MPA | 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 MPA Director of Education, Mary Farrington, at (517) 377-0234 or Mary@MichiganPharmacists.org.

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