Point-of-care testing (POCT) in pharmacies has grown from A1C and cholesterol screenings to testing for infectious diseases such as hepatitis C virus. POCT by pharmacists for influenza and streptococcal pharyngitis infection has been especially well received, along with the ability of pharmacists in certain states to dispense needed medications when those tests come back positive. Because of ease of access, the community pharmacy is an ideal choice to provide this service. An example of how POCT can be implemented in the community pharmacy is demonstrated by eTrueNorth. This Texas-based company has partnered with numerous community pharmacies to help expand clinical services through Clinical Laboratory Improvement Amendments (CLIA)–waived POCT, wellness screenings, and preventive health services. The cofounders—Michael McEntee, a clinical laboratory professional, and Coral May, a registered nurse with health plan experience—used their vision of leveraging the most accessible health professional, pharmacists, to provide clinical services for patients. “Pharmacists’ education, training, and clinical knowledge are invaluable assets, and when combined with patient access, makes them uniquely positioned to meet the needs of a changing health care environment,” said May. POCT assays are waived under CLIA of 1988, and pharmacists who offer POCT must register with CMS as a CLIA-waived laboratory. More than 120 tests are considered CLIA waived. “CLIA-waived POCT allows pharmacists to provide patients with clinical information on the efficacy of their medications (e.g. statins, antihypertensives) as well as screening for undiagnosed conditions,” May added. The model is twofold. The first part focuses on working with pharmacy partners to help them establish CLIA-waived laboratories within the pharmacy. The second part focuses on contracting with organizations whose employees can benefit from clinical services provided in a pharmacy setting. Establishment within the pharmacy setting requires meeting regulatory compliance with national, state, and county (in California) requirements. May noted that her company provides guidance on the application process for a CLIA Certificate of Waiver, state laboratory license (if required), laboratory director requirements, and testing personnel requirements. “CLIA-waived POCT allows pharmacists to provide patients with clinical information on the efficacy of their medications as well as screening for undiagnosed conditions.” In addition, training is provided on all aspects of waived testing, from analyzer use to quality control requirements. Pharmacists have access to support via telephone from trained laboratory professionals if a question should arise while working in the pharmacy. Numerous organizations have partnered with eTrueNorth to offer their employees an alternative site for wellness screening. It is estimated that approximately 35% of eligible employees are unable to participate in a screening offered at their employer location and seek alternative testing sites. An organization’s employees can enter their zip code on the eTrueNorth website to search for participating pharmacies in their area that provide the list of services they need, such as a lipid profile, glucose, and administration of flu shots or common vaccines. After selecting their preferred location, the patient receives a voucher with details on the location they selected and any pretest instructions. The voucher allows for convenient access and payment to a pharmacy providing services. Upon completion and documentation of the services, eTrueNorth bills the organization and reimburses the pharmacy partner for services provided. This model eliminates many of a pharmacy’s billing and reimbursement challenges. In the second half of 2020, eTrueNoth expects to launch programs to health plan members who have gaps in their recommendations for evidence-based care. For example, a plan member who has diabetes may not have had an A1C test to monitor their glycemic control or may need to have a dilated retinal exam to screen for retinopathy. “Working with the health plan and pharmacy partners, we’re able to catch the patient at the pharmacy counter and provide services to meet their needs,” said May. By working with the payer, the plan can improve the patient’s quality scores, provide the patient’s physician with information for clinical follow-up, and strengthen the role of the pharmacist as a critical member of the health care team. Expanded clinical services in the retail setting allow conversations between pharmacists and patients to be further enhanced by focusing on all aspects of health, from preventive medicine to medication adherence to improved clinical outcomes.
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