​This letter serves to notify all clinics and ASCs that also meet the definition of an "Outpatient Setting" as specified in HSC Chapter 1.3 (Sections 1248-1248.85) of a new statutory requirement for reporting adverse events.

An "outpatient setting" is defined in HSC Section 1248 as "any facility, clinic, unlicensed clinic, center, office or other setting that is not part of a general acute care facility, as defined in Section 1250, and where anesthesia, except local anesthesia, or peripheral nerve blocks, or both, is used in compliance with the community standard of practice, in doses that, when administered have the probability of placing a patient at risk for loss of the patient’s life-preserving protective reflexes." A clinic or ASC that does not meet this definition (i.e. use general anesthesia) is not subject to these reporting requirements.

Pursuant to HSC 1248.15 (h), effective January 1, 2012, outpatient settings are subject to the reporting requirements of Section 1279.1 and the penalties for failure to report specified in Section 1280.4.

All outpatient settings must now report adverse events to the California Department of Public Health (CDPH), Licensing & Certification Program (L&C), no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel or visitors, not later than 24 hours after the adverse event has been detected. In addition to reporting the incident to CDPH, the clinic/outpatient setting is required to notify the patient or the patient’s representative of the adverse event within the same reporting timeframes.
Outpatient settings are further subject to a one hundred dollars ($100)-a-day penalty for each day that the facility failed to report an adverse event following the five-day or 24-hour reporting period.

HSC 1279.1 identifies 28 various events that qualify as "adverse events;" see Attachment A for a complete list.

To report a possible adverse event, a licensed clinic/outpatient setting should contact its respective CDPH L&C District Office responsible for its oversight. At this time there is no prescribed format for reporting. Licensed clinics/outpatient settings may submit adverse event reports in the manner of their choosing (by phone, fax, email, or letter). L&C District Office staff will request any additional information necessary to confirm whether or not the circumstances would be considered an adverse event and/or to determine whether further investigation is required.

While not an exhaustive list, the department has identified the following information as beneficial to making such determinations:

• Clinic/Facility name
• Location of facility; Address and City
• Contact person; including name, telephone number and fax number
• Date adverse event occurred or date detected
• Date the adverse event is being reported
• Identification of adverse event category
• A brief description of the event (for events categorized under 1279.1 (b)(7))
• Date patient or party responsible for the patient was notified of the adverse event

It is important to note that outpatient settings that do not report a possible adverse event to CDPH are subject to penalties for the period of time the event remained unreported if it is later determined that the incident should have been reported. Further, this new reporting requirement in no way replaces or alters the reporting requirements for "Unusual Occurrences" as defined in California regulations.

Licensed clinics and ASCs are responsible for following all applicable laws. The California Department of Public Health’s failure to expressly notify facilities of statutory or regulatory requirements does not relieve them of their responsibility for following all laws and regulations. All clinics and outpatient settings should refer to the full text of all applicable sections of the Health and Safety Code.

If you have any questions, please contact your respective L&C District Office.

Sincerely,

Original Signed by Debby Rogers

Debby Rogers, RN, MS, FAEN
Deputy Director

Attachment: Adverse Events