Three years after the PSQIA was enacted, a couple years after some listening sessions on the subject, and a couple weeks after Ted Kennedy’s latest inquiry about the status of the regs (coincidence?), HHS finally issued draft Patient Safety and Quality Improvement Act regs. See the press release and the draft PSQIA regs. Establishing a national standard for protected review of adverse events is a great idea, as is expanding the peer-review-like protections beyond the typical settings to all health care settings. (For example, Massachusetts peer review protections have been written into law separately, at different times, for different provider types; PSQIA cuts across all provider types.) The new regs dovetail with HIPAA, and contemplate having the patient safety organization (PSO) sign a business associate agreement with the provider.
(The protections under the regs attach to materials prepared for PSO review, not the underlying patient or business records.)
The new program is to be administered by AHRQ, which will designate PSOs and collect and publish de-identified statistical reports on patient safety.