New legislation in California takes hospital reporting of serious medication errors to a new and very public level. Signed by the governor in late September, the law requires all hospital medical errors posing serious harm, including medication errors, to be posted on the state Department of Health Services' Web site. The Web site must include a description of the error, any corrective steps taken by the hospital or the state, and the name of the facility.
The legislation, opposed by the state hospital association, makes California's medical error reporting system one of the toughest in the nation. According to its sponsor, State Senator Elaine Alquist, its purpose is to "see that hospitals are a safe place for sick people, not to castigate anyone." Alquist estimates that five to 10 medical errors resulting in a patient death occur at every hospital in the state every year. Her legislation, S.B. 1301, amends the state's current health and safety code. It passed both houses of the State Legislature in August.
Right now state law requires facilities to report "unusual occurrences" that threaten patient safety and to make these reports available to the public. No timetable is set for those reports, and hospital safety records are available only in voluminous paper files at a state office.
The changes also require the state to investigate any complaint of an adverse event within 45 days, instead of the current six months, and it requires surprise state inspections of all hospitals yearly, instead of the current three years. The legislation brings hospitals into line with what the state expects from nursing homes and child-care facilities, said Alquist (D, San Jose). "The changes will help hospitals be safer," she said. "It's going to help the providers in the hospitals and the public."
The Internet posting of adverse events would not take effect until 2015. It would be a change in the state health code and unique to California. According to a 2005 report by the Congressional Research Service (CRS) of the Library of Congress, 22 states mandate medical error reporting by hospitals but do not post those reports on a Web site. The CRS report acknowledges that such public reporting could reduce provider willingness to report but states that "providers are reluctant to report adverse events in part because they fear the information will be used in malpractice litigation. States have sought to allay those concerns by passing laws to protect reported data from legal discovery and by de-identifying data and receiving reports anonymously."
Public reporting of medical errors, including medication errors, is controversial. "It depends how it's done," said Kasey Thompson, Pharm.D., director of patient safety for ASHP. "When a medication error results in death or injury, it is very difficult for a facility to sweep it under the rug. But using medication errors to compare facilities is problematic. And to use the information to publicly embarrass hospitals could have a chilling effect on reporting and the creation of the kind of database of errors that could improve safety."
"We don't take a position on the public reporting of medication errors," said Virginia Herold, M.S., interim executive officer of the California State Board of Pharmacy. The board does investigate all complaints of medication errors brought by consumers, and every three to fours years it inspects all state pharmacies, including facility pharmacies. "We expect to see a quality assurance program in place that notes any medication error and an assessment of how the error occurred and the steps taken to avoid a recurrence," said Herold. "Failure to have such a program in place leads to a citation and fine. Our position is there is no such thing as an acceptable number of medication errors."