83_FR_37084 83 FR 36937 - Patient Safety Organizations: Voluntary Relinquishment From Diagnostic Quality Assurance

83 FR 36937 - Patient Safety Organizations: Voluntary Relinquishment From Diagnostic Quality Assurance

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

Federal Register Volume 83, Issue 147 (July 31, 2018)

Page Range36937-36937
FR Document2018-16327

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 Diagnostic Quality Assurance of its status as a PSO, and has delisted the PSO accordingly. Diagnostic Quality Assurance, PSO number P0170, submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.

Federal Register, Volume 83 Issue 147 (Tuesday, July 31, 2018) 
[Federal Register Volume 83, Number 147 (Tuesday, July 31, 2018)]
[Notices]
[Page 36937]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16327]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment From 
Diagnostic Quality Assurance

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 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 Diagnostic Quality 
Assurance of its status as a PSO, and has delisted the PSO accordingly. 
Diagnostic Quality Assurance, PSO number P0170, 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 July 1, 2018.

ADDRESSES: Both directories can be accessed electronically at the 
following HHS website: 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: pso@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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 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 Diagnostic Quality Assurance, 
a component entity of Quality Star, LLC, to voluntarily relinquish its 
status as a PSO. Accordingly, Diagnostic Quality Assurance was delisted 
effective at 12:00 Midnight ET (2400) on July 1, 2018. AHRQ notes that 
that Diagnostic Quality Assurance submitted this request for voluntary 
relinquishment following receipt of the Notice of Preliminary Finding 
of Deficiency sent on April 10, 2018.
    More information on PSOs can be obtained through AHRQ's PSO website 
at http://www.pso.ahrq.gov.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-16327 Filed 7-30-18; 8:45 am]
 BILLING CODE 4160-90-P

Federal Register / Vol. 83, No. 147 / Tuesday, July 31, 2018 / Notices 36937 thresholds for certain data items to meet the requirements of the Patient it is found to no longer meet the reduce reporting burden. The comment Safety Act and Patient Safety Rule, requirements of the Patient Safety Act period expired June 29, 2018. when a PSO chooses to voluntarily and Patient Safety Rule, when a PSO relinquish its status as a PSO for any chooses to voluntarily relinquish its Detailed Discussion of Public reason, or when a PSO’s listing expires. status as a PSO for any reason, or when Comments AHRQ has accepted a notification of a PSO’s listing expires. Section 3.108(d) The Federal Reserve received one voluntary relinquishment from of the Patient Safety Rule requires comment from a banking association. Diagnostic Quality Assurance of its AHRQ to provide public notice when it The commenter noted several status as a PSO, and has delisted the removes an organization from the list of inconsistencies on the FR Y–9C report PSO accordingly. Diagnostic Quality federally approved PSOs. form and one inconsistency on the Assurance, PSO number P0170, AHRQ has accepted a notification instructions when compared to the Call submitted this request for voluntary from Diagnostic Quality Assurance, a Report pertaining to Schedule HC–Q relinquishment after receiving a Notice component entity of Quality Star, LLC, Memoranda items 4.b and 4.d, column of Preliminary Finding of Deficiency. to voluntarily relinquish its status as a A and Schedule HC–S Column G DATES: The directories for both listed PSO. Accordingly, Diagnostic Quality instructions and requested clarification and delisted PSOs are ongoing and Assurance was delisted effective at on the proper reporting. The draft report reviewed weekly by AHRQ. The 12:00 Midnight ET (2400) on July 1, form was inadvertently updated to delisting was effective at 12:00 Midnight 2018. AHRQ notes that that Diagnostic reflect the removal of items 4.b and 4.d ET (2400) on July 1, 2018. Quality Assurance submitted this and a line item reference on the request for voluntary relinquishment ADDRESSES: Both directories can be instructions for Schedule HC–S Column following receipt of the Notice of accessed electronically at the following G was also inadvertently struck through. Preliminary Finding of Deficiency sent HHS website: http://www.pso.ahrq.gov/ The Board has revised these items so on April 10, 2018. listed. that both the report form and More information on PSOs can be FOR FURTHER INFORMATION CONTACT: instructions align with the Call Report. obtained through AHRQ’s PSO website Additionally, the commenter noted an Eileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, at http://www.pso.ahrq.gov. inconsistency between the caption on the report form and the caption on the 5600 Fishers Lane, Room 06N94B, Francis D. Chesley, Jr., instructions pertaining to Equity Rockville, MD 20857; Telephone (toll Acting Deputy Director. investments without readily free): (866) 403–3697; Telephone (local): [FR Doc. 2018–16327 Filed 7–30–18; 8:45 am] determinable fair values on Schedule (301) 427–1111; TTY (toll free): (866) BILLING CODE 4160–90–P HC–F line item 4 on the FR Y–9C report. 438–7231; TTY (local): (301) 427–1130; The Board has updated the instructions Email: pso@ahrq.hhs.gov. so that the report form and instructions SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND align. Background HUMAN SERVICES The revisions will be implemented as proposed, with the modifications The Patient Safety and Quality Food and Drug Administration described above, effective for the June Improvement Act of 2005, 42 U.S.C. [Docket No. FDA–2017–N–0007] 30, 2018, report date. 299b–21 to b–26, (Patient Safety Act) and the related Patient Safety and Biosimilar User Fee Rates for Fiscal Board of Governors of the Federal Reserve Quality Improvement Final Rule, 42 System, July 25, 2018. Year 2019 CFR part 3 (Patient Safety Rule), Michele Taylor Fennell, published in the Federal Register on AGENCY: Food and Drug Administration, Assistant Secretary of the Board. November 21, 2008, 73 FR 70732– HHS. [FR Doc. 2018–16265 Filed 7–30–18; 8:45 am] 70814, establish a framework by which ACTION: Notice. BILLING CODE 6210–01–P hospitals, doctors, and other health care providers may voluntarily report SUMMARY: The Food and Drug information to Patient Safety Administration (FDA) is announcing the DEPARTMENT OF HEALTH AND Organizations (PSOs), on a privileged rates for biosimilar user fees for fiscal HUMAN SERVICES and confidential basis, for the year (FY) 2019. The Federal Food, Drug, aggregation and analysis of patient and Cosmetic Act (FD&C Act), as Agency for Healthcare Research and safety events. amended by the Biosimilar User Fee Quality The Patient Safety Act authorizes the Amendments of 2017 (BsUFA II), listing of PSOs, which are entities or authorizes FDA to assess and collect Patient Safety Organizations: component organizations whose user fees for certain activities in Voluntary Relinquishment From mission and primary activity are to connection with biosimilar biological Diagnostic Quality Assurance conduct activities to improve patient product development; review of certain AGENCY: Agency for Healthcare Research safety and the quality of health care applications for approval of biosimilar and Quality (AHRQ), Department of delivery. biological products; and each biosimilar Health and Human Services (HHS). HHS issued the Patient Safety Rule to biological product approved in a ACTION: Notice of delisting. implement the Patient Safety Act. biosimilar biological product AHRQ administers the provisions of the application. daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: The Patient Safety Rule Patient Safety Act and Patient Safety BsUFA II directs FDA to establish, authorizes AHRQ, on behalf of the Rule relating to the listing and operation before the beginning of each fiscal year, Secretary of HHS, to list as a PSO an of PSOs. The Patient Safety Rule the amount of initial and annual entity that attests that it meets the authorizes AHRQ to list as a PSO an biosimilar biological product statutory and regulatory requirements entity that attests that it meets the development (BPD) fees, the for listing. A PSO can be ‘‘delisted’’ by statutory and regulatory requirements reactivation fee, and the biosimilar the Secretary if it is found to no longer for listing. A PSO can be ‘‘delisted’’ if biological product application and VerDate Sep<11>2014 18:30 Jul 30, 2018 Jkt 244001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\31JYN1.SGM 31JYN1


Document Created: 2018-11-06 10:29:16
Document Modified: 2018-11-06 10:29:16
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of delisting.
DatesThe 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 July 1, 2018.
ContactEileen 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 Citation83 FR 36937 
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