By Gary Evans, Medical Writer
Despite pleas for flexibility by infection control groups, the Occupational Safety and Health Administration (OSHA) is being urged by one of its more prominent former directors to adopt a tough standard that emphasizes airborne precautions to protect healthcare workers from COVID-19.
In doing so, OSHA need not remain in lockstep with Centers for Disease Control and Prevention (CDC) guidelines, said David Michaels, PhD, whose 2009-2017 tenure makes him the longest serving director in the agency’s history. This is a point of great contention, since others warn that breaking with the CDC could create an inevitably outdated OSHA standard preserved in amber.
OSHA is finalizing its Emergency Temporary Standard (ETS) to protect healthcare workers from COVID-19, and held an April 27, 2022, hearing before the comment period closed.1,2
Now a professor at George Washington University in the nation’s capital, Michaels testified at the OSHA hearing along with representatives for the Association for Professionals in Infection Control and Prevention (APIC), and the Society for Healthcare Epidemiology of America (SHEA).
Michaels leveled a broadside at the CDC for emphasizing the importance of droplet spread over airborne transmission when the pandemic began. In May 2021, the CDC reported there were cases of airborne spread beyond six feet.3 The World Health Organization (WHO) eventually reversed its position as well.
Saying “there is no longer debate over the importance of aerosol exposure,” Michaels urged OSHA to develop an evidence-based standard that formally recognizes “the primacy” of this route to protect workers from all respiratory pathogens.
“The final OSHA standard must be evidence-based and recognize the ease with which this airborne disease is transmitted,” Michaels said at the hearing. “It should require employers to follow the hierarchy of controls, including engineering controls, to provide clean indoor air, including ventilation, filtration, and/or application of germicidal, ultraviolet technology, [and] respiratory protection programs requiring NIOSH [National Institute for Occupational Safety and Health]-certified respirators.”
APIC: Stay Linked to CDC
OSHA announced plans to finalize the ETS on March 23, 2022, showing a willingness to be more flexible without committing to a regulation that would change with future CDC revisions.
“OSHA is considering linking regulatory requirements to measures of local risk, such as CDC’s community transmission used in CDC’s guidance for healthcare settings or the CDC’s COVID-19 Community Levels used in CDC’s guidance for prevention measures in community settings,” the agency stated. (See Hospital Infection Control & Prevention, May 2022.)
This is more in line with the position advocated by APIC and SHEA, although it does not appear to grant the level of flexibility they are calling for.
“An OSHA regulation should allow healthcare facilities the flexibility to tailor their approach on infection prevention and control based on their risk assessment, rapidly changing evidence-based CDC guidance, supply availability and shortages, community transmission rates, and other factors that may change quickly and are specific sometimes to that facility or even that unit,” Lisa Sturm, MPH, CIC, FAPIC, said in testifying for APIC at the hearing.
Although the CDC guidance does not have the specific force of regulation, the Centers for Medicare and Medicaid Services (CMS) require compliance with CDC recommendations.
“Since our facilities’ funding and accreditation depends on our compliance with CDC guidance, this guidance is a requirement for us in practice, if not in fact,” said Sturm, senior director of infection prevention for Ascension in St. Louis, MO. “Healthcare facilities and personnel cannot remain compliant with conflicting guidance from federal government agencies.”
Michaels refuted Sturm’s perception that an OSHA final rule could be “one size fits all.”
“In this new final standard, as with many other evidence-based OSHA standards, employers should be required to develop and implement an exposure control plan that reflects their specific situation,” he said. “These plans are not one-size-fits-all, but will be appropriate to the type and size of the workplace covered.”
That seemed to open some common ground — shaky though it may be — with groups advocating a flexible standard that could change with CDC guidelines. “All of CDC’s guidance related to infection prevention, occupational health, and vaccination for COVID-19 are considered interim,” said Sharon Wright, MD, testifying for SHEA. “For this reason, we encourage OSHA to design a COVID-19 standard that aligns with the CDC and directs healthcare facilities to follow the most up-to-date CDC COVID-19 guidance and recommendations. If OSHA instead was to codify public health guidance within a final rule, it would quickly become outdated and could hold healthcare facilities to obsolete and potentially unsafe protocols.”
For example, the current OSHA ETS provides a list of aerosol-generating procedures that the CDC based on the 2002-2003 severe acute respiratory syndrome (SARS) outbreak. However, the CDC certainly may revise this list based on ongoing research and other information gleaned from the pandemic, said Wright, an infectious disease physician and chief infection prevention officer at Beth Israel Lahey Health in Cambridge, MA.
“It is imperative that the new OSHA standard defer to CDC guidance in order to maintain relevance and, most importantly, to ensure healthcare facilities are applying the most current safety protocols for the protection of healthcare personnel,” she said.
In short, local epidemiology and circumstances may necessitate modifications to CDC guidance, as they have throughout the pandemic.
“Thus, where COVID-19 guidance from local public health departments differs from CDC guidance, the OSHA final rule should allow for healthcare facilities to establish compliance with the standard through compliance with local public health department guidance as they currently do for all other infection prevention and control requirements,” Wright said. “SHEA recommends that OSHA refer to CDC guidance whenever possible for definitions and evaluation of exposure to SARS-CoV-2, surveillance and reporting, and necessary personal protective equipment.”
Moreover, Sturm argued that facilities “that, in good faith, have developed comprehensive programs based on CDC recommendations should be considered in compliance with the OSHA standard.”
Michaels: ‘No safe harbor’
In contrast, Michaels was skeptical of an OSHA regulation that would change to reflect CDC guidance, in part because of the different standards the agencies use to create policy.
“OSHA standards that protect healthcare workers must be based on the best scientific evidence gathered through a transparent, public notice and comment process and rigorous study of current science to assure, and I quote, ‘to the extent feasible, that no employee will suffer material impairment of health or functional capacity,’” he said. “That’s what the OSHA law requires. In contrast to OSHA’s evidence-based standards, CDC recommendations are not required by law to be based on the latest scientific evidence, nor do they go through any transparent public comment process as OSHA standards do.”
In continuing this line of thought, Michaels said the CDC should have continued recommending N95 respirators to protect healthcare workers treating COVID-19 patients, although a supply chain drought made them scarce and surgical masks and N95 reprocessing procedures were used to bridge the gap. This has been a widely repeated criticism, but it should be noted that the CDC does not have the regulatory authority to require respirators.
Although CDC advisory committee meetings and guidelines generally are open to public review and comment, the agency had to change COVID-19 recommendations on the fly to meet the threat of a highly mutable virus.
“CDC guidance is evidence-based and is updated based on sometimes rapidly changing data,” Sturm said. “The frequent changes in guidance from the CDC often look indecisive, but on the contrary, it shows that the CDC is able to update and flex their guidance as new data emerge.”
However, with the benefit of hindsight, not every new decision was a positive one. The CDC compounded the situation by errors of its own making, including deferring a WHO offer of a SARS-CoV-2 test to pursue a faulty diagnostic panel that delayed case identification in the United States when the pandemic began. Another incident that harmed the agency’s credibility was its 2021 announcement that those fully vaccinated could unmask indoors. Then came the Delta variant outbreak in Provincetown, MA, which showed SARS-CoV-2 could cause breakthrough infections that then could be transmitted to others. (See Hospital Infection Control & Prevention, August 2021.)
“Given the inadequacy of many of CDC’s recommendations, providing a safe harbor enforcement policy for employers who are in compliance with the CDC guidance but not in compliance with OSHA standards could endanger the safety and health of that employer’s workers,” Michaels said.
For example, if an eventual OSHA standard requires N95s for COVID-19 or other novel respiratory pathogens, healthcare facilities may be forced to correct supply line problems and have more foresight on increased needs during a future pandemic. “Standards are OSHA’s most powerful tool,” Michaels testified. “Standards tell millions of employers across the country, first, that they’re required to ensure workers are safe, and, second, what OSHA expects them to do to meet those requirements. Recommendations and guidelines, such as those issued by CDC, are voluntary. And while some employers may follow some or even all recommendations, we know that many will not.”
OSHA ID Reg Is Back
In further testimony, Sturm said that APIC believes the OSHA regulation should not be COVID-specific. More beneficial would be a broader infectious disease standard that would be consistent with the current evidence-based guidance from the major federal healthcare agencies, she said.
“The SARS-CoV-2 virus has been continuing to mutate over the last two years, with each variant having differing levels of transmissibility, morbidity, and mortality,” she said. “We also know that there will always be another pathogen. We need to have a response plan that is based on emerging data, specific to that pathogen, without having to wait for the next OSHA regulation or update. Similar to how the legacy OSHA bloodborne pathogen standard is not specific to just one virus, nor should this standard be.”
SHEA took a somewhat different tack on this point, saying the OSHA standard should not necessarily be aimed at future strains of SARS-CoV-2, in part because of the existence of four other endemic human coronaviruses that are not subject to regulation.
“These endemic coronaviruses cause mild upper respiratory tract illnesses, such as the common cold,” Wright said. “They are less transmissible and cause less severe disease than SARS-CoV-2, and, thus, do not warrant the same infection prevention measures. We’re concerned that applying the standard to future strains may be interpreted to unnecessarily apply to these endemic coronaviruses, imposing burden on healthcare personnel and healthcare facilities without improving safety.”
Opening the potential regulation beyond COVID-19 also could further the revival of OSHA’s proposed infectious disease standard, which originally was opened to rulemaking in 2010 but never finalized. It eventually was dropped in 2017, given the incoming Trump administration’s antiregulatory stance.
However, the infectious disease standard was put back on the OSHA agenda in the fall of 2021, with the agency saying “employees in healthcare and other high-risk environments face longstanding infectious disease hazards, such as tuberculosis, varicella disease, and measles, as well as new and emerging infectious disease threats, such as SARS, the 2019 novel coronavirus (COVID-19), and pandemic influenza. OSHA is examining regulatory alternatives for control measures to protect employees from infectious disease exposures to pathogens that can cause significant disease.”4
Thus, OSHA has opened up the option of developing a final rule specifically for COVID-19 or expanding to a broader healthcare rule that would address occupational infectious disease threats in general.
REFERENCES
- Occupational Safety and Health Administration. Occupational exposure to COVID-19 in healthcare settings. Published March 23, 2022. https://www.osha.gov/laws-regs/federalregister/2022-03-23-0
- Occupational Safety and Health Administration. Subpart U — COVID-19 emergency temporary standard. https://www.osha.gov/sites/default/files/covid-19-healthcare-ets-reg-text.pdf
- Centers for Disease Control and Prevention. Scientific brief: SARS-CoV-2 transmission. Updated May 7, 2021. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html
- Reginfo.gov. Infectious diseases. U.S. General Services Administration, Office of Information and Regulatory Affairs. https://www.reginfo.gov/public/do/eAgendaViewRule? pubId=202110&RIN=1218-AC46
Despite pleas for flexibility by infection control groups, the Occupational Safety and Health Administration is being urged by one of its more prominent former directors to adopt a tough standard that emphasizes airborne precautions to protect healthcare workers from COVID-19.
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