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October 29, 2007

Patient Safety: A Tough Act to Follow
By Annie Macios
For The Record
Vol. 19 No. 22 P. 18

Signed into law in 2005, the Patient Safety and Quality Improvement Act remains in federal limbo. Where does it stand and will it be worth the wait?

“The Patient Safety and Quality Improvement Act [PSQIA] will help ensure that Americans continue to benefit from the greatest medical system in the world. To maintain the highest standards of care, doctors and nurses must be able to exchange information about problems and solutions.”

— President George W. Bush after signing the PSQIA into law on July 29, 2005

The 1999 Institute of Medicine (IOM) report “To Err Is Human: Building a Safer Health System” points to a desperate need for a reduction in medical errors, purportedly one of the nation’s leading causes of death and injury. Thus, the impetus for the PSQIA was born.

The IOM report says that healthcare is one decade or more behind other high-risk industries when it comes to ensuring basic safety. It says the chance of dying in a domestic airline flight or the workplace has declined dramatically in recent decades, in part because of the creation of federal agencies focusing on safety.

Using that model, the report suggests that Congress create a center for patient safety within Health and Human Services (HHS) that would set national safety goals, track progress in meeting them, and invest in research to learn more about preventing mistakes. In response, the PSQIA was conceived, adopted as a bill, and signed into law; however, the regulations to enact the ruling are still on the drawing board.

The PSQIA at a Glance
On its Web site, the Agency for Healthcare Research and Quality (AHRQ), a division of HHS, describes the PSQIA as providing the following:

“The Patient Safety and Quality Improvement Act of 2005 (Public Law 109-41), signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States. The goal of the act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.

“The Patient Safety and Quality Improvement Act signifies the Federal Government’s commitment to fostering a culture of patient safety. It creates Patient Safety Organizations (PSOs) to collect, aggregate, and analyze confidential information reported by health care providers. Currently, patient safety improvement efforts are hampered by the fear of discovery of peer deliberations, resulting in underreporting of events and an inability to aggregate sufficient patient safety event data for analysis. By analyzing patient safety event information, PSOs will be able to identify patterns of failures and propose measures to eliminate patient safety risks and hazards.”

Additionally, it specifies the role of PSOs and defines the concepts of “patient safety work product” and “patient safety evaluation systems,” which focus on how patient safety event information is collected, developed, analyzed, and maintained.

Finally, the act calls for the establishment of a network of patient safety databases to provide an interactive, evidence-based management resource for providers, PSOs, and other entities. It proposes using the database to analyze national and regional statistics, including trends and patterns of patient safety events and, ideally, to employ common formats and promote interoperability among reporting systems.

Why We Need the PSQIA
The 1999 IOM report places the number of deaths related to medical errors between 44,000 and 98,000 per year. However, a more comprehensive report, “Patient Safety in American Hospitals,” published in 2006 by HealthGrades, a healthcare ratings organization based in Golden, Colo., estimates that number to be more than 300,000.

Meanwhile, in launching the 5 Million Lives Campaign in December 2006, the Institute for Healthcare Improvement (IHI) shared its estimate that 15 million incidents of medical harm occur each year in the United States. This figure is based on an estimate of approximately 40 incidents of harm per 100 admissions (more than one harm event for every three admissions) and roughly 37 million hospital admissions per year in the United States, according to American Hospital Association statistics.

Where Does It Stand Now?
Since the PSQIA was signed into law, it has been a slow road to implementation. Enactment has been met with both hope and skepticism among healthcare advocacy groups, given what seems to be a two-year lull in activity since the bill became law. However, William Munier, MD, acting director of the Center for Quality Improvement and Patient Safety, an organization within the AHRQ, explains that while the regulations called for by the new law are not yet a reality, the process by which they must be put into place is long and methodical, and progress has been made in putting the PSQIA into action.

“The regulations are delayed, which is regrettable, but it’s the inherent nature of federal regulations,” says Munier. He says the law is precise in several areas, and regulations must be carefully crafted to meet its requirements.

One challenge is that the law must be HIPAA-compliant. Adding to the complexity is that confidentiality under the PSQIA is extended not only to doctors and other providers but also to institutions and those who report adverse events. Disclosure of confidential information carries with it a potential fine of up to $10,000. HIPAA, by contrast, has a maximum fine of $100 per inappropriate disclosure.

The regulations are currently undergoing a clearance process where other federal health agencies with a role in patient safety review and comment on the proposed regulations. The draft regulations, which Munier says are in the “final stages,” will soon be in the hands of the Office of Management and Budget for review. After that, the proposed rule will be open for public comment. Once that process is complete, the regulations are rewritten to reflect comments as appropriate. “The final rule should be available by mid-2008,” Munier says.

After the final rule is published in the Federal Register, potential PSOs certify to HHS Secretary Michael Leavitt that they will comply with the rule, and he makes the final decision to list them as official PSOs.

James Conway, MS, senior vice president at the IHI who was involved in the original planning of the PSQIA, says one of the questions that consistently emerged was, “How do we establish a culture of safety?”

He points to the aviation field as an example of an industry that successfully collects and analyzes data to ensure safety and continued improvements. “We have no similar example in healthcare but want to see the same improvements occur in this field,” Conway says. With the enactment of the PSQIA, Conway believes as PSOs create proper guidelines, characteristics, and linkages for reporting, information derived from the data collection and analysis will drive change.

Susan Delbanco, CEO of The Leapfrog Group, a patient safety advocacy organization, believes PSOs have a place but says it won’t be enough to simply report errors. She views the PSQIA as an important aspect of reaching a higher standard of care among healthcare providers but is unsure that the collected data on medical errors will be used in a meaningful way. “One of the challenges is whether they’ll be asking doctors and hospitals to report in a standardized way,” says Delbanco. She says that without a structured system, it could be difficult to compare data among local entities, let alone nationally.

Munier agrees that the data must not simply be collected but used to make a change in improving patient safety. “It’s easier to identify problems from aggregating data from large populations rather than from small samples,” he says. Munier adds that PSOs will help in establishing a common language and method for reporting to enable more robust reporting. With information aggregated in such a way and on a large scale, hopefully, institutions can learn sooner about improving patient safety practices. “We need to always have an eye toward patient safety goals,” he says.

Sticking Their Necks Out
“One of the crucial elements to the act is that people need to feel safe to report what they see,” says Conway. He notes that the movement is still young, and healthcare providers are struggling with “sticking their necks out” to report incidents without worrying about shame and blame.

In Conway’s 40 years in healthcare, he has found that “people absolutely want to do the right thing” but are concerned about the consequences of disclosure. The PSQIA, however, will put in place a system of confidentiality.

Delbanco describes the PSQIA as an important step toward reducing medical errors but, at the same time, is skeptical of its effectiveness as originally adopted. “What’s important from a philosophical standpoint is that we need to learn from mistakes in aggregate and look at the information to improve care,” she says.

The Leapfrog Group would like to see transparent reporting—something the act currently doesn’t address—included in the PSQIA implementation. “Transparency is a critical element to improvement,” says Delbanco, who adds that public reporting creates an environment for improvement. “It’s a real balancing act. We don’t want to push errors under the rug.”

Voluntary vs. Mandatory Reporting
Currently, the decision to implement voluntary or mandatory reporting is still a matter of interpretation, with a variance in the vocabulary used among statewide entities that have reporting systems in place. “At the end of the day, in regard to patient safety, all reporting is voluntary,” says Conway. “Most people want to do the right thing.”

Delbanco believes the PSQIA must require mandatory reporting to be effective. For example, The Leapfrog Group has occasionally received a lukewarm response when it conducted a voluntary online survey assessing hospital performance on 30 safe practices for better healthcare. “Even in the voluntary process, only about half of the facilities participate,” says Delbanco.

As the regulations develop, Munier says PSOs will allow data to be sent in a nonidentifiable manner. As it stands, the statute calls for voluntary reporting rather than mandatory. Munier says mandatory reporting tends to be prevalent among state systems and is most common for reporting “never events,” errors in medical care that are clearly identifiable, preventable, and serious in their consequences for patients, such as amputating the wrong limb or discharging an infant to the wrong parent. The Centers for Medicare & Medicaid Services no longer pays providers when these events occur.

Voluntary reporting is more common with “near-miss” events. “Voluntary reporting depends on the good will of the reporter,” says Munier. “It’s hard to mandate reporting for ‘near-miss’ events.” However, by providing a system that offers protections at a local level, healthcare professionals can feel more at ease in reporting these events.

Worth the Wait
In enacting the PSQIA, Delbanco believes it will require a cultural shift among healthcare professionals to take the time and energy to actually do the reporting. “Will hospitals receive enough tangible, quickly realized benefits when the law is enacted?” she asks, adding that if not, reporting may not be their priority. She believes implementation of the PSQIA will prepare hospitals to take the steps that will reduce medical errors.

“We have to become experts in looking for trouble,” says Conway, because systems can then be put in place to mitigate a problem before it reaches the patient care stage. With the IHI as a trusted and respected partner in the process, Conway says the process of enacting the PSQIA will put in place the appropriate firewalls and processes to meet its original goal. “While we wish it was already enacted, we’re glad it’s being done in a way that will stand to the test and not break down,” he says.

“I really think it has a chance to make a big difference in patient safety,” says Munier.

— Annie Macios is a freelance medical writer based in Doylestown, Pa.

Kennedy Urges HHS to Make Final Ruling on PSQIA
Reaffirming his commitment to making sure the implementation of the Patient Safety and Quality Improvement Act (PSQIA) moves forward, Sen Edward Kennedy (D-Mass.), chairman of the Health, Education, Labor and Pensions Committee, has sent a letter to Health and Human Services (HHS) Secretary Michael Leavitt urging the agency to finalize rules to implement the act. Originally passed on July 29, 2005, the PSQIA, when officially implemented, will give the federal government stronger control over healthcare safety issues.

In his most recent communication to Leavitt, Kennedy cited a previous letter sent to the secretary more than four months ago in which he outlined his concern that while the Agency for Healthcare Research and Quality submitted recommendations for the regulations at the end of 2006, finalization of the regulations is not yet complete. “I am extremely disappointed and troubled to discover that today, the regulations have still not been issued, and the timeline I requested has not been provided to me,” Kennedy wrote.

The senator also stressed his continued concern for the delay in the regulation review process, as well as for the delay in responding to his earlier request for a timeline detailing the act’s development.

As such, Kennedy, a cosponsor of the original bill, has requested that HHS provide him with a precise timeline describing what he calls the “paper trail” detailing who has reviewed the draft regulations during the past year and a half. He also requested a proposed timeline detailing the next steps that the draft regulations will undergo before they are finalized and released to the public.

He has set November 2 as the deadline for HHS to produce this timeline “to ensure that this important law is fully implemented.”

— AM