Two questions were posted on an American Health Law Association listserv as follows: “Not all hospitals and ASCs are testing patients before surgical procedures. What is the standard of care? Are these facilities potentially liable for risk to health care providers and other patients?”. The questions are applicable to whether to test patients for COVID-19 symptoms for non-emergent, non-COVID-19 care or elective surgery or procedures in any health care setting—medical office, hospital or ambulatory surgery center. COVID-19 testing has generally not been available to individuals if they are asymptomatic for the disease.
This memorandum addresses the standard of care and liability risk issues by examining existing rules and recommendations from the federal government, professional associations and societies, and Texas state agencies.
Questions about the standard of care and liability risks relating to COVID-19 testing for non-emergent, non-COVID-19 care have arisen since the White House published Opening Up America Again: Testing Blueprint on April 16, 2020 stating the following Core Principle for testing plans to ”guide States as they develop and execute programs and plans that are tailored to their unique circumstances and challenges” for re-opening:
“Every symptomatic patient should receive a timely and accurate diagnostic test.”
CMS, CDC and Professional Associations and Societies Rules and Recommendations
In its announcement of April 19, 2020, the Centers for Medicare and Medicaid Services (CMS) issued recommendations for Re-Opening Facilities to Provide Non-emergent, Non-COVID-19 Healthcare. CMS recommends health care facilities establish Non-COVID Care (NCC) zones for screening all non-emergent patients for symptoms of COVID-19, including temperature checks. Staff should be routinely screened as would others who work in the facility (physicians, nurses, housekeeping, delivery and all people who would enter the area).
Sufficient resources should be available to the facility across phases of care, including personal protective equipment, healthy workforce, facilities, supplies, testing capacity, and post-acute care, without jeopardizing surge capacity.
CMS stated that the testing decision depends on whether there is adequate testing capacity in a state, locality or facility:
“Testing Capacity
- All patients must be screened for potential symptoms of COVID-19 prior to entering the NCC facility, and staff must be routinely screened for potential symptoms as noted above.
- When adequate testing capability is established, patients should be screened by laboratory testing before care, and Staff working in these facilities should be regularly screened by laboratory test as well.”
In the April 17, 2020 Joint Statement: Roadmap for Resuming Elective Surgery after COVID-19 Pandemic, the American College of Surgeons (ACS), American Society of Anesthesiologists, Association of peri-Operative Registered Nurses, and American Hospital Association recommend after the first wave of the pandemic is “behind us” the following for elective surgery:
Principle: Facilities should use available testing to protect staff and patient safety whenever possible and should implement a policy addressing requirements and frequency for patient and staff testing.
Considerations: Facility COVID-19 testing policies should account for:
a. Availability, accuracy and current evidence regarding tests, including turnaround time for test results.
b. Frequency and timing of patient testing (all/selective).
1. Patient testing policy should include accuracy and timing considerations to provide useful preoperative information as to COVID-19 status of surgical patients, particularly in areas of residual community transmission.
2. If such testing is not available, consider a policy that addresses evidence-based infection prevention techniques, access control, workflow and distancing processes to create a safe environment in which elective surgery can occur. If there is uncertainty about patients’ COVID-19 status, PPE appropriate for the clinical tasks should be provided for the surgical team.
c. Indications and availability for health care worker testing.
d. How a facility will respond to COVID-19 positive worker, COVID-19 positive patient (identified preoperative, identified postoperative), “person under investigation” (PUI) worker, PUI patient.
ACS issued its own recommendations in the publication Local Resumption of Elective Surgery Guidance on April 17, 2020:
DIAGNOSTIC TESTING: Know your COVID-19 diagnostic testing availability and develop operational testing policies for patients and health care workers.
- Know, understand, and update your local COVID-19 diagnostic testing capabilities and turnaround times. The testing availability will likely change during the ramp-up period. While it is to be hoped that availability is on the rise, some predict that availability may actually decrease as the community testing demands increase.
- Develop local diagnostic testing policies for patients. Rapid testing for COVID-19 infection through real-time reverse transcription polymerase chain reaction (RT-PCR) testing may be considered for all patients undergoing planned surgery, or for selected patients after screening with or without mandatory preoperative quarantine. The prevalence of asymptomatic/pre-symptomatic patients is unknown, but likely varies according to the pretest probability, i.e., prevalence of disease in the community. Surgeons should be involved in institutional policymaking since the risk to the patient and the staff varies with the type of procedure, the patient’s condition, local circumstances, and over time. Some surgeon discretion is necessary and should be permitted.
- Develop diagnostic screening testing policies for health care workers. With near-future reversal of physical distancing, local incidence may increase, including among health care workers. As ramp up proceeds, screening and testing policies and planning for staff should be considered.
- Consider false negative test rates and need for retesting. False negatives have been reported as high as 30 percent. Guidelines for potential retesting in negative patients might be considered. A particular challenge to health care worker safety is our current lack of under-standing of duration for transmissibility of the virus in either asymptomatic COVID-19-positive patients or individuals who have recovered from a COVID-19 illness. There is evidence that even after respiratory samples are negative in patients who have recovered from a COVID-19 illness, viral RNA remains in the stool for >30 days. The clinical significance of fecal RNA is not well understood.
- Consider guidelines for postoperative COVID-19 testing of symptomatic patients/patients under investigation (PUI). Atelectasis, fevers, etc., are not uncommon in the postoperative course. Establishing operational guidelines for COVID-19 testing in these patients and concurrent testing results should be considered.
- There is not likely to be a highly sensitive and specific mass testing ability in the U.S. for at least several months. Therefore, reasonable alternative methods of determining risk versus benefit to the patient and public health in all facilities, inpatient and outpatient, will be required in the interim in order to continue the care of patients now waiting for surgeries previously delayed during the first phase of the pandemic. If optimal screening/testing is unavailable locally, implementation of such alternative screening methods is a local decision and should be done in conjunction with local public health officials.
The Centers for Disease Control issued Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19), updated May 3, 2020, with the following information, priorities and recommendations for COVID-19 testing of patients and staff:
PRIORITIES FOR COVID-19 TESTING
(Nucleic Acid or Antigen)
High Priority
- Hospitalized patients with symptoms
- Healthcare facility workers, workers in congregate living settings, and first responders with symptoms
- Residents in long-term care facilities or other congregate living settings, including prisons and shelters, with symptoms
Priority
- Persons with symptoms of potential COVID-19 infection including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat.
- Persons without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to: public health monitoring, sentinel surveillance, or screening of other asymptomatic individuals according to state and local plans.
“Clinicians considering diagnostic testing of people with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or work with commercial or clinical laboratories using diagnostic tests authorized for emergency use by the U.S. Food and Drug Administration.
Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Asymptomatic infection with SARS-CoV-2, the virus that causes COVID-19, has been reported. Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing) but some people may present with other symptoms as well. Other considerations that may guide testing are epidemiologic factors such as the occurrence of local community transmission of COVID-19 in a jurisdiction. Clinicians are encouraged to test for other causes of respiratory illness.
Other considerations that may guide testing are epidemiologic factors such as known exposure to an individual who has tested positive for SARS-CoV-2, and the occurrence of local community transmission or transmission within a specific setting/facility (e.g., nursing homes) of COVID-19. Clinicians are strongly encouraged to test for other causes of respiratory illness, for example influenza, in addition to testing for SARS-CoV-2. Another population in which to prioritize testing of minimally symptomatic and even asymptomatic persons are long-term care facility residents, especially in facilities where one or more other residents have been diagnosed with symptomatic or asymptomatic COVID-19.
SARS-CoV-2 can cause asymptomatic, pre-symptomatic, and minimally symptomatic infections, leading to viral shedding that may result in transmission to others who are particularly vulnerable to severe disease and death. Even mild signs and symptoms (e.g., sore throat) of COVID-19 should be evaluated among potentially exposed healthcare personnel, due to their extensive and close contact with vulnerable patients in healthcare settings.”
TEXAS RULES AND RECOMMENDATIONS
The Texas Medical Board requires that physicians post a “Notice of 22 TAC § 190.8(2)(U) Compliance Requirements for COVID-19 Minimum Standards of Safe Practices”. The Notice states all physicians providing patient care or engaging in an in-person patient encounter must implement minimum COVID-19 standards of safe practice including:
“ (II) Follow policies the physician, medical and healthcare practice, or facility has in place regarding COVID-19 screening and testing and/or screening patients;
(III) That, before any encounter, patients must be screened for potential symptoms of COVID-19 or verified previously screened within last 20 days;…”
Effective March 22, 2020, Texas Governor Greg Abbott issued Executive Order GA-09 concerning the postponement of surgeries and procedures, in certain circumstances, in response to the state of disaster declared in Texas and the United States relating to COVID-19. Effective April 22, 2020, Governor Abbott issued Executive Order GA-15 ordering all licensed health care facilities to postpone all surgeries and procedures that are not medically necessary to diagnose or correct a serious medical condition of, or to preserve the life of, a patient who without timely performance of the surgery or procedure would be at risk for serious adverse medical consequences or death as determined by the patient’s physician.
The Texas Health and Human Services Commission, Department of State Health Services (DSHS) in its May 11, 2020 publication DSHS Surveillance Case Definitions for 2019 Novel Coronavirus Disease (COVID-19) issued case classification definitions of Confirmed and Probable cases that may assist Texas health care facilities and professionals decide whether a COVID-19 diagnostic test is necessary for a non-emergent patient:
Confirmed: A case that is laboratory confirmed (detection of SARS-CoV-2 RNA in a clinical specimen using a molecular amplification detection test)
Probable: A case that:
- Meets clinical criteria AND epidemiologic linkage criteria with no confirmatory laboratory testing performed for COVID-19,
OR
- Using a method approved or authorized by the FDA or designated authority, meets presumptive laboratory evidence of o Detection of specific antigen (Ag) in a clinical specimen, OR o Detection of a specific antibody in serum, plasma, or whole blood indicative of a new or recent infection,
- AND meets either clinical criteria OR epidemiologic linkage criteria.
OR
Meets vital records criteria (death certificate lists COVID-19 disease or SARS-CoV-2 as a cause of death or a significant condition contributing to death) with no confirmatory laboratory testing performed for COVID-19.
Clinical criteria:
- At least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s); OR
- At least one of the following symptoms: cough, shortness of breath, or difficulty breathing; OR
- Severe respiratory illness with at least one of the following: clinical or radiographic evidence of pneumonia, or acute respiratory distress syndrome (ARDS)
AND
- No alternative more likely diagnosis
Epidemiologic linkage criteria:
One or more of the following exposures in the last 14 days before onset of symptoms:
- Close contact* with a confirmed or probable case of COVID-19 disease
- Close contact* with a person with clinically compatible illness AND linkage to a confirmed case of COVID-19 disease.
- Travel to or residence in an area with sustained, ongoing community transmission of SARS-CoV-2.
- Member of a risk cohort as defined by public health authorities during an outbreak (ex. symptomatic residents of a nursing home where at least one laboratory confirmed COVID-19 case has been identified).