Cambridge Healthtech Institute’s Third Annual
Pharmacy-Based Point-of-Care Testing
Case Studies and Models for Sustainable POCT in Community and Retail Pharmacies
August 16-17, 2017 | Grand Hyatt Washington | Washington, DC
As more people have health care coverage, and cost and access are gaining focus, there is new thinking that point-of-care testing could be more widespread. One emerging setting for such testing is retail and community pharmacies. Pharmacists have been performing laboratory tests, such as glycosylated hemoglobin (A1C) and cholesterol screenings, for years. As consumers begin to see their local pharmacy, a place traditionally reserved for medications and greeting cards, as a stop for acute care and chronic disease management, there is a huge opportunity for growth. Cambridge Healthtech Institute’s Third Annual Pharmacy-Based Point-of-Care Testing will primarily focus on case studies showcasing sustainable POCT business models in community and retail pharmacies. The role of pharmacists in areas such as chronic disease management, strep and flu testing, antimicrobial stewardship, and population health will also be explored. Legal considerations will be discussed from state-to-state practice laws to pharmacy-based CLIA waivers and Collaborative Practice Acts. Overall, this event will bring together representatives from both diagnostics and pharmacy to continue planning a path forward.
Final Agenda
Recommended Short Course(s)*
SC3: Technologies, Applications and Commercialization of Point-of-Care Diagnostics
SC6: Rapid Diagnostics for Antimicrobial Resistance
*Separate registration required
WEDNESDAY, AUGUST 16
10:30 am Registration
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing
2:05 Chairperson’s Opening Remarks
Donald Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
2:10 Pharmacy-Based Point-of-Care Testing: Moving from a Pilot to a Sustainable Service
Donald Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
Community pharmacies have a long but limited history of providing CLIA-waived point-of-care testing (POCT) services. Much of the testing has taken place as part of small research or pilot programs. Based on the success of the pilots, pharmacies are expanding these services to a larger number of stores. This session will describe the current landscape of pharmacy-based POCT and the challenges of moving from a pilot to a sustainable service.
2:40 Innovative Clinical Services in Community Pharmacy: Pharmacogenetics and Precision Medicine
Edana Holliday, Pharm.D., Clinical Pharmacist, Community Ambulatory Care Services, Rx Clinic Pharmacy; Vice President, Communications, Pharmacogenetics Center of Excellence
Learn from community pharmacists providing innovative clinical services such as pharmacogenetic testing. One of the clinical pharmacists of the Pharmacogenetics Centers of Excellence will share successful business models that incorporate best practices for the clinical application and implementation and their journey on how they are making pharmacogenetic testing in a community and ambulatory care setting a reality.
3:10 Workflow Management of Point-of-Care Testing Services in Community Pharmacy
Suzanne Higginbotham, Pharm.D., BCACP, Director, Duquesne University Pharmacy
This presentation will be an overview of workflow management for point-of-care testing services in a community pharmacy setting. The speaker will seek to demonstrate the use of point-of-care testing within a medication therapy management framework and provide clinical pearls on the economic and clinical outcomes of providing these services within a community practice model.
3:40 Point-of-Care Testing in a Retail Health Environment
Alexander Sbordone, J.D., OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health
Healthcare consumers are increasingly visiting nontraditional settings for medical care. Retail clinics are exploring how Point-of-Care (POC) testing can deliver quality care to this population. This presentation will review the benefits and challenges of offering POC testing in a retail health environment. The discussion will cover the operational, financial and regulatory material that MinuteClinic considers when reviewing POC testing performed in our clinics. It will also contrast the differences we have discovered between testing in the clinic environment and in the retail pharmacy.
4:10 Refreshment Break in the Exhibit Hall with Poster Viewing
5:00 Positioning the Pharmacist in the Healthcare Delivery System: Piloting Point-of-Care Testing in the Community Pharmacy
Andrea G. Vastis, MPH, Senior Manager, Pharmacy Product Development, Patient Care Programs, CVS Health
CVS Health is committed to creating a path for accessible quality healthcare via community pharmacy by increasing access to clinical services, influencing the legislative agenda to promote expanded authority and working with payers to drive adoption of establishing the Pharmacist’s role in the healthcare delivery system. Our team piloted Flu/Strep Point-of-Care testing at Pharmacy to assess patient demand, determine impact to workflow and evaluate clinical outcomes. Essential processes and results of our work will be shared.
5:30 STUDENT COMPETITION
Cambridge Healthtech Institute’s Pharmacy-Based Point-of-Care Testing conference will play host to the Second Annual Disease Management at the POC Competition for pharmacy students during our event in Washington, DC, in August 2017. Our competition emulates the APhA Patient Counseling Competition and the ASHP Clinical Skills Competitions. For more information and for the local competition case and instructions, please visit www.nextgenerationdx.com/pharmacy-diagnostics/disease-management/
6:30 Close of Day
6:30 Dinner Short Course Registration
6:45- 9:15 pm Recommended Dinner Short Course(s):
SC15: Use of CLIA-Waived Point-of-Care and Rapid Diagnostic Tests in Community Pharmacies
*Separate registration required
THURSDAY, AUGUST 17
7:30 am Problem-Solving Breakout Discussions with Continental Breakfast
Bridging Pharmacogenetics with Community and Ambulatory Care Pharmacy
Moderator: Edana Holliday, PharmD, Clinical Pharmacist, Community Ambulatory Care Services, Rx Clinic Pharmacy; VP, Communications, Pharmacogenetics Center of Excellence
- Can preemptive pharmacogenetic testing help guide therapy?
- How can Pharmacogenetic testing be implemented into a community or ambulatory care pharmacy setting?
- How can patients use pharmacogenetic results as a tool to work with providers to improve therapy?
- How can pharmacogenetic results be integrated into Medication Therapy Management consults?
Point of Care Testing at the Pharmacy
Moderator: Andrea Vastis, MPH, CHES, Sr. Manager, Rx Product Development, Patient Care Programs, CVS Health
- Does patient care “break” the pharmacy work flow?
- How do we change patient/consumer perceptions of care at pharmacy?
- Who do we need to partner with to be successful?
- What services make the best sense?
8:25 Chairperson’s Opening Remarks and POCT Student Competition Winner Announcement
Michael Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
8:30 Community Pharmacists Can Effectively Provide POCT HCV Screening
Betty J. Dong, Pharm.D., FASHP, FAPHA, FCCP, AAHIVP, Professor, Clinical Pharmacy and Family and Community Medicine, University of California Schools of Pharmacy and Medicine
During a 3 month pilot, six community pharmacists performed 83 HCV-Ab POCT, with a 1.2% positive rate. Pharmacists attested to the feasibility of incorporating HCV screening into their routine pharmacy work. Two major barriers that pharmacists identified for implementing HCV screening included getting people to come into the pharmacy to perform the test and balancing the time required to receive test results within the normal pharmacy workflow
9:00 Promoting Good Point-of-Care Practices for Waived Testing Sites
Heather L. Stang, Deputy Branch Chief, Laboratory Practice Standards Branch, Division of Laboratory Systems, Centers for Disease Control and Prevention (CDC)
Laboratory testing is a critical part of health care, and ultimately, the public's health. Facilities in the United States that perform laboratory testing on human specimens for health assessment/monitoring or disease diagnosis, prevention, or treatment are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the CLIA regulations, facilities performing only waived tests are not subject to routine regulatory oversight or personnel requirements; but are only required to obtain a Certificate of Waiver (CW), pay biennial certificate fees, and follow manufacturers' test instructions. To assure the quality of laboratory testing under CLIA, CDC has been successful in developing and providing educational materials in an effort to protect and promote patient safety in the nation and beyond. In addition, by providing the material free-of-charge, all individuals and laboratory testing sites can access the information regardless of socioeconomic status.
9:30 Collaborative Practice Agreements (CPAs): Pharmacist-Physician Collaborative Working Relationships
Donald Klepser, Ph.D., MBA, Associate Professor, Pharmacy Practice, University of Nebraska Medical Center
Michael Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
This interactive presentation will describe the individual, context, and exchange factors that drive pharmacist-physician collaborative working relationship (CWR) development for community pharmacy-based point-of-care (POC) testing. Examples of CPAs will be provided and an extended Q&A period will allow attendees to get their state-specific questions answered.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Pharmacy-Based POCT: Legal Authority in United States
Alex Adams, Pharm.D., MPH, Executive Director, Idaho State Board of Pharmacy
This session will provide an overview of the legal landscape for pharmacy-based POCT examining both federal and state law. This session will discuss state variations in CLIA laws and Collaborative Practice Agreement laws.
11:30 PANEL DISCUSSION: Common Challenges for POCT in Community Pharmacy: Turning Barriers into Wins
Moderator:
Blair Thielemier, Pharm.D., Pharmacy Consultant, BT Pharmacy Consulting
- Reshaping patient expectations
- Space constraints
- Pharmacist vs. pharmacy techs
- Reimbursement and maximizing revenue
Panelists:
Edana Holliday, Pharm.D., Clinical Pharmacist, Community Ambulatory Care Services, Rx Clinic Pharmacy; Vice President, Communications, Pharmacogenetics Center of Excellence
Alex Adams, Pharm.D., MPH, Executive Director, Idaho State Board of Pharmacy
Betty J. Dong, Pharm.D., FASHP, FAPHA, FCCP, AAHIVP, Professor, Clinical Pharmacy and Family and Community Medicine, University of California Schools of Pharmacy and Medicine
Additional Panelists to be Announced
12:30 pm Sponsored Presentation (Opportunity Available)
1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:30 Session Break
2:00 Chairperson’s Remarks
Elena Grigorenko, Vice President, Research and Development, Diatherix, Eurofins Clinical Diagnostics, LLC
2:05 One Size Does Not Fit All – Individualized Approaches Are Needed to Optimize Rapid Diagnostic Test Impact and Integration into Stewardship Programs
Ritu Banerjee, M.D., Ph.D., Associate Professor, Pediatric Infectious Diseases, Vanderbilt University Medical Center, Director of Pediatric Antimicrobial Stewardship, Monroe Carell Jr. Children’s Hospital at Vanderbilt
The clinical impact of rapid diagnostic tests for infectious diseases is maximized when testing is integrated with antimicrobial stewardship interventions. The ideal approach to diagnostic testing and implementation strategies will vary between healthcare institutions, and will be based on local microbiology, prevalence of resistance mechanisms, laboratory workflow, antimicrobial prescribing patterns, and antimicrobial stewardship activities.
2:35 The Challenges of Rapid Diagnostics for Infectious Diseases, Is Anyone Paying Attention?
Nathan Ledeboer, Ph.D., Associate Professor of Pathology and Medical Director, Medical College of Wisconsin
Over the past few years, several point-of-care and near point-of-care molecular assays have been developed for detection of influenza and S. pyogenes. These new assays are CLIA-waived and offer the ability to perform testing during a physician office visit. However, few studies have evaluated the impact of rapid diagnostic tests on clinical decision-making. This session will evaluate the antimicrobial stewardship and outcome benefits of POC testing for infectious agents.
3:05 Using CLIA-Waived POCT for Outpatient Antimicrobial Stewardship
Michael Klepser, Pharm.D., FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
The White House has published a national action plan to combat antibiotic resistant bacteria. Central to the plan is the use of POC diagnostics. This talk will review the goal of the action plan and review data regarding the use of CLIA-waived POCT to improve antibiotic use in the outpatient setting. Areas of future needs will be discussed.
3:35 The Role of Molecular Diagnostics in Antibiotics Stewardships Programs and Challenges Associated with Implementation of Genotypic Assays for Detection of Multi-Drug Resistant Organisms
Elena Grigorenko, Vice President, Research and Development, Diatherix, Eurofins Clinical Diagnostics, LLC
Rapid molecular testing can offer a change in paradigm for susceptibility testing and can have a significant impact on patient care. The direct testing for genes associated with resistance to 4 major classes of antibiotics with a high-throughput PCR platform is a powerful screening tool that can be utilized in clinical settings to lower healthcare costs, reduce unnecessary antibiotic use, and improve patient care.
4:05 Close of Conference
4:30 Symposia & Short Course Registration
RECOMMENDED CONFERENCE SYMPOSIA:
Microfluidics and Lab-on-a-Chip Devices for POCT
Separate registration required
Rapid Critical and Urgent Care Testing
Separate registration required