[Federal Register Volume 78, Number 35 (Thursday, February 21, 2013)]
[Notices]
[Pages 12063-12065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03911]


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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.

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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 8:30 a.m. to 4:00 p.m. on Friday, 
April 26, 2013.

ADDRESSES: The meeting will be held at the John M. Eisenberg Conference 
Center, Agency for Healthcare Research and Quality, 540 Gaither Road 
Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT: Eileen Hogan, 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; 
Email: [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 at (301) 827-4840, no later than April 10, 2013.

SUPPLEMENTARY INFORMATION: 

Background

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

[[Page 12064]]

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 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 PS0s, so that the Common Formats can be 
submitted electronically to the PSO Privacy Protection Center (PSOPPC) 
for data de-identification and transmission to the Network of Patient 
Safety Databases (NPSD).
    Most recently, AHRQ and the PSWG announced the release of Common 
Formats--Hospital Version 1.2 in the Federal Register on April 13, 
2012: 77 FR 22322-22324. The Common Format--Readmissions Version 0.1 
Beta for analysis of the circumstances surrounding readmissions into 
acute care hospitals was announced in the Federal Register on July 20, 
2012: 77 FR 42736-42737.
    The Software Developer's meeting will focus on discussion of the 
implementation and use of Hospital Common Formats 1.1 and 1.2; the 
technical specifications, which provide direction to software 
developers that plan to implement the Common Formats electronically; 
and future development plans for the Common Formats. The technical 
specifications are a critical component that allow for the aggregation 
of patient safety event data.
    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 file to transmit the Common 
Formats Patient Safety data from the PSO to the PSO 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 PSO 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 Friday, April 26, 2013, a pre-meeting seminar will convene at 
8:30 a.m. with focus on data submission, including discussion of 
technical specifications and aggregate reports. Then, the general 
meeting will start at 10:00 a.m. with an overview of Federal efforts 
related to the Common Formats. The agenda will continue with 
presentations and discussion of implementations of Hospital Common 
Formats Version 1.1 and 1.2 and next steps for upcoming Common Formats 
releases. AHRQ staff and contractors will also 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

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meeting participants not only to provide input, but also to respond to 
the input provided by others. A more specific agenda will be provided 
to meeting registrants before the meeting.
    AHRQ requests that interested persons register with the PSO PPC to 
participate in the meeting. The contact at the PSO PPC is Mark Baliff 
who can be reached by telephone at (866) 571-7712 and by email at 
[email protected]. 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 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 [email protected] no later than April 10th, 2013. AHRQ will 
use the input received at this meeting to further update and refine the 
Common Formats.

    Dated: February 7, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-03911 Filed 2-20-13; 8:45 am]
BILLING CODE 4160-90-M