Skip Navigation Links12-03-21-CLTAC-Meeting-Minutes

LABORATORY FIELD SERVICES

CLINICAL LABORATORY TECHNOLOGY ADVISORY COMMITTEE (CLTAC)

Minutes of the Meeting held on December 03, 2021
Meeting held through WebEx


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 Oā€™Keefe, 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. Thomasā€™s 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 facilityā€™s 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 Governorā€™s 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 governorā€™s 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 CDPHā€™s 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 CDPHā€™s Office of Communications at CDPHpress@cdph.ca.gov. LFS stands behind their staff and the report on VBL.

On-site Licensing Section Report (Elsa Eleco)

  • Summary of basic functions
    • Approval of accrediting organizations (AOs) for deemed status
    • Oversight of California-approved AOs
    • Biennial on-site inspections of California-licensed laboratories that are located in state and out of state.
    • Monitoring of complaints
    • Enforcement activities
    • Initial State licensure review
      • Initial inspections and issue of licenses
  • Approved accrediting organizations are listed on the LFS website. (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/ao.aspx)
  • Approval of a new AO:
    • American Society for Histocompatibility and Immunogenetics (ASHI) ā€“ received approval on October 27, 2021
      • Specialty and Subspecialty Approval:
        • Histocompatibility
        • General Immunology
        • ABO/Rh Group
      • Contact Info
  • Questions from CLTAC Participants
  • When is the date of when the executive order is set to expire or be revoked?
    • Response: There are a lot of speculated dates, and we cannot comment on speculation. More guidance will come from the governorā€™s office on the exact time frame.

Facilities Licensing Section Report (Martha Obeso)

  • Since going online adoption of ELLFS, overall adoption rate is increasing and is expected to increase as more features on ELLFS go live to allow applicants to make changes/updates information themselves.
  • LFS is excited to announce the implementation of an online search tool that allows the public to verify a clinical or public health laboratory license issued by the California Department of Public Health.
    • Individuals can verify clinical and public health laboratory license at the Facilities Verification link on the LFS home page. (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/FacilitiesVerification.aspx)

CLIA Survey Section Report (Donna McCallum)

  • Work performed during the Federal Fiscal Year (October 1, 2020, through September 30, 2021)
    • 46 initial surveys, 672 recertifications, 22 PT desk reviews, and 6 complaint surveys, for a total of 756. This does not include 5 validation surveys and 53 certificate of waiver survey
  • Future activities by the section:
    • CMS is currently asking that 1.7% of waived and PPMP laboratories be inspected annually to ensure the reporting of COVID-19 test results to the state agencies.
    • For Californiaā€™s 17,562 waived laboratories, we would inspect 299 laboratories.
    • For 2,867 PPMP laboratories, we would inspect 49 laboratories.
  • Survey Notice:
    CMS has extended the expiration dates of all laboratories with expiring CLIA certificate dates to December 31, 2021, due to the survey delays caused by the pandemic. If there are additional extensions, we will receive notification from CMS.

Personnel Licensing Section Report (Dolapo Afolayan)

  • The personnel section conducted an analysis to determine the impact of COVID-19 on the submission of applications for licensure.
    • New applications received fell from 807 in 2019 to 678 in 2020.
    • New applications approved fell from 679 in 2019 to 558 in 2020
    • Renewal applications received rose from 1675 in 2019 to 2005 in 2020.
    • Renewal applications approved rose from 1672 in 2019 to 2005 in 2020.
      • Trends indicate all licenses are up except for Clinical Lab Scientist (CLS) licensure

Administrative Unit (Yancarlo Escarate)

  • No new updates from Admin Unit.

Legislative Report (Mary Wogec)

As a reminder:

  • When LFS analyses a bill, we do not take a position until the governor chooses a position, unless the bill is sponsored by the department. LFS makes an internal recommendation in the analysis that we send through the Office of Legislative and Governmental Affairs to the legislators and governor. We do not share the recommendation or analysis outside the department.
  • This report is not an internal recommendation. It provides an overview of the bills assigned to LFS this year and the status of those bills.
  • For more information on current and past legislation, visit the Legislative Counselā€™s website (http://leginfo.legislature.ca.gov).

Bills signed and chaptered:

  • Assembly Bill (AB) 526, Dentists
    • Introduced by Assembly Member Jim Wood
    • Signed and Chaptered: October 8, 2021 (Chapter 653), effective: October 8, 2021
    • Amends Business and Professions Code section 1209 and adds sections 1625.6, 1645.2, 2473, and 2496.5.
      • AB 526 expands the definition of ā€œlaboratory directorā€ to include a duly licensed dentist serving as the director of a laboratory that performs only clinical laboratory tests classified as waived that are authorized under Section 1625.
      • The bill also authorizes a dentist or podiatrist to independently prescribe and administer influenza and COVID-19 vaccines approved or authorized by the United States Food and Drug Administration for persons 3 years of age or older.
      • Amended to add an urgency clause.
  • AB 556, Misuse of Sperm, Ova, or Embryos
    • Introduced by Assembly Member Brian Maienschein
    • Signed and Chaptered: September 16, 2021 (Chapter 170), effective: January 1, 2022
    • Adds Section 1708.5.6 to the Civil Code
      • Existing law makes it a felony for anyone to knowingly use sperm, ova, or embryos in assisted reproduction technology for any purpose other than that indicated by the providerā€™s signature on a written consent form, and to knowingly implant sperm, ova, or embryos, through the use of assisted reproduction technology, into a recipient who is not the provider, without the signed written consent of the provider and recipient.
      • AB 556 authorizes a private cause of action for damages against a person who misuses sperm, ova, or embryos in violation of the provisions of current law. The bill specifies that a prevailing plaintiff who suffers harm as a result of such a violation may be awarded actual damages or statutory damages.
  • AB 691, Optometrists
    • Introduced by Assembly Member Ed Chau
    • Signed and Chaptered: October 8, 2021 (Chapter 654), effective: October 8, 2021
    • Amends Sections 3041 of, and adds Section 3041.5 to, the Business and Professions Code
      • Effective immediately upon signing, AB 607 expands the authorization for a therapeutic pharmaceutical agent (TPA)-certified optometrist to perform procedures to include a clinical laboratory test or examination classified as waived under CLIA necessary to detect the presence of SARS-CoV-2. The bill establishes the substance of an application form for the immunization certification and expands the certificate to cover the administration of immunization for SARS-CoV-2.
      • On January 1, 2022, AB 607 enacts a version of Section 3041 of the Business and Professions Code incorporating similar SARS-CoV-2 testing provisions and changes relating to the scope of practice of optometry, including the revision of existing provisions and new authorizations regarding the use or prescription of therapeutic pharmaceutical agents and the administration of immunizations.
  • Senate Bill (SB) 306, Sexually Transmitted Disease Testing
    • Introduced by Senator Richard Pan
    • Signed and Chaptered: October 4, 2021 (Chapter 486), effective: January 1, 2022
    • Amends
      • Health and Safety Code sections 1367.31, 120582, 120685, and 12091
      • Insurance Code section 10123.202
      • Welfare and Institutions Code sections 14105.181, 14132, and 24007
    • Authorizes an HIV counselor to perform a rapid STI test, or any combination HIV/HCV/STI test, as specified. Requires an HIV counselor to demonstrate sufficient knowledge of HIV, HCV, and STDs to provide appropriate counseling and referrals to patients before performing skin puncture tests and to demonstrate proficiency in administering rapid HIV, HCV, and STD tests before administering those tests.
    • Allows HIV counselors to receive HIV counseling training through a training course that has been certified by the Office of AIDS.
    • Makes extensive changes to other sections of law.
  • SB 409, Pharmacists
    • Introduced by Senator Anna Caballero
    • Signed and Chaptered: October 6, 2021 (Chapter 604), effective: January 1, 2022
    • Amends Business and Professions Code sections 1206.5, 1209, and 4052.4 and adds Section 4119.10
      • SB 409 authorizes a pharmacist to perform any aspect of an FDA-approved or -authorized test classified as waived under CLIA if the test is used to detect or screen for certain illnesses, conditions, or diseases identified in the bill. The bill also authorizes a pharmacist-in-charge to serve as the director of a waived laboratory. It also makes changes to the pharmacist scope of practice.

Bills vetoed:

  • AB 70, Gene Synthesis Providers
    • Introduced by Assembly Member Rudy Salas
    • Enrolled: September 7, 2021
    • Vetoed: October 5, 2021
    • Would have added Chapter 1.5 to Division 20 of the Health and Safety Code
      • AB 70 would have required gene synthesis providers and manufacturers of gene synthesis equipment to adhere to customer and sequence screening protocols equivalent to, or stronger than, the International Gene Synthesis Consortium Harmonized Screening Protocol by January 1, 2025.
      • Required the department to create a process to verify that providers and manufacturers were in compliance with the billā€™s requirements, beginning January 1, 2025.
      • Authorized the Department to begin charging fees beginning January 1, 2022, to establish a verification process.
      • Established financial penalties on companies or institutions that did not comply with requirements.
    • Governorā€™s Veto Message

      I am returning Assembly Bill 70 without my signature. In order to fund the establishment of the program, the bill would authorize CDPH to begin charging fees from the entities to be regulated before the program is established and before businesses are required to be in compliance. This structure is not implementable and General Fund resources needed to support the establishment of a new regulatory program should be considered in the annual budget process. Furthermore, consideration should be given to whether a patchwork of state and federal regulations on biosecurity is the most effective way to approach an issue of international magnitude.

Two-year bills:

  • AB 240, Local Health Department Workforce
  • AB 392, Plasma Collection Centers
  • AB 852, Nurse Practitioners
  • AB 1120, Blood Withdrawal
  • AB 1328, Pharmacists
  • AB 1494, Blood Collection

CAMLT Initiatives to Increase CLS and MLT Internships (Dora Goto)

Please note that a copy of the presentation slides and a recording of the meeting will be available upon request

Highlights

  • There has been a long-standing shortage of training opportunities for qualified candidates to receive the clinical experience required by law to fulfill the requirements necessary to become a CLS/MLT.
    • There are estimated to be over 1,200 vacant (CLS/MLT) positions currently and the number is expanding every year, compounded by the aging demographics of the profession and an increase in retirements.
  • The Covid-19 pandemic dramatically exposed this need, resulting in massive testing demands placed upon both public health and hospital
    • Important testing demands either went un-met or were significantly delayed. Those that met demands did so by increasing overtime upon existing staff or contracting out for extra personnel---both of which produced significant cost increases.
    • There was also the issuance of an Executive Order to relax laboratory testing personnel standards, which compromised results at significant risks to patients and the publicā€™s overall health at some clinical laboratories.
  • CAMLT is proposing that the State do a one-time funding of $12.6 million in the 2021-22 State Budget for the purpose of making grant funding available over the next three years to hospitals or training programs that are currently credentialed to offer training programs for Clinical Laboratory Scientists (CLS) and Medical Laboratory Technicians (MLT) to create 200 additional training positions to address a shortage of CLS/MLT positions and required training internships throughout the state.
    • Grants would be available in blocks of up to $60,000 per position supported, and $600,000 allocated to the Office of Statewide Health Planning and Development (OSHPD; or, if preferred, by the Department of Public Health) for administrative costs related to implementing the program. OSHPD shall hold a convening of relevant/interested stakeholders (hospitals, universities, organizations representing CLS/MLS, and others) on how to ensure proper distribution of the funds in the creation of new internship positions. After three years of availability, any funds remaining would revert and OSHPD shall report back to the Legislature the number of placements created by the program.
    • Proposal document link (https://camlt.org/wp-content/uploads/2021/11/CLS-and-MLT-Internship-BUDGET-PROPOSAL.pdf).
  • Current Progress by CAMLT
    • CAMLT reached out to legislators, including legislative budget leaders and officials in the Newsom Administration with healthcare jurisdiction.
    • Despite some very positive responses from all quarters, the Administration ultimately did not include the training funding proposal in their healthcare budget trailer measure.
    • However, much ground has been gained on the need to increase training opportunities for CLS and MLT and it will be a holdover item for legislative action in the second part of the session in 2022.
    • CAMLT and other stakeholders are committed to seeking this goal and will be meeting soon to develop an aggressive action plan which may include the introduction of a standalone piece of legislation.

Current Challenges and Efforts to Expand the Certified PHM Workforce (Kelly Riddle)

Please note that a copy of the presentation slides and a recording of the meeting will be available upon request

Highlights

  • The public health microbiologist (PHM) training program is funded partially through Public Health Emergency Preparedness (PHEP) Funding.
    • Funding has not kept up with costs to students
      • Currently funds 12 trainee grants of $30K stipend each so that students can focus on the training program.
      • Funds also cover assistance grants to pay for trainers, supplies that might be needed each training session.
  • Currently the PHM training program in the State is divided between northern and southern regions.
  • Over the last four years a total of:
    • 116 total PHM trainees
    • 48 stipends granted
    • 68 unfunded trainees (cost was absorbed by other the employer or self-supported)
  • Although PHM training has increased, it is not enough to meet the needs of public health labs and labs required to have licensed PHMs.
    • Currently 52 unfilled PHM positions in the state.
  • Issues that need to be addressed
    • Funding needs to be increased in key areas in order to increase workforce
      • Possible request for state funding
      • Possible reallocation of current federal funding
    • Recruitment changes and possible expansion of requirements need to be taken into consideration.
      • Partnerships with colleges/universities
      • Accreditation via National Accreditation Agency for Clinical Laboratory Sciences (NAACLS)
      • Changes to minimum qualification for trainees
    • Retention
      • Retaining PHMs in Public Health labs has proven difficult.
        • Loss of public health lab jobs
        • Salaries not competitive to private industry

CLTAC Subcommittee Reports ā€“ Public Health Lab Regulations Subcommittee (Zenda Berrada)

Please note that a copy of the document and a recording of the meeting will be available upon request

Highlights

  • Review and update regulations applicable to the public health microbiology profession and laboratories.
  • Recommendations for changes to be made will be presented to the department for review and comment.
    • Motion to send document with minor edits was motioned and consensus was 3 no and 7 yes, as long edits discussed are made.
    • Motion passed and document will be presented to the department.

CLTAC Subcommittee Reports ā€“ Clinical and Public Health Laboratory Workforce Subcommittee (Robert Thomas)

  • In order to plan for the future workforce needs of Californiaā€™s clinical and public health laboratories, pursuant to its authority under Business and Professions Code section 1228, LFS charges the CLTAC Clinical and Public Health Laboratory Workforce Subcommittee to gather information and report its findings in a white paper to address the following topics:
    • The need to increase the number of qualified testing personnel in California labs
      • What are the needs for each category of testing?
      • Is there a greater need for a particular category?
    • Which areas or specialties are in greatest demand? Which areas are expected to experience growth or expansion?
    • What are the needs for training programs?
      • Are there suggestions for increasing the number of training programs?
      • Are there suggestions for increasing the number of trainees in labs?
    • What are the implications of these problems for public health and safety? What are the implications of proposed solutions?
    • How might LFS assist in meeting these needs?
    • Other concerns the subcommittee may identify in the course of its research.
  • CLTAC members and non-CLTAC members interested in the subcommittee
    • Isabel Bjork
    • Mark Richardson
    • Joselita Joaquin
    • Gabor Hertz
    • Jowin Rioveros
    • Elma Kamari Bidkorpeh
    • AABB

New Business (Zenda Berrada)

  • Election of the CLTAC Chair
    • Dora Goto nominated Zenda Berrada as CLTAC chair.
    • Jamie Marks, Jowin Rioveros, Dora Goto, Anne Deucher, Tula Nieva, Christine Darmanian, Gabor Hertz, Tony Mills, and Dan Leighton seconded the nomination of Zenda Berrada.

Adjournment

  • Motion to adjourn the meeting
    • Moved by Jamie Marks, seconded by Anthony Mills, Dora Goto, and Christine Darmanian
  • Meeting ended at 12:35 PM.
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