82 FR 10015 - Patient Safety Organizations: Voluntary Relinquishment From the Fresenius Medical Care PSO, LLC

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 82, Issue 26 (February 9, 2017)

Page Range		10015-10015
FR Document		2017-02623

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.

Federal Register, Volume 82 Issue 26 (Thursday, February 9, 2017)

[Federal Register Volume 82, Number 26 (Thursday, February 9, 2017)]
[Notices]
[Page 10015]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 82, No. 26 / Thursday, February 9, 2017 / Notices 10015

Agenda items for these meetings are FOR FURTHER INFORMATION CONTACT: More information on PSOs can be
subject to change as priorities dictate. Eileen Hogan, Center for Quality obtained through AHRQ’s PSO Web site
Improvement and Patient Safety, AHRQ, at http://www.pso.ahrq.gov.
Sharon B. Arnold,
5600 Fishers Lane, Room 06N94B,
Acting Director. Sharon B. Arnold,
Rockville, MD 20857; Telephone (toll
[FR Doc. 2017–02624 Filed 2–8–17; 8:45 am] free): (866) 403–3697; Telephone (local): Acting Director.
BILLING CODE 4160–90–P (301) 427–1111; TTY (toll free): (866) [FR Doc. 2017–02623 Filed 2–8–17; 8:45 am]
438–7231; TTY (local): (301) 427–1130; BILLING CODE 4160–90–P
Email: pso@ahrq.hhs.gov.
DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION:
HUMAN SERVICES DEPARTMENT OF HEALTH AND
Background HUMAN SERVICES
Agency for Healthcare Research and
Quality The Patient Safety Act authorizes the Agency for Healthcare Research and
listing of PSOs, which are entities or Quality
Patient Safety Organizations: component organizations whose
Voluntary Relinquishment From the mission and primary activity are to Scientific Information Request on
Fresenius Medical Care PSO, LLC conduct activities to improve patient Treatment-Resistant Depression: A
safety and the quality of health care Narrative and Systematic Review of
AGENCY: Agency for Healthcare Research delivery. Definitions and Methods in Clinical
and Quality (AHRQ), Department of HHS issued the Patient Safety Rule to Research Studies
Health and Human Services (HHS). implement the Patient Safety Act.
ACTION: Notice of delisting. AHRQ administers the provisions of the AGENCY: Agency for Healthcare Research
Patient Safety Act and Patient Safety and Quality (AHRQ), HHS.
SUMMARY: The Patient Safety and Rule relating to the listing and operation ACTION: Request for Scientific
Quality Improvement Act of 2005, 42 of PSOs. The Patient Safety Rule Information Submissions.
U.S.C. 299b–21 to b–26, (Patient Safety authorizes AHRQ to list as a PSO an
Act) and the related Patient Safety and SUMMARY: The Agency for Healthcare
entity that attests that it meets the Research and Quality (AHRQ) is seeking
Quality Improvement Final Rule, 42 statutory and regulatory requirements
CFR part 3 (Patient Safety Rule), scientific information submissions from
for listing. A PSO can be ‘‘delisted’’ if the public. Scientific information is
published in the Federal Register on it is found to no longer meet the
November 21, 2008, 73 FR 70732– being solicited to inform our review of
requirements of the Patient Safety Act Treatment-Resistant Depression: A
70814, establish a framework by which and Patient Safety Rule, when a PSO
hospitals, doctors, and other health care Narrative and Systematic Review of
chooses to voluntarily relinquish its Definitions and Methods in Clinical
providers may voluntarily report status as a PSO for any reason, or when
information to Patient Safety Research Studies, which is currently
a PSO’s listing expires. Section 3.108(d) being conducted by the AHRQ’s
Organizations (PSOs), on a privileged of the Patient Safety Rule requires
and confidential basis, for the Evidence-based Practice Centers (EPC)
AHRQ to provide public notice when it Program. Access to published and
aggregation and analysis of patient removes an organization from the list of
safety events. The Patient Safety Rule unpublished pertinent scientific
federally approved PSOs. information will improve the quality of
authorizes AHRQ, on behalf of the AHRQ has accepted a notification
Secretary of HHS, to list as a PSO an this review. AHRQ is conducting this
from the Fresenius Medical Care PSO, systematic review pursuant to Section
entity that attests that it meets the LLC, a component entity of Fresenius
statutory and regulatory requirements 902(a) of the Public Health Service Act,
Medical Holdings, Inc., PSO number 42 U.S.C. 299a(a).
for listing. A PSO can be ‘‘delisted’’ by P0081, to voluntarily relinquish its
the Secretary if it is found to no longer DATES: Submission Deadline on or
status as a PSO. Accordingly, the
meet the requirements of the Patient before March 13, 2017.
Fresenius Medical Care PSO, LLC was
Safety Act and Patient Safety Rule, delisted effective at 12:00 Midnight ET ADDRESSES: Email submissions:
when a PSO chooses to voluntarily (2400) on January 6, 2017. AHRQ notes SEADS@epc-src.org.
relinquish its status as a PSO for any that the Fresenius Medical Care PSO, Print submissions:
reason, or when a PSO’s listing expires. LLC submitted this request for voluntary Mailing Address: Portland VA
AHRQ has accepted a notification of relinquishment following receipt of the Research Foundation, Scientific
voluntary relinquishment from the Notice of Preliminary Finding of Resource Center, ATTN: Scientific
Fresenius Medical Care PSO, LLC of its Deficiency sent to the PSO on December Information Packet Coordinator, P.O.
status as a PSO, and has delisted the 12, 2016. Box 69539, Portland, OR 97239.
PSO accordingly. The Fresenius Shipping Address (FedEx, UPS, etc.):
Fresenius Medical Care PSO, LLC has
Medical Care PSO, LLC submitted this Portland VA Research Foundation,
patient safety work product (PSWP) in
request for voluntary relinquishment Scientific Resource Center, ATTN:
its possession. The PSO will meet the
after receiving a Notice of Preliminary Scientific Information Packet
requirements of section 3.108(c)(2)(i) of
Finding of Deficiency. Coordinator, 3710 SW U.S. Veterans
the Patient Safety Rule regarding
DATES: The directories for both listed Hospital Road, Mail Code: R&D 71,
notification to providers that have
and delisted PSOs are ongoing and Portland, OR 97239.
reported to the PSO. In addition,
sradovich on DSK3GMQ082PROD with NOTICES

reviewed weekly by AHRQ. The according to sections 3.108(c)(2)(ii) and FOR FURTHER INFORMATION CONTACT:
delisting was effective at 12:00 Midnight 3.108(b)(3) of the Patient Safety Rule Ryan McKenna, Telephone: 503–220–
ET (2400) on January 6, 2017. regarding disposition of PSWP, the PSO 8262 ext. 51723 or Email: SIPS@epc-
ADDRESSES: Both directories can be has 90 days from the effective date of src.org.
accessed electronically at the following delisting and revocation to complete the SUPPLEMENTARY INFORMATION: The
HHS Web site: http:// disposition of PSWP that is currently in Agency for Healthcare Research and
www.pso.ahrq.gov/listed. the PSO’s possession. Quality has commissioned the

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Document Created: 2017-02-09 01:03:08
Document Modified: 2017-02-09 01:03:08

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of delisting.
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.
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]
FR Citation		82 FR 10015

82 FR 10015 - Patient Safety Organizations: Voluntary Relinquishment From the Fresenius Medical Care PSO, LLC

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 82, Issue 26 (February 9, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality