New legislation protects ED staff who ID unsafe care
Law ensures discussions about safety won't "show up in a courtroom"
By Staci Kusterbeck, Contributing Editor
The Patient Safety and Quality Improvement Act of 2005 provides full privilege for information shared with a patient safety organization, with the goal of encouraging voluntary error reporting. How will the new legislation affect EDs and malpractice cases?
"As usual in the law, the answer is: 'it depends,'" says Bryan A. Liang, MD, PhD, JD, executive director of the Institute of Health Law Studies at California Western School of Law in San Diego, CA and co-director and adjunct associate professor of anesthesiology at University of California—San Diego School of Medicine.
Original patient care information, such as the medical charts, won't be protected from discovery under the law. However, any analysis or discussion of improving system safety and quality by those involved, as well as any transfer of that information beyond the ED entity, will not be discoverable if the hospital fulfills the requirements of the law by working with one or more Patient Safety Organizations (PSOs).
"This is of great advantage to emergency departments, which are high intensity clinical settings where errors and system weaknesses can result in significant patient harm," says Liang. "It allows for sharing of experiences and data to improve system safety and quality, without fear of having these discussions show up in a courtroom."
On the one hand, reporting errors may subject ED staff to liability suits just as any patient injury might, says Liang. However, reporting errors that lead to system improvements may ultimately benefit EDs, since unsafe practices will be identified.
Reporting information that already is documented in the patient's chart won't increase or decrease ED provider liability. "If the patient is going to sue, the chart has all the relevant information and will be accessible to the patient's attorney," says Liang. "Ethically, of course, we should always report errors if safety and quality will be improved."
This idea is at the heart of the patient safety legislation, which recognizes that many in the health care field want to do the right thing and talk about errors to give safer care to their patients, says Liang.
"But with a legal system that is expensive, not very accurate in determining poor care versus bad outcomes, and in an environment of distrust, it is inevitable that there were few reports," says Liang. "However, now with the protections set up by the act, ED staff should be looking toward a new infrastructure where care can be improved and their efforts won't be used against them."
Lessons can be shared
The legislation specifically covers reports to PSOs, but may include broader reporting as well, says Liang. The critical requirement is that the health care entity work with PSOs for the statutory protections to occur, however.
However, since the reports and analysis created by the entity for the PSO are considered "patient safety work product," these may be shared with other hospitals or organizations, with the protections of the law following the materials.
This is something that gives the law "teeth," since under uneven state peer review privilege, the protections were for the peer review committee discussions, and not for the materials, says Liang.
"If someone talked about the safety and quality analysis outside the peer review meeting, everything became discoverable," he says. "So no one could talk, and no one could share outside the meeting, including to the ED or hospital next door. Now, with the protections following the materials, sharing of lessons learned and information to everyone in the facility and in the world can occur to promote patient care while still being protected."
Because the law is federal, EDs will no longer need to rely on uneven state-based peer review protections for safety and quality improvement activities, says Liang. State peer review statutes have not been a good protector of safety information and analysis, and materials, such as root causes, analyses have been deemed discoverable.
If a malpractice suit is coupled with a federal claim and filed in a federal court, rather than state court where malpractice actions are usually filed, the state peer review protections don't apply—a fact that plaintiffs' attorneys are using to avoid state peer review laws.
"Hence, the new federal law will address that very important issue through its protections, and block end run efforts by plaintiff's attorneys—assuming that hospitals fulfill the terms of the statute by working with PSOs," Liang says.
Liang gives the following recommendations for EDs:
- Ensure that your ED sets up Patient Safety Evaluation Systems (PSESs) to discuss and analyze patient safety data on actual adverse events and near misses.
- Report errors and system weaknesses through this system, to ensure the maximum potential protections for the information. Discuss the data and analyses in official PSES meetings.
- Work with PSOs to assist in identifying, analyzing, and improving system delivery safety and quality. "It is very important to note that health care entities must work with PSOs to garner the broad protections of the new law," says Liang. "PSO requirements will be announced in forthcoming regulations."
As for liability issues when ED staff report an error internally, or to an external agency such as the Institute for Safe Medication Practices (ISMP), the answer is again "it depends," says Liang. "Reporting errors by itself doesn't create liability internally or externally," he says. "What it may do is support a lawsuit."
Internal reports that are discoverable can be used by plaintiff's lawyers to support their case—which is why creating and maintaining a PSES is so important, says Liang. "Original materials such as the patient's chart are always discoverable—so if the report just repeats what's in the chart, there's no protection," he says. "But if there is analysis within the report and it's intended to go to a PSO for quality and safety purposes, then protection arguably applies."
For external reports to organizations such as ISMP, the same analysis applies—if it's for quality and safety purposes, and part of the PSES working with a PSO, the protections go with the materials. "But if it just repeats what's in the chart, there's no protection," says Liang.