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Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES

TTY local: 301 4271130; Email:
pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background on Common Formats Development The Patient Safety and Quality Improvement Act of 2005 Patient Safety Act, 42 U.S.C. 299b-21 to b-26, and the related Patient Safety and Quality Improvement Final Rule Patient Safety Rule, 42 CFR part 3, published in the Federal Register on November 21, 2008, 73 FR 7073170814, provide for the formation of Patient Safety Organizations PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The collection of patient safety work product allows for the aggregation of data that help to identify and address underlying causal factors of patient safety and quality issues.
The Patient Safety Act provides for AHRQ to develop standardized reporting formats using common language and definitions Common Formats for reporting on health care quality and patient safety that will ensure that data collected by PSOs and other entities have comparable clinical meaning. The Common Formats facilitate aggregation of comparable data at local, PSO, regional and national levels. In addition, the Common Formats are intended to enhance the reporting of information that is standardized.
Since February 2005, AHRQ has convened the Federal Patient Safety Work Group PSWG to assist AHRQ in developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS as well as the Departments of Defense and Veterans Affairs. The PSWG helps assure the consistency of definitions/
formats with those of relevant government agencies. In addition, AHRQ has solicited comments from the private and public sectors, since 2008, regarding proposed versions of the Common Formats through a contract with the National Quality Forum NQF, which is a non-profit organization focused on health care quality. After receiving comments, the NQF solicits review of the formats by its Common Formats Expert Panel. Subsequently, NQF provides this input to AHRQ who then uses it to refine the Common Formats before issuing a production version.
AHRQ previously developed and maintains Common Formats for three settings of careacute care hospitals, skilled nursing facilities, and community pharmaciesfor use by
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healthcare providers and PSOs. AHRQlisted PSOs are required to collect patient safety work product in a standardized manner to the extent practical and appropriate, a requirement the PSO can meet by collecting such information using Common Formats.
Additionally, health care providers and other organizations not working with an AHRQ-listed PSO can use the Common Formats in their work to improve quality and safety; however, they cannot benefit from the federal confidentiality and privilege protections of the Patient Safety Act.
The CFERDS is the first AHRQ
Common Formats for Event Reporting that can be used across healthcare settings. It is designed to capture standardized, structured data to facilitate the reporting of diagnostic safety events for the purpose of learning about how to improve diagnostic safety and better support clinicians in the diagnostic process.
The CFERDS is not designed for frontline incident reporting. It is intended to facilitate the collection and organization of a basic set of meaningful data about diagnostic safety events that can be used, aggregated and analyzed for learning and improvement. Having a common frame of reference and standardized data elements is what makes shared learning possible at local, regional and national levels. Users decide if and how to integrate collection of specific data elements into their incident reporting systems and other existing work processes.
AHRQ is specifically interested in receiving feedback in order to guide improvement of the CFERDS V0.1. As with other Common Formats, the Event Description is available for public comment. Additionally, AHRQ is seeking feedback on a user guide and a form. Additional supporting documentation will be finalized and made available following AHRQs receipt of comment from the public and NQFs Common Format Expert Panel.
Information on how to comment is available at: http
www.qualityforum.org/Project_Pages/
Common_Formats_for_Patient_Safety_
Data.aspx.
Additional information about the AHRQ Common Formats can be obtained through AHRQs PSO website:
https pso.ahrq.gov/common-formats.
Dated: May 25, 2021.
Marquita Cullom, Associate Director.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid Services Document Identifier: CMS29, CMS437
and 10452

Agency Information Collection Activities: Submission for OMB
Review; Comment Request Centers for Medicare &
Medicaid Services, Health and Human Services HHS.
ACTION: Notice.
AGENCY:

The Centers for Medicare &
Medicaid Services CMS is announcing an opportunity for the public to comment on CMS intention to collect information from the public. Under the Paperwork Reduction Act of 1995
PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agencys functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
DATES: Comments on the collections of information must be received by the OMB desk officer by July 1, 2021.
ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/
PRAMain. Find this particular information collection by selecting Currently under 30-day ReviewOpen for Public Comments or by using the search function.
To obtain copies of a supporting statement and any related forms for the proposed collections summarized in this notice, you may make your request using one of following:
1. Access CMS website address at website address at: https
www.cms.gov/Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
SUMMARY:

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