Point-of-care testing empowers clinicians to use effective, fast technology to aid their decision making at the “point-of-care” to improve patient health. Community pharmacy-based point-of-care testing utilizes CLIA-waived (Clinical Laboratory Improvement Amendments -waived) tests that offer near immediate results in non-laboratory settings. Pharmacies are increasingly offering this public health service to promote prevention, early detection, and disease management.
Clinical Laboratory Improvement Amendments- Waived Tests
In 1988, the Clinical Laboratory Improvement Amendments (CLIA) were passed in an amendment to the Public Health Services Act where Congress revised the federal program for certification and oversight of clinical laboratory testing. CLIA regulations establish quality standards for laboratory testing on clinical specimens for the purpose of diagnosis, prevention, or treatment of disease or assessment of health.
An exception was created to CLIA for CLIA-waived tests. CLIA defines waived tests as “simple laboratory examinations and procedures that have an insignificant risk of an erroneous result.” Manufacturers apply to the FDA to have their tests classified as a CLIA-waived test, as the FDA determines which tests meet the CLIA waiver criteria. Once the FDA approves the CLIA-waiver application, the test can be performed in a non-traditional laboratory setting, including pharmacies, if the site follows good laboratory practices and has a valid CLIA waiver.
Although CLIA-waived tests are required to be simple, there is still the potential for errors to occur. Likewise, some CLIA-waived tests do have the potential to negatively impact health of patients if performed incorrectly. For this reason, CLIA-waived tests must be performed by trained personnel in a good laboratory environment. The CDC has additional information on good laboratory practices, a self-assessment checklist, and considerations for testing.
Ohio pharmacists can currently perform CLIA-waived tests if they have a valid CLIA certificate (apply here). Some examples of CLIA-waived tests are influenza, Strep A, HIV, A1c, and INR testing. Many of these tests can be performed without specialized equipment and provide results within five to 20 minutes. These point-of-care tests are a great opportunity for pharmacists to expand their patient care services and improve patient outcomes.
While Ohio pharmacists can perform the CLIA-waived tests, they are unable to prescribe based on the result of a rapid diagnostic test. The Ohio Pharmacists Association is working to expand the scope of practice of pharmacists, so they are able to quickly identify patients with treatable infections with rapid diagnostic tests and treat the patient under a protocol.
- Centers for Medicare and Medicaid Services
- Centers for Disease Control and Prevention good laboratory practices, a self-assessment checklist, and considerations for testing
- Food and Drug Administration List of CLIA-waived Tests
- National Alliance of State Pharmacy Association Current Landscape for Point-of-Care Testing and Additional Resources
- National Association of Chain Drug Stores Community Pharmacy-Based Point-of-Care Testing Certificate Program
- National Community Pharmacists Association Instructions on Filling CLIA-Waiver Form