Clinical Laboratory Technology Advisory Committee (CLTAC)​

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)
  

Legislation Report (Mary Wogec)

• Ms. Wogec, Health Program Specialist I, explained that when LFS is assigned a bill, no position is taken until the Governor chooses a position, unless the bill is sponsored by CDPH. LFS makes an internal recommendation in its analysis, which is sent through the Office of Legislative and Governmental Affairs (LGA) to the legislators and the Governor.
• Ms. Wogec noted that for any bill that affects laws under the regulatory authority of LFS, including laboratory law, blood banking law, and tissue bank and biologics law, LFS is asked as the subject matter experts to provide an analysis of how we understand the bill and what the effect would be on our program as well as our regulated community. This report is an overview of the bills assigned to LFS for analysis, but does not indicate our analysis or recommendations, which are not shared outside the Department.
• Ms. Wogec gave a report on the legislation in the current session of the legislature that has been assigned to LFS for review and analysis:
• AB 269 – Public health: COVID-19 testing and dispensing sites
  This bill was introduced by Assemblymember Marc Berman on January 23, 2023. It was signed and chaptered on March 2, 2023.
• AB 1341 – Public health: COVID-19: testing and dispensing sites: oral therapeutics
  This bill was also introduced by Assemblymember Marc Berman on February 16, 2023.
• AB 1741 – Healing arts: clinical laboratories: personnel
  This bill was introduced by Assemblymember Marie Waldron on February 17, 2023.
• SB 570 – Prenatal screening program
  This bill was introduced by Senator Josh Becker on February 15, 2023.
• SB 667 – Healing arts: pregnancy and childbirth
  This bill was introduced by Senator Bill Dodd on February 16, 2023.
• ​Ms. Wogec advised that information on current and past legislation, including the full text of the bills, is available on the Legislative Counsel’s website at: https://leginfo.legislature.ca.gov.
• Ms. Wogec also provided an update on the progress of the regulations for the MLT to CLS transitional program. The regulations writing team has completed all the required documents and will submit the package to the Office of Legal Services for its final review of the package. If the package is approved, it will then be submitted to Director Aragon of CDPH for review. After Department approvals are obtained, it will be submitted to the Health and Human Services Agency and the Department of Finance for review and approval. After that approval is obtained, it will be submitted to the Office of Administrative Law (OAL). Once it is accepted by OAL for review, it has exactly one year to be approved or rejected. As soon as that package has been submitted, the team will start working on a package for requirements for scientist and director level licenses for clinical laboratory geneticist and reproductive biologist licensure. ​​

CLTAC Laboratory Workforce Report Re-Approval (Gabor Hertz)

• Dr. Hertz revisited the workforce report as the initial report could not be posted on the CDPH website due to ADA (The Americans with Disabilities Act) compliance issues regarding portions of the report that did not interface or function appropriately with site reader software. Non-substantive changes have been made to correct formatting. 
• Dr. Hertz noted that due to demographic changes, the demand for public health services places a greater burden on laboratory services. But the staff who provide these services are also aging, and so there will be a higher incidence of retirement and an anticipated reduced supply of staff or workforce. These combined factors may cause increased stress in the system. LFS seeks advice from CLTAC to help plan future workforce needs and how to help mitigate anticipated increased demand with decreased staffing resources.
• The workforce report, with the non-substantive changes to correct the ADA compliance issues, was re-approved by CLTAC board members.
• ​Moved to vote by John Geisse
• Seconded by Zenda Berrada
• Seconded by Gina Crain
  The Workforce Subcommittee Report will be posted to the LFS website. ​​
  

CLTAC By-Laws Update (Gabor Hertz)

• Dr. Hertz mentioned that he is reviewing the by-laws and examining the needs to increase representation of public health laboratorians. This will be discussed at the next meeting. ​

New Business (Gabor Hertz)

• Dr. Hertz asked the committee for suggestions for new business for the next meeting. There were none. ​

Future Items (Gabor Hertz)

• Dr. Hertz suggested that the next meeting should follow the CLTAC meeting format as mentioned by Mr. Thomas. ​

Adjournment (Gabor Hertz)

• Motion to adjourn by John Geisse.
• Seconded by Zenda Berrada.
• Meeting closed at 12:17 PM. ​