Adverse healthcare events are a leading cause of morbidity and mortality in the United States. The 1999 Institute of Medicine (IOM) report To Err is Human; Building a Safer Health System recommended the establishment of mandatory reporting systems for state governments for the collection of standardized information about adverse events that result in death and serious harm.
The National Quality Forum (NQF) was funded and tasked by the federal government to identify a list of preventable adverse healthcare events that should never occur in a hospital, and to define them in such a way that, should they occur, the information that had to be reported would be clear. The NQF published a list of 27 preventable adverse healthcare events in its 2002 report Serious Reportable Events in Healthcare. The NQF encouraged adoption of this list of serious reportable events by states.
Senate Bill 1301 was introduced and chaptered to promote patient safety by ensuring that there is a system in place for early detection of, and response to, systemic problems that cause adverse healthcare events leading to death or serious disability. Senate Bill 1301 defines the errors that must be reported, sets timelines for reporting and inspection/investigation, and requires the posting of substantiated event information for consumers on the California Department of Public Health (CDPH) website.
Passage of Senate Bill 1301 requires all General Acute Care Hospitals (GACHs), Acute Psychiatric Hospitals (APHs) and Special Hospitals (SHs), effective July 1, 2007, to report the occurrence of the defined adverse events to CDPH, formerly known as the California Department of Health Services.
The types of adverse events to be reported to the CDPH are defined at Health and Safety Code (HSC) Section 1279.1 (b) (1-7). A list of the reportable adverse events is attached for your convenience. Upon detection of a reportable adverse event, a hospital is required to report no later than five (5) days, or, if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, no later than twenty-four (24) hours after the adverse event is detected. Hospitals shall report adverse events to their local Licensing and Certification Program district office.
In addition to reporting the event to the CDPH, the hospital must also inform the patient or the party responsible for the patient of the adverse event by the time the report is made.
If a hospital fails to report an adverse event, the department may assess a civil penalty in an amount not to exceed one hundred dollars ($100) for each day that the adverse event was not reported following the initial five (5) day or twenty-four (24) hour period. If the hospital disputes a determination by the department regarding alleged failure to report an adverse event the hospital may, within 10 days, request a hearing.
The enactment of the new statute will lead to improvements in patient safety and healthcare quality for the residents of California. If you have questions regarding this requirement, please contact your local Licensing and Certification district office.
Original Signed by Kathleen Billingsley, R.N.
Kathleen Billingsley, R.N.
Attachment: Reportable Adverse Events