CLINICAL LABORATORY TECHNOLOGY ADVISORY COMMITTEE (CLTAC)
Minutes of the Meeting held on June 5, 2020
Meeting held on the Telephone Bridge Line
CLTAC Members Participating
Jonathan Bautista, Zenda Berrada, Richard Bennett, Marjorie Braasch, Kathleen Doty, Daniel Dominguez, Robert Freedman, William Gardener, John Geisse, Dora Goto, Gabor Hertz, Anthony Mills, Margie Ann Morgan, Rebecca Rosser
Former CLTAC Members Participating
Rhonda Becker, Carmen Maldonado
California Department of Public Health (CDPH) Staff Participating
Dolapo Afolayan, Yu-Chen Chang, Megan Cornejo, Karen Demby, Elsa Eleco, Paul Kimsey, Ted Lee, Katya Ledin, Donna McCallum, Kim Nachazel, Greta Nash, Martha Obeso, Beatrice O’Keefe, Jan Otey, Bessda So, Robert Thomas, Armando Tiong, Clint Venable III, Mary Wogec, Jenny Yun
Public Members Participating
Angela Aguiluz, Michael Aidan, Sara Ansari, Chanida Anukul, Thomas P. Barrow, Lydia Bourne, Angela Castillo, Anne Deucher, Brett Holmquist, Cynthia Hurst, Jerry Hurst, Jessica Huynh, Lin Kassouni Walker, Susan Kazarian, Dianne Keen-Kim, Julie Kingery, Margaret Knapp, Shiu-Land Kwong, Elizabeth Lucas, Lois Langs, Hamida Nusrat, Jamie Marks, Brian Reuwer, Rodney Roath, James Rundell, Osvaldo Santiago, Caroline Satyadi, Rachielle Sheffler, Barbara Sevilla, Laura Tucker, Denise VonBargen, Keau Wong, Tammy Zinsmeister
Welcome, General Announcements (Jonathan Bautista)
- Meeting opened at 9:02 AM.
- Mr. Bautista conducted roll call and determined that a quorum was present.
Approval of December 6, 2019, and March 13, 2020, CLTACMinutes (Jonathan Bautista)
- December 6, 2019
- March 13, 2020
- Minutes approved by Rebecca Rosser and seconded by Dora Goto
COVID-19 Update (Jonathan Bautista)
- Reviewed Governor Newsom’s resilience roadmap stages.
- Stage 1: Safety and Preparedness - Making essential workforce environment as safe as possible.
- Stage 2: Lower Risk Workplaces - Creating opportunities for lower risk sectors to adapt and re-open.
- Modified school programs and childcare re-open.
- Stage 3: Higher Risk Workplace – Creating opportunities for higher risk sectors to adapt and re-open.
- Stage 4: End of Stay-at-Home order – Return to expanded workforce in highest risk workplaces. Requires Therapeutics.
- Reviewed California’s 6 indicators for modifying the Stay-At-Home Order:
- Widespread testing with contact tracing.
- The state’s ability to care for the elderly and medically vulnerable Californians.
- Hospital capacity to handle a potential surge in patients, plus resume normal preventative and other medical care.
- The identification of promising treatments.
- The development of guidelines for businesses and schools to allow physical distancing even as they re-open.
- The creation of a data tracking system that provides an early warning if the state needs to reinstate a stay-at-home order.
- California needs to achieve “epidemiologic stability”: No more than 5% increase hospitalizations, fewer than 25 coronavirus cases per 100,000 residents in the last 14 days, and less than 8% test positivity.
Department News (Paul Kimsey)
- Department COVID-Response:
- We are on the frontlines of the response.
- Many CDPH staff have been assigned to work on the response.
- The Testing Task Force (TTF) is successful in increasing testing in California.
- TTF to stand down in June.
- All data is online through CDPH.
- New Center for Laboratory Science update:
- We have delayed the new center launch until January 2021.
- There will be phased-in responses in between.
- Data and analytics
- There will be a change in disease reporting requirements.
- There will be mandatory race/ethnicity data reporting by August 1st.
- A subcommittee will be set up to review these requirements and provide insight.
- Any feedback is welcomed and should be emailed through the
Overview of Serological Tests (Katya Ledin)
- SARS-CoV-2 Serology Testing Update:
- Food and Drug Administration (FDA) oversight:
- Allowed serological tests to be marketed without review until April 28, 2020.
- Is now reviewing test performance and publishing data on FDA website.
- 29 rapid serology tests were removed from FDA EUA application list as of May 26, 2020, and should not be distributed.
- There are three types of serological tests available:
- Rapid lateral flow.
- Antibodies are not detectable until 10-14 days after disease onset.
- Sensitivity and specificity are important.
- Enzyme immunoassay (EIA).
- None are currently approved for diagnosing COVID-19.
- Serology tests can be for total antibody, or IgG, IgM, and/or IgA.
- Interpretation of serology results – not diagnostic:
- Rapid lateral flow test:
- Positive results do not definitely indicate prior exposure to coronavirus (COVID-19 or other).
- Positive results do not indicate protection from future coronavirus infections.
- Negative results do not exclude either current or recent COVID-19 infection.
- EIA and chemiluminescent tests:
- Positive results indicate antibody response to coronavirus (COVID-19 or other).
- Cannot distinguish between current active vs. prior resolved coronavirus infection.
- Not known at this time if response is partially or fully protective against future infection.
- Negative results mean patient has not developed an immune response to COVID-19 but does not exclude current or recent infection.
- Antibody levels typically not detectable until 7-14 days after disease onset.
- Uses for Serology Tests:
- Identification of individuals with adaptive immune response to SARS-CoV-2.
- Studies on immunity duration and protection to prevent or minimize severity of re-infection.
- Studies on seroprevalence in exposed populations.
- Determining who may donate convalescent plasma, a possible treatment for those who are seriously ill from COVID-19.
Laboratory Field Services (LFS) COVID-19 Response (Robert Thomas)
- COVID-19 Email Box
Prioritization of License Applications
- LFS created a new email address specifically for issues or questions related COVID-19: the address is LFSCOVID@cdph.ca.gov.
- You can use this email for personnel or lab questions.
- The mailbox is monitored seven days a week.
- We try to respond within 48 hours.
- The mailbox is being used for applications for licensure, registration, or to change your present license to enable your lab to perform COVID testing.
- We try to process these applications within 10 days.
- As of June 4, 2020, a total of 1257 inquiries have been received.
- As of June 3, 2020, 2,182,671 tests have been conducted in California and reported to CDPH.
- 320 labs identified by LFS and the TTF are currently testing and 171 are planning to test.
Temporary Testing Sites
- LFS has received non-traditional applications from:
- Research laboratories
- Cannabis laboratories
- Pharmacy laboratories
- Dental laboratories
- LFS has received inquiries pertaining to veterinarians performing testing.
- For those laboratories that are eligible to perform COVID-19 testing, the applications are processed in 10 days or less.
- Renewal applications
- New applications for laboratories not performing COVID-19 testing
Specimen Collection Issues
- The general requirement, as stated in the Business and Professions Code (BPC) section 1265, is that a separate license or registration must be obtained for each laboratory location.
- Exceptions to the general requirement that each laboratory location obtain a separate license/registration are to be strictly interpreted.
- BPC section 165(d)(1): Exception for “laboratories that are not at a fixed location”
- Examples provided by statute:
- Mobile units providing laboratory testing.
- Health screening fairs.
- Other temporary testing locations.
- The requirements for a temporary testing site are:
- Same owner.Qualified laboratory personnel.
- Laboratory Director.
- Qualified technical supervisor.
- Specimen collection site regulations:
- California law requires State and federal licensure and certification for sites performing clinical lab testing, including COVID-19 testing.
- A site does not need LFS licensure if it is only collecting specimens.
- Licensed testing laboratory directors are responsible for ensuring the integrity of specimens accepted by the laboratory, and this extends to collection.
- Personnel authorized to collect specimens for COVID-19 testing:
- Tests require different specimen types:
- Molecular polymerase chain reaction (PCR) tests require a nasal specimen collected with a nasopharyngeal swab, which is not in the scope of practice of any clinical laboratory personnel certified or licensed under Chapter 3.
- Serological or antibody tests require a blood specimen, which all clinical personnel licensed by LFS under Chapter 3 are authorized to collect.
- Testing personnel qualifications:
- Governor Gavin Newsom’s Executive Order N-25-20 temporarily suspends certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 for all persons who meet the requirements under Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing (42 CFR § 493.1489) and who are performing analysis samples to test for SARS-CoV-2.
- These requirements are suspended for the duration of the California emergency order.
- Waived tests are not mentioned because none were available at the time the order was issued.
- Laboratory directors are responsible for assessing and documenting the competency of all personnel testing for SARS-CoV-2.
- This order does not waive or otherwise affect any other personnel requirements or facility licensing requirements.
- This order has been addressed on our LFS COVID-19 for Labs website.
- Any specific questions can be directed to the LFSCOVID mailbox.
- Guidance regarding testing and collection sites as stated on the LFS COVID-19 for Labs website:
- Specimen Collection Sites vs. Specimen Testing Sites
- Tests and Test Classification
- Laboratory and Personnel Requirements
- Information for Pharmacists
- Information for Physician Offices and Urgent Care Clinics
- California Reportable Disease Information Exchange (CalREDIE) Disease Reporting and Test Report Notifications
- Note Regarding Enforcement Actions
- One of the major unmet needs to enable increased testing for COVID-19 is the capacity for efficient and timely transmission of patient sample information between collection sites, testing laboratories, and facilities receiving results.
- To assist the Department in gathering information that will enable it to work toward a resolution of this problem, the Department is requesting CLTAC to convene a subcommittee to provide a white paper addressing the following questions:
- What prevents clinical and public health laboratories from full, timely reporting of test results?
- What would an ideal patient data system include?
Review of Questions Received (Mary Wogec and Katya Ledin)
- What test is being used?
Regarding testing personnel, who can perform testing?
- A variety of tests are being used.
What individuals should be tested or should not be tested?
- According to Governor Newsom’s Executive Order, certification and licensure requirements of California Code of Regulations, Title 17, section 1079 and Business and Professions Code section 1206.5 are suspended for all persons who meet the requirements under Clinical Laboratory Improvement Amendments of section 353 of the Public Health Service Act for high complexity testing (42 CFR § 493.1489). At the time the order was issued, all testing was high complexity testing, therefore testing personnel must be able to perform high complexity testing.
What validation studies does LFS recommend for SARS-CoV-2 antibody testing?
- Any individual can be tested. Serology results of serology testing are not useful for diagnostic purposes.
With the Shelter-in-Place due to COVID-19 emergency, residents have requested blood collections at home to minimize unnecessary trips. While there are independent phlebotomy services operating under their own Clinical Laboratory Improvement Amendments (CLIA) certificate of Waiver and State registration, what are the compliant elements the testing laboratory needs to document if an independent phlebotomy service is utilized for blood collection at home?
- CDPH refers people to the FDA, which provides information and a validation panel.
Was the need for a physician test order waived for COVID RNA testing? If not, how are the drive-up sites performing COVID-RNA testing with no provider directed under CA law?
- If a company has a CLIA certificate and a California clinical laboratory license or registration, it is a laboratory, not an independent phlebotomy service. Existing California law does not allow phlebotomists to work independently of a clinical lab director, unless they are performing phlebotomy for insurance purposes, or for forensic purposes in a jail or other law enforcement facility, and in those circumstances they must work under supervision or a licensed physician and surgeon or designee, who is responsible for their work. A laboratory director is responsible for determining the competency and performance of laboratory staff, including phlebotomists, as well as ensuring the adequacy and integrity of specimens accepted for testing.
Are there longer wait times for facility licensing?
- Business and Professions Code 1288 requires that a clinical or public health laboratory accept assignments for clinical laboratory tests only from licensed healthcare providers with a scope of practice that authorizes ordering clinical laboratory tests, or their representatives. All the available tests for SARS-CoV-2 must be ordered by an authorized healthcare provider.
- If patients don’t have an order from their own provider, sites may have an ordering provider on site, and in other cases (Verily, Optum Serve, Avellino) the local or State health officer acts as the ordering provider.
When will audits resume a normal schedule?
- There is no delay in processing laboratory renewals or new applications.
What has the impact been to CLS training sites? When will training resume?
- Schedules for Federal CLIA inspections are under Centers for Medicare and Medicaid Services (CMS) and are not determined by LFS. At this time, state inspections are only being conducted for complaint investigations. LFS is not able to say when the California state of emergency will end, and normal operations will resume. We will post information on our website as it becomes available.
Is there data on prevalence in the population? Are there any studies being conducted?
- LFS notified MLT and CLS training programs that it will accept distance-learning and simulation instruction for didactic coursework leading to CLS or MLT licensure. However, LFS does not have the authority to approve simulated laboratory experience to meet the practical rotation requirements, as these requirements are set in the California Business and Professions Code sections 1260-1261 and have not been waived.
- At present, LFS cannot give a date for resumption of training. Decisions regarding schools reopening are still under consideration and may vary from one system to another. Again, we will post information on our website as it becomes available.
- A vast amount of data is being collected on every aspect of this disease and the virus that causes it, and the data is being studied closely by scientists and researchers at institutions across the state and around the world. There are excellent sources of information on the CDC and FDA webpages. Another helpful resource is the
California Testing Task Force website.
New Business (Jonathan Bautista)
Any new business to be sent to Megan Cornejo at
Future Items (Jonathan Bautista)
Any future items to be sent to Megan Cornejo at
Adjournment (Jonathan Bautista)
Meeting closed at 10:37 am.