2024-04767. 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 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 1.0 for public review and comment.

DATES:

End of initial comment period: April 5, 2024.

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: [e-mail].

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 (Common Formats) 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 Event Reporting for three settings of care—acute care hospitals, nursing homes, and community pharmacies—as well as for diagnostic safety events across all care settings. 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 solicit 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 will solicit review of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC will review this input and provide its feedback to AHRQ who then uses it to refine the Common Formats.

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.

AHRQ is specifically interested in receiving feedback in order to guide the improvement of the formats. The draft Event Descriptions for the Common Formats for Surveillance—Hospital Version 1.0 are available at: https://www.psoppc.org/​psoppc_​web/​publicpages/​surveillancecommonformats. Comments on the Common Formats for Surveillance—Hospital Version 1.0 can be submitted through: 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: March 1, 2024.

Marquita Cullom,

Associate Director.