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Laboratory Field Services

Guidance for Schools Performing Waived Antigen Testing

Introduction

This guidance is intended to help schools 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 (click on an item below to skip to that section):

Regulations for COVID-19 Testing

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) §§ 1200-1326) and public health (Health and Safety Code (HSC) §§ 101160 – 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).

Test Complexity

Under CLIA regulations, when the federal Food and Drug Administration (FDA) approves a clinical laboratory test, it specifies the complexity of the test. A test may be categorized as "non-waived" (high or moderate complexity) or "waived." 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 is categorized as a CLIA waived test. 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 the Abbott BinaxNOW test.

"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. SARS-CoV-2 tests authorized by the FDA for point-of-care use are deemed to be CLIA waived tests and, for the duration of the emergency declaration, such 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.

SARS-CoV-2 Tests

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 virus’s 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. The most 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 is granting Emergency Use Authorization (EUA) for tests for SARS-CoV-2 instead of the usual approval process. The EUA letter issued to a test manufacturer indicates the complexity of the test.

The FDA lists all authorized tests for SARS-CoV-2 on its EUA webpage, and for each test indicates complexity (High, Moderate, Waived), and provides the EUA letter as well as the manufacturer’s instructions for use (IFU).

State and Federal Requirements

Facilities performing waived SARS-CoV-2 clinical tests in California must meet all the requirements of State and federal law. Facilities performing only waived COVID-19 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).
  • Report all results through the state electronic reporting system (CalREDIE). Reporting requirements are specified in HSC section 120130 and 17 CCR section 2505.

In addition, California law requires COVID-19 tests to be ordered by a licensed healthcare provider authorized to order clinical tests. (BPC § 1288) The ordering healthcare provider must report test results to the local health officer of the jurisdiction where the patient resides. (17 CCR § 2500)

Facilities should always check with their local health officer for any local regulations or requirements.

How to Apply for a State Clinical Laboratory Registration and CLIA Certificate of Waiver

If a school already has a valid State registration or license and CLIA certificate, it may begin waived testing. The school should

  •  Notify LFS that it is performing COVID-19 testing by completing an online form.
  • Notify the federal Centers for Medicare & Medicaid Services (CMS) by submitting a new CMS 116 form to add SARS-CoV-2 to its test menu.
  • Check with the local health officer for local requirements.

If a school does not have a State registration and CLIA certificate, it must obtain required state licensure and federal certification by applying to Laboratory Field Services before it begins testing.

How to Apply for a Registration and Certificate of Waiver

Visit our 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.

When completing the application:

  • Leave blank the fields for CLIA number.
  • The school district is the owner of the laboratory. The owner attestation must be signed by an authorized representative of the owner. This can be the principal, superintendent, or anyone else who is allowed to sign for the school district.
  • 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.
    • You 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 can begin testing as soon as you submit your application to LFS and receive a payment receipt with your APL number. You can begin testing before you pay for and receive your CLIA certificate.

LFS tries to process new applications for facilities performing COVID testing within 10 days of receiving a complete application.

Emergency Temporary Allowance

For the duration of the California state of emergency, LFS is allowing facilities to begin waived antigen testing for SARS-CoV-2 as soon as they have submitted a complete application and received an acknowledgment of receipt, without waiting to receive their California registration or CLIA certificate of waiver. To qualify for this allowance:

  • You must submit the application online.
    • If you submit a paper application, you must wait to receive approval of your California registration before beginning to test.
  • You may only perform waived antigen testing for SARS-CoV-2 using a test authorized for emergency use by the FDA (EUA) for point-of-care (POC) testing, and this allowance applies only for the duration of the California state of emergency.
    • Once you receive your California registration and CLIA certificate of waiver, you may perform any other waived testing for which you are approved.
  • If your application is not approved, LFS will notify you of the reason.
    • You must meet the registration requirements or submit missing information within 10 calendar days. If you do not respond within 10 calendar days, you must cease all SARS-CoV-2 testing until you meet the requirements and receive approval of your California registration.
  • You must arrange with CalREDIE to report all results from SARS-CoV-2 antigen tests. See How to Report Test Results below for detailed information about reporting.

Federal CLIA regulations require a facility to be a CLIA certified laboratory that meets applicable regulatory requirements appropriate for the complexity designation of the test in order to do COVID-19 testing.

The federal Centers for Medicare & Medicaid Services (CMS) have stated that they are applying CLIA Enforcement Discretion to Certificate of Waiver (CoW) applications for facilities using POC COVID testing devices. The enforcement discretion allows any entity with a COVID POC testing device (including, but not limited to, BinaxNOW) to begin using the device once they have applied for a CoW. The State Agency (SA) must still process the application. CMS advises facilities that have submitted a CMS-116 application for a CLIA CoW to check with their SA before they begin testing as states may have additional licensure requirements that must be met before testing can begin.

Facilities that have applied for a CLIA CoW to perform SARS-CoV-2 POC testing (as indicated on section VI of the submitted CMS-116) can begin SARS-CoV-2 POC testing and reporting patient-specific results as soon as they have submitted their completed application to their State Agency (SA).

Who Can Serve as a Laboratory Director

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).

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.

If a facility does not have a qualified laboratory director available, there are a number of options for meeting this requirement. Please see below for some options for finding a director.

Who Can Perform Waived Testing

Personnel who are authorized under BPC section 1206.5(a) to perform waived COVID-19 testing at school sites 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.
  • 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 school personnel who are caring for students under their responsibility. The lab director is responsible for ensuring that these personnel receive training in the use of personal protective equipment (PPE), State and federal requirements, including privacy laws, and performance of the specific test they are using.

Testing personnel must perform clinical laboratory testing under the overall operation and administration of the laboratory director, who is responsible for evaluation and documentation of their qualifications and competency.

For the duration of the California state of emergency, executive order N-25-20 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 on testing personnel for more information about testing personnel requirements.

How to Report Test Results

California law [17 CCR § 2505] requires all facilities performing tests for SARS-CoV-2 to report results through the state electronic reporting system (CalREDIE), including schools and other facilities performing waived testing. They must report:

  • All positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results.
  • Results from molecular (PCR), antigen, and antibody/serology tests.
    • This includes point-of-care (POC) tests conducted in emergency departments, at mass testing events, during screening for institutions, schools, businesses, etc.
  • Within eight hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
  • Patient data, including name, gender, race, ethnicity, address, and telephone number (if known).

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.

For more information about reporting requirements, visit our Guidance for SARS-CoV-2 Reporting and Enforcement.

Options for Laboratory Directors for School Testing Sites

If a school wants to perform COVID-19 testing but does not have a laboratory director, there are a number of options:

  • An individual school may arrange for a person qualified under BPC section 1209 (a), such as a doctor, a clinical laboratory scientist, or a bioanalyst, to serve as laboratory director for its onsite testing.
    • The school must apply for a State Registration and a CLIA Certificate of Waiver to operate as a waived laboratory.
    • The qualified person serves as the school laboratory director.
    • Personnel from the school perform testing at the school.
    • The tests must be ordered by an authorized licensed health care provider.
    • The school must report results through CalREDIE.
  • A school district may arrange for a person qualified under BPC section 1209 (a) to serve as laboratory director. If the district operates as a not-for-profit or local government laboratory that engages in limited public health testing, all schools in the district may perform testing as secondary testing sites of the school district laboratory, which is the primary site.
    • The school district must apply for a State Registration and a CLIA Certificate of Waiver to operate as the primary laboratory.
      • The primary laboratory must list each secondary site operating under its State registration and CLIA certificate when it applies for registration and certification.
      • Individual schools do not need to apply for their own CLIA certificate or state registration.
    • The director of the primary laboratory serves as director for all the secondary school testing sites in the district.
    • Personnel from the primary laboratory or the secondary site perform testing.
    • The primary laboratory must report all test results through CalREDIE from tests performed at all the schools operating as secondary sites.
    • The tests must be ordered and reported by an authorized licensed health care provider.
  • A school or district may arrange with the local public health laboratory (PHL) to operate as a branch site of the PHL.
    • The PHL must notify LFS of the arrangement and list each school or district operating as a branch site on its state public health laboratory license.
    • The school or district must apply for its own CLIA certificate of waiver.
    • The PHL director serves as the director for the school or district site.
    • Personnel from the PHL or the school or district perform testing at the school site.
    • The school or district site must report results through CalREDIE.
    • The tests must be ordered and reported by an authorized licensed health care provider.
  • A school may arrange with a commercial laboratory company to send testing personnel to the school to perform testing on site.
    • The school does not need a CLIA certificate or registration. The testing laboratory must be licensed and certified and meet other state and federal requirements.
      • However, the laboratory and school should inform the local health officer of testing at the school as a temporary location for the laboratory's testing.
    • The school does not need a director. The laboratory must have its own director.
    • The school does not need testing personnel – personnel from the laboratory perform the testing.
    • The laboratory must report results through CalREDIE.
    • The tests must be ordered and reported by an authorized licensed health care provider.

For additional information about your specific needs, please contact Laboratory Field Services at LFSCOVID@cdph.ca.gov.

Additional Resources

The Centers for Disease Control and Prevention (CDC) provide excellent information for facilities performing waived testing:

Information about the Abbott BinaxNOW test:

 

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