Patient Safety Team: Near-Miss Medication Errors and Predicting Serious Safety Events

Medical errors remain a leading cause of death and poor patient outcomes during hospitalization in the United States (Oyebode, 2013; Rodziewicz & Hipskind, 2019). The Institute of Medicine reported that medical errors result in at least 7,000 deaths and cost 17-29 billion dollars annually (Oyebode, 2013). Healthcare organizations have recognized the importance of including healthcare workers in the process of error identification. Incident reporting systems have been in place since the early 2000s as a way of identifying medical errors in the healthcare arena (De Feijter et al., 2012). Healthcare organizations across the nation use internal self-reporting systems as a critical piece in process improvement and identification of potential threats to patient safety. "To Err is Human: Building a Safer Health System" (2000) states: Voluntary reporting systems are particularly useful for identifying types of errors that occur too infrequently for an individual health care organization to readily detect based on their own data, and patterns of errors that point to systemic issues affecting all health care organizations (p. 87)In addition to reporting actual medical errors and serious safety events, incident reporting has expanded beyond voluntary reporting systems to help prevent errors, including chart reviews, investigation of patient complaints, even prediction of future events based off of past errors. Medication errors are recognized as a form of preventable patient injury, and as such have long been the focus of improvement projects including the fostering of safety cultures in which medication errors can be investigated (Kavanagh, 2017 & Benjamin, 2003). Because most medication errors are considered preventable, the reporting of safety events is important to healthcare organizations always looking to improve quality, processes, and outcomes (Ferracini et al., 2016). While not all safety events lead to permanent or even temporary patient harm, the identification of "near miss" events or process flaws can greatly improve the odds of catching deviances in performance or processes that could eventually lead to serious safety events (Kaplan, 2005). In 2015, Crane et al., writes "near-miss events, or errors that are corrected before a patient is harmed, represent an opportunity to identify and correct flaws that jeopardize patient safety" (452). Using reported near miss events in quality improvement strategies makes the process proactive rather than reactive, hopefully preventing adverse reactions and patient outcomes before they occur.

MEDICATION ERRORS AND PREDICTING SAFETY EVENTS Patient Safety Team: Near-Miss Medication Errors and Predicting Serious Safety Events Alexis Gashler, BSN, RN, CCRN University of Utah April 25, 2020 In partial fulfillment of a Master of Science degree College of Nursing Major: Nursing Specialty: Nursing Education 1 MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 2 Introduction Medical errors remain a leading cause of death and poor patient outcomes during hospitalization in the United States (Oyebode, 2013; Rodziewicz & Hipskind, 2019). The Institute of Medicine reported that medical errors result in at least 7,000 deaths and cost 17-29 billion dollars annually (Oyebode, 2013). Healthcare organizations have recognized the importance of including healthcare workers in the process of error identification. Incident reporting systems have been in place since the early 2000s as a way of identifying medical errors in the healthcare arena (De Feijter et al., 2012). Healthcare organizations across the nation use internal self-reporting systems as a critical piece in process improvement and identification of potential threats to patient safety. "To Err is Human: Building a Safer Health System" (2000) states: Voluntary reporting systems are particularly useful for identifying types of errors that occur too infrequently for an individual health care organization to readily detect based on their own data, and patterns of errors that point to systemic issues affecting all health care organizations (p. 87) In addition to reporting actual medical errors and serious safety events, incident reporting has expanded beyond voluntary reporting systems to help prevent errors, including chart reviews, investigation of patient complaints, even prediction of future events based off of past errors. Medication errors are recognized as a form of preventable patient injury, and as such have long been the focus of improvement projects including the fostering of safety cultures in which medication errors can be investigated (Kavanagh, 2017 & Benjamin, 2003). Because most medication errors are considered preventable, the reporting of safety events is important to healthcare organizations always looking to improve quality, processes, and outcomes (Ferracini MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 3 et al., 2016). While not all safety events lead to permanent or even temporary patient harm, the identification of "near miss" events or process flaws can greatly improve the odds of catching deviances in performance or processes that could eventually lead to serious safety events (Kaplan, 2005). In 2015, Crane et al., writes "near-miss events, or errors that are corrected before a patient is harmed, represent an opportunity to identify and correct flaws that jeopardize patient safety" (452). Using reported near miss events in quality improvement strategies makes the process proactive rather than reactive, hopefully preventing adverse reactions and patient outcomes before they occur. Methods The goal of this project was to examine safety events related to medication administrations with the intent of finding patterns that could potentially help the Patient Safety Team at a large urban medical center in the Intermountain West to predict future medication errors and prevent any serious safety events from occurring, if possible. Medication errors are some of the most dangerous mistakes that occur in healthcare organizations, and as such a great deal of effort goes into process and quality improvement projects to help healthcare professionals avoid them. The first step in this process was to examine near-miss safety events reported through the institution's error reporting platform. Through this platform, employees self-report safety concerns and incidences. The error reporting platform was used to examine and organize all safety data reported. Once reported, a root cause analysis of the more serious safety events was conducted. The events were classified using the Safety Event Classification system adapted from HPI, the Healthcare Performance Improvement Organization (2011). Using this classification MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 4 system, events were identified into "serious safety events", "precursor safety events", and "near miss safety events" (HPI, 2011). Events reported through the institution's error database were then sorted, and nine serious safety events were further examined for common themes related to the errors. Serious safety events are examined by the Patient Safety Team and any involved groups in order to conduct a root cause analysis. Root cause analyses were conducted using "RCA2 Improving Root Cause Analysis and Actions to Prevent Harm" from the National Patient Safety Foundation (2015) and the Institute of Healthcare Improvement's Patient Safety Essentials Toolkit (2019). Part of this process included creating a cause and effect fishbone diagram containing further dissection of contributing factors, a common method utilized by the Institute of Healthcare Improvement and further described in their QI Essentials Toolkit (2007). The team analyzes the event and organizes details into contributing categories of Methods, Materials, Equipment, Environment, and People (IHI, 2007). Analysis of all factors results in the team concluding two primary contributing factors and an official problem statement containing the root cause, along with an action plan from key stakeholders to remedy any system failures identified along the process. Using the data gathered from each analysis and respective action plans, the Patient Safety Team gathered qualitative data with the intent of using common themes in medication errors leading to serious safety events to identify factors that may help units and practitioners prevent future errors and subsequent harm. Because the nature of the project data is qualitative and exploratory, interventions may not be implemented without further analysis and input from other key stakeholders. MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 5 Reporting safety data is always an ethical concern to hospital teams. This team is aware of the sensitive nature of the data collected thus all data collected is password protected and only collected on encrypted computers and platforms. Any data further used was properly deidentified of any patient descriptors, dates, etc. Any written communication between project members contained applicable disclosures and protective "PHI" subject headings. Results The major findings in this project were the analysis of the near-miss data, the classification of data using a fishbone diagram. Because the nature of this project was qualitative and retrospective, the team did not have to implement any interventions during the course of the project. The primary goal was to analyze the data to determine if an implemented intervention could be helpful in preventing serious safety events from occurring based off reported near-miss events. In the end the near-miss data did not reveal many strong trends; there was some support for trends surrounding errors including medication administration rights not being followed, distraction during administration, and machinery/equipment looking too similar to one another. This data was confirmed via the analysis of the serious safety event reports, with noncompliance around the six rights of medication administration being the strongest deviance resulting in serious errors. Analysis of the serious safety events included further classification using a fishbone diagram which distributed contributing factors into categories such as machinery (technology), methods, materials, measurements, people, and mother nature (environment) using the Institute for Healthcare Improvement's Cause and Effect diagram (2017). Root cause analyses had also been performed on each of the cases, per the IHI's guidelines, which information was also taken MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 6 into consideration when determining classifications of the contributing factors (2017). As stated, the major contributing factors that emerged included omission of one or more rights of medication administration, distraction occurring during or just prior to administration, and errors caused by equipment misuse or mix ups. Of roughly 50 near-miss events analyzed, only about 10 events were relevant to medication administration via nursing; remaining events were more heavily related to pharmacy or system delivery errors. Distraction is largely purported as a primary reason for medication errors occurring, and was well supported by the serious safety events in this study. In at least seven of the nine serious safety events at the studied institution distraction was a reported factor in the subsequent root cause analyses findings. Distraction was noted as a factor in the fishbone diagram classification but is worth further discussion due to higher prevalence than any other contributing factor in the errors examined. Limitations Limitations to the data include the current error reporting structure at this institution. As of now, the error reporting platform is the only reporting system being used organization-wide. This means that pharmacy, nursing, transportation services, blood bank, lab services, etc. all report to one database, making information harder to sift through. A large portion of events classified as near-miss events reported to the patient safety team included errors unrelated to nursing process and more closely related to pharmacy such as medication delivery errors, missing medications, improperly labeled medications, etc. Another limitation in the project included the retrospective nature of the data and the limited view of each event. Because this Intermountain West institution uses a voluntary reporting system, the information of each event is limited to narrator perspective and any details MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 7 are minimal and subjective in nature. Time, access restrictions, and limited information availability inhibited the patient safety team from further exploration into each near-miss and serious safety event. In order to conduct a more thorough analysis of near-miss events and their subsequent contributions to serious safety events the team would require access to staff and equipment immediately following an event to gather accurate situational information surrounding the environment, acuity of the unit on the day the error occurred, and any additional contributing factors which would not be detailed in patient charts. Discussion Distraction was a notable contributing factor in the majority of medication error events analyzed. Various studies reported that distractions and interruptions during medication administration occur anywhere from 19 - 99% of administration processes (Johnson et al., 2017; Rivera & Karsh, 2010; Wondmieneh et al., 2020). Evidence of interruption increasing medical error even extends beyond the inpatient realm into ambulatory settings as well, where disruptions were thought by one study to increase errors by more than three percent (Flynn et al., 1999). However, despite strong support that distraction increases medical error, more studies are needed in order to determine to what extent distraction can be blamed for medication errors and serious safety events. Of the medication errors examined that resulted in serious safety events, nearly all could be classified as "action-based errors" or "technical errors" (Aronson, 2009). Unlike errors occurring from lack of knowledge or memory lapses, action-based errors occur due to inattention in the dispensing and administration. From the information available to the patient safety team from the error reporting platform, it did not appear that the mistakes were due to a lack of MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 8 knowledge on behalf of the caretakers but rather errors in medication preparation or distractions encountered during administration process, as previously discussed. However, one important limitations of this study lies within the knowledgebase the patient safety team had access to surrounding event occurrences. Without further knowledge of the specific staff involved, their professional experience, the overall acuity of the patient setting that day, etc., there is very limited insight into the "latent factors" that made error more possible, like exhaustion, systems failure, or environmental distractions (Nichols et al., 2008). Besides environmental distraction, research has noted other factors such as hunger, fatigue, noise, and other patients as having significant impact on cognitive load for nurses, which in turn results in greater error and "procedure failures" (Thomas et al., 2017). As noted in the Results section of this paper, further investigation into environment, circumstances, and personnel would be required in order to adequately determine where errors arose within the medication administration steps, and what factors contributed to cognitive failures. There is also very little research into how medical equipment confusion impacts medical error and results in subsequent harm. Existing data classifies errors due to human interaction with technology as socio-technical errors, much of which describes improper use of equipment and technology whether it be a result of ignorance or blatant misuse (Samaranayake, 2012). However, most errors from the analyzed data resulted more from equipment confusion rather than misuse or improper technological interfacing. Of the data analyzed by the patient safety team, error resulting from equipment confusion was a strong theme. Medications, IV tubing, syringes, etc. all look alike, including many with similar standardized labeling making it difficult to quickly distinguish meds one from another. Much of the data surrounding medical equipment MEDICATION ERRORS AND PREDICTING SAFETY EVENTS 9 technical errors involves pediatric medicine. Additional research should investigate adult populations and errors resulting from medication and technology confusion. Recommendations for further research include a method in which nurses can recover from workplace and environmental distractions that interrupt them prior to medication administrations and therefore avoid mistakes. Further studies examining the failure to observe the six rights of medication administration would also be helpful in determining where nurses typically deviate in the process, and how hospital systems can prevent future deviation from resulting in medication error. Continuing research on the impact of cognitive load of nurses would support and increase understanding of these issues as well. Research also supports that errors in medication fulfillments and dispensing are highly prevalent and contribute to preventable medical errors (Kaprielian et al., 2008). These medication issues and others of similar categories unrelated to nursing would be better served via a separate data base or further sorting configuration to be addressed more directly by the appropriate service lines. Conclusion The findings of this project were helpful in determining areas for further research in analyzing errors that may lead to serious safety events, but lacked conclusive strength due to the study limitations of data size, study time, and available information. 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