The California State Board of Pharmacy is providing the following news release on behalf of the California Department of Consumer Affairs (DCA). Links to the waiver and guidance issued by DCA are provided below the news release.
FOR IMMEDIATE RELEASE
August 25, 2020
Contact: Veronica Harms
Expanding the State’s COVID-19 Testing
DCA Issues Waiver to Expand Access to Tests and Ensure the Timely and Accurate Reporting of Test Results
SACRAMENTO – The Department of Consumer Affairs (DCA) issued a new waiver today to expand COVID-19 testing in California and allow for timely and accurate reporting of COVID-19 test results. DCA Waiver DCA-20-45 would allow pharmacists and pharmacists technicians to collect specimens for, administer, and interpret results for authorized COVID 19 tests. This waiver supersedes DCA waiver DCA-20-14, which only allowed pharmacists to order and collect specimens necessary to perform tests for the virus.
“Allowing additional healthcare personnel to perform tests, allowing tests at pharmacies, and getting test results quickly are crucial steps to help manage the spread of COVID-19,” said Kimberly Kirchmeyer, Director of DCA. “Allowing pharmacists and pharmacists technicians to perform tests was a natural fit in finding ways to help slow the spread and keep consumers safe.”
Prior to the waiver, COVID-19 tests classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) could not be performed by pharmacists or pharmacy technicians at pharmacies. Now, a pharmacy, pharmacist or pharmacy technician can perform on individual patients point-of-care clinical laboratory tests or examinations for the presence of the virus that are deemed or classified as CLIA waived.
The waiver is subject to the following conditions:
- Testing is limited to waived COVID 19 tests authorized by the United States Food and Drug Administration (FDA) and is performed consistent with the provisions of an Emergency Use Authorization issued by the FDA.
- The pharmacy complies with applicable federal requirements, including CLIA certificate of waiver requirements.
- The pharmacy is registered by the California Department of Public Health.
- Pharmacists must comply with disease reporting requirements applicable to health care providers ordering COVID 19 tests.
- Pharmacies must comply with the disease reporting requirements applicable to laboratories testing for COVID 19.
- The pharmacist or pharmacy technician is competent and trained to collect the specimen and perform the test, and the specimen is collected and the test is performed consistent with the provisions of an Emergency Use Authorization issued by the FDA.
- The pharmacy, pharmacist or pharmacy technician complies with such other requirements as the California Department of Public Health, in consultation with the Department of Consumer Affairs, may impose that are not inconsistent with this Order.
The full waiver can be read on the DCA website along with other waivers issued.
The waiver is issued as the Director exercises the authority under Governor Gavin Newsom’s Executive Order N-75-20, which authorized the Director of DCA, in consultation with the Department of Public Health, to amend scopes of practice to allow pharmacists and pharmacy technicians to conduct any aspect of any point-of-care test for the presence of COVID-19 that is deemed or classified as waived under CLIA.
The Department of Consumer Affairs is a consumer protection department under the Business, Consumer Services and Housing Agency and has been working closely with other state departments and stakeholders to respond to and protect all Californians during the COVID-19 pandemic.
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ABOUT THE DEPARTMENT OF CONSUMER AFFAIRS: The Department of Consumer Affairs (DCA) promotes and protects the interests of California consumers while ensuring a competent and fair marketplace. DCA helps consumers learn how to protect themselves from unscrupulous and unqualified individuals. The department also protects professionals (licensees) from unfair competition by unlicensed practitioners. Consumers can file complaints against licensees by contacting DCA at (800) 952-5210. Consumers can also file a complaint online at dca.ca.gov.