1. Laboratory Field Services
11/4/2016
Laboratory Field Services
Presented by:
Robert J. Thomas, Chief

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

3. Changes at LFS On-site Licensing Section
Elsa Eleco, Section Chief
Gilberto Wilson, Complaints
Facility Licensing and Registration
Martha Obeso, Section Chief
Edward Campos, Program Technician II Supervisor
Nai Saechao, Staff Services Analyst, Out-of-State Licensing
LFS Recruitment and Retention
Priorities

4. California State Auditors 2015 Report
CSA report and recommendations can be found at:
Recommendations
LFS should inspect all in-state and out-of-state licensed laboratories every two years (#2 Pending)
Implement a procedure to identify out-of-state laboratories that fail proficiency testing (#3 Fully Implemented)

5. California State Auditors 2015 Report
Improve complaints procedures and establish policies for on-site visits to verify corrective actions (#4 Fully Implemented)
Update sanctioning procedures (#5 Fully Implemented)
Develop a process to assess the Budget Act annually and adjust fees accordingly (#6 Pending)
Partner with accrediting organizations for laboratory oversight (#7 Fully Implemented)

6. California State Auditors 2015 Report
Develop a succession plan for staff recruitment and retention (#8 Partially Implemented)
Update information technology data systems (#9 Pending)
Update and develop regulations as necessary (#10 Pending)

7. 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
Full information and updates available on the LFS website at:

8. 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

9. 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

10. 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 may be performed by LFS
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

11. 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

12. Online Application Systems
Phase I, PERL system activated for initial personnel license and certificate
Phase II, PERL system in development for renewal of personnel licenses and certificates
PERL II
PERsonnel Licensing
Online renewal of personnel licenses and certificates
Continuing Education submitted online
Training school approval applications submitted online

13. Online Application Systems
ECM
Electronic Content Management
High speed scanning and automatic document appending
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

14. AACRAO
AACRAO (American Association of Collegiate Registrars and Admissions Officers) educational transcript evaluation service informed LFS that it would cease review of foreign transcripts effective August 15, 2016.
Interim solution: LFS will accept transcript evaluations from:
Current members of NACES
Endorsed members of AICE
LFS working with the CDPH Office of Legal Services on a permanent solution

15. 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.

16. 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.

17. 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.

18. LFS Website www.cdph.ca.gov/lfs New Department website coming
More user friendly
ADA accessible
Increased interactive capacity
Enhanced search functions

19. QUESTIONS?

20. THANK YOU!