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  Federal Register  

Link:  Pharm/Biotech Resources

Notice: Meeting for Software Developers on the Technical Specifications 
for Common Formats for Patient Safety Data Collection and Event 
Federal Register: Volume 77, Number 32 (Thursday, February 16, 2012)
                  Pages 9252-9254

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 
health care 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 health care 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 
Common Formats technical specifications. This meeting is designed as an 
interactive forum where PSOs and software developers can provide input 
on these technical specifications. 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 April 12, 

ADDRESSES: The meeting will be held at the Hyatt Regency Bethesda, 7400 
Wisconsin Avenue, Bethesda, MD 20814.

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; 
    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 March 28, 2012.



    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other health care 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.

[[Page 9253]]

    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 
    In collaboration with the interagency Federal Patient Safety 
Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ 
has developed Common Formats for two settings of care--acute care 
hospitals and skilled nursing facilities--in order to facilitate 
standardized data collection. The term ``Common Formats'' refers to the 
common definitions and reporting formats that allow health care 
providers to collect and submit standardized information regarding 
patient safety events. AHRQ's Common Formats include:
     Event descriptions (descriptions of patient safety events 
and unsafe conditions to be reported),
     Specifications for patient safety aggregate reports and 
individual event summaries,
     Delineation of data elements to be collected for different 
types of events to populate the reports,
     A user's guide and quick guide, and
     Technical specifications for electronic data collection 
and reporting.
    AHRQ convenes the PSWG to assist AHRQ with developing and 
maintaining the Common Formats. The PSWG includes major health agencies 
within the Department of Health and Human Services (HHS)--the Centers 
for Disease Control and Prevention, Centers for Medicare & Medicaid 
Services, Food and Drug Administration, Health Resources and Services 
Administration, Indian Health Service, National Institutes of Health, 
National Library of Medicine, Office of the National Coordinator for 
Health Information Technology, Office of Public Health and Science, and 
Substance Abuse and Mental Health Services Administration--as well as 
the Department of Defense and Department of Veterans Affairs.
    When developing Common Formats, AHRQ first reviews existing patient 
safety event reporting systems from a variety of health care 
organizations. In collaboration with the PSWG and Federal subject 
matter experts, AHRQ drafts and releases beta versions of the Common 
Formats for public review and comment.
    Through a contract with AHRQ, NQF solicits feedback on the beta 
(and subsequent) versions of the Common Formats from private sector 
organizations and individuals. The NQF, a nonprofit organization that 
focuses on health care quality, then convenes an expert panel to review 
the comments received and provide feedback to AHRQ. Based upon the 
expert panel's feedback, AHRQ, in conjunction with the PSWG, further 
revises the Common Formats.
    The technical specifications promote standardization of collected 
patient safety event information by specifying rules for data 
collection and submission, as well as by providing guidance for how and 
when to create data elements, their valid values, conditional and go-to 
logic, and reports. These specifications will ensure that data 
collected by PSOs and other entities have comparable clinical meaning.
    The technical specifications also provide direction to software 
developers, so that the Common Formats can be implemented 
electronically, and to PSOs, so that the Common Formats can be 
submitted electronically to the PSO Privacy Protection Center (PSO PPC) 
for data de-identification and transmission to the Network of Patient 
Safety Databases (NPSD).
    Most recently, AHRQ and the PSWG released the beta version of the 
Venous Thromboembolism (VTE) format for reporting of VTE-related 
patient safety events as announced in the Federal Register on November 
1, 2011: 76 FR 67456-67457.
    The Software Developer's meeting will focus on discussion of an 
anticipated Spring release--Hospital Common Formats 1.2--and 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.
    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 file to transmit the 
Common Formats Patient Safety data from the PSO to the PSO 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 PSO 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 Thursday, April 12, 2012, the meeting will convene at 10 a.m. 
with an overview of the Common Formats, including the Hospital Common 
Formats Version 1.2 technical specifications, and next steps for 
upcoming Common Formats releases. AHRQ staff and contractors will 
review database functionality, which is available through the PSO PPC, 
for PSOs to generate aggregate reports with technical specifications. 
Finally, the meeting will review 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
    AHRQ requests that interested persons register with the PSO PPC on 
the Internet at 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 email at supportpsoppc.ORG. 
Additional logistical information for the meeting is also available 
from the PSO PPC. The meeting space will accommodate approximately 150 
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.
    Prior to the meeting, AHRQ invites review of the technical 
specifications for Common Formats. The formats can be

[[Page 9254]]

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, and welcomes questions from prospective meeting 
participants and interested individuals on the technical 
specifications. These questions should be emailed to support@psoppc.ORG 
no later than March 21, 2012. AHRQ will use the input received at this 
meeting to further 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 email to supportpsoppc.ORG and it will be sent 
as soon as it is available after the meeting.

    Dated: January 25, 2012.
Carolyn M. Clancy,
[FR Doc. 2012-2937 Filed 2-15-12; 8:45 am]

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