[Federal Register Volume 76, Number 184 (Thursday, September 22, 2011)]
[Notices]
[Pages 58812-58813]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24100]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Delisting for Cause of Patient 
Safety Organization One, Inc.

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice of Delisting.

-----------------------------------------------------------------------

SUMMARY: Patient Safety Organization One, Inc.: AHRQ has delisted 
Patient Safety Organization One, Inc. as a Patient Safety Organization 
(PSO) pursuant to 42 CFR 3.108(b). The Patient Safety and Quality 
Improvement Act of 2005 (Patient Safety Act), Pub. L. 109-41, 42 U.S.C. 
299b-21--b-26, provides for the formation of PSOs, which collect, 
aggregate, and analyze confidential information regarding the quality 
and safety of health care delivery. The Patient Safety and Quality 
Improvement Final Rule (Patient Safety Rule), 42 CFR part 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.

DATES: The delisting was effective at 12 Midnight ET (2400) on July 5, 
2011.

ADDRESSES: The directories of both listed and delisted PSOs can be 
accessed electronically at the following HHS Web site: http://www.pso.AHRQ.gov/index.html.

FOR FURTHER INFORMATION CONTACT: Diane Cousins, RPh., Center for 
Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, 
Rockville, MD 20850; Telephone (toll free): (866) 403-3697; Telephone 
(local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): 
(301) 427-1130; E-mail: [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 
is 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 (PDF file, 450 KB. PDF Help) 
relating to the listing and operation of PSOs. 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.
    Patient Safety Organization One, Inc. failed to respond to two 
findings of deficiency contained in a Notice of Proposed Revocation and 
Delisting: (1) Failure to provide required notification to AHRQ that 
the PSO has complied with the requirement of entering into two Patient 
Safety Act contracts within 24-months of the date of initial listing, 
as required by 42 U.S.C. 299b-24(b)(1)(C); and (2) failure to submit 
information necessary for AHRQ to conduct a compliance assessment of 
the PSO, as required by 42 CFR 3.110. Patient Safety Organization One, 
Inc. has not responded to either preliminary notice of deficiency sent 
by AHRQ pursuant to 42 CFR 3.108(a)(2), nor provided any evidence of a 
good faith effort to correct either deficiency. Accordingly, pursuant 
to 42 CFR 3.108(b), AHRQ delisted Patient Safety Organization One, 
Inc., PSO number P0059, effective at 12:00 Midnight ET (2400) on July 
5, 2011.

[[Page 58813]]

    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.gov/index.html.

    Dated: September 8, 2011
Carolyn M. Clancy,
Director.
[FR Doc. 2011-24100 Filed 9-21-11; 8:45 am]
BILLING CODE 4160-90-M