81_FR_20710 81 FR 20642 - Common Formats for Reporting on Health Care Quality and Patient Safety

81 FR 20642 - 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 81, Issue 68 (April 8, 2016)

Page Range20642-20643
FR Document2016-08021

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.

Federal Register, Volume 81 Issue 68 (Friday, April 8, 2016) 
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20642-20643]
From the Federal Register Online  [www.thefederalregister.org]
[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

20642 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN Number of Average Total burden Total Form Name respondents/ hourly hours cost burden POCs wage rate* Eligibility/Registration Form ............................................................................. 304 15 $53.17 $798 Data Use Agreement ....................................................................................... 304 15 53.17 798 Hospital Information Form ............................................................................... 304 76 53.17 4,041 Data Files Submission ..................................................................................... 304 304 53.17 16,164 Total .......................................................................................................... 1,216 410 NA 21,801 * Wage rates were calculated using the mean hourly wage based on occupational employment and wage estimates from the Dept. of Labor, Bureau of Labor Statistics’ May 2014 National Industry-Specific Occupational Employment and Wage Estimates NAICS 622000—Hospitals, lo- cated at http://www.bls.gov/oes/current/naics3_622000.htm. Wage rate of $53.17 is based on the mean hourly wages for Medical and Health Services Managers (11–9111). Request for Comments definitions and reporting formats assembled and developed by providers In accordance with the Paperwork (Common Formats) for reporting on for reporting to PSOs and the Reduction Act, comments on AHRQ’s health care quality and patient safety. information received and analyzed by information collection are requested The purpose of this notice is to PSOs—called ‘‘patient safety work with regard to any of the following: (a) announce the availability of new product’’—is privileged and Whether the proposed collection of formats for public review and comment, confidential. Patient safety work information is necessary for the proper Common Formats for Event Reporting product is used to conduct patient performance of AHRQ health care for Hospitals Version 2.0. safety activities, which may include research and health care information DATES: May 9, 2016. identifying events, patterns of care, and dissemination functions, including ADDRESSES: The Common Formats for unsafe conditions that increase risks whether the information will have Event Reporting for Hospitals Version and hazards to patients. Definitions and practical utility; (b) the accuracy of 2.0, and the remaining Common other details about PSOs and patient AHRQ’s estimate of burden (including Formats, can be accessed electronically safety work product are included in the hours and costs) of the proposed at the following HHS Web site: http:// Patient Safety Act and Patient Safety collection(s) of information; (c) ways to www.pso.ahrq.gov/common/. Rule which can be accessed enhance the quality, utility, and clarity electronically at: http:// FOR FURTHER INFORMATION CONTACT: of the information to be collected; and www.pso.ahrq.gov/legislation/. Cathryn Bach, Center for Quality (d) ways to minimize the burden of the Improvement and Patient Safety, AHRQ, Definition of Common Formats collection of information upon the 5600 Fishers Lane, Rockville, MD respondents, including the use of 20857; Telephone (toll free): (866) 403– The term ‘‘Common Formats’’ refers automated collection techniques or 3697; Telephone (local): (301) 427– to the common definitions and reporting other forms of information technology. 1111; TTY (toll free): (866) 438–7231; formats, specified by AHRQ, that allow Comments submitted in response to TTY (local): (301) 427–1130; Email: health care providers to collect and this notice will be summarized and PSO@AHRQ.hhs.gov. submit standardized information included in the Agency’s subsequent regarding patient quality and safety to SUPPLEMENTARY INFORMATION: request for OMB approval of the PSOs and other entities. The formats are proposed information collection. All Background not intended to replace any current comments will become a matter of The Patient Safety and Quality mandatory reporting system, public record. Improvement Act of 2005, 42 U.S.C. collaborative/voluntary reporting Sharon B. Arnold, 299b–21 to b–26, (Patient Safety Act) system, research-related reporting Acting Director. and the related Patient Safety and system, or other reporting/recording Quality Improvement Final Rule, 42 system; rather the formats are intended [FR Doc. 2016–08020 Filed 4–7–16; 8:45 am] CFR part 3 (Patient Safety Rule), to enhance the ability of health care BILLING CODE 4160–90–P published in the Federal Register on providers to report information that is November 21, 2008, (73 FR 70732– standardized both clinically and DEPARTMENT OF HEALTH AND 70814), provide for the formation of electronically. HUMAN SERVICES Patient Safety Organizations (PSOs), In collaboration with the interagency which collect, aggregate, and analyze Federal Patient Safety Workgroup Agency for Healthcare Research and confidential information regarding the (PSWG), the National Quality Forum Quality quality and safety of health care (NQF), and the public, AHRQ has delivery. The collection of patient safety developed Common Formats for three Common Formats for Reporting on work product allows the aggregation of settings of care—acute care hospitals, Health Care Quality and Patient Safety data that help to identify and address nursing homes, and retail pharmacies— AGENCY: Agency for Healthcare Research underlying causal factors of patient in order to facilitate standardized data mstockstill on DSK4VPTVN1PROD with NOTICES and Quality (AHRQ), Department of quality and safety problems. collection and analysis. The scope of the Health and Human Services (HHS). The Patient Safety Act and Patient formats applies to all patient safety ACTION: Notice of availability—new Safety Rule establish a framework by concerns including: Incidents—patient common formats. which doctors, hospitals, skilled safety events that reached the patient, nursing facilities, and other health care whether or not there was harm; near SUMMARY: As authorized by the providers may assemble information misses or close calls—patient safety Secretary of HHS, AHRQ coordinates regarding patient safety events and events that did not reach the patient; the development of sets of common quality of care. Information that is and unsafe conditions—circumstances VerDate Sep<11>2014 17:48 Apr 07, 2016 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1

Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices 20643 that increase the probability of a patient National Library of Medicine, Office of reduce the burden on health care safety event. the National Coordinator for Health providers and to facilitate data AHRQ’s Common Formats for patient Information Technology, Office of transmission. These formats have two safety event reporting include: Public Health and Science, and tiers, or data sets. The first tier, or • Event descriptions (definitions of Substance Abuse and Mental Health national data set, contains elements that patient safety events, near misses, and Services Administration—as well as the are collected for submission to the unsafe conditions to be reported); DoD and VA. PSOPPC. The second tier, or local data • Specifications for patient safety When developing Common Formats, set, is optional and is designed for use aggregate reports and individual event AHRQ first reviews existing patient at the local level for additional analyses. summaries that derive from event safety practices and event reporting This local data set is not meant for descriptions; systems. In collaboration with the transmission to the PSOPPC. • Delineation of data elements and PSWG and Federal subject matter The Agency is specifically interested algorithms to be used for collection of experts, AHRQ drafts and releases beta in obtaining feedback from both the adverse event data to populate the versions and updates to current versions private and public sectors on the reports; and of the Common Formats for public updated Common Formats for Event • Technical specifications for review and comment. The prior version Reporting—Hospitals Version 2.0. At electronic data collection and reporting. of Common Formats for Event Reporting this time, only the event descriptions— The technical specifications promote for Hospitals, Version 1.2, was released which define adverse events of interest standardization of collected patient in April 2013. The PSWG assists AHRQ in the inpatient hospital setting—are safety event information by specifying with assuring the consistency of available. Other elements of the rules for data collection and submission, definitions/formats with those of Common Formats, including aggregate as well as by providing guidance for relevant government agencies as reports and technical specifications, how and when to create data elements, refinement of the Common Formats will be developed following revision of their valid values, conditional and go-to continues. the Common Formats for Hospital logic, and reports. These specifications Since the initial release of the Version 2.0 based on public comment will ensure that data collected by PSOs Common Formats in August 2008, and NQF advice. Information on how to and other entities have comparable AHRQ has regularly revised the formats comment and provide feedback on the clinical meaning. They also provide based upon public comment. AHRQ Common Formats for Hospital Version direction to software developers, so that solicits feedback on beta, and 2.0 is available at the NQF Web site: the formats can be implemented subsequent, versions of Common http://www.qualityforum.org/Project_ electronically, and to PSOs, so that the Formats from private sector Pages/Common_Formats_for_Patient_ Common Formats can be submitted organizations and individuals. Based Safety_Data.aspx. electronically to the PSO Privacy upon the feedback received, AHRQ AHRQ appreciates the time and effort Protection Center (PSOPPC) for data de- further revises the formats. To the extent individuals invest in providing identification and transmission to the practicable, the Common Formats are comments. The Agency will review and Network of Patient Safety Databases also aligned with World Health consider all feedback received to help (NPSD). Organization (WHO) concepts, guide the development of a revised frameworks, and definitions. Common Formats Development Participation by the private sector in version. The process for updating and In anticipation of the need for the development and subsequent refining the formats will continue to be Common Formats, AHRQ began their revision of the Common Formats is an iterative one. development by creating an inventory of achieved through working with the Further information on the Common functioning private and public sector NQF. The Agency engages the NQF, a Formats can be obtained through patient safety reporting systems. This non-profit organization focused on AHRQ’s PSO Web site: http:// inventory provided an evidence base to health care quality, to solicit comments www.pso.ahrq.gov/. To receive inform construction of the Common and advice regarding proposed versions notifications about final versions of Formats. The inventory included many of the Common Formats. AHRQ began AHRQ Common Formats, please systems from the private sector, this process with the NQF in 2008, subscribe to ‘‘E-Mail Updates’’ at: including prominent academic settings, receiving feedback on AHRQ’s 0.1 Beta https://pso.ahrq.gov/about/subscribe. hospital systems, and international release of the Common Formats for Sharon B. Arnold, reporting systems (e.g., from the United Event Reporting—Hospital. After Acting Director. Kingdom and the Commonwealth of receiving public comment, the NQF [FR Doc. 2016–08021 Filed 4–7–16; 8:45 am] Australia). In addition, virtually all solicits the review and advice of its BILLING CODE 4160–90–P major Federal patient safety reporting Common Formats Expert Panel and systems were included, such as those subsequently provides feedback to from the Centers for Disease Control and AHRQ. The Agency then revises and DEPARTMENT OF HEALTH AND Prevention (CDC), the Food and Drug refines the Common Formats and issues HUMAN SERVICES Administration (FDA), the Department them as a production version. AHRQ of Defense (DoD), and the Department of has continued to employ this process for Centers for Medicare & Medicaid Veterans Affairs (VA). all subsequent versions of the formats. Services Since February 2005, AHRQ has Commenting on Common Formats for [Document Identifier: CMS–317, CMS–319, mstockstill on DSK4VPTVN1PROD with NOTICES convened the PSWG to assist AHRQ with developing and maintaining the Event Reporting—Hospital Version 2.0 CMS–10166, CMS–10178, and CMS–10184] Common Formats. The PSWG includes AHRQ used a tiered approach to Agency Information Collection major health agencies within HHS— develop Hospital Version 2.0. This Activities: Proposed Collection; CDC, Centers for Medicare & Medicaid approach was done in response to Comment Request Services, FDA, Health Resources and feedback from PSOs and the public to Services Administration, Indian Health decrease the number of questions for AGENCY: Centers for Medicare & Service, National Institutes of Health, each module of the formats in order to Medicaid Services. VerDate Sep<11>2014 17:48 Apr 07, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\08APN1.SGM 08APN1


Document Created: 2018-02-07 13:49:59
Document Modified: 2018-02-07 13:49:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability--new common formats.
DatesMay 9, 2016.
ContactCathryn 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]
FR Citation81 FR 20642 
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