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Laboratory field services

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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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:

Regulations Changes

Proposed Regulations for Clinical Laboratory Personnel Standards DPH 20-007 (Trainees, MLTs, MLTs transitioning to CLS licensure)

The California Department of Public Health has issued a 45-Day Notice of Proposed Action for Clinical Laboratory Personnel Standards, DPH-20-007 (PDF)​. The 45-day comment period on the proposed regulations package opened on December 1, 2023, and will close on January 20, 2024.

​T​he purpose of the proposed rulemaking action is to amend the regulations to update standards regarding clinical laboratory personnel. 

The regulatory documents for this action can be found at: DPH-20-007 Clinical Laboratory Personnel Standards​. 

To request a copy of the notice, the changes to the regulation text, or the initial statement of reasons in an alternate format, please call Veronica Rollin at (279) 217-0836 or Michael Boutros at (916) 440-7822. ​

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)

Old Section
Title Moved to
Article 1 Definitions
BLANK
1029.xx All definitions have been moved into section 1029 in alphabetical order. 1029
Article 1.5 Licensure of Clinical Laboratory Personnel BLANK
1030 Examination for Bioanalysts' Licenses.
1030.20
1030.5 Licensure of Clinical Chemists, Clinical Microbiologists, Clinical Toxicologists, Clinical Genetic Molecular Biologists and Clinical Cytogeneticists. 1030.21
1030.6 Licensure of Clinical Cytogeneticists 1030.25
1030.7 Licensure of Clinical Genetic Molecular Biologists. 1030.26
1030.8 Licensure of Oral Pathology Laboratory Directors. 1030.27
1031 Licensure of Clinical Laboratory Specialists. 1030.10
1031.1 Licensure of Clinical Laboratory Histocompatibility Scientists 1030.15
1031.2 Licensure of Clinical Cytogeneticist Scientists. 1030.16
1031.3 Licensure of Clinical Genetic Molecular Biologist Scientists. 1030.17
1031.4 Requirements and Timeframes for Applications for Licensure and Certification. 1031
1031.5 Requirements and Timeframes for Renewal of Licenses and Certificates. 1031.1
1031.7 Conditions for Approval of Certifying Organizations to Administer Phlebotomy Certification Examinations. 1031.7
1031.8 Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes. 1031.8
1031.9 Conditions for Renewal of a Certifying Organization's Approval to Administer Examinations Acceptable for Licensure Purposes 1031.9
1032 Examination for Clinical Laboratory Technologist's License. 1030.7
1032.5 Licensure of Medical Laboratory Technicians. 1030.6
1033 Trainee Requirements. 1030.5
1034 Certification of Phlebotomy Technicians 1030
Article 2 Training
BLANK
1035 Training Schools. [CLS] 1035.2
1035.1 Phlebotomy Training Program Requirements. 1035
1035.3 Medical Laboratory Technician Training Program Standards. 1035.1
1035.4 Timeframes for Approval of Training Programs. 1035.10
Article 2.5 Continuing Education BLANK
1038 Definitions. 1038
1038.1 Continuing Education Requirements.
1038.1
1038.2 Accrediting Agencies. 1038.5
1038.3 Approval of Providers. 1038.6
1038.4 Approved Providers 1038.7
1038.5 Waiver of Requirement. 1038.2
1038.6 Inactive Status 1038.3
1038.7 Fees 1038.4


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

New Section Title Moved from
Article 1 Definitions BLANK
1029 All definitions have been moved into section 1029 in alphabetical order. 1029.xx
Article 1.5 Licensure of Clinical Laboratory Personnel BLANK
1030 Certification of Phlebotomy Technicians 1034
1030.5 Trainee Requirements. 1033
1030.6 Licensure of Medical Laboratory Technicians. 1032.5
1030.7 Examination for Clinical Laboratory Technologist's License. 1032
1030.10 Licensure of Clinical Laboratory Specialists. 1031
1030.15 Licensure of Clinical Laboratory Histocompatibility Scientists 1031.1
1030.16 Licensure of Clinical Cytogeneticist Scientists. 1031.2
1030.17 Licensure of Clinical Genetic Molecular Biologist Scientists. 1031.3
1030.20 Examination for Bioanalysts' Licenses. 1030
1030.21 Licensure of Clinical Chemists, Clinical Microbiologists, Clinical Toxicologists, Clinical Genetic Molecular Biologists and Clinical Cytogeneticists. 1030.5
1030.25 Licensure of Clinical Cytogeneticists 1030.6
1030.26 Licensure of Clinical Genetic Molecular Biologists. 1030.7
1030.27 Licensure of Oral Pathology Laboratory Directors. 1030.8
1031 Requirements and Timeframes for Applications for Licensure and Certification. 1031.4
1031.1 Requirements and Timeframes for Renewal of Licenses and Certificates. 1031.5
1031.7 Conditions for Approval of Certifying Organizations to Administer Phlebotomy Certification Examinations. 1031.7
1031.8 Conditions for Approval of a Certifying Organization to Administer a Certifying Examination for Licensure Purposes. 1031.8
1031.9 Conditions for Renewal of a Certifying Organization's Approval to Administer Examinations Acceptable for Licensure Purposes 1031.9
Article 2 Training BLANK
1035 Phlebotomy Training Program Requirements. 1035.1
1035.1 Medical Laboratory T​echnician Training Program Standards. 1035.3
1035.2 Training Schools. [CLS] 1035
1035.10 Timeframes for Approval of Training Programs. 1035.4
Article 2.5 Continuing Education BLANK
1038 Definitions. 1038
1038.1 Continuing Education Requirements.
1038.1
1038.2 Waiver of Requirement. 1038.5
1038.3 Inactive Status 1038.6
1038.4 Fees 1038.7
1038.5 Accrediting Agencies. 1038.2
1038.6 Approval of Providers. 1038.3
1038.7 Approved Providers 1038.4



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