[Federal Register Volume 75, Number 63 (Friday, April 2, 2010)]
[Pages 16817-16818]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7049]



Agency for Healthcare Research and Quality

Meeting for Software Developers on the Technical Specifications 
for Common Formats for Patient Safety Data Collection and Event 

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, 

[[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.



    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 
    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; 
    [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,
[FR Doc. 2010-7049 Filed 4-1-10; 8:45 am]