Diagnostic Testing

The days are long gone when a pharmacist’s job consisted solely of dispensing and managing prescription medications. Your role today is much more holistic, thanks to a more rounded education.

Nowadays, patients can visit your independent pharmacy for numerous healthcare services, including immunizations, weight-loss programs, medication therapy management, and point-of-care (POC) testing. The latter has become significantly more important since the beginning of the pandemic, which raised consumer awareness of the role testing plays and encouraged them to take health care into their own hands. Patients are now taking advantage of rapidly developing technologies to track, diagnose, and manage their health.

The four primary goals of POC testing are behavior modification, disease identification, disease monitoring, and reduced barriers to care. POC testing produces reliable results within minutes to aid in the identification and monitoring of acute infections or chronic diseases. This data can be used to improve services, target marketing efforts, and identify potential business opportunities. And with the physician shortage across the nation, your pharmacy becomes more valuable while alleviating some of the burden on physicians and emergency rooms.

“From the pharmacies’ perspective, I think whenever you can provide a healthcare solution service that’s affordable, accessible, and appropriate, it builds loyalty to that pharmacy and builds your presence,” said Cheryl Miller, Vice President of retail sales and marketing at QuidelOrtho. “Pharmacists are already trusted in their community. Having the ability to bring testing in really gives your community more access points.”

When it comes to pharmacy-based POC testing services, what you’re allowed to do depends on state-level regulatory requirements. Your state determines whether you can order tests, administer lab tests, interpret lab test results, and prescribe medication based on the results of a lab test. The requirements for POC testing in pharmacies depend on where you live, and they may include collaborative practice agreements (CPA), additional certifications, or written protocols.

Be aware that when you begin trying to incorporate POC testing into your pharmacy, difficulties can arise. You first need to file for a Clinical Laboratory Improvement Amendment (CLIA) waiver. You can find a list of CLIA-waived tests by visiting the U.S. Food & Drug Administration website. You will then complete the CLIA application and mail it to your CLIA State Agency contact based on your pharmacy location. You also have to pay applicable certificate fees every two years and update CLIA waivers each time a new test is added to the workflow.

In addition to acquiring a waiver, policies and procedures are needed for training your staff, especially if you’re working in conjunction with providers. It’s also important to note that other healthcare providers may be resistant due to a lack of awareness or trust in your pharmacy’s service.

Community pharmacists across the nation are already offering POC testing services. But before you prepare your pharmacy to follow suit, several things should be considered. Ensure protocols are in place to prevent liability. They must define POC testing procedures for each device used and any disease state encountered. Follow manufacturer test instructions and obey CLIA regulations. If you’re providing vaccinations, you should already have policies in place.

Make sure you know where POC testing will take place in your pharmacy, what tests will be administered, what services local competitors are providing, what training your staff will need, whether patients will receive a prescription medication following test results, and so on.

Last but not least, if you really want your POC testing program to be successful, you will need patient referrals. Patient referrals are critically important to the success of POC testing in your pharmacy.

Opportunities for Your Independent Pharmacy

The growth of at-home diagnostic tests has given buyers better diagnostic knowledge. Capture market share by prepping for the future while considering the buyer. Here are a few ways to profit from this growing diagnostic trend:

Get ready for swift change:

Community pharmacies like yours can expand self-testing kits into additional offerings and further establish your expanding role in health care. Adaptation is key to adjusting quickly to a market facing amazing change.

Offer thorough solutions:

Patients who purchase a diagnostic solution often want to know more than whether they have a specific illness or disease. What they really want is to feel better. So, the most desirable solution would be a complete solution to the problem, including all elements, from diagnosis to treatment. For example, when you link testing and telehealth, you make it easy to get the counseling that’s needed. The more that you link at-home diagnostics to complete solutions, the more successful you’ll be in building your diagnostics revenue.

Provide more patient counseling and education:

You are well-positioned to give your patients valuable insights related to diagnostic testing through educational programs. This is an important part of effective at-home diagnostics usage. Inform your patients through one-on-one conversations, written material, and even large forums. Your pharmacy can build its diagnostics category business through counseling and education. This will get rid of confusion and help customers understand the tests, their results, and the next steps to take.

Try category management:

COVID-19 at-home diagnostic tests are the beginning of an expanded retail pharmacy category. A proliferation of at-home combined tests for COVID-19, flu, and RSV will be popping up soon, if they haven’t already. But where should they reside on the pharmacy shelves? An essential part of this emerging category will likely be multi-indicator tests for various disease types, such as respiratory illnesses or STDs. Your best bet regarding shelf space for at-home tests is to try a few different approaches. Set up a whole at-home testing section in one area, or try placing specific tests in condition-specific sections.

Helpful links:

Interested in learning how to obtain a CLIA certificate of waiver? This link is for you.


Looking for the list of CLIA-waived tests? Here’s your link:


From the Magazine

This article was published in our quarterly print magazine, which covers relevant topics in greater depth featuring leading experts in the industry. Subscribe to receive the quarterly print issue in your mailbox. All registered independent pharmacies in the U.S. are eligible to receive a free subscription.

More articles from the June 2023 issue:

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