Patient Safety Organizations: Delisting for Cause for Independent Data Safety Monitoring, Inc., 12065 [2013-03909]

Download as PDF Federal Register / Vol. 78, No. 35 / Thursday, February 21, 2013 / Notices meeting participants not only to provide input, but also to respond to the input provided by others. A more specific agenda will be provided to meeting registrants before the meeting. AHRQ requests that interested persons register with the PSO PPC to participate in the meeting. The contact at the PSO PPC is Mark Baliff who can be reached by telephone at (866) 571– 7712 and by email at SUPPORT@.PSOPPC.ORG. Additional logistical information for the meeting is also available from the PSO PPC. The meeting space will accommodate approximately 150 participants. Interested persons are encouraged to register as soon as possible for the meeting. Non-registered individuals will be able to attend the meeting in person if space is available. Prior to the meeting, AHRQ invites review of the technical specifications for Common Formats. The formats can be accessed through AHRQ’s PSO Web site at http://www.pso.AHRQ.GOV/formats/ commonfmt.htm. AHRQ is committed to continuing refinement of the Common Formats, and welcomes questions from prospective meeting participants and interested individuals on the technical specifications. These questions should be emailed to SUPPORT@PSOPPC.ORG no later than April 10th, 2013. AHRQ will use the input received at this meeting to further update and refine the Common Formats. Dated: February 7, 2013. Carolyn M. Clancy, Director. [FR Doc. 2013–03911 Filed 2–20–13; 8:45 am] BILLING CODE 4160–90–M 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 for Healthcare Research and Quality (AHRQ), HHS. ACTION: Notice of Delisting. AGENCY: 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 erowe on DSK2VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 14:47 Feb 20, 2013 Jkt 229001 12065 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: 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. 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 National Institute for Occupational Safety and Health Personal Protective Technology for Pesticide Handlers: Stakeholder Meeting PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 Dated: February 11, 2013. Carolyn M. Clancy, Director. [FR Doc. 2013–03909 Filed 2–20–13; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of public meeting. AGENCY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ‘‘Pesticide Handler Personal Protective Technology Stakeholder Meeting’’. Stakeholder Meeting Time and Date: 4 p.m.–6 p.m. EDT, March 25, 2013 [Optional] 8 a.m.–6 p.m. EDT, March 26, 2013. Place: NIOSH, Patriots Plaza 1, 395 E. Street, SW., Room 9000, Washington, DC 20201. This meeting will also be accessible remotely through Live Meeting with advanced registration. Purpose of the Meeting: This meeting is being held to motivate and educate pesticide handlers and pesticide workers to use best pesticide personal protective equipment practices. This stakeholder meeting allows NIOSH to facilitate focused communication and exchange ideas and solutions between key stakeholder groups. Stakeholder feedback is sought to provide input to future updates of the NIOSH Personal SUMMARY: E:\FR\FM\21FEN1.SGM 21FEN1

Agencies

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


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

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.

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

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