TABLE 2.

Considerations prior to utilizing a CLIA-waived POCT in a pharmacy

Element	Consideration(s)
CLIA-waived test	Is an appropriate CLIA-waived test available?
	Does the test have adequate performance characteristics?
	What types of specimens are required to perform the test?
Data sharing	How will data be shared with the patient, their primary care provider, and public health (if necessary)?
Education and training	Are staff trained to identify and manage patients with the diseases of interest?
	Are staff trained to collect the appropriate specimens required for the test?
	Have staff been trained to counsel patients on diseases of interest (e.g., HIV, HCV)?
Partnerships	Is a collaborative practice agreement required to provide follow-up care to patients?
	Has public health been consulted regarding reporting reportable diseases?
Patient follow-up	Has a plan been developed to check in with patients once they leave the pharmacy to ensure their safety?
Permissibility	Do state rules or regulations that may prohibit a CLIA-waived test from being performed in a pharmacy exist?
	Do state rules or regulations that prohibit the pharmacist from providing follow-up care to the patient based on the test results exist?
Physical space	Is an appropriate exam and testing space available?
	Is a private room required for counseling?
Sustainability	How will the pharmacy recover its investment in the service?