[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65628-65629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17927]


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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 (CFS-H) Version 1.0.

DATES: Ongoing public input.

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 to ensure that 
health care quality and patient safety

[[Page 65629]]

data collected by PSOs and other entities are comparable. The Common 
Formats facilitate aggregation of comparable data at local, PSO, 
regional and national levels.
    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 solicits 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 solicits review 
of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC 
will provide this input to AHRQ who then uses it to refine the Common 
Formats.
    At AHRQ, the Common Formats for Surveillance--Hospitals (CFS-H) are 
applied in the Quality and Safety Review System (QSRS), a surveillance 
system designed to detect and calculate patient safety event rates 
through retrospective in-patient record review. QSRS uses the CFS-H 
Event Descriptions to create standardized specifications to ensure 
adverse events are reliability identified across all hospitals and 
records. 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.
    The Common Formats for Surveillance--Hospital Version 1.0 are 
categorized into the following topic areas (modules):

 Birth--Maternal
 Birth--Neonatal
 Blood or Blood Product
 Device
 Fall
 Hospital-Acquired Infection (HAI)
 Medication
 Other
 Pressure Injury
 Surgery or Anesthesia
 Venous Thromboembolism

    At this time, AHRQ is releasing the CFS-H Version 1.0 Event 
Descriptions and supporting materials, including an overview and user 
guide, tabular accounting, and technical release notes.
    Comments can be provided on the Common Formats for Surveillance--
Hospital Version 1.0 using the commenting tool at: 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: August 7, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-17927 Filed 8-9-24; 8:45 am]
BILLING CODE 4160-90-P