[Federal Register Volume 77, Number 72 (Friday, April 13, 2012)]
[Notices]
[Pages 22322-22324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-8743]


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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: As authorized by the Secretary of HHS, AHRQ coordinates the 
development of a set of common definitions and reporting formats 
(Common Formats) for reporting patient safety events to Patient Safety 
Organizations (PS0s). The purpose of this notice is to announce the 
availability of new Common Formats--Hospital Version 1.2 for public 
review and comment.

DATES: Ongoing public input.

ADDRESSES: The new Common Formats--Hospital Version 1.2, version dated 
April 2012, 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: Cathryn Niane, Center for Quality 
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 
20850; Telephone (toll free): (866) 403-3697;

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Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY 
(local): (301) 427-1130; Email: PSO.AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Background

    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 
PS0s, 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 healthcare providers to 
voluntarily collect and submit 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. The collection of patient safety 
work product allows the aggregation of sufficient data to identify and 
address underlying causal factors of patient safety problems.
    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other healthcare providers may assemble 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 Act 
and Patient Safety Rule which can be accessed electronically at: http://www.PSO.AHRQ.gov/REGULATIONS/REGULATIONS.htm.

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.
    In collaboration with the interagency Federal Patient Safety 
Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ 
has developed Common Formats for two settings of care--acute care 
hospitals and skilled nursing facilities--in order to facilitate 
standardized data collection. 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.
    AHRQ's Common Formats include:
    <bullet> Event descriptions (descriptions of patient safety events 
and unsafe conditions to be reported);
    <bullet> Specifications for patient safety aggregate reports and 
individual event summaries;
    <bullet> Delineation of data elements to be collected for different 
types of events to populate the reports;
    <bullet> A user's guide and quick guide, and
    <bullet> Technical specifications for electronic data collection 
and reporting.
    The technical specifications promote standardization of collected 
patient safety event information by specifying rules for data 
collection and submission, as well 'as by providing guidance for how 
and when to create data elements, their valid values, conditional and 
go-to logic, and reports. These specifications will ensure that data 
collected by PSOs and other entities have comparable clinical meaning. 
They also provide direction to software developers, so that the Common 
Formats can be implemented electronically, and to PS0s, so that the 
Common Formats can be submitted electronically to the PSO Privacy 
Protection Center (PPC) for data de-identification and transmission to 
the Network of Patient Safety Databases (NPSD).
    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.
    Since the initial release of the Common Formats in August 2008, 
AHRQ regularly revises the formats based upon public comment. The 
Common Formats--Hospital Version 1.2 features new content to 
incorporate the event specific formats entitled Venous Thromboembolism 
(VTE) and Device or Medical/Surgical Supply including Health 
Information Technology (HIT) Device. Common Formats--Hospital Version 
1.2, which also includes minor changes to existing modules and 
technical specifications, is available at the PSO PPC Web site: https://www.PSOPPC.ORG/web/patientsafety.

Common Formats Development

    In anticipation of the need for Common Formats, AHRQ began their 
development 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 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 convened the PSWG to assist AHRQ with 
developing and maintaining the Common Formats. The PSWG includes major 
health agencies within HHS--CDC, Centers for Medicare & Medicaid 
Services, FDA, Health Resources and Services Administration, Indian 
Health Service, National Institutes of Health, National Library of 
Medicine, Office of the National Coordinator for Health Information 
Technology, Office of Public Health and Science, and Substance Abuse 
and Mental Health Services Administration--as well as the DoD and VA.
    When developing Common Formats, AHRQ first reviews existing patient 
safety event reporting systems from a variety of health care 
organizations. In collaboration with the PSWG and Federal subject 
matter experts, AHRQ drafts and releases beta versions of the Common 
Formats for public review and comment. 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

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contained in their draft International Classification for Patient 
Safety (ICPS).

Commenting on Common Formats Hospital 1.2

    To allow for greater participation by the private sector in the 
subsequent development of the Common Formats, AHRQ engaged the 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 then convenes an expert panel to review the comments 
received and provide feedback. 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 the PSWG, 
revises and refines the Common Formats.
    The Agency is specifically interested in obtaining feedback from 
both the private and public sectors on the new Common Formats--Hospital 
Version 1.2 to guide the improvement of the formats. Information on how 
to comment and provide feedback on the Common Formats--Hospital Version 
1.2, is available at the NQF Web site for Common Formats: http://www.Quality.forum.ORG/projects/commonformats.aspx.
    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: April 5, 2012.
Carolyn M. Clancy,
Director.
[FR Doc. 2012-8743 Filed 4-12-12; 8:45 am]
BILLING CODE 4160-90-M