​

Minutes of the Meeting Held on June 7, 2024

CLTAC Members Participating​

Marc Bernaldez, Gina Crain, Christine Darmanian, Anne Deucher, Dora Goto, Brett Holmquist, Yanyan Hong, Xiao Hui Lau, Jamie Marks, Anthony Mills, Sandra Prado Nava, Christine Sabol, Anthony Salazar

California Department of Public Health (CDPH) Staff Participating

Public Members Participating

Maureen Ahler, Julie Ballard, Elma Kamari Bidkorpeh, Marjorie Braasch, Mousumi Crowley, Alex Febo, Robert Footlik, Andrew Fountaine, Cecile Giron, Colleen Goodman, Shannon Kastner, Dianne Keen-Kim, Shiu-Land Kwong, Lois Langs, Huy Le, Elizabeth Lucas, David Luong, Stephen M., Iris Miu, Melisand Mohseni, Shanker Munshani, Eliana Ochoa-Bolton, Erica Padilla, Dede Pierry, Kat R., Stacy Ralston, Salustiano Riberio, Jowin Rioveros, Rodney Roath, Osvaldo Santiago, Rajesh Sharma, Rachielle Sheffler, Fernando Torres, Tim Tubman, Carol Wong, Christine Yee​

Welcome, General Announcements

• Anne Deucher, MD, called the meeting to order at 9:04 AM.
• Dr. Deucher noted that the meeting was being recorded and participants were encouraged to turn on their cameras. ​

A. Introduction of New Members
​Dr. Deucher introduced three new CLTAC board members:

• Utsav Pandey (PhD, D(ABMM), MLS(ASCP)) nominated by American Society of Microbiology as a Licensed Clinical Microbiologist.
• Xiao Hui Lau (M.Sc., PHM, TS(ABB)) nominated by California Association of Public Health Laboratory Directors as a Certified Public Health Microbiologist.
• Sandra Prado nominated by the Engineers and Scientists of California Local 20, IFPTE as a Licensed Clinical Laboratory Scientist, Union Member.​

B. Roll Call

• Dr. Deucher conducted the roll call, and asked the board members to briefly introduce themselves and their respective nominating organization. ​​
  

Approval of Minutes from March 1, 2024, Meeting

• Dora Goto moved to approve the March 1, 2024, minutes; the motion was seconded by Christine Sabol. ​

Overview of Laboratory Field Services

Dr. Deucher presented the Overview of Laboratory Field Services:

• CLTAC meetings will be structured to follow the mission outlined in the Business and Professions Code 1228​: 
• ​“The department shall appoint a multidisciplinary committee to assist, advise, and make recommendations for the establishment of rules and regulations necessary to insure proper administration and enforcement of the provisions of this chapter and to assist and advise the department in matters concerning examinations for licensees of this chapter. Appointments shall be made from lists of nominees solicited by the department and shall provide adequate and proper representation of all persons affected by this chapter. Subcommittees of the committee may be appointed consisting of committee members and consultants having particular knowledge in a subject area for the purpose of assisting the department on special administrative problems and in making recommendations to the committee for consideration in the establishment of rules and regulations. The terms of office of the members shall be determined by the department.”

Old Business

A. CLTAC By-Law Update

Dr. Deucher presented the CLTAC By-Law Update, and discussed the results from a survey sent to board members in early April on potential changes to the bylaws:​

Survey Results:

• There were 6 board members that completed the survey. 
• Do you believe the CLTAC bylaws need to be updated? 
• 5 out of the 6 responders answered “Yes.” 
• If yes, do you think having a Vice Chair would be beneficial? 
• 4 responses for: “Yes”; 2 responders skipped the question. 
• If you answered yes to Q3, how do you think the new members should be added? 
• 3 responses for: “Keep 21-member number constant and modify membership composition.” 
• 2 responses for: “Expand the committee from 21 members to 25 members.” 
• 1 responder skipped the question. 
• If you answered yes to Q3, which new membership categories should be added? 
• 2 responses for: “Bioinformation/IT Specialist” 
• 1 response for: “Molecular geneticist” 
• 1 response for: “Reproductive biologist” 
• 1 response for: “Other” – All of above 
• What should be the Chair’s term duration? 
• 3 responses for: “2 years” 
• 2 responses for: “1 year” 
• 1 response for: “Other” – “1-2 years, depending on what Chair is willing to serve.” 
• Other comments/requests for inclusion in possible CLTAC bylaw update discussion. 
• 3 responses for: “Yes” 
• 3 responders skipped the question. 
• Would you like to serve on CLTAC bylaw update working group/subcommittee? 
• ​3 responses for: “No” 
• 2 responses for: “Yes” ​

B. Possible Modification of CLTAC Date/Time

Dr. Deucher presented the Possible Modification of CLTAC Date/Time:

• LFS suggested reducing meetings to semi-annually due to the current needs of the department.
• While the suggestion is to meet twice a year, the bylaws allow the chair or LFS to call additional meetings if necessary.
• A motion to update the bylaws for this change could be made in the current meeting, requiring a two-thirds committee presence.
• Currently, not enough board members are present to vote on the motion. The motion will be tabled for now, and the committee will revisit in the next meeting. ​

Update: Laboratory Developed Tests (LDTs) Final Rule​

Dr. Anthony Tran presented an update on the Laboratory Developed Tests (LDTs) Final Rule, which was previously discussed in the December CLTAC meeting:​

• The last update presented was in December 2023 when the proposed FDA rule on laboratory-developed tests (LDTs) was released for comments.
• The final rule was released on April 29, 2024, and officially posted on May 6, 2024. The rule spans 538 pages and reaffirms that LDTs are considered devices under the Federal Food, Drug, and Cosmetic Act, requiring FDA approval or clearance.
• Previously, laboratories could validate LDTs without FDA submission, but this discretion has now been removed under the new rule.
• In response, the American Clinical Laboratory Association (ACLA) has sued the FDA, arguing that the FDA lacks the authority to enforce this rule. The lawsuit could potentially delay the rule’s implementation.
• Center for Laboratory Sciences (CLS) is currently:
• ​Working closely with professional organizations (APHL, ASM) to examine national perspectives.
• Analyzing current rule to determine if there are exceptions and carve outs for public health.
• Preparing for the new landscape. ​

Laboratory Field Services​

A. Licensing Section

Dolapo Afolayan presented the Personnel Licensing Section Update:

• ​As of May 28, 2024, LFS has been able to resolve all applications received for Clinical Reproductive Biologist Scientists (CRBS) applications.
• As of May 28, 2024, approximately 60% of applications received for Clinical Laboratory Geneticist (CLG) Director applications have been resolved.
• As of May 28, 2024, approximately 39% of applications received for Clinical Reproductive Biologist Director applications have been resolved. ​

B. Legislation Update

Mary Wogec presented the Legislation Update:​

• ​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 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 Counsel’s website at: http://leginfo.legislature.ca.gov​.

LFS Bill Assignments 2024:

• ​SB 570 – Prenatal Screening Program (2-year bill)
• AB 2107 – Clinical Laboratory Technology: Remote Review
• AB 2702 – Schools for Clinical Laboratory Scientists and Medical Laboratory Technicians: Grants
• AB 3009 – Healing Arts (Spot)
• AB 3059 – Healing Arts 

​Mary Wogec also presented the Regulations Update:

• DPH 20-007: Trainee, Medical Laboratory Technician, Medical Laboratory Technician Transition to Clinical Laboratory Scientist
• ​The public comment period for this package closed on January 20.
• LFS has received approximately 80 emails with comments. We reviewed the comments and made revisions, and the package was released for a second 15-day comment period, which closed on June 17, 2024.
• The next step will be to make revisions based on comments and submit the text and a final statement of reasons to the Office of Administrative Law for their review. ​ ​ ​
  ​
  

New Business​

A. Queries from CLTAC Board and Public Members to LFS

Jamie Marks presented on the topic of former process improvement team working to improve licensing issues:​

Background: Possible Process Improvement Project regarding Licensure (Lab and Operator)

• While the CLTAC is an advisory committee, not an oversight committee, the rules and regulations requiring CLIA certification and California Clinical Laboratory licensure should mean that processes meet the needs of laboratories licensed by the department.
• CLTAC feels that reports of quality metrics for CDPH-LFS based on the types of complaints received by the department may provide actionable data. These indicators could be identified by the department or together with a CLTAC subcommittee. Proper channels could be followed to allow release of data publicly.
• For example, licensure TAT for both labs and testing operators is important for patient care in California.
• Errors leading to delays in licensure compromises patient care through:
• Inadequate clinical care if timely laboratory testing cannot be achieved.
• Workforce issues if testing operator positions cannot be filled.
• ​Obtaining data regarding error rates, types of errors, and error resolution options may identify possible quality improvement project CLTAC may contribute to.

Initial Proposal: Obtain Quality Metrics

• The department, on its own or together with a CLTAC subcommittee:
• Identify quality indicators for tracking and monitoring important to explore Licensure Error Project
• Obtain necessary approval to make metrics public (either fully public or only to CLTAC Subcommittee)
• Examples of possible quality indicators are:
• ​Turnaround time for facility licensure changes.
• Percentage of errors in licenses issued, broken down by CDPH or applicant causes and electronic or paper submissions.
• Ease of contact with CDPH personnel able to resolve complaints.

Possible CLTAC Subcommittee: Licensure Process Improvement Recommendations

• If metrics indicate Licensure Process Improvement Project is needed, suggest to LFS that official CLTAC subcommittee be formed. 
• Examples of possible areas for discussion by subcommittee:
• ​Recommendations to improve education of applicants completing forms.
• Recommendations to modify online and paper applications and submission process.
• Recommendations to improve resolution process. ​

Salustiano Ribeiro presented on IVF Lab Demystified & Reproductive Biology Scientists Licenses:

Background:

• ​In vitro environment is a very stressful place to be temperature, pH fluctuate; light exposure and high levels of oxygen. In addition, nutrients, and energy sources.
• A pre-requisite for implantation and successful pregnancy, in vitro induced stress factors must be reduced to a minimum.
• The ART laboratory has been designed to provide an environment that is as close to optimum as possible for the growth of human embryos and to provide the best resulting pregnancy rates for patients undergoing IVF cycles.
• The layout of the laboratory must be sensibly planned and logically designed to allow smooth running of routine procedures.
• An embryology lab is a specialized facility that plays a critical role in assisted reproductive technology (ART). The key equipment typically includes: 

1. ​Incubators: To maintain embryos at optimal growth conditions.
2. Inverted Microscopes: For egg retrieval, sperm injection (ICSI), and embryo transfer. 
3. Micromanipulation Equipment: For handling eggs and embryos, especially during ICSI. 
4. Cryopreservation Systems: To freeze and store embryos and gametes. 
5. Stereo Microscopes: For assessing oocyte maturation and for preparation steps. 
6. CO2 Incubators: To control the environment during cell culture. 
7. Laminar Flow Hoods: To provide a sterile environment for handling gametes and embryos. 
8. Heating Blocks/Plates: To keep gametes and embryos at body temperature during handling. 
9. Time-Lapse Imaging Systems: For continuous monitoring of embryo development.

• Clinical Reproductive Biologists are now recognized under California State Law. ​ ​ ​

Purpose:

• ​A​bility to run clinical tests within our discipline. 
• Ability to perform competency within waived, moderate, and high complexity (within our discipline). 
• Ability to train and supervise new Reproductive Biologists trainees. 
• California leading on the recognition in this specialty. ​

Closing​

Dora Goto moved to end the meeting and the motion was seconded by Xiao Hui Lau. The meeting ended at 12:04 pm.

Minutes of the Meeting Held on March 1, 2024 

CLTAC Members Participating​

Zenda Berrada, Christine Darmanian, Anne Deucher, John Geisse, Dora Goto, Gabor Hertz, Brett Holmquist, Yanyan Hong, Jeff Majdali, Jamie Marks, Anthony Mills, Christine Sabol, Anthony Salazar, Ming Zhou​​​​​​

California Department of Public Health (CDPH) Staff Participating

Dolapo Afolayan, Akeesha Barrett, Jason Boatman, Amber Davis, Karen Demby, Elsa Eleco, Elaine Flores, Najib Gul, Bryant Hard, Christina LaFave, Kim Van Le, Katya Ledin, Nadia Madden, Donna McCallum, Martha Obeso, Jan Otey, Jorge Palacios, Stacey Peralta, Nai Saechao, Jaleh Samani, Indranil Sen, Clint Venable, Mary Wogec, Jenny Yun​

Public Members Participating

Bob Achermann, Maureen Ahler, Michael Baker, Julie Ballard, Margarita Boiadji, Mousumi Crowley, Megan Crumpler, Amy Daniels, Danny Dasig, Kathleen Doty, Diana Dupuy, Robert Footlik, Andrew Fountaine, Cecile Giron, Colleen Goodman, Justin Hanenberg, Navdeep Kaur, Shiu-Land Kwong, Lois Langs, Xiao Hui Lau, Clayton LaValley, Elizabeth Lucas, Huy Le, Sharon McGoldrick, Ryan Miller, Iris Miu, Cathie Nakasone, Allison B. Nomura, Eliana Ochoa-Bolton, Erica Padilla, Kimball Pomeroy, Kat R., Stacy Ralston, Salustiano Ribeiro, Jowin Rioveros, Rodney Roath, Brytal Romero, Osvaldo Santiago, Mitchel Schiewe, Gina Sicat, Sue Traub, Timothy Tubman, Nickole Wann, Myra Wong

Welcome, General Announcements

• Anne Deucher, MD, called the meeting to order at 9:09 AM.
• Dr. Deucher introduced herself as the new Chair for the 2024-2025 term.
• Dr. Deucher noted that the meeting was being recorded and participants wereencouraged to turn on their cameras.​

A. Introduction of New Members​​

Dr. Deucher introduced three new CLTAC board members:

• Brett Holmquist (PhD, DABCC, FADLM) nominated by Association for Diagnostics & Laboratory Medicine (ADLM) as a Licensed Clinical Chemist.
• Christine Sabol (CG (ASCP), CCS, CPC) nominated by California ClinicalLaboratory Association (CCLA) as a Licensed Clinical Laboratory Scientist.
• Yanyan Hong (PhD, HCLD (ABB)) nominated by California Association ofBioanalysts (CAB) as a Licensed Clinical Laboratory Bioanalyst.
  

B. Roll Call​

• Dr. Deucher conducted the roll call, and asked the board members to briefly introduce themselves and their respective nominating organization.
• Dr. Deucher also requested LFS staff present to briefly introduce themselves.

Approval of Minutes from December 1, 2023, Meeting

• Anthony Mills moved to approve the December 1, 2023, minutes; the motion was seconded by Gabor Hertz.

Overview of Laboratory Field Services

Mary Wogec presented the Overview of Laboratory Field Services:

• Mission: Ensure quality standards for clinical and public health laboratories and laboratory scientists through licensing, examination, inspection, education, and proficiency testing, and to protect donors and recipients of human blood and tissue through licensing and inspection of blood banks, tissue banks, and biologics production facilities.

Laboratory Licensing Section:

• The Laboratory Licensing and Registration Section issues licenses and registrations, and enforces proficiency testing standards for clinical and public health laboratories.
• With certain exceptions, clinical laboratories located in California and out-of-state laboratories that receive or test samples originating in California must maintain licensure by the Department and certification under the federal CLIA program.
• Laboratory licenses and registrations are renewed annually; over 23,500 facilities licensed by Laboratory Field Services.

Tissue Bank Licensing Program:

• The Tissue Bank program oversees over 1,000 facilities handling human tissue for implantation or transplantation from living or deceased donors.
• It also oversees facilities that produce, store, and distribute biologics, including stem cell therapeutics, derived from human tissue.
• Tissue regulated under California law includes sperm, ova, and embryos used for assisted reproduction treatment, donor milk, bone marrow, adipose, dental, umbilical cord and other perinatal tissue, and cadaveric tissue and its derivatives.

Biologics and Blood Bank Licensing Program:

• The Biologics and Blood Bank program oversees approximately 350 licensed facilities. ​
• Blood bank facilities include blood banks, stationary, mobile, and temporary blood collection sites, hospital blood bank depositories, plasma collection facilities, and cord blood banks and collection centers.
• Biologics facilities produce, store, and distribute biologics, including stem cell therapeutics, derived from circulating human blood.

On-Site Inspections Section:

• The On-Site Licensing Section oversees and inspects approximately 3,000 licensed clinical laboratories in California and roughly 520 labs state-licensed laboratories located outside California.
• Approves private non-profit accrediting organizations (AOs) to ensure lab compliance with state and federal laws; approximately 45% of state-licensed labs opt for AO oversight.
• Responsible for complaint investigations, working with LFS legal counsel on enforcement actions against non-compliant laboratories and may issue principle, intermediate, or alternative sanctions to ensure compliance with California laws and requirements.

CLIA Section:

• CLIA (Clinical Laboratory Improvement Amendments), passed by the U.S. Congress in 1988, establishes quality standards for all clinical laboratory testing to ensure accurate, reliable, and timely patient test results.
• The CLIA Survey Section, in partnership with the federal Centers for Medicare & Medicaid Services, is responsible for the implementation of this program for the State of California.
• Performs routine inspections of over 800 laboratories and validation surveys of 32 facilities accredited by organizations annually.

Personnel Licensing Section:

• The Personnel Licensing Section ensures compliance with education, training, examination, licensing, and competency standards for clinical and public health laboratory personnel.
• Administers over 65,000 certified and licensed laboratory personnel licenses in California across 40 categories, including phlebotomy technicians, cytotechnologists, medical lab technicians, clinical laboratory scientists, and laboratory directors.
• Oversees approximately 600 training programs and approves national certification board exams for California licensure.

Administration Unit:

• The Administration Unit provides support for LFS operations. This unit oversees the branch’s budget, contracts, and purchasing, office administration, human resources, and coordinates travel requests for staff. 
• It also manages the branch’s customer service call center.

Branch Chief's Team:

• Coordinates legislative affairs and regulations.
• Researches and advises on policy issues and special projects.
• Coordinates public records act requests and communications with the CDPH directorate and external stakeholders.
• Coordinates IT projects and houses the data research program.

Questions:

• Outside of LFS, what other programs and facilities are present on the CDPH Richmond campus? ​

A: The campus houses various other programs, such as the Childhood Lead Prevention Program and the Food and Drug Branch Lab. Additionally, there are public health programs like Healthcare Associated Infections located on the campus. ​​

• Could you explain the relationship between LFS and CLTAC? ​

A: CLTAC is an advisory body mandated by state law to provide guidance to LFS on regulatory matters. CLTAC is not part of the state government, but rather advises LFS. ​

• If a laboratory in California undergoes any changes, how should they notify LFS? ​

A: Any changes to laboratory licenses should be communicated to the Richmond campus first, where the state license is updated. Then, the information is forwarded to the CLIA team for updating the certificate. It is a sequential process where changes go through Richmond before reaching CLIA. ​

• If a provider group wants to open their own lab, whom should they contact within LFS for assistance? ​

A: LFS is a regulatory agency and cannot provide consultancy on opening labs due to conflict of interest. However, they can refer interested parties to relevant legal codes, such as Business and Professions Codes and Title 42 of the Code of Federal Regulations, Part 493, along with CLIA interpretive guidelines available on the CLIA website.

Old Business

A. Voting on Recommendations of the CLTAC Public Health Regulations Subcommittee White Paper 

Zenda Berrada presented the Voting on Recommendations of the CLTAC Public Health Regulations Subcommittee White Paper:

Background

• Department charged CLTAC to form a subcommittee to review and provide recommendations for updates to Public Health Laboratory Regulations. 
• ​Initial Subcommittee formed in March 2018; report submitted March 2019. 
• Reconvened in March 2021 to incorporate additional recommendations in light of COVID emergency.

PHL Regulations Subcommittee Report:

• White paper summarizing Subcommittee recommendations approved by the CLTAC in December 2021. 
• Request for additional revisions to clarify LFS role in Subcommittee membership and contributions. 
• Minor edits made and approved by all members of Subcommittee. 
• ​Revision submitted for review by CLTAC February 1, 2023.

Request for PHL Regulations Subcommittee Report Revisions:

• Three edits were made, all to page 1:

1. Added the following at the top of page:

​a. Updated – January 23, 2024: Edited to clarify Contributing Members.

2. Removed LFS from “Contributing Members list.” 
3. Removed “LFS and” from the following sentence and updated grammar:

a. The following definitions, updates, and recommendations have been agreed upon by the Subcommittee: “LFS and t The Subcommittee are is asking the full CLTAC to approve the recommendations included.”

B. Digital Data Review Query​

Dr. Deucher presented the Digital Data Review Query:

• Remote review of digital clinical laboratory data and digital results were permitted during the pandemic. Pandemic regulations allowed for remote review of digital data at remote sites, including physical slide review by pathologists. 
• Post-pandemic, enforcement discretion has been continued, permitting laboratory personnel to review digital data, digital results, and digital images remotely from primary locations. 
• However, this practice contrasts with California state law, which does not permit digital data review. California law does not recognize the argument that a VPN effectively places one within the CLIA lab. 
• According to California, the physical location where the review takes place must have a CLIA license.

Questions:

Regarding the enforcement, would this practice open one’s house to inspection?

A: It would be considered as an extension of the laboratory. Therefore, responsibilities that apply within the laboratory’s four walls and for the personnel you oversee would also apply to these remote locations. Training, competency, and report disclosure requirements will persist as obligations extended from the laboratory.

C. By-Law Modification Update​

Dr. Deucher presented the By-Law Modification Update, and introdu​ced the following potential future changes to the By-laws:

• Potential Introduction of Vice Chair
• Vice chair would serve for one year, primarily as an observer in support of the Chair and to fill in if Chair is absent during meetings. They will assist with managing meetings and transitions. 
• ​Potential Modification of Composition of Board
• ​​There are three positions that have been historically difficult to fill: Licensed Cytotechnologist, Registered Nurse (Hospital Bedside Testing), and Healthcare (Hospital) Administrator. 
• Dr. Deucher proposed expansion of the board by 2 to 4 members, or maintain 21 members, but modify composition. 
• In terms of expansion, Dr. Deucher suggested the following new positions: 
• Molecular Director/CLS 
• Reproductive Biology 
• Digital Pathology/Bioinformatics 
• Quality Assurance 
• 2nd Public Health Microbiologist 
• Point of Care Testing Coordinator 
• ​Reimbursement Policy 
• ​The current By-laws state members serve without compensation, but are reimbursed for expenses relating to CLTAC. 
• With the current situation with hybrid meetings and LFS budget, reimbursement is not offered. 
• Dr. Deucher suggested updating By-laws to reflect current reimbursement policy.​​​​

Laboratory Field Services

A. Licensing Section​

Dolapo Afolayan presented the Personnel Licensing Section Update:

Implementation of New License Types Progress Update:​

• LFS announced that they continue to make significant progress with the second phase of its implementation plan for the new license types.
• LFS has approved one Clinical Reproductive Biologist (CRB) director application and five Clinical Laboratory Geneticist (CLG) director applications and has issued the licenses. 
• Currently, LFS is working with stakeholders to ensure that the licensure pathways for the clinical reproductive biologist scientist and the clinical laboratory geneticist scientist license types are efficiently implemented. 
• Stakeholders will be notified when the requirements will be published on our website and when application review and approval will begin. 
• For inquiries about the scientist new license types contact: LFSnewapplications@cdph.ca.gov​​​​

Questions:

A constituent has been attempting to apply for a director license since January 1, 2023. How can they schedule the oral exam?

A: To schedule the oral exam, Ms. Afolayan advised the constituent to send an email to the LFS staff member they have been previously corresponding with to follow up. It has been a priority for LFS to schedule these exams as soon as possible.

B. Regulation Creation/Finalization Process​​

Mary Wogec presented an overview of the Regulation Creation/Finalization Process and Rulemaking Process:

Statues and Regulations:

• Statutes (Business and Professions Code, Health and Safety Code) are state laws adopted, amended, or repealed by the legislature or by vote of the people of California. 
• Regulations (the California Code of Regulations) are rules, regulations, orders, or standards of general application or the amendment, supplements, or revisions of any rule, regulation, order, or standard adopted by any state agency to implement, interpret, or make specific the law enforced or administered by it, or to govern its procedure. (Government Code section 11342.600) 
• Regulations are adopted, amended, or repealed by administrative agencies in the executive branch to implement statutes, when a statute gives them authority to do so. Agencies in the Executive branch are delegated this rulemaking power by the Legislature.

The Process:

• Establishing authority and need for regulations. 
• LFS ensures legal authority and necessity for drafting regulations. This includes authority, reference, program need, and stakeholder input. 
• Requesting approval. 
• Approval is sought out from various authorities, including the Center for Laboratory Sciences (CLS), CDPH, and Department of Health and Human Services (DHHS). 
• Submission to the CDPH Office of Regulations (OOR). 
• Once approved, the request is assigned a number and listed on the Office of Regulations Tracking Log. 
• Regulations Writing Team (RWT) 
• A team is assembled comprising legal assistance, subject matter experts, regulations writer, and an OOR liaison. This team collaborates to draft regulations, considering input from stakeholders and internal staff. 
• Stakeholder Engagement 
• Stakeholders are engaged throughout the regulatory process from the very beginning. For instance, CLTAC may convene an advisory committee. 
• Drafting Documents 
• Supporting documents include proposed regulation text, initial statement of reasons (explaining changes), economic and fiscal statement, and cost estimation methodology. 
• Approval Process 
• The RWT submits the rule making package for review and approval to LFS, Center for Laboratory Sciences, Office of Regulations, Office of Legal Services, CDPH Budgets Office, CDPH, DHHS, Department of Finance, and the Governor’s Office. 
• Submission to the Office of Administrative Law (OAL). 
• OOR sends the package to OAL, opening the public comment period (public hearings, written and oral comments). 
• OAL Process 
• ​OOR publishes notice and documents on the OOR website for a 45-day public comment period. The Program summarizes and responds to comments, makes revisions, and submits revised package. Substantive changes open a 15-day public comment period on the changes. When the final draft is submitted, OAL has 30-day period to review and accept or reject the package.​

C. Legislation and Regulations​​

Mary Wogec presented the Legislation Report:

• 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 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 Counsel​’s website at: http://leginfo.legislature.ca.gov​​​

LFS Bill Assignments 2024:

• SB 570 – Prenatal Screening Program (2-year bill) 
• AB 2107 – Clinical Laboratory Technology: Remote Review 
• AB 2702 – Schools for Clinical Laboratory Scientists and Medical Laboratory Technicians: Grants 
• AB 3009 – Healing Arts (Spot) 
• AB 3059 – Healing Arts 
• SB 570 – Prenatal Screening Program ​

​Mary Wogec also presented the Regulations Update:

• DPH 20-007: Trainee, Medical Laboratory Technician, Medical Laboratory Technician Transition to Clinical Laboratory Scientist 
• The public comment period for this package closed on January 20. 
• LFS has received approximately 80 emails with comments. We are now reviewing the comments and drafting responses, which will be available on the OOR website. 
• The next step will be to make revisions based on comments and submit the text and a final statement of reasons to the Office of Administrative Law for their review.

Questions:

• How does one initiate the process of changing a regulation? 

New Business

A. Queries from CLTAC Board and Public Members to LFS

1. Delay in Licensing of Reproductive Biology Scientists

The presentation on Delay in Licensing of Reproductive Biology Scientists by Salustiano Riberio was postponed due to time constraints, and will be addressed in the next meeting on June 7, 2024. 

2. Question regarding former process improvement team working to improve licensing issues.

This discussion introduced by Jamie Marks was postponed due to time constraints, and will be addressed in the next meeting on June 7, 2024.

Closing​​

Yanyan Hong moved to end the meeting and the motion was seconded by Dora Goto. The meeting ended at 12:46 pm.​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

Minutes of the Meeting held on December 1, 2023

CLTAC Members Participating

Marc Bernaldez, Zenda Berrada, Gina Crain, Christine Darmanian, Anne Deucher, William Gardner, John Geisse, Dora Goto, Gabor Hertz, Dan Leighton, Anthony Mills, Anthony Salazar, Lu Song

California Department of Public Health (CDPH) Staff Participating

Dolapo Afolayan, Charlet Archuleta, Jason Boatman, Yu-Chen Chang, Linda Cortez, Chad Crain, Karen Demby, Elsa Eleco, Maral Farsi, Jinong Feng, Elaine Flores, Najib Gul, Bryant Hard, Joselita Joaquin, Christina LaFave, Kim Van Le, Katya Ledin, Nadia Madden, Donna McCallum, Martha Obeso, Jorge Palacios, Dana Parlee, Nai Saechao, Jill Tellioglu, Catherine Tolentino, Anthony Tran, Debra Wadford, Mary Wogec, Jenny Yun

Public Members Participating

Bob Achermann, Angela Melanie S. Aguiluz, Maureen E. Ahler, Julie Ballard, Regina Gallick Bertolucci, Margorie Braasch, Blythe Brownlow, Rowena Carino, Irene Chen, Neng Chen, Gina Crain, Erin Cox, Rosa Cuevas, Amy Daniels, Heather M. Davis, Kathleen Doty, Denise Driscoll, Theresa A. Dunning, Erin N. Estacio, Donna Ferguson, Andrew Fountaine, Karen Fuller, Colleen Goodman, Kellie Graham, Justin Hanenberg, Brett Holmquist, Morris Jones, Susan Kazarian, Dianne Keen-Kim, Elham Khanafshar, Shiu-Land Kwong, Lois Langs, Zolton Lasik, Huy Le, Ying Q. Lin, David Luong, Carmen Maldonado, Caroline Martinez, Sharon K. McGoldrick, Stephen Medland, Melisand Mohseni, Ernest Nkwuzor-Osuagwu, Erica N. Padilla, Victoria Partida-Young, Lori P. Potter, Gloria C. Preza, Yong Qu, Stacy-Eleanor Ralston, Elaine Ramsey, Rachel Rees, Regan, Jowin Rioveros, Rodney Roath, Mike Robson, Brystal Romero, R Y, Chrisine E. Sabol, Osvaldo Santiago, Rachielle R. Sheffler, Fernando A. Torres, Susan E. Traub, Timothy J. Tubman, Maria Victorio, Nickole Wann, Lyn Wielgos, Carol Wong, Gary Yamamoto, Christine Yee, Regan Yu ​

Welcome, General Announcements

• Gabor Hertz, MD, called the meeting to order at 9:08 AM.
• Dr. Hertz noted that the meeting was being recorded.​ ​

Roll Call

• Dr. Hertz conducted the roll call, and asked the board members to briefly introduce themselves. 
• A quorum was present, but not the two-thirds required to change the bylaws. ​

Approval of Minutes from September 8, 2023, Meeting

• Dora Goto provided a correction to the CLTAC minutes to clarify who nominated Anne Deucher.
• Dora Goto moved to approve the September 8, 2023, minutes; the motion was seconded by Zenda Berrada. ​

Election of the CLTAC Chair

• Dr. Anne Deucher was elected as the CLTAC Chair.

CLTAC By-Laws Subcommittee Update

Dr. Hertz presented an update on the CLTAC bylaws.

• Propose to amend the bylaws to allow LFS to appoint representation from either RNs performing POC testing or a laboratorian practicing molecular and genetic testing.
• ​Considering the rising levels of molecular testing and the difficulty in filling the RN advisory role.
• ​Propose to expand the board to 22 possible members by including representation from public health microbiologists.
• Considering the recent COVID19 public health emergency, the development of multiple novel tests under FDA EUA, reporting requirements, and unique issues faced by public health laboratories.
• Propose the creation of a vice-chair position.
• ​It would provide redundancy in the position and address the steep learning curve due to the complexities of laboratory regulations. ​​​

Initiation of Legislative Change

Maral Farsi and Kim Van Le of the CDPH Office of Legislative and Governmental Affairs presented an overview of the legislative process and the process to amend California statutes.

• ​Three paths to new (statutory) laws in California 
• Legislation—Elected representatives in the Assembly or Senate. 
• Budget—the Governor via the budget process to allocate or provide funding (which may enact a law). 
• Ballot Measure—individuals or organizations may introduce ballot measures. 
• Stages of Legislation 
• Policy development 
• ​​Private entities may contact members of the Senate, Assembly, or Administration about their legislative interests. 
• Discussions are held on the legislative language. 
• The product is introduced as a bill in the Assembly or Senate. 
• Legislation originating with the department is rare and is typically technical in nature. 
• Policy Engagement 
• ​Various public and private entities and individuals view, analyze, and discuss the bill. 
• The various departments create analyses for the governor’s review and use. 
• The goal of policy development and engagement is to create well-written and effective law for everyone’s benefit. 
• Timeframes 
• Legislative sessions begin in February and end in late September or early October. 
• Unless they have urgency clauses, laws passed through this process go into effect the following year. 
• If required, funds are allocated through the normal budget process. 
• If required, agencies may adopt clarifying regulations. 

​Contact information: Maral Farsi Maral.Farsi@cdph.ca.gov, Kim Van Le KimVan.Le@cdph.ca.gov​

Questions:

• Whom should individuals contact regarding their concerns or ideas on changing the law? 
• For legislation, contact members of the Assembly, Senate, Administration, or the department. 
• For regulations, contact the Administration or department. ​
• With respect to digital pathology, is legislation or regulation required? 
• Generally, house counsel would need to determine if there is an existing statutory baseline where there is ambiguity that can be addressed through regulations. If there is not enough statutory authority, then legislation is required. 
• With respect to digital pathology or the remote viewing of digital slides, if legislation is pursued, how long would it take to allow this type of review in California? 
• ​Generally, legislation may pass in a few months, and absent an emergency, the law goes into effect the following year. If regulations are required to clarify or administer the statute, the process of drafting and adopting regulations usually takes two to three years. ​ ​

Proposed FDA Rules on Laboratory Developed Tests

Dr. Anthony Tran, Director of the State Public Health Laboratory and Deputy Director of the Center for Laboratory Sciences, reported on the FDA’s proposed rules for laboratory developed tests (LDT).

• FDA proposed rule would remove enforcement discretion regarding LDTs. 
• Laboratories creating a test, or modifying a commercial test, would need to submit the LDT (including supporting data) to the FDA for pre-market approval.
• The proposed rule affects many laboratories including public health laborat​ories. 
• Dr. Tran encouraged interested parties to submit comments before the 60-day comment period closes on December 4, 2023. ​

​​​

Laboratory Field Services

A. Branch Update

Charlet Archuleta presented the LFS update report.

• ​Following Robert Thomas’ retirement, Ms. Archuleta took over as the Acting Branch Chief effective October 2, 2023. 
• Ms. Archuleta has been with CDPH for over a decade and served in various management positions in the Office of Regulations (OOR). She most recently served as the Assistant Deputy Director of CDPH’s Office of Legislative and Governmental Affairs. 
• The Call Center is working to provide FAQs to address the community’s concerns and issues. They will be posted on the LFS website when completed. 
• CLTAC is mandated by California law to advise the Department on the establishment of rules and regulations necessary to ensure proper administration and enforcement of the provisions under its authority and matters concerning examinations for clinical laboratory licensees (Business & Professions Code § 1228). LFS is working with the CLTAC board to revise the order of the meeting agenda to encourage stakeholder engagement by prioritizing items regarding stakeholder participation on the agenda.

B. CLIA Survey Section

Donna McCallum reported the section’s report.

• ​Electronic CLIA certificates 
• ​CMS began delivery on March 22, 2023, to the contact email on record; the electronic certificate may be printed online at CMS.hhs.gov/clia​. 
• Laboratories must submit form CMS-116 to opt in or change their contact email. 
• Certificates can only be generated in the 30-day period prior to the current expiration date. 
• CMS sends the first payment coupon one year prior to expiration, and the second coupon at 120 days prior. Failure to pay by the expiration date will result in certificate termination. 
• Regarding certificates pending renewal due to the backlog of recertification surveys, CMS will only extend expiration dates on a month-to-month basis and have extended them through 12/31/23. 
• Ms. McCallum answered questions about individuals’ certificates or applications; topics included exemptions, multiple sites qualifications, and application processing.

C. Legislation and Regulations

Mary Wogec reported on legislation and regulations.

2023 Legislation:

Minutes of the Meeting held on September 8, 2023

CLTAC Members Participating

Marc Bernaldez, Zenda Berrada, Gina Crain, Christine Darmanian, Anne Deucher, Dora Goto, Gabor Hertz, Jessica Huynh, Dan Leighton, Jeff Majdali, Jamie Marks, Anthony Mills, Anthony Salazar

California Department of Public Health (CDPH) Staff Participating

Yu-Chen Chang, Archana Dhillon, Elsa Eleco, Najib Gul, Joselita Joaquin, Donna McCallum, Kim Nachazel, Martha Obeso, Maria Olson, Jorge Palacios, Rocky Pramanik, Nai Saechao, Jill Tellioglu, Robert Thomas, Catherine Tolentino, Anthony Tran, Clint Venable, Mary Wogec, Jenny Yun

Public Members Participating

Angela Aquiluz, Maureen Ahler, Nathalie Apke, Julie Ballard, Marge Braasch, Blythe Brownloe, Robert Footlik, Andrew Fountaine, Colleen Goodman, Justin Hannenberg, Brett Holmquist, Navdeep Kaur, Dianne Keen-Kim, Peggy Kollars, Shiu-land Kwong, Carmen Maldonado, Lori Marzick, Bea O’Keefe, Erica Padilla, Gloria Preza, Raju, Rachel Rees, Jowin Rioveros, Rodney Roath, Mike Robson, Brystal Romero, Christine Sabol, Osvaldo Santiago, Barbara Sevilla, Meredith Staples, Timothy Tubman, Keau Wong, Christine Yee, Susan Zhang

Welcome, General Announcements

• Gabor Hertz, MD, called the meeting to order at 9:04 AM. 
• Dr. Hertz noted that the meeting was being recorded.
• A roll call was conducted of CLTAC board members and a quorum was present. 

Approval of Minutes 

• Zenda Berrada moved to approve the July 2, 2023, minutes without changes; the motion was seconded by Dora Goto.
• The motion passed unanimously with no abstentions. 

Department News 

Anthony Tran, DrPH, MPH, presented Department news:

• CLS has moved to phase 2: Improve Operational Efficiencies.
• CLS has achieved fiscal independence.
• Areas of focus will be strategic planning, enhancements, and efficiencies.
• September is Public Health Awareness month. 

LFS Update 

Robert Thomas presented the LFS branch report:

• CLTAC meeting model will be a hybrid of remote and in-person meeting.
• High-level state support has been received for regulation packages, which are moving forward.
• The Office of Regulations (OOR) will provide workflow templates, timetables, and support for regulations packages.
• Public Health Laboratory (PHL) regulation recommendations received from the Subcommittee prior to the COVID pandemic will be revisited and prioritized.
• Regulations regarding a Medical Laboratory Technician (MLT) to Clinical Laboratory Scientist (CLS) pathway have been submitted to Agency for review.
• Implementing regulations for SB 1267 will be LFS’ next focus.
• Conferences
• Workforce Action Alliance Summit national meeting held in Ft. Worth, Texas in May 2023
• CMS National Surveyor Training Meeting in Maryland in August 2023 

Mr. Thomas announced that his second bid at retirement would begin September 29, 2023; he briefly revisited his 35 years of state service and his time at LFS, thanking the department, his staff, particularly the section chiefs for their efforts during the pandemic, and the CLTAC for its continued support of LFS. Mr. Thomas reaffirmed his confidence in LFS’ ability to aid and serve the community after his departure. 

Mr. Thomas was met with congratulations, gratitude for his service, and well wishes from those present.

Administrative Items 

Jorge Palacios introduced Maria Olson and Archana Dhillon from the team who worked on the Continuous Quality Improvement (CQI) for the LFS Call Center (LFSCC). 

Ms. Olson and Ms. Dhillon reported that the team gathered and analyzed the available call center data. The group found that the majority of inquires related to facility licensing, and provided a list of nine frequently asked questions relating to CLIA. The group also identified several areas for improvement, noting that further research and improved data collection were needed. 

CLIA Survey Section Report 

Donna McCallum reported on her section’s work, and answered the questions identified by the Admin Unit’s research.

• Section activities, surveys, complaint investigations, PT review
• CMS National Surveyor Training meeting on August 8-10, 2023, CLIA regional organization, CLIA statistics
• Gave answers to the CLIA FAQs from the LFSCC CQI project and took questions from those present
• Most questions pertained to the initial certification process, how to renew or make changes to existing certificates, and the issue of electronic certificates 

Facility Licensing Section Report 

Martha Obeso presented the section report.

• Quarterly statistics
• Across the board gradual increase in the number of applications (initial registration, initial license, renewals) during the year
• The initial registration application backlog peaked at 1,700 in February but has since been reduced to 331 in August.
• Initial and renewal applications moved to online only beginning in March.
• Laboratories that mail applications will be required to complete them online.
• Laboratory changes must still be done by mail or email.

On-site Licensing Inspection Section Report 

Elsa Eleco presented her section report.

• The On-site Licensing Section is responsible for handling complaints, performing initial, routine, and complaint surveys, approval and oversight of accrediting organizations.
• COLA has been granted deemed authority for the specialty of histopathology, again.
• Technical consultant (TC) qualifications:
• For state law, 17 CCR section 1036.2 has parts (a) and (b), where (a) is specific to the state, and (b) is the base federal requirement.
• TC must meet both (a) and (b)

Personnel Licensing Section Report 

Elsa Eleco presented the section report in place of Dolapo Afolayan.

• LFS is currently reviewing clinical laboratory geneticist director and clinical reproductive biologist director applications. These applications will be reviewed in the order received and in the same manner as other license types in accordance with state law.
• Licensure pathways for the specialties of clinical laboratory geneticist and clinical reproductive biologist are awaiting implementing regulations.
• The statute is written in such a way as to allow LFS to process applications and issue licenses for these two categories while regulations for them are being drafted.
• Passage of these regulations will not require LFS to reconsider the licenses that have already been issued.
• For inquires pertaining to applications for the new director license types, contact LFSdirectors@cdph.ca.gov​

Administrative Unit Report 

Reported earlier.

Legislation Report 

Mary Wogec presented the branch report on legislation and regulations. 

On legislation, LFS has been assigned the following bills for this session:

• AB 269, COVID Testing and Dispensing Sites
• AB 1341, COVID Testing and Dispensing Sites
• AB 1741, Clinical Laboratories: Personnel
• SB 570, Prenatal Screening Program
• SB 667, Healing Arts: Pregnancy and Childbirth 

For information regarding the text and history of these bills, please refer to the California Legislative Information website.

On regulations:

• MLT pathway 
• ​The package has been approved by the department and is under review by the Health and Human Services Agency. After review by the Department of Finance and Governor’s Office, the package will be submitted to the Office of Administrative Law, which will make the package available for public comment. Anyone who wishes to be notified of the public comment period may contact Mary Wogec. The department anticipates the approval of this package, and is hopeful for adoption by the end of 2024.
• ​​Clinical Laboratory Geneticist and Clinical Reproductive Biologist Licensure. The program plans to begin work on this package next.
• Public Health Laboratories The department also plans to begin work on this package soon. The department has received substantial input from the CLTAC subcommittee and plans to continue working with stakeholders once the regulations package team has been assembled. 

COVID Email box: 

• The email box was created to field COVID-related questions and received 14,000 questions, comments, suggestions, complaints, and input. The department thanks all those who made use of it, but now that the state of emergency has been lifted, the email box will be retired, and all emails sent to it will be redirected to the LFS Call Center. LFS is still available to answer questions related to COVID, which should be addressed to the LFS Call Center.

Case Studies of Evolving Technology in Laboratory Medicine 

Dr. Hertz presented three cases studies to illustrate evolving technology in laboratory medicine.

• ​Case 1 - Malaria
• A rare occurrence of malaria in a US patient, who had had recently visited Africa. Due to its rarity, the specimen was sent to a specialist. The gold standard diagnostic test was established in 1907. While a PCR test is available, it does not provide usable information to doctors. There is a new rapid test, point of care, lateral flow like with COVID tests.
• Case 2 – Colon cancer
• Case 3 – Cervical Squamous Cell Carcinoma

CLTAC By-Laws Subcommittee Update 

Dr. Hertz reported the following:

• ​Subcommittees are created through a charge given by the department.
• Membership on a subcommittee to revise by-laws is limited to current CLTAC board members.
• The full CLTAC itself may discuss matters without a charge.
• The proposed subcommittee would look at updating the bylaws regarding:
• The composition of the CLTAC, both the number of seats and the groups represented
• Creation of a Vice-Chair position
• LFS will seek the advice of counsel regarding whether the Vice-Chairperson position may be discussed by the CLTAC later.

New Business 

None. 

Nominations for CLTAC Chair 

Zenda Berrada nominated Anne Deucher, MD, and was seconded by Dora Goto. Dr. Deucher accepted the nomination. The vote for a new Chairperson will occur at the next CLTAC meeting.

Discussion of Business and Professions Code section 1209 and Point of Care Testing 

Anne Deucher raised several stakeholder concerns. Robert Thomas briefly touched on the subjects, but due to time limitations and the legal implications of the issues, he directed stakeholders to provide more details, formulate their questions, concerns, or recommendations, and then submit them to LFS, specifically to Mary.Wogec@cdph.ca.gov. LFS will forward such questions relating to the interpretation, enforcement, or changes to state law to their legal counsel for review, and then respond accordingly.

• Clinical laboratory licensure requirements for the remote reading of slides 
• The issue was raised several times during the meeting and a composite reply is given here. It is important to understand that when state and federal law differ, the more stringent law applies. CMS may have issued guidelines for discretionary enforcement relating to CLIA certification requirements during the public health emergency (which has since ended), but where state law was more stringent, it still applied. The state opted to set aside, via executive order, some testing requirements relating specifically to COVID testing; the order did not affect “digital pathology.” As these are statutory requirements, recommendations for changes to these laws would be more appropriately addressed to members of the State Legislature, but LFS will still take inquiries to better understand the community’s concerns.
• Requirements for blood gas technical consultants
• On the matter of blood gas technical consultants, Mr. Thomas pointed out that the laws for testing and consulting or supervising should not be conflated. Personnel who are allowed to test are not necessarily allowed to consult or supervise. LFS can provide further clarification if a more detailed inquiry is submitted.
• Competency requirements for waived laboratories issued by accrediting organizations.
• ​As for the question of AO requirements, Mr. Thomas said that it was not clear what the circumstances or issues were and asked for clarification. Generally, state-approved AOs are required to enforce state and federal laws but are allowed to have additional requirements for their members. Members of AOs must meet all such requirements to maintain the laboratory’s accredited status or seek oversight by other organizations. LFS requested more detailed information so the department can better understand and respond to the individual situation.

Future Items

Dora Goto moved to end the meeting and was seconded by Anne Deucher. The meeting adjourned at 1:16 PM. ​​​​

​

Minutes of the Meeting held on June 2, 2023
Meeting held through Microsoft Teams​​

CLTAC Members Participating​​​

Marc Bernaldez, Zenda Berrada, Gina Crain, Christine Darmanian, Anne Deucher, Bill Gardner, John Geisse, Dora Goto, Gabor Hertz, Dan Leighton, Jeff Majdali, Jamie Marks, Anthony Salazar, Ming Zhou.​

California Department of Public Health (CDPH) Staff Participating

Dolapo Afolayan, Patricia Bolivar, Yu-Chen Chang, Wenn Chen, Archana Dhillon, Deana Eden, Elsa Eleco, Elaine Flores, Najib Gul, Blesilda Honorio, Pedro Jimenez, Joselita Joaquin, Christina LaFave, Katya Ledin, Vincent Lee, Nema Lintag, Lorelie Marquez, Donna McCallum, Martha Obeso, Jorge Palacios, Dana Parlee, Rocky Pramanik, Paula Schultz, Mai Sgamba, Jill Tellioglu, Robert Thomas, Brandi Thompson, Anthony Tran, Yvette Urrutia-Giacalone, Wilfred Velasco, Gordon Vrdoljak, Mary Wogec, Kevin Yang, Jenny Yun.​

Public Members Participating

Bob Achermann, Angela Melanie Aguiluz, Daniela Aron, Elma Kamari Bidkorpeh, Marge Braasch, Alka Chaubey, Neng Chen, Irene Chen, Hencelyn Chu, Cengiz Cinnioglu, Megan Crumpler, Danny Dasig, Denise Driscoll, Theresa Dunning, Diana Dupuy, Donna Ferguson, Karen Fuller, Colleen Goodman, Justin Hanenberg, Navdeep Kaur, Dianne Keen-Kim, Margaret Knapp, Peggy Kollars, Shiu-Land Kwong, Lois Langs, Feng Li, Elizabeth Lucas, Carmen Maldonado, Cecilia Mui, Valerie Ng, Daniel Pach, Al Peyketewa, Teresa Prince, Stacy-Eleanor Ralston, Salu Ribeiro, Jowin Rioveros, Rodney Roath, Christine Sabol, Osvaldo Santiago, Barb Sevilla, Meredith Staples, Denisse Valencia, Manuel Viotti, Marissa Vismara, Carol Wong, Tammy Zinsmeister.​

Welcome, General Announcements (Dr. Gabor Hertz, Chair)​

• Meeting started at 9:05 AM.
• Dr. Hertz announced that the meeting was being recorded.
• Dr. Hertz conducted roll call and determined that a quorum was present. ​

Approval of March 3, 2023, CLTAC Meeting Minutes (Dr. Hertz)

• Bill Gardner moved to approve March 3, 2023, meeting minutes.
• John Geisse seconded move to approve March 3, 2023, meeting minutes. ​

Department News (Anthony Tran)

• Dr. Tran, Director of State Public Health Laboratory and Deputy Director of Center for Laboratory Sciences (CLS), provided the following updates for CLS:
• CLS Continues Hiring Efforts 
• Noted that high priority initiative is continuing to fill vacant positions, especially at Center level, as quickly as possible to support CLS.
• Welcomed and introduced Dr. Gordon Vrdoljak, the new Chief of Division of Environmental Health Laboratories.
• National Medical Professional Laboratory Week (Lab Week)​
• ​Held the Lab Week for the first time under the CLS here at the Richmond campus in the last week of April.
• Presented snapshots to show the highlights of the Lab Week event.​​
• Dr. Tran also highlighted the Association of Public Health Laboratories Annual Conference (APHL 2023), which was held at the SAFE Credit Union Convention Center in Sacramento, California from May 22 through May 25, with over 1500 attendees.
• ​CDPH was the host laboratory, along with the Sacramento County Public Health Laboratory. 
• Emphasized that “… we need to do our work in continuing to move the needle forward for laboratory sciences across all of our laboratory sectors and making sure that we have a seat at the table, making sure that folks are listening to us as a profession and that our compensation, our standing of recruitment and retention efforts are all right there in line with all of our other health care partners.” ​
• Dr. Tran shared what he had presented at the APHL 2023:
• ​​Public Health Laboratories in California are part of the Laboratory Response Network, the network that was formulated by the APHL and the Centers for Disease Control and Prevention (CDC) in 1999 to respond to biothreat or chemical threat situations that might arise in the US. 
• There are 29 public health laboratories within the 61 local health jurisdictions in the State of California. CLS laboratories are among the 29 public health laboratories. Not all the local health jurisdictions have their own public health laboratories. ​
• Dr. Tran noted the laboratories that have moved under CLS, and stated that starting July 1, CLS will have its own budget authority. In addition to that, CLS also continues to receive federal funding initiatives, including the CDC’s Data Modernization Initiative (DMI). (https://www.cdc.gov/surveillance/data-modernization/index.html​) ​

Branch Report (Robert Thomas)

• Mr. Thomas, LFS Branch Chief, welcomed two new CLTAC board members.
• Gina Crain, Clinical Lab Scientist, was nominated by the Philippine Association of Medical Technologists, Northern California Chapter to serve the remainder of the four-year term left vacant by the departure of Dan Dominguez from the committee.
• Dr. Ming Zhou, licensed Physician and Surgeon, was nominated by the California Medical Association.
• Mr. Thomas provided updates on Public Health Laboratory regulations.
• Discussion started in 2018-19. In 2019, a CLTAC subcommittee was formed to consider the need for revisions to public health laboratory regulations. After extensive work, a report was submitted with the recommendations, which was approved by the CLTAC board.
• During the COVID-19 emergency, staff from LFS and CDPH office of regulations were redirected to COVID response assignments. Now those staff have returned to the regular work assignments and LFS is able to resume work on regulations.
• A package to implement a pathway for licensed MLTs to transition to become CLS is now ready for departmental and agency review.
• Another package to implement the new license categories of laboratory geneticists and reproductive biologists created by SB 1267 is also being worked on.
• We will also begin work on a package to update the public health laboratory regulations and will be reaching out to stakeholders. Stakeholder input for proposed regulations is required by the Office of Regulations and the Office of Administrative Law (OAL).
• ​Mr. Thomas discussed laboratory workforce issues.
• ​​At the last CLTAC meeting, the CLTAC Subcommittee on Laboratory Workforce presented a white paper that has been approved by the board.
• Mr. Thomas attended the Workforce Action Alliance Summit, held in Fort Worth, Texas on May 2. Participants were from a broad section of clinical laboratories, laboratory professional associations, public health organizations and regulatory agencies. These groups gathered to identify ways to increase the number of laboratory professionals in America’s clinical and public health laboratories and to attract and train more students and ways laboratory organizations can collaborate to increase recruitment and retention.
• Participants in the Workforce Alliance will continue to work to finalize an action plan for its ongoing work on three priorities for further action during this next year:
• Strengthen data to understand the current laboratory workforce shortage.
• Working together to communicate career pathways, including related educational and experience requirements to make them more uniform across the country.
• Standardize the laboratory professional titles to promote unity and educate the public.
• Mr. Thomas also attended the 2023 APHL Annual Conference in Sacramento. 
• Mr. Thomas mentioned that our guest speaker, Karen Fuller, manager of the CLIA Western and Central Operations Branch at the federal Centers for Medicare & Medicaid Services, will be able to answer questions and issues about federal policies at the later part of the meeting.
• Mr. Thomas revisited the idea of a new CLTAC meeting format.
• ​During the COVID-19 pandemic, LFS opted for a hybrid model with the option of calling in via Teams or attending in person at the CDPH Richmond campus.
• LFS is now planning to implement a new meeting model: the September meeting will be held as an in-person meeting at the Richmond campus, the next one will be held in Southern California. The location for in-person meetings will alternate between Northern and Southern California.
• LFS believes that in-person meetings provide a meeting environment free of distraction and also give an opportunity for interaction among committee members that isn’t possible with the online format.
• LFS can pay for board members’ travel expenses such as plane tickets or mileage to attend the meetings.
• The format of meeting minutes will change as well. Assistant Branch Chief Jorge Palacios will explain the new format in his report. ​

Administrative Items (Jorge Palacios)

• Jorge Palacios, LFS Assistant Branch Chief, presented the following administrative items.
• Laboratory Field Services (LFS) Update
• Mr. Palacios introduced Kim Nachazel and Archana Dhillon from the Research Data and Maria Olson from the Admin Support team.
• ​Lean Processes
• Summary Meeting Minutes
• After studying what the Healthcare-Associated Infections Advisory Committee is doing with the Center for Healthcare Quality, Mr. Palacios also believes that CLTAC can create meeting minutes more efficiently if we provide the resources and training.
• Customer Service Center Inquiries
• ​Mr. Palacios thinks there is an opportunity for us to improve the call center response rate by studying closely the process for responding to emails from our stakeholders.
• With the support of Archana, Kim, and Maria, the Continuous Quality Improvement (CQI) research team will implement a CQI process: PDSA (Plan. Do. Study. Act.)
• The plan is to study the questions from constituents before creating responses to improve the FAQs that are currently posted, with the understanding that responses to complicated questions will require collaboration among the research team unit, admin support, and section subject matter experts.
• Mr. Palacios noted that the PDSA process will concentrate only on emails coming into the call center. The goal is to show the data for calls before and after the revision of the FAQs for the facility licensing program as well as the personnel licensing program. The team could have some preliminary results for the December meeting. ​

Admin Section Report (Brandi Thompson)

• Ms. Thompson, Administrative Unit Chief, provided the following updates.
• LFS Admin Updates
• Ms. Thompson noted that there were 24 job openings in October 2022. Five of them were filled. Ms. Thompson welcomed the five new hires.
• Call Center Developments
• ​Ms. Thompson has been supervising the call center for several months since the call center supervisor exited. She is looking into ways to increase the call center response rate to above 80%.
• Ms. Thompson identified some gaps and implemented processes to improve capabilities. ​

Personnel Licensing Section Report (Dolapo Afolayan)

• Ms. Afolayan, Personnel Licensing Section Chief, announced that significant progress has been made with the second phase of the implementation plan for the new license types.
• LFS can move forward with the review of the Clinical Laboratory Geneticist and Clinical Reproductive Biologist Director applications.
• Webpages are posted with information regarding the requirements for Clinical Laboratory Geneticist licensure and Clinical Reproductive Biologist licensure per California law:
• Clinical Laboratory Geneticist
• Clinical Reproductive Biologist​
• In response to a question regarding review of scientist level applications, Ms. Afolayan noted that the personnel licensing section have just begun the review of the director application. Once that is completed, they will move on to review the scientist application and will update the committee.​

Facilities Licensing Section Report (Martha Obeso)

• Ms. Obeso, Facility Licensing Section Chief, presented the following laboratory licensing updates.
• Quarterly Statistics
• Ms. Obeso pointed out that for last quarter, January 2023 to March 2023, there was an increase in the number of applications received. Prior to COVID-19, there were, on average, about 200 or fewer applications received per month. During COVID, over 600 applications were received in a one-month period. For renewal applications, fluctuations during the year are normal.
• Online System Changes
• IT team is working to enhance log-in features and plans to implement a multifactor authentication (MFA) system to make the site more secure for users.
• The options for laboratory director name on the license certificate were also changed to allow up to three professional designations for laboratory directors to be displayed on the certificate. The director’s name is also reordered to display as first name, middle initial, last name, suffix.
• The system also can reprint previous certificates.
• ​Renewal Notice Update
• ​Ms. Obeso noted that starting in March, new renewal notices were sent out, redirecting applicants to renew online, in place of mailing in paper applications for renewal.
• The objective is to improve the overall turnaround time for renewal processing by decreasing the number of paper application coming in, and it appears to be working. ​

On-Site Licensing Section Report (Elsa Eleco)

• Ms. Eleco, On-Site Licensing Section Chief, provided the following updates.
• Initial State License Application
• ​Ms. Eleco explained what was involved when filing for an initial state licensing application, which is used to apply for both the state license and the CLIA certificate. The state license is for labs performing moderate and high complexity testing. The application is either for a State license under State oversight and a CLIA Certificate of Compliance (COC), or a certificate of deemed status under the oversight of a California-approved accrediting organization (AO) and a CLIA Certificate of Accreditation (COA).
• Initial State Registration Application
• Ms. Eleco explained what was involved when filing for an initial state registration application. Registration is for laboratories performing waived testing and provider performed microscopy procedures (PPMP). Like initial state license applications, initial state registration applications are also used to apply for either a CLIA Certificate of Waiver or a CLIA Certificate of PPMP. 
• Ms. Eleco also mentioned that registration applications do not go through the On-Site Licensing Section. They are handled in Richmond by the Facility Licensing Section.
• Ms. Eleco encouraged labs to renew their license online through the ELLFS online system to facilitate the licensure process. 
• Ms. Eleco noted that proof of accreditation is required for a lab opting to be under the oversight of a California-approved AO.
• Out-of-State Inspections (OOS)
• Ms. Eleco provided updates on OOS inspections for the current state fiscal year, July 2022 – June 2023. At least 44 trips to inspect at least 90 laboratories were approved for State fiscal year (SFY) 22-23, across 35 states.
• Ms. Eleco noted there are six remaining states to be inspected in June 2023. As the process continues, the number of inspections may change because there may be some OOS facilities that have closed or did not renew. The final number will be presented at the end of the SFY. 
• Ms. Eleco presented the OOS inspection plan for the next SFY July 2023 – June 2024. The travel blanket is not approved yet. The proposal is to have at least 54 trips, including at least 118 labs, across 30 states.
• Technical Consultant Qualifications (Moderate Complexity)
• ​Ms. Eleco presented the requirements for technical consultants, referring to 42 CFR Section 493.1411 and Title 17 of the California Code of Regulations (17 CCR) Section 1036.2. ​

CLIA Section Report (Donna McCallum)

• Ms. McCallum, CLIA Survey Section Chief, presented the following updates.
• CLIA Survey Activities
• ​Ms. McCallum provided the number of survey activities conducted from February 1, 2023, through April 30, 2023: 23 initial surveys, 118 recertification surveys, and one complaint investigation survey.
• Ms. McCallum noted that Form CMS-116 is required to update information in the CLIA database.
• Ms. McCallum presented the data for California laboratories by certification types for May 2023, taken from the federal database for the State of California: 1,587 Certificate of Compliance labs, 20,144 Certificate of Waiver labs, 2,520 Certificate of PPMP labs, and 1,230 Certificate of Accreditation labs.
• Ms. McCallum provided clarifications about standards of enforcement discretion or flexibility in the pre and post Public Health Emergency (PHE) period. The State PHE ended on Feb 28, 2023, and the Federal PHE ended on May 11, 2023.
• Ms. McCallum emphasized that a temporary testing site is a site in which reagents, supplies, equipment, etc., are transported each day to a particular site and removed each day. Nothing can be left at that temporary site; otherwise, it is not considered temporary. ​

SMC CLIA Comments (Karen Fuller)

• Ms. Fuller, Manager of Western and Central Operations Branch, commented that the in-depth PHE ending summary Ms. McCallum presented was excellent. She also noted that she works closely and collaboratively with Ms. Obeso, Ms. Eleco, and Ms. McCallum.
• Ms. Fuller also noted that the PowerPoint is available by emailing Najib Gul (Najib.Gul@cdph.ca.gov) and provided the following links to the CLIA Post-PHE Guidance FAQs:-
  https://www.cms.gov/regulations-and-guidance/legislation/clia
  LabExcellence@cms.hhs.gov
  CLIA_SanFrancisco_Office@cms.hhs.gov
  QSO-23-15-CLIA (cms.gov)​ (PDF)​