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

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Information about this document as published in the Federal Register.

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Agency for Healthcare Research and Quality (AHRQ), HHS.


Notice of public meeting.


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:​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 Start Printed Page 16818plan to implement, the formats electronically.


The meeting will be held from 10 a.m. to 5 p.m. on May 5, 2010.


The meeting will be held at the Hyatt Regency Baltimore, 300 Light Street, Baltimore, Maryland 21202.

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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:

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.

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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:

○ Descriptions of patient safety events and unsafe conditions to be reported (event descriptions),

○ Specifications for patient safety aggregate reports and individual event summaries,

○ Delineation of data elements to be collected for specific types of events,

○ A user's guide and quick guide, and

○ 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:

○ 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;

○ 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;

○ 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;

○ Common Formats flow charts—diagrams the valid paths to complete generic and event specific formats (a complete event report);

○ Local specifications—provides specifications for processing, linking and reporting on events and details specifications for reports; and

○ 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​web/​patientsafety.

AHRQ requests that interested persons register with the PSO Privacy Protection Center (PSO PPC) on the Internet at​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 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​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 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 and it will be sent as soon as it is available after the meeting.

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Dated: March 24, 2010.

Carolyn M. Clancy,


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