May 21, 2020
Elective Surgeries to Resume in New Jersey
On May 19, 2020, the New Jersey Department of Health (“DOH”) issued anticipated guidelines outlining the conditions for New Jersey hospitals and ambulatory surgery centers (“ASCs”) to resume elective surgeries and invasive procedures as of 5 a.m. on May 26, 2020, pursuant to Governor Phil Murphy’s recent Executive Order No. 145 (“EO 145”). Due to the decrease in the rates of confirmed COVID-19 spread, EO 145 permits hospitals and ASCs, subject to the DOH guidelines, to resume both medical and dental elective surgeries and invasive procedures that were suspended or delayed by the Governor’s prior Executive Order 109 initially issued in response to the COVID-19 pandemic.
The DOH guidelines outline the conditions and additional steps necessary for hospitals and ASCs to take in order to protect health care workforce and patients while resuming elective surgeries and invasive procedures. The following are some of the requirements that both types of facilities will need to address in order to resume such procedures:
- Compliance with State and CDC guidelines to protect against further spread of COVID-19;
- Screening of health care staff for symptoms of COVID-19 and have policies in place for removal of symptomatic employees from the workplace;
- Enforce social distancing in work areas and common areas, which may require that the physical layout and flow of care delivery areas change;
- Require masks for patients (except patients receiving services that would not allow for the use of a mask) and for any patient support person;
- Establish a plan for cleaning and disinfecting prior to using facilities to serve non-COVID-19 patients;
- Prohibit visitors except for limited circumstances, which includes labor and delivery and pediatric patient surgery; and
- Test each patient no more than 96 hours before a scheduled procedure with a preoperative COVID-19 RT-PCR test to ensure COVID-19 negative status and counsel patients to self-quarantine following testing until the day of surgery.
Hospital Specific Requirements
Hospitals must ensure that they have available and adequately staffed Intensive Care Unit (“ICU”), Critical Care and Medical Surgical beds to meet capacity needs and they must cohort COVID-19 patients and non-COVID-19 patients. Importantly, in order to resume procedures, hospitals must have a sustained downward trajectory for 14-days, with each day’s data calculated using the average of the three most recent days based on the following:
- Influenza-like illness or COVID-19 like illness;
- COVID-19 Infection rates;
- COVID-19 Hospitalizations;
- COVID-19 Emergency room admissions;
- COVID-19 ICU, Critical Care and Medical Surgical bed use;
- Ventilator use; and
- Ventilatory availability.
Hospitals will also need to establish a prioritization policy for providing care and scheduling procedures and all cases must be reviewed by a site-based governance group to ensure consistency with such policies. The governance group should model capacity based on extended turnover, spacing out of procedures and any pre-procedure or post-procedure appointments. The DOH guidelines further require the governance group to consider the following guidelines for prioritization:
- Level 1 - Lifesaving/critical: less than 72 hours will result in substantial health decline or death;
- Level 2 - Urgent/intensive: less than 30 days will result in substantial health decline or irreversible negative health trajectory;
- Level 3 - Essential/acute: will result in substantial health decline or irreversible negative health trajectory or irreversible deterioration;
- Level 4 – Selective: minor or major surgery with health impact but may be safely delayed for a period of time; and
- Level 5 – Optional: surgery with minimal health impact.
Hospital patients who test positive for COVID-19 can only receive Level 1, Level 2, and Level 3 procedures.
The DOH guidelines require that health care workers treating COVID-19 positive and presumptive patients have appropriate training on, and access to, appropriate Personal Protective Equipment (“PPE”) and that hospitals have a plan, consistent with CDC and DOH recommendations, for patient and patient support person use of PPE. Hospital policies for PPE should account for: 1) adequacy of available PPE supply, with a minimum seven (7) day supply on hand; 2) staff training on and optimized use of PPE according to non-crisis standards of care; and 3) the conservation of PPE and for any extended use or reuse of PPE per CDC and DOH recommendations and FDA emergency use authorizations. Such COVID-19 PPE policies and procedures must also be in place for health care workers who are not in direct patient care roles (i.e. front desk registration, schedulers, environmental cleaning, etc.).
In order to prepare for the potential for a second wave of COVID-19 infections in New Jersey, hospitals need to implement a strategy for responding to surge needs in the future and continue to collect and report 1) COVID-19 case counts; 2) Non-COVID-19 case counts; and 3) capacity data.
Ambulatory Surgery Center Specific Requirements
The DOH guidelines for resumption of same-day ambulatory surgical and invasive procedures are similar to those for hospitals, except that the guidelines prohibit ASCs from performing procedures on COVID-19 positive patients and the DOH has not provided a Level 1-5 prioritization framework for ASCs. In addition, to prepare for a potential second wave of COVID-19, each ASC must confirm that it has a transfer agreement in place with an acute health care facility partner and confirm and document before each surgery day that its acute health care facility partner has appropriate number of ICU and non-ICU beds to support its potential need for emergent transfers, PPE, ventilators, medications, and trained staff to treat all patients. Further, the hospital that the ASC has a transfer agreement with should have the downward trajectory calculated using the average of the three (3) most recent days of the capacity data indicated above for hospitals.
New Jersey’s COVID-19 crisis has had a severe financial impact on many hospitals and ASCs, largely due to the suspension of elective procedures. While facilities are understandably eager to resume elective surgeries and invasive procedures, they should not act hastily. It is imperative that health care facilities review the guidelines in their entirety and implement the necessary requirements. Schenck Price’s Health Care Law Practice Group is available to help guide facilities with their compliance efforts.
DISCLAIMER: This Alert is designed to keep you aware of recent developments in the law. It is not intended to be legal advice, which can only be given after the attorney understands the facts of a particular matter and the goals of the client.