Common Formats for Patient Safety Data Collection and Event Reporting, 9214-9215 [2014-03492]
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9214
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: January 29, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–03482 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Common Formats for Patient Safety
Data Collection and Event Reporting
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) for reporting patient safety
events to Patient Safety Organizations
(PSOs) and other entities. The purpose
of this notice is to announce the
availability of a new type of Common
Formats for public review and
comment—Common Formats for
Surveillance—Hospital.
DATES: Ongoing public input.
ADDRESSES: The newly released
Common Formats for Surveillance—
Hospital—which includes modules
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:58 Feb 14, 2014
Jkt 232001
entitled Generic Adverse Event
Information, Blood or Blood Product,
Delivery-Maternal, Delivery-Neonatal,
Device or Medical/Surgical Supply
Including Health Information
Technology (HIT), Fall, Medications,
Pressure Ulcer, Readmissions, Surgery
or Anesthesia, Venous
Thromboembolism, and Other
Outcomes of Interest—can be accessed
electronically at the following HHS Web
site: https://www.PSO.AHRQ.gov/
index.html
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 and Quality
Improvement Act of 2005, 42 U.S.C.
299b-21 to b-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 PSOs, which collect,
aggregate, and analyze confidential
information regarding the quality and
safety of healthcare delivery. The
Patient Safety Act (at 42 U.S.C. 299b24(b)(1)(F)) requires PSOs to collect
information from providers in a
standardized manner that permits valid
comparisons of similar cases among
similar providers, to the extent practical
and appropriate. As explained in 42
CFR 3.102(b)(1)(iii)(A)(1), one option for
a PSO to satisfy this requirement is by
certifying that it is using the Secretary’s
published guidance for common formats
and definitions in its collection of
information from healthcare providers.
The Patient Safety Act and Patient
Safety Rule establish a framework by
which doctors, hospitals, skilled
nursing facilities, and other healthcare
providers may assemble 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
conduct patient safety activities, which
may include identifying events, patterns
of care, and unsafe conditions that
increase risks and hazards to patients.
Definitions and other details about PSOs
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
and patient safety work product are
included in the Patient Safety Act and
Patient Safety Rule which can be
accessed electronically at: https://
www.PSO.AHRQ.gov/REGULATIONS/
REGULATIONS.htm.
Definition of Common Formats
The term Common Formats refers to
the common definitions and reporting
formats, specified by AHRQ, that allow
healthcare providers to collect and
submit standardized information
regarding patient safety events. The
Common Formats are not intended to
replace any current mandatory reporting
system, collaborative/voluntary
reporting system, research-related
reporting system, or other reporting/
recording system; rather the formats are
intended to enhance the ability of
healthcare providers to report
information that is standardized both
clinically and electronically.
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 scope of Common
Formats applies to all patient safety
concerns including: Incidents—patient
safety events that reached the patient,
whether or not there was harm; near
misses or close calls—patient safety
events that did not reach the patient;
and unsafe conditions—circumstances
that increase the probability of a patient
safety event.
Until now, Common Formats have
been designed to support only
traditional event reporting. Common
Formats for Surveillance—Hospital are
designed to provide, through
retrospective review of medical records,
information that is complementary to
that derived from event reporting
systems. These formats will facilitate
improved detection of events and
calculation of adverse event rates in
populations reviewed.
Common Formats Development
In anticipation of the need for
Common Formats, AHRQ began their
development by creating an inventory of
functioning private and public sector
patient safety reporting systems. This
inventory provides an evidence base
that informed construction of the
Common Formats. The inventory
includes many systems from the private
sector, including academic settings,
hospital systems, and international
reporting systems (e.g., from the United
Kingdom and the Commonwealth of
E:\FR\FM\18FEN1.SGM
18FEN1
Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Australia). In addition, virtually all
major Federal patient safety reporting
systems are included, such as those
from the Centers for Disease Control and
Prevention (CDC), the Food and Drug
Administration (FDA), the Department
of Defense (DoD), and the Department of
Veterans Affairs (VA).
Since February 2005, AHRQ has
convened the PSWG to assist AHRQ
with developing and maintaining the
Common Formats. The PSWG includes
major health agencies within HHS—
CDC, Centers for Medicare and
Medicaid Services, FDA, 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 DoD and
VA.
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. The PSWG assists AHRQ
with assuring the consistency of
definitions/formats with those of
relevant government agencies as
refinement of the Common Formats
continues. To the extent practicable, the
Common Formats are also aligned with
World Health Organization (WHO)
concepts, framework, and definitions for
patient safety.
Commenting on Common Formats:
Common Formats for Surveillance—
Hospital
To allow for greater participation by
the private sector in the subsequent
development of the Common Formats,
AHRQ engaged the NQF, a non-profit
organization focused on health care
quality, to solicit comments and advice
to guide the further refinement of the
Common Formats. The NQF then
convenes an expert panel to review the
comments received and provide
feedback. Based upon the expert panel’s
feedback, AHRQ, in conjunction with
the PSWG, revises and refines the
Common Formats.
The Agency is specifically interested
in obtaining feedback from both the
private and public sectors to guide the
improvement of the formats.
Information on how to comment and
provide feedback on the Common
Formats for Surveillance—Hospital is
available at: https://
VerDate Mar<15>2010
20:58 Feb 14, 2014
Jkt 232001
www.Qualityforum.ORG/projects/
commonformats.aspx.
More information about the Common
Formats can be obtained through
AHRQ’s PSO Web site: https://
www.PSO.AHRQ.gov/.
Dated: February 6, 2014.
Richard Kronick,
Director.
9215
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03350 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2014–03492 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0283]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Final Guidance for Industry on
Chemistry, Manufacturing, and
Controls Postapproval Manufacturing
Changes To Be Documented in Annual
Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Final Guidance for Industry on
Chemistry, Manufacturing, and Controls
Postapproval Manufacturing Changes to
be Documented in Annual Reports ’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 6, 2013; the Agency
submitted a proposed collection of
information entitled ‘‘Final Guidance
for Industry on Chemistry,
Manufacturing, and Controls
Postapproval Manufacturing Changes to
be Documented in Annual Reports’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0758. The
approval expires on January 31, 2017. A
copy of the supporting statement for this
information collection is available on
SUMMARY:
PO 00000
Frm 00059
Fmt 4703
Sfmt 9990
[Docket No. FDA–2013–N–0795]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Medical Devices; Third Party Review
Under the Food and Drug
Administration Modernization Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Medical Devices; Third Party Review
Under the Food and Drug
Administration Modernization Act
(FDAMA)’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
December 19, 2013, the Agency
submitted a proposed collection of
information entitled ‘‘Medical Devices;
Third Party Review Under FDAMA’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0375. The
approval expires on January 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
Dated: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03354 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\18FEN1.SGM
18FEN1
]]>Agencies
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9214-9215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03492]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Common Formats for Patient Safety Data Collection and Event
Reporting
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) for reporting patient safety events to Patient Safety
Organizations (PSOs) and other entities. The purpose of this notice is
to announce the availability of a new type of Common Formats for public
review and comment--Common Formats for Surveillance--Hospital.
DATES: Ongoing public input.
ADDRESSES: The newly released Common Formats for Surveillance--
Hospital--which includes modules entitled Generic Adverse Event
Information, Blood or Blood Product, Delivery-Maternal, Delivery-
Neonatal, Device or Medical/Surgical Supply Including Health
Information Technology (HIT), Fall, Medications, Pressure Ulcer,
Readmissions, Surgery or Anesthesia, Venous Thromboembolism, and Other
Outcomes of Interest--can be accessed electronically at the following
HHS Web site: https://www.PSO.AHRQ.gov/
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 and Quality Improvement Act of 2005, 42 U.S.C.
299b-21 to b-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 PSOs, which collect,
aggregate, and analyze confidential information regarding the quality
and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C.
299b-24(b)(1)(F)) requires PSOs to collect information from providers
in a standardized manner that permits valid comparisons of similar
cases among similar providers, to the extent practical and appropriate.
As explained in 42 CFR 3.102(b)(1)(iii)(A)(1), one option for a PSO to
satisfy this requirement is by certifying that it is using the
Secretary's published guidance for common formats and definitions in
its collection of information from healthcare providers.
The Patient Safety Act and Patient Safety Rule establish a
framework by which doctors, hospitals, skilled nursing facilities, and
other healthcare providers may assemble 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
conduct patient safety activities, which may include identifying
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 Act and
Patient Safety Rule which can be accessed electronically at: https://www.PSO.AHRQ.gov/REGULATIONS/REGULATIONS.htm.
Definition of Common Formats
The term Common Formats refers to the common definitions and
reporting formats, specified by AHRQ, that allow healthcare providers
to collect and submit standardized information regarding patient safety
events. The Common Formats are not intended to replace any current
mandatory reporting system, collaborative/voluntary reporting system,
research-related reporting system, or other reporting/recording system;
rather the formats are intended to enhance the ability of healthcare
providers to report information that is standardized both clinically
and electronically.
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 scope of Common Formats applies to
all patient safety concerns including: Incidents--patient safety events
that reached the patient, whether or not there was harm; near misses or
close calls--patient safety events that did not reach the patient; and
unsafe conditions--circumstances that increase the probability of a
patient safety event.
Until now, Common Formats have been designed to support only
traditional event reporting. Common Formats for Surveillance--Hospital
are designed to provide, through retrospective review of medical
records, information that is complementary to that derived from event
reporting systems. These formats will facilitate improved detection of
events and calculation of adverse event rates in populations reviewed.
Common Formats Development
In anticipation of the need for Common Formats, AHRQ began their
development by creating an inventory of functioning private and public
sector patient safety reporting systems. This inventory provides an
evidence base that informed construction of the Common Formats. The
inventory includes many systems from the private sector, including
academic settings, hospital systems, and international reporting
systems (e.g., from the United Kingdom and the Commonwealth of
[[Page 9215]]
Australia). In addition, virtually all major Federal patient safety
reporting systems are included, such as those from the Centers for
Disease Control and Prevention (CDC), the Food and Drug Administration
(FDA), the Department of Defense (DoD), and the Department of Veterans
Affairs (VA).
Since February 2005, AHRQ has convened the PSWG to assist AHRQ with
developing and maintaining the Common Formats. The PSWG includes major
health agencies within HHS--CDC, Centers for Medicare and Medicaid
Services, FDA, 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 DoD and VA.
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. The PSWG assists AHRQ with
assuring the consistency of definitions/formats with those of relevant
government agencies as refinement of the Common Formats continues. To
the extent practicable, the Common Formats are also aligned with World
Health Organization (WHO) concepts, framework, and definitions for
patient safety.
Commenting on Common Formats: Common Formats for Surveillance--Hospital
To allow for greater participation by the private sector in the
subsequent development of the Common Formats, AHRQ engaged the NQF, a
non-profit organization focused on health care quality, to solicit
comments and advice to guide the further refinement of the Common
Formats. The NQF then convenes an expert panel to review the comments
received and provide feedback. Based upon the expert panel's feedback,
AHRQ, in conjunction with the PSWG, revises and refines the Common
Formats.
The Agency is specifically interested in obtaining feedback from
both the private and public sectors to guide the improvement of the
formats. Information on how to comment and provide feedback on the
Common Formats for Surveillance--Hospital is available at: https://www.Qualityforum.ORG/projects/commonformats.aspx.
More information about the Common Formats can be obtained through
AHRQ's PSO Web site: https://www.PSO.AHRQ.gov/.
Dated: February 6, 2014.
Richard Kronick,
Director.
[FR Doc. 2014-03492 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-90-P
