[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20642-20643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08021]


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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 availability of new formats 
for public review and comment, Common Formats for Event Reporting for 
Hospitals Version 2.0.

DATES: May 9, 2016.

ADDRESSES: The Common Formats for Event Reporting for Hospitals Version 
2.0, and the remaining Common Formats, can be accessed electronically 
at the following HHS Web site: http://www.pso.ahrq.gov/common/.

FOR FURTHER INFORMATION CONTACT: Cathryn Bach, 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 Patient Safety Organizations 
(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 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--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 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, nursing homes, and retail 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

[[Page 20643]]

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);
     Specifications for patient safety aggregate reports and 
individual event summaries that derive from event descriptions;
     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 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. 
They also provide direction to software developers, so that the 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 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 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 and updates to current versions of the Common Formats for 
public review and comment. The prior version of Common Formats for 
Event Reporting for Hospitals, Version 1.2, was released in April 2013. 
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 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 formats.

Commenting on Common Formats for Event Reporting--Hospital Version 2.0

    AHRQ used a tiered approach to develop Hospital Version 2.0. This 
approach was done in response to feedback from PSOs and the public to 
decrease the number of questions for each module of the formats in 
order to reduce the burden on health care providers and to facilitate 
data transmission. These formats have two tiers, or data sets. The 
first tier, or national data set, contains elements that are collected 
for submission to the PSOPPC. The second tier, or local data set, is 
optional and is designed for use at the local level for additional 
analyses. This local data set is not meant for transmission to the 
PSOPPC.
    The Agency is specifically interested in obtaining feedback from 
both the private and public sectors on the updated Common Formats for 
Event Reporting--Hospitals Version 2.0. At this time, only the event 
descriptions--which define adverse events of interest in the inpatient 
hospital setting--are available. Other elements of the Common Formats, 
including aggregate reports and technical specifications, will be 
developed following revision of the Common Formats for Hospital Version 
2.0 based on public comment and NQF advice. Information on how to 
comment and provide feedback on the Common Formats for Hospital Version 
2.0 is available at the NQF Web site: http://www.qualityforum.org/Project_Pages/Common_Formats_for_Patient_Safety_Data.aspx.
    AHRQ appreciates the time and effort individuals invest in 
providing comments. The Agency will review and consider all feedback 
received to help guide the development of a revised version. The 
process for updating and refining the formats will continue to be an 
iterative one.
    Further information on the Common Formats can be obtained through 
AHRQ's PSO Web site: http://www.pso.ahrq.gov/. To receive notifications 
about final versions of AHRQ Common Formats, please subscribe to ``E-
Mail Updates'' at: https://pso.ahrq.gov/about/subscribe.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2016-08021 Filed 4-7-16; 8:45 am]
 BILLING CODE 4160-90-P