Agency for Healthcare Research and Quality September 2009 – Federal Register Recent Federal Regulation Documents

AHRQ is announcing the availability of a document entitled: ``Patient Safety Organizations: A Compliance Self-Assessment Guide.'' The Patient Safety and Quality Improvement Act of 2005, Public Law 109- 41, 42 U.S.C. 299-b21b-26 (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety and Quality Improvement Final Rule (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; and request additional information and conduct reviews (including announced or unannounced site visits) to assess PSO compliance. To assist PSOs in making the required attestations and preparing for a compliance review, AHRQ developed the sample questions in this guide to encourage each PSO to take a thorough and systematic approach to compliance. The guide recognizes that each PSO's approach to compliance may be different based upon the specific mission it has chosen, the specific activities and expertise it offers to healthcare providers, and its size and mode of operation. Thus, these questions are merely illustrative; some questions will not be applicable or even appropriate for every PSO. The guide does not establish new standards or requirements beyond those that are established by the Patient Safety Rule.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26 (Patient Safety Act), provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23) authorizes the collection of this information in a standardized manner, as explained in the related Patient Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient Safety Rule), published in the Federal Register on November 21, 2008: 73 FR 70731-70814. As authorized by the Secretary of HHS, AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The initial release of the formats, Version 0.1 Beta, was announced in the Federal Register on August 29, 2008: 73 FR 50974-50976. The purpose of this notice is to announce the availability of the expanded and enhanced Common Formats Version 1.0 and the process for their continued development and refinement.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Health IT Community Tracking Study 2009.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.