Attachment G -- 30 day FRN

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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Hours per
response

Total
burden hours

Data entry into GRS ........................................................................................

500

4

10/60

333

Total ..........................................................................................................

500

na

na

333

EXHIBIT 2. ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total
burden hours

Average
hourly wage
rate *

Total cost
burden

Data entry into GRS ........................................................................................

500

333

$35.35

$11,772

Total ..........................................................................................................

500

333

na

$11,772

* Based upon the average wages for Healthcare Practitioner and Technical Occupations (29–0000), ‘‘National Compensation Survey: Occupational Wages in the United States, May 2012,’’ U.S. Department of Labor, Bureau of Labor Statistics.

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) whether the
proposed collection of information is
necessary for the proper performance of
AHRQ healthcare research and
healthcare information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: February 6, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–03487 Filed 2–14–14; 8:45 am]

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Health care Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Health care
Research and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Assessing the Impact of the National
Implementation of TeamSTEPPS Master
Training Program.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on August 27th, 2013 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by March 20, 2014.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
SUMMARY:

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can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Assessing the Impact of the National
Implementation of TeamSTEPPS Master
Training Program
As part of their effort to fulfill their
mission goals, AHRQ, in collaboration
with the Department of Defense’s (DoD)
Tricare Management Activity (TMA),
developed TeamSTEPPS® (aka Team
Strategies and Tools for Enhancing
Performance and Patient Safety) to
provide an evidence-based suite of tools
and strategies for training teamworkbased patient safety to health care
professionals. In 2007, AHRQ and DoD
coordinated the national
implementation of the TeamSTEPPS
program. The main objective of this
program is to improve patient safety by
training a select group of stakeholders
such as Quality Improvement
Organization (QIO) personnel, High
Reliability Organization (HRO) staff, and
health care system staff in various
teamwork, communication, and patient
safety concepts, tools, and techniques
and ultimately helping to build national
capacity for supporting teamwork-based
patient safety efforts in health care
organizations and at the state level. The
implementation includes the
availability of voluntary training of
Master Trainers in various health care
systems capable of stimulating the
utilization and adoption of
TeamSTEPPS in their health care
delivery systems, providing technical
assistance and consultation on

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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
implementing TeamSTEPPS, and
developing various channels of learning
(e.g., user networks, various educational
venues) for continuation support and
improvement of teamwork in health
care. During this effort, AHRQ has
trained more than 2400 participants to
serve as the Master Trainer
infrastructure supporting national
adoption of TeamSTEPPS. Participants
in training become Master Trainers in
TeamSTEPPS and are afforded the
opportunity to observe the tools and
strategies provided in the program in
action. In addition to developing Master
Trainers, AHRQ has also developed a
series of support mechanisms for this
effort including a data collection Web
tool, a TeamSTEPPS call support center,
and a monthly consortium to address
any challenges encountered by
implementers of TeamSTEPPS.
To understand the extent to which
this expanded patient safety knowledge
and skills have been created, AHRQ will
conduct an evaluation of the National
Implementation of TeamSTEPPS Master
Training program. The goals of this
evaluation are to examine the extent to
which training participants have been
able to:
(1) Implement the TeamSTEPPS
products, concepts, tools, and
techniques in their home organizations
and,
(2) spread that training, knowledge,
and skills to their organizations, local
areas, regions, and states.
This study is being conducted by
AHRQ through its contractor, Health
Research & Educational Trust (HRET),
pursuant to AHRQ’s statutory authority

to conduct and support research on
health care and on systems for the
delivery of such care, including
activities with respect to the quality,
effectiveness, efficiency,
appropriateness and value of health care
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this
assessment the following two data
collections will be implemented:
(1) Web-based questionnaire to
examine post-training activities and
teamwork outcomes as a result of
training from multiple perspectives. The
questionnaire is directed to all master
training participants. Items will cover
post-training activities, implementation
experiences, facilitators and barriers to
implementation encountered, and
perceived outcomes as a result of these
activities.
(2) Semi-structured interviews will be
conducted with members from
organizations who participated in the
TeamSTEPPS Master Training program.
Information gathered from these
interviews will be analyzed and used to
draft a ‘‘lessons learned’’ document that
will capture additional detail on the
issues related to participants’ and
organizations’ abilities to implement
and disseminate the TeamSTEPPS posttraining. The organizations will vary in
terms of type of organization (e.g., QIO
or hospital associations versus health
care systems) and region (i.e., Northeast,
Midwest, Southwest, Southeast, MidAtlantic, and West Coast). In addition,

we will strive to ensure
representativeness of the sites by
ensuring that the distribution of
organizations mirrors the distribution of
organizations in the master training
population. For example, if the
distribution of organizations is such that
only one out of every five organizations
is a QIO, we will ensure that a
maximum of two organizations in the
sample are QIOs. The interviews will
more accurately reveal the degree of
training spread for the organizations
included. Interviewees will be drawn
from qualified individuals serving in
one of two roles (i.e., implementers or
facilitators). The interview protocol will
be adapted for each role based on the
respondent group and to some degree,
for each individual, based on their
training and patient safety experience.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondent’s time to participate in the
study. Semi-structured interviews will
be conducted with a maximum of 9
individuals from each of 9 participating
organizations and will last about one
hour each. The training participant
questionnaire will be completed by
approximately 10 individuals from each
of about 240 organizations and is
estimated to require 20 minutes to
complete. The total annualized burden
is estimated to be 881 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to participate in the
study. The total cost burden is estimated
to be $38,923.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents

Number of responses per
respondent

Semi-structured interview ................................................................................
Training participant questionnaire ...................................................................

9
240

9
10

60/60
20/60

81
800

Total ..........................................................................................................

249

NA

NA

881

Average hourly wage rate*

Total cost burden

Form name

Hours per response

Total burden
hours

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of respondents

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Form name

Total burden
hours

Semi-structured interview ................................................................................
Training participant questionnaire ...................................................................

9
240

81
800

$44.18
44.18

$3,579
35,344

Total ..........................................................................................................

249

881

NA

38,923

* Based upon the mean of the average wages for all health professionals (29–0000) for the training participant questionnaire and for executives, administrators, and managers for the organizational leader questionnaire presented in the National Compensation Survey: Occupational
Wages in the United States, May, 2012, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#37–
0000.

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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices

Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQ’s information
collection are requested with regard to
any of the following: (a) Whether the
proposed collection of information is
necessary for the proper performance of
AHRQ health care research and health
care information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: January 29, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014–03482 Filed 2–14–14; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Common Formats for Patient Safety
Data Collection and Event Reporting
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of Availability—New
Common Formats
AGENCY:

As authorized by the
Secretary of HHS, AHRQ coordinates
the development of common definitions
and reporting formats (Common
Formats) for reporting patient safety
events to Patient Safety Organizations
(PSOs) and other entities. The purpose
of this notice is to announce the
availability of a new type of Common
Formats for public review and
comment—Common Formats for
Surveillance—Hospital.
DATES: Ongoing public input.
ADDRESSES: The newly released
Common Formats for Surveillance—
Hospital—which includes modules

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SUMMARY:

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entitled Generic Adverse Event
Information, Blood or Blood Product,
Delivery-Maternal, Delivery-Neonatal,
Device or Medical/Surgical Supply
Including Health Information
Technology (HIT), Fall, Medications,
Pressure Ulcer, Readmissions, Surgery
or Anesthesia, Venous
Thromboembolism, and Other
Outcomes of Interest—can be accessed
electronically at the following HHS Web
site: http://www.PSO.AHRQ.gov/
index.html
FOR FURTHER INFORMATION CONTACT:
Glenn Egelman, M.D., 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 70731–70814, provide for the
formation of PSOs, which collect,
aggregate, and analyze confidential
information regarding the quality and
safety of healthcare delivery. The
Patient Safety Act (at 42 U.S.C. 299b24(b)(1)(F)) requires PSOs to collect
information from providers in a
standardized manner that permits valid
comparisons of similar cases among
similar providers, to the extent practical
and appropriate. As explained in 42
CFR 3.102(b)(1)(iii)(A)(1), one option for
a PSO to satisfy this requirement is by
certifying that it is using the Secretary’s
published guidance for common formats
and definitions in its collection of
information from healthcare providers.
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

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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/REGULATIONS/
REGULATIONS.htm.
Definition of Common Formats
The term Common Formats refers to
the common definitions and reporting
formats, specified by AHRQ, that allow
healthcare providers to collect and
submit standardized information
regarding patient safety events. 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
healthcare 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 two
settings of care—acute care hospitals
and skilled nursing facilities—in order
to facilitate standardized data
collection. 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.
Until now, Common Formats have
been designed to support only
traditional event reporting. Common
Formats for Surveillance—Hospital are
designed to provide, through
retrospective review of medical records,
information that is complementary to
that derived from event reporting
systems. These formats will facilitate
improved detection of events and
calculation of adverse event rates in
populations reviewed.
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 provides an evidence base
that informed construction of the
Common Formats. The inventory
includes many systems from the private
sector, including academic settings,
hospital systems, and international
reporting systems (e.g., from the United
Kingdom and the Commonwealth of

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