key: cord-0074578-n6bcftos authors: Freiser, Dana; Roca, Merjo; Chung, Tony; Bhakta, Tanvi; Winston, Lisa G.; Ortiz, Gabriel M. title: The Evolution of a Hospital-Based Covid-19 Vaccination Program for Inpatients date: 2022-01-19 journal: NEJM Catal Innov Care Deliv DOI: 10.1056/cat.21.0340 sha: 9d891a1ee30c55717ce167cac7161aab657685d4 doc_id: 74578 cord_uid: n6bcftos The Inpatient Vaccine Program at Priscilla Chan and Mark Zuckerberg San Francisco General Hospital and Trauma Center identified and mitigated a dozen workflow considerations and proved flexible enough to adapt to evolving vaccination eligibility. " The IP Program administered a total of 526 vaccine doses to 486 patients with zero wasted doses over the study period from February 18, 2021, to July 14, 2021." Implementation Phase 1: Unit-Based PDSA A designated 32-bed nursing unit performed rapid PDSA cycles to test screening and administration workflows, led by a certified nurse specialist, a unit-based medical doctor champion, and a designated vaccination registered nurse (RN). This phase defined staff roles using swim lane maps and standard work (Figure 1a ). Over time, as we addressed hurdles, the program evolved through several viable workflow iterations in response to staffing and other operational changes (Figures 1b and 1c ). An accompanying Appendix includes a detailed PDSA table (Appendix Exhibit A). After addressing initial barriers, the task force expanded the program to the 184-bed medicalsurgical department in March 2021. Program success depended on multimodal educational campaigning ( Figure 2 ). The Inpatient Vaccine Program's (IP Program) first iteration required staffing a Covid-19 vaccine registered nurse (RN) to identify eligible patients 1 day prior to administration. The Covid-19 vaccine RN completed screening, dose preparation and administration, and monitoring for reaction management. The primary provider secured consent, confirmed medical stability, and ordered the vaccine. Twelve IP Program barriers were identified and mitigated (Table 1) . health orders. Stable chronic conditions were not a contraindication to vaccination. To mistake-proof the workflow, guidance was built into the electronic health record (EHR) vaccine order, and nursing staff reconfirmed medical stability with the primary team immediately prior to administration. The Inpatient Vaccine Program's (IP Program) third iteration decentralized screening, vaccine administration, and patient monitoring responsibilities from the dedicated nurse-based roving team to the patient's primary bedside registered nurse (RN). A Covid-19 vaccination hub distributed predrawn syringes to allow for efficient same-day distribution and administration. " The zero-waste mandate presented challenges because approximately 15% of patients initially consenting either changed their decision or experienced a change in medical condition disqualifying them from vaccination." Due to inherent workflows, the pharmacy dispensed entire BNT162b2 vaccine vials, while the outpatient clinic dispensed predrawn unit doses to inpatients. To support the dual workflows, pharmacy staff trained medical-surgical nurse champions in preparation techniques for BNT162b2 vaccine vials. In terms of convenience, unit dose dispensing was certainly the more favorable workflow. Educational The zero-waste mandate presented challenges because approximately 15% of patients initially consenting either changed their decision or experienced a change in medical condition disqualifying them from vaccination. Countermeasures against this drop-off evolved with IP Program iterations. Initially, the Covid-19 vaccine RN identified more patients (n 5 7) than doses available per BNT162b2 vaccine vial (n 5 6), and vials were requested prior to 1:00 p.m. the day before administration for thawing. Later, program advancements allowed for same-day administration with dose distribution from the outpatient clinic. Infrequently, the outpatient clinic absorbed extra inpatient doses. Once ordered, the vaccine remained on the hospital medication administration record (MAR), but without a set administration time, to permit for flexibility based on clinical presentation, patient preference, and dose availability. Debunking Covid-19 vaccine misinformation represented a significant barrier. By mid-June 2021, approximately 90% of unvaccinated patients refused vaccination (Figure 3 ). Patients expressed distrust in vaccination due to at least one of the following mistruths: (1) experts failed to sufficiently study the Covid-19 vaccines; (2) Covid-19 vaccinations do not work; (3) vaccination inserts tracking chips; or (4) if hospitalized with Covid-19, vaccination is believed to be unnecessary. To address misperceptions early, Covid-19 vaccine screening occurred during the admission process. All clinical team members, ranging from spiritual care services to nursing leadership, were encouraged to engage in humble conversations with unvaccinated inpatients. 13 When Discussions with patients (n 5 37) declining Covid-19 vaccination revealed that 40.5% of patients refused to engage in a dialogue around vaccination, precluding exact determination of refusal. Nearly a quarter of unvaccinated patients expressed vaccine distrust, while 10.8% declined vaccination after initially agreeing, despite health care teams engaging in informative discussions. ZSFG guaranteed series completion for all patients, regardless of insurance, if they were able to return to a clinic. Clinicians placed second-dose order referrals and provided patients educational materials with the follow-up date and location details. When patients were discharged out of network, providers coordinated follow-up directly with out-of-network receiving facilities. Observations early after project launch noted duplicate efforts in vaccine screening, obtaining consent, and patient monitoring. To minimize overprocessing, the MAR displayed patient consent documented by the provider. PI staff set up a report to see all active Covid-19 inpatient vaccine orders and secured a vaccination phone line to streamline communications. Standard work was defined at the end of phase 1 and refined with program spread to explicitly lay out the roles of each team member (Figures 1a, 1b, and 1c) . Nurse staffing shortages have plagued hospitals nationally throughout the pandemic, and ZSFG is no exception. The IP Program prescheduled a Covid-19 RN on only 65% of available shifts. PI and nurse educators reprioritized existing responsibilities to fill uncovered shifts. Limited bandwidth existed for exhausted frontline staff to learn new standard work. By April 2021, medical-surgical department screening and order placement compliance was only 70% and 75%, respectively. As the outpatient demand for vaccines decreased, staffing resources shifted to create a dedicated inpatient nurse-based roving vaccination service (Figure 1b) . This service provided a centralized "owner" and "mistake proofer" of the IP Program to ensure 100% screening and vaccination compliance. State Covid-19 funds temporarily financed this role. As funding priorities shifted, the decentralized workflow was implemented (Figure 1c) , removing the need to staff this extra role. " Debunking Covid-19 vaccine misinformation represented a significant barrier. By mid-June 2021, approximately 90% of unvaccinated patients refused vaccination." The outpatient clinic allocated weekly supplies of vaccine administration materials, such as syringes and vaccination cards, for the IP Program. Nurse educators ensured Emergency Use Authorization information materials were available on each unit. To assess the value of the program, we considered both cost and efficacy metrics. The IP Program administered a total of 526 vaccine doses to 486 patients with zero wasted doses over the study period from February 18, 2021, to July 14, 2021 (Figure 4a ). Of the 526 doses administered during the study period, 400 (76%) were the BNT162b2 vaccine, 89 (16.9%) were the Ad26.COV2.S vaccine, and 37 (7%) were the mRNA-1273 vaccine. Of the 437 mRNA vaccine doses administered, approximately 297 (68%) were first doses. Table 2 provides details of the patient vaccination cohort. Notably, 395 patients (81%) vaccinated by the IP Program completed their vaccination series (Figure 4b ). At least 247 (47%) doses were administered to individuals living in zip codes with disproportionately low vaccination rates. An increased LOS due to postvaccination fever was " The IP Program resulted in a successful and flexible model, and vaccinations continue to be administered to our hospitalized patients. Program flexibility will be important for future responses to variants of concern as well as for changes to approved vaccine schedules." The volume of vaccines administered peaked in May 2021 and trended downward as community vaccination rates increased, averaging about 6.7% of all patients discharged over the study period (Figure 4a) . The majority of patients in the intensive care, pediatric, labor and delivery, and postpartum units did not qualify for vaccination based on medical instability and health department eligibility requirements. Administration of third doses to immunocompromised patients started near the end of the study period. The IP Program resulted in a successful and flexible model, and vaccinations continue to be administered to our hospitalized patients. Program flexibility will be important for future responses to variants of concern as well as for changes to approved vaccine schedules. Highlighting the importance of this flexibility, booster doses were strategically incorporated into the program in November 2021. Given that the federal government provided the Covid-19 vaccines and ancillary administration supplies at no charge, the program expenses were primarily a function of labor costs. The first 2 months of the program required initial investments in strategic planning, project management, and staff training. The labor required per administration decreased over time and will continue to improve as Covid-19 vaccines become part of routine patient care ( Figure 5 ). The full benefit of vaccinating 486 underserved community members in the City of San Francisco is difficult to measure. According to the CDC, unvaccinated persons are 5 times more likely to be infected and 10 times more likely to be hospitalized and die from Covid-19. 14 San Francisco has observed similar numbers, suggesting large cost savings from preventable hospitalizations, morbidity, and mortality. The task force believes the value of the inpatient vaccination program (preventable admissions, limitation of community spread, mortality, etc.) was worth the investment on behalf of ZSFG. ZSFG intends to sustain a decentralized, adaptable Covid-19 inpatient vaccination program indefinitely (Figure 1c) . Given the rapidly evolving eligibility criteria and vaccine science (including which patients benefit from additional doses), patient identification workflows currently lag. Leveraging features within the EHR remains a work in progress and a means to enhance workflow compliance. Launching the Inpatient Vaccine Program (IP Program) required vital commitments to project planning, mitigating hurdles, and staff training with an observed low volume of vaccinations administered to start. As a result, initial labor hours per vaccine dose administration averaged more than 7 hours. Over time, as vaccine administration increased with streamlined standard work and removal of overprocessing workflow steps, labor hours decreased to 1.4 hours per dose administered. ZSFG serves as a case study for how an academic, safety-net hospital can harness rapid PDSA cycles in combination with committed interdisciplinary leaders to provide a value-added service and address vaccine hesitancy in underserved communities during a pandemic. Given that safety-net settings disproportionately serve vulnerable communities with lower vaccination rates, hospital-based vaccination programs can help address health disparities. 14 A committed team can roll out a timely (within 2 weeks), safe (two patients with increased LOS), effective (526 vaccinations administered), and sustainable IP Program. Patients expressed gratitude for the ease of access to vaccines, especially those receiving a second dose for series completion. Clinical staff leveraging rapport and expertise engaged in meaningful dialogues with patients refusing vaccination, and, in this regard, hospitalization offers a unique means of dispelling false information. Inpatient staff, especially those on Covid-19 care units, expressed empowerment by contributing to the prevention of harm that they bear witness to daily. Hospitals and regulatory agencies should consider inpatient care areas as essential hubs for Covid-19 vaccination. Effectiveness of Covid-19 vaccines against the B.1.617.2 (delta) variant Herd immunity: understanding COVID-19 immunity Centers for Disease Control and Prevention. COVID-19. Vaccination Toolkits. Updated Vaccine hesitancy: the next challenge in the fight against COVID-19 Hospital-based influenza and pneumococcal vaccination: Sutton's Law applied to prevention Effective and equitable influenza vaccine coverage in older and vulnerable adults: the need for evidence-based innovation and transformation Hospitalization is an underutilized opportunity to vaccinate for influenza Racial and ethnic health disparities related to COVID-19 COVID-19: magnifying the effect of health disparities BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting How to Serve Up a Tasty 'Truth Sandwich?' The Secret Sauce Is Emphatic Word Order. Poynter Building Confidence in COVID-19 Vaccines How to Address COVID-19 Vaccine Misinformation COVID-19 and health disparities: the reality of "the Great Equalizer We extend special thanks to our Executive Sponsor Lukejohn W. Day, Chief Medical Officer. Additional contributors to program development include Elaine Dekker, Edgar Pierluissi, Annelie Nilsson, Elizabeth Adviento, and Jaime Martin.Disclosures: Dana Freiser, Merjo Roca, Tony Chung, Tanvi Bhakta, Lisa G. Winston, and Gabriel M. Ortiz have nothing to disclose. Exhibit A: Pilot Unit PDSA Document. Exhibit B: Inpatient Vaccination Program Timeline