Know Your Data

To initiate elective surgery, it is important to know that the number of new infections has been declining for at least 14 d, and that the community’s health-care facilities have capacity. This suggests that the “curve may be flattening” and gives a degree of confidence that elective cases may begin. The primary caveat to this is that the data are only as good as the collection. Regions that do vigorous testing with high quality tests can provide a more accurate estimate than places that only test symptomatic patients. Review of these data are recommended to occur daily as new clusters may occur, thus prompting one to cease elective surgery.

Communicate With the Local Department of Public Health

It is important to inform the local department of public health, municipality, or county, about the plans to start elective surgery. It provides a 2-way communication about cases and a deeper understanding of the data within local communities. This is a measure of goodwill that can strengthen a local community’s health-care system.

Personal Protect Equipment Inventory

Ambulatory Surgery Centers across the United States have converted their mission from providing high-quality outpatient care to contributing health-care resources to the frontlines of those battling COVID-19. Personal protective equipment, or PPE, in the COVID-19 pandemic has been scarce in certain regions of the United States. Redistribution of such goods including other medical equipment such as ventilators, medications, or cleaning supplies is paramount to helping areas where the number of cases surpasses health-care system capacity. The first step to determine if elective and less urgent surgeries can resume is whether the local community has enough PPE. Communication about inventory, incoming supply chain, local case counts, and trends all should be considered before moving forward with any elective procedures. If the local government has indicated the need for redistribution of essential resources, such as PPE, due to scarcity, those orders must be followed.

Tests

Currently, there are 2 forms of testing for the SARS-CoV-2 virus: polymerase chain reaction (PCR) and serology. PCR was invented in 1983 in Emeryville, California, and has been used for decades. ^{Reference Nolan, Huggett and Sanchez11} It involves determining a unique segment of nucleic acids of the virus and creating a reagent that selects for that specific segment of RNA of the virus. The attachment is amplified and detected, thus providing a positive test. The test will only be positive if an individual is shedding the virus, and if the culture is performed appropriately. For example, if the swab does not appropriately brush the nidus of the virus, a false negative result may occur.

Serology testing is where one has blood drawn, and antibodies to the virus are detected using methods such as the enzyme-linked immunoabsorbent assay (ELISA). Positive results of immunoglobulin (Ig) M can indicate active infection in a patient, although the significance of IgG positivity remains uncertain. Seroconversion can take anywhere from 11-12 d postinfection; thus serology testing can lead to false negative results within 2 wk of initial innoculation. ^{Reference Hsueh, Kao and Lee12} Additionally, immunosuppressed patients may fail to produce an adequate antibody response. Serology testing thus has numerous limitations that should be considered before widespread use.

Testing Workflow

Patients are notified and screened by means of telephone and email the day before about the testing protocol. If they are unwilling to be tested, they forfeit their opportunity for elective surgery. Patients are informed that only they will be allowed in the facility. Any aid in mobility or language interpretation will be done by means of the nursing staff of the ASC. A screening update regarding symptoms (eg, cough, shortness of breath, fever, etc.) and contacts is performed. If any of the screening questions are concerning for COVID-19, the patient is advised to postpone. Patients are advised that measures are taken to reduce the risk of acquiring SARS-CoV-2 but that the possibility of transmission would still exist and would sign consent to proceed with surgery in light of this risk.

The creation of a CFZ requires remote outdoor testing, similar to what was implemented in South Korea for testing. Vehicles would enter a specific location with the health-care workers fully donned in PPE (airborne, droplet, and contact precautions). Alternate arrangements (eg, walk up zone) can be made in advance for testing of those patients without access to vehicles. The patient would be identified with the proper identification and would consent to testing and how the results would be shared with the county Department of Public Health (DPH). The health-care staff would first implement a nasopharyngeal swab sample. The swab would be directed to a PCR with a high positive percentage agreement (PPA). Because there is no standard lab test for the detection of SARS-COV-2, the exact sensitivity and specificity of each test is unknown. However, as per the data submitted to the FDA under the emergency use authorization (EUA) paperwork, certain PCR test kits have a PPA of 95% or above. This would correspond to an approximate false negative rate of 5% or below.

However, this would mean that for every 20 patients, 1 might actually be positive for COVID-19. Given the limited PPA information available, the authors advise a second PCR test to reduce the false negative rate to well below 1% (Figures 1 and 2). Until further data come out from the widespread testing results of the current PCR tests, a second PCR test can help to ensure a lower overall false negative rate. A secondary approach would be to implement a serology test followed by a rapid PCR test, although this is certainly less ideal given the uncertainty with serology testing as described above. Indeed, a negative PCR test with a positive IgG may provide some information as to possible recovery of a patient, although that is not completely clear at this time. The patient would be asked to wait at a specific parking spot and patients would not be allowed to leave their vehicles until the results return. All screening staff within 6 feet of the vehicle would require appropriate PPE. We envision test results taking anywhere from 10 to 40 min, depending on whether a single or dual test is performed. ¹³

Figure 1. Primary testing workflow to open ambulatory surgery centers after the COVID-19 pandemic.

Figure 2. Secondary testing workflow to open ambulatory surgery centers after the COVID-19 pandemic.

If an individual is deemed positive, he or she will be provided information on what to do if symptoms limit their respiratory function, and how to seek help. This would depend on the community’s protocol for hospitalization. Positive individuals are advised to return home with mandatory 14 d of isolation from their friends and family members. The county DPH will be notified about the individual, including demographic information to aid in the understanding of this virus. The health-care workers involved in testing will need to be decontaminated ± doff and don new PPE. Protocols would be subject to change.

If an individual is deemed negative after the entire protocol, they are given signage that reflects this result, and they may enter the facility by means of 1 designated entrance. The other members of the vehicle are asked to remain in the vehicle or leave the premises with their contact information obtained.

All individuals that will enter the ASC must be tested. This includes surgeons, nurses, techs, custodial services, vendors, repair/utility services, essential administrative staff, and patients. The first individuals to arrive at the center must be the test-screeners. They must self-test or test each other and await the results before entering the facility. As this is a time-consuming process, it is imperative that all patients arrive at least 1-2 h before their scheduled procedure/surgery to ensure an efficient ASC operation. Any individual that leaves the premises may not return. The rationale for this rule is that, if an individual leaves and picks up the virus at a different location (eg, the hospital), they will not test positive immediately.

Use of PPE in the CFZ

Standard precautions are to be used once inside the CFZ. There is no need to use the PPE necessary for contact, droplet, and airborne precautions for facilities that continue to combat COVID-19, unless required by the individual case (eg, for intubation). Staff members should use regular surgical masks and standard precautions, aside from procedures such as intubations.

Decontamination Process

Fortunately, SARS-CoV-2 is destroyed relatively easily by the agents that are typically used in a health-care facility. The primary change would be to wipe down and decontaminate all surfaces, including door handles, stair rails, etc., from outside the facility and inside the facility on a periodic basis based on the EPA approved cleaning supplies list (eg, quaternary ammonium, hydrogen peroxide, chlorine dioxide, etc.). ¹⁴

Daily Debrief

At the end of each day, the test-screeners decontaminate first, then remove PPE without entering the CFZ. They may not enter the CFZ at any point. Screeners may become infected and would have a false negative result if they tested themselves to enter the facility. The screening leader calls the hospital administrators and provides an update on whether any individuals tested positive that day. Individuals who are not scheduled for surgeries are not allowed to be tested unless there is any immediate threat, such as if a person tests positive and is in the same vehicle.

Postprocedural Follow-Up

It is advised that patients receive not only a postprocedural or postsurgical follow-up phone call regarding the procedure, but also be informed to call the ASC if any symptoms of COVID-19 arise (eg, dry cough, fever, shortness of breath, nausea, vomiting, diarrhea, and myalgias). All patients should receive a phone call 14 d after their procedure to ensure that they did not develop symptoms. This is done to help identify any false negatives.

Optics of Performing Elective Surgeries

We understand that, even if we take all the precautionary measures to mitigate the risk of transmission of SARS-CoV-2, it may be deemed inappropriate to perform elective surgery as other parts of the United States may have shortages in specific equipment. For this reason, it is important to determine if there are dire needs for expendable equipment daily. Media coverage and social media must be managed appropriately. ASC staff and personnel should limit any media or social media during the COVID-19 crisis. Also, given the varying viral load across the country, our strategy can be used as certain parts of the country are opened before others.

Advancing the Public Good

As a testing center, the ASC can be a very helpful resource for the county DPH and the international scientific community. Providing information on positive cases can be enlightening and akin to “random” testing in the community, as patients undergoing elective surgeries otherwise are a representative slice of the community’s population. Information from our testing should be made available to the DPH. Additionally, data gathered from the newly emerging PCR and serology tests can help establish more accurate sensitivity and specificity data for the public.

Understanding the Socioeconomic Impact

The impact of COVID-19 extends far beyond that of medical surgery centers. As we flatten the curve, we must come up with effective strategies to re-open the country on a more widespread scale. If we fail to adopt an efficacious testing strategy, there will be great economic impacts on the world that cannot be overlooked. Researchers at the University of Chicago understood the loss of productivity that occurs with isolation policies alone and argued for widespread testing as a solution for gradual re-entry into normal day-to-day life. ^{Reference Berger, Herkenhoff and Mongey15} The World Bank conservatively estimates that the costs of pandemics can be as high as 1% of global gross domestic product (GDP), compared with 2% of GDP for climate change and provides compelling arguments on how to effectively invest in health security. ¹⁶ The anticipated losses in the United Sates are estimated to be around $10-15 trillion dollars of GDP reduction. ^{Reference Allen, Stanczyk and Sethi17} The cost of investing in aggressive and technologically advanced contact tracing, widespread testing (by means of reverse transcriptase-PCR and serology testing), and advanced isolation methods, however, is approximately $2-3 trillion dollars. ^{Reference Allen, Stanczyk and Sethi17} Therefore, by establishing testing protocols that could be applied by local businesses to test their staff and customers, life can gradually begin to return to normalcy, with both the public’s health and overall economy’s interest in mind.