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###### Department of Health and Human Services

###### Agency for Healthcare Research and Quality

# AGENCY:

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

# ACTION:

Notice of public meeting.

# 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                               ( print page 16786)                            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: PSO@AHRQ.HHS.GOV.*

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:

                    ○ Data dictionary—defines data elements and their attributes (data element name, answer values, field length, guide for use,                     *etc.*) included in Common Formats;                

○ 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 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                     *support@psoppc.ORG.*                     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                           ( print page 16787)                        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                     *support@psoppc.ORG*                     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                     *support@psoppc.ORG*                     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