[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16785-16787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6852]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Meeting for Software Developers on the Technical Specifications
for Common Formats for Patient Safety Data Collection and Event
Reporting
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Notice of public meeting.
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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
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. 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. In order to support the Common Formats, AHRQ has
provided technical specifications to promote standardization by
ensuring that data collected by PSOs and other entities are clinically
and electronically comparable. More information on the Common Formats,
including the technical specifications, can be obtained through AHRQ's
PSO Web site: http://www.PSO.AHRQ.GOV/index.html.
The purpose of this notice is to announce a meeting to discuss the
technical specifications, including the Hospital Common Formats
technical specifications and the Skilled Nursing Facility Common
Formats. This meeting is designed as an interactive forum where PSOs
and software developers can provide input on these technical
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specifications for the Common Formats. AHRQ especially requests input
from those entities which have used AHRQ's technical specifications and
implemented, or plan to implement, the formats electronically.
DATES: The meeting will be held from 10 a.m. to 3:30 p.m. on May 11,
2011.
ADDRESSES: The meeting will be held at the Hilton Washington DC/
Rockville Meeting Center, 1750 Rockville Pike, Rockville, MD 20852.
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: [email protected].
If sign language interpretation or other reasonable accommodation
for a disability is needed, please contact the Food and Drug
Administration (FDA) Office of Equal Employment Opportunity and
Disability Management at (301) 827-4840, no later than April 28, 2011.
SUPPLEMENTARY INFORMATION:
Background
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, AHRQ develops
and maintains 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. Most recently, AHRQ released the beta version of the Skilled
Nursing Facilities format for reporting of patient safety events in
skilled nursing facilities as announced in the Federal Register on
March 7, 2011: 76 FR 12358-12359.
This meeting will focus on discussion of the technical
specifications, which provide direction to software developers that
plan to implement the Common Formats electronically. The technical
specifications are a critical component that allow for the aggregation
of patient safety event data by standardizing the patient safety event
information collected and specifying standard rules for data
collection, as well as providing guidance for how and when to create
data elements, their valid values, and conditional and go-to logic for
the data elements. In addition to standardizing the information
collected, they specify the data submission file format.
The technical specifications consist of the following:
[cir] Data dictionary--defines data elements and their attributes
(data element name, answer values, field length, guide for use, etc.)
included in Common Formats;
[cir] Clinical document architecture (CDA) implementation guide--
provides instructions for developing a Health Level Seven (HL7) CDA
Extensible Markup Language (XML) file to transmit the Common Formats
Patient Safety data from the PSO to the PPC using the Common Formats;
[cir] Validation rules and errors document-specifies and defines
the validation rules that will be applied to the Common Formats data
elements submitted to the PPC;
[cir] Common Formats flow charts--diagrams the valid paths to
complete generic and event specific formats (a complete event report);
[cir] Local specifications--provides specifications for processing,
linking and reporting on events and details specifications for reports;
and
[cir] Metadata registry--includes descriptive facts about
information contained in the data dictionary to illustrate how such
data corresponds with similar data elements used by other Federal
agencies and standards development organizations [e.g., HL-7,
International Standards Organization (ISO)].
Agenda, Registration and Other Information About the Meeting
On Wednesday, May 11, 2011, the meeting will convene at 10 a.m.
with an overview of the Common Formats, including the Hospital Common
Formats Version 1.1 technical specifications, the next steps for the
Skilled Nursing Facility Common Formats, and Common Formats version
issues. Next, AHRQ staff and contractors who developed the formats will
provide an update on the report specifications scheduled to be released
in March 2011. Finally, the meeting will focus on data submission both
by PSOs and by vendors on behalf of a PSO. Throughout the meeting there
will be interactive discussion to allow meeting participants not only
to provide input, but also to respond to the input provided by others.
A more specific proposed agenda will be posted before the meeting at
http://guest.cvent.com/d/wdqbt8/6X.
AHRQ requests that interested persons register with the PSO Privacy
Protection Center (PSO PPC) on the Internet at http://GUEST.cvent.com/d/wdgbt8/4W to participate in the meeting. The contact at the PSO PPC
is Rhonda Davis who can be reached by telephone at (866) 571-7712 and
by e-mail at [email protected]. Additional logistical information for
the meeting is also available from the PSO PPC. The meeting space will
accommodate approximately 144 participants. Interested persons are
encouraged to register as soon as possible for the meeting. Non-
registered individuals will be able to attend the meeting in person if
space is available.
We invite review of the technical specifications for Common Formats
prior to the meeting. The formats can be accessed through AHRQ's PSO
Web site at http://www.pso.AHRQ.GOV/formats/commonfmt.htm. AHRQ is
committed to
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continuing refinement of the Common Formats. AHRQ welcomes questions
from prospective meeting participants and interested individuals on the
technical specifications for Common Formats. These questions should be
e-mailed to [email protected] no later than April 27, 2011. AHRQ will
use the input received at this meeting as we continue to update and
refine the Common Formats.
A summary of the meeting will be provided upon request. If you are
unable to participate in the meeting and would like a copy of the
summary, please send an e-mail to [email protected] and it will be
sent as soon as it is available after the meeting.
Dated: March 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-6852 Filed 3-24-11; 8:45 am]
BILLING CODE 4160-90-M