CLINICAL LABORATORY TECHNOLOGY ADVISORY COMMITTEE (CLTAC)

Minutes of the Meeting held on March 4, 2022
Meeting held through WebEx

CLTAC Members Participating

Mark Bernaldez, Zenda Berrada, Christine Darmanian, Dan Dominguez, Anne Deucher, Bill Gardner, Dora Goto, Gabor Hertz, Dan Leighton, Jamie Marks, Tula Nieva, Jowin Rioveros.

California Department of Public Health (CDPH) Staff Participating

Dolapo Afolayan, Zane Dundon, Elsa Eleco, Yancarlo Escarate, Elaine Flores, Robert Hunter, Paul Kimsey, Christina LaFave, Donna McCallum, Martha Obeso, Robert Thomas, Mary Wogec.

Approval of December 3, 2021, CLTAC Minutes (Zenda Berrada)

• Jamie Marks moved to approve minutes.
  
• Jowin Rioveros seconded move to approve minutes.
  

Department News (Carol Glaser)

• Dr. Glaser announced that she is the Acting Deputy Director of the Office of the State Public Health Laboratory Director.
• Dr. Kimsey retired, and he is back as a retired annuitant. Dr. Kimsey could not join us today because he is busy with the Department’s strategic planning.
• Dr. Rita Nguyen is the new Health Officer working with CDPH Director Dr. Tomás Aragón.
• CLTAC members worked with Laboratory Field Services (LFS) on antigen testing at schools. Currently there are over 3500 schools testing under the Department’s school testing program.
• The Department is currently working with a program that trains dogs to detect COVID-19.

Branch Report (Robert J. Thomas)

• Regulation’s update
  
• Most LFS staff were redirected to COVID-19 emergency response during the last two years. This included LFS staff who worked on regulations. LFS recently received approval from the CDPH Office of Regulations to resume working on regulations. The first priority is a package to implement SB 334, which requires LFS to create a pathway to allow licensed Medical Laboratory Technicians (MLT) to transition to Clinical Laboratory Scientist (CLS) licensure. Please email mary.wogec@cdph.ca.gov if you would like to receive information, notifications, and updates regarding SB 334. 
  
• Reports from LFS Sections
  
• Mr. Thomas discussed Executive Order (EO) N-25-20, which suspended California licensure requirements for personnel performing testing for SARS-CoV-2. If they meet CLIA requirements for high complexity testing. The Governor issued the EO in March of 2020 to allow personnel who meet CLIA high-complexity testing requirements to perform COVID-19 testing for the duration of California State of Emergency. This order helped the state of California increase capacity for COVID-19 testing during the emergency.
  
• Laboratory Workforce
  
• An issue of concern for clinical and public health laboratories is the need to increase the laboratory workforce. The shortage of qualified testing personnel and directors is a problem not only for laboratories, but also for CDPH, and LFS. LFS has asked CLTAC to research this concern and provide advice and data to LFS.
  
• LFS Personnel Changes
  
• Robert Thomas stated that his assistant, Megan Cornejo, left LFS in September to work with the CDPH school testing program headed by Dr. Carol Glaser. LFS hired a new assistant, Mr. Najib Gul, and he will be joining LFS on March 15, 2022. Among his other tasks, he will be the coordinator for CLTAC meetings.
  
• Mary Wogec was promoted in January from Associate Government Program Analyst to Health Program Specialist I. Ms. Wogec will be identifying the impact of both state and federal legislation and working on regulations, as well as consulting with LFS management on other issues. 
  

CLIA Survey Section Report (Donna McCallum) 

• CMS has extended the expiration date of CLIA certificates to March 31, 2022.
• Ms. McCallum provided and updated on the CLIA surveys completed from October 1, 2021 – January 31, 2022.
• The CLIA Survey Section has completed 411 recertification surveys, 4 validations, 1 initial survey, 6 PT desk review sanctions, and 21 PPMP surveys.
• Ms. McCallum provided an update on the number of CLIA certified laboratories in California.
• According to data provided by CMS on October 31, 2021, California has 1,592 compliance labs. (Not including newly opened/closed labs), 20,489 certificate of waiver labs, 2,879 PPMP labs, and 1,209 accredited labs. Ms. McCullum noted that these numbers have increased since the emergence of COVID-19. 

Facilities Licensing Section Report (Martha Obeso)

• LFS opened its online laboratory application portal to the public a year ago.
• LFS clients are successfully submitting their applications online. LFS is constantly working with the IT Department to improve the online application process. 

Personnel Licensing Section Report (Dolapo Afolayan)

• The suspension of California licensure requirement for laboratory testing personnel performing SAR-CoV-2 tests specified in EO N-25-20, paragraph 9, is still in force.
  
• EO N 25-20 Paragraph 9 will be applicable until the Governor lifts the state of emergency or withdraws the order.
• The governor may terminate individual paragraphs of the EO and leave other paragraphs in force.
  
• Currently, LFS does not have any information about when the governor will modify or terminate paragraph 9, and LFS has no authority to change the terms of the EO.
  
• As soon as we have clear information, we will post it on our website, but for the present, we only know that it is still applicable. We understand that this makes it difficult for laboratories to plan and appreciate your need for a firm end date.
  

On-Site Inspection Section Report (Elsa Eleco)

• The On-Site Licensing Section’s primary function is to conduct out of state inspections. Due to the Delta and Omicron variant surges, LFS scaled down on conducting out of state inspections. As of January 2022, On-Site Licensing has fully resumed working on out of state activities. The section is conducting inspections for initial licensure and complaint investigations in California. The On-Site Licensing Section currently has 3 examiners conducting out of state inspections.
  
• The On-Site Licensing Section is currently conducting investigations on number of complaints LFS has received regarding COVID-19 testing and collection sites.
  

Administrative Unit Update (Yancarlo Escarate)

• The LFS Call Center is receiving a large increase in the number of inquiries since it was established in 2019.
• Mr. Escarate spoke about the call center statistics for 2019, 2020, and 2021. He mentioned that the number of inquiries (phone calls and emails) LFS has received has almost doubled from 2019 to 2021. The workload for the Call Center has stabilized since 2021. The administrative unit is working with the call center staff to make sure the center is working efficiently. 

Legislative Report (Mary Wogec)

• Legislation 2021

• When LFS analyses a bill, the program 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. 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 status of those bills.
• For more information on current and past legislation, visit the Legislative Counsel’s website (https://leginfo.legislature.ca.gov/).

• LFS Two-Year Bill Assignments – March 2022

• AB 240, Local Health Department Workforce
• AB 392, Plasma Collection Centers
• AB 852, Nurse Practitioners
• AB 1120, Blood Withdrawal
• AB 1328, Pharmacists
• AB 1494, Blood Collection
  

• New Bills introduced this year

• AB 1709, Tax Credits for Blood Donation
• AB 1896, Gamete Banks
• AB 2574, Optometry
• SB 962, Laboratory Directors
• SB 1267, Clinical Laboratory Personnel
• SB 1475, Blood Collection (= AB 1494) 

CLTAC Subcommittee Report (Zenda Berrada)

• 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 topics.
• 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 specialties are in demand? Which areas are expected to experience growth?
• What are the needs for training programs?
• What are the implications of those problems for public health and safety? What are the implications of proposed solution?
• How might LFS assist in meeting these needs?
• Laboratory Workforce Subcommittee Members
• Jowin Rioveros (UCLA) – Subcommittee Co-Chair
• Rachel Rees (Sonoma County PHL) – Subcommittee Co-Chair
• Alka Chaubey (Bio Nano Genomics)
• Megan Crumpler (Orange County PHL)
• Kathleen Doty (Past CLTAC member)
• Joselita Joaquin (OSPHLD, CDPH PHM Training Program)
• Mark Richardson (Quest)
• Salustiano Ribeiro (UCSF)
• Rodney Roath (Loma Linda University)
• Update
• The subcommittee held its introductory meeting on February 25, 2022. The members reviewed charge and determined meeting schedule. The next meeting is scheduled on March 18, 2022, at 10-11:30 am.
• Meeting schedule and meeting links information will be available on the CLTAC Website 
  (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/AdvisoryCommittee-CLTAC.aspx)

Report On Pop-Up Covid-19 Testing Sites (Robert J. Thomas and Mary Wogec)

• LFS has received many complaints and media inquiries about COVID-19 pop-up testing sites during the last seven months. You may have seen COVID-19 pop-up test sites at shopping malls, parks, parking lots, and sidewalks, offering free COVID-19 tests. LFS has responded to inquiries from local health officers and federal investigators. LFS is in the process of conducting its own investigation regarding these operations, including onsite visits. LFS cannot comment any further on these operations since this is an ongoing investigation.
• Information about laboratory laws for pop-up sites.
• Testing or collections? Many of these sites are offering COVID-19 rapid testing with results in 15 minutes. Other operations collect specimens for molecular testing, which are submitted to an off-site laboratory for testing.
• Any location where clinical testing is performed is considered to be a laboratory under federal and state law. Laboratories testing California specimens must have California licensure.
• A facility performing waived testing must have a federal CLIA certificate of waiver and state registration. A facility performing non-waives testing must have a CLIA certificate of compliance or accreditation and state license or certificate of deem status.
• Collection sites that are not performing testing onsite do not need a CLIA certificate or state license. LFS has no regulatory authority for collection sites that are not operated by a laboratory.
• State licenses and federal CLIA certificate are issued for the address listed on the license or certificate. A laboratory cannot copy a license from the one location and use it in a temporary location, unless the laboratory has authorization to operate a temporary testing site.