Clinical Laboratory Technology Advisory Committee (CLTAC)

Minutes of the Meeting held on September 9, 2022
Meeting held through WebEx

CLTAC Members Participating

Zenda Berrada, Christine Darmanian, Anne Deucher, Jennifer Dien-Bard, Bill Gardner, John Geisse, Dora Goto, Dan Leighton, Lu Song, Anthony Mills, Jowin Rioveros

California Department of Public Health (CDPH) Staff Participating

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

Public Members Participating

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

Welcome, General Announcements (Zenda Berrada)

• Meeting started at 9:00 AM.
• Dr. Berrada announced that the meeting was being recorded.
• Dr. Berrada conducted roll call and determined that a quorum was present.
• Dr. Berrada asked participants to complete the attendance sheet at the provided link.
  

Approval of March 4, 2022, CLTAC Meeting Minutes (Zenda Berrada)

• Anne Deucher moved to approve March 4, 2022, meeting minutes.
• John Geisse seconded move to approve March 4, 2022, meeting minutes. 

Approval of June 3, 2022, CLTAC Meeting Minutes (Zenda Berrada)

• Jowin Rioveros moved to approve June 3, 2022, meeting minutes.
• Lu Song seconded move to approve June 3, 2022, meeting minutes.

Department News (Paul Kimsey)

• Dr. Kimsey stated that the Department’s plan to consolidate the six public health laboratories into one administrative structure called the Center for Laboratory Science on the Richmond Campus, was approved by California Department of Human Resources on September 1, 2022.
• Dr. Kimsey added that there would be a presentation about the California Data Exchange Framework later in the meeting, from a group who are implementing Assembly Bill 133, which the governor signed last year.
• Dr. Kimsey announced his retirement last year in December and noted that he came back as a retired annuitant in January. He mentioned, there is a candidate to fill his position.

Monkeypox (Debra Wadford, PhD, MS, PHM, M(ASCP)

• What is Monkeypox (MPX)
• MPX was first identified in 1958 as a pox-like disease in cynomolgus monkeys.
  
• The first human case of MPX was discovered in the Democratic Republic of the Congo in Central Africa in 1970.
• MPX was spread outside Africa, due to international travel or imported animals.
• Anyone with close contact to MPX is at risk of being infected with the disease.
• Patients with MPX typically experience febrile prodrome 5-13 days after being exposed.
• The most common symptoms of MPX are: 
• Rash (99 percent)
• Malaise (70 percent)
• Fever (64 percent)
• Lymphadenopathy (63 percent)
• Transmission
• MPX can be transmitted by direct or indirect contact with infected body fluids or lesion/crusts/scabs.
• MPX can also be transmitted through contaminated fomites such as bedding, surfaces, etc.
• Globally there are 54,911 confirmed cases of MPX as of September 6, 2022. There are 20,733 confirmed cases in the United States. There are 4,140 confirmed cases in California.
• Monkeypox virus (MPXV)
• There are two clades of MPXV. Clade I is the formerly Congo basin and Clade II is the formerly Western African clade. There are two subclades of clade II which are IIA and IIB. The current epidemic we are working with is the IIB.
• Laboratory testing for Monkeypox virus.
• The Advisory Committee and Immunization Practices voted to recommend vaccination for select persons at risk for occupational exposure to Orthopox virus. There are two types of vaccines available for MPX. One is the ACAM2000 and the other is JYNNEOS.
• Confirmed Orthopox (OPX) vs. Confirmed Monkeypox
• There is a two-step process for testing specimens for MPX. First, State labs can perform the generic OPX test which confirms the presence of OPX DNA from the rash lesion. Second, confirmatory testing can be done using PCR. The Center for Disease Control (CDC) confirmed that all the positive orthopox cases did turn out to be MPX virus. For this reason, all confirmed orthopox cases are treated as if they are monkeypox.

Updated Laboratory Reporting Requirements Title 17 Section 2505 (Allison Jacobsen, MPH)

• Title 17 of the California Code of Regulations (17 CCR) section 2505 specifies the reporting requirements for laboratories performing testing in California. Laboratories are required to report resting results suggestive of disease of public health importance to the local health department within a specified timeframe. A subsection of Section 2505 specifies isolates or specimens that submitted to the public health laboratory.
• CDPH has two new reporting for laboratory requirement.
• New requirements to report monkeypox or orthopox virus infection and Candida auris, colonization or infection results within one working day.
  
• The SARS_CoV-2 reporting timeframe requirement has changed from 8 hours to within one working day.
• New requirement to submit Candida auris fungal isolates from sterile sites to public health has changed to within 10 working days from the date of report to public health.
  

California Data Exchange Framework (Dr. Rim Cothren)

• Dr. Cothren stated that he is a consultant to the Center for Data Insights and Innovation for the Date Exchange Framework. He added that he has been working at the federal level since 2004 and in California since 2010.
• Vision for Data Exchange in California:
• Every Californian, and the health and human service providers and organizations that care for them, will have timely and secure access to usable electronic information that is needed to address their health and social needs and enable the effective and equitable delivery of services to improve their lives and wellbeing.
• The first health information exchange organization went live in California in the late 1990s. Presently there are half a dozen separate independent health information exchange programs that are operational in California.
• On July 27, 2021, Governor signed AB-133 to establish the California Health and Human Services (CHHS) Data Exchange Framework. The new law requires that “California Health and Human Services Agency… shall establish the California Health and Human Services Data Exchange Framework that shall include a single data sharing agreement and common set of policies and procedures… designed to enable and require real-time access to, or exchange of, health information among health care providers and payers.”
• The Data Exchange Framework components includes the following:
• Data Exchange Framework that requires and enables health information to be exchanged among health care organizations through any health information exchange network, health information organization, or technology that adheres to specific standards and policies.
• Data Sharing Agreement and Common Set of Policies and Procedures that spell out the standards for and governance of information exchange.
• Strategy for Digital Identities that enables health and social services organizations to match shared clients while keeping identities secure.
• The entities required to sign the data sharing agreement are:
• General acute care hospitals, as defined by Health and Safety Code (HSC) section 1250.
• Physician organizations and medical groups.
• Skilled nursing facilities, as defined by HSC section 1250, that currently maintain electronic records.
• Health care service plans and disability insurers that provide hospital, medical, or surgical coverage that are regulated by the Department of Managed Health Care or the Department of Insurance, and Medi-Cal managed care plans under a comprehensive risk contract with the State Department of Health Care Services that is not regulated by the Department of Managed Health Care or the Department of Insurance.
• Clinical laboratories, as that term is used in Section 1265 of the Business and Professions Code, and that are regulated by the State Department of Public Health.
• Data Exchange Framework’s path forward:
• Broadly communicate the purpose and content of the Data Exchange Framework (“DxF”) to stakeholders.
• CDII will launch a new informational webinar series starting next week (Tuesday, Sept. 13th). Register here.
• Establish the Implementation Advisory Committee (“IAC”) and the Data Sharing Agreement Policies & Procedures (“DSA P&P”) Subcommittee.
• Both are advising CDII on Data Exchange Framework implementation, and will launch Sept. 21st and 23rd, respectively, and will be open to the public.
  
• Develop policy and programs to support participants in meeting Data Exchange Framework requirements.
• CalHHS is establishing a Data Exchange Framework Grants Program and a Qualified Health Information Organization (QHIO) Program.
• More information on the DxF is available on the CDII DxF website.
  
• Contact CDII@chhs.ca.gov to be added to our DxF Community Listserv.

Branch Report (Robert Thomas)

• Mr. Thomas began with a recognition of the contributions of Tom Barrow to the Department and announced that Tom Barrow passed away in April of 2022.
• LFS Personnel Changes
• Ted Lee, the Assistant Branch Chief, has announced he will be retiring this month. Ted previously worked at the Tuberculosis Control Branch and joined LFS in 2017.
• Ellen Yasumura will temporarily serve as the acting assistant branch chief until the position is filled.
• LFS has filled all positions in personnel and facility licensing sections. LFS is currently working on filling positions in the administrative unit.
• LFS is working to fill its examiner positions in the CLIA and Onsite Inspection Sections.
• Visit www.linkedin.com and search for “Clinical Laboratory Surveyor” to learn about and apply for Examiner I and Examiner II exams for positions in the LFS Richmond and Los Angeles offices.
• Mr. Thomas highlighted the contributions of the onsite inspection program. He recognized an examiner from onsite licensing for testifying in a federal case.
• Mr. Thomas added that LFS has received inquiries for in-person CLTAC meetings and LFS will consult with the department for in-person sites in both southern and northern California for future CLTAC meetings.

On-site Licensing inspection update (Elsa Eleco)

• Out-of-State (OOS) Inspection for current fiscal year July 2022 -June 2023.
• Travel for examiner staff was approval on August 31, 2022.
• At least 44 trips across 35 states were included in the travel blanket approval for SFY 21-22. At least 90 labs will be inspected in these travels.
• Effective September 8, 2022, LFS is granting COLA the authority to deem California clinical laboratories in compliance with California law in the specialty of Pathology, including the subspecialties of Histopathology, Cytology, and Oral Pathology, for the purposes of licensure and the responsibilities of inspection and oversight to ensure ongoing compliance with California law.

Personnel Licensing Report (Robert Thomas)

• Mr. Thomas provided an update regarding the pathway from Medical Laboratory Technician (MTL) to Clinical Laboratory Scientist (CLS).
• The MLT to CLS pathway to facilitate transition from MLT to CLS Licensure is awaiting implementing regulations but is not yet in effect.
• The timeline in Senate Bill 334 required the creation of the MLT to CLS transition program by Jan. 1, 2022.
• The creation of the pathway required new regulations, which is a process that generally takes about 2 years.
• LFS began working on a regulations package to create the program in 2019, but work was interrupted in 2020 when all staff assigned to the package were redirected to COVID-19 response work.
• LFS has recently been able to resume work on the package, and is currently working on those regulations now as our top regulatory priority and hopes to have them ready within the next year.

Facility Licensing Section Report (Martha Obeso)

• Ms. Obeso encouraged everyone to use the online portal when renewing licenses for laboratories. She pointed out that the processing for license renewal through the online system is ten days compared to three months for renewing by mailed applications.
• Ms. Obeso spoke about upgrades to the online application portal and the contact us page.

CLIA Survey Section Update (Donna McCallum)

• Ms. McCallum discussed an important notice from the Center of Medicare & Medicaid Services (CMS).
• CMS has extended the expiration dates of all laboratories with expiring CLIA certificates awaiting a survey to September 30, 2022, due to the survey delays caused by the pandemic. LFS is awaiting notification from CMS if there will be additional extensions.
• CLIA Survey activity report (October 1, 2021 – August 31, 2022)
• 51 initial inspections
• 541 recertification surveys
• 96 waived/PPMP surveys
• 9 validations
• 2 onsite complaints
• 8 PT reviews
• The total survey activity is 707
• Ms. McCallum pointed out that the PT final rule (CMS-3355-F) was published in the Federal Register on July 11, 2022. First, the CLIA recommendations were presented in 2010. Second, the CMS/CDC teams were formed to work on the CLIA recommendations. Third, the CMS/CDC team meet with PT programs in 2012. The proposed rule was initially put forth in 2019 and extended on January 18, 2022. This resulted in the final rule on July 11, 2022.
• Regulations 42 CFR sections 493.2 and 493.801 through 493.959 are effective two years after publication in the Federal Register – July 11, 2024. Amended regulations at 42 CFR section 493.20 and 493.25 became effective August 10, 2022. These are related to laboratories performing tests of moderate and high complexity testing that also perform waived testing.
• Some of the finalized requirements included changes in PT Microbiology, Non-Microbiology PT, testing of samples, PT referral for waived tests.
• Ms. McCallum added that LFS is near the end of the current federal fiscal year October 30, 2021, to September 30, 2022. LFS is currently short staffed and working hard to resolve our survey backlog due to the pandemic. We are looking forward to completing our back log and filing our examiner vacancies. Ms. McCallum thanked everyone for their patience and cooperation. She also thanked all her staff for their hard work during the past year. She also mentioned that John King, an examiner from her section retired on August 31, 2022.

Legislative Report (Mary Wogec)

• When LFS analyses a bill, LFS does 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 is sent through the Office of Legislative and Governmental Affairs to the legislators and governor. LFS does 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 current status of those bills.
• LFS Bill Assignments September 2022 (Two Year bills)
• AB 240, local Health Department Workforce
• AB 392, Plasma Collection Center
• AB 1120, Blood withdrawal.
• AB 1328, Pharmacists (Dead)
• AB 1494, Blood Collection (Dead)
• LFS Bills Assignments September 2022 (New Bills)
• AB 1709, Tax Credit for Blood Donation (Dead)
• AB 1896, Gamete Banks
• AB 2107, Clinical Laboratory Testing
• AB 2574, Optometry
• SB 962, Laboratory Directors (Dead)
• SB 1267, Clinical Laboratory Personnel
• SB 1475, Blood Collection (AB 1494)
• SB 1500, Biologics, investigational Use
• Ms. Wogec provided the link below to the Legislative Counsel’s website for anyone who is interested or needs additional information on current and past legislation: (http://leginfo.legislature.ca.gov).
  

Robert Thomas thanked all the Sections Chiefs for providing information for their sections to the CLTAC Committee. He thanked Mary Wogec for her work on bill analysis and mentioned that a single bill can be amended 5 times which requires detailed analysis and reviews.

CLTAC Laboratory Workforce Subcommittee Report (Jowin P. Rioveros)

• “In order to plan for the future workforce needs of California’s clinical and public health laboratories, pursuant to its authority under BPC 1228, LFS charges the CLTAC Clinical and Public Health Laboratory Workforce subcommittee to gather information and report its findings in a white paper to address the following:
• The need to increase the number of qualified testing personnel in California Labs
• What are the needs for each category of testing?
• Is there a greater need for a particular category?
• Which areas or specialties are in greatest demand?
• Which areas are expected to experience growth or expansion?
• What are the needs for training programs?
• Are there suggestions for increasing the number of training programs?
• Are there suggestions for increasing the number of trainees in labs?
• What are the implications of these problems for public health and safety?
• What are the implications of proposed solutions?
• How might LFS assist in meeting these needs?
• Other concerns the subcommittee may identify in the course of its research.” 
• Subcommittee meetings have been held bi-weekly since February 2022
• Issues and possible solutions discussed
• A major challenge is the limited training opportunities for CLS and PHMs
• A survey was developed to query training programs on their current capacity, challenges in supporting more trainees, and resource needs to support increasing training spots within their programs
• Current Status: Data Review Phase
• The survey was sent out to LFS-approved training program coordinators (n=82) on 6/29/22 and was closed on 8/1/22.
• A total of 49 responses were received.
• Additional data containing the total number of active licenses (new and renewed) for various testing personnel categories was requested from LFS.
• Subcommittee members are in process of reviewing available data and will utilize information to support the white paper.
• Example questions sent on the survey:
• What California license or certification is your training program approved to provide training for?
• How many training internships is your program approved for by CDPH LFS (if these data are available) to train annually?
• How many trainees is your program able to accept and train annually with your current resources?
• If your program is approved to train for more than one category of license or certificate, why are some categories actively training and others not?
• On average, how many total qualified applicants did your training program/lab have annually for the years listed below?
• For programs that offer didactic AND clinical laboratory training (public health microbiology, academic and hospital-based programs), on average how many students / trainees did your program accept annually for the years listed below?
• For programs offering academic or didactic instruction only (no lab-based training), on average how many students did your program accept annually for the years listed below?
• For programs offering clinical laboratory/bench training internships only, on average how many trainees was your program able to accept annually?
• Please rank all applicable factors that internships or training spots may remain unfilled in your program. Some factors include commute/travel/location of training, difficulties meeting licensed personnel: trainee ratio, insufficient number of instructors/trainers, insufficient number of partner training labs, insufficient qualified applicants, leadership advocacy for lab, limited test menu at lab, physical space, not enough funds to support training, etc.
• The subcommittee continues to work on outlining the white paper based on available information
• The white paper will be completed in November 2022
• Web-based meetings are public and the schedule and Teams meeting link can be accessed on the CLTAC website: (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/AdvisoryCommittee-CLTAC.aspx)

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

Future Items (Zenda Berrada)

• Dr. Berrada provided updates on the CLTAC by-laws and mentioned that the last update was in 2016. Dr. Berrada mentioned that the CLTAC Board consists of 21 individuals. She added that the CLTAC board members are presently discussing new areas such as clinical laboratory geneticist, molecular biology, public health laboratory director, reproductive biology, blood banking, biologics, laboratory informatics, and many other issues that are applicable in the by-laws. CLTAC members receive a four-year term, and they are currently discussing the term lengths as well.
• The goal is to update and bring the new by-laws to the December CLTAC meeting.

New Business (Zenda Berrada)

• Dr. Berrada added that she will be reaching out the CLTAC board members to request nominations for the CLTAC chair position. The CLTAC chair position is a one-year term, and the members nominate a member of the board each year. She asked any current board members who are interested and would like to be nominated for this roll, to please reach out.
• The next CLTAC meeting will be on December 2, 2022.

Adjournment (Zenda Berrada)

• Motion to adjourn by Jowin P. Rioveros
• Seconded by Bill Gardner
• Meeting closed at 11:40 AM.