[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Pages 65359-65360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26667]



Agency for Healthcare Research and Quality

Common Formats for Patient Safety Data Collection and Event 

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Notice of availability--revised and enhanced event-specific 
common format.


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].



    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 
    The scope of Common Formats applies to all patient safety concerns 
    [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,
[FR Doc. 2010-26667 Filed 10-21-10; 8:45 am]