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Patient Safety and Quality Healthcare
May / June 2006

Barcode Implemenation

IVs First:
A New Barcode Implementation Strategy

The Institute of Medicine's report To Err Is Human focused national attention on the need to improve medication safety to prevent harm (IOM, 2000). Medication errors with the greatest potential to cause significant patient harm are those involving high-risk drugs. Many of the highest-risk drugs (NCC MERP, 1998; USP MedMarx, 2001; Winterstein, et al., 2002) are delivered by intravenous (IV) infusion, and administration is the stage most vulnerable to error (Leape, et al., 1995). The IV route of administration for medications often results in the most serious outcomes of medication errors (Hicks, et al., 2003). Thus, as detailed below, the prevention of IV medication errors at the point of care needs to be a primary focus of hospitals' safety improvement efforts (Williams & Maddox, 2005).

Two medication safety technologies that address different aspects of IV administration errors are barcode medication administration (BCMA) and "smart" infusion systems with dose error reduction systems (DERS). Most hospitals recognize the need to implement both of these technologies, and some have already implemented both. To achieve maximum safety benefits and full functionality, these technologies should be integrated into a seamless system. However, despite several years of development effort, the full functionality of BCMA has not been applied to IV infusions to the same extent that it has been applied to non-infusion medications.

A common strategy is to implement BCMA for non-infusion drugs and then extend traditional barcoding to IV infusion devices, i.e., "IV last." As detailed below, this creates workflow and technical difficulties, especially in intensive care units (ICUs), where most IV infusions are administered. Now a recently introduced infusion technology platform includes BCMA as a built-in component of a computerized infusion safety system with DERS (Figure 1). This integrated system overcomes many of the problems encountered in applying elements of comprehensive BCMA systems to IV infusions. Most importantly, the new system allows hospitals to attain the greatest "speed to impact" in improving medication safety by using both barcode scanning and DERS together to first address the highest-risk IV medication errors.



Figure 1. Comprehensive IV Infusion Safety System with Barcode Scanning

The purpose of this article is to explore an option to focus first on improving the safety of high-risk IV medications, discuss the unique aspects of IV infusions that have made their integration with BCMA challenging, and describe the new technology platform that offers an innovative alternate starting point for BCMA. This approach combines smart infusions systems with DERS and barcode scanning at the point of care to overcome many of the challenges and help improve the safety of IV infusion medications.

Need to Improve IV Medication Safety
In terms of risk of harm, medications are "not all created equal." Only a few oral medications—e.g., warfarin, some forms of chemotherapy, and some sedatives—are considered high-risk drugs. A greater number of medications that can be delivered intravenously pose a high risk of harm, e.g., sedatives, insulin, anticoagulants and narcotics (NCC MERP, 1998; USP MedMarx, 2001; Winterstein, et al., 2002). Potential infusion-related errors include wrong drug, wrong patient, and wrong dose. A nurse is unlikely to give a patient 10 or 100 pills, but all too easily can commit errors in programming a general-purpose infusion device—e.g., programming 603, instead of 6.3 mg/hr—and inadvertently deliver a comparatively massive overdose (Hatcher, et al., 2004).

Serious IV medication errors are widespread. In one 8-hour assessment at a major teaching hospital, 67% of the IV infusions had one or more errors (Husch, et al., 2005). An ethnographic study found 49% of the IV medications had one or more errors in the preparation and administration phases; one-third were potentially harmful, and 73% of the IV bolus doses were administered too rapidly (Taxis, 2005; Taxis & Barber, 2003). Data from a major teaching hospital indicate that overall, 61% of the most serious and life-threatening potential adverse drug events are IV drug-related (Communication with D.W. Bates, M.D., M.Sc. of Brigham & Women's Hospital in Boston, October 2001).

Advanced infusion safety systems with DERS help prevent IV medication errors by providing comprehensive drug libraries, best practices for each IV infusion, and alerts when pump programming is outside of hospital-established limits. A review of aggregated data from IV safety systems in 18 hospitals representing 425,000 patient days showed that for every 1,000 patient days there were 1.1 potentially life-threatening IV medication programming errors and an additional 1.5 potentially significant IV medication programming errors averted by implementation of IV safety systems (Cardinal Health, 2005).

Gaps in Protection
Most of the approximately 1 million large volume infusion pumps used in the United States every day do not have DERS. Moreover, none of the pumps have limitations on who can program them. Most IV infusions are not stored in access-controlled cabinets but are readily available in medication-room refrigerators or bins. Chemotherapy medications involving some of the highest-risk drugs may be obtained from a medication room, set up on an infusion pump, and programmed for infusion with virtually no restrictions. In addition, a recent study revealed huge variability in all aspects of infusion best-practice rules—including drug names, concentrations, dosing units, and dose limits, maximum infusion rates, weight limits, volume limits, etc.—which further increases the possibility of errors (Bates et al., 2005).

Sophisticated smart infusion systems, which have the most evidence for reducing IV infusion-related harm (Eskew, et al. 2002; Hatcher, et al. 2004; Wilson & Sullivan, 2004; Williams & Maddox, 2005), have not been capable of insuring the 5 rights of drug administration, while traditional BCMA systems that help ensure the 5 rights for non-infusion drugs provide only limited safety value for the highest-risk IV medications. A variety of operational and technical challenges have prevented the linkage of traditional BCMA and smart infusion pumps in a seamless, workflow-friendly, and comprehensive system. Although they offer great potential to help prevent administration errors, current systems have significant limitations. "To realize maximum patient safety benefit, an ideal BCMA system should be capable of both point-of-care medication verification and automatic programming of infusion pumps" (ECRI Health Devices, 2003).

IV Infusion-BCMA Integration Challenges
When traditional BCMA systems are implemented first for non-IV drugs, extending the systems to include IV infusion medications is challenging in terms of both workflow and technology integration (Spisak, 2005), and additional development is required for use in the ICU (Patterson, et al., 2002).

Workflow
Applying a traditional BCMA process to IV infusions requires the concurrent use of two separate devices, which is not user-friendly. Holding a personal digital assistant (PDA), maneuvering a mobile computer, or using a bedside computer placed some distance from the patient (and pump) all create proximity issues in setting up and programming the infusion pump. It may not be possible to get a laptop near the head of the bed, where the pump typically is located.

Perhaps the biggest challenge in integrating BCMA with IV infusions is related to major differences in what constitutes a "dose." For an oral solid, an intramuscular (IM) injection, or eye drops, administration of a dose is a one-point-in-time "event." If the dose changes, a new physician's order is required. However, for most IV infusion medications, administration is a "process" that occurs over time and may involve many dosage adjustments based on physiological response or laboratory monitoring. This difference can be illustrated by comparing the use of BCMA in the administration of two different anticoagulants: a warfarin tablet and a heparin infusion.

Administration of a warfarin tablet involves scanning the patient's wristband, the clinician's ID, and the medication package's barcode. The BCMA system ensures the 5 rights of drug administration and documents the administration "event" in the electronic medication administration record (eMAR). If required, warnings or advisories can be posted and additional patient information collected. But no further action is taken on the warfarin order until the next scheduled oral dose or the physician's order is changed.

Administration of a heparin infusion "dose" is considerably more complex. Using the BCMA system for the initial start of a heparin infusion involves scanning the patient's wristband, the IV container's label, and the caregiver's ID. The administration of heparin will be documented in the eMAR, but the actual programming of the IV infusion typically is performed separately from the BCMA process. Until the infusion device and the BCMA system are fully integrated, the BCMA system cannot confirm that the programming is accurate. For some newer infusion pumps, communication between the pump and the device used for BCMA scanning/documentation is under development; however, the communication is not direct "device to device," but rather via remote computers. This can lead to several communication issues, including time delays in accessing the network and exchanging programming information.

Subsequent interactions after the initial set-up are even more problematic. Heparin typically is infused over an extended period of time, often spanning multiple shifts, with multiple clinicians making periodic adjustments in continuous dose and possibly interrupting the infusion for extended periods. Intermittent bolus doses may be administered, often from the same IV container used for the continuous infusion. Loading and initial continuous doses based on body weight are often switched to maintenance doses based on units/hour. Dosage adjustments are based on laboratory results and predefined protocols rather than specific physician's orders, so they typically would not be included in the BCMA system.

For complete electronic documentation, an infusion device must be assigned to a specific patient, and a caregiver ID must be associated with each infusion interaction. However, beta-trial experience suggests that nurses may value the use of a traditional BCMA system for IV infusions such as heparin only during initial programming of the pump (Spisak, 2005). Subsequent interactions with the heparin infusion, such as adjusting the infusion rate or stopping the infusion, frequently are not associated with a scan of the patient, the caregiver, and the heparin infusion container. This is problematic for several reasons, including inconsistent use of a traditional BCMA system (lack of compliance) and no caregiver ID linked to pump interactions (lack of documentation).

The complexity of applying traditional BCMA systems to IV infusions increases even further in the ICU. Many infusions are initiated following verbal orders and on a STAT basis, making it even less likely that an intensive-care nurse would use a BCMA system for IV infusion set-up. The frequency of infusion pump interaction further decreases productivity by adding steps to the infusion process. For both ICUs and non-critical-care units, the medication safety challenge is to integrate smart pumps and BCMA in a user-friendly system that effectively addresses the complexity of high-risk IV infusions.

"IV First" BCMA Technology
As discussed above, modifying the technology and workflow of current BCMA systems to integrate infusion pumps poses significant challenges. A different approach starts with an infusion safety system that incorporates barcode scanning technology specifically designed to meet the unique requirements of IV infusions. In contrast to traditional BCMA systems, which have focused first on non-IV infusions, this new system starts with IVs first. By addressing the more complex challenges of IV infusions, the infusion safety-BCMA system gives first priority to preventing the IV-related medication errors, which are associated with the highest risk of patient harm.

The "IV first" approach is based on a comprehensive IV infusion safety system with DERS which includes all types of IV infusions (i.e., large-volume, syringe, and patient-controlled analgesia [PCA]), safety software with a comprehensive drug library linked to barcodes on IV infusion containers, and an image camera that reads multiple types of barcodes, including NDC codes and two-dimensional barcodes (Figure 1).

Instead of using a device that has to be carried or pushed to the bedside, the new infusion safety system uses a built-in scanning device that is already at the point of care. Having the scanner readily available has a positive impact on productivity, requires the use of only one device, and captures both patient and clinician ID for each infusion pump interaction. Having the scanning device built into the infusion safety system also reduces or eliminates communication time delays between two devices and their respective servers, devices dropping off networks, sharing of devices between multiple caregivers, and the need to maintain battery charge. Since the scanner connects directly to the infusion system computer, a single system can be used for multiple types of infusion pumps. Having a single interface for multiple pumps improves workflow and reduces complexity, the need for training, and opportunities for error.

Initial Implementation
The heparin example illustrates how the new system addresses many of the IV-BCMA challenges. For a new order for heparin, the nurse first assigns the infusion system to the patient by a one-time scan of the patient's wristband with either the built-in or a tethered scanner (Figure 2). This stores the patient's ID in the infusion-system computer, and all subsequent infusion pump interactions are verified against that patient ID. Activities such as administering a piggyback infusion, replacing a PCA drug syringe, or titrating a continuous infusion may not involve disturbing the patient for any additional scans.



Figure 2. Optional tethered scanner associates patient and infusion system.

The second step is to scan a patient-specific, pharmacy-applied two-dimensional barcode on the heparin-container label (Figure 3). The barcode contains patient ID and a unique drug identifier that automatically selects and/or programs the correct drug, concentration, and dosing units using the infusion system's drug library. This single scan ensures that the heparin is intended for the patient to whom the infusion system is assigned and reduces the number of manual programming steps. It also activates the DERS system to provide dose limits for initial and all subsequent programming. Scanning of replacement IV containers helps ensure use of the same drug and concentration. For manufacturer-supplied premixed IV drugs, the system uses the barcode label NDC to select the medication and concentration from the infusion system library.

   
Figure 3. Scanning IV Infusion Bag
By requiring caregiver ID badge scanning to gain access to the infusion system, several additional features become available. Programming is restricted to authorized clinicians only, and a specific caregiver is automatically associated to each interaction. Titrations, alarm response, container replacements, etc., are automatically linked to a specific caregiver.

This initial phase of IV First implementation includes a "smart" infusion system with DERS and an extensive drug library and allows hospitals to realize the safety and productivity benefits of barcoding without requiring a wireless infusion system interface. This phase also allows a hospital to have an early "win" by implementing a barcode system that is easy to install, easy to use, has minimal impact on workflow, and helps avert many of the most serious medication errors.

A major advantage of this system is the fit with current drug distribution practices. The IV infusion safety-barcode system will function effectively in hospitals that depend heavily on access-controlled drug cabinets or in traditional admixture programs where each IV dose is dispensed directly from pharmacy. It is also an initial first step that introduces a small change in caregiver practice, yet can help eliminate significant sources of IV pump programming errors and does not depend on a wireless infrastructure and multiple system interfaces. In addition, a "smart" pump provides protection for when a barcode is not available, such as with STAT medications and other unscheduled or emergency events (Sims, 2003).

Wireless Networking
For more advanced implementation, incorporation of a wireless interface connects each infusion device to the hospital's network. The "IV first" system then sends infusion data with patient identifier and clinician signature to an eMAR, so that all infusion interactions are electronically documented and can be analyzed for quality improvement efforts. In addition to the eMAR data, DERS-related data such as alerts, soft-limit overrides, and reprogrammings are captured and can be assessed for compliance, use of best practices, and staffing effectiveness. Each infusion system's drug library can be more easily maintained and new drugs added by means of the wireless network.

The ideal BCMA-infusion safety system integration will ultimately link the pharmacy information system directly to the infusion safety system via a two-way wireless communication.* The physician's IV orders are reviewed and approved by the pharmacist and automatically transmitted to the infusion device server. When the medication's barcode for an active order is scanned, the infusion system selects the corresponding order from the IV order list, selects the correct entry in the infusion safety software, and automatically populates the infusion parameters. The nurse reviews the programming and starts the infusion. This further enhancement of the BCMA/infusion system with DERS shows great promise to close the loop between the physician's order, pharmacist's review and dispensing, and the nurse's administration and documentation.

Conclusions
BCMA systems and IV infusion safety systems with DERS are still relatively new technologies, but both have rapidly matured and expanded the coverage they provide to help reduce medication errors. Although BCMA systems initially focused on medications, they now provide enhanced safety for blood, blood products, and laboratory specimens. DERS systems started out focusing on a small number of high-risk infusions, but now extend programming safety to bolus doses, chemotherapy, and PCA applications. Common to both technologies is the desire of clinicians, information technology experts, administrators, and medication safety companies to have integrated systems. However, the unique nature of IV medication infusions has proven challenging in terms of both workflow and technology integration.

"IV first" implementation of a smart infusion safety system with barcoding for high-risk IV infusions is an alternative starting point for implementing BCMA that helps close the gaps in protection. With or without a wireless network, this allows an incremental approach that does not force major workflow changes to the existing IV administration process. It addresses the need to improve high-risk IV medication safety and represents an improved approach to integrating smart pumps and BCMA. As smart infusion safety and BCMA systems continue to mature and be more widely adopted, it is imperative that the integration of these technologies evolve in a manner that will address the safety of all medications, most importantly high-risk medications, increase productivity, and meet the operational needs of hospitals and end users.

Technology Overview

Tim Vanderveen is currently the vice president of the Cardinal Health Center for Medication Safety and Clinical Improvement. From 1972 to 1982, Vanderveen was the director of clinical pharmacy at the Medical University of South Carolina. Since 1983, he has been in the medical device industry, with IMED, Alaris, and most recently Cardinal Health. He has been instrumental in many of the safety and performance enhancements and safety innovations in drug infusion. Vanderveen has authored numerous patents, is a frequent speaker on medication safety at educational programs, and routinely contributes to the medical, pharmacy, and nursing literature. He may be contacted at [email protected].

References

Bates, D. W., Vanderveen, T., Seger, D. L., Yamaga, C. C., Rothschild, J. (2005). Variability in intravenous medication practices: implications for medication safety. Joint Commission Journal of Patient Safety and Quality, 31(4), 203-210.

Cardinal Health (2005). Data on file.

ECRI. (2003 October) Bar Code Medication Administration Systems. Health Devices, 32(10), 372-382

Eskew, J. A., Jacobi, J., Buss, W., Warhurst, H., & DeBord, C. (2002). Using innovative technologies to set new safety standards for the infusion of intravenous medications. Hospital Pharmacist, 37(11), 1179-1189.

Hatcher, I., Sullivan, M., Hutchinson, J., Thurman, S., & Gaffney, F. A. (2004). An intravenous medication safety system: preventing high-risk medication errors at the point of care. Journal of Nursing Administration, 34(10), 437-439.

Hicks, R. W., Cousins, D. D., & Williams, R. L. (2003). Summary of information submitted to MEDMARX in the year 2002. The quest for quality. Rockville, MD: USP Center for the Advancement of Patient Safety.

Husch, M., Sullivan, C., Rooney, D., et al. (2005). Insights from the sharp end of intravenous medication errors: implications for infusion pump technology Quality and Safety in Health Care, 14, 80-86.

Institute of Medicine (IOM). (2000). To err is human: building a safer health system. L.T. Kohn, J. M. Corrigan, & M. S. Donaldson (Eds.). Washington, DC: National Academy Press.

Leape, L.L., Bates, D.W., Cullen, D.J., et al. (1995). Systems analysis of adverse drug events. Journal of the American Medical Association, 274, 35-43.

National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). (1998). NCC MERP taxonomy of medication errors.

Patterson ES, Cook RI, Render ML. (2002). Improving patient safety by identifying side effects from introducing bar coding in medication administration. Journal of the American Informatics Association, 9, 540-553.

Sims, N. (2003). IV Infusion pumps: the missing component in bar code medication administration systems. In: Schneider, P.J. (Ed). Bar Code Medication Administration. Hospital Pharmacy, 38(11, Suppl.1), S26-S27.

Spisak, P. (2005). The unique challenge of IV medications in a bar code medication administration system. In: Schneider PJ (ed). Drug Dispensing and Administration. Health Leaders, December(suppl), 17-18.

Taxis, K. Who is responsible for the safety of infusion devices? It's high time for action! (2005). Quality and Safety in Health Care, 14, 76.

Taxis, K. & Barber, N. (2003). Ethnographic study of incidence and severity of intravenous drug use. British Medical Journal, 326, 684-688.

USP MedMarx. (2001). Analysis of participating hospital data.

Williams, C., & Maddox, R. R. (2005). Implementation of an i.v. medication safety system. American Journal of Health-System Pharmacists, 62, 530-536.

Wilson, K., & Sullivan, M. (2004). Preventing medication errors with smart infusion technology. American Journal of Health-System Pharmacists, 61, 177-183.

Winterstein, A. G., Hatton, R. C., Gonzalez-Rothi, R., et al. (2002). Identifying clinically significant preventable adverse drug events through a hospital's database of adverse drug reaction reports. American Journal of Health-System Pharmacists, 59, 1742-1749.

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