[Federal Register Volume 75, Number 63 (Friday, April 2, 2010)]
[Notices]
[Pages 16817-16818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7049]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: This notice announces a meeting to discuss the technical
specifications for AHRQ's common definitions and reporting formats
(Common Formats) Version 1.1 that allow for reporting of patient safety
information to Patient Safety Organizations (PSOs). 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 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 the Common Formats that allow healthcare providers to
voluntarily collect and submit standardized information regarding
patient safety events. More information on the Common Formats Version
1.1, including the technical specifications, can be obtained through
AHRQ's PSO Web site: http://www.PSO.AHRQ.gov/index.html.
Technical specifications promote standardization by ensuring that
data collected by PSOs and other entities are clinically and
electronically comparable. This meeting is designed as an interactive
forum where PSOs and software developers can provide input on these
technical specifications for the Common Formats Version 1.1. AHRQ
especially requests input from those entities which have implemented,
or
[[Page 16818]]
plan to implement, the formats electronically.
DATES: The meeting will be held from 10 a.m. to 5 p.m. on May 5, 2010.
ADDRESSES: The meeting will be held at the Hyatt Regency Baltimore, 300
Light Street, Baltimore, Maryland 21202.
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 on (301) 827-4840, no later than April 21, 2010.
SUPPLEMENTARY INFORMATION:
Background
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. AHRQ develops and maintains the Common Formats to
improve the safety and quality of healthcare delivery. AHRQ's Common
Formats Version 1.1 includes:
[cir] Descriptions of patient safety events and unsafe conditions
to be reported (event descriptions),
[cir] Specifications for patient safety aggregate reports and
individual event summaries,
[cir] Delineation of data elements to be collected for specific
types of events,
[cir] A user's guide and quick guide, and
[cir] Technical specifications for electronic data collection and
reporting.
This meeting will focus on presentation and discussion of these new
technical specifications, which provide direction to software
developers that plan to implement the Common Formats electronically.
The technical specifications are a critical component that will 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 Version 1.1;
[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 5, 2010, the meeting will convene at 10 a.m. with
an overview of the Common Formats Version 1.1, including the technical
specifications. Next, AHRQ staff and contractors who developed the
formats will review the different components of the technical
specifications. 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 https://www.psoppc.org/web/patientsafety.
AHRQ requests that interested persons register with the PSO Privacy
Protection Center (PSO PPC) on the Internet at https://www.psoppc.org/web/patientsafety to participate in the meeting. The contact at the PSO
PPC is Lauren Richie who can be reached by telephone at (630) 792-5977
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 130 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
Version 1.1 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 continuing refinement of the Common Formats. AHRQ
welcomes questions from prospective meeting participants and interested
individuals on the technical specifications for Common Formats Version
1.1. These questions should be e-mailed to [email protected] no later
than April 28, 2010. 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 to all meeting
participants. 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 24, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-7049 Filed 4-1-10; 8:45 am]
BILLING CODE 4160-90-M