Point-of-Care Testing 101: Get Started Today

Point-of-care testing can be profitable, but there are steps pharmacists must take to ensure that their pharmacy is eligible to offer these key services to their community.

There are 4 main goals for POCT: identify disease, improve access to care, monitor parameters for different disease states, and modify patient behaviors. During a presentation at the National Community Pharmacists Association 2022 Annual Convention & Expo, held October 1 through 4 in Kansas City, Missouri, Matthew J. Meyer, PharmD, owner and pharmacist in charge at Hospital Pharmacy West discussed these goals, as well as the ideal POCT site characteristics, which can be broken down into 6 separate categories.

These categories are accessibility without a scheduled appointment; extended hours of availability; staff that is proficient in sample collection, preparation, and operation of analyzers; qualified providers to interpret results in context to patient history; immediate access to prescription and OTC therapies; and prompt reporting and follow-up with patients, providers, and other required agencies.

Pharmacies, Meyer said, are great point-of-care testing sites because they typically already possess the 6 categories that make for a great point-of-care testing site.

“Key partnerships in the point-of-care testing game, you can have those pharmacy wholesalers, your state associations, physicians are all going to be huge vitals for us in order to be more successful for your testing programs,” Meyer explained.

Pharmacy wholesalers provide things like analyzers, testing supplies, policies and procedures, required documentation, and personal protective equipment which provides turnkey solutions for point-of-care testing services in the pharmacy. They also provide access to education and training materials.

Prescriber collaboration is essential, Meyer added. Primary wholesalers may have a physician on protocol, or may be able to help with physician outreach. A collaborative practice agreement is a formal agreement that allows the pharmacist to perform specific patient care functions. They may cover and individual or an entire pharmacy, and whether or not you need a collaborative practice agreement is up to the individual states’ statutes.

Collaborative practice agreements should contain the following:

• The purpose of the agreement
• The parties involved
• The patient population being treated
• The authorized care functions
• Pharmacist training and education requirements
• Liability insurance requirements
• The documentation plan
• The physician-pharmacist communication plan
• A quality assurance plan 
• The length of the agreement
• Record retention details
• How the agreement can be rescinded or amended
• Clinical references, and
• Signatures of parties involved.

Reimbursement for point-of-care testing depends on costs which can vary depending on suppliers and supplier contracts. Patients can pay through either a cash-based or insurance-based model.

“The FDA has a website that basically goes out and lists every single [Clinical Laboratory Improvement Amendments]-waved test that is available for purchase and use in the United States today,” Meyer said. “Once you’ve identified what tests that you want to offer for your particular area, your next step is to fill out your CMS 116 form, which is your application for CLIA waiver.”

A CLIA waver allows a non-clinical facility to utilize CLIA-waived tests. It costs $180 and the certificate is valid for 2 years.

Meyer also shared tips pharmacists should keep in mind before they start offering point-of-care testing, including reviewing current legislation and scope of practice; reviewing community market access and competition; establishing workflow; appointing a medical laboratory director;and reaching out to local providers to promote your new services.

Reference

1. Meyer, M. The Point of Care Testing Playbook. Presented at: National Community Pharmacists Association 2022 Annual Convention; October 1-4, 2022; Kansas City, MO.