Health and Human Services Agency
California Department of Public Health

AFL 25-15

April 29, 2025

TO:

Acute Psychiatric Hospitals (APHs)

SUBJECT:

Adverse Event and Unusual Occurrence Reporting Requirements

AUTHORITY: Title 22 California Code of Regulations (CCR) sections 71567 and 71535

Health and Safety Code (HSC) sections 1279.1 and 1280.4

All Facilities Letter (AFL) Summary

This AFL reminds Acute Psychiatric Hospitals (APHs) of the requirements to report adverse events (AEs) and unusual occurrences.
APHs that fail to meet the AE reporting requirements within the required timeframes may be subject to civil penalties issued by the California Department of Public Health (CDPH).

Adverse Event Reporting Requirements

Pursuant to Title 22 CCR section 71567 and HSC section 1279.1, APHs must report AEs no later than five days after the APH detects an adverse event. If the event is an ongoing, urgent, or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, APHs must report no later than 24 hours after detection. The detection of or allegation of sexual assault is considered an ongoing or emergent threat and the APH must report the incident within 24 hours. By the time the APH reports the AE to CDPH, APHs must also notify patients or the party responsible for the patients affected by an AE.

AEs include the following:

Surgical events
Product or device events
Patient protection events, including suicide and suicide attempts
Care management events
Environmental events
Criminal events, including physical and sexual assaults
An AE or series of AEs that cause the death or serious disability of a patient, personnel, or visitor

APHs must report AEs via CDPH's California Healthcare Event and Reporting Tool (CalHEART). In the event that CalHEART is not operational, the APH must report the AE to their local CDPH district office by email or telephone. For additional information on reporting AEs to CalHEART, please see AFL 13-12.

The following information must be reported to CDPH:

Name and address of the hospital
Location and service area where the AE occurred
Date and time the AE occurred and was detected, if known
Name of each individual affected by the AE and any patients, personnel, and visitors involved or a witness to the AE, if known
Description of the circumstances surrounding the AE, including the nature and extent of injury or harm
If an individual affected by the AE is a patient, the date the patient, or the party responsible for the patient, was informed of the AE

NOTE: This date must not be later than the date the hospital reported the AE to CDPH

Name, title, area code, and telephone number of a hospital representative for CDPH to contact for additional information
Hospital's immediate corrective or mitigating action in response to the AE
Any additional information as it becomes available regarding the AE

Civil Penalties for Failure to Report AEs

HSC section 1280.4 authorizes CDPH to issue civil penalties if an APH fails to report an AE within the required timeframes set forth in HSC section 1279.1. APHs are subject to a $100/day civil penalty for every day that the facility fails to report an AE.

Unusual Occurrence Reporting Requirements

APHs must also report unusual occurrences and reportable diseases. Title 22 CCR section 71535 requires APHs to report any unusual occurrence such as an epidemic outbreak, poisoning, fire, major accident, disaster, other catastrophe or unusual occurrence that threatens the welfare, safety, or health of patients, personnel, or visitors, as soon as reasonably practicable, to the local health officer and to their respective CDPH district office. Examples of incidents that may threaten the welfare, safety or health of patients include elopements, abuse, and assaults.

The information in this AFL is a brief summary of the laws and regulations governing AE and unusual occurrence reporting. APHs are responsible for complying with all applicable laws. Consequences of not complying will result in a deficiency that may lead to administrative penalty, civil penalty, and/or civil action against the licensee of the APH.