COVID-19 for Laboratories: Frequently Asked Questions (FAQ's)
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General Questions | Clinical Training Providers & Students | Laboratory Questions | Testing and Collection Sites | Laboratory Personnel
CDPH warns consumers against use of COVID-19 tests not approved by the U.S. Food and Drug Administration (FDA)
There are two different types of tests currently used to detect SARS-CoV-2, the virus that causes COVID-19 disease: diagnostic tests, which show current infection, and antibody tests, which may indicate infection in the past.
Diagnostic tests can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. There are currently two types of diagnostic tests for SARS-CoV-2: molecular tests, such as RT-PCR tests, which detect the virus’s genetic material, and antigen tests, which detect specific proteins on the surface of the virus.
Molecular tests diagnose COVID-19 based on detection of the virus’s genetic material in a sample from the patient’s nose or throat. Some terms for different types of molecular tests are diagnostic test, viral test, molecular test, nucleic acid amplification test (NAAT), RT-PCR test, and LAMP test. Molecular diagnostic tests that detect the genetic material of the virus are generally the most accurate method for diagnosing active COVID-19 infection, although no test is 100% accurate all of the time. California’s community-based testing sites, including Verily’s Project Baseline and OptumServe, use viral PCR tests. Molecular tests are used to determine if a person has an active infection.
Antigen tests detect viral proteins on the outer surface of the coronavirus, using a sample from the nose or throat. Antigen tests may also be called rapid diagnostic tests. They usually provide results faster than molecular PCR tests but have a higher chance of missing an active infection than molecular tests or returning a false positive when used to test asymptomatic persons. Your health care provider may order a confirmatory molecular test if your antigen test shows a negative result, but you have symptoms of COVID-19. Point-of-care antigen tests are currently being used in skilled nursing facilities, schools, and other communal living settings to monitor for outbreaks. Antigen tests are used to determine if a person has an active infection.
Antibody tests, also called serological, serology, or blood tests, use a blood sample (finger prick or blood draw) to look for antibodies, which may tell if you had a past infection with the virus that causes COVID-19. Antibodies are disease-specific proteins made by your immune system to help fight off infections and can provide immunity against getting that disease again. Antibodies can take one to three weeks to develop after you have an infection and may stay in your blood for several weeks or more after recovery, so antibody tests are not reliable or approved for diagnosing a current COVID-19 infection or showing that you do not have COVID-19. Antibody tests can indicate that a person has had an infection in the past. To see if you are currently infected, you need a viral test. Antibody tests are also an important tool used by public health authorities for tracking the spread of a disease to control outbreaks.
California residents should understand that:
- There is currently no guidance from the Centers for Disease Control and Prevention (CDC) on how to interpret or take public health action in response to a positive or negative COVID-19 serology result.
- They should check the federal Food and Drug Administration (FDA) website to determine if a company or physician that claims FDA approval or authorization for a serology test is actually approved.
- Only a few COVID-19 serology test kits have been reviewed by the FDA or received Emergency Use Authorization.
- Negative results do not rule out COVID-19 in a patient and results from serological testing should not be used as the sole basis to diagnose or exclude infection, or to determine infection status.
For more information about unauthorized COVID-19 tests, visit the FDA website for an update on serological tests and the California Testing Task Force website (PDF) for more guidance on serology testing.
For general information about coronavirus test types, visit the FDA Coronavirus Testing Basics webpage.
Where can I get tested?
Laboratory Field Services does not have a comprehensive list of all labs that provide COVID-19 testing, but you can use the following resources to locate a lab:
If you think you are sick, check the Coronavirus.gov website for the latest information about COVID-19 prevention, symptoms, and answers to common questions.
Do I need a doctor's order to get tested?
California law (BPC section 1288) requires that a clinical or public health laboratory accept assignments for clinical laboratory tests only from persons licensed under the provisions of law relating to the healing arts as healthcare providers with a scope of practice that authorizes ordering clinical laboratory tests or their representatives. On May 12, 2020, the Director of the Department of Consumer Affairs issued a waiver authorizing licensed pharmacists to order tests and collect samples for SARS-CoV-2 testing for the duration of the COVID-19 emergency.
Five over-the-counter tests can be performed without an order (pregnancy, glucose level, cholesterol, fecal occult blood, and HIV), but all the tests for SARS-CoV-2 must be ordered by licensed medical personnel authorized to order such tests.
A recent Physician or Practitioner Order for COVID-19 Tests (PDF) issued by CMS states that CMS will not require an order from a treating practitioner as a condition of Medicare coverage of COVID-19 testing during the COVID-19 emergency.
However, this statement clarifies that FDA requirements for a prescription and state requirements around ordering diagnostic tests still apply.
I will be travelling to a country that requires a COVID-19 test and I need an official letter certifying that the lab that conducts my COVID-19 test is certified or accredited by the government. Can you supply such a letter?
Yes, Laboratory Field Services is the State regulatory agency for clinical laboratories and can supply the letter you need. Please send an email to LFSCOVID@cdph.ca.gov and provide the name and address, including street address and zip code, of the laboratory performing your test. If you want the original letter, please provide your USPS mailing address.
We will verify licensure of the lab and email you a scan of the letter, and mail the original by USPS.
If you are using a service like a pharmacy or a community site that collects samples and sends them to another lab for testing, be sure to provide the name and address of the lab that performs the testing. We do not license collection sites and cannot verify lab licensure using a collection site. You will need the name and address of the lab that will perform your test and issue the test results. For more information, please visit our Information for Travelers webpage.
Where can I report a coronavirus scam?
Report coronavirus scams to the National Center for Disaster Fraud Hotline at 866-720-5721 or by email to email@example.com, or report it on the FBI tips website. If it is a cyber scam, submit your complaint through the government cybercrime website. Criminals are exploiting COVID-19 through scams including selling fake cures, posing as legitimate organizations to obtain private information, activating malicious websites and apps to gain access to your devices, and seeking donations for illegitimate organizations. Also visit the U.S. Department of Justice - Report COVID-19 Fraud website.
You can also submit reports about suspected fraudulent testing or therapy to the FDA's Health Fraud Program or by email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
Where can I file a complaint concerning a laboratory?
Please visit the Laboratory Field Services - Contact Us webpage for details on filing a complaint about a clinical laboratory. If you believe it is a cyber scam, submit your complaint through the government cybercrime website.
What are the COVID-19 workplace safety rules for healthcare workers and/or non-healthcare workers?
Please visit the Cal/OSHA website: Cal/OSHA Guidance on Requirements to Protect Workers from Coronavirus.
I had a COVID-19 test but I have not gotten my results. Can you help me get my results?
Laboratory Field Services does not have access to test results. Test results are released only to the authorized healthcare provider who ordered the test or, with the provider’s authorization, to the patient. For questions about your test results, please contact the healthcare provider who ordered your test or the laboratory that performed the test.
Does the governor’s executive order allowing waiver of licensing requirements apply to clinical laboratory scientist (CLS) or medical laboratory technician (MLT) students, trainees, and phlebotomists?
Governor Newsom's Executive Order N-39-20 (March 30, 2020), allowing waivers for some medical professional licensing requirements, does not apply to CLS or MLT students and trainees, including medical laboratory technicians and phlebotomists, licensed or certified under Business and Professions Code Chapter 3.
Can Clinical Laboratory Scientist (CLS) or Medical Laboratory Technician (MLT) licensure candidates receive clinical rotation training in a simulated lab?
There are currently no alternate means of meeting required practical experience for CLSs and MLTs. Laboratory Field Services (LFS) recognizes that many locations for required clinical laboratory experience may be unavailable for CLS and MLT preparation during the COVID-19 emergency. Although LFS accepts distance-learning and simulation instruction for didactic coursework leading to CLS or MLT licensure, LFS does not have authority to approve simulated laboratory experience to meet the practical rotation requirements of California law (Business and Professions Code § 1260-1261).
I cannot reach my school or laboratory to provide documents needed for certification or licensing. I cannot reach my previous school or employer to request documents supporting my application for MLT or CLS licensure or for CPT certification.
For the duration of the COVID-19 emergency, Laboratory Field Services will not consider a CLS, MLT, or Trainee license application abandoned if the application remains incomplete beyond the standard 60-day time limit because of missing education or experience documents. This temporary policy also applies to CPT applications only for the duration of the COVID-19 emergency.
I am a trainee. My training was interrupted by the COVID-19 emergency and I haven’t been able to complete it, but my trainee license is about to expire. What can I do?
LFS is extending the licensure duration of existing trainee licenses by six months from the date of expiration listed on the license. This extension is valid for the duration of the COVID-19 emergency and subject to the following conditions:
- The trainee license expires between March 31, 2020 and December 31, 2020.
- The trainee must request for an extension.
- The trainee must provide training rotation schedule.
This extension may be amended at the discretion of LFS.
Which labs can test for COVID-19?
Laboratories testing for COVID-19 must meet all requirements mandated in California and federal CLIA law.
Laboratories performing waived tests must have a CLIA certificate of waiver and a California clinical laboratory registration and a laboratory director and waived laboratory supervisor who meet all State and federal personnel requirements.
Laboratories performing tests classified under CLIA as moderate or high complexity must have a CLIA certificate of compliance or a certificate of accreditation and a California laboratory clinical license, as well as a laboratory director, general supervisor, technical supervisor, or technical consultant who meet all State and federal personnel requirements.
Please note that all laboratory-developed tests and all tests not classified by the FDA default to high-complexity testing, and require a CLIA certificate of compliance or certificate of accreditation and a California laboratory clinical license.
The FDA has not specified a specialty or subspecialty for SARS-CoV-2 testing. A laboratory with a license in any specialty or subspecialty may perform SARS-CoV-2 testing.
However, California law specifies the scope of practice for personnel licenses, and requires a laboratory director to hold a license that authorizes the licensee to direct testing in the specialty or subspecialty of a test as specified in BPC section 1207 and 17 CCR sections 1030.6, 1030.7, and 1031. Testing for COVID-19, the disease caused by the SARS-Cov-2 virus, is under the sub-specialty of virology in the specialty of microbiology. The specialist licenses that allow a person to direct molecular SARS-CoV-2 testing are clinical chemistry and clinical microbiology.
Therefore, a laboratory performing testing for COVID-19 must have a director licensed to direct one of these specialties, or the laboratory must have a clinical consultant, general supervisor, or technical supervisor qualified in these specialties, depending on the complexity of testing.
California law allows for multiple laboratory directors, with one who meets CLIA qualifications designated as the CLIA director; this gives a laboratory the option of adding a person qualified to direct COVID-19 testing as a co-director.
California licensed personnel authorized to direct moderate and high complexity COVID-19 testing include the following:
- Board Certified Pathologist
- Doctor of Medicine or Doctor of Osteopathy with experience directing a non-waived CLIA certified laboratory.
- Clinical Laboratory Bioanalyst
- Clinical Chemist
- Clinical Microbiologist
How can a laboratory obtain a license to perform COVID-19 testing?
In order to be approved for licensure, a laboratory must fulfill requirements mandated by State and federal law.
The LFS licensing webpage includes a list of forms required for the license application package.
Although California has waived the state licensing requirements for COVID-19 testing personnel, the state personnel requirements for other laboratory personnel remain in effect, including requirements for laboratory directors, supervisors, and consultants.
The laboratory's director, technical supervisor, technical consultant, clinical consultant, or general supervisor must meet requirements for the complexity and specialty of testing being performed. State requirements for these personnel can be found in Business and Professions Code sections 1207 and 1209, and Title 17 California Code of Regulations sections 1030-1036. The federal qualifications for these laboratory personnel can be found in Subpart M - Personnel for Nonwaived Testing (42 CFR §§ 493.1351 - 493.1495).
If you are submitting an application for COVID-19 testing only, we will do our best to expedite the process and notify you of the decision within 10 days of receipt of a complete application. If the application is approved, the licensed laboratory can begin testing as soon as the PDF certificate is received by email.
An out-of-state CLIA laboratory without a California license may not test COVID-19 specimens originating in California unless it has a California license.
Does an out-of-state lab licensed in California need CDPH Laboratory Field Services approval to conduct COVID-19 testing?
An out-of-state lab with a California state clinical laboratory license does not need further approval from Laboratory Field Services to perform COVID-19 testing. CDPH requests that all labs notify LFS and indicate 1) the name of the COVID-19 test and testing platform, and 2) if the test was approved through the EUA process or if it has been validated through the LDT process specified in 42 CFR § 493.1253.
Out-of-state laboratories performing testing on samples originating in California are required to report results for California patients through the CalREDIE electronic reporting system. For more information, please visit the CalREDIE webpage.
How can I list my lab on the Testing Task Force Lab List?
The California Testing Task Force (TTF) is working to ensure that Californians who need COVID-19 testing have access to tests. As part of this effort, the TTF is publishing a list of laboratories that are willing to receive samples to provide COVID-19 testing for a variety of sectors (e.g., routine healthcare facility testing, occupational health testing, hospitals, skilled nursing facilities, local health departments, etc.). To be included on this list, a lab must meet 4 criteria:
- Lab has a valid California clinical laboratory license and a CLIA certificate.
- Lab is running FDA EUA molecular or antigen diagnostic tests.
- Lab has notified Laboratory Field Services that it performs COVID-19 testing via the COVID-19 Notification Form.
- Lab is submitting data to CalREDIE (either via ELR or .csv).
To list your laboratory, you will need to submit an online notification form. For information about listing your laboratory and a link to the online notification form, please visit the California COVID-19 Testing Task Force Lab List webpage.
Where can we find information about lab safety and COVID-19?
Please 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).
What are the reporting requirements for COVID-19?
On March 9, 2020, the list of reportable diseases in Title 17, California Code of Regulations (17 CCR) section 2500 was amended to include COVID-19 and Novel coronavirus infections, and 17 CCR section 2505 was amended to include SARS-CoV-2 and Coronavirus, novel strains, effective immediately.
On July 28, 2020, the reporting regulations at 17 CCR section 2500 and 2505 were amended to change reporting times and require additional patient information.
Clinical laboratory reporting
- All clinical laboratories operating and testing California specimens for SARS-CoV-2, including those operating at drive-through sites or off-site, and laboratories located outside California, are required to report through the CalREDIE Electronic Laboratory Reporting system (ELR) all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from molecular and antigen diagnostic tests and antibody/serology tests for SARS-CoV-2 within 8 hours from the time the laboratory notifies the health care provider or other person authorized to receive the report. Please note that laboratories no longer need to report SARS-CoV-2 results by telephone within one hour.
- Title 17, California Code of Regulations section 2505 now requires laboratories to report data on patients’ race and ethnicity for all COVID-19 test results. Please revise your 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.
Further information about reporting requirements is available on the CalREDIE webpage.
Healthcare provider reporting
- Ordering health care providers are required to report to the local health officer for the jurisdiction where the patient resides results of cases or suspected cases of COVID-19 immediately by telephone, and should contact the local health officer for specific requirements. (17 CCR section 2500 (b))
- Title 17, California Code of Regulations section 2500 now requires healthcare providers to report data on patients’ race, ethnicity, current gender identity, sex assigned at birth, and sexual orientation for all COVID-19 test results. Please revise your requisition forms to include this information so that you can include it when you report test results.
Serological/antibody test results
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, 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.
Further information about reporting requirements is available on the CalREDIE webpage.
Where can I learn more about Electronic Laboratory Reporting?
For more information about the CalREDIE Electronic Laboratory Reporting (ELR), visit the CDPH California Reportable Disease Information Exchange ELR webpage. CalREDIE has established a special team to assist labs with questions about COVID-19 testing. You can contact them directly for help with COVID-related questions at CalREDIEHelp@cdph.ca.gov.
What is the timeline for laboratories to report COVID-19 test results?
Any laboratories approved to test for SARS-CoV-2 must report all positive and non-positive (negative, indeterminate, and specimen unsatisfactory) test results from both antigen and molecular and antibody/serology tests for SARS-CoV-2
through the CalREDIE Electronic Laboratory Reporting system (ELR) within 8 hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
How can I get clarification on SNOWMED codes for SARS-COV-2 assays?
Please use the encoding guidelines for ELR messages for SARS-CoV-2. The LOINC codes are pre-release codes, developed for special use. You can find them, and check for future updates, at https://loinc.org/prerelease/.
In addition, please use the following SNOMED codes:
- 260373001 Detected
- 260415000 Not detected
- 419984006 Inconclusive
- 125154007 Specimen unsatisfactory
Please visit the California Reportable Disease Information Exchange ELR webpage for all questions regarding lab codes for SARS-COV-2 assays.
Does California approve Lab Developed Tests (LDT) for COVID-19. We would like to develop our own test/assay. Can we submit an EUA to the CDPH? I heard on the news that the FDA said states can approve COVID-19 tests?
California has not established a process to authorize manufacturing, use, and distribution of COVID-19 tests. However, the CDPH guidance letter to lab directors suggests that clinical laboratories utilize an alternative pathway in California law authorizing modifications to existing FDA approved tests or development of an entirely new lab developed test (LDT), provided that the lab director maintains responsibility for all quality control testing procedures, personnel procedures, personnel competency assessment, test results reporting, and compliance with all other applicable state and federal clinical laboratory laws.
Are testing labs able to use commercially available testing kits right away? What sort of approvals must we obtain prior to testing either a commercially available test or a lab developed test?
Before testing for clinical purposes, laboratories must first validate COVID-19 testing methods available under an EUA in the specific lab where they will be conducted. For more information about Emergency Use Authorization (EUA) needed to perform testing, download the FDA document Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
Who does a laboratory notify about its development and use of lab developed (LDT) for COVID-19?
LFS requests that you also notify CDPH Laboratory Field Services at LFSCOVID@cdph.ca.gov if you are using a laboratory-developed test or are modifying a test with an FDA EAU. A laboratory under California-approved accrediting organization oversight should direct questions to its respective accrediting organization and copy Laboratory Field Services at LFSCOVID@cdph.ca.gov.
When the FDA authorizes a SARS-CoV-2 test under an EUA for use at the point of care, does that mean it is CLIA waived?
Yes. The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. Under an EUA, such tests 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 is qualified to have the test performed there under a CLIA Certificate of Waiver or Certificate of Compliance.
The term “point of care” in the EUAs may include settings such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel to perform the test and are operating under a CLIA Certificate of Waiver or Certificate of Compliance. These terms generally do not apply to home specimen collection or at home testing unless otherwise specified.
When tests are offered prior to or without an EUA under the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, what is their CLIA categorization?
Tests being offered prior to or without an EUA under the policies outlined in the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 that have not yet been reviewed by the FDA, are not FDA authorized, and have not received a CLIA categorization. In accordance with CLIA, tests offered under FDA policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.
For information about the complexity of FDA authorized COVID-19 tests, visit the FDA EUA website.
I am a physician with a Certificate of Waiver. What tests can I perform in my office or urgent care? Can I perform rapid serology/antibody testing?
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. Only one of the currently available serological tests, the Assure COVID-19 IgG/IgM Rapid Test Device manufactured by Assure Tech. Ltd., may be performed under a Certificate of Waiver.
Do serological tests need an EAU from the FDA?
The FDA revised its policy on antibody tests on May 4 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 this policy, whichever is later. The FDA also provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers. Visit the FDA website for an update on serological tests and information about serology test performance.
On July 21, 2020, the FDA revoked the umbrella Emergency Use Authorization issued on April 28, 2020, for SARS-CoV-2 antibody tests. Visit the FDA website for information about the revocation and a listing of serology tests with an individual EAU.
What are the Standard Operating Procedures (SOPs) for drive-up COVID-19 testing sites?
Drive-through, walk-in, or pop-up sites that advertise as "COVID-19 testing sites" may offer on-site testing for serological (antibody) tests; they may also collect specimens for molecular (RNA) or antigen testing, which are then submitted to an off-site laboratory for diagnostic testing. Some sites do 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. For information about regulatory requirements for drive-through and other types of testing and collection sites, please visit the LFS Guidance for COVID-19 Collection and Testing Sites.
Does a drive-up COVID-19 specimen collection site need a medical doctor present?
California law requires an order clinical laboratory testing from a person licensed under the provisions of law relating to the healing arts as a healthcare provider with a scope of practice that authorizes ordering clinical laboratory tests or the representative of such a provider. To perform any COVID-19 testing, a laboratory must have such an order. If people coming for testing do not have an authorized licensed healthcare provider’s order for the test, a physician or other authorized provider must be present onsite to provide the required order for testing.
Do I need a doctor'srder for a COVID-19 test?
Yes. California law (BPC section 1288) requires that a clinical or public health laboratory accept assignments for clinical laboratory tests only from persons licensed under the provisions of law relating to the healing arts as healthcare providers with a scope of practice that authorizes ordering clinical laboratory tests or their representatives.
Although some over-the-counter tests (pregnancy, glucose level, cholesterol, fecal occult blood, and HIV) can be performed without an order, all the tests for SARS-CoV-2 must be ordered by licensed medical personnel authorized to order such tests.
A recent Physician or Practitioner Order for COVID-19 Tests (PDF) issued by CMS states that CMS will not require an order from a treating practitioner as a condition of Medicare coverage of COVID-19 testing during the COVID-19 emergency. However, this statement clarifies that FDA requirements for a prescription and state requirements around ordering diagnostic tests still apply.
Can pharmacists perform COVID-19 testing?
On August 25, 2020, the Director of the Department of Consumer Affairs issued an Order, DCA-20-45, that waives specified professional licensing requirements and amends the scopes of practice of pharmacists and pharmacy technicians to allow them to perform waived, point-of-care tests used to detect SARS-CoV-2, the virus that causes COVID-19 disease.
For information about licensure requirements, reporting requirements, and activities authorized for pharmacists and pharmacy technicians under this order, please consult our Guidance for Pharmacies, Pharmacists, and Pharmacy Technicians Performing Waived, Point-of-Care COVID-19 Tests.
Can phlebotomists draw blood in a tent or a car to preent sick people from entering a clinic?
Phlebotomists or other authorized clinic personnel can draw blood in a tent or car at a clinic as long as they follow lab protocols approved by the lab director and have the required level of supervision to ensure the safety of patients and clinicians.
What licensed personnel are authorized to perform the swab specimen collection for COVID-19 testing? CPT 1, Certified Medical Assistants, Licensed Respiratory Therapists, LVNs, CLS?
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 as long as 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) as long as 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 physician’s order.
- Respiratory care practitioners are authorized under their scope of practice to collect specimens using swabs, including NP and OP swabs.
- For other licensed personnel, please contact the appropriate licensing board for information about scope of practice.
Who can observe self-collection?
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.
What are the requirements to perform accessioning and other preanalytical laboratory tasks?
Under California law, persons who perform accessioning in a clinical laboratory setting must, at a minimum, meet educational and training
requirements of “unlicensed laboratory personnel” specified in Business and Professions Code section 1269(a).
LFS considers accessioning to include the following activities:
- specimen receipt and sorting;
- logging of specimen information into the laboratory’s database;
- labelling the specimen with a unique identifier or accessioning number;
- barcoding or tagging the specimen;
- performing any additional preparation prior to the submission of the sample for analysis.
- Depending on the accessioning task performed and level of training, unlicensed personnel are subject to the direct and constant supervision, or supervision and control, of a physician and surgeon or licensed clinical laboratory staff.
Unlicensed personnel who meet the minimum criteria outlined in BPC section 1269(a) and perform accessioning are prohibited from performing a clinical laboratory test or otherwise engaging in clinical laboratory practice. They may not do any of the following:
- Record test results, but they may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument.
- Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers.
- Perform any mathematical calculation relative to determining the results or the validity of a test procedure.
- When mechanical or electronic instruments are employed, unlicensed laboratory personnel may not standardize or calibrate the instrument or assess its performance by monitoring results of appropriate standards and control.
Please note that the laboratory director remains responsible for the for ensuring the competence of unlicensed personnel and for the work performed by unlicensed personnel.
Who is authorized to perform COVID-19 testing?
Executive Order N-25-20 suspends California licensure and certification requirements for testing personnel in BPC section 1206.5 and 17 CCR 1079. The executive order allows personnel who do not meet California personnel licensure requirements to perform SARS-CoV-2 testing, for the duration of the State of California declaration of emergency, if they meet federal CLIA personnel requirements for high complexity testing.
This means that testing may be performed by:
- For waived testing, anyone who meets the requirements of Business and Professions Code (BPC) section 1206.5(a) or anyone who meets federal requirements at 42 CFR § 493.1489.
- For moderate complexity testing, anyone who meets the requirements of BPC section 1206.5(b) or anyone who meets federal requirements at 42 CFR § 493.1489.
- For high-complexity testing, anyone who meets the requirements of BPC section 1206.5(c) or anyone who meets federal requirements at 42 CFR § 493.1489.
BPC Section 1206.5 authorizes anyone who works in a licensed physician office lab to perform any complexity testing without having a California license, but the person must work under the onsite supervision of the patient’s physician and surgeon or podiatrist, who must ensure the person performs the testing as required for accurate and reliable tests and have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.
Note that “analysis of samples” includes performing tests and reporting results.
On August 25, 2020, the Director of the Department of Consumer Affairs issued an Order, DCA-20-45, that waives specified professional licensing requirements and amends the scopes of practice of pharmacists and pharmacy technicians to allow them to perform waived, point-of-care tests used to detect SARS-CoV-2, the virus that causes COVID-19 disease. A Guidance for Pharmacies, Pharmacists and Pharmacy Technicians Ordering, Collecting Specimens for, and Performing COVID-19 Tests with general information on the Order is available on the DCA website. Information for testing requirements is available on the LFS website.
Who can transcribe results obtained, reported, and reviewed by a CLS into a report format accepted by electronic or other reporting system?
A person who simply transcribes, but does not perform any aspect of testing or making decisions about reporting, need not meet the requirements for testing personnel. To do this transcription, an unlicensed person must meet the requirements in Business and Professions Code (BPC) section 1269:
(a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria:
(1) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA.
(2) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities:
(A) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens.
(B) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory.
(C) The skills required for performing preventive maintenance, and troubleshooting.
(D) A working knowledge of reagent stability and storage.
(E) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory.
(F) An awareness of the factors that influence test results.
(d) Unlicensed laboratory personnel shall not do any of the following:
(1) Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument.
(f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities:
(1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control.
(2) Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument.
(3) Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers.
Please check the full text of BPC section 1269 for further information regarding what unlicensed personnel are allowed to do.
Have any California license requirement changes been made to the Pharmacy Technician role in light of COVID-19?
On August 25, 2020, the Director of the Department of Consumer Affairs issued an Order, DCA-20-45, that amends the scopes of practice of pharmacy technicians to allow them to collect specimens and perform waived, point-of-care tests to detect SARS-CoV-2, the virus that causes COVID-19 disease.
Under the terms of the DCA Order, a pharmacy technician may collect specimens for COVID-19 tests with the following conditions:
- Is limited to collecting specimens in a pharmacy under the direct supervision and control of a supervising pharmacist.
- Is limited to collecting specimens for waived tests and is limited to the following collection methods: nasal swab, nasopharyngeal swab, and throat swab.
- Must be competent and trained to collect the specimen and the specimen collection must be consistent with the test’s FDA EUA.
In addition, a pharmacy technician may perform waived, point-of-care COVID-19 tests but is limited to performing testing in a pharmacy and must do so under the direct supervision and control of a supervising pharmacist pursuant to Business and Professions Code section 4115(a).
A Guidance for Pharmacies, Pharmacists and Pharmacy Technicians Ordering, Collecting Specimens for, and Performing COVID-19 Tests with general information on the Order is available on the DCA website.
My lab needs more testing personnel- can you help me find qualified personnel?
The California Association of Medical Laboratory Technology has partnered with LFS to provide a hub to connect laboratories in need of testing personnel with qualified personnel who are available for testing. Please visit the CAMLT testing hub webpage for more information.
I am a retired CLS and I would like to help with testing.
For the duration of the COVID-19 emergency, anyone who meets CLIA requirements for high-complexity testing at 42 CFR § 493.1489 may perform COVID-19 tests in California. All other requirements for lab directors, supervisors, and technical consultants remain unchanged. The lab director is responsible for assessing employee competency. Please refer to the document CLIA Personnel Policies for Individuals Directing or Performing Non-waived Tests (PDF) posted on the CLIA website and Governor Gavin Newsom's Executive Order N-25-20 (PDF). If you are a retired CLS you will not need to reactivate your license to perform COVID-19 testing during the COVID-19 emergency. The California Association of Medical Laboratory Technology has partnered with LFS to provide a hub to connect laboratories in need of testing personnel with qualified personnel who are available for testing. Please visit the CAMLT testing hub webpage for more information.
I am a California licensed physician and surgeon and am also the director of a clinical laboratory performing testing for SARS-CoV-2. Can I order tests for people who come to my lab for testing?
A director of a clinical laboratory who is a licensed physician and surgeon or otherwise authorized to order clinical laboratory tests may
order tests for people who come to the laboratory for testing.
Note that if a person serves as ordering healthcare provider as well as a lab director, the person must report all results of SARS-CoV-2 tests as required in 17 CCR section 2500 (as a provider) and section 2505 (as a lab director).
During this emergency, may blood banks deviate from their currently approved protocols for blood drives and collection sites?
LFS recognizes that the response to the COVID-19 public health emergency will strain blood bank collection centers operating in the state. In the event of an emergency such as COVID-19, the California regulations governing blood banks (17 CCR § 1003) allow for deviations. The extent of the deviation is to be determined by the blood bank director with concurrence by LFS. The deviation is required to be commensurate with the degree of emergency.
LFS requests blood bank directors to:
- Request initial approval from LFS to use this variance to deviate from the requirements outlined in Section 1002 for the duration of the California COVID-19 emergency.
- When LFS receives this information, we will approve the request for the duration of the COVID-19 emergency and notify the blood bank of approval.
- Notify LFS of each collection event for which they use the variance and include
- The blood bank’s California biologics license number.
- The location, date, and time of each collection event.
- The nature of the deviation.
- Notify LFS after the event of adverse events associated with the collection event, if any occur.
Please contact LFS through LFSCOVID@cdph.ca.gov if you have questions.
Do blood and plasma collection centers have to report the results of SARS-CoV-2 tests ordered for purposes of donor screening?
Any clinical laboratory performing SARS-CoV-2 testing, including a laboratory performing testing to screen blood donors, must report the results as required in 17 CCR section 2505. In addition, the healthcare provider who orders the test must also report the results as required in 17 CCR section 2500. For information about reporting requirements, see above.