Achieving Compliance with The Joint Commission’s Sentinel Event Alert
August 10, 2021
Achieving compliance with The Joint Commission’s Sentinel Event Alert on optimizing smart infusion pump safety with DERS.
The Fresenius Kabi Pharmacy Team
Robert Canfield, Director of Marketing, Fresenius Kabi, USA, LLC
The Joint Commission recently issued a Sentinel Event Alert regarding optimizing smart infusion pump safety with dose error reduction software (DERS).1 Currently, DERS is the standard of care for ensuring healthcare organizations safely administer IV infusions1. Best practices state that healthcare organizations should have Dose Error Reduction Software (DERS) compliance goals of at least 95% or better.2 However, many healthcare organizations implementing infusion technology do not realize all of the benefits of smart infusion pumps.
We will examine each of the recommendations identified in “Sentinel Event Alert 63: Optimizing Smart Infusion Pump Safety with DERS” made by The Joint Commission. We will also share how the Ivenix Infusion System supports hospitals in improving patient safety by addressing the challenges presented by these recommendations.
Leadership assigns responsibility by identifying a multidisciplinary project team or department (such as the pharmacy and therapeutic committee) responsible for smart infusion pump interoperability, including DERS, the oversight of drug library revisions or additions, infusion protocols, smart infusion pump maintenance, and related issues1.
Smart pump infusion technology is more successful when multidisciplinary teams collaborate and work together. For example, during drug library creation, health systems with a group of pharmacists or smaller hospitals with only one pharmacist will gather a project team with representatives from each department or unit to gain consensus for infusion pump safety configurations. Because these settings may be different for each department, it is critical to ensure that respective departments contribute and approve the infusion pump safety configurations. This process is time-consuming and requires aligned coordination of each attendee’s time, and participation from a representative from each department, and traditionally is done using paper worksheets. These printed worksheets are often distributed, completed, and collected during each meeting. Values like DERS limits, the audio volume level of alarms, the occlusion pressure setting, and air-in-line alarm thresholds are just a few examples of the customization a department representative is asked to decide.
The Ivenix Infusate Library Manager supports collaboration across hospital and health system infusion therapy committees in real-time via a secure browser-based data repository. Once the drug library editors add content, they can add notes viewable across the project team. In addition, drug library editors can transition infusates into a draft state for reviewers to evaluate and comment on the content.
Changes are made in the draft state, team reviewers can test the draft settings on a web-based pump simulator, and changes can be sent to the Ivenix Infusion System Large Volume Pumps (LVP) as they are approved.
Traditional processes require in-person or virtual meetings and a line-by-line discussion of the build of a drug library. Ivenix evaluated these processes and created new tools for multidisciplinary collaboration on interoperability, DERS, drug library oversight, infusion protocols, and the total cost of ownership associated with infusion technology. This evaluation revealed a strong need for a system of systems approach to problem-solving. As a result, Ivenix implemented a data-driven design and released to market the Ivenix Infusion System.
The nurses, doctors, pharmacists, and engineers at Ivenix built the Ivenix Infusion System to support nursing and patient safety collaboration between pharmacists, informaticists, and biomedical engineering. This software-based tool supports the rapid build and collaborative revision of the drug library and pump settings, rapid adoption tools for expediting smart pump auto-programming, and reduction of the total cost of ownership attributed to infusion pump maintenance. In addition, biomedical engineers experience advantages from predictive maintenance reporting, no device calibrations, and exceptional battery life.
Define a process to create, test, regularly engage with, and maintain a drug library1.
Hospitals we have spoken with have shared their concerns about being overburdened with the upkeep and maintenance of technology in their facilities. In many cases, drug libraries are not maintained when infusion pump technology is implemented because updating the drug library is too challenging to perform frequently. Traditional processes for updating drug libraries are often reliant on the power-off and power-on sequence of the infusion pump and the reset of the pump to a “New Patient” status. In nearly all cases, the clinician is expected to wait for the update process to execute. This update process is traditionally accomplished by wireless transmission of the drug library as a complete file. This file is then applied to the pump in a rip and replace fashion and requires the clinician to wait for the update to complete while viewing a “please standby” message.
At Ivenix, we view this rip and replace process as equivalent to asking an airline pilot to wait while a new map is loaded into the onboard navigation system. Delays like this are not practical. In a modern hospital environment, we consider this kind of delay unacceptable and a contributor to the underutilization of DERS.
The Ivenix Infusion System is built to meet hospital infusion therapy needs by eliminating pain points that often lead to clinicians underutilizing DERS. Recent studies identified drug library update delays of up to 6 months.3,4 Over 30% of infusions were infused with outdated drug libraries.3,4 And over 22% of alerts were unnecessary.3,4 The clinician experience when using an outdated drug library can be negatively impacted by the alert fatigue resulting from avoidable alerts. The Ivenix pump workflow defaults the clinician prompts to the drug library. Automating this process ensures drug library compliance is high.
Wirelessly sending updates to the pumps is accomplished in near real-time to the entire fleet. Drug library updates are sent and applied to individual limit configuration items quickening the update process. The update of the pumps is immediate, taking only minutes to be applied. If an infusate with a change is running, the change is applied after the infusion is completed. This rapid drug library update capability minimizes the chances of a clinician infusing with the wrong DERS or without DERS protection at all. The drug updates sent to the pump are immediately available, do not interrupt actively running infusions, and do not require clinician acknowledgment or a pump power off. This lack of reliance on user interaction to trigger the drug library update allows nurses and pharmacists to focus on patient care.
Train and assess competency of all clinical staff, including nurses and other clinicians who travel to various care settings1.
Ivenix has a shared company vision of eliminating infusion-related patient harm. This vision includes a commitment to ensure clinicians fully understand how to use the infusion system, are well trained in a short time, and have a library of guidance resources at the pump display when programming an infusion order.
Figure 1: Ivenix Resource Library
Guidance and training resources are viewed as fundamental clinician needs. Ivenix meets this need with e-training modules compatible with hospital training software platforms and a unique instructional resource library built into the menus of the pump display. As shown in Figure 1 above, this Resource Library is accessible on the infusion pump to help clinicians with hospital policy, best practices documents, or supporting references.
Simplifying infusion pump programming workflows translates to an intuitive and simplified training experience. The user interface is designed from the ground up with a focus on task efficiency and safety. The infusion pump setup process identifies the clinician. It automatically selects the care profile of their assigned unit or department to simplify input options and limit the possibility of an incorrect care profile selection. The workflow simplicity reduces training time and IV setup steps.
Joint Commission Recommendation #4:
Make the optimal use of DERS expected practice1.
The Ivenix Infusion System defaults directly into DERS programming. Clinicians do not have to “opt in” to use the drug library. In addition, clinicians can readily see a graphical representation of the DERS limits with an obvious indication of when the infusion is operating outside DERS. This “Not in Library” indication is displayed on the pump when a clinician has chosen programming without DERS as shown in Figure 2 below.
Figure 2: Infusion programmed “Not in Library” indicator (shown circled in red)
The Ivenix Infusion System also aligns drug library editor views with a unique visual display on the infusion pump. This “Visual DERS” is displayed as a red-yellow-green “rainbow” for both the drug library contributors and the clinician at the bedside to visualize limits. Figure 3 below shows the graphic presented to the drug library contributor within the editor software.
Figure 3: Visual DERS in drug library editor software
Figure 4 below shows examples of the three visual alerts displayed on the pump screen corresponding to infusion parameters programmed within range, out of the soft limit range, and out of the hard limit range.
Figure 4: Visual DERS displayed by Ivenix large volume pump
The Ivenix Infusion System DERS updates are transferred wirelessly and take effect without interrupting clinical use. Real-time drug library build and revision collaboration software can reduce or replace in-person, and often challenging to coordinate, infusion committee meetings. This software-based collaboration tool supports the rapid creation and revision of the drug library and pump settings. By simplifying deployment and visualizing DERS within the infusion pump programming workflows, the Ivenix Infusion System encourages optimal use of DERS to achieve better compliance.
Monitor alerts, overrides, equipment or software recalls, and adverse event and close call reports1.
Traditional infusion technologies include a continuous quality improvement (CQI) process for monitoring alerts, overrides, DERS compliance, and infusion practice. These data analysis CQI report presentations address DERS alert frequency as a reactive means of adjusting a drug library configuration. This retrospective inquiry of infusion programming events is used to determine changes to the drug library or adjustments to hospital policies. There are three goals of this data harvesting exercise. The first goal is to reduce alerts triggered by the override of soft limits to reduce alert fatigue. The second goal is to identify the need to add a missing hard limit to improve patient safety. The third goal is to identify and adjust restrictive limits possibly interfering with safe clinical practice. Other investigations may uncover opportunities to quiet audio alarm events from the pump or focus on process improvement for specific medications. Unfortunately, the data source often lacks helpful elements like IV administration set tubing type, device location, patient identity, or medication name in many cases.
The Ivenix Infusion System provides a rich data analysis experience. Programming workflows can capture the pump’s location and the patient’s identity without the traditional need for infusion pump to EHR interoperability. The medication name is also identified by the system and is available in analysis reports.
During the programming of an infusion, the Ivenix System displays the dosing information on a rainbow-like colored scale to guide the clinician visually. This indicator helps avoid exceeding a limit and reduces the incidence of hard and soft limit alert events. Alert avoidance is accomplished by actively informing the user how the infusion dosing parameters align with hospital policy as the infusion is programmed.
Ivenix is driving innovation of infusion management and practice optimization using a series of advisories. These advisories inform the team in real time when the infusion is running outside of a drug library or infusing outside of recommended DERS limits. For example, when an infusion is programmed outside the normal range but within a hard limit, the pump and supporting software reports an advisory event to external systems like the Ivenix Infusions Dashboard or a third-party alarm notification platform. The status of this DERS override can be viewed by the patient’s care team such as pharmacists on the dashboard or can be routed to mobile alerting solutions.
Figure 1: DERS Advisory Messages can be sent to connected systems
This quick analysis and evaluation may help hospitals reduce medication errors in near real-time. Infusion monitoring and CQI analytics with the Ivenix Infusion System provide a broad picture of when the IV programming occurred, where medication administration occurred, to whom infusions were administered, and details on the supplies used for the infusion setup. The software automatically calculates the thresholds for triggering these out of guidance events to simplify drug library compliance monitoring and near real time interventions to minimize adverse events. Hospitals focusing on drug library compliance and reduction of medication error events now have a new tool in their arsenal for improving practice.
If your organization has the capability, connect your smart infusion pump fleet with your EHR system1.
According to a 2012 ECRI article, 75% of reported infusion-related medication errors could have been averted by successful pump integration (interoperability).3 The percentage of hospitals estimated to have implemented interoperability is less than 15%. This adoption rate is extremely low considering that implementation of auto-programming of infusion orders from the EHR has been shown to be the most robust means of eliminating programming errors.
The Ivenix Infusion System is designed with the key tenet of keeping technology out of the clinician’s way while leveraging information systems to support simplified clinical workflows. The pump is built to be interoperable and supports the bi-directional exchange of information between the pump and the electronic health record (EHR) through connectivity with the Infusion Management System (IMS). IMS has built-in tools that ensure the interoperability is seamless with various EHR companies such as Epic, Cerner, and Meditech via Iatric and alert notification platforms. The rapid adoption of auto-programming of orders is achieved through tools that automate the manual testing of medication scans.
This manual scanning of every medication traditionally prolongs an infusion pump EHR interoperability implementation making the project a heavy lift for a multi-disciplinary team. However, the automated processes available with the Ivenix Infusion Solution reduces the overall testing time from months to weeks or even days.
Another critical task in the infusion pump to EHR interoperability workflow is scanning the infusion pump identifier (barcode).
Traditionally accomplished by the time-consuming application of a sticker or tag physically applied to the pump by hospital staff, this process can sometimes lead to human error caused by the mismatch of pump identifiers. As discussed in a recent ISMP article, duplicating the same barcode identity on two different infusion channels has occurred leading to incorrect EHR documentation of a continuous insulin infusion. ISMP recommends an independent double-check of the accuracy of pump serial number barcodes when these adhesive stickers are affixed to a pump.
At Ivenix, we think differently…
To improve the accuracy of the scan of the infusion pump, the Ivenix Infusion System displays the barcode on-screen. The value of the barcode is controlled and checked by software in the pump.
Figure 2: Ivenix LVP barcode displayed on screen
The Ivenix Infusion System is also interoperable with other healthcare IT systems through Admission, Discharge & Transfer (ADT) interfaces. This simplified workflow allows clinicians to make a patient-to-pump association without relying on an EHR interoperability interface or additional scanning. In addition, the patient-to-pump association enables interfacing to alarm notification software solutions, enhances the quality of reports, and can assist with error investigation. ADT integration and patient-to-pump association can also help outpatient infusion services billing automation, a charge capture and cost recovery source for many institutions.
This patient identifier workflow, the barcode on display, and the rapid adoption capability allow hospitals to implement bridge solutions to full EHR Interoperability, making auto-programming and auto-documentation more easily implemented when the hospital is ready.
Identify and address human and environmental factors — such as understaffing, variation in pumps that can create confusion in controls, workflow distractions, and low lighting or glare — that contribute to smart infusion pump programming errors in your hospital1.
Industry watch groups and the FDA have identified design shortcomings of traditional infusion technologies. Some examples of infusion pump problems reported to the FDA are:
Confusion of controls like key bounce causing extra digits to be entered
Ambiguous trouble codes making problem isolation a challenge
Infusion pump fails to generate an audible alarm for a critical problem, such as an occlusion3
At Ivenix, we think differently…
The Ivenix Infusion System design focuses on infusion therapy challenges with modern human factors and simplicity as core requirements. This approach resulted in a fundamentally different way of pumping fluid, interacting with clinicians, and simplifying workflows. Reducing cognitive load is achieved by utilizing one-step intuitive processes. Ivenix removes technology distractions from the workflow by minimizing reliance on product tip sheets and redundant steps. This simplification is achieved by keeping the clinical user on a single data entry path wherever possible. Workarounds are deterred by providing clinicians a simple user interface with minimal steps and consistent workflows. The usability of the Ivenix Infusion System has received industry recognition as demonstrated by the Human Factors and Ergonomics Society (HFES) 18thAnnual Stanley Caplan User-Centered Product Design Award.
Figure 7: Programming screen of the Ivenix Infusion System
Key bounce is not possible with the Ivenix Infusion System large volume pump (LVP) because a cellphone-like touch screen has replaced touchpad keys. Trouble codes displayed include a complete yet concise text-based explanation of the issue in plain language to make resolving the cause quick and straightforward. Because the pump has an automated secondary IV management system, it actively pumps the secondary medication while sensing occlusions often caused by a forgotten closed roller clamp and alarms to notify the clinician. Also, with the automatic occlusion recovery, patients can straighten their arm, and the clinician does not have to go into the room to clear an occlusion alarm.
Low lighting and glare should be considered in the design of any modern infusion system. Screen visibility is optimized by backlight and brightness configurations, a high-resolution display, clear text-based screens, and configurable intelligence supporting the timed dimming of the screen to reduce glare and support a restful patient sleep period. This unique configuration can be customized in different units or departments as preferred by the hospital.
Keep the smart pump fleet safe from security threats and during downtime1.
Cybersecurity continues to be a real threat to the integrity and safety of medical devices. Multiple infusion device manufacturers have published product alerts and recalls associated with product vulnerabilities. Many infusion pumps presently in use in hospitals today lack a modern capability to address cybersecurity issues responsively. Too often, best practices in network security are relied on by medical devices as the only barrier between a poorly secured system and a nefarious actor.
At Ivenix, we think differently…
The Ivenix Infusion System is designed from the bottom up to be cyber-secure. Ivenix provides protections against attacks, active software tools to detect intrusions and respond, and the ability to apply security patches in minutes when new vulnerabilities are discovered. The Ivenix Infusion System Large Volume Pump (LVP) has no external wired connections making it impossible to connect with a cable and attack the software integrity of the pump. The pump communicates wirelessly over an encrypted connection to the proprietary Ivenix Infusion Management System (IMS) (server software) using the same protocols the banking industry uses. These protocols ensure that both the pump and server software verify their identity, and multiple types of cyberattacks are stopped. This identity verification is critically important to assure hospitals that corruption of the pump software is not possible. The system also ensures the drug library cannot be nefariously altered, and data communication from the pump to other systems like the EMR, alarm notification platforms are secure.
While other systems may use lightweight protocols to increase speed, this requirement is outdated. All modern wireless networks support more than enough speed and capacity to support encrypted wireless network connectivity.
Data stored on the Ivenix LVP (pump) and IMS (server software) are encrypted at rest and when in transit. This securing of data protects the smart pump fleet from security threats during clinical use and downtime.
The Ivenix Infusion System is the first and only infusion system fully developed and cleared under the new FDA guidance with increased scrutiny around cybersecurity.3