[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23371-23372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09180]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment for the 
Sigma PSO, LLC

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

ACTION: Notice of Delisting.

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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. AHRQ accepted a notification of proposed 
voluntary relinquishment from the Sigma PSO, LLC, PSO number P0190, of 
its status as a PSO, and has delisted the PSO accordingly.

DATES: The delisting was effective at 12:00 Midnight ET (2400) on April 
1, 2021.

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): (866) 403-3697; Telephone 
(local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): 
(301) 427-1130; Email: [email protected].

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.
    AHRQ has accepted a notification of proposed voluntary 
relinquishment from the Sigma PSO, LLC to voluntarily relinquish its 
status as a PSO. Accordingly, the Sigma PSO, LLC, P0190, was delisted 
effective at 12:00 Midnight ET (2400) on April 1, 2021.
    Sigma PSO, LLC 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.
    More information on PSOs can be obtained through AHRQ's PSO website 
at http://www.pso.ahrq.gov.


[[Page 23372]]


    Dated: April 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-09180 Filed 4-30-21; 8:45 am]
BILLING CODE 4160-90-P