1. Laboratory Field Services
11/03/2017
Laboratory Field Services
Presented by:
Elsa Eleco, Section Chief
On-site Licensing Section

2. LFS Organization
Under the Office of the State Public Health Laboratory Director
Paul Kimsey, Deputy Director
Tina Kruthoff, Assistant Chief
Laboratory Field Services
Robert Thomas, Chief
Laboratory Licensing and Registration
Martha Obeso, Section Chief
Tissue and Blood Banks, Biologics, and Cytology
Ron Harkey, Section Chief
On-site Licensing Section
Elsa Eleco, Section Chief
CLIA Survey Section
Donna McCallum, Section Chief
Personnel Licensing Section
Shoreh Ershadi

3. Changes at LFS LFS Strategic Planning Meetings
LFS Recruitment and Retention
On-site Licensing Section
Asraf Tootla, Associate Governmental Program Analyst, Complaints
Sharon Tom, Examiner
Aurora Dimaya, Examiner
Facility Licensing and Registration
Minda Imbong, Staff Services Analyst, In-State Initial Licensing
CLIA
Rocky Pramanik

4. New LFS Website More user friendly ADA accessible
More user friendly
ADA accessible
Increased interactive capacity
Enhanced search functions

5. LFS Group Mailboxes
Complete list of group mailboxes can be found on the LFS website
Below are examples:
General Information
Laboratory Complaints

6. Online Application Systems
Phase I, PERL system activated for initial personnel license and certificate
Phase II, PERL system for renewal of personnel licenses and certificates: Week of Nov. 13, 2017
PERL II
PERsonnel Licensing
Online renewal of personnel licenses and certificates
Continuing Education submitted online
Qualification letters no longer issued by LFS on behalf of clinical laboratory scientist licensure applicants

7. Online Application Systems
ELLFS
Electronic Laboratory Licensing and Registration for Facilities System
Will bring facilities licensing online
Apply for licenses and registrations online
Online renewal
Option to pay online
Applicants can track application process

8. On-site Licensing Section
Approval of Accrediting Organizations (AOs) for deemed status
Oversight of California-approved AOs
Biennial on-site inspections of California-licensed laboratories located:
In-State
Out-of-State

9. On-site Licensing Section
Complaints
Enforcement
Initial State License
Inspections
Issue licenses
Cross-train examiners to conduct on-site inspections

10. Accrediting Organizations
The following federally approved accrediting organizations (AO) have been approved by LFS for deeming authority
COLA approved September 2013
The Joint Commission (JC) approved May 2016
College of American Pathologists (CAP) approved May 2016
Quarterly Reporting of Survey Activity to LFS
AO Meetings
July 7, 2016
September 15, 2017

11. Accrediting Organizations
Validation surveys will begin in January 2018
Applications from two additional AOs are currently under review

12. All Clinical Laboratories Letter (ACLL)
All ACLLs are posted on the LFS website
This mechanism can only be used for AOs
An ACLL is a letter from LFS that has the force of regulations

13. ACLLs
ACLLs explain the requirements for private non-profit AOs to inspect clinical laboratories and the requirements for laboratories choosing deemed status
ACLL (May 14, 2016): Laboratory requirements to qualify for deemed status
ACLL (August 20, 2016): AO requirements for deeming authority
LFS may issue future ACLLs

14. What does this mean for your lab?
If you choose LFS oversight:
On-site inspections performed by LFS examiners
Fees paid to LFS
Inspection records subject to Public Records Act (PRA) requests
Complaints referred to LFS
If you choose deemed status under an AO:
On-site inspections performed by AO
Validation surveys will be performed by LFS beginning January 2018
Fees paid to LFS and AO
Inspection records not subject to PRA requests*
Complaints primarily under AO, LFS retains jurisdiction
*Records supplied to LFS by the AO may be subject to PRA request

15. How to choose deemed status
If a laboratory is affiliated with an LFS-approved AO, the laboratory will be under AO oversight until the time of annual state renewal
Applying for deemed status
Submit an application to LFS
Laboratories must now select LFS oversight or AO oversight
Have a current, valid CLIA certificate
Be enrolled with an LFS-approved AO
Submit a written request to the AO to be considered for deemed status
Pay the LFS application or renewal fee
Laboratories must meet the requirements found in ACLL 16-01

16. Regulations Update
Repeal of Title17 of the California Code of Regulations §1050
Effective May 25, 2016.
This action repeals all subsections of §1050 except old item (d), which pertains to facility requirements.
Due to publication of the crosswalk, the Department is pursuing the repeal of the remaining §1050 item (d) regarding facilities to update CA law.

17. CLIA 2003 Crosswalk
The CLIA 2003 Crosswalk was published October 7, 2016, in the California Notice Register, Cal. Reg. Notice Register 2016, No. 41-Z, p
The Crosswalk lists provisions of CLIA 2003 deemed equivalent to or more stringent than California law.
Those provisions deemed equivalent to or more stringent than California law are adopted into California law.

18. Regulations Update
Repeal of Title17 of the California Code of Regulations §1050
Effective July 24, 2017.
Repeal of all subsections of §1050
California Code of Regulations, Title 1, Section 100

19. Regulations Update DPH-11-012, Personnel Licensing Regulations
This regulation package updates personnel licensing standards to facilitate licensure of qualified persons for various categories of laboratory professionals.
Personnel license and certificate requirements
MLTs, CLS, director categories, trainees, cytotechnologists, phlebotomists
Training program requirements
MLT, CLS, post-doc, phlebotomy
Continuing education
Unlicensed personnel
Changes to conform with new application and renewal forms
Current draft is being finalized by LFS working with assigned attorneys from the Office of Regulations.

20. AB 658 Clinical Laboratory Licensing Fees
AUTHOR: Assembly Member Marie Waldron
R - District 75
Introduced: February 14, 2017

21. AB 658 Clinical Laboratory Licensing Fees
Current law provides for the licensure and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Under existing law, the department inspects clinical laboratories and assesses a fee for licensure of those facilities. This bill would temporarily suspend the annual renewal fee for clinical laboratory licenses for the calendar years 2018 and 2019.

22. AB 658 Clinical Laboratory Licensing Fees
Support:
Opposition:
California Clinical Laboratory Association (sponsor)
LabCorp
Prometheus Laboratories
Quest Diagnostics
Spectra Laboratories
None

23. AB 658 Clinical Laboratory Licensing Fees
Introduced: February 14, 2017
Amended: April 6, 2017
Votes: Assembly floor, April 20, 2017 – Y:74 N:0 A:6
Signed by the governor and chaptered: September 28, 2017
Effective: January 1, 2018 until January 1, 2020

24. AB 658 Clinical Laboratory Licensing Fees
After January 1, 2020
The bill would allow for the annual adjustment of application and renewal fees for clinical laboratory licensure in the manner specified in Section of the California Health and safety Code.

25. QUESTIONS?

26. THANK YOU!