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An IV Workflow Management System Implementation Journey

June 2019 - Vol.16 No. 6 - Page #12
The risks of manual sterile compounding are well known, presenting hazards to patients and health care workers alike; when using a manual process, even a small discrepancy can result in a serious adverse event. Consider that the manual inspection of IV admixture ingredients is not a foolproof method of preventing errors. Moreover, when manually verifying sterile compounds, it is not uncommon for the process to go undocumented. In addition, utilizing manual sterile compounding methods complicates an organization’s ability to maintain USP <797> and <800> compliance. Transitioning from manual IV verification to an IV workflow management system increases safety, reduces waste, and standardizes processes.

St. Elizabeth Healthcare is a five-facility health care system located in Northern Kentucky, just south of Cincinnati, Ohio. The system has over 1200 licensed beds and four outpatient infusion centers, plus a comprehensive cancer center that is scheduled to open in the fall of 2020. Our largest facility also operates a level 3 neonatal intensive care unit (NICU), in addition to a medical ICU (MICU), a surgical ICU (SICU), a cardiac ICU (CICU), and several ORs. Our smallest facility is a critical access hospital with an average inpatient census of 1 to 2 patients per day; however, this facility also operates a robust ED and busy outpatient infusion center. Our health system utilizes carousel storage within the pharmacy, ADCs on the nursing units, BCMA, and a robot for drug delivery. In recent years, we have considered automated IV management to increase patient safety and standardization, decrease waste, and ensure adherence to all regulatory standards.

Implementing Our First IV Workflow Management System

In 2013, our health system adopted its first IV workflow software system. At the time, the decision was made to implement the system only at our largest facility and to solely target high-risk, high-dollar medications, including (but not limited to) NICU and chemotherapy preparations.

Throughout this initiative, we experienced a mix of successes and failures. One of the most significant challenges was the lack of a bidirectional interface between the EMR and the IV workflow software system. Thus, even with the added safety the system afforded, there remained opportunities for error. Moreover, the system did not have a forced function for all required documentation, including lot numbers for each ingredient.

A few years later, our pharmacy director discovered that a different IV workflow system offered increased functionality and customizability, incorporated the use of gravimetrics, and provided a robust (HL7) interface with the EMR, as well as hard stops during the compounding process. Pharmacy believed these features would enhance the accuracy of our compounding, while increasing patient safety and decreasing waste.

When presenting our case for the new IV workflow system to hospital administration, the patient safety benefits were at the forefront of the conversation, as the health care system had already committed to this value by previously investing in BCMA. (To learn how pharmacy gained staff buy-in for the new technology, see the SIDEBAR.) The manual process of compounding sterile products was recognized as a gap in patient safety, as was using an IV workflow management system without gravimetric verification. Because hospital administration is a strong proponent of patient safety and standardizing medication preparations, they supported our decision to implement the new IV workflow system for all doses in all locations throughout the health system.

Switching Systems

System build began in January 2017. We chose a big bang approach, wherein all facilities went live on the system simultaneously. All hazardous drug (HD) preparations were included in April, and by October all non-hazardous preparations followed suit. Utilizing this approach, we can ensure that all medications are held to the same safety and regulatory standards. Our team recognized the positive impact of the IV workflow system and believed that no preparation should be excluded. Because some EMR build changes were necessary, it was prudent to standardize the workflow at one time. Therefore, we took advantage of having the proper teams in place (eg, pharmacy, EMR, and IV workflow software) to build everything at once.

St. Elizabeth’s experience is unique in that pharmacists and technicians working in the facility with the original IV workflow system were already familiar with the technology, while staff in the other facilities switched directly from a manual process to using the IV workflow management system. Our patient populations, censuses, and other factors also vary; thus, the learning curve differed among facilities, providing a wide platform from which to discuss our experience.

Prior to implementing an IV workflow management system, our manual process for checking the accuracy of compounded sterile preparations (CSPs) also varied by facility. Some technicians used the syringe pull-back method, wherein the syringe is drawn back to a particular volume after the drug has been injected, and placed next to the associated vials for the verifying pharmacist to check. Another commonly used method involved the technician hand-writing the volume injected on the label, without showing a syringe drawn back. This process occurred without documentation in a compounding record or log. Although we did manually document the compounding of all batched preparations, we did not have the same documentation requirement in place for patient-specific doses.

The new IV workflow management system features the following attributes:

  • Bar code scanning of each ingredient
  • Lot, expiration, and NDC documentation of each ingredient
  • Customizable photo documentation of each step of the process
  • Gravimetric confirmation of correct volume drawn up and injected, as well as gravimetric confirmation of final product
  • Compounding record documentation
  • Standardization of all compounding across the health system
  • Reporting capabilities

Hard stops are programmed into the software, which technicians must correctly satisfy before being permitted to proceed. For example, the bar code of the product must correctly scan, the product must be verified gravimetrically, the bar code of the base fluid (if utilized) must be correctly scanned, and injection into the final container must be confirmed gravimetrically. All of these benefits are absent when using a manual process.

The system includes an option to process a dose as volumetric rather than gravimetric. While volumetric checking still employs safety features—such as bar code scanning, directions for technicians to correctly compound the dose, pictures and documentation of the process—it omits the crucial safety step of gravimetric verification. With this step omitted, the process now relies on the pharmacist to manually verify the volume used in the preparation. This, in turn, potentially increases the risk of error, and thus the risk of increased waste, as incorrect doses must be wasted.

Nonetheless, there are occasions when the volumetric option is necessary. For example, because the minimum weight on our scales is 0.5 mL, we rely on the volumetric approach for any doses under 0.5 mL (eg, basal insulin). Another use for volumetric checking is if a technician becomes out of sync with the software (eg, accidentally injects the dose prior to weighing the base fluid bag). Because there is no option to go back, rather than wasting the dose, the technician can switch to volumetric mid-preparation and continue preparation (while still utilizing photo documentation, bar code scanning, etc).

The Implementation Rollout

The health system created a build team for the IV workflow management implementation project that initially consisted of four pharmacists: one lead and three functioning in supportive roles. Our internal build teams, including pharmacy, IV workflow software, and EMR, met with the vendor’s IV workflow management system team at the start of the project and thereafter on a weekly basis. These weekly meetings also included IT and others, depending on where we were in the build process.

Throughout the implementation, our team members developed a positive relationship with the IV workflow vendor’s team, which was a key contributor to the success of our project. Their customer service was excellent and continues to be so today. As an early adopter of the new system, we built the vast majority of our database. Looking back, building our own database from the beginning proved highly beneficial, as we have a comprehensive understanding of how the system works. Adding a new medication build to the system is a simple process that requires only a few minutes, while adding a new NDC takes less than 1 minute.

During the build, we validated the process from beginning to end for all dose and preparation types. The process includes the following steps:

  • An order is entered into the EMR
  • The dose is prepared using the IV workflow system
  • A pharmacist verifies the dose
  • The completed dose is provided to the EMR team
  • The EMR team scans the label through to the IV pump software

From the beginning of the project through the go-live 4 months later, a pharmacist was dedicated to the build on most days to maintain continuity and ensure every issue was addressed. In addition to building the database and completing the validation testing, our process also included adjusting and validating settings, building changes into the EMR, and designing and validating our label logic.

We decided to adopt a dual pharmacist verification model for all build within the IV workflow software; this process continues for new medication builds or NDC additions. To properly track these changes, we created a document that comprises every medication built into the system and associated pertinent build information.

Staff Training

Ensuring that all staff members who use the IV workflow management system are properly trained was one of our top priorities. At the outset of the implementation, the vendor’s IV workflow team trained our internal project team. Training sessions were typically conducted during lunch-and-learns within the 2 weeks prior to go-live. The software team also supplied online learning modules that can be accessed at any time and we utilized Super User training (ie, train-the-trainer). Supplemental training included the creation of training documents. Pharmacists and technicians are required to show they are able to use the correct procedures via compliance verification.

Overcoming Challenges

We encountered certain challenges during the implementation process, including EMR rebuilds to address proper communication to the IV workflow system and inconsistencies in the EMR build, which also led to some rework. A lack of practice standardization across facilities, both in workflow and in compounding processes, was another barrier. Finally, to ensure proper practice, we had to retrain some staff members who were utilizing workarounds.

  • Variations in the EMR Build. To address proper communication with the IV workflow system and certain inconsistencies in the EMR build, we tested and ensured that all doses of each dose type were built equivalently.

    It was imperative that the EMR team was consistently present during meetings with the vendor’s IV workflow software team and our pharmacy build team. Their input was crucial to guide our understanding of how the EMR and IV workflow software interfaced together, the ramifications of our builds, and our ability to decide if changes should be made on the EMR side or via custom interface logic on the IV workflow software side. The majority of the time, we decided to make EMR adjustments, as this was well within our control. Once we understood how the builds worked together, the remainder of the adjustments and the validation process were completed seamlessly.

  • Standardizing Workflow and Compounding Practices. Adjusting the EMR build and implementing the IV workflow software across the system forced us to standardize our workflow and compounding processes. At times this was a significant challenge, but it was ultimately beneficial as we are now able to provide safer patient care. For example, we can better utilize both pharmacist and technician float positions, as staff no longer need to change their practice based on which facility they are working at that day. Using the IV workflow system standardized care so we are confident that patients receive the same level of care regardless of location within the health system. By addressing challenges with stakeholders across the system, as well as with representatives from the EMR and IV workflow software teams, we were able to leverage challenges to facilitate excellence.

  • Eliminating Workarounds. After implementing the initial IV workflow software system, we were surprised by the number of workarounds that some staff members had discovered, either by chance or in an attempt to complete work more quickly. When implementing the new system, we were aware of the tendency to develop workarounds, and thus could take steps to prevent them. In fact, the second IV system prevented many of these workarounds due to the usage of gravimetrics and hard stops at each step of the compounding process. For example, one potential workaround using the new system was to switch the preparation mode from gravimetric to volumetric, which would allow the compounder to manipulate the dose without weighing the withdraw or injection into the final container. While the safety delivered by bar code scanning and documenting each step is retained during this workaround, the verification process is much riskier. Preventing such workarounds requires vigilance and proper staff training.

A Call to Action

Since implementing our gravimetric IV workflow management system, we have realized meaningful benefits, including increased safety, reduced waste created by improper compounding, and increased standardization across the health system.

After realizing these successes, we find it striking that uptake of IV workflow software systems has been slower than expected in US health systems. Pharmacy leaders should share their experiences using these systems; consider publishing data demonstrating the benefits realized while detailing the impact on workflow, which experience suggests may be less significant than is often expected.

Pharmacy leaders must invest time and resources into advocating for the use of these important safety systems. It would also prove beneficial for professional organizations to advocate on behalf of the profession to support system adoptions. In fact, professional organizations and boards of pharmacy can consider making utilization a requirement.

To ensure successful implementation of IV workflow management systems, it is imperative that everyone involved in the process express an openness and willingness to change; anything less is detrimental to patient safety.

Amanda R. McCoy, PharmD, is the coordinator for compounding sterile and non-sterile products at St. Elizabeth Healthcare in Edgewood, Kentucky. She received a BS in chemistry from Georgetown College and a PharmD from the University of Kentucky College of Pharmacy. Actively involved in professional pharmacy organizations, Amanda’s professional interests include NICU dose rounding, pharmacy operations, staff development, and regulatory compliance.


Gaining Staff Buy-In for IV Workflow Technology

Making any meaningful change to workflow can create trepidation among staff. Thus, pharmacy leadership at St. Elizabeth Healthcare aimed to ensure a smooth process. We prepared staff with required training sessions and supplemental educational documents. Due to the differences among our facilities—staff at one facility had prior experience with a different IV workflow system, while staff at our other facilities had been utilizing a purely manual IV process—experiences with implementing the new system varied among the different sites. The staff at our largest facility had previously utilized another IV software system, and thus, had to adapt to a new system. Consequently, they compared any challenges with the new system to the old one. Our other facilities went directly from a manual process to the IV workflow management system, which presented a somewhat steeper learning curve.

Ultimately, staff widely accepted the system and we proceeded to a successful go-live. Nonetheless, it is interesting to note that technicians more quickly accepted the system, while pharmacists required additional convincing, mainly associated with no longer physically holding the product to verify it as well as having to navigate the preparation data.

Our technicians are among the strongest advocates for the IV workflow system. They view the technology as a safety net, with some of them referring to it as their compounding companion. Several have also expressed that they feel uncomfortable compounding without it. Once the technicians learned the system, recognized the benefits, and realized that it would not significantly impede workflow, they were extremely supportive.

Pharmacists were a bit more skeptical about accepting this new technology. Those who had previously worked with the initial IV workflow software program had to become familiar with new processes, in particular, gravimetric verification. While the pharmacists clearly recognized the incorporation of gravimetrics as an important safety measure, they were initially reluctant to rely on it. For example, it took time for them to understand the role of density and navigating the deviation percentages provided by the software. Pharmacists who had been using the manual process and moved to the IV workflow management system initially expressed unease at not physically holding the products during verification.

However, now that the new process is firmly in place, the system is both accepted and preferred. Pharmacists appreciate the increased safety benefits and the additional data received throughout the compounding process that aids in dose verification. They also value the documentation, which allows them to refer back to the steps taken if a preparation is called into question. The data is readily available and easily retrievable to double check and/or reference.


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