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

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) Regulations 2015 11/6/2015

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) Regulations 2015 11/6/2015

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 1644.5(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

DPH-10-010 Clinical Laboratory Standards Proficiency Testing, Part 1 This action would repeal outdated and unnecessary requirements on clinical labs.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

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

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

DPH-15-005 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 1639.01 11/6/2015

DPH-15-006 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 1639.01 11/6/2015

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

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

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

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 Regulations 2015 11/6/2015

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

THANK YOU Regulations 2015 11/6/2015