[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Page 12065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03909]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Delisting for Cause for Independent 
Data Safety Monitoring, Inc.

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

ACTION: Notice of Delisting.

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SUMMARY: AHRQ has delisted Independent Data Safety Monitoring, Inc. due 
to its failure to correct a deficiency. The Patient Safety and Quality 
Improvement Act of 2005 (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 and 
Quality Improvement Final Rule (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.

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 15, 2013.

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

FOR FURTHER INFORMATION CONTACT: Eileen Hogan, 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; 
Email: psoAHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Background

    The Patient Safety Act, Public Law 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 Rule, 42 CFR part 3, 
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 no longer to meet the requirements of the Patient Safety 
Act and Patient Safety Rule. 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.
    Independent Data Safety Monitoring, Inc. failed to respond to a 
Notice of Preliminary Finding of Deficiency sent by AHRQ pursuant to 42 
CFR 3.108(a)(2) and a Notice of Proposed Revocation and Delisting sent 
by AHRQ pursuant to 42 CFR 3.108(a)(3)(iii)(C) which found that 
Independent Data Safety Monitoring, Inc. had not complied with its 
attestation to notify the Secretary if there has been a change in the 
accuracy of the information it submitted for initial listing, which 
includes contact information for the PSO (42 CFR 3.102(a)(1)(vi)). 
Independent Data Safety Monitoring, Inc. did not exercise its 
opportunity to be heard in writing to respond to the deficiency 
specified in the notices, and has not provided any evidence of a good 
faith effort to correct the deficiency. As such, pursuant to 42 CFR 
3.108(a)(4)(iii), the notice of proposed revocation became final as a 
matter of law and the basis for revocation.
    Accordingly, AHRQ has revoked the listing of Independent Data 
Safety Monitoring, Inc., PSO number P0114, effective at 12:00 Midnight 
ET (2400) on January 15, 2013.
    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.gov/index.html.

    Dated: February 11, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-03909 Filed 2-20-13; 8:45 am]
BILLING CODE 4160-90-M