80 FR 60385 - 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 80, Issue 193 (October 6, 2015)

Page Range		60385-60387
FR Document		2015-25364

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.

Federal Register, Volume 80 Issue 193 (Tuesday, October 6, 2015)

[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Notices]
[Pages 60385-60387]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25364]


=======================================================================
-----------------------------------------------------------------------

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 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: PSO@AHRQ.hhs.gov.

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

[[Page 60387]]

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

Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60385

This clearance covers the following burden of this collection of information FOR FURTHER INFORMATION CONTACT:
requirements: is accurate, and based on valid Cathryn Bach, Center for Quality
(a) FAR 52.245–1(f)(1)(ii) requires assumptions and methodology; ways to Improvement and Patient Safety, AHRQ,
contractors to document the receipt of enhance the quality, utility, and clarity 540 Gaither Road, Rockville, MD 20850;
Government property. of the information to be collected; and Telephone (toll free): (866) 403–3697;
(b) FAR 52.245–1(f)(1)(ii)(A) requires ways in which we can minimize the Telephone (local): (301) 427–1111; TTY
contractors to submit report if overages, burden of the collection of information (toll free): (866) 438–7231; TTY (local):
shortages, or damages and/or other on those who are to respond, through (301) 427–1130; Email: PSO@
discrepancies are discovered upon the use of appropriate technological AHRQ.hhs.gov.
receipt of Government-furnished collection techniques or other forms of SUPPLEMENTARY INFORMATION:
property. information technology.
(c) FAR 52.245–1(f)(1)(iii) requires Obtaining Copies of Proposals: Background
contractors to create and maintain Requesters may obtain a copy of the The Patient Safety and Quality
records of all Government property information collection documents from Improvement Act of 2005, 42 U.S.C.
accountable to the contract. the General Services Administration, 299b–21 to b–26, (Patient Safety Act)
(d) FAR 52.245–1(f)(1)(iv) requires Regulatory Secretariat Division (MVCB), and the related Patient Safety and
contractors to periodically perform, 1800 F Street NW., Washington, DC Quality Improvement Final Rule, 42
record, and report physical inventories 20006, telephone 202–501–4755. Please CFR part 3 (Patient Safety Rule),
during contract performance, including cite OMB Control No. 9000–0075, published in the Federal Register on
upon completion or termination of the Government Property, in all November 21, 2008, (73 FR 70732–
contract. correspondence. 70814), provide for the formation of
(e) FAR 52.245–1(f)(1)(vii)(B) requires
Edward Loeb, Patient Safety Organizations (PSOs),
contractors to investigate and report all
Acting Director, Federal Acquisition Policy which collect, aggregate, and analyze
incidents of Government property loss
Division, Office of Governmentwide confidential information regarding the
as soon as the facts become known.
Acquisition Policy, Office of Acquisition quality and safety of health care
(f) FAR 52.245–1(f)(1)(viii) requires
Policy, Office of Govenrmentwide Policy. delivery. The collection of patient safety
contractors to promptly disclose and
[FR Doc. 2015–25366 Filed 10–5–15; 8:45 am] work product allows the aggregation of
report Government property in its
BILLING CODE 6820–EP–P data that help to identify and address
possession that is excess to contract
underlying causal factors of patient
performance.
(g) FAR 52.245–1(f)(1)(ix) requires quality and safety problems.
contractors to disclose and report to the DEPARTMENT OF HEALTH AND The Patient Safety Act and Patient
Property Administrator the need for HUMAN SERVICES Safety Rule establish a framework by
replacement and/or capital which doctors, hospitals, skilled
rehabilitation. Agency for Healthcare Research and nursing facilities, and other healthcare
(h) FAR 52.245–1(f)(1)(x) requires Quality providers may assemble information
contractors to perform and report to the regarding patient safety events and
Common Formats for Reporting on quality of care. Information that is
Property Administrator contract
Health Care Quality and Patient Safety assembled and developed by providers
property closeout.
(i) FAR 52.245–1(f)(2) requires for reporting to PSOs and the
AGENCY: Agency for Healthcare Research
contractors to establish and maintain information received and analyzed by
and Quality (AHRQ), Department of
source data, particularly in the areas of PSOs—called ‘‘patient safety work
Health and Human Services (HHS).
recognition of acquisitions and product’’—is privileged and
ACTION: Notice of Availability—New confidential. Patient safety work
dispositions of material and equipment. Common Formats.
(j) FAR 52.245–1(j)(2) requires product is used to conduct patient
contractors to submit inventory disposal SUMMARY: As authorized by the safety activities, which may include
schedules to the Plant Clearance Officer Secretary of HHS, AHRQ coordinates identifying events, patterns of care, and
via the Standard Form 1428, Inventory the development of sets of common unsafe conditions that increase risks
Disposal Schedule. definitions and reporting formats and hazards to patients. Definitions and
(k) FAR 52.245–9(d) requires a (Common Formats) for reporting on other details about PSOs and patient
contractor to identify the property for health care quality and patient safety. safety work product are included in the
which rental is requested. The purpose of this notice is to Patient Safety Act and Patient Safety
announce the availability of two new Rule which can be accessed
B. Annual Reporting Burden electronically at: http://
sets of Common Formats for public
Number of Respondents: 11,375. review and comment: 1) Common www.pso.ahrq.gov/legislation/.
Responses per Respondent: 1,057. Formats for retail pharmacies—Common Definition of Common Formats
Total Responses: 12,023,375. Formats for Retail Pharmacy; and 2) the
Average Burden Hours per Response: healthcare associated infection (HAI) The term ‘‘Common Formats’’ refers
.3092. module for Common Formats for to the common definitions and reporting
Total Burden Hours: 3,717,627. Surveillance. formats, specified by AHRQ, that allow
health care providers to collect and
C. Public Comments DATES: Ongoing public input. submit standardized information
tkelley on DSK3SPTVN1PROD with NOTICES

Public comments are particularly ADDRESSES: The Common Formats for regarding patient quality and safety to
invited on: Whether this collection of Retail Pharmacy, the HAI module for PSOs and other entities. The Common
information is necessary for the proper Common Formats for Surveillance, and Formats are not intended to replace any
performance of functions of the Federal the remaining Common Formats can be current mandatory reporting system,
Acquisition Regulations (FAR), and accessed electronically at the following collaborative/voluntary reporting
whether it will have practical utility; HHS Web site: http:// system, research-related reporting
whether our estimate of the public www.pso.ahrq.gov/common/. system, or other reporting/recording

VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1

Federal Register / Vol. 80, No. 193 / Tuesday, October 6, 2015 / Notices 60387

Description—which defines adverse which will be incorporated into QSRS DEPARTMENT OF HEALTH AND
events of interest in the retail pharmacy software. Information on how to HUMAN SERVICES
setting—is available. Other elements of comment and provide feedback on the
the Common Formats, including HAI module is available at the NQF Administration for Children and
aggregate reports and technical Web site: http://www.qualityforum.org/ Families
specifications, will be developed Project_Pages/Common_Formats_for_
following revision of the Common Submission for OMB Review;
Patient_Safety_Data.aspx.
Formats for Retail Pharmacy based on Comment Request
public comment and NQF advice. AHRQ appreciates the time and effort
individuals invest in providing Title: National Youth in Transition
Information on how to comment and Database and Youth Outcome Survey.
provide feedback on the Common comments. The Agency will review and
consider all feedback received to help OMB No.: 0970–0340.
Formats for Retail Pharmacy is available Description: The Foster Care
at the NQF Web site: http://www.quality guide the development of a revised
Independence Act of 1999 (42 U.S.C.
forum.org/Project_Pages/Common_ version. The process for updating and
1305 et seq.) as amended by Public Law
Formats_for_Patient_Safety_Data.aspx. refining the formats will continue to be
106–169 requires State child welfare
an iterative one.
Commenting on HAI Module for agencies to collect and report to the
Common Formats for Surveillance Future versions of the Common Administration on Children and
Formats are planned to be developed for Families (ACF) data on the
Common Formats addressing all additional ambulatory settings, such as characteristics of youth receiving
QSRS modules—except for those for ambulatory surgery centers and independent living services and
HAIs—were made available for public physician and practitioner offices. More information regarding their outcomes.
comment in 2014. During the information on the Common Formats The regulation implementing the
intervening time, AHRQ was able to can be obtained through AHRQ’s PSO National Youth in Transition Database,
consult with CDC in order to refine the Web site: http://www.pso.ahrq.gov/. listed in 45 CFR 1356.80, contains
HAI module. When integrated with the standard data collection and reporting
remaining modules of QSRS, the HAI Sharon B. Arnold, requirements for States to meet the law’s
module will allow completion of the AHRQ Deputy Director. requirements. ACF will use the
first version of QSRS. [FR Doc. 2015–25364 Filed 10–5–15; 8:45 am] information collected under the
The Agency is specifically interested BILLING CODE 4160–90–P regulation to track independent living
in obtaining feedback from both the services, assess the collective outcomes
private and public sectors on the HAI of youth, and potentially to evaluate
module for Common Formats for State performance with regard to those
Surveillance. Only the Event outcomes consistent with the law’s
Description—which defines six HAI mandate.
adverse events of interest—is available. Respondents: State agencies that
Based on public comment and NQF administer the John H. Chafee Foster
advice, AHRQ will finalize this module, Care Independence Program.

ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response

Youth Outcome Survey ................................................................................... 20,667 1 0.50 10,334
Data File .......................................................................................................... 52 2 1,849 192,296

Estimated Total Annual Burden is best assured of having its full effect DEPARTMENT OF HEALTH AND
Hours: 202,630 if OMB receives it within 30 days of HUMAN SERVICES
Additional Information publication. Written comments and
recommendations for the proposed Food and Drug Administration
Copies of the proposed collection may information collection should be sent [Docket No. FDA–2015–D–3378]
be obtained by writing to the directly to the following: Office of
Administration for Children and Management and Budget, Paperwork Acceptability of Draft Labeling To
Families, Office of Planning, Research Reduction Project, Fax: 202–395–7285, Support Abbreviated New Drug
and Evaluation, 370 L’Enfant Application Approval; Guidance for
Email: OIRA_SUBMISSION@
Promenade SW., Washington, DC 20447, Industry; Availability
OMB.EOP.GOV, Attn: Desk Officer for
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title the Administration for Children and AGENCY: Food and Drug Administration,
of the information collection. Email Families. HHS.
address: infocollection@acf.hhs.gov. Robert Sargis, ACTION: Notice.
tkelley on DSK3SPTVN1PROD with NOTICES

OMB Comment Reports Clearance Officer.
SUMMARY: The Food and Drug
[FR Doc. 2015–25370 Filed 10–5–15; 8:45 am]
OMB is required to make a decision Administration (FDA or Agency) is
concerning the collection of information BILLING CODE 4184–01–P announcing the availability of a
between 30 and 60 days after guidance for industry entitled
publication of this document in the ‘‘Acceptability of Draft Labeling to
Federal Register. Therefore, a comment Support ANDA Approval.’’

VerDate Sep<11>2014 18:31 Oct 05, 2015 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\06OCN1.SGM 06OCN1

Document Created: 2015-12-15 08:51:19
Document Modified: 2015-12-15 08:51:19

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		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]
FR Citation		80 FR 60385

80 FR 60385 - Common Formats for Reporting on Health Care Quality and Patient Safety

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 80, Issue 193 (October 6, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality