[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30715-30716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13661]


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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 0.3 Beta for public review 
and comment.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Surveillance--Hospital Version 0.3 
Beta can be accessed electronically at the following website: http://hare.qualityforum.org/Projects/Common-Formats/Pages/default.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; 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

[[Page 30716]]

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 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, nursing homes, 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, 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.
    Previously, AHRQ's primary focus with the formats has been to 
support traditional event reporting. 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. 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.
    The Common Formats for Surveillance--Hospital Version 0.3 Beta 
include two general types of formats, generic and event-specific. The 
generic Common Formats pertain to all patient safety concerns. The 
event-specific Common Formats pertain to frequently-occurring and/or 
serious patient safety events. The Common Formats for Surveillance--
Hospital Version 0.3 Beta event-specific formats are: Blood or Blood 
Product, Birth--Maternal, Birth--Neonatal, Device, Fall, Medication, 
Pressure Ulcer/Pressure Injury, Surgery or Anesthesia, Venous 
Thromboembolism, Healthcare Associated Infection (HAI)--Catheter 
Associated Tract Infection (CAUTI)/Clostridium Difficile--
Clostridioides Infection (CDI)/Central Line Associated Blood Stream 
Infection (CLABSI)/Pneumonia/Surgical Site Infection (SSI)/Urinary 
Tract Infection (UTI), Other HAI, and Other Outcomes of Interest (OOI).
    AHRQ is specifically interested in receiving feedback in order to 
guide the improvement of the formats. Information on how to comment on 
the Common Formats for Surveillance--Hospital Version 0.3 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/.

Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-13661 Filed 6-26-19; 8:45 am]
 BILLING CODE 4160-90-P