BACKGROUND AND OBJECTIVES

Intravenous infusions have the potential to cause significant harm in patients and are associated with a high rate of adverse drug events and medication errors. Infusion pumps with dose error reduction software (DERS) can be used to reduce errors by establishing safe infusion parameters. In 2019, a quality improvement project was initiated with the aim to increase DERS compliance from 46% to 75% at our specialty institution by October 1, 2022.

METHODS

An interdisciplinary group was tasked with improving compliance with DERS by identifying key drivers, including informed staff, engaged staff, and an accurate smart pump library. We used the Model for Improvement framework to guide this improvement project, and Plan-Do-Study-Act (PDSA) cycles were used to plan for interventions. PDSA cycles included drug library updates, education, and unit-level compliance reporting. Weekly average DERS compliance was monitored as the outcome measure, and weekly pump alerts per 100 infusions were monitored as a balancing measure; statistical process control charts were used to monitor measures from 2018 to 2022.

RESULTS

Over the course of 25 months, 8 PDSA cycles resulted in 5 centerline improvements from a baseline mean of 46% to a final mean of 78%. Pump alerts per 100 infusions decreased from 15.9 to 6.4 with the first PDSA cycle and then continued to decrease to 3.9 with subsequent interventions.

CONCLUSIONS

Although features like DERS can help ensure safe medication administration, continuous improvement efforts to increase DERS compliance without increasing alert burden are needed to ensure that benefits of this technology are optimized.

Intravenous (IV) infusions have the potential to cause significant harm in patients and are associated with a high rate of adverse drug events and medication errors.1,2  It is estimated that 90% of hospitalized patients receive IV infusions, many of which are high-alert or have a higher risk of causing significant patient harm when used in error.14  Examples of high-alert medications include heparin infusions, vasopressors, and insulin.4  Overall, IV infusions are associated with 54% of all adverse drug events, 56% of medication errors, and 61% of serious and life-threatening errors.3  Infusion pumps with dose error reduction software (DERS), also known as “smart pumps”, are increasingly common, with 87.9% of surveyed hospitals reporting use of these pumps in 2020.5  Infusion pumps with DERS promote safety by reducing the incidence of adverse drug events and medication administration errors by alerting users when exceeding preset parameters such as dosing limits, rate limits, duration limits, and duplicate infusion identification.6  Schnock et al found that errors associated with DERS not being used occurred in 10% of observed medication administrations.7  Increasing compliance to DERS can prevent errors in drug selection, administration technique, and programming.8 

DERS parameters are stored within the drug library of a smart pump and require periodic maintenance to ensure that all available medications are built into the software.7,9  An out-of-date or improperly maintained drug library can cause end users to operate in a basic function mode, where the end user manually programs the pump outside of the prebuilt DERS parameters.7  Using this basic function introduces the risk of error if unsafe infusion parameters are used and has been reported to lead to patient harm.7,8,10,11  Alert fatigue can also lead end users to bypass DERS. When faced with overriding inappropriate alerts on the pump, end users become desensitized to them over time and ignore important alerts leading to patient harm.7,8,12  To experience the benefits of reducing medication administration errors, infusion pump technology must be used correctly, and a thorough review of internal usage data and external literature should be used to establish infusion limits.11,13,14 

Smart pump–electronic health record (EHR) interoperability is an additional safety feature that provides a 2-way wireless communication between the infusion pump and the EHR.15,16  This technology facilitates automated pump programming by populating the infusion parameters directly from the EHR, preventing keystroke errors seen in manual entry by users, and incorporates real-time infusion data flow with auto-documentation into the EHR.3,8,16  A 2013 study evaluated infusion-related events over a 2-year period and found that 28% of events could have been prevented with DERS, and 75% of events could have been averted with smart pump–EHR interoperability.17  Existing literature on efforts to overcome compliance hurdles after smart pump–EHR interoperability is limited because only 13.4% of hospitals with smart infusion pumps were live with interoperability in 2020.5 

Because of ongoing challenges with sustained DERS compliance at our institution after the implementation of both DERS and smart pump–EHR interoperability, a performance improvement project was initiated in 2019. In the Institute for Safe Medication Practices Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps, a DERS compliance goal of 95% is recommended, but the rationale for this goal is unclear.18  Our global aim for this project was to prevent IV medication errors by promoting safe and efficient use of smart pump technology, and the specific, measurable, achievable, relevant, time-bound (SMART) aim was to increase DERS compliance from 46% to 75% by October 1, 2022.

Our institution is a 77-bed specialty hospital that provides care for pediatric patients with oncologic, hematologic, and other catastrophic diseases. Our institution sees 8600 patients annually in inpatient and outpatient settings with an average of 7200 infusions weekly. Most patients admitted to the hospital receive IV infusions during their admission, and 52.6% of admissions include administration of IV chemotherapy during that admission. Guardrails on Alaris pumps (BD, Franklin Lakes, NJ) is the infusion pump DERS that is used at our institution. These pumps had interoperability with the EHR (Oracle Health EHR, Oracle Corporation, Redwood Shores, CA; formerly, Millennium, Cerner Corporation) at the beginning of this project and transitioned to interoperability to another EHR (Epic, Verona, WI) in October 2022.

At our institution, DERS was implemented in 2002 for select drugs. Interoperability between the EHR and smart infusion pump was implemented in 2017, and it decreased the number of steps for the end user to program a medication on an infusion pump by ∼20 steps. In preparation for smart pump–EHR interoperability implementation, a focus point was to update the drugs built in DERS. At that time, use of DERS was limited to only high-alert drugs, and so only 8.9% of all infusions were being programmed using DERS. The drug library update in preparation for smart pump–EHR interoperability increased compliance from 8.9% to 40.6%. After implementation of smart pump–EHR interoperability, DERS compliance increased to ∼50%. A review of DERS compliance in 2019 revealed that compliance remained at 46% despite 2 years of active smart pump–EHR interoperability. This low compliance indicated a high rate of end users bypassing the smart pump safety features and ultimately led to the formation of an interdisciplinary workgroup to optimize the benefits of this technology.

An interdisciplinary workgroup was formed, comprising members from nursing, nursing education, medication safety, informatics, and clinical research pharmacists. The group was tasked with deciding the aims, key drivers, and appropriate interventions for the project. Three key drivers were identified, including informed staff, engaged staff, and an accurate smart pump library (Fig 1). The Model for Improvement framework was used to guide this improvement project, and iterative Plan-Do-Study-Act (PDSA) cycles were used to plan for interventions during this project.19,20  PDSA cycle descriptions and lessons learned from each cycle are outlined in Table 1.

FIGURE 1

Key driver diagram outlining 3 key drivers and interventions to prevent IV medication errors by promoting safe and efficient use of smart pump technology. SMART, specific, measurable, achievable, relevant, time-bound.

FIGURE 1

Key driver diagram outlining 3 key drivers and interventions to prevent IV medication errors by promoting safe and efficient use of smart pump technology. SMART, specific, measurable, achievable, relevant, time-bound.

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TABLE 1

PDSA Cycles and Lessons Learned

PDSA CycleMonth/YearPlan/DoStudyAct
April 2019–present Reviewed top 20 alerting medications and recommended DERS changes on the basis of drug information sources 10 of 20 top alerting medications were updated. DERS compliance significantly increased, and alerts significantly decreased as a result. Adopt: Continue review of top alerting medications and make frequent updates to drug library 
February 2021 Educated staff on the use and safety implications of DERS versus basic infusion mode in nursing newsletter Education made no improvements to DERS compliance Adapt: Continue to explore better ways to reinforce education of proper use of DERS 
March 2021 Provided instructions for using DERS for blood products and flushes in nursing newsletter More targeted education on specific workflows resulted in an increase in compliance Adopt: Continue to educate on specific workflows to nursing staff 
May 2021 Provided instructions on what to do when interoperability failed in nursing newsletter Targeted education for when interoperability failed did not seem to have any lasting effect on compliance Abandon 
August 2021–July 2022 Implemented safety rounds targeted questions on when basic infusion mode is used with follow-up questions of how flushes and blood products were being infused. In both units where rounding took place, multiple nurses stated they never used basic infusion mode. However, when asked about flushes and blood products, they admitted to using basic infusion mode. Adopt: Continue rounding to educate on identified workflows influencing compliance 
Abandoned in July 2022 when nursing competency was implemented to reach all nursing staff 
August 2021–present Created report to identify locations for infusions so that unit-specific compliance could be monitored. DERS compliance saw a sustained increase in compliance after unit-specific reporting was initiated. Adopt: Continue to report unit-specific compliance 
November 2021–present Implemented quarterly drug library updates. Updates included changes to top 10 alerting drugs and addition of drugs reported to be missing during EHR transition. Added minimum concentration limits to those medication continuous infusions that allowed custom concentrations. Sustained DERS compliance was seen after the initial drug library update and continued to increase as the second and third updates were made. Adopt: Continue quarterly DERS updates 
July 2022 Created hands-on nursing competency. Competency included demo of the appropriate steps to take for IV push medications, flushes, blood products, and medications not built into the drug library. This competency reached all of the nursing staff and proved to be a better way to reach nursing compared with a newsletter; however, there were no improvements seen in DERS compliance, but overall compliance remained consistent. Adopt: Recurring competency for nursing on workflows contributing to low compliance rates 
PDSA CycleMonth/YearPlan/DoStudyAct
April 2019–present Reviewed top 20 alerting medications and recommended DERS changes on the basis of drug information sources 10 of 20 top alerting medications were updated. DERS compliance significantly increased, and alerts significantly decreased as a result. Adopt: Continue review of top alerting medications and make frequent updates to drug library 
February 2021 Educated staff on the use and safety implications of DERS versus basic infusion mode in nursing newsletter Education made no improvements to DERS compliance Adapt: Continue to explore better ways to reinforce education of proper use of DERS 
March 2021 Provided instructions for using DERS for blood products and flushes in nursing newsletter More targeted education on specific workflows resulted in an increase in compliance Adopt: Continue to educate on specific workflows to nursing staff 
May 2021 Provided instructions on what to do when interoperability failed in nursing newsletter Targeted education for when interoperability failed did not seem to have any lasting effect on compliance Abandon 
August 2021–July 2022 Implemented safety rounds targeted questions on when basic infusion mode is used with follow-up questions of how flushes and blood products were being infused. In both units where rounding took place, multiple nurses stated they never used basic infusion mode. However, when asked about flushes and blood products, they admitted to using basic infusion mode. Adopt: Continue rounding to educate on identified workflows influencing compliance 
Abandoned in July 2022 when nursing competency was implemented to reach all nursing staff 
August 2021–present Created report to identify locations for infusions so that unit-specific compliance could be monitored. DERS compliance saw a sustained increase in compliance after unit-specific reporting was initiated. Adopt: Continue to report unit-specific compliance 
November 2021–present Implemented quarterly drug library updates. Updates included changes to top 10 alerting drugs and addition of drugs reported to be missing during EHR transition. Added minimum concentration limits to those medication continuous infusions that allowed custom concentrations. Sustained DERS compliance was seen after the initial drug library update and continued to increase as the second and third updates were made. Adopt: Continue quarterly DERS updates 
July 2022 Created hands-on nursing competency. Competency included demo of the appropriate steps to take for IV push medications, flushes, blood products, and medications not built into the drug library. This competency reached all of the nursing staff and proved to be a better way to reach nursing compared with a newsletter; however, there were no improvements seen in DERS compliance, but overall compliance remained consistent. Adopt: Recurring competency for nursing on workflows contributing to low compliance rates 

The first PDSA cycle focused on evaluating smart infusion pump data to identify medications that were firing the most pump alerts to the clinician. The top 20 medications presenting alerts were evaluated to identify potential drug library changes (Supplemental Fig 4). After review by the workgroup, the drug library settings of 10 medications were changed in April 2019 (Supplemental Table 2).

Because of competing priorities, the interdisciplinary workgroup did not meet again for ∼18 months. Once reconvened, the workgroup began to plan the next action steps. PDSA cycles 2 to 4 focused on education, including the importance of using DERS versus basic infusion mode, instructions for using DERS for blood products and flushes, and training for when smart pump–EHR interoperability fails. PDSA cycle 5 included implementation of DERS monitoring and education during monthly walking safety rounds, and PDSA cycle 6 incorporated reporting of unit-specific compliance data to nursing leadership. PDSA cycle 7 integrated implementation of quarterly drug library updates; updates to the drug library were based on alert override data, feedback from nursing, event reports, and medications being built into the future EHR that were not already present in the pump library. Finally, PDSA cycle 8 reinforced previous nursing education through the creation and completion of an interactive nursing competency.

Weekly DERS compliance rates were monitored from July 2018 to December 2022. DERS compliance was calculated by reviewing usage reports of medications and IV fluids from the vendor’s tool (Integrated Analytics Knowledge Portal by BD). Blood products and IV flush entries were excluded. The compliance rate was defined as the number of DERS infusions per total infusions administered. The balancing measure was defined as pump alerts per 100 infusions and monitored from July 2018 to December 2022. The weekly frequency of DERS pump alerts was determined by calculating the number of alerts per 100 DERS infusions based on vendor-supplied data. This metric was selected as the balancing measure to ensure that alerts did not increase because of efforts to improve compliance, particularly as more drugs were added to the drug library and more nurses began to use DERS.

Weekly compliance rate percentages over time were analyzed by using a statistical process control (SPC) chart (Laney p’chart) in Excel. Weekly alerts per 100 DERS infusions over time were analyzed using an SPC chart (u-chart) that was created with SPC for Excel. Accepted statistical conventions for SPC were followed.21  The average (center line) was recalculated when a special cause shift was detected for 8 data points above or below the centerline.22 

This project was reviewed by the institution’s institutional review board and found to be a quality improvement project.

After the initial DERS library update took place in April 2019, our outcome measure of DERS compliance increased from 46% to 61% (Fig 2). PDSA cycles 2 to 4 showed only incremental improvements. PDSA cycles 5 and 6 were implemented in proximity, and an increase in compliance was noted. The average DERS compliance was recalculated at 67%, identifying PDSA cycles 5 and 6 as the reasons for the system change. PDSA cycle 7 and subsequent drug library updates resulted in an increase in compliance to 73%. Compliance rates experienced a centerline shift beginning June 5, 2022, bringing the new DERS compliance rate to 78%. No increases in compliance were seen after PDSA cycle 8. The institution transitioned to a new EHR in October 2022, and DERS compliance remained consistent throughout this time.

FIGURE 2

Weekly DERS compliance, with PDSA cycles notated. Laney p’chart. The week (and data point) of April 14, 2019 was not included because of implementation of PDSA cycle 1 (new drug library) in the middle of the week. Avg, compliance average.

FIGURE 2

Weekly DERS compliance, with PDSA cycles notated. Laney p’chart. The week (and data point) of April 14, 2019 was not included because of implementation of PDSA cycle 1 (new drug library) in the middle of the week. Avg, compliance average.

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For the balancing measure of pump alerts per 100 infusions, the baseline rate of 15.9 alerts per 100 infusions decreased to 6.4 after the first PDSA cycle (Fig 3). Pump alerts per 100 infusions continued to decrease throughout the project, with the largest decreases after PDSA cycles 5 and 6 (5.4 alerts per 100 infusions) and after PDSA cycle 8 and the EHR transition (3.9 alerts per 100 infusions).

FIGURE 3

Pump alerts per 100 infusions. U-chart. The week (and data point) of April 14, 2019 was not included because of implementation of PDSA cycle 1 (new drug library) in the middle of the week. Avg, average.

FIGURE 3

Pump alerts per 100 infusions. U-chart. The week (and data point) of April 14, 2019 was not included because of implementation of PDSA cycle 1 (new drug library) in the middle of the week. Avg, average.

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In this improvement project, DERS compliance increased, although our balancing measure of pump alerts did not increase. Interventions were facilitated through interdisciplinary collaboration, and the greatest improvements were seen after PDSA cycle 1, with changes to the drug library based on the most common alerts, PDSA cycles 5 and 6 with targeted discussion during safety rounds and unit-specific feedback on compliance, and PDSA cycle 7 with quarterly drug library updates. Because of the increase in compliance seen with these interventions, they were incorporated into the routine functions of the interdisciplinary workgroup, which was expanded to oversee all pump issues and continues to meet routinely.

To our knowledge, this is the first published improvement project focused on improving DERS compliance in the context of smart pump–EHR interoperability. Although it’s reasonable to assume that nurses would want to use this technology because of the reduction in pump keystrokes and the EHR auto-documentation, some studies have suggested there may be an upper limit to DERS compliance after the implementation of pump–EHR interoperability.23,24  Indeed, after implementation of smart pump–EHR interoperability at our institution, DERS compliance increased to ∼50%, but did not improve for ∼2 years until the interventions described in this report. In short, these technologies are not “plug and play” and require significant institutional investment after implementation to realize the full safety benefits.14  Continuous monitoring and improvement efforts are needed to fully realize the safety benefits of DERS with smart pump–EHR interoperability.

Our experience illustrates the importance of a continuously updated and accurate drug library on the use of the pump’s safety features because this intervention improved compliance the most. DERS compliance improvements were seen after PDSA cycle 1, with changes to the drug library based on the most common alerts and PDSA cycle 7, with quarterly drug library updates. Abboudi and colleagues modestly increased compliance from 77% to 83% over a 2-year period, with the greatest impact coming from nurses directly communicating DERS issues to informaticists making library updates. Although their specific interventions were different than our experience, the common thread for improvement is consistently monitoring and updating the underlying drug library information. Like our experience, the group did not observe meaningful improvement with education only.25 

To sustain these improvements and reach the goal of 95% compliance suggested by the Institute for Safe Medication Practices, a next step is to instill standardization between the drug library and EHR.18  As our hospital transitioned to a new EHR vendor, a thorough review of the drug library in the EHR afforded an opportunity to carefully review the drug library in the pumps, as well. Compliance remained consistent during the transition. However, data post go-live are limited, and changes to the EHR drug build process continue to be refined. Joseph and colleagues also highlight the need for complete alignment of the drug library and EHR medication orders; otherwise, interoperability may fail, and the drug library may not be used.24 

Although our work reinforced the importance of drug library maintenance, it also emphasized the magnitude of unit-specific feedback. PDSA cycles 5 and 6 included targeted discussion on using DERS during monthly walking safety rounds and reporting of unit-specific compliance data. Similarly, others have described using weekly compliance reports and education with feedback to improve the drug library and DERS compliance.3 

Our facility cares primarily for pediatric patients with oncologic, hematologic, and other catastrophic diseases, and therefore, our patient population frequently requires high-alert drugs (eg, chemotherapy), which may make this project less generalizable to other facilities. Further, only 13.4% of institutions have implemented smart pump–EHR interoperability.5  However, our interventions could be implemented at institutions with DERS only, and our experience may provide insights for improvement as other hospitals pursue smart pump–EHR interoperability. Further, the substantial ongoing effort to increase compliance with DERS may have diverted our attention from other necessary improvements in infusion safety. However, our improvements appear sustainable, and this project developed new processes and collaboration to inform a more comprehensive strategy for the safety of all infusions.

Our quality improvement efforts significantly improved DERS compliance in an institution with smart pump–EHR interoperability. The most critical of interventions were related to review of most common alerting medications with subsequent changes to the drug library, targeted discussion during safety rounds, unit-specific compliance reporting, and routine drug library updates. Although features like DERS can help ensure safe medication administration, continuous improvement efforts are needed to ensure that benefits of this technology are optimized.

We thank all members of the DERS compliance group at St Jude for their collaboration and support toward this quality improvement initiative to promote safe and efficient use of smart pump technology at St Jude Children’s Research Hospital. We thank David Aguero, PharmD, MSTL, ACHIP, and Samuel Bowker, PharmD, MHIIM, for their support in optimizing the safety features for our infusion pumps, and Ben Moore, PharmD, MS, and Murad Hasan, DrPH, for their support with data analytics; Chad Compagner, PharmD, for being vital in implementing a new drug build process that includes pump drug library additions; and Jonathan Burlison, PhD, William Mabry, PharmD, MBA, and Paul Sharek, MD, MPH, for helpful feedback on drafts of the article.

Drs Hughes, Cole, and Tims acquired data, conducted analysis and interpretation of data, and drafted the manuscript; Drs Robertson and Hoffman conceptualized and designed the project, and coordinated and supervised data collection; Mr Wallach, Mr Spencer, and Ms Page analyzed and interpreted data; and all authors critically reviewed and revised the manuscript for important intellectual content, approved the final version of the manuscript as submitted, and agree to be accountable for all aspects of the work.

FUNDING: No external funding.

CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no potential conflicts of interest to disclose.

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Supplementary data