The Occupational Safety and Health Administration’s (OSHA) emergency temporary standard (ETS)1 to protect healthcare workers from COVID-19 is drawing mixed reviews. There certainly is a broad appreciation of OSHA’s effort to protect healthcare workers, but the benefits of the ETS are somewhat mitigated by the fact that it comes 18 months into the pandemic. Many employees are now vaccinated.

“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, safety advisor at the City of Houston Department of Health. “We will never know how many exposures could have been prevented had exposure prevention controls been implemented and enforced earlier in the pandemic.”

Regarding enforcement, the ETS puts regulatory teeth into the CDC’s recommended practices, some of which were politicized and undermined during the pandemic.

“Because this is an OSHA regulation, it mitigates the subjective risk assessments of some organizations that did not implement exposure prevention controls because they did not believe the pandemic to be a threat based on political opinions,” says Worden, Region 2 Director for the Association of Occupational Health Professionals in Healthcare (AOHP).

OSHA’s delay in issuing regulatory protections against COVID-19 is partly explained by the fact that it essentially required a change in presidential administrations. President Joe Biden issued an executive order on Jan. 21, calling for OSHA to take action to protect workers.

“Consider whether any emergency temporary standards on COVID-19, including with respect to masks in the workplace, are necessary, and if such standards are determined to be necessary, issue them by March 15, 2021,” according to the executive order.2

However, OSHA did not issue the ETS until June 10. At a press conference, Jim Frederick, Acting Assistant Secretary of Labor for Occupational Safety and Health, said, “OSHA has determined the most impactful action we can take at this time is to issue an emergency temporary standard that is focused on healthcare settings where workers are most likely to come into contact with someone carrying the virus. This includes workers in hospitals, nursing homes, and other high-risk areas in healthcare settings.”

OSHA determined healthcare workers are in “grave danger” from COVID-19 — a requirement for an ETS — but did not broach the controversial subject of vaccine mandates some hospitals are adopting. (For more information, see related story in this issue.) Hospitals and other facilities under the regulation are required to “provide reasonable time and paid leave for vaccinations and vaccine side effects.”

In addition to hospitals and nursing homes, the standard applies to emergency responders, home healthcare workers, and ambulatory care facilities where suspected or confirmed COVID-19 patients are treated, according to an OSHA fact sheet on the standard.3

“The ETS exempts fully vaccinated workers from masking, distancing, and barrier requirements when in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID-19 will be present,” OSHA stated, in keeping with CDC guidelines.

However, in most situations involving patient care, it appears personal protective equipment (PPE) still is required even if healthcare workers are vaccinated.

Healthcare Workers Called OSHA

While essentially codifying CDC recommendations, Frederick warned OSHA will continue to respond to complaints of unsafe working conditions and conduct inspections to ensure compliance with the standard.

“Throughout the pandemic, healthcare workers in these settings continue to be the source of the highest number of complaints OSHA has received,” he said. “We will continue inspections under our national emphasis program to hold bad actors accountable for failing to protect employees. When we open up an inspection, we are showing up to investigate.”

In a provision protecting workers from retaliation, OSHA stated healthcare facilities must: “Inform employees of their rights to the protections required by the standard and do not discharge or in any manner discriminate against employees for exercising their rights under the ETS or for engaging in actions required by the standard.”

The ETS requirements generally apply to all settings where any employee provides healthcare services or healthcare support services. “Our estimates are that there are approximately 10.3 million employees or workers in the establishments who will need to comply with the requirements of the standard,” Frederick said.

OSHA posted a flowchart for employers who are unsure if the regulation applies to their facility or employees. “The ETS does not apply to the dispensing of prescriptions by pharmacists in retail settings, healthcare support services not performed in a healthcare setting (e.g., off-site laundry, off-site medical billing), and telehealth services performed outside of a setting where direct patient care occurs,” OSHA noted in the chart.4

All healthcare facilities with more than 10 employees must develop and implement a written COVID-19 plan that “includes a designated safety coordinator with authority to ensure compliance, a workplace-specific hazard assessment, involvement of non-managerial employees in hazard assessment and plan development/implementation, and policies and procedures to minimize the risk of transmission of COVID-19 to employees,” OSHA stated.

The plan does not have to be in writing for facilities with 10 or fewer employees, nor do these small sites have to create a COVID-19 log. All others must establish a log of all COVID-19 cases in healthcare workers “without regard to occupational exposure,” OSHA wrote. Employers also must report work-related COVID-19 fatalities and inpatient hospitalizations of workers to OSHA.

For organizations with a good safety and occupational health culture, most of the ETS requirements already should be in place this late in the pandemic, Worden says.

“For example, if an organization does not have an exposure prevention plan or even a hazard assessment, these will be needed quickly before the other controls can be implemented,” he says. “Likewise, if an organization has not done due diligence to respiratory protection in the past, the now-urgent needs of the hazard assessment, medical evaluations, training, and fit testing will create a large to-do list.”

In this sense, the COVID-19 ETS creates requirements for respiratory disease prevention with benefits beyond COVID-19.

“These same [requirements] are effective for other airborne transmissions, including influenza and tuberculosis,” Worden says. “Ideally, COVID-19 exposure prevention will also help other disease exposure prevention efforts.”

Single-Use N95s Are Back

Employees must “use respirators and other PPE for exposure to people with suspected or confirmed COVID-19, and for aerosol-generating procedures on a person with suspected or confirmed COVID-19,” according to OSHA.

This requirement aligns OSHA with a recent call for a return to conventional single-use N95 respirators by the CDC and the FDA. (For more information, see the June 2021 issue of Hospital Employee Health.)

The longstanding recommendation by the CDC is to don a single-use N95 respirator (or comparable PPE) to care for a patient with a novel respiratory virus like COVID-19. However, an acute shortage of N95 masks occurred as the pandemic spread, and various contingency and reprocessing techniques were adopted.

In a “situational update” as of May 2021, the CDC stated, “The supply and availability of NIOSH-approved respirators have increased significantly over the last several months. Healthcare facilities should not be using crisis capacity strategies at this time and should promptly resume conventional practices.”5

The FDA wrote in a letter to industry that hospitals should begin phasing out reprocessing systems for single-use N95 respirators, as national supplies have been replenished and it is time to end the temporary crisis response to the pandemic.6

“With these workarounds, many interpreted this as legitimized ‘permission’ instead of a temporary [fix] due to pandemic circumstances,” Worden says. “However, there are big caveats to these workarounds. [For example], the statements allowing [surgical masks] were due to N95 shortages, but not a change in the hazard analysis or risk assessment of the COVID-19 virus.”

Likewise, the respirator reprocessing tactics for repeated use were “stopgap” measures until N95 stocks could be replenished. “It’s important for there to be an emphasis on appropriate respirators so that the previous year’s workarounds are not continued to be interpreted as long-term measures,” Worden says. “With this ETS and actions taken by the current administration and many manufacturers to build production, organizations hopefully can now consistently procure NIOSH-approved respirators without emergency workarounds. From what I’ve seen and heard, I believe availability is much better than it was during 2020.”

OSHA also made a technical requirement on ventilation, calling for HVAC systems to be used in accordance with the manufacturer’s instructions and design specifications for the systems. Air filters must be rated Minimum Efficiency Reporting Value (MERV) 13 or higher if the system allows it. “If MERV-13 or higher filters are not compatible with the HVAC system(s), employers must use filters with the highest compatible filtering efficiency for the HVAC system(s),” the OSHA ETS noted.

This section also requires that “all air filters are maintained and replaced as necessary to ensure the proper function and performance of the HVAC system(s); and all intake ports that provide outside air to the HVAC system(s) are cleaned, maintained, and cleared of any debris that may affect the function.”

However, in a note in the standard that might be open to some interpretation and discussion with OSHA inspectors, the ETS stated “this section does not require installation of new HVAC systems or AIIRs [airborne infection isolation rooms] to replace or augment functioning systems.”

“Most hospitals already have [HVAC] ducts in place,” says Gabor Lantos, PEng, MBA, MD, president of Occupational Health Management Services in Toronto. “There will be some requirement for redirection and isolation measures. It will require stronger fans to force the air through higher resistance of MERV-13 or higher HEPA filters.”

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

“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 similar debates when SARS-CoV-1 struck in 2002-2003. The CDC recently said emerging science shows transmission of SARS-CoV-2 airborne viral particles can occur beyond six feet, particularly in enclosed, poorly ventilated spaces.

This risk increases in “enclosed spaces with inadequate ventilation or air handling within which the concentration of exhaled respiratory fluids, especially very fine droplets and aerosol particles, can build up in the air space,” the CDC reported.7

“I have been advocating for airborne precautions since SARS-1,” Lantos says. “Of course, there will be costs, but tremendous benefits as well. How much has it cost society? 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? During SARS-1, Toronto was an absolute ghost town for weeks. How much did that cost?”

Will ETS Be Finalized?

The OSHA standard became effective upon its June 21 publication in the Federal Register. Employers must comply with most provisions within 14 days, but can take up to 30 days for requirements involving physical barriers, ventilation, and training.

The temporary standard also serves as a proposed permanent standard, at which point it is expected to be open to review and comment for six months before possible finalization. Some question whether finalizing a permanent standard for COVID-19 makes sense. The pandemic is expected to fade at some point as widespread vaccine availability increases globally. 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. This trend will most certainly continue,” Lantos says.

The ETS could form the basis of some more general respiratory protection standard for healthcare, but that remains to be seen.

“The ETS has benefits and merits,” Worden says. “Depending on the longevity of the COVID-19 virus, and pending a natural disappearance of the virus, the exposure prevention controls in the ETS will be useful. The need for exposure prevention of airborne-transmitted diseases will always be beneficial.”

That said, the specific parameters and characteristics of airborne diseases differ in ways that could require rethinking surface and airborne persistency and finding effective disinfectants.

“While the COVID-19 ETS contains principles and tenets that will be useful in the long term for all airborne-transmitted diseases, each organization will still need to analyze each [occupational] hazard and disease,” Worden says.

REFERENCES

  1. Occupational Safety and Health Administration. Subpart U — COVID-19 Emergency Temporary Standard. June 10, 2021.
  2. The White House. Executive Order on Protecting Worker Health and Safety. Jan. 21, 2021.
  3. Occupational Safety and Health Administration. Fact sheet: Subpart U — COVID-19 Healthcare ETS. June 10, 2021.
  4. Occupational Safety and Health Administration. Is your workplace covered by the COVID-19 Healthcare ETS? June 10, 2021.
  5. Centers for Disease Control and Prevention. Strategies for optimizing the supply of N95 respirators. Situational update as of May 2021.
  6. Food and Drug Administration. Update: FDA recommends transition from use of decontaminated disposable respirators — letter to health care personnel and facilities. May 27, 2021.
  7. Centers for Disease Control and Prevention. Scientific brief: SARS-CoV-2 transmission. Updated May 7, 2021.