CLTAC Members Participating
Marc Bernaldez, Zenda Berrada, Christine Darmanian, Anne Deucher, Bill Gardner, Gabor Hertz, Dan Leighton, Jeff Majdali, Jamie Marks, Anthony Mills, Lu Song.
California Department of Public Health (CDPH) Staff Participating
Dimaya Aurora, Patricia Bolivar, Anne Deucher, Elsa Eleco, Ruby Garcia, Wilson Gilberto, Najib Gul, Bryant Hard, Joselita Joaquin, Paul Kimsey, Christina LaFave, Lorelie Marquez, Donna McCallum, Anthony Mills, Martha Obeso, Jan Otey, Stacey Subaba, Robert Thomas, Jill Tellioglu, Anthony Tran, Clint Venable, Mary Wogec, Jenny Yun.
Public Members Participating
Maureen Ahler, Nathalie Apke, Lydia Bourne, Neng Chen, Megan Crumpler, Tara Eagle, Rose Edwards, Niza D Fernandez, Rabara Fleurdeliza, Ginger Huang, Jerry Hurst, Jessica Huynh, Navdeep Kaur, Shiu-Land Kwong, Jennifer Lantz, Jeff Majdali, Mohseni Melisand, Angela Melanie Aguiluz, Cecilia Mui, Deanna Reinacher, Rodney Roath, Karen Nickel, Sean Pae, Salim Rafidi, Stacy Ralston, Salustiano Ribeiro, Susan E Traub, Meredith Staples, Devang Tendel, Fernando A Torres, Keau Wong, Christine Yee, Lin Ying.
Welcome, General Announcements (Gabor Hertz)
- Meeting started at 9:03 AM.
- Dr. Hertz announced that the meeting was being recorded.
- Dr. Hertz conducted roll call and determined that a quorum was present.
Approval of December 2, 2022, CLTAC Meeting Minutes (Dr. Hertz)
- Zenda Berrada moved to approve December 2, 2022, meeting minutes.
- Anthony Mills seconded move to approve December 2, 2022, meeting minutes.
Department News (Anthony Tran)
- Dr. Tran announced he is the new Deputy Director of Center for Laboratory Sciences (CLS) and provided the reasons below why the new center was created.
- Business Triggers
- Laboratory reductions in funding & capacity.
- Shrinking resources in Laboratories.
- Laboratory operational redundancies & inefficiencies.
- Request for Association of Public Health Laboratories (APHL) Assessment
- Meet California’s need for disease and environmental surveillance by 2035.
- APHL Recommendations
- “… raise the visibility and impact of laboratory science… solely to support and deliver the highest quality public health laboratory services.”
- Dr. Tran mentioned the California Department of Public Health (CDPH) has an on-going urgency to respond to the needs of Californians impacted by an emerging infectious disease outbreak. Dr. Tran provided the information below regarding the vision for CLS.
- Increase laboratory capabilities to deliver the highest quality public health services.
- Increase laboratory operational efficiencies.
- Enhance administrative operational efficiencies.
- Improve program and laboratory communications.
- Sustain partnerships with external stakeholders initiated and strengthened by COVID.
- Continue data, technology and infrastructure efforts initiated to support the COVID surge.
- Dr. Tran provided the information below about Phase I for CLS.
- No projected negative impacts to internal or external stakeholders, including the citizens of California
- Lift and Shift: No major changes in duties for staff transitioning into new Center
- No significant work location changes for staff on Richmond Campus
- No projected significant changes to building space, equipment, forms, and records
- Cost neutral
Branch Report (Robert Thomas)
- Mr. Thomas welcomed the following CLTAC board member.
- Mr. Thomas welcomed Dr. Gabor Hertz as new chair of CLTAC. He added that Dr. Hertz has been nominated to a second term on the CLTAC Committee by CDPH Director Dr. Tomás J. Aragón.
- Mr. Thomas welcomed a new CLTAC member Mr. Jeff Majdali nominated by the California Society of Respiratory Care to serve the remainder of the four-year term left vacant by the retirement of Tula Nieva from the committee.
- Mr. Thomas also welcomed Mr. Anthony Salazar nominated by the Blood Centers of California to serve the remainder of the four-year term left vacant by the retirement of Jowin Rioveros from the committee.
- Mr. Thomas added that LFS also received a nomination from the Philippine Association of Medical Technologists, Northern California Chapter for Ms. Gina Crain.
- LFS Personnel Changes:
- Mr. Thomas announced that Najib Gul, who has served as his assistant for the past year, will be moving to a new position in LFS on March 6, 2023. Najib has received a promotion to Associate Governmental Program Analyst and will be serving LFS as the personnel liaison with HR.
- Mr. Thomas announced that LFS has hired a new Staff Services Manager II, Jorge Palacios, who will serve as the new Assistant Branch Chief. Mr. Palacios comes to LFS from the CDPH Genetic Disease Screening Program’s Newborn Screening Program, where he has been serving as a Health Program Specialist II.
- He also thanked Ellen Yasumura, for her service to LFS as a retired annuitant and most recently as the assistant branch chief.
- Robert Thomas spoke about the end of the California State of Emergency and provided the following information.
- He added that on February 28, Governor Newsom terminated the California COVID-19 State of Emergency proclaimed on March 4, 2020. Effective March 1, any Executive Order (EO) related to the terminated state of emergency will no longer be in effect. This includes one provision that is particularly important for clinical and public health laboratories, specifically, paragraph 9 of EO N-25-20. That order suspended California licensure requirements for personnel testing for SARS-CoV-2 in California clinical and public health laboratories, as long as the State Laboratory Personnel met the federal CLIA requirements for high-complexity testing personnel in 42 CFR 493.1489. The EO limited these personnel to testing only for SARS-CoV-2.
- Yesterday, AB 269, was approved by the governor and chaptered into and became effective immediately as an urgency measure. This bill codifies the licensure suspension of EO N-25-20 permanently. Mary Wogec will explain more about this bill in her legislative report.
- Now that the State of Emergency has been terminated, we will also be making other changes to the LFS COVID-19 for Lab’s webpages to reflect changes.
- CLTAC Working Format:
- Mr. Thomas mentioned that at the last CLTAC meeting we asked for your feedback on meeting format. He added that with the most recent surge of COVID variants, many people are still cautious about exposure, so we have opted for a hybrid model with the option of calling in via Teams or attending in person at the CDPH Richmond Campus. In-person attendees are encouraged to wear well-fitting masks and maintain social distancing during the meeting. LFS is providing N95 masks for all who are attending the meeting in person this morning.
- He added before COVID-19, LFS had joint in-person meetings at Kaiser in North Hollywood and here on the Richmond campus, with a phone bridge for remote callers. We are exploring options for a CDPH site for in-person meetings in Southern California.
- Mr. Thomas mentioned that LFS is considering ideas for new meeting models. One proposal would be to have two meetings each year as hybrid meetings, with participation in person and online, and two meetings with all CLTAC committee members meeting in person, once at Richmond, and once in Los Angeles.
- He stated that an in-person meeting provides a meeting environment free from distractions, and it also gives an opportunity for interaction among committee members that is not possible with an online format. We are hoping that in-person meetings will enable committee members to build a stronger team.
California Data Exchange Framework (Dee Anne McCollin)
- Ms. McCollin mentioned she is the new Deputy Director at the Center for Data Insights and Innovation (CDII) for the Data Exchange Framework (DxF) Group. CDII will share today’s presentation slide deck with CDPH’s LFS for distribution to attendees and others. She shared the resources below for the Data Exchange Framework.
- To learn more about the DxF, please visit the
CalHHS DxF website
- The DxF Data Sharing Agreement Signing Portal is open for business!
- Ms. McCollin mentioned the vision for the DxF is that every Californian, and the health and human service providers and organizations that care for them, will have timely and secure access to usable 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. She added that AB-133 put California on the path to building a Health and Human Services Data Exchange Framework that will advance and govern the exchange of electronic health information across the state. In 2021, with the passage of AB 133, the Governor and Legislature agreed it was time to disrupt our health and human service information silos —by resolving the numerous information exchange barriers that make it difficult for millions of Californians to receive inform and effective care. AB 133 is codified in statute Cal. Health and Safety Code Section 130290. The legislation directed CalHHS to develop a Data Exchange Framework (DxF) that would govern the seamless and secure exchange of health and human service data between healthcare entities across California
- Ms. McCollin provided the following information for individuals who are interested in the program.
Introduction to the CMS DCLIQ structure and overview of CLIA (Karen Fuller)
- Karen Fuller thanked CLTAC for allowing CMS to participate in the CLTAC meeting to provide basic information about CMS as the information relates to California, LFS, and Clinical Laboratory Improvement Amendments (CLIA). Ms. Fuller introduced herself as the operations and branch manager for the San Francisco location for the Division of Clinical Laboratory and Quality (DCLIQ). The branch is in the quality and oversight group, covering seventeen states in the US. The branch conducts oversights, CLIA application processing, and handling Federal Jurisdiction Surveys. She added Gillian Edwards, Al Peyketewa, and Gary Yamamoto from CLIA will be presenting in today’s meeting as well.
- Gillian Edwards spoke about the history of CLIA and added the CLIA law passed in 1988. CLIA regulations were effectuated in 1992 and major revisions to CLIA took place in 2003. Some of the major issues which prompted the CLIA regulations into effect included deaths from incorrect pop smears and proliferation of physician office laboratories (POL) using bench-top technology. The above were some of the reasons why CLIA laws were put in place to ensure accurate, reliable, and timely clinical laboratory testing. She added that CLIA is funded entirely by user fees or by Labs who pays for their CLIA certificates, and not the government. CLIA certification is required for all clinical laboratory, not only those facilities receiving Medicare/Medicaid funding or using FDS-approved test systems. CLIA covers all clinical laboratory testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings. There are exceptions which excludes research, forensic, and VA laboratories. CLIA certification is required for research laboratories when patient-specific test results are issued. Currently over 304,000 laboratories are CLIA certified, and requirements are minimal and based on test complexity
- Gary Yamamoto mentioned the CLIA regulations implied on the complexity of tests being performed and therefor, all tests were categorized in the following categories.
- Waived Tests
- Moderate Complexity Tests
- Provider Performed Microscopy Procedures (PPMP)
- High Complexity Tests
- Mr. Yamamoto added there are four types of CLIA Certificates and provided the list below.
- Certificate of Waiver
- Certificate of PPMP
- Certificate of Compliance
- Waived, PPMP, Moderate, High
- Certificate of Accreditation
- Waived, PPMP, Moderate, High
- Mr. Yamamoto provided information about the CLIA application and certification process. Laboratories required to have a CLIA certificate must apply and pay fees for the type of certificate required. He added that the federal government has a contract with the States to carry out the CLIA program. In California the contracted State Agency is LFS who process the applications.
Statistics CLIA Certification (Al Peyketewa)
- Mr. Peyketewa spoke about the number of CLIA certificate processed by the San Francisco location which includes the State of California, Arizona, Hawaii, and the Pacific Island. He added the San Francisco location alone processed a total of 36, 629 certificates as described below.
- Waived Certificates: 29,289
- PPMP: 3,358
- Compliance: 2,228
- Accreditation: 1,754
- Mr. Peyketwa provided statistics for CLIA certificates issued for the top self-determined laboratories for the San Francisco location below.
- POL: 12%
- Pharmacy: 7%
- Nursing Facility: 10%
- Home Health Agency: 15%
- Hospital: 11%
- Community Clinic: 15%
- Independent: 14%
- Mr. Peyketwa provided the following information for individuals who are interested in the program and contact information for the San Francisco locations.
- Information can be found on the
- CLIA SF Branch Location Contact Information:
CLIA Survey Section Update (Donna McCallum)
- Ms. McCallum mentioned that the Center for Medicare & Medicaid Services (CMS) has extended the expiration dates of all laboratories with expiring CLIA certificates awaiting a survey to March 31, 2023, due to the survey delays caused by the pandemic. If there are additional extensions, LFS will inform you as we receive the information.
- Ms. McCallum provided the CLIA Survey Activity Report for the CLIA Survey Section (October 1, 2022 – January 31, 2023):
- 30 initial inspections.
- 63 recertification surveys.
- 0 waived/PPMP surveys.
- 2 validations.
- 0 onsite complaints.
- 6 PT reviews.
- The total survey activity is 101.
- Ms. McCallum spoke about the CLIA priorities to ensure laboratories release accurate and reliable test results nationwide and provided the following information regarding survey consistency and stakeholder engagement:
- Survey Consistency
- Maintain a strong and effective survey program.
- Maximize operational efficiencies across the nation.
- Collaborate with the State Agencies, Accreditation Organizations, and Exempt States.
- Stakeholder Engagement:
- Increase outreach activities with stakeholders.
- Strengthen stakeholder engagement and program accountability.
- Improve awareness and compliance with CLIA regulations and guidance.
- Ms. McCallum provided the following statistics from the CLIA Survey Section for California laboratories by certification types as of February 2023.
- Compliance: 1,599
- Waiver: 20,312
- Microscopy: 2,553
- Accreditation: 1,218
- Ms. McCallum added LFS is now in the current federal fiscal year (October 01, 2022, to September 30,2023). LFS is continuing to be short staffed, and we are working hard to resolve our survey backlog due to pandemic. LFS is working on completing the back logged surveys and filling our Examiner vacancies.
On-site Licensing Inspection Update (Elsa Eleco)
- Ms. Eleco stated the On-site Licensing Section works close with Facility Licensing Section and the CLIA section. She added the On-site Licensing Inspection Section is the primary complaint handing section for LFS. The complaint analyst receives the complaints and forwards them to the appropriate LFS sections for handling and On-site Licensing Section conducts the state complaint investigation. Ms. Eleco provided the following information regarding the In-State and Out-of-State types of inspections her section performs.
- In-State inspections:
- Initial State inspections.
- Desk Review.
- State validation inspections.
- State inspectors also perform CLIA inspections.
- Out-of-State (OOS) inspections of California licensed clinical labs.
- Accrediting Organizations (AO):
- Review and Approval.
- Communications and coordination with California approved AOs.
- Ms. Eleco encouraged everyone to use the online applications through the Electronic Laboratory Licensing for Facilities and System (ELLFS) database. She provided the following links to the online applications.
- Ms. Eleco explained the LFS process for online applications below
- CDPH-LFS Richmond Team will review the completeness of the online application.
- The timeline will depend on how fast the laboratory can submit everything to LFS Richmond Team.
- CDPH- LFS Richmond Team will forward the application to the CDPH-LFS-Los Angeles office whenever their preliminary review is finished.
- The examiner from CDPH-LFS Los Angeles office will contact the laboratory for the initial State inspection/survey (either via desk review or onsite inspection).
- The examiner would issue the recommendation letter for the State of California clinical lab license if the laboratory passed the initial State inspection.
- The laboratory can always download the State of California clinical laboratory license in the ELLFS database where the laboratory submitted its online application.
- The timeline will depend on how fast the laboratory can complete all the requirements required by both the State and CLIA regulations.
- 11. For a lab opting to be under the oversight of a CA-approved AO, the State LFS examiner will also ask for the letter issued by the private accrediting organization (AO) to confirm that the laboratory is enrolled in AO laboratory accreditation program.
- Ms. Eleco provided the following information about Out-of-State (OOS) inspections for current State fiscal year July 2022 – June 2023
- Travel Blanket was approved last August 31, 2022.
- At least 44 trips were included in the travel blanket approval for SFY 22-23
- Across 35 states
- At least 90 labs
Legislative Report (Mary Wogec)
- Ms. Wogec stated 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 we send through the Office of Legislative and Governmental Affairs to the legislators and 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 at the present moment. For more information on current and past legislation, visit the
Legislative Counsel’s website.
- Ms. Wogec stated
AB 269 was introduced by Assembly Member Marc Berman on January 23, 2023 and was amended on February 8, 2023. AB 269 adds Section 1206.7 to the Business and Professions Code and Section 101161 to the Health and Safety Code. AB 269 adds and repeals Section 4176 to the Business and Professions Code, and declaring the urgency thereof, to take effect immediately. This bill would authorize a person to perform an analysis of samples to test for SARS-CoV-2 in a clinical laboratory or a city, county, or city and county public health laboratory if they meet the requirements under the Clinical Laboratory Improvement Amendments in Section 493.1489 of Title 42 of the Code of Federal Regulations for high complexity testing. Until January 1, 2024, authorize an entity contracted with and approved by the State Department of Public Health to operate a designated COVID-19 testing and dispensing site to acquire, dispense, and store COVID-19 oral therapeutics, as defined, at or from a designated site. Declare that it is to take effect immediately as an urgency statute.
- Ms. Wogec added that AB 7141 was introduced by Assembly Member Marie Waldron on February 17, 2023. AB 7141 amends Sections 1206, 1261, 1261.5, and 1269 of the Business and Professions Code. This bill would allow a person’s experience as an unlicensed person performing specified duties in a California-licensed laboratory for at least 18 months to count toward qualification of licensure. (BPC §§ 1261 and 1261.5)
- This bill will revise the activities that may be performed by an unlicensed person to specify those activities that may be performed under direct and constant supervision of a physician and surgeon or licensed person, those activities that may be performed under supervision and control, and those activities that may not be performed by an unlicensed person. (BPC § 1269)
- Provide an exception to the prohibition of unlicensed laboratory personnel from performing any test or part thereof that involves the quantitative measurement of the specimen or test reagent or any mathematical calculation relative to determining the results or validity of a test procedure, if the unlicensed person is assisting a licensed physician and surgeon or a licensed person, other than a trainee, in a licensed clinical laboratory. (BPC § 1269)
- Prohibit unlicensed laboratory personnel from releasing waived, moderate, or high-complexity testing. (BPC § 1269)
- Ms. Wogec provided links to the
LFS COVID-19 for Labs webpages
Personnel Licensing Report (Dolapo Afolayan)
- Ms. Afolayan gave an update on the implementation of new license types. She added LFS is excited to announce that it has completed the first phase of its implementation plan for the new license types. LFS can move forward with drafting policies to ensure that applications submitted for these license types are evaluated and approved in same manner as existing license types. Currently, licensure pathways for the specialties of clinical laboratory geneticist and clinical reproductive biologist are awaiting implementing regulations. However, LFS is working urgently to create policies that will ensure that applications submitted for these specialties are evaluated in a consistent manner and approved in accordance with California law. LFS is aware of the urgent need for licensed laboratory personnel in these specialties and appreciates the patience of its stakeholders as it navigates the next phase of its implementation plan. Once these polices have been implemented all stakeholders will be notified accordingly.
- Ms. Afolayan gave an update on the Clinical Genetic Molecular Biologist Scientist scope of practice. She added that effective September 30, 2022, individuals licensed as a clinical genetic molecular biologist scientist may use molecular biology techniques to perform a clinical laboratory test or examination for the detection of any disease affecting humans. This scope of practice expansion does not apply to persons licensed as a clinical genetic molecular biologist director. LFS has updated its website accordingly.
Facility Licensing Section Report (Martha Obeso)
- Ms. Obeso discussed the number of applications received by the Facility Licensing Section from October 2022 to December of 2022. She added LFS received 873 initial and 3165 registrations. 136 initial applications for License and 798 for renewal.
- Ms. Obeso added the updated Welcome Screen on the website allows individuals to search for a license or an application number as long as it is linked to the facility’s account. She added labs will be receiving license renewal notices online and clients can also submit their payments online. She encouraged everyone to submit their applications online for faster services.
LFS Admin Section (Brandi Thompson)
- Ms. Thompson provided an update about the Call Center and added since its inception, the Call Center has worked to stabilize the inquiries that routinely come into LFS. Emails have been proven to be an effective form of communication into the Call Center. She provided her email below for concerns with the Call Center: email@example.com
- Ms. Thompson spoke about the job vacancies at LFS and encouraged everyone to go to the
CalCareers website and apply for positions listed.
CLTAC Laboratory Workforce Subcommittee Report (Dr. Berrada)
- Dr. Berrada added the CLTAC Lab Workforce Subcommittee submitted white paper to the CLTAC board for review on 12/02/2022, and comments were solicited through 01/20/2023. The recommended additions or edits included the following:
- Adding administration support for training programs as a barrier to entry.
- Recommendation to supply a boiler plate application process and program manual as a resource for new potential laboratory training programs.
- Under accelerated pathways, revision of language related to education in lieu of experience to: “Consider relevant, applicable education and experience obtained during baccalaureate and post-baccalaureate education to reduce training time.”
- Under accelerated pathways portion of paper, adding “military” experience/certifications.
- When discussing other ideas for increasing testing capacity and adopting CLIA standards for testing personnel, clarify whether this would include waiving license requirements.
- Added additional emphasis for need for funding
- Text font corrections in References (post submission)
- Dr. Berrada called on the CLTAC board members to vote to move the Lab Workforce Subcommittee white paper (with amends) to the Department. The following CLTAC board members voted yes. Dr. Hertz, Anthony Mills, Christine Darmanian, Jamie Marks, Anne Deucher, Zenda Berrada, Dan Leighton, Marc Bernaldez, Bill Gardner, Jeff Majdali, and Jessica Huynh.
By-Laws (Dr. Hertz)
- Dr. Herts mentioned the by-laws were last updated in 2016. Dr. Berrada began the process to review and update the by-laws in 2022 and continued the process in 2023. He spoke about the CLTAC objective and function. He added the by-laws have the CLTAC objectives and functions to implement objectives and requirements of BPC section 1228 to assist CDPH LFS by advice, and recommendations. He added there are 21 voting members on the CLTAC board and currently 17 positions are filled. Each member gets a 4-year terms staggered. There are three positions with history of vacancies.
Adjournment (Dr. Hertz)
- Motion to adjourn by Zenda Berrada.
- Seconded by Anthony Mills.
- Meeting closed at 12:00 PM.