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For other articles and previous issues click here. November 28, 2005 Patient
Safety, Act I Unlike HIPAA, the federal Patient Safety and Quality Improvement Act doesn’t require anything. Its success will play out based on how the new law fosters a culture of safety in healthcare facilities. Everyone can learn from other people’s mistakes—presuming they will share them. When healthcare practitioners make mistakes, fear of litigation, blame, and shame are powerful reporting disincentives to acknowledging errors. Solving that problem is the goal of the recently passed federal Patient Safety and Quality Improvement Act of 2005, commonly known as the Patient Safety Act. Signed by President Bush in July, the law aims to create a nationwide database of anonymous medical errors healthcare organizations will use to study and reduce the too-often deadly mistakes. “To maintain the highest standards of care, doctors and nurses must be able to exchange information about problems and solutions,” President Bush said at the law’s signing ceremony. “Yet in recent years, many doctors have grown afraid to discuss their practices because they worry that the information they provide will be used against them in a lawsuit. “This bill will help solve that problem. This is a common-sense law that gives legal protections to health professionals who report their practices to patient safety organizations. By providing critical information about medical procedures, doctors and nurses can help others learn from their experiences.” The law’s creators hope healthcare professionals and organizations will benefit in two ways from the patient safety law. First, they hope people will learn from a large database of medical errors to help them provide better care. Second, they want to provide a measure of protection against litigation by having medical professionals report their errors to the database. Many experts believe it will take this privilege protection to entice providers and facilities to report errors to the organizations that will manage the databases. Voluntary
Reporting The legal privilege of reporting isn’t absolute. Reporting to a designated patient safety organization (PSO) still means a facility can be sued for an error. When a facility investigates an incident internally and then files its report with a PSO, the findings and conclusions can’t be used against the hospital by a plaintiff or accrediting body, explains Margaret VanAmringe, JCAHO’s vice president for public policy and government relations. So an organization that investigates its own incidents and reports them will not be penalized by being forced to turn over the information to an opposing attorney. The law also prohibits accrediting organizations from using information supplied to PSOs against the individuals and organizations that report. Some states have already built similar protections into their peer review laws. The new law’s roots go back to 1999 when a now-famous report from the Institute of Medicine (IOM), To Err is Human: Building a Safer Health System, found that as many as 98,000 people die each year from medical mistakes in the United States. The study attached a surprisingly high number to the deadly mistakes that healthcare professionals knew occurred—but, not at such an alarming rate. The IOM report launched a six-year process that led to the Patient Safety and Quality Improvement Act. While opposing patient safety seems tantamount to coming out against motherhood and apple pie, physicians, nurses, and hospitals were concerned about the reporting rules’ requirements. Professional organizations worried that submitted data would be used against healthcare providers in malpractice suits and would simply stop many people from reporting incidents. Some wanted a law requiring reporting errors. For example, according to published reports, the American Nurses Association believes the law would be more effective if it mandated reporting, but its government affairs office supports the idea of a blame-free structure for reporting and analyzing errors. Conversely, physician groups vigorously opposed mandatory reporting, concerned that it would require providers to give regulators and litigators the rope that would in turn be used to hang doctors. In the end, VanAmringe believes voluntary reporting made it possible for the law to pass. The compromise eliminating a legal requirement to report errors cleared the way for the law, establishing the mechanism to create the national database. “This is a voluntary process; it would not have passed if it weren’t,” VanAmringe says. “In the final analysis, all reporting is voluntary.” Incentive
to Report “This legislation establishes a system for reporting and analyzing errors to improve health care safety and quality,” said American Medical Association president J. Edward Hill, MD, in a prepared statement. “When physicians can report errors in a voluntary and confidential manner, everyone benefits. Future system errors can be avoided as we learn from past mistakes.” Another challenge is implementing the law to improve healthcare delivery. The Patient Safety Act alone won’t solve anything, but many in the medical field see the law as a step toward fostering the culture of safety many in healthcare envision. “I think it’s the right thing for a lot of reasons,” says Carol Haraden, PhD, vice president of the Institute for Healthcare Improvement (IHI), a not-for-profit organization that works with large healthcare-related organizations and societies to develop the best practices to improve healthcare service delivery. “The truth will be in the changes it drives—and they won’t be known for a while.” The key to real success, according to Haraden, won’t come from reporting. “Nothing has shown that people are safer by reporting alone,” she says. “There has to be a culture of finding out and fixing problems. No amount of reporting will inculcate that into an organization.” Haraden admits to being cautiously optimistic that information learned from an error registry with legal confidentiality protection will start the ball rolling in the right direction. AHRQ
Direction VanAmringe eagerly awaits news of the PSO process because JCAHO wants to be one of them. JCAHO already accredits thousands of hospitals, and it has both the existing infrastructure and experienced people with long track records of working on safety issues and best practices. VanAmringe speculated that JCAHO would, if selected, create a subsidiary organization to clearly separate any new PSO work from its existing accreditation function. IHI’s Haraden agrees that the PSOs will play a crucial role if the Patient Safety Act ultimately achieves its objective. Presuming that healthcare providers and their organizations become comfortable with reporting to PSOs and the database grows, Haraden believes they will be instrumental in analyzing the information and getting it back into the hands of providers. “Data has to be shared in a real-time fashion,” she says. “Places can’t improve just by receiving a yearly report. That’s not going to change anything.” Both VanAmringe and Haraden suspect it will take some time for the process to build acceptance after it is launched. But both see it as an opportunity to improve a difficult situation. “Hopefully, we’ll all be [pleasantly] surprised at the information that will come in,” VanAmringe says. “We’ll have to see what comes out. What the rules of the road are, and how PSOs will function.” Litigation
Fear “There’s probably no small amount of angst about what’s happening out there,” Haraden says of the healthcare community, “but there is also a belief the we have to get beyond litigation to know what’s going on.” Haraden explains that large-scale reporting is the only way to identify serious problems that occur frequently around the country. “It’s just the nature of rare events that you’re not going to be vigilant about them unless you know about them,” Haraden says. She firmly believes that gathering information and then analyzing and understanding are the first steps toward correcting and building an organizational culture of safety—the best way to approach patient safety issues. — Radiology Today staff report
To Haraden, “up” means outside the organization. Hospital workers report rules when an accident or a mistake occurs, and so do—to differing degrees—workers in different sized medical practices. She speculates that reports to patient safety organizations (PSOs) would follow the same basic channels they do now. As for now, Haraden believes the Agency for Healthcare Research and Quality, or possibly the individual PSOs, will develop a uniform reporting form or format. When an organization chooses to report an incident, the paperwork (or electronic filing) would likely be completed by the same person responsible for reporting now. As a practical matter, a report going “outside” the organization to a PSO would likely require a higher level of management review and approval. Most people don’t think the law will add a large burden to organizations that choose to report. The real burden,
so to speak, may be getting comfortable with what happens when a
report leaves the facility for the PSO—at least until facilities
get more comfortable with the process.
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