[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Page 15992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04767]



[[Page 15992]]

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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), Department 
of Health and Human Services (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 
or formats) for reporting on health care quality and patient safety. 
The purpose of this notice is to announce the availability of Common 
Formats for Surveillance--Hospital Version 1.0 for public review and 
comment.

DATES: End of initial comment period: April 5, 2024.

ADDRESSES: The Common Formats for Surveillance--Hospital Version 1.0 
can be accessed electronically at the following website: https://www.psoppc.org/psoppc_web/publicpages/surveillancecommonformats.

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

SUPPLEMENTARY INFORMATION:

Background on Common Formats Development

    The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 
299b-21 to 299b-26, (Patient Safety Act) and 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, provide for the formation of Patient Safety Organizations 
(PSOs), which collect and analyze confidential and privileged 
information regarding the quality and safety of health care delivery 
that meets the definition of PSWP. Aggregation of these data enables 
PSOs and others to identify and address underlying causal factors of 
patient safety and quality issues.
    The Patient Safety Act provides for the development of standardized 
reporting formats using common language and definitions (Common 
Formats) to ensure that health care quality and patient safety data 
collected by PSOs and other entities are comparable. The Common Formats 
facilitate aggregation of comparable data at local, PSO, regional and 
national levels. In addition, the formats are intended to enhance the 
reporting of information that is standardized both clinically and 
electronically.
    AHRQ has developed Common Formats for Event Reporting for three 
settings of care--acute care hospitals, nursing homes, and community 
pharmacies--as well as for diagnostic safety events across all care 
settings. AHRQ-listed PSOs are required to collect patient safety work 
product in a standardized manner to the extent practical and 
appropriate; this is a requirement the PSO can meet by collecting such 
information using Common Formats. Additionally, 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.
    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 solicit comments from the 
private and public sectors regarding proposed versions of the Common 
Formats through the Patient Safety Organization Privacy Protection 
Center (PSOPPC). After receiving comments, the PSOPPC will solicit 
review of the formats by its Common Formats Expert Panel. Subsequently, 
PSOPPC will review this input and provide its feedback to AHRQ who then 
uses it to refine the Common Formats.
    For the Common Formats, it should be noted that AHRQ uses the term 
``surveillance'' in this context to refer to the improved detection of 
events and calculation of adverse event rates in populations reviewed 
that will allow for collection of comparable performance data over time 
and across populations of patients. These formats are designed to 
provide, through retrospective review of medical records, information 
that is complementary to that derived from event reporting systems.
    AHRQ is specifically interested in receiving feedback in order to 
guide the improvement of the formats. The draft Event Descriptions for 
the Common Formats for Surveillance--Hospital Version 1.0 are available 
at: https://www.psoppc.org/psoppc_web/publicpages/surveillancecommonformats. Comments on the Common Formats for 
Surveillance--Hospital Version 1.0 can be submitted through: https://www.psoppc.org/psoppc_web/publicpages/openforcomment.
    Additional information about the Common Formats can be obtained 
through AHRQ's PSO website: https://pso.ahrq.gov/common-formats.

    Dated: March 1, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-04767 Filed 3-5-24; 8:45 am]
BILLING CODE 4160-90-P