key: cord-0943343-kk39ywfa
authors: Searing, Daniel A.; Dutmer, Cullen M.; Fleischer, David M.; Shaker, Marcus S.; Oppenheimer, John; Grayson, Mitchell H.; Stukus, David; Hartog, Nicholas; Hsieh, Elena W.Y.; Rider, Nicholas L.; Vander Leek, Timothy K.; Kim, Harold; Chan, Edmond S.; Mack, Doug; Ellis, Anne K.; Abrams, Elissa M.; Bansal, Priya; Lang, David M.; Lieberman, Jay; Golden, David BK.; Wallace, Dana; Portnoy, Jay; Mosnaim, Giselle; Greenhawt, Matthew
title: A Phased Approach to Resuming Suspended Allergy/Immunology Clinical Services
date: 2020-05-22
journal: J Allergy Clin Immunol Pract
DOI: 10.1016/j.jaip.2020.05.012
sha: 8700f0bed1a9e50bf154745161051cbf28f0d57a
doc_id: 943343
cord_uid: kk39ywfa

Abstract: In early 2020, the first US and Canadian cases of the novel SARS-CoV-2 infection were detected. In the ensuing months, there has been rapid spread of the infection. In March 2020, in response to the virus, state/provincial and local governments instituted shelter-in-place orders, and non-essential ambulatory care was significantly curtailed, including allergy/immunology services. With rates of new infections and fatalities potentially reaching a plateau and/or declining, restrictions on provision of routine ambulatory care are lifting, and there is a need to help guide the allergy/immunology clinician on how to re-initiate services. Given COVID-19 will circulate within our communities for months or longer, we present a flexible, algorithmic best-practices planning approach on how to prioritize services, in 4 stratified phases of re-opening according to community risk level, as well highlight key considerations for how to safely do so. The decisions on what services to offer and how fast to proceed are left to the discretion of the individual clinician and practice, operating in accordance with state and local ordinances with respect to the level of non-essential ambulatory care that can be provided. Clear communication with staff and patients before and after all changes should be incorporated into this new paradigm on continual change, given the movement may be forward and even backward through the phases as this is an evolving situation.

In early 2020, the first US and Canadian cases of the novel SARS-CoV-2 infection were 187 detected. In the ensuing months, there has been rapid spread of the infection. In March 2020, in 188 response to the virus, state/provincial and local governments instituted shelter-in-place orders, 189 and non-essential ambulatory care was significantly curtailed, including allergy/immunology 

In early 2020, the first US and Canadian cases of the novel SARS-CoV-2 infection were 205 detected. 1,2 In the ensuing months, there has been rapid spread of the infection in the US, with 206 >1,350,000 cases and >81,000 fatalities, and in Canada, >70,00 cases and >5,000 fatalities, both 207 as of May 12, 2020. 3,4 5 With an R 0 =3 (e.g., for every one person infected, it will spread to 3 208 others) and asymptomatic transmission evident, strict social/physical distancing protocols at 209 local, state, and federal levels were enacted. [6] [7] [8] [9] No proven effective treatment has been 210 identified, and a vaccine for widespread use is not yet available. In response to the virus, 211 state/provincial and local governments instituted shelter-in-place orders, and non-essential 212 ambulatory care was significantly curtailed. This included either outright cancellation or 213 considerable prioritization of allergy/immunology services. 2,10,11 Guidance on how to scale 214 down services in the setting of the COVID-19 pandemic was recently published in mid-March, 215 supported by the AAAAI, ACAAI, and CSACI jointly. 2 At the time of this writing, rates of new 216 infections and fatalities may be reaching a plateau and/or declining to levels where some state 217 and local municipalities are now lifting shelter-in-place orders, with or without "safer-at-home" 218 or other less restrictive orders, though in certain areas, the infection rate may not yet have 219 peaked. 12,13 Correspondingly, restrictions on provision of routine ambulatory care will likely be 220 lifted. While there may be oscillation between shelter-in-place and safer-at-home orders over the 221 next several months as additional waves of the virus may occur, there is a need to help guide the 222 allergy/immunology clinician on how to re-initiate services. Similar to other epidemic forms of 223 coronavirus and viral pandemics, it is expected that COVID-19 will circulate within our 224 communities for months or longer. 14 As such, it is essential that we stratify the provision of 225 services and develop a plan for how to increase or decrease service capacity. While some visits 226 for allergic conditions, such as allergic rhinitis and proactive medication allergy delabeling can 227 be reasonably delayed, others such as primary immunodeficiency, infant food allergy, 228

Hymenoptera induced anaphylaxis, medication allergy limiting current necessary therapy, and 229 moderate-severe asthma cannot afford long-term delay. Herein, we present an algorithmic 230 approach on how to prioritize such visits and services. Recognizing that there are variable 231 economic considerations involved in decisions regarding restarting in-person clinical care, this 232 report is focused singularly on the logistical restart of in-person care. We emphasize that these 233

are not evidence-based guidelines, but rather guidance in the form of consensus-based best-234 practice recommendations from a diverse North American group of academic and private 235 practice allergy/immunology specialists, as an organized discussion of the issues and potential 236 approaches to opening up a clinical allergy/immunology practice after having reduced services or 237 shut down due to 239

While making a decision to reinitiate services, there is an essential need to have certain key 241 information in order to assess infrastructure capacity and safety concurrently. Future variables 242 that may affect these decisions include optimizing efficient and effective contact tracing, 243 development of a vaccine, the potential for herd immunity, and acquiring firmer evidence that 244 there is individual long-lasting immunity post-infection. Part of the difficulty is accurate 245 forecasting of the level at which community transmission is ongoing and being able to detect 246 new cases in real time before such persons expose others. 3, 15 This presents a unique challenge to 247 the clinician, since many patients may be asymptomatic or presymptomatic during the office 248 visit. 7 As such, reinitiation decisions also involve balancing supply and usage of personal 249 protective equipment (PPE). 16,17 Therefore, when considering restoring in-person patient visits, 250 a few constraints are essential to understand and be able to implement: 251 1. Accurate ongoing assessment of the current level of local community transmission of 252 SARS-CoV-2 (low, medium, high) 253 2. A sustainable supply of PPE that can reduce the risk of SARS-CoV-2 transmission to the 254 greatest extent possible, a plan for providing PPE for patient visits, and ongoing 255 reassessments of best practices regarding PPE as new evidence emerges on SARS-CoV-2 256 transmission. 18,19 257

3. An effective patient and staff screening process to assess risk of symptomatic or 258 asymptomatic SARS-CoV-2 infection. 259 4. Adequate availability of rapid, accurate SARS-CoV-2 testing (RT-PCR for viral load 260 assessment and serologic assessment for evidence of antibody formation) with 261 appropriate PPE available to assess if a patient with an upcoming or recent 262 visit/procedure is potentially infected, or to assess staff scheduled to work. 263 5. Accurate understanding of the degree to which a patient (or staff member) may be at risk 264

for severe or life-threatening COVID-19. 265 6. Implementation of recommendations for reducing patient density and achieving 266 distancing requirements with respect to waiting rooms and patient care rooms and 267 minimizing close contact time per encounter to reduce transmission risk. We recommend that service roll-out occur in stages, allowing for time to monitor demand for in-326 person services, changes to the rate of community exposure to COVID-19, recommendations for and access to PPE, and staffing issues. Phasing is in accordance with national as well as many 328 state and local plans to cautiously ease toward prior levels of service. 12, 24 . these protocols should be communicated with all office staff and reviewed regularly. Visits for 356 skin testing and ingestion challenges that will lead to immediate changes in 357 management/decision making can resume for the utmost priority conditions, but should be deferred in this phase for more moderate and lower acuity evaluations, in particular for routine 359 non-urgent evaluation of allergic rhinoconjunctivitis. Patient-to-clinician contact under 6 feet 360 must be minimized, and use of phone call/video visits to obtain key portions of the history, 361

interpret the results of any procedures, formulate a plan, and answer patient questions should be 362 strongly considered to help reduce direct face-to-face time. Patients should also be encouraged to 363

provide as much information about medical history and current clinical concern prior to the visit 364 in order to reduce in-office time. Patients who refuse to wear a facial covering as recommended 365 by the CDC/Health Canada may be refused the opportunity to be seen for in-person visits, 366 although this will depend on or be superseded by office or institutional policy. 17,26 367 368

The second phase begins as there is a continued, noted plateau and/or decline of the community 370 transmission of SARS-CoV-2 to a moderate risk level, in conjunction with increased availability 371 and use of testing/contact tracing and more consistent achievement of criteria met to re-open 372 previously restricted services per public health experts. Community and office PPE supply 373 remains adequate in line with recommendations provided by the CDC/Health Canada. There are 374 no changes to issues surrounding immunity from phase 1. Overall, while this phase represents a 375 significant improvement from phase 1, it is still recommended to 1) continue maximizing 376 telehealth for visits as long as that is a continued option under the expanded policies, 2) maintain 377 limited face-to-face contact time and 6 feet of social/physical distancing as above, and 3) there 378 should continue to be strong consideration that no patient should be seen if they refuse to wear a 379 facial covering as per CDC/Health Canada, Joint Commission, and local health department 380 recommendations, to the degree office or institutional policy will allow. Shared decision-making 381 regarding preference for type of visit should be initiated, providing telehealth remains an option 382 under expanded policies. High and moderate priority recommended services, including skin 383 testing, food/drug challenges, and wait list patients unable to connect to telehealth, can be 384 scheduled with a modified template accounting for the social/physical distancing 385 recommendations and plan for roll out of resuming such procedures. Spirometry is still not 386 recommended in most circumstances, outside of tests that would be essential for immediate is not yet clearly understood for such patients. 29 Additionally, while some outcomes have been 436 published and depict vulnerability within this patient population, the true risk faced by those who 437 are immunocompromised is not yet well understood but should still be considered as high in 438 light of known infection susceptibility patterns in such individuals. 30, 31 As noted in Tables 1 and  439 2, immunodeficiency is given the highest priority within every acuity, meaning that when these 440 patients require in-person services, they should be prioritized. However, the approach as to 441 when such patients should be seen in the clinic setting is still nuanced, and the following points those with type I interferon pathway defects who are at increased risk for RNA viruses) 32-450 • Maintain vigilance of testing capabilities of the community.

• Have an isolation plan with PPE in place for COVID + patients/patients under investigation still requiring office-based care, or who elude screening • Actively monitor and modify your scheduling template.

• Maintain a list for prioritizing in-person patient visits to manage a gradual increase in capacity • Plan for staff coverage if a staff member has a high risk medical condition or if he/she has to self-isolate • For up to date information on office preparedness please consult https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-prepa redness.html; https://www.cdc.gov/coronavirus/2019ncov/hcp/guidance-risk-assesment-hcp.html PPE

• Use of at minimum cloth facial coverings or surgical masks for patients, except for very young children • Surgical mask/face shield in office for lower risk/standard risk contacts • N95, P100, or PAPR level protection for aerosolizing procedures and/or known COVID+ patients/contacts/suspected contacts • Gowns, gloves and hair nets where indicated • Clear donning and doffing procedures, and assessment of clinician and staff competency in these procedures • Please check with https://www.cdc.gov/coronavirus/2019ncov/community/reopenguidance.html?deliveryName=USCDC_2067-DM26911 for up to date guidance on PPE, which may change • Please refer to institutional, office, or local policies that may take governance for your particular situation Social/Physical Distancing, Exam Room and Waiting Room Issues • Maximize use of telemedicine procedures to communicate with patients to minimize time in the room • Be mindful to clean the office at regular intervals throughout the day • Follow CDC guidance on use of disinfecting agents for particular office furniture or medical equipment (https://www.cdc.gov/coronavirus/2019-ncov/community/reopenguidance.html?deliveryName=USCDC_2067-DM26911) Spirometry/Nitric Oxide • Carefully consider the re-opening phase and utility of the information being gained from the procedure • Strict hand hygiene protocols before and after the procedure for patients and staff • Consider unique spacing issues between patient and tester, as well as ensure tester has proper PPE including an N95 or higher level mask, gown, face shield hair net (if needed), additional eye protection if needed and disposable gloves, in compliance with local/institutional policy. Staff should doff PPE used in the spirometry area before entering other office/clinical space • Ensure filter is in place, and maximize use of any single use materials • Ensure equipment and room cleaning procedures are in place, as well as time needed to clean equipment in between procedures • Assess ability to provide a negative pressure room if indicated • In phase 1 and 2, consider using telemedicine for remote testing/instructions to limit face-to-face time in a room with an aerosolizing procedure. Utilize home peak flow meters to assist in asthma monitoring.

• Restrict use of in-office nebulized treatment in phases 1 and 2 to the extent possible • Defer spirometry in patients with acute respiratory symptoms • Defer methacholine challenge in phases 1 and 2.

• Please refer to current ERS (https://ers.app.box.com/s/zs1uu88wy51monr0ewd990itoz4ts n2h) and ATS (https://www.thoracic.org/professionals/clinicalresources/disease-related-resources/pulmonary-functionlaboratories.php) guidance • New evaluation of a food allergy occurring >1 year previously • New onset EoE not seen by GI or newly diagnosed EoE seen by GI with or without impaction history • Second/additional opinions not meeting aforementioned prioritization • Allergic proctocolitis • New evaluation, any duration, dye or other non-common 8/seed allergen (e.g. atypical culprits like fruit, vegetable, meat, etc.) • New evaluation/updosing for oral immunotherapy Immunodeficiency/Immune Dysregulation/Blood Cell Disorder

• Patients with a history of recurrent, common infections without severe manifestations • New evaluation of patients with mildly/moderately low immunoglobulin levels, mild/moderate cytopenia, or another similar mild/moderate finding, in which there is no history of severe or otherwise worrisome infections • History of intermittent or new onset low-moderate eosinophilia of less than 6 months duration Skin/other • New or follow up visits for refractory urticaria except for those on in-office biologic therapy (who are higher acuity) • New or follow up evaluation for cutaneous mast cell disorder • Ongoing evaluation of established urticaria • New or established patients with mild atopic dermatitis (currently on low potency topical corticosteroids) • Suspected mast cell activation syndrome • Evaluation or follow up for allergic contact dermatitis Immunotherapy (SCIT, SLIT, OIT)

• Maintenance IT visits/resumption • Initiation of all forms of new IT 

1) Food challenges to common 8 foods (focus on milk, egg, peanut, wheat, soy, possibly fish) in infants <18 months being done to allow reintroduction based on testing that dictated the nutritionally relevant item be removed, or in older children with critical nutritional issue related to the food avoidance and a defined anaphylaxis risk precluding home introduction. 2) Drug/vaccine challenges to something that is of high probability of re-administration in the next 3-4 months, in anticipation of an upcoming procedure, or will be associated with improved health care outcomes (e.g., aspirin for secondary cardioprotection) 3) Rapid drug desensitization for a patient with an IgEmediated reaction to a medication required for a serious or life-threatening indication, without an equivalent therapeutic alternative. 4) Urgent penicillin or drug allergy delabeling. 5) Early food introduction meeting very clear NIAID addendum 1 criteria (severe eczema and/or egg allergy) for early peanut introduction to prevent peanut allergy MODERATE PRIORITY 1) Reintroduction food challenges in children of any age with a documented history of a non-eczema, non-EoE clinical reaction who now have likely outgrown the allergy, and that the family will reintroduce. Prioritize younger over older children. FPIES reintroduction and challenges to establish either milk/soy or rice/oat crossreactivity in FPIES. 2) OIT updosing in patients where therapy was initiated, with some build up, but was held due to the pandemic LOW PRIORITY 1) Potentially cross-reactive foods with a defined reaction to a food in the class, but the challenge item itself has not been ingested. (Examples: any tree nut if allergic to peanut or another tree nut, cross-reactivity with fish/shellfish) 2) Baked milk/baked egg 3) Challenge before initiation of OIT 4) Proactive penicillin or drug allergy delabeling 5) Routine aspirin challenge/desensitization 6) Eczema/EoE reintroduction of foods being avoided without specific history of prior allergy 7) Any non-common food reintroduction of low likelihood to be an allergen but parent reluctant to introduce at home 8) Non-milk/soy or rice/oat FPIES cross reactivity introduction 9) Early food introduction in NIAID addendum 2 children (children without egg allergy, with other food allergy, or with mild or moderate eczema) for early peanut introduction to prevent peanut allergy 10) Observed food ingestion in patients with positive food IgE tests from an outside clinician in a patient with no history of allergy 11) Dye/additive challenges

Telemedicine in the Era of COVID-19

Health-Related 572 Quality of Life in Common Variable Immunodeficiency Italian Patients Switched to Remote 573

Assistance During the COVID-19 Pandemic

Managing childhood allergies and immunodeficiencies during respiratory virus epidemics -the 579 2020 COVID-19 pandemic. Pediatr Allergy Immunol 2020

Two X-linked 581 agammaglobulinemia patients develop pneumonia as COVID-19 manifestation but recover

Recurrent rhinovirus 584 infections in a child with inherited MDA5 deficiency

Life-threatening 586 influenza and impaired interferon amplification in human IRF7 deficiency

Severe viral 589 respiratory infections in children with IFIH1 loss-of-function mutations. Proceedings of the 590 National Academy of

Defective 592 RNA sensing by RIG-I in severe influenza virus infection

Deployment of 595 convalescent plasma for the prevention and treatment of COVID-19

to the care of the patient (vs. telehealth services, as deemed by their clinical 452 immunologist). Furthermore, immunocompromised patients are more likely to have a 453 pre-existing need for droplet/contact/reverse precautions, and thus a more specific 454 requirement for provider or patient PPE. Given the nature of clinic/consultation visits 455 with clinical immunologists, many of the services provided -including counseling and 456 data review -can be provided remotely (via telehealth). Exceptions to remote services 457 include: 458i. Infusion Services -For those patients who require intravenous infusions of blood-459 derived products (such as immune globulin) or biologic agents that are not 460 provided in-home, they will continue to receive such services in their respective 461 infusion centers. For those patients who require subcutaneous injections of 462 biologic agents that are not provided in-home, they will continue to receive such 463 services in a clinical setting, with consideration for use of visiting nurses to 464 convert this to home administration if appropriate. For patients on intravenous 465 immune globulin (IVIG), the risks and benefits of transitioning to self-466 administered subcutaneous immune globulin (SCIG) should be discussed with the 467 patient/family. 468ii. Vaccinations -Select patients will require administration of vaccines for either 469 added protection against specific pathogens to which they may be uniquely 470 susceptible and/or as part of their diagnostic evaluation. Preferably, vaccines 471 would be administered by the primary care provider of the patient; however, in 472 instances where this may not be possible, administration of select vaccines may be 473 coordinated through an allergy/immunology office or practice. 474iii. Spirometry/Plethysmography -Select patients will require spirometry or 475 plethysmography, which are services they will continue to receive through either 476 the office/practice, pending resumption of these services once deemed to be safe, 477 or, if needed, could be arranged in a setting that minimizes aerosolization risk. 478 iv. Imaging Services -Select patients will require diagnostic imaging, which is a 479 service they will continue to receive through local radiology practices in an 480 outpatient or hospital setting. 481 v. Laboratory Services -Select patients will require blood, urine, stool, and/or nasal 482 virology studies, which are services they will continue to receive through the 483 outpatient or hospital setting. 484 vi. Consideration for Convalescent Plasma Administration -As we better understand 485 the risks and benefits of convalescent plasma in both preventing and treating 486 COVID-19, some patients may be considered for such therapy (or other newly 487 developed preventative therapy that may emerge) either clinically or as part of 488 national trials. 36 489 Some of the above considerations may be applicable to patients without immune deficiency. should be incorporated into this new paradigm on continual change, given the movement may be 505 forward and even backward through the phases as this is an evolving situation. This document, 506 in combination with the COVID-19 preparation document, can provide a rationale for handling 507 the uncertain future with respect to the SARS-CoV-2 or any other potential pandemic. Please 508 check the AAAAI website COVID-19 resource page (https://education.aaaai.org/resources-for-a-509 i-clinicians/covid-19) for ongoing updates and recommendations that have been issued regarding 510 resuming practice as well, which offers some more general recommendations. 24 511 512 provider-fact-sheet Accessed April 28, 2020. 556