By Carolyn M. Clancy, MD

Passage of the Patient Safety and Quality Improvement Act of 2005 (the Act) provides a unique opportunity to improve the safety, quality, and outcomes of patient care. The Act addresses many of the barriers that have long frustrated the efforts of healthcare providers to improve the healthcare they provide. The Act fosters the development of organizations, known as Patient Safety Organizations (PSOs), with expertise in the analysis and mitigation of threats to patient safety. Healthcare providers that report to PSOs will be able to work together, in a legally protected environment, to learn from their own experience, and the experience of other providers, to improve patient care. The ability of PSOs to aggregate cases from multiple clients and from other PSOs will provide insights that were simply not possible to develop on a routine basis before the passage of this Act.

Passage of the Patient Safety and Quality Improvement Act of 2005 (the Act) provides a unique opportunity to improve the safety, quality, and outcomes of patient care. The Act addresses many of the barriers that have long frustrated the efforts of healthcare providers to improve the healthcare they provide. The Act fosters the development of organizations, known as Patient Safety Organizations (PSOs), with expertise in the analysis and mitigation of threats to patient safety. Healthcare providers that report to PSOs will be able to work together, in a legally protected environment, to learn from their own experience, and the experience of other providers, to improve patient care. The ability of PSOs to aggregate cases from multiple clients and from other PSOs will provide insights that were simply not possible to develop on a routine basis before the passage of this Act.

The Patient Safety Act designates the Department of Health and Human Services' (HHS) Agency for Healthcare Research and Quality (AHRQ) to administer the Patient Safety Organization Program, and the HHS secretary has designated the Office for Civil Rights (OCR) as the entity responsible for enforcing the privacy provisions of the law. In addition to mandating the development of PSOs, the Act includes other specific provisions, such as facilitating the establishment of a network of patient safety databases, requiring annual reporting of findings, and mandating that the controller general study the effectiveness of the Act by 2010. In addition, the law stipulates that the program is entirely voluntary.

As many of you may have read in this journal and others, there has been much speculation and discussion regarding the implementation and effectiveness of this new law. Questions have been raised about whether providers will voluntarily report patient safety events; others have pointed out that many patient safety reporting systems already exist. As we get closer to finalizing the regulations and implementing the law, we are more certain than ever of the need for a voluntary, non-punitive system. As is customary for most regulations, a proposed rule will be published in the near future, and we will be very interested in your comments and feedback.

A number of other questions may occur to you regarding this new program. I hope that this and future AHRQ commentaries will answer some of them. If additional questions arise, please feel free to contact us at www.ahrq.gov and click on "Questions?" or "Contact Us" in the upper right corner of the page. The following Q and A addresses some of the more frequent inquiries that we have received over the last few months regarding the Patient Safety Act and implementation of the PSO program.

Q. What is the problem that the Patient Safety and Quality Improvement Act is trying to address?
A. The impetus for this legislation was the Institute of Medicine's landmark report, To Err Is Human: Building a Safer Health System (IOM, 2000). That report highlighted the fact that the level of avoidable patient injury and death was higher than many realized. It recognized that efforts by healthcare providers to improve care were often frustrated by obstacles that were outside their control. This Act addresses many of those roadblocks to improving the safety of patient care.

Q. What do you mean by obstacles?
A. One obstacle is the hesitancy of providers to report patient safety events due to fears of liability or sanctions. While identification of patient safety events and analysis of what went wrong are essential for improving patient safety, providers worry that the knowledge of these events or the analyses of the causal factors could be used against them if a malpractice case is filed. Staff are also hesitant to report patient safety events for fear of reprisal from their employers and professional sanctions, or concern for their professional reputations.

There are also obstacles at the institutional level. While many states enable individual hospitals to undertake patient safety analyses, those analyses can seldom be shared outside the facility, undermining the ability, for example, of multi-hospital systems to develop a system-wide approach to patient safety. Moreover, most state laws provide no protections for patient safety analyses undertaken in other settings of care.

Finally, there are also analytic obstacles. Definitions of what constitutes an event are not standard; there is a lack of uniform terminology for patient safety event classifications and for data collection. Research shows that hospital staff tend to report data differently from physicians regarding the same event. Thus, even within a protective legal framework for sharing data from multiple facilities, the lack of consistent use of terminology undermines the tremendous potential for learning that derives from data aggregation.

Q. How does the Act address these obstacles?
A. First, the Act provides federal protections for the information that is collected and reported to Patient Safety Organizations. These include strong nationwide confidentiality protections and limitations on the use of this information in criminal, civil, administrative, and disciplinary proceedings, known as privilege protections. The law provides for tough penalties, up to $10,000 for each inappropriate disclosure of information subject to these protections, and encourages the creation of a "culture of safety" within each provider that participates in this system.

Second, these protections are available to all state-sanctioned clinicians and institutional providers, a significant expansion beyond state hospital protections. The law also enables health systems to work with PSOs to develop system-wide improvement initiatives. Third, the Act encourages the collection of patient safety information in a standardized manner that permits valid comparisons of similar cases among similar providers.

Q. What exactly are PSOs?
I have never heard of them before.

A. While a number of organizations currently undertake these types of activities today, the concept of a PSO envisioned by the law is new. Congress developed a patient safety improvement system that is provider-driven, rather than one directed by the federal government. The statute permits public or private entities, either for-profit or not-for-profit, to certify to the secretary of Health and Human Services that they have the expertise and ability to assist healthcare providers in their efforts to improve the safety, quality, or outcomes of patient care. HHS will not fund PSOs or determine their agendas; in most cases, providers will fund PSOs and determine the work that they do.

The statute envisions a dual system of accountability. It establishes criteria that entities must meet to become a PSO, additional requirements to remain a PSO, and a requirement for recertification every 3 years. But ultimate accountability is likely to come in the marketplace from healthcare providers, the customers for PSO services.

Q. How is AHRQ preparing to implement the Patient Safety Organization Program?
A. AHRQ has been primarily a research agency. This new law moves the Agency into an operational role, as administrator of the PSO Program. The Agency views the PSO Program as an opportunity to work collaboratively with PSOs and participating providers to advance the science for undertaking patient safety analyses, undertaking targeted research to identify options for overcoming obstacles to their work, and facilitating shared learning and rapid dissemination of effective interventions to improve patient safety and reduce medical errors. It is our goal to promote a blame-free culture of patient safety, so that when patient safety events occur, organizations and practitioners will be eager to understand their causes, establish procedures to reduce the risk of recurrence, and teach others about their findings. Patients in our country deserve our constant diligence in the effort to improve safety, and we welcome this unique opportunity to improve patient quality and safety in American healthcare.

References

Brennan, T. A., Gawande, A., Thomas, E., & Studdert, D. (2005). Accidental deaths, saved lives, and improved quality. New England Journal of Medicine, 353(13), 1405-1409.

Institute of Medicine. (2000). To err is human: Building a safer health system. L. T. Kohn, J. M. Corrigan, & M. S. Donaldson (Eds.). Washington, DC: National Academy Press.

Facts on Healthcare Costs. (2006). Washington, DC: National Coalition on Health Care.

Guthrie, P. (2006). US creates blame-free adverse event reporting. CMAJ (Canadian Medical Association Journal), 174(1), 19-20.

Journal of Patient Safety, 2, 140 - 146.

Phillips, R. L., Dovey, S. M., Graham, D., Elder, N. C., & Hickner, J. (2006). Learning from different lenses: Reports of medical errors in primary care by clinicians, staff, and patients. Journal of Patient Safety, 2, 140 - 146.

Pronovost, P. J., Miller, M. R., & Wachter, R. M. (2006). Tracking progress in patient safety: An elusive target. Journal of the American Medical Association, 296(6), 696-699.

Roberts, D. (2005). What does the new patient safety law mean? Patient Safety and Quality Healthcare, September/October. Last accessed on November 27, 2006 at http://www.psqh.com/sepoct05/hill.html