New Law Requires Hospitals to Report Adverse Events

A new California law (SB 1301) mandates that hospitals report within five days to the California Department of Health Services (DHS) when one of 27 adverse events occurs, according to Ernie Ring, MD, chief medical officer at UCSF Medical Center. If the event is an ongoing, urgent or emergency threat to the welfare, health or safety of patients, personnel or visitors, hospitals must report the adverse event within 24 hours, according to the law which went into effect on July 1, 2007. An adverse event includes any of 27 specified occurrences involving or posing the risk of unexpected death or serious injury. See the list below. When an incident is reported, DHS will then conduct an investigation, which may include a site visit to the hospital. Failure to report one of these adverse events within five days is a violation of the law and will result in a fine to hospitals, including UCSF Medical Center. Compliance with the rapid-reporting timeframe of this new law requires immediate notification of DHS. Those who suspect that any of these events has occurred at UCSF should immediately call Risk Management at 415/353-1842. Each reported event will be internally evaluated and discussed, using a root-cause analysis process, at the medical center's weekly Clinical Events Oversight Committee meeting. Lessons learned from these reviews will be communicated in a variety of ways, including the Patient Safety and Quality Bulletins. Adverse Events to Report to DHS: * Surgery performed on wrong body part
* Surgery performed on wrong patient
* Wrong surgical procedure performed on patient
* Unintended retention of foreign object in patient after surgery or other procedure
* Death during or up to 24 hours after induction of anesthesia in low-risk surgical patient
* Stage 3 or 4 ulcer, acquired after admission to hospital
* Patient death or serious disability associated with:
o Medication error
* Use of contaminated drug, device or biologic material
* Use of device in which device functions other than as intended
* A fall
* Use of restraints or bed rails
* Electric shock, excluding events involving planned treatments
* Patient disappearance *Intravascular air embolism
* Burn incurred from any source while being cared for in hospital
* Hemolytic reaction due to ABO-incompatible blood or blood products
* Labor or delivery in low-risk pregnancy, within 42 days post delivery
* Patient death or serious disability, including kernicterus, associated with failure to treat hyperbilirubinemia in neonates
* Patient death or serious disability directly related to hypoglycemia that develops in the hospital
* Patient death or serious disability due to spinal manipulative therapy performed at the hospital
* Patient suicide or attempted suicide resulting in serious disability while being cared for in the hospital
* Incident in which oxygen or other gas contains wrong gas or is contaminated by a toxic substance
* Infant discharged to wrong person
* Abduction of patient
* Care ordered by or provided by someone impersonating physician, nurse or pharmacist
* Sexual assault on patient within the hospital or on hospital grounds
* Death or significant injury of patient or staff member resulting from physical assault within the health facility
Related Links: California Department of Health Services