The theory behind the new Patient Safety and Quality Improvement Act is simple: create an incentive for healthcare providers to report medical errors to a centralized database where researchers will analyze the information and report data to the providers that will use it to improve patient safety. Under the law, that incentive is liability protection. But as a number of healthcare quality experts say, converting theory into practice is much easier said than done.
The hurdles facing such a system include developing a common reporting language to allow data to be aggregated, building a public- and private-sector partnership to run the system and perhaps offering a financial incentive for providers to participate in the now-voluntary system.
Still, the passage of the law was hailed as an important milestone in the patient-safety movement.
Donald Berwick, president and chief executive officer of the Institute for Healthcare Improvement, said the law should help assuage "a secretive and frightened healthcare culture that doesn't discuss things they need to. You can't have safety without transparency."
"The very fact that we're passing legislation is another step forward to indicate that we care about it," said Berwick, a physician whose not-for-profit organization said it has enlisted 2,000 hospitals in a patient-safety campaign to prevent avoidable deaths.
Passage of the new law represents "a step toward maturation," Berwick said.
"It's a good first step," said Kenneth Kizer, a physician and president and CEO of the National Quality Forum. "It deals with one of the issues that has consistently been held out as a barrier to reporting--fear of litigation--and appears to deal with that issue. It deals less well with a lot of other issues. The legislation, with as long a gestation as it has had, leaves a lot to be clarified."
The NQF board last week approved 36 performance standards for ambulatory care (See story, p. 10), and a classification system that will likely aid the government in setting up the patient-safety reporting system called for in the legislation, signed into law by President Bush on July 29.
The law goes into effect immediately, although government and industry experts say it will take some unspecified time before the reporting mechanisms are up and running. No appropriations or cost estimates were included in the text of the act, although a report by the Congressional Budget Office in March estimated it would cost $5 million in 2006 and $58 million from 2006-10 to implement the law.
Industry experts said that level of funding would fall far short of what would be needed because the act is incomplete in scope, lacking specifications for thorough analysis of the data gleaned by the reporting mechanism and the provision of timely feedback to providers.
William Munier, acting director of the Center for Quality Improvement and Patient Safety at HHS' Agency for Healthcare Research and Quality--the agency charged with implementing the law--said the AHRQ has been "contemplating for some time" how to deal with such data and how the new patient-safety organizations would be set up (See box, p. 6).
One key element of the legislation is the requirement that patient-safety organizations collect information in a standardized manner and report to a network of patient-safety databases for national trend and pattern analyses. The AHRQ already prepares annual reports on health quality and health disparities, so Munier envisions that patient safety will be added to that list.
The law provides that the HHS secretary "may determine common formats for the reporting to and among the network of patient-safety databases," while the AHRQ director is obliged to assist the HHS secretary in providing technical assistance to patient-safety organizations on methodology and data collection.
Under the new law, patient-safety organizations will self-certify that they meet certain qualifying criteria to the HHS secretary for re-view. HHS will publish a list of qualifying organizations.
Munier said he has no idea how many groups might step forward to become patient-safety organizations, but for those that do--including the many organizations now doing similar patient-safety work--it would be essential that they all report data in a compatible format. He said the AHRQ is contracting with the Rand Corp. to conduct an assessment of state reporting systems and their definitions of patient-safety incidents to come up with a common system.
"Some of them conflict with the same event," Munier said. "It's not malevolent. We have that with federal agencies. They are set up by different statutes (but) if we're going to have to come up with a national report, we're going to have to choose one."
The lack of a common language for patient safety is a problem that must be solved early on, said Dennis O'Leary, president and CEO of the Joint Commission on Accreditation of Healthcare Organizations. The JCAHO supported the legislation and will apply to become a certified patient-safety organization. "Absent a common lexicon, we will create a tower of Babel," he said.
Feedback seen an key
In July, the New England Journal of Medicine published a JCAHO study highlighting the importance of communication between quality organizations and providers in driving clinical quality improvement. In 15 of 18 measures, the study's authors found a statistically significant improvement in quality based on data taken from hospitals involved in the JCAHO's quality-of-care program.
Scott Williams, director of the JCAHO's Center for Public Policy Research and a study co-author, said that although the study did not focus on causation, "We'd like to believe that a part of the improvement has been because we've been able to provide quarterly feedback."
Berwick also said feedback is critical to the success of the new program and needs to come more often than in an annual report. "It's continuous," he said of the needed back-and-forth among providers and safety organizations.
Yet the law makes no mention of financing feedback or the expert analysis of the data gathered, both major shortcomings, Berwick said. "Simple, graduate student-level analysis of these reports is not what we need. We need the best minds."
The legislation, introduced in the Senate on March 8 by James Jeffords (Ind-Vt.), sailed easily to passage this year. A committee and the full Senate passed it unanimously on the same day, July 21, and the House passed it by 428-3 just six days later. President Bush signed it into law two days after that.
But like a Hollywood star whose overnight success was preceded by a decade of dance, voice and acting lessons, a lot of work went into the seemingly sudden legislative success. The cause received a major boost from the Institute of Medicine in November 1999. The IOM's now famous report, To Err is Human, called on Congress to extend peer-review protections to data shared to improve patient safety.
The IOM also recommended setting up two separate national reporting structures. One would be a standardized, mandatory system to report adverse events that resulted in death or serious harm. The second system was to be voluntary with the level of events reported as unspecified. Neither of the IOM's formal recommendations called for public reporting, although the report said, "The committee believes there is a role for both for mandatory, public reporting systems and voluntary, confidential 1/4 systems."
"I think people have been negotiating on this for five years," said Sean Donohue, a Jeffords senior policy adviser who has worked on the legislation for three years. "I wouldn't say it's gone through quickly. It's gone through various iterations in various congresses and adapted to the best thinking on this."
Last year, patient-safety legislation passed both houses in different forms, but Congress adjourned before legislators could be named to a conference committee to resolve differences.
Despite the bipartisan backing of the measure, not everyone thinks the new law is a good thing.
Jeff Deist, press secretary for Rep. Ron Paul (R-Texas)--an obstetrician with libertarian leanings who voted against the new law--said Paul "doesn't believe that you make medicine safer" by federalizing matters best left to the states. Also, as a doctor, Paul distrusts a federal database. "If a person is harmed by a doctor, they should sue the doctor, but my boss doesn't see that as being under the federal purview at all," Deist says.
Ilene Corina, co-president of the advocacy group Persons United Limiting Substandards and Errors in Healthcare, said that if a full and accurate report of national medical-error statistics comes out of the new patient-safety law, "then that is a good thing. Patients do not know the statistics" on medical errors.
But Corina, who lost a 2-year-old son to a medical error during a tonsillectomy 15 years ago, is worried about what would be kept confidential. "I think we have enough confidential information out there already," she said. "I think we do need a public reporting system. We're looking for information so we can make better choices. The only time we find out there is a problem is from the media."
Members of the National Business Coalition on Health, a not-for-profit organization that includes some of the nation's largest employers and healthcare purchasers, will lean on providers to report serious errors and near misses under the new system, said coalition President Helen Darling.
Until now, "the biggest problem we've had is there has absolutely been no breakthrough in identifying safety problems, determining where the drivers are and taking steps to correct them," Darling said. "This is a huge breakthrough in changing the system, making it safer, making it higher quality and saving money.
"All of those bad things cost employers a lot of money, but if they (providers) were not reporting into a system that was protected, they were not going to report," she said. "They claimed if they reported information and studied near misses, they'd create files for plaintiffs' attorneys. I can't tell you the number of meetings I've attended over the years where they've said they couldn't do it because of the legal liability.
"They now no longer have an excuse for not reporting information when we ask for it," Darling said.
She said she is unconcerned that the program specifies only voluntary participation. The business community can and will take it the rest of the way now that the legal liability fears are quelled.
"We, as payers, can mandate, if we choose to. Large employers will encourage hospitals to participate," she said. And if they don't, she said, they risk being dropped from preferred provider networks.
Hospitals on board
Joining the program won't be a problem for hospitals, according to Nancy Foster, vice president for quality and patient-safety policy at the American Hospital Association, which supported the legislation. Maintaining participation in the voluntary program might be.
"My guess is that hospitals and other providers will choose to sign up fairly readily," Foster said. "I can't imagine why they wouldn't."
It's too early to tell whether financial carrots would be needed to induce participation in the program. In December 2002, the CMS announced it would set up a voluntary hospital-reporting program around 10 clinical quality measures.
But before it could begin generating data, Congress intervened and pre-empted the voluntary program with the Medicare Modernization Act of 2003, according to a CMS spokesman. The law calls for withholding 0.4% of the annual Medicare update payment for hospitals that don't report (See story, p. 10). About 4,000 hospitals, about 98% that are eligible, are submitting data and receiving payments under the program.
Foster said continued participation of hospitals in a patient-safety reporting program "will depend on the value of the information they get back from the" patient-safety organizations.
Hill Physicians Medical Group, an independent network of 2,600 physicians based in San Ramon, Calif., has been talking seriously for two or three years about setting up a reporting program for member physicians who either committed an error or who knew of one. But it never got past the talking stage, said Hill's CEO, Steve McDermott. "The issue has always been protection," McDermott said. "For too long those mistakes have been buried."
That will change with the new law, he said, as the network plans to be certified as a patient-safety organization, submit and receive data under the program. The goal will be to develop "systemic solutions to what we think are problems we think good people are making because, oftentimes, the system isn't working in the appropriate way."
McDermott said his physicians won't need any external financial incentives to participate in the initiative, but will build participation into the network's existing pay-for-performance regimen, under which primary-care physicians already receive about 20% of their compensation.
What is necessary is for the entire industry to set up a standardized reporting, language and coding system for patient safety as part of an institutionalized patient-safety infrastructure.
"It's long overdue," McDermott said. "We've got a whole industry built around how to code to increase revenue. We need to know how to code to reduce errors."
Thomas Royer, CEO of 31-hospital Christus Health, Dallas, said his system would participate in the program without any CMS-like financial inducements.
"We feel all good organizations are working on improving quality and part of that is patient safety," Royer said. "Certainly, getting paid more if your scores are better is positive. But the incentive to get to excellent care is to do it because it's the right thing to do. Excellence is not a luxury, it's a necessity for our patients."
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Key provisions of the error-reporting law
* Confidential, voluntary reports of medical errors will be made to new entities called patient-safety organizations, or PSOs, which will gather and
analyze information about patient safety and provide feedback to providers.
* PSOs will be self-certified, but must have patient safety and quality of care as primary activities. They can't be part of a health insurer.
* The Agency for Healthcare Research and Quality will provide technical assistance to the PSOs and convene annual meetings to discuss methodology, communication, data collection and privacy concerns.
* HHS' secretary will work on developing an accessible network database on medical errors. Regional and national analyses of data collected will be made available to the public, but no reports can be used in lawsuits.
* Cost: $58 million from 2006 to 2010.