In the Eye of the Storm

After fireworks and barbeques mark Independence Day celebrations this month, states along the Gulf and Atlantic coasts will be turning their attention to a more sobering fact of summer: hurricane season. With climatologists warning that a trend toward extreme summer heat will likely continue to spawn the kind of destructive storms that have wreaked havoc from Texas to New York in recent years, disaster preparedness has become a top priority for hospitals and other healthcare providers, and the clinical lab is no exception.

In particular, laboratorians' experiences in disasters such as Hurricanes Katrina, Ike, and Sandy have pushed point-of-care testing (POCT) to the forefront of response efforts. When electricity, air conditioning, fresh water, and other essentials fail, POCT becomes the only testing available. As these instruments have proliferated in recent years, hospitals now expect basic lab testing to continue even when central lab systems crash.

In response, laboratorians—especially point-of-care coordinators—have stepped up their efforts in local, regional, and national disaster preparedness plans, and the nation is now better prepared, according to experts. However, the limitations of current POCT instruments still present important challenges that require a response from both laboratorians and the in vitro diagnostics industry. "We are better prepared, but not completely prepared," said Gerald Kost, MD, PhD, director of the Point-of-Care Testing Center for Teaching and Research at the University of California Davis School of Medicine in Sacramento. "While as a nation we have progressed substantially, current point-of-care testing reagents and devices are not environmentally robust, and that has to change." Kost has spent nearly 2 decades developing POCT technology and analyzing the response to public health disasters around the world.

POCT on Front Lines

For labs and the healthcare community as a whole, Hurricane Katrina in 2005 was a major turning point. Within days of Katrina making landfall in Louisiana, only three hospitals remained operational in the New Orleans area. Even then, in some cases emergency generators couldn't maintain air conditioning, quickly crippling clinical lab analyzers and other sophisticated equipment. Since then, labs in Louisiana and other states have made plans to stock battery operated POCT devices that can also tolerate somewhat broader temperature and humidity fluctuations compared to traditional central lab instruments.

The need to rely on POCT in disasters became strikingly clear again just 3 years after Katrina, when Hurricane Ike hit the island city of Galveston, Texas, causing more damage than any other storm in the state's history. The University of Texas Medical Branch (UTMB Health) in Galveston experienced an enormous amount of damage due to salt water flooding, which inundated the ground floors of several campus clinical buildings and took out all utilities, elevator banks, generators, computer systems, the blood bank, pharmacy, and all food service areas. The fifth floor clinical laboratory became nonfunctional due to lack of electricity and a generator failure, and all refrigerated reagents were lost.

While the hospital and clinical laboratory were non-functional, patients depended heavily on UTMB Health ambulatory care clinics in the months after the hurricane. This required shifting all clinical laboratory testing to commercial reference laboratories or increasing the volume of POC systems, recalled Peggy Mann, MS, MT(ASCP), quality, safety, and environment program manager and ambulatory practices POC coordinator. "We had evacuated before, but this was the first time that our campus hospital and campus clinics were completely shut down," she recalled. "We realized that we had to see all of our patients outside of the campus and off the island if possible, since patients who lived in Galveston were unable to return to their homes due to the damage and were living on the mainland. Fortunately, we were already performing a considerable volume of point-of-care testing at these clinics and it was a real benefit to us to have the redundancy of POCT instruments available."

As both new and established patients poured into the UTMB Health clinics, it was up to Mann to organize staff, instruments, and manual testing products, as well as arrange logistics to facilitate patient care that continued in the storm's aftermath. "It was a solid year or more of non-stop work," said Mann, who had 32 years of experience under her belt by then. "I was really happy that I was not an inexperienced medical technologist right out of school, or I probably would have just cried and left!"

In the 5 years since, Mann has navigated UTMB Health's recovery from Ike—the campus is still rebuilding—and has strived to parlay her experience into education for other POC coordinators. On August 1, Mann will join three other experts at the 11th Annual Point-of-Care Coordinators Forum, taking place during the 2013 AACC Annual Meeting and Clinical Lab Expo in Houston. The forum will focus on the role of POC coordinators in disaster planning (See Box, below).

After events like Hurricanes Katrina and Ike, the federal government has made significant strides in its ability to support recovery efforts in disasters, according to Kost. He praised the work of commander Daniel Hesselgesser, MT(ASCP), in the U.S. Public Health Service, who serves as the program lead for the federal government's emergency response laboratories under the Office for the Assistant Secretary of Preparedness and Response (ASPER). Among other projects, Hesselgesser has led an effort to improve the nation's strategic emergency caches of POCT instruments and supplies.

"Dan Hesselgesser and his colleagues have really done wonders for our national disaster caches," Kost said. "Before his efforts a few years ago, disaster caches consisted mainly of boxes in local emergency departments with stuff thrown in them. No one was trained to use those devices, and there was little quality control. Now Dan and his colleagues have fixed the system and established strict rules for good laboratory practices." Hesselgesser, who is also a lab surveyor for the Centers for Medicare and Medicaid Services, also will present at the POCC forum in Houston.

Under ASPER, Hesselgesser is a regional incident support team commander, and deployed with a disaster medical assistance team (DMAT) to Galveston in the aftermath of Hurricane Ike. The equipment for these teams was greatly enhanced after Hurricane Katrina, according to Hesselgesser. DMATs support federal medical stations deployed by ASPER and the Federal Emergency Management Agency (FEMA). "DMATs arrive with a lab package that includes the ability to perform moderate complexity POCT for everything from basic triage to acute care, and can include testing for analytes such as blood glucose, electrolytes, chemistry panels, blood gases, and even cardiac markers," Hesselgesser said.

FEMA and ASPER deploy these assets only when state resources become exhausted, Hesselgesser noted. "All of these scenarios are planned for," he said. "The federal government is aware of what the state has and the state is aware of what the federal government has, and they both work very closely together." DMATs are designed to be self-sustaining for 72 hours so they can operate in the immediate aftermath of a disaster, with deployments lasting up to 2 weeks.

Of course, not every disaster is the same. When a powerful EF5 tornado hit Moore, Okla., on May 20, killing 23 people and destroying nearly 13,000 homes, the impact on local hospitals was intense, but brief, according to Debbie Oberst, MT(ASCP), the point-of-care analyst for the Norman Regional Health System in Norman. "For this particular disaster, we had a high volume of patients in the emergency department right at the beginning, and then it slowly went down," she said. "We had a lot of people with broken bones, but not quite as many people who were severely wounded as you might think." Oberst oversees POCT at several hospitals and clinics in the area, including the 45-bed Moore Medical Center that was severely damaged by the tornado. Although the storm sheared off the second floor of Moore Medical Center, no lives were lost: after evacuating patients, the remaining employees found shelter in the hospital cafeteria.

Compared to other weather disasters, the Moore tornado's confined sphere of damage allowed the two unaffected hospitals to operate normally, albeit with higher volumes of patients. Oberst's main challenge was to meet demand for many more POCT instruments in the emergency department (ED) to treat the initial waves of the injured. "We scrambled to make sure we had enough i-STATs available from other floors for the ED. I think it really underscores the value of having some extra units," Oberst said. "Second, we were fortunate to have enough cartridges for the i-STATs. That's kind of a sticky wicket, because you want to make sure that you have enough on hand, but you don't want to have so many that they begin to expire. But I know that if I'd had to, I could have borrowed some from the other hospital."

Hospital Disaster Plans Focus on Local Risks

As hospitals respond to the growing threat of extreme weather events, terrorism, and other disasters, POC coordinators are taking the lead in making disaster plans for labs, focusing on the unique scenarios that face their communities. Often, coordinators are on their own when it comes to developing lab disaster plans, and bear the burden of championing the cause for the lab in the first place, despite hospital plans for other departments.

"Working with the rest of the hospital and getting fully integrated into their plans has been one of my biggest challenges," said Diane Davis, MT(ASCP), core lab and POCT manager at All Children's Hospital in St. Petersburg, Florida, a member of Johns Hopkins Medicine. "Many times people don't think about the lab until they need their lab results. So in a disaster plan, they're planning for the patients and they're planning for the nurses to come in, but they haven't thought about the lab. Then laboratorians have to raise the red flag and say, 'hold on, you're going to want to think about us too.'" Davis will outline her hospital's POCT disaster plan at the AACC POCC forum.

Due to its vulnerability to hurricanes, All Children's has developed an advanced plan for coping with the region's inevitable storms, including a dedicated power plant that can provide up to 3 weeks of full power for the hospital. Built in 2011, All Children's sits just four blocks from the waters of Tampa Bay. The lab, however, resides in a building across the street from the hospital connected by a pedestrian bridge. "Unfortunately, if the winds become too high, there is a possibility that the lab will not be able to work in this building," Davis said. "We would have to move across the street to the hospital. Then, POCT would become incredibly important, since at that point, that's all we'd really have."

With many nurses already proficient in POCT, Davis's plan focuses on training laboratorians on using POCT instruments before the storm so they can function as a mobile unit if the laboratory has to be abandoned. Within 72 hours of the news that a hurricane could make landfall, Davis will begin real-time training for lab staff designated for the hospital's disaster assistance relief team (DART). Davis manages what she calls a point-of-care sim lab for POCT training and competency assessment, in which her plan includes training the lab DART members in about an hour on the POCT instruments they will be using.

This unique, real-time training plan came about in response to Davis's experience with storms. "What we have found is that the people who sign up to stay for a storm, don't end up being the people who actually stay. The concept of staying during a hurricane is different from the reality of staying during a hurricane."

Davis recommends that other POC coordinators perform a risk analysis based on the threats in their location. "You should consider where you live and what the most likely disaster is that could befall you," Davis said. "I really believe that if you plan for that, you will be even more prepared for something that you had not anticipated."

The Regional View

In other areas of the country, hospitals have taken a regional approach to disaster planning. Thirty hospitals in the Minneapolis-St. Paul Twin Cities metro area, which encompasses the densest population center of Minnesota, have signed a mutual aid agreement to support each other in emergencies and disasters. On the lab side, the Minnesota Department of Health coordinated a team called the Metro Lab Preparedness Group, composed of lab safety officers, POC coordinators, lab managers, and other key lab staff from area hospitals. In most cases, the lab safety officers were also POC coordinators, explained Kerstin Halverson, MT(ASCP), BA, MS, POC coordinator for Children's Hospitals and Clinics of Minnesota in Minneapolis, Minn. "It seems to go hand-in-hand," she said. "If you have some kind of emergency or disaster, you're going to be using POCT to get results for the patients affected by the disaster."

Established after September 11, 2001, the Twin Cities lab plan includes procedures for a mobile medical unit (MMU) acquired by the state, job action sheets that outline special responsibilities for technologists, phlebotomists, runners, and other roles, as well as the logistics of setting up an alternative care site if needed.

As in other disaster plans put together by labs, managing POCT instruments and reagent stock is a high priority. "An important part of our contract compact is that the hospitals agree to house additional designated POCT instruments and supplies, with the understanding that if needed, they would bring them to another hospital, the MMU, or an alternative care site in the event of an emergency," Halverson said.

In the near future, POC coordinators won't have to formulate their emergency and disaster plans from scratch. A new guideline under development from the Clinical and Laboratory Standards Institute (CLSI), Emergency and Disaster Point-of-Care Testing, will include guidance on standards of care in a crisis, structure and support of POCT, resources and logistics, the role of POC coordinators, and other topics. At the POCC Forum in August, Mann, a member of the CLSI subcommittee developing the new guideline, will give an update on its progress (See Box, above). Commander Hesselgesser also serves on this panel, which is co-chaired by Kost and James Nichols, PhD, a professor of pathology and medical director of clinical chemistry at Vanderbilt University Medical Center in Nashville, Tenn.

Up to the Task?

Even as POC coordinators, hospitals, local networks, and the federal government have improved POCT disaster preparedness, Kost and other researchers are sounding the alarm over the shortcomings of instruments and analytes. Hand-held chemistry and blood gas instruments, as well as blood glucose meters, have the advantage of portability, battery power, and overall toughness compared to central lab analyzers. However, with hurricanes, floods, and other warm-weather related events topping the list of potential disasters, temperature and humidity limits continue to pose problems for POCT in disaster scenarios, according to Kost.

Researchers at the Point-of-Care Testing Center for Teaching and Research (POCT·CTR), which Kost founded, are exploring the limits of instruments and reagents. Richard Louie, PhD, an assistant professor of pathology and laboratory medicine at the University of California, Davis and the associate director of POCT·CTR, has led investigations into the effects of temperature and humidity on POCT reagents and devices. Louie's environmental studies push just beyond manufacturers' specifications for these instruments. But they simulate the real-world scenarios in which POCT instruments are needed most.

In one series of experiments, Louie modeled with an environmental chamber weather conditions observed at disaster sites (Disaster Med Public Health Preparedness 2012;6:232–40). With the help of a team of climatologists, meteorologists, and atmospheric scientists, Louie produced a dynamic temperature and humidity profile of New Orleans during Hurricane Katrina to evaluate the performance of two glucose meter systems.

"The environmental profiles cover not only the conditions of temperature and humidity during the event, but also the conditions during the rescue phase of the disaster," Louie explained. "We wanted to investigate whether the point-of-care devices would produce accurate, reliable, actionable test results, or if these conditions would introduce measurement bias that could potentially impact treatment decisions and safety."

In the glucose meter study, the researchers checked the performance of meter strips in the environmental chamber at multiple time points, from 8 hours up to 4 weeks. With one system, glucose dehydrogenase-based test strips produced elevated results compared to controls after 72 hours. In contrast, the glucose oxidase-based test strips from another meter system showed a negative bias. Louie observed measurement errors as high as 21.9% at mean glucose concentrations of 109.6 mg/dL.

"These elevated results could potentially mislead insulin dosing, which could cause serious patient harm," Louie noted. "The effects of environmental stress on glucose test strips has implications for not only health professionals operating these devices in adverse field conditions, but also consumers at home. For example, one could imagine a patient storing glucose test strips in their car during the summer, where conditions could easily exceed 45 degrees Celsius (113 degrees Fahrenheit)."

Studies of other analytes have found impaired measurements when test cartridges and cassettes were environmentally challenged. For example, one study reported that heat-stressed blood gas reagent cartridges generated significantly higher results compared to room-temperature controls (Disaster Med Public Health Preparedness 2009;3:13–7). Louie's recent unpublished evaluations of cardiac biomarkers also found significant errors in a hot, humid environment.

Kost is urging more engagement among laboratorians and POCT manufacturers to improve the robustness of these test systems. "It's simply not true that all of these devices are ready to go out into the field," Kost said. "They're fine in the hospital environment, but you can't take the hospital environment with you out into the field during a disaster. We need to energize the whole field to get more behind this cause, deal with the deficiencies that we have, and close the gaps to better prepare the nation."