AFL 20-30.3 From the California Department of Public Health
March 3, 2021
TO: Primary Care Clinics (PCCs)
Mobile Health Care Units (MHCUs)
SUBJECT: Suspension of Regulatory Enforcement of Specified PCC and MHCU Requirements
(This AFL supersedes AFL 20-30.2)
AUTHORITY: Executive Order N-35-20
All Facilities Letter (AFL) Summary
- This AFL notifies PCCs and MHCUs of a temporary waiver of specified regulatory requirements due to the state of emergency related to the Coronavirus Disease 2019 (COVID-19) outbreak.
- This revision extends the waiver for all clinics until April 1, 2021. For any clinics conducting COVID-19 vaccinations, treatment, and/or testing, the waiver is extended until June 1, 2021.
Pursuant to the Governor’s Executive Order N-35-20 (PDF), the Director of the California Department of Public Health (CDPH) may waive any of the licensing and staffing requirements of Chapters 1 and 9 of Division 2 of the Health and Safety Code (HSC) and accompanying regulations with respect to any PCC identified in HSC section 1200 and MHCU identified in HSC section 1765.105.
For capacity tracking purposes during COVID-19, PCCs and MHCUs shall submit an application when seeking initial licensure or changing services listed on their license. This shall not require approval before the facility may provide care, although CDPH will reach out to provide technical assistance to ensure patient safety and quality of care. Application materials and guidance are available on the CDPH Health Care Facilities Application webpage.
CDPH is temporarily waiving specified clinic licensing requirements and suspending regulatory enforcement for clinics conducting COVID-19 vaccinations for the following requirements.
1. HSC sections 1205 and 1212(b); Title 22 California Code of Regulations (CCR) section 75021.1
A PCC that has submitted an application to CDPH for any of the following may begin providing care prior to obtaining approval and licensure by CDPH:
- Initial licensure
- Addition of a special service
- Addition of a service that is not a special service
- Remodel or modification
- Addition of an additional physical plant maintained and operated on separate premises
A PCC shall not be subject to the 60-day prior notice requirement when changing a service, remodeling, modifying, or adding an additional physical plant.
A clinic corporation that has applied to CDPH for either of the following may begin providing care prior to obtaining official approval and licensure by CDPH:
- Initial licensure of a PCC as an affiliate clinic at an additional site
- Initial licensure of an MHCU as an affiliate clinic
2. HSC sections 1765.125(a), 1765.130(d) & (f), and 1765.150(d)-(e)
An applicant that has submitted an application to CDPH for any of the following may begin providing care prior to obtaining approval and licensure by CDPH:
- Initial licensure of an MHCU
- Addition of an MHCU to an existing license
- Modifications to previously approved services and procedures of an MHCU or to the unit itself
An applicant or licensee operating an MHCU is not required to report to CDPH the location of any service site 24 hours prior to its operation at that site for the first time but must retain a record of sites for future review by CDPH.
3. HSC sections 1765.135(a) and 1765.140
An MHCU operated by a PCC is subject to all applicable suspensions of PCC statutes and regulations specified in this AFL. An MHCU operated as a supplemental service of a general acute care hospital (GACH) is subject to all applicable suspensions of GACH statutes and regulations specified in AFL 20-26 or any superseding AFL.
4. HSC sections 1218 and 1245
Any licensee that has submitted an application to CDPH for renewal of a license or special permit, or for reinstatement of a license or special permit that has been voluntarily and temporarily suspended, may begin or continue providing care prior to obtaining approval of the renewal or reinstatement by CDPH.
5. HSC section 1206(h)
An intermittent clinic operated by a PCC may extend operating hours beyond 40 hours a week.
6. HSC section 1226.1(a)(2)
The tuberculosis test requirement for PCC personnel at the time of employment is suspended until 60 days after the end of the declared emergency.
7. HSC section 1765.160(f)(7)(C)
A transfer agreement with a nearby hospital or other health facility is not required for the operation of an MHCU.
8. Title 22 CCR section 75025
A PCC must report to CDPH any change in principal officer or administrator no later than 30 days following the change.
9. Title 22 CCR section 75055(c)
A PCC that ceases operation must inform CDPH of the closure and all required arrangements for the safe preservation of patients’ health records no later than 5 days after closure.
10. HSC section 1231(a) and Title 22 CCR section 75072
A PCC seeking to convert space to provide additional patient care or triage areas may do so without obtaining prior approval from CDPH provided any space conversions are implemented to ensure safe and adequate patient care and follow recommended COVID-19 mitigation strategies. Mitigation strategies are detailed in the COVID-19 Health Care System Mitigation Playbook (PDF) and include:
- Extension of clinic hours
- Use of non-patient areas for patient care
- Creation of overflow space for screening, triage, isolation, and transfer/discharge
- Establishment of separate screening areas on the facility property (e.g., room to cohort patients, tents erected in the parking lot, “Drive By” testing locations)
- Establishment of safety checkpoints at portals of entry
11. HSC section 1765.165(a)
Due to the state of emergency, an MHCU operated by a GACH may be used to provide a basic service of a hospital.
This waiver is approved under the following conditions – PCCs and MHCUs shall:
- Report any substantial staffing or supply shortages that jeopardize patient care or disrupt operations.
- Follow their disaster response plan.
- Follow infection control guidelines from the Centers for Medicare and Medicaid Services (CMS) and from the Centers for Disease Control and Prevention (CDC) related to COVID-19.
- Comply with directives from their local public health department, to the extent that there is no conflict with federal or state law or directives or CDPH AFLs.
CDPH will continue to investigate and conduct enforcement activities for allegations of the most serious violations impacting health and safety, pursuant to Executive Order N-27-20 (PDF).
CDPH understands the importance of ensuring the health and safety of all Californians and maintaining vital access to healthcare services. CDPH encourages facilities to implement contingency plans to address staff absenteeism and the rapid influx of patients. CDPH will continue to promote quality healthcare, provide technical assistance, and support compliance with core health and safety requirements, pursuant to Executive Order N-27-20 (PDF). CDPH is taking this unprecedented action due to the significant challenges California’s health care system is facing as a result of the COVID-19 outbreak. As a result of this temporary waiver, PCCs and MHCUs do not need to submit individual program flexibility requests for the regulations specified above.
This waiver is valid until April 1, 2021 for all clinics and June 1, 2021 for any clinics conducting COVID-19 vaccinations, treatment, and/or testing. This waiver may be extended based on any updated Executive Orders or guidance from CMS or the CDC.
If you have any questions about this AFL, please contact your local district office.
Original signed by Heidi W. Steinecker
Heidi W. Steinecker