key: cord-0053261-d6aqkgbz authors: Allen, Emily; Iyasere, Julia; Woo Baidal, Jennifer; Deland, Emme title: Covid-19 and Health Care Systems’ Need to Anticipate and Advocate for Essential Regulatory Changes date: 2020-11-24 journal: NEJM Catal Innov Care Deliv DOI: 10.1056/cat.20.0507 sha: bec38e18e457f3c946ca318a435006604f651b8f doc_id: 53261 cord_uid: d6aqkgbz The flood of executive orders and regulatory waivers has been critical in enhancing care delivery during the Covid-19 pandemic. Leaders at NewYork-Presbyterian cite the dual tasks of actively informing regulators of specific needs and also carefully implementing policies and procedures to build clinical teams and deliver care for patients. Changes in regulatory requirements allowed us to creatively modify facilities and expand our space capacity. On March 16, 2020 New York City Mayor Bill de Blasio announced an executive order for all New York City hospitals to suspend elective surgeries. 8 The state's governor issued a similar state-wide order on March 23, effective March 25.9 At March 22 press conference, the governor explained the aim of ending elective surgeries was to enable hospitals to increase bed capacity for Covid-19 patients by at least 50%, with a goal of doubling capacity. The New York State Department of Health (DOH) eased some restrictions to expedite this effort, including temporarily suspending certificate-of-need requirements for projects deemed necessary for Covid-19. With DOH granting emergency approval for these projects and suspending most visitation and all elective surgeries, we were able to focus on reconfiguring our spaces with out-of-the-box solutions. New regulations allowed for the creation of units that looked atypical but were still safe and effective ( Figure 1 ). NYP used creative ways to add space such as ICUs in procedural areas, and med/surg units in hospital cafeterias and athletic centers. A rapid expansion of our ICU footprint included redefining the ICU in its simplest form, focusing on the fundamental needs to create new spaces. We prioritized the essential elements to make these spaces safe, such as visibility, power, and oxygen. Our facilities, IT, biomed, and other teams went to great lengths given limitations in the procedural areas that were converted. In some cases, they installed windows, rewired units, put up heavy plastic curtains to separate patients and staff, or set up baby monitors when visibility was restricted. With the decline in procedural volume, due to the suspension of nonessential surgeries, NYP reconfigured select ORs, PACUs, and Cath Labs into ICUs ( Figure 2 ). With regulatory barriers relaxed, we quickly created approximately 200 ICU beds in OR, Ambulatory Surgery, Endoscopy, and Cath Lab procedural spaces during the first wave of the surge. More than 100 staff members from teams such as Facilities, Biomed, Operations, and Pharmacy, worked together to open a 12-bed ICU at the David H. Koch Center, an ambulatory care facility at our NYP/Weill Cornell campus, with plans to add at least 90 more beds if needed. Additionally, we partnered with former United States military medical and support personnel and Columbia University to establish the Ryan Larkin Field Hospital10 within the athletic multi-sport dome at Columbia's Baker Field. The 216-bed hospital was built within one week, and more than 130 patients with Covid-19 were cared for in the facility while it was open from April 14, 2020 to May 14, 2020. While NYP created additional space within our walls and field hospitals on our campuses, external field hospitals were difficult to utilize to create capacity. The Javits Convention Center and USNS Comfort were originally intended for non-Covid patients and, with strict admission requirements, we were unable to take advantage of those spaces. While most regulatory actions were helpful to the efforts to create space, the criteria and process surrounding these field hospitals run by federal entities was difficult for hospitals to navigate. Additional space and additional beds without the adequate staffing (such as physicians, nurses, and respiratory therapists) would have been a non-starter. New York State executive orders issued in March allowed us to temporarily expand our staffing in several ways." Additional space and additional beds without the adequate staffing (such as physicians, nurses, and respiratory therapists) would have been a non-starter. New York State executive orders issued in March allowed us to temporarily expand our staffing in several ways. First, retired New York State health care providers were allowed to return to practice. Perhaps most important, nurses, physicians, respiratory therapists, lab techs, and other clinicians licensed outside of New York State were allowed to practice in New York. New York generally does not participate in health professional compacts to permit reciprocity with other states regarding licensure. The state, for example, is not a member of the Interstate Medical Licensure Compact, which includes more than half of the U.S. states; legislation that would authorize the state to join the compact was being considered by a committee of the state Senate as of October 18, 2020.11 Additionally, individuals who graduated from registered or accredited medical programs located in New York in 2020 were allowed to practice without the need to obtain a license, so long as they were under the supervision of a licensed physician. The emergency orders also permitted physician assistants and specialist assistants to provide medical services appropriate to their education, training, and experience without oversight from a supervising physician. Additionally, an executive order dictated that health care professionals would be immune from civil liability for injury or death in the course of providing medical services in support of New York State's response to the Covid-19 outbreak, unless it was established that such injury or death was caused by gross negligence. These policies advanced our ability to supplement our existing health care providers with additional team members and redeploy staff more efficiently (Figure 3 ). " Adding volunteers to our team and redeploying staff was crucial to caring for the surge of patients. Patients admitted with Covid-19 often needed multiple interventions over an extended admission, with average length of stay between 14-21 days.12 To meet the prolonged clinical demands, clinicians whose typical responsibilities were postponed (e.g., elective surgeries and outpatient procedures) formed new specialized teams based on their expertise. Vascular surgeons performed line insertions. Orthopedic clinicians were dedicated to proning. Even with redeployment, ICU nurse staffing was one of the most challenging limitations to overcome during the surge. It was not until a large influx of travel nurses and volunteers from peer hospitals across the United States arrived, shortly after the peak, that we were able to comfortably staff the increase in beds across the system. NYP team members are grateful for the support from the volunteer physicians and nurses, and the flexibility displayed by our own staff was remarkable. Our ability to form these new teams with clinicians from across states, retired clinicians, and others who joined NYP to fight Covid-19, was essential during the surge. Even with redeployment, ICU nurse staffing was one of the most challenging limitations to overcome during the surge. It was not until a large influx of travel nurses and volunteers from peer hospitals across the United States arrived, shortly after the peak, that we were able to comfortably staff the increase in beds across the system." The first executive order on March 7, 2020, allowed for emergency medical personnel to provide telemedicine to facilitate treatment of patients in place. Additional orders allowed more providers to deliver care via telehealth. By supporting telemedicine, we were able to supplement our workforce and limit patients visiting our campuses by caring for them virtually, where possible ( Figure 4 ). " Given the demand for intensive care specialists as the surge progressed, we used an e-ICU model, called tele-ICUs, staffed by teams of volunteers from the University of Pittsburgh Medical Center (UPMC) and the Mayo Clinic at two of our hospitals.13 Intensivists at those institutions virtually supported on-site NYP teams by rounding daily using iPads on wheels and remotely monitoring patients' vital signs. This remote staffing support allowed us to expand our bed capacity into new ICU locations. We created a similar program for e-palliative care at our NYP/Columbia campus, using a virtual subspecialty consultation model staffed by out-of-state subspecialist volunteers from academic palliative care programs. These programs were possible given the increased support of access to telehealth. Virtualization also enabled communication between staff, patients, and families. Senior leadership conducted virtual rounds at each hospital to understand their experiences and concerns throughout the pandemic. Given that non-essential visitation in hospitals was suspended, we deployed iPads to allow patients to virtually connect to their families via Zoom and FaceTime. Regulatory flexibility is critical in preparing for a surge. Without the removal of regulatory burdens, we would not have been able to reconfigure our services to provide life-saving care to patients. • Creating relationships and building credibility with government leaders goes a long way. At the start of the pandemic, NYP leveraged existing relationships to share expertise, guidance, and communication tools with our elected officials to help them support their constituents. We developed 1-page documents on Covid-19 that could be shared with their communities as a trusted resource for Covid-19-related questions. The document directed questions to our hotline so the public had an easy-to-use source for the most recent information. This quick dissemination of reliable information strengthened the trust the officials had with our organization. We also communicated with officials, directly and through state and regional hospital associations, to advocate early for potential future challenges, such as the need for financial assistance. Consistent sharing of information through the associations and conversations with the governor and state regulators were effective to articulate our concerns and needs. Even in non-pandemic times, providing clinical expertise and support helps to shape and bolster our relationships with government officials. • Communicating with other systems makes learning and advocating easier and more effective. Sharing information through the associations and peer groups allowed us to align our goals and learn from one another. Organizing with other systems locally and across the nation allowed us to better advocate for regulation and respond to the pandemic. We participated in regular calls that industry associations organized for executives, government relations, and other teams across health systems to communicate. At the height of the surge, these calls occurred daily, and were an opportunity for us to share our experience with other hospitals that were preparing for a surge in their area. In the fall of 2020, as we prepare for another surge, we are developing processes to rapidly launch and standardize these information-sharing collaboratives to continue to have an opportunity to share best practices and learn from others. For example, as we have seen early warning signs of potential resurgence in our local area, communication forums increase in frequency to ensure timeliness of information. • Quick actions once regulatory changes are made is essential. Hospitals should waste no time taking advantage of the relaxed regulatory environment, and need to be flexible and adapt quickly to limitations. Every moment counts. Managing a health care system in a pandemic is a Herculean task but, with regulatory support, New York's health care systems were able to rapidly create capacity, build clinical teams, and care for patients. A retrospective review of the executive orders and regulatory relief during the pandemic is instructive as we prepare for resurgence and as other states consider effective Covid-19 response strategies. Looking ahead, we are prepared to leverage many of the successful strategies we developed during the first surge to expand our capacity. We are updating our emergency preparedness plans, including thinking through how to use spaces and structures we created during the first surge, and continuing to cross-train and prepare staff for redeployment. We also have a greater understanding of what regulatory changes would be most effective should another surge occur; and while there is uncertainty around what regulations may expire and what may stay long term, we continue to work with our associations to communicate needs with state and local governments. Our direct experience in this crisis has demonstrated that communication and education is extremely important as the Covid-19 pandemic evolves, and we will continue information sharing efforts among regulators, peer hospitals, and the public moving forward. New York City Confirms A Second COVID-19 Case Executive Order No. 202. Declaring a Disaster Emergency in the State of New York COVID-19 Data, Main Data Page, Daily Counts Conserving Supply of Personal Protective Equipment-A Call for Ideas Epidemiology, clinical course, and outcomes of critically ill adults with COVID-19 in New York City: a prospective cohort study Preliminary Estimate of Excess Mortality During the COVID-19 Outbreak Executive Order No. 202.69. Continuing Temporary Suspension and Modification of Laws Relating to the Disaster Emergency Executive Order No. 202.10 Continuing Temporary Suspension and Modification of Laws Relating to the Disaster Emergency When COVID-19 struck New York, this Ontario prof. began running a hospital staffed by special forces medics States Are Temporarily Letting Doctors Chase COVID-19 Across State Lines. Make it Permanent. Niskanen Center Innovative ICU Physician Care Models: Covid-19 Pandemic At NewYork-Presbyterian Rapidly Deploying Critical Care Telemedicine Across States and Health Systems During the Covid-19 Pandemic The authors would like to acknowledge the following for their leadership during the Disclosures: Emily Allen, Julia Iyasere, Jennifer Woo Baidal, and Emme Deland have nothing to disclose.