[Federal Register Volume 76, Number 44 (Monday, March 7, 2011)]
[Pages 12358-12359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4813]



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--new 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 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.



    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 
     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-

[[Page 12359]]

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,
[FR Doc. 2011-4813 Filed 3-4-11; 8:45 am]