Patient safety legislation removes reporting barriers
Law ends fear of reprisal that stops many reports
It’s a balancing act for most organizations — weighing the need for error disclosure, which may lead to system changes that prevent harm to future patients, against the threat of lawsuits.
Newly passed patient safety legislation now offers protection, with the goal of encouraging voluntary error reporting.
The Patient Safety and Quality Improvement Act of 2005 provides full federal privilege to patient safety information reported to a patient safety organization (PSO).
A very significant step
This is a significant step for the health care industry, according to James W. Saxton, JD, chairman of the health care litigation group at Stevens & Lee, based in Lancaster, PA, and immediate past chairman of the American Health Lawyers Association’s practice group on health care litigation.
"A significant hurdle for some organizations is the fear of reprisal to the reporting health care providers and the potential for discovery of disclosed information in any subsequent lawsuit that may result from the event," he says.
This legislation will help to remove those barriers by permitting voluntary disclosure of medical errors to a qualified PSO. The reported information will be used to share improvements in processes and procedures, which can lead to increased patient safety.
"Many organizations struggle with balancing the task of encouraging error disclosure, which can lead to improvements, against the potential for discovery and use of the information against the health care provider at a later time," says Saxton. "Our work has shown that getting to the root cause of frequency and severity is essential to reducing liability risk, as we have seen such efforts work effectively."
The legislation is long-awaited. Since 1997, the Joint Commission and other patient safety advocates have testified on numerous occasions before congressional committees, urging passage of a comprehensive patient safety bill.
By analyzing the underlying causes of adverse events reported to JCAHO’s Sentinel Event database, organizations can be alerted to patient safety dangers, with recommendations provided for preventive solutions.
However, the number of reports in the database is only a small fraction of the actual number of adverse events that experts estimate occur each year.
"We’ve been trying to find ways to encourage more reporting of errors since 1997, when we went up to Capitol Hill to start the ball rolling for this legislation," says Margaret VanAmringe, vice president for public policy and government relations for JCAHO. "Our assessment of reasons why organizations didn’t report was quite striking."
One major reason was fear of retaliation — that the information revealed during an in-depth analysis of the root cause, as required by JCAHO, would be used against the organization.
"We were asking people to open up very sensitive information about the organization. So there was a lot of fear that this information, in the hands of the wrong people, could be used as fodder for legal action as opposed to education," says VanAmringe.
Since the legislation provides a safe harbor for information reported to a PSO, voluntary reporting should increase because the biggest barrier is removed.
"We think that this is going to be the boost that people need. But it doesn’t take away all barriers. Organizations still have to have a culture that makes it clear to staff that there is no retaliation for reporting," VanAmringe says.
Look for added value
The PSOs should do more than provide a safe harbor; they also are charged with giving constructive feedback to organizations — an added value to encourage organizations to report, she explains.
"We have great hope for the PSOs, but this is a new animal, so we have to see what are they going to look like, who is going to create them, and what kind of activities will prove to be most helpful," VanAmringe says.
"But we will hopefully have more information than we have today, or at least we will be able to validate what we think are the major issues, by looking at what is reported," she notes.
During on-site surveys, JCAHO surveyors will be asking questions about how errors are handled within the organization and will ask staff about the process for reporting, VanAmringe says.
"Surveyors may even pull a staff member aside and ask If there is an error, do you know where to report it?’ and Do you feel comfortable reporting?’" she continues. "And after the legislation goes through, on survey we can certainly ask, Do you report to a PSO or to multiple PSOs? Or what have you done to take advantage of the legislation?’"
The Joint Commission has not yet decided whether to change any standards as a result of this legislation, VanAmringe explains.
"It is just too early," she says. "Reporting to a PSO is voluntary, and we respect that. It’s up to organizations to take advantage of the legislation, and hopefully they do. That would certainly be a good thing."
The Joint Commission expects to create a PSO or become part of one under the auspices of its new International Center for Patient Safety.
"And if we do that, we would move the Sentinel Event database there, so hopefully reports will increase," VanAmringe notes.
As it stands now, the Joint Commission’s Sentinel Event database is "probably the most comprehensive database of medical errors in the country," VanAmringe says.
"There are other niche databases that only collect anesthesia or medication events, but we collect all types of events that meet the threshold of being serious errors," she notes. "We would work with other PSOs to share anonymous data as envisioned by the legislation."
The first step
As a quality manager, your first step should be to inform leadership and staff about the legislation and its impact.
"There needs to be some education within the hospital, to let people know that the information that’s provided will be kept confidential and privileged, and that will be very helpful for them. Shortly, we expect some guidance as to the certification of PSOs, and once that is out, there will be PSOs out there for reporting purposes," says VanAmringe.
"It’s better to report now than to wish you reported later, when somebody comes knocking on your door asking for information that you wish you kept closer to the vest," she points out.
Quality managers can expect the need for additional full-time equivalents, since there will be expanded external reporting for hospitals, as well as aggregate evaluative information on the cause and prevention of medical errors, says Jeffrey Driver, chief risk officer for Stanford (CA) University Medical Center.
Education should begin immediately so administrators, managers, and caregivers understand that the legislation will create a federal privilege that in effect creates a nonpunitive safe space to transmit medical error, accident, and near-miss information beyond a hospital’s organized peer-review committees, without fear that such information could be discovered and used in a lawsuit, he advises.
In the future, the safe space will extend further to PSOs as defined by the legislation.
"However, at this point, it is important to stress that there are no designated PSOs and therefore, a hospital’s medical error, accident, and near-miss external reporting policy must be followed in its present form, until further notice," Driver points out.
Choose carefully
The legislation may create a perception that a general federal privilege already is in place that allows hospitals and providers to share medical error and near-miss information outside traditional protected borders, such as a hospital peer-review committee, Driver says.
"This can be remedied by implementing education about the legislation, its key features, as well as its limitations," he adds.
Consider having a defined position within a particular hospital department handle reporting of medical errors to external sources, Driver recommends.
"This will help to reduce the possibility of external reports of medical errors or near-misses being reported to a third party for which there is no evidentiary discovery privilege," he points out.
When PSOs do become available, it’s important to choose carefully which one you report to, VanAmringe advises.
"You want to make sure that you are reporting to a PSO that provides you added value. If you just get the safe harbor, that doesn’t take you as far as the legislation intended," she says.
"It intended for PSOs to work with organizations to answer questions and give tools, resources, and comparative data, so you can make changes in systems, policies, and practices," VanAmringe adds.
[For more information, contact:
- Jeffrey Driver, Chief Risk Officer, Stanford University Medical Center, Administrative Services, 860 Stanford Shopping Center, MC 5716, Room 213, Stanford, CA 94304. Phone: (651) 725-6996. E-mail: [email protected].
- James W. Saxton, JD, Stevens & Lee, 25 N. Queen St., Suite 602, P.O. Box 1594, Lancaster, PA 17608-1594. Phone: (717) 399-6639. Fax: (717) 394-7726. E-mail: [email protected].]
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