“Point-of-care testing services are anticipated to surpass immunizations to drive revenue. Pressure from payers to detect high-cost diseases early will help speed up the growth of pharmacy-based diagnostic screening services. (https://www2.deloitte.com/content/dam/Deloitte/us/Documents/risk/us-risk-deloitte-retail-health-and-wellness.pdf)”
Over the past decade (and even the last year), we have seen many changes in Community Pharmacy, especially in the clinical arena. Many National Pharmacy Organizations are promoting Point-of-Care Testing (POCT) in Pharmacy, and many Pharmacies have started to add POCT to their clinical and collaborative practice offerings. This push makes sense, especially as we see the continued assault on Pharmacy with dropping reimbursements and draconian audit tactics. Pharmacy needs to be looking for additional revenue sources that align with traditional Pharmacy services, thus showing the added value your Pharmacy can have to your patient and the prescriber community (i.e., Immunization, MTM, CPA, POCT, and other services).
You will need to set up your Pharmacy to provide POCT effectively. Some considerations are privacy, storage, environmental control, disposal, and infection control.
When starting a service like POCT, you need to consider the overall actions you will perform and make sure the patient is comfortable. This includes ensuring the patients have a place to sit and be supported (have armrests), and the patients are comfortable with the privacy afforded. There is no need to construct a new room; most Pharmacies are putting up room dividers or curtains to separate the testing area from other areas of the Pharmacy. You will also be creating patient records with Protected Health Information (PHI), so you will need to make sure all records with PHI are maintained according to HIPAA.
Storage and Environmental Control
When performing POCT, you will notice many items you need to manage (i.e., testing kits, machines, reagents, equipment, PPE, cleaning supplies, and other supplies). Some of these items will be temperature-sensitive, such as reagents, and require specific room temperature ranges or even cold storage. And you will have items like reagents and testing kits that expire and change periodically over time. The testing kits and machines may also have their temperature requirements to ensure optimum performance and accuracy. This will require that you monitor the temperature when you receive inventory to ensure the previous storage conditions are the same. Occasionally, the storage requirements of a reagent or testing kit may change as the manufacturers change the formula.
Note: One of the first things to do when looking into starting POCT or even adding a new test to your existing POCT Services is to review the storage requirements of testing devices, machines, reagents, and other necessary chemicals and supplies.
Disposal, Cleanliness, and Infection Control
Your Pharmacy employees, patients, and the environment will potentially be exposed to infectious material, whether blood or other bodily fluids. Because of this, you will need to make sure your Pharmacy has a Bloodborne Pathogen Exposure Control Plan and that your employees are trained on your Plan (see our blog, “Does your Pharmacy Need an Exposure Control Plan?”). This Plan will provide employees with the necessary steps to clean the Testing area, wash their hands, wear PPE (we should all be experts at this now), and what to do when disposing of potentially infectious waste. Testing acquisition and lab areas need to have medical waste disposal receptacles to dispose of contaminated PPE, swabs, and other contaminated supplies, which is key to preventing accidental exposure to pathogens. This area will also need cleaning agents and supplies, including PPE, to effectively protect Pharmacy Employees from pathogens and chemicals (cleaning and disinfecting agents).
The unfortunate rule of thumb is that we need to use Universal Precaution by assuming all blood or other potentially infectious material (OPIM) is contagious.
POCTTrack and COVID-19 and BLOODBORNE PATHOGEN EXPOSURE CONTROL PLAN.
The POCTTrack program by PRS helps Pharmacies with the best practices and meeting any State requirements. The Program supplies you with the guidance, policies, procedures, and forms to set up the Pharmacy to provide Point of Care Testing. Additionally, the Program will give the questions you need to ask the State Agency responsible for Clinical Laboratories and the State Board of Pharmacy related to state-specific rules.
The COVID-19 and Bloodborne Pathogen Exposure Control Plan by PRS helps Pharmacies meet OSHA’s Bloodborne Pathogen Standards. The Program supplies you with the guidance, policies, procedures, template, forms, and employee training to ensure compliance.
Please give us a call at 1-800-338-3688 or visit our POCTTrack page and COVID-19 and Bloodborne Pathogen Exposure Control Plan page for more information.
See our previous blog, Point of Care Testing in Pharmacy, which talks about some of the ground steps related to obtaining your CLIA – Certificate of Waiver and contacting your State Agencies.