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Laboratory Field Services

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Presentation on theme: "Laboratory Field Services"— Presentation transcript:

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!


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