For many states with a growing number of coronavirus disease 2019 (COVID-19) cases, a real issue has been the challenge of understanding exposures. With surging cases in Arizona, California, Texas, and Florida, this means that exposure risks for healthcare workers are growing in the community. For those of us in healthcare, this adds to the challenge of identifying when healthcare workers become sick. Checking against exposures we know might have happened, this can be problematic. How many of us truly know when we’ve been exposed? The knowledge we have in healthcare can be both a gift and burden. We know who has COVID-19, but once we leave the hospital, that knowledge of potential exposures likely goes right out the window.

 from the Centers for Disease Control and Prevention (CDC) 

 (MMWR) has shed light on how many people truly know where their exposure to SARS-CoV-2 occurred. Interviewing 364 participants during March 9-27 across Colorado, the researchers found some interesting sources for these COVID-19 cases.

The authors noted that “among the 265 (73%) participants without known contact with a laboratory-confirmed COVID-19 patient, 30% (79 of 265) reported contact with a person they knew who had fever or respiratory symptoms. The most commonly reported activities in the 2 weeks before becoming ill included attending gatherings of >10 persons (116; 44%), traveling domestically (76; 29%), working in a healthcare setting (75; 28%), visiting a healthcare setting not as a healthcare worker (61; 23%), and using public transportation (57; 22%).”

Moreover, nearly 30% reported contact with at least one person who had laboratory confirmed COVID-19. A majority of this group reported that their exposure was related to a household member, whereas 25% noted that exposure to a confirmed case occurred in the workplace. These two types of exposures represented the majority of those reported from people with known exposures to confirmed cases. Of those with workplace exposures, a majority stated that this contact occurred in healthcare settings (60% were in healthcare personnel), followed by public administration or military.

While these findings are important, perhaps the most concerning is that so many of newly diagnosed cases aren’t aware where their infection stemmed from – where the exposure occurred. This is an increasingly important trend as infection preventionists work to respond to surges of COVID-19 cases. While healthcare worker exposures can and do occur, so many also occur out in the community. It’s easy to assume the greatest risk is in the hospital, where cases occur. This is also where the greatest protection occurs though – the near universal masking, presence of enhanced isolation precautions, and intense focus on isolation precautions. It’s when we leave the hospital or go to get a coffee in the cafeteria, our behaviors can become lax. We opt to take breaks from masking, exhausted from it all. Communicating these risks are important though. Since it’s so easy to focus on those high-risk exposures, we may not realize how frequent those small moments occur. It’s a helpful to remind staff about the risk in the community and how they can protect themselves while still living their lives. Discussing risk spectrums and harm reduction measures can go a long way and help staff stay safe beyond the walls of the healthcare facility, which is ultimately our goal.

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It’s when infection preventionists leave the hospital or go to get a coffee in the cafeteria, that behaviors can become lax. We opt to take breaks from masking, exhausted from it all. 

Low-Risk Exposures to COVID-19 Can Sometimes Pack Deadly Punch

The race among pharmaceutical companies to produce a vaccine for coronavirus disease 2019 (COVID-19) might have been going on for months, but the rules of the road were made more formal today. The US Food and Drug Administration issued 

 to manufacturers that the agency hopes will facilitate the creation of a vaccine while still ensuring any such product’s safety.

FDA officials describe the guidance as providing an outline of key considerations that the manufacturers must keep in mind when trying to develop the vaccine. They include requirements for manufacturing and control, chemistry, and the development and licensure of clinical and nonclinical data. It also details how the vaccine will be evaluated after its approved.

Peter Marks, MD, the director of the FDA’s Center for Biologics Evaluation and Research, said in a 

 that “right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials. Once data are generated, the agency is committed to thoroughly and expeditiously evaluating it all. But make no mistake: the FDA will only approve or make available a COVID-19 vaccine if we determine that it meets the high standards that people have come to expect of the agency.”

The guidance says that “it is critical that vaccine production processes for each vaccine are well defined and appropriately controlled to ensure consistency in manufacturing.”

In addition, it says: “A quality control system should be in place for all stages of manufacturing, including a well-defined testing program to ensure in process/intermediate product quality and product quality throughout the formulation and filling process.”

The size of the clinical trials for the vaccine need to be large enough to validate its safety and efficacy. The FDA guidance says that any vaccine would need to be able to either prevent COVID-19 or decrease the severity of its symptoms in at least 50% of those who are vaccinated.

“The FDA strongly encourages the inclusion of diverse populations in all phases of clinical development, including populations most affected by COVID-19, specifically racial and ethnic minorities, as well as adequate representation in late phase trials of elderly individuals and those with medical comorbidities,” the FDA said in its press release. “Sponsors are also encouraged to include studies in their development plans that would provide data to support use during pregnancy, as well as plan for pediatric assessments of safety and effectiveness.”

FDA Commissioner Stephen M. Hahn, MD, said in the statement that the agency is willing to work with the pharma industry and researchers and other federal or even international partners to accelerate the creation of a vaccine.

“While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards,” Hahn said. “This is particularly important, as we know that some people are skeptical of vaccine development efforts.”

A vaccine that almost everybody takes would produce the herd immunity that health experts hope will finally defeat COVID. But Anthony Fauci, MD, a member of the White House Coronavirus Task Force, recently pointed out that many Americans say that they would refuse to get vaccinated even if a COVID-19 vaccine is manufactured.

In the FDA statement, Hahn said: “We have not lost sight of our responsibility to the American people to maintain our regulatory independence and ensure our decisions related to all medical products, including COVID-19 vaccines, are based on science and the available data. This is a commitment that the American public can have confidence in and one that I will continue to uphold.”

The FDA issues guidance on just how pharmaceutical companies should go about the manufacture of a COVID-19 vaccine.  

Guidance for COVID-19 Vaccine Manufacturing Issued

Infection preventionists and other healthcare workers caring for patients in a healthcare setting who have, or may have, coronavirus disease 2019 (COVID-19), should be equipped with N95 respirators and not just surgical masks, argues an 

. N95s and medical or surgical masks have been shown to offer equal protection in some recent studies, and that’s the point being disputed by investigators with the Marshall B. Ketchum University College of Pharmacy, Fullerton, Calif., and the Providence-St. Jude Medical Center, Fullerton, Calif.

The meta-analyses that the investigators cite mix outpatient and inpatient data, they say, and therefore underestimate the benefit of N95s, as opposed to surgical masks. “It poses a danger to HCWs [healthcare workers] for inpatient COVID-19 guidelines to rely on meta-analysis of randomized controlled trials that mix different methods, settings, and outcomes,” the authors state. “On the basis of recent data, aerosol transmission is possible.”

N95 respirators are better at filtering out aerosol generating particles. The investigators want guidelines for use of N95s to be re-evaluated.

“It is apparent that the risk for HCW infection is related to duration and magnitude of exposure,” the investigators state. “A COVID-19 inpatient unit with multiple patients coughing and breathing will have far higher exposure to droplets, resuspended droplets, and aerosols than an outpatient setting. The data the guidelines referenced do not support the conclusion that medical masks are equivalent to N95 respirators in reducing risk for infection.”

They directly appeal to healthcare administrators who have been struggling with inadequate supplies of N95s and other personal protective equipment during the COVID-19 pandemic. The investigators are concerned that studies suggesting protective equivalency between the two types of masks might tamper administrators’ efforts to ensure enough N95s for healthcare workers working with COVID patients in inpatient settings.

“Because various organizations have claimed that medical masks are acceptable, health system administrators may believe that they have a valid reason to deny N95 respirators to HCWs on COVID-19 units and reserve them for AGPs [aerosol-generating procedures] even when other guidelines do recommend their use,” the investigators write.

Yes, there are shortages of N95s, but “instead of allowing our HCWs to work in substandard protection, countries should focus on allocating resources to increase production of … N95 respirators.”

In the end, say the investigators, N95s are more cost-effective. “Use of N95 respirators to protect HCWs should not merely be a preference or a recommendation based on availability,” the study states. “The data indicate that it should be the standard for all inpatient COVID-19 management.”

They conclude that “use of N95 respirators to protect HCWs should not merely be a preference or a recommendation based on availability. The data indicate that it should be the standard for all inpatient COVID-19 management.”

Investigators argue in the Annals of Internal Medicine that all healthcare workers in inpatient settings caring for COVID-19 patients should be equipped with N95s. 

N95s Should Be Standard Use for All Inpatient COVID Care, Say Investigators

Having drilled for a pandemic and having put in place a pandemic plan helped hospital staff and the infection control and prevention department a lot when the real thing struck in the form or COVID-19, says Fibi Attia, MD, the infection prevention coordinator at Penn State Milton S. Hersey Medical Center. Attia, who is also a member of 

’s Editorial Advisory Board, says that before the COVID-19 pandemic, making sure that hospital staff followed standard precautions represented the main challenge for infection preventionists. After COVID-19, the main challenge was treating patients with the knowledge that they could be carriers of the coronavirus. And limiting exposure of healthcare workers to COVID-19 remains a constant concern.

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Fibi Attia, MD, the infection prevention coordinator at Penn State Milton S. Hersey Medical Center, says that the main challenge for infection preventionists in the COVID-19 pandemic is not knowing who might be carrying the disease. 

Q&A: Preparation Paid Off When COVID-19 Struck

Preconceived notions play a huge part in how clean hospitals can keep their pediatric wards, according to a 

 that looks at surfaces of a pediatric ward before and after cleaning. “The findings from this study suggest that perceptions of risk to the patient and cleanability are important factors in cleaning efficacy,” the study states.

Investigators with University College London and Great Ormond Street Hospital NHS Foundation Trust in London collected 1160 tryptone soya agar (TSA) contact plate samples from 55 sites within the hematology-oncology ward at Great Ormond Street Hospital. The samples were taken over a 2-week period in the ward, which comprised 6 consultation rooms, 2 reception areas, 3 separate 4-bed bays, 3 single rooms with bathrooms, 4 treatment rooms, a playroom, and a height and weight room. They measured the difference in the amount of colony forming units (CFUs).

Overall, CFUs in the entire ward were reduced by 68% after cleaning.

“The corridor was the most contaminated area within the ward,” the study states. “There were differences in the CFUs among the various areas within the ward, which were cleaned with varying efficiency. The surface material, who interacted with the surface, levels of initial contamination, perceived risk, and perceived cleanability were all found to have a varying impact on the cleaning effectiveness.”

Metal surfaces should be easier to clean than other types of surfaces, but this knowledge may have contributed to a lack of cleaning efficiency. The CFU loads on metal surfaces increased 167.68% after cleaning. Of the 10 metal surfaces, 5 were said to be easy to clean, 4 difficult to clean, and 1 moderate.

“Surfaces considered to be easy to clean were shown to have the greatest increase in CFUs (+34.12) after cleaning,” the study states. “Surfaces made from plastic and coated wood had an overall reduction, potentially due to the majority of plastic surfaces being considered as high risk and because wood surfaces have been shown to be linked to a decrease in contamination.”

The surfaces cleaned by environmental services (EVS) were more contaminated after cleaning than those surfaces that were cleaned by clinicians.

“Some areas were consistently clean, both before and after cleaning, including surfaces in the height and weight room,” the study states. “Some areas were cleaned more effectively than others; for example, the treatment room, on average, showed an 80% reduction in contamination levels following cleaning, while the out-patient reception area saw an increase of 12% following cleaning. Some areas, such as the sluice, were cleaner than others both before and after cleaning, but other individual surfaces had consistently higher CFU counts, including a bookcase in the corridor and a play-room shelf.”

The investigators hope that their findings might lead to better training for those responsible for cleaning pediatric wards. The investigators believe that theirs is the only study that looks at the cleanliness of surfaces in a pediatric ward before and after cleaning.

Sometimes the surfaces that are deemed easiest to keep clean in a hospital pediatric ward wind up being the most contaminated after cleaning. Preconceived notions may play a part. 

Attitude, Perception of Hospital Staff Hinders Cleaning of Pediatric Wards

In terms of infection, and how infection travels, have there been any new studies or breakthrough findings about how buildings should be laid out.

That’s a very good question. And one of the things that I have found in my work is that initially, the building metrics that we follow even healthcare facilities as well as other commercial buildings have had more to do with how much energy is being consumed, because that’s a clear cost for a hospital or any other building. One of the shifts that we’re seeing and one of the shifts that COVID-19 has actually accelerated is the focus on how to manage a building to actually protect the occupant health. As you mentioned, I’ve been working in this area now for, I don’t know, 15 years, because in my medical practice, I became concerned that the building had a role in patient infections. When I began to do research actually using patient outcomes as a metric for the building, lo and behold, certain indoor air management strategies stood out as being either protective or putting people at risk. And so, there have been a couple of shifts. And thankfully, we also have some new ways of actually understanding the relationship between indoor air management and human health in hospitals, schools, medical office buildings, even in our homes. So the short answer to your question is yes, we definitely have some new information about how important building management is for infection control.

Airflow will become even more important thanks to COVID-19. Is that a fair assumption?

It’s a very fair assumption. And the indoor environment has always been an important component of human health. And if you think about how the average human being spends 90% of their time indoors. So COVID-19 has really focused our attention on how a building can either protect us or not from disease. It’s always been important, but people are now aware of the importance of managing the building to prevent health problems.

How cognizant are infection preventionists about the importance of airflow?

That’s a great question. And it’s also a complicated answer, because I think human nature is that we want to address transmission routes that we have some control over. If you think about airborne transmission, that’s probably the hardest route to control. So going back in time—not to be a historian here—but going back to the Bubonic plague, the transmission route that was assigned was fleas from rats, because you can see a rat, you can stop a rat. However, in 2018, those corpses were exhumed and we found that actually the airborne transmission route was huge. So, back to your question. Infection preventionists tend to focus on behavioral strategies for reducing transmission of pathogens; bacteria, viruses, the microbes that cause disease. However, there is acknowledgement that the air is important for certain diseases: measles, tuberculosis, influenza. However, in general, airflow has been managed by the engineers, by the architects, by the facility managers and not so much by the clinicians. There is a lot you can do in indoor air management to decrease transmission of infections. And my research has made me focus on how we can actually intervene in controlling aerosolization of, for example, right now COVID-19. There is a lot we can do, and I’ll tell you what that is, if you want me to.

In my initial studies, when I didn’t really have any idea of which component of the indoor environment might contribute to infections or prevent infections, I was really open to whatever the data was going to show me. And what has come to light again and again and again. And it’s sort of anti-intuitive, is that when the air is overly dry, we actually have increased transmission of infections. And so this was a surprise to me. But since that time, through further research of mine plus many other people, we are now finding that to decrease the transmission of infections indoors, there’s an optimal range of relative humidity that happens to be 40% to 60%. Humidity indoors that is actually optimal for human beings. Our immune system is the most robust, and other organ systems as well. Our brains work better, for example. And in this range 40% to 60%, we’re also finding that pathogenic or disease-causing bacteria and viruses are both less infectious and they’re fewer of them in the air in the airborne environment where we can breathe them in. To my great surprise, 15 years ago, that this zone of relative humidity as being so important. It’s become clear to me and again to many other people.

You first got into this when you were a physician. You went back to school and became a certified infection preventionist. You also went back to school for architecture. Do you think the two fields can talk to each other now to figure out a better way to improve airflow not only in buildings under construction even in buildings that have been around for a long time?

I think that the that the medical profession and the building profession, whether it’s architecture, engineering, facility management; we do need to be talking to each other. Do I think that’s easy? No, I think it’s actually quite difficult for several reasons. I think the more competent you are in your field, the less willing you are to embrace a whole other body of knowledge that you don’t know anything about. I personally found it very difficult to go back to architecture school in my 40s and learn a whole new way of thinking.

Well, thanks. It was hard and it gave me more respect for the difficulties in different professional groups communicating with each other. And yet, if we don’t, if we ignore the impact of the environment and indoor air, specifically, on our health, we’re missing the utilization of one of the most effective toolboxes for controlling infections. It’s just absolutely…. It’s exciting that we do have the ability to manage the indoor environment. And there are also significant obstacles. They mostly have to do with our willingness to accept new concepts.

You mentioned environmental services. How do they fit into this and or do they?

Actually, the facility manager and housekeeping are critical to optimal patient outcomes. Unfortunately, sometimes, I think, how some of the custodial positions are not educated about how important their work is in patient outcomes. As a physician, we weren’t taught anything about the building. And I don’t think that building professionals are taught enough about human health. But in a hospital for example, managing filtration, managing indoor humidification, managing proper pressurization of patient rooms is absolutely key to whether or not that person is going to leave the hospital when they hope to, and leave in good shape. So environmental services are as important in my opinion as a lot of clinical medicine that we practice in inpatient settings.

So infection preventionists: What concrete steps can they do to monitor what’s going on with airflow?

Well, that’s a good question. I mean, the first thing an infection preventionist can do is to realize that the environment is critical. And in my research, we’ve learned that low humidity in the patient room is harmful. So, as an infection preventionist, you can be aware of this, you can in meetings try to inform and educate the building component of clinical care about the importance in this case of humidification. You know, beyond that, it’s hard to know what the role of an infection preventionist is in managing the hospital building. But I think being aware, being educated, and being vocal about air about humidification is really a step forward. So if you have mold, or if you have a humidification system or ductwork that’s been inactive or closed down, you don’t want to turn it on and just dehumidify your air because the result will be that you will be disseminating into the breathing zone of people, all of the segments of, for example, mold that can cause respiratory disease.

This interview has been edited for clarity and length.

Stephanie Taylor, MD: “In general, airflow has been managed by the engineers, by the architects, by the facility managers, and not so much by the clinicians. There is a lot you can do in indoor air management to decrease transmission of infections.”

Q&A: Hospital Airflow Plays a Crucial Role in Infection Prevention

J. Hudson Garrett, Jr., PhD, MSN, MPH, talks to 

 about how the battle against COVID-19 might encourage healthcare departments in a hospital setting to work more closely together to battle other infections as well. And it's no surprise to him that COVID-19 infects younger people. Garrett also discusses pediatric COVID care.

Q&A: COVID-19's Pediatric Patients, and Other Pandemic Challenges

As the United States sees a steep rise in cases across several states like Arizona, California, Florida, and Texas, there is increasing concern for long-term implications within healthcare. Perhaps one of the most challenging aspects of healthcare’s response to coronavirus disease 2019 (COVID-19), is the ongoing fatigue and readiness as cases rollercoaster.

For so many of us, one rather odd piece to infection prevention in the time of COVID-19 is the more quiet moments when elective surgeries are cancelled, but COVID-19 units are busy and the hospital is a mixture of chaotic and quiet. When hospitals cancel elective surgeries to hold for surge capacity, it creates a unique situation in which we are busy while simultaneously being emptier.

In Arizona, this was the case and the stress of the COVID-19 units was drastically different than the quiet areas in the hospital that would normally be teeming with people due to have surgeries. Another piece to this though is that during the spring, many people avoided hospitals for two reasons. First, there was fear of catching COVID-19, which is always a misconception during outbreaks. Second, they hear on the news that hospitals are stressed and don’t want to add to it or were worried about quality of care.

 from the Center for Disease Control and Prevention (CDC) 

(MMWR) points to this very issue by looking to the indirect effects of the pandemic on use of emergency departments for acute life-threatening conditions. By utilizing national syndromic surveillance data, they found that in the ten weeks following the declaration of COVID-19 as a national emergency, those emergency department visits were significantly impacted.

Overall, emergency department visits dropped 42% during the initial months of the outbreak. Their analysis focused primarily on myocardial infarction (MI), stroke, and hyperglycemic crisis, that occurred before and after the declaration. While this list is not exhaustive, it provides a good representation of the impact the pandemic had on emergency departments and thus hospitals. The authors note that “in the 10 weeks following the emergency declaration (March 15–May 23, 2020), ED visits declined 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis, compared with the preceding 10-week period (January 5–March 14, 2020). EDs play a critical role in diagnosing and treating life-threatening conditions that might result in serious disability or death.”

Interestingly, the decline of these ED visits was similar across all age groups for MI and stroke, but for hyperglycemic crisis, those younger who were female tended to avoid the emergency departments. When looking across all ages and conditions, the researchers found that the largest differences were in those adults over 65 years of age going to the emergency department for MI or stroke, those between 18-44 and less than 18 years of age who would visit for hyperglycemic crisis.

While these findings aren’t particularly surprising, they do shed light on the implications for people experiencing medical crises and their willingness to seek care during a pandemic. It is critical that efforts be made to communicate to the public the safety of hospitals and not to avoid seeking care during events, like the COVID-19 pandemic. Delays in seeking care can result in potentially avoidable severe illness or death.

While the rest of the hospital bustles with energy as healthcare workers fight COVID-19, emergency departments have been oddly quiet because of the drop in elective surgeries.

Emergency Departments Now the Quiet Eye of the COVID Hurricane

One of the scourges of a lot of people’s teen years now dogs infection preventionists and other healthcare workers who fight coronavirus disease 2019 (COVID-19). It’s a lot like acne, so much so that it’s called “maskne.” It’s the rash or pimples that break out on the face as a result of wearing a mask. Anybody can get it, but healthcare workers are particularly susceptible because they wear masks for longer periods and their masks tend to fit tighter, according to a 

Journal of the American Academy of Dermatology

Investigators with Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, write that it might be best to ease frontline healthcare workers into being masked for extended periods.

The write that “the prevalence of skin damage of first-line healthcare workers was very high. Moreover, we found that longer exposure time was a significant risk factor, which highlights that the working time of first-line staff should be arranged reasonably. Besides, prophylactic dressings could be considered to alleviate the device-related pressure injuries….”

The study looks at data collected from January to February 2020 in self-administered questionnaires from 542 physicians and nurses working in tertiary hospitals in Hubei, China. Investigators note that hand eczema is quite common among healthcare workers because of frequent hand washing and the wearing of plastic gloves for long periods.

“Considering the frequent hand hygiene and long-time wearing of tertiary protective devices (N95 mask, goggles, face shield, and double layers of gloves) among healthcare workers during the epidemic period of COVID-19, we aimed to estimate the prevalence, clinical features, and risk factors of this skin damage among them,” the study states.

Investigatgors found that healthcare workers who wore "some medical devices more than 6 hours had higher risks of skin damage in corresponding sites than those who did for less time (N95 masks: odds ratio [OR], 2.02; 95% confidence interval [CI], 1.35-3.01; 

 < .01); goggles: OR, 2.32; 95% CI, 1.41-3.83, 

 < .01), whereas a longer time of wearing a face shield was not a significant risk factor in causing forehead skin damage (OR, 1.52; 95% CI, 0.93-2.50; 

Maskne has traveled the globe along with coronavirus disease 2019 (COVID-19) ,and there are ways to avoid and/or treat it. On the WebMD 

, dermatologist Laurel Naversen Geraghty, MD, offers some pointers. They include:

Don’t wear the masks too tightly. “Healthcare workers, individuals at high risk of infection, and certain others may need to wear a tight-fitting, medical-grade mask…. [B]ut they don’t need to squeeze or press so tightly that they leave indented marks behind. The more heat, rubbing, friction, and pressure against our complexion, the greater the chance of breakouts.”

Clean the masks regularly. “Remove any makeup, dirt, oil and bacteria from the skin by washing the face once or twice daily with a mild cleanser.”

Replace the mask regularly. “Bacterial buildup inside a warm, damp mask are part of this problem, which is one more reason to wash (or replace) a mask regularly.”

Target the bacteria that’s causing the maskne. “C

 is a bacterium on the skin that’s known for causing pimples. Fight it with an over-the-counter ingredient, such as salicylic acid, benzoyl peroxide, glycolic acid, sulfur, or tea tree oil.”

Treat your skin gently. “Avoid rubbing, picking, or overscrubbing your skin. Exfoliate no more than once or twice a week, protect from the sun with broad-spectrum SPF, and soothe your complexion with a moisturizer once or twice daily.”

 notes, taking maskne seriously and taking the proper measures to prevent, or at least lessen, it makes for a happier and—presumably—more efficient healthcare worker. “Skin damage caused by enhanced infection-prevention measures among health care workers, which could reduce their enthusiasm for overloaded work and make them anxious, has been reported frequently.”

Healthcare workers are particularly susceptible to maskne because they tend to wear their masks for extended periods. 

Nasty ‘Maskne’: Ways Healthcare Workers Fighting COVID-19 Can Deal With It

Hand hygiene has been on everybody’s mind since the advent of coronavirus disease 2019 (COVID-19), but the raising of public consciousness unveiled the embarrassing fact that proper hand hygiene at hospitals and other healthcare facilities has been low for decades. What to do? Well, as with so much else that needs fixing in society, perhaps technology can provide the answer. Enter electronic hand hygiene monitoring systems (EHHMS). The systems can range from the simple (having soap dispensers record each time they are activated), to the more complex that involve giving healthcare workers badges or wristbands that sense if a healthcare worker has entered a patient area and, if so, if they used proper hand hygiene.

This communication can occur using different methods: radio-frequency identification,ultrasound, infrared, Wi-Fi, remote video monitoring, or alcohol vapor sensing systems.

Whether simple or complex, EHHMS seem to have one thing in common, according to a 

. They don’t work. Or, if they do work, they won’t continue to work for an extended period unless they exist within a healthcare culture that makes proper hand hygiene a priority. Whether such a culture needs to use EHHMS at all remains an open question, according to investigators with Widener University.

They cited “consistent and constant messaging and staff empowerment as key drivers of success, and noted empowering and inspiring staff to be crucial components for realizing the full benefits of an EHHMS.” One facility reported “great success with traditional hand hygiene monitoring techniques, using patient surveys and direct observation through an intradepartmental infection control team, and attributed their high rates of hand hygiene compliance to their robust hand hygiene culture.”

The data were gathered through surveys and interviews at 56 acute care hospitals in New York State. The investigators wanted to evaluate the impact EHHMS had on 

 infection (HA-CDI) rates. Only 2 of the 56 hospitals had actually installed the systems, and only one of those hospitals shared their experience.

Many of the hospitals in the study were rural, nonacademic hospitals with fewer annual discharges. That may account for the lack of EHHMS, the study notes. “Overwhelmingly, facilities indicated the initial investment of money and staff resources required to implement an EHHMS to be the main reason hospitals have declined this intervention,” the study states.

And there is some benefit to EHHMS. Investigators write that the hospital with the EHHMS found that it “vastly improved data collection and was effective at improving hand hygiene compliance rates, at least in the short-term, serving as a catalyst for renewed attention on hand hygiene.”

However, officials at that hospital also stressed that EHHMS is no substitute for a strong hand hygiene culture. The improved hand hygiene rates can “easily be dismantled through staff turnover. The trend analysis supported this experience, revealing a sharp decline in HA-CDI rates following implementation, which persisted for approximately 12 months before regressing,” the study states.

It should be noted that “the trend analysis for the hospital with an EHHMS that declined to share their experience showed limited impact on HA-CDI rates pre- and postimplementation of the system.”

The study concludes that “adoption of EHHMS appears to be low in acute care facilities in New York State and hospitals with these systems are experiencing mixed results regarding improved hand hygiene compliance and number of related HAIs…. Strong organizational culture in support of hand hygiene was emphasized by multiple facilities as essential to attaining high rates of compliance. It seems an EHHMS could be a powerful tool for igniting that culture, though hospital staff needs to be diligent in their efforts to maintain the initial enthusiasm.”

Hand hygiene monitoring devices and systems only work within the confines of a strong hand hygiene culture, a new study says. 

Strong Hand Hygiene Culture Trumps Monitoring Devices

 in which the authors argued that all healthcare workers in hospitals who have to deal with patients who either have coronavirus disease 2019 (COVID-19) or could have the disease should be equipped with N95 respirators. “We believe that a thoughtful evaluation of past and existing data in the setting of the COVID-19 pandemic strongly supports the use of N95 respirators for all inpatient care of patients with COVID19, not only during AGPs [aerosol-generating procedures],” the authors wrote. They took aim at the notion that in many cases surgical or medical masks can offer healthcare workers enough protection against SARS-CoV-2. “A COVID-19 inpatient unit with multiple patients coughing and breathing will have far higher exposure to droplets, resuspended droplets, and aerosols than an outpatient setting,” they wrote. One of the authors of the piece is Harry Peled, MD, the director of cardiology and critical care at St. Jude Medical Center, Fullerton, Calif. Peled recently sat down with 

 to discuss the implications of his findings.

Great question. There’s a lot of angst about this issue and there was really a lot of moral distress and a lot of disunity going on. You had healthcare workers who said, “I clearly need to have an N95.” You had administration and supply chain people in good faith saying, “You know what? That’s not guideline-based. I have to save these masks for the aerosol generating procedure. So, you can’t really have these in N95s.” And in the midst of a COVID-19 crisis, you had a really horrible clash between the workers and the administration. Everybody was trying to do the right thing, but it was certainly a very poisoned atmosphere. And whenever people quote the guidelines, I think one of the most important things is to go what is behind the guidelines, right? At the end of the day, guideline writers like all of us try to do the best thing. There are a bunch of people sitting in a room trying to put this together. Especially in a setting where everything was done pretty quickly. So, I took the time to look at the articles which were supporting that the [surgical and medical] face mask or equivalent, and I found that the evidence was just simply not there to say that they were equivalent. And it also was interesting that the data supporting N95s for the AGPs, the aerosol generating procedures, was not very impressive either.

What I read in your article is that you think that healthcare workers in a hospital that is treating COVID-19 patients should be wearing N95 respirators.

That is correct. I think anybody who is on an inpatient side and you’re taking direct care of COVID patients, you should be having an N95.

And when you talk about the guidelines, you’re talking about guidelines from the US Centers for Disease Control and Prevention?

So, it’s interesting. There are differences amongst the guidelines. The CDC guidelines, say that N95 is preferred, but then they say [surgical and medical masks are] acceptable if there is a shortage. And I think the problem there is you are conflating two different issues. If it is preferred based on the science, it is preferred. Now, if they’re not enough and you have to ration them, then one has to admit that you are rationing something useful. I think the CDC guidelines are a bit problematic when they say the N95 is preferred, but it is acceptable to use [surgical or medical masks] when there is insufficient supply. I think that’s where the problem is on the CDC guidelines. When you look at the Surviving Sepsis Campaign guidelines, they actually explicitly say that face masks are preferred to N95s based on the evidence that I think in particular, is not at all supported by a careful look at the evidence and by their own footnotes and references.

Do you think the guidelines will be adjusted in light of what you wrote or what others are writing or just the idea of having healthcare workers be as safe as possible?

That is my sincere hope. One of my goals when I was writing this was very specifically for the guidelines to be changed. There is a difference between saying I’ve proven the N95s are superior versus saying I’ve unequivocally shown equivalency between N95s and face masks. And I think it is simply based on the evidence: One cannot say that equivalency has been shown. You know, one study is done on outpatients, so that’s not a reasonable extrapolation. You look at the 

 and that study, the people wore the N95 only when they walked into the room. They’re just an extrapolation without evidence behind it. So, you have those two studies, which are a bit more towards the negative side. When you look at the two randomized control trials by 

 done in China, those actually showed a benefit when you look at clinical respiratory illness. So very much the hope is that the guidelines will be changed. They’re continuously updated. You know, people do the best they can, and I’m hoping that they will be updated.

Again, I’m paraphrasing from what you wrote, and tell me if I'm wrong here, but I think you made the point that this allowing surgical masks and medical masks to be used in circumstances where N95s should be used detracts from the effort to supply enough N95s.

I think you hit the nail on the head. And that is a fundamental problem. As long as the guideline writers and society say that they are leveling, you’re not going to have the focused effort to make the N95s. I think once that we as a society admit that there is reasonable evidence to show that N95s are better, my hope is that we will produce them. One has to remember that before this all started, the cost of an N95 mask was about $1. And 3M has made a point of saying that they’ve actually not jacked the prices up. You might not be able to get a 3M N95, but they have not jacked the prices up. Remember, it’s a piece of plastic and it’s made from oil and a crude barrel of oil is relatively cheap. So, I think exactly as you said it, that if we admit that there is reasonable evidence that N95s are better than face masks for impatient here, instead of us fighting over the supply, we will increase it.

Have you gotten much feedback from people? Have you heard from a lot from fellow healthcare professionals?

Well, I got a little feedback. I mean, I’ve sort of been getting feedback over the past, you know, month or two, on this when we get well-intentioned with the system. And so I got one comment already on the article. They made the point that although we showed a benefit for the N95, the confidence interval didn’t cross 1. The comment was correct. So, we actually did give them several other examples where there was benefit to N95 and the confidence interval completely favored that. Certainly, some feedback that you’ve not definitively proved the point. And again, one can criticize the randomized controlled trials, but the question is, right, if you want to be somewhat a precautionary principle. Right? How certain do I have to be? I don’t think it has to be 99% sure. And the question is, what is the magnitude of benefit? If you look at the 

, they felt that, you know, if I got the flu, it probably wasn’t that big a deal. So, unless I reduce the incidents by 20% to 25%, it’s not a big deal. Well, that may be true if your case mortality rate is 0.1%. If the case mortality rate is 1%, then that same risk of infection becomes much greater. I think it’s making sure people get the extrapolation that we know that this is more infectious than H1N1. That case mortality rate is certainly higher than regular seasonal flu. We can argue the magnitude. So, I do get pushback, somewhat on the interpretation, but I think it’s important that we separate the interpretation from the facts

We had to postpone our interview twice because you’re in Fullerton, California, and you’re in the midst of a surge right now. Do you have enough N95s where you’re working?

Thank goodness we do have enough PPE. We do have enough N95s. You know, one sometimes has the problem that what you have is not necessarily what people are fitted for. But overall, I think that this we’ve been doing OK with that.

Have other studies come out since your article that back up what you said?

Everybody is still fighting over those four randomized control trials. There have been no new randomized control trials. Loeb, who’s one of the authors, is actually planning on doing a randomized control trial. I’m not sure where they are with that. Sort of that came out before we published this. There was the 

article that got a lot of press about the possibility of aerosols and N95s being better. Again, that was critiqued as being an observational study, rather than a randomized control trial. But again, one has to do the best they can. There was another article that sort of did a more detailed review than we did of these four randomized control trials, and sort of came to the same conclusion that there is evidence that N95s are better by some criteria, not by other criteria. But again, as a society we’re not allocating the resources for the PPE and the N95s.

Any advice for infection preventionists, EVS teams, hospital administrators, procurement teams as far as masks are concerned?

I think it’s a very tough position for them to be in. And in my article, I actually commented on that, because I think the term moral distress can often be thrown around too loosely. I think these people have serious moral distress. And it doesn’t do society or anybody good for frontline healthcare workers to beat up on these people, right? These people got a supply chain. They have guidelines that say we have to keep them for the aerosol generating procedures, even if the risk is much less. Those are the guidelines. You can’t fault the administrative people for following the guidelines. I think they’re put in a tough spot. But I do think from the administrator point of view, you have to look at the other side. If you look carefully at the evidence, you cannot fairly extrapolate from some of these outpatient studies of 20 patients. I think when healthcare workers uniformly say, “We’re on the frontline, this is what we think we need.” And they have evidence to support that. I think the plan has to be that we will supply N95s for you, understanding that there has been evolution in the guidelines. The other thing I should mention since we started this paper in April—it takes a while before it comes out—is that the American College of Physicians has very specifically 

 N95s for COVID care defined as being within six feet of the patient. So again, you’ll know guidelines are in flux, and the evidence is in flux. I think for administrators and infection control people, the attitude has to be there is enough evidence that the wearing of N95s should be official. The claim that we’re going to wait for perfect evidence is just not tenable. We don’t do that for anything else in medicine, and goal has to be how are we going to get N95s in sufficient quantity. Everything is mitigation right now. Nothing we do is going to be perfect. I think people have to remember that we’re mitigating risk, we are not eliminating risk.

Harry Peled, MD: “I think for administrators and infection control people, the attitude has to be there is enough evidence that the wearing of N95s should be official. The claim that we’re going to wait for perfect evidence is just not tenable. We don’t do that for anything else in medicine.”

Q&A: Nearly All Healthcare Workers Fighting COVID-19 Need N95s

The search for a vaccine to for coronavirus disease 2019 (COVID-19) got a push from the US Food and Drug Administration (FDA) yesterday when the agency granted fast track status for 2 products under development. The agency gave the go-ahead to Pfizer and Biopharmaceutical New Technologies (BioNTech) for the investigational vaccines BNT162b1 and BNT162b1. The vaccines are the result of a joint research venture between the biopharmaceutical companies.

BNT162b1 and BNT162b2 are the two most advanced vaccine candidates in the 2 companies’ BNT162 program currently being evaluated in ongoing Phase 1/2 clinical studies in the US and Germany.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president, Global Regulatory Affairs, Pfizer, said. “We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”

Project Lightspeed is a vaccine development program, which is based on BioNTech’s proprietary mRNA-based technology platforms and supported by Pfizer’s global vaccine development capabilities. The BNT162 vaccine candidates are undergoing clinical studies and are not currently approved for distribution anywhere in the world.

“We are pleased to have received Fast Track designation from the FDA for two of our vaccine candidates and look forward to working closely with the FDA, along with our partner Pfizer, to expedite the clinical development path forward,” Chief Medical Officer Özlem Türeci at BioNTech reiterated.

Pfizer and BioNTech are developing these novel vaccines with pre-clinical and clinical data at the forefront of all decision-making of both companies.

Along with the development and manufacture of health care products, including medicines, Pfizer has a well-established footprint in vaccines.

BioNTech is an immunotherapy company working on novel therapies for cancer and other serious diseases.

The companies are expecting to start a Phase 2b/3 trial possibly later this month and are anticipating enrolling up to 30,000 subjects.

According to the companies’ joint release, if the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

Biopharmaceutical New Technologies (BioNTech) for the investigational vaccines BNT162b1 and BNT162b1. The vaccines are the result of a joint research venture between Pfizer and Biopharmaceutical New Technologies (BioNTech).

2 Possible COVID-19 Vaccines Given Fast-Track Status

One of the many elements of that make coronavirus disease 2019 (COVID-19) so difficult to treat is that one can’t pinpoint exactly where or how someone might have gotten the disease. Healthcare workers who’ve gotten COVID-19 (and the families of healthcare workers who’ve died from the disease) are finding that trying to obtain workers compensation benefits or death benefits can be nearly impossible, Kaiser Health News (KHN) 

Up until now, the workers had to prove convincingly that they became infected on the job, not an easy argument to win given that there are so many asymptomatic carriers out in the community.

Now, according to KHN, 16 states and Puerto Rico want to put the onus on the hospital: make it prove that the worker didn’t get the disease on the job.

“Bills vary in the scope of workers they cover,” KHN reports. “Some protect all who left home to work during stay-at-home orders. Others are limited to first responders and health care workers. Some would cover only workers who get sick during states of emergency, while others would cover a longer period.”

Different states are taking different approaches, and some of those approaches are being opposed by hospitals and business associations. KHN cites a bill in New Jersey that makes it easier for essential workers who got COVID-19 during the state of emergency to prove that they got it on the job.

Chrissy Buteas is the chief government affairs officer for the New Jersey Business & Industry Association, which opposes the bill, which was passed by the state Senate and is pending in the General Assembly. “Our concerns are primarily that the cost of these claims can overwhelm the system, which was not designed to handle claims during a worldwide pandemic,” says Buteas.

KHN also looks at a case in Virginia in which a physician assistant (PA) who administered COVID tests had to be hospitalized when he came down with the disease for a week, and wound up missing five weeks of work.

The PA asked to fill out workers’ compensation forms. He was refused the forms and was then laid off five days later, with a $60,000 hospital bill. Attorney Michele Lewane is representing the PA in the case. According to KHN: “Lewane said the law in Virginia will likely consider COVID-19 an ‘ordinary disease of life,’ akin to a cold or the flu. She said she’d have to prove by “clear and convincing evidence” that he caught the coronavirus at work.”

Up until now, the workers had to prove convincingly that they became infected on the job. But 16 states are now considering putting the onus on the hospital: Make it prove that the worker didn’t get the disease on the job. 


Healthcare Workers Stricken by COVID Fight for Compensation Benefits

Hospital systems and primary care physician practices were consolidating before the onslaught of coronavirus disease 2019 (COVID-19). The internationally known and respected healthcare expert Brent James, MD, talks to 

 about how COVID-19 now makes it a question of survival. James, a clinical professor at Stanford University School of Medicine, was at one time the chief quality officer and executive director of the Institute for Health Care Delivery Research at Intermountain Healthcare. He knows about both the provider and the health plan side, in other words. And the provider side is bleeding revenue mostly because of missed routine care and postponed elective surgeries. “COVID has consumed the resources of the health system in the vast majority of communities.”

COVID-19 has forced people to put off routine care and elective surgeries. Where do you think that’s going to lead?

Well, a couple of ideas. First, I serve on a number of national health policy groups. And we’ve actually been calling in real experts to discuss exactly these topics, what’s happening out there on a broad scale. In that framework, the next thing to be said, it differs from community to community. So, among those likely to be listening to this video, one experience may not reflect all experiences across the entire board. On the other hand, there’s some markers that will help people see. Here’s the first big one. Turns out that primary care and standalone specialty care has taken a real hit with COVID. Visit rates have dropped dramatically. It’s not just the physician practices, small hospitals have taken a real hit too. So, here’s my first prediction. You’ve all seen in your communities the rate of consolidation. Smaller practices, independent practices join in larger systems. That has been happening. It’s accelerating. The reason is, is that those practices and those hospitals have no choice. A number of them face going out of business, even with the loans the government’s giving today. It’s going to be a shift. On the other hand this is really not a new thing. It’s an acceleration of an old thing. Some of the communities of your readers are going to be so far down this it will make very little difference. For others, it could really pick up the pace.

Will there be layoffs with for healthcare workers because of that?

Potentially, I think when you consolidate services, especially at the administrative level, that can always happen. Also, to a lesser degree, at the specialty levels. Now, there’ll be some compensating factors. You’re right in thinking in those directions, that kind of large systemness. At one level, it protects people. But at another level, it only protects people who are part of the system. You see what I mean? It’s going to concentrate.

Has anybody come up with any ideas about what to do about this?

I don’t know if it’s something that we do anything about. It’s something that’s just going to happen. But you can tell in your own community, how fast…. Now there’s a second element behind that. There has been a very remarkable slowdown in elective services. Many hospitals, of course, have taken a real hit by losing those services. Frankly, in a few communities, COVID has consumed the resources of the health system in the vast majority of communities. It’s partly based on fear among patients. People who should have been coming in aren’t well. As you would expect, as it normalizes a bit, as people get more experienced, the fears go away, and those rates are starting to come back up. Now, the other problem, of course, is that COVID and the shutdown have been associated with a major economic downturn. Here would be my advice to your readers. It will be about like 2008. We’ve been through major economic downturns before him. You lived through them. I’ve lived through them. We know what happens in the long haul. It will be mostly like that. We know how to make our way through them. Again, it differs from community to community. But I think that if you think of it that way, think of it as a major economic downturn. Was it a bit anomalous? Sure. The reason is, is it just cut off cold. But now most places are opening back up. There's still a bit of fear of people being afraid to come back and put themselves at what they see as at risk in a healthcare delivery environment. I think that will normalize pretty quickly. In fact, that’s one of our problems right now is maybe it’s normalizing too quickly, especially among younger patients. They’re not obeying the social distancing rules, the masking rules that would really help us out moving forward. But we know how to manage that. I think that’s a second thing right there. I treat it as a major economic downturn. We’ve lived through those before and we kind of know how they behave in our communities.

Are you hearing from your business associates in private industry that they might hire infection preventionists or at least depend on IP expertise?

That’s the third area. I really wanted to talk about. I think that most infection control specialists, they have training that others do not have. Now I’m a biostatistician. As part of that I’m trained in epidemiology. It’s just a background. Let’s just say I’ve been pulling out of my closet and spinning up to full speed basic infection control principles at a population level. It means a certain amount of 

. Frankly, I need to resurrect sensitivity and specificity. The idea of a positive predictive value. I need to be able to share those with people. I see that happening at several levels. The first, of course, is just how do you control the spread of this disease—this specific disease—in the general population. I realized that many of us don’t have our hands strictly on those controls, but holy cow, I get hit on that every day. I bet that your readers do, too, on a regular basis, because they have that specialized expertise. The second thing, I’ve been amazed at how many care delivery groups—those physicians and nurses—they want guidelines. And they’re a little confused about where to find the right guidelines, you see. There’s a third area: Where is it going next? Looking forward, well, it means that I’ve had to spin myself up. I keep fairly careful track of that literature. I find trusted sources. Oh, there’s so much information all over the board, on the Internet, from various news agencies, and so much of it is just, frankly, wrong, just bad. And what people are really looking for is a trusted voice. Even if you’re not in direct control of the response to that system, people need your voice. But it means that a certain amount of preparation along the way so that you’re able to speak authoritatively and help people see a path through the thicket. Now, this isn’t going to be the last one. COVID’s just the current one. It’s a wonderful opportunity. There are so many other common infectious diseases that take a major toll every year. Maybe this is an opportunity to expand the good that we can do in a community at this time, given that people are finally listening a bit. I hear a lot of people saying that we really need to expand public health. What do they mean? Seems to me that we’d have a large voice in defining not just their future, but our future, as those conversations take place in our communities.

Do you have an idea of what direction you’d like to see public health going?

I think that we knew in the past, how to handle a major epidemic. It’s very clear that because the time between was so long we dropped the ball. There’s no question. Here in Utah, I have a former Secretary of HHS, we spend a little time together from time to time—

. He was there during SARS-1. And hearing Secretary Leavitt talk about what we learned with SARS-1. And then how frankly, the Bush administration was on top of it, the Obama administration actually lowballed that, they took money out of it to support the ACA insurance expansion program. I thought that was a major policy mistake at the time. Turns out it was. The Trump administration, of course, did not follow through and pull it back. And then we find ourselves a day late and $1 short when the real crisis hit. So, here’s an opportunity to lay some foundation for the next one. We know how, but it takes leadership. And it’s not just at a national level. It’s done at your local level. Who’s the voice that’s going to help people understand that moving forward in your community.

What about the insurers? How are they doing these days?

They’re standing on the sidelines a little bit. They have pluses and minuses. Their payments for COVID patients are up but frankly, for insurance, general use of services are down so much that most of them are doing quite well financially. It’s a a bit of a mixed bag for them, but for most of them, this has been a little bit of a financial windfall. I don’t see them…. Maybe this is just my bias as a physician. I’ve never seen insurance companies really leading in this site. It’s not their natural sweet spot typically. It’s not how they typically think about their role.

How do they typically think about their role?

They think about it as supplying funding for healthcare and making sure that only necessary services are provided. They do a series of important functions. One is transaction processing, claims processing. Surprisingly difficult. They do actuarial risk analysis to figure out how to price. They do network formation. There’s a series of things that they do. The thing they don’t do is deliver care.

Has any country in the world handled this right?

There’s a clear winner to my mind in the world. And not just mine, a number of our colleagues who watch these things, too. Taiwan. Taiwan’s done it right. They are a wonderful example of doing it right. South Korea was doing well. They got surprised. Singapore was doing surprisingly well. They left a hole in their defenses and their immigrant worker population in large dormitories and high rate of spread. Outside of that they’re a pretty program. There are countries like New Zealand that have done very, very well. We have to remember, they’re an island in the ocean, and they can close their borders. So, they’re kind of a special case. But Taiwan, a short distance from China. Massive amount of travel. Early-on exposure. They learned from SARS-1. They were ready. They were ready with testing and were ready with contact tracing. They’ve had less than 200 deaths in a population of around 24 million. It’s dramatically different from the experience of the rest of the world. So that’s the one to study. Right there. They had some special factors in their culture, wearing a mask was already really common. As it turns out, COVID-19 is mostly spread through respiratory droplets. It’s an upper respiratory infection. Mostly through respiratory droplets as a main route. And, so, masks are effective. Of course, most masks—the way people mostly wear them—it’s not effective in protecting yourself. It’s just effective in protecting others. That was part of their society. People before this happened routinely wore masks. It was an easy step. Their contact tracing. Let’s just say they may not have quite the sensitivity to human rights that we have. They did a great job of identifying and isolating potential infectors. They’re the one to study.

Let’s circle back to what you said about hospital systems. As we’re going through a situation where when we need more healthcare workers, they seem to be getting laid off.

So, people will get laid off, first of all, to answer your question, but we need to be more precise than that. It’s what kind of healthcare workers will get laid off. You said hospitals and hospital services. I think they’re going to mostly come back. So, people associated with hospital services, it will take a while for it to swing back. Currently, most hospitals are reopening their doors, they have a backlog. We call it elective, but it’s really hard to draw a hard, black line between essential and non-essential surgical services. Maybe we can delay, but that doesn’t mean they’re not essential. So, they have a bit of a backlog and they’ve been working it off. So those services are coming back nicely. We need to wait until the population at need—also sometimes the population at risk, particularly the elderly—feel confident coming back into a healthcare setting. So, part of the problem is just fear in the patient population. But I predict over time that’s probably going to ameliorate. It typically does. And as that happens, we’ll actually be working off a bit of a backlog for a while, but it’ll come back up over time. Again, remember though, anytime we’ve had a major economic downturn, there’s a drop in demand for healthcare services: 2008 was a pretty strong one. That one is a good experience. That’s close enough in our recent history that most of us remember it. We know what it was like. We’ve seen it. Well, here it comes again. And it’s probably a pretty good model. The anomaly is of course, with COVID, it shut us down cold. That was a little bit different, but I think that’s a temporary phenomenon that’s now starting to sweep back up. But the economic downturn; that’s going to be with us for a while.

What did former Secretary Leavitt had to say about all this?

He basically said what I just said and he published it, by the way. It was testimony to Senator Lamar Alexander’s Committee on Health, Education Labor and Pensions. You get him and his staff. It wasn’t just Governor Leavitt. They have strong opinions about it. But it had to do with careful central coordination and planning. By this point, we know that the initial modeling was off. So, it was a wiser approach to how we modeled. It was having the necessary supplies. It was a clear consistent message down to the states and to the people of the United States about what’s high risk, what’s not high risk. You don’t want to trust those kinds of things to the news media. The news media is not a reliable source of information. And then, of course, the supplies, a properly coordinated response. But of course, Mike Leavitt would have started this probably in November, December of last year. That’s when we were first getting a signal.

What surprised you most about this whole thing? Is there something that sticks out in your mind?

Things that I, and not just me, but any trained epidemiologist should see as obvious. You know, as a statistician, we call them proportional hazards models. That means there’s not just one risk. There’s a human tendency, probably evolutionarily built into us, that we focus on the one big threat—that saber-toothed tiger that’s about to eat us, right? Well, COVID is kind of a slow tiger that eats us a little bit at a time. But the fact is, is even as you focus on that threat, you shouldn’t lose track of the other threats. And that’s my biggest disappointment. People that should have known better focused just on this one threat. I thought our national leadership should have been a little bit broader in their application. There are real health risks associated with this that aren’t directly from the SARS-CoV-2 virus. I wish that we had been broader in our understanding.

Here’s one that’s topical for me because I get involved in health policy level nationally. We were talking an awful lot about the social determinants of health. Social networks, access to care, access to safe housing, food, water, a whole series of things like that. We knew that they were associated with major significant health risks. Associated with mortality rates. We were trying to call attention to it. Well, it turns out that damage to social determinants of health is associated with a major economic downturn. So, SARS-2 hits the streets, we shut down our economy. People lose jobs. We try to backfill with government programs, but a little bit unsuccessfully. We haven’t seen the end of it yet. But we weren’t considering the health consequences of the economic downturn. It’s not about the money, at least not directly. It’s about the lives. And you’re balancing these two and how do you balance the back and forth? It’s that kind of a conversation. Now to really have that conversation takes some real training and expertise. But then how do we tap the kind of training expertise as well? How do we make that available to people so that it reduces the fear levels? It gives people a clear path forward to a greater degree. They know what’s safe, they know what’s dangerous. They don’t see just the one risk, they see the other risks too, so they can kind of balance them out. And that means we respond more intelligently. We respond more wisely, than we have.

And the social determinants of health have come into play in this epidemic, too.

Oh, heavens, yes. And we’re seeing it especially in underserved populations. They have higher risk factors to begin with in terms of comorbid diseases, obesity, other risk factors directly associated with social determinants of health. They have poor access to the health system. So, we see disproportionate mortality rates in African American communities, for example. If you look at the way that those diseases play out, that was completely predictable.

Is there anything you’d like to add, Doctor James?

I’ll give you one thing. OK. This comes from some of the national groups in which I participate. I’m really hoping—both fingers crossed, and it would take a minor miracle—but what I’m hearing is to really have an effective vaccine could take two, three or four years. The earliest we would probably have it is at the end of 2021. Now, it’s not just developing a vaccine that actually works and testing it and showing that it works. The complications associated with it. It’s getting it available at scale. It’s getting a good distribution network, picking the populations that are higher or highest risk. There’ll be all sorts of hype around this coming up. The best expertise that I’ve been able to find suggests that probably it’s two to three years out. Now we could get lucky. Let’s hope for it right? What will happen short term is far better treatment. We already have readily available steroids that we’ve used forever that seem to stop 

 and get better outcomes for people with the most serious disease. What I’m hearing is, around November or December, monoclonal antibodies will be available at scale that could be a game-changer in terms of treatment of the disease. Now, the reason I mentioned this, I believe that your constituency, infectious disease doctors know about this stuff, they know how to track it. Again, it’s supplying that expert voice by tracking those things so that people have a realistic expectation about what comes next and how they need to behave. This is within our reach, but it does take some specialized training, a little bit of wisdom along the way. Where do we turn for wisdom? Where do we turn for knowledge? Some groups it seems to me are heading shoulders above the rest. So, guys, get out there and get to work.

This interview has been edited for clarity and length

Brent James, MD: “Those practices and those hospitals have no choice. A number of them face going out of business, even with the loans the government's giving today.”  

Join or Die: How COVID-19 Forces More Healthcare Consolidation

Since the beginning of the SARS-CoV-2/COVID-19 pandemic in the United States, we have widely known the vulnerability of certain patient populations. Early on, skilled nursing facilities and other long-term care facilities began to show a propensity for transmission of the viral infection.

There is a desperate need to infuse SNFs with more resources, not only in terms of personal protective equipment, but also the critical infection prevention resources and staffing.