[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3815-3816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01242]
[[Page 3815]]
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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 and Event Reporting
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation
of Patient Safety Organizations (PSOs), which collect, aggregate, and
analyze confidential information regarding the quality and safety of
health care delivery. The Patient Safety Act (at 42 U.S.C. 299b-23)
authorizes the collection of this information in a standardized manner,
as explained in 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. AHRQ
coordinates the development of common definitions and reporting formats
(Common Formats) that allow health care providers to voluntarily
collect and submit standardized information regarding patient safety
events. In order to support the Common Formats, AHRQ has provided
technical specifications to promote standardization by ensuring that
data collected by PSOs and other entities are clinically and
electronically comparable. More information on the Common Formats,
including the technical specifications, can be obtained through AHRQ's
PSO Web site: http://www.PSO.AHRQ.GOV/index.html.
The purpose of this notice is to announce a meeting to discuss the
Common Formats. This meeting is designed as an interactive forum where
PSOs and software developers can provide input on 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 formats electronically.
DATES: The meeting will be held from 10:00 a.m. to 3:30 p.m. on Friday,
April 25, 2014.
ADDRESSES: The meeting will be held at the John M. Eisenberg Conference
Center, Agency for Healthcare Research and Quality, 540 Gaither Road,
Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Glenn Egelman, M.D., Center for
Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road,
Rockville, MD 20850; 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 Act and Patient Safety Rule establish a
framework by which doctors, hospitals, skilled nursing facilities, and
other health care providers may voluntarily report information
regarding patient safety events and quality of care. Information that
is assembled and developed by providers for reporting to PSOs and the
information received and analyzed by PSOs--called patient safety work
product--is privileged and confidential. Patient safety work product is
used to identify events, patterns of care, and unsafe conditions that
increase risks and hazards to patients. Definitions and other details
about PSOs and patient safety work product are included in the Patient
Safety Rule.
The Patient Safety Act and Patient Safety Rule require PSOs, to the
extent practicable and appropriate, to collect patient safety work
product from providers in a standardized manner in order to permit
valid comparisons of similar cases among similar providers. The
collection of patient safety work product allows the aggregation of
sufficient data to identify and address underlying causal factors of
patient safety problems. Both the Patient Safety Act and Patient Safety
Rule, including any relevant guidance, can be accessed electronically
at: http://www.PSO.AHRQ.GOV/REGULATIONS/REGULATIONS.htm
In collaboration with the interagency Federal Patient Safety
Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ
has developed Common Formats for two settings of care -- acute care
hospitals and skilled nursing facilities -- in order to facilitate
standardized data collection. The term Common Formats refers to the
common definitions and reporting formats that allow health care
providers to collect and submit standardized information regarding
patient safety events. AHRQ's Common Formats include:
Event descriptions (descriptions of patient safety events
and unsafe conditions to be reported),
Specifications for patient safety aggregate reports and
individual event summaries,
Delineation of data elements to be collected for different
types of events to populate the reports,
A user's guide and quick guide, and
Technical specifications for electronic data collection
and reporting.
AHRQ convenes the PSWG to assist AHRQ with developing and
maintaining the Common Formats. The PSWG includes major health agencies
within the Department of Health and Human Services (HHS)--the Centers
for Disease Control and Prevention, Centers for Medicare and Medicaid
Services, Food and Drug Administration, Health Resources and Services
Administration, Indian Health Service, National Institutes of Health,
National Library of Medicine, Office of the National Coordinator for
Health Information Technology, Office of Public Health and Science, and
Substance Abuse and Mental Health Services Administration--as well as
the Department of Defense and Department of Veterans Affairs.
When developing Common Formats, AHRQ first reviews existing patient
safety event reporting systems from a variety of health care
organizations. In collaboration with the PSWG and Federal subject
matter experts, AHRQ drafts and releases beta versions of the Common
Formats for public review and comment.
Through a contract with AHRQ, NQF solicits feedback on the beta
(and subsequent) versions of the Common Formats from private sector
organizations and individuals. The NQF, a nonprofit organization that
focuses on health care quality, then convenes an expert panel to review
the comments received and provide feedback to AHRQ. Based upon the
expert panel's feedback, AHRQ, in conjunction with the PSWG, further
revises the Common Formats.
The technical specifications promote standardization of collected
patient safety event information by specifying rules for data
collection and submission, as well as by providing guidance for how and
when to create data elements, their valid values, conditional and go-to
logic, and reports. These specifications will ensure that data
collected by PSOs and other entities have comparable clinical meaning.
The technical specifications also provide direction to software
developers, so that the Common Formats can be implemented
electronically, and to PSOs, so that the Common Formats can be
submitted electronically to the PSO Privacy Protection Center (PSOPPC)
for data de-identification and transmission to the
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Network of Patient Safety Databases (NPSD).
The Software Developer's meeting will focus on discussion of the
implementation and use of Common Formats for Event Reporting--Hospital
1.1 and 1.2; the technical specifications, which provide direction to
software developers that plan to implement the Common Formats
electronically; and future development plans for the Common Formats.
The technical specifications are a critical component that allow for
the aggregation of patient safety event data.
The technical specifications consist of the following:
[cir] data dictionary--defines data elements and their attributes
(data element name, answer values, field length, guide for use, etc.)
included in Common Formats;
[cir] clinical document architecture (CDA) implementation guide--
provides instructions for developing a file to transmit the Common
Formats Patient Safety data from the PSO to the PSO PPC using the
Common Formats;
[cir] validation rules and errors document--specifies and defines
the validation rules that will be applied to the Common Formats data
elements submitted to the PSO PPC;
[cir] Common Formats flow charts--diagrams the valid paths to
complete generic and event specific formats (a complete event report);
[cir] local specifications--provides specifications for processing,
linking and reporting on events and details specifications for reports;
and
[cir] 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 2014 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
overview of Federal efforts related to the Common Formats;
presentations and discussion of implementations of Common Formats Event
Reporting--Hospital Version 1.1 and 1.2; discussion of next steps for
upcoming Common Formats releases; and a review of data submission both
by PSOs and by vendors on behalf of PSOs.
AHRQ requests that interested persons send an email to the PSO PPC
at [email protected] for registration information. The meeting space
will accommodate approximately 150 participants. A detailed agenda and
logistical information will be provided to meeting registrants before
the meeting. Prior to the meeting, AHRQ invites review of the technical
specifications for Common Formats which can be accessed through AHRQ's
PSO Web site at http://www.pso.AHRQ.GOV/formats/commonfmt.htm.
Dated: January 14, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-01242 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-90-P