HHS Attempts to Set the Stage for Breakthroughs in Improving Patient Safety by Issuing the Final Rule of the Patient Safety and Quality Improvement Act

Many states, including Indiana, have implemented long-standing regulations protecting communications to and deliberations, proceedings, and determinations connected with a peer review process, to improve hospitals' systems of quality patient care and to create an atmosphere that allows hospitals to prevent risks to future patients.

Recently, the Department of Health and Human Services (HHS) issued the final rule of the Patient Safety and Quality Improvement Act (the Act), effective on January 19, 2009. The Act's underlying premise is in line with the purpose of the peer review privilege enacted by many states. Its main objectives are to encourage the expansion of voluntary, provider-driven initiatives to improve the safety of health care, to promote rapid learning about the underlying causes of risks and harms in the delivery of health care, and to share those findings widely, thereby speeding the pace of improvement.

What does the Act do?

The Act encourages the development of Patient Safety Organizations (PSOs) to work with clinicians and health care organizations to identify, analyze and reduce the risks of hazards associated with patient care. Much like state peer review procedures, the Act fosters a culture of safety by establishing strong federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians and other clinicians for deliberations and analyses regarding quality and safety.

The Act sets forth specific procedural mandates for the application of confidentiality and privilege protections to patient safety event information. For example, to be listed as a PSO, entities must submit a certification form to the Secretary of HHS, which includes a number of specific certification requirements. An entity must certify that its mission and primary activity is to conduct activities to improve patient safety activity and quality of health care. Additionally, an entity must certify that it has two contracts with a different provider for the purpose of receiving and reviewing patient safety work.

PSOs will report de-identified and aggregated patient safety event information to the Agency for Healthcare Research and Quality (AHRQ). Thereafter, the AHRQ will use a Network of Patient Safety Databases (NPSD), an interactive, evidence-based management resource for providers, PSOs and other entities to analyze national and regional statistics, including trends and patterns regarding patient safety events. Findings are to be made public and included in AHRQ's annual National Healthcare Quality Report.

Why should health care providers participate?

This program is not federally funded. So, what's the incentive for health care providers to participate? The more provider participation, the more robust and valid the data that goes into the NPSD, and the more accurate and informative the trends and patterns in the report. State peer review procedures lack a cross-analysis of the common threads among health care providers within the same region. Two hospitals in the same Indiana city may conduct the same peer review of the same patient safety event, and, absent a report on regional trends, neither hospital will know the commonality of the event and/or how to best mitigate or prevent it. In the end, knowledge of these common threads will, hopefully, cultivate improvement in patient care which will save health care providers from expending time and money on preventable medical errors in the future.

For more information, visit http://www.pso.ahrq.gov. You can also contact Jody DeFord, Carly Everett or your Ice Miller attorney.

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice.  The reader must consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.