Clinical Laboratory Technology Advisory Committee (CLTAC)

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. ​​​