Clinical Laboratory Technology Advisory Committee (CLTAC)

Minutes of the Meeting held on June 3, 2022
Meeting held through WebEx

CLTAC Members Participating

Marc Bernaldez, Zenda Berrada, Christine Darmanian, Ann Deucher, Dan Dominguez, Bill Gardner, Dora Goto, Dan Leighton, Jamie Marks, Tula Nieva, Jowin Rioveros

California Department of Public Health (CDPH) Staff Participating

Robert Thomas, Dolapo Afolayan, Elsa Eleco, Elaine Flores, Paul Kimsey, Donna McCallum, Christina LaFave, Najib Gul, Martha Obeso, Beatrice O’Keefe, Armando Tiong, Mary Wogec, Clint Venable, Jason Boatman, Beatrice O’Keefe, Jinong Feng, Ted Lee, Armando Tiong

Public Members Participating

Lu Song, Mattias Pitka, Lois Langs, Erica Padilla, David Luong, Michael Bieraugel, Shiu-Land Kwong, Rodolfo Garcia, Osvaldo Santiago, Christine Yee, Christine E Sabol, Tammy Zinsmeister, and Salim Rafidi

Welcome, General Announcements (Zenda Berrada)

• Meeting Started at 9:05 AM.
• 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 Minutes (Zenda Berrada)

• Due to staff turnover, the March 2022 CLTAC Minutes will be available to our board members at the September meeting to for approval. 

Department News (Paul Kimsey)

• Dr. Kimsey announced his retirement in December and came back as a retired annuitant in January. There are two candidates to fill his position.
• The Department’s Testing Task Force (TTF) data on COVID Reporting (Source: CalREDIE)
• Turnaround time for PCR testing during the week of 05/22 to 5/28 was less than one day.
• Turnaround time for 98% of the test was less than two days, increase from 97% from the previous week.
• CalREDIE Statewide testing volumes have gone up (5/22 to 5/28).
  
• Statewide PCR 7-day average test rate per 100K of 461K this week an increase from the average test rate per 100K of 451K last week. The weekly average has gone up 2.3% per week.
• Statewide testing capacity.
• 900,000/day.
• Antigen testing 93,000 per day.
• Public Health Laboratories testing 740 per day.
• The Department has switched from COVID-19 testing with PerkinElmer to a contract with Color Genomics for employees.
• During the transition the Department maintained all the existing specimen collection sites and transportation routes. Color is now performing the Department’s PCR testing for COVID-19.
• Internal Department reorganization.
• The Department plans to consolidate the six public health laboratories into one administrative structure called the Center for Laboratory Science by September of this year at the latest. 

Branch Report (Robert Thomas)

• CLTAC is the Department’s official advisory committee.
• CLTAC is vital for LFS and the Department to receive stakeholder advisory guidance.
• CLTAC is also a means for LFS to update our regulated community on our activities.
• LFS Personnel Changes.
• LFS is working to fill its examiner positions in the CLIA and Onsite Inspection Sections.
• LFS is also working to fill vacancies in our Administration Unit.
• All vacancies in Facility Licensing & Personnel Licensing are filled.
• The chief’s assistant, Megan Cornejo, left LFS in September to work with the CDPH School Testing Program.
• The chief’s new assistant, Najib Gul, joined LFS on March 15. Among his other tasks he serves as the coordinator for CLTAC.
• Our chief of the Administrative Unit, Yancarlo Escarate, has taken another position in the CDPH Environmental Health Investigation Program.
• Ted Lee has returned from his leave of absence to his position as Assistant Branch Chief. We are happy to have him return to LFS.
• LFS Report
• LFS is working to improve data reports generated by our data unit.
• Electronic Licensing Platform, PERL for personnel and ELLFS for facilities, are producing data to identify trends, and outliers and respond with greater efficiency.
• Our data reporting unit is in the process of developing new reporting processes that will summarize this data in the formats we need to respond most effectively.
• Clinical and Public Health Laboratory Workforce
• There is need to increase the laboratory workforce. This is a problem for clinical and public health labs as well as LFS.
• To meet this challenge, CLTAC has formed a subcommittee headed by Jowin Rioveros and Rachel Rees to research this issue and draft documents to provide advice and data to LFS.
• Milk Bank Issues
• A National issue involving LFS is the shortage of infant formula.
• Under California Law, human milk is regulated as tissue and is regulated by the LFS Tissue Bank Program.
• The LFS Tissue Bank program licenses six donor milk processing banks and several milk depots that collect frozen milk from qualified donors and send it to licensed milk banks.
• Milk banks in California are required to test donors for infectious disease before qualifying them.
• California law requires that all tissue banks located within, and outside California have a California Tissue Bank license issued by LFS.

On-site Licensing inspection update (Elsa Eleco)

• Out-of-State (OOS) Inspection for current fiscal year July 2021 -June 2022.
• Travel Blanket approval on August 13, 2021.
• At least 45 trips across 32 states, involving 102 labs, were included in the travel blanket approval for SFY 21-22.
• Inspections of 102 OOS labs were scheduled at the beginning of State FY 2021-2022
• 30 labs switched to California-approved accrediting organizations.
• 11 labs ceased testing.
• 102 – 41 = 61 labs are required to be inspected in order to complete 100% of out-of-state (OOS) inspections.
• As of June 3, 2022, 57 OOS labs or 93% have been inspected.
• 61 labs or 100% OOS labs will be completed by the end of the current fiscal year, June 30, 2022.
• We are required to inspect any lab that possess a clinical laboratory license performing moderate or high complexity testing once every two years.
• Ms. Eleco thanked On-site licensing field examiners Elaine Flores, Catherine Tolentino, Jinong Feng, Aurora Dimaya, and Sharon Tom for their work.

Personnel Licensing Report (Dolapo Afolayan)

• Trends in new applications received 2019-2021 to determine whether the submission of application pattern displayed as a result of the pandemic has changed.
• As a result of shelter in place order in March 2020, the number of applications received after March 2020 decreased.
• As a result of California opening the economy, the number of applications received after May 2021 increased compared to 2019.
• Trends in new applications resolved 2019-2021.
• Trends in renewal applications received 2019-2021
• The number of renewal applications received after March 2020 increased significantly, compared to the number of applications received in 2019 and 2021.
• Trends in renewal applications resolved 2019-2021
• Comparing the number of applications received and approved in 2019 with 2021, in 2021 the number of applications received and approved was higher. The pattern shows 11% increase in the submission of clinical laboratory scientists train me licensure.

Facility Licensing Section Report (Martha Obeso)

• Information on the Facility Licensing webpage has been updated.
• Revised Certificate
• Updated Renewal Webpage
• Updated Help Page
• Updated User Manuals
• Mail-in-Payments
• The laboratory license application has been available online for over a year now and LFS continues to work with the CDPH IT department to upgrade the application to obtain a smoother online experience for customers.
• LFS needs more laboratories to go online if possible.
  
• To avoid confusion between federal CLIA Certificate ID and the State License number, the CLIA ID is no longer printed on the California License.
• The QR code links directly to verification website, where viewers can also see the latest version number of the certificate, which is 02-2022.
• LFS has updated the renewal webpage
• Renewal can be submitted online.
• If there are changes, waived labs must submit LAB 182, 183, and CMS 116.
• Renewals with no changes must submit LAB 182 and 183.
• Updated help page
• The link for License renewals will take users to the updated user manual. Forms required are linked here as well.
• Payment option is handy for facilities that are set to pay online. The payment link will take users to a 4-step mail in payment page.
• Mailing a check with payment forms will help prioritize the process in our mail room.
• LFS is working to improve response time.
• In addition to the help page, the LFS call center is available to answer questions. Please call 510-620-3800.

CLIA Survey Section Update (Donna McCallum)

• The last couple of years were very busy for the CLIA section and there have been delays with as a result of the COVID-19 emergency. Ms. McCallum thanked her staff for their work processing updates and applications as well as performing onsite surveys.
• CLIA Survey activity report (01/01/22 – 04/30/22)
• 5 initial inspections
• 232 recertification inspections
• 58 certificate of waiver and PPMP
• 2 onsite complaints
• The total survey activity is 297
• Important Notice – Action Needed.
• CMS has extended the expiration dates of all laboratories with expiring CLIA certificates awaiting a survey to June 30, 2022, due to the survey delays caused by the pandemic. If there are additional extensions, LFS will notify labs at the next CLTAC meeting.
• Update to interim final rule (IFC), CMS-3401-IFC; Updates to Interim Final Rule (IFC), CMS-3401-IFC; Requirements and Enforcement Process for Reporting of COVID-19 Data Elements for Hospitals and Critical Access Hospitals and Clinical Laboratories.
• Updates to Interim Final Rule
• CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19.
• CMS has revised the frequency of reporting specific to psychiatric and rehabilitation hospitals
• Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.
• In past it was required/regulatory to report all positive and negative results and that’s why it been updated. Based on updated from the COW and PPMP Certificate, all antigen test platform all positive are required to be reported. The negative and inconclusive result are optional. This is also based on your state requirement. For molecular tests, the positive is required and negative and inconclusive results are optional. For the serology antibody test reporting requirement for positive and negative are optional. The certificate of accreditation, compliance, and registration all of these applied to non-wave tasks.

Legislative Report (Mary Wogec)

• 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 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 provides an overview of the bills assigned to LFS this year and the status of those bills.
• For more information on current and past legislations, visit the Legislative Counsel’s website (https://leginfo.legislature.ca.gov/).
• LFS Bill Assignments June 2022 (Two Year bills)
• AB 240, local Health Department Workforce
• AB 392, Plasma Collection Center (Inactive)
• AB 852, Nurse Practitioners. This Bill is currently at the Senate
• AB 1120, Blood withdrawal. This Bill is currently at the Senate
• AB 1328, Pharmacists. This Bill is currently at the Senate
• AB 1494, Blood Collection (Dead at the end of the year)
• LFS Bills Assignments June 2022 (New)
• AB 1709, Tax Credit 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 which died)
• SB 1500, Biologics, investigational Use.
  

CLTAC Laboratory Workforce Subcommittee Report (Jowin P. Rioveros)

• Schedule for subcommittee meetings is posted on the LFS CLTAC webpage.
• The subcommittee was tasked by LFS to gather information and report its findings to address the following questions in the powerpoint.
• The subcommittee members along with the public participants, have discussed and addressed these questions and the meeting minutes that will be available to everyone soon.
• The subcommittee is the data gathering phase.
• Working on draft survey to be sent out to academic/clinical training providers.
• The subcommittee is drafting a survey to be send out to academic/clinical training providers.
• Zenda Berrada clarified subcommittee meetings are every other week. The Teams link for the meetings is on the CLTAC Website. Anybody can join the meeting. 
• Mary Wogec reported The Department is working on a regulation package to implement the MLT to CLS bridge program. The Legislative mandate was that the bridge program be implemented January 1st of 2022. The implementing regulations package was moving on schedule, but as a result of the COVID-19 emergency, all the staff in the Office of Regulations and LFS who were working on that package were redirected to full time COVID Response. LFS resumed working on that package February of this year and has completed the draft text. LFS is working with an attorney from the Office of Regulations who will be assisting with supporting documents. LFS will also have to complete an economic and fiscal analysis. LFS is hoping to finish the text and supporting documentation by the end of the summer.
• Anyone who is interested or would like to be notified of our stakeholders’ meetings can send an email to mary.wogec@cdph.ca.gov to be notified of meetings.

CLTAC Subcommittee Update (Elma F. Kamari Bidkorpeh)

• CLTAC subcommittee members are Jonathan Bautista, Elma F. Kamari Bidkorpeh, Megan Crumpler, Gabor Hertz, Dan Leighton, and Elizabeth Lucas.
• COVID-19 Pandemic Response, Laboratory Date Reporting CARES Act Section 18115. Effective date April 4, 2022. The information is on the Website.
• Reporting requirements by entity and type of testing. Also covered by Donna above.
• Reporting required by STLT Health Department.
• Timing, frequency, and methods of submission.
• Minimum requirement date elements.
• Date reporting and transmission requirements.
• Guidance on laboratory date reporting health records and electronic health records.
• Update on Self-administered tests. 
• Ms. Bidkorpeh also presented a brief overview of the impact of COVID-19 and on healthcare and healthcare professionals. 
• Zenda Berrada thanked the subcommittee for their work.

CLTAC Subcommittee Update (Elma F. Kamari Bidkorpeh)

• Tests authorized as of April 11, 2022
• 294 Molecular diagnostic tests
• 50 antigen diagnostic tests
• 84 Serology and other immune response tests.
• 20 authorized OTC tests.
• Current Statistics-Enrollment
• Total number of CLIA certified laboratories: 323,086
• Total laboratories in exempt states (NY & WA): 12,956
• Total Non-Exempt laboratories: 310,130
• Certificate of Waiver 246,358
• Provider Performed Microscopy 29,759
• Certificate of Compliance 18,060
• Certificate of Accreditation 15,953

Donna McCallum

• Clarification on over-the-counter test. An over-the-counter test performed by the individual being tested and read by that individual themselves does not require CLIA certification. If an over-the-counter test is being administered by someone other than the individual in their home, that still requires CLIA certification and must meet California regulatory requirements as well. If individuals are to do over-the-counter tests on themselves, they need to make sure it’s the over-the-counter waiver tests and not the waiver tests for professional use because there is a distinction.

New Business (Zenda Berrada)

• CLTAC will be working to revise the CLTAC by-laws over the next few months. Dr. Berrada will be organizing meetings of the CLTAC board members to go over the current by-laws. The goal is to update and bring the new by-laws to the September meeting.

Future Items (Zenda Berrada)

• No future items.

Adjournment (Zenda Berrada)