Common Formats for Patient Safety Data Collection, 65628-65629 [2024-17927]
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Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
Action Alternatives for the Sumas
LPOE are described below.
Sumas Alternative 2 (Feasibility
Study Preferred Alternative) would
involve potential acquisition of land
south and east of the LPOE, site
preparation, and construction to
modernize and expand the LPOE. The
maximum proposed limits of
disturbance for Sumas Alternative 2
would be approximately 12.9 acres.
Sumas Alternative 3 (Commercial
Inspection West) would include the
same action and maximum proposed
limits of disturbance as Alternative 2,
with a difference of a ‘‘flipped’’
alignment of the commercial inspection
facility.
Sumas Alternative 4 (Multi-Story
Construction LPOE Expansion) would
include the same action and maximum
proposed limits of disturbance as Sumas
Alternative 2, with a difference of multistory Main Building being constructed.
Construction sequencing options are
described below.
Under the Concurrent Construction
option, both ports would remain open
during construction. Pedestrian access
would be maintained through the ports
by utilizing and resetting, as necessary,
various access and safety controls. POV
access would also be maintained
through both ports using various
controls, which may require limits on
the number of open processing lanes
and shifting of POVs to commercial
owned vehicle (COV) lanes for limited
times. COVs may need to be detoured at
times to other ports to permit adequate
space for continued POV processing.
Under the Sequential Construction
Option, GSA and CBP are considering
the potential for closure of the Lynden
LPOE. All traffic, pedestrians, POVs,
and COVs would be detoured from the
Lynden LPOE during the majority of its
construction. Once the modernized and
expanded Lynden LPOE is reopened,
construction that impacts traffic would
begin on the Sumas LPOE. The Sumas
LPOE would remain open to pedestrians
and POVs during construction to the
greatest extent possible. COVs would be
detoured from the Sumas LPOE to other
LPOEs during portions of the
construction period.
The Draft EIS addresses the potential
environmental impacts of the proposed
alternatives on environmental resources
including land use; water resources;
biological resources; geology,
topography, and soils; air quality,
climate change, and greenhouse gases;
human health and safety; infrastructure
and utilities; traffic and transportation;
noise and vibration; socioeconomics;
and environmental justice and
protection of children’s health and
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safety. Based on the analysis presented
in the Draft EIS, impacts to all resource
areas would be less-than-significant
(i.e., negligible, minor, or moderate)
adverse or beneficial. Impact reduction
measures are presented in the Draft EIS
to reduce potential adverse effects.
GSA is currently undergoing formal
consultation with the State Historic
Preservation Officer (SHPO) and
consulting parties to follow
coordination procedures as required
under section 106 of the NHPA to
determine impacts to historic
properties. Mitigation measures may be
determined in consultation between
GSA, SHPO, and applicable consulting
parties.
GSA is in the process of conducting
informal consultation with the U.S. Fish
and Wildlife Service (USFWS) under
section 7 of the Endangered Species Act
to determine potential effects to
federally protected species and
migratory birds. GSA initiated
consultation with the USFWS regarding
the Lynden LPOE and Sumas LPOE and
is awaiting USFWS responses and
findings. Once received, USFWS
responses and findings would be
included in the Final EIS.
GSA coordinated with the Natural
Resources Conservation Service (NRCS)
via email concerning the Federal
Farmland Protection Policy Act
conversion impact rating forms
completed for both the Lynden and
Sumas LPOEs and is awaiting NRCS
responses and findings. Once received,
the NRCS responses and findings would
be included in the Final EIS.
The Sumas LPOE project area is
located within the 1-percent-annualchance floodplain (also referred to as
the base flood or 100-year flood) and
0.2-percent-annual-chance floodplain
(also referred to as the 500-year flood).
In compliance with Executive Order
11988 (Floodplain Management), GSA
prepared a Floodplain Assessment and
Statement of Findings addressing
potential impacts on floodplains, which
is included in the Draft EIS for public
review and comment. As described in
the Draft EIS, GSA would follow
Federal, state, and local regulatory
compliance requirements and
incorporate design standards at the
Sumas LPOE to minimize impacts to
floodplains.
Anamarie Crawley,
Director, R10 Facilities Management Division
Northwest/Arctic Region 10, U.S. General
Services Administration.
[FR Doc. 2024–17864 Filed 8–9–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Common Formats for Patient Safety
Data Collection
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of availability—new
common formats.
AGENCY:
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
(CFS–H) Version 1.0.
DATES: Ongoing public input.
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/surveillance
commonformats.
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:
pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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 to ensure that
health care quality and patient safety
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khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 155 / Monday, August 12, 2024 / Notices
data collected by PSOs and other
entities are comparable. The Common
Formats facilitate aggregation of
comparable data at local, PSO, regional
and national levels.
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 solicits 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 solicits review of the
formats by its Common Formats Expert
Panel. Subsequently, PSOPPC will
provide this input to AHRQ who then
uses it to refine the Common Formats.
At AHRQ, the Common Formats for
Surveillance—Hospitals (CFS–H) are
applied in the Quality and Safety
Review System (QSRS), a surveillance
system designed to detect and calculate
patient safety event rates through
retrospective in-patient record review.
QSRS uses the CFS–H Event
Descriptions to create standardized
specifications to ensure adverse events
are reliability identified across all
hospitals and records. 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.
The Common Formats for
Surveillance—Hospital Version 1.0 are
categorized into the following topic
areas (modules):
• Birth—Maternal
• Birth—Neonatal
• Blood or Blood Product
• Device
• Fall
• Hospital-Acquired Infection (HAI)
• Medication
• Other
• Pressure Injury
• Surgery or Anesthesia
• Venous Thromboembolism
At this time, AHRQ is releasing the
CFS–H Version 1.0 Event Descriptions
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and supporting materials, including an
overview and user guide, tabular
accounting, and technical release notes.
Comments can be provided on the
Common Formats for Surveillance—
Hospital Version 1.0 using the
commenting tool at: 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: August 7, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–17927 Filed 8–9–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
ACTION:
Notice.
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve a revision of the
currently approved information
collection project: ‘‘Patient Safety
Organization Certification for Initial
Listing and Related Forms, Patient
Safety Confidentiality Complaint Form,
and Common Formats.’’ In accordance
with the Paperwork Reduction Act of
1995, AHRQ invites the public to
comment on this proposed information
collection.
SUMMARY:
Comments on this notice must be
received by October 11, 2024.
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at
REPORTSCLEARANCEOFFICER@
ahrq.hhs.gov.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at
REPORTSCLEARANCEOFFICER@
ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Proposed Project
Patient Safety Organization
Certification for Initial Listing and
Related Forms, Patient Safety
Confidentiality Complaint Form, and
Common Formats
AHRQ requests that OMB approve a
revision to AHRQ’s collection of
information for the Patient Safety
Organization Certification for Initial
Listing and Related Forms, Patient
Safety Confidentiality Complaint Form,
and Common Formats: OMB Control
number 0935–0143, expiration
September 30th, 2024.
The Patient Safety and Quality
Improvement Act of 2005 (the Patient
Safety Act), signed into law on July 29,
2005, was enacted in response to
growing concern about patient safety in
the United States and the Institute of
Medicine’s 1999 report, To Err is
Human: Building a Safer Health System.
The Patient Safety Act signifies the
Federal Government’s commitment to
fostering a culture of patient safety
among health care providers; it offers a
mechanism for creating an environment
in which the causes of risks and hazards
to patient safety can be thoroughly and
honestly examined and discussed
without fear of penalties and liabilities.
It provides for the voluntary formation
of Patient Safety Organizations (PSOs)
that can collect, aggregate, and analyze
confidential information reported
voluntarily by health care providers. By
analyzing substantial amounts of patient
safety event information across multiple
institutions, PSOs are able to identify
patterns of failures and propose
measures to eliminate or reduce risks
and hazards.
In order to implement the Patient
Safety Act, the Department of Health
and Human Services (HHS) issued the
Patient Safety and Quality Improvement
Final Rule (Patient Safety Rule, 42 CFR
part 3), which became effective on
January 19, 2009. The Patient Safety
Rule outlines the requirements that
entities must meet to become and
remain listed as PSOs, the process by
which the Secretary of HHS (Secretary)
will accept certifications and list PSOs,
and provisions pertaining to the
confidentiality and privilege protections
for patient safety work product (PSWP).
When specific statutory requirements
are met, the information collected and
the analyses and deliberations regarding
the information receive confidentiality
and privilege protections under this
legislation. The Secretary delegated
authority to the Director of the Office for
Civil Rights (OCR) to interpret and
enforce the confidentiality protections
of the Patient Safety Act (Federal
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Agencies
[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65628-65629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17927]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
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 (CFS-H) Version 1.0.
DATES: Ongoing public input.
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: [email protected].
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 to ensure that
health care quality and patient safety
[[Page 65629]]
data collected by PSOs and other entities are comparable. The Common
Formats facilitate aggregation of comparable data at local, PSO,
regional and national levels.
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 solicits 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 solicits review
of the formats by its Common Formats Expert Panel. Subsequently, PSOPPC
will provide this input to AHRQ who then uses it to refine the Common
Formats.
At AHRQ, the Common Formats for Surveillance--Hospitals (CFS-H) are
applied in the Quality and Safety Review System (QSRS), a surveillance
system designed to detect and calculate patient safety event rates
through retrospective in-patient record review. QSRS uses the CFS-H
Event Descriptions to create standardized specifications to ensure
adverse events are reliability identified across all hospitals and
records. 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.
The Common Formats for Surveillance--Hospital Version 1.0 are
categorized into the following topic areas (modules):
Birth--Maternal
Birth--Neonatal
Blood or Blood Product
Device
Fall
Hospital-Acquired Infection (HAI)
Medication
Other
Pressure Injury
Surgery or Anesthesia
Venous Thromboembolism
At this time, AHRQ is releasing the CFS-H Version 1.0 Event
Descriptions and supporting materials, including an overview and user
guide, tabular accounting, and technical release notes.
Comments can be provided on the Common Formats for Surveillance--
Hospital Version 1.0 using the commenting tool at: 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: August 7, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-17927 Filed 8-9-24; 8:45 am]
BILLING CODE 4160-90-P