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.

• ​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

• When it accepts a proposed rulemaking package for review, the Office of Administrative Law (OAL) publishes the announcement of the availability of a proposed regulation for public comment. 
• This opens a 45-day comment period. 
• The department must respond to each comment. ​
• If substantive changes are made because of those comments: 
• There will be an additional 30-day comment period. 
• Additional comments can only be made on the changes. 
• The department does not need to respond to this set of comments. 
• The process must be completed, and final approval of the package obtained within one year of beginning the 45-day comment period.

Regulation packages:

• ​DPH-20-007: Trainee, Medical Laboratory Technician, Medical Laboratory Technician Transition to Clinical Laboratory Scientist 
• Submitted to OAL and will be opened for public comment soon. 
• Interested parties can contact LFS at LFSRegulations@cdph.ca.gov​ for additional information. 
• Final approval may occur by the end of 2024. 
  
• DPH 19-009: Laboratory Genetics and Reproductive Biology 
• Implements two new license categories introduced by SB 1267 last year. 
• Surveys for stakeholder input will be sent in January. 
• DPH 18-018 Public Health Laboratories 
• Work is in progress. 
• Stakeholder input will be sought soon. 
• Future packages and issues 
• Revisions to requirements and scope of work for clinical laboratory scientists (CLS), limited license CLS, director level masters and doctoral degree specialists, Bioanalysts, unlicensed personnel, requirements for clinical laboratory training programs, and the personnel license application process.

New Business

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

Dr. Anne Deucher presented a report detailing stakeholder concerns on competency assessments for waived point-of-care testing personnel.

• Background
• CAP began including waived competency assessment in its inspection list beginning in early summer 2023. 
• Competency assessments have been required in California law for some time, but waived laboratories are not routinely inspected and may not be aware of this requirement. 
• The issue
• General supervisors must perform the assessment, which includes direct observation. 
• General supervisors must have a California license, bachelor’s degree, and one year of experience performing the tests supervised. 
• The majority of those performing testing are nurses and medical assistants, who receive training from qualified personnel, but whose supervision may not meet current state standards. 
• The requirements pose a burden due to the shortage of qualified supervisors and the circumstances of the testing. 
• The request
• ​Can the department comment on the path to modifying this law? As the requirement is in a regulation, if the department were to seek changes, they would be addressed in a new regulations package relating to enforcement or inspections.

Recognition

On the department’s behalf, Ms. Archuleta presented Dr. Hertz with a certificate of appreciation for his contributions to the CLTAC as member and chair. 

Future Items

Zenda Berrada moved to end the meeting and the motion was seconded by Dora Goto. The meeting ended at 12​:17pm.