Federal occupational health officials are being blasted for an Emergency Temporary Standard (ETS) requiring potentially labor-intensive changes to address a pandemic threat that is diminishing as vaccinations increase.

Designed to protect healthcare workers from COVID-19, the bulk of the ETS particularly sections that relate specifically to SARS-CoV-2 could be woefully out of date if growing mandated vaccination policies lead to immunizing virtually the entire hospital workforce against the pandemic virus.

“I hope there is an understanding that when you get people vaccinated some of these ETS requirements are not going to make sense,” says Connie Steed, MSN, RN, CIC, director of infection prevention and control at Prisma Health in Greenville, SC.

The Occupational Safety and Health Administration’s (OSHA) ETS was published in the Federal Register on June 21, 2021.1 That means that employers must comply with most provisions within 14 days, but can take up to 30 days for requirements involving physical barriers, ventilation, and training. (See Hospital Infection Control & Prevention, July 2021). The ETS is in effect for six months, and OSHA requested comments by July 21, 2021, on whether it should become a final rule after that period.

Comments at the recent annual conference of the Association for Professionals in Infection Control and Epidemiology (APIC), as well as those submitted to the Federal Register, found little to like about regulatory action this late in the pandemic. (SeeComments to OSHA on ETS: ‘Too Much, Too Late.’”)

“For me, the frustration is that this seems a little bit like too little too late,” says Ann Marie Pettis, RN, president of APIC. “A lot of what is being recommended seems very much after the fact.”

On its website, APIC encourages members to submit their own comments to amplify the voice of infection preventionists and provide input on the effect on their facilities. In a message sent to its members that likely will be part of its formal comments submitted to OSHA, APIC said it “is concerned that many parts of the ETS are not up-to-date with current scientific evidence or Centers for Disease Control and Prevention (CDC) guidelines, especially post-vaccination guidance.”2

Provisions on screening patients and employees, physical distancing, and the use of barriers also need to updated to be consistent with current knowledge about SARS-CoV-2 transmission, APIC noted.

“This [ETS] could be temporary, and it could change again,” Pettis says. “So, you spend all this time trying to implement this — and then is it going to change? There is a lot of frustration, a lot of work, and a lot of scrambling. You wonder just how much of this was advised by infection preventionists and epidemiologists.”

Interim Final Rule

The ETS was published as an “interim final rule,” meaning it has the potential to gain permanent status. Some question whether finalizing a permanent standard for COVID-19 makes sense, since the pandemic is expected to fade as widespread vaccine availability increases globally. In that regard, the ETS could form the basis of a more general respiratory protection standard for healthcare. Some support the regulation in part because of the inevitable pandemic to follow.

“In our globalized world, since SARS-1, there has been an epidemic about every five years, and this trend will most certainly continue,” says Gabor Lantos, P.Eng, MBA, MD, president of Occupational Health Management Services in Toronto.

The OSHA delay in issuing regulatory protections against COVID-19 was caused, in large part, by the fact it essentially required a change in presidential administrations. President Joe Biden issued an executive order on Jan. 21, 2021, calling for OSHA to take action, if needed, to protect workers by March 15, 2021. The official ETS was published more than three months beyond that deadline, adding a level of exasperation to those tasked with implementing the requirements.

“Unfortunately, the ETS is very late in the pandemic, to the point where many negative outcomes have already been experienced,” says Cory Worden, PhD (ABD), MS, CSHM, Region 2 director for the Association of Occupational Health Professionals in Healthcare (AOHP). “We will never know how many exposures could have been prevented had exposure prevention controls been implemented and enforced earlier in the pandemic.”

Steed was a little more blunt about the timing of the OSHA ETS.

“It’s horrible you couldn’t have picked a worse time,” she says. “If this had come out in March as President Biden requested at that time we had a lot of COVID. But now it is a completely different picture. It’s going to be really hard for organizations to apply this when our employees are seeing the public [without masks] with everything opened up. We have visitors who are resisting mask wearing in our hospitals.”

Many of the basic measures, which are essentially codified CDC recommendations, already are in place at many hospitals, Steed says. Other requirements are more problematic, particularly since employee immunization seems to be largely irrelevant for most requirements.

“This standard talks about social distancing of all employees,” she says. “It doesn’t say only those [who] aren’t vaccinated.”

Hospital engineers have been consulted about building barriers in tight spaces where six feet of distance will not be possible between employees.

They also will assess the HVAC system, which the OSHA ETS requires be used and maintained in accordance with the manufacturer’s instructions. Air filters must be rated Minimum Efficiency Reporting Value (MERV) 13 or higher if the system allows it.

“[Engineers] have to assess [initially] and we need to make sure that their ongoing plan of assessment is conducted with the filters etc.,” Steed says. “I think hospitals in general have this under control, but we also have to make sure that our airborne isolation rooms are negative and that the pressure differential is checked.”

Just bringing existing systems up to standard may create a compliance problem, since many healthcare HVAC systems vary widely by installation dates and technical specifications, Worden says.

“While the benchmark in the past has been to optimize air filtration and circulation with the existing system, specific ETS specifications may require technical needs or maintenance needs, both of which possibly require personnel, costs, or both,” Worden says.

The issue of airborne spread beyond aerosol-producing procedures has been somewhat contentious with COVID-19, recalling a similar debate when the original severe acute respiratory syndrome (SARS) struck in 2002-2003.

“I have been advocating for airborne precautions since SARS-1,” Lantos says. “Of course, there will be costs, but tremendous benefits as well. How many lives have been destroyed physically, mentally, financially by the transmission of COVID in nursing homes, hospitals, and workplaces, and by the consequent lockdowns?”

Elephant in the Room

The elephant in the room in all this comes back to COVID-19 vaccination of healthcare workers. OSHA requires that hospitals and other facilities under the regulation “provide reasonable time and paid leave for vaccinations and vaccine side effects.” Beyond that, for the most part, those vaccinated essentially must follow the OSHA regulations as if they were not immunized.

“I didn’t see anywhere in the standard where they say it is OK not to mask if you are vaccinated in a hospital,” Steed says. “I think people are asking the question and what [OSHA] is saying is, ‘If you have a controlled area in the hospital where you know there is not going to be anyone with COVID and you know everybody is vaccinated you can take off a mask.”

Meeting those requirements without mandating staff vaccinations is going to be problematic.

“It’s going to be hard. I think this pushes employers to require vaccine,” Steed says, noting that she is not in favor of the ETS being finalized as written currently.

“I’m concerned about this standard,” she says. “I believe employees have a right to be protected. Are we overdoing it a little bit? Because this is a droplet, aerosol disease. Are we going to keep people in masks, socially distanced, forever? That doesn’t make sense to me. To be honest with you, requiring COVID vaccine for employees is the only reasonable way for organizations to survive.”

While pointing out that approximately a quarter of healthcare workers have not yet completed COVID-19 vaccination and it is duty bound to protect them OSHA left the door open for revisions as the pandemic continues and more people are vaccinated.

“OSHA will continue to monitor trends in COVID-19 infections and deaths as more of the workforce and the general population become vaccinated and the pandemic continues to evolve,” the ETS states.

In other words, widespread mandatory vaccination of healthcare workers could be a game-changer, unless OSHA wants to make the questionable argument that employees in hospitals with fully immunized staff still meet the “grave danger” threshold required for an ETS.

In that regard, hospital and healthcare systems all over the country, representing tens of thousands of employees, are announcing mandatory vaccine policies with limited medical and religious exemptions. Some are going into effect in the immediate future while other hospitals announced they will go into effect when the Emergency Use Authorization (EUA) on the vaccines is lifted by the Food and Drug Administration. However, a recent judicial ruling on a lawsuit showed that COVID-19 vaccine can be mandated successfully even under EUA status.

Judge: Vaccines Not ‘Experimental’

A federal judge in Texas threw out a lawsuit filed against Houston Methodist Hospital for mandating the COVID-19 vaccine for healthcare workers as a condition of employment. The dismissal of the suit is being appealed, but the action sends a shot across the bow to healthcare workers and others who plan to challenge mandated COVID-19 vaccination programs in hospitals. 

The hospital policy called for all employees to be vaccinated by June 7, 2021, with the lawsuit being filed a little more than a week before that deadline. Filed by 117 unvaccinated employees, the lawsuit claimed Houston Methodist is “forcing an employee to participate in an experimental vaccine trial as a condition for continued employment.”3

Arguing that the hospital employees were not allowed to refuse an experimental product, the suit compared the mandated immunization of American healthcare workers for COVID-19 to the medical experiments the Nazis conducted on unwilling volunteers. These atrocities led to the Nuremberg Code on Permissible Medical Experiments, which states “The voluntary consent of the human subject is absolutely essential,” the lawsuit states. In dismissing the case, Lynn Hughes, a federal judge for the Southern District of Texas, demolished the experimental vaccine claim and took the plaintiffs to task for citing the Holocaust to support their argument.

“The hospital’s employees are not participants in a human trial,” Hughes states in the dismissal ruling.4 “… The hospital has not applied to test the COVID-19 vaccines on its employees. The Nuremburg Code does not apply because Methodist is a private employer and not a government. Equating the injection requirements to medical experimentation in a concentration camp is reprehensible.”

The ruling clarifies that Texas law only protects employees from refusing to commit an act carrying criminal penalties to the worker. 

“Receiving COVID-19 vaccination is not an illegal act and it carries no criminal penalties,” the dismissal states. “[Plaintiffs are] are refusing to accept inoculation that in the hospital's judgment will make it safer for their workers and the patients in Methodist’s care.”

Judge Hughes also cited the recent position taken by the Equal Employment Opportunity Commission, which said employers can require COVID-19 vaccination of employees with reasonable accommodations for exemptions and staying within existing anti-discrimination laws. 

The momentum for mandated shots only will increase with two other developments, the first of which was APIC’s announcement at its recent conference that the association favored mandatory COVID-19 vaccination and wanted to support the hospitals that are beginning to implement it.

“As healthcare professionals, we have an ethical responsibility to protect those individuals entrusted to our care,” Pettis said.

APIC also is joining the Society for Healthcare Epidemiology of America (SHEA) and other infectious disease groups in an upcoming joint position paper that is expected to endorse mandated COVID-19 vaccines as a condition of employment in healthcare.

David Henderson, MD, who represented SHEA at the APIC meeting, said, “All the vaccines we have right now are under emergency use authorization and there is language in the EUA document that says that you can refuse the vaccine. The lawyers tell us that, ‘You can refuse the vaccine, but you can’t work here.’ We make a lot of vaccines conditions of employment and I am very hopeful that the whole country will embrace this, and it will become mandatory for healthcare workers.”

REFERENCES

  1. 86 Fed Reg 32376 (June 21, 2021).
  2. Association for Professionals in Infection Control and Epidemiology. APIC assessment of the OSHA COVID-19 Emergency Temporary Standard. Published June 30, 2021. https://apic.org/wp-content/uploads/2021/06/APIC-recommendations-on-OSHA-ETS.pdf
  3. Jennifer Bridges et al. v The Methodist Hospital. In the District Court of Montgomery County, TX. May 28, 2021. https://assets.documentcloud.org/documents/20792874/methodist-lawsuit-1.pdf
  4. United States District Court. U.S. Judge Lynn Hughes Southern District of Texas. Jennifer Bridges et al, plaintiffs v Houston Methodist Hospital et al, defendants. Order on Dismissal. June 12, 2021.