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Laboratory Field Services
Regulations 2015
Robert J. Thomas, Acting ChiefCDPH Laboratory Field Services
11/6/2015 1Regulations 2015
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)
11/6/2015Regulations 2015 2
LFS Tracking Log• DPH-11-011, Tissue Donors: HIV Sperm Washing• DPH-10-010, Clinical Lab Standards (Proficiency Testing),
Part 1 • DPH-15-013, CLIA 2003 Crosswalk, Part 1
File & Print • DPH-11-012, Clinical Laboratory Personnel Standards• DPH-15-005, Tissue Bank • DPH-15-006, Tissue Storage • DPH-16-004, Clinical Lab Standards (Proficiency Testing),
Part 2 • DPH-16-002, CLIA 2003 Crosswalk, Part 2 • DPH-18-001, Update to Clinical Lab Regulations (Excluding
Personnel Categories)
11/6/2015Regulations 2015 3
DPH-11-011Tissue 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
1644.5(c)(3)(B)(ii)
11/6/2015Source and Enabling Legislation : SB 443 (Ch. 207, St 2007); AB 1487 (Ch. 444, St 2010); AB 2356 (Ch. 699, Section 2, St 2012)
4
DPH-10-010Clinical 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• This action would repeal outdated and unnecessary requirements on clinical labs.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
11/6/2015Source and Enabling legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
5
DPH-15-013CLIA 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, 201611/6/2015
Source and Enabling Legislation : SB 113 (Ch. 510, Sections 8 and 17, St 1995); BPC 1208(b) and (c) and 1224
6
DPH-11-012Clinical 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
11/6/2015Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
7
DPH-15-005Tissue Bank
• This action would set standards for tissue bank licensees.
• Regulation text development start date: January 2, 2016
• Estimated filing date: December 1, 2018
11/6/2015Source and Enabling Legislation: SB 1135 (Ch. 929, Section 1, St 2002); HSC 1639.01
8
DPH-15-006Tissue 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
11/6/2015Source and Enabling Legislation: SB 1135 (Ch. 929, Section 1, St 2002); HSC 1639.01
9
DPH-16-004Clinical 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
11/6/2015Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
10
DPH-16-002CLIA 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
11/6/2015Source and Enabling Legislation: SB 113 (Ch. 510, Sections 8 and 17, St 1995); BPC 1208(b) and (c) and 1224
11
DPH-18-001Update 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
11/6/2015Source and Enabling Legislation: SB 113 (Ch. 510, Section 17, St 1995); BPC 1224
12
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
• http://www.cdph.ca.gov/programs/lfs/Pages/default.aspx
11/6/2015Regulations 2015 13
FOLLOW UP QUESTIONS
• Bob Thomas, Chief of LFS [email protected]
• Tammy Pahland, Attorney III of CDPH OLS [email protected]
• CLTAC member or Chair
11/6/2015Regulations 2015 14
THANK YOU
11/6/2015Regulations 2015 15
