By Tim Vanderveen, PharmD, MS; and Marla Husch, BSc Pharm, RPh, MS, CBBSS
It has been more than a decade since a major study at a 725-bed academic medical center found that 67% of 426 in-process intravenous (IV) infusions had one or more discrepancies, including potentially fatal errors such as heparin ordered for 1300 units/hour that was infusing at 200 units/hour, an amiodarone infusion ordered for 24 hours still infusing four days later, and dopamine infusing at four times the intended dose. The hospital at that time did not have computerized prescriber order entry (CPOE), barcode medication administration (BCMA), an electronic medical record (EMR), or computerized infusion pumps (smart pumps) with dose error reduction software (DERS). Investigators concluded that to address the many issues of highly complex IV infusions, the various safety systems would have to be integrated (Husch et al, 2005).
Today many hospitals have implemented those technologies, yet very few have integrated them into an intelligent infusion system. Although DERS software has resulted in a reduction in inadvertent programming errors, smart pumps have not addressed the traditional five rights of medication safety. If the smart pump has no knowledge of the specific physician’s order, then programming the wrong drug, concentration, dosage units, or dose is still possible. Selecting dobutamine when dopamine was ordered, programming heparin in units/hr when the order was for units/kg/hr, and selecting “maintenance fluids” when sodium phosphate was ordered are examples of errors that the DERS cannot prevent.
Fortunately, a small but growing number of hospitals have implemented the kind of interoperability urged by many since 2005 (Husch et al., 2005; Trbovich, et al., 2010; Ohashi, et al., 2013; Pettus and Vanderveen, 2013) in which barcode scanning is used to trigger the transmission of physician-ordered, pharmacist-reviewed infusion parameters from the EMR to pre-populate the smart pump, and time-coded infusion data are automatically sent from the smart pump to the EMR for the nurse to review and document.
Keeping the benefits of this interoperability in mind is important, because implementation can be challenging. The infusion, BCMA, and EMR systems were created in separate “silos,” so integrating them requires extensive effort. Experience to date has shown that the technical aspects are pretty straightforward; the biggest challenges are on the clinical side.
This article draws on the extensive experience gained by a leading infusion vendor’s clinical and technical support staff in implementing smart pump-BCMA-EMR interoperability in pediatric, general, and specialty hospitals. The purpose is to help others gain a broad understanding of what is involved in making this journey and to guide project managers and team members through not just the steps, but the complexity, to successful implementation and continuing use. The “Top Ten Lessons Learned” are described from the smart pump vendor’s perspective; similar or related issues are likely to be found on the EMR vendor’s side, as well.
Top Ten Lessons Learned
1. Infusion interoperability is unique.
Two-way, continuous wireless communication
Interoperability between the integrated smart infusion pumps and EMR is very different from most of the wireless communication that happens over a hospital network. A patient monitor sending data to the EMR is one-way communication. Pharmacy uploading software revisions to the pumps or downloading continuous quality improvement (CQI) data from the smart pumps is one-way communication of “batched” data, often at set times. With interoperability, both smart pump and EMR have to be able to “talk” and “listen” to each other continuously in near-real time.
Benefits of Integrated, Closed-Loop IV Medication Safety System
Working with two vendors
Unlike the implementation of a single technology, interoperability requires a hospital to work with two different vendors: smart pump and BCMA/EMR. Since only the hospital can see the complete picture, the lead project manager (PM) must be from the hospital. Among the PM’s major responsibilities are to ensure that necessary resources are available, that collaboration and communication take place, and that vendors’ need for confidentiality is balanced against the overall need for transparency. Smart pumps are regulated by the Food and Drug Administration (FDA), while EMR regulation is more limited (HIT Policy Committee, 2013). Making changes to the smart pumps will require more time for regulatory approval, which is not currently required for EMRs. Also, the smart pump vendor is required to report certain events that the EMR vendor is not. The PM needs to ensure that all involved respect and allow for these differences, during and after implementation.
2. Project teams need to be multidisciplinary.
Collaboration within and across the health system and
With interoperability, technologies no longer operate in silos. Neither do people. Collaboration between the hospital/IDN and both vendors, and between the vendors themselves,
The implementation team needs to include nursing, pharmacy, physicians, IT, clinical engineering, and others. Stakeholders from many different organizational levels—decision-makers, subject matter experts and front-line clinicians—must be involved. As the ultimate end-user, nursing must be very involved to integrate already complex, highly variable clinical workflows. Nursing educators are not enough; direct input from bedside nurses is critical. Vendors must provide highly experienced, expert support personnel, from pharmacists and nurses to information technology (IT) specialists, biomedical engineers, and more.
In most cases, one department takes the lead on each aspect of the system: pharmacy manages the data set and physicians’ order sets; IT is responsible for the wireless infrastructure; and nursing is responsible for bedside practice and workflow issues. Experts from both the smart pump and the EMR vendors must work together with hospital staff to ensure that dataset, order sets, nursing workflows, wireless connectivity, bedside equipment, and room layout all support each other for seamless interoperability. Any change has to be considered with regard not only to that particular system but to all others, keeping the overall goals in mind. For example, IT has to focus on making the system easy for the nurse to use, not just for IT to maintain.
A common experience voiced by customers is that they underestimated the number of hours required. One hospital estimated that it took their interdisciplinary team more than 30 hours of meetings just to standardize practice with regard to the use of normal saline (NS) for “keep vein open” (KVO) orders, intermittent drug administration, line flushing, titration based on nurse’s clinical judgement for the hydration needs of a patient, and manipulation of rates to avoid perceived “nuisance” alerts. In the interoperability world, practices such as administering fluids without a fully aligned order and with imprecise documentation of infusions will become obsolete.
3. Determine scope and go-live upfront.
All parties need to discuss whether to implement full interoperability (infusion parameters sent from EMR to pre-populate the smart pump, and infusion data sent back to the EMR for documentation) or partial interoperability (only sending programming data from the EMR to the smart pump). This decision, in turn, will affect decisions around nursing and pharmacy workflows.
Another decision is whether to approach go-live as a hospital-wide or incremental installation. Experience shows that with proper preparation, the hospital-wide approach is easier and definitely safer. Patients and nurses move among various locations, and house-wide installation covers that. A prolonged roll-out would necessitate nurses and patients going back and forth between integrated and non-integrated environments, increasing opportunities for error. For hospitals that have implemented BCMA and smart pumps, hospital-wide installation typically is accomplished in one day.
4. In-depth assessment of the current state is imperative.
Before implementing interoperability, it is recommended that the EMR platform and wireless network are stable and that clinicians have at least six months’ experience using CPOE and smart pumps that are working independently. Low compliance with use of DERS may indicate a mismatch between physician orders and the smart pump drug library, which needs to be corrected before go-live.
To plan for the future state of interoperability and eliminate “surprises” and unintended consequences, it is imperative to gain a truly in-depth understanding of how technologies and systems currently support every stage of the medication use process, from procurement to administration, documentation and monitoring. Checkboxes, flow maps, and a simulation center are not enough; what should happen is often very different from what does happen. To achieve the necessary understanding and identify in advance possible challenges that can lead to workarounds, ideally implementation teams will work with nurses assigned to specific care areas to walk through their actual processes in real time.
The environment of care can pose unexpected challenges, e.g., if a lead-shielded portable X-ray machine is positioned between the smart pump and the wireless access point, the infusion parameters cannot be transmitted from the EMR to the smart pump. Other potential challenges include smart pumps on opposite side of the bed from the workstation, workflow that requires computers on wheels to remain outside the patient room, and tethered scanners that must “reach” across a patient’s bed. Since room configurations often vary throughout a hospital and among IDN hospitals, each patient care area must be assessed.
About 90% of hospitalized patients receive IV infusions at some point during their admission, and medications and dosages often change. Clinicians interact with infusion pumps frequently, both patients and devices are mobile, and infusion is more a process than an event. The care environment has to be able to support these frequent interactions both within a patient’s room and as a patient moves from location to location within the hospital. An in-depth assessment of wireless infrastructure is critical, including network mapping or a full network survey. Wireless coverage must be robust, highly reliable, pervasive and able to support BCMA activities in all patient-care areas. If nurses have identified areas where certain types of scanners are not working as well as others, that needs to be corrected prior to connectivity.
5. Achieve 100% match among orders, formularies, and databases.
Interoperability means that every IV infusion order has to go through the closed-loop medication safety system (with a few critical exceptions such as emergency treatment). Transmission of the infusion parameters from the EMR and receipt by the smart pump have to match 100%, which requires standardization and simplification far beyond anything achieved with single technologies. All databases from CPOE through smart pump drug library must be standardized, so that all orders work for the pre-population of infusion parameters from the EMR to the smart pump and for the smart pump to send infusion data back to the EMR.
Clinical pharmacists, IT pharmacists, and pharmacy purchasing agents have to understand the inter-relatedness of hospital formulary, CPOE, pharmacy label, order display of dosing units on the automated dispensing cabinet (ADC), and the smart pump drug library. In a domino-like effect, any software or order-set change affects everything connected to that part of the workflow. Synchronizing the timing of making changes to the drug libraries of hundreds or a thousand or more smart pumps with the timing of making the corresponding changes in the CPOE orders is critical.
Some drug infusions and drug orders are consistently challenging for interoperability, for example:
- Multi-ingredient infusions. The smart pump library cannot accommodate an infinite number of variations, so careful consideration of how to manage these infusions is required.
- Weight-based vs. non-weight-based infusions. While the CPOE system can allow physicians a choice in drug-dosing units (e.g., heparin as either weight-based or units per hour), typically the infusion order is for one dosing unit. For many drugs, the DERS is designed to provide safety alerts based on per-kg dosing, especially for pediatrics and the neonatal intensive care unit (NICU). If the dosing is changed, and weight-based limits are not used, there may be a negative impact on safety for titrated infusions.
- Intermittent antibiotic infusions. These may come from the EMR to the smart pump with a specified volume that may not match what nurses typically program to account for overfill and drug additive volume.
- Multistep infusions, oncology drug priming, test doses, and the use of secondary (piggyback) administration procedures are additional examples of nursing practices that present challenges that must be resolved for interoperability. (Bolus dosing is discussed below.)
Once standardization has been established, procedures must also be established to maintain this standardization and practice alignment. Drug shortages, new drugs, new protocols, and other realities can force the need to update electronic databases frequently. These changes need to be aligned across all systems and clinical practices to improve compliance and maximize the benefits. Thus, the hospital/IDN may need to reallocate resources for ongoing maintenance of standardization and continuous staff training and engagement.
6. Achieve 100% match between technology workflows and actual practice.
Smart pumps are extremely tolerant of variation in how infusions are programmed, the order of the programming, and even if they are used for some fluid and drug administration. However, interoperability does not tolerate such variability, and practices need to be standardized to gain the full benefit from this new system.
The way a bolus dose is ordered must align with nursing practice. Bolus-dose orders often are carried out inconsistently, with some care units administering bolus doses from continuous infusions, while others prefer to bolus from separate dose vials. If a physician orders a bolus as a separate order, but nurses typically administer boluses from the continuous infusion container, there will be a mismatch when the nurse attempts to pre-populate the smart pump and possibly a delay in therapy.
With interoperability, pharmacy has to verify the order before the infusion parameters can be sent from the EMR to pre-populate the smart pump. Therefore, verification has to occur in a timely manner, or the system will not accept the order, thereby preventing the use of discontinued or future orders. To address this issue, auto-verified orders can be used in the emergency department (ED) and specialty areas such as the catheterization laboratory.
Admission protocols should include a KVO order for hanging secondary medications to standardize nursing workflow and documentation when no other fluids are currently infusing. As with other considerations, orders and practices for KVOs can vary widely and need to be standardized.
Even if a department such as the ED will not be using interoperability to pre-populate infusions, staff members still need to read notices about interoperability. For example, the drug library list will be longer, changing the way ED staff select drugs in manually programming the smart pump. Not being aware of such changes creates opportunities for errors, even when a particular area is not using interoperability.
Many nurses scan the PO and IV medications all together at the same time, before proceeding to other tasks. For interoperability they have to scan one IV infusion medication at a time: first the patient, then the medication, and then the smart pump. This will seem awkward at first, until nurses develop the “muscle memory” of the new workflow.
Associating and dissociating pump and patient
If a smart pump is not dissociated correctly, an order could be sent or documented to the wrong patient. With interoperability, if no information is received from the smart pump, after a given period of time, the system will auto-dissociate the smart pump. Nurses will have to work with the EMR vendor to ensure that the rules for time-based disassociation fit their practice.
A patient who is transferred from the ED or operating room to another area may already have infusions in process. Procedures must be developed to instruct nurses on how to accomplish back-association, i.e., link smart pump and patient so the in-process infusion will be safeguarded by DERS and automatically sent to the EMR for documentation. If an infusion is back-associated, the impact on billing must be carefully considered, in order to avoid having duplicate or missing charges.
Nurses also will need to be trained on what to do when there is no order or if the system goes down. Procedures need to be established for when a nurse should manually program the smart pump and begin infusion, even without interoperability.
7. Test and test again.
Before go-live, the system must be tested multiple times. Even with a fully detailed analysis of the current state, not all points of failure can be predicted. The testing done to verify periodic data flow during smart pump implementation is not sufficient to assess the continuous wireless coverage necessary for interoperability. Rigorous testing in a non-patient environment prior to go-live is critical. Something as simple as correct installation of the barcode label on each smart pump or pump channel is a vitally important step. Otherwise, the same infusion parameters could be sent to two smart pumps at the same time.
A hospital with 4000 IV-infusion standard-order sets will want to test all 4000 infusion order sets during connectivity validation prior to go-live. Testing does not end with go-live, of course; it becomes an integral part of continuous improvement.
8. Provide comprehensive training, go-live and post-implementation support.
While finding time to train all nurses can be challenging, 100% training on interoperability before go-live is the goal. On every care unit, one or more nurses can be trained as “super users” to serve as a resource for the other nurses before, during, and after implementation. During go-live, super users and support staff from both vendors and the hospital should be on the units 24 hours a day to share lessons learned, provider refresher or general tips, and identify and address issues and best practice improvements. Hours can be gradually reduced as staff members become more comfortable with the new technology. Super users can continue to serve as practice experts with regard to interoperability.
Following go-live, unit-based super users and clinical educators can partner with the project team to provide ongoing support and education. Identifying and resolving issues quickly helps to maintain consistent workflows and compliance.
9. Maintain a continuous improvement mentality.
To achieve the benefits of interoperability most rapidly and avoid the unintended consequences documented with almost all new technologies (HealthIT.gov, 2015), interoperability has to be approached with a continuous improvement mindset. Rigorous analysis of what went right, as well as what could have been done better, is critical. Make errors visible. Establish a procedure up front for communicating and quickly responding to unintended errors or unexpected occurrences. This should include a clear escalation path for the nurses and nurse educators to communicate issues to both the smart pump vendor and EMR vendor for resolution. Post-implementation rounding and review by technical staff, including from the EMR and smart pump vendors, can help identify areas where the nurses may be having issues. It is important to resolve any issues quickly; otherwise, the nurse may go back to manual programming. When nurses learn they can identify needed improvements and see those issues resolved, they become more engaged in process improvement and further improve compliance.
An important part of continuous improvement is to begin planning for new capabilities that will result from interoperability. For example, interoperability requires smart pump-patient association. This combined with wireless connectivity creates several new opportunities. Pharmacy will be able to view the actual status of each infusion to enhance workflow planning for subsequent bags, to identify infusions where rates have changed, and to receive immediate notification of discontinued infusions. In keeping with the current focus on alarms management (Joint Commission, 2013), alarms and alerts from the smart pumps can be distributed directly to the nurse, reducing alarm fatigue and patient dissatisfaction. In addition, reimbursement for outpatient, ED, and observation-patient infusions requires accurate start and stop time documentation, which is a byproduct of smart pump-EMR interoperability.
10. Work with experienced, expert support staffs.
Hospitals need to work with vendors who have already been through this process many times and who allocate their top experts to the project. Implementation may involve 30 or more pharmacists, nurses, biomedical engineers, IT specialists, and others from each vendor. The lessons learned described above only begin to convey the level of detail and type of comprehensive thinking required for successful implementation. Vendors should be able to provide guidelines to help the hospital/IDN navigate all stages of implementation. For example, from a smart pump vendor’s perspective, a
thorough assessment of the current state would include
questions such as:
- Are intermittent medications infused via port above
- the device or long-line? (Primary or secondary or other set-up?)
- Pump module: Is the flush volume included in total volume given documentation (i.e., “I’s and O’s”)?
- How do the nurses move around the rooms to hang IVs, chart, and gather equipment?
- Do you use a primary saline/flush bag when you give intermittent medications? Is this ordered or by protocol?
- When patients return from the OR, do the smart pumps stay with the patient?
The smart pump and EMR vendors can provide a list of additional questions that need to be considered prior to implementation. The right questions, based on the type of hospital, smart pump-EMR combination, and current administration and documentation practices, will help guide a successful implementation.
Hospitals tend to have a multi-year road map for moving toward interoperability. Implementation is a continuing journey, not a destination. It is important to reach out to other hospitals that have already begun this process and to ask both vendors, “How do we make this journey? What are the necessary steps we need to take, and in what order? How can we make it easier to get to the point where we’re ready to really work on our drug library and finally use the new system? How do we get to the point where we look back and say, as a growing number of hospitals and health systems now say, ‘This journey is more than worth it.’”
Tim Vanderveen is vice president of the CareFusion Center for Safety and Clinical Excellence in San Diego, California. He may be contacted at email@example.com.
Marla Husch is clinical director of the CareFusion Solutions Management and Business Development team in San Diego, California. She may be contacted at firstname.lastname@example.org.
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