A Quick Guide to CLIA Compliance for Pharmacies Offering Point-of-Care Testing
Over the last few years, pharmacies have stepped into a much bigger clinical role. They are administering vaccines, offering test-and-treat services, and becoming go-to destinations for basic healthcare. But with that evolution comes a key piece many still overlook: CLIA regulations.
If your pharmacy is doing any kind of diagnostic testing, even something as simple as a rapid flu test, CLIA matters.
What is CLIA?
CLIA stands for the Clinical Laboratory Improvement Amendments. These are federal standards enacted to ensure the accuracy, reliability, and timeliness of lab testing. The regulations apply to any facility that tests human specimens for health assessment, diagnosis, or treatment.
Pharmacies that want to offer basic diagnostic services need a CLIA Certificate of Waiver. This allows them to perform waived tests, which are simple tests with a low risk of error.
Some common waived tests include:
- COVID-19 antigen tests
- Influenza A/B tests
- Strep throat tests
- Blood glucose monitoring
- Lipid panels (in some formats)
Why It Still Matters
CLIA compliance is not optional. It is federally required. Operating without a valid CLIA waiver puts a pharmacy at risk of:
- Fines and citations from CMS or state boards
- Loss of ability to provide testing services
- Reputational damage and loss of patient trust
Beyond the legal risks, there is also the operational risk of not staying up to date. Test statuses can change. Scope-of-practice laws evolve. New technologies bring new regulatory considerations.
Navigating CLIA in Real Life
Here are a few key things every pharmacist offering testing should keep in mind:
- Know what’s considered a “waived” test
The FDA maintains a list of all CLIA-waived tests. If a test is not on that list, you likely need a higher-level certificate, which most pharmacies do not have. - Understand your state’s rules
Even if a test is federally waived, state laws might add extra steps. Some states require collaborative agreements for test-and-treat. Others limit pharmacist testing authority altogether. - Stay organized with renewals
CLIA waivers must be renewed every two years. It is easy to let it lapse, and that can halt your services immediately. - Document everything
From staff training to test logs to patient communications, good documentation supports both compliance and quality care.
Staying Informed Without Getting Overwhelmed
CLIA compliance is not something you can set and forget. It is part of running a modern, clinically focused pharmacy. Staying informed about both federal regulations and state-specific requirements is essential.
Whether you are checking CMS updates manually or following changes through a tool, the goal is the same. Make sure your pharmacy can serve your community without getting tripped up by preventable compliance issues.
Final Thoughts
The pharmacy landscape has changed, and testing is here to stay. CLIA regulations might feel like red tape, but they are designed to ensure patients receive safe, reliable care no matter where they go.
Need Help Keeping Track?
If you are managing multiple services, test types, or locations, tools like Bula can help you track CLIA waivers, stay up to date with state-specific regulations, and receive alerts when laws change. It is a practical way to keep compliance under control and out of your inbox.
Learn more about how Bula can simplify compliance for your pharmacy team.