[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Pages 29263-29264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11386]



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.


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;

[[Page 29264]]

TTY (local): (301) 427-1130; Email: [email protected].


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 
    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]