December 15, 2021

Navigating the Healthcare Regulatory Landscape: What to Expect in 2022

The end of the year means it’s time for healthcare organizations to look ahead to plan and refine their compliance efforts. The coming year is shaping up to be significant in terms of evolving and emerging regulations that pertain to healthcare facilities. The following sections offer a brief glimpse of what’s in store. 

OSHA’s Emergency Temporary Standard for SARS-CoV-2 Remains in Place

In June 2021, the federal Occupational Safety and Health Administration (OSHA) promulgated the COVID-19 Healthcare Emergency Temporary Standard (ETS) (29 CFR 1910, Subpart U), requiring compliance by July 2021. The standard applies to settings where employees provide healthcare or healthcare support services. This may include hospitals, nursing homes, assisted living facilities, home health agencies, and ambulatory care settings where suspected or confirmed COVID-19 patients are treated. The standard addresses a variety of topics, such as the need to create a COVID-19 plan and have processes for patient screening, personal protection, physical distancing, cleaning and disinfection, ventilation, vaccination, training, and more. As of November 2021, OSHA has determined that the requirements of the healthcare ETS remain necessary to address the potential hazards associated with COVID-19 in healthcare workplaces. OSHA will continue to monitor and assess the need for the ETS each month. Whether the ETS remains a temporary standard or becomes a permanent OSHA regulation is yet to be seen. To check that you are maintaining compliance, it’s important to familiarize yourself with the federal requirements, as well as any additional regulations that your state may have. Stericycle has resources to help you understand the federal requirements. 

The Respiratory Protection Standard Is Receiving Significant Attention from OSHA Inspectors

Given that respirators are used as one means of protection against COVID-19, OSHA has been paying particular attention to compliance with the Respiratory Protection Standard (29 CFR 1910.134). If your organization has determined that employees must wear respirators (such as an N95 mask) to protect themselves at work, the following components must be in place:

  • A written respiratory protection program (RPP). This should outline the processes for respirator selection, medical clearance, fit testing, training, and so on. There are sample plans available from OSHA, the Centers for Disease Control and Prevention (CDC), and Stericycle, which can help you develop a compliant program.

  • A qualified administrator. The program administrator should have appropriate training or experience to administer or oversee the respiratory protection program and conduct the required evaluations of program effectiveness.

  • Medical evaluations. A medical evaluation is required to determine the employee's ability to use a respirator. This evaluation must be performed by a physician or other licensed health care professional.

  • Fit testing. Employees must be fit tested at least annually with the same make, model, style, and size of respirator that will be used.

  • Annual training. An employee must receive respiratory protection training before they don a respirator and at least annually thereafter. 

Note that if an employee is not required to wear a respirator but elects to wear one anyway, there are also rules for such voluntary use, if permitted. For example, the employer must provide the worker with a copy of Appendix D to the Respiratory Protection Standard (“Information for Employees Using Respirators When Not Required Under the Standard”). 

Compliance With The Bloodborne Pathogens Standard Should Remain a Top Priority

OSHA’s Bloodborne Pathogens Standard (29 CFR 1910.1030) remains a frequently cited OSHA standard. It applies to all occupational exposures to blood or other potentially infectious materials. Conducting an annual review of your Exposure Control Plan is essential to avoid compliance shortfalls. Your plan should address topics like training, personal protective equipment (PPE), workplace controls, vaccinations, and more. It should also outline what happens if an incident occurs, how an exposed worker receives care, and any documentation requirements. 

There May Be Adjustments to the Hazard Communication Standard

The Hazard Communication Standard (29 CFR 1910.1200) is also frequently cited by OSHA in inspections of healthcare organizations. It requires employers to communicate with employees about the hazards associated with chemicals they may be exposed to at work. The standard’s requirements align with Revision 3  of the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), which classifies chemicals by type of hazard and standardizes communication of hazard information via labels and symbols. In February of 2021, OSHA proposed to modify the Hazard Communication Standard to conform to Revision 7 of the GHS. A publication date for the final rule has not yet been set, but employers should continue to monitor these potential changes in 2022. 

A Workplace Violence Standard Could Be on the Horizon

Cases of workplace violence are increasing, and the pandemic has only made things worse. OSHA does not currently have a standard regarding the prevention of violence in healthcare workplaces, but the topic remains on its regulatory agenda. Some states, such as California, already have such a standard. Stericycle is working to develop a training program on this topic. More details will be released in the coming months. 

July 2022 Brings the Final Compliance Date for EPA Subpart P

The federal Environmental Protection Agency’s (EPA) “Subpart P” (40 CFR Part 266, Subpart P) rule regulates the management of hazardous waste pharmaceuticals. It was promulgated in 2019. The rule prohibits the “sewering” (i.e., disposing of a drug down the sink or toilet) of hazardous waste pharmaceuticals and sets additional standards for managing the waste stream.  States were required to adopt Subpart P by July 1, 2021, unless statutory amendment is required, in which case the adoption deadline is July 1, 2022.

As of the time this article was published, around half the states have fully adopted Subpart P. Once your state adopts Subpart P, you have 60 days to notify the EPA of your waste generator status and compliance intentions. Taking the time at the beginning of 2022 to determine whether your state has adopted the regulations and whether you have fulfilled your notification responsibilities can help prevent compliance issues in the future. Find out more about Subpart P on Stericycle’s EPA Resource Hub.

The Office of National Coordinator for Health Information Technology Information Blocking Rule Will Expand in October 2022

Through the 21st Century Cures Act, Congress has established penalties for healthcare entities that engage in information blocking—interfering with the access, exchange, or use of electronic health information (EHI). The information blocking rule applies to all health care providers, health IT developers of certified health IT, health information networks, and health information exchanges. From now through October 5, 2022, the blocking requirements are limited to the data elements represented in the United States Core Data for Interoperability (USCDI Version 1). This smaller scope gives organizations time to gain experience with the information blocking rule and figure out when any exceptions may apply and what technology they’ll need to implement - before the full scope of the regulations goes into effect. The best way to prepare for October 2022 is to identify EHI and the systems they reside in and plan for how the entire set of EHI will be delivered to patients through the use of third-party, typically mobile, health apps. This way,  you can identify potential issues in order to resolve them before the full rule takes effect on October 6, 2022.

With the regulatory landscape evolving in 2022, healthcare facilities need to be prepared. Learn how Stericycle can help with your compliance efforts.

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