Outpatient Offices
Patient Referral. Patients with symptoms or concerns of COVID-19 exposure can make physician appointments via telemedicine or in person at Mount Sinai Medical Center’s primary care and specialty offices. At the time of patient encounter, physicians suspecting a COVID-19 diagnosis will refer patients for outpatient COVID-19 polymerase chain reaction (PCR) laboratory testing, which has an approximate 24-hour turnaround to results. Physicians also assess whether the patient meets EUA criteria for use, pending results of testing. In the event a patient meets EUA criteria for use, the physician provides patient counseling and requests verbal consent. Following this, the physician enters a note in the EHR describing the patient’s condition, criteria for use evaluation, and the patient’s verbal agreement to therapy. This preliminary screening is beneficial to begin planning with both the patient and ED to minimize delays. Patients are notified of the results of their test once available. If the COVID-19 PCR test returns positive, the physician will call the ED at the main campus and schedule the patient for COVID-19 monoclonal therapy. As the desired timeframe for administering COVID-19 monoclonal therapies is within less than 10 days of symptom onset, timely scheduling of appointments is crucial. Infusion appointments are typically provided the same or next day. The patients are informed that they must bring documentation of their positive COVID-19 PCR test to their ED visit. Lastly, because patients are pretreated with medication that may potentially impair driving, they are instructed that they cannot drive themselves home; ride shares also are not allowed in order to limit the spread of infection.
Emergency Department
Patient Arrival and Screening. A COVID-19 patient can be evaluated in the ED 1 of 2 ways. The first option is via outpatient office referral, as described previously. Upon arrival to the ED, a second screening is performed to ensure the patient still meets EUA criteria for use and the positive COVID-19 PCR test result is confirmed. If the patient no longer meets criteria, the patient is triaged accordingly, including evaluation for higher-level care (eg, supplemental oxygen, hospital admission). The second optoion is via new patient walk-ins without outpatient physician referral (Figure 4). In these cases, an initial screening is performed, documenting EUA criteria for use in the preliminary assessment (Figure 5). Physicians will consider an outside COVID-19 test as valid, so long as documentation is readily available confirming a positive PCR result. Otherwise, an in-house COVID-19 PCR test will be performed, which has a 2-hour turnaround time.
Infusion Schedule. The ED offers a total of 16 COVID-19 monoclonal infusions slots daily. These are broken up into 4 infusion time blocks (eg, 8 am, 12 pm, 4 pm, 8 pm), with each infusion time block consisting of 4 available patient appointments. A list of scheduled infusions for the day is emailed to the pharmacy department every morning, and patients are instructed to arrive 1 hour prior to their appointment time. This allows time for patient registration, assessment, and pharmacy notification in advance of order entry. For logistical purposes, and as a patient safety initiative to reduce the likelihood of medication errors, each of the available COVID-19 monoclonal antibodies is offered on a designated day. Bamlanivimab is offered on Tuesday, Thursday, Saturday, and Sunday, while casirivimab/imdevimab is offered Monday, Wednesday, and Friday. This provides flexibility to adjust should supply deviate based on Department of Health allocation or should new therapy options within this class of medication become available.
Patient Education. Prior to administration of the monoclonal therapy, physician and nursing staff obtain a formal, written patient consent for therapy and provide patients with the option of participating in the institutional review board (IRB) approved study. Details of this are discussed in the risk management and IRB sections of the article. Nursing staff also provides the medication-specific Fact Sheet for Patients and Caregivers in either Spanish or English, which is also included as a hyperlink on the COVID-19 Monoclonal Antibody Order Set for ease of access. Interpreter services are available for patients who speak other languages. An ED decentralized pharmacist is also available onsite Monday through Friday from 12 pm to 8:30 pm to supplement education and serve as a resource for any questions.
Infusion Ordering. Once the patient is ready to begin therapy, the he/she is brought to a dedicated overflow area of the ED. There are few, if any, patients in this location, and it is adjacent to the main emergency center for easy access by the patients, nurses, pharmacists, and physicians. The physician then enters orders in the EHR using the COVID-19 Monoclonal Antibody Order Set (Figure 3). Three discrete questions were built into the medication order: (1) Was patient consent obtained? (2) Was the Fact Sheet for Patient/Caregiver provided to the patient? (3) Is the patient COVID-19 PCR-positive? These questions were built as hard stops so that the medication orders cannot be placed without a response. This serves as another double-check to ensure processes are followed and helps facilitate timely verification by the pharmacist.