OSHA! OSHA! OSHA!

 

In many parts of the country, as rates of COVID-19 are declining and vaccination coverage is increasing (albeit with substantial variation across the US and the world), reopening has commenced.  Masking requirements and guidelines have relaxed, gatherings have increased, and we’re entering the post-COVID reality.  In healthcare, discussions regarding how to safely relax various interventions put in place during the height of the pandemic are underway:  When do we (should we ever) stop active screening of healthcare workers, patients, and visitors? Can we stop requiring admission and pre-procedural asymptomatic screening testing? How does a fully vaccinated workforce affect this relaxation? Can we safely gather? Do we stop social distancing? Will universal facemask use in clinical areas be the new standard practice from here on out?

Last week, a massive regulatory curveball crashed into this discussion when OSHA released the Emergency Temporary Standard on COVID-19. Catching many facilities by surprise, the new Standard, which many are required to meet within 14 days of publication in the Federal Register, harkens back to Spring of 2020 in many ways.  The requirements do not seem to take into account the declining rates of infection and increasing vaccination coverage and instead read as if rates were still climbing and vaccines were still under clinical trials. As a regulatory branch of the government with “teeth,” OSHA can cite and fine facilities for failure to comply (unlike other parts of the federal government infection prevention experts are also used to following, like the CDC).  In many ways, this makes OSHA’s directives and perspective on interventions the final say, even when evidence may not fully support them.

OSHA’s mission is a very important one: to ensure employers provide a safe working environment and that employees have safeguards in place to minimize/eliminate harm from their working environment.  OSHA standards have paved the way for safe, protected workplaces, and their guidance applies to all types of industries, from manufacturing plants to construction sites to hospitals and clinics. However, OSHA’s approach to healthcare has been criticized for failing to account for patients and potential patient harm in their mission to protect healthcare workers. While at the manufacturing plant, any regulatory requirements put in place won’t harm the widgets being produced, in healthcare, we have to work to ensure protection of the workforce while also accounting for practices that could result in harm to the patients that that workforce serves.

Enter the “ETS,” as it’s (not really) affectionately called. With a massive preamble of 916 pages (one can only imagine how long such a document took to go through gaining internal consensus), the ETS outlines expected practices that must be in place for facilities who may see persons with suspected or confirmed COVID-19.  Some key concerns about the new guidance are as follows:

• I won’t rehash the mask vs N95 for the care of COVID-19 patients debate, other than to note that this is an issue where the science is still very much in conflict (see recent debate at SHEA and upcoming one at IDWeek 2021 on just this topic). OSHA’s ETS has essentially made the argument moot: N95s must be worn for care of any suspect or confirmed COVID-19 patient – not just with those undergoing an AGP. Imagine the implications of this: now, even fully vaccinated pediatricians, seeing wave after wave of children with URIs this fall, must wear the full COVID-19 PPE for every patient. Every day. If such workers aren’t facing burnout now, that may tip them over the edge. It’s one thing if such conservative use of precautions were necessary; however, that’s unclear, especially in a fully vaccinated person.  Maybe a facemask and eye protection is all that one needs, but that doesn’t matter now.
• The ETS requires employers to notify employees if a case of COVID-19 is reported in their workspace. The notification is not just to close contacts but to anyone working in the “well-defined” workplace who weren’t wearing a respirator. This seems more burdensome to already stretched occupational health programs, but what’s even more curious is if such notification was important, it is not necessary if the COVID-19 case occurs in a patient in area where care of suspected and confirmed COVID-19 patients occurs. So if alerted to a case of COVID-19 in the sterile processing department, all employees in that area (not just close contacts) not wearing an N95 (why would they be??) must be notified, but if that case happens to have been on one of the clinical units where COVID-19 patients reside, notification is not required.  Hmm . . .
• Some of the ETS requirements are confusing and vague, such as this statement: “When the employer establishes it is not feasible for an employee to maintain a distance of at least 6 feet from all other people, the employer must ensure that the employee is as far apart from all other people as feasible.”  “Must ensure” is very strong language yet how is this even remotely possible to monitor, enforce, or even set expectations for?
• The ETS does allow exemptions for fully vaccinated persons, but only in areas where “people with suspected or confirmed COVID-19 are not permitted to enter those settings.” Unfortunately, in healthcare settings, many such persons are coming to the facility for care for those exact symptoms or require urgent medical interventions that cannot be delayed, and prohibiting them from entering the location runs counter to that mission and can result in patient harm. As a result, the fully vaccinated status of the workforce will not matter for many of the requirements.
• Despite being the most effective interventions to protect the workforce (which has an added benefit of protecting the widgets . . . I mean, the patients too), OSHA does not take a firm stance on requiring COVID-19 vaccination for healthcare personnel.  (In fairness, they do strongly encourage vaccination and require employers to provide time off for vaccine-related symptoms).

Despite my cynical attitude, I do think some of the ETS requirements are very positive: the emphasis on cleaning, ventilation requirements, use of transmission-based precautions, and a much stronger expectation around reporting of employee respiratory illness and staying home when ill. I do, however, worry about the overly burdensome requirements at a time when COVID rates are falling, especially when we enter the fall and our good friends influenza, RSV, and other viruses make a return (but maybe, given the near elimination of those viruses last winter, that’s part of the intended impact of the Standard?).  Interestingly, OSHA opted only to release an ETS regarding COVID-19 for healthcare and not for other industries.  But if COVID-19 is still an occupational risk for workers in healthcare, isn’t it for other industry workers as well? I also realize that the emergence of variants of concern can change the epidemiology of COVID-19 rapidly, but thankfully, vaccination does still provide substantial protection against the currently circulating variants.

So as you scramble to unroll back/reinstitute interventions that had been in place last year and struggle with messaging to the workforce of the new requirements, know you are not alone.  Hopefully, with public comment and more science, the positive aspects of the Standard can be kept while eliminating or revising the more burdensome and arguably non-protective requirements. As Marcia Brady would say, "Sure, Jan . . ."

[This document represents my individual personal views and opinions and are not necessarily the views and opinions of Vanderbilt University Medical Center]

Lifting Mask Requirements in Nonclinical Workspaces in Healthcare Facilities

This guest post was written by Jorge Salinas, MD, Hospital Epidemiologist at the University of Iowa Hospitals & Clinics. 

The COVID-19 epidemiologic situation in the United States has improved tremendously. The Centers for Disease Control and Prevention (CDC) recently modelled that the United States will continue seeing a decreasing incidence in coming months. There is also increasing recognition that vaccines are protective against infection and transmission. Because of these factors, an updated CDC guidance for settings other than healthcare facilities states that fully vaccinated people may attend indoor gatherings without wearing a mask. These indoor locations include restaurants, bars, gyms, movie theaters, and full-capacity worship services. They even allow singing in an indoor chorus. This qualitative jump has —of course— been received with skepticism by many members of the public including some public health practitioners. 

Some of the reasons for the criticism arise from 1) how difficult it is to determine if unmasked persons are in fact vaccinated, 2) the low vaccine uptake in some localities, and 3) the relatively high incidence in these communities. These are adequate indicators that should influence de-escalation of universal mask requirements in the community. However, confirming the vaccination status of people in public indoor spaces represents the hardest challenge to overcome. We may be able to bypass it by assuring that high vaccination levels and a low incidence have been achieved in the community. If these principles hold true for the community, I believe they are true for some areas in healthcare settings too. Healthcare facilities (Hospitals, nursing homes, long-term care facilities) have several factors that make them special such as caring for vulnerable people: elderly, ill, or immunosuppressed patients. However, healthcare facilities have better administrative and engineering controls than community settings, namely, higher vaccination rates and air handling. Healthcare facilities also have several spaces, some of which, host only healthcare workers while other areas have visitors and patients. 

The latest CDC recommendation for COVID-19 infection prevention and control in healthcare facilities from April 2021 states that “In general, fully vaccinated HCP should continue to wear source control while at work. However, fully vaccinated HCP could dine and socialize together in break rooms and conduct in-person meetings without source control or physical distancing”. This recommendation acknowledges that the COVID-19 vaccines approved in the United States are quite good at preventing both infection and transmission. However, the same guidance states that “If unvaccinated HCP are present, everyone should wear source control and unvaccinated HCP should physically distance from others”. Because of the astonishing protection derived from vaccination, healthcare workers may be able to have maskless meetings and lift mask requirements in shared workspaces and gatherings even if the vaccination status of each individual worker is not known. To achieve that safely, healthcare facilities will need to ensure high vaccine acceptance rates among healthcare workers (e.g., >70%), vaccination among those eligible in the public is high (e.g., >50%), and community incidence is low (e.g., <10/100,000 population). Facilities should require that healthcare workers who were not vaccinated continue wearing masks. 

As the incidence of COVID-19 continues to decline and vaccination rates go up, further de-implementation will also need to be considered in the future: for example, lifting mask requirements in hallways and waiting areas for healthcare workers, visitors, and patients. Lastly, mask wearing when providing patient care will also need to be evaluated. Many societal milestones will need to be met before these next de-implementation phases.

As with other de-implementation efforts, it will be important to have adequate surveillance in place to detect if this change is associated with increases in transmission.  Other factors such as potential future increases in community incidence either because of emerging variants of concern or waning immunity are also possible but not very likely in the short term.

Throughout the pandemic, everyone in charge of national, local public health, as well as healthcare epidemiologists/infection prevention professionals have made decisions with incomplete information and risking the possibility of being wrong. We must, however, not let our fear of being wrong keep us from implementing —or de-implementing — measures when the epidemiologic parameters support it.

A Momentous Week in Our Pandemic Response

This guest post was written by Jorge Salinas, MD, Hospital Epidemiologist at the University of Iowa Hospitals & Clinics. 

Her saturation had dropped to 89. Fever persisted. She was being admitted. This was the telegraphic message that started a roller coaster of a week. My mother had been symptomatic for a few days but had suddenly worsened. By 7:45 that same morning, we received confirmation—shipment was completed, 975 doses were on the dock, the vaccination deployment plan was a go.

A quick morning huddle. Everyone knew their positions and what to do: teams to prepare the doses, employee health nurses to administer them, planners to manage schedules. It was nicely choreographed and rehearsed.

The New York Times, 12/18/20

ED nurse, environmental services custodian, doctor, resident. How many people received the dose before me? Ten? Twenty? Jorge, this way. Immediately after the shot, I was asked, on camera, how I felt now that I had received the precious vaccine. This was undoubtedly a triumph of science. One of the greatest medical breakthroughs in years. And I had received it. Yet, I couldn’t avoid feeling unworthy of it. Because I am part of our system pandemic response I had more access to the vaccine than those more at risk. I had reluctantly persuaded myself that being a Hospital Epidemiologist and a Hispanic physician it would be advantageous to our response. To lead by example, show my healthcare colleagues here and abroad that I have confidence in the vaccine development process, that these vaccines are efficacious and safe. Took a big swallow, don’t think of mom right now, take a deep breath, go on.   

I am not an ethicist. I believe that the fair allocation of scarce resources is one of the hardest feats in medicine. We had debated extensively: how could we allocate these first thousand doses amongst almost 20,000 healthcare workers? Who should get it? Those over the age of 65? Those working in COVID units? Those on oncology and transplant floors? Should it be a lottery? Should we factor in healthcare worker comorbidities? Why did they send only 975 doses? We decided to prioritize every frontline, doctor, nurse, respiratory therapist, trainee, environmental services worker, etc., assigned to our inpatient and outpatient COVID units. After them, healthcare workers across all lines in all other units would be given the vaccine. Most States have less than 20% of doses needed for healthcare workers at the moment. 

Source: Vox.com

By mid-week we had vaccinated hundreds of people across all work lines in the first priority group. Questions of course came in: When is my turn? Why is my unit in phase one or two? But all in all, people were gracious and kind and most are still patiently awaiting their turn. A question arose though that was a bit harder to answer. If there is a cancellation, who should get that dose? Whoever can come in faster? Here again, came another simple realization: there are barriers to vaccination, even among healthcare workers. Those in support services and trainees even within our system would have a harder time to stop doing what they are doing at work, arrange day care, or plan for the possibility of a couple of days off after their shot in case of side effects. Quickly reacting and sprinting to get into an opening could disadvantage some groups over others. We had planned for an equal allocation to all work lines in high-risk areas but it was clear that some employees have additional barriers to vaccination.

Support service workers, trainees, housekeepers. Weren’t they also at higher risk of exposure outside of work? Our data has shown that most exposures among healthcare workers were nonoccupational. Had my job as a healthcare epidemiologist biased me to focus protection mostly while at work? But what about when in the community? I realized that when deploying vaccines, we should think of high risk of exposure at work of course, but some groups had a higher risk of COVID outside of work, in addition to potential barriers to getting the first doses of vaccines even if allocated to them.

Fair allocation of vaccine doses is not easy. Aiming for fair may not even be enough. At work and in the community, we need to work extra hard to reach those with less resources, those who chronically have barriers to access to care. These lessons from my own healthcare system will guide how I think about vaccine allocation for subsequent groups. After healthcare workers and people living in long-term care facilities are vaccinated, how are we to prioritize the next groups? It is clear that we have to actively reach those at an increased risk of acquisition however hard it may be.

While it will take several months and ethical conundrums will continue to arise locally, what about the rest of the world? Mom was a laboratory technician before she had us. If she had still been working, when would a dose have reached her in distant Peru? The global vaccine pipeline is not looking very promising for resource limited countries. The same challenges seen locally are present on a world scale. Resource limited countries may not reach full coverage until very late in 2021 or 2022. Who looks after a fair allocation of vaccines on a global level?

Source: Duke Global Health Innovation Center

 

Source: The Economist

As we close this week, I feel grateful to have received the vaccine, to work in healthcare epidemiology, to continue learning from my mistakes, and I strive to be just in our protection efforts for healthcare workers and our communities. I am grateful my mother is recovering, for my colleagues taking care of her and the hundreds of thousands of people battling COVID-19 worldwide.

The next weeks and months will continue being challenging. It is clear we have entered a new phase in the pandemic, but until we reach high vaccination coverage we must continue implementing nonpharmacologic interventions, masks, avoiding indoor crowds, and maintaining our distance. We must also advocate for just allocation of medical resources in our local and global societies. Hundreds of thousands of lives can still be saved.

COVID-19 Transmission: Medicine Grand Rounds at UCSF

Let's Just Get Every Face Covered

Photo by cottonbro at pexels.com

In the over decade-long history of this blog, Dan's recent post, A Tiresome SPAT, has been viewed more times than any other post we've ever written. And it's only been up 48 hours. This is a testament to Dan's ability to encapsulate the controversy regarding SARS-CoV-2 transmission in a billiant way. As I reflected on his writing, it became increasingly clear to me that the source of the controversy of whether we are dealing with droplet transmission or aerosol transmission is deeply rooted in the framework through which you're viewing the issue. These frames are associated with different values and ways of thinking, and depending on the frame utilized determines your recommmendations for mitigating transmission.

The first framework I'll describe is the medical (i.e., individual patient) frame. Imagine a patient visiting their physician and asking what they can do to best avoid COVID-19 infection. In addition to social distancing and hand hygiene, the physician would likely recommend a mask and eye protection. The physician might even recommend an N95 respirator depending on the patient's underlying conditions, the context of their exposures, and the patient's risk tolerance. In general, in this framework, risk tolerance is low, and the goal is typically to reduce the individual's risk to the irreducible minimum. This approach drives the occupational health perspective. PPE is viewed from the standpoint of efficacy--how do we provide ideal protection?

Now, let's look at the public health (i.e., population) framework. From this perspective, the goal is not necessarily to prevent every possible case of COVID-19, but rather to bring the outbreak to an end. This requires reducing the R0 to less than one. Thus, the interventions don't need to be perfect, and individual risk is tolerated to a somewhat greater degree. And in this framework, the PPE recommended is that which is most effective (i.e., how well does it work in the real world?), which factors in adherence. Let's say that face covering A is 90% efficacious, but only 20% of people are willing to wear it. On the other hand, face covering B is 60% efficacious, but 80% of people are willing to wear it. We're clearly better off with face covering B. The public health framework is driven by a utilitarian perspective--accomplishing the greatest good for the population, not for any given individual patient. 

Our recent JAMA viewpoint, Moving Personal Protective Equipment into the Communnity, in which we argue for universal face shields in the community settting, was written from a public health framework. This was perhaps not clear to the many individuals who pointed out that in some cases there could be airborne transmission of the virus for which a face shield may not work. Yes, we get that, but the epidemiology convinces us that the airborne route is a minor mechanism of transmission.

The bottom line here is that we can't let perfect be the enemy of the good. We recommend influenza vaccine every year despite an average seasonal effectiveness of approximately 40%. The best face covering is the face covering that people will wear. Though I personally favor face shields for community use, I am happy to see faces covered in almost any way possible (which is why I love the photo above). 

And if it's not bad enough that experts are not in agreeement, we have the additional problems of botched messaging by the CDC and political leaders who by intentionally sowing doubt and refusing to be good role models, make this work all the harder. Kudos to those leaders who are mandating face coverings. And my message to everyone is this: for community settings, let's just get everyone in a face covering now, whichever one works for them. After the pandemic is over, we can sort it out once and for all. 

A tiresome SPAT

I’m surprised that we can’t stop arguing about the modes of SARS-CoV-2 transmission, despite the fact that most experts (including our friends at WHO) agree on the important issues. Our colleague Jorge Salinas very nicely summarized these issues (and their implications) in this post.

The latest kerfuffle: media coverage of 239 experts who are upset that the WHO is not acting as decisively as they’d like on an evidence base that the experts themselves admit is far from definitive.

As we’ve outlined here and here, a major problem plaguing this discussion is the false dichotomy between “droplet” and “airborne” transmission that we use in healthcare settings (for simplicity of messaging, and because it has served us well for several decades—for reasons I’ll get back to later). This dichotomy divides application of transmission-based precautions between those pathogens spread via respiratory droplets, all of which must absolutely fall to the ground within 6 feet of the source, and those pathogens which become airborne, meaning they travel long distances on air currents, remain in the air for very long periods of time, and most importantly, can cause infection after their airborne sojourns if they find the right mucosal surface.

But we know (and WHO experts know) that there is no such dichotomy—it’s more of a continuum. At the very least there is a middle category, let’s call it Small Particle Aerosol Transmission (or SPAT). Many respiratory viruses (not just SARS-CoV-2) can remain suspended in aerosols and travel distances > 6 feet. As Jorge outlined, it’s probable that transmission events occur when these aerosols are concentrated in closed, poorly ventilated spaces or in very large amounts (e.g. a 2+ hour choir practice, a 3 hour indoor birthday party, a crowded bar). This may explain the superspreading events that drive a lot of SARS-CoV-2 transmission.

It’s important to distinguish SPAT from “classic airborne transmission” (let’s call it CAT). The CAT pathogens (TB, measles, VZV) have very different transmission dynamics than SPAT pathogens, as I outlined here (R0s of >10, household transmission rates of 50-90%). The distinction is important because for most healthcare epidemiologists, using the term “airborne” implies a common set of “one-size fits all” interventions to prevent transmission, interventions that require resource-intensive engineering controls and PPE requirements. It is not at all clear that such interventions are required to prevent transmission of SPAT pathogens. In fact, most evidence (and real world experience) suggests that they are not. This is why the droplet-airborne dichotomy has served us fairly well over the years—either because droplet precautions appear to be pretty effective at preventing SPAT, or because SPAT is rare even among those viruses capable of it.

I could say more about my feelings about aerosol-scientists criticizing epidemiologists and clinicians for having an “overly medicalized view” of the evidence, but I don’t want to be CAT-ty. I just want to end the SPAT.

So let’s redirect the discussion instead to: with the limited information we have, what additional interventions should WHO and/or CDC recommend for transmission prevention during the pandemic? Masks in crowded indoor spaces? Sure, but avoiding such spaces is preferred. Improved ventilation in all indoor environments? Absolutely, let’s get to work on that. N95s in the community? Don’t make me laugh, it might generate aerosols.* N95s for all patient care? Fair to consider, but by now we’ve gathered quite a lot of experience safely delivering care using existing WHO recommendations. And as Jorge aptly pointed out, “a debate only centered on whether respirators or medical masks are needed can distract us from the bigger challenges.” Indeed.

*Clarification as this comment, made in jest, has been misinterpreted.  N95 masks do not generate aerosols. They are unrealistic for community use, as they must be fit-tested and worn properly (even if we had an unlimited supply, which we do not). Nor are they, in my opinion, necessary for community protection. Face shields or medical/cloth masks are preferred for community use.

COVID-19 Can Have Airborne Transmission but You Don't Need to Run for an N95

This is a guest post by Jorge Salinas, MD, Hospital Epidemiologist at the University of Iowa Hospitals & Clinics. 

There is virtually no doubt that SARS-CoV2 is transmitted by droplets and contact. However, the debate continues about whether SARS-CoV2 can be transmitted through the air, in what epidemiologists call “airborne transmission.” As with most biologic processes, unfortunately this is not a dichotomy. Many (too many) factors play a role.

Population density matters. As people breathe, speak, sneeze, or cough we all produce many particles that have a continuum of sizes. These particles are unfortunately called too many names in the literature and the lay press (e.g., droplets, aerosols). Viruses and biologic processes don’t read textbooks. These particles can be large (what healthcare epidemiologists call “droplets”), medium size (no fancy name for them), and small (these are called “aerosols” by some but “droplet nuclei” by others). If we are near only one infectious person, the number of small particles (aerosols) expelled may not be enough to meaningfully contribute to infection. But if we are exposed to many infectious people at once, the number of small particles can increase. In such instances, airborne transmission in addition to contact and droplet transmission can play a role in outbreaks.

Patient characteristics are also tremendously important. Some may extrapolate that COVID is not as contagious or rule out the possibility of airborne transmission because of a paucity of hospital outbreaks, even if not following airborne precautions. If we follow the natural history of COVID, we now know that a person is possibly infectious 48 hours before symptom onset. Most people do not require hospitalization, and those that require hospitalization may be in later stages of the disease. We are learning daily that COVID, the disease caused by SARS-CoV2, is likely a continuum. Initially, the disease is predominantly caused by direct injury of the virus to tissues, but as days go by some patients will have immunologic or para-infectious syndromes that may require hospitalization. By the time a patient with COVID requires hospitalization, their infectiousness has likely decreased. It is now clearly recognized that presence of viral RNA does not equal risk of transmission in many cases.

The setting is also very important. How big is the space where the infectious person and their potential contact are located. If outdoors, the risk is tremendously decreased as air flows freely greatly decreasing the possibility of breathing “the same air.” Indoors, the number of air exchanges is very important: the more air exchanges, the lesser the likelihood of spread. Fortunately, most hospitals have already implemented an increased number of air exchanges likely decreasing the possibility of airborne transmission of pathogens in hospitals.

If airborne transmission plays a role in SARS-CoV-2 transmission, I believe it is predominantly in the early stages of the disease, in the viral phase. That may explain why most healthcare outbreaks have occurred in nursing homes and long-term care facilities. Not only because of potential infection prevention deficits but because patients are already in the facility when they become infectious. They are at the peak of infectiousness when in the facility. Hospitals on the other hand, will usually admit patients days or even weeks after the beginning of the infectious period, likely attenuating the risk of transmission in hospitals.

Recognizing that SARS-coV2 can also spread via small particles should not lead to panic. It should lead us to modify our behaviors in the community by avoiding crowded indoor settings, using universal source control with face coverings, and maintaining physical distance.

Modified from CDC.

In healthcare facilities, we need to continue educating stakeholders about the hierarchy of infection controls. Administrative and engineering controls are by far the most important measures. Decreasing population density, protocols for early identification and isolation of potentially infectious cases, especially those early in the disease course, and increased air exchanges are likely the most important measures. Personal protective equipment is also important. However, a debate only centered on whether respirators or medical masks are needed can distract us from the bigger challenges of administrative and engineering controls.

Reducing population density in healthcare facilities (patient census and personnel) can lead to increased safety but has a tremendous impact on population health (less capacity to take care of patients) and potential economic implications if healthcare personnel numbers are decreased. Engineering controls are also costly but fortunately most hospital design standards already address increased air exchanges compared to regular buildings and homes.

This pandemic has been challenging for all. COVID-19 keeps me humble as what I thought I knew yesterday may not be true today. Let’s all remain humble and nimble as we respond to COVID-19 in the community and in healthcare facilities.