SUPPLEMENTARY INFORMATION:

Background

The Patient Safety Act, 42 U.S.C. 299b-21 to 299b-26, and the related Patient Safety Rule, 42 CFR part 3, published in the Federal Register on November 21, 2008 (73 FR 70732-70814), establish a framework by which individuals and entities that meet the definition of provider in the Patient Safety Rule may voluntarily report information to PSOs listed by AHRQ, on a privileged and confidential basis, for the aggregation and analysis of patient safety work product.

The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery.

HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of PSOs.

AHRQ has accepted a notification of proposed voluntary relinquishment from the Michigan Surgical Quality Collaborative to voluntarily relinquish its status as a PSO. Accordingly, the Michigan Surgical Quality Collaborative, PSO number P0143, was delisted effective at 12:00 Midnight ET (2400) on April 21, 2025.

Michigan Surgical Quality Collaborative has patient safety work product (PSWP) in its possession. The PSO will meet the requirements of section 3.108(c)(2)(i) of the Patient Safety Rule regarding notification to providers that have reported to the PSO and of section 3.108(c)(2)(ii) regarding disposition of PSWP consistent with section 3.108(b)(3). According to section 3.108(b)(3) of the Patient Safety Rule, the PSO has 90 days from the effective date of delisting and revocation to complete the disposition of PSWP that is currently in the PSO's possession.

Proximie PSO failed to submit a response to the findings of deficiency in the Notice of Proposed Revocation and Delisting by the deadline. As stated in the Patient Safety Rule at 42 CFR 3.108(a)(4)(iii), this failure means that the Notice of Proposed Revocation and Delisting becomes final as a matter of law. It also serves as the basis for AHRQ to revoke acceptance of Proximie PSO certifications for listing, remove Proximie PSO from the list of PSOs, and provide public notice in the Federal Register and on the AHRQ PSO website that Proximie PSO has been delisted for cause. Accordingly, the Proximie PSO, P0244, was delisted effective at 12:00 Midnight ET (2400) on January 11, 2025.

More information on PSOs can be obtained through AHRQ's PSO website at http://www.pso.ahrq.gov.

90 FR 25044