State of California Enacts Adverse Event Reporting

"Never 27" Reporting in Effect July 1

As of July 1, 2007, a new California law (S.B.1301) mandates that the Department of Health Services (DHS) Health Facility Reporting requirements now include the “Never 27” list of serious, preventable adverse events. The legislation requires that information about reported events and the outcomes of investigations or inspections of substantiated adverse events be made readily accessible to consumers by January 2009 and be posted on the DHS Web site and available in written form by January 2015.

As of December 2006, 27 states had passed legislation or regulation related to hospital reporting of adverse events to a state agency. States use the list developed by the National Quality Forum (NQF); a list that consists of 27 serious, preventable adverse events, such as performing surgery on the wrong patient or body part, leaving objects inside a patient after surgery (retained foreign objects), and discharging a newborn to the wrong person. At least 25 percent of the states with mandatory reporting require that a version of each of the 27 events on the NQF list be reported.

The reportable events are grouped into six categories—surgical events, product or device events, patient protection events, care management events, environmental events, and criminal events. California hospitals must report any of these events within five days of discovery.

The DHS will then conduct an investigation, which may include a site visit. If there is an ongoing threat of injury, the event must be reported within 24 hours, and the DHS must conduct an immediate on-site inspection. Even if the DHS does not conduct a site visit or investigation, every event report will be reviewed in some way. Beginning on January 1, 2009, the DHS will make information about these events available to the public and to any other entities that it deems appropriate.

The Doctors Company is committed to helping physicians improve quality, reduce medical errors, and maximize patient safety. The threshold question is whether a state-wide standardized mandatory set of serious reportable events would materially improve patient care and facilitate increased public accountability.

The Hospital Association of Southern California says that “hospital reports of ‘unusual occurrences’ pursuant to 22 CCR. Sec. 70737 and 71535 are subject to the Public Records Act [Government Code Sec. 6xxx] and are thus obtainable by medical malpractice plaintiffs’ attorneys. DHS redacts any patient name or medical information prior to releasing the documents, but the facility name, date, and other information are not redacted.”¹ These reports may be used by plaintiffs’ attorneys to show a pattern of practice or used as evidence in a case brought by the subject of a report. The law’s language does not shield the reports from discovery nor prohibit their introduction into evidence in any civil, criminal, or administrative judicial proceeding or arbitration.

For more information, see: http://info.sen.ca.gov/pub/05-06/bill/sen/sb_1301-1350/sb_1301_bill_20060929_chaptered.html

J6868 10/07

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