1. Laboratory Field Services Regulations 2015
Robert J. Thomas, Acting Chief
CDPH Laboratory Field Services
Regulations 2015
11/6/2015

2. An Overview of the Regulations Process
Step 1 – Identify need for regulations
Step 2 – Multi-team collaboration with LFS, Office of Legal Services (OLS), and Office of Regulations (OOR) to assess need, assign resources, and track progress.
Updates – Provided to LFS, OLS, OOR, and Clinical Laboratory Technical Advisory Committee (CLTAC)
Once package is approved by CDPH, Health and Human Services, and Department of Finance, package is routed to Office of Administrative Law (OAL)
OAL process: Review, publish for public comment, review program’s reply to comments, and approval/rejection/ withdrawal. Status update on OAL website (oal.ca.gov)
Regulations 2015
11/6/2015

3. LFS Tracking Log DPH-11-011, Tissue Donors: HIV Sperm Washing
DPH , Clinical Lab Standards (Proficiency Testing), Part 1
DPH , CLIA 2003 Crosswalk, Part 1 File & Print
DPH , Clinical Laboratory Personnel Standards
DPH , Tissue Bank
DPH , Tissue Storage
DPH , Clinical Lab Standards (Proficiency Testing), Part 2
DPH , CLIA 2003 Crosswalk, Part 2
DPH , Update to Clinical Lab Regulations (Excluding Personnel Categories)
Regulations 2015
11/6/2015

4. DPH-11-011 Tissue Donors: HIV Sperm Washing
This action would set standards for the handling and storage of HIV- or HTLV-reactive sperm samples for use in assisted reproduction.
Regulation text development start date: January 31, 2013
Estimated filing date: November 30, 2017
Health and Safety Code Section HSC (c)(3)(B)(ii)
Source and Enabling Legislation : SB 443 (Ch. 207, St 2007); AB 1487 (Ch. 444, St 2010); AB 2356 (Ch. 699, Section 2, St 2012)
11/6/2015

5. DPH-10-010 Clinical Laboratory Standards Proficiency Testing, Part 1
This action would repeal outdated and unnecessary requirements on clinical labs.
Regulation text development start date: September 30, 2015
Estimated filing date: March 31, 2016
Business and Professions Code Section 1208
Source and Enabling legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
11/6/2015

6. DPH-15-013 CLIA 2003 Crosswalk, Part 1 File and Print
This action would evaluate any new CLIA regulations. This part of the proposed regulations automatically adopts the latest CLIA 2003 federal standards which are more strict than existing state law after publication by the department.
Regulation text development start date: August 30, 2015
Estimated filing date: March 31, 2016
Source and Enabling Legislation : SB 113 (Ch. 510, Sections 8 and 17, St 1995); BPC 1208(b) and (c) and 1224
11/6/2015

7. DPH-11-012 Clinical Laboratory Personnel Standards
This action updates licensing standards to facilitate licensure of qualified persons for various categories of laboratory professional staff from outside California. Current draft is being revised by the Office of Regulations and an assigned Legal Services regulation attorney.
History
Latest package regulation text development start date: March 24, 2011
Estimated filing date: March 31, 2018
Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
11/6/2015

8. DPH Tissue Bank
This action would set standards for tissue bank licensees.
Regulation text development start date: January 2, 2016
Estimated filing date: December 1, 2018
Source and Enabling Legislation: SB 1135 (Ch. 929, Section 1, St 2002); HSC
11/6/2015

9. DPH Tissue Storage
This action would set standards for tissue storage handling and transport.
Regulation text development start date: January 2, 2016
Estimated filing date: April 1, 2019
Source and Enabling Legislation: SB 1135 (Ch. 929, Section 1, St 2002); HSC
11/6/2015

10. DPH-16-004 Clinical Laboratory Standards Proficiency Testing, Part 2
This action would adopt updated 17CCR 1050 regulations.
Regulation text development start date: January 7, 2014
Estimated filing date: December 31, 2018
Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
11/6/2015

11. DPH-16-002 CLIA 2003 Crosswalk Part 2
This action would promulgate CLIA 2003 regulations which are less strict than existing state law.
Regulation text development start date: January 31, 2016
Estimated filing date: February 28, 2019
Business and Professions Code Section 1208
Source and Enabling Legislation: SB 113 (Ch. 510, Sections 8 and 17, St 1995); BPC 1208(b) and (c) and 1224
11/6/2015

12. DPH-18-001 Update to Clinical Laboratory Regulations Part 2
This action would update facility licensing regulations.
Regulation text development start date: January 2, 2017
Estimated filing date: December 1, 2019
Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
11/6/2015

13. CLTAC Clinical Laboratory Technology Advisory Committee
Updates to the regulations will be provided at CLTAC meetings and recorded in the CLTAC minutes and information will be updated on the LFS website
Regulations 2015
11/6/2015

14. FOLLOW UP QUESTIONS Bob Thomas, Chief of LFS Robert.Thomas@cdph.ca.gov
Tammy Pahland, Attorney III of CDPH OLS
CLTAC member or Chair
Regulations 2015
11/6/2015

15. THANK YOU
Regulations 2015
11/6/2015