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Common Formats for Patient Safety Data Collection

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Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS).


Notice of availability—new Common Formats


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.


Ongoing public input.


The Common Formats for Surveillance—Hospital Version 0.3 Beta can be accessed electronically at the following website:​Projects/​Common-Formats/​Pages/​default.aspx.

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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:

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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 Start Printed Page 30716PSWP. 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:​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:​Project_​Pages/​Common_​Formats_​for_​Patient_​Safety_​Data.aspx.

Additional information about the Common Formats can be obtained through AHRQ's PSO website:​.

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Virginia L. Mackay-Smith,

Associate Director.

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[FR Doc. 2019-13661 Filed 6-26-19; 8:45 am]