[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65359-65360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26667]
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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--revised and enhanced event-specific
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
healthcare 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. As authorized
by the Secretary of HHS, AHRQ coordinates the development of a set of
common definitions and reporting formats (Common Formats) that allow
healthcare providers to voluntarily collect and submit standardized
information regarding patient safety events. The purpose of this notice
is to announce the availability of a significant revision of a
previously released Common Format for public review and comment.
DATES: Ongoing public input.
ADDRESSES: The revised Device or Medical/Surgical Supply including
Health Information Technology (HIT) Device format and the remaining
Common Formats Version 1.1 can be accessed electronically at the
following HHS Web site: http://www.PSO.AHRQ.gov/index.html.
FOR FURTHER INFORMATION CONTACT: Deborah Perfetto, 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;
E-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act and Patient Safety Rule establish a
framework by which doctors, hospitals, and other healthcare 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 practical 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 can be accessed electronically at: http://www.PSO.AHRQ.gov/requlations/regulations.htm.
In order to facilitate standardized data collection, the Secretary
of HHS authorized AHRQ to develop and maintain the Common Formats to
improve the safety and quality of healthcare delivery. In August 2008,
AHRQ issued the initial release of the formats, Version 0.1 Beta. The
second release of the Common Formats, Version 1.0, was announced in the
Federal Register on September 2, 2009: 74 FR 45457-45458. This release
was later replaced by Version 1.1, as announced in the Federal Register
on March 31, 2010: 75 FR 16140-16142.
Version 1.1 includes updated event descriptions, forms, and
technical specifications for software developers.
Definition of Common Formats
The term ``Common Formats'' is used to describe clinical
definitions and technical requirements developed for the uniform
collection and reporting of patient safety data, including all
supporting material. 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.
The scope of Common Formats applies to all patient safety concerns
including:
[cir] Incidents--patient safety events that reached the patient,
whether or not there was harm,
[cir] Near misses or close calls--patient safety events that did
not reach the patient, and
[[Page 65360]]
[cir] Unsafe conditions--circumstances that increase the
probability of a patient safety event.
Common Formats Version 1.1 is currently limited to patient safety
reporting for acute care hospitals and is designed to support the first
stage in the improvement cycle. Version 1.1 includes 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. The eight
event-specific formats are: Blood or Blood Product, Device or Medical/
Surgical Supply, Fall, Healthcare-Associated Infection, Medication or
Other Substance, Perinatal, Pressure Ulcer, and Surgery or Anesthesia.
As part of the Agency's efforts to continually refine and update
the formats, AHRQ has issued a significant revision of the previously
released Common Format--Device or Medical/Surgical Supply. In
conjunction with the Food and Drug Administration (FDA) and the Office
of the National Coordinator for Health Information Technology (ONC),
AHRQ developed the beta version of this event-specific format to
capture information about patient safety events that are related to
HIT. Subsequently, the format was reviewed and revised by an
interagency Federal Patient Safety Work Group (PSWG). The enhanced
format, Device or Medical/Surgical Supply including HIT Device, will be
incorporated into the next version of the Common Formats (Version 1.2).
This revised format includes a description of patient safety events
and unsafe conditions to be reported (event description) and a sample
patient safety aggregate report and individual event summary. The
Device or Medical/Surgical Supply including HIT Device Common Format is
available at the Patient Safety Organization (PSO) Privacy Protection
Center (PPC) Web site: https://www.psoppc.org/web/patientsafety.
Commenting on Device or Medical/Surgical Supply Including HIT Device
Common Format, Version 1.1
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. Based upon the expert
panel's feedback, AHRQ, in conjunction with the PSWG, further revised
and refined the Common Formats and released Version 1.0.
The review process above was repeated again from September 2009
through February 2010 to further refine Common Formats Version 1.0 and
incorporate public comments prior to finalization of the technical
specifications for electronic implementation. These revised formats are
now available as Version 1.1.
As evidenced by the release of this Device or Medical/Surgical
Supply including HIT Device format, AHRQ is committed to continuing
refinement of the Common Formats. The Agency is specifically interested
in obtaining feedback from both the private and public sectors,
particularly from those who use the Common Formats, to guide their
improvement. Information on how to comment and provide feedback on the
Common Formats, Version 1.1 and the Device or Medical/Surgical Supply
including HIT Device 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 now numbers 69 and 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), 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 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, 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. 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. More information on the Common Formats Version 1.1
can be obtained through AHRQ's PSO Web site: http://www.PSO.AHRQ.qov/index.html.
Dated: October 12, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-26667 Filed 10-21-10; 8:45 am]
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