The California Department of Public Health (CDPH), Licensing and Certification (L&C) Program has the authority to grant program flexibility from regulatory requirements if the facility requesting the program flexibility demonstrates its ability to meet statutory requirements. Requests for program flexibility must include justification for the program flexibility request and adequate supporting documentation that the proposed alternative does not compromise patient care.

Program Flexibility Request

L&C reviews requests for program flexibility on a case-by-case basis. When requesting a program flexibility, health facilities must submit the “Program Flexibility” form (CDPH-5000 (PDF)) to the district office (DO) that oversees the facility. The form must contain:

• Each regulation for which the facility requests flexibility.
• An explanation of the alternative concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or pilot projects the facility proposes to use.
• Supporting evidence demonstrating how the facility’s alternative concepts, methods, procedures, techniques, equipment, personnel qualifications, bulk purchasing of pharmaceuticals, or pilot projects meet the intent of the regulation.
• A licensee, administrator, or authorized facility representative signature on all forms and/or requests.

DO Responsibility

If the DO determines the program flexibility request is not complete, the DO will request that the facility submit additional supporting documentation. Upon receipt of a completed program flexibility request, the DO will review and respond within 60 days. As part of their review, the DO will determine the duration of the program flexibility and identify any terms and conditions applicable to the approval.

Approved Program Flexibility

All approved requests for program flexibility will specify an expiration date and are subject to specific terms and conditions. If the facility fails to comply with the terms and conditions, or L&C determines the alternative does not adequately protect patient safety, L&C may revoke the program flexibility. CDPH will review all approved program flexes during the facility’s relicensing survey.

In addition to reviewing any documentation, L&C may conduct an on-site inspection during the program flexibility review process.

Facilities seeking program flexibility to address health care emergencies or unforeseen events, such as an infectious disease outbreak, a disaster, or mass casualty incident (generally related to a natural or human-caused disaster) that may lead to a rapid influx or “surge” in patients should refer to AFL 18-09 for an alternative application process.

If you have any questions or concerns regarding this AFL, please contact your local DO.

Sincerely,

Original signed by Jean Iacino

Jean Iacino
Deputy Director