By Lisa Fratt

 September 2003: The Southern California Red Cross lost three days of its blood supply when 3,500 units of blood products spoiled. The incident made headlines and underscored a national health care challenge. That is, in many facilities, monitoring of blood products, chemical reagents, vaccinations and other vital medical supplies hinges on an inefficient and precarious system.

 Facilities can use temperature and security sensors in their emergency rooms, allowing the emergency rooms to maintain their own blood supplies.

Glenn Billman, MD, and medical safety officer at Children’s Hospital San Diego, says the temperature monitoring system used at most hospitals often consists of a “sneaker patrol.” This low-tech and inefficient system relies on human memory, and pencil and paper; and it may predispose hospitals to the catastrophic losses of vital and expensive medical supplies.

How does the sneaker patrol work? A nurse, laboratorian, pharmacy technician, or other staff member sets out on foot with a thermometer, pencil, and paper to record temperatures of blood products, vaccinations, and chemical reagents. This system presents a number of challenges. For starters, it is expensive to pay a professional to complete these tasks. William Son, president and CEO of Isensix Inc of San Diego, says most hospitals are unknowingly burdened with approximately $70,000 to $100,000 in salary expenses each year for this type of episodic monitoring. These projected expenses do not include the cost of products and reagents thrown away due to spoilage. Moreover, when nurses and other hospital staff assume environmental monitoring duties, it takes time and attention away from patient care. Finally, nurses and laboratorians are inundated with paperwork, creating an atmosphere ripe for human error.

The high costs in dollars, patient care, and potential for error are not the only disadvantages associated with the sneaker patrol. Experience has demonstrated that once- or twice-daily episodic monitoring cannot prevent spoilage of blood products and other vital medical supplies. That’s because once- or twice-daily episodic monitoring leaves significant gaps of time for problems to develop and escalate, and it does not provide any type of early warning indicating possible spoilage. “If a 7 pm temperature check identifies possible spoilage of chemical reagents, hospitals are in a bind,” says Edward Geehr, MD and chief medical officer with Isensix Inc. If episodic monitoring identifies a refrigeration problem after the fact, the hospital cannot assess quality of reagents. It is forced to make the difficult decision of whether to dispose of the questionable reagents or use them with uncertain accuracy.

Real-time monitoring can solve these issues and it offers a much more efficient way of doing business. The value of real-time monitoring is clear in many cases. With diabetic patients, for example, studies show that when the number of finger sticks is increased from one to four times daily, the patient’s ability to intercept problems and forestall complications rises dramatically. The same principles can be applied to environmental monitoring. More frequent monitoring of temperatures and other measures provides a hospital with the ability to prevent spoilage and other losses.

The explicit linkage between quality, patient safety, and an organization’s ability to appropriately and accurately monitor and regulate temperature is reflected in accreditation standards from a wide variety of surveying organizations, including the Department of Health Services, the Food and Drug Administration (FDA), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and the College of American Pathologists (CAP). The number of products and devices involved, the wide diversity of temperature ranges, variable staffing patterns on nights and weekends, and the wide distribution of temperature regulated products, devices, and areas add to the challenge. Temperature-regulated areas include not only refrigerators to store blood products, analytic reagents, pharmaceuticals, and specimens, but also the operating room, computer room, telecommunications closets, and food-storage refrigerators. In modern facilities, the range of temperatures needing to be accurately assessed can easily span 100°F. Out-of-control conditions for any of these monitored products, devices, and locations need to be identified in a timely and efficient manner.

Real-Time Monitoring
Isensix offers a solution to the problems associated with episodic monitoring programs. The company’s Advanced Remote Monitoring System (ARMS) provides a real-time wireless temperature monitoring solution. The system is designed to notify appropriate staff before a simple incident becomes a problem. “This is a very efficient way to use resources. From a resource-management perspective, hospitals no longer need to look for the needle in the haystack. Isensix blows away the hay and points out the needles,” Billman says.

The system is easy to implement and use. Because Isensix is wireless it does not need to be integrated into existing IS technology. Instead it rides on the wireless network. In contrast, a hard-wired monitoring system requires cabling and, in some cases, relocation of the lab. Geehr says, “Isensix is competing with episodic handwritten systems and hard-cabled systems. Neither of those options is scalable or cost-effective.”

For some facilities, the high cost of relocating labs or hard wiring means that wireless is the only option for real-time monitoring. Billman, who implemented Isensix at Children’s Hospital San Diego several months ago, admits, “This is the only way we could have implemented real-time monitoring, and it costs less than a hard-wired system. In fact, when the hospital implemented Isensix, installation of each wireless sensor was complete in a mere 15 minutes.”

Reasonable cost and simple installation are not the only advantages of the Isensix system. Postinstallation use is equally simple. Son says, “The system is very easy to use. There is no program to learn, it has a simple user interface, and it is 100% Web-based.” This user-friendly interface is paired with a comprehensive monitoring and notification service. Isensix can be accessed worldwide via the Internet, and it provides 24/7 real-time remote alerts. Users can choose from a variety of notification services within its monitoring programs, including email, pager, and mobile phone contact for emergencies. “The back end of the system is where the magic really happens,” Geehr says. “After the sensors are deployed, they can be used to monitor temperature, pressure, and CO2 content. The information is sent safely to the back end for coordinated tracking, trending, messaging, and alarming to alert a hospital before a disaster.”

Children’s Hospital San Diego was one of the first hospitals in the nation to adopt Isensix. “The system has done exactly what it was supposed to do. In fact, Isensix almost immediately identified issues that the hospital was not aware of, allowing the hospital to recalibrate some devices and purchase new units before a catastrophe occurred,” Billman says. “One thing new users need to realize is that when they install the system it won’t just pat them on the back. It will identify vulnerabilities and issues.”

The real value of the system is that it enables hospitals to take proactive action to prevent catastrophic losses of blood, donated organs, or chemical reagents. In one installation, Isensix warned staff of rising, erratic temperatures in a walk-in refrigerator/freezer, indicating a possible failure with the fan or compressor. The staff member notified facilities and relocated $125,000 worth of chemical reagents to other refrigerators. The next day, the compressor blew. The end result? A $125,000 save. In another incident, an Isensix sensor warned of rising temperatures in a deep freezer. Staff moved frozen plasma units before the fuse blew, and they were able to document the event without paper.

The system can save time and money and enhance patient care in other ways as well. One facility uses temperature and security sensors in its emergency room (ER), allowing the ER to maintain its own blood supply. An ER staff member can remove a unit of blood when needed, bypassing a time-consuming and labor-intensive request to the blood bank. At the same time, the blood bank is automatically notified, so that it can refill the blood storage unit at scheduled intervals rather than on demand.

There are dozens of other scenarios throughout the hospital environment. Take the NICU freezer where breast milk is stored. The door could be inadvertently left open for several hours, and then closed by a nurse, allowing breast milk to spoil without anyone’s knowledge. Isensix, however, would have identified the problem as soon as the temperature began to rise, enabling staff to close the door immediately. “We’ve had an overwhelming positive response from our customers. This is a solution that saves money and time. It also allows professionals to focus on patient care instead of testing cycles,” Son says.

Isensix ARMS technology streamlines day-to-day work flow by taking on labor-intensive monitoring duties. It also simplifies hospital work flow on other levels. The system provides 30 years of data retention capabilities and complies with the FDA’s 21CFR11 guidelines. Isensix is also fully redundant. Isensix provides a secure server behind the firewall at the hospital, and the server is backed up at two different locations. Finally, the system is secure; only authorized users can access the system.

The system is also future-oriented. “Temperature is just the beginning. As hospitals identify other environmental monitoring needs, they can change the sensors and use the system’s backbone to capture other measurements such as humidity, pressure, or security,” Billman says.

Lisa Fratt is a contributing writer for Clinical Lab Products.