[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4301-4302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01353]


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

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.

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

SUMMARY: AHRQ coordinates the development of sets of common definitions 
and reporting formats (Common Formats) for reporting on health care 
quality and patient safety. In order to support the Common Formats, 
AHRQ has provided technical specifications to promote standardization 
by ensuring that data collected by Patient Safety Organizations (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 8:00 a.m.-2:30 p.m. on Friday, 
April 15, 2016.

ADDRESSES: The meeting will be held at 5600 Fishers Lane, Rockville, MD 
20857.

FOR FURTHER INFORMATION CONTACT: A. Gretchen Buckler, MD MPH, CDR, 
USPHS Commissioned Corps, Medical Officer, Center for Quality 
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Rockville, MD 
20857; 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 and Quality Improvement Act of 2005, 42 U.S.C. 
299b-21 to b-26, (Patient Safety Act) and 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 
70732-70814), provide for the formation of PSOs, which collect, 
aggregate, and analyze confidential information regarding the quality 
and safety of health care delivery. The collection of patient safety 
work product allows the aggregation of data that help to identify and 
address underlying causal factors of patient quality and safety 
problems.
    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other healthcare providers may assemble 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 
conduct patient safety activities, which may include identifying 
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 Act and 
Patient Safety Rule which can be accessed electronically at: http://www.pso.ahrq.gov/legislation/.

Definition of Common Formats

    The term ``Common Formats'' refers to the common definitions and 
reporting formats, specified by AHRQ, that allow health care providers 
to collect and submit standardized information regarding patient 
quality and safety to PSOs and other entities. The Common Formats are 
not intended to replace any current mandatory reporting system, 
collaborative/voluntary reporting system, research-related reporting 
system, or other reporting/recording system; rather the formats are 
intended to enhance the ability of health care providers to report 
information that is standardized both clinically and 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 three settings of care -- acute 
care hospitals, skilled nursing facilities, and retail pharmacies -- in 
order to facilitate standardized data collection and analysis. The 
scope of Common Formats applies to all patient safety concerns 
including: incidents--patient safety events that reached the patient, 
whether or not there was harm; near misses or close calls--patient 
safety events that did not reach the patient; and unsafe conditions--
circumstances that increase the probability of a patient safety event.
    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.

Common Formats Development

    In anticipation of the need for Common Formats, AHRQ began their 
development by creating an inventory of functioning private and public 
sector patient safety reporting systems. This inventory provided an 
evidence base to inform construction of the Common Formats. The 
inventory included many systems from the private sector, including 
prominent academic settings, hospital systems, and international 
reporting systems (e.g., from the United Kingdom and the Commonwealth 
of Australia). In addition, virtually all major Federal patient safety 
reporting systems were included, such as those from the Centers for 
Disease Control and Prevention (CDC), the Food and Drug Administration 
(FDA), the Department of Defense (DoD), and the Department of Veterans 
Affairs (VA).
    Since February 2005, AHRQ has convened the PSWG to assist AHRQ with 
developing and maintaining the Common Formats. The PSWG includes

[[Page 4302]]

major health agencies within HHS--CDC, Centers for Medicare & Medicaid 
Services, FDA, 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 DoD and VA.
    When developing Common Formats, AHRQ first reviews existing patient 
safety practices and event reporting systems. 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. The PSWG 
assists AHRQ with assuring the consistency of definitions/formats with 
those of relevant government agencies as refinement of the Common 
Formats continues.
    Since the initial release of the Common Formats in August 2008, 
AHRQ has regularly revised the formats based upon public comment. AHRQ 
solicits feedback on beta (and subsequent) versions of Common Formats 
from private sector organizations and individuals. Based upon the 
feedback received, AHRQ further revises the Common Formats. To the 
extent practicable, the Common Formats are also aligned with World 
Health Organization (WHO) concepts, frameworks, and definitions.
    Participation by the private sector in the development and 
subsequent revision of the Common Formats is achieved through working 
with the NQF. The Agency engages the NQF, a non-profit organization 
focused on health care quality, to solicit comments and advice 
regarding proposed versions of the Common Formats. AHRQ began this 
process with the NQF in 2008, receiving feedback on AHRQ's 0.1 Beta 
release of the Common Formats for Event Reporting--Hospital. After 
receiving public comment, the NQF solicits the review and advice of its 
Common Formats Expert Panel and subsequently provides feedback to AHRQ. 
The Agency then revises and refines the Common Formats and issues them 
as a production version. AHRQ has continued to employ this process for 
all subsequent versions of 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 Patient Safety Organization Privacy 
Protection Center (PSOPPC) for data de-identification and transmission 
to the NPSD.
    Common Formats 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 PSOPPC 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 PSOPPC;
     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

    The 2016 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 
update of Federal efforts related to the Common Formats, including 
development of formats for new settings; Common Formats software 
products demonstrations; a discussion of data integrity related to 
submission of patient safety adverse events; and a question and answer 
session.
    AHRQ requests that interested persons send an email to the PSOPPC 
at [email protected] for registration information. 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 https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview.

Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2016-01353 Filed 1-25-16; 8:45 am]
BILLING CODE 4160-90-P