[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7605-7606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


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

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (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 
healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23(b)) 
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 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.
    The purpose of this notice is to announce a meeting to discuss the 
Common Formats. This meeting is designed as an interactive forum where 
software developers and PSOs can provide input on the formats. AHRQ 
especially requests participation by and 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 10:00 a.m. to 3:30 p.m. on Friday, 
April 24, 2015.

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].

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 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 practicable 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/LEGISLATION.
    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. 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.

[[Page 7606]]

    AHRQ convenes the PSWG to assist AHRQ with developing and 
maintaining the Common Formats. The PSWG includes major health agencies 
within HHS--the Centers for Disease Control and Prevention, Centers for 
Medicare and 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, the NQF solicits feedback on the 
initial 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 (PSOPPC) 
for data de-identification and transmission to the Network of Patient 
Safety Databases (NPSD).
    Common Formats 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 PSOPPC 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 PSOPPC;
    [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

    The 2015 meeting will be an interactive forum designed to allow 
meeting participants not only to provide input but also to respond to 
the input provided by others. The meeting agenda will include: An 
overview of Federal efforts related to the Common Formats; 
presentations and discussion of implementation of Common Formats Event 
Reporting--Hospital Versions 1.1 and 1.2; and, a review of data 
submission both by PSOs and by vendors on behalf of PSOs.
    AHRQ requests that interested persons send an email to the PSOPPC 
at [email protected] for registration information. The meeting space 
will accommodate approximately 150 participants. Before the meeting, a 
detailed agenda and logistical information will be provided to 
registrants. Prior to the meeting, AHRQ invites review of the technical 
specifications for Common Formats which can be accessed through AHRQ's 
PSO Web site at http://www.pso.AHRQ.GOV/formats/commonfmt.htm.

    Dated: February 3, 2015.
Richard Kronick,
Director.
[FR Doc. 2015-02590 Filed 2-10-15; 8:45 am]
BILLING CODE 4160-90-P