Point-of-care testing (POCT) presents a significant opportunity for community pharmacies to not only diversify revenue streams but also to play a more proactive role in patient care and public health initiatives. By establishing a robust Point Of Care Testing Program, pharmacies can become essential healthcare access points within their communities, offering convenient and timely diagnostic services.
Understanding the Point of Care Testing Program
At its core, a point of care testing program in a pharmacy setting is designed to deliver rapid and reliable diagnostic results directly at the patient’s convenience. These tests, conducted “at or near the point of care,” provide actionable insights within minutes, facilitating quicker diagnosis, monitoring, and management of both acute infections and chronic conditions. The integration of such a program allows pharmacies to extend their healthcare offerings beyond traditional dispensing services.
Key Objectives of a Pharmacy POCT Program
Implementing a point of care testing program should be driven by four primary objectives:
- Enhanced Disease Identification: Offering a range of tests enables the early and accurate identification of prevalent diseases within the community.
- Proactive Disease Monitoring: Regular testing programs can effectively monitor the progression of chronic conditions, ensuring timely intervention and adjustments to patient care plans.
- Positive Behavior Modification: Accessible testing services can encourage patients to take a more active role in managing their health, leading to healthier lifestyle choices and improved adherence to treatment.
- Barrier Reduction to Healthcare Access: Community pharmacies, with their extended hours and convenient locations, can significantly reduce geographical and logistical barriers to essential healthcare services, especially diagnostic testing.
Why Your Pharmacy is Ideal for a POCT Program
Community pharmacies are uniquely positioned to lead the way in point of care testing programs. They are already established as accessible, trusted, and frequently visited healthcare destinations within neighborhoods. This inherent accessibility, combined with the pharmacist’s expertise, makes pharmacies the perfect setting for expanding healthcare services through POCT. Early detection facilitated by pharmacy-based programs leads to quicker diagnoses and faster access to necessary treatments, potentially saving lives and improving overall community health outcomes. Furthermore, pharmacy-led POCT programs contribute positively to antibiotic stewardship by ensuring appropriate and timely use of antibiotics based on diagnostic evidence.
Industry research from Deloitte suggests that point-of-care testing is poised to become an even greater revenue generator for community pharmacies than immunizations, highlighting the significant financial and service potential of these programs.
Navigating Regulations and Compliance for Your POCT Program
The scope and permissible activities within a pharmacy-based POCT program are governed by state-level regulations. Pharmacists need to be well-versed in their state’s specific requirements to ensure full compliance. In some states, the regulatory framework even permits pharmacists to prescribe medications based on the outcomes of rapid diagnostic tests conducted within their POCT program.
State pharmacy practice laws delineate the extent to which pharmacists can engage in POCT services, specifying whether they are authorized to:
- Order laboratory tests as part of a program.
- Administer laboratory tests within the pharmacy setting.
- Interpret the results derived from POCT.
- Prescribe medications based on POCT results, where permitted.
The prerequisites for operating a POCT program can vary significantly from state to state. These might include the necessity for Collaborative Practice Agreements (CPAs) with physicians, the acquisition of specialized certifications such as Collaborative Practice Pharmacist Certification, or the establishment of detailed written protocols for testing and patient management.
Key Questions to Address Before Program Launch:
- Will patients require a doctor’s prescription before they can participate in POC tests offered by your program?
- Is a Collaborative Practice Agreement or specific Protocol needed to enable pharmacists to act upon test results within the program framework?
- What are the mandatory reporting requirements for test results to public health agencies or patient’s primary care providers?
To ensure your program is fully compliant and legally sound, it is crucial to seek definitive answers to these questions from your state’s regulatory bodies – including the State Pharmacy Association, the State Board of Pharmacy, and the State Health Department.
Essential Resources for Program Compliance:
Securing CLIA Waivers for Your POCT Program
Point-of-Care tests utilized in pharmacy programs generally fall under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 waived test category. Pharmacies intending to offer POCT services must secure a CLIA Certificate of Waiver. This waiver is specifically designed for facilities performing only waived tests, allowing “non-clinical” settings to conduct these simple laboratory examinations.
Before initiating the CLIA waiver application, it is essential to determine the specific tests your pharmacy plans to incorporate into its POCT program. A comprehensive list of CLIA-waived tests is readily available on the U.S. Food & Drug Administration website.
The application process involves completing the CLIA application form, CMS-116, and submitting it to the relevant CLIA State Agency contact based on your pharmacy’s geographical location.
In addition to obtaining the CLIA waiver, pharmacies are required to pay associated certificate fees biennially and must update their CLIA waiver whenever new tests are added to the program’s service offerings.
Valuable CLIA Resources for Program Setup:
Implementing Your Pharmacy Point of Care Testing Program Effectively
Successful implementation of a POCT program in your pharmacy requires careful planning and consideration of several key aspects.
Ensuring Legal and Liability Frameworks:
To mitigate liability, it is crucial to establish clear protocols for every POCT procedure conducted, covering each device used and each disease state tested. Most pharmacy liability insurance policies extend coverage to point-of-care testing services, provided that these are conducted within appropriate legal and professional practice standards. Strict adherence to manufacturer’s instructions for each test and full compliance with CLIA regulations are paramount. Pharmacies already offering vaccinations will have existing relevant policies in place for record-keeping, sharps safety, bloodborne pathogen protocols, and appropriate disposal of biohazardous materials, which can be adapted for POCT programs.
Strategic Business Plan Considerations for Program Sustainability:
- Location within Pharmacy: Where will POCT be administered to ensure patient privacy and efficient workflow?
- Test Menu: Which specific tests will be offered based on community needs and pharmacy capabilities?
- Competitive Landscape: What POCT services are already available from local healthcare providers and competitors?
- Target Market Identification: Who is the primary demographic for your pharmacy’s POCT program?
- Marketing and Promotion: How will these new services be effectively advertised to the target market?
- Staff Training Needs: What specific training will pharmacy staff require to proficiently administer tests and manage the program?
- Results Reporting Protocols: How will test results be communicated to patients, physicians, and relevant public health agencies in compliance with regulations?
- Patient Counseling Resources: What additional resources will be needed to provide effective counseling and support to patients receiving test results?
- Support Staff Deployment: How can support staff be optimally utilized to ensure the POCT service is sustainable and efficiently managed within the pharmacy operation?
Planning for Follow-up Patient Care:
- Will the POCT program include the provision of prescription medications based on test results, where legally permissible?
- Are collaborative practice agreements in place to allow pharmacists to manage patient care based on POCT findings?
Ideal Site Characteristics for a Successful POCT Program:
- Offer appointment scheduling to manage patient flow and minimize wait times.
- Provide extended operating hours to enhance accessibility for working individuals and urgent testing needs.
- Ensure staff are highly proficient in sample collection techniques and the operation of all testing devices used in the program.
Essential Program Implementation Resources:
Sourcing Supplies for Your POCT Program
POCT supplies can be procured directly from testing device manufacturers. Establishing relationships with multiple suppliers is advisable to ensure supply chain resilience and competitive pricing. Many pharmacy wholesalers also offer comprehensive programs that include POCT protocols, training resources, supply procurement, business guidance, and ongoing support to help pharmacies effectively implement and expand their POCT services.
Key POCT Supplies to Consider:
- CLIA-waived POCT Tests
- HbA1c and blood glucose monitoring
- Cholesterol screening
- Urine albumin testing
- Strep throat testing
- Mononucleosis testing
- Urinary Tract Infection (UTI) testing
- Tuberculosis purified protein derivative (PPD) test
- Sexually Transmitted Infections (STIs) testing (including chlamydia, gonorrhea, hepatitis, HIV, herpes, syphilis, trichomoniasis, genital warts)
Directory of POCT Device Manufacturers:
Revenue Generation from Your POCT Program
Many patients are accustomed to co-pays for POCT services at urgent care centers or physician offices. With average urgent care visits potentially costing patients over $100 (Debt.org), and a significant portion of individuals seeking POCT being younger adults without primary care providers or health insurance (Rand Corp), pharmacies are well-positioned to offer competitively priced cash-pay POCT services directly to patients. Alternatively, pharmacies can navigate the process to seek reimbursement from third-party payers.
Conducting a thorough market analysis to understand local pricing for POCT services is essential for setting optimal cash prices for your pharmacy’s program. It is also vital to account for all program-related costs, including staff training, testing supplies, and ancillary materials.
Typical Cost Ranges for POCT (Vary by Supplier and Test Type):
- Flu Antigen Test: ~$15
- Flu NAAT Test: ~$49
- Strep Antigen Test: ~$4
- Strep NAAT Test: ~$28
- COVID-19 Antigen Test: ~$16
- COVID-19 PCR Test: ~$60
- COVID-19 NAAT Test: ~$41
- RSV NAAT Test: ~$38
Additional Program Cost Considerations:
- Consumables: Testing supplies and Personal Protective Equipment (PPE)
- Marketing and advertising expenses
- Staff training and certification costs
- Potential test failure rates and waste management
- Quality control measures and documentation
For Medicare billing, pharmacies will need to engage with their designated Medicare Administrative Contractor (MAC) to enroll as an Independent Clinical Laboratory. Pharmacies already possessing a Provider Transaction Access Number (PTAN) will receive an additional PTAN for laboratory services. A comprehensive list of CLIA-waived testing manufacturers along with relevant CPT codes is available on the Centers for Medicare and Medicaid (CMS) website.
Companies Providing Medical Billing Support for POCT Programs:
Financial and Billing Resources:
Learning from Existing POCT Programs
Many community pharmacies nationwide are successfully operating point-of-care testing programs, improving patient access to essential healthcare services and enhancing their revenue streams. Exploring established programs can offer valuable insights and best practices.
Examples of Successful Pharmacy POCT Programs:
Further Resources for Program Development
To deepen your understanding and enhance your pharmacy’s point-of-care testing program, consider reviewing current literature and resources focused on community pharmacy-based POCT services. Explore companies that specialize in assisting community pharmacies with POCT program implementation and management.
Figueira, I., et al. Point-of-care HIV and hepatitis screening in community pharmacies: a quantitative and qualitative study. Int J Clin Pharm (2022).
Community pharmacy interventions to improve antibiotic stewardship and implications for pharmacy education: A narrative overview. Res Social Adm Pharm. 2019 Jun;15(6):627-631.
Additional Program Resources:
