, and whose actions are interconnected so that one agent's actions changes the context for other agents," 59 the intervention design process can only hope to be safe and effective if it is informed by stakeholder participation (including that of patients 60 as well as staff).…”

“…Failures of competence and diligence have real impacts on the health care mission that, at a minimum, have implications for justice, beneficence, and nonmaleficence. Health care risk management practice has been built primarily on good intentions, expert opinion, and (often underexamined) consensus standards of practice rather than on evidence 58 -a foundation for practice that is no longer seen as morally acceptable in other areas of health care. 66 To meet their obligations under this principle, risk managers must move toward a practice based on evidence and excellence.…”

“…66 To meet their obligations under this principle, risk managers must move toward a practice based on evidence and excellence. Examples of practice changes that might support this principle include adopting evidence-based approaches for risk control, 50,51,57,58,67,68 adopting proactive disclosure and settlement, and reducing or deimplementing 69,70 practices that have not proven effective, such as overuse of retrospective risk assessment at the expense of prospective risk assessment 54,71,72,73,74 or excessive focus on categorizing and reporting risks in ways that do not inform action. 75,76,77,78 Respect for privacy.…”

Understanding the Nature, Contributing Factors, and Corrective Actions of Medication Administration Errors: Insights from Saudi Arabia

“…[2,20] One of the key data sources that the health-care organizations use to monitor medication errors is the reports collected through their respective voluntary incident reporting systems. [21,22] Voluntary incident reporting systems enable data to be collected, aggregated, and synthesized to determine patterns that may lead to corrective action [23] and they are a requirement of several national accreditation bodies in the United States, [24] Canada, [25] and the Central Board of Healthcare Institution. [26] Proactively managing medication errors include reporting existing medication errors and providing an opportunity to identify and correct the errors that threaten patient safety by communicating and sharing the knowledge and learnings from the reported medication errors.…”