[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67456-67457]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27892]
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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.
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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 a set of common definitions and
reporting formats (Common Formats) that allow health care providers to
voluntarily collect and submit standardized information regarding
patient safety events. The purpose of this notice is to announce the
availability of a new beta version Common Format for Venous
Thromboembolism (VTE) for public review and comment.
DATES: Ongoing public input.
ADDRESSES: The new beta version of the Common Format for Venous
Thromboembolism (VTE), version dated October 2011, and the remaining
Common Formats, can be accessed electronically at the following HHS Web
site: http://www.PSO.AHRQ.gov/index.html.
FOR FURTHER INFORMATION CONTACT: Susan Grinder, 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. 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.
AHRQ develops and maintains the Common Formats in order to
facilitate standardized data collection and improve the safety and
quality of health care delivery. Since the initial release of the
Common Formats in August 2008, AHRQ regularly revises the formats based
upon public comment. Earlier this year, AHRQ released the beta version
of the Skilled Nursing Facilities format, as announced in the Federal
Register on March 7, 2011: 76 FR 12358-12359. With this release, AHRQ
had made available Common Formats for two settings of care--acute care
hospitals and skilled nursing facilities. The new beta version of the
Common Format for Venous Thromboembolism (VTE), which includes Deep
Vein Thrombosis (DVT) and Pulmonary Embolism (PE), will apply to both
settings of care.
Definition of Common Formats
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. 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.
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,
[[Page 67457]]
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.
The Common Formats include two general types of formats, generic
and event-specific. The generic Common Formats pertain to all patient
safety concerns. The three generic formats are: Healthcare Event
Reporting Form, Patient Information Form, and Summary of Initial
Report. The event-specific Common Formats pertain to frequently-
occurring and/or serious patient safety events. When used as designed,
the Common Formats allow collection of information on all harms to
patients: ``All-cause harm.''
The VTE format includes a description of the patient safety events
to be reported (event description), and a sample patient safety
aggregate report. The Venous Thromboembolism (VTE) Common Format is
available at the PSO Privacy Protection Center (PPC) Web site: https://www.psoppc.org/web/patientsafety.
Commenting on Venous Thromboembolism (VTE) Common Format
To allow for greater participation by the private sector in the
subsequent development of the Common Formats, AHRQ engaged the National
Quality Forum (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 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 an interagency
Federal Patient Safety Work Group (PSWG), revises and refines the
Common Formats.
The Agency is specifically interested in obtaining feedback from
both the private and public sectors on this new beta VTE format to
guide their improvement. Information on how to comment and provide
feedback on the Common Formats, including the Venous Thromboembolism
(VTE) beta version, is available at the National Quality Forum (NQF)
Web site for Common Formats: http://www.Quality.forum.org/projects/commonformats.aspx.
Common Formats Development
In anticipation of the need for Common Formats, AHRQ began their
development in 2005 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 systems from the private sector, including prominent
academic settings, hospital systems, and international reporting
systems (e.g., 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 of Defense (DoD), and the Department of Veterans Affairs
(VA).
Since February 2005, AHRQ has coordinated the PSWG to assist AHRQ
with developing and maintaining the Common Formats. The PSWG includes
major health agencies and offices within the HHS--CDC, Centers for
Medicare & Medicaid Services, FDA, Health Resources and Services
Administration, the Indian Health Service, the National Institutes of
Health, the National Library of Medicine, Office of Healthcare Quality,
Office of the National Coordinator for Health Information Technology
(ONC), the Office of Public Health and Science, the Substance Abuse and
Mental Health Services Administration--as well as the DoD and the VA.
The PSWG assists AHRQ with assuring the consistency of definitions/
formats with those of relevant government agencies as refinement of the
Common Formats continues. When developing Common Formats, AHRQ first
reviews existing patient safety event reporting systems from a variety
of health care organizations. Working with the PSWG and Federal subject
matter experts, AHRQ drafts and releases beta versions of the Common
Formats for public review and comment. 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).
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: http://www.PSO.AHRQ.gov/index.html.
Dated: October 20, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-27892 Filed 10-31-11; 8:45 am]
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