Point-of-Care Testing

The role of the pharmacist is ever changing.

According to a 2015 report in Pharmacy Times^®, “60% of pharmacists provided medication therapy management and 53% performed immunizations, versus 13% and 15%, respectively, in 2004.”¹

Pharmacists’ roles have expanded from only dispensing medications to counseling, immunizing, and now diagnosing and treating.

History of CLIA

In 1988, there were multiple Papanicolaou smears that had inaccurate results, leading to multiple deaths that could have been attributed to false-negative findings. This caused a call to action from the public, causing Congress to pass the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The misreadings that led to these deaths occurred in federal laboratories. However, Congress decided to regulate all clinical tests, including those that occurred in physician offices, to ensure that this would not happen again in any setting.² Because of the CLIA, any facility in the United States that performs laboratory testing for any step in the health care process, including diagnosis, prevention, or treatment of disease, is now regulated by the CLIA.³ All laboratory tests are expected to meet the standards set forth by the CLIA. However, “CLIA-waived tests” are an exception to this rule. Waived tests include systems that have been tested and approved for home use by the FDA. These criteria include that the tests and symptoms be simple and have a low probability of producing erroneous results.

Pharmacists and the CLIA

The US Department of Health & Human Services expects the number of primary care physicians needed in the United States to reach 20,000 by 2020.⁴ Because of this, there will be an overwhelming need for pharmacists to become involved in primary care. Pharmacists are the most accessible health care providers, and they enjoy a strong level of trust in communities. CLIA-waived tests are expected to be a large part of pharmacists’ forecasted role.

Allowing certain laboratory testing by pharmacists will help pharmacies generate income while boosting patient satisfaction as well as outcomes. Patients can receive a diagnosis for a condition and be treated during a single visit instead of having to wait weeks between lab exams and appointments. A list of services that are CLIA waived can be found on the FDA’s website. Some services include testing for serum creatinine, electrolytes, thyroid-stimulating hormone, and the international normalized ratio (INR). These may allow pharmacists to help patients maximize drug therapies, avoid adverse reactions, and improve disease states. Testing for acute conditions such as influenza and strep, screening for chronic diseases like HIV and hepatitis, and chronic disease monitoring of glycated hemoglobin and INR are all possible opportunities for pharmacists to contribute to patient care.

In coordination with the CDC and FDA, CMS has produced guidelines for how CLIA-waived tests are to be handled. The testing site, whether the laboratory or the pharmacy, should use the test system’s instructions for calibration. These instructions must detail the “number, type, and concentration of the calibration material to use.”⁵ Calibration should be completed as often as the instructions specify and be documented and recorded each time it is completed for quality assurance.⁵ There are no federal requirements for qualifications of personnel who perform CLIA-waived testing. However, each state may have its own requirements addressing who can perform these tests, and these regulations must be met. Employees who do perform CLIA-waived testing should be thoroughly trained to do so, and this training should be well documented.⁶ In addition to documentation of training, every test result must also be recorded. Documentation should also include what products were recommended because of the test or, if there is a collaborative care agreement, what medication was provided for each patient. Whether or not a primary care provider referred a patient for testing, results should be shared with that provider. Otherwise, sharing of these tests should be considered on a case-by-case basis.

The 1988 addition of CLIA-waived tests opened a new door for pharmacists to enhance the patient care model. With collaborative-care agreements, pharmacists will have the ability to play a greatly enhanced role in assisting patients using the standard operations outlined between practitioners, and we can fully expect that certain lab tests performed in the pharmacy will be an important part of that.

Leah W. Ginter is a 2018 PharmD graduate of the University of Kentucky College of Pharmacy in Lexington.Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy.

References:

• Eckel FM. The pharmacist’s expanded roles. Pharm Times.pharmacytimes.com/publications/issue/2015/october2015/the-pharmacists-expanded-role. Published October 13, 2015. Accessed June 11, 2018.
• Clinical Laboratory Improvement Act (CLIA). Association of American Physicians and Surgeons website. aapsonline.org/msas/clia.php. Accessed June 11, 2018.
• Clinical Laboratory Improvement Act (CLIA). CDC website. wwwn.cdc.gov/clia/resources/waivedtests/default.aspx. Updated June 11, 2018. Accessed June 11, 2018.
• Timmons E, Norris C. Pharmacists can provide the right prescription for a projected crisis in health care. RealClearHealth. realclearhealth.com/articles/2016/10/26/pharmacists_can_provide_the_right_prescription_for_a_projected_crisis_in_health_care__110192.html. Published October 26, 2016. Accessed June 11, 2018.
• Clinical Laboratory Improvement Amendments (CLIA): calibration and calibration verification. CMS website. cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6065bk.pdf. Accessed June 11, 2018.
• CDC. To test or not to test? Considerations for waived testing. cdc.gov/clia/resources/waivedtests/pdf/wavedtestingbookletweb.pdf. Published 2012. Accessed June 11, 2018.