[Federal Register Volume 82, Number 26 (Thursday, February 9, 2017)]
[Notices]
[Page 10015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment From the 
Fresenius Medical Care 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 Act of 2005, 42 
U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient 
Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient 
Safety Rule), published in the Federal Register on November 21, 2008, 
73 FR 70732-70814, establish a framework by which hospitals, doctors, 
and other health care providers may voluntarily report information to 
Patient Safety Organizations (PSOs), on a privileged and confidential 
basis, for the aggregation and analysis of patient safety events. The 
Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, 
to list as a 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 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 has accepted a notification of voluntary 
relinquishment from the Fresenius Medical Care PSO, LLC of its status 
as a PSO, and has delisted the PSO accordingly. The Fresenius Medical 
Care PSO, LLC submitted this request for voluntary relinquishment after 
receiving a Notice of Preliminary Finding of Deficiency.

DATES: The directories for both listed and delisted PSOs are ongoing 
and reviewed weekly by AHRQ. The delisting was effective at 12:00 
Midnight ET (2400) on January 6, 2017.

ADDRESSES: Both directories can be accessed electronically at the 
following HHS Web site: http://www.pso.ahrq.gov/listed.

FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality 
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N94B, 
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 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 federally approved PSOs.
    AHRQ has accepted a notification from the Fresenius Medical Care 
PSO, LLC, a component entity of Fresenius Medical Holdings, Inc., PSO 
number P0081, to voluntarily relinquish its status as a PSO. 
Accordingly, the Fresenius Medical Care PSO, LLC was delisted effective 
at 12:00 Midnight ET (2400) on January 6, 2017. AHRQ notes that the 
Fresenius Medical Care PSO, LLC submitted this request for voluntary 
relinquishment following receipt of the Notice of Preliminary Finding 
of Deficiency sent to the PSO on December 12, 2016.
    Fresenius Medical Care 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. In addition, according to 
sections 3.108(c)(2)(ii) and 3.108(b)(3) of the Patient Safety Rule 
regarding disposition of PSWP, 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 Web 
site at http://www.pso.ahrq.gov.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-02623 Filed 2-8-17; 8:45 am]
BILLING CODE 4160-90-P