Late Tuesday, the New Jersey Department of Health modified its previous guidance on the resumption of elective surgeries in ambulatory surgery centers. One of the most significant changes was to extend the time for COVID-19 testing. Under the initial guidance that was issued on May 19, 2020, patients had to undergo COVID-19 testing and receive results within four days before the scheduled surgery. However, many laboratories could not get COVID-19 test results back within that four-day period, thereby causing the cancellation of surgeries. The modified guidance extends the four-day period to six days.
The modified guidance also clarifies that the COVID-19 testing by a laboratory must be a nucleic acid amplification test and be either approved by FDA, authorized by the FDA through an Emergency Use Authorization, or approved by the New Jersey Clinical Laboratory Improvement Services as permitted by the FDA. The modified guidance makes clear that antibody testing may not be used to fulfill the COVID-19 testing requirement.
Surgery centers still cannot perform procedures on patients who test positive for COVID-19 unless, according to the modified guidance, it is excepted in Executive Order 109 as an “urgent case.”
Under the modified guidance, patients without COVID-19 testing can still have procedures performed if the procedure is time-sensitive and the health of the patient would be endangered if the procedure was delayed as long as (1) the physician documents that the patient’s health will be endangered if the procedure is delayed and (2) the surgery center follows certain infection control procedures set forth in the modified guidance.
Please visit Riker Danzig’s COVID-19 Resource Center to stay up to date on all related legal issues.