Point-of-Care Testing

Pharmacists are dedicated to further improve access to quality care with physicians and other health care team members through research initiatives such as point-of-care testing, collaborative practice agreements, transitions of care and emergency medical response.

Pharmacists have unsurpassed access to patients. Additionally, with the number of newly-insured individuals increasing by several million, there is going to be additional stress on already strained primary care health providers. This places pharmacists in an ideal position to improve patient access to primary care through the expansion of clinical services.

In 1988, the Clinical Laboratory Improvement Amendments (CLIA) were passed in an effort to ensure the accuracy, reliability and timeliness of laboratory test results regardless of where the test was performed. Under these regulations, laboratories had to undergo a rigorous certification process in order to be able to perform tests on clinical specimens. However, an exception was created if a laboratory test could be performed with a minimal level of complexity and had a low risk of erroneous results. If these criteria were met, the manufactures of the test were allowed to apply for a CLIA-waiver. Approval of the CLIA-waiver application indicated that the test could be performed in a nontraditional laboratory setting if that site followed good laboratory practices and possessed a valid CLIA waiver. This includes pharmacies. Surprisingly, this one piece of legislation passed nearly 30 years ago to regulate clinical laboratories created one of the most significant opportunities for pharmacists to play a valuable role in advancing public health. Unfortunately, pharmacists have not yet taken full advantage of this legislation. Currently, there are more than 120 different CLIA-waived laboratory tests available in the U.S. Many of these tests can be performed without specialized equipment and provide results within 5-20 minutes. Imagine the impact a pharmacist could have in the care of a patient if they were able to quickly identify patients with treatable infections like influenza or streptococcal pharyngitis versus those whose symptoms were caused by a non-treatable etiology that required only symptomatic management.

Several challenges to the use of CLIA-waived rapid diagnostic tests and point-of-care testing have been identified, including maintaining familiarity with new tests on the market and establishing active care relationships with the patients and physician providers. 

In an effort to help pharmacists identify and overcome challenges such as those listed above, a certificate program on RDTs was jointly developed by clinicians, faculty from Ferris State University College of Pharmacy and the University of Nebraska Medical College of Pharmacy, and the Michigan Pharmacists Association. This program was created to fill knowledge and skills gaps that would hinder pharmacists from safely and effectively developing disease state management programs based on physical assessment of POC testing. The intent of the certificate program is to provide a refresher course for practicing pharmacists.

In addition, click on the black bars below to learn more about the Community Pharmacy-Based Point-of-Care Testing Certificate Course and Train-the-Trainer Program as well as upcoming offerings.

If you have any questions about MPA's upcoming programs or continuing education, please contact Cynthia Rowe, MPA office operations and building manager, at (517) 377-0222 or Cynthia@MichiganPharmacists.org.

If you have any questions about the National Association of Chain Drug Stores training program, please contact NACDS at (703) 549-3001. 

Certificate Course Information

Course Description 

  • WHO: This course provides community pharmacists and members of academia, industry and government with the skills necessary to develop and implement a collaborative testing program for influenza, Group A streptococcus, HIV and hepatitis C. 
  • WHY: There is a recognized need for community pharmacists to collaboratively improve patient access to care through the use of point-of-care tests. 
  • HOW: The course's 20 hours of continuing education (12 hours of home study and 8 hours of live training) will cover information on the targeted disease state, the physical assessment of a patient presenting to a community pharmacist, point-of-care tests and how to establish a point-of-care testing service. 
  • WHEN: Please visit the upcoming trainings webpage for more information. 

Certificate Course Agenda (Sample for 8 Hour Live Training) 

7:30-8 a.m. - Registration 

8-8:30 a.m. - Introduction and Use of Point-of-Care (POC) Tests by Pharmacists

  • Identify opportunities for pharmacists to expand their practice in the community setting through the utilization of POC tests. 
  • Summarize the prevalence and impact of various infectious diseases, including diabetes, dyslipidemias, influenza, Group A streptococcus, HIV and hepatitis C in the United States.

8:30-9:45 a.m. - Physical Assessment 

  • Discuss the value and limitations of various physical assessment procedures, including temperature, pulse, blood pressure, respiratory rate, pulse oximetry and physical inspection. 
  • Describe the procedures for conducting a systematic physical assessment and identify normal and critical findings. 
  • Interpret physical assessment data and recognize limitations of the data. 

9:45-10 a.m. - Break 

10-10:30 a.m. - Physical Assessment Competency 

  • Demonstrate the ability to appropriately collect a patient's temperature, pulse, blood pressure, respiratory rate and pulse oximetry. 

10:30-11:15 a.m. - Disease State Presentation and Patient Cases

  • Differentiate influenza, Group A streptococcus, HIV and hepatitis C from other disease states with similar presentations. 
  • Discuss the complications associated with influenza, Group A streptococcus, HIV and hepatitis C. 
  • Given a patient case, identify patients that may qualify for pharmacy-based POC testing by a pharmacist versus those that require immediate referral to a physician/provider. 

11:15 a.m.-12:15 p.m. - Specimen Collection 

  • Describe the process for collecting patient specimens, including throat swab, nasal swab, oral fluid and whole blood. 
  • Demonstrate the ability to correctly collect patient specimens, including throat swab, nasal swab, oral fluid and whole blood. 

12:15-1 p.m. - Lunch Break 

1-2 p.m. - Pharmacy Law and Risk Management 

  • Define CLIA. 
  • Explain CLIA-waiver and the process for becoming a CLIA-waived site. 
  • Recognize the procedures necessary for legal processing of CLIA-waived tests. 
  • List at least three risk management techniques to manage liability when conducting CLIA-waived tests. 
  • Search statutes and regulations to determine his/her state's requirements for pharmacist involvement in CLIA-waived testing. 

2-3 p.m. - Developing and Implementing a POC Testing Service  

  • Discuss specific strategies for designing and implementing a successful pharmacy-based POC testing program. 
  • Explain how to bill for POC testing using the appropriate CPT codes. 
  • Document services in a manner appropriate for evaluating patient progress, sufficient for billing purposes, and that facilitates tracking clinical and financial outcomes. 

3-3:15 p.m. - Break 

3:15-4:15 p.m. - Test Utilization and Interpretation 

  • Given the performance characteristics of a test (e.g., sensitivity, specificity, percent agreement, etc.), determine the reliability of the test in a community pharmacy setting.
  • Identify ways for community pharmacists to maximize the reliability of a given diagnostic test. 
  • Discuss some limitations to utilizing POC tests in the community pharmacy setting. 
  • Recognize common missteps in POC test processing and interpretation that could lead to incorrect results. 
  • List the steps a pharmacy can take to ensure compliance with Good Laboratory Practice (GLP) standards. 

4:15-5:15 p.m. - POC Cases and Proficiency Assessment 

  • Identify clinically unstable patients who should be immediately referred to the appropriate source of care. 
  • Provided a patient scenario, make recommendations for the use of POC tests. 
  • Collaboratively develop a patient care plan based on medical history, physical assessment data and results of POC tests. 

5:15 p.m. - Adjourn 

Certificate Course Home-Study Module (12 hours) 

Introduction

  • Recognize the need for pharmacist intervention in the community setting to improve patient access to medical care through the use of point-of-care tests. 
  • Summarize testing recommendations for influenza, Group A streptococcus, HIV and hepatitis C. 

Target Disease States 

  • Describe the transmission and pathogenesis of influenza, Group A streptococcus, HIV and hepatitis C. 
  • Identify patients at high-risk for acquiring and experiencing complications related to influenza, Group A streptococcus, HIV and hepatitis C. 
  • Summarize the time course of influenza, Group A streptococcus, HIV and hepatitis C infections. 
  • Discuss the management options for a patient with influenza, Group A streptococcus, HIV and hepatitis C infection.
  • List important counseling points for prescription medications used to treat influenza, Group A streptococcus, HIV and hepatitis C infections. 

Physical Assessment 

  • List common signs and symptoms of influenza, Group A streptococcus, HIV and hepatitis C infections. 
  • Describe the steps involved with the physical assessment of a patient presenting to a community pharmacy with an ongoing infectious disease.

POC Tests 

  • Recognize how POC tests differ from the historical "gold standards" for diagnostic testing. 
  • Define the terms sensitivity, specificity, positive predictive value and negative predictive value. 
  • Describe how POC tests may be utilized in the community pharmacy setting as part of innovative practice models. 
  • Explain what it means for a diagnostic test to be CLIA-waived and what is required in order to use CLIA-waived POC tests in the community pharmacy setting. 

POC Tests in Practice 

  • Outline the process and key considerations of making a pharmacy-based infectious diseases management program operational and integrated with existing services. 
  • Explain the legal, regulatory and liability issues involved in offering a pharmacy-based infectious diseases management program. 
  • Discuss important considerations in documenting, marketing and obtaining compensation for a pharmacy-based infectious diseases management program. 
  • Identify measures to track the economic, clinical and humanistic outcomes for a pharmacy-based infectious diseases management program. 

Home Study Competency Assessment 

  • Online multiple-choice assessment.

Program Developers

This program, conducted by the National Association of Chain Drug Stores, is based on a Michigan Pharmacists Association (MPA) educational program entitled Community Pharmacy-Based Point-of-Care Testing, originally developed by:

  • Allison Dering-Anderson, Pharm.D., RP, is the community pharmacy specialist on faculty at the University of Nebraska College of Pharmacy. She is one of the developers of a Point of Care Testing Certificate program, training pharmacists to conduct point of care testing and provide follow-up care. Dr. Ally lectures in Pharmacy Law & Ethics, Immunizations, Pharmacotherapy, Pharmacy & Health Care, and Pharmaceutical Care, all with a focus on community pharmacy. Dr. Ally coordinates both the OTC Products elective and the Point of Care Testing elective. Dr. Ally has been a guest on the Digity radio show “Problems and Solutions” for over 17 years. This live, call-in radio show is hosted by Cathy Blythe, a 2-time Marconi winner, and broadcast on 9 mid-west radio stations.

  • Paul Dobesh, Pharm.D., FCCP, BCPS, Bachelor of Science in Pharmacy from South Dakota State University. Two year add-on Pharm.D. degree also from South Dakota State University. Internal Medicine Specialty Residency with the University of Texas at Austin at Brackenridge Hospital. Currently Associate Professor of Pharmacy Practice with the University of Nebraska Medical Center in Omaha, Nebraska. Currently maintains clinical practice with internal medicine and cardiology services at Nebraska Medical Center. Responsible for teaching pharmacy and medical students as well as pharmacy and medical residents and lectures in the area of ischemic heart disease, antithrombotic therapy, and other cardiology and critical care topics. Dr. Dobesh has conducted research on antiplatelet and antithrombotic therapy, focusing on real-world utilization and health-economics. He has also published book chapters and several manuscripts in this area. Dr. Dobesh was awarded the “Distinguished Educator or the Year” award at the University of Nebraska Medical Center College of Pharmacy in 2012, an award he has received 3 times since 2007. In 2013 he was also awarded the University of Nebraska Medical Center campus wide Outstanding Educator Award.

  • Mary Farrington, CMP, is Director of Continuing Education at Michigan Pharmacists Association and oversees all educational activity offerings for the Association.

  • Donald Klepser, Ph.D., MBA, is associate professor of pharmacy at the University of Nebraska Medical Center College of Pharmacy. He has PhD in Pharmaceutical Socioeconomics from the University of Iowa, an MBA from the University of Minnesota’s Carlson School of Management, and a Bachelors degree in Communications from the University of Michigan. He has studied the use of POC testing in community pharmacies for the past 7 years and is currently the primary investigator on grants to develop community pharmacy practice models for managing diseases such as HIV, diabetes, hypertension, influenza, and group A Streptococcus. He is also the primary investigator on grants to better understand how state and local health departments perceive the role of pharmacists conducting POC tests.

  • Michael Klepser, Pharm.D., FCCP, is Professor of Pharmacy Practice at Ferris State University College of Pharmacy. He received his Doctor of Pharmacy from the University of Michigan College of Pharmacy in 1992. He has also completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in infectious diseases at Hartford Hospital in Hartford Connecticut. Dr. Klepser has held academic appointments at the University of Iowa and most recently at Ferris State University where he has held the rank of professor since 2001. Dr. Klepser has studied numerous pharmacy-based CLIA-waived POC screening programs for influenza, group A Streptococcus, HIV, and HCV over the past 10 years. He has also been instrumental in expanding educational opportunities for pharmacists in the area of CLIA-waived POC tests and collaborative disease management programs.

  • Stephanie Klepser, Pharm.D, has been the Director of Clinical Services at OptiMed Pharmacy (formerly MSU-KCMS Pharmacy) since January 2010. In this capacity, she has had direct responsibility for developing and implementing a number of innovative pharmacist-run clinical programs including a comprehensive travel health clinic, child and adult immunization services, and specialty programs for Hepatitis C and a number of autoimmune diseases. Since 2007, Dr. Klepser has been actively involved with several research protocols evaluating the use of rapid diagnostic testing in community pharmacies for diseases such as influenza, group A streptococcus, and HIV. Through these projects she has gained experience and expertise in providing pharmacist training and education, as well as project management and implementation in the community pharmacy setting. Dr. Klepser earned her Doctorate of Pharmacy with Highest Distinction from Ferris State University in 2007 and subsequently completed her post-graduate pharmacy practice (PGY1) residency at Northwestern Memorial Hospital, Chicago, Illinois. She is a member of the Michigan Pharmacists Association (MPA), Michigan Society of Community Pharmacists (MSCP), Society of Infectious Diseases Pharmacists (SIDP), and the International Society of Travel Medicine (ISTM).

  • Dianne Malburg, R.Ph., CPIA, is the Chief Operations Officer with the Michigan Pharmacists Association (MPA) and Pharmacy Services Inc. based in Lansing, Michigan. She earned her bachelors in pharmacy and applied biology from Ferris State University in 1987. Malburg has worked nine years in hospital practice and 10 years owning an independent pharmacy in addition to working for the Association since 1995. She has led MPA initiatives related to immunizations and point of care testing in an effort to advance the profession, as well as promoting collaborative practice agreements with medical providers. Malburg has been recognized as the Distinguished Young Pharmacist by MPA, Pharmacist of the Year by the Michigan Society of Health System Pharmacists and the Clark Andresen Distinguished Pharmacy Alumnus from Ferris' State University College of Pharmacy.

  • Keith Olsen, Pharm.D., FCCP, FCCM, is a Professor of Pharmacy and Chair, Department of Pharmacy Practice at the University of Nebraska Medical Center and a Critical Care Specialist for the Nebraska Health System, both in Omaha. He earned his Pharm.D. and completed a residency at the University of Nebraska Medical Center. He is recognized as a fellow of the American College of Clinical Pharmacy and the American College of Critical Care Medicine. Twice graduating doctor of pharmacy classes has recognized him as the teacher of the year. He has published over 275 peer-reviewed publications, abstracts, and book chapters in the areas of critical care pharmacotherapy, and infectious diseases. He was elected as a Regent for the American College of Critical Care Medicine in 2010 and re-elected in 2013 and was elected to the Board of Trustees Research Institute for the American College of Clinical Pharmacy-2012.

Continuing Education Information

The National Association of Chain Drug Stores is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Practice-based Community Pharmacy-Based Point-of-Care Testing Certificate ACPE University Activity #0206-9999-15-012-B04-P. Initial Release Date: 1/08/2015; Expiration Date: 1/08/2018.


Target Audience
This course provides community pharmacists and members of academia, industry and government with the skills necessary to develop a testing program for influenza, Group A streptococcus, HIV and hepatitis C.

Claiming Credit
Continuing pharmacy education (CPE) credit will be awarded for the certificate training course only. This is a practice-based activity and is primarily constructed to instill, expand or enhance practice competencies through the systematic achievement of specified knowledge, skills, attitudes and perfomance behaviors. Successful completion of the live seminar component involves passing the final exam with a grade of 70 percent or higher and demonstrating proficiency in diagnostic testing techniques.

Successful completion of this component will result in 8.0 contact hours of continuing pharmacy education credit. Successful completion of the self-study component involves passing the self-study assessment questions with a grade of 70 percent or higher and will result in 12.0 contact hours of continuing pharmacy education. Attendance and participation are required before obtaining CPE credit. Partial credit will not be awarded.

CPE Monitor, a national, collaborative effort by ACPE and the National Association of Boards of Pharmacy (NABP) to provide an electronic system for pharmacists to track their completed PCE credits, went into effect on Jan. 1, 2013. NACDS, as an ACPE-accredited provider, is required to report pharmacist CPE credit using this new tracking system. Pharmacist participants must provide their NABP e-Profile identification number and date of birth (in MMDD format) when they register for a CPE activity. It will be the responsibility of the pharmacist to provide the correct information (i.e., e-Profile identification number and date of birth in MMDD format). If this information is not provided, NABP and ACPE prohibit NACDS from issuing CPE credit. Online access to their inventory of completed credits will allow pharmacists to easily monitor their compliance with CPE requirements and print statements of credit. Therefore, NACDS will not provide printed statements of credit to pharmacists. If you have not signed up for CPE Monitor, please go to MyCPEMonitor.net.