2011-24100. 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): [phone]; Telephone (local): [phone]; TTY (toll free): [phone]; TTY (local): [phone]; E-mail: [e-mail].

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.

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.