key: cord-0729821-ae493hem
authors: Panesar, Kanvar; Dodson, Thomas; Lynch, John; Bryson-Cahn, Chloe; Chew, Lisa; Dillon, Jasjit
title: Evolution of COVID-19 Guidelines for University of Washington Oral and Maxillofacial Surgery Patient Care
date: 2020-04-28
journal: J Oral Maxillofac Surg
DOI: 10.1016/j.joms.2020.04.034
sha: fb130adca7347f7984cdf23ede36c006468ee5ec
doc_id: 729821
cord_uid: ae493hem

Abstract The emergence of coronavirus disease 2019 (COVID-19), caused by the SARS-CoV-2 (SC2) virus, in late December 2019 has placed an overwhelming strain on healthcare institutions nationwide. The modern healthcare system has never dealt with a pandemic of this magnitude, the ramifications of which will undoubtedly lead to lasting changes in policy and protocol development for viral testing guidelines, personal protective equipment (PPE), surgical scheduling, and residency education and training. The State of Washington (WA) had the first reported case and death related to COVID 19 in the United States (US). Oral and maxillofacial surgeons are at a unique risk of exposure to SC2 and developing COVID-19 due to our proximity of working in and around the oro- and nasopharynx. This article summarizes the evolution of COVID-19 guidelines in four key areas: 1. preoperative SARS-CoV-2 (SC2) testing, 2. personal protective equipment (PPE) stewardship, 3. surgical scheduling guidelines, and 4. resident education and training for oral and maxillofacial surgery (OMS) at the University of Washington, Seattle, WA.

The emergence of coronavirus disease 2019 , caused by the SARS-CoV-2 (SC2) virus, in late December 2019 has overwhelmed healthcare institutions nationwide. 1 The modern healthcare system has never dealt with a pandemic of this magnitude. The ramifications of which will lead to lasting changes in policy and protocol development for viral testing guidelines, personal protective equipment (PPE), surgical scheduling, and residency education and training.

On January 19, 2020, the first reported COVID-19 case in the United States was seen in an urgent care clinic in Snohomish County, Washington and confirmed two days later on January 21, 2020. 2 The UW SOD is the only dental school in the State of Washington. The states of Wyoming, Alaska, Montana, and Idaho have no dental school. This presented a unique challenge for the OMS service; to provide care for the patients in the direst need while ensuring the safety of residents, staff, nurses, and clinical faculty.

With CDC guidelines cautioning against AGP and the lack of precedent in operating during a pandemic, it became incumbent upon the UW OMS Department to develop a set of guidelines consistent with UW Medicine to ensure the delivery of appropriate patient care, protect vital resources, e.g. access to PPE and intensive care facilities, and protect providers and staff from unnecessary risk.

This article summarizes the evolution of COVID-19 guidelines for UW OMS patient care in four key areas:

1. preoperative SARS-CoV-2 (SC2) testing, 2. personal protective equipment (PPE) stewardship, 3. surgical scheduling guidelines, and 4. resident education and training.

Initially, testing for SC2 relied on the real-time polymerase chain reaction (RT-PCR) test using a nasopharyngeal swab. Results were available within an average of 15 hours (range 10-19) at our institution. 8 UW Virology laboratory has the capacity to run 4000 cases per day of a "non-rapid" SC2 test called "SARS-CoV-2 (COVID-19) Qualitative PCR." Results are expected the same day for specimens received in the morning, next day otherwise. 8 In principle, the RT-PCR test has 100% sensitivity (true positive rate). Due to sampling error or biology of the disease, e.g., virus present in the lower, but not upper respiratory tract, in the clinical setting the test results in some false negatives. A 2020 study compared chest CT and RT-PCR on 51 patients in China. Chest CT showed a sensitivity of 98% while RT-PCR showed a sensitivity of 71% from the first throat swab or sputum. On the 2 nd RT-PCR, 23% of those initial negatives were positive, on the 3 rd test 4% were positive, and on the 4 th test 2% were positive. 9, 10 The current clinical sensitivity and specificity for SC2 testing using RT-PCR at UW is reported to be high, but actual values are unknown, as there is no gold standard for COVID-19 status.

By March 21, 2020 the Federal Drug Administration (FDA) approved the first rapid SARS-CoV-2 (SC2) RT-PCR. 11 The rapid test available at our institution is currently run every 2 hours on the even hour with results available within 80 minutes. 12 If a specimen is submitted immediately after the 2 hour run the result will be delayed accordingly. The capacity of this test is limited to 40 tests per day due to machine capabilities and supply of reagents and is thus reserved for inpatients developing new or worsening symptoms, select cases in the emergency department (ED), and in pre-procedural areas. 12 symptoms include new onset fever >100F, cough, shortness of breath, myalgias, rhinorrhea, sore throat, anosmia, aguesia. 13 Given the limited numbers of daily samples that can be tested, providers must directly speak to the COVID-19 Infection Control physician on call to justify the necessity of the test and receive formal approval.

On March 23, 2020, UW Medicine released an initial COVID-19 testing algorithm for preoperative surgical patients (figure 1). This algorithm distinguishes whether a surgery was emergent or not and then, based on SC2 test results, recommends appropriate PPE. The second and current iteration of the COVID-19 testing algorithm was released on March 31, 2020 (see figures 2a for inpatients and 2b for clinic patients). Of note, given the rapidly evolving recommendation of managing operative treatment in the COVID-19 era, as of April 20, 2019, this algorithm has not changed.

The current process for choice of operative venue (standard vs. negative pressure operating rooms) and PPE (standard vs aerosolized transmissible disease (ATD) precautions) is based on 3 parameters: operative urgency, symptom status, and SC2 testing (Figures 2a and 2b ). All operative procedures were limited to urgent or emergent cases. To qualify for urgent operative treatment, the patient must be asymptomatic and have a negative SC2 test result within 72 hours of the procedure. If the same patient required reoperation after 72 hours he or she would need to be re-tested. Given an asymptomatic patient who tested SC2 negative, we advised, standard precautions (i.e., mask, face shield or goggles, gown, surgical cap, and gloves.) As an example, we operated using standard precautions on an asymptomatic and SC2 tested negative patient with a mandible fracture.

If the case was urgent, but the patient symptomatic or tested SC2 positive; the operation was deferred.

If the case could not be delayed for 14 days, the emergent case limb of the algorithm was followed. If the case was emergent and symptoms and SC2 test status could be ascertained, the emergent case limb of the algorithm was followed. If symptom and test status could not be determined ATD precautions were implemented, e.g. airborne/respiratory/contact precautions, negative pressure room, powered air purifying respirators (PAPR) or N95, eye shield/goggles, gown, gloves surgical cap, and a trained observer for donning and doffing.

Of special note was the definition of 'urgent'. Urgency is widely variable and dependent on specialty and provider. However, with institutional prioritization of PPE preservation urgent cases were defined as those where the patient's health outcome would be adversely affected in a specific timeline. At UW, this timeline was initially 2 weeks, and then was changed to 4 weeks. As of April 13 th, 2020, consistent with Governor Inslee's proclamation, UW medicine changed the cutoff to 90 days. 14 These changes reflect COVID-19 projections within WA and the need to conserve PPE and the availability of PPE. 15 For special circumstances or questions, a COVID-19 resource clinician could be reached for testing questions. In our experience, we had one patient with Le Fort II fractures with a displaced nasal fracture.

Due to risk of performing a nasopharyngeal swab, an anterior nasal swab was recommended with possibility that the more anterior sample would result in a false negative. In another case, a pan-facial fracture patient with tracheostomy, a lower respiratory tract aspirate was acquired for testing.

Furthermore, preoperative testing of urgent or emergent operating room cases provided additional information. Of the first 240 asymptomatic patients tested, 2 tested positive 0.8 %; (upper limit 95% confidence interval was 3%). Of symptomatic patients tested at UW Virology Laboratory, the range of SC2 positive tests ranged from 3-15%. Currently, among symptomatic patients, the frequency of SC2 positive tests hovers around 10%. 16, 17 On April 13, 2020 UW Medicine initiated SC2 testing of all patients admitted to all of its four hospitals.

Between mid-January to early March, no official recommendations on PPE were in place to help providers reduce risk of exposure to SC2. However, in March, various guidelines from the CDC were implemented. For instance, it was initially thought that if an AGP was performed on an asymptomatic patient who tested SC2 negative at minimum a N95 disposable respirator mask would be required. 5,18 In addition, there was still confusion when a non-AGP was performed on an asymptomatic patient and if that situation would only require standard PPE precautions. The need to conserve PPE complicated matters.

The current UW Medicine and Department of OMS protocol is to use standard PPE precautions, i.e. no N-95, when treating an asymptomatic, SC2 negative patient tested within the last 72 hours. Standard PPE precautions include a mask, face shield or goggles, gown, surgical cap, and gloves. Standard PPE applies to AGP and non-AGP procedures. It should be noted that as of submission no OMS provider at UW has had a known work-related exposure. If the patient is SC2+, and treatment cannot be deferred, care is rendered in the operating rooms as our OMS outpatient clinics are not suitable environments to manage patients with ATDs. No OMS outpatient clinic within the four hospitals or UW SOD served by the Department, has a negative pressure room.

On March 23, 2020, UW Medicine began to implement operative COVID PPE training seminars. These included both in-person powered air purifying respirators (PAPR) training and an online video of donning and doffing a PAPR after use. In addition, a trained observer is required to monitor and aid in proper doffing to prevent contamination (figure 3).

Manufacturers release different styles of single use face masks, surgical masks, and N95 disposable respirator masks with different levels of bacterial filtration effectiveness (BFE), particle filtration effectiveness (PFE), and fluid resistance in accordance with performance specifications from the American Society for Testing and Materials (ASTM). 19 In selecting the appropriate mask one must consider what level of protection is required ( figure 4 ). Consider that a respiratory droplet averages 6 microns, while the size of a single SC2 virion is reported to be 0.1 micron. 20 In the case of SC2, mask levels 1-3 provide acceptable protection. For OMS, it is especially important to choose a mask that also provides adequate fluid resistance.

At our institutions, the current prevalence of being asymptomatic and having a positive SC2 tests is 0.03 (upper 95% confidence interval (CI) limit). Assuming a Level 1 mask provides >95% effectiveness in limiting exposure to respiratory droplets, the risk of SC2 exposure from an asymptomatic patient while wearing a Level I surgical mask is estimated to be 15 (0.03 x 0.05) per 10,000 exposures. The risk of SC2 from a symptomatic patient is estimated to be 50 per 10,000 (0.10 x 0.05) exposures. Compared to an asymptomatic patient, there is a 3.3-fold increased risk for exposure to SC2 from the symptomatic patient.

Computations of exposure risk are based on local estimates of disease prevalence and assumptions regarding mask leakage. Estimates of SC2 exposure should be based on the reader's local prevalence of SC2 and assumptions regarding mask leakage. As such, it is likely that readers may compute a different estimate of the risk for SC2 exposure and should adjust behavior and PPE accordingly.

Ultimately, three factors need to be evaluated to assess level of PPE requirements and to ensure provider, patient, and staff safety: 1) procedure acuity (urgent/emergent); 2), symptom status (asymptomatic/symptomatic); and 3) SC2 test results (positive/negative)

Initial surgical scheduling guidelines were sparse. After the CDC released its interim guidance on March into domains of anesthesia, trauma, pathology, orthognathic surgery, and reconstructive or cosmetic surgery. 28 The decision to delay an operating room or clinic procedure was at the discretion of the attending OMS surgeon and based on a professional determination that delay would not have a significant impact on the patient's health outcomes within the next 90 days. 14 

By mid-March, the Department transitioned to limited clinical services to minimize provider exposure and comply with physical/social distancing recommendations. All residents and faculty had 'fit' testing for N-95s if not previously done within the past year. This 'fit' test confirms that the N95 (a disposable respirator mask) fits the user. At Harborview Medical Center (HMC), the chief resident coordinates and schedules for one to two junior residents to come to HMC and provide support for managing in-and out-patients, perform urgent clinical procedures, or if needed, assist in operating room procedures.

Rounding on inpatients was limited to the chief resident and attending to limit unnecessary personnel exposure and conserve PPE. There was no physical pre-rounding. Pre-rounds consisted of chart review.

The residents not on site were available on stand-by to be called into hospital as needed. Visitors were restricted for clinical visits. Ideally, it would only be the patient. If a visitor needed to accompany the patient, it was limited to 1 person. If possible, the accompanying visitor was asked to wait in the car.

We implemented telehealth consultations to ascertain urgency of a patient's condition and develop a tentative treatment plan. The goal of telehealth consultations was to eliminate physical exposure associated with an in-person clinical visit and limit the number of times a patient had to be physically present in the clinic. Additionally, a telehealth consultation allows for a single physical visit to render treatment. Follow-up appointments are executed using telehealth where possible. All post-operative patients are routinely called 1 week later as per our regular clinical work flow.

Additionally, patients in our clinic are reassessed for new-onset COVID-19 symptoms one week postoperatively given the incubation period of SC2 is up to 14 days. Per UW Medicine, in the event a patient has new onset symptoms, they are retested. If positive for SC2, staff members and clinicians who may have been exposed to a SC2 positive patient are notified and asked to perform twice daily temperature checks and assess for other COVID -19 symptoms. With any new onset symptom, that staff member or clinician is tested. If negative for SC2, they are asked to self-isolate until symptom free for 72 hours.

Once back at work a mask is required for 14 days after symptom onset. 29 In the unusual circumstance of performing an AGP on an asymptomatic patient with unknown SC2 status in the outpatient clinic, the recommended practice was for the surgeon and assistants to wear, in addition to standard precautions (i.e., face shield or goggles, gown, surgical cap, and gloves), a N95 with a conventional surgical mask over the N95. The purpose of double masking was to conserve and permit the re-use of the limited N95s. The surgical mask prevented the N95 from being soiled, thus permitting its re-use. The covering surgical mask was discarded.

In addition, the hospitals issued residents and staff re-usable protective eyewear that could be cleaned after use. At HMC, each resident received a plastic box labelled with their name to store re-usable googles and an unused appropriately sized N-95 disposable respirator mask. The used N95 was subsequently placed into a breathable paper bag labeled with the user's name. If an N95 was not available PPARs (powered air purifying respirator hoods) were available for use in either clinic or operating room locations. Once universal SC2 testing for all procedures became available PPE was determined by SC2 test results and symptoms status (see paragraph 'Preoperative SARS-CoV-2 (SC2) Testing'). SC2+ patients' treatments were deferred. If they could not be deferred, they were performed in the operating room, not the outpatient clinic setting.

To allow for the department's continued didactic and administrative functions, weekly meetings transitioned to web-based video conferencing. Remote communication facilitated important departmental discussions and resident didactics. Resident operative exposure is decreased as a consequence of limiting operations to those deemed to be urgent or emergent. Residents took advantage of this time to emphasize didactic education through journal clubs, directed book readings, lectures, and research.

It is an unfortunate truth that from the initial COVID-19 case on January 19, 2020 until March 13, 2020, the SARS-CoV-2 virus was spreading across WA. Due to a lack of testing, dental, OMS, and other healthcare providers were performing AGP with standard PPE. Among the medical community, oral and maxillofacial surgeons are at high risk of contracting respiratory infections due to our proximity of working in and around the oro and nasopharynx. 30 The final number of preventable SC2 exposures will remain unknown. This eight-week period of unpreparedness demonstrates the fundamental need for pandemic protocols to be developed proactively and rapidly implemented when needed.

For many academic institutions, ensuring the safety of providers is a priority. News reports detailed one OMS resident at Brooklyn Hospital Center in New York requiring ICU admission after testing positive and, with great sadness, the death of another resident at Ascension Macomb Hospital in Detroit. 31, 32 The development of our department's protocol for virus testing, PPE stewardship, surgical scheduling, and resident didactics ensures that the essential functions of the resident training program continues in a safe, productive manner.

The lessons learned from this pandemic will shape our profession for years to come. The protocols and guidelines released over the month of March, while vital, demonstrate a medical community playing catch-up in dealing with a once in a lifetime crisis. We must remain vigilant and ensure the protocols developed during this pandemic continue to evolve so we may act proactively for when, not if, the next pandemic strikes. It is our hope that the protocols developed at the UW will provide guidance for when that time comes.

As of April 19, 2020 WA has 12,085 confirmed cases, 652 deaths, has tested 141,011 individuals with a percent positive rate of 8.6%. 33 

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Thank you to all the healthcare and essential workers in this country and around the world, who have continued to work selflessly, in some cases without proper PPE, to ensure the well-being and survival of their patients.To UW Medicine and Laboratory Medicine for tireless efforts in formulating testing algorithms.