[Federal Register Volume 77, Number 124 (Wednesday, June 27, 2012)]
[Notices]
[Pages 38294-38295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15612]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Delisting for Cause for Medical 
Informatics

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

ACTION: Notice of Delisting.

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SUMMARY: AHRQ has delisted Medical Informatics as a Patient Safety 
Organization (PSO) 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 June 1, 2012.

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: [email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 38295]]

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.
    Medical Informatics 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 Medical Informatics failed to 
have, within every 24-month period following the PSO's date of initial 
listing, at least two bona fide contracts with different providers for 
the purpose of receiving and reviewing patient safety work product, and 
to notify AHRQ no later than 45 calendar days prior to the last day of 
the pertinent 24-month period that the PSO has met this requirement. 
Medical Informatics did not exercise its opportunity to be heard in 
writing to respond to the deficiencies specified in the notices, and 
has not provided any evidence of a good faith effort to correct the 
deficiency. Accordingly, AHRQ has revoked the listing of Medical 
Informatics, PSO number P0086, a component entity of Medical 
Informatics, LLC, effective at 12:00 Midnight ET (2400) on June 1, 
2012.
    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.clov/index.html.

    Dated: June 19, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-15612 Filed 6-26-12; 8:45 am]
BILLING CODE 4160-90-M