[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63389-63390]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24888]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Meeting for Software Developers on the 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 public meeting.

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SUMMARY: AHRQ coordinates the development of sets of standardized 
definitions and formats (Common Formats) that make it possible to 
collect, aggregate, and analyze uniformly structured information about 
health care quality and patient safety for local, regional, and 
national learning. The Common Formats include technical specifications 
to facilitate the collection of electronically comparable data by 
Patient Safety Organizations (PSOs) and other entities. Additional 
information about the Common Formats can be obtained through AHRQ's PSO 
website at https://pso.ahrq.gov/common-formats and the PSO Privacy 
Protection Center's website at https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview.
    The purpose of this notice is to announce a meeting to discuss 
implementation of the Common Formats with software developers and other 
interested parties. This meeting is designed as an interactive forum 
where software developers can provide input on use of the formats. AHRQ 
especially requests participation by and input from those entities 
which have used AHRQ's technical specifications and implemented, or 
plan to implement, the Common Formats electronically.

DATES: The meeting will be held from 1:00 to 3:30PM Eastern on 
Thursday, December 16th, 2021.

ADDRESSES: The meeting will be held virtually.

FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Medical Officer, 
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

    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 Federal listing of Patient Safety 
Organizations (PSOs), which collect, aggregate, and analyze 
confidential information (patient safety work product) regarding the 
quality and safety of health care delivery.
    The Patient Safety Act requires PSOs, to the extent practical and 
appropriate, to collect patient safety work product from providers in a 
standardized manner that permits valid comparisons of similar cases 
among similar providers. (42 U.S.C. 299b-24(b)(1)(F)).

[[Page 63390]]

The Patient Safety Act also authorizes the development of data 
standards, known as the Common Formats, to facilitate the aggregation 
and analysis of non-identifiable patient safety data collected by PSOs 
and reported to the network of patient safety databases (NPSD). (42 
U.S.C. 299b-23(b)). The Patient Safety Act and Patient Safety Rule can 
be accessed at: http://www.pso.ahrq.gov/legislation/.
    AHRQ has issued Common Formats for Event Reporting for three 
settings of care--hospitals, nursing homes, and community pharmacies. 
As part of the agency's efforts to improve diagnostic safety and 
quality in healthcare, AHRQ is in the process of developing Common 
Formats for Event Reporting--Diagnostic Safety (CFER-DS). The CFER-DS 
is intended to help healthcare providers identify and report missed 
opportunities in the diagnostic process in a standardized manner across 
healthcare settings and specialties. Widespread use of the CFER-DS will 
make it possible to collect, aggregate, and analyze diagnostic safety-
related information from healthcare providers across the country, which 
in turn can accelerate learning in this vital area of patient safety. 
Public comment has been received on a version 0.1 of the CFER-DS, and 
an Expert Panel convened by the National Quality Forum (NQF) is 
currently in the process of reviewing the public comments and providing 
feedback to AHRQ.
    Federally listed PSOs can meet the requirement to collect patient 
safety work product in a standardized manner to the extent practical 
and appropriate by using AHRQ's Common Formats. The Common Formats are 
also available in the public domain to encourage their widespread 
adoption. An entity does not need to be listed as a PSO or working with 
one to use the Common Formats. However, the Federal privilege and 
confidentiality protections only apply to information developed as 
patient safety work product by providers and PSOs working under the 
Patient Safety Act.
    Each version of the Common Formats is released with accompanying 
technical specifications, intended to provide direction to software 
developers and to PSOs that plan to submit data to the Patient Safety 
Organization Privacy Protection Center (PSOPPC) to ensure non-
identification for transmission to the NPSD. For existing Common 
Formats for Event Reporting, technical specifications include the 
following:
     Data dictionary--defines data elements and their 
attributes (data element name, answer values, field length, guide for 
use, etc.) included in Common Formats;
     Clinical document architecture (CDA) implementation 
guide--provides instructions for developing a file to transmit the data 
from the PSO to the PSOPPC using the Common Formats;
     Validation rules and errors document--specifies and 
defines the validation rules that will be applied to the Common Formats 
data elements submitted to the PSOPPC;
     Common Formats flow charts--diagrams the valid paths to 
complete the formats (a complete event report);
     Local specifications--provides specifications for 
processing, linking, and reporting on events and details specifications 
for reports; and
     Metadata registry--includes descriptive facts about 
information contained in the data dictionary to illustrate how such 
data corresponds with similar data elements used by other Federal 
agencies and standards development organizations (e.g., HL--7, 
International Standards Organization (ISO)).

Agenda, Registration, and Other Information About the Meeting

    The December 16, 2021 meeting will be an interactive forum designed 
to allow meeting participants not only to provide input but also to 
respond to the input provided by others. The meeting agenda will 
include: An update of Federal efforts related to the PSO Program and 
Common Formats; discussion of the CFER-DS, including requesting 
feedback on planned technical support materials and general 
integration/implementation; and, planning for future meetings, 
including discussing potential topics of interest for regular future 
meetings with software developers. AHRQ requests that interested 
persons send an email to [email protected] for 
registration information. Before the meeting, an agenda and logistical 
information will be provided to registrants. Prior to the meeting, AHRQ 
invites review of the CFER-DS which can be accessed through NQF's 
website at https://www.qualityforum.org/Common_Formats_for_Patient_Safety_Data.aspx.

    Dated: November 9, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-24888 Filed 11-15-21; 8:45 am]
BILLING CODE 4160-90-P