Reporting Adverse Events

                                                        IMPORTANT INFORMATION

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UCSDHS is required to report certain significant events to the California Department of Public Health (CDPH).  These events are ones which may be associated with the serious harm or death of a patient or which may represent an ongoing threat of serious bodily harm or death for other patients.  In addition to state reporting requirements, our commitment to safe patient care requires us to thoroughly investigate these events and implement corrective actions to improve our systems of care delivery.

The detailed list of reporting indications is attached for your review and reference.  Examples of the 28 “Adverse Events” defined by SB 1301 for mandatory state reporting include:

·         Retained foreign objects

·         Air embolism

·         Wrong site/patient procedures

·         Wrong procedures

·         Death within 24 hours of surgery in a healthy patient or low-risk delivery

·         Death or serious disability associated with a device malfunction

·         Death or serious disability associated with a medication error, hemolytic reaction, hypoglycemia, hyperbilirubinemia

·         Suicide/attempt within our facility

·         Any adverse event or series of adverse events that cause death or serious disability

UC San Diego Health System must report an adverse event to the California Department of Public Health no later than five (5) days after the adverse event has occurred or been detected. If the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, the report must be made no later than 24 hours after the adverse event has been detected. The California Department of Public Health may assess a civil penalty for each day that the adverse event is not reported following the initial five-day period or 24-hour period.  TIMELY REPORTING IS CRITICAL!

Responding to an Adverse Event:

1.       The attending must be notified if they are not already involved or aware.  Chain of Command Policy (MCP 520.1)

2.       The attending should notify administration of the event by contacting one of the following individuals: Administrator on Call (AOC), Director of Regulatory Affairs- Patrick Olsen, Director of Risk – Belinda Hein, or Chief Medical Officer- Angela Scioscia. 

3.       If appropriate, implement immediate corrective actions to ensure of the safety of other patients.

4.       An iReport must be filed

5.       The Significant Events Committee will work with the individuals involved to investigate the situation, evaluate for state reporting and develop the final corrective action plan.

For more details refer to MCP 561.1 Sentinel Event and Significant Adverse Events

If you have any questions or concerns, you may contact Patrick Olsen, Director of Regulatory Affairs at 619-543-7220 polsen@ucsd.edu