[Federal Register Volume 73, Number 169 (Friday, August 29, 2008)]
[Notices]
[Pages 50974-50976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-19910]


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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), DHHS.

ACTION: Notice of Availability--Common Formats for Safety Data 
Collection and Event Reporting.

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SUMMARY: The Patient Safety and Quality Improvement Act of 2005 
(Patient Safety Act) provides for the formation of Patient Safety 
Organizations (PSOs), which would collect and analyze confidential 
information reported by healthcare providers. 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 Notice of Proposed 
Rulemaking published in the Federal Register on February 12, 2008: 73 
FR 8112-8183. As requested by the Secretary of DHHS, AHRQ has 
coordinated the development of a set of common definitions and 
reporting formats (Common Formats) which would facilitate the voluntary 
collection of patient safety data and reporting of this information to 
PSOs. The purpose of this notice is to announce the initial release of 
the Common Formats, Version 0.1 Beta, and the process for development 
of future versions.

DATES: Ongoing public input.

ADDRESSES: The Common Formats can be accessed electronically at the 
following Web site of the Department of Health and Human Services: 
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#5e2e2d313d1e3f362c2f7036362d70393128"><span class="__cf_email__" data-cfemail="0f7f7c606c4f6e677d7e2167677c21686079">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Background

    The Patient Safety Act establishes a framework by which doctors, 
hospitals, and other health care providers may voluntarily report 
information on a privileged and confidential basis regarding patient 
safety events and quality of care. The Patient Safety Act provides for 
voluntary formation of PSOs, which can be public or private 
organizations, that collect, aggregate, and analyze information 
regarding the quality and safety of care delivered in any healthcare 
setting. Information that is assembled and developed by providers and 
PSOs--called ``patient safety work product''--is privileged and 
confidential; it can be used to identify patient safety events and 
unsafe conditions that increase risks to patients.
    The Patient Safety Act requires 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.
    One of the goals of the legislation is to allow aggregation of 
sufficient data to identify and address underlying causal factors of 
patient safety problems. In order to facilitate standardized data 
collection, the Secretary of DHHS requested AHRQ to coordinate the 
development of Common Formats for patient safety events.
    Definitions and other details about PSOs and patient safety work 
product have been prepared for publication at 42 CFR Part 3; a Notice 
of Proposed Rulemaking was published in the Federal Register on 
February 12, 2008, as noted above, and a final regulation implementing 
the Patient Safety Act is under review.

Definition of Common Formats

    The term Common Formats is used to describe technical requirements 
developed for the uniform collection and reporting of patient safety 
data, including all supporting material:
    <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,

[[Page 50975]]

    <bullet> Examples of patient safety population reports,
    <bullet> A metadata registry with data element attributes and 
technical specifications,
    <bullet> Paper forms to allow immediate implementation, and
    <bullet> A users guide.
    Common Formats delineate definitional and reporting specifications 
that will allow healthcare 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 systems.

Scope of Common Formats

    The scope of Common Formats will apply 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.
    In the interest of supporting PSO data collection from the outset, 
AHRQ is releasing Version 0.1 Beta of the Common Formats, which have a 
defined focus on patient safety reporting for hospital inpatients. It 
should be noted, however, that the Patient Safety Act confers 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 has 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. It is planned that updated versions of the formats 
will be released annually by AHRQ as guidance. While the dvelopment and 
release of Common Formats is outside the scope of the regulations 
implementing the Patient Safety Act, AHRQ described its proposed 
development process in the Notice of Proposed Rulemaking referenced 
above and sought public comment. There were a significant number of 
strongly supportive comments about the process; there were no negative 
comments.
    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 to inform construction of the Common Formats. The 
inventory now numbers 64 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).
    AHRQ convened an interagency Patient Safety Work Group (PSWG) to 
develop draft formats. Included in the PSWG are major health agencies 
within the Department--CDC, Centers for Medicare and Medicaid Services 
(CMS), FDA, Health Resources and Services Administration (HRSA), the 
Indian Health Service (IHS), the National Institutes of Health (NIH), 
the Office of the National Coordinator for Health Information 
Technology (ONC)--as well as the DoD and the VA.
    The PSWG reviewed the AHRQ inventory, created draft Common Format 
data sets, harmonized individual data elements where possible, and 
created new data elements where necessary. From February through May of 
2008, the draft Common Formats underwent two pilot tests in a 
significant number of healthcare facilities within DoD, IHS, and VA. 
These pilot tests were designed to provide guidance to refine the draft 
formats prior to their release as Version 0.1 Beta. The PSWG, acting as 
the focus for original development and continuing upgrading/maintenance 
will assure consistency of definitions/formats with those of relevant 
government agencies as refinement of the Common Formats continues.
    The PSWG aligned the formats, to the extent practicable, with World 
Health Organization (WHO) concepts, framework, and definitions 
contained in their draft International Classification for Patient 
Safety (ICPS). The ICPS is currently under development.
    AHRQ's initial construction of Common Formats thus draws on 
information from systems in both the public and private sectors, but 
was completed by a work group comprising only Federal agencies. To 
allow for greater participation by the private sector in the subsequent 
development of the Common Formats, AHRQ has engaged the National 
Quality Forum (NQF) to solicit comments and advice to guide future 
versions, as described below. It should be noted that the Common 
Formats Version 0.1 Beta can be implemented now, using AHRQ paper forms 
and the users guide. Other supporting materials will be made available 
shortly via the AHRQ Web site.

Commenting on Common Formats Version 0.1 Beta

    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--and it has established a process to receive initial 
feedback that will guide rapid improvement of the formats.
    AHRQ has contracted with the NQF, a non-profit organization focused 
on healthcare quality, to assist with gathering and analyzing feedback 
on the Common Formats. In this role, the NQF will assist AHRQ in 
updating future versions of the formats by: Soliciting public comments 
from providers, professional organizations, the general public, and 
PSOs; triaging comments in terms of immediacy of importance; setting 
priorities; and convening expert panel(s) to offer advice on suggested 
improvements to the formats. This process will be a continuing one, 
guiding periodic updates of the Common Formats and, most importantly, 
reflecting the feedback of those using the formats. This latter group, 
the users, will be the most sensitive to and aware of needed updates 
and improvements to the formats.

Future Releases

    While AHRQ's Version 0.1 Beta has been developed based on evidence, 
consensus of the PSWG, and results from initial testing, this version 
does not reflect the refinement that will come from large-scale use and 
repeated revision. We anticipate that we may get much helpful guidance 
from early users of the formats. For this reason, AHRQ

[[Page 50976]]

plans to release a second version of the formats in six to nine months, 
or perhaps sooner, depending on the nature of initial feedback. Once 
the formats are stabilized, AHRQ plans to release new versions 
annually. The Agency will follow the same process for formats developed 
for other settings.
    AHRQ realizes that using Version 0.1 Beta paper forms is not the 
optimal way to collect patient safety data. Over time, computer 
software (developed in the private sector) will make use of the formats 
much more efficient. However, because the Agency plans an early second 
release of the Common Formats, it cautions software developers to 
understand that the first release of the formats will likely be 
substantially enhanced.
    More information on the feedback process can be obtained through 
AHRQ's PSO Web site: http://www.pso.ahrq.gov/index.html.

    Dated: August 21, 2008.
Carolyn M. Clancy,
Director.
[FR Doc. E8-19910 Filed 8-28-08; 8:45 am]
BILLING CODE 4160-90-M


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