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)
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.
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
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 http://www.cvent.com/d/0cQkQx/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 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
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]
BILLING CODE 4160-90-M