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10/24/2020 11:42 PM
Pennsylvania State Senate
https://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=S&SPick=20190&cosponId=31863
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Senate of Pennsylvania
Session of 2019 - 2020 Regular Session

MEMORANDUM

Posted: May 26, 2020 02:53 PM
From: Senator Judy Ward
To: All Senate members
Subject: Pharmacists and COVID-19 Testing
 
I am introducing legislation amending “The Clinical Laboratory Act” to exempt a pharmacy or pharmacists from the laboratory experience requirements of the law to permit them to order or administer tests for COVID-19 approved or authorized by the U.S. Federal Drug Administration (FDA) or the Centers for Disease Control and Prevention (CDC).
 
Many community pharmacies would like to be able to assist with the COVID-19 crisis by providing COVID-19 testing, particularly around antibody testing. These FDA authorized or approved tests currently require a Clinical Laboratory Improvement Amendments (CLIA) waived lab license. CLIA generally requires all facilities that perform even one applicable test, including waived tests, on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to meet certain Federal requirements. If a facility or pharmacy performs tests for these purposes, it is considered a laboratory under CLIA and generally must apply and obtain a certificate from the CLIA program that corresponds to the complexity of tests performed.
 
CLIA-waived tests are low complexity, rapid response, point-of-care tests. Unfortunately, Pennsylvania is one of the few states where even this low, simple lab license is difficult to come by, as the PA Clinical Lab Act is more restrictive than the federal law that governs these tests. Under the current state law, The Clinical Laboratory Act, applicant pharmacies and other sites must have a lab director who has two years (if PharmD) or 5 years (if RPh) employment experience in a  laboratory.  This is an unattainably high threshold as the vast majority of pharmacists graduating from school go to work in pharmacies, not laboratories, though pharmacists are trained and educated as part of the pharmacy school curriculum to perform these tests. My legislation would revise the Act by removing the laboratory experience requirements for pharmacy and pharmacists and allow them to order or administer COVID-19 tests approved or authorized by the FDA or the CDC.
 
Many other states accept the federal CLIA waiver only or have a simple process where you get the federal waiver and then submit that waiver to the state. I am not aware of any other state that requires the extra hurdle of the lab experience. Pharmacists graduate from pharmacy school with experience in administering, reading and interpreting point-of-care test results as part of their curriculum.
 
With COVID-19 testing becoming critical to the reopening of businesses, I believe this change will enable pharmacy and pharmacists to play a vital role in partnering with the Commonwealth to meet that goal through increased testing capacity.
 
Please join me in co-sponsoring this important initiative. 
 
 



Introduced as SB1210