Final Federal Patient Safety Regulations Provide Broad Protection to Patient Safety Data

March 13, 2009 Advisory

On November 21, 2008, the Department of Health and Human Services (HHS) promulgated final regulations establishing a framework to certify patient safety organizations (PSOs) under the Patient Safety and Quality Improvement Act of 2005 (PSQIA) and prescribing the process through which voluntary reporting to PSOs on a privileged basis may occur. With the promulgation of the final regulations, which went into effect on January 19, 2009, providers can now begin to take advantage of the PSQIA's protections. The PSQIA and the final regulations apply broadly to any provider "licensed or authorized" under state law to provide health care (including any parent organization), such as hospitals, nursing homes, home health care agencies, ambulatory surgery centers, pharmacies, behavioral health providers, physician practices and individual licensed practitioners.
Health care providers historically have been reluctant to report patient safety information, such as medical errors and near misses, for quality improvement analysis because of the perceived risk that the information could be used against a provider in a civil lawsuit or otherwise to impugn a provider's reputation. The PSQIA laid the foundation for the first national voluntary patient safety reporting system, allowing health care providers to report certain patient safety information -- called "patient safety work product" (PSWP) -- to PSOs without fear that the information will be available to plaintiffs in civil actions or otherwise made public. By providing federal privilege and confidentiality protection to PSWP, the PSQIA aims to encourage providers to share patient safety data for quality improvement analysis in order to better understand errors and enhance the quality of patient care. For providers that choose to report PSWP to a PSO, the PSQIA regulations may provide an opportunity for greater protection to patient safety information than existing peer review or other protections under state law.
This advisory highlights the key provisions of the final PSQIA regulations and the opportunity they present to enhance the protection of sensitive patient safety information.