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Briefing on the Patient Safety Act

Submitted March 7, 2008
by Dawn Briskey, CAE
ASSH Deputy Executive Director

Earlier this week, at Dr. Nagle’s request I attended a briefing at the AMA regarding the proposed rule related to the Patient Safety and Quality Improvement Act (Patient Safety Act).  The purpose of the Patient Safety Act is to improve patient safety by encouraging the collection of data on “patient safety work products.” This data is then to be analyzed and used to establish evidence-based best practices to improve patient safety. The hope is to create a culture of safety for clinicians to talk about those things they would otherwise be afraid to talk about.

Here’s a brief summary of key points in the proposed rule:

• The rule establishes Patient Safety Organizations (PSOs), and defines what sorts of organizations may qualify as a PSO. The organizations are expected to self-form around the issue of patient safety, to develop databases where safety issues can be tracked, to analyze the issues and to recommend changes which will ultimately improve patient safety.
• A provider is any person or entity licensed or authorized under state law to provide health care. Provider participation in this program is entirely voluntary.
• Information reported to the PSO and any investigation around that information will be confidential, with exceptions. At least eleven such exceptions were listed during the briefing. Strict monetary penalties may be imposed for violations of confidentiality.
• This is not a traditional federal program. The government is providing no funding or direction to PSOs. They will provide “technical assistance” only. The government’s regulatory authority only extends to PSOs. It does not regulate providers who work with PSOs. In addition, the government is not providing any funding to PSOs or providers for the time and effort involved in reporting and recording safety incidents.

Summary
The Patient Safety Act does not regulate changes that will improve patient safety. Instead, it creates a suggested framework for the self-organization of entities and providers to record, analyze and address safety issues. It affords some level of a guarantee of confidentiality, and imposes civil penalties for breaches of confidentiality.

Call for comments
The proposed rule on the Patient Safety Act was posted in the Federal Register on February 12, 2008. The government has provided for a 60 day comment period, during which time the public is invited to submit comments on the proposal. You can access information on the rule and provide comments on the act through the AHRQ website.