The California Department of Public Health (CDPH) adopted new regulations for General Acute Care Hospitals and Acute Psychiatric Hospitals, effective January 1, 2022. The regulations are intended to improve patient care, reduce the occurrence of patient safety events, and encourage a culture of safety in hospitals. The new regulations are available here.

Adverse Event Reporting

In line with current requirements, hospitals must report adverse events to CDPH within five calendar days after the adverse event is detected. Additionally, hospitals must report within 24 hours adverse events that are ongoing urgent or emergent; threatening the welfare, health, or safety of patients, personnel, or visitors; and sexual assault or allegations of sexual assault of a patient.

Hospitals must report adverse events through CDPH's secure, electronic web-based portal. If the portal is not operational, hospitals should submit reports to CDPH via email or telephone.

Investigations

Pursuant to the regulations, hospitals are subject to an onsite investigation if CDPH determines that an adverse event or complaint is an ongoing threat of imminent danger of death or serious bodily harm. If CDPH determines there is no ongoing threat of imminent danger of death or serious bodily harm, the hospital is subject to an onsite inspection and/or an offsite investigation that includes interviews and records reviews.

Culture of Safety and Policy Review

Hospitals must develop and implement policies and procedures for internally reporting preventable patient safety events, documenting reportable patient safety events, conducting root cause analyses, and assessing the hospital's culture of safety at least every 24 months. Hospitals should review their current patient safety plans or similar policies and procedures and ensure that they have the required processes in place to comply with these new requirements by the effective date.