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Logistics 2.0 endures heat, on ice [Healthcare Purchasing News](Healthcare Purchasing News Via Acquire Media NewsEdge) Monitoring product temperature en-route, in-house a continuous exercise Professional haulers and shippers, by and large, employ specially designed packaging and on-board and remote tracking of temperature-sensitive products in transit. For example, "active" containers may sport internal electronics that adjust the interior of the container when necessary. "Passive" containers, however, simply may include thick insulation or gel packs. When you're transporting biological, food or nutritional products, pharmaceuticals and medical devices you not only have to provide the containers, temperatureadjustment mechanisms and tracking devices but also the requisite paperwork that demonstrates compliance to industry guidelines and recommendations. For the transportation industry, this can be challenging because the requirements frequently change as the definition of "room temperature" may span a 20-degree spread. Once these products arrive at their destination the receiving healthcare facility must have its own storage and tracking mechanisms in place and operational - particularly in the event of a power loss or some kind of electronic or mechanical failure. These include permanent and portable refrigeration and freezer units and insulated packaging, potentially equipped with radiofrequency identification (RFID) tags or real-time location system (RTLS) software. Just how prepared are healthcare facilities to properly manage their temperature- and humidity - sensitive stock Wiring the paper chase Unless they rely on computer-directed applications, they're likely struggling with data collection, let alone temperature reliability, as well as falling behind in compliance with changing regulations and moving guidelines. "The biggest challenge facing monitoring of product temperature and humidity is the fact that it still relies heavily on manual processes, in which nurses and other staff are tasked with checking and logging temperatures periodically throughout the day," said Marcus Ruark, vice president, Intelligent InSites Inc., Fargo, ND. "As a single hospital may have hundreds of refrigerators, freezers, and warming cabinets, it is impossible to monitor the status of each at any given time using manual processes." In fact, "paper-based systems, individual chart recorders and standalone data loggers are considered antiquated in today's heavily regulated and cost-sensitive environment, noted Chris Babcock, product manager, Thermo Fisher Scientific Inc., Waltham, MA. "Their static output typically requires manual intervention for collection and long term storage that traditionally does not lend itself to trend analysis or easy presentation during audits. Hardwired systems are expensive to install, intrusive, inflexible and simply not scalable for today's dynamic laboratory environment. Current regulations require laboratory workers to provide continuous and constant audit trails with traceability for any excursions beyond defined limits and the notation of cause and corrective action for compliance to FDA CFR 21 part 11." Joel Cook, director, Healthcare Solutions, Stanley Healthcare Solutions/ AeroScout, Framingham, MA, indicated that many healthcare organizations continue to monitor temperature and humidity manually. This means someone must go to each refrigerator, freezer, warmer or storage location, whether these reside in a patient room or an operating room suite or elsewhere, read a monitoring device and record its findings several times per day. A tedious process, particularly for a nurse, that can invite errors, he added. "Unfortunately, with this process, compliance ends up being a problem in many organizations," Cook said. "People are busy with other tasks and may forget to check the environmental monitors, or the assigned person may be unavailable at times, perhaps on a sick day. Since the recordings are manual, no one knows that these readings are missing until an auditor arrives and asks to see the data. There are many documented cases of refrigerators or freezers failing in a healthcare organization, ruining thousands of dollars, or even tens of thousands of dollars, worth of pharmaceuticals, vaccines, food, tissues or other valuable items. "We know of a case, for example, where a refrigerated storage cabinet failed in a research pharmacy during a weekend," Cook added. "Even though there was an audible alarm, no one was working on site, and the pharmacy lost $80,000 worth of research drugs." Emilio Frattaruolo, product engineer, BioPharma team, Pelican Products Inc., Torrance, CA, emphasized the serious challenge to monitor product temperature and humidity within the cold chain and the "devastating effects on the cargo" that failure brings. "One key challenge is the use of data loggers when sending product to end users versus simply using just a temperature indicator," he said. "It is essential for decision makers to have a system in place to capture data that can be used to assure the safe transport of the cargo within the temperature and humidity requirements. The risk of damage to product is significant throughout the cold chain. This risk cannot be managed if decision makers do not have access to the data they need to do so." But implementing an automated monitoring system has its own set of challenges. That's why Matt Perkins, Chief Technology Officer and senior vice president, Engineering, Awarepoint Corp., San Diego, suggests three steps to smooth the migration/ transition. "First, deploy a real-time location system-based temperature monitoring system," Perkins recommended. "Second, monitor refrigeration units for 90 days. Watch upper and lower temperature boundaries, and for trends that exceed those thresholds. Third, adjust refrigerator settings or adjust policies as needed to streamline workflow and ensure compliance. "It's the last step that is the most important and can be the most challenging," he continued. "The technology doesn't fix these issues - just points them out. Underlying policies or processes may need fine-tuning based on the alerts and reports the technology produces." But healthcare organizations have to check their infrastructure and adapt their workflow habits for any automated system to operate successfully, according to Jonathan Karl, director, sales, CDW Healthcare Solutions, Vernon Hills, IL. For example, start with bandwidth. "Monitoring technology will most likely run on your existing wireless network, along with many other new systems you are likely adding, and the additional traffic will have an impact on overall network performance," Karl indicated. "Ensure that you have appropriate wireless coverage in place to support the scale of the monitoring deployment - today and tomorrow." Next, prepare for workflow changes. "Systems will be better, but they will also be different," Karl continued. "Identify key stakeholders that can affect [and] become affected by the changes. Having a welldefined process for receiving, asset management and internal delivery - especially one that is understood not only by procurement but by department heads supporting the initiative - will drive awareness, adoption, utilization and overall impact to quality of care and cost reduction." Finally, develop and activate a planned response. "With a new system in place to monitor the environment, be prepared to actually utilize it," Karl advised. "Plan processes and execution by ensuring that systems are in place to send warnings [and] alerts, and that resources are in place to respond to alerts in a timely manner. When - not if - a refrigeration system fails - which could be as simple as a door not shutting properly - you need to have the appropriate level of response ready to prevent the loss of temperate sensitive materials." To do this a facility should set, define and agree on alert capabilities, versus just reporting and logging, he continued. Then set wide enough parameters to enable necessary response times. Then determine the cost savings and loss of potential events to reinforce the process impact. Dropping the ball Sans a clinical or research background or pedigree, supply chain professionals may not grasp the seriousness and severity of temperature fluctuations on medications, blood, tissues, food and fluids - until those products have to be replaced. That's why investing in an automated system to safeguard these products can strengthen ties with clinical and research departments, as well as control costs and help them deliver high-quality patient care. "Something as simple as leaving the door open can cause temperatures to go outside acceptable levels - which can spoil temperature-sensitive items such as pharmaceuticals, blood, specimens, or food," Ruark noted. "Our clients tell us that a single failure where medications need to be discarded could easily cost upwards of $40,000." Accountability remains a common oversight by supply chain, according to Cook. "They must determine whose job is it to ensure that the temperature and humidity are correct, that they are recorded on time and that the appropriate people are notified if there is a discrepancy," he said. "Even in well-performing organizations, how do managers know that the data was recorded and analyzed at every scheduled interval It could be several days or more before the manual logs make it to them. Individuals must be designated to manage temperature and humidity compliance." Perkins cautioned against purchasing temperature monitoring as a standalone application because it can be expensive. Rather, he urged, supply chain professionals should consider total cost of ownership and investigate an "integrated platform of technology, software and services that leverage a shared infrastructure across multiple applications" to get the most of out the process. Jon Poshywak, managing director, RTLS Workflow Consulting, TeleTracking Technologies Inc., Pittsburgh, pointed out that not having a specific action plan in place when finding an out-of-range temperature alert may be the biggest oversight. "There's the problem of determining whether the items in the refrigerator or freezer are still good - that is, how long was the temperature out of range, and are the products still stable for that length time " he noted. "This can be especially crucial for items like blood, medications, vaccines, etc." Karl urged supply chain professionals to remain involved with temperaturesensitive products beyond the receipt of materials. "While every action is taken to ensure that sensitive materials arrive safely to a facility, there is often a disconnect postdelivery," he said. "The supply chain team can have a tremendously positive impact on cost control and ultimate patient care if they apply their processes through to the ultimate endpoint of material handling." Karl used a vaccine as an example, highlighting the path it needs to take to get to a patient in a timely manner. Supply chain must track this vaccine while it's in the warehouse, in transit, at the point of care, in the field and all the way to the patient's room. This also includes communicating with the clinical teams and ensuring the quality of the RFID tag. "The role played by supply chain professionals does not end when the items procured arrive at the facility," he continued. "They must ask, 'Are sensitive materials getting to the right locations on time ' 'Do inbound supplies require monitoring while moving through the facility ' 'Are arrival notifications necessary for temperature- or time-sensitive materials '" "One glaring error is having monitoring parameters set without the ability to interpret and react to the data in a timely fashion so that the product is not damaged or destroyed," Frattaruolo indicated. "The cold chain poses a significant risk to costly and in some cases life-saving product. This risk must be managed by a dependable solution." What can software do A software program that reliably monitors the temperature of medications, blood and tissue products can inspire clinical confidence, according to Perkins, and avoid cumbersome and error-prone manual checking. For example, refrigeration units must be checked twice every 24 hours. "A refrigerator could be open all day except for the two times it's manually checked, and it technically would be in compliance," he noted. "At minimum, software provides auditing/reporting tools that are often required for healthcare policy compliance," Karl emphasized. "Beyond that, collaboration tools can drive synergy between supply chain, pharmacy and clinical endpoint, and setting up mutual goals and parameters around efficiencies can drive the performance of these groups as a whole. Software also makes it easier to understand effects on patient care and cost when desired outcomes aren't met, creating a shared level of accountability. "Software's application reporting abilities provide the opportunity to highlight evidence-based savings," Karl continued. "Software enables an organization to show optimization in materials delivery/ use and restock, demonstrating that funds are no longer tied up in long cycles, above-threshold inventory levels, or in wasted inventory - resulting in immediate positive reinforcement of the impact of the process for all stakeholders. That information, coupled with the optimization of nurse responsibilities tied to monitoring/managing inventory flow, results in positive returns not only in cost, but in patient care." Continuous monitoring of temperature 24/7 is something that can't reasonably be done manually, Poshywak insisted, nor can staff be alerted as quickly when a temperature is out of range. "A good application should have the ability to monitor every parameter in the organization on a regular basis, typically every 5 to 15 minutes, process that data with a rules engine to ensure that it is correct for each device, alert people if it is out of range, escalate alerts when staffers do not respond to them in a timely manner, provide reports to managers on a daily, weekly and monthly basis, or even on-demand when an auditor requests it," Cook noted. "The software should also provide for documenting corrective actions when a problem exists - such as when staffers move the contents of a failed refrigerator. It should also provide the ability to archive the data for audit purposes for at least three years and in some cases, up to 10 years." Yet software isn't enough, according to Babcock, who recommended that any monitoring system also include additional components such as a repeater, a receiver, and an immediate notification by means of your preferred alert method, including audio/ visual siren, fax, telephone, e-mail and/ or text message. "Put simply, software is the 'glue' that controls a monitoring system," he added. Software also can function as a bridge between supply chain and clinicians. "By automatically collecting data from refrigerators, freezers, and other storage units, hospitals can free-up clinical staff time so they can attend to patients and perform other tasks," Ruark said. "This enables converting non-value-added time to value-added time. Nurses become nurses to care for patients - not to log temperature readings. "Automated environmental monitoring systems also enable supply chain professionals to help clinicians provide the best care for patients, since proper temperature controls can prevent healthcare providers from treating patients with medication that has been compromised by improper storage," he added. "Software is only valuable if it can paint a complete picture of the time the product is out of its intended temperature and humidity range from formulation to end-use," Frattaruolo noted. "This data must be easily searchable using simple parameters such as the carrier, date, product and destination. "Until clinicians have the infrastructure and support from product manufacturers and supply chain professionals it will be difficult for data to be shared effectively and completely," he added. "One of the dangers of gathering data without proper planning is an inability to determine the severity of any potential temperature/ humidity excursions." Taking that first step What's the first step healthcare supply chain professionals must take when they discover problems in monitoring/managing product temperature and humidity Seven experts recommend where to start. The first step, in my opinion, is working with the various constituents to understand the current processes, including the action plans when an out of range situation is discovered. Regulatory agencies like The Joint Commission will look for a consistent action plan for how the hospital resolves out of range situations. They want to know what happens when a temperature goes out of range. For example, if a nurse says they contact facilities to get the refrigerator fixed, but don't also have a plan for determining whether the items in the refrigerator are still safe, that is likely going to be a problem. - Jon Poshywak, managing director, RTLS Workflow Consulting, TeleTracking Technologies Inc., Pittsburgh We would recommend that healthcare supply chain professionals form a steering committee with relevant stakeholders to assess the nature of the problem, determine the other members of the organization who have similar issues and provide leadership in the selection, implementation and ongoing support of an automated environmental monitoring system. Supply chain professionals may be surprised at the number and roles of people in their organization who have a stake in the success of temperature and humidity monitoring. These can range from nurses, doctors, pharmacists, and engineers to the staff in food services, blood bank, laboratory, engineering, HVAC, security, safety/compliance and even the morgue. - Joel Cook, director. Healthcare Solutions, Stanley Healthcare Solutions/ AeroScout, Framingham, MA Before any system is installed, the supply chain manager should have a team in place that understands the sample, the equipment and the monitoring system. This team approach ensures that no aspect is overlooked. If something does go wrong, it is essential that all team members are gathered and briefed, and a plan of action is developed as rapidly and efficiently as possible. In our experience, the best teams are comprised of lab directors and technology managers, but also include representatives from different departments including people from IT, along with procurement and quality assurance members. Each of these individuals offers support and resources to the overall team - contributing to the overall success of the project and the lab. For example, the technology manager and the lab director expect the solution will meet the expectations of stakeholders and that it is reliable, easy to use and maintain, provides good service, meets regulation standards and falls within the budget. On the other hand, the QA specialist is looking for a solution that meets the regulation requirements but also offers customers the flexibility they need and meets the prescribed vendor requirements. Furthermore, the IT, metrology and procurement team members are in search of a solution that offers the best value, fastest delivery time and the most protection and security. - Chris Babcock, product manager, Thermo Fisher Scientific Inc., Waltham, MA Automated temperature monitoring helps with all three steps that need to be taken in case of a problem: 1. Real-time alerting speeds issue resolution 2. Automated reports ease Joint Commission reporting 3. Policy modification doesn't require re-training - just modify the software and the new policy is implemented. - Matt Perkins, Chief Technology Officer and senior vice president. Engineering, Awarepoint Corp., San Diego Failure to maintain correct parameters for a temperature-sensitive medication or vaccination can compromise patient care. For this reason alone, it is imperative that anyone involved in the process from beginning to end who sees a problem - or even the potential for a problem - follows a defined process for flagging the problem. This is a key foundational requirement for a successful monitoring system, and the process must incorporate a necessary action plan. This ensures the removal of any improperly handled medications from the supply lines. Supply chain professionals must feel empowered not only to create an alert, but also to take the necessary follow-up steps to ensure action. Appropriate software/auditing tools and real time dashboards can help make this possible. - Jonathan Karl, director, sales, CDW Healthcare Solutions, Vernon Hills, IL Discovering problems in monitoring product temperature and humidity is not enough. Supply chain professionals need to provide a proper documentation surrounding the event to prove that they responded correctly. With the Intelligent InSites solution, all temperature and humidity readings are stored automatically with any required annotations regarding corrective actions. - Marcus Ruark, vice president. Intelligent InSites Inc., Fargo, ND It is our hope that these steps will not have to be taken by the healthcare supply chain professionals because a dependable solution was utilized in the first place - such as the new Pelican Biopharma solution. Failures in the cold chain can have disastrous effects on vaccines and other life-saving biopharma materials and it is our aim to make instances of cold chain failure a thing of the past. Healthcare supply chain professionals should observe industry best practices if a cold chain failure occurs by segregating any potentially affected product. Once the extent of the potential damage has been determined the supply chain professionals should work with their quality assurance groups to determine the disposition of any affected products. - Emilio Frattaruolo, product engineer, Biopharma team, Pelican Products Inc., Torrance, CA Temperature tips to take to the bank What are some recommendations for successful environmental monitoring of product temperature and humidity that can reap short-term benefits and long-term returns-on-investment - including clinical outcomes Seven sources share their secrets. Regardless of what monitoring system you select, the following elements are essential: Smart, scalable and simple. It should be smart in that it offers the laboratory professional peace of mind, scalable in that it can grow as the lab grows, while continuously saving time and money, and simple in that it should be easy to install, use and maintain. A system with these characteristics will offer both short and long term benefits for the researcher, the lab and the finance department. - Chris Babcock, product manager, Thermo Fisher Scientific Inc., Waltham, MA * Deploy an RTLS-based temperature monitoring system. * During the first 90 days monitor units for their upper and lower bounds and trends for exceeding those thresholds. * Adjust refrigerator settings or policies to accommodate best practices. - Matt Perkins, Chief Technology Officer and senior vice president. Engineering, Awarepoint Corp., San Diego * Establish department leaders from each stakeholder group to help drive awareness, foster education, and execute process change to drive the best outcomes. * Develop and maintain clear and consistent processes with regular reviews and the flexibility to implement change when it is needed. * Report savings and benefits to clinical work back to the organization by: * Educating all stakeholders involved in the process. * Driving awareness around the cost of consequences that occur when processes are not properly followed. * Driving awareness around the value and benefits to patient care that result from efficiency improvements. - Jonathan Karl, director, sales, CDW Healthcare Solutions, Vernon Hills, IL * Use a flexible, hardware-independent software solution that can automatically collect real-time data from any temperature sensor or environment sensor from any sensor manufacturer. * Take advantage of Joint Commission-compliant reports to document your temperature compliance and to guide your improvement of internal processes. * When justifying a purchase of a real-time environmental monitoring solution, consider all of the benefits, including reducing waste, increasing value-added time for your staff and increasing patient safety. - Marcus Ruark, vice president. Intelligent InSites Inc., Fargo, ND * My first recommendation is to set up a steering committee at the outset to discuss the issues, goals and expected outcomes, then continue to have them meet at least quarterly to ensure that the goals are being met. * Next, try to identify and purchase one solution that can meet all of your temperature and humidity monitoring requirements, across all disciplines and departments, and across the full temperature range, which can span from -200 degrees Celsius to +1 00 degrees Celsius or more. Additionally, consider possible future needs of the organization and look for a system that can be expanded to other use cases, such as asset tracking and management. * Finally, carefully plan for change management once the system is in place and ensure that corrective actions are being documented, that reports are reviewed in a timely manner and that escalations are appropriately handled. - Joel Cook, director. Healthcare Solutions, Stanley Healthcare Solutions/ AeroScout, Framingham, MA When evaluating an RTLS automated temperature monitoring solution: * Conduct a thorough walk through of all temperature controlling assets in the facilities and involve all the right stakeholders - nurses, facilities, food & nutrition, pharmacy. Document the staff time involved in the current manual process and understand the action plans currently in place. Record any previous product losses or safety situations that occurred as a result of the current manual process. * Provide infrastructure options for the facility's IT Team (Wi-Fi, 900MHz, etc), clearly identifying the pros and cons of each backhaul solution and helping to address gaps through consulting or hardware alternatives. * Work with each group to determine the appropriate parameters for out of range alerts for each specific unit. This will differ by the types of items stored in these units and the sensitivity of those items to temperature fluctuations. If multiple types of items are stored in the same unit, set your alerts to the most sensitive of those assets. * Have a specific action plan for out of range situations. For example, for medication storage, it may not be enough to simply call facilities to check out the refrigerator. Your protocol may also need to involve calling the pharmacy, who in turn may need to check the package inserts or call the manufacturer to determine what the disposition of the medications should be. - Jon Poshywak, managing director, RTLS Workflow Consulting, TeleTracking Technologies Inc., Pittsburgh * Use a reliable solution, such as the Pelican BioPharma solution, that assures product stays within the specified temperature and humidity range. * Create a thorough monitoring plan that includes the process by which data is recorded, the monitoring systems to be utilized, and response plans that can be executed in the event of any excursions. * Create a system to archive all temperature data recorded in a manner that allows easy searching and cross reference of data. - Emilio Frattaruolo, product engineer, BioPharma team. Pelican Products Inc., Torrance, CA For the additional sidebars: Watch out for these warning signs and Shoot for these successful results visit www.hpnonline.com/ inside/2012-11/1211-SF-ProdTemp-sidebars.html (c) 2012 KSR Publishing |