[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60385-60387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25364]


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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 two new sets 
of Common Formats for public review and comment: 1) Common Formats for 
retail pharmacies--Common Formats for Retail Pharmacy; and 2) the 
healthcare associated infection (HAI) module for Common Formats for 
Surveillance.

DATES: Ongoing public input.

ADDRESSES: The Common Formats for Retail Pharmacy, the HAI module for 
Common Formats for Surveillance, 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, 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 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 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

[[Page 60386]]

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 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 Common 
Formats can be implemented electronically, and to PSOs, so that the 
Common Formats can be submitted electronically to the PSO Privacy 
Protection Center (PPC) 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 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.
    Beginning in 2013, AHRQ began development of Common Formats for 
Surveillance for hospitals which are also called the Quality and Safety 
Review System (QSRS). These formats are different than previously-
developed Common Formats because they do not support event reporting in 
hospitals or other settings. QSRS supports retrospective review or 
audit of medical records in hospitals, and data are entered by medical 
record coders/abstractors. While Common Formats that support event 
reporting are of great importance to the quality improvement process, 
by informing users on the nature and causes of patient safety events, 
they do not support collection of populations at risk and hence do not 
allow generation of rates. QSRS allows generation of rates of adverse 
events and benchmarking and trending of performance in hospitals, 
including documentation of improvement over time. The principle 
immediate use planned for QSRS is to update and expand on the scope of 
the Medicare Patient Safety Monitoring System (MPSMS) that is currently 
in use by HHS to audit a sample of U.S. medical records for purposes of 
establishing national adverse event rates.

Commenting on Common Formats for Retail Pharmacy

    In 2014, representatives from U.S. retail pharmacies approached 
AHRQ regarding collaboration to develop Common Formats for the retail 
pharmacy setting. Development of the new Formats began using the 
existing AHRQ Common Formats Medication module from the AHRQ Common 
Formats for Event Reporting--Hospital, version 1.2, as a starting 
point. AHRQ, in conjunction with retail pharmacy representatives, 
designed Common Formats for Retail Pharmacy for use in U.S. retail 
pharmacies. These formats will facilitate improved detection and 
understanding of medication-related events originating in pharmacies 
and, if implemented as specified, will allow aggregation of medication-
related data across different pharmacy providers.
    The Agency is specifically interested in obtaining feedback from 
both the private and public sectors on the new Common Formats for 
Retail Pharmacy. At this time, only the Event

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Description--which defines adverse events of interest in the retail 
pharmacy setting--is available. Other elements of the Common Formats, 
including aggregate reports and technical specifications, will be 
developed following revision of the Common Formats for Retail Pharmacy 
based on public comment and NQF advice. Information on how to comment 
and provide feedback on the Common Formats for Retail Pharmacy is 
available at the NQF Web site: http://www.qualityforum.org/Project_Pages/Common_Formats_for_Patient_Safety_Data.aspx.

Commenting on HAI Module for Common Formats for Surveillance

    Common Formats addressing all QSRS modules--except for those for 
HAIs--were made available for public comment in 2014. During the 
intervening time, AHRQ was able to consult with CDC in order to refine 
the HAI module. When integrated with the remaining modules of QSRS, the 
HAI module will allow completion of the first version of QSRS.
    The Agency is specifically interested in obtaining feedback from 
both the private and public sectors on the HAI module for Common 
Formats for Surveillance. Only the Event Description--which defines six 
HAI adverse events of interest--is available. Based on public comment 
and NQF advice, AHRQ will finalize this module, which will be 
incorporated into QSRS software. Information on how to comment and 
provide feedback on the HAI module 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.
    Future versions of the Common Formats are planned to be developed 
for additional ambulatory settings, such as ambulatory surgery centers 
and physician and practitioner offices. More information on the Common 
Formats can be obtained through AHRQ's PSO Web site: http://www.pso.ahrq.gov/.

Sharon B. Arnold,
AHRQ Deputy Director.
[FR Doc. 2015-25364 Filed 10-5-15; 8:45 am]
 BILLING CODE 4160-90-P