The proposed rule comes less than a month after Sen. Edward Kennedy (D-Mass.) asked the Government Accountability Office to investigate why HHS has not implemented the law.
The law requires HHS to facilitate, through certified patient safety organizations, creation of a network of databases to collect, aggregate and analyze voluntarily submitted reports of medical errors or near errors. The law also requires that analysis of regional and national statistics and trends be made public via annual reports from the patient safety organizations.
The proposed rule, published on Feb. 12 in the Federal Register, establishes the authorities, processes and rules necessary to implement the act. It also outlines confidentiality protections for submitted data to facilitate participation by hospitals and other provider organizations.
HHS will publish a separate proposed rule covering development of the network of patient safety databases. Text of the initial proposed rule is available at gpoaccess.gov/fr/index.html.
The department will accept comments on the proposed rule until April 14. HHS also will host an audio conference on Feb. 29 to provide additional details and answer questions. More information is available at academyhealth.org.
Text of the Patient Safety and Quality Improvement Act, Public Law 109-41, is available at congress.gov.
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