The Value of Point-of-Care Data For Clinical Care and IT Systems
For years, clinicians and researchers have focused on identifying and reducing the frequency of medication errors. Now, attention is progressing from a focus on medication errors in general to the harm that results from a significant fraction of them. Instead of treating all medication errors equally, it is more effective, in terms of both safety and cost, to concentrate on high-risk medications and high-risk patients, where errors have the greatest potential for harm.
Research shows that 61 percent of the most serious and lifethreatening potential adverse drug events (ADEs) are intravenous (IV) drug related.1 Compounding the problem is the increasingly complex environment for the delivery of medical services and therapies. As the number of available drugs increases, the possibility of ADEs increases exponentially, and shorter patient stays coupled with shortages of nurses, pharmacy professionals, and financial resources further increase the challenge.
A new generation of IV medication systems can provide increased medication safety as well as data for continuous quality improvement (CQI) data. Although CQI is not a new concept, its application to infusion therapy data was not possible before the introduction of IV medication safety systems. Hospital administrators are just now learning what they can do with this information to track and prevent errors.
In addition, this medication safety technology can help lower the length of stay at the hospital, lower the cost of the organization by reducing the incidence of errors, lower the cost of treatment while patients are in the hospital by eliminating the need to add more nurse time and/or more medication, and provide financial opportunities and compensations for improved outcomes.
Immediate Benefits: Safety
IV medication safety systems provide error prevention software (to help avert harm from infusion administration errors) and data collection applications (to automatically collect data for CQI). IV medication safety systems may also permit integration of all types of IV administration to cover all clinical uses, including patient-controlled analgesia (PCA), pediatrics and adult care, and select monitoring on a single platform.
IV medication safety systems are programmed to send alerts when doses are too high or low, or infused too fast or slow. These sophisticated systems incorporate parameters for specific drugs and care areas. The parameters are selected by the institution to reflect generally established standards and the institutions own best practices. IV medication safety systems act as the final check when a dose exceeds the programmed standard; in essence asking, Are you sure you want to continue? or You cannot proceed. Dose exceeds limit. Such safeguards protect clinicians as well as patients from mistakes that can be costly both in patient harm and practitioner/institutional liability.
The error prevention software applications in this new generation of safe medication delivery systems facilitate the collection, review, and analysis of clinical information. In particular, CQI data collection provides new insights into IV drug administration at the point of care.
Ongoing Benefits: Continuous Quality Improvement Data
The benefits of point-of-care safety alone constitute sufficient reason to invest in IV medication safety technology. But, beyond these immediate patient care benefits, the CQI data recorded by the technology can then be analyzed by a cross-functional team nurses, pharmacists, physicians, safety officers, quality, and risk managers. This team can help determine:
- What caused specific data points, i.e., events which prompt an alert when programming has been changed, indicating a near miss?
- How well did actual practice compare with best practice parameters?
- Where did it diverge?
- Why did it diverge?
- What caused alerts?
- Why did alerts cluster at a particular time or in a particular care area?
From that point, the advisory team can work to determine what the new best practice should be and how best to institute it in light of the new information.
Case Study I: Childrens Hospital And Health Center, San Diego
The experience of Childrens Hospital and Health Center (CHHC), San Diego, is relevant not only to the special case of pediatrics but also to the ability for any system to respond to patient-specific concerns. These concerns often include size, maturation, physiologic maturity, or varying degrees of organ dysfunction. These concerns are not unique to pediatrics, but unite all organizations that care for a diverse patient population whether the aged, the young, or patients with serious liver or kidney disease.
CHHC is a 220-bed dedicated pediatric facility, including a pediatric intensive care unit, medical/surgical unit, and trauma program. In early 2002, the hospital conducted an internal risk assessment to examine specific vulnerabilities that children have and how the CHHC system could prevent or mitigate errors. The risk of potential medication errors in children is roughly triple that of adults due to the immaturity of childrens metabolism and compounded by dramatic variation in their weight.2 Medications that impact children must be carefully dosed by weight, but there are a limited number of dosages available, and very little research into the use of medications in pediatrics. It has been found that IV was the most common route of administration in pediatric inpatient medication errors.2
Target IV Medication Safety
The stakes were high, since the equipment would represent the entire capital equipment budget for that year. Furthermore, as Glenn Billman, M.D., CHHCs medical safety officer noted, Nothing is more personal to nurses than infusion pumps. They live and work with them constantly throughout their shifts. The CHHC office of safety recommended specific goals for selecting a new pump system. These recommendations include minimizing the number of devices used, standardizing the devices, and considering different IV medication safety technologies to mitigate risks to patients and staff.
A multidisciplinary group led by nurses and including physicians, anesthesiologists, pharmacists, biomedical engineers, staff from the materials management department, and safety and infection control personnel embarked on a very aggressive process of evaluating medication safety systems. After reaching an agreement on vendor and IV medication safety systems (the Medley Medication Safety System with the Guardrails Safety Software by ALARIS Medical Systems, Inc.), the nurse/physician/ pharmacist teams for each care area developed dosing limits to program into the new infusion system.
In October, 2002, CHHC converted hospitalwide to 400 new IV medication safety systems and about 750 pumping modules in a single day. The conversion took less than five hours and was finished by noon. During the process, personnel were connected via two-way radios to address any problems with the manufacturer, who provided outstanding support. When questions arose, digital photos taken at the bedsides were used to manufacture flyers which were used to transmit lessons learned across the institution, said Dr. Billman.
Measurable Results: CQI Data Analysis
At six months, the data downloaded from the pumps documented more than 400 instances when a Guardrails alert had caused the pump operator to reprogram the pump. These self-acknowledged errors equated to roughly 2.3 errors intercepted and corrected every day. The top five medications that required reprogramming included dopamine, morphine, insulin, milrinone, and epinephrine.
While the new IV medication safety systems allow CHHC to prevent errors, CQI data provide a record as a basis for change and improvement. The hospital has found that, retrospectively, the data are helping to identify areas of vulnerability. Some of these areas include:
- Specific medications that warrant additional education;
- The need for more training resources;
- The use of core and noncore nursing staff;
- Patterns such as the timing of alerts (e.g., most common in the 11th hour of 12-hour shifts coinciding with change of shift and the arrival of next-day elective admissions).
The data empower the institution to ask, What can we do to adjust responsibilities so we can reduce the number of alerts occurring at this time?
CHHC is already using the IV medication safety system data to direct and provide feedback for performance improvement. The hospital used the six-month data to redesign its medication use system. Following the second data download at one year, it is apparent that the number of alerts is steadily declining evidence that the interventions are having positive impact.
There are important lessons to be learned from our results that could really benefit other organizations, said Dr. Billman. As IV medication safety technology is introduced, institutions will be tapping data they never had before, and they urgently need to understand the tremendous potential of what they can do with it.
Improving Safety, Efficiency, and Economy
Dr. Billman believes that before IV medication safety systems were introduced, the national estimate was that less than 5 percent of infusion errors were being captured. Most were missed because the person programming the system never realized they had made a mistake, or were too busy to report it. Now data are captured automatically on all events. CHHC nurses recognized the long-term value of the new IV medication safety systems with the first CQI data download at six months. The team was able to see for the first time how the use of IV medication safety systems was able to intercept errors in programming and dosing calculation, preventing harm to patients.
Another factor that underscored the value of the new system was the introduction of the syringe pumping modules. This system provides a single technological platform for both syringe and large volume infusion. We expect to see the same thing when patient-controlled analgesia (PCA) modules come out as well, said Dr. Billman. Then we will truly have a system supporting a variety of pumping mechanisms from one safety platform.
Like many pediatric organizations, CHHC faces financial challenges and the decision to invest in new capital equipment was very closely scrutinized with respect to its fiscal impact. Roughly one year later the ROI has been substantial. Replacing custom-built IV tubing sets with limited off-theshelf product choices tightly standardized and reduced the inventory of disposables. Retiring the aging pump population eliminated significant costs for repairs and pump rentals. The projected saving of about $300,000 in the first year is on track. Its the best of all possible worlds, says Dr. Billman. The nursing staff embraced the new technology, It created a safer environment for the patient, and its generating a solid ROI.
Case Study II: Hospital of the University of Pennsylvania
The Hospital of the University of Pennsylvania (HUP) is the flagship of the four-hospital and multiple-physician practices that comprise the University of Pennsylvania Health System (UPHS) network. With a $1.7 billion revenue, this is the second largest hospital system in the Philadelphia marketplace.
HUP Entity Chief Information Officer and UPHS Chief Technology Officer, Stephen R. Smith, views IV medication safety technology as a perfect example of the dawning of a new era in the industry the convergence of IT software technology with biomedical equipment. In May, 2003, HUP began a pilot to bring IV medication safety systems into its ICUs, where there is a high concentration of critical care requiring advanced technology.
HUP was looking for technology that would provide data to document infusion therapy data that previously were unavailable, unless someone was sitting beside the patient, watching the equipment and taking notes.
The goal of the original project was to see if the claims being made about IV medication safety systems and their safety benefits would hold true against the daily rigors of HUPs intensive acute care environment, Smith noted. Another question was that of error versus harm to what extent were there significant consequences associated with infusion administration errors?
To find out, HUP began by installing 45 Medley Medication Safety Systems with the Guardrails Safety Software throughout two adult surgical and medical ICUs. While the first collection of data is still being evaluated, the initial review of documented preventable ADEs (PADEs) shows that the IV medication safety technology is delivering the anticipated value in terms of alerting and avoiding PADEs. We now have a better handle on how many PADEs were prevented, which is leading to a better sense of what we can do to avoid them, said Smith. Initial results already demonstrate dramatic improvement in this major metric of safety in the inpatient care process.
Measurable Results: Actionable CQI Data
An additional area that HUP has examined so far is day-of-week analysis. This is an interesting slice, according to Smith. We learned, to our surprise, that there are more potential PADEs later in the week than earlier. The HUP team is now probing with follow-up questions to learn the reasons evaluating staffing patterns, determining when most of the critical or intensive cases occur, and considering other variables that might explain the phenomenon. The results will lead to determination of whether operational changes are needed.
The data clearly not only demonstrated when an IV drug administration was going outside acceptable bounds, but also measured the extent of the problem and indicated the level of tuning called for, said Smith. The IV medication safety systems HUP selected provided a superior intelligent alarming system by specific drug or diluent, rather than just general guidelines. The technology is truly valuable, quantifying issues in specific areas, as well as showing us how we could help alleviate and resolve some of those issues before errors happen, he added.
Although capital budgets are very tight, the HUP team quickly concluded that the results demand that the hospital fund further conversion to the new technology. Since the initial pilot began less than a year ago, HUP has already added more IV medication safety systems, and has committed to replacing all its infusion pumps with the new technology.
Network Connectivity
A second phase of the HUP pilot involves linking the IV medication safety systems and data communications through a wireless network. The IV medication safety system enables wireless transmission of information to and from the infusion systems. Real-time data gathering was difficult when the devices were tethered to a wall, said Smith. Now we can tap into the data whenever we choose, without worrying about logistics.
The next step is expected to integrate the IV medication safety systems seamlessly into computerized physician order entry and pharmacy systems, ultimately enabling all systems to work together. The new IV medication safety technology marks a new era of greater intelligence at the bedside, streamlining the clinicians activities so that they can focus on patient care rather than administration, said Smith.
Ongoing Developments In IV Medication Safety Systems
IV medication safety systems will not be an end in themselves. They will be part of an integrated medication safety health management network, enabling providers to view what is happening at the bedside, respond in real time, and coordinate care and workflow based on this information. The creation of this network leads the way to provide data management for IV medication delivery, an extremely significant component of therapy management.
The adoption of IV medication safety systems also presents an opportunity to embrace the convergence of medical device and clinical data at the point of care. And equally important the infusion systems can contribute data to the hospital information network supporting the clinical information strategy. These new data are an essential part of the clinical information system.
Networks integrating these IV medication safety systems into the hospital clinical information systems will become the standard of care. With monitoring and IV medication delivery on the same platform, medication safety networks will enable care providers at centralized and distributed locations to monitor medication delivery to achieve CQI and improved patient outcomes.
The primary driver is patient safety. The experiences of institutions that have already implemented IV medication safety technology clearly demonstrate substantially improved safety. Although quantifying cost savings has been challenging, CHHC has documented a positive ROI by moving away from custom tube sets. Safety advancements improve savings and revenues by increasing the quality of care and decreasing the errors and their related costs. In sum, errors in IV infusion have the greatest risk of harm, but with IV medication safety systems, error reduction is dramatic, immediate, and cost-effective.
1 Communication with David W. Bates, M.D., M.S.c., of Brigham and Womens Hospital in Boston, October 9, 2001.
2 Kaushal R., Bates D.W., Landrigan C., et. al., Medication errors and adverse drug events in pediatric inpatients. JAMA, 2001; 285: 2114-20.
