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Laboratory Field Services

Guidance for Pharmacies, Pharmacists, and Pharmacy Technicians Performing Waived, Point-of-Care COVID-19 Tests

On August 25, 2020, the Director of the Department of Consumer Affairs issued an Order, DCA-20-45, that waives specified professional licensing requirements and amends the scopes of practice of pharmacists and pharmacy technicians to allow them to perform waived, point-of-care tests used to detect SARS-CoV-2, the virus that causes COVID-19 disease. This DCA Order, among other requirements, requires pharmacies where such testing is performed to obtain a California Clinical Laboratory Registration from Laboratory Field Services (LFS) and a federal CLIA Certificate of Waiver, and to comply with applicable SARS-CoV-2 reporting requirements. DCA-20-45 supersedes the previous Department of Consumer Affairs Order issued on May 12, 2020, and the subsequent extension granted on July 7, 2020. A Guidance for Pharmacies, Pharmacists and Pharmacy Technicians Ordering, Collecting Specimens for, and Performing COVID-19 Tests with general information on the Order is available on the DCA website.

In order to inform and educate pharmacies, pharmacists, and pharmacy technicians of the clinical laboratory requirements that apply under the DCA Order, LFS provides the following general information on the laboratory registration/certification process and testing personnel and reporting requirements.

State Registration and Federal CLIA Certification Requirements

  • DCA-20-45 requires that a pharmacy performing waived, point-of-care testing for SARS-CoV-2 must obtain a California Clinical Laboratory Registration and a federal CLIA Certificate of Waiver.
    • Pursuant to DCA-20-45, for the duration of the California state of emergency, a pharmacy is authorized to perform waived, point-of-care tests used to detect the presence of SARS-CoV-2 authorized by the FDA.
    • DCA-20-45 does not affect pharmacists’ authority to perform other waived tests not related to SARS-CoV-2, such as blood glucose, hemoglobin, A1c, or cholesterol tests.
  • To obtain a California Clinical Laboratory Registration:
    • The pharmacy must complete and submit to LFS the following State application form, with the application fee, for new laboratory registration applications:
  • To obtain a CLIA Certificate of Waiver:
    • The pharmacy must complete and submit to LFS the following federal application form:
      • CMS 116 - CLIA application (PDF)
        • Pursuant to DCA-20-45, the pharmacist-in-charge is required to be identified as the laboratory director on the federal application.
        • CLIA will bill the applicant separately for the application fee.
  • For more information about the application process, please contact LFS at LFSCOVID@cdph.ca.gov. Please submit forms to the same email address, to ensure that they are received as COVID-19 applications. LFS will process applications sent to this email within 10 days of receipt of a complete application.

State Registration Requirements for Mobile Units and Temporary Testing Sites

  •  In general, Business and Professions Code section 1265(d) requires a separate registration for each laboratory location where testing is performed.
  • However, for the duration of the California state of emergency, a pharmacy that performs waived COVID-19 tests at locations other than at the pharmacy site may be exempt from the separate registration requirement if certain criteria are met.
    • Temporary Testing Site: A pharmacy operating a temporary testing site is exempt from the separate registration requirement if all of the following conditions are met:
      • The pharmacy identifies a designated primary site or “home base” where personnel, testing equipment, supplies, and reagents are stored, and records and files are maintained.
      • The pharmacy notifies LFS of the temporary testing site locations.
      • No equipment, supplies, and reagents are stored permanently at the temporary site.
      • A temporary testing site may include the following: diagnostic screening health fairs, skilled nursing facilities, and other locations conducive to waived, point-of-care testing.
    • Mobile Units Providing Laboratory Testing: A pharmacy that operates a mobile laboratory unit is exempt from the separate registration requirement for all testing locations if the following conditions are met:
      • The mobile unit is a self-contained operational laboratory with its own personnel, equipment, and records. Typically, the mobile unit is a vehicle such as an ambulance or van.
      • The laboratory equipment must be permanently located within the mobile unit.
      • The mobile unit is not used solely for transport of the equipment from one testing site to another.
      • The mobile unit must be affiliated with a home base. If testing occurs at the home base, the home base and the mobile unit must maintain separate State registrations and CLIA certificates.

Specimen Collection Activities Authorized Pursuant to DCA-20-45​​

Pursuant to DCA-20-45, both a pharmacist and a pharmacy technician may collect specimens for COVID-19 tests. However, the respective scopes of practice vary.

  • Pharmacists: Under the terms of the DCA Order, a pharmacist
    • Is authorized to collect specimens for a COVID-19 test of any complexity level (waived, moderate, or high-complexity).
    • May collect specimens using any method of collection.
    • Must be competent and trained to collect the specimen and specimen collection must be consistent with the test’s FDA Emergency Use Authorization (EUA).
  • Pharmacy Technicians: By contrast, under the terms of the DCA Order, a pharmacy technician:
    • Is limited to collecting specimens in a pharmacy under the direct supervision and control of a supervising pharmacist.
    • Is limited to collecting specimens for waived tests and is limited to the following collection methods: nasal swab, nasopharyngeal swab, and throat swab.
    • Must be competent and trained to collect the specimen and the specimen collection must be consistent with the test’s FDA EUA.

State Testing Personnel Requirements for DCA-20-45 Testing Pharmacies

  • Pursuant to DCA-20-45, both a pharmacist and a pharmacy technician may perform waived, point-of-care tests for SARS-CoV-2 that are FDA-authorized. The pharmacist and pharmacy technician may perform these waived tests absent the supervision of a qualified laboratory director only if all conditions and requirements in the DCA Order are met.
    • The pharmacist and pharmacy technician must be competent and trained to perform the waived test.
    • Test performance must be consistent with the waived test’s FDA EUA.
  • While a pharmacist may perform waived, point-of-care COVID-19 tests independent of a laboratory director, a pharmacy technician is limited to performing testing in a pharmacy and must do so under the direct supervision and control of a supervising pharmacist pursuant to Business and Professions Code section 4115(a).
  • Note: The temporary suspension and waiver effectuated by DCA-20-45 does not affect the separate suspension of the certification and licensure requirements under the Governor’s March 12, 2020, Executive Order N-25-20 (PDF). Pharmacists or pharmacy technicians who elect to perform COVID-19 tests outside of the parameters of DCA-20-45 and who do not meet existing laboratory personnel licensure or certification requirements may otherwise perform analysis of samples to test for SARS-CoV-2 if they meet the federal requirements of 42 C.F.R. section 493.1389 for high-complexity testing personnel.

State Reporting Requirements Applicable to Ordering Pharmacists and Testing Pharmacies

  • A pharmacist who orders a COVID-19 test of any complexity level (waived, moderate, or high-complexity) is required to comply with the infectious disease reporting requirements applicable to health care providers outlined in 17 CCR section 2500.
    • Laboratory Field Services advises pharmacists ordering COVID-19 tests for patients to contact their local public health department and the California Reportable Disease Information Exchange (CalREDIE) program at CDPH to discuss options for reporting patient data and test results in compliance with regulations.
  • In addition, a pharmacy that performs waived, point-of-care COVID-19 tests pursuant to the authority and conditions established in DCA-20-45 is required to comply with the infectious disease reporting requirements applicable to laboratories outlined in 17 CCR section 2505.
    • A pharmacy that has a California clinical laboratory registration and federal CLIA certificate of waiver to test for SARS-CoV-2 must report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from the waived, point-of-care, FDA-authorized test for SARS-CoV-2 through the CalREDIE Electronic Laboratory Reporting system (ELR) within eight hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
      • Pharmacies unable to report results via ELR can submit results in a .CSV file or use the CalREDIE Manual Lab Reporting Module instead. For information about this reporting option, please contact calrediehelp@cdph.ca.gov.
    • A pharmacy must report data on patients’ race and ethnicity for all COVID-19 test results. Pharmacies should ensure that requisition forms include this information and are encouraged to work with healthcare providers to ensure that demographic information is collected during patient intake so that it can be included when results are reported through the CalREDIE system.
    • For more information about the ELR and reporting requirements, please visit the CDPH CalREDIE ELR webpage.
    • Pharmacies are requested to use the encoding guidelines for ELR messages for SARS-CoV-2. The LOINC codes are pre-release codes, developed for special use. These codes, as well as future updates, can be found at the LOINC website.
    • In addition, pharmacies are requested to use the following SNOMED codes:
      • 260373001 Detected
      • 260415000 Not detected
      • 419984006 Inconclusive
      • 125154007 Specimen unsatisfactory

Resources

More information about testing in pharmacies:

 

 

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