Guidance for COVID-19 Testing
Introduction
This guidance is intended to help health care facilities, schools, businesses, and other entities understand the legal requirements for performing waived antigen testing such as Abbot BinaxNOW for SARS-CoV-2, the virus that causes COVID-19 disease. It includes information about:
California and federal law consider any site where clinical laboratory testing is performed to be a laboratory. Clinical laboratory testing is testing used to detect, identify, or monitor disease in order to prevent, diagnose, monitor, or treat disease or asses the health of an individual. It is regulated under California clinical (Business and Professions Code (BPC) Ā§Ā§ 1200-1326) and public health (Health and Safety Code (HSC) Ā§Ā§ 101160 ā 101165) laboratory law and implementing regulations (Title 17 of the California Code of Regulations (17 CCR)), as well as federal Clinical Laboratory Improvement Act (CLIA) regulations (42 Code of Federal Regulations (CFR) Part 493).
Under CLIA regulations, when the federal Food and Drug Administration (FDA) approves a clinical laboratory test, it specifies the complexity of the test. Test complexity specifies the type of federal CLIA certification required for the laboratory performing the test. A test may be categorized as "waived" or "non-waived" (which can be moderate complexity or high complexity). State and federal requirements for laboratory certification and licensure, director qualifications, and testing personnel qualifications vary depending on the complexity of testing a laboratory or facility performs. In California, a laboratory performing waived tests must have a California Clinical Laboratory Registration and a CLIA Certificate of Waiver, and a laboratory performing non-waived tests must have California Clinical Laboratory or Public Health Laboratory License and a CLIA Certificate of Compliance or Certificate of Accreditation.
The Abbott BinaxNOW test for SARS-CoV-2 (the virus that causes COVID-19 disease) is an example of a test categorized as waived under CLIA. Waived tests are simple tests that have a low risk for erroneous results. However, waived tests are not completely error-proof. Errors can occur anywhere in the testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the test system. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel in an environment where good laboratory practices are followed. Adequate training of testing personnel is especially important for obtaining accurate results with waived antigen tests for SARS-CoV-2.
"Point-of-care testing" is a phrase used to describe the location where testing is performed, such as at the bedside or near the site of patient care. For a list of SARS-CoV-2 tests authorized by the FDA for point-of-care use and information about the authorized use of such tests, visit the
FDA websiteā.
Tests designated as CLIA waived tests can be performed in a patient care setting that has a California Clinical Laboratory Registration and a CLIA Certificate of Waiver or Certificate of Compliance. Please note that as of the end of the public health emergency on May 11, 2023, all CLIA-certified laboratories are required to follow the manufacturerās Instructions for Use (IFU), including the intended use, for SARS-CoV-2 testing. For further information on this issue, please see the
Post-Public Health Emergency Guidance (PDF)ā.
With some exceptions, California law requires waived and non-waived testing to be ordered by a licensed health care professional authorized to order clinical laboratory testing (BPC Ā§ 1288).
Some tests are approved by the FDA for sale without a prescription, either for direct-to-consumer collection at home and testing in a laboratory (āDTCā) or for over-the-counter testing at home ("OTC").
A DTC test is a test kit available for purchase without a prescription that allows an individual to collect a specimen at home and then send it to a certified laboratory for testing and analysis.
An OTC test kit can be purchased without a prescription and used by anyone to collect a specimen and test it at home. Manufacturers who sell their test kits over the counter must demonstrate that untrained lay persons can perform the tests and get good results.
OTC tests may be performed by individuals upon themselves, or by parents and guardians on children under their care, without a CLIA certificate or state registration, whether they do it in their own home or at another location. However, if an OTC test is performed on a patient by another person, for example, by a care giver performing a test on a resident in a skilled nursing facility or by a school employee performing a test on a student, the test is then considered a waived test. The facility where the test is performed must have a CLIA certificate and a California registration, and the person who performs the test must meet state requirements for waived testing personnel and perform the test under the responsibility of the facilityās laboratory director.
There are two types of tests for SARS-CoV-2:
Diagnostic tests detect parts of the SARS-CoV-2 virus. These include
molecular (or PCR) tests that detect the virusās genetic material and
antigen tests that detect specific proteins on the surface of the virus. These tests use nasal or saliva samples and are used to detect current infection. Many molecular tests are high complexity tests, but some are waived tests. Many antigen tests are waived tests. Some common waived antigen tests are the Abbott BinaxNOW, the Quidel Sofia, and the Becton Dickinson Veritor.
Antibody tests detect antibodies that develop in response to infection. These tests use blood samples.
During the COVID-19 emergency, the FDA granted Emergency Use Authorization (EUA) for tests for SARS-CoV-2 instead of using the usual approval process. The EUA letter issued to a test manufacturer indicates the type and complexity of the test.
The FDA lists all authorized tests for SARS-CoV-2 on its
EUAs webpage. The page contains links to pages for three different types of tests, molecular, antigen, and antibody. Antigen tests are listed on the
In Vitro Diagnostics EUAs - Antigen Diagnostic Tests webpage. The FDA tables indicate authorized settings for testing as
H (high-complexity laboratory),
M (moderate complexity laboratory),
W (waived laboratory), and
Home (tests authorized for DTC or OTC home use). They also provide links to the testās EUA letter as well as the authorization documents, which include the manufacturerās instructions for use (IFU). You can check these documents for any further restrictions on the use of a test, such as age limits or self-collection authorization.
Facilities performing waived SARS-CoV-2 clinical tests in California must meet all the requirements of State and federal law. Facilities performing only waived SARS-CoV-2 tests must:
- Have a California Clinical Laboratory Registration (or Clinical Laboratory License or Public Health Laboratory License) and a federal CLIA Certificate of Waiver (or a Certificate of Compliance or Accreditation).
- Have a laboratory director qualified to direct a waived lab. Director qualifications and responsibilities are listed in
BPC section 1209.
- Have testing personnel who meet the requirements for persons performing waived testing. Qualified personnel are listed in
BPC section 1206.5(a) and 1206.7.
- Report test results through the state electronic reporting system (CalREDIE). Reporting requirements are specified in
HSC section 120130 and
17 CCR section 2505. For updated reporting requirements, please see the
Laboratory Reporting Letter (PDF)ā from CalREDIE.
In addition, California law requires SARS-CoV-2 tests, including waived tests, to be ordered by a licensed healthcare provider authorized to order clinical tests (BPC Ā§ 1288). The ordering healthcare provider must report test results to the local health officer of the jurisdiction where the patient resides (17 CCR Ā§ 2500).
The requirements for waived testing apply to OTC tests when they are performed by a person other than the person being tested.
Molecular (PCR) testing is usually performed in a clinical laboratory. Specimens may be collected at a location (for example, a community center or COVID testing site) and sent to a laboratory for testing, and results may not be available for hours or days. For that reason, rapid antigen testing is often performed in facilities such as clinics, schools, residential care facilities, or other settings where results are needed within a few minutes. The rapid antigen testing process involves three steps.
- āCollection: The first step is collection of a specimen. For antigen testing, this is usually done by nasal or oral swabbing. The FDA Emergency Use Authorization (EUA) and manufacturerās instructions for use (IFU) for some test kits require specimens to be collected by a health care provider. Other tests allow individuals to self-collect their own specimens. There may be further restrictions, such as age limits, or requirements that self-collection be observed by a health care provider in person or by video.
- Check the FDA EUA and the IFU for the requirements for the test you are using. Information for antigen tests can be found on the
FDA websiteā.
- The FDA specifies collection requirements, such as nasopharyngeal or mid-turbinate swab, in the EUA and IFU for each test. Laboratory Field Services does not regulate these requirements and does not have authority to change them. Questions about specimen collection for a specific test should be directed to the test manufacturer or the FDA.
- Authorization for health care personnel to perform various types of specimen collection is regulated by the licensing boards for each profession. Please address any questions about personnel who can perform specimen collection to their licensing boards to be sure of specific requirements.
- āLFS does not regulate collection of specimens or set the scopeā of work for health care professionals other than laboratory personnel licensed or certified by LFS, who are not authorized to collect nasal or oral specimens using swabs.
- āPlease note that many aspects of specimen collection are not directly regulated under laboratory law. The laboratory director of the testing laboratory is responsible for the overall operation of the laboratory, including ensuring the integrity of specimens accepted for testing and the competency of laboratory personnel.
- Testing: The second step is the actual testing (or āprocessingā) of the specimen. For antigen tests, this typically involves adding a reagent to a test card or container and inserting the specimen swab into the test card, and reading and interpreting test results.
- For waived tests, this part of the process must be done by a person who meets the requirements for waived testing personnel. See the section below for more information about
who can perform waived tests.
- For OTC home test kits, this is done by the individual being tested. If someone other than the person being tested does this step for an OTC test (for example, a staff person does this part of the test for employees), the test is considered to be a waived test and all requirements for waived testing must be met.
- Be sure to check the EUA and IFU to find the requirements for the test you are using.
- Reporting: The third step is reporting. Results of SARS-CoV-2 tests must be reported through the State CalREDIE Electronic Laboratory Reporting system.
- For OTC home tests, federal and state regulations do not require reporting of testing performed by patients on their own specimens, but some test kits use a reporting app to provide results.
- Note that if the test results are interpreted and reported by someone other than the individual being tested (e.g., other staff, employee health personnel), then the test is a waived test and all requirements for waived testing must be met.
āPlease note: Local health jurisdictions may have local ordinances regulating specimen collection, testing, and reporting. Any facility offering specimen collection or testing should check with local officials to ensure compliance. Businesses should also check CalOSHA requirements if they plan to arrange for onsite collection and testing.
Facilities and organizations have several options for providing testing for staff and visitors.
-
The facility provides OTC tests that people use to test themselves at home or onsite
- The test must be authorized by the FDA for OTC sale to the public without a prescription.
- Individuals must collect the specimen, do the test, and read the results for themselves, whether they do it at home or at the worksite.
- Note that testing performed by a parent or guardian for a child or adult unable to test themselves, when authorized in the manufacturerās Instructions for Use (IFU), is considered self-testing.
- āOtherwise, if someone else (e.g., another employee or a health care staff person) performs the test or interprets and reports the results for the person being tested, it becomes waived testing, and the company needs to meet requirements for waived testing listed above.
- The facility where testing is done does not need to have federal CLIA certification, State licensure, qualified testing personnel, tests do not require a health care providerās order, and results do not need to be reported through the State reporting system, but the business should check with the local health officer and CalOSHA for further requirements.
- Some OTC tests require the individual to use a reporting app to obtain results, but the facility where testing is done does not need to report separately.
-
The facility tests people on the site
- If personnel from the facility or other health care personnel perform waived tests on staff or visitors or interpret and report test results, the facility where testing takes place is considered a clinical lab and must meet all the requirements for waived laboratories:
- A federal CLIA Certificate of Waiver and a California clinical laboratory registration (See below for information on applying for certification and licensure)
- A qualified lab director (See below for information on requirements)
- Qualified personnel to perform the testing (See below for information on requirements)
- A healthcare providerās order for the testing
- Result reporting through the State reporting system (See below for information on requirements)
- If the facility provides OTC tests and staff or visitors collect for themselves but someone else performs the test or interprets and reports the results, or if someone else collects and performs the test or interprets and reports the results, it becomes waived testing, and the facility needs to meet requirements for waived testing listed above.
- āNote that testing performed by a parent or guardian for a child or adult unable to test themselves, when authorized in the manufacturerās Instructions for Use (IFU), is considered self-testing.
-
The business contracts with a lab to do testing, with various options:
- The lab sends personnel who collect onsite and send specimens to the lab for testing, the business where collection takes place does not need certification or licensure; the offsite lab where testing takes place must meet state and federal lab requirements. Note that the local health jurisdiction may have requirements for specimen collection, and the business should also check CalOSHA requirements.
- The lab sends personnel who collect and test specimens on the premises. The testing laboratory must be authorized to operate a temporary testing site. The laboratory should contact LFS to add temporary testing to its license or registration.
Visit the LFS
Clinical and Public Health Laboratories webpage for information on how to submit an application for a new California Clinical Laboratory Registration and CLIA Certificate of Waiver. On the webpage, click on "New Online Application" to complete and submit your application and payment online.
Completing the Application
When completing the application:
- Leave blank the fields for the CLIA number.
- The company or organization where testing will take place is the owner of the laboratory. The owner attestation must be signed by an authorized representative of the owner. This can be anyone else who is allowed to sign for the company or organization.
- Enter the name and manufacturer of your test as it appears on the FDA EUA website.
- Pay your State registration fee online when you submit the application.
- āYou will receive a separate fee coupon from CMS to pay the CLIA certificate fee. You will receive your CLIA certificate in the mail from CMS after you have paid.
When LFS approves your application, you will receive an email notice of approval from LFS with a .pdf file attached to print your registration. You cannot begin testing until you receive your State registration and CLIA certificate.
The director of a waived laboratory must be qualified under
BPC section 1209(a) as:
- A California licensed
physician and surgeon.
- A California licensed
clinical laboratory scientist.
- A California licensed
limited clinical laboratory scientist.
- A California licensed
naturopathic doctor.
- A person licensed to direct a clinical laboratory under
Chapter 3 of the BPC (bioanalyst or
master's or doctoral degree scientist limited to a specialty).
- A licensed optometrist or a licensed dentist, only for a lab that performs testing for their own practice.
- A pharmacist-in-charge, only for a pharmacy lab.
California law does not limit the number of waived laboratories an individual may direct, but the director must be available for consultation by electronic means and must be on-site as frequently as is necessary to ensure the laboratory operates in compliance with State and federal requirements.
Authorization for health care personnel to perform various types of specimen collection is regulated by the licensing boards for each profession. Please address any questions about specimen collection for health care personnel to their licensing boards to be sure of specific requirements.
LFS regulates collection of specimens and sets the scope of work only for laboratory personnel licensed or certified by LFS, who are not authorized to collect nasal or oral specimens using swabs.
Self-collection is not regulated under federal CLIA regulations, but the CDC has published
Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19ā.
Personnel who are authorized under
BPC section 1206.5(a) to perform waived COVID-19 testing include:
- A licensed
physician and surgeon holding an M.D. or D.O. degree.
- A person licensed under
Chapter 3 of the BPC to engage in clinical laboratory practice or to direct a clinical laboratory. This includes
medical laboratory technicians (MLT), clinical laboratory scientists (CLS), bioanalysts, and master's or doctoral degree scientists limited to a specialty.
- BPC section 1206.7 suspends California licensure requirements for testing personnel performing COVID-19 testing if they meet the CLIA requirements for high-complexity testing personnel at 42 CFR 493.1489. Please refer to the
LFS letter to laboratories testing for SARS-CoV-2ā for more information about testing personnel requirements.
- A
public health microbiologist director and
public health microbiologist authorized to perform tests pursuant to a certificate issued under
Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the HSC.
- A licensed
physician assistant if authorized by a supervising physician and surgeon in accordance with
Section 3502 or 3535 of the BPC.
- A
registered nurse licensed under
Chapter 6 (commencing with Section 2700) of the BPC.
- A
licensed vocational nurse licensed under
Chapter 6.5 (commencing with Section 2840) of the BPC.
-
Other health care personnel providing direct patient care.
- This includes personnel who provide point-of-care testing in facilities such as long-term care facilities, hospitals, physician offices, urgent care and outreach clinics, and temporary patient care settings. These people must have adequate training and have demonstrated competency to perform the test.
All testing personnel must perform clinical laboratory testing under the overall operation and administration of the laboratory director, who is responsible for:
- Ensuring that these personnel receive training, including training in the use of personal protective equipment (PPE), State and federal requirements, including privacy laws, and hands-on training in the performance of the specific test they will be using.
- The lab director is responsible for keeping a written record documenting each personās training.
- Evaluation and written documentation of their qualifications and competency. Competency assessment must be performed:
- Prior to performing testing on patients
- āEvery six months during the first year
- Annually after the first year
- The laboratory director may provide additional in-service training and education as needed to comply with the requirements of 17 CCR Ā§ 1036.3.
California law [17 CCR Ā§ 2505] regulates the reporting of test results through the state electronic reporting system (CalREDIE), including businesses, organizations, and other facilities performing waived testing. For updated information about reporting requirements, please visit the āāāāāReportable Diseases and Conditionsāā webpageā.
The CalREDIE program assists with onboarding to the CalREDIE reporting system and offers alternative means of reporting until onboarding is complete. For information about reporting requirements and assistance with reporting, please visit the
CalREDIE webpage or contact
CalREDIEHELP@cdph.ca.gov.ā
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