82 FR 22830 - Common Formats for Reporting on Health Care Quality and Patient Safety
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 82, Issue 95 (May 18, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 95 (May 18, 2017)
| Page Range | 22830-22831 | |
| FR Document | 2017-10068 |
[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)] [Notices] [Pages 22830-22831] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10068] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 [[Page 22831]] 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
![22830 Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices
automated collection techniques or Patient Safety Organizations (PSOs), applies to all patient safety concerns
other forms of information technology. which collect, aggregate, and analyze including: incidents—patient safety
Comments submitted in response to confidential information regarding the events that reached the patient, whether
this notice will be summarized and quality and safety of health care or not there was harm; near misses or
included in the Agency’s subsequent delivery. Information that is assembled close calls—patient safety events that
request for OMB approval of the and developed by providers for did not reach the patient; and unsafe
proposed information collection. All reporting to PSOs and the information conditions—circumstances that increase
comments will become a matter of received and analyzed by PSOs—called the probability of a patient safety event.
public record. ‘‘patient safety work product’’—allows AHRQ’s Common Formats for patient
for the aggregation of data that help to safety event reporting include:
Sharon B. Arnold,
identify and address underlying causal • Event descriptions (definitions of
Deputy Director. factors of patient safety and quality patient safety events, near misses, and
[FR Doc. 2017–10066 Filed 5–17–17; 8:45 am] issues. unsafe conditions to be reported);
BILLING CODE 4160–90–P The Patient Safety Act and Patient • Delineation of data elements and
Safety Rule establish a framework by algorithms to be used for collection of
which doctors, hospitals, skilled adverse event data to populate the
DEPARTMENT OF HEALTH AND nursing facilities, and other health care reports; and
HUMAN SERVICES providers may assemble information • Technical specifications for
regarding patient safety events and electronic data collection and reporting.
Agency for Healthcare Research and quality of care. Information that is The technical specifications promote
Quality assembled and developed by providers standardization of collected patient
for reporting to PSOs and the safety concerns by specifying rules for
Common Formats for Reporting on data collection and submission, as well
information received and analyzed by
Health Care Quality and Patient Safety as by providing guidance for how and
PSOs is privileged and confidential.
AGENCY: Agency for Healthcare Research Patient safety work product is used to when to create data elements, their valid
and Quality (AHRQ), Department of conduct patient safety activities, which values, conditional and go-to logic, and
Health and Human Services (HHS). may include identifying events, patterns reports. These specifications will ensure
of care, and unsafe conditions that that data collected by PSOs and other
ACTION: Notice of availability—new
increase risks and hazards to patients. entities have comparable clinical
common formats.
Definitions and other details about PSOs meaning. They also provide direction to
SUMMARY: As authorized by the and patient safety work product are software developers, so that the
Secretary of HHS, AHRQ coordinates included in the Patient Safety Act and Common Formats can be implemented
the development of sets of common Patient Safety Rule which can be electronically, and to PSOs, so that the
definitions and reporting formats accessed electronically at: http:// Common Formats can be submitted
(Common Formats) for reporting on www.pso.ahrq.gov/legislation/. electronically to the PSO Privacy
health care quality and patient safety. Protection Center (PSOPPC) for non-
Definition of Common Formats identification and data transmission to
The purpose of this notice is to
announce the release of the Common The term ‘‘Common Formats’’ refers the Network of Patient Safety Databases.
Formats for Event Reporting—Hospital to the standardized reporting formats—
using common language and Common Formats Development
Version 2.0.
definitions—that AHRQ has developed In anticipation of the need for
DATES: Ongoing public input.
for reporting safety concerns from a Common Formats, AHRQ began its
ADDRESSES: The Common Formats for variety of health care settings and development by creating an inventory of
Event Reporting—Hospital Version 2.0 throughout the quality improvement functioning private and public sector
and the remaining Common Formats cycle. The Common Formats allow patient safety reporting systems. This
can be accessed electronically at the health care providers to collect and inventory provided an evidence base to
following Web site: https:// submit standardized information and inform construction of the Common
www.psoppc.org/psoppc_web/. facilitate aggregation of comparable data Formats. The inventory included many
FOR FURTHER INFORMATION CONTACT: Dr. at local, PSO, regional, and national systems from the private sector,
Barbara Choo, Center for Quality levels. The formats are not intended to including prominent academic settings,
Improvement and Patient Safety, AHRQ, replace any current mandatory reporting hospital systems, and international
5600 Fishers Lane, Room 06N100B, system, collaborative/voluntary reporting systems (e.g., from the United
Rockville, MD 20857; Telephone (toll reporting system, research-related Kingdom and the Commonwealth of
free): (866) 403–3697; Telephone (local): reporting system, or other reporting/ Australia). In addition, virtually all
(301) 427–1111; TTY (toll free): (866) recording system; rather, the Common major Federal patient safety reporting
438–7231; TTY (local): (301) 427–1130; Formats are intended to enhance the systems were included, such as those
Email: pso@ahrq.hhs.gov. ability of health care providers to report from the Centers for Disease Control and
SUPPLEMENTARY INFORMATION: information that is standardized both Prevention (CDC), the Food and Drug
clinically and electronically. Administration (FDA), the Department
Background In collaboration with the interagency of Defense (DoD), and the Department of
The Patient Safety and Quality Federal Patient Safety Workgroup Veterans Affairs (VA).
Improvement Act of 2005, 42 U.S.C. (PSWG), the National Quality Forum Since February 2005, AHRQ has
jstallworth on DSK7TPTVN1PROD with NOTICES
299b–21 to b–26, (Patient Safety Act) (NQF), and the public, AHRQ has convened the PSWG to assist AHRQ
and the related Patient Safety and developed Common Formats for three with developing and maintaining the
Quality Improvement Final Rule, 42 settings of care—acute care hospitals, Common Formats. The PSWG includes
CFR part 3 (Patient Safety Rule), skilled nursing facilities, and major health agencies within HHS—
published in the Federal Register on community pharmacies—in order to CDC, Centers for Medicare & Medicaid
November 21, 2008, 73 FR 70732– facilitate standardized data collection Services, FDA, Health Resources and
70814, provide for the formation of and analysis. The scope of the formats Services Administration, Indian Health
VerDate Sep<11>2014 13:43 May 17, 2017 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1](https://thefederalregister.org/doc/82_FR_22925/page/1.svg)
![Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices 22831
Service, National Institutes of Health, Beginning with this version, AHRQ will Reports Clearance Officer, AHRQ, by
National Library of Medicine, Office of no longer publish aggregate report email at doris.lefkowitz@AHRQ.hhs.gov.
the National Coordinator for Health specifications, which were initially Copies of the proposed collection
Information Technology, Office of provided for versions 1.0, 1.1, and 1.2 plans, data collection instruments, and
Public Health and Science, and as a local resource for providers, specific details on the estimated burden
Substance Abuse and Mental Health because the report specifications are no can be obtained from the AHRQ Reports
Services Administration—as well as the longer needed to guide providers Clearance Officer.
DoD and VA. regarding aggregating output. FOR FURTHER INFORMATION CONTACT:
Since the initial release of the The Common Formats for Event Doris Lefkowitz, AHRQ Reports
Common Formats in August 2008, Reporting—Hospital Version 2.0 Clearance Officer, (301) 427–1477, or by
AHRQ has regularly revised the formats constitutes a major release of the AHRQ email at doris.lefkowitz@AHRQ.hhs.gov.
based upon public comment. First, Common Formats and reflects these key SUPPLEMENTARY INFORMATION:
AHRQ reviews existing patient safety changes:
practices and event reporting systems. • Data elements are designated as Proposed Project
Then, AHRQ works in collaboration either ‘core’ or ‘supplemental’ for In accordance with the Paperwork
with the PSWG and Federal subject reporting purposes; Reduction Act, 44 U.S.C. 3501–3521,
matter experts to develop and draft the • Event descriptions for each module AHRQ invites the public to comment on
Common Formats. In addition, the are condensed; and this proposed information collection.
PSWG assists AHRQ with assuring the • Module-specific paper forms are
The AHRQ Safety Program for
consistency of definitions/formats with eliminated.
The formats have two tiers, or data Enhancing Surgical Care and Recovery
those of relevant government agencies. is a quality improvement project that
Next, AHRQ solicits feedback from sets. The first tier, or core data set,
contains elements that are collected for aims to provide technical assistance to
private sector organizations and hospitals to help them implement
individuals. Finally, based upon the submission at the national level to the
PSOPPC. The second tier, or evidence-based practices to improve
feedback received, AHRQ further revises
supplemental data set, is optional for outcomes and prevent complications
the Common Formats.
use at the local level to support among patients who undergo surgery.
Participation by the private sector in
the development and subsequent additional analyses, and is not required Enhanced recovery pathways are a
revision of the Common Formats is for transmission to the PSOPPC. All constellation of preoperative,
achieved through work with the NQF. documentation for the Common Formats intraoperative, and postoperative
The Agency engages the NQF, a non- for Event Reporting—Hospital Version practices that decrease complications
profit organization focused on health 2.0 is posted on the PSOPPC Web site. and accelerate recovery. A number of
care quality, to solicit comments and https://www.psoppc.org/psoppc_web. studies and meta-analyses have
advice regarding proposed versions of More information on the Common demonstrated successful results. In
the Common Formats. AHRQ began this Formats can be obtained through order to facilitate broader adoption of
process with the NQF in 2008, receiving AHRQ’s PSO Web site: http:// these evidence-based practices among
feedback on AHRQ’s 0.1 Beta release of www.pso.ahrq.gov/. U.S. hospitals, this AHRQ project will
the Common Formats for Event adapt the Comprehensive Unit-based
Sharon B. Arnold, Safety Program (CUSP), which has been
Reporting—Hospital. After receiving
public comment, the NQF solicits the Deputy Director. demonstrated to be an effective
review and advice of its Common [FR Doc. 2017–10068 Filed 5–17–17; 8:45 am] approach to reducing other patient
Formats Expert Panel and subsequently BILLING CODE 4160–90–P harms, to enhanced recovery after
provides feedback to AHRQ. The surgery. The approach uses a
Agency then revises and refines the combination of clinical and cultural
Common Formats and issues them as a DEPARTMENT OF HEALTH AND (i.e., technical and adaptive)
production version. AHRQ has HUMAN SERVICES intervention components, which
continued to employ this process for all include promoting leadership and
Agency for Healthcare Research and frontline staff engagement, close
subsequent versions of the Common
Quality teamwork among surgeons, anesthesia
Formats.
providers, and nurses, as well as
Common Formats for Event Reporting— Agency Information Collection
enhancing patient communication and
Hospital Version 2.0 Activities: Proposed Collection;
engagement. Interested hospitals will
Comment Request
On April 8, 2016, AHRQ announced voluntarily participate.
the availability of the Common Formats AGENCY: Agency for Healthcare Research This project has the following goals:
for Event Reporting—Hospital Version and Quality, HHS. • Improve outcomes of surgical patients
2.0 for review and comment in the ACTION: Notice. by disseminating and supporting
Federal Register (81 FR 20642–20643). implementation of evidence-based
At the time of the initial release of the SUMMARY: This notice announces the enhanced recovery practices within
formats, only the event descriptions— intention of the Agency for Healthcare the CUSP framework
which define adverse events of interest Research and Quality (AHRQ) to request • Develop a bundle of technical and
in the inpatient hospital setting—were that the Office of Management and adaptive interventions and associated
made available. Based on public Budget (OMB) approve the proposed
jstallworth on DSK7TPTVN1PROD with NOTICES
tools and educational materials to
comment and NQF Expert Panel advice, information collection project: ‘‘The support implementation
AHRQ updated the event descriptions AHRQ Safety Program for Enhancing • Provide technical assistance and
and developed additional Surgical Care and Recovery.’’ training to hospitals for implementing
documentation for the Common Formats DATES: Comments on this notice must be enhanced recovery practices
for Event Reporting—Hospital Version received by July 17, 2017. • Assess the adoption, and evaluate the
2.0, including data element definitions, ADDRESSES: Written comments should effectiveness of, the intervention
algorithms, and technical specifications. be submitted to: Doris Lefkowitz, among the participating hospitals
VerDate Sep<11>2014 13:43 May 17, 2017 Jkt 241001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 E:\FR\FM\18MYN1.SGM 18MYN1](https://thefederalregister.org/doc/82_FR_22925/page/2.svg)
Document Created: 2017-05-18 01:20:48
Document Modified: 2017-05-18 01:20:48
| 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 availability--new common formats. | |
| Dates | Ongoing public input. | |
| 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] | |
| FR Citation | 82 FR 22830 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR