Anticipating OSHA’s Healthcare Rulemakings

The agency plans to issue a permanent standard sometime in December for exposures to COVID-19 in healthcare settings; it had already published an industry-specific emergency temporary standard (ETS) in 2021.

OSHA also plans to release proposals in December for its rulemakings on infectious diseases and workplace violence prevention in healthcare and social assistance. The infectious disease and workplace violence rulemakings are two of its six “economically significant” rulemakings.

COVID-19, again

COVID-19 is the respiratory disease caused by the SARS-CoV-2 virus, and on March 11, 2020, the World Health Organization declared a COVID-19 pandemic. OSHA’s track record during the pandemic was mixed, according to the subsequent audits and investigations:

• In 2021, the Labor Department’s Office of the Inspector General (OIG) found that reduced OSHA workplace inspections during the pandemic increased the risk to U.S. workers’ safety.
• In 2022, the OIG reported that OSHA failed to collaborate or coordinate efforts with other federal agencies during the pandemic.
• A 2022 OIG audit again found that as safety and health complaints increased significantly during the pandemic, OSHA reduced the number of inspections it conducted.

In a sample of inspections performed, auditors found that in 15% of fatality inspections, OSHA didn’t issue citations enforcing its injury and illness recording and reporting standards. The agency also lacked complete information on COVID-19 infection rates at worksites and closed inspections without ensuring it received and reviewed all information requested from employers to demonstrate that health hazards had been mitigated.

In November 2021, OSHA issued a COVID-19 “vaccinate-or-test” ETS, which required all employers with 100 or more employees to implement a program of COVID-19 vaccination or regular testing and use face coverings to protect unvaccinated workers. The following January, the U.S. Supreme Court issued a stay of the rule.

The court concluded that when OSHA issued the ETS, it had exceeded the authority granted by the Occupational Safety and Health (OSH) Act. The majority ruled that the statute didn’t authorize the agency to issue a broad public health measure with such vast economic significance.

OSHA issued an industry-specific ETS in 2021, addressing the risks posed by COVID-19 in healthcare workplaces. The agency announced an attempt to develop a permanent standard but couldn’t complete its rulemaking activity within the OSH Act’s ETS framework, so it stopped enforcing provisions of the ETS other than the emergency rule’s recordkeeping requirements.

The upcoming final regulation would likely contain some of the same requirements as the healthcare ETS. In 2022, the American Hospital Association (AHA) urged OSHA not to establish a permanent healthcare COVID-19 standard, suggesting that a permanent standard could create confusion, lower employee morale, and worsen healthcare staffing shortages.

The AHA noted that hospitals and other healthcare facilities were already subject to a vaccine mandate issued by the Centers for Medicare and Medicaid Services (CMS) and OSHA’s personal protective equipment (PPE) and respiratory protection standards. The group also pointed out that most hospital staff were fully vaccinated.

Additionally, the AHA argued that a permanent healthcare COVID-19 standard wouldn’t offer any additional benefit beyond what hospitals were doing to protect frontline healthcare workers.

The group characterized OSHA’s 2021 ETS as complex and overly specific, advocating for less prescriptive employer requirements. The AHA also cautioned against regulating subsequent novel strains of the SARS-CoV-2 virus, which OSHA described as a “hypothetical COVID-22.”

Infectious disease proposal

Infectious disease hazards in healthcare and other high-risk environments, such as correctional facilities, drug treatment programs, emergency response, and homeless shelters, include tuberculosis (TB), varicella disease (chickenpox and shingles), methicillin-resistant Staphylococcus aureus (MRSA), measles, and emerging infectious disease threats like COVID-19, pandemic influenza, and severe acute respiratory syndrome (SARS). In 2010, the agency issued a request for information (RFI) for the rulemaking and began and concluded a Small Business Regulatory Enforcement Fairness Act (SBREFA) review in 2014. The next step in the rulemaking would be a notice of proposed rulemaking (NPRM).

OSHA has made several background documents available about the rulemaking, including an Infectious Diseases Stakeholder Summary Report, a Small Entity Representative Background Document, and a Small Business Advocacy Review Panel (SBAR Panel) Final Report.

This wouldn’t be OSHA’s first foray into addressing workplace infections. For decades, there’s been a federal standard for occupational exposure to bloodborne pathogens (29 Code of Federal Regulations (CFR) §1910.1030), which applies to “all occupational exposure to blood or other potentially infectious materials,” regardless of industry.

Workplace violence

There’s currently no federal standard for workplace violence prevention, so OSHA cites employers, often following an injury report, a hospitalization, or a fatality, using its authority under the OSH Act’s General Duty Clause (Section 5(a)(1)).

The Occupational Safety and Health Review Commission, which reviews employers’ challenges of OSHA citations, has both upheld and vacated OSHA’s general duty citations. The commissioners apply a four-pronged test for General Duty Clause violations in which the agency must show that:

• “A condition or activity in the workplace presented a hazard.”
• “The employer or its industry recognized this hazard.”
• “The hazard was likely to cause death or serious physical harm.”
• “A feasible and effective means existed to eliminate or materially reduce the hazard.”

Commissioners have characterized the agency’s General Duty Clause enforcement—especially in cases of heat hazards—as a “gotcha” or “catchall” for workplace hazards without an established standard.

However, OSHA continues workplace violence enforcement using its General Duty Clause authority. In May, the agency cited a pair of home healthcare providers following the death of a licensed practical nurse during a home visit. The employers face $163,627 in OSHA fines. Investigators determined that the employers exposed home healthcare workers to workplace violence from patients who exhibited aggressive behavior and were known to pose a risk to others.

According to the agency, the employers could have reduced workplace violence hazards by performing root cause analyses on previous incidents of violence and near misses, providing healthcare workers with comprehensive background information on patients before home visits, providing workers with emergency panic alert buttons, and using safety escorts for visits to patients with high-risk behaviors.

OSHA’s industry-specific rulemaking has its roots in voluntary workplace violence prevention guidelines for health care and social services issued in 2015. In December 2016, the agency published an RFI for a formal rulemaking, and at the end of 2022, it initiated a SBREFA review, which concluded in March 2023.

Under the voluntary guidelines, the recommended elements of an effective workplace violence prevention program include management commitment and employee participation, worksite hazard analysis, hazard prevention and control methods, safety and health training, recordkeeping, and program evaluation.

OSHA isn’t the only organization concerned with workplace violence in healthcare settings. The nonprofit Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)), which oversees the accreditation of hospitals and other healthcare facilities, issued revised workplace violence guidelines in 2021.

Many states, private insurers, and the CMS will only reimburse medical services performed at healthcare facilities accredited by the Joint Commission or another accreditation organization.

The Joint Commission’s accreditation standards cover other facets of hospital operations, such as infection control, in addition to the workplace violence guidelines.

The Joint Commission’s definition of workplace violence is “an act or threat occurring at the workplace that can include any of the following: verbal, nonverbal, written, or physical aggression; threatening, intimidating, harassing, or humiliating words or actions; bullying; sabotage; sexual harassment; physical assaults; or other behaviors of concern involving staff, licensed practitioners, patients, or visitors.”

The organization requires hospitals and critical care facilities to establish a prevention framework with the following elements:

• Managing safety and security risks: conducting an annual worksite analysis related to the facility’s workplace violence prevention program and taking actions to mitigate or resolve the workplace violence safety and security risks based on findings from the analysis;
• Collecting information to monitor conditions in the facility’s environment: injuries to patients and others within the facility, occupational illnesses and staff injuries, incidents of property damage, safety and security incidents like workplace violence, fire safety management problems, medical or laboratory equipment problems, and problems with utility systems;
• Offering ongoing staff education and training at the time of hiring, annually, and whenever changes are made to the workplace violence prevention program; and
• Offering leadership to create and maintain a culture of safety and quality throughout the hospital that includes policies and procedures to prevent and respond to workplace violence; a process for reporting incidents to analyze incidents and trends; a process for follow-up and support for victims and witnesses affected by workplace violence, if necessary; and a procedure for reporting workplace violence incidents to the hospital’s governing body.

According to the Joint Commission, 73% of nonfatal workplace injuries and illnesses causing days of missed work in health care are connected to workplace violence. The group said the actual figure is probably much higher because incidents of workplace violence may be underreported.

In 2022, the CMS’s Quality, Safety, and Oversight Group urged healthcare industry leaders to protect healthcare workers from workplace violence. The group recommended steps to prevent workplace violence in hospitals, including ensuring workers receive adequate training, having sufficient staffing levels, providing ongoing assessments of patients and residents for aggressive behavior and violence indicators, and adapting patients’ or residents’ care interventions and environment appropriately.

The CMS recommends that hospitals identify patients at risk for intentional harm to themselves or others to ensure a safe setting for patients, visitors, and healthcare workers. Hospitals also should identify environmental safety risks for patients and educate and train staff and volunteers.

Environmental risks for both self-harm and harming others include access to medications, accessible light fixtures, bell cords, breakable windows, harmful substances, ligatures, plastic bags that may suffocate, oxygen tubing, and sharps.

The CMS recommended that hospital worker training cover identifying patients at risk for harm to themselves or others, identifying environmental patient safety risk factors, and implementing mitigation strategies.

While the Joint Commission and CMS have addressed infectious disease and workplace violence risks in standards and recommendations, OSHA plans to proceed with its industry-specific regulation.