Guidance for Congregate Living Facilities Performing Waived Antigen Testing

Introduction

This guidance is intended to help skilled nursing facilities, assisted living facilities, board and care home, and other congregate living facilities understand the legal requirements for performing waived antigen tests for SARS-CoV-2, the virus that causes COVID-19 disease. Waived antigen tests include Abbot BinaxNOW, CareStart, and others. It provides information about

• Regulations for COVID-19 testing, including test complexity, types of SARS-CoV-2 tests, and state and federal requirements for testing

• How to apply for licensure to perform testing

• Who can serve as a laboratory director

• Who can perform testing using waived antigen tests

• How to report results

• Options for finding a qualified laboratory director

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 assess 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.

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. Antibody tests can indicate that a person has had an infection with SARS-CoV-2 in the past but are not reliable or approved for diagnosing a current COVID-19 infection or showing that a person does not have COVID-19.

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 facility already has a valid State registration or license and CLIA certificate, it may begin waived testing. The facility 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 (PDF) form to add SARS-CoV-2 to its test menu.
  
• Check with the local health officer for local requirements.

If a facility 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 Submit an Application 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.
• 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 application (APL) number. You can begin testing before you pay for and receive your CLIA certificate.

Emergency Temporary Allowance

For the duration of the California state of emergency, LFS is allowing facilities to begin waived 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 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 waived tests, including 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 (PDF) 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).

How to Add a New Test to an Existing Certificate of Waiver and Registration

The federal Centers for Medicare & Medicaid Services (CMS) want to know which laboratories are testing for SARS-CoV-2. Laboratories should submit this information as follows: 

• If a laboratory with an existing CLIA certificate wants to start performing waived COVID tests but has not added COVID testing to their test menu (by listing it on the CMS 116 application), the laboratory must notify CMS by submitting a CMS 116 (PDF) form to LFSCLIA@cdph.ca.gov.
• Submit a CMS 116 form indicating that the laboratory is performing COVID testing and listing the name of the test kit you intend to use.
• The laboratory may begin using a new waived SARS-CoV-2 test as soon as it has submitted the CMS 116 form.
• If a laboratory has already notified CMS on its CMS 116 form that it is performing COVID testing, the laboratory can add new test kits of the same, or lower, complexity without further notification.
  
• If a laboratory wants to upgrade to a higher complexity, for example, a laboratory with a certificate of waiver wants to start doing high-complexity testing, it must submit a New Online Application to change its certificate type. 

The State Testing Task Force Lab List includes information about state licensed or registered labs doing COVID testing. Listing your lab is voluntary. To list your lab on the TTF list, or to change information about test type if you are already listed, visit the COVID-19 Testing Notification link to submit your information.

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 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.

“Other health care personnel providing direct patient care” 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. Although these people do not necessarily need licensure, they must have adequate training and have demonstrated competency to perform the test.

Testing personnel must perform clinical laboratory testing under the overall operation and administration of the laboratory director, who is responsible for ensuring that all personnel working in the laboratory have adequate training to perform testing, in this case, antigen testing for SAR-CoV-2 using the specific test being performed. The laboratory director is also responsible for documenting that testing personnel have demonstrated competency to perform the test.

For the duration of the California state of emergency, executive order N-25-20 (PDF) 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 congregate living and other facilities performing waived testing. They must report:

• All positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from molecular (e.g., PCR) and antibody/serology tests.
  
• This includes point-of-care (POC) molecular tests conducted in emergency departments, at mass testing events, during screening for institutions, schools, businesses, etc.
  
• All positive and non-positive results from antigen tests, including rapid point-of-care (POC) tests conducted in emergency departments, at mass testing events, during screening for institutions, schools, businesses, etc.:
  
• Laboratories unable to report via ELR must report using one of the methods below.
• The National Healthcare Safety Network (NHSN) point-of-care test reporting tool (For Long-Term Care Facilities (LTCFs) and Skilled Nursing Facilities ONLY)
• This platform can accommodate either manual text entry of results or bulk upload via .csv file
• The Navica app for Binax tests
• Can be downloaded from the Apple App Store and the Google Play Store
• The CDC’s Simple Report platform
• This platform can accommodate either manual text entry of results or bulk upload via .csv file
• CalREDIE’s Manual Laboratory Reporting Module
• Facilities may request an authorized account via the CalREDIE Manual Lab Reporting Account Authorization Form
• This platform requires manual text entry of results
• Within twenty four 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 Congregate Living Facilities to Perform SARS-CoV-2 Antigen Testing