In order to increase testing in the state of Michigan Executive Order 2020-104 authorizes licensed pharmacists, physician assistants and nurse practitioners the authority to establish and administer a COVID testing service in the state, using FDA approved tests, without an additional state license or permit at any site. The EO also temporarily suspends regulations for strict compliance with the scope-of-practice, supervision and delegation provisions.
Licensees administering a COVID-19 testing service or testing laboratory shall comply with the following:
- Any specimen collected at a COVID-19 testing service shall be tested at a laboratory or entity in accordance with federal CLIA regulations as facilitated by the Department of Licensing and Regulatory Affairs. High-complexity tests, including PCR tests, must be tested at a laboratory that is CLIA certified. Waived tests, including rapid point-of-care diagnostic tests, must be tested at an entity that has obtained a CLIA waiver.
- The licensee shall provide personnel with any training necessary to operate a COVID-19 testing service.
- The licensee shall comply with any reporting requirements issued by DHHS.
- COVID-19 testing service personnel shall use proper personal protective equipment when administering and conducting specimen collection and testing.
- A licensee collecting specimens for testing who does not perform testing shall securely store specimens pending retrieval by the entity that will test the specimens.
- A licensee shall refer patients to appropriate medical providers for follow up, if not available through the entity conducting testing.
Note that unlicensed personnel working at one of these testing sites would have to be trained by the licensee, and can perform any of the tasks and functions of COVID-19 testing services, including screening of patients, observing self-swabbing, temporarily storing specimens pending transmittal to a laboratory, transmitting specimens to a laboratory, reporting test results to the Michigan Disease Surveillance System, and referring patients to appropriate medical providers for follow-up.