[Federal Register Volume 76, Number 211 (Tuesday, November 1, 2011)]
[Notices]
[Pages 67456-67457]
From the Federal Register Online via the Government Publishing 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: [email protected].

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]
BILLING CODE 4160-90-M