Skip Navigation Links09-10-21-CLTAC-Meeting-Minutes

Laboratory Field Services

CLINICAL LABORATORY TECHNOLOGY ADVISORY COMMITTEE (CLTAC)

Minutes of the Meeting held on September 10, 2021

Meeting held through WebEx

CLTAC Members Participating:

Zenda Berrada, William Gardner, Tula Nieva, Jamie Marks, Dan Leighton, John Geisse, Daniel Dominguez, Dora Goto, Lu Song.

California Department of Public Health (CDPH) Staff Participating:

Zenda Berrada, Paul Kimsey, Elsa Eleco, Elaine Flores, Carol Glaser, Joselita Joaquin, Paul Kimsey, John King, Donna McCallum, Katya Ledin, Robert Thomas, Catherine Tolentino, Clint Venable, Mary Wogec.

Public Members Participating:

Rey Andrin, Brett Holmquist, Anna Choi, Kathleen Doty, Cecile Giron.

Welcome, General Announcements (Zenda Berrada, PhD)

  • Meeting opened at 9:01 AM.
  • Dr. Berrada conducted roll call and determined that a quorum was present to continue holding the meeting.

Approval of June 4, 2021 CLTAC Minutes (Zenda Berrada)

  • Correction needed: Tula Nieva was present at the meeting and not listed in current minutes.
  • Tula Nieva and Daniel Leighton motioned to approve minutes with a minor correction to be done later.

Unfinished Business (Zenda Berrada)

  • None to report or follow up on.

Department News (Paul Kimsey)

  • Robert Thomas is out on a leave of absence, and during his leave of absence, Elsa Eleco, chief of the LFS Onsite Licensing section, will serve as acting branch chief.
  • Information updates on testing and the current state of emergency can be found on the LFS website.
  • Answers to many questions sent to the LFS COVID mailbox (LFSCOVID@cdph.ca.gov) can be found on the LFS website.
  • Please send questions or suggestions for clarification to the LFSCOVID mailbox.
  • Updated guidance on testing (https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/COVID-19/Updated-COVID-19-Testing-Guidance.aspx).
  • The guidance covers all the public health officer orders currently in place, and FAQs associated with the orders.

Branch Report (Elsa Eleco)

  • Elsa Eleco, Chief of the LFS Onsite Licensing section, will be serving as acting branch chief while Robert Thomas is on leave.
  • At the June CLTAC meeting, LFS stated that the urgency to increase testing in the state had begun to wind down.
  • Vaccines were starting to be distributed to select age groups.
  • However, the state now finds itself in the midst of a surge of cases caused by the Delta variant of SARS-CoV-2.
  • LFS has had a large number of bill assignments this legislative session.
  • Mary Wogec will report on this later.
  • Public health mandates for frequent workplace testing have elicited many questions from businesses and agencies outside of the lab community.
  • LFS is working on a guidance for businesses and organizations regarding employee testing.
  • This will supplement the guidances for schools and congregate living facilities on the LFS COVID-for-Labs website.
  • The guidance will contain information on regulations that will affect these new testing entities, including links to Federal and State guidance on waived testing and the FDA website on Emergency Use Authorizations (EUAs).
  •  Tests authorized by the FDA for Over the Counter (OTC) use can be used by individuals to test themselves without a CLIA certification or State license or registration. However, if another person performs an OTC test on a patient’s specimen, for example, for onsite employee testing, the FDA defaults the OTC test to a waived test, and the facility where testing is performed must have a CLIA certificate and State registration.
  • Clinical laboratory law does not regulate specimen collection, and LFS does not license or inspect collection sites. LFS regulates the performance of clinical lab tests. The director of a laboratory to which specimens are sent is responsible for ensuring specimen integrity and sufficiency.
  • However, many local health jurisdictions have additional requirements, so specimen collection sites should check with the local health officer and comply with local requirements.
  • For more information, please visit our guidance for collection and testing sites 
    (https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVID-19Guidance.aspx).

Administrative Update (Yancarlo Escarate)

  • No updates.

Legislative Report (Mary Wogec)

  • This report provides an overview of the bills assigned to LFS this year and the status of those bills at the present moment.
  • LFS bill assignments as of September 2021:
    • AB 70, Gene Synthesis Providers:
      • AB 70 would require the California Department of Public Health to develop gene sequence and customer screening guidelines for gene synthesis companies with the purpose of increasing biosecurity efforts relating to the misuse of gene synthesis.
      • It would also require the department to create a process to certify that gene synthesis providers and manufacturers of gene synthesis equipment comply with established guidelines beginning January 1, 2024.
      • It would additionally establish financial penalties on companies or institutions that do not comply with the new screening guidelines.
    • AB 240, Local Health Department Workforce:
      • AB 240 would require the Department of Public Health to contract to conduct an evaluation of the adequacy of the local health department infrastructure and make recommendations for future staffing, workforce needs, and resources, in order to accurately and adequately fund local public health.
      • The bill would also require the department to convene an advisory group of representatives from public, private, and tribal entities to provide input on the selection of the entity that would conduct the evaluation.
      • The bill would require the department to report the findings and recommendations of the evaluation to the Legislation by July 1, 2024.
      • This is now a two-year bill.
    • AB 392, Plasma Collection Centers:
      • Existing law allows an unlicensed person to perform a total protein test using a digital refractometer in a licensed plasma collection center, under specified conditions, including that the person records the test results in a federally approved computer system and verifies the test results in a specific manner.
      • AB 392 would delete the requirements for recording and verifying the results of a test in a specific manner and make the authorization of unlicensed persons permanent.
      • This is now a two-year bill.
    • AB 526, Dentists:
      • AB 526 would expand the definition of “laboratory director” to include a duly licensed dentist serving as the director of a laboratory that performs only clinical laboratory tests classified as waived that are authorized under Section 1625.
      • The bill would also authorize a dentist to independently prescribe and administer influenza and COVID-19 vaccines approved or authorized by the United States Food and Drug Administration for persons 3 years of age or older. 
    • AB 556, Misuse of Sperm, Ova, or Embryos:
      • This is a watch bill.
      • AB 556 would authorize a private cause of action for damages against a person who misuses sperm, ova, or embryos in violation of the provisions of current law.
      • The bill would specify that a prevailing plaintiff who suffers harm as a result of such a violation may be awarded actual damages or statutory damages.
    • AB 691, SARS-CoV-2 tests and vaccinations:
      • AB 691 would expand the authorization for an optometrist to perform procedures to include a clinical laboratory test or examination classified as waived under for SARS-CoV-2.
      • The bill would also authorize optometrists to administer immunizations for SARS-CoV-2.
    • AB 852, Nurse Practitioners:
      • AB 852 would authorize licensed nurse practitioners to use a brightfield or phase/contrast microscope to perform CLIA provider-performed microscopy examinations on a specimen obtained from their own patient or from a patient of a group medical practice of which the nurse practitioner is a member or employee, during the patient’s visit.
      • It would also make changes to the nurse practitioner scope of practice.
      • This is now a two-year bill.
    • AB 1120, Blood Withdrawal:
      • AB 1120 would amend Section 1246 of the Business and Profession Code to replace the phrase “venipuncture or skin puncture” with the phrase “blood withdrawal.”
      • This is now a two-year bill.
    • AB 1328, Pharmacists:
      • AB 1328 would expand the definition of “laboratory director” to include a pharmacist and a licensed intern pharmacist performing clinical laboratory tests classified as waived under CLIA when the results can be used in their practice or if ordering tests related to drug therapy or performing skin puncture.
      • The bill also removes restrictions on CLIA waived tests authorized to be performed by a pharmacist upon patient request or hospital authorization.
      • The bill also makes changes to the pharmacist scope of practice.
      • This is now a two-year bill.
    • AB 1494, Blood Bank Collections:
      • AB 1494 would authorize blood collection at a blood bank when a physician or surgeon is not physically present if the medical director and medical advisory committee approve and if the employee placed in charge is a registered nurse.
      • The bill would authorize the registered nurse placed in charge to be physically present or available via telehealth and would exempt a blood bank from the requirement to obtain verbal or written consent from a patient for the use of telehealth.
      • This is now a two-year bill.
    • SB 306, Sexually Transmitted Disease Testing:
      • LFS is secondary on this bill.
      • SB 306 would authorize an HIV counselor to perform a rapid STI test, or any combination HIV/HCV/STI test, as specified.
      • The bill would also allow HIV counselors to receive HIV counseling training through a training course that has been certified by the Office of AIDS.
      • It makes extensive changes to other sections of the law.
    • SB 409, Pharmacists:
      • SB 409 would authorize a pharmacist to perform any aspect of any FDA-approved or authorized point-of-care test for the presence of SARS-CoV-2 or influenza classified as waived under CLIA.
      • The bill would also authorize a pharmacist-in-charge to serve as the director of a waived laboratory.
      • It also makes conforming changes to the pharmacist scope of practice.

Presentations

  • COVID-19 Update and SFO Pilot by Dr. Kathleen Jacobson
  • Proposed Reportable Conditions: Carbapenemase-producing organisms and Candida auris by Sam Horwich-Scholefield
  • CLTAC - PHL Regulations Subcommittee by Dr. Zenda Berrada
  • CLTAC - CalREDIE Reporting Subcommittee by Elma Kamari Bidkorpeh
  • Copies of slide presentations are available on request.

Personnel report (Elsa Eleco for Dolapo Afolayan)

  • Executive order N-25-20 suspends California licensure requirements to allow persons who meet personnel requirements for performing high-complexity testing specified in Title 42, Code of Federal Regulations, Section 493.1489 to perform the following tests for the duration of the California state of emergency:
    • Testing for SARS-CoV-2.
    • Testing using EUA or validated laboratory-developed multiplex tests for SARS-CoV-2 and Influenza A and B, as long as the test detects SARS-Cov-2 and Influenza A and B within the same sample at the same time.
  • For information about the CDC Influenza SARS-CoV-2 Multiplex Assay, please visit the CDC diagnostic tests for COVID-19 and Influenza webpage (https://www.cdc.gov/coronavirus/2019-ncov/lab/testing.html).

Onsite Licensing Report (Elsa Eleco)

  • Out-of-State (OOS) Inspections for current State Fiscal Year (FY) July 2021 – June 2022
    • Out of State Travel Blanket was approved by California Health and Human Services (CHHS) Agency on August 13, 2021.
      • At least 45 trips for LFS inspectors were included in the travel blanket approval for FY 21-22.
      • Inspectors will visit at least 102 labs in 32 states.
  • Out-of-Country (OOC) Inspections from July 2021 – June 2022
    • At least 5 trips will be submitted for approval for FY 21-22.
      • These trips will be submitted as individual trip requests, as they are not part of the normal travel blanket approval process.

Facilities Licensing Section Report (Elsa Eleco for Martha Obeso)

  • The percentage of applications submitted to LFS using the new ELLFS online application, as of August 31, 2021:

​Application Type
​Month:
March - May
​Month:
June - August
​New Registrations
​71% online
​67% online
New Licenses
​50% online
​68% online
Renewals
48% online
​52% online

  • Future Improvements to ELLFS
    • Laboratory Facility License Verification Website will go live to allow constituents to easily verify laboratory licensure online.
    • The launch is planned for early October.
  • Online Mid-Cycle Changes
    • This change will allow users to make changes online at any time, not just during renewal. This change is in process.

CLIA Report (Donna McCallum)

  • Section staff have resumed doing surveys in the field.
    • Due to COVID travel restrictions, staff were not able to go out in the field, so some facilities are past due for their inspections.
  • This has led to some lapse in approval time.
    • CLIA is allowing an extension of expiration dates and is providing a letter of verification as needed.
    • The verification letter can be requested on the CLIA website.
  • Currently the program has completed 192 recertifications and initial CLIA surveys.
  • The CLIA section is currently also performing waived and PPMP lab inspections.
    • Some of these inspections have been onsite but most are virtual.
    • The section has completed approximately 40 waived surveys.
  • Reminder that:
    • The type of CLIA certificate requested should be consistent with the type of testing that is being performed at facility.
    • CMS requires the reporting of all positive and negative test results for SARS-CoV-2.

New Business

  • Mo Crowley requested training for CalREDIE data reporting.
  • Katya Ledin stated that Testing Task Force (TTF) member labs are requesting assistance regarding the severe state shortage of qualified by increasing the number of California training programs for CLS, PHM, and other qualified testing personnel.
    • Dr. Ledin will bring this topic up again in the December meeting.
    • Elma Bodkorpeh from Kaiser Permanente says that Kaiser Permanente will be taking a stance to get money for more training dollars to handle the shortage.

Future Items (Zenda Berrada)

  • Nominations for CLTAC board chair in December.
    • CLTAC members will vote for CLTAC board chair in December.
      • Dora Goto nominated Dr. Berrada for a second term.

Adjournment (Zenda Berrada)

  • Motion to adjourn by Jamie Marks and seconded by Dora Goto
  • Meeting closed at 12:05 PM.


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