March 23, 2020

Infection Control Guidance in a Time of Scarcity

On March 4, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that State Survey Agencies and Accrediting Organizations would be limited exclusively to issues related to infection control and other serious health and safety threats due to the threat of Novel Coronavirus Disease 19 (COVID-19).1 On the same day, CMS also issued new guidance regarding infection control and prevention to hospitals and nursing homes as providers work to combat the spread COVID-19.2 This guidance included protocols for inspection processes and usage of adequate personal protective equipment. A few days later, CMS restated its requirement that Medicare-certified hospitals with emergency departments provide an appropriate medical screening examination to every patient that comes to the department, including those suspected of having COVID-19. 3

In the past days and weeks, however, providers across the country have begun to experience shortages of personal protective equipment (PPE) as they test and care for individuals who are confirmed or suspected COVID-19 patients, making it increasingly challenging to comply with guidance from CMS and the Centers for Disease Control and Prevention (CDC). Health care facilities remain responsible for protecting their health care personnel (HCP) from exposure to pathogens like COVID-19, including by providing appropriate PPE. The recommended PPE when caring for a patient with known or suspected COVID-19 includes: a respirator or face mask, eye protection, gloves, and gowns.4 Major distributors in the U.S. have reported shortages of PPE, specifically N95 respirators, facemasks and gowns.

Federal agencies have quickly taken note of growing shortages of equipment that is central to infection control and prevention — especially when treating COVID-19 patients. On March 10, CMS issued another memo recognizing the expansion of acceptable face masks allowed under CDC and Food and Drug Administration (FDA) guidance for situations involving COVID-19 and other respiratory infections.5

The CDC guidance considered by CMS acknowledged that, based on local and regional situational analysis of PPE supplies, there may not be enough respirators, gowns or other materials to meet current health care provider needs.6 In such a situation, the CDC now recommends that these supplies should be prioritized for circumstances where the risk of exposure is highest for health care personnel. The CDC has also provided considerations for designating entire units within the facility — with dedicated HCP — to care for known or suspected COVID-19 patients and options for extended use of PPE like respirators, facemasks and eye protection on such units.

The FDA guidance in question approved the CDC’s request for an emergency use authorization to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care settings.7 This action now allows respirators that are not currently regulated by the FDA, but are approved by the National Institute for Occupational Safety and Health (NIOSH), to be used in a health care setting by health care personnel during the COVID-19 outbreak to maximize the number of respirators available to meet the needs of the nation’s health care system.

Since this initial guidance, the FDA has issued new guidance allowing limited modifications of previously approved models of ventilators, anesthesia gas machines, and other respiratory devices and their accessories without worrying about federal enforcement when it is not possible to use conventional respirators.8 The FDA has said that it “believe[s] this approach will help manufacturers that want to add production lines or manufacture at alternative sites which may have different manufacturing equipment to increase manufacturing capacity and supply and reduce supply change interruptions and manufacturing bottlenecks.”9 

CMS has also recognized in a memo to nursing homes that state and federal surveyors should not cite facilities for not having certain supplies (i.e. PPE or alcohol-based hand sanitizer) if the facilities are having difficulty obtaining these supplies for reasons outside their control.10 CMS does, however, expect such facilities to mitigate resource shortages and show that they are taking all appropriate steps to obtain the necessary supplies as soon as possible. With respect to PPE, facilities should contact local and state public health agencies to notify them of the shortage, follow national guidelines for optimizing their current supply, or identify the next best option to care for patients.

Finally, on March 18, CMS put out new recommendations for providers to limit all nonessential planned surgeries and procedures to preserve critical resources like ventilators and PPE.11 In discussing the new recommendations, CMS Administrator Seema Verma stated that “[t]he reality is clear and the stakes are high: we need to preserve personal protective equipment for those on the front lines of this fight.”12 

Current CDC guidance attempts to take into account the reality that providers are facing increased patient loads and scarcity of necessary materials. The CDC has published several strategies to optimize current supplies of PPE, including N95 Respirators.13 The CDC’s most recent guidance provides some leeway to providers who must prioritize the use of appropriate PPE for situations in which health care personnel are at higher risk of exposure to COVID-19, suggesting alternatives for some equipment. The CDC also notes that any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses, and facilities should have policies and procedures describing a recommended sequence for safely donning and doffing PPE.

See Guidance:

Provider Efforts

According to a survey from Premier Inc., a group purchasing organization, more than half of hospitals had changed practices by the end of February to preserve supplies of personal protective equipment.14 Many hospitals, however, are only receiving partial shipments of supplies that they ordered because distributors are allocating fulfillment of orders based on previous usage, not projected use. 15

Major hospital systems are running out of supplies quickly and are turning to unexpected alternatives. One such system — a 51-hospital system headquartered in Washington — had administrative staff make homemade face shields out of vinyl, foam and elastic to supplement their dwindling supply of face masks.16 One hospital ordered protective equipment from a company that supplies masks to construction workers.17Some individual providers have been washing and reusing single-use masks.18 

In addition to limiting admissions for elective procedures, many health care institutions have turned to telehealth as a way to expand access to patients without increasing risk of exposure or use of hospital supplies. For example, Massachusetts General Hospital mentions new efforts to increase patient access and protect its workforce via telehealth services.19 As of March 20, eighteen states and the District of Columbia had amended existing laws or issued new declarations to expand the use of telehealth and mHealth tools during the COVID-19 outbreak.20 For more information on current telehealth laws, see A Day in Telehealth History: Access to Telehealth Services Expanded, Requirements to Facilitate Virtual Visits Relaxed in Response to Coronavirus.

Some providers have considered 3-D printing as a solution to produce their own supplies of materials for which they have an urgent need. A few hospitals in Italy have provided a model for this production; these hospitals responding to the COVID-19 outbreak desperately needed valves for intensive care machines and turned to 3-D printing firms to print valves for immediate use.21 3-D printing may help to provide a source for much-needed supplies, but facilities should be sure to consider additional concerns related to 3-D printing their own materials — including copyright and patent issues as well as product liability risks.

Various officials and advocacy groups have begun to call on the federal government to unleash its full reserve of medical supplies contained in the Strategic National Stockpile (SNS), which is controlled by the Department of Health and Human Services, to relieve providers’ shortages. The stockpile, however, may not contain enough face masks or respirators to cover the needs that providers currently face.22 

Last week, the Trump administration said that it would invoke the Defense Production Act (DPA) to increase the domestic production of medical supplies necessary for fighting the COVID-19 pandemic. The DPA gives the executive branch great discretion to exercise power over the nation’s industrial base for national defense—including production of essential goods, like medical supplies and devices.23 Governors of several states and health care trade groups are pushing for the president to use the DPA to increase production of needed supplies. The American Medical Association and American Hospital Association sent a letter to President Trump urging him to “immediately use the DPA to increase the domestic production of medical supplies and equipment that hospitals, health systems, physicians and all front line providers so desperately need.24 

Although the Trump administration has invoked the DPA, the administration has not yet ordered manufacturers to engage in production based on the administration’s belief that American businesses will ramp up production voluntarily.25 Moreover, the ability of the Trump administration to use the DPA to increase domestic production of needed medical supplies may be hindered by companies’ inability to obtain needed equipment and raw materials. For example, there are a number of companies that would like to start manufacturing masks but cannot secure a steady flow of nonwoven polypropylene, a dense network of fibers that serves as the primary filtering material for masks.26 

All health care providers should monitor the CMS and CDC websites daily, as changes in guidance may offer greater flexibility or clarification with respect to best policies for infection control and prevention, particularly in light of PPE scarcity. Further, facilities should adopt structures to ensure lines of communication both internally — within each facility and system — and externally — with local, state, and federal agencies and health partners — to keep abreast of policy changes and communicate about potential shortages. Facilities should designate specific persons to be responsible for communicating with public health officials and disseminating information to health care personnel. Clear communication will hopefully facilitate faster and more effective decision-making at government levels, and will help providers to monitor and keep track of their own efforts to comply with relevant guidance.

Further CDC Resources:

  1. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/suspension-survey-activities. Since then, the Joint Commission has suspended all regular surveying for an indefinite period of time. If any organizations accredited by the Joint Commission go past their accreditation due date, accreditation will be extended without disruption to their accreditation status, and Medicare payment status will not be affected. https://www.jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/infection-prevention-and-hai/coronavirus_march_16_update.pdf.
  2. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-concerning-coronavirus-disease-covid-19-faqs-and.
  3. https://www.cms.gov/files/document/qso-20-15-emtala-requirements-and-coronavirus-0311-updated-003pdf.pdf-1.
  4. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html.
  5. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-use-certain-industrial-respirators-health-care-personnel.
  6. https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html.
  7. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-and-cdc-take-action-increase-access-respirators-including-n95s.
  8. https://www.fda.gov/media/136318/download.
  9. https://www.bloomberglaw.com/exp/eyJjdHh0IjoiSExOVyIsImlkIjoiMDAwMDAxNzEtMDM1ZC1kZWNjLWFmNzEtZDdmZDUxYTIwMDAwIiwic2lnIjoiUWtQTlhFaWxxa1Nhcmd5Ymt2d1NKdE14eEUwPSIsInRpbWUiOiIxNTg0OTAwMzY5IiwidXVpZCI6InlzckRtSTlGMzN1MzY4NStteDFneFE9PUwvb2tQZllrR1cyNk9vYkRHT094aGc9PSIsInYiOiIxIn0=?usertype=External&bwid=00000171-035d-decc-af71-d7fd51a20000&qid=6879355&cti=LFVL&uc=1320000017&et=CHANNEL_NOTIFICATION&emc=bhlnw_cn%3A1&context=email&email=00000171-036a-d47d-a375-b76a43cd0000.
  10. https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and/guidance-infection-control-and-prevention-concerning-coronavirus-disease-covid-19-faqs-and.
  11. https://www.cms.gov/files/document/31820-cms-adult-elective-surgery-and-procedures-recommendations.pdf.
  12. https://www.cms.gov/newsroom/press-releases/cms-releases-recommendations-adult-elective-surgeries-non-essential-medical-surgical-and-dental.
  13. CDC Strategies for Optimizing the Supply of PPE, a Checklist for Healthcare Facilities to Optimize the Supply of N95 Respirators During the COVID-19 Response
  14. https://www.bloomberg.com/news/articles/2020-03-18/hospital-makes-face-masks-covid-19-shields-from-office-supplies?utm_campaign=news&utm_medium=bd&utm_source=applenews.
  15. https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/faqs-shortages-surgical-masks-and-gowns. There are a number of potential contract terms that could apply depending on context. Many supplier contracts do not guarantee availability of supply. Many manufacturing and distribution contracts permit distributors and manufacturers to allocate products to customers when existing inventories are not sufficient to fill current demand or place items on backorder. A manufacturer or distributor also may be able to avoid liability for failing to comply with contract terms during the current pandemic based on the terms of its force majeure clause. From a purchaser standpoint, the purchaser may have remedies against a supplier under a failure to supply clause; unfortunately, this remedy usually involves the additional cost of acquiring the same or a similar product from another supplier. This remedy does not really solve the critical problem of making the product available to the purchaser as soon as possible.
  16. https://www.bloomberg.com/news/articles/2020-03-18/hospital-makes-face-masks-covid-19-shields-from-office-supplies?utm_campaign=news&utm_medium=bd&utm_source=applenews.
  17. Id.
  18. Id.
  19. https://www.massgeneral.org/news/coronavirus/coronavirus-latest-updates.
  20. https://mhealthintelligence.com/news/states-move-quickly-to-address-coronavirus-pandemic-with-telehealth.
  21. https://www.3dprintingmedia.network/covid-19-3d-printed-valve-for-reanimation-device/.
  22. See https://www.npr.org/sections/health-shots/2020/03/14/814121891/why-even-a-huge-medical-stockpile-will-be-of-limited-use-against-covid-19.
  23. https://www.modernhealthcare.com/supply-chain/trump-boost-medical-supply-production-covid-19.
  24. https://www.ama-assn.org/delivering-care/public-health/emergency-steps-needed-boost-production-ppe-covid-19.
  25. https://thehill.com/policy/healthcare/488526-frustration-mounts-at-trumps-reluctance-to-use-emergency-production-powers; https://www.nytimes.com/2020/03/22/us/politics/coronavirus-trump-defense-production-act.html?smid=em-share.
  26. https://www.wsj.com/articles/new-manufacturers-jump-into-mask-making-as-coronavirus-spreads-11584792003?mod=searchresults&page=1&pos=1.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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