The law requires the Department of Health and Human Services to facilitate, through certified patient safety organizations, creation of a network of databases to collect, aggregate and analyze submitted reports of medical errors or near-errors. The law also calls on the department to adopt standard formats for reporting data to the databases. Further, it requires analysis of regional and national statistics and trends be made public via annual reports from the patient safety organizations.
Kennedy, chair of the Committee on Health, Education, Labor and Pensions, in May and October of 2007 sent letters to HHS Secretary Michael Leavitt asking for quick promulgation of rules to implement the law.
“Last week, my office was informed by HHS that Secretary Leavitt will not be providing the requested timeline or an explanation for their egregious delay,” Kennedy wrote in a Jan. 17 letter to GAO, the investigatory arm of Congress. “For this reason, I request that the GAO initiate an investigation into the cause for the delay at HHS in finalizing these regulations so that this important law can finally be implemented.”
Text of the Patient Safety and Quality Improvement Act, Public Law 109-41, is available at congress.gov.
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