Proposed regulations for the Patient Safety and Quality Improvement Act of 2005 establish a framework for hospitals, doctors, and other healthcare providers to voluntarily report information to Patient Safety Organizations (PSOs) for privileged and confidential analysis. The framework for this system is outlined in a notice of proposed rulemaking, issued by the Department of Health and Human Services in the February 12 Federal Register.  

This site provides ongoing information about the proposed rule and Patient Safety Organizations. Please check back frequently for updated information. 

• Special Advisory: Patient Safety Organization Proposed Rule Lays Groundwork for Patient Safety Improvements 
  
  ECRI Institute's Special Advisory answers questions about the proposed PSO rule, defines PSOs and patient safety work product, and discusses how the law will be enforced.
  
  
  
• ECRI Institute’s Comments on the PSO Proposed Rule 
  
  

Anticipated Status as Patient Safety Organization
ECRI Institute anticipates becoming federally certified as a Patient Safety Organization. For nearly 40 years, ECRI Institute has operated a voluntary medical device problem reporting system used by hospitals and other providers around the world and it operates other broad patient safety reporting and analysis systems for public and private entities. We also have a long history of investigating events and publishing authoritative risk reduction strategies. 

• Patient Safety Designations
  ECRI Institute is a designated an Evidence-based Practice Center by the U. S. Agency for Healthcare Research and Quality, and is designated a Collaborating Center for Patient Safety, Risk Management, and Healthcare Technology by the World Health Organization.
• State-Wide Patient Safety Reporting Experience
  ECRI Institute has developed and implements the Pennsylvania Patient Safety Reporting System, a mandatory error and near-miss reporting program for Pennsylvania hospitals and other healthcare facilities, under contract to the Pennsylvania Patient Safety Authority.
• PSO Capabilities
  As a PSO, ECRI Institute can provide healthcare providers with data collection and analytics, culture-of-safety recommendations, best practices and advisories, and more.

How Can We Help You?
Whether you have questions about the proposed rule or want to learn more about ECRI Institute’s plans to become a federally certified PSO, we would be happy to hear from you. Please contact ECRI Institute at aalberts@ecri.org or call
(610) 825-6000, ext. 5389.