[Federal Register Volume 74, Number 169 (Wednesday, September 2, 2009)]
[Notices]
[Pages 45457-45458]
From the Federal Register Online via the Government Publishing 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: <a href="/cdn-cgi/l/email-protection#3343405c73525b41421d5b5b401d545c45"><span class="__cf_email__" data-cfemail="f181829eb190998380df999982df969e87">[email protected]</span></a>.

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:
    <bullet> Descriptions of patient safety events and unsafe 
conditions to be reported,
    <bullet> Delineation of data elements to be collected for specific 
types of events,
    <bullet> Specifications for patient safety population reports,
    <bullet> Technical specifications for electronic data collection 
and reporting, and
    <bullet> 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:
    <bullet> Incidents--patient safety events that reached the patient, 
whether or not there was harm,
    <bullet> Near misses or close calls--patient safety events that did 
not reach the patient, and
    <bullet> 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]
BILLING CODE 4160-90-M


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