Since the beginning of the COVID-19 pandemic, the healthcare industry has been engaged in strategic initiatives to identify outbreaks and prevent the spread of the virus. The CDC, along with the Federal Emergency Management Agency (FEMA) and other agencies are currently working with local health departments to stand up venues to make vaccinations more readily available, especially in rural areas. Often, these agencies are working with healthcare providers, pharmacies, employers, faith-based organization, and others to accomplish their mission. Similar to mobile COVID-19 testing units, these mobile sites may be temporary pop-up sites, or may be on wheels—able to travel from place to place. As eligibility to receive the vaccine expands and as the vaccine supply increases, it will become increasingly important to make the vaccine readily available to all. While these efforts to make testing and vaccination broadly available and convenient may have a positive impact on regional prevention tactics, operating mobile vaccination and mobile testing units are not without risk.
A primary liability risk issue associated with mobile COVID-19 testing services is inadvertently establishing a physician-patient relationship. The point at which the physician-patient relationship is established is not always clear and absolute. It depends on the specific facts of each situation and in some cases, the jurisdiction in which the service is taking place. Once a relationship has been established, a physician has a duty to provide care until it is no longer necessary, or the relationship is terminated by one of the parties.
A preliminary consideration in the planning of mobile COVID-19 unit is determining the limitations of the services contemplated. For example, in a testing scenario, will you only be notifying individuals of their results; or will you be providing a more comprehensive service that includes interpreting results, diagnosing COVID-19, and/or recommending treatment? Any involvement with patients at a mobile unit beyond either vaccination, or collecting a specimen and delivering test results, most likely creates a physician-patient relationship. Consequently, if the plan is to provide additional services, non-patients should be treated as would any other new patient to the practice. If the plan is to provide limited services, such limitations should be clearly communicated.
Consider the following risk management recommendations when providing vaccinations or testing to non-patients with whom a physician-patient relationship is not contemplated:
- Inform the individual that testing for COVID does not establish a physician-patient relationship, which provides notice to the patient of your expectations and understanding.
- Results only to a non-patient: Clearly communicate what the encounter does and does not include.
- Inform the patient that your encounter does not establish a physician-patient relationship, which provides notice to the patient of your expectations and understanding.
- Refer individuals who do not have a primary care provider to the local medical society for assistance in finding a one.
- State clearly that the individual is responsible for following up with his or her primary care provider for treatment of symptoms.
- Document this process (including the individual’s understanding/consent).
- Provide the patient with a handout reiterating limitations of the relationship and patient responsibilities.
- Collect sufficient clinical and demographic information to comply with the standard of care and test result or vaccine reporting laws and regulations.
- See for example, COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115 and CDC COVID-19 Vaccination Program Provider Requirements and Support.
- Determine how you will retain non-patient records.
- Make sure that the testing or vaccine plan complies with federal and state laws.
- Become familiar with CDC reporting guidelines, such as those for reporting COVID-19 lab data, and vaccine administration, adverse events, and inventory; as well as state and local requirements.
- Follow all CDC infection control recommendations, including: Infection Control Guidance for Healthcare Professionals about Coronavirus (COVID-19), Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19, and Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).
- Have a plan for responding to a patient emergency.
- Inform the patient that your encounter does not establish a physician-patient relationship, which provides notice to the patient of your expectations and understanding.
Additional Resources
Vaccination
CDC: Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations.
Detailed guidance and recommendations for every phase of mobile vaccination, from planning activities to post-clinic considerations, including links to more resources, such as the Checklist of Best Practices for Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations, COVID-19 Patient Safety Checklist for these clinics, and a supply checklistCDC: Mobile Vaccination Resources
Materials to help jurisdictions set up mobile vaccination sites and expand their use as vaccine supply increasesTesting
HHS TRACIE: COVID-19 Drive-Through Testing/Community Screening Resources
Plans, tools, templates, and other immediately implementable resources to help with COVID-19 preparedness, response, recovery, and mitigation efforts, focusing on community-based testing sitesCDC: Overview of Testing for SARS-CoV-2 (COVID-19)
Guidance on the categories of viral testing and intended uses of testing for SARS-CoV-2 in light of additional testing capacity throughout the countryHHS: COVID-19 Pandemic Response, Laboratory Data Reporting: CARES Act Section 18115
Guidelines for reporting COVID-19 test resultsHHS: Frequently Asked Questions: Laboratory Data Reporting for COVID-19 Testing
NORCAL Group Resources
NORCAL Group Insureds can access information on the creation of a physician-patient relationship in NORCAL Group Risk Management Resource, “Establishing and Terminating the Physician-Patient Relationship,” and about test result follow up systems the “Follow Up” Risk Management Resource available through MyACCOUNT.
- Results only to a non-patient: Clearly communicate what the encounter does and does not include.