[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Notices]
[Pages 53003-53004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18877]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment for the 
Institute for Safe Medication Practices (ISMP)

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 Institute for Safe Medication 
Practices (ISMP), PSO number P0009, of its status as a PSO, and has 
delisted the PSO accordingly.

DATES: The delisting was effective at 12:00 Midnight ET (2400) on 
August 17, 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): (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

[[Page 53004]]

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 Institute for Safe Medication Practices (ISMP) 
to voluntarily relinquish its status as a PSO. Accordingly, the 
Institute for Safe Medication Practices (ISMP), P0009, was delisted 
effective at 12:00 Midnight ET (2400) on August 17, 2020. Institute for 
Safe Medication Practices (ISMP) 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.

Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2020-18877 Filed 8-26-20; 8:45 am]
BILLING CODE 4160-90-P