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Federal Register / Vol. 86, No. 116 / Monday, June 21, 2021 / Rules and Regulations
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can be critical to protecting healthcare workers. For example, one typical precaution is that patients and visitors who enter a waiting room before being seen or triaged must wear facemasks, or face coverings, as a source control device to prevent them from spreading airborne droplets near the employees.
These source control devices may also be critical to reducing the likelihood that COVID19 is spread as the patients are transported from the admission area to a treatment area.
The critical need for implementing Standard and Transmission-Based Precautions in healthcare settings is evident in the Healthcare Infection Control Practices Advisory Committees HICPACs 2017 Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings.21 The core practices included in that document include Standard and Transmission-Based Precautions, which, HICPAC recommended, need to be implemented in all settings where healthcare is delivered.
That Standard and TransmissionBased Precautions are a long-standing and essential element of infection control in healthcare industries is also evidenced by the CDCs 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings, which incorporate Standard and Transmission-Based Precautions into their recommendations. This 2007 Guideline updated 1996 guidelines, which introduced the concept of Standard Precautions and also noted the existence of infection control recommendations dating back to 1970 Siegel et al., 2007.
Both Standard and TransmissionBased Precautions are recommended by the CDC for healthcare personnel during the COVID19 pandemic CDC, February 23, 2021. The CDC considers healthcare personnel HCP to include all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure 21 HICPAC is a federal advisory committee that provides guidance to the CDC and the Secretary of the Department of Health and Human Services HHS regarding the practice of infection control. In March 2013, CDC charged HICPAC with a review of existing CDC guidelines to identify all recommendations that warrant inclusion as core practices. In response, a HICPAC workgroup was formed that contained representatives from the following stakeholder organizations: Americas Essential Hospitals, the Association for Professionals in Infection Control and Epidemiology APIC, the Council of State and Territorial Epidemiologists CSTE, the Public Health Agency of Canada PHAC, the Society for Healthcare Epidemiology of America SHEA, and the Society of Hospital Medicine SHM HICPAC, March 15, 2017. This process resulted in HICPACs Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings.

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to patients or infectious materials, including body substances e.g., blood, tissue, and specific body fluids;
contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel.
The CDC also has recommendations for protection of workers in industries associated with healthcare. According to the CDCs Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 COVID19
Pandemic incorporated by reference, 1910.509, on-site management of laundry, food service utensils, and medical waste should also be performed in accordance with routine procedures CDC, February 23, 2021.
The work of the College of American Pathologists CAP illustrates the importance of taking core precautionary measures in healthcare industries during the pandemic. CAP has provided recommendations for staff protection during the COVID19 pandemic. For example, CAP has provided COVID19specific autopsy recommendations which include biosafety considerations such as performing autopsies on COVID19-positive cases in an airborne infection isolation room College of American Pathologists, February 2, 2021.22
The Standard and TransmissionBased Precautions required by the ETS
only extend to exposure to SARSCoV
2 and COVID19 protection. The agency 22 CAP is known for its peer-based Laboratory Accreditation Program. The Centers for Medicare &
Medicaid Services CMS allows a CAP inspection in lieu of a CMS inspection. CAP inspections have a similar status with a number of other leading healthcare and biomedical laboratory authorities including the Joint Commission, United Network for Organ Sharing, the National Marrow Donor Program, the Foundation for the Accreditation of Cellular Therapies, and many state agencies College of American Pathologists, February 1, 2021b. CAP has worked with the CMS to implement virtual laboratory inspections allowing labs to remain in compliance with Clinical Laboratory Improvement Amendments regulations College of American Pathologists, February 1, 2021a.

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does not intend the ETS to apply to other workplace hazards.
References Centers for Disease Control and Prevention CDC. 2016, January 7. Transmissionbased precautions. https www.cdc.gov/
infectioncontrol/basics/transmissionbased-precautions.html. CDC, January 7, 2016.
Centers for Disease Control and Prevention CDC. 2021, February 23. Interim infection prevention and control recommendations for healthcare personnel during the Coronavirus Disease 2019 COVID19 pandemic.
https www.cdc.gov/coronavirus/2019ncov/hcp/infection-controlrecommendations.html. CDC, February 23, 2021.
College of American Pathologists. 2021, February 2. Amended COVID19
autopsy guideline statement from the CAP Autopsy Committee. https
documents.cap.org/documents/COVIDAutopsy-Statement.pdf. College of American Pathologists, February 2, 2021.
Healthcare Infection Control Practices Advisory Committee HICPAC. 2018, December 27. Core infection prevention and control practices for safe healthcare delivery in all settings. https
www.cdc.gov/hicpac/recommendations/
core-practices.html. HICPAC, December 27, 2018.
Siegel, J., Rhinehart, E., Jackson, M., Jackson, M., Chiarello, L. 2007. Guideline for isolation precautions: Preventing transmission of infectious agents in healthcare settings. https www.cdc.gov/
infectioncontrol/pdf/guidelines/
isolation-guidelines-H.pdf. Siegel et al., 2007.

E. Personal Protective Equipment PPE
As previously discussed in Grave Danger Section IV.A. of the preamble, COVID19 infections occur mainly through exposure to respiratory droplets referred to as droplet transmission when a person is in close contact with someone who has COVID19. COVID
19 can sometimes also be spread by airborne transmission CDC, May 13, 2021. As the CDC explains, when people with COVID19 cough, sneeze, sing, talk, or breathe, they produce respiratory droplets, which can travel a limited distancethereby potentially infecting people within close physical proximitybefore falling out of the air due to gravity. Facemasks, face coverings, and face shields are all devices used for their role in reducing the risk of droplet, and potentially airborne, transmission of COVID19
primarily at the source. Additional discussion on the efficacy of each device, and the need for facemasks and face shields specifically, is explained below. Respirator use is also included in the ETS and more information on the
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