Primary care clinics are licensed under Section 1200 of the California Health & Safety Code and must obtain licensure through the California Department of Public Health (CDPH) Licensing & Certification Program (L&C). The L&C program evaluates health facility compliance using standards defined in state and federal law and regulations.
The Department of Health Care Access and Information (HCAI) develops building standards and regulations for licensed clinics. These standards are codified in the California Building Standards Code as OSHPD 3 and apply to clinics licensed under Health and Safety Code Section 1200, including primary care and specialty care clinics. Refer to the Health Facility Checklist for more information.
Applying for a Clinic License
To apply for a primary care clinic license, visit the Centralized Applications Branch (CAB) website. The CAB is responsible for initial review of all licensing applications. Applications deemed complete are then passed on to one of the 15 regional district offices (DOs) that perform site surveys, investigate complaints, and issue licenses if all requirements have been met.
Clinic sites have several options available to them when seeking licensure. The type of application required is based on the organization’s current standing with CDPH and any prior licensure.
Initial/Primary Care Clinic (PCC)
An application is required to establish a license for a primary care clinic. The application process for an initial/PCC is detailed on the CAB website.
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Affiliate
The affiliate process results in the same license type as an initial/PCC but requires less documentation from the applicant. Affiliate applications receive priority in processing over other application types. To be able to use the affiliate process to license an additional site, an organization must have at least one clinic that has held a valid, unrevoked, and unsuspended license for at least five years immediately prior to the date of application with no history of repeated or uncorrected serious violations affecting patient safety, constituting “immediate jeopardy,” and no pending action to suspend or revoke its license.
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Consolidated
An organization with an existing licensed clinic that seeks to license an additional clinic location that is within 0.5 miles of the existing licensed site, may opt to use the consolidated licensing process instead of the initial or affiliate. The consolidated licensing process requires even less upfront documentation than the initial and affiliate processes.
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Mobile
To obtain an Initial Mobile license, complete the required application packet. An organization that meets the criteria for an Affiliate license can apply for an Affliate Mobile License. Refer to HSC sections 1200 through 1245 for licensure requirements. Refer to HSC sections 1765.101 through 1765.175 for information regarding Mobile Health Care Units.
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Intermittent Clinics
According to Health & Safety Code (HSC) Section 1206, intermittent clinics, defined as clinics operated by a licensed primary care clinic (PCC) operated on separate premises from the licensed clinic and only open for limited services of no more than 40 hours a week, are exempt from the licensure process. Click here for CPCA guidance on establishing an intermittent clinic and converting an existing PCC to an intermittent clinic.
Applying for Medi-Cal Certification
Each licensed clinic that will participate in the Medi-Cal program is required to individually certify and enroll. For clinics required to be licensed, CAB also processes the forms required for Medi-Cal certification. The forms should be submitted simultaneously with the appropriate licensing application as outlined on the PCC application checklist here, and once processed by CAB, will be forwarded to DHCS PED. For FQHCs, this is the beginning of the PPS rate-setting process for Medi-Cal.
Additional Resources
Application Form Guidance
L&C launched several online training videos to provide guidance to providers completing application packets for facility licensing. Training videos are available for the following forms:
- Licensure & Certification Application Form (HS 200)
- Applicant Individual Information (HS 215A)
- Administrative Organization Form (HS 309)
- Certification Form for Clinics and Freestanding Outpatient Clinic Services of a Hospital (CDPH 270)
CDPH 270 – Written Certification of Title 24 Compliance
This form may be completed by a licensed architect OR by the local building authority, (at the clinic’s discretion), in order to meet licensure requirements.
STD 850 – Fire Clearance
To assist clinics with fire authorities who may be hesitant to accept a clinic-initiated STD 850, the CAB website provides a checklist for PCC licensing that includes a cover letter to Fire Authorities in the State of California, alerting them that the STD 850 form can be initiated either by the clinic directly, or by the CAB staff. In addition, CAB has provided a pre-populated STD 850 form that clinics can use which includes the Licensing Agency Name and Address. Clinics having trouble obtaining a fire clearance from their local authority may contact the CAB to request that CAB initiate the form on their behalf. Please note that the STD 850 should be obtained prior to submitting any application or change request.
Mobile Clinic Resources
- Mobile Clinic Basics: This document provides an overview of mobile clinic licensing requirements, key considerations, and best practices for establishing a mobile clinic.
- Mobile Clinic Webcast: This webcast provides an overview of how to establish a mobile clinic.
- Motor Carrier Permit/CA Number: If using a mobile unit to provide any care
- California Air Resources Board (CARB): If using an older mobile unit with a diesel engine
Departments and Requirements related to opening a clinic site
- Biohazardous Waste Transport Permit: Managed by county agencies; the quantity of waste created and how it is handled may trigger the need for this permit.
- California Board of Pharmacy (BOP): Clinics must have a BOP clinic permit to purchase drugs at wholesale that is used for either administration or dispensing to clinic patients. Refer to this FAQ for more information.
- California Department of Industrial Relations: Consult if running an elevator in one of your clinics.
- CLIA Certificate Information
- California Laboratory Field Services Branch: A branch of CDPH that issues licenses for entities conducting CLIA or CLIA-waived testing on-site
- California Lead Poisoning Prevention Branch: A branch of CDPH that grants authorization for entities conducting CLIA-waived blood lead testing on-site
- Centers for Medicare and Medicaid Services (CMS): Issues federal license for entities conducting CLIA or CLIA-waived testing on-site
- California Radiologic Health Branch: A branch of CDPH which oversees entities using radiologic equipment.
- California Vaccine for Children Program (VFC): Issues the PIN for each provider VFC location.
- City Business License: Each municipality will have different requirements based on what is being opened.
- Dental Board of California: Used for running any dental clinics or using a mobile unit for dental services.
- Drug Enforcement Agency (DEA): Issues a unique DEA number and Controlled Substance Registration Certificate by location so controlled meds can be ordered by location and do not have to be attached to a single specific ordering provider
- Family PACT (FPACT) Enrollment: This document outlines the requirements of enrollment and responsibilities as a program provider.