Common Formats for Patient Safety Data Collection and Event Reporting, 42736-42737 [2012-17529]
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42736
Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
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), HHS.
ACTION: Notice of Availability—New
Common Format.
AGENCY:
As authorized by the
Secretary of HHS, AHRQ coordinates
the development of a set of common
definitions and reporting formats
(Common Formats) for reporting patient
safety events to Patient Safety
Organizations (PSOs). The purpose of
this notice is to announce the
availability of a new Common Format—
Readmissions Version 0.1 Beta for
public review and comment.
DATES: Ongoing public input.
ADDRESSES: The new Common Format—
Readmissions Version 0.1 Beta, version
dated July 2012—and the remaining
Common Formats can be accessed
electronically at the following HHS Web
site: https://www.PSO.AHRQ.gov/
index.html.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Cathryn Niane, 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:
mstockstill on DSK4VPTVN1PROD with NOTICES
Background
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 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–23) authorizes healthcare
providers to voluntarily collect and
submit 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. This collection allows the
aggregation of sufficient data to identify
and address underlying causal factors of
patient safety problems.
The Patient Safety Act and Patient
Safety Rule establish a framework by
which doctors, hospitals, skilled
VerDate Mar<15>2010
18:18 Jul 19, 2012
Jkt 226001
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 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 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
health care 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 health
care 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.
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.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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. They 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 (PPC) for data
de-identification and transmission to
the Network of Patient Safety Databases
(NPSD).
Since the initial release of the
Common Formats in August 2008,
AHRQ has regularly revised the formats
based upon public comment. Most
recently, AHRQ and the PSWG
developed Common Format—
Readmissions Version 0.1 Beta to allow
hospitals to aggregate data that describe
circumstances associated with the
readmission of patients. These factors
include actions taken at the index
hospitalization to prevent a
readmission, risk factors for
readmission, length of stay, presence of
an adverse event, location of discharge
setting, as well as other attributes. Using
this standardized method of review,
hospitals can identify factors associated
with unnecessary readmissions. In
addition, hospitals can compare their
data to others and analyze trends on a
community, regional, and national level.
The Common Format—Readmissions
Version 0.1 Beta, dated July 2012, is
available at the PSO PPC Web site:
https://www.PSOPPC.ORG/web/
patientsafety.
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 informs construction of the
Common Formats. The inventory
includes many systems from the private
sector, including prominent academic
settings, hospital systems, and
international reporting systems (e.g.,
from the United Kingdom and the
Commonwealth of 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
E:\FR\FM\20JYN1.SGM
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Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices
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 & 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
contained in their draft International
Classification for Patient Safety (ICPS).
mstockstill on DSK4VPTVN1PROD with NOTICES
Commenting on Common Format—
Readmissions Version 0.1 Beta
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. The NQF began this process
with feedback on AHRQ’s 0.1 Beta
release of the Common Formats in 2008.
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 on the new
Common Format—Readmissions
Version 0.1 Beta to guide the
improvement of the formats.
Information on how to comment and
provide feedback on the Common
Format—Readmissions Version 0.1 Beta
is available at the NQF Web site for
Common Formats: https://
VerDate Mar<15>2010
18:18 Jul 19, 2012
Jkt 226001
www.Quality.forum.ORG/projects/
commonformats.aspx.
The process for updating and refining
the formats will continue to be an
iterative one. Future versions of the
Common Formats will be developed for
ambulatory settings, such as ambulatory
surgery centers and physician and
practitioner offices. More information
on the Common Formats can be
obtained through AHRQ’s PSO Web site:
https://www.PSO.AHRQ.gov/.
Dated: July 13, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–17529 Filed 7–19–12; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations: Delisting
for Cause for The Steward Group PSO
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Notice of delisting.
AGENCY:
AHRQ has delisted The
Steward Group PSO as a Patient Safety
Organization (PSO) due to its failure to
correct a deficiency. The Patient Safety
and Quality Improvement Act of 2005
(Patient Safety Act) authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity is to
conduct activities to improve patient
safety and the quality of health care
delivery. HHS issued the Patient Safety
and Quality Improvement Final Rule
(Patient Safety Rule) to implement the
Patient Safety Act. AHRQ administers
the provisions of the Patient Safety Act
and Patient Safety Rule relating to the
listing and operation of PSOs.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on June 19, 2012.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.PSO.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, 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.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 9990
42737
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act, Public Law
109–41, 42 U.S.C. 299b–21—b–26,
provides for the formation of PSOs,
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of health care
delivery. The Patient Safety Rule, 42
CFR part 3, authorizes AHRQ, on behalf
of the Secretary of HHS, to list as a PSO
an entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found no longer to
meet the requirements of the Patient
Safety Act and Patient Safety Rule.
Section 3.108(d) of the Patient Safety
Rule requires AHRQ to provide public
notice when it removes an organization
from the list of federally approved
PSOs.
The Steward Group PSO failed to
respond to a Notice of Preliminary
Finding of Deficiency sent by AHRQ
pursuant to 42 CFR 3.108(a)(2) and a
Notice of Proposed Revocation and
Delisting sent by AHRQ pursuant to 42
CFR 3.108(a)(3)(iii)(C) which found that
The Steward Group PSO failed to have,
within every 24-month period following
the PSO’s date of initial listing, at least
two bona fide contracts with different
providers for the purpose of receiving
and reviewing patient safety work
product, and to notify AHRQ no later
than 45 calendar days prior to the last
day of the pertinent 24-month period
that the PSO has met this requirement.
The Steward Group PSO did not
exercise its opportunity to be heard in
writing to respond to the deficiencies
specified in the notices, and has not
provided any evidence of a good faith
effort to correct the deficiency.
Accordingly, AHRQ has revoked the
listing of The Steward Group PSO, PSO
number P0088, a component entity of
The Steward Group, Inc., effective at
12:00 Midnight ET (2400) on June 19,
2012.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.PSO.AHRQ.gov/
index.html.
Dated: July 3, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012–17532 Filed 7–19–12; 8:45 am]
BILLING CODE 4160–90–M
E:\FR\FM\20JYN1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Notices]
[Pages 42736-42737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17529]
[[Page 42736]]
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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), HHS.
ACTION: Notice of Availability--New Common Format.
-----------------------------------------------------------------------
SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the
development of a set of common definitions and reporting formats
(Common Formats) for reporting patient safety events to Patient Safety
Organizations (PSOs). The purpose of this notice is to announce the
availability of a new Common Format--Readmissions Version 0.1 Beta for
public review and comment.
DATES: Ongoing public input.
ADDRESSES: The new Common Format--Readmissions Version 0.1 Beta,
version dated July 2012--and the remaining Common Formats can be
accessed electronically at the following HHS Web site: https://www.PSO.AHRQ.gov/.
FOR FURTHER INFORMATION CONTACT: Cathryn Niane, 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) provides 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-23) authorizes healthcare providers to
voluntarily collect and submit 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. This collection allows the
aggregation of sufficient data to identify and address underlying
causal factors of patient safety problems.
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
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 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 health care 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 health care
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.
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.
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.
They 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 (PPC) for data de-identification and transmission to
the Network of Patient Safety Databases (NPSD).
Since the initial release of the Common Formats in August 2008,
AHRQ has regularly revised the formats based upon public comment. Most
recently, AHRQ and the PSWG developed Common Format--Readmissions
Version 0.1 Beta to allow hospitals to aggregate data that describe
circumstances associated with the readmission of patients. These
factors include actions taken at the index hospitalization to prevent a
readmission, risk factors for readmission, length of stay, presence of
an adverse event, location of discharge setting, as well as other
attributes. Using this standardized method of review, hospitals can
identify factors associated with unnecessary readmissions. In addition,
hospitals can compare their data to others and analyze trends on a
community, regional, and national level. The Common Format--
Readmissions Version 0.1 Beta, dated July 2012, is available at the PSO
PPC Web site: https://www.PSOPPC.ORG/web/patientsafety.
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 informs construction of the Common Formats. The
inventory includes many systems from the private sector, including
prominent academic settings, hospital systems, and international
reporting systems (e.g., from the United Kingdom and the Commonwealth
of 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
[[Page 42737]]
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 & 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
contained in their draft International Classification for Patient
Safety (ICPS).
Commenting on Common Format--Readmissions Version 0.1 Beta
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. The NQF began this process with feedback
on AHRQ's 0.1 Beta release of the Common Formats in 2008. 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 on the new Common Format--
Readmissions Version 0.1 Beta to guide the improvement of the formats.
Information on how to comment and provide feedback on the Common
Format--Readmissions Version 0.1 Beta is available at the NQF Web site
for Common Formats: https://www.Quality.forum.ORG/projects/commonformats.aspx.
The process for updating and refining the formats will continue to
be an iterative one. Future versions of the Common Formats will be
developed for ambulatory settings, such as ambulatory surgery centers
and physician and practitioner offices. More information on the Common
Formats can be obtained through AHRQ's PSO Web site: https://www.PSO.AHRQ.gov/.
Dated: July 13, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-17529 Filed 7-19-12; 8:45 am]
BILLING CODE 4160-90-M
