Performing point-of-care testing at your pharmacy is a great way to bring in extra revenue and expand the services you offer to your patients. POC testing is even expected to “exceed immunizations as a driver of revenue for community pharmacies.”
There are several tests that the FDA has labeled as having “waived complexity” – simple, low-risk tests that can be performed without highly-trained laboratory personnel. These tests facilitate disease management and prevention through screening and monitoring at the point of care. Offering these tests at a pharmacy allows for improved patient outcomes by increasing the access and ease of getting tested.
It’s important to do research and know the logistics and legal requirements of performing POC testing at your pharmacy. Especially with COVID-19 testing currently in high demand, pharmacies are looking into setting up their stores as a testing site for their communities.
The FDA has a continuously updated database of analytes that are currently “waived” for use in point-of-care testing. Each analyte also lists the specific brands of test that are approved for that type of test.
Tests for SARS-Cov-2, the virus that causes COVID-19, have been granted emergency use authorization (EUA) by the FDA. This authorization results in the tests being deemed as CLIA-waived for use in a properly certified healthcare setting.
CLIA Certificate of Waiver
Before you perform any tests, your pharmacy must obtain a CLIA Certificate of Waiver. This certifies you to legally perform any FDA-waived tests. In addition to having a valid certificate, you must:
- Pay the certificate fees every 2 years as specified by your state
- Follow the manufacturer instructions for every test you perform
- Notify your state agency of any changes to your information
For step-by-step instructions on how to get CLIA certified, read our detailed guide with sections for each State Agency:
Training + Preparation
The next important step is figuring out the logistics of setting up POC testing in your store. Reference these resources for some more information on best practices and properly training your employees.
For ongoing patient care, remember to follow up with patients to manage disease or continue monitoring and prevention. This can even be incorporated into a care plan as a reminder to check a patient’s progress or identify preventative care opportunities.
Check out our blog on Point-of-Care Testing with PioneerRx to learn more.