[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22830-22831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10068]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Common Formats for Reporting on Health Care Quality and Patient 
Safety

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice of availability--new common formats.

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SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the 
development of sets of common definitions and reporting formats (Common 
Formats) for reporting on health care quality and patient safety. The 
purpose of this notice is to announce the release of the Common Formats 
for Event Reporting--Hospital Version 2.0.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Event Reporting--Hospital Version 2.0 
and the remaining Common Formats can be accessed electronically at the 
following Web site: https://www.psoppc.org/psoppc_web/.

FOR FURTHER INFORMATION CONTACT: Dr. Barbara Choo, Center for Quality 
Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N100B, 
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 Patient Safety Organizations 
(PSOs), which collect, aggregate, and analyze confidential information 
regarding the quality and safety of health care delivery. 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''--allows for the aggregation of data that help to 
identify and address underlying causal factors of patient safety and 
quality issues.
    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other health care 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 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 standardized reporting 
formats--using common language and definitions--that AHRQ has developed 
for reporting safety concerns from a variety of health care settings 
and throughout the quality improvement cycle. The Common Formats allow 
health care providers to collect and submit standardized information 
and facilitate aggregation of comparable data at local, PSO, regional, 
and national levels. The 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 Common 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 community pharmacies--
in order to facilitate standardized data collection and analysis. The 
scope of the 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 for patient safety event reporting include:
     Event descriptions (definitions of patient safety events, 
near misses, and unsafe conditions to be reported);
     Delineation of data elements and algorithms to be used for 
collection of adverse event data to populate the reports; and
     Technical specifications for electronic data collection 
and reporting.
    The technical specifications promote standardization of collected 
patient safety concerns 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. They 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 non-identification and data transmission to the Network of 
Patient Safety Databases.

Common Formats Development

    In anticipation of the need for Common Formats, AHRQ began its 
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 major 
health agencies within HHS--CDC, Centers for Medicare & Medicaid 
Services, FDA, Health Resources and Services Administration, Indian 
Health

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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.
    Since the initial release of the Common Formats in August 2008, 
AHRQ has regularly revised the formats based upon public comment. 
First, AHRQ reviews existing patient safety practices and event 
reporting systems. Then, AHRQ works in collaboration with the PSWG and 
Federal subject matter experts to develop and draft the Common Formats. 
In addition, the PSWG assists AHRQ with assuring the consistency of 
definitions/formats with those of relevant government agencies. Next, 
AHRQ solicits feedback from private sector organizations and 
individuals. Finally, based upon the feedback received, AHRQ further 
revises the Common Formats.
    Participation by the private sector in the development and 
subsequent revision of the Common Formats is achieved through work 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.

Common Formats for Event Reporting--Hospital Version 2.0

    On April 8, 2016, AHRQ announced the availability of the Common 
Formats for Event Reporting--Hospital Version 2.0 for review and 
comment in the Federal Register (81 FR 20642-20643). At the time of the 
initial release of the formats, only the event descriptions--which 
define adverse events of interest in the inpatient hospital setting--
were made available. Based on public comment and NQF Expert Panel 
advice, AHRQ updated the event descriptions and developed additional 
documentation for the Common Formats for Event Reporting--Hospital 
Version 2.0, including data element definitions, algorithms, and 
technical specifications. Beginning with this version, AHRQ will no 
longer publish aggregate report specifications, which were initially 
provided for versions 1.0, 1.1, and 1.2 as a local resource for 
providers, because the report specifications are no longer needed to 
guide providers regarding aggregating output.
    The Common Formats for Event Reporting--Hospital Version 2.0 
constitutes a major release of the AHRQ Common Formats and reflects 
these key changes:
     Data elements are designated as either `core' or 
`supplemental' for reporting purposes;
     Event descriptions for each module are condensed; and
     Module-specific paper forms are eliminated.
    The formats have two tiers, or data sets. The first tier, or core 
data set, contains elements that are collected for submission at the 
national level to the PSOPPC. The second tier, or supplemental data 
set, is optional for use at the local level to support additional 
analyses, and is not required for transmission to the PSOPPC. All 
documentation for the Common Formats for Event Reporting--Hospital 
Version 2.0 is posted on the PSOPPC Web site. https://www.psoppc.org/psoppc_web.
    More information on the Common Formats can be obtained through 
AHRQ's PSO Web site: http://www.pso.ahrq.gov/.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-10068 Filed 5-17-17; 8:45 am]
 BILLING CODE 4160-90-P