Is it strep or the flu? When they’re sick, your patients want the answer as soon as they can get it, and the shortage of primary care physicians makes you a logical, trusted, and easy alternative. Point-of-care testing hits a sweet spot for community pharmacists: market analysts predict it will eventually exceed immunizations as a revenue generator, and your patients are pleased to have a quicker route to relief when they’re feeling awful. So how do you get started?
Before deciding if you should provide point-of-care testing from a business perspective, discover if it’s legally possible. Probably most important is understanding that participation depends on the requirements of where you live, such as your state practice act, collaborative practice agreements, and any other state pharmacy board rules.
Research to make sure you understand the details that apply to you, including whether you’re allowed to give patients a prescription medication or otherwise treat them based on their test results. Also make sure your liability insurance covers properly done point-of-care testing and follow-up care.
The next stop is the CLIA waiver. To provide a little background, when a spate of deaths occurred in the 1980s following inaccurate lab test results, Congress passed the Clinical Laboratory Improvement Amendments (CLIA). However, some simpler tests with a low risk of inaccuracy are waived from the law’s requirements. You’ll need to apply for a CLIA waiver with the Centers for Medicare & Medicaid, which provides the information for doing so. Also note that in addition to completing a CLIA waiver, you’ll have to pay certificate fees regularly.
Now think about business. Millions of annual cases of influenza and acute pharyngitis, and millions of people needing Hepatitis C, HIV, or diabetes screening, make for compelling numbers. But again, the real question is how it applies to your pharmacy. Ask yourself:
The step-by-step of exactly how you’ll do the testing in your pharmacy should be completely thought through. Ask yourself questions about even the “obvious” things:
Other big considerations are:
The federal government doesn’t have qualifications for people who administer CLIA-waived tests, but your state might. Either way, employees who’ll be doing testing should be thoroughly trained. That means deciding on training requirements, protocols, and paperwork — who’s going to do what and when, and how you’ll keep a record.
CMS guidelines address how CLIA-waived tests are to be handled. You must calibrate and administer tests according to the manufacturer’s instructions, and other safety regulations must be followed. Luckily, if you’re already providing vaccinations, you should have a leg up with safety procedures regarding needles and blood-borne pathogens.
No surprise that you’ll need to keep records —from start to finish. This means documenting each test result. You’ll also need to record what happened based on the results: what products you recommended to the patient or, if you’re allowed to in your state, what prescription you dispensed.
With all that said, sometimes there’s no substitute for experience, so talk to people who’ve gone before you. In this era of pharmacists as care providers, more of your colleagues will be ready to diagnose what point-of-care testing does for their patients and their business.
