The COVID-19 pandemic and ensuing shut-down have negatively impacted pediatric well and preventive care. Children of all ages have not been seen for routine check-ups to screen for growth and development; to assess diet, screen time, and exercise; and perhaps most importantly, to be vaccinated against infections that despite COVID-19, continue to be a threat to their well-being.1, 2 The cause of missed care is likely multifactorial, and includes ambulatory service ramping down early on, and parent and patient apprehension in seeking care during the pandemic.3 As public health officials relax restrictions and ambulatory care resumes, primary care providers will look to help their patients catch up with well child care.

One of the challenges ambulatory providers face is conflicting personal protective equipment (PPE) guidance from health authorities and professional societies, and anxiety on the part of providers and families alike. In this white paper, we provide some basic guidance to help primary care and other ambulatory providers decide what PPE is most appropriate for their setting and justify those decisions to their stakeholders. Local practice varies, and clinics and providers should consult their health system and local health authorities to ensure choices do not deviate from existing recommendations or requirements, such as pre-visit screening for COVID-19 symptoms.

Recommendations

  1. Aerosol generating procedures (AGPs) should be avoided in ambulatory clinic settings whenever possible
    • Respiratory therapies should be given through alternative routes such as multidose inhaler (MDI) plus spacer or subcutaneous injection.
  2. Routine N95 respirator fit testing and use is not recommended for most ambulatory and primary care settings
    • Few, if any, practices have airborne-infection isolation (AII) rooms. In the absence of engineering controls, the utility of N95 respirator (or powered air purifying respirator, PAPR) use for care of patients with COVID-19 is unclear.
  3. Adherence to standard precautions should be reinforced and ensured at all times
    • A child with any type of symptoms should be placed in the appropriate precautions (e.g., a draining wound requires contact precautions)
    • Consideration should be made for PPE use in the absence of symptoms (e.g., universal masking with eye protection worn by the healthcare provider)
  4. Strategies to conserve PPE should be employed whenever possible
    • Policies such as extended wear for masking and eye protection could help maintain a safe environment, reduce waste, and preserve PPE supplies.

Aerosol Generating Procedures

SARS-CoV-2 is transmitted primary through respiratory droplets that contact a mucous membrane directly, or land on a surface and someone touches the droplet and then their mucous membranes.4 The term aerosol generating procedures (AGPs) has become a common topic of discussion in healthcare circles because of COVID-19. At its core, an AGP is a procedure that when performed could generate small particle (<0.5 micron) respiratory aerosols from patient secretions. If those secretions are contaminated with a pathogen, it could present a different mode of transmission for the pathogen that may require a change in PPE and/or environmental controls to protect providers.5 However, whether the aerosol generated is as infectious as nuclei generated in known airborne diseases like varicella, measles, or tuberculosis is unclear.5 Although it is unlikely aerosols from patients with COVID-19 can travel long distances, factors such as persistence in air, reversion to large droplets when contacting a surface or other nuclei, and effectiveness of higher level PPE such as N95 respirators are not well understood. Furthermore, it is unclear whether all aerosols are created equal – is the risk different for intubation or bronchoscopy compared to coughing following a nebulized treatment or pulmonary function testing (PFT)?6

Risk from AGPs became prominent during the SARS-CoV-1 outbreaks of the early 2000s and subsequent MERS-CoV outbreaks in the 2010s. Studies consistently showed that prolonged exposure, especially during intubation, extubation, and bronchoscopy, was a significant risk factor for patient-to-provider transmission and that protection from airborne transmission reduced the risk.6, 7 This is the rationale for the World Health Organization and CDC recommendations to use N95 respirators and AII rooms while performing AGPs on patients with COVID-19.4

A continued challenge during this pandemic is defining an AGP. There is no universal list, although all seem to agree intubation/extubation, bronchoscopy, and CPR should be included.4, 6, 8 Controversies, in part fueled by professional societies publishing lists unique to their area, have emerged around pulmonary function tests, colonoscopy, nebulized treatments, nasogastric tube placement, and simple crying or coughing.9, 10 A full discussion of why a procedure is or is not an AGP is beyond the scope of this white paper, and the question of how infectious any of these aerosols truly are is not yet answered. However, a few observations from this pandemic may help ambulatory providers assess risk.

The first is that large droplets are the primary respiratory secretions produced during cough or crying. Past studies have shown that a medical facemask and eye protection is not inferior to N95 respirators when caring for patients with laboratory-confirmed viral respiratory infections.11  To date, the use of surgical masks has not been identified as a risk factor for healthcare-associated occupational transmission of COVID-19, with no reported increased incidence among providers who perform procedures such as NG tube placement or who care for children who are coughing or crying. The second observation is from other respiratory viruses, such as influenza. Influenza is known to be present in aerosols generated during specific care, and airborne transmission has been hypothesized.12 But such transmission has not been proven,13, 14 and AGPs are not called out as a particular risk needing higher level protection for influenza, RSV, or other respiratory viruses.15

Despite a lack of evidence, many organizations and authorities have established that certain procedures constitute an AGP that poses significant risk. Nebulized medications are an excellent example of this inconsistency. There is no specific evidence showing nebulized therapy generates infectious aerosols sufficient to lead to transmission. However, The Joint Commission has listed nebulizer treatments as an AGP,16 as have some local public health authorities. The CDC is equivocal on the subject due to limited evidence, and cite a theoretical association of proximity and the result of nebulized treatments.17 WHO does not include nebulized treatments in its March 19, 2020 infection control guidance18 or its April 6, 2020 PPE use guidance,8 but does list nebulized treatments in its March 19 healthcare worker exposure risk assessment instrument.19 Many institutions have chosen to not classify nebulized treatments as an AGP due to a lack of evidence. Practices may be left to decide for themselves how to handle nebulized treatments. As relevant, they should first verify what is required by their umbrella organization and/or health authorities. In the absence of such mandates, they could consult facilities to which they refer in order to align with local practice.

One way to avoid the AGP controversy is to not perform AGPs in the ambulatory setting. Due to uncertainty around nebulized treatments, practices may elect to convert to other delivery modes. Albuterol for reactive airways could be given by MDI-spacer, which is as, if not more, effective as nebulizer.20 Oral or intramuscular dexamethasone is effective for croup of any severity, and may be more effective than nebulized racemic epinephrine.21, 22 Patients with tracheostomies requiring suction could have filters placed in their circuits, or suction could be made in-line to avoid possible plumes. Additionally, routine measures such as pre-screening patients and scheduling ill patients at the end of the day may help reduce exposure risk.

N95 Fit Testing

One thing that COVID-19 has not changed is that ambulatory and primary care clinic staff typically do not need routine respirator fit testing. Use of an appropriately fitted N95 respirator for airborne isolation is not sufficient on its own. Instead, it is meant to be bundled in a comprehensive, OSHA-mandated respiratory protection program23 that likely few practices can support. Such a program, typically implemented for tuberculosis prevention, includes an annual risk assessment and documented systems for administrative, engineering, and practice controls. Fit testing, education and practicing donning and doffing, and availability of N95 respirators and PAPRs are a significant part of practice controls, and involve considerable time and financial investment.24

A key engineering control is AII rooms. Many refer to these rooms as ‘negative pressure’, but they are more than just that. Regulations require AII rooms to be balanced negative to the adjacent area, to have a dedicated exhaust system to the outside, and to have a minimum of 12 air changes per hour (ACH).25 The ACH is important to consider because it is a measure of how often air in the room is replaced, or ‘scrubbed’, and there are requirements for all areas of a healthcare facility. Minimum ACH in an operating room is 20, in a procedure room or trauma bay is 15, in a bathroom is 10, and in an exam room or patient bedroom is 6. The difference can be measured in the time required to replace 99% of the air: in an AII (12 ACH), it takes about 23 minutes, while in an exam room (6 ACH) it takes twice as long.16 In contrast, there is not a standard ACH for outpatient areas. Many ambulatory clinics may not measure balance, and air may be recirculated without filtration. This means that rather than rapid removal of potentially infectious nuclei, the nuclei may remain suspended or be transported into adjacent areas, like waiting rooms or hallways.

PPE Conservation

Not only is PPE to be prioritized for critically ill patients, it is in short supply because of COVID-19. Availability is lower, cost is higher, and supply chains are less reliable than usual. This places ambulatory clinics, especially those independent of large health systems, at a disadvantage to procure PPE for regular use. It therefore makes sense that clinics consider ways to conserve and extend the life of the PPE they are able to receive.

Eye protection is perhaps the most straightforward PPE to conserve. HICPAC guidance does not require eye protection for droplet precautions;15 some institutions have added an eye protection requirement, others have maintained standard precautions, where eye protection is recommended for situations where risk of exposure is increased, such as when caring for children who cannot tolerate a mask (due to developmental or age issues). Most goggles and face shields are approved for multiuse and can be cleaned and disinfected regularly without compromising function. Some clinics may institute a requirement to don eye protection throughout a clinical shift, both to ensure providers are protected and to avoid waste. Healthcare workers may re-use masks for multiple different patient encounters provided the mask is not soiled or damaged. Care needs to be taken to ensure no HCW self-contamination during donning or doffing the mask.  For example, a mask worn during a well child check could likely be used for the next patient encounter, while one worn during an ill visit for cough should not. Crying alone need not be a reason for changing a mask. Alternatively, donning a reusable face shield over a regular mask could prevent soiling and preclude the need to change. Cloth masks have not been proven effective in a healthcare setting, and generally should not be used for providers.26 However, cloth masks will likely provide adequate protection for families and patients, and may be received more readily than a medical mask.27 By encouraging families to bring their own, or providing clean, reusable cloth masks for them, clinics can reserve medical-grade facemasks for providers.

Future Directions

This document is targeted primarily at ambulatory, primary well child visits. Similar questions exist for ambulatory sub-specialty and surgical settings. Future guidance will be needed to address issues such as the use of air cleaning machines (‘HEPA scrubbers’) to reduce the risk of aerosols in certain contexts, air flow in clinics with an open-bay design, and the care of ill and post-hospital discharge patients who may or may not be suspected of COVID-19 infection. For all settings, resolution of controversies like AGPs and the utility of universal PPE would enable providers to feel reassured they are protected adequately so they can focus on patient care.

In conclusion, ambulatory settings should feel comfortable providing basic preventive care without higher level respiratory protection. Regular medical facemasks and eye protection are adequate protection. To be safe, clinics can avoid performing procedures that may generate aerosols such as nebulized therapy. N95 respirator fit testing and managing a respiratory protection program is impractical and likely not indicated in most settings. Ambulatory sites should implement PPE conservation and re-use when possible.

REFERENCES

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