81 FR 4301 - Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 16 (January 26, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 16 (January 26, 2016)
| Page Range | 4301-4302 | |
| FR Document | 2016-01353 |
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)] [Notices] [Pages 4301-4302] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4301
meeting will commence in open session DATES: The meeting will be held from PSOs and other entities. The Common
before closing to the public for the 8:00 a.m.–2:30 p.m. on Friday, April 15, Formats are not intended to replace any
duration of the meeting. The 2016. current mandatory reporting system,
subcommittee meetings will be closed to ADDRESSES: The meeting will be held at collaborative/voluntary reporting
the public in accordance with the 5600 Fishers Lane, Rockville, MD system, research-related reporting
provisions set forth in 5 U.S.C. App. 2 20857. system, or other reporting/recording
section 10(d), 5 U.S.C. 552b(c)(4), and 5 system; rather the formats are intended
FOR FURTHER INFORMATION CONTACT: A.
U.S.C. 552b(c)(6) The grant applications to enhance the ability of health care
Gretchen Buckler, MD MPH, CDR,
and the discussions could disclose providers to report information that is
USPHS Commissioned Corps, Medical
confidential trade secrets or commercial standardized both clinically and
Officer, Center for Quality Improvement
property such as patentable material, electronically.
and Patient Safety, AHRQ, 5600 Fishers
and personal information concerning In collaboration with the interagency
Lane, Rockville, MD 20857; Telephone
individuals associated with the grant Federal Patient Safety Workgroup
(toll free): (866) 403–3697; Telephone
applications, the disclosure of which (PSWG), the National Quality Forum
(local): (301) 427–1111; TTY (toll free):
would constitute a clearly unwarranted (NQF), and the public, AHRQ has
(866) 438–7231; TTY (local): (301) 427–
invasion of personal privacy. developed Common Formats for three
1130; Email: PSO@AHRQ.hhs.gov.
Agenda items for these meetings are settings of care — acute care hospitals,
SUPPLEMENTARY INFORMATION: skilled nursing facilities, and retail
subject to change as priorities dictate.
Background pharmacies — in order to facilitate
Sharon B. Arnold, standardized data collection and
AHRQ Deputy Director. The Patient Safety and Quality
analysis. The scope of Common Formats
Improvement Act of 2005, 42 U.S.C.
[FR Doc. 2016–01354 Filed 1–25–16; 8:45 am] applies to all patient safety concerns
299b-21 to b-26, (Patient Safety Act) and
BILLING CODE 4160–90–P including: incidents—patient safety
the related Patient Safety and Quality
events that reached the patient, whether
Improvement Final Rule, 42 CFR part 3
or not there was harm; near misses or
DEPARTMENT OF HEALTH AND (Patient Safety Rule), published in the
close calls—patient safety events that
HUMAN SERVICES Federal Register on November 21, 2008,
did not reach the patient; and unsafe
(73 FR 70732–70814), provide for the
conditions—circumstances that increase
Agency for Healthcare Research and formation of PSOs, which collect,
the probability of a patient safety event.
Quality aggregate, and analyze confidential AHRQ’s Common Formats include:
information regarding the quality and • Event descriptions (descriptions of
Meeting for Software Developers on safety of health care delivery. The patient safety events and unsafe
the Common Formats for Patient collection of patient safety work product conditions to be reported),
Safety Data Collection and Event allows the aggregation of data that help • Specifications for patient safety
Reporting to identify and address underlying aggregate reports and individual event
causal factors of patient quality and summaries,
AGENCY: Agency for Healthcare Research
and Quality (AHRQ), Department of
safety problems. • Delineation of data elements to be
The Patient Safety Act and Patient collected for different types of events to
Health and Human Services (HHS). Safety Rule establish a framework by populate the reports,
ACTION: Notice of public meeting. which doctors, hospitals, skilled • A user’s guide and quick guide, and
nursing facilities, and other healthcare • Technical specifications for
SUMMARY: AHRQ coordinates the providers may assemble information electronic data collection and reporting.
development of sets of common regarding patient safety events and
definitions and reporting formats quality of care. Information that is Common Formats Development
(Common Formats) for reporting on assembled and developed by providers In anticipation of the need for
health care quality and patient safety. In for reporting to PSOs and the Common Formats, AHRQ began their
order to support the Common Formats, information received and analyzed by development by creating an inventory of
AHRQ has provided technical PSOs—called ‘‘patient safety work functioning private and public sector
specifications to promote product’’—is privileged and patient safety reporting systems. This
standardization by ensuring that data confidential. Patient safety work inventory provided an evidence base to
collected by Patient Safety product is used to conduct patient inform construction of the Common
Organizations (PSOs) and other entities safety activities, which may include Formats. The inventory included many
are clinically and electronically identifying events, patterns of care, and systems from the private sector,
comparable. More information on the unsafe conditions that increase risks including prominent academic settings,
Common Formats, including the and hazards to patients. Definitions and hospital systems, and international
technical specifications, can be obtained other details about PSOs and patient reporting systems (e.g., from the United
through AHRQ’s PSO Web site: http:// safety work product are included in the Kingdom and the Commonwealth of
www.pso.ahrq.gov/. Patient Safety Act and Patient Safety Australia). In addition, virtually all
The purpose of this notice is to Rule which can be accessed major Federal patient safety reporting
announce a meeting to discuss the electronically at: http://www.pso.ahrq. systems were included, such as those
Common Formats. This meeting is gov/legislation/. from the Centers for Disease Control and
mstockstill on DSK4VPTVN1PROD with NOTICES
designed as an interactive forum where Prevention (CDC), the Food and Drug
software developers and PSOs can Definition of Common Formats Administration (FDA), the Department
provide input on the formats. AHRQ The term ‘‘Common Formats’’ refers of Defense (DoD), and the Department of
especially requests participation by and to the common definitions and reporting Veterans Affairs (VA).
input from those entities which have formats, specified by AHRQ, that allow Since February 2005, AHRQ has
used AHRQ’s technical specifications health care providers to collect and convened the PSWG to assist AHRQ
and implemented, or plan to implement, submit standardized information with developing and maintaining the
the formats electronically. regarding patient quality and safety to Common Formats. The PSWG includes
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![4302 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices
major health agencies within HHS— logic, and reports. These specifications detailed agenda and logistical
CDC, Centers for Medicare & Medicaid will ensure that data collected by PSOs information will be provided to
Services, FDA, Health Resources and and other entities have comparable registrants. Prior to the meeting, AHRQ
Services Administration, Indian Health clinical meaning. invites review of the technical
Service, National Institutes of Health, The technical specifications also specifications for Common Formats
National Library of Medicine, Office of provide direction to software which can be accessed through AHRQ’s
the National Coordinator for Health developers, so that the Common PSO Web site at https://www.psoppc.
Information Technology, Office of Formats can be implemented org/psoppc_web/publicpages/common
Public Health and Science, and electronically, and to PSOs, so that the FormatsOverview.
Substance Abuse and Mental Health Common Formats can be submitted
Sharon B. Arnold,
Services Administration—as well as the electronically to the Patient Safety
AHRQ Deputy Director.
DoD and VA. Organization Privacy Protection Center
When developing Common Formats, (PSOPPC) for data de-identification and [FR Doc. 2016–01353 Filed 1–25–16; 8:45 am]
AHRQ first reviews existing patient transmission to the NPSD. BILLING CODE 4160–90–P
safety practices and event reporting Common Formats technical
systems. In collaboration with the specifications consist of the following:
PSWG and Federal subject matter • Data dictionary—defines data DEPARTMENT OF HEALTH AND
experts, AHRQ drafts and releases beta elements and their attributes (data HUMAN SERVICES
versions of the Common Formats for element name, answer values, field
Centers for Disease Control and
public review and comment. The PSWG length, guide for use, etc.) included in Prevention
assists AHRQ with assuring the Common Formats;
consistency of definitions/formats with • Clinical document architecture Request for Nominations of
those of relevant government agencies (CDA) implementation guide—provides Candidates To Serve on the Advisory
as refinement of the Common Formats instructions for developing a file to Committee on Immunization Practices
continues. transmit the Common Formats Patient (ACIP)
Since the initial release of the Safety data from the PSO to the PSOPPC
Common Formats in August 2008, using the Common Formats; The Centers for Disease Control and
AHRQ has regularly revised the formats • Validation rules and errors Prevention (CDC) is soliciting
based upon public comment. AHRQ document—specifies and defines the nominations for membership on ACIP.
solicits feedback on beta (and validation rules that will be applied to The ACIP consists of 15 experts in fields
subsequent) versions of Common the Common Formats data elements associated with immunization, who are
Formats from private sector submitted to the PSOPPC; selected by the Secretary of the U.S.
organizations and individuals. Based • Common Formats flow charts— Department of Health and Human
upon the feedback received, AHRQ diagrams the valid paths to complete Services (HHS) to provide advice and
further revises the Common Formats. To generic and event specific formats (a guidance to the Secretary, the Assistant
the extent practicable, the Common complete event report); Secretary for Health, and the CDC on the
Formats are also aligned with World • Local specifications—provides control of vaccine-preventable diseases.
Health Organization (WHO) concepts, specifications for processing, linking The role of the ACIP is to provide
frameworks, and definitions. and reporting on events and details advice that will lead to a reduction in
Participation by the private sector in specifications for reports; and the incidence of vaccine preventable
the development and subsequent • Metadata registry—includes diseases in the United States, and an
revision of the Common Formats is descriptive facts about information increase in the safe use of vaccines and
achieved through working with the contained in the data dictionary to related biological products. The
NQF. The Agency engages the NQF, a illustrate how such data corresponds committee also establishes, reviews, and
non-profit organization focused on with similar data elements used by as appropriate, revises the list of
health care quality, to solicit comments other Federal agencies and standards vaccines for administration to children
and advice regarding proposed versions development organizations [e.g., HL—7, eligible to receive vaccines through the
of the Common Formats. AHRQ began International Standards Organization Vaccines for Children (VFC) Program.
this process with the NQF in 2008, (ISO)]. Nominations are being sought for
receiving feedback on AHRQ’s 0.1 Beta individuals who have expertise and
release of the Common Formats for Agenda, Registration, and Other qualifications necessary to contribute to
Event Reporting—Hospital. After Information about the Meeting the accomplishments of the committee’s
receiving public comment, the NQF The 2016 meeting will be an objectives. Nominees will be selected
solicits the review and advice of its interactive forum designed to allow based on expertise in the field of
Common Formats Expert Panel and meeting participants not only to provide immunization practices; multi-
subsequently provides feedback to input but also to respond to the input disciplinary expertise in public health;
AHRQ. The Agency then revises and provided by others. The meeting agenda expertise in the use of vaccines and
refines the Common Formats and issues will include: an update of Federal immunologic agents in both clinical and
them as a production version. AHRQ efforts related to the Common Formats, preventive medicine; knowledge of
has continued to employ this process for including development of formats for vaccine development, evaluation, and
all subsequent versions of the Common new settings; Common Formats software vaccine delivery; or knowledge about
mstockstill on DSK4VPTVN1PROD with NOTICES
Formats. products demonstrations; a discussion consumer perspectives and/or social
The technical specifications promote of data integrity related to submission of and community aspects of
standardization of collected patient patient safety adverse events; and a immunization programs. Federal
safety event information by specifying question and answer session. employees will not be considered for
rules for data collection and submission, AHRQ requests that interested membership. Members may be invited
as well as by providing guidance for persons send an email to the PSOPPC at to serve for four-year terms.
how and when to create data elements, support@psoppc.org for registration The next cycle of selection of
their valid values, conditional and go-to information. Before the meeting, a candidates will begin in the fall of 2016,
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Document Created: 2018-02-02 12:37:57
Document Modified: 2018-02-02 12:37:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public meeting. | |
| Dates | The meeting will be held from 8:00 a.m.-2:30 p.m. on Friday, April 15, 2016. | |
| 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] | |
| FR Citation | 81 FR 4301 |
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