Guidance for COVID-19 Collection and Testing Sites
The California Department of Public Health (CDPH) has received numerous requests and queries regarding the operation of testing sites, including "drive-through sites," for SARS-CoV-2, the virus that causes COVID-19, or novel coronavirus infection. CDPH is providing the following information to address concerns raised by the California public health and clinical laboratory communities.
On this page:
Specimen Collection Sites vs. Specimen Testing Sites
Test and Test Classification
Laboratory and Personnel Requirements
Information for Pharmacists
Information for Physician Offices and Urgent Care Clinics
CalREDIE Disease Reporting and Test Report Notifications
Note Regarding Enforcement Actions
Drive-through sites that advertise as "drive-through COVID-19 testing sites" may offer on-site testing for serological (antibody) tests; they may also collect specimens for molecular testing, which are then submitted to an off-site laboratory for clinical testing. Some sites are doing both. Sites that do not actually perform clinical laboratory tests for SARS-CoV-2 on the premises are operating as specimen collection sites and not clinical laboratory testing sites.
Any clinical laboratory operating in California or testing specimens originating in California must hold CLIA certification and California licensure or registration from CDPH. Although CDPH does not license specimen collection sites operating independently of a licensed clinical laboratory, CDPH has regulatory authority over the clinical laboratory receiving specimens collected at such collection sites. CDPH notes that in these instances, the laboratory director of the clinical laboratory receiving a specimen collected at a drive-through site is responsible for the integrity of the specimen for clinical laboratory testing purposes.
It is critically important that collection and testing sites observe best practices for handling and testing infectious disease specimens. For information specific to testing for SARS-CoV-2, visit the CDC webpage, Frequently Asked Questions about Laboratory Biosafety and SARS-CoV-2 as well as the Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19).
Serological (Antibody) Test Classification
Serological tests look for antibodies to the SARS-CoV-2 virus, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection. Serological, or antibody, tests should not be used to diagnose active infection. The United States Food and Drug Administration (FDA) has issued several Emergency Use Authorizations (EUA) for serological (antibody) tests for SARS-CoV-2. The EUAs issued to date authorize performance of these tests by clinical laboratories authorized under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988 to perform moderate and high-complexity tests.
Under federal CLIA law, a test that has not yet been classified by the FDA for test complexity or one that is developed in-house (laboratory-developed test or LDT) is a high complexity test. (See title 42 CFR §493.17(c)(4)).
Because all existing serological (antibody) tests are currently classified as moderate or high complexity, they can only be performed by a laboratory with a CLIA certificate of compliance or certificate of accreditation and a California clinical laboratory license.
On May 4, The FDA revised its policy on antibody tests to require commercial manufacturers of serological tests to meet FDA requirements for performance and submit EUA requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of the new policy, whichever is later. The FDA also provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.
The FDA publishes a list of serological tests that should no longer be distributed. The FDA has removed these tests from its notification list of commercial manufacturers distributing serology test kits without an EUA under FDA's previous policy. Antibody tests on this new list include those voluntarily withdrawn from the notification list by the test's manufacturer, those for which the manufacturer has not submitted an EUA request, and those for which the FDA has not issued EUA because of significant problems that cannot be or have not been addressed.
FDA expects that the tests on this list will not be distributed unless and until an EUA is issued for the test, and may take additional actions as appropriate.
Molecular (RNA) Test Classification
The FDA has issued many EUAs for molecular tests for SARS-CoV-2, including a recent EUA for an antigen test.
Molecular polymerase chain reaction (PCR) tests detect genetic material from the virus and can help diagnose an active COVID-19 infection. PCR tests can be highly accurate but running the tests and analyzing the results can take time. Other types of molecular tests and antigen tests also test for active infection and can provide results in minutes. Antigen tests are very specific for the virus but are not as sensitive as molecular PCR tests. This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives. Negative results from an antigen test do not rule out infection and may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.
Most of the molecular tests authorized under EUAs classified as moderate and high-complexity tests. To date, three molecular tests and one antigen test have been approved by the FDA for waived testing in a patient care setting under a CLIA Certificate of Waiver:
- Abbott ID NOW COVID-19
- Cepheid Xpert Xpress SARS-CoV-2 test
- Mesa Biotech Inc. Accula SARS-Cov-2 test
- Quidel Corporation Sofia 2 SARS Antigen FIA
- Cue Health CUE COVID-19 Test
- Becton, Dickinson and Company BD Veritor System for Rapid Detection of SARS-CoV-2
Molecular tests that have not been approved by the FDA and have not yet been classified by the FDA for test complexity, including tests approved under an EUA that have been modified by the testing laboratory and LDTs, are considered to be high complexity tests. (See title 42 CFR §493.17(c)(4)).
In order to comply with California clinical laboratory laws, a drive-through site testing for SARS-CoV-2 that collects specimens and performs clinical laboratory tests on the premises must consider, at a minimum, the following:
Laboratory licensure requirements.
- The clinical laboratory performing moderate or high complexity testing on the premises of the drive-through testing site must have a CLIA certificate of compliance and California clinical laboratory license.
- The clinical laboratory performing waived tests on the premises of the drive-through testing site must have a CLIA certificate of waiver and California clinical laboratory registration.
- If specimens collected at the drive-through site are sent to an off-site laboratory, the testing laboratory must have California licensure or registration and CLIA certification appropriate to the complexity of testing.
- If specimens collected in California are submitted to a laboratory located outside California, the out-of-state laboratory must have a California license and meet the California laboratory requirements outlined in this section.
Physician requisition requirement.
- The clinical laboratory may only accept test assignments from licensed physicians or other persons authorized to order tests under their scope of practice, as specified in California Business and Professions Code section 1288.
Specimen collection and testing personnel requirements.
- The laboratory director of the clinical laboratory operating on the premises of the drive-through testing site and the laboratory director of an off-site laboratory receiving specimens collected at a drive-through site must ensure that specimen collection and testing personnel are appropriately qualified.
- Testing personnel performing high-complexity SARS-CoV-2 tests must meet CLIA requirements for high-complexity testing personnel at 42 CFR section 493.1489.
- Testing personnel performing moderate-complexity SARS-CoV-2 tests must meet California and CLIA requirements for moderate-complexity testing personnel.
- Phlebotomists collecting blood samples must be certified by LFS and must work under the responsibility of a laboratory director, under appropriate supervision.
- Laboratory personnel certified or licensed under Chapter 3 of the Business and Professions Code are not authorized to collect specimens using nasopharyngeal, oropharyngeal, nasal, or throat swabs.
Test validation requirements.
- A laboratory performing a non-waived test approved by the FDA under an EUA must verify the performance specifications of the test following the verification process specified in 42 CFR 493.1253 (b)(1) and (3) and (c) and is requested to notify LFS that it is using the test.
- A laboratory performing a modified test approved under an EUA, or an LDT, must establish the performance specifications of the test following the establishment process specified in 42 CFR 493.1253 (b)(2) and (3) and (c) and is requested to notify FDA and LFS that it is using the test.
- A laboratory performing a waived test need not validate the test, but must follow manufacturer’s instructions.
On May 12, the Director of the Department of Consumer Affairs issued a waiver authorizing pharmacists licensed in California to order and collect specimens for authorized COVID-19 tests. The test must be authorized by the FDA, the pharmacist must be competent and trained to collect the specimen needed for the particular test, and the specimen must be collected consistent with the provisions of an Emergency Use Authorization issued by the FDA.
The waiver is in effect for 60 days from May 12, 2020, unless further extended by the director of the Department of Consumer Affairs.
The Department encourages pharmacists ordering COVID-19 tests to collect information on patients' race and ethnicity and provide it on test requisition forms so the testing laboratories can include this information in their reports through the CalREDIE electronic reporting system.
Pharmacists ordering tests are also encouraged to report test results along with information on the patient’s race and ethnicity to the local health officer for the jurisdiction where the patient resides.
Pharmacists may serve as qualified laboratory testing personnel to perform COVID-19 tests under the provisions of Executive Order N-25-20 (PDF) for the duration of the COVID-19 emergency, but they may perform testing only in an appropriately licensed or registered laboratory, and only under the direction of a laboratory director.
A pharmacist may not perform COVID-19 testing not otherwise authorized by law and may not direct a laboratory unless otherwise qualified as a clinical laboratory director under federal and State law.
Physician office laboratories and urgent care clinics must have federal CLIA certification and California state licensure or registration required for the tests they are performing, as indicated above under Tests and Test Classification.
All currently available serology/antibody tests authorized by the FDA under an EUA are classified as high or moderate complexity. Tests not authorized or approved by the FDA, including all laboratory-developed tests, default to high complexity.
To perform tests classified as moderate or high complexity, a laboratory, including a physician’s office laboratory, must have a CLIA certificate of compliance or certificate of accreditation and a California clinical laboratory license.
None of the currently available serological tests may be performed under a Certificate of Waiver.
All clinical laboratories operating and testing for SARS-CoV-2 at drive-through sites or off-site, including laboratories located outside California, are required to report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from both antigen/molecular and antibody/serology tests for SARS-CoV-2 at least daily through the CalREDIE Electronic Laboratory Reporting system (ELR). Further information about reporting requirements is available on the CalREDIE website.
Ordering health care providers are also required to report results of cases or suspected cases of COVID-19 to the local health officer for the jurisdiction where the patient resides (17 CCR section 2500 (b)) and should contact the local health officer for specific requirements.
Results of all serological tests that do not have an FDA EUA must be accompanied by the following FDA warnings recommended in the Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency (PDF), section IV. D.:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The Department of Public Health [CDPH] asks that laboratories report data on patients' race and ethnicity for all COVID-19 test results. Please revise requisition forms to include this information, and work with the healthcare providers you serve to ensure that demographic information is collected during patient intake so that you can include it when you report results through the CalREDIE system.
In general, CDPH LFS has regulatory authority over clinical laboratories and clinical laboratory personnel performing diagnostic tests on California specimens. This authority extends to clinical laboratories located outside California that perform testing on specimens originating in California. Due to the unique facts and circumstances that each drive-through testing site and operation may present, LFS cannot make general statements on the enforcement actions it may initiate when a specific scenario requires its own separate analysis and investigation.
Please be advised that depending on the particular facts and circumstances, a COVID-19 drive-through collection or testing site may also be subject to an enforcement action initiated at the local or federal level. For example, a Local Health Officer under the authority granted pursuant to Health and Safety Code section 120175 may take appropriate action if it is necessary "to prevent the spread of the disease or occurrence of additional cases." Furthermore, the federal government has committed to detecting, investigating, and prosecuting wrongdoing related to the COVID-19 emergency.
We hope the above guidelines are helpful to you as you assess COVID-19 testing needs within your community. Please note that the guidelines highlighted above do not constitute an exhaustive list of all state and federal regulatory requirements applicable to a drive-through COVID-19 specimen collection and testing site.
Please refer to the LFS COVID-19 for Laboratories webpage for further information. You may also contact LFS at LFSCOVID@cdph.ca.gov.
Thank you for your work to serve the people of California during this public health emergency.