Infusion pump interoperability provides bidirectional communication of data between the electronic health record (EHR) and the infusion pump. Data are validated through several interface processes from the EHR to the pump, ultimately sending a confirmation back to the EHR. At that point, the nurse should confirm that the information in the order details and on the infusion pump match before initiating the infusion. This final step is the culmination of strategic work from multiple disciplines to close the loop of safe medication administration with infusion pump interoperability.
As with any introduction of new technology, existing clinical applications and workflow are disrupted. Even with the highest level of detail given to preparation, every possible scenario cannot be identified or predicted. Although using the principles of high reliability and evaluating possible safety risks can mitigate unintended consequences, they will still occur. This article uses the three categories of people, processes, and technology to describe safety risks and resulting consequences. Figure 1 illustrates the relationship between these components and their effects.
People
Engaging nursing informaticists and frontline nurses is key to a successful infusion pump interoperability project. From design through implementation of infusion pump integration, ensuring nurses are engaged in basic and complex workflows is paramount. Altering ingrained practices and introducing new technology span a generation of clinicians in age, skill set, and abilities. However, most important is that the nurse not only understands the clinical component but also has the ability to critically think about how the device's interoperability and programming can affect clinical outcomes. It is imperative not to rely solely on the technology. It is this last component that is typically the cause of most unintended consequences. Often, users:
* are in a hurry;
* "read, but doesn't read";
* do not recognize their own skill sets; and
* make assumptions.
The introduction of other disciplines in the clinical world may be new to many nurses. Engaging clinical engineering, or application teams such as developers and other information technology support, is a new concept for staff in the development of clinical workflows. Nurse informaticists can also support the interaction between clinical disciplines and technical staff who are building and managing new technology.
Processes
The process of infusion pump device integration is a complex task that occurs for an extended period. Clinical teams must collaborate and fully understand the cause and effect of version iterations and changes to clinical workflow. Areas affected include the following:
* Pharmacy: building data sets, which may include combining multiple data sets and setting standard safety limits for concentrations, dosing, and rates, as well as understanding the impact of these changes to nursing workflow. In addition, ongoing data set release processes will continue to affect clinicians over time.
* Medication management technical team: Changes to the initial build of pharmacy drug records and architecture requirements affect the data that are displayed for clinicians and the rules around how these records behave.
* Clinical documentation team: Documentation changes are also affected because of interoperability, and some flow sheet elements may need to be added, deleted, or changed, which affects nursing workflows.
* Networking and clinical engineering: Validating infrastructure requirements to support increased messaging across the wireless network and managing the hardware assets and software updates. Based on the number of infusion pumps, and network capacity to accommodate data transmission, there may be interruptions in integration between the EHR and the pump.
* Education: Initial and ongoing training requirements need to be managed and updated.
* Nursing: reviewing preintegration workflow, validating changes to workflows, and consistently following established postintegration workflows.
Changing components of clinical practice is difficult when clinical acuity or severity varies. This applies regardless of whether the integration involves a single-entity or multientity organizational implementation. To ensure safe practice, consistent education and ongoing monitoring of correct clinical workflow are essential. In addition, ongoing monitoring of individual practice and swift remediation is important. Other areas that require a high degree of detailed attention to process include drug library data set and device management. To ensure reliability and safety, new requests and changes should be vetted in a standard change management process.
Technology
With the implementation of infusion pump interoperability, technology closes the loop of delivering intravenous fluids and medications, and it is assumed that a higher degree of safety is achieved. Organizations may have questions related to efficiency, error reduction, process improvement, and the promotion of system standards of care when evaluating the return on investment. Infrastructure requirements must be evaluated and optimized to handle increased message traffic that previously did not exist on the in-house network. The effect of system downtime will interrupt messaging through interfaces, ultimately affecting user workflow, satisfaction, and safety. Device management is constantly affected with software updates, vendor recalls, and routine preventive maintenance. This component also includes urgent and standard drug data set updates, wherein the end user must touch each pump to ensure that the most up-to-date drug limits and configurations are in place to support the expected workflow.
Technology is often perceived to be the solution to problems. Engaging key stakeholders to understand governance, change management, and implementation processes, as well as attending to the highest level of detail, is necessary to ensure safe practice. This will help avoid unintended consequences resulting in errors, possibly with a negative impact on patients. Table 1 compares several common interoperability issues with their cause and impact on safety.
Infusion pump interoperability implies the highest standards of safety, and a thorough review must be given to even the smallest details. Workflows should be vetted by all stakeholders. When an event occurs, root cause and effect analysis should be completed. Cross-checks by end users at all levels should be taught and monitored. No one component of the project lifecycle has greater importance than any other. With any change in technology, process, or the users (people), cause and effect requires attention to ensure safe implementation, practice, and ongoing monitoring.