Veterans Affairs and Military Medicine OUTLOOK 2021, Fall Edition

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GERM-ZAPPING ROBOTS

Disinfecting UV systems add a layer of protection against health careacquired infections.

The VACO Index A Better Way To Detect Kidney Disease INTERVIEWS

James McCormick National Commander, Military Order of the Purple Heart

Ivette Motola, MD, MPH Assistant Director, Gordon Center for Simulation and Innovation in Medical Education Director, Prehospital and Emergency Healthcare, Gordon Center





CONTENTS 2

INTERVIEW: IVETTE MOTOLA, MD, MPH

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VA’S NATIONAL PRECISION ONCOLOGY PROGRAM CONTINUES EXPANSION

Assistant Director, Gordon Center for Simulation and Innovation in Medical Education Director, Prehospital and Emergency Healthcare, Gordon Center By Chuck Oldham

By Gail Gourley

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INTERVIEW: JAMES McCORMICK National Commander, Military Order of the Purple Heart By Chuck Oldham

20 GERM-ZAPPING ROBOTS

Disinfecting UV systems add a layer of protection against health care-acquired infections. By Scott R. Gourley

Published by Faircount Media Group 450 Carillon Parkway, Suite 105 St. Petersburg, FL 33716 www.defensemedianetwork.com www.faircount.com EDITORIAL Editor in Chief: Chuck Oldham Managing Editor: Ana E. Lopez Senior Editor: Rhonda Carpenter Contributing Writers: Craig Collins Gail Gourley, Scott R. Gourley DESIGN AND PRODUCTION Art Director: Robin K. McDowall ADVERTISING Beth Hamm OPERATIONS AND ADMINISTRATION

VA RESEARCH

28 THE VACO INDEX

To protect the vulnerable, VA experts design a rigorous, validated calculation of COVID-19 mortality risks. By Craig Collins

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A BETTER WAY TO DETECT KIDNEY DISEASE

Chief Executive Officer: Robin Jobson Chief Operating Officer: Lawrence Wayne Roberts Business Development and Marketing: Damion Harte FAIRCOUNT MEDIA GROUP Publisher: Ross Jobson

Experts at the San Francisco VA are pioneering a more accurate – and race-independent – measure of kidney function. By Craig Collins

©Faircount LLC. All rights reserved. Editorial content ©The Black Angel Company LLC. Reproduction of editorial content in whole or in part without written permission is prohibited. Faircount LLC does not assume responsibility for the advertisements, nor any representation made therein, nor the quality or deliverability of the products themselves. Reproduction of articles and photographs, in whole or in part, contained herein is prohibited without expressed written consent of the publisher, with the exception of reprinting for news media use. Printed in the United States of America.


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INTERVIEW

IVETTE MOTOLA, MD, MPH

Assistant Director, Gordon Center for Simulation and Innovation in Medical Education Director, Prehospital and Emergency Healthcare, Gordon Center By Chuck Oldham

Veterans Affairs and Military Medicine Outlook: What is the background of the Gordon Center? When was it established? What is its mission and philosophy? Ivette Motola, MD, MPH: The Gordon Center’s mission is to save lives through simulation technology. Our vision is to create a safe and engaging environment where innovation, simulation, and education come together to prepare learners to provide life-saving care to patients. We are a designated Center of Excellence of the University of Miami Miller School of Medicine. The Center was established almost 50 years ago for the application of advanced technology to training for health care students, physicians, physician assistants, nurses, first responders, and educators. Since then, more than 2,000 institutions worldwide have been using the educational systems developed at the Gordon Center.

How did the Gordon Center’s partnership with the U.S. Army begin? The Army Trauma Training Detachment began as a partnership with the University of Miami in the wake of the attacks on Sept. 11, 2001. We knew we had to band with the brave men and women of our military to provide them with the best possible trauma care through medical simulation training of their forward surgical teams. And that’s what we did. The relationship with the University of Miami, Ryder Trauma Center, and the Gordon Center is the Army’s longest-running civilian partnership for trauma training. How has the partnership changed over the years and what is the nature of the program or programs?

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What are some of the more important achievements of the Gordon Center? We train thousands of first responders and frontline personnel annually at more than 740 agencies in the state of Florida. Through our Advanced Stroke Life Support program, we train around 10,000 health care professionals every year, on four continents and in 13 languages. More than 700 institutions in over 50 countries use Harvey, the cardiopulmonary patient simulator we first introduced in 1968.


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Initially, the partnership began with helping Army Forward Surgical Teams with team training and skills practice for wartime readiness. This included training to properly don and doff personal protective equipment to stay safe during attacks using weapons of mass destruction, such as nerve and biological agents. Over the years, the Gordon Center has helped support the Army Trauma Training Detachment and the Forward Surgical Teams in many ways, including cadre faculty development in simulation education, training space and equipment, and exploring novel ways to train their teams. We have also collaborated with them on several research projects and educational initiatives. How do such partnerships benefit the military, and how do they benefit civilian first responders? Our partnership has benefitted the military by helping provide forward surgical and other military health care teams

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Augmented reality simulations are one of the ways the Gordon Center has applied advanced technology to training.

with the latest, evidence-based training in battlefield and acute-care medicine. This training has been directly linked to helping save the lives of military personnel in harm’s way. Some of the courses taught today for first responders, such as the Gordon Center’s Active Shooter Hostile Events and Emergency Response to Terrorism courses, evolved from Army Forward Surgical Teams training. These courses teach the same skills to civilian providers – such as tourniquet application and rescue task force – and incorporate the same training techniques, simulations, and tactics that had been used previously in the military context.

Can you describe the Gordon Center’s role in training U.S. Army Forward Surgical Teams? The Gordon Center has served as a center for pre-deployment training of Army Forward Surgical Teams, giving military health care professionals the clinical expertise they require to help save lives. Army Forward Surgical Teams and Special Operations military teams are trained in a multitude of challenging scenarios. During the two weeks the teams are on site, we provide the resources to intentionally replicate what they are going to experience downrange. The training focuses on both skills refinement and team training to help with readiness upon deployment. Each team member needs to be proficient in multiple skills and ready for anything. Could you explain how the Gordon Center was chosen as an international simulation center of excellence that trains U.S. Special Operations Military Teams?

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The University of Miami partners with Ryder Trauma Center, a level 1 trauma center which treats many conditions and injuries that are similar to traumatic battlefield-type injuries, such as gunshot wounds, burns, and traumatic hemorrhages. This setting allows military healthcare teams practice in the skills they will require to treat soldiers. Additionally, the Gordon Center had a well-established reputation and expertise in training using simulation and innovative technologies and educational research. Has medical simulation grown in importance over the years? How have the technologies and their applications changed? Yes. The use of health professions simulation training and assessment has grown exponentially over the past two decades, driven largely by the need to provide uniform learning experiences, improve patient safety, and to ensure competence of health care providers. The Gordon Center offers training programs in various disciplines, such as emergency medicine, disaster response, and cardiology, using blended-learning platforms that combine online interactive educational materials and hands-on skills practice. In addition, Gordon Center curricula are based on best practices, latest scientific evidence, and guidelines from professional organizations. Innovative tools are incorporated in the immersive learning experience and include simulation scenarios, videos, interactive 3D graphic animations, extended reality, diagnostic imaging, and, in certain courses, hands-on practice with Harvey, the cardiopulmonary simulator. Can you tell us about the recent research study conducted for the Department of Defense? There have been numerous research studies conducted over more than a

The Gordon Center has worked for years with Army Trauma Training Detachment personnel.

decade in partnership with the Department of Defense. For example, we help demonstrate the effectiveness of “just in time” training for certain procedural skills for military providers. The Gordon Center has also helped to develop and validate materials for the Defense Health Agency’s Deployed Medicine website. This past year, the Gordon Center conducted a research study sponsored by the U.S. Department of Defense to evaluate whether complex procedures can be taught to trainees using telemedicine while a remote expert instructor guides them through procedures with the assistance of augmented reality. For example, a virtual overlay of the relevant anatomy is displayed to assist learners as they perform procedures on an actual, physical task trainer.

In another DHA study, the Gordon Center is evaluating the effectiveness of Tactical Combat Casualty Care training for all service members. In particular, we are focusing on training tourniquet application skills. We are also conducting research to validate assessment instruments used in this training. How do you see the Gordon Center’s programs and partnerships in medical simulation and education going forward in the future? Going forward, we envision greater use of simulations involving extended reality and artificial intelligence technologies. In addition, with the use of evolving communications platforms, new applications such as telemedicine and tele-simulation offer increasing opportunities to reach learners and providers remotely. This is particularly relevant in the military context to provide ongoing training and maintenance of skills for deployed personnel.

“The Gordon Center offers training programs in various disciplines, such as emergency medicine, disaster response, and cardiology, using blended-learning platforms that combine online interactive educational materials and hands-on skills practice.” www.defensemedianetwork.com

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VA’S NATIONAL PRECISION ONCOLOGY PROGRAM CONTINUES EXPANSION

By Gail Gourley

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Michael Kelley, MD, is the VA National Oncology Program director, chief of hematology–oncology at Durham VA Medical Center, and professor of medicine at Duke University in North Carolina.

molecular basis of [an individual’s] cancer – not cancer in general, but an individual’s cancer – and using that to guide care and, in particular, treatment decisions.” As described in an August 2020 abstract authored by Kelley and published in the Federal Practitioner, one of the earliest examples of precision oncology was tumor testing for the estrogen receptor in breast cancer, distinguishing those breast tumors sensitive to hormonal treatments from those that are not. Another early example, in 2004, linked mutation of the EGFR gene with response to medications like gefitinib and erlotinib, and it was subsequently shown that patients without

the EGFR mutation derived no benefit from those drugs. Thus, Kelley wrote, “the precision oncology paradigm is using a molecular diagnostic as part of the indication for an antineoplastic agent, resulting in improved therapeutic efficacy and often reduced toxicity. By 2015, multiple examples of DNA-based gene alterations that predict drug response were known, including at least five in non-small cell lung cancer.” The VA demonstrated its commitment in 2015 to implementing precision oncology, launching a regional program for DNA sequencing of solid tumors. That program transformed into NPOP in 2016 with the Moonshot initiative and has continued to develop and expand. In 2016, prostate cancer was the first included in the program, and lung cancer was formally added last year, Kelley said. Breast cancer’s inclusion in NPOP was announced last year and is being

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VA PHOTO

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n 2016, President Barack Obama announced launch of the National Cancer Moonshot initiative, aimed at accelerating a decade’s worth of advances in cancer research, treatment, and prevention into five years, essentially doubling the rate of progress against cancer. The Department of Defense and the Department of Veterans Affairs (VA) were, from the beginning of the initiative, elements of the envisioned whole-of-government approach devoting resources to this effort. The National Precision Oncology Program (NPOP) is part of the VA’s dynamic effort to support the Moonshot initiative. Led by the VA National Oncology Program, NPOP provides genetic testing and reporting of tumor samples, expertise to interpret testing results for the best treatment of veterans’ cancer, and information sharing for clinical and research purposes. As the country’s largest integrated health care network, the VA sees about 50,000 new cancer diagnoses per year among enrolled veterans. For male veterans, prostate and lung cancer are the most common, and breast and lung cancer are the most prevalent in women veterans. Compared to the non-veteran U.S. population, veterans have slightly higher overall cancer rates. Historically, medical treatment for cancer has been non-precise, where patients with the same cancer diagnosis and stage receive the same treatment. In contrast, Michael Kelley, MD, VA National Oncology Program director; professor of medicine, Duke University; and chief, hematology-oncology, Durham VA Medical Center, described precision oncology as “understanding the


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DURHAM VA HEALTH CARE SYSTEM PHOTO

One of the earliest examples of precision oncology was tumor testing for the estrogen receptor in breast cancer, which distinguishes breast tumors sensitive to hormonal treatments from those that are not. Breast cancer is the most common cancer in women veterans.

implemented starting this fiscal year. Experts already in the system are working on future inclusion of melanoma, brain cancers, and gynecologic malignancies. In precision oncology, tumor testing is necessary to understand an individual’s cancer. “We’re systematically going through lung and prostate cancer [patients] to make sure that they have the appropriate testing,” Kelley said. “But there are other tumor types that we think also should have systematic testing. Breast is one of those and we’ll be [developing] that,” he said, adding that they’re working to identify recommended testing for bladder cancer, esophageal cancer,

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kidney cancer, and head and neck cancer. “There is a whole list that we’ve made for many tumor types, not every tumor type because there are about 700 of them, but for many tumor types in terms of identifying what type of testing we recommend.”

PAST YEAR’S PROGRAM GROWTH – ACCESS, CLINICAL PATHWAYS, TELEONCOLOGY Kelley identified some of the most significant developments as expansion. “Access to precision oncology has continued to expand over the last year. The

use of the testing that’s necessary to do precision oncology has increased over 100%, so that’s been a very significant uptick. And the number of sites where it’s done routinely is also going up, and now I think has been used in the last year pretty much at every oncology practice in VA,” he said. As of 2021, more than 14,000 veterans have been tested through NPOP. Another ongoing endeavor within NPOP is development of clinical pathways, or standardized, evidence-based disease management and treatment protocols. “The very beginning is to formally define what it is we want to happen for patients most of the time, and this is called a clinical pathway,” Kelley explained. “We’ve gotten together groups of experts to talk about what the pathway should look like and written that down now for four cancer types and starting on three more. That defines what we want to have happen, and then

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DURHAM VA HEALTH CARE SYSTEM PHOTO

Precision oncology utilizes the molecular basis of an individual’s cancer to guide treatment decisions.

start to measure that [so] we make sure that we don’t miss anybody, essentially; so, systematically provide that advice to clinicians.” A third area of robust effort has been teleOncology, seeking to realign the urban supply and the rural demand for oncologists. About one-third of enrolled veterans live in rural areas, where telehealth can provide important health care services to veterans in locations where that care might be otherwise inaccessible. That is true for precision oncology, which has worked over the past year to expand its use and applications.

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“Our teleOncology service is expanding access to expert oncologists in areas where they don’t have those oncologists, such as in many rural areas,” Kelley said. “That has been a big area that we’ve been working on this past year.” He explained, “If you have a problem and you go to the person who is an expert in your problem, you’re probably going to get it fixed. You’re going to get it fixed the first time, you’re not going to get things that you don’t need, and it’s going to be better.” For example, Kelley said, “I’m a thoracic oncologist, so I specialize in patients

with lung cancer. I have seen lung cancer patients basically every day of my professional career, 35 years, so when I see another patient with lung cancer, I probably have seen something similar. And if I haven’t, I’ve probably read about it. Whatever it is, I’m going to probably be able to deal with it and deal with it on the spot, and do so in a way which is consistent with the very best practice. It’s the same thing for my colleagues who see patients with colon cancer or kidney cancer or bladder cancer or brain cancers. So, if you’re in central South Dakota, and you have a melanoma, a type of skin cancer, and have the need for an expert opinion, that expert opinion could come to you, or it could be your doctor. That person who’s at a major cancer center can come to you and take care of you where you are. You don’t have to go to Minneapolis or San Diego or anyplace else in the country. This is what telehealth is doing for precision oncology. You can see this in action, and it’s tremendous.” Kelley said the use of telehealth for oncology care has increased during the COVID-19 pandemic, specifically between one hospital and another, but mostly because teleOncology was expanding even before the pandemic. “We were already building plans in 2019 to expand the service,” he said, and also acknowledged the pandemic’s effect reduced early skepticism in some, “including patients and providers. I think the COVID pandemic has helped expand this type of care at a very rapid pace.”

PRECISION ONCOLOGY SYSTEM OF EXCELLENCE These highlighted areas of the program’s progress over the last year – access expansion, establishment of clinical pathways, and utilization of telehealth to provide oncology care to veterans – is all within the context of a “system of excellence.”

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Left: The VA’s first teleOncology session was conducted on June 25, 2018 by Dr. Michael Kelley with a veteran from the Veterans Health Care System of the Ozarks in Fayetteville, Arkansas, which had lost its on-staff oncologist and reached out for assistance and expertise. Expansion of teleOncology services, especially to veterans in rural areas, has remained a strong priority. Below left: Expansion of types of precision oncology testing and their applications could help determine which individuals are at higher risk of getting cancer and result in earlier screening imaging, such as CT scans.

providing education to physicians on “what this testing can do, what it can’t do, when to use it, when not to use it, how to interpret it when you do the testing, and how to apply that for different types of patients,” he said, adding that through electronic consults, “any physician or any provider, anywhere in the system, can ask for help with this type of testing.” Kelley continued, “You need a team to be able to do this really well, and you have to have access to that expertise. Our precision oncology system of excellence delivers that expertise to the place where it’s needed, when it’s needed.”

VA PHOTO BY PUBLIC AFFAIRS SPECIALIST JOSH EDSON

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“That’s the big vision,” Kelley said. “In the past, we talked about centers of excellence, a physical location where we have experts.” Some patients would have access to those centers, but others might need to travel there. “But we’ve envisioned something different than having centers of excellence. We want a system of excellence where the veterans don’t have to go anywhere [for cancer care]. The system comes to them,” Kelley continued. For example, some of the 130 sites of clinical care would have

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cancer experts, “but if you’re at a site that doesn’t have an expert in your tumor type, you could still access an expert either because your oncologist communicates with that person, and the oncologist is using a clinical pathway which is already designed by the experts, or the expert oncologist could actually come to you by telehealth.” Additionally, Kelley pointed to the complexity of precision oncology testing and interpretation, and that another benefit of a system of excellence is

The integration of research and clinical practice is another important aspect of cancer care that works to improve results for patients. “Research has been involved from the very beginning,” Kelley said. As part of standard clinical practice for many patients with cancer, it involves not only research, but also access to clinical trials or enrollment in clinical studies. Research also contributes to the success of programs that are being implemented, such as the teleOncology service, for example. “We want [the programs] to be successful, and our research colleagues can be very helpful in designing implementation strategies, measuring the success of those strategies, and then providing feedback to us on what the effectiveness of that is,” Kelley said. “There is good alignment in terms of the big picture, what the goals are.”

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DURHAM VA HEALTH CARE SYSTEM PHOTO

CREDIT

LINKING RESEARCH AND CLINICAL PRACTICE


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The VA is participating in a study doing germline genetic testing for possible inherited genetic variants on women who would be screened for breast cancer. Using risk results from that genetic testing could, within the clinical study context, impact recommended frequency or starting age of mammograms.

Kelley said that with the core of precision oncology consisting of doing molecular testing and then treating patients, much can be learned from the large number of patients who are being treated in the VA and their outcomes of care. In this link between research and clinical, “information from one is fed into the other, and that drives this engine of immediate application of new discoveries. You have discoveries and then you immediately are able to apply them,” he said.

DURHAM VA HEALTH CARE SYSTEM PHOTO

FUTURE OUTLOOK Kelley highlighted three future developments in precision oncology looking ahead five to 10 years that he believes improve patient outcomes. First, he said, “I think this has probably been true for some time already, but what is needed to drive the learning health care system to be more efficient is better information systems. What I see is that those information systems will continue to improve, so that it allows us to be able to gather the information needed for any individual patient more quickly and accurately, and it will also allow us to learn from that data more quickly. “Another thing I see is that the types of testing that will be available and their applications will become larger,” he continued. “For example, right now [as] we’re talking about the precision oncology program, the way it’s practiced is mostly for patients who have metastatic or advanced stage disease, but that testing is going to be applied more and more for patients with earlier stage disease. And it’s already being applied in some limited ways, but it will probably be applied more frequently, in patients who don’t have cancer at all, but who are at risk for getting cancer, which is everybody.”

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For example, he explained, “For lung cancer screening, right now, we ask patients, ‘How much did you smoke, how long ago did you quit?’ and then we decide, ‘Okay, you get a CT scan, and you don’t.’ But it may be that we do a test, and say, ‘[although] you smoked a lot, this test shows that you’re not at high risk for getting cancer,’ whereas this other person is at high risk, and maybe doesn’t even have a smoking history, and so that person might get a CT scan. “This is being applied in breast cancer,” he continued. Currently, there are recommendations that are tailored based on family history or risk, “but there’s a study that VA is participating in that is doing germline genetic testing [testing healthy cells for genetic variants that may have been inherited] on women who would be screened for breast cancer and using the result of that testing to make recommendations, within the context of a clinical study, as to how soon and how frequently they would get the testing. If you’re low risk, you might not need a mammogram every year; every other year may be more than enough. And you may start [mammograms] younger if you have a high risk for

getting breast cancer, for example.” Kelley added, “We’re talking a lot about genes and DNA sequencing, but there are other types of molecular testing, and many of those will become more prominent,” including that “the ability to measure a lot of proteins all at once is becoming easier… These types of molecular tests, I think, will start to have more and more applications in oncology.” A third area Kelley identified “is the treatment options that we’ll be able to reach for will continue to expand. They’ve been expanding at a vicious rate the last five years. It’s amazing how many drugs have been approved, and new indications for old drugs. That is going to continue to accelerate. New types of drugs, new categories of drugs that we don’t have right now will start to become more prevalent.” With the continued expansion of access and expertise of NPOP in mind, Kelley concluded with a message to veterans: “For cancer treatment, if you’re a veteran, I think we have the very best cancer care in the world, and it can come to you,” he said. “If you have cancer, please consider using the VA and we will extend our expertise to you wherever you are.”

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ZipThaw202 – compact footprint.

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One way to maintain high plasma throughput with water baths is to use multiple devices. That’s expensive and requires its own additional maintenance overhead: More hot water baths means more staffers to maintain them. And since baths can’t easily be moved, working around fixed equipment creates more complexity of work flow and requires more hands on deck. This is particularly challenging when there’s a labor shortage for blood bank technicians. Now there’s an easier, faster, less staff-intensive way to increase plasma throughput. ZipThaw is a new, made-inthe-USA, FDA-cleared plasma thawing medical device that uses dry technology, advanced safety features, and other thoughtful innovations that make it ideal for military applications. Many current hot water baths have four chambers. Excluding warm up and

recovery times, it takes about 40 minutes to thaw four standard-size plasma bags to an unknown temperature. ZipThaw has two independent chambers, and in that same 40 minutes, it can thaw six bags to 31°C for transfusion, or up to eight bags to 15°C for refrigeration.

HOW FEWER CHAMBERS CAN EQUAL MORE THAWED PLASMA ZipThaw is an advanced, portable device that requires almost zero maintenance and no downtime. Because it uses fully dry thawing technology, it is lightweight, meaning you can thaw anywhere that works best for your clinic: at point-ofcare on a wheeled cart, or in temporary locations like hallways or anywhere else. All ZipThaw needs is an outlet. Since water baths require cleaning downtime after heavy use, on a daily

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anaging efficient and timely plasma thawing, especially for massive transfusion protocols, is a significant challenge for military blood banks and emergency rooms. Current plasma thawing methods rely on hot water baths, which are slow, messy, and outdated. These baths require large amounts of time at every stage of the thawing process: time to heat up, time to thaw the plasma, and further time to recover. They also tend to result in splashed water at the point of use, causing wasted time and effort to clean up after the plasma is thawed. Additionally, after a day of heavy use for a massive transfusion event, hot water baths will need to be taken offline and deep cleaned near a sink. With only a single working water bath, another massive transfusion event would result in a serious crisis in plasma availability.


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basis, ZipThaw produces more than twice the thawed plasma per hour than aging water baths. Why? Because ZipThaw works every day, all day. A water bath’s downtime for maintenance or cleaning is lost plasma thawing time, all while ZipThaw keeps humming away.

HOW ZIPTHAW WORKS ZipThaw is fast, reliable, accurate, and dry. There are no spills to clean, and it’s light enough to carry. • Dry technology – no cleaning and light enough to carry • Safety features – ZipSleeve® smart barrier and catch trays • Easy to use – touch screen and built-in barcode reader A thoughtful combination of innovative features make ZipThaw a consistent and reliable plasma thawer that needs almost zero maintenance.

DRY THAWING To thaw plasma with ZipThaw, slide a frozen plasma bag into a ZipSleeve, ZipThaw’s proprietary reusable leakproof pouch, then place that into one of two independent chambers. The chamber has cushions that conform to the plasma bag. The chamber gently conducts heat and almost silently massages the plasma until it warms to refrigeration or transfusion temperatures. This dry technology means there’s no water in circulation. The device is light enough to carry with one hand. Combined with a small footprint, this means that ZipThaw doesn’t take up limited bench space and you can streamline operations by placing ZipThaws where you need them, when you need them. Many clinics put them on a rolling cart; others carry them from point to point as needed.

SAFETY FIRST The ZipSleeve smart barrier protects the both device and clinicians from any cracked plasma bags. It also contains RFID sensors to carefully measure plasma

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ZipThaw Plasma Thawer at the Naval Medical Center San Diego.

temperature, so you always know the final thaw temp. ZipThaw advanced safety features mean the device is safe for you, your lab, and your patients. If a thawing bag of plasma tears, the ZipSleeve will contain it so there’s no contamination to the device or the other chamber. Simply toss out the ZipSleeve and start over. There are also catch trays and sealed off electronics, so that if even a ZipSleeve was to somehow tear, no liquid enters the core of the machine; you can clean out the drip tray and start again. An array of heat sensors in ZipSleeve and the ZipThaw chambers measures the temperature of the plasma itself, not its surroundings, which gives you the information you need to better care for your patients.

EASY TO USE It takes about 20 minutes of training to use ZipThaw, either via remote videos or on site with a distributor. Operating ZipThaw is quick to learn because the device is easy to use. A graphical touch screen, color-coded lights, and an integrated barcode reader make using ZipThaw exceptionally straightforward. There are no separate

parts to keep track of and no complex instructions or procedures. Simply press the touch screen, wave a bag of plasma to read the barcode, and insert a bag into a ZipSleeve that slides into a chamber. Scheduled maintenance for ZipThaw includes replacing the warming cushions within each chamber about once a year, depending on usage. Replacing the warming cushions can be done by a staff member in a few minutes, so there’s no need for a distributor to send a technician. Outside of that, there are periodic software updates that can be done via a USB key inserted by a staff member. Beyond these annual tasks of a few minutes each, there’s no additional maintenance needed. Each ZipThaw device is quality tested before it leaves the factory, and each ZipThaw comes with a three-year full replacement warranty. If you’re tired of the complexity and relative sluggishness of water baths, contact us for a ZipThaw demo and see how it can increase your plasma throughput. ZipThaw and ZipSleeve are made by FreMon Scientific, whose co-founder is a decorated two-tour Vietnam War combat veteran. The company is based in San Diego, California. ZipThaw and ZipSleeve are manufactured in the USA.

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INTERVIEW

GEORGIA ARMY NATIONAL GUARD PHOTO BY MAJ. WILL COX

JAMES McCORMICK

National Commander, Military Order of the Purple Heart By Chuck Oldham James McCormick was born in West Virginia, the son of a Vietnam veteran. He spent 22 years in the Army and Army National Guard. He served as an enlisted man for 16 years before deciding to become an officer, and retired as a captain. McCormick is a combat veteran of Operation Desert Storm and Operation Iraqi Freedom. During combat operations in Iraq during 2004-2005, he was wounded on three separate occasions. He has been a Life Member of the Military Order of the Purple Heart (MOPH) since 2008. Among his awards are the Silver Star, three awards of the Bronze Star with Valor, three Purple Hearts, the Meritorious Service Medal, the Army Commendation Medal, the Army Achievement Medal, the Good Conduct Medal, the National Defense Service Medal, the Southwest Asia Service Medal with three service stars, the Iraq Campaign Medal, the Armed Forces Expeditionary Medal, the Global War on Terrorism Service and Expeditionary Medal, the Army Reserve Component Achievement Medal, the Kuwait Liberation Medal, and the Combat Action Badge. His civilian awards include the Congressional Medal of Honor Society “Citizen Service Above Self” Medal and the Jefferson Award for civic service.

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James McCormick: Well, [it was] because I was qualified to join the organization as a Purple Heart recipient, number one, but also the fact that I was seriously looking at trying to get involved

COURTESY OF MOPH

Veterans Affairs and Military Medicine Outlook: Was it your personal experience that motivated you to become a part of this organization or was it a combination of things?

Top: The Purple Heart Medal is linked to the Badge of Military Merit established by George Washington during the Revolutionary War, and has since been awarded to those wounded or killed while serving in the U.S. military. Above: James McCormick, National Commander, Military Order of the Purple Heart.

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U.S. MARINE CORPS PHOTO BY LANCE CPL. ANDRE DAKIS, COMBAT CAMERA, MCB CAMP LEJEUNE

to help my fellow veterans if I could do it. So this seemed like a good fit for me. I was actually still in the Army. I had not been retired. So I joined the Military Order of the Purple Heart in 2008, and I retired from the Army in 2009. From 2008 until probably 2010, I was just a member. I had never held a position or did anything outside of being a member, paying my dues and participating. The Purple Heart wasn’t necessarily an award just for being wounded. It was a valor award, is that right? It was originally created by Gen. George Washington in 1782. … If you go back and study the history, there were a lot of things that were going on; the Revolutionary War had just tapped everyone out of money, soldiers weren’t getting paid, there were just a lot of things that were happening, and the morale was low. What George Washington wanted to do was to come up with a way to boost morale, but also recognize sacrifices that were made by enlisted soldiers. So back then, it was only for the enlisted soldiers because officers got a lot of things, but that poor enlisted soldier who actually does the fighting and

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Members of the Military Order of the Purple Heart sit in attendance for an annual remembrance ceremony at the 9/11 Memorial site in Jacksonville, North Carolina, Sept. 11, 2013. The ceremony was held as an annual tribute to all the fallen victims during the 9/11 terrorist attacks in 2001.

lifts the heavy weight doesn’t. So that was what the medal – it was actually a badge, the badge of military merit – was meant to do. We only have records that two of those were awarded, and they were for exceptional valor – they were what you would get the Medal of Honor for today. Do you have any idea of how many service members have received the Purple Heart? We can tell you that we have a list of about 486,000 that comes out in a publication that we update every three years. It’s a voluntary entry. It’s a huge book – living, deceased, everybody that we can get to sign on voluntarily or, if they’re deceased, we would put their names into this book. But there is obviously a lot more than that. So the answer is that no one really has that number. There are several initiatives out there. One, which we

have sponsored, working in collaboration with the National Flag Foundation, is to ask the Secretary of Defense to start collecting those names of current recipients and allow those who want to have their names or family members’ names that can provide documentation, to add their names to that list. But it would be purely voluntary. Some of the pushback we’ve had on that has been, ‘well, it violates their personal rights, maybe they don’t want you to know that they have a Purple Heart.’ Maybe that’s true, but we do think it’s important to start cataloging, that somebody have that data, whether it be a publicly accessible list or whether it be a list that just the Secretary of Defense has that people can get access to. Whatever the case, we’ve got to do something more than what we’re doing now. I would be able to tell you that we have 4 million recipients or 6 million recipients, but I just can’t give you that number now. What proportion of Purple Heart recipients have medical issues that follow them for the rest of their lives due to the wounds received while they were serving their country?

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For the physical aspect, I’ve been gunshot three different times, and I was in a roadside bomb blast. So, I know for me personally, I can tell you that I’ve experienced difficulties and still do. The majority that I’ve seen have some sort of physical ailment. When I say the majority, I’ll give you a percentage of somewhere around 96 percent. That’s a pretty good estimate: 95 percent on the low end and 96.5 percent on the high end have permanent disabling conditions from their injuries related to the Purple Heart. But again, that’s within our organization. I can tell you that every one of them – they never forget the incident. I don’t think that they are mentally deficient or they can’t do their jobs or something like that,

Then-Commandant of the Marine Corps Gen. Robert B. Neller speaks at the Military Order of the Purple Heart National Convention in Norfolk, Virginia, Aug. 13, 2016. The organization held its 88th annual convention in 2021.

because most of us do go on to successful careers outside of the military. But even I, as the National Commander, can tell you that I myself personally deal with post-traumatic stress disorder [PTSD]. So there are some times when I really reflect on the injuries. And more so, not just the injuries, but the actions that led to the injuries, because mine were all in

direct combat operations. It was a very serious, deadly situation where people were killed, people were horrifically wounded. It wasn’t just all about me, and I remember a lot about that. So, as far as the physical ailments, yes, there’s definitely parts of me that will never work right again. When I was shot through the hand, I can tell you there was a time probably three years after that occurred – this would have been about the time that I was getting ready to retire – when I asked a surgeon to just please remove my hand because the pain was just so excruciating, and I was going through surgeries where they would have to re-break bones, because when you tear up tendons and cartilage, it’s very hard for

“The other thing that we really want to look at is we’d like to see more emphasis on alternative therapies, on non-traditional medicine – on the ability to send a person to see a chiropractor or an acupuncturist in lieu of just tossing them a bottle of pills.” 16

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U.S. MARINE CORPS PHOTO BY CPL. SAMANTHA K. DRAUGHON

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V E TE R AN S AFFAI R S & M I LITARY M E D I CI N E O UTLO O K

U.S. MARINE CORPS PHOTO BY LANCE CPL. GINNIE LEE

that to ever heal back. So that number I gave you probably would be a really close, accurate number. What is the order’s position on the invisible wounds of war, such as traumatic brain injury (TBI) and PTSD? We support traumatic brain injury as a qualifying Purple Heart injury. Posttraumatic stress disorder is a little more difficult for us, and the reason being is because at what point does it stop? We don’t want to devalue this medal. I see a lot of people that have got a PTSD diagnosis that were never in combat. Now it doesn’t mean their situation wasn’t bad, horrible, terrible, because it was. But this medal is for combat injuries. The physical injury that’s caused by a blast to the brain, now that one absolutely needed to be identified and needed to be included, because I can tell you, I’ve seen people that have come out of roadside bomb blasts and seemed just perfectly fine, and then months and in some cases years later, they start

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U.S. Marine Corps Col. Curtis V. Ebitz, left, commanding officer, Marine Corps Air Station New River, assists Gunnery Sgt. Michael King, right, an ordnance staff noncommissioned officer in charge with Headquarters and Headquarters Squadron, MCAS New River, during a coffee donation event on MCAS New River, June 9, 2020. The Military Order of the Purple Heart donated the coffee to show their appreciation for the continued services of Marines and sailors throughout the COVID-19 pandemic.

experiencing the residuals of that injury, whether it be massive headaches, dizziness, forgetfulness … and then some of them have strokes. I mean, there’s a lot of things that occur. So our position is we fully support traumatic brain injury as a qualifying factor, but obviously when it comes to post-traumatic stress disorder, that’s something that’s a little bit different, because every one of my members – we have 49,000 members – every single one of them has PTSD. Every single one in the Order. Now, some

of them will say, ‘well, it doesn’t bother me,’ but every single one has a trait or a diagnosis or something. But it’s because of the injury. It’s because of the combat. Now, if the Department of Defense comes out and says, ‘hey, we’re going to award the Purple Heart for PTSD’ and that’s what they decide, we would offer our suggestion on that, but ultimately we’re not lawmakers. We support whatever they tell us to do; we would welcome all members that qualify for entry into the MOPH, and will treat them all with a level of dignity and respect. What are some of the pressing concerns and key issues of importance of the MOPH? The key issues of importance include access to health care, to have VA medical facilities that mirror each other around the country. Because I can have some recipients that go to a VA medical center in Huntington, West Virginia, and have a beautiful experience and no problems. But I can have them go to

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another VA medical facility and it’s wait times, rude staff, something. And some of them in the more rural, outlying areas seem to have more problems. Now, I don’t know if it’s harder to hire people, I don’t know what the deal is, but we’d like to see some standardization in the way that these facilities operate. Because, honestly, it would be different if it was some isolated cases. But it’s not isolated. These are consistent complaints that I see all the time. So that’s important, ensuring that we’re taking care of our veterans’ physical and emotional disabilities – not just our Purple Heart recipients; we like to feel that we’re looking out for all veterans. The other thing that we really want to look at is we’d like to see more emphasis on alternative therapies, on non-traditional medicine – on the ability to send a person to see a chiropractor or an acupuncturist in lieu of just tossing them a bottle of pills. You know, we still have a way to go on prescriptions. They’ve fixed a lot of it, it’s not nearly as bad as it was, but we’re still dealing with that. But we have to totally correct that. And the only way to do that is to have the VA and the U.S. government be more willing to accept [and] embrace alternative therapies that will allow more options on the table. And one more thing: The third thing is we want to see better opportunities for veterans – especially our combatwounded veterans – to be able to transition into jobs. You know, in the federal and state sector, there’s a lot of this, ‘oh you can just go get a job in the Post Office,’ and while that may be partially true, it’s definitely not altogether true, and it’s a long, difficult process that generally requires way too much red tape. We’ve just got to do better. We have to do a better job. I don’t think that we’re failing, but I do think that we are coming to a point to where we could fail if we’re not careful. What are some of the services and benefits the Military Order of the Purple Heart provides its members? One of the tangible benefits we have, outside of camaraderie and the ability to

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network and work with other recipients, is that we have a life insurance policy. We have a network of veterans that work together on legislative issues. We have a legislative director who has built a team, and we go into the Military Order of the Purple Heart, and we simply ask what needs to be addressed. Each year, we come up with three legislative agendas, and we build up grassroots and grasstops efforts around those things. The other thing that we have, if you go to our website at purpleheart.org, you’ll see that we have two very specific training programs. One is where we actually just partnered with Wounded Eagles, which is an organization that trains disabled veterans how to fly drones. We took it one step further with them and we wanted them to develop a program that helps to get our recipients and their members licensed so that they can be commercial drone pilots. Another thing we have is a program that trains people in software development in IT [information technology], and that’s all free for members. And kids, grandkids, they can sign on to the website, and they can take these classes, which is really cool. It’s not something that’s normally done, but it’s something that I’ve started to do. And then this year, I got us a free life insurance policy – it’s like $2,000, a death and dismemberment policy – and then there’s a discount card that we give all the members as well, and we’re continuously working on improving those tangible benefits for members and their families. One of the issues you have expressed concern for in the past is suicide, with respect to both veterans and their families, in that while the veterans’ suicide rate seems to be falling, that of family members is going up. Could you discuss that? It’s terrible, yes. It’s very true. That’s the reason why I have included families in everything that we do. If the families can’t be involved, then just forget it. It won’t work. A lot of these veterans want to see their kids succeed, they want to see their spouses succeed. And here’s the real problem: The real problem is that we’ve

got ourselves into this mindset, for lack of a better term, that it’s just all about the veteran and nothing else bothers us. But what really, really bothers us is the fact that we’ve got our family members that are out there suffering too, and nobody’s really doing anything to address that. So, at the Military Order of the Purple Heart, anything that we set up and do, we encourage a family-level participation, especially our youth … I believe that it is absolutely critical that we as veterans – every veteran organization out there – conduct outreach to our youth, and to our family members, and to make it more inclusive and less exclusive. So I say that being in an organization where the only way you can get in is to be combatwounded. I didn’t make those rules, but I do believe that does include our families. If I have 40,000 members, I can assure you I have three times that in family members that are affected by everything that we do to either improve or not improve the lives of our recipients of the Purple Heart. It’s just what we should do. We need to do a better job all the way around in my opinion. What should I have asked that I didn’t ask? I’m a believer that I’m going to be judged on how I treat my fellow man and woman. I can earn every medal, every accolade, everything you can imagine, but it doesn’t do me a bit of good if I’m not doing anything with it. So if someone calls me and says, ‘hey, this is a Silver Star recipient,’ if it gets me a chance to go and stand in front of a group of people and encourage them to support a program like the Military Order of the Purple Heart, or the Hershel Woody Williams Foundation, or a suicide awareness and prevention program, then buddy, you can put me on a chain, and you can tell people every single story you want to tell them about my service and combat as long as it will get me into a position to where it can be used for the betterment of other people. I tell people, get engaged: Whatever it is that you think is your strength, engage it, move on it, and don’t look back.

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GERM-ZAPPING ROBOTS

Disinfecting UV systems add a layer of protection against health care-acquired infections. By Scott R. Gourley

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ne technology that has become an increasing presence in hospital settings over the last 10 to 15 years is the use of ultraviolet (UV) light to help sanitize those facilities to reduce the risk of health care-acquired infections. And both the Department of Veterans Affairs (VA) and U.S. military medical systems have become leaders in the application of that technology to help protect patients and improve their medical care. “Our scientists have been looking at the factors that lead to infection transmission within the hospital settings, what we call health care-acquired infections or nosocomial infections,” explained Chetan Jinadatha, MD, MPH, chief of the Infectious Diseases Section at Central Texas Veterans Health Care System, “and they can be lumped into two broad categories. One is what we call device-related infection, and examples could be infections resulting from a catheter or throat tube. The second major category are nondevice infections, which are further broken down into surgical site infections that are process related and MRSA [Methicillinresistant Staphylococcus aureus] and C. diff. [Clostridium difficile] infections. And the majority of the infections in the hospital are in these two categories: Either they are MRSA, with or without device, or Clostridium difficile infections.” Jinadatha added that researchers attribute approximately half of these infections to contamination that is around the patient’s room. “For example, let’s say you are a patient who comes into the hospital for chest pain, and you get admitted to a room that was previously occupied by a MRSA patient.

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You are two to three times more likely to get a MRSA infection as compared to somebody going into a non-MRSA previously occupied room. And it’s a similar number for some bacteria and some viruses. So what we found out is that the surfaces in the hospital rooms are grossly contaminated when occupied by a patient carrying the disease.” He was quick to clarify that housekeeping staffs are extremely dedicated and apply their best efforts to cleaning rooms after patients are discharged, but added that some residue or contamination can be left on surfaces in spite of these efforts. “And then UV technology came about as an addition to manual cleaning as a way to improve disinfection,” he said. “You need to give adequate time and dose. One flash is not going to do it. But ‘X’ kilojoules of UV for ‘X’ amount of time is a lethal dose for these organisms. And the hypothesis is that killing the bugs on those surfaces leads to better patient outcomes.” He explained that the UV light is generated by a bulb that contains a gas, like mercury vapor or an inert gas like xenon, adding, “The bulb and the intensity of the electricity across the gas produces an arc that has UV spectrum in it.” There are three wavelength ranges within the UV light spectrum: UV-A, UV-B, and UV-C. It is within the UV-C wavelengths that the germicidal effects are achieved. Noting that his VA medical system began to receive the initial UV disinfection systems in the 2011 time frame, Jinadatha asserted that they were one of the first ones to adapt the UV technology within

the entire VA system. “I know people thought I was crazy when we bought the first ones,” he said. “I still remember people saying, ‘You are giving an almost $50,000 piece of equipment to housekeepers who barely can keep up with the many things they are already tasked to do. How do you expect them to operate?’ I said that we couldn’t expect people to do a good job if we didn’t enable and supplement them with the latest and best technology. So we fought for it and we convinced them. And it has been a good success. People are very proud now of using them. They see that it actually makes them look better and so they actually use it more often.” In addition to the VA, the UV technology

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U.S. MARINE CORPS PHOTO BY LANCE CPL. ANDRE DAKIS, COMBAT CAMERA, MCB CAMP LEJEUNE

V E TE R AN S AFFAI R S & M I LITARY M E D I CI N E O UTLO O K

L-VIRA, a germ-zapping robot, emits a flash of ultraviolet-c (UVC) light for disinfection of an intensive care unit hospital room at William Beaumont Army Medical Center in 2015. The robot contains special bulbs that emit UVC light – destroying cells within a certain radius and reducing the number of health care–associated infections (HAIs) in the area. William Beaumont Army Medical Center began using the robot in March 2015 and continues its use to provide patients innovative, life-saving care through cutting-edge research and technology.

is also demonstrating its benefits in many military medical facilities as a supplement to traditional cleaning. According to Donnell R. Williams, chief of the Environmental Services Branch at Brooke Army Medical Center (BAMC), primary hygiene emphasis in that facility is still on FROG, an acronym for “friction rubs off germs.” “We have to clean and disinfect with a chemical first and then we utilize the

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non-toxic UV disinfection to ensure a complete disinfection,” he said. “The UV disinfection through various studies has been shown to be effective in reducing superbugs and minimizing the potential of hospital-acquired infections.” “It’s the initial friction and removal with the chemical for disinfection that we absolutely must have first,” echoed Bernadette L. Thompson, RN, BSN, CIC, chief of Infection Prevention and Control

at BAMC. “We can’t do just one without the other. So they complement each other very well to allow an extreme terminal disinfection.” Observing that there are “probably more than 20 UV disinfection systems out there today,” Williams said that BAMC received its first UV system around 2017. While declining to identify a specific manufacturer, he added that the primary system used there today is a robotic design that looks like the “R2-D2” droid from Star Wars. Comparing the various design options available, he offered, “Some are big and bulky while some are smaller and easier to maneuver through the facility to get them where they need to go. “And then you have different UV light,” he added. “For example, one of the systems here utilizes the pulsating xenon ultraviolet light system, and that gives you the burst of light that is supposed to kill the microorganisms a little bit better than the broad-spectrum lights.” Asked to elaborate on the advantages and disadvantages of the different UV-generating and design technologies, Jinadatha began by pointing to a historical preponderance of mercury lamp/mercury vapor designs, with “very few” pulsedxenon lamp designs across the world. “We mainly did research on pulsedxenon,” he said. “And the idea is that they produce varying wavelengths of UV, with UV-C mainly the germicidal UV. And the dose of output is also different [from mercury vapor designs]. So, based on those two things, the required time to disinfect may be different. For example, some of the mercury vendors require 5 minutes, some of them require 10 minutes, some of them require 20 minutes. And the pulsedxenon protocols are about 5 minutes in a couple of positions around the room, then one position in the bathroom, and you’re done. So it’s about 10 to 15 minutes of UV disinfection. It is a slightly quicker process based on their protocol, and some of that we have validated in studies to be effective in reducing the environmental contamination.”

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U.S. ARMY PHOTO BY PATRICIA DEAL, CRDAMC PUBLIC AFFAIRS

V E TE R AN S AFFAI R S & M I LITARY M E D I CI N E O UTLO O K

One company applying pulsed-xenon technology is San Antonio-based Xenex, which was founded in 2009. Founder and chief science officer Dr. Mark Stibich explained that the company’s initial disinfection studies were conducted in 2010 and published in 2011. “We were basically looking at: Can we make a room cleaner? Can we bring down

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Ed Manley, government accounts representative for TRUDefense, Inc., demonstrates the capabilities of the TRU-D (Total Room Ultraviolet Disinfector) SmartUVC robot to Carl R. Darnall Army Medical Center (CRDAMC) operating room staff. The robots use ultraviolet light energy proven to kill 99.99 percent of viruses, bacteria and fungal spores.

the amount of organisms in a room better than housekeeping? And the answer was yes, we are about 20 times better than traditional housekeeping at doing that.

So that was really an exciting moment. And since then, I believe we’ve partnered with over 900 hospitals to bring our technology in and try to help them,” he said.

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PHOTO BY MARCY SANCHEZ

Alex Buda, infection prevention specialist, William Beaumont Army Medical Center (WBAMC), prepares L-VIRA, a germ-zapping robot, for disinfection of an intensive care unit hospital room at WBAMC.

“This battle is not only against COVID,” he added. “It’s also against these antimicrobial-resistant infections and C. diff. All of these things that can be hospitalacquired infections are just horrible, because someone’s going into the hospital for one thing, and we certainly don’t want them to pick up an infection.”

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The Xenex designs match the broad “R2-D2” description, with Stibich characterizing the robots as “tools for the housekeepers.” He added, “The pathogens keep evolving. The bacteria get worse and worse and harder and harder to treat. And we need to make sure that housekeepers

in the VA system have all the tools they need to do the job of making a room safe for the next patient.” Elaborating on the underlying pulsedxenon UV technology, Stibich explained, “We are taking xenon gas, which is an inert gas, and we’re putting electricity into it to create a microsecond flash. Sometimes we do that so fast that you don’t even see it. But that flash is high intensity with high-energy UV in all these different wavelengths of what’s called germicidal UV, which is from 200 to 280 nanometers. And the reason that works really great is because it’s actually those wavelengths that are filtered by the ozone layer. Bacteria and viruses, when they evolved over 4 billion years on Earth, were never exposed to that energy. So they don’t have a lot of defenses to it, because it doesn’t naturally occur on Earth. So, they don’t have a way to protect themselves like they do from other types of light. And so we’re able to produce the whole range of wavelengths, including germicidal. And we do that at a really high intensity that’s about 4,000 times more intense than just a conventional UV light. And as a result, we’re pretty fast.” Referring to alternative mercury-based lamp designs, he asserted, “Those obviously have mercury in them, which is something hospitals are trying to get rid of. And the VA specifically has orders to reduce the amount of mercury. It also produces a single wavelength, really concentrating on 253.7 nanometers. And that’s going to have just one type of kill, whereas we are creating different approaches, different wavelengths, different energies

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U.S. AIR FORCE PHOTO BY STAFF SGT. ANTOINETTE GIBSON

Geri Genant, Xenex Healthcare Services implementation manager, demonstrates the capabilities of a germ-zapping robot to U.S. Air Force airmen at Langley Air Force Base, Virginia, in 2014. The 633rd Medical Group partnered with Xenex, creator of the robot, in an effort to provide a safer health care facility for the Joint Base Langley-Eustis community.

that we’re using, that cause different types of damage.” Stibich said that the robot is an original Xenex design, with the company supported by an in-house engineering team that modifies and improves the robot design. “We’ve been through about six versions of the robot to date,” he said. “The light that we’re emitting is essentially the same in each version, but we’ve learned a lot about how hospitals can be really tough on equipment. But not only do you have to deliver a great technology that has good efficacy, it has to be in a form that facilitates the use of these robots.” Modifications have included safety features to reflect the intensity of the UV light as well as usability enhancements like an embedded tablet that provides real-time data on robot use, including who used it and where it was used. Observing that the current design setup and movement is controlled by housekeeping staff, he said, “We’ve actually designed and tested robots with more autonomy, where they can move around a room. But surprisingly, what we found was that the number of rooms that got done dropped a lot, because hospitals are such a complex environment for trying to get a robot that moves. So it’s much better to have a person and a robot working together.” The Xenex systems are currently in 130 VA and Department of Defense facilities, with anywhere from two to 12 robots at each site. Looking toward the future, Stibich said, “We are continually improving the robots. And we just launched a new version of the robot, which has, again, some of those enhanced usability features. And we are continually trying to make it easier and easier for people to use and operate.”

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Other recent developments include a handheld “spotlight” design that casts a 2-meter cone diameter at a distance of 2 meters. “We’re thinking about using it in places like workstations,” he said. “From a military perspective, there are a lot of places on settings like a ship that are hard to get equipment into. By contrast, this could be carried in to provide a lot of flexibility in the format and application.” Jinadatha agreed on the importance of simple operational design but acknowledged that challenges ranged from the reality that it can only be done in an empty room after patient discharge to the fact that light only penetrates certain areas. “For obvious reasons, it won’t go in shadow areas or inside cabinets,” he said. “So that is an additional challenge in terms of thoroughness of cleaning. Some people debate whether that’s even needed, because nobody’s putting their hands with MRSA inside a cabinet. So you really need to disinfect it.” Jinadatha summarized, “I firmly believe that the VA has been in the forefront in providing leadership on the adoption of newer technologies,

especially things that make it a safer place for our veterans. In the trenches, I can tell you that even back in 2014, shortly after we first adopted it, I testified in front of the U.S. Congress Space and Technology Committee about this particular technology. And we reassured Congress at that time that we were doing our best. Our leadership had the courage to invest in this. We made it a safer place. We have seen the fruits of our results here in terms of preventing infections.” He concluded, “The hope is that there will be more and more of these technologies, and we will become the leader in setting the standard for care.” BAMC’s Williams agreed, echoing, “I believe this technology enhances the disinfection [process] and reduces the risk of pathogenic microorganism transmission. Utilizing the UV technology is quickly becoming the best practice throughout the health care cleaning community. BAMC is definitely committed to constantly looking for ways to increase the safety of our staff and patients, and the UV disinfection is definitely an added layer of protection.”

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VA RESEARCH

THE VACO INDEX

To protect the vulnerable, VA experts design a rigorous, validated calculation of COVID-19 mortality risks. By Craig Collins

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he speed at which the virus we now call SARS-CoV-2 spread throughout the world in the spring of 2020 proved more than our institutions could handle: Within a matter of weeks, more than 100 countries were reporting cases of COVID-19, the complex – and sometimes deadly – disease caused by the virus. So much was unknown in those first weeks: Why were there such a variety of symptoms – or sometimes no symptoms at

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all – among those who’d been infected? Why were there such vast differences in patient outcomes? Some people seemed to recover quickly, while others – some of whom were otherwise healthy, with no other diagnosed health conditions – succumbed to the disease. As clinicians and researchers worked to gather information and devise strategies for detection, prevention, and treatment, a noisy and often contradictory data set emerged. Some early pieces of

the puzzle didn’t seem to fit with others. It seemed clear that older people, and people with underlying health conditions such as diabetes, were more likely to have severe cases of the disease – but plenty of questions remained. In these uncertain months, the capacity for testing was limited; the effectiveness of treatments was unknown; and a good protective vaccine was estimated to be anywhere from 12 months to 10 years away. Clinicians needed a way to understand their patients’ risks for the worst outcomes, independent of these unknowns. Amy Justice, MD, PhD, a clinical epidemiologist, is the C.N.H. Long Professor of Medicine and Public Health at the Yale School of Medicine and a staff physician at the VA Connecticut Healthcare System. She has spent much of her career developing large national research cohorts based on data in the VA’s electronic health record (EHR), other national databases, patient surveys, and tissue repositories, and she knew a close look at VA patients could offer some insights into

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NIAID IMAGE

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U.S. NAVY PHOTO BY MASS COMMUNICATION SPECIALIST 2ND CLASS MICHAEL H. LEHMAN

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Opposite page: This scanning electron microscope image shows SARS-CoV-2 (orange) — also known as 2019-nCoV, the virus that causes COVID-19 — isolated from a patient in the United States, emerging from the surface of cells (green) cultured in the lab. Above: U.S. Navy Lt. Cmdr. Leonard Aranas, a critical care nurse from Navy Medicine Readiness and Training Command Bethesda, replaces an oxygen tank for a COVID patient at Ochsner Lafayette General Medical Center during the COVID-19 response operations in Lafayette, Louisiana, Aug. 26, 2021. The VACO Index estimates an individual patient’s risk of all-cause mortality within 30 days after COVID-19 infection.

individual risks for COVID-19 mortality. Justice began to assemble a team of researchers to look at VA patient data and devise an index that could accurately predict whether a person, once infected with SARS-CoV-2, would die within 30 days. “We wanted to come up with some things that could be used to look at people before they get COVID, and be able to say:

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This person is really at risk for a bad outcome,” said Justice. “Because early on, we were talking about having to decide who should get vaccines, or even who should get tested, because even testing was limited then. So we wanted to be able to target the folks who were at the greatest risk – and we wanted to use information that was generally available.”

Joseph King, MD, MSCE, chief of neurosurgery at the Connecticut VA and an associate professor at the Yale School of Medicine, became a valued team member soon after the effort was launched. He earned a master’s degree in clinical epidemiology and biostatistics while training as a neurosurgeon, and since the 1990s has been performing epidemiological research on big data sets; today he directs Yale’s neurosurgical outcomes research program.

STEP ONE: FINDING THE RIGHT DATA The starting point for developing the index was a review of every VA patient

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The last thing Arvin McCray remembered was waving goodbye to his sister. Doctors didn’t think he’d live through the night. Or the night after that. For 18 days, the Army veteran was sedated and on a ventilator as his body fought the coronavirus despite multiple organ failure. On May 5, 2020, McCray left the hospital for the first time in 50 days. VA patient data provided a large sample to enable development of the VACO Index.

in common among them. Cutting through the noise and focusing on meaningful data, said King, required clinical experience: “We have experience treating patients and treating diseases, so we don’t just look at every single variable that’s available in the dataset. There may be spurious connections, or there may be things that just don’t make sense clinically.” The team’s analysis focused exclusively on data available before the positive test: demographics such as age, race, and gender, as well as comorbid conditions. Some associations were clear: being older, or male, clearly increased one’s chance of dying of COVID-19. Other correlations weren’t as immediately apparent. Looking at comorbidities individually – heart disease, for example,

or diabetes – led the team to think a bigger-picture view of a patient’s disease burden would offer a better prediction of mortality. This work, to an extent, had already been done for them: In 1987, Mary Charlson, MD, an internist and now-professor of medicine at Weill Cornell Medical College, developed a weighted index of 17 specific conditions to predict a hospitalized patient’s risk of death within one year. The Charlson Comorbidity Index has since been used in literally thousands of medical research publications. “She found that hypertension by itself – which is incredibly common; after the age of 65, more people have hypertension than don’t, right? – isn’t actually a risk factor, when you account for the other conditions,” Justice said. “Once people

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who tested positive for SARS-CoV-2 between Feb. 8 and Aug. 18, 2020: a total of 13,323 individual records. The knowledge and expertise needed to analyze and make sense of a dataset this large is considerable – but at the VA, it was already available: a team of clinician researchers such as Justice and King, data scientists, programmers, and other analysis experts. The team needed to do more than simply pull the data out, said Justice. “You have to really know what’s behind that data; you need to understand what missing data means,” she said. “You need to understand how to clean the laboratory data – which is not trivial. You need to understand how to calculate what medications people are on. But we’ve been doing that for 25 years.” The VA team split the sample into three temporal cohorts and looked for commonalities among the 946 people who died within 30 days of testing positive. As one might imagine, 946 people had a lot


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U.S. ARMY NATIONAL GUARD PHOTO BY SPC. CHRISTOPHER SHANNON II

Air Force Senior Airman India Whittle, COVID-19 test administrator assigned to the 186th Air Refueling Wing, Mississippi Air National Guard, talks to a patient at a mobile testing site for COVID-19 in Port Gibson, Mississippi, April 22, 2020. The Mississippi National Guard was working with the Mississippi State Department of Health facilitating multiple mobile testing sites throughout the state.

are 65, they tend to have more than one condition. They tend to have two or three or four conditions, and one of them might be hypertension – but hypertension isn’t what’s driving your risk for bad outcomes with COVID. So that was one of the things we thought was the most important thing to tease apart: To what extent was it particular diagnoses – everyone was talking about diabetes; you kept reading about the COVID risk of diabetes in the newspapers – and to what extent was that just burden of disease?” The Charlson Index score turned out to be a better predictor of COVID mortality than a look at nearly all the individual comorbidities – except for heart attack or peripheral vascular disease, each of which sent a strong enough signal that they were scored separately by the VA team. “So basically,” said King, “our index uses age, gender, and Charlson score,

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and then whether or not you have had a heart attack or peripheral vascular disease.” The team’s result – the Veterans Health Administration COVID-19 Index for COVID-19 Mortality, widely known as the VACO Index - was validated among the VA patient population and published in the journal PLOS One in November 2020.

A RACE-FREE INDEX Anyone who has followed news media coverage of the pandemic may be surprised by at least two factors that are excluded from the VACO Index: race and body mass index (BMI). From the beginning of the pandemic, the public has been told, in a variety of ways, that a person’s risk of dying of COVID-19 is greater if they are non-white and/or if they are overweight. The VACO Index team’s work reveals that while this isn’t exactly wrong,

it’s not exactly right in the way a clinician caring for an individual needs it to be right. An explanation begins with clarifying what the index is for: It’s a screening tool that estimates an individual patient’s risk of all-cause mortality within 30 days after a COVID-19 infection. “All-cause” means simply that the patient died of something after being infected by the virus; whether COVID-19 could be specified as the cause of death, or even foremost among multiple contributing causes, clouds the purpose of the VACO Index: simply to determine a patient’s risk of dying (of anything) after a COVID-19 infection. When peer-reviewed articles are titled for medical journals, their language is more precise than the headlines of news articles reporting on it. For example, a National Institutes of Health (NIH) study on racial disparities in COVID-19 outcomes was published in the journal Annals of Internal Medicine in October 2021, titled: “Racial and Ethnic Disparities in Excess Deaths During the COVID-19 Pandemic, March to December 2020.” The team’s findings – that there were “profound

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racial/ethnic disparities in excess deaths in the United States in 2020 during the COVID-19 pandemic” – were summarized in an article on the Healthline website titled: “Why Black, Native American, and Latino Communities Experience Higher COVID-19 Death Rates.” The word “rates” is unintentionally misleading in this context; studies such as these have indicated that overall, non-white groups are at greater risk for dying of COVID. But importantly, the estimates are typically based on everyone in a specified racial or ethnic group, whether they’ve been infected with the virus or not. It’s an important distinction, said Justice: “So many of the papers that have talked about race being an incredible risk factor were asking: OK, if I am

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Genesis Nursing Home patients in Maryland receive COVID-19 vaccinations in December 2020. The VACO Index has been successfully tested against varying patient populations.

Black, what’s the chance that I will die of COVID? Not: If I am Black, and I have COVID, what’s the chance that I’ll die with COVID? Most of those publications did not specify who had tested positive.” The VACO Index group, and other VA investigators, have made that distinction, and they’ve found, “if you account for who tests positive, the risk for mortality – given that you’re positive – is no different by race,” said Justice. “But the risk of testing positive was dramatically higher for people of minority status, especially Black and Hispanic patients.

So if we are to intervene on that disparity, we need to keep people from getting the infection. It’s not that we need to manage them differently once they get the infection.” The VACO team also found that obesity – a BMI of 30 or higher – wasn’t a strong risk factor for COVID-related mortality after accounting for other risk factors; it wasn’t until BMI reached about 35 that it became modestly significant.

VALIDATION AND ROLLOUT One of the pressing questions, after the VACO Index had been developed, was whether it would be validated by other samples. VA patients are a diverse group overall, but they are not without some distinctions. For example, said King: “Within

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MARYLAND GOVPICS PHOTO BY PATRICK SIEBERT

U.S. AIR FORCE PHOTO BY STAFF SGT. ANTOINETTE GIBSON

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V E TE R AN S AFFAI R S & M I LITARY M E D I CI N E O UTLO O K

TED EYTAN VIA WIKIMEDIA COMMONS

American flags representing those dead from COVID-19 planted at the base of the Washington Monument.

the VA, minority groups have better access to health care than they do in the general population … so the quality of care they receive, and their access to care, is better within the VA than it is for many people who receive care outside the VA.” The big question, then, after the VACO Index was developed, was whether it would accurately predict short-term COVID-related mortality in other patient populations. The team ran data from two additional sources: more than 1,300 COVID-positive patients from Yale New Haven Hospital, and more than 425,000 Medicare patients. There were some obvious differences among these patients: The VA sample included both outpatients (some of whom took a drive-through test and never got very sick) and inpatients; the Yale hospital patients were all inpatients – in other words, sick enough to require hospital admission. Medicare patients are, by definition, at least 65 years of age, so their risk skews higher than a population with a wider age range, such as the VA patient population. According to Justice, testing the index with these different patient populations was key to validating its effectiveness.

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“I’ve spent a lot of my life working on how you decide when a predictive index generalizes to the next patient who walks through your door – because you can only base it on what you’ve seen in other patients,” she said. “We looked at these three groups that were intentionally different from each other, and the index worked reasonably well in all three.” After validation, the team looked for ways to help clinicians use the VACO Index for three specific purposes: to prioritize patients for primary vaccination (and now booster vaccinations); to motivate highrisk people and their contacts to practice social distancing until vaccinated; and to identify people testing positive at driveup or other off-campus sites who should undergo clinical examination and possibly laboratory evaluation. The VACO Index has been widely adopted by clinicians in its first year, after the team presented it to the Centers for Disease Control and Prevention (CDC), the Department of Defense, the Food and Drug Administration (FDA); the Centers for Medicare and Medicaid Services (CMS); Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the chief medical

adviser to the president; and several HMOs. With MDCalc, the online medical reference that provides web-based and mobile decision-support tools for health care professionals, Justice – who has worked with the company to develop other decision-support tools – was able to get a VACO Index calculator available to web and mobile users. More than twothirds of U.S. attending physicians regularly use MDCalc. “That made it available to VA and non-VA docs alike,” said Justice. MDCalc reported more than 31,000 users of the index worldwide, from Omaha to Ho Chi Minh City, by October 2021. The rollout of the index has revealed another use for the VACO Index: It can inform larger-scale risk models for health insurers. CareJourney, an analytics company founded in 2014 to provide accountable care organizations (ACOs) with insights from health record data, used the index to both look back at examples – individual cases – that might have been managed differently, and look forward to managed care. “The output from this model,” said Aneesh Chopra, president of CareJourney, “has been incredibly useful for health plans looking to improve their risk models.” The VACO Index will no doubt be refined over time, but because its sample was split into three validation cohorts (the first as the model was being developed; the second and third as testing became more widely available, treatments improved, and the Delta variant of SARS-CoV-2 emerged as a more transmissible and possibly more pathogenic virus), King and Justice expect it to hold up. “The disease is kind of a moving target,” said Justice, and the unfolding of new developments such as more testing and better treatments, “set the bar higher for us to show our index was, in fact, a solid index that could give good value – and it still did, even as we used this later group of people to validate it.”

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VA RESEARCH

A BETTER WAY TO DETECT KIDNEY DISEASE

Experts at the San Francisco VA are pioneering a more accurate – and race-independent – measure of kidney function. By Craig Collins

O

n Sept. 23, 2021, the American Society of Nephrology (ASN) and the National Kidney Foundation (NKF) released a joint statement titled “Removing Race from Estimates of

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Kidney Function.” Of the more than 37 million American adults with kidney disease, a disproportionate number are people of color. The work of the organizations’ joint Task Force on Reassessing

the Inclusion of Race in Diagnosing Kidney Disease had, after countless hours of research, analysis, and discussion, arrived at the conclusion that the way kidney function was currently assessed – using equations that included race as a factor – is a likely contributor to these worse outcomes. As part of the joint statement, the president of the NKF, Paul M. Palevsky, MD, – who is also chief of the Pittsburgh VA Medical Center’s renal section – said: “The use of race in clinical algorithms normalizes and reinforces misconceptions of racial determinants of health and disease. We must move beyond this if we are to address the racism and racial disparities that impede the care of people with kidney disease.” The work discussed by the ASN/ NKF Task Force included that of Michael Shlipak, MD, MPH, associate

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VA ORD PHOTO

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chief of medicine for research at the San Francisco Veterans Affairs Health Care System (SFVA) and a professor of medicine, epidemiology, and biostatistics at the University of California-San Francisco (UCSF). For nearly 20 years, Shlipak has been looking for better measures of kidney function, and he’s been joined in recent years by Michelle Estrella, MD, MHS, chief of nephrology at the San Francisco VA and an associate professor of medicine at UCSF. Both are co-leaders – Estrella as executive director, Shlipak as scientific director – of UCSF’s Kidney Health Research Collaborative, a worldwide consortium of scientists dedicated to improving kidney health. What does race have to do with kidney function? In their joint statement, the NKF and ASN point out that “race is a social, not a biological, construct.” Nevertheless, the standard test used to measure kidney health for more than seven decades continues to include race

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Opposite page: Both the ubiquitous kidney function test, used for decades, that measures creatinine, and the test measuring cystatin C require a simple blood draw, but the latter test has proven to be more accurate. Above: Michael Shlipak, MD, MPH, associate chief of medicine for research for the San Francisco Veterans Affairs Health Care System (SFVA) and professor of medicine, epidemiology, and biostatistics at the University of California-San Francisco (UCSF), and Michelle Estrella, MD, MPS, chief of nephrology at SFVA and an associate professor of medicine at UCSF, are co-leaders of UCSF’s Kidney Health Research Collaborative and are promoting a test of kidney function that is more accurate than the current one.

in its interpretation as an estimate of kidney function. Shlipak and Estrella are among a growing number of medical professionals who want to do better – and they’re promoting a test of kidney function they have helped to prove is more accurate.

THE PROBLEM(S) WITH CREATININE Kidneys perform a variety of functions to balance blood components and keep the body healthy: They regulate electrolytes; maintain fluid and acid/

base balance; help the body absorb amino acids, glucose, and other compounds; produce hormones; activate vitamin D; remove toxins from the blood; and regulate blood pressure. The primary measure of how well kidneys are working is the rate at which their microscopic clusters of capillaries – the glomeruli – are filtering waste and extra water out of the blood while retaining the proteins and blood components the body needs. This is expressed as the glomerular filtration rate, or GFR – essentially, how much blood is filtered by the kidneys each minute. In 1926, a Danish physiologist was the first to

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U.S. ARMY PHOTO BY D. MYLES CULLEN

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estimate GFR by measuring the level of creatinine – a breakdown product of muscle activity – in the blood. While it has been the standard measure of kidney function ever since, using serum creatinine alone to measure GFR, say Shlipak and Estrella, is a fundamentally flawed approach. “Our muscles are full of creatine,” said Shlipak. “And after we are active, as muscle repairs itself, it dumps out creatine that becomes creatinine in the blood. Therefore, the more active you are, the more creatinine comes from your muscles and has to be eliminated from the body.” Estrella pointed out that serum creatinine levels are clearly affected by variables that have nothing to do with kidney function. “Our veterans,” she said, “who tend to be older, and some of whom are frail, may have misleadingly low creatinine.” As a result, when such patients’ creatinine levels are used to estimate GFR, their kidney disease may

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World War II veteran Spencer Moore is greeted by a former service member at the conclusion of the ceremony to mark the 60th anniversary of the integration of the armed forces in the Capitol Rotunda, Washington, D.C., July 23, 2008. The most popular kidney function test used today has over-emphasized race in equations associated with creatinine levels, and this has created treatment disparities for Black patients.

go undetected or its degree of severity underestimated. Likewise, many active-duty military service members may have elevated creatinine levels despite having healthy kidneys – something that came to Shlipak’s attention when he was working with his colleagues in the military to develop the VA/DOD Clinical Practice Guidelines for the Management of Chronic Kidney Disease. In fact, these highly fit service members “just had so much muscle that they were making a ton of creatinine,

which created the illusion that they had kidney disease.” Creatinine, Shlipak said, is a good test of kidney function in average, reasonably healthy people who don’t use their muscles too much, or too little – but those are not the people most at risk for kidney disease. “So there’s this irony that the sicker you are, and the more likely you are to have kidney disease, the less likely we are to be able to detect it accurately with creatinine.”

RACE AND KIDNEY HEALTH INEQUITIES The medical community has long been aware of the pitfalls involved in relying on serum creatinine and has attempted to refine and weigh factors in the equation used to arrive at a reliable estimated GFR (eGFR). The eGFR equations commonly used today, known as the MDRD and CKD-EPI, include age, sex,

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Why race? Several studies have indicated that Black patients, for reasons that are only partly understood, have slightly higher average measured GFR than non-Black patients with the same age, sex, and serum creatinine.

and race to approximate the unknown quantity of creatinine that each individual produces. The idea is that if you could accurately account for the amount of creatinine that a person makes, then the blood creatinine level would only reflect kidney function, the rate of creatinine being filtered out into urine. Why race? Several studies have indicated that Black patients, for reasons that are only partly understood, have slightly higher average measured GFR than non-Black patients with the same age, sex, and serum creatinine. The most recent version of the CKD-EPI formula, updated in 2009, automatically adjusted the eGFR of any Black patient by a factor of 15.9 percent.

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Race-based considerations in measuring kidney function – in making any medical judgments – are on their way out, Shlipak said; he’s physically active, and if he theoretically had an identical twin who was bedridden, the difference in their serum creatinine would be huge even if they had identical kidney function. In contrast, a man his age of African descent with the same kidney function, and who worked out about as much would show a much smaller difference in serum creatinine, if any. Race, Shlipak said, “is not nearly as important a factor for determining creatinine production as other health factors, so it has been over-emphasized by these equations.”

Boosting Black patients’ creatinine eGFR by 16 percent – essentially, making their kidney function look 16 percent better than a white patient evaluated with the same formula – has had consequences. An article published in the Journal of General Internal Medicine in October 2020 reviewed records for 57,000 patients in the Boston area and found that a third of the Black patients would have had their disease classified as more severe if the same eGFR formula had been used for them as for white patients.1 The study identified 64 cases in which patients’ recalculated score would have qualified them for placement on a kidney transplant waitlist – but none was

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The 300th Sustainment Brigade conducting a brigade 5-kilometer run. Many members of the U.S. military may have elevated creatinine levels despite having healthy kidneys, simply because they have more muscle mass and thus more creatinine in their bodies.

U.S. ARMY RESERVE PHOTO BY CAPT. JERRY DUONG

disease earlier, then I think we would be more aggressive in starting medications like ACE-inhibitors or statins to lower their risk of heart disease.” Lifestyle interventions, such as diet and exercise and quitting smoking, can also alter the course of kidney disease – but only if the clinicians detect a problem with kidney function and inform patients of their risk. Despite the good intentions the medical community had when incorporating race to calculate eGFR, Shlipak said, “it certainly has adverse consequences, it’s terrible for morale, and it leads some patients to lose trust in their medical care.” For all those reasons, the use of race in the eGFR formula is on its way out. “The VA is committed to taking race out of creatinine equations by the end of calendar year 2021.”

referred or evaluated for a transplant. That’s a huge, potentially life-altering, consequence – and it’s dramatic enough to overshadow more subtle implications for veterans’ health care. “I think our reliance on creatinine,” said Estrella, “leads to missed opportunities – to start medications, for example, that we know decrease the risk for heart disease and slow the progression of kidney disease.” As she pointed out, most of those opportunities arise within the primary care settings where most patients with kidney disease are treated. “The biggest killer in our patients with kidney disease is heart disease,” Estrella said. “For these patients with kidney disease, if we could detect the kidney

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A BETTER MEASURE: CYSTATIN C The good news is that there is – and has been, for two decades – a more reliable measure of GFR. “The concept of GFR,” said Shlipak, “is that you try to find some blood protein that is exclusively eliminated through the kidney, such that the blood level is a direct indicator of kidney function. So the ideal marker would be something that’s produced at such a steady rate that the amount that’s in the blood is determined only by the kidney, and not influenced by differences in our body size, our activity level, or how sick we are.” More than 40 years ago, a pair of Swedish scientists discovered just such a protein in human biological fluids and

observed it in high plasma concentration in patients with advanced renal failure: cystatin C, a protein secreted by most cells in the body and found in virtually all tissues and bodily fluids. 2 Like creatinine, cystatin C levels are measured in the blood. They are also mostly independent of age and muscle mass. Cystatin C comes from all our cells. “And all humans, roughly, make about the same amount of cystatin C,” said Shlipak. “There’s a slight fudge factor for gender and age, but it’s a lot less than for creatinine. It’s a lot more of a direct relationship of cystatin C to GFR.” Cystatin C enables accurate GFR estimations without requiring race-based adjustments in the equation. To Estrella, the use of a new marker has the added benefit of turning attention away from the Black/white dichotomy of discussions around creatinine. “A large number of our veterans are non-Black and nonwhite,” she said, “and I think cystatin C may actually offer more accurate GFR estimations in those populations as well, although they’re less well studied.” In separate studies, cystatin C has also been shown to predict higher risks of heart disease, stroke, and death among older people with no known kidney problems. Creatinine measures largely miss those risks. The bad news – so far – is that almost no clinicians are using cystatin C as a test to estimate GFR. That’s predominantly because the test has not been available, so clinicians have not had experience using the test. Very few – about 7 percent – of U.S. hospital laboratories are currently set up to perform a cystatin C test. “Most doctors have never heard of it,” Shlipak said. “So we have a huge task to educate clinicians that there is this better test.” Both Estrella and Shlipak say that, by far, the biggest obstacle toward the inclusion of cystatin C in estimating GFR is institutional inertia: The creatinine eGFR formula is simply the way things have always been done. The perceived expense and/or difficulty of cystatin C testing have also been cited as obstacles to cystatin C adoption.

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Sgt. 1st Class Rob Harmon shows off his “Donor” bracelet and Kai Johns his “Recipient” bracelet before undergoing kidney transplant surgery April 27, 2017, at MedStar Georgetown University Hospital in Washington, D.C. They became friends in the Army more than 20 years ago. The more accurate cystatin C test will likely mean treatment for kidney disease will begin earlier, and more patients will be assessed as qualifying to be placed on the kidney transplant list.

personnel and veterans need access to cystatin C testing, to make sure we’re getting kidney function measurement right.” Chuanyi Mark Lu, MD, chief of lab medicine service at the SFVA and professor and vice chair of the department of laboratory medicine at UCSF, led the adoption of routine cystatin C testing at the SFVA in 2012, recognizing its potential to improve patient care. As interest and demand for cystatin C grows nationally, Lu has prepared SFVA to serve as

a reference lab for other VA facilities across the network to help them bring in cystatin C testing to the local laboratories. For clinicians and patients without local access to cystatin C testing, the SFVA clinical lab can serve as a “sendout” laboratory so that all veterans can receive optimal testing of their kidney function when needed. The expert team at the SFVA is committed to helping make the cystatin C testing available to all veteran patients and their health care providers. 1. Ahmed, S., Nutt, C.T., Eneanya, N.D. et al. Examining the Potential Impact of Race Multiplier Utilization in Estimated Glomerular Filtration Rate Calculation on African-American Care Outcomes. Journal of General Internal Medicine, 36, 464–471. https://doi. org/10.1007/s11606-020-06280-5 2. H. Löfberg & A. O. Grubb. Quantitation of y-trace in human biological fluids: Indications for production in the central nervous system, Scandinavian Journal of Clinical and Laboratory Investigation, 39:7, 619-626, DOI: https://doi. org/10.3109/00365517909108866

A growing number of institutions – recently and most notably the National Kidney Foundation and the American Society of Nephrology – have already called for change, and momentum is clearly on the side of a race-free test of kidney function using cystatin C. 40

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COURTESY PHOTO

The better news is that these assumptions are easily disproven: “It’s a $5.00 test,” Shlipak said. “It can generally run on the machine that already sits in the hospital lab, and in our lab, the results come back as fast as creatinine – within an hour.” A growing number of institutions – recently and most notably the NKF and the ASN – have already called for change, and momentum is clearly on the side of a race-free test of kidney function using cystatin C. Neither Shlipak nor Estrella think clinicians should focus solely on cystatin C; for some patients, an equation that combines the two markers will work well, and there is a small subset in whom cystatin C might not work well. “But our main message for the DOD and VA is that cystatin C has to be available,” said Shlipak. Since 2019, the cystatin C test has been part of the VA/ DOD kidney care practice guidelines. “We recommended that both military


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