[Federal Register Volume 76, Number 44 (Monday, March 7, 2011)]
[Notices]
[Pages 12358-12359]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4813]
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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
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 new beta version of the Common
Format for Skilled Nursing Facilities for public review and comment.
DATES: Ongoing public input.
ADDRESSES: The new beta version of the Ski/led Nursing Facilities
format (version dated February 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: 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; ITY (local): (301) 427-1130;
E-mail: 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 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, including any relevant guidance, can be accessed electronically
at: http://www.PSO.AHRQ.gov/regulations/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,
developed for acute care hospitals. 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. As an
update to this release, AHRQ developed the beta version of an event-
specific format--Device or Supply, including Health Information
Technology--to capture information about patient safety events that are
related to health information technology. This update was announced in
the Federal Register on October 22, 2010: 75 FR 65359-65360. With the
release of the beta version of the Skilled Nursing Facilities format,
AHRQ has made available Common Formats for two settings of care--acute
care hospitals and skilled nursing facilities.
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.
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.
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-
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occurring and/or serious patient safety events. The skilled nursing
facilities event-specific formats are: Device or Supply, including
Health Information Technology; Fall; Healthcare-Associated Infection;
Medication or Other Substance; and Pressure Ulcer.
This new 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 in skilled
nursing facilities. The Skilled Nursing Facilities Common Format is
available at the PSO Privacy Protection Center (PPC) Web site: https://www.psoppc.org/web/patientsafety.
Commenting on Skilled Nursing Facilities 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. 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. The latest version of the
formats is Version 1.1.
The Agency is specifically interested in obtaining feedback from
both the private and public sectors on this new format for skilled
nursing facilities to guide their improvement. Information on how to
comment and provide feedback on the Common Formats, the Skilled Nursing
Facilities 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), the Food and Drug
Administration (FDA), the Department of Defense (DoD), and the
Department of Veterans Affairs (VA).
Since February 2005, AHRQ has coordinated an interagency Federal
Patient Safety Work Group (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, 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: February 23, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-4813 Filed 3-4-11; 8:45 am]
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