2021 Summer GAPNA Newsletter Volume 40 Number 2

Healthcare Workers Continue to Suffer PPE Shortages

By Mary T. Dierich

Healthcare workers, especially those in long-term care and outpatient setting are becoming ill, suffering from long-haul COVID-19 and dying as a result of working without appropriate personal protective equipment (PPE) during the COVID-19 pandemic.

This article examines the etiology of the PPE shortage and current federal measures taken to alleviate the shortage. Three issues were significant root causes of the shortage: (1) lack of an adequate strategic national stockpile, (2) shortages of raw materials coupled with supply chain issues, and (3) CDC/OSHA guidance that allows healthcare systems to conserve PPE by allowing re-use on equipment that is meant for single-use only.

Since the onset of the Biden administration, executive orders have been used to address the shortage. Additionally, the American Rescue Plan provides significant funding to address the PPE shortage. It is incumbent on healthcare workers to ensure pressure continues on both the administration and Congress to secure adequate PPE, as the need is expected to continue well into 2022.

As the COVID-19 tragedy continues to unfold and healthcare workers die at alarming rates from COVID-19 infections, the GAPNA Health Affairs Committee has been investigating the etiology of the PPE shortage and responses to pressure government officials and healthcare facilities to address the shortages. The following is a brief overview of the issues that have compounded the crisis and efforts at the federal level to improve the situation.

Nurses watched in horror 1 year ago as their colleagues in hospitals across the country wore garbage bags and scarves as personal protective equipment (PPE) while caring for patients with the novel coronavirus (COVID-19).

One year later, as we have learned more about the virus, reports continue to filter in from across the country about healthcare workers in long-term care (LTC) settings and community settings still not being afforded properly fitted PPE when caring for patients with suspected or confirmed cases of COVID-19.

Healthcare workers without adequate PPE have a 30% greater chance of infection than those colleagues armed with appropriate PPE (Mendoza & Linderman, 2020).

The magnitude of the PPE shortage quickly became apparent when Health and Human Services Secretary Alex Azar testified in the Senate Appropriations Committee in February 2020 the United States needed about 300 million N-95 masks to fight the coronavirus (Fink, 2020).

However, a week later, the agency clarified the United States actually needed 3.5 billion N-95 masks in a pandemic year. Prior to the pandemic, U.S. healthcare organizations typically bought more than 2 million N-95 masks each month. Over 90% of N-95 mask production was occurring overseas (Mendoza & Linderman, 2020) in countries that had stopped shipping to the United States because of increased demand in their own countries (Butcher, 2020).

At the start of the pandemic, domestic production of N-95 masks was about 40 million per month (480 million/year) (Rose, 2020) but is expected to top one billion masks in 2021, according to the Department of Defense (Lopez, 2020). Though this is a hopeful development, the number of N-95 masks needed still far exceeds domestic supply capability.

Changing Guidance

Additionally, loopholes in Occupational Safety and Health Administration (OSHA) regulations compound the current crisis. In 2007, OSHA regulations were significantly strengthened to “control of those occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors, the primary objective shall be to prevent atmospheric contamination” (author’s italics) (OSHA, 2007).

OSHA was given authority to leverage fines for each incidence of companies not supplying appropriate PPE for their workers (U.S. Department of Labor, 2006). Conspicuously absent in the regulations were references to airborne contamination in healthcare settings.

In 2015, guidance released for healthcare settings recommended N-95 masks for healthcare workers exposed to patients with suspected aerosolized routes of infection (OSHA, 2015). The guidance clearly states that suspected or confirmed diseases requiring airborne precautions necessitate at least an N-95 mask for both routine patient care and support operations as well as aerosol generating procedures (OSHA, 2015).

The guidance also gives great leeway to healthcare facilities to develop their Respiratory Protection Program (RPP), but within parameters outlined by OSHA. These parameters include: (1) written respiratory protection program with policies and procedures including a designated program administrator; (2) fit testing for respirators; (3) procedures for use, storage, repair, and disposal of respirators; (4) program training; and (5) record keeping. Given financial constraints in LTC and clinic settings, it is unlikely the RPP could be easily instituted or maintained even in the best of times.

However, as the pandemic quickly revealed severe shortages of PPE, both OSHA and the Centers for Disease Control and Prevention (CDC) changed guidance regarding PPE through a temporary suspension of rules that currently continue in place (Allen & Williams, 2020). The temporary guidance allowed use of single-use N-95 masks up to 8 hours per day and re-use of the mask up to 5 times provided masks were properly dried out for 72 hours between donning (CDC, 2020).

Achieving Herd Immunity

Achieving herd immunity is expected to help address the PPE shortage. However, the earliest herd immunity is expected to usher in the new normal is early 2022 based on current vaccination rates (Crouch, 2021), and research on vaccine use in children (Mascarenhas, 2021).

Achieving herd immunity depends on four factors:

  1. Speed of vaccinating the population which varies greatly across states.
  2. Persistence of natural immunity after infection with COVID-19, which is currently unknown.
  3. Whether vaccination will be useful against the emerging viral variants, also unknown.
  4. Vaccine hesitancy/refusal which is currently 31% (Callaghan et al., 2021). Experts such as Dr. Anthony Fauci suggest children to be vaccinated for herd immunity, which he believes will be achieved at the 70%-85% vaccination uptake (Ellis, 2021).

Given persistent problems with N-95 supply chain/raw materials shortages and that three of these four factors regarding herd immunity are presently unknown, it is unlikely the need for PPE will diminish anytime soon.

Rescue Measures

Several executive actions taken shortly after President Biden took office (The White House, n.d.), coupled with passage of the American Rescue Plan Funding in March 2021, laid groundwork to alleviate PPE shortages. In addition, several bills were introduced to address supply chain issues and funding manufacturing retooling (Congress.gov, n.d.).

The most important measure is American Rescue Plan Funding (Congress.gov, 2021a). Several sections address PPE funding.

Section 2303: Funding for Supply Chain Activities. Over $6 billion, part of which goes to research, development, manufacturing, production, and the purchase of vaccines, therapeutics, and ancillary medical products and supplies to prevent, prepare, or respond to SARS-CoV-2 or any viral variant or any disease with potential for creating a pandemic.

Section 2304: Funding for COIVD-19 vaccine, therapeutic and device activities at the Food and Drug Administration. $500 million, part of which goes to facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials; facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to COVID-19; and oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices.

Section 2501: Funded Public Health Workforce – over $7.6 billion. One provision includes personal protective equipment, data management, and other technology or other necessary supplies.

Section 3101: COVID-19 Emergency Medical Supplies Enhancement – $10 billion. One provision is related to PPE and stipulates funds shall be used for the purchase, production (including the construction, repair, and retrofitting of government-owned or private facilities as necessary), or distribution of medical supplies and equipment (including durable medical equipment) related to combating the COVID-19 pandemic, including face masks and PPE (face shields, nitrile gloves, N-95 filtering facepiece, respirators), and other masks or equipment (including durable medical equipment) needed to respond to the COVID-19 pandemic, and the materials, machinery, additional manufacturing lines or facilities, or other technology necessary to produce such equipment.

In addition, there are five current bills at the time of this writing that bear monitoring:

  1. S. 308 Protecting Providers Everywhere in America Act introduced by Sens. Dick Durbin (D-IL) and Bill Cassidy (R-LA) to establish a pilot program to address shortages of testing equipment and PPE through enhanced domestic production, and for other purposes. This bill is currently referred to Committee on Health, Education, Labor, and Pensions (Congress.gov, 2021b).
  2. HR. 1024 COVID-19 Supply Chain Resiliency Act of 2021 establishes in the Executive Office of the President the Office of COVID-19 Supply Chain Resiliency introduced by Rep. Brad Schneider (D-IL). This bill was referred to the House Committee on Energy and Commerce and establishes in the Executive Office of the President the Office of COVID-19 Supply Chain Resiliency (Congress.gov, 2021c).
  3. H.R. 316 introduced by Rep. Schneider directs the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the federal government regarding the supply and distribution of certain supplies and equipment relating to COVID-19. This bill has been referred to the Committee on Energy and Commerce, and the Committee on Financial Services (Congress.gov, 2021d).
  4. H.R. 212 COVID Prepare Act of 2021 requires federal agencies to submit to Congress plans for responding to COVID-19. It was introduced by Rep. Schneider and has been referred to the Committee on Oversight and Reform, in addition to the Committee on the Budget (Congress.gov, 2021e).
  5. S. 179 authorizes the appropriation of an additional $10 billion to secure critical materials and supplies to combat the COVID-19 pandemic. It was introduced by Sen. Tammy Baldwin (D-WI) and referred to the Committee on Health, Education, Labor, and Pensions (Congress.gov, 2021f).

Nurses are the largest workforce in the country. The GAPNA Health Affairs Committee urges individuals and organizations to continue to pressure public officials to reverse measures that put healthcare workers at risk. We also urge our colleagues to describe their individual experiences when contacting their officials and urge them to continue to support funding initiatives designed to alleviate the PPE shortage.

Mary T. Dierich, PhD, APRN, CNP
https://orcid.org/0000-0003-2989
dieri001@umn.edu
Clinical Associate Professor ad Honorem
University of Minnesota
School of Nursing

References

Allen, S.T., & Williams, K.M. (2020, April 8). OSHA guidance allows alternatives in light of N95 shortage due to coronavirus. Foley and Lardner, LLP. https://www.foley.com/en/insights/publications/2020/04/osha-allows-alternatives-n95-shortage-coronavirus

Butcher, L. (2020, February 26). The coronavirus and the healthcare supply chain: What hospitals need to know about N95 masks, drugs and devices. Healthcare Financial Management Association. https://www.hfma.org/topics/operations-management/article/the-coronavirus-and-the-supply-chain-what-hospitals-need-to-know.html

Callaghan, T., Moghtaderi, A., Lueck, J.A., Hotez, P., Strych, U., Dor, A., … Motta, M. (2021). Correlates and disparities of intention to vaccinate against COVID-19. Social Science & Medicine, 272, 113638-113642. https://doi.org/10.1016/j.socscimed.2020.113638

Centers for Disease Control and Prevention (CDC). (2020, March 27). Recommended guidance for extended use and limited reuse of N95 filtering facepiece respirators in healthcare settings. The National Institute for Occupational Safety and Health Pandemic Planning. https://www.cdc.gov/niosh/topics/hcwcontrols/recommendedguidanceextuse.html

Congress.gov. (n.d.). Current Congress. https://www.congress.gov/

Congress.gov. (2021a). American Rescue Plan Act text. https://www.congress.gov/congressional-record/2021/3/15/senate-section/article/s1510-1?q=%7B%22search%22%3A%5B%22american+rescue+plan%22%5D%7D&s=1&r=1

Congress.gov. (2021b). PPE in America Act. https://www.congress.gov/search?searchResultViewType=expanded&q=%7B%22source%22%3A%5B%22congrecord%22%2C%22legislation%22%5D%2C%22search%22%3A%22S+308%22%7D

Congress.gov. (2021c). COVID-19 Supply Chain Resiliency Act of 2021. https://www.congress.gov/search?searchResultViewType=expanded&q=%7B%22source%22%3A%5B%22congrecord%22%2C%22legislation%22%5D%2C%22search%22%3A%22HR+1024%22%7D

Congress.gov. (2021d). To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19. https://www.congress.gov/search?searchResultViewType=expanded&q=%7B%22source%22%3A%5B%22legislation%22%5D%2C%22search%22%3A%2 2HR+316%22%7D

Congress.gov. (2021e). COVID PREPARE Act of 2021. https://www.congress.gov/bill/117th-congress/house-bill/212?q=%7B%22search%22%3A%5B%22HR+212%22%5D%7D&s=9&r=1

Congress.gov. (2021f). A bill to authorize the appropriation of an additional $10,000,000,000 to secure critical materials and supplies to combat the COVID-19 pandemic. https://www.congress.gov/search?searchResultViewType=expanded&q=%7B%22source%22%3A%5B%22legislation%22%5D%2C%22search%22%3A%22S+179%22%7D

Crouch, M. (2021, March 3). When will the pandemic end and life return to normal? AARP. https://www.aarp.org/health/conditions-treatments/info-2021/when-will-covid-end.html

Ellis, M. (2021, March 22). Fauci: Child vaccinations needed for herd immunity. WebMD. https://www.webmd.com/vaccines/covid-19-vaccine/news/20210322/fauci-says-child-vaccinations-needed-for-herd-immunity

Fink, J. (2020, February 25). America has 30 million masks, needs 300 million for health care workers fighting coronavirus, HHS Secretary says. Newsweek. https://www.newsweek.com/alex-azar-coronavirus-masks-30-million-have-need-30-million-fight-america-senate-committee-1489058

Lopez, C.T. (2020, June 10). Domestic N95 mask production expected to exceed 1 billion in 2021. U.S. Department of Defense. https://www.defense.gov/Explore/News/Article/Article/2215532/domestic-n95-mask-production-expected-to-exceed-1-billion-in-2021/

Mascarenhas, L. (2021, March 25). When will kids and teens be vaccinated against Covid-19? CNN Health. https://www.cnn.com/2021/03/23/health/children-teens-vaccine-timeline/index.html

Mendoza, M. & Linderman, J. (2020, October 6). U.S. medical supply chains failed, and COVID deaths followed. PBS Frontline. https://www.pbs.org/wgbh/frontline/article/us-medical-supply-chains-failed-covid-deaths-followed/

Occupational Safety and Health Administration (OSHA). (2015). Hospital respiratory protection program toolkit resources for respirator program administrators. https://www.osha.gov/sites/default/files/publications/OSHA3767.pdf

Occupational Safety and Health Administration (OSHA). (2007). Respiratory protection. https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134

Rose, J. (2020, September 17). Why can't America make enough N95 masks? 6 months into pandemic, shortages persist. Wisconsin Public Radio. https://www.npr.org/2020/09/17/913093387/why-cant-america-make-enough-n95-masks-6-months-into-pandemic-shortages-persist

The White House. (n.d.). Presidential actions. https://www.whitehouse.gov/briefing-room/presidential-actions/

U.S. Department of Labor. (2006, November 22). Occupational Safety and Health Administration standards. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=STANDARDS