[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Pages 29263-29264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11386]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Common Formats for Patient Safety Data Collection
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of Availability--New Common Formats.
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SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the
development of common definitions and reporting formats (Common
Formats) for reporting on health care quality and patient safety. The
purpose of this notice is to announce the availability of Common
Formats for Event Reporting--Diagnostic Safety (CFER-DS) Version 0.1
for public review and comment.
DATES: July 1, 2021.
ADDRESSES: The Common Formats for Event Reporting--Diagnostic Safety
(CFER-DS) Version 0.1 can be accessed electronically at the following
website: https://www.qualityforum.org/Common_Formats_for_Patient_Safety_Data.aspx.
FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Center for Quality
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Rockville, MD
20857; Telephone (toll free): (866) 403-3697; Telephone (local): (301)
427-1111; TTY (toll free): (866) 438-7231;
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TTY (local): (301) 427-1130; Email: [email protected].
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 70731-
70814, 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 care--acute care hospitals, skilled nursing facilities, and
community pharmacies--for use by healthcare providers and PSOs. AHRQ-
listed 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 CFER-DS 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 CFER-DS 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 CFER-DS 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
AHRQ's receipt of comment from the public and NQF's 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 AHRQ's PSO website: https://pso.ahrq.gov/common-formats.
Dated: May 25, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-11386 Filed 5-28-21; 8:45 am]
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