Attachment M -- Federal Register Notice

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Estimated Annual Costs to the Federal
Government

modules (15 per year for 3 years). The
total cost is estimated to be $3,963,150.

Exhibit 3 shows the total and
annualized cost for the 45 CME/CE/CEU

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST
Cost component

Annualized cost

Development of CME/CE/CEU Module .......................................................................................................
Module Accreditation ...................................................................................................................................
Module Dissemination .................................................................................................................................
Evaluation instrument development and dissemination, data collection, processing and analysis ............

$2,256,300
900,000
450,000
356,850

$752,100
300,000
150,000
118,950

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

$3,963,150

$1,321,050

Request for Comments
In accordance with the Paperwork
Reduction Act, 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 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–4130 Filed 2–25–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare

SUMMARY:

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Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘Improving Patient Safety System
Implementation for Patients with
Limited English Proficiency.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on December 2010 and allowed
60 days for public comment. One
comment was 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 30, 2011.
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 [email protected]
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project

Agency for Healthcare Research and
Quality
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Total cost

Improving Patient Safety System
Implementation for Patients With
Limited English Proficiency
According to the 2009 American
Community Survey (U.S. Census
Bureau), approximately 57 million
people—20% of the U.S. population—
speak a language other than English at
home. Of that number, approximately
24 million (8.6% of the U.S. population)
are defined as having Limited English
Proficiency (LEP), meaning that they

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report speaking English less than ‘‘very
well.’’ Recent research suggests that
adverse events affect LEP patients more
severely than they affect Englishspeaking patients. In addition to
linguistic barriers, LEP patients often
face cultural barriers to care and low
health literacy as well.
AHRQ proposes to develop a new
training program to improve patient
safety system implementation for
patients with limited English
proficiency. The new training program
is designed as a continuing education
module within the TeamSTEPPS
system. TeamSTEPPS is an evidencebased framework to optimize team
performance across the healthcare
delivery system with the goal of
improving patient safety. This system
has been successfully implemented in
numerous hospitals across the United
States. The TeamSTEPPS curriculum is
an easy-to-use comprehensive
multimedia kit that includes modules in
text and presentation format, video
vignettes to illustrate key concepts, and
workshop materials, including a
supporting CD and DVD, on change
management, coaching, and
implementation. Portions of the training
module may also be useful for hospitals
that have not implemented
TeamSTEPPS. The new training module
will show how TeamSTEPPS principles
can be better implemented to improve
the safety of patients with LEP.
AHRQ proposes to field-test this
module by conducting case studies of its
implementation in three hospitals. The
primary goals of this field test are to
identify needed changes in the training
module content or format to increase the
feasibility of implementation and
improve module outcomes including
audience response, learning, adoption of
recommended team behaviors, and
improved outcomes for LEP patients.
Patient outcome measures for this
project include the patient’s access to an
interpreter and how well they

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Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices

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understood instructions from the
hospital staff.
This study is being conducted by
AHRQ through its contractor, Abt
Associates Inc., pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
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 project the
following activities will be
implemented:
(1) Readiness Assessment Survey of
whether a hospital has the right policies
in place to implement the training
module. The readiness assessment will
be completed by the key contact person
(hospital champion) at each site. The
assessment may be completed in
consultation with other members of a
‘‘change team’’ that the hospital
champion may form to support the
initiative.
(2) Pre-work for Master-Training,
including a survey, process map
exercise, and a request to locate the
hospital’s or organization’s policy on
accessing language services. The prework will be completed by one of the
hospital staff persons selected to be a
Master-Trainer at each site.
(3) Master Training session in which
two staff members from each of three
participating hospitals will learn how to
teach the training module. The
TeamSTEPPS system requires at least
two trainers for each hospital because
its implementation is a team endeavor.
Trainers will be selected either by the
hospital champion, or by the ‘‘change
team’’ formed by the hospital champion
to support the intervention. Trainers
will be selected from among natural
leaders working within the hospital unit
where the training will take place.
Ideally the team will include a provider
(e.g., doctor, nurse) and an interpreter.
Hospital staff selected to attend the
training will be required to travel to
Boston for the training session.
(4) Staff Training session using the
training module developed for this
project. Training participants will be
drawn from the interprofessional care
team in one or more hospital units (e.g.,
ob/gyn, surgery, etc.). This team may
include nurses, physicians, technicians,
front desk staff, and interpreters. Since
the training teaches team behaviors, the
entire interprofessional care team in a
given hospital unit will be asked to
attend the training session together. The

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training will be conducted onsite by the
hospital staff members who attended the
Master Training.
(5) Training Participant Satisfaction
Survey to assess trainee satisfaction
with, and perceived adequacy of, the
training module. This questionnaire will
be administered at the end of the
training module.
(6) Learning Outcomes Survey to
assess staff knowledge about the best
way to handle situations with LEP
patients. To measure the change in staff
knowledge resulting from the training
module this questionnaire will be
administered both before and after the
training.
(7) Pre-training Behavior Survey to
assess trainee behavior change resulting
from the training. The behavior
measured by this survey is the hospital
staffs’ use of interpreters when
interacting with LEP patients. To
measure the change in staff behavior
resulting from the training module,
questions from this survey are repeated
in the post-training behavior survey.
Interpreters are exempt from this
questionnaire because the questions
relate to interpreter use.
(8) Post-Training Behavior Survey to
assess trainee use of interpreters when
interacting with LEP patients (repeated
from the Pre-Training Behavior Survey)
and questions to assess the use of team
communication tools demonstrated
during the training.
(9) Patient Outcome Survey to
measure change in patient
communication and safety outcomes
resulting from the training. This
survey’s target audience is all patients
identified as LEP. The purpose of this
survey is to measure intermediate
outcomes related to LEP patients’ access
to language services, comprehension,
and satisfaction with services.
(10) Semi-Structured Follow-Up
Interview to assess hospitals’
experiences implementing the training
module. This semi-structured
interview’s target audience consists of
up to two master-trainers or change
team members in each hospital where
the training module is implemented.
These interviews will be conducted 3
times at the 2-week, 6-week and 10week mark after the training.
(11) Semi-Structured Site Visit
Interview to assess the hospitals’
experiences implementing the training
module. This semi-structured
interview’s target audience consists of
up to 6 persons who may include
master-trainers, change team members,
frontline staff members, or other persons
designated by the ‘‘hospital champion’’
as persons who might provide insight
into module implementation and

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10903

outcomes. These interviews will be
conducted 3 months after the training.
Estimated Annual Respondent Burden
Exhibit 1 presents estimates of the
reporting burden hours for this one-year
data collection process. Time estimates
are based on experience with similar
instruments used with comparable
respondents. The Readiness Assessment
Survey will be completed by the key
contact/project champion at each of the
3 participating hospitals and will take
about 5 minutes. The pre-work for the
Master-Training will be completed by
the two trainers selected for each site
and will take about 30 minutes. The
Master-Training will be conducted with
2 staff members from each hospital and
will last 4.5 hours; the burden estimate
of 12.5 hours includes 8 hours of travel
time to and from the training site. Staff
Training will include up to 30 staff
members at each hospital (plus the 2
trainers who are staff members) and will
last 1 hour. The Training Participant
Satisfaction Survey will be completed
by Staff Training participants at the end
of the training and takes 5 minutes to
complete. The Learning Outcomes
Survey will be administered twice,
before and after the training, and will
require 10 minutes. The Pre-Training
Behavior Survey will be administered to
all staff invited to the training except for
interpreters. It will require
approximately 5 minutes. Interpreters
do not complete this questionnaire
because the questions relate to
interpreter use. The Post-training
Behavior survey will be administered
two or more weeks after the training to
all staff who were invited to the
training, and will take approximately
7.5 minutes to complete. The Patient
Outcome Survey will be administered
twice, before and after the intervention,
to a sample of approximately 90 patients
(30 from each of the 3 participating
hospitals) and requires about 10
minutes to complete. Semi-Structured
Follow-up interviews will be conducted
three times over a 12-week period with
two master trainers or change team
members from each hospital. Each semistructured follow-up interview will last
for about an hour. Semi-Structured Site
visit interviews will be conducted with
6 staff members from each hospital and
will take an hour to complete. The total
annualized burden hours are estimated
to be 295 hours.
Exhibit 2 presents the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total cost burden is
estimated to be about $6,980.

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Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Data collection method

Number of
responses per
respondent

Hours per
response

Total burden
hours

Readiness Assessment Survey .......................................................................
Pre-Work for Master-Training ..........................................................................
Train the Trainer Training ................................................................................
Staff Training ...................................................................................................
Training Participant Satisfaction Survey ..........................................................
Learning Outcomes Survey .............................................................................
Pre-Training Behavior Survey .........................................................................
Post-Training Behavior Survey ........................................................................
Patient Outcome Survey ..................................................................................
Semi-Structured Follow-up interview ...............................................................
Semi-Structured Site visit interview .................................................................

3
3
3
3
3
3
3
3
90
3
3

1
2
2
32
30
60
25
30
2
6
6

5/60
30/60
12.5
1
5/60
10/60
5/60
7.5/60
10/60
1
1

0.25
3
75
96
8
30
6
11
30
18
18

Totals ........................................................................................................

117

na

na

295

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Data collection method

Total burden
hours

Average hourly wage rate *

Totals cost
burden

Readiness Assessment Survey .......................................................................
Pre-Work for Master-Training ..........................................................................
Train the Trainer Training ................................................................................
Staff Training ...................................................................................................
Training Participant Satisfaction Survey ..........................................................
Learning Outcomes Survey .............................................................................
Pre-Training Behavior Survey .........................................................................
Post-Training Behavior Survey ........................................................................
Patient Outcome Survey ..................................................................................
Semi-Structured Follow-up interview ...............................................................
Semi-Structured Site visit interview .................................................................

3
3
3
3
3
3
3
3
90
3
3

0.25
3
75
96
8
30
6
11
30
18
18

$26.50
26.50
26.50
22.02
22.02
22.02
22.04
$22.02
20.90
26.50
26.50

$7
80
1,988
2,114
176
661
132
$242
627
477
477

Totals ........................................................................................................

117

295

na

6,980

* The average hourly wage rate for readiness assessments, train-the-trainer trainings, semi-structured site visit interviews, and semi-structured
follow-up interviews was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all
professions), $31.02 and the average hourly wage rate for interpreters and translators, $21.97. The average hourly rate for staff receiving training
was calculated based on the average of the mean hourly wage rate for healthcare practitioners and medical occupations (all professions),
$31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean hourly wage rate for healthcare support occupations, $13.06.
The average hourly wage rate for respondents to the pre-training behavior survey was calculated based on the average of the mean hourly wage
rate for healthcare practitioners and medical occupations (all professions), $31.02, and mean hourly wage rate for healthcare support occupations, $13.06. The average hourly wage rate for patients was calculated on the mean hourly wage rate for all occupations. Average hourly rate
for unit staff, non-interpreter was calculated based on the average of the mean hourly rate for healthcare practitioners and medical occupations
(all professions), $31.02, and occupations (all professions), $31.02, mean hourly wage rate for interpreters and translators, $21.97, and mean
hourly wage rate for healthcare support occupations, $13.06. Mean hourly wage rates for these groups of occupations were obtained from the
Bureau of Labor & Statistics on ‘‘Occupational Employment and Wages, May 2009’’ found at the following urls: http://www.hls.gov/oes/current/
naics4_622100.htm, http://www.hls.gov/ocs/current/ocs273091.htm, http://www.hls.gov/oes/current/oes_nat.htm.

Estimated Annual Costs to the Federal
Government
The total cost of this contract to the
government is $499,978. The project

extends over 4 fiscal years, although
data collection will take place over the
course of a single year. Exhibit 3 shows
a breakdown of the total cost as well as

the annualized cost for the data
collection, processing and analysis
activity.

EXHIBIT 3—ESTIMATED COST

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Cost component

Total cost

Annual cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................

$301,664
52,629
52,629
51,658
41,399

$75,416
13,157
13,157
12,915
10,350

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

499,978

124,995

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Federal Register / Vol. 76, No. 39 / Monday, February 28, 2011 / 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 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 15, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–4135 Filed 2–25–11; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:

The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26, (Patient Safety
Act), and its implementing regulation at
42 CFR part 3, provides for the
formation of Patient Safety
Organizations (PSO5), which collect,
aggregate, and analyze confidential
information regarding the quality and
safety of healthcare delivery. On
December 30, 2010, HHS issued
‘‘Guidance Regarding Patient Safety
Organizations’ Reporting Obligations
and the Patient Safety and Quality
Improvement Act of 2005’’ (Guidance)
which can be accessed electronically at:

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SUMMARY:

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http://www.PSO.AHRQ.gov/regulations/
guidance.pdf.
This notice announces the intention
of AHRQ to request that the Office of
Management and Budget (OMB) amend
the approved clearance, OMB No. 0935–
0143, that allows information collection
related to implementation of the Patient
Safety Act. This amendment includes a
new attestation form related to the
Guidance. In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection. The purpose of this notice is
to allow 30 days for public comment on
the new attestation form related to the
Guidance.
DATES: Comments on this notice must be
received by March 30, 2011.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
AHRQ, Reports Clearance Officer, by fax
at (301) 427–1000 (attention: AHRQ
Reports Clearance Officer) or by e-mail
at [email protected].
Copies of this proposed form and
specific details on the estimated burden
can be obtained from AHRQs Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
SUPPLEMENTARY INFORMATION:
Proposed Form
This notice proposes the addition of
a new attestation form, ‘‘Supplemental
Attestations Regarding FDA Reporting
Obligations Of PSOs,’’ to the existing
approved clearance, ‘‘Patient Safety
Organization Certification for Initial
Listing and Related Forms and a Patient
Safety Confidentiality Complaint Form’’
(OMB No. 0935–0143).
In order to implement the Patient
Safety Act, HHS issued the Patient
Safety and Quality Improvement Final
Rule (Patient Safety Rule), published in
the Federal Register on November 21,
2008: 73 FR 70731–70814. Pursuant to
the Patient Safety Rule, entities seeking
to become and remain listed by the
Secretary as PSOs submit certifications
to the Secretary. These entities must
certify that they meet or will meet
specified statutory criteria and
requirements for PSOs, as further
explained in the Patient Safety Rule.
On December 30, 2010, HHS issued
Guidance to address questions that have
arisen regarding the obligations of PSOs
where they or the organization of which
they are a part are legally obligated
under the Federal Food, Drug, and
Cosmetic Act and its implementing
regulations to report certain information
to the FDA and to provide FDA with

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10905

access to its records, including access
during an inspection of its facilities.
This proposed form will collect
information from PSOs as described in
the Guidance.
Methods of Collection
Existing PSOs will be required to
complete this proposed form
immediately; an entity seeking listing as
a PSO will be required to complete this
proposed form at the time it submits its
certifications for initial listing. Every
entity completing this proposed form
will be required to attest whether it is
subject to the Guidance. Entities that are
subject to the Guidance will be required
to make one to three additional
attestations. To complete this form, a
respondent will need to review each
attestation, check the appropriate ‘‘yes’
or ‘‘no’’ box that follows each applicable
attestation, and complete and sign the
form.
The burden estimate for completing
this form is 15 minutes per respondent;
fewer than 100 entities are expected to
submit responses.
Estimated Annual Costs to the Federal
Government
Under the Patient Safety Act and
Patient Safety Rule, AHRQ collects and
reviews certifications from entities that
seek listing or continued listing as
PSOs. Entities applying to be PSOs and
existing PSOs may also be required to
provide additional information to
AHRQ. The cost to AHRQ of processing
the information collected with the
above-described form is minimal: An
estimated equivalent of approximately
0.01 FTE or $1,500 and no new
overhead costs.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on the above
described attestation form are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research, quality improvement and
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

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