Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting, 3815-3816 [2014-01242]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
Agency for Healthcare Research and
Quality
Meeting for Software Developers on
the Common Formats for Patient
Safety Data Collection and Event
Reporting
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: PSO@
AHRQ.HHS.GOV.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Background
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
AGENCY:
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: https://
www.PSO.AHRQ.GOV/.
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
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
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: https://
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,
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
3815
• 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 deidentification and transmission to the
E:\FR\FM\23JAN1.SGM
23JAN1
3816
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices
sroberts on DSK5SPTVN1PROD with NOTICES
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:
Æ data dictionary—defines data
elements and their attributes (data
element name, answer values, field
length, guide for use, etc.) included in
Common Formats;
Æ 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;
Æ 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;
Æ Common Formats flow charts—
diagrams the valid paths to complete
generic and event specific formats (a
complete event report);
Æ local specifications—provides
specifications for processing, linking
and reporting on events and details
specifications for reports; and
Æ 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
VerDate Mar<15>2010
21:50 Jan 22, 2014
Jkt 232001
at support@psoppc.ORG 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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Public Meeting of the Presidential
Commission for the Study of
Bioethical Issues
Presidential Commission for
the Study of Bioethical Issues, Office of
the Assistant Secretary for Health,
Office of the Secretary, Department of
Health and Human Services.
ACTION: Notice of meeting.
AGENCY:
The Presidential Commission
for the Study of Bioethical Issues (the
Commission) will conduct its sixteenth
meeting on February 10–11, 2014. At
this meeting, the Commission will
discuss the BRAIN Initiative and
ongoing work in neuroscience.
DATES: The meeting will take place
Monday, February 10, 2014, from 9 a.m.
to approximately 5 p.m. and Tuesday,
February 11, 2014, from 9 a.m. to
approximately 5 p.m.
ADDRESSES: Washington Marriott, 1221
22nd St. NW., Washington, DC 20037.
Telephone (202) 872–1500.
FOR FURTHER INFORMATION CONTACT:
Hillary Wicai Viers, Communications
Director, Presidential Commission for
the Study of Bioethical Issues, 1425
New York Avenue NW., Suite C–100,
Washington, DC 20005. Telephone:
202–233–3960. Email: Hillary.Viers@
bioethics.gov. Additional information
may be obtained at www.bioethics.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to the Federal Advisory Committee Act
of 1972, Public Law 92–463, 5 U.S.C.
app. 2, notice is hereby given of the
sixteenth meeting of the Commission.
The meeting will be open to the public
with attendance limited to space
available. The meeting will also be
webcast at www.bioethics.gov.
Under authority of Executive Order
13521, dated November 24, 2009, the
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
President established the Commission.
The Commission is an expert panel of
not more than 13 members who are
drawn from the fields of bioethics,
science, medicine, technology,
engineering, law, philosophy, theology,
or other areas of the humanities or
social sciences. The Commission
advises the President on bioethical
issues arising from advances in
biomedicine and related areas of science
and technology. The Commission seeks
to identify and promote policies and
practices that ensure scientific research,
health care delivery, and technological
innovation are conducted in a socially
and ethically responsible manner.
The main agenda item for the
Commission’s sixteenth meeting is to
discuss the BRAIN Initiative and
ongoing work in neuroscience.
The draft meeting agenda and other
information about the Commission,
including information about access to
the webcast, will be available at
www.bioethics.gov.
The Commission welcomes input
from anyone wishing to provide public
comment on any issue before it.
Respectful debate of opposing views
and active participation by citizens in
public exchange of ideas enhances
overall public understanding of the
issues at hand and conclusions reached
by the Commission. The Commission is
particularly interested in receiving
comments and questions during the
meeting that are responsive to specific
sessions. Written comments will be
accepted at the registration desk and
comment forms will be provided to
members of the public in order to write
down questions and comments for the
Commission as they arise. To
accommodate as many individuals as
possible, the time for each question or
comment may be limited. If the number
of individuals wishing to pose a
question or make a comment is greater
than can reasonably be accommodated
during the scheduled meeting, the
Commission may make a random
selection.
Written comments will also be
accepted in advance of the meeting and
are especially welcome. Please address
written comments by email to info@
bioethics.gov, or by mail to the
following address: Public Commentary,
Presidential Commission for the Study
of Bioethical Issues, 1425 New York
Avenue NW., Suite C–100, Washington,
DC 20005. Comments will be made
publicly available, including any
personally identifiable or confidential
business information that they contain.
Trade secrets should not be submitted.
Anyone planning to attend the
meeting who needs special assistance,
E:\FR\FM\23JAN1.SGM
23JAN1
Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Pages 3815-3816]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: https://www.PSO.AHRQ.GOV/.
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: PSO@AHRQ.HHS.GOV.
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: https://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
[[Page 3816]]
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 support@psoppc.ORG 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 https://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