Skip Navigation Links12-02-22-CLTAC-Meeting-Minutes

Laboratory Field Services

Clinical Laboratory Technology Advisory Committee (CLTAC)

Minutes of the Meeting held on December 2, 2022
Meeting held through Microsoft Teams


CLTAC Members Participating

Marc Bernaldez, Zenda Berrada, Christine Darmanian, Anne Deucher, Bill Gardner, John Geisse, Dora Goto, Gabor Hertz, Dan Leighton, Jamie Marks, Anthony Mills, Jowin Rioveros

California Department of Public Health (CDPH) Staff Participating

Jason Boatman, Yu-Chen Chang, Kevin Columa, Elsa Eleco, Jinong Feng, Elaine Flores, Sabrina Gilliam, Najib Gul, Bryant Hard, Alison Jacobsen, Joselita Joaquin, Paul Kimsey, Christina LaFave, Katya Ledin, Donna McCallum, Dana Moore, Martha Obeso, Beatrice O’Keefe, Dana Parle, Robert Thomas, Armando Tiong, Jill Tellioglu, Clint Venable, Debra Wadford, Mary Wogec, Jenny Yun

Public Members Participating

Bob Achermann, Maureen Ahler, Nathalie Apke, Julie Ballard, Michael Bieraugel, Lydia Bourne, Blythe Brownlow, Rim Cothren, Mousumi Crowley, Denise Driscoll, Suzanne Driver, Kathleen Doty, Diana Dupuy, Donna Ferguson, Robert Footlik, Rodolfo Garcia, Colleen Goodman, Nicole Green, Alex Gener, Margaret Knapp, Shiu-Land Kwong, Peggy Kollars, Lois Langs, Elizabeth Lucas, David Luong, Lara Martens, Anthony Mills, Karen Nickel, Erica Padilla, Mattias Pitka, Salim Rafidi, Stacy Ralston, Christine Sabol, Osvaldo Santiago, Arell Shapiro, Rachielle Sheffler, Lori Taylor, Stephanie Trammel, Katie Wilkinson, Keau Wong, Christine Yee, Tammy Zinmeister

Welcome, General Announcements (Zenda Berrada)

  • Meeting started at 9:03 AM.
  • Dr. Berrada announced that the meeting was being recorded.
  • Dr. Berrada conducted roll call and determined that a quorum was present.​

​Dr. Berrada asked participants to complete the attendance sheet at the provided link (https://forms.office.com/Pages/ResponsePage.aspx?id=URsxH9n2U0GbrFXg75ZBuBCA5stZIpBGpFsJMIClO_5UNEpBQ1hFVDlBVU5YVEVGWFhMS0RBOTk1RC4u)

Approval of September 9, 2022, CLTAC Meeting Minutes (Zenda Berrada)

  • Anne Deucher moved to approve September 9, 2022, meeting minutes.
  • Dora Goto and John Geisse seconded move to approve September 9, 2022, meeting minutes.​

Branch Report (Robert Thomas)

  • LFS Personnel Changes
    • ​Mr. Thomas announced that Dr. Anthony Tran is the new Deputy Director for the CDPH Center for Laboratory Science Division. He congratulated Dr. Anthony Tran on his appointment and thanked Dr. Kimsey for his leadership, and for assisting the program since 1996. Mr. Thomas mentioned that LFS is looking forward to working with Dr. Tran on issues affecting clinical and public health labs such as biologics, blood, and tissue banking.
    • Mr. Thomas presented a certificate of appreciation to Dr. Zenda Berrada, in recognition of her outstanding service to the Clinical Laboratory Technology Advisory Committee, Laboratory Field Services, and California Department of Public Health. Mr. Thomas mentioned that Dr. Berrada directed the work for three sub-committees to assist Laboratory Field Services on important issues such as the sub-committee on public health laboratory regulation, the sub-committee on COVID-19 data collection, and the sub-committee on laboratory workforce needs. Mr. Thomas thanked Dr. Berrada for her contribution to CLTAC, representing Public Health Microbiologists since December of 2017, and as a CLTAC Chair since March of 2020. Dr. Berrada will continue serving as a CLTAC chair and assist with the transition on the new CLTAC Chair.
  • CLTAC Working Format
    • ​Mr. Thomas added the meeting would include a presentation about the CLTAC Workforce Sub-Committee. He mentioned that in December of 2021, LFS requested CLTAC to create a Sub-Committee to plan for future workforce needs to assist with reports on California Clinical and Public Health Labs. Pursuant to the Business and Professions Code section 1228, LFS charged the CLTAC Sub-Committee 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?
  • ​LFS Quality Improvement Project:
    • ​Mr. Thomas added that during the last few quarterly CLTAC meetings, LFS received many comments about the license application process. LFS has learned that applications submitted online are processed much faster compared to the number of paper applications mailed. LFS has reached out the CDPH Directorate for assistance with processing applications. The CDPH director encouraged LFS to work with the Lean Transformation Consultant to review the license processing system for LFS to address the issues our constituents are experiencing. Starting in January of 2023, LFS with be working with the Lean Transformation Team to review the licensing application processing program and to review the processing system for the LFS Call Center. LFS will continue to inform you as we work towards improvement of our processes.

Department News (Paul Kimsey)

  • ​Dr. Kimsey announced he is retiring, and this is the last CLTAC meeting which he will be attending as a representative from the Director’s Office. He thanked the CLTAC Board for their hard work and services over the years. Dr. Kimsey also thanked LFS for organizing the quarterly CLTAC meetings during the past years, and he thanked Robert Thomas for his service to LFS and the Department.
  • Dr. Kimsey provided an update for the Center for Laboratory Science (CLS) and mentioned that the state regulatory agencies, the Department of Finance, CalHR, and many other agencies’ approvals for the new center were finalized in September of 2022. The Department will meet its goals for CLS to be fully functional by January of 2023.
  • Dr. Kimsey announced that Dr. Anthony Tran will be the new deputy director for the new CLS. ​

Dr. Anthony Tran (New Deputy Director)

  • ​Dr. Tran thanked Dr. Kimsey and Robert Thomas for introducing him during the meeting. He mentioned that he is looking forward to working with everyone and that his official employment start date is on Monday, December 5, 2022.

Respiratory Viruses Update (Debra Wadford, PhD, MS, PHM, M(ASCP))

  • ​Ms. Wadford mentioned that there are many outbreaks of respiratory pathogens currently circulating in the state of California, especially in the San Diego area. She added that there is a vaccine available for Influenza which is a close match to the strain currently circulating. Ms. Wadford mentioned that the Respiratory Syncytial Virus (RSV) is also on the rise and added that because of the outbreak of this virus, Orange County declared an emergency. There is no vaccine or treatment available for the RSV, which is very concerning. The rise in the number of RSV cases started in September of 2022. Ms. Wadford spoke about the rise in other viruses contributing to respiratory illnesses this year such as Parainfluenza, Adeno Virus, Corona Virus, and SARS-Cov-2. She encouraged everyone to get vaccinated, wear a mask, and stay home if they have symptoms for the above-mentioned viruses to help prevent transmission. Ms. Wadford provided the following link for anyone who is interested in learning more or receiving updates about the above-mentioned viruses: (https://calcat.covid19.ca.gov/cacovidmodels/). 
  • Ms. Wadford extended her gratitude to Dr. Kimsey for his services to state of California, public health, and laboratories.

Mpox Update (Dr. Jill Hacker)

  • ​The first human case of mpox was discovered in the Democratic Republic of the Congo in Central Africa in 1970.
  • The virus is acquired through bits or fluids of infected animals. Cases of mpox were rarely seen outside of Western and Central Africa before 2000. Between the years of 2018 and 2021, there have been over 200 cases of mpox in Nigeria, and three percent of those cases were fatal. There were eight cases of mpox reported in other countries outside of Nigeria by the year 2022. Many cases of mpox have been reported in Europe, USA, and many other countries around the word since May of 2022.
  • Mpox is usually a mild disease with symptoms lasting from 2 to 4 weeks. Lesions can be extremely painful. Other infections or permanent scarring from rashes and sores may occur.
  • Individuals who may be at higher risk for severe disease are people with weakened immune systems, history of eczema, if pregnant or breastfeeding, and children under 8 years of age. The current strain of mpox virus is rarely fatal (less than one percent).
  • As of November 30, 2022, globally there have been 80,634 confirmed cases of mpox in 110 countries with sixty-one confirmed deaths reported. The majority of the recorded cases are outside Western and Central Africa. As of November 30, 2022, there have been 29, 603 cases of mpox reported in the United States with seventeen confirmed deaths reported. 5,572 confirmed/probable cases of mpox were reported in California with 229 hospitalizations. Approximately 96 percent of the cases were among males. Most cases of mpox are among gay, bisexual, trans, and other men who have sex with men, as well as household contacts.
  • US mpox laboratory testing data.
    • ​Public health labs, four commercial labs, and other smaller labs have tested 127, 241 specimens for mpox with 27.4 percent cumulative positivity since May of 2022.
    • The JYNNOES Vaccine was approved in 2019, and during the mpox outbreak it was made available for laboratory staff to ensure their safety as well as anyone else coming to the laboratories.

Ebola Update

  • ​​Ms. Messenger mentioned that as of September 20, 2022, the country of Uganda reported an outbreak of Ebola disease, caused by the Sudan Ebola virus. On October 6, 2022, the Center for Disease Control (CDC) released a health alert health advisory regarding the Ebola outbreak. On October 7, 2022, CDPH also released Outbreak of Ebola Virus Disease due to the Sudan Virus in Central Uganda.
  • Ms. Messenger added that as of November 25, 2022, there are 142 confirmed cases of the Ebola Virus, of which 19 cases were reported among health care workers, including 19 deaths. There are also 22 suspected cases and there are 1,086 contacts cases which are being followed up on to help contain this outbreak. During the last several weeks we have seen a large decrease in the number of Ebola cases. Uganda has done a great job, following up with the contacts cases, containment, and in quarantining certain regions of the country to minimize the spread of the disease. The good news is that during the last eleven days only one case was reported in Uganda as of November 26, 2022. Uganda has extended quarantines for another three weeks. In preparation of this outbreak the CDC has published a travel advisory for anyone traveling to Uganda.
  • As of October 11, 2022, Airlines required to route passengers who have been in Uganda during the past 21 days through one of five airports in US
    • New York John F. Kennedy International Airport, New York
    • Newark Liberty International Airport, New Jersey
    • Atlanta Hartsfield-Jackson International Airport, Georgia
    • Chicago O'Hare International Airport, Illinois
    • ​Washington D.C. Dulles International Airport, Virginia
  • Temperature checks and risk assessments on arriving passengers are taken. State and local officials follow up with traveler for 21 days post-departure date from Uganda
  • Currently there are no cases identified outside of Uganda. Ms. Messenger added that the difficulty of evaluating cases is that Ebola disease does not have specific clinical symptoms and in fact they are non-specific. She added that during the 3-21 days incubation period anyone who is infected with Ebola virus can show any of the following symptoms.
    • Fever
    • Aches and pains, such as severe headache and muscle and joint pain
    • Weakness and fatigue
    • Sore throat
    • Loss of appetite
    • Gastrointestinal symptoms including abdominal pain, diarrhea, and vomiting
    • Unexplained hemorrhaging, bleeding, or bruising
    • Death rate ranges: 25-90%

California Data Exchange Framework (Dr. Rim Cothren)

Dr. Cothren stated that he is a consultant to the Center for Data Insights and Innovation for the Date Exchange Framework. He mentioned that the vision for Data Exchange in California is that every Californian, the health and human service providers, and organizations that care for them, will have timely and secure access to usable electronic information that is needed to address their health and social needs and enable the effective and equitable delivery of services to improve their lives and wellbeing.

  • ​Dr. Cothren added that AB 133 put California on the path to building a Health and Human Services Data Exchange Framework that will advance and govern the exchange of electronic health information across the state.
    • In 2021, with the passage of AB 133, the Governor and Legislature agreed it was time to disrupt our health and human service information silos —by resolving the numerous information exchange barriers that makes it difficult for millions of Californians to receive information and effective care.
    • ​The legislation directed California Health and Human Services (CalHHS) to develop a Data Exchange Framework (DxF) that would govern the seamless and secure exchange of health and human service data between healthcare entities across California.
  • Dr. Cothren noted that the Date Exchange Framework comprises six component policy documents as well as a single statewide Data Sharing Agreement (DSA) and its associate Policies and Procedures (P&Ps). Components include the following:
    • DxF Development Process
    • Vision and Guiding Principles
    • CA Date Exchange Landscape
    • Date Exchange Scenarios
    • DxF Governance
    • ​Data Sharing Agreement and Common Set of Policies and Procedures that spell out the standards for and governance of information exchange.
  • Dr. Cothren provided information on the DxF Data Sharing Agreement and mentioned that AB– 133 requires the establishment of a single data sharing agreement and a common set of policies and procedures that govern and require the exchange of health information.
    • The DxF Data Sharing Agreement (DSA) is:
      • A legal agreement that a broad spectrum of health organizations will be required to execute by January 31, 2023. Most signatories will be required to begin exchanging data in January 2024.
      • Intended to facilitate data exchange between participants in compliance with applicable federal, state, and local laws, regulations, and policies.
      • Sets forth a common set of terms, conditions, and obligations to support secure real-time access to, or exchange of, Health and Social Services Information between and among participants.
    • ​​The DSA is not intended to replace or supersede any existing or future agreement between or among participants that provides for more extensive data exchange than it requires.
    • Dr. Cothren provided information on the progress of California DxF and added that AB 133 passed the Senate and Assembly and was signed by Governor Newsom in July 2021. The DxF published the policy documents associated with DxF, the data sharing agreement, and strategies for digital identities in July 2022. DxF launched a self-service portal to allow organizations to begin signing the Data Sharing Agreement in November of 2022. All mandatory signatures are required by AB-133 to execute the DSA by January of 2023, and the goal for the entities is to start sharing data by January of 2024.
  • Dr. Cothren added that the entities required to sign the data sharing agreement are:
    • ​General acute care hospitals, as defined by Health and Safety Code (HSC) section 1250.
    • Physician organizations and medical groups.
    • Skilled nursing facilities, as defined by HSC section 1250, that currently maintain electronic records.
    • Health care service plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care or the Department of Insurance. This section shall also apply to a Medi-Cal managed care plan under a comprehensive risk contract with the State Department of Health Care Services pursuant to Chapter 7 (commencing with Section 14000) or Chapter 8 (commencing with Section 14200) of Part 3 of Division 9 of the Welfare and Institutions Code that is not regulated by the Department of Managed Health Care or the Department of Insurance.
    • Clinical laboratories, as that term is used in Section 1265 of the Business and Professions Code, and that are regulated by the State Department of Public Health.
    • Acute psychiatric hospitals, as defined by Section 1250.
  • Dr. Cothren provided information for signing the DSA and added that CDII created a self-service portal application to sign the DSA electronically. Organizations signing the DSA will need to determine the following:
    • Who is authorized to sign the DSA within their organization?
    • What facilities are included; a signatory may sign on behalf of multiple facilities or subordinate entities if authorized.
    • ​Information about the individual signing, their organization and contact information, all subordinate entities, including their state license number.
  • Dr. Cothren provided the following information for individuals who are interested in the program.
    • The next DxF ‘Information is Power’ webinar is scheduled on December 13, 2022, from 11:00 AM to 12:00 PM.
    • Participate in IAC or DSA P&P SC meetings.
    • DSA P&P SC Meeting #3: December 15, 2022, 9:00 AM to 11:30 AM.
    • IAC Meeting #3A: December 20, 2022, 10:00 AM to 12:30 PM.
    • Meeting materials, participation information, and recordings will be posted on the CalHHS DxF website.
    • Join the DxF mailing list by emailing cdii@chhs.ca.gov​.​

Legislative Report (Mary Wogec)​

  • Ms. Wogec provided an update on the status of the Bills assigned to LFS for analysis as well as an update on Regulations. She added that the following bills assigned to LFS in 2022, died or were vetoed.
    • ​o AB 240, Local Health Department Workforce (Vetoed)
    • AB 1328, Pharmacists (Dead)
    • AB 1494, Blood Collection (Dead)
    • AB 1709, Tax Credits for Blood Donation (Dead)
    • AB 1896, Gamete Banks (Vetoed)
    • SB 962, Laboratory Directors (Dead)
  • Ms. Wogec stated that the following seven bills were passed by the legislature and were sent to the Governor’s desk and were signed and chaptered. She added that the following bills are either effective now or will be effective on January 1, 2023.
    • Bills Signed and Chaptered
      • ​AB 392, Plasma Collection Centers
      • AB 1120, Blood Withdrawal
      • AB 2574, Optometry
      • SB 1267, Clinical Laboratory Personnel
      • SB 1475, Blood Collection
      • SB 1500, Biologics, Investigational Use
  • Ms. Wogec provided the following links for further information.
    • For information on legislative changes affecting Laboratory Field Services programs, visit our new Regulatory Information web page​: (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/RegulatoryInformation.aspx)
    • For the complete text of revised code sections or for more information on current and past legislation, visit the Legislative Counsel’s website​ (http://leginfo.legislature.ca.gov)

CLIA Survey Update (Donna McCallum)

  • ​​Ms. McCallum mentioned that the Center for Medicare & Medicaid Services (CMS) has extended the expiration dates of all laboratories with expiring CLIA certificates awaiting a survey to December 31, 2022, due to the survey delays caused by the pandemic. If there are additional extensions, LFS will inform you as we receive the information.
  • Ms. McCallum provided the CLIA Survey Activity Report (September 1, 2022 – October 30, 2022)
    • 22 initial inspections
    • 52 recertification surveys
    • 0 waived/PPMP surveys
    • 12 validations
    • 0 onsite complaints
    • 12 PT reviews
    • The total survey activity is 96
  • Regulations in Title 42 CFR sections 493.2 and 493.801 through 493.959 are effective two years after publication in the Federal Register – July 11, 2024. Amended regulations at 42 CFR sections 493.20 and 493.25 became effective August 10, 2022. These are related to laboratories performing moderate and high complexity testing that also perform waived testing.
  • Ms. McCallum spoke about the CLIA priorities and provided the following:
    • ​Survey Consistency
      • Maintain a strong and effective survey program
      • Maximize operational efficiencies across the nation
      • Collaborate with the State Agencies, Accreditation Organizations, and Exempt States
    • Stakeholder Engagement
      • Increase outreach activities with stakeholders
      • Strengthen stakeholder engagement and program accountability
      • ​Improve awareness and compliance with CLIA regulations and guidance
  • Ms. McCallum added that under the QSO-22-14-CLIA Survey Prioritization Guidance the memo allowed state survey agencies to perform all regulatory required on-site surveys:
    • Complaints
    • Initial Certification Surveys
    • Recertification Surveys
    • Validation Surveys
    • Revisits
    • COW/PPM Special Surveys
    • ​Resume Enforcement actions
  • Ms. McCallum mentioned that the flexibilities implemented during the Public Health Emergency (PHE) that will continue are the following:
    • Pathologist remote review of digital images of slides and data
    • Expedited lab certification
    • Single certificate allowance for hospitals
    • ​Use of alternate specimen collection devices and media
  • Ms. McCallum added that we are now in the current federal fiscal year (10/01/2022 to 09/30/2023). LFS is continuing to be short staffed, and we are working hard to resolve our survey backlog due to pandemic. LFS is working on completing the back logged surveys and filling our Examiner vacancies.
  • Ms. McCallum thanked everyone for their patience and cooperation. She also thanked all her staff for their hard work during the past year.

​​Facility Licensing Section Report (Martha Obeso)

  • ​​Ms. Obeso discussed the number of applications received by the Facility Licensing Section during the fiscal year 2021-2022. She stated that LFS received a total of 22, 628 applications and LFS is currently planning to reduce the number of paper applications for license renewals. LFS started accepting online applications in January 2021, and for the past two years LFS has been accepting both online and paper applications. The goal is to process all applications online. She mentioned that all new applications received online have been processed. 35% of renewal applications are submitted in paper and 65% are submitted online.
  • Ms. Obeso mentioned that she would like to hear from facilities who are having issues with making payments online to make this transition as easy as possible. She provided her email martha.obeso@cdph.ca.gov​
  • Ms. Obeso encouraged everyone to use the online portal when renewing licenses for laboratories and making payments. She pointed out that the processing for license renewal through the online system is ten days compared to three months for renewing by mailed applications.

​Personnel Licensing Report (Dolapo Afolayan)

  • ​Ms. Afolayan gave an update on the trends in phlebotomy application approvals from 2018 to 2021, and provided the following information.
    • As a result of the pandemic, the number of applications we approved significantly deceased in 2020. However, in 2021, we noticed an increase in the number of applications approved weekly.
    • LFS analyzed the number of applications approved from 2018- 2021, to determine whether the approval of application trends displayed has returned to pre-pandemic trends.
    • The result of our findings indicates applications approved in 2021 have nearly returned to pre-pandemic trends.
    • Interestingly, when comparing 2020 with 2021, the number of phlebotomy applications approved in 2021 significantly increased as compared to 2020.
    • ​Further analysis conducted to determine the magnitude of the increase indicates a 40% increase in the number of applications approved for phlebotomy certification. ​
  • Ms. Afolayan, provided an update for the Occupational Employment Projection for phlebotomists for the year 2020-2030
    • To understand how the increase in the number of applications approved for phlebotomy certification translates into employment, LFS reviewed data and reports from the California Employment Development Department (EDD).
    • Findings from EDD reports estimate a 23.6% rise in phlebotomy employment by 2030.
    • ​This growth estimate ranks phlebotomist as the 7th fastest growing occupation for postsecondary non-degrees in the State of California.
  • Ms. Afolayan added that LFS is excited to announce the implementation of new license types within the Personnel Electronic Renewal Licensing (PERL) system.
    • ​Effective January 1, 2023, LFS will be receiving applications and issuing clinical laboratory geneticist and clinical reproductive biologist licenses to trainees, scientists, and directors through PERL.
    • Application fee will be the same as existing categories. For example, the current initial application fee for a clinical laboratory scientist is $230, therefore, the fee for a clinical reproductive biologist scientist will be the same. Fee information can be found at Fee Schedule (PDF).​
    • Information on how to create an on​line account​ to submit an application/log into your account can be found on the LFS website (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/ClinicalLaboratoryPersonnel.aspx).
  • A video tutorial on how to apply for laboratory personnel licensure can be found at New Application Video Tutorial.​

​On-site Licensing Inspection Update (Elsa Eleco)

  • ​Ms. Eleco stated that the On-site Licensing Section works close with Facility Licensing and the CLIA section. She added that the On-site Licensing Inspection Section is the primary complaint handing section for LFS. The complaint analyst receives the complaints and forwards them to the appropriate LFS sections for handling and On-site Licensing Section conducts the state complaint investigation. Ms. Eleco provided the following information regarding the In-State and Out-of-State inspections. ​
    • ​In-State inspections
      • ​Initial State inspections
      • Desk Review
      • On-Site
      • State validation inspections
      • State inspectors also perform CLIA inspections
    • Out-of-State (OOS) inspections of California licensed clinical labs
    • Accrediting Organizations (AO)
      • ​Review and Approval
      • Oversight
      • Communications and Coordination with California approved AOs
    • Ms. Eleco mentioned that the state of California has six approved accrediting organizations:
      • ​COLA
      • The Joint Commission (TJC)
      • College of American Pathologists (CAP)
      • American Association of Blood Banks (AABB)
      • Accreditation Commission for Health Care (ACHC)
      • American Society for Histocompatibility and Immunogenetics (ASHI)
    • As of July 2022, there are 1,184 confirmed accredited labs in California. These are labs which we inspected and are new. Five percent of the 1,184 laboratories will be subject to validation inspections during the current State fiscal year (July 1, 2022 – June 30, 2023)
    • State inspectors will contact the AOs first via e-mail or phone call notifying them of the planned validation inspection. State inspectors will confirm with the AO representative the AO survey date, to ensure that the State validation inspection will be performed within 90 calendar days of the AO inspection date. After contacting the AO, State inspectors will contact the laboratories and schedule the validation inspection.
    • Ms. Eleco added that the California Business and Professions Code Section 1225, authorizes representatives from On-site Licensing Section to carry out the following.
      • ​Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with or prevent a violation of this chapter or the regulations adopted pursuant thereto.
      • Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter, or the regulations adopted pursuant thereto.
      • Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the regulations adopted pursuant thereto.

​​CLTAC Laboratory Workforce Subcommittee Report (Jowin P. Rioveros)

  • ​“In order to plan for the future workforce needs of California’s clinical and public health laboratories, pursuant to its authority under BPC 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:
    • 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 during its research.” ​​
  • Mr. Rioveros provided the following updates on the Subcommittee progress.
    • Subcommittee meetings held bi-weekly since February 2022
    • Current Status: Working on the final white paper draft
    • Some recommendations that may be included in the white paper includes:
      • ​Increasing the number of training programs and sites or participating county laboratories but would need to consider:
        • ​Provide funding opportunities (increase ability to hire trainers, expand physical space, etc.)
        • Revisit past initiatives between CLS, PHM, and other clinical fields that may benefit or provide solutions to needs of training programs
        • Facilitate partnership formation between academic program and biotechnology laboratories/blood banks/other training locations
        • ​Facilitate training program where trainee could obtain required generalist clinical training across institutions
    • Development of remote or alternative training options
    • Update regulations to increase the number of trainees-to-licensed personnel/trainer ratio
    • Update or revise regulations related to training programs to allow more programs to train
    • Develop accelerated pathways to clinical licensure (including new MLT to CLS pathway that is currently being developed by LFS)
    • Update licenses or licensing requirements (training, education, prerequisites) to meet current workforce needs
      • ​Scope of classes/coursework may be expanded in some academic settings
      • Time required to train (reduce or modify training requirements)
      • Access to those that have out of state or international experience
  • Mr. Rioveros discussed the Subcommittee’s next steps and provided the following.
    • Finalize white paper draft and present to CLTAC on a separate meeting
    • Web-based meetings are public and the schedule and Teams meeting link can be access on the CLTAC web page​: (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/AdvisoryCommittee-CLTAC.aspx)

Zenda Berrada thanked Jowin P. Rioveros and Rachel Rees for their hard work. She also thanked the CLTAC subcommittee members for their work.

​Future Items (Zenda Berrada)

  • Dr. Berrada mentioned that the board members started working on updating the CLTAC by-laws early this year and will continue to work on updating the by-laws next year. Dr. Berrada mentioned that the CLTAC Board consists of 21 individuals.
  • Dr. Berrada announced that Dr. Gabor Hertz has been nominated to the new CLTAC Chair position and he has accepted the nomination. She mentioned that her term as the CLTAC Chair is coming to an end, and she will be pleased to transition the new CLTAC Chair for the position. Dr. Berrada asked the CLTAC board member if they will approve Dr. Hertz nomination to serve as the CLTAC Chair starting January 1, 2023, and requested a motion to vote. The following CLTAC board members were in favor and approved Dr. Hertz’s nomination.
    • John Geisse
    • Anne Deucher
    • Bill Gardner
    • Jowin Rioveros
    • Christine Darmanian
    • Anthony Mills
    • Jamie Marks
    • Dora Goto
    • Zenda Berrada
    • Daniel Leighton
  • Dr. Berrada added that there were no objections to the CLTAC Chair nomination and there is a quorum for Dr. Hertz to serve as the CLTAC Chair.
  • Dr. Berrada asked the CLTAC board members to approve the CLTAC meeting dates March 3rd, June 2nd, September 8th, and December 1st of 2023. The following board members moved to approve the CLTAC dates for 2023.
    • Motion to approve the meeting dates for 2023 by Jamie Marks.
    • Seconded by John Geisse

Adjournment (Zenda Berrada)

  • Motion to adjourn by Jowin P. Rioveros
  • Seconded by Bill Gardner
  • Meeting closed at 12:26 PM.




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