[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45457-45458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21080]
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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--Common Formats Version 1.0.
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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 initial release of the
formats, Version 0.1 Beta, was announced in the Federal Register on
August 29, 2008: 73 FR 50974-50976. The purpose of this notice is to
announce the availability of the expanded and enhanced Common Formats
Version 1.0 and the process for their continued development and
refinement.
DATES: Ongoing public input.
ADDRESSES: The 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;
E-mail: pso@ahrq.hhs.gov.
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
[[Page 45458]]
underlying causal factors of patient safety problems. 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.
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. AHRQ's Common Formats include:
Descriptions of patient safety events and unsafe
conditions to be reported,
Delineation of data elements to be collected for specific
types of events,
Specifications for patient safety population reports,
Technical specifications for electronic data collection
and reporting, and
A user's guide.
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.
Score of Common Formats
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.
Version 1.0 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.
The Common Formats Version 1.0 has a defined focus on patient
safety reporting for acute care hospitals. It should be noted, however,
that the Patient Safety Act and Patient Safety Rule confer both
privilege and confidentiality on all patient safety work product
developed under the aegis of a PSO with respect to healthcare in any
setting. AHRQ anticipates expanding future versions of the Common
Formats to include other settings such as: Nursing homes and other
bedded facilities; ambulatory surgery centers; other ambulatory care
settings, including community health centers, rehabilitation centers,
and hemodialysis centers; physician and practitioner offices; and
retail establishments such as pharmacies.
Common Formats Development
AHRQ established a process to develop Common Formats that: (1) Is
evidence based; (2) harmonizes across governmental health agencies; (3)
incorporates feedback from the private sector, including professional
associations/organizations, those who use the formats, and the public;
and (4) permits timely updating of these clinically-sensitive formats.
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 66 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).
In addition, AHRQ convened 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
Department--CDC, Centers for Medicare and Medicaid Services, FDA,
Health Resources and Services Administration, the Indian Health
Service, the National Institutes of Health, the National Library of
Medicine, the Office of the National Coordinator for Health Information
Technology, the Office of Public Health and Science, the Substance
Abuse and Mental Health Services Administration--as well as the DoD and
the VA.
Subsequently, AHRQ, in conjunction with the PSWG, developed and
released Common Formats Version 0.1 Beta. To the extent practicable,
the Common Formats were aligned with World Health Organization (WHO)
concepts, framework, and definitions contained in their draft
International Classification for Patient Safety (ICPS). 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 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 healthcare
quality, to solicit comments and advice to guide the further refinement
of the Common Formats. The NQF convened an expert panel to review the
comments received on Version 0.1 Beta and provide feedback to AHRQ.
Based upon the expert panel's feedback, AHRQ, in conjunction with the
PSWG, further revised and refined the Common Formats that are now
available as Version 1.0.
Commenting on Common Formats Version 1.0
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. Although AHRQ's Version 1.0
has been developed based on evidence, consensus of the PSWG, public
comments and input, and feedback from the NQF expert panel, the formats
do not yet reflect the refinement that will come from large-scale use
and repeated revision. The process for updating and refining the
formats will be an iterative one. AHRQ anticipates that it will receive
helpful guidance from early users of the Common Formats.
The NQF will continue to assist AHRQ in updating future versions of
the formats by soliciting public comments from providers, professional
organizations, the general public, PSOs, and other users of Common
Formats. More information on the Common Formats Version 1.0, including
the feedback process, can be obtained through AHRQ's PSO Web site:
http://www.pso.ahrq.gov/index.html.
Dated: August 26, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-21080 Filed 9-1-09; 8:45 am]
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