Drive-through sample collection sites for COVID-19 testing are being implemented across the United States in an attempt to more efficiently screen individuals showing signs of the virus while simultaneously limiting exposure to the virus and easing the burden on emergency rooms and other urgent care settings. In the last week, the number of drive-through sample collection sites for COVID-19 testing has dramatically increased, in large part due to the rapid approval of new testing kits and, therefore, lab availability.
Drive-Through Sample Collection Considerations
It is important to highlight that these drive-through sites only provide sample collection, not on-site testing which implicates significant increased regulatory standards. Following sample collection, specimens must still be dispatched to a qualified clinical laboratory for analysis. Some drive-through collection points may be sending samples to state public health laboratories, whereas others are utilizing commercial laboratories or a combination of both based upon capacity constraints.
Accordingly, those planning to initiate drive-through testing programs need to ensure compliance with both federal and state-level regulatory requirements for each contemplated collection site, such as:
- Whether state law requires registration or licensure of the sample collection site, whether the site is a pharmacy, clinic, or even remote site (e.g., parking lot tents);
- Licensure and training requirements for personnel performing specimen collection;
- Diagnostic test manufacturer specimen collection and handling requirements; and
- Laboratory collection and sample processing requirements.
On top of the regulatory considerations discussed above, drive-through collection operators must also coordinate specimen collection with the requirements set forth by the diagnostic test manufacturers. Some test manufacturers, including clinical laboratories that have developed tests, may require drive-through collection sites to take specific precautions when collecting and transportation specimens, while others may only require that collection sites follow standard collection procedures. Manufacturers of COVID-19 tests may also mandate that any individuals collecting samples at a drive-through location complete certain training before collecting samples for a specific test.
As new tests are developed and marketed, drive-through collection providers should be prepared to comply with the guidelines established for the proper collection, storage, and transportation of specimens for testing. Doing so will help ensure the site’s safety and efficacy as well as the delivery of accurate testing results.
New Diagnostic Test Development
Expansion of sample collection capabilities is increasingly important in light of the obvious public health need and has been supported by the president’s March 13 Memorandum on Expanding State-Approved Diagnostic Tests (the “Memorandum”). This Memorandum directed the Secretary of Health and Human Services to work with “…additional States [that] request flexibility to authorize laboratories within the State to develop and perform tests used to detect COVID-19” and take such actions as are appropriate to facilitate those requests. The increased availability of testing labs means that sample collection sites will become increasingly feasible.
Subsequently, on Monday, March 16, the U.S. Food and Drug Administration (“FDA”) released its current thinking on the topic as Guidance for Commercial Laboratories, Commercial Manufacturers, and FDA Staff (the “Guidance”). In accordance with the Memorandum, this Guidance provides additional information related to accelerating the development of certain diagnostic laboratory tests for the virus that causes COVID-19. More specifically, the Guidance describes how states and territories that authorize laboratories within their jurisdiction to develop their own COVID-19 tests and perform specimen testing may do so without the need for an Emergency Use Authorization (“EUA”) submission to the FDA, a process discussed in greater detail here.
The Guidance further indicates that when a new COVID-19 test is developed under the authorities of the state in which the laboratory resides, and the state takes responsibility for COVID-19 testing by laboratories in its state, then the FDA will not require an EUA request and instead will exercise enforcement discretion regarding these tests despite their lack of validation data submitted to the FDA for premarket review. Note, however, that the FDA’s policy leading to an EUA remains unchanged from its initial guidance published on February 29, 2020.
Other Considerations
Despite the flexibility and convenience afforded to health care providers and patients via drive-through locations, any sample collection must be performed in conjunction with state and federal laws, including any handling and transportation guidelines from relevant regulatory agencies. The Centers for Disease Control and Prevention (“CDC”) has issued Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) (the “Biosafety Guidelines”). The Biosafety Guidelines provide that any personnel transporting confirmed or suspected COVID-19 patient specimens “must be trained to pack and ship according to the regulations and in a manner that corresponds to their function-specific responsibilities.”
In addition, operators of drive-through collection sites should carefully consider Interim Guidance for Healthcare Workers and Employers issued by the Occupational Safety and Health Administration (“OSHA”), in which OSHA sets forth guidelines for engineering controls, administrative controls, safe work practices and personal protective equipment to help protect health care workers who are exposed to the virus.
Practical Takeaways
As more COVID-19 tests are developed and approved for use, the demand for collection sites is likely to increase. A number of larger laboratory companies are not conducting sample collection due to the considerations referenced above, but others on the front line—including pharmacies, hospitals, clinics—will almost certainly need to going forward in order to meet patient demands while managing infection-control risks.
Hall Render attorneys are closely monitoring the regulatory developments related to drive-through collection sites, EUAs and clinical laboratory testing for the virus that causes COVID-19. Please contact any of the attorneys listed below or your regular Hall Render attorney if you have questions related to any of the regulatory or compliance considerations discussed above, and particularly if you plan to begin offering drive-through collection sites for COVID-19 testing.
- Todd Nova at 414-721-0464 or tnova@hallrender.com;
- Amy Poe at 919-228-2404 or apoe@hallrender.com;
- Andrew Harrison at 414-721-0467 or aharrison@hallrender.com; or
- Your regular Hall Render attorney.
The post COVID-19 Testing Update: Legal Considerations for Drive-Through Collection Sites, Diagnostic Testing Sites and Diagnostic Test Development appeared first on Law Firm | Health Care Law Firm in the USA | Hall Render.