```

[Federal Register Volume 76, Number 58 (Friday, March 25, 2011)]
[Notices]
[Pages 16785-16787]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6852]

-----------------------------------------------------------------------

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: 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

[[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:
    [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 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

[[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
```