[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Notices]
[Pages 21295-21296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09870]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 Surveillance--Hospital Version 0.2 Beta for public review 
and comment.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Surveillance--Hospital Version 0.2 
Beta can be accessed electronically at the following website: http://www.qualityforum.org/Project_Pages/Common_Formats_for_Patient_Safety_Data.aspx.

FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Center for Quality

[[Page 21296]]

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 b-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, 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 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; 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 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 Common Formats before 
issuing as a production version.
    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.

Commenting on Common Formats: Common Formats for Surveillance--Hospital 
Version 0.2 Beta

    AHRQ is specifically interested in receiving feedback in order to 
guide the improvement of the Common Formats. Information on how to 
comment on the Common Formats for Surveillance--Hospital Version 0.2 
Beta is available at: http://www.qualityforum.org/Project_Pages/Common_Formats_for_Patient_Safety_Data.aspx.
    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. 2018-09870 Filed 5-8-18; 8:45 am]
 BILLING CODE 4160-90-P