Is it ok for pediatric practices to perform COVID-19 testing on their patients’ parents?

Yes, as long as you are limiting to only testing and not providing clinical advice. All providers need to understand if they ever cross over to offering clinical advice and something happens, the pediatrician would be held to the same standard of care as an internal medicine physician. There should be a documented protocol outlining the process and limitations. Both physicians and patients need to understand those limitations.

Curi, recommends the following action steps to mitigate risk:

• Develop a written protocol that outlines the steps to take and limitations of relationship,
• Follow protocol consistently by all providers,
• Understand the importance of not offering clinical advice and if you do offer clinical advice understand you will be held to standards of care same as Internist not a Pediatrician,
• Only offer testing for parents/guardians of established patients,
• Define when you would test a parent/guardian, for example, only after their child test positive,
• Educate the parent/guardian in purpose and limitations of test,
• Plan for managing patients (parents/guardians) who test positive,
• Decide and document the name of the physician test results will be sent for follow up, before you test the parent/guardian
• Have parent/guardian sign a release form to send test results to their physician for follow up
• Send all test results to the parent/guardians physician for follow up and treatment,
• Report results to health department for both child and parent,
• Have parent/guardian sign a limited relationship consent and acknowledgment form for COVID-19 testing
• Make sure you are using a test that has either EUA or FDA approval, and meeting all CLIA, FDA requirements, and State laws for testing based on your lab certification (see CLIA statement below)
• Decide on how you are going to document the encounter and limited assessment if required for testing
• Clearly document the limited relationship discussion between you and the parent/guardian
• Discuss work notices for parents who work in a public job. If a parent tests positive and needs any type of a work notice, they need to discuss this with whomever they choose to provide their treatment and follow-up care (typically their personal PCP). In addition, whomever treats the patient would be the clinician to provide clearance for returning to work. For post-illness return to work guidance, follow the CDC’s criteria for when patients can be around others and return to work.

Note: It would be appropriate for pediatric practices to provide work notices for parents whose children test positive and need to be quarantined at home with their child. See sample work notices.

CLIA Waived Testing and COVID-19 Testing Systems:

Physician offices that are certified for CLIA Waived Testing need to exercise caution when selecting COVID-19 testing kits or systems. Not all COVID-19 testing kits are approved as CLIA Waived Tests.  There are some COVID-19 testing systems which have not been granted an Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA) and therefore are categorized as a test requiring high complexity testing certification. Use caution, as we are seeing CLIA investigations and the issuance of threatening letters from CMS due to improper CLIA licensure.

The advice to practices is that if their laboratory currently has a Certificate of Waiver, they must use a COVID-19 test system that is waived or has been granted an EUA from the FDA. Do not rely on the information from a vendor or the company who made the test. Check the FDA website for the latest information and do your own due diligence. COVID-19 test systems that have not been granted an EUA from the FDA are categorized as a high complexity. In order to do high complexity testing, a physician laboratory must meet the CLIA requirements to perform high complexity testing under 42 C.F.R. §§ 493.1441 through 493.1495.

To stay up to date on the most current information for testing refer to CDC testing page.

Resource:

• FDA: FAQs on testing