Proposed regulation will create
private patient safety organizations
The U.S. Department of Health and Human Services (HHS) is in an information-gathering stage following its Feb. 12 announcement of proposed regulation to improve patient safety.
HHS plans to do so through fostering the establishment of patient safety organizations (PSOs). These PSOs will be private entities recognized by HHS to collect and analyze patient safety events reported by healthcare providers and will be new and separate from all currently existing organizations that address patient safety and healthcare quality.
The PSOs could ensure confidentiality of reports of patient safety events, allowing clinicians to voluntarily report patient safety events without fear of legal liability or sanctions, removing an important barrier to current reporting of patient safety events. Strong confidentiality provisions are the key to voluntary reporting, and breaches of these confidentiality provisions may result in the imposition of civil monetary penalties.
This provision of the proposed regulation is expected to encourage clinicians and healthcare organizations to voluntarily share data on patient safety events more freely and consistently.
The proposal includes information on how organizations can become PSOs and how PSOs can collect, aggregate and analyze data and provide feedback to help clinicians and healthcare organizations improve healthcare quality.
Listing as a PSO does not entitle an entity to Federal funding, according to the Feb. 12 Federal Register, in which the regulation was proposed. HHS said it expects companies to gage viability and value prior to establishing a PSO.
"The financial viability of most PSOs will derive from their ability to attract and retain contracts with providers or to attract financial support from other organizations, such as charitable foundations dedicated to health system improvement," the HHS said.
Members of the public are invited to view and comment on the proposed regulation until April 14, 2008. Comments can be left by visiting Regulations.gov and searching for PSO, under the "Comment or Submission" field. Public feedback will be used in shaping the final regulation.