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EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


AFL 21-40
November 12, 2021


TO:
General Acute Care Hospitals (GACHs)
Acute Psychiatric Hospitals (APHs)

SUBJECT:
Regulatory Update for Adverse Events Reporting

AUTHORITY:     California Health and Safety Code (HSC) sections 1279.1, 1279.2, and 1279.6


All Facilities Letter (AFL) Summary

This AFL informs hospitals of new regulations, effective January 1, 2022.

  • The regulations are available at the Office of Regulations website.
  • The regulations require hospitals to identify, report, and correct systemic problems contributing to preventable patient safety events, including adverse events (AEs).
  • The regulations also specify statutory requirements for the purpose of improving patient safety in hospitals and encouraging a culture of safety in hospitals.

This AFL notifies hospitals that the California Department of Public Health (CDPH) has adopted new Title 22 California Code of Regulations (CCR) sections 70970 – 70974 for GACHs and sections 71565 – 71569 for APHs. These regulations are effective January 1, 2022. Hospitals should update any facility policies and procedures as appropriate to align with the new regulatory requirements.

Reporting and Investigation Requirements

Consistent with existing law, hospitals are required to report AEs no later than five days after the AE is detected. If the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, the hospital 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 must be reported within 24 hours. In addition, the regulations specify the hospital is subject to an onsite investigation when CDPH determines that an adverse event or complaint is an ongoing threat of imminent danger of death or serious bodily harm.

Secure Electronic Web-based Portal

The regulations require hospitals to report AEs via the Department's secure electronic web-based portal. The Department provides alternative means, by email or telephone, for submission if the web-based portal is unavailable. This requirement preserves patient confidentiality and standardizes reporting requirements.

Root Cause Analyses and Assessing the Culture of Safety

Hospitals are required to develop policies and procedures for the internal reporting of preventable patient safety events, conducting a root cause analysis, and assessing the hospital's culture of safety every 24 months. These practices improve patient care and reduces the occurrence of patient safety events.

Hospitals are responsible for following all applicable laws. CDPH's failure to expressly notify hospitals of statutory or regulatory requirements does not relieve hospitals of their responsibility to follow all laws and regulations. Hospitals should refer to the full text of all applicable sections of the HSC and Title 22 CCR.

If you have questions about the content of this AFL, please contact­­ the Center for Health Care Quality Regulation Development Section at CHCQRegulationsUnit@cdph.ca.gov.

           

Sincerely,

Original signed by Cassie Dunham

Cassie Dunham

Acting Deputy Director


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