CLTAC Board Members Participating:
Zenda Berrada, Christine Darmanian, Ann Deucher, Dan Dominguez, William Gardner, Dora Goto, Gabor Hertz, Jessica Huynh, Dan Leighton, Jamie Marks, Anthony Mills, Tula Nieva, Jowin Rioveros, Lu Song
California Department of Public Health (CDPH) Staff Participating:
Zenda Berrada, Jason Boatman, Yu Chen Chang, Elsa Eleco, Yancarlo Escarate, Elaine Flores, Carol Glaser, Robert Hunter, Joselita JoaquĆn, Paul Kimsey, John King, Jennifer Kyle, Katya Ledin, Donna McCallum, Bea OāKeefe, Bessda So, Robert Thomas, Catherine Tolentino, Clint Venable, Deb Wadford, Mary Wogec
Public Members Participating:
Angela Melanie Aguiluz, Maureen Ahler, Isabel Bjork, Katherine Borkovich, Jeanette Chang, Lifang Chiang, Kathleen Doty, Gina Douville, Denise Driscoll, Cynthia Hurst, Frances Ivester, Harmeet Kaur, Peggy Kollars, Lois Langs, Elizabeth Jean Picardal Lucas, David Luong, Carmen Maldonado, Salu Ribeiro, Mark Richardson, Rodney Roath, Melanie Sloan, Ann Tonini, Carol Wong
Welcome, General Announcements (Zenda Berrada, PhD)
- Meeting Opened at 9:01AM
- Dr. Berrada announced that attendance record will be taken via Microsoft Forms and that all participants should check in via the link in the chat.
- This will be used to capture interest in being included on the CLTAC email list and to re-establish mailing list.
- Dr. Berrada conducted roll call and determined that a quorum of CLTAC board members was present.
Approval of September 10, 2021, CLTAC Meeting Minutes (Zenda):
- CLTAC board members moved to approve the minutes.
Department News (Dr. Paul Kimsey, PhD):
- Announced that Robert Thomas has returned to Lab Field Services (LFS) after an extended leave of absence.
- Thanked Elsa Eleco for serving as acting chief in Mr. Thomasās absence and the other section chiefs of LFS for stepping in to steer LFS in his absence.
- Announced that effective December 30, Dr. Kimsey will be retiring from State service but will be transitioning to a new role as a retired annuitant in CDPH.
- Tentative return of early to mid-January in this role. Will be tasked to continue internal projects at CDPH.
- Noted that the emergence and spread of the new COVID variant, Omicron, has resulted in inquiries from the public.
- In order to give a picture of what the department is doing, Dr. Carol Glaser, with input from Dr. Deb Wadford, will present some of the latest information about the new variant.
Update on SARS-COV-2 Omicron ā Variant of Concern (Dr. Carol Glaser and Dr. Deb Wadford)
Please note that a copy of the presentation slides and a recording of the meeting will be available upon request
Highlights
- Dr. Wadford informed Dr. Glaser the week of Thanksgiving of a recent news report on a development coming out of South Africa about a potentially more infectious COVID variant.
- Although at the time the new variant was not present in the US, the pandemic has shown itself to be unpredictable.
- First known case in the US was in California and quickly more cases were identified nationwide.
- The emergence of this new variant highlights the need for strong laboratory testing infrastructure to identify cases and detect variants of concern.
- First cases out of southern Africa were identified in Gauteng province area of South Africa in early November.
- Cluster outbreaks among students led to inquiries to detect the variant that was causing the increase in infections.
- Upon detection and sequencing of the new variant, between 50-60 mutations were identified, many that seemed to increase its transmissibility.
- Early reports indicate that current vaccines are capable of limiting the virusā capability to cause severe disease, but more information needs to be collected.
- Current detection methods such as PCR and antigen should still work, and data is being collected to confirm.
- Current antiviral treatments are expected to work, and more clinical information will be coming through in the weeks ahead.
Monoclonal antibodies treatments may still work but further data needs to be collected.
- Questions
- Does the number of mutations in Omicron reflect pressure from vaccines targeting the spike protein?
- Response: More information needs to be collected.
Branch Report (Robert Thomas)
- Reminded participants that the session is being recorded and that the recording will be available upon request.
- Clarified his return to LFS on November 25, 2021.
- Thanked LFS Section chiefs and admin for supporting the program in his absence.
- Special thanks to Elsa Eleco for stepping in to fill his role while he was out on leave.
- Thanked onsite inspection examiners for continuing to work during the pandemic to inspect labs for compliance.
- The program has prioritized filling vacancies over the last several months and has been successful in hiring for several key positions.
- Modernizations of LFSā application process have led to improvements in licensing and implementation of other tools for public use.
- Over-the-counter (OTC) Testing
- LFS has received inquiries requesting guidance on the use of OTC test kits for COVID 19.
- FDA OTC tests can be performed by individuals on themselves, or by parents/guardians on children or adults that are under their care, without needing a CLIA certificate or a State lab license or registration.
- However, if an OTC test is performed on a patient by another person, for example, a staff person on an employee, or by school staff on a student, it is considered a waived test.
- In this case the facility performing the test must meet all applicable state and federal requirements for waived testing and the person performing the test must do so under the responsibility of the facilityās laboratory director.
- The Food and Drug Administration (FDA) has provided a
Frequently Asked Questions (FAQ) (https://www.cms.gov/files/document/over-counter-otc-home-testing-and-clia-applicability.pdf)
- On November 15, 2021, the FDA revised its policy concerning laboratory developed tests (LDTs).
- The new guidance supersedes the policy issued in May 2020, which suspended requirements for premarket review and approval for LDT COVID-19 tests.
- The new policy withdraws that suspension, and updates FDA policies for COVID-19 tests, including COVID-19 LDTs. Going forward the FDA now generally expects newly offered COVID-19 tests, including LDTs, to have an EUA, or traditional marketing authorization prior to clinical use.
- For tests currently being offered without the submission of an EUA request, the FDA generally expects the submission of an EUA request as described in the guidance.
- If a lab is using an LDT that it was performing prior to the new policy announcement on November 15, the lab can continue to use it but should submit documentation for FDA review as soon as possible.
- For such tests and notified tests with pending EUA requests, FDA generally intends to review the EUA requests and, if the test is not subsequently authorized, expects developers to cease marketing the test within 15 calendar days of being notified.
- The FDA stated that it is revising the prior policies because we are at a different stage of the pandemic, and there are many more EUA-authorized COVID-19 tests available now. In addition, experience has shown that many of the COVID-19 tests offered prior to FDA review were determined to have poor performance, when the FDA reviewed the EUA request.
- The policy is subject to change again pending the evolving nature of the pandemic.
- More information can be found at the following links:
- Issues regarding laboratory personnel requirements
- Under the Governorās executive order suspending California laboratory personnel licensure requirements, unlicensed personnel who meet the federal CLIA requirements for high-complexity testing at 42 CFR 493.1489 are allowed to test ONLY for SARS-CoV-2 in California laboratories for the duration of the California State of Emergency.
- However, upon the expiration of the state of emergency, the governorās executive order will no longer be in effect.
- LFS does not have authority to extend the suspension. These statutory requirements can only be changed by an executive order or through the legislative process.
- Neither LFS nor the Department cosponsors legislation proposed by external parties.
- Any question regarding legislation should be directed the CDPH Office of Legislative and Governmental Affairs.
- Questions from CLTAC Participants
- Request for a summary of findings by LFS at the Valencia Lab Branch (VBL) and any comments from LFS on findings.
- Response: LFS does not address questions regarding a specific laboratory or personnel issue in the context of a CLTAC meeting. Questions regarding an application or about a regulatory action regarding a specific facility need to be directed to the appropriate LFS section.
A brief on the VBL has been posted on the CDPH website (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/VBL-issue-brief.aspx). The report of the findings can be requested via public records request inquiries to CDPH Office of Communications.
- Regarding COVID-19 testing done by lab personnel in a public health lab, once the executive order has been lifted, would a clinical laboratory scientist (CLS) no longer be able to test in a public health lab?
- Response: Yes, judging from the way the executive order is written, CLS would not be allowed to perform COVID 19 testing in a public health lab. Only public health microbiologists (PHMs) would be allowed to continue performing testing in public health labs.
- To continue performing testing, a CLS would need to get PHM certification as well.
- Regarding the CDPH summary on the LFS inspections, did Elsa or Bob draft the summary? Does LFS agree with CDPHās assessment given the magnitude of deficiencies found at VBL? And can LFS comment on that and do they agree with the summary by CDPH?
- Response: Questions and concerns regarding the VBL can be directed to CDPHās Office of Communications at
Media@cdph.ca.gov. LFS stands behind their staff and the report on VBL.ā