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Laboratory Field Services

Guidance for Employee COVID-19 Testing

Introduction

This guidance is intended to help businesses, health care facilities, 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:

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) 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).

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. 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. 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.

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 (ā€œDTCā€) 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 do so under the responsibility of the facilityā€™s laboratory director.

Types of 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 virusā€™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. 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 is granting 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 testā€™s EUA letter as well as the authorization documents, which include the manufacturerā€™s 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.

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 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).
  • 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 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)

These requirements apply to OTC tests when they are performed by a person other than the person being tested.

Information About the Testing Process

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, businesses testing employees before allowing them to enter the workplace usually prefer to use rapid antigen testing that provides results within a few minutes.

Rapid antigen testing is often performed in settings such as clinics, schools, or other settings where results are needed within a few minutes. The rapid antigen testing process involves three steps.

  • Collection: 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 manufacturerā€™s 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 website.
    • 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. LFS has contacted many licensing boards to check which professionals can perform NP swab collection. General information is provided in the section on specimen collection below, but you should address any questions about personnel who can perform specimen collection to their licensing boards to be sure of specific requirements.
      • LFS does not regulate collection of specimens or set the scope 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.
    • Please 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 ā€œprocessingā€) 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. All results (positive and non-positive) of all SARS-CoV-2 tests, including waived antigen tests, must be reported through the State CalREDIE Electronic Laboratory Reporting system.
    • 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. 
    • See the section below for more information about reporting requirements.
    • 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.

Please 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.

Options for providing staff and visitor testing

Businesses and organizations have a number of options for providing testing for staff and visitors.

  1. The business 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 manufacturerā€™s Instructions for Use (IFU), is considered self-testing.
      • Otherwise, 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 business or 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 providerā€™s 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.
  2. The business tests people on the site
    • If personnel from the business 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 providerā€™s order for the testing
      • Result reporting through the State reporting system (See below for information on requirements)
    • If the business 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 company needs to meet requirements for waived testing listed above.
      • Note that testing performed by a parent or guardian for a child or adult unable to test themselves, when authorized in the manufacturerā€™s Instructions for Use (IFU), is considered self-testing.
  3. 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.

How to Apply for a Registration and Certificate of Waiver

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.
    • 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 antigen tests. See How to Report Test Results below for detailed information about reporting.

Laboratory Personnel Requirements

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).
  • 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.

Who Can Collect Specimens

LFS has contacted various professional boards to collect information about practitioners who are authorized under their scope of practice to collect specimens using swabs. Our current information is as follows:

  • Collecting specimens using swabs, including nasopharyngeal (NP) or oropharyngeal (OP) swabs, is not in the scope of practice for personnel licensed under Chapter 3 of the BPC, including phlebotomists, MLTs, and CLS. They are all authorized to collect blood samples but are not authorized to collect samples using swabs.
  • The Medical Board of California and the Osteopathic Medical Board of California state that allopathic and osteopathic physicians can collect these specimens.
  • Physician assistants can perform collections of specimens for COVID-19 testing using nasal swabs if they meet the current waiver requirements of DCA Waiver 02-04, in the following circumstances:
  • According to the Dept. of Consumer Affairs medical assistant webpage, medical assistants can collect using nasal swabs, but front of the nose only. They may not collect using nasopharyngeal or oropharyngeal swabs.
  • EMTs and paramedics are authorized by the Director of the California Emergency Medical Services Authority to collect nasopharyngeal swabs only for COVID-19 testing and only for the duration of the COVID-19 emergency. Additional information about the local option scope of practice allowing them to do this is available on the California Emergency Medical Services Authority webpage.
  • Registered nurses can collect specimens using nasopharyngeal or oropharyngeal swabs.
  • Nasopharyngeal or oropharyngeal swab collection is within the scope of practice for a licensed vocational nurse (LVN) and psychiatric technician (PT) if the LVN or PT:
    • Receives specialized instruction in the proper procedure from a registered nurse or licensed physician;
    • Demonstrates the requisite knowledge, skills, and ability prior to performance of the procedure; and
    • Performs the procedure in accordance with a licensed physicianā€™s order.
  • Respiratory care practitioners are authorized under their scope of practice to collect specimens using swabs, including NP and OP swabs.
  • For the duration of the DCA order DCA-20-45, pharmacists may collect specimens using nasal, nasopharyngeal, or throat swabs, necessary to perform any category of test for the presence of the virus SARS-CoV-2, provided:
    • The test is authorized by the FDA; and,
    • The pharmacist is competent and trained to collect the specimen and perform the test, and the specimen is collected and the test is performed consistent with the provisions of any applicable Emergency Use Authorization issued by the FDA.
  • For the duration of the DCA order DCA-20-45, pharmacy technicians in a pharmacy may collect specimens using nasal, nasopharyngeal, or throat swabs necessary to perform point-of-care tests for the presence of SARS-CoV-2 that are deemed or classified as CLIA waived, provided:
    • The pharmacy technician is competent and trained to collect the specimen and perform the test, and the specimen is collected and the test is performed consistent with the provisions of any applicable Emergency Use Authorization issued by the FDA. Pharmacy technicians collecting specimens and performing tests, as specified, must remain under the direct supervision and control of a pharmacist.
  • For other licensed personnel, please contact the appropriate licensing board for information about scope of practice.

The observation of self-collection is not listed in the scope of practice for any California licensed healthcare professionals, to our knowledge. Observation of self-collection does not appear to be regulated under current law and is not currently a regulatory issue. 

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-19.

ā€‹Who Can Perform 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.
    • 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.
  • 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, or paid and unpaid adults serving in school settings, including registered volunteers, who are caring for students under their responsibility. Although these people do not necessarily need health care licensure, they 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 personā€™s training.
  • Evaluation and written documentation of their qualifications and competency. Competency assessment must be performed:
    • Prior to performing testing on patients
    • Every 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.

How to Report Test Results

California law [17 CCR Ā§ 2505] requires all facilities performing tests for SARS-CoV-2 to report results through the state electronic reporting system (CalREDIE), including businesses, organizations, 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.:
  • Within 24 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.

 

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