[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61382-61383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25971]


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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 0.2 Beta.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Surveillance--Hospital Version 0.2 
Beta can be accessed electronically at the following website: https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview.

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 patient safety work product. 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 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 three settings of care--acute 
care hospitals, skilled nursing facilities and community pharmacies--
for use by health care providers and PSOs. 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,

[[Page 61383]]

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 with 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 regarding proposed versions of the Common 
Formats through a contract, since 2008, 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 formats.
    Previously, AHRQ's primary focus with the Common Formats has been 
to support traditional event reporting. For the Common Formats, it 
should be noted that AHRQ uses the term ``surveillance'' 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 settings. These formats are 
designed to provide, through retrospective review of medical records, 
information that is complementary to that derived from event reporting 
systems. For more information on AHRQ's efforts measuring patient 
safety in this area, please go to: https://www.ahrq.gov/news/blog/ahrqviews/new-system-aims-to-improve-patient-safety-monitoring.html.
    AHRQ announced the availability of the, Common Formats for 
Surveillance--Hospital Version 0.2 Beta, for review and comment on May 
9, 2018 in the Federal Register (83 FR 21295-21296). After obtaining 
feedback, the Agency revised and finalized the formats through the 
development of event descriptions which are definitions of patient 
safety events, near misses, and unsafe conditions. The Common Formats 
for Surveillance--Hospital Version 0.2 Beta will be posted at the 
PSOPPC website: https://www.psoppc.org/psoppc_web.
    Additional information about the Common Formats can be obtained 
through AHRQ's PSO website: https://pso.ahrq.gov/.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-25971 Filed 11-28-18; 8:45 am]
 BILLING CODE 4160-90-P