Regulations and the Regulatory Process

Regulations in Effect

All LFS regulations that have been adopted and filed with the Secretary of State are published in the California Code of Regulations, Title 17 (Public Health), Division 1 (State Department of Health), Chapter 2 (Laboratories), Subchapter 1 (Service Laboratories), Group 2 (Clinical Laboratory Regulations), and Group 3 (County and Municipal Laboratories). This is available on the Office of Administrative Law website by searching under California Code of Regulations, Title 17.

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• Governing Legislation for LFS Operations 
  
• The Regulation Adoption Process (PDF) 
  
• Regulations Changes New!
  
• Legislative Information New!
  

The Process

Before a regulation adoption or change is ready for formal publication of a public notice for a 45 day public comment period, a draft proposal will have been processed through a series of internal reviews. The internal reviews within the Department of  Public Health (CDPH) are by the Office of Regulations, Office of Legal Affairs, and Financial Management Branch Budget Section. A summary of the proposal is also circulated to Division Chiefs within CDPH for comment. The proposal is submitted to the Health and Human Services Agency and, if there are any fiscal concerns, to the Department of Finance.

Following acceptance by these organizations, the proposal is formally noticed, and copies are distributed to individuals and organizations that have expressed interest in the subject matter. The proposed regulations have a 45-day public comment period. "Post-hearing" changes made in response to comments have a subsequent 15-day public comment period. Comments, which should include the regulation title and its regulation tracking number [e.g., DPH-XX-XXX], must be received by 5:00 p.m. on the date the public comment period closes, and should be directed to:

CDPH Office of Regulations
General Phone: (916) 558-1710
Fax: (916) 636-6220
Mailing & ​Physical address:
California Department of Public Health
Office of Regulations
1415 L Street, Ste. 500, MS 0507
Sacramento, CA 95814

A regulation's Notice of Rulemaking/Informative Digest provides further information on submitting comments. Procedural inquiries about rulemaking actions that have been formally noticed may be directed to the Office of Regulations.

Once CDPH completes the regulatory process and formally adopts the proposed regulation, it submits the regulation package, including responses to public comments, to the Office of Administrative Law (OAL). OAL has 30 working days to review the regulation and approve or reject it. If approved by OAL, it is filed with the Secretary of State, becoming effective in 30 calendar days.

An emergency regulation, on the other hand, is submitted to OAL following all of the same internal reviews and approvals, but prior to formal public proceedings. OAL has 10 calendar days to review and render a decision on an emergency regulation. During the first five days of the OAL review, the public may submit comments regarding the emergency action directly to OAL. If approved by OAL, it may become effective immediately upon filing with the Secretary of State, and its public comment period usually occurs after the regulation is effective. An emergency regulation is effective for only 120 days unless it is replaced through the regular regulation adoption process or is extended for another 120 days.

Governing Legislation for LFS Operations

LFS administers state and federal laws and regulations. Some applicable sections are:

• California Business and Professions Code, Division 2, Chapter 3, Articles 1-7, Sections 1200 - 1326 govern personnel licensing.
  

• California Code of Regulations (CCR), Title 17, Division 1, Chapter 2, Subchapter 1, Group 2, Sections 1029 – 1075 govern occupational licensing and continuing education requirements for clinical laboratory personnel.

• California Business and Professions Code section 1246 and 17 CCR section 1030 regulate phlebotomists.
  

• California Health and Safety Code Division 101, Part 3, Chapter 2, Article 5, Sections 101160 – 101165 govern municipal and county laboratories and their compliance with the Clinical Laboratory Improvement Amendment (CLIA).

• California Business and Professions Code sections 1200 et seq. and 17 CCR section 1029 regulate state clinical laboratories.

• California Health and Safety Code sections 1600 et seq. govern blood banks, plasma collection facilities, and blood collection facilities.

• California Health and Safety Code sections 1635 et seq. regulate tissue transplantation and tissue banks.

• Section 1864 of the federal Social Security Act and Title 42 of the Federal Code of Regulations commencing with Section 493.1 govern surveys and inspections of non-accredited clinical laboratories in California.

• California Health and Safety Code sections 101150 et seq. govern public health laboratories.

• California Code of Regulations (CCR), Title 17, Division 1, Chapter 2, Subchapter 1, Group 2 govern public health laboratories and laboratory personnel.

• California Business and Professions Code Sections 1206.5, 1213, 1222, 1222.5, 1243, 1263, and 1286 govern clinical laboratory training programs and trainees.

• California Code of Regulations (CCR), Title 17, Division 1, Chapter 2, Subchapter 1, Group 2, Sections 1030.5 and 1035.2 govern clinical laboratory training programs and trainees.
  

• California Code of Regulations (CCR), Title 17, Division 1, Chapter 2, Subchapter 1, Group 2, Section 1035.10 governs time frames for approval of training programs.
  

• California Code of Regulations (CCR), Title 17, Division 1, Chapter 2, Subchapter 1, Group 2, Section 1038.5 governs time frames for approval of accrediting agencies.

Regulations Changes

New Order for 17 CCR Sections

In October 2022, several non-substantive changes were made to Clinical Laboratory Regulations in Title 17 of the California Code of Regulations (17 CCR). These changes renumbered several sections, in preparation for further substantive changes, including the revision of existing sections and the adoption of several new sections, which will be made in forthcoming rulemaking packages.

All definitions in Article 1, Definitions, have been relocated to section 1029 in alphabetical order. Personnel licensing sections in Article 1.5 and training program sections in Article 2 have been renumbered to present licensure requirements and training program requirements in order, starting with phlebotomy certificates, then trainee licenses, MLT licenses, CLS licenses, and licenses requiring a master’s or doctoral degree. Regulations in Article 2.5 pertaining to continuing education requirements and providers have also been reordered. 

This means that many sections of 17 CCR relating to personnel licensing are no longer found in their familiar sections. Please refer to the table below to locate renumbered sections.

New Order for 17 CCR Sections (Old Section Listed First)

New Order for 17 CCR Sections (New Section Listed First)