2020-22484. Patient Safety Organizations (PSO): Expired Listing for FailSafe PSO

AGENCY:

Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).

ACTION:

Notice of delisting.

SUMMARY:

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be “delisted” by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (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. The listing for FailSafe PSO, PSO number P0196, has expired and AHRQ has delisted the PSO accordingly.

DATES:

The delisting was effective at 12:00 Midnight ET (2400) on September 21, 2020.

ADDRESSES:

The directories for both listed and delisted PSOs are ongoing and reviewed weekly by AHRQ. Both directories can be accessed electronically at the following HHS website: http://www.pso.ahrq.gov/​listed.

FOR FURTHER INFORMATION CONTACT:

Cathryn Bach, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, MS 06N100B, Rockville, MD 20857; Telephone (toll free): [phone]; Telephone (local): [phone]; TTY (toll free): [phone]; TTY (local): [phone]; Email: [e-mail].

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 events.

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.

Section 3.104(e)(1) of the Patient Safety Rule specifies that a PSO's listing, unless revoked or relinquished earlier, automatically expires at midnight of the last day of the three-year listing period if, prior to this deadline, the required certifications for a new three-year listing are not submitted by the PSO and accepted by AHRQ . FailSafe PSO, a component entity of Newsura, Inc., did not seek continued listing. Accordingly, FailSafe PSO was delisted effective at 12:00 Midnight ET (2400) on September 21, 2020.

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

Dated: October 5, 2020.

Marquita Cullom-Stott,

Associate Director.