Notice2021-24888
Meeting for Software Developers on the Common Formats for Patient Safety Data Collection
Primary source
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Published
November 16, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 218 (Tuesday, November 16, 2021)</title>
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[Federal Register Volume 86, Number 218 (Tuesday, November 16, 2021)]
[Notices]
[Pages 63389-63390]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://pso.ahrq.gov/common-formats">https://pso.ahrq.gov/common-formats</a> and the PSO Privacy
Protection Center's website at <a href="https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview">https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview</a>.
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: <a href="/cdn-cgi/l/email-protection#c5b5b6aa85a4adb7b4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="1767647857767f6566397f7f6439707861">[email protected]</span></a>.
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: <a href="http://www.pso.ahrq.gov/legislation/">http://www.pso.ahrq.gov/legislation/</a>.
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:
<bullet> Data dictionary--defines data elements and their
attributes (data element name, answer values, field length, guide for
use, etc.) included in Common Formats;
<bullet> 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;
<bullet> 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;
<bullet> Common Formats flow charts--diagrams the valid paths to
complete the formats (a complete event report);
<bullet> Local specifications--provides specifications for
processing, linking, and reporting on events and details specifications
for reports; and
<bullet> 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 <a href="/cdn-cgi/l/email-protection#5300171e3636273a3d3420133a3d353a3d3a272a303c3d353621363d3036207d303c3e"><span class="__cf_email__" data-cfemail="81d2c5cce4e4f5e8efe6f2c1e8efe7e8efe8f5f8e2eeefe7e4f3e4efe2e4f2afe2eeec">[email protected]</span></a> 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 <a href="https://www.qualityforum.org/Common_Formats_for_Patient_Safety_Data.aspx">https://www.qualityforum.org/Common_Formats_for_Patient_Safety_Data.aspx</a>.
Dated: November 9, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-24888 Filed 11-15-21; 8:45 am]
BILLING CODE 4160-90-P
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