Agency Information Collection Activities: Proposed Collection; Comment Request, 16574-16579 [2024-04786]
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adoption, use, authorization,
monitoring, acquisition, and security of
cloud computing products and services
to enable agency mission and
administrative priorities. The purposes
of the Committee are:
• To examine the operations of
FedRAMP and determine ways that
authorization processes can
continuously be improved, including
the following:
Æ Measures to increase agency reuse
of FedRAMP authorizations.
Æ Proposed actions that can be
adopted to reduce the burden,
confusion, and cost associated with
FedRAMP authorizations for cloud
service providers.
Æ Measures to increase the number of
FedRAMP authorizations for cloud
computing products and services
offered by small businesses concerns (as
defined by section 3(a) of the Small
Business Act (15 U.S.C. 632(a)).
Æ Proposed actions that can be
adopted to reduce the burden and cost
of FedRAMP authorizations for
agencies.
• Collect information and feedback
on agency compliance with, and
implementation of, FedRAMP
requirements.
• Serve as a forum that facilitates
communication and collaboration
among the FedRAMP stakeholder
community.
The FSCAC will meet no fewer than
three (3) times a calendar year. Meetings
shall occur as frequently as needed,
called, and approved by the DFO.
Purpose of the Meeting and Agenda
The March 28, 2024 public meeting
will be dedicated to deliberations in
order to determine what priority or
priorities the Committee would like to
work on next. Presentations may be held
on updates to the Office of Management
and Budget’s (OMB) draft Memorandum
titled ‘‘Modernizing the Federal Risk
Authorization Management Program
(FedRAMP)’’ (OMB Draft Memo),
FedRAMP’s updates in response to the
OMB Draft Memo, and Third Party
Assessment Organization (3PAO) user
experiences with the FedRAMP process.
A vote will be held to approve the
priority or priorities the Committee
chooses to work on next. The meeting
agenda will be posted on https://
gsa.gov/fscac prior to the March 28,
2024 meeting.
Meeting Attendance
This meeting is open to the public
and can be attended in-person or
virtually using the live stream link.
Meeting registration and information is
available at https://gsa.gov/fscac.
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Registration for attending the meeting in
person is highly encouraged by 5 p.m.
on Thursday, March 21, 2024 for easier
building access. In-person public
attendance is limited to the available
space, and seating is available on a first
come, first serve basis.
If you plan to attend virtually, you
will need to register by 5 p.m. on
Thursday, March 21, 2024 to obtain the
virtual meeting information. After
registration, individuals will receive
meeting attendance information via
email.
For information on services for
individuals with disabilities, or to
request accommodation for a disability,
please email the FSCAC staff at
FSCAC@gsa.gov at least 10 days prior to
the meeting. Live captioning may be
provided virtually, and ASL interpreters
may be present onsite.
Public Comment
Members of the public will have the
opportunity to provide oral public
comment during the FSCAC meeting by
indicating their preference when
registering. Written public comments
can be submitted at any time by
completing the public comment form on
our website, https://gsa.gov/fscac. All
written public comments will be
provided to FSCAC members in advance
of the meeting if received by
Wednesday, March 20, 2024.
Margaret Dugan,
Service-Level Liaison, Federal Acquisition
Service, General Services Administration.
[FR Doc. 2024–04844 Filed 3–6–24; 8:45 am]
BILLING CODE 6820–34–P
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, 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
updates to the currently approved
information collection project:
‘‘Implementation and Testing of
Diagnostic Safety Resources.’’ In
accordance with the Paperwork
Reduction Act of 1995, AHRQ invites
SUMMARY:
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the public to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by May 6, 2024.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at REPORTSCLEARANCE
OFFICER@ahrq.hhs.gov.
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
email at REPORTSCLEARANCE
OFFICER@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Implementation and Testing of
Diagnostic Safety Resources
Patient safety is a pillar of the Agency
for Healthcare Research and Quality’s
(AHRQ’s) mission to support the highest
quality healthcare. While progress has
been made in many areas of patient
safety, the field of diagnostic safety has
emerged as a particular area of concern.
It is estimated that every person in the
United States will experience a
diagnostic error in their lifetime
(Institute of Medicine, 2015) which can
lead to inappropriate, delayed, or
withheld treatment and ultimately poor
health outcomes, distress, and increased
costs. Diagnostic errors can occur for
many reasons: lack of meaningful
engagement between clinicians,
patients, and families; a fragmented
healthcare system not designed to
account for an increasingly complex
diagnostic process; minimal (if any)
feedback to clinicians about their
diagnostic performance; and a culture
that does not always support
transparent disclosure of diagnostic
errors (Institute of Medicine, 2015).
Leaders in diagnostic excellence suggest
that multi-pronged efforts are needed to
address this complex problem and go
beyond individual behaviors to systemlevel changes and empowering patients
to engage in their care (Institute of
Medicine, 2015; Henriksen, et al., 2017).
Improving diagnostic safety and
quality is an AHRQ priority. In
recognition of the multifaceted
approach needed to effectively advance
diagnostic safety, AHRQ recently
supported the development of three
tools to prevent diagnostic errors and
have prioritized these tools for
implementation and testing. These
resources vary in the types of
stakeholders they target, a critical
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advancement in our approach to
diagnostic excellence.
• Calibrate Dx. This tool, targeted to
individual clinicians, invites users to
select a topic or condition, review
diagnostic performance on a sample of
cases for insights and learning
opportunities, and debrief with a peer.
This resource will be tested in all
settings where clinicians are involved in
the diagnostic process, including both
inpatient and ambulatory settings.
• Measure Dx. This tool supports
healthcare organizations in building
sustainable teams for improving
diagnostic excellence, identifying
current capacity gaps, engaging in
measurement strategies as part of a
systematic approach to reviewing
available data, and translating findings
into learning opportunities. This
resource will be tested in both inpatient
and ambulatory settings; it is expected
to be implemented more commonly in
inpatient settings.
• Toolkit for Engaging Patients to
Improve Diagnostic Safety (Patient
Toolkit). This tool prepares patients,
families, and health professionals to
work together as partners to improve
diagnostic safety; encourages patients to
prepare for visits; and encourages
providers to listen for 60 seconds before
interrupting the patient. This resource
will be tested in ambulatory settings
only.
The goal of this research is to
implement and test these three
diagnostic safety resources to identify
specific ways in which each resource
can be used to maximize its value. For
each resource the following will be
examined:
(1) Feasibility of implementation—
barriers, facilitators, success factors,
and time needed for
implementation
(2) Level of adoption—number and type
of clinicians aware of and/or using
the resource, number of
organizational leaders endorsing the
resource
(3) Effectiveness of the resource—
number of diagnostic safety events
(Measure Dx and Patient Toolkit),
clinician self-efficacy for diagnostic
decision-making (Calibrate Dx)
(4) Maintenance and sustainability—the
number and type of patient safety
processes in place, barriers and
facilitators to maintenance and
sustainability
This project will implement and test
these three diagnostic safety resources
across a minimum of 150 sites to up to
219 sites (i.e., 50 to 73 sites per
resource). An Implementation and
Testing period for each resource will
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last 12 months, with Calibrate Dx
starting implementation first and
Measure Dx and the Toolkit for
Engaging Patients starting
implementation six months later. This
timing allows for staggered recruitment
to ensure adequate sample size and to
pilot implementation processes with a
single diagnostic safety resource first,
transferring lessons learned about
implementation and testing to the
implementation of the two other
resources. A Sustainability period will
begin as soon as the 12-month
Implementation and Testing Period is
complete and will continue for 14
additional months for each resource.
To achieve the goals of this project the
following data collections will be
implemented:
1. Site Interest Form—A short form
completed once by up to 1,060 sites
interested in participating in the project.
Used to indicate interest in the project
and by AHRQ to evaluate whether the
site meets the minimum participation
criteria.
2. Site Information Form—Completed
once by site leaders at 265 sites that
begin the project enrollment process,
this form collects additional contact
information, data on patient mix, and
information on the organization’s
diagnostic safety teams, resource
commitments, and capacity for
implementing the resources.
3. Safer Dx Checklist—Completed
once by 219 sites who fully complete
enrollment activities and begin
implementation of one of the three
resources (82.6% of the 265 sites who
begin enrollment activities). The Safer
Dx Checklist is a tool that allows
healthcare organizations to understand
the current state of their diagnostic
practices, identify areas to improve, and
track progress toward diagnostic
excellence over time. This will be
completed prior to actual
implementation of the resource.
4. Exit Interviews Protocol—
Completed once by an estimated 69 sites
(30% of those implementing one of the
three resources) that withdraw from the
project, this telephone interview will
collect information on why the site
could not sustain their efforts or
participation.
5. A baseline assessment of patient
safety culture will be conducted once
for each of the 219 sites that begin
participation. Completed once by site
leads depending on the setting:
a. SOPS® Medical Office Survey with
Diagnostic Safety Supplemental Item
Set—Completed once by the site lead for
109 ambulatory clinics.
b. SOPS® Hospital Survey with
Diagnostic Safety Supplemental Item
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Set—Completed once by the site lead for
110 inpatient sites.
6. Post-training Evaluation Form—
Completed once by 1,350 clinicians and
managers (90% of the 1,500
participants) attending the project’s
training sessions. The data will be used
to track the perceived value of the
training provided to enrolled sites.
7. Post-technical Assistance
Evaluation Form—Administered up to 3
times to 1,500 clinicians and managers
participating in the project’s Learning
Collaborative sessions; an estimated
90% response rate to this collection
with a total of 4,050 forms completed.
The data will be used to track the
perceived value of the technical
assistance provided to enrolled sites.
8. Clinical Sustainability Assessment
Tool (CSAT)—Completed by 219 site
leaders once between months 9 to 12 in
advance of the 14-month sustainability
period. The CSAT is a self-assessment to
evaluate sustainability capacity of a
clinical practice.
9. Implementation Interviews
Protocol—A qualitative, semi-structured
interview will be conducted with 438
site leads and/or frontline staff (up to 2
individuals from each site) at two points
in time during implementation (e.g., 6and 18-months). The protocol is
designed to elicit participant
perspectives on implementation of the
resource, capture lessons learned and
best practices, and when possible, to
provide support for adjustment to the
implementation.
In addition to those noted above, the
project will implement the following
data collections specific to the
individual resources.
For Measure Dx, the following data
collections will be implemented:
10. Measure Dx Organizational SelfAssessment—This is one of the main
components of the Measure Dx resource
and is designed to gauge the
organization’s readiness to engage with
Measure Dx. This checklist will be
completed once by up to 73 Measure Dx
sites during the project onboarding
process.
11. Measure Dx Declaration of
Measurement Strategy—The 73 Measure
Dx sites will complete this form once to
indicate their selection of measurement
strategy to be implemented and provide
confirmation of minimum necessary
capabilities.
12. Diagnostic Safety Event Report—
These reports will provide aggregate
information on diagnostic safety events
identified during a 12-month reporting
period. The report will be completed by
each participating site 3 times over the
course of the testing and sustainability
period at 3-, 12-, and 24-months; a total
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of 219 reports will be completed over
the course of the project. Note that the
contractor is not attempting to collect
these reports at Month 0. Since part of
the Measure Dx resource’s goal is to
support implementation of a
measurement strategy, Month 3 will
serve as the baseline.
13. Additional information on site
safety culture, including use of
diagnostic safety event data, activities to
improve the quality of care, and the
work environment will be collected
through a survey at 3-, 12-, and 24months during the implementation/
sustainment. Five members of the
Measure Dx team at each site will be
surveyed; the expected response rate is
85% at each of the three administration
periods. Depending on the setting, the
following survey will be fielded:
a. Omnibus Safety and Culture
Survey_Medical Offices—Completed by
clinicians at 36 ambulatory clinics.
b. Omnibus Safety and Culture
Survey_Hospitals—Completed by
clinicians at 37 inpatient sites.
For Calibrate Dx, the following data
collections will be implemented:
14. Calibrate Dx Survey—This survey
collects clinicians’ reflections on their
diagnostic performance for 3–5 cases,
with additional metrics around time to
complete the review and the number of
cases reviewed. This will be completed
quarterly (following the Calibrate Dx
guidance for implementation) during
the implementation and testing period
by up to 5 clinicians per site; with an
estimated a 90% response rate to this
collection.
15. Clinician Self-Efficacy Survey—
The survey assesses clinician selfefficacy with diagnostic safety case
review and improvement. Up to 5
clinicians per site will be asked to
complete this survey two times, after
training and again at the end of the
testing phase, with an estimated 90%
response rate to this collection.
For Patient Toolkit, the following data
collections will be implemented:
16. Provider Characteristics Form—
This form will be completed once by up
to 15 providers at each of the 73
enrolled sites. This form collects
information on practitioner type, years
in practice, specialty, subspecialty, and
percent of time spent in clinical
practice.
17. Patient Toolkit Survey—
Provider—This survey assesses
provider-perceived skills and quality of
communication. It will be administered
to up to 15 providers at each site at five
timepoints (Baseline, 3-, 6-, 9-, and 12months), with a 90% anticipated
response rate.
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18. Provider Interview Protocol—A
total of 50 qualitative, semi-structured
interviews with site clinicians will be
conducted during implementation. The
interview protocol collects information
related to diagnostic safety events;
patient safety culture; feasibility,
acceptability, utility, adoption, and
spread of the Patient Toolkit; and
insights into clinician experience.
19. Patient Toolkit Survey—Patient—
The survey assesses patient-perceived
experience and quality of
communication, and collects basic
patient demographics (e.g., age, gender,
education, race, ethnicity). This will be
administered to site patients over a 1week period at five timepoints
(Baseline, 3-, 6-, 9-, and 12-months). The
survey will be provided to patients
upon check-out from a healthcare visit.
A total of 12,500 surveys will be
completed during each 1-week period.
20. Patient Interview Protocol—A total
of 50 qualitative, semi-structured
interviews will be completed with site
patients during implementation. The
interview protocol collects information
on reason for visit, provider
communication, and other insights into
patient experience.
This study is being conducted by
AHRQ through its contractor, RAND,
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
The data collection methods for this
evaluation were selected to reduce
participant burden and, where possible,
to allow participants a choice of
response mode. In addition, technology
is used for data capture and qualitative
coding and analysis.
Several forms and data collection
instruments will be administered using
a web mode. Site leads and participants
will receive a link allowing them to
complete the form online. The Site
Interest Form will also be accepted as a
hardcopy should organizations prefer to
mail or fax these forms. All other forms
will be administered either by a fillable
form that can be returned via email,
mail, or fax depending on the site or
participant preference.
Interviews will be conducted by
phone or video call (e.g., Microsoft
Teams, Zoom) with interviewers using a
hardcopy version of the protocol.
Interviews will be audio-recorded and
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transcribed, following verbal consent
from participants. Qualitative software
will be used for data coding and
analysis of interviews.
The patient surveys will be provided
to patients upon check-out from a
healthcare visit and they will be
encouraged to complete the survey
before leaving the office. The survey
will include a QR code to allow patients
to access a web version of the form.
Alternatively, the patient can complete
the paper survey and it will be collected
at the site, minimizing the need for
patients to return the paper survey by
mail. The paper surveys will be
formatted for data scanning, and data
from all paper surveys returned to the
contractor will be scanned into an
electronic datafile.
Estimated Annual Respondent Burden
This section summarizes the total
burden hours for this information
collection effort in addition to the cost
associated with those hours.
Exhibit 1 contains estimated response
burdens for each subject population
participating in the evaluation’s data
collection activities.
1. Site Interest Form—A physician or
manager at an interested site will
complete the form only once to indicate
interest in participating. The form will
be completed by 1,060 respondents and
requires 6 minutes to complete.
2. Site Information Form—A
physician or manager at an interested
site will complete the form only once to
provide additional contact information,
data on patient mix, and information on
the organization’s diagnostic safety
teams, resource commitments, and
capacity for implementing the
resources. The form will be completed
by 265 respondents and requires 20
minutes to complete.
3. Safer Dx Checklist—A physician or
manager at participating sites will
complete the form only once to allow
the participating site to understand the
current state of their diagnostic
practices, identify areas to improve, and
track progress toward diagnostic
excellence over time. The form will be
completed by 219 respondents and
requires 15 minutes to complete.
4. Exit Interviews Protocol—A
physician or manager at sites that
withdraw from the project will complete
the form once to provide information on
why the site could not sustain their
efforts or participation. The form will be
completed by 69 respondents and
requires 10 minutes to complete.
5a. SOPS® Medical Office Survey with
Diagnostic Safety Supplemental Item
Set—A physician or manager at
participating ambulatory sites will
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complete the form to provide a baseline
assessment of patient safety culture. The
form will be completed by 109
respondents and requires 15 minutes to
complete.
5b. SOPS® Hospital Survey with
Diagnostic Safety Supplemental Item
Set—A physician or manager at
participating hospital sites will
complete the form to provide a baseline
assessment of patient safety culture. The
form will be completed by 110
respondents and requires 15 minutes to
complete.
6. Post-training Evaluation Form—A
physician, nurse practitioner, physician
assistant, or manager will complete the
form once to indicate the perceived
value of the training provided to
participating sites. The form will be
completed by 1350 respondents and
requires 3 minutes to complete.
7. Post-technical Assistance
Evaluation Form—A physician, nurse
practitioner, physician assistant, or
manager will complete the form up to
three times to indicate the perceived
value of the technical assistance
provided to participating sites. The form
will be completed by 1350 respondents,
three times, and requires 2 minutes to
complete.
8. Clinical Sustainability Assessment
Tool (CSAT)—A physician or manager
at participating sites will complete the
form to evaluate the sustainability
capacity of a clinical practice. The form
will be completed by 219 respondents
and requires 15 minutes to complete.
9. Implementation Interviews
Protocol—A physician, nurse
practitioner, physician assistant, or
manager will participate in an interview
two times to provide their perspectives
at different stages of the
implementation. The interview will be
completed by up to 438 respondents,
two times, and requires 1 hour to
complete.
10. Measure Dx Organizational SelfAssessment—A physician, nurse
practitioner, physician assistant, or
manager will complete the form only
once to gauge the organization’s
readiness to engage with Measure Dx.
The form will be completed by 73
respondents and requires 30 minutes to
complete.
11. Measure Dx Declaration of
Measurement Strategy—A physician,
nurse practitioner, physician assistant,
or manager will complete the form only
once to indicate their selection of
measurement strategy to be
implemented and provide confirmation
of minimum necessary capabilities. The
form will be completed by 73
respondents and requires 5 minutes to
complete.
12. Diagnostic Safety Event Report—
A physician, nurse practitioner,
physician assistant, or manager will
complete the form three times to
provide aggregate information on
diagnostic safety events. The form will
be completed by 73 respondents, three
times, and requires 1 hour to complete.
13a. Omnibus Safety and Culture
Survey_Medical Offices—A physician,
nurse practitioner, physician assistant,
or manager will complete the form three
times to provide information on safety
culture at ambulatory sites. The form
will be completed by 162 respondents,
three times, and requires 20 minutes to
complete.
13b. Omnibus Safety and Culture
Survey_Hospitals—A physician, nurse
practitioner, physician assistant, or
manager will complete the form three
times to provide information on safety
culture at inpatient sites. The form will
be completed by 167 respondents, three
times, and requires 20 minutes to
complete.
14. Calibrate Dx Survey—A physician,
nurse practitioner, or physician
assistant will complete the form four
times to provide reflections on their
diagnostic performance for 3–5 cases,
with additional metrics around time to
complete the review and the number of
cases reviewed. The form will be
completed by 329 respondents, four
times, and requires 30 minutes to
complete.
15. Clinician Self-Efficacy Survey—A
physician, nurse practitioner, or
physician assistant will complete the
form two times to provide information
on their self-efficacy with diagnostic
safety case review and improvement.
The form will be completed by 329
respondents, two times, and requires 3
minutes to complete.
16. Provider Characteristics Form—A
physician, nurse practitioner, or
physician assistant will complete the
form once to provide information on
practitioner type, years in practice,
specialty, subspecialty, and percent of
time spent in clinical practice. The form
will be completed by 986 respondents
and requires 1 minute to complete.
17. Patient Toolkit Survey—
Provider—A physician, nurse
practitioner, or physician assistant will
complete the form five times to provide
information on provider-perceived skills
and quality of communication. The form
will be completed by 986 respondents,
five times, and requires 2 minutes to
complete.
18. Provider Interview Protocol—A
physician, nurse practitioner, or
physician assistant will participate in an
interview once to provide information
related to diagnostic safety events;
patient safety culture; feasibility,
acceptability, utility, adoption, and
spread of the Patient Toolkit; and
insights into clinician experience. The
interview will be completed by up to 50
respondents and requires 45 minutes to
complete.
19. Patient Toolkit Survey—Patient—
Patients will complete the form only
once to provide information on their
experience and quality of
communication, and demographics
information. The form will be
completed by 62,500 respondents and
requires 5 minutes to complete.
20. Patient Interview Protocol—
Patients will participate in an interview
once to provide information on reason
for visit, provider communication, and
other insights into patient experience.
The interview will be completed by up
to 50 respondents and requires 45
minutes to complete.
For the three-year clearance period,
the estimated annualized burden hours
for the data collection activities are
8,195.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
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Form name
1: Site Interest Form ........................................................................................
2: Site Information Form ..................................................................................
3: Safer Dx Checklist .......................................................................................
4: Exit Interviews Protocol ...............................................................................
5a: SOPS® Medical Office Survey with Diagnostic Safety Supplemental
Item Set ........................................................................................................
5b: SOPS® Hospital Survey with Diagnostic Safety Supplemental Item Set
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Number of
responses per
respondent
Hours per
response
Total
burden hours
1,060
265
219
69
1
1
1
1
6/60
20/60
15/60
10/60
106
88
55
12
109
110
1
1
15/60
15/60
27
28
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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total
burden hours
6: Post-training Evaluation Form .....................................................................
7: Post-technical Assistance Evaluation Form ................................................
8: Clinical Sustainability Assessment Tool (CSAT) .........................................
9: Implementation Interviews Protocol .............................................................
10: Measure Dx Organizational Self-Assessment ...........................................
11: Measure Dx Declaration of Measurement Strategy ..................................
12: Diagnostic Safety Event Report ................................................................
13a: Omnibus Safety and Culture Survey_Medical Offices ............................
13b: Omnibus Safety and Culture Survey_Hospitals ......................................
14: Calibrate Dx Survey ..................................................................................
15: Clinician Self-Efficacy Survey ....................................................................
16: Provider Characteristics Form ...................................................................
17: Patient Toolkit Survey-Provider .................................................................
18: Provider Interview Protocol .......................................................................
19: Patient Toolkit Survey—Patient .................................................................
20: Patient Interview Protocol ..........................................................................
1,350
1,350
219
438
73
73
73
162
167
329
329
986
986
50
62,500
50
1
3
1
2
1
1
3
3
3
4
2
1
5
1
1
1
3/60
2/60
15/60
1
30/60
5/60
1
20/60
20/60
30/60
3/60
1/60
2/60
45/60
5/60
45/60
68
135
55
876
37
6
219
162
167
657
33
16
164
38
5,208
38
Total ..........................................................................................................
........................
........................
........................
8,195
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to complete the data
collection forms. The total cost burden
is estimated to be $457,432.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
khammond on DSKJM1Z7X2PROD with NOTICES
Form name
Average
hourly
wage rate *
Total
burden hours
1: Site Interest Form ........................................................................................
2: Site Information Form ..................................................................................
3: Safer Dx Checklist .......................................................................................
4: Exit Interviews Protocol ...............................................................................
5a: SOPS® Medical Office Survey with Diagnostic Safety Supplemental
Item Set ........................................................................................................
5b: SOPS® Hospital Survey with Diagnostic Safety Supplemental Item Set
6: Post-training Evaluation Form .....................................................................
7: Post-technical Assistance Evaluation Form ................................................
8: Clinical Sustainability Assessment Tool (CSAT) .........................................
9: Implementation Interviews Protocol .............................................................
10: Measure Dx Organizational Self-Assessment ...........................................
11: Measure Dx Declaration of Measurement Strategy ..................................
12: Diagnostic Safety Event Report ................................................................
13a: Omnibus Safety and Culture Survey_Medical Offices ............................
13b: Omnibus Safety and Culture Survey_Hospitals ......................................
14: Calibrate Dx Survey ..................................................................................
15: Clinician Self-Efficacy Survey ....................................................................
16: Provider Characteristics Form ...................................................................
17: Patient Toolkit Survey-Provider .................................................................
18: Provider Interview Protocol .......................................................................
19: Patient Toolkit Survey—Patient .................................................................
20: Patient Interview Protocol ..........................................................................
1060
265
219
69
106
88
55
12
a $97.30
109
110
1350
1350
219
438
73
73
73
162
167
329
329
986
986
50
62500
50
27
28
68
135
55
876
37
6
219
162
167
657
33
16
164
38
5208
38
a 97.30
Total ..........................................................................................................
........................
........................
a 97.30
a 97.30
a 97.30
Total cost
burden
$10,314
8,562
5,352
1,168
d 29.76
2,627
2,724
6,997
13,892
5,352
90,140
3,807
617
22,535
16,670
17,184
67,559
3,393
1,645
16,864
3,908
154,990
1,131
........................
457,432
a 97.30
b 102.90
b 102.90
a 97.30
b 102.90
b 102.90
b 102.90
b 102.90
b 102.90
b 102.90
c 102.83
c 102.83
c 102.83
c 102.83
c 102.83
d 29.76
* National Compensation Survey: Occupational wages in the United States May 2022, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29–1210; 60%) and Medical and Health Services
Managers ($61.53; Code 11–9111; 40%).
b Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29–1210; 70%); nurse practitioners (broad)
($59.94; occupation code 29–1170; 15%); physician assistants (broad) ($60.23; occupation code 29–1070; 10%); and medical and health services managers (broad) ($61.53; Code 11–9111; 5%).
c Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29–1210; 70%); nurse practitioners (broad)
($59.94; occupation code 29–1170; 15%); and physician assistants (broad) ($60.23; occupation code 29–1070; 15%).
d Based on the mean wages for All Occupations (Code 00–0000).
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Federal Register / Vol. 89, No. 46 / Thursday, March 7, 2024 / Notices
Request for Comments
In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3520,
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’s 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: March 1, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024–04786 Filed 3–6–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Reorganization of the National Institute
for Occupational Safety and Health
Centers for Disease Control and
Prevention (CDC), the Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
CDC has modified its
structure. This notice announces the
reorganization of the World Trade
Center (WTC) Health Program within
the National Institute for Occupational
Safety and Health (NIOSH). The WTC
Health Program has established three
branches.
DATES: This reorganization was
approved by the HHS Secretary on
March 4, 2024, and became effective.
FOR FURTHER INFORMATION CONTACT:
D’Artonya Graham, Office of Strategic
Business Initiatives, Office of the Chief
Operating Officer, Office of the Director,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:13 Mar 06, 2024
Jkt 262001
TW–2, Atlanta, GA 30329; Telephone
770–488–4401; Email: reorgs@cdc.gov.
SUPPLEMENTARY INFORMATION: Part C
(Centers for Disease Control and
Prevention) of the Statement of
Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (45 FR 67772–76, dated
October 14, 1980, and corrected at 45 FR
69296, October 20, 1980, as amended
most recently at Vol. 88, No. 132, pg.
44359–44363, dated July 12, 2023) is
amended to reflect the reorganization of
the World Trade Center (WTC) Health
Program, National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC). Specifically, the
changes are as follows:
I. Under Part C, Section C–B,
Organization and Functions, insert the
following:
• Office of the Director (CCP1)
• Healthcare Benefits Branch (CCPB)
• Research and Evaluation Branch
(CCPC)
• Business Operations Branch (CCPD)
II. Under Part C, Section C–B,
Organization and Functions, after the
World Trade Center Health Program
(CCP) insert the following:
Office of the Director (CCP1).
Conducts the legislatively mandated
World Trade Center (WTC) Health
Program established by the James
Zadroga 9/11 Health and Compensation
Act of 2010, as amended. (1) Provides
management, strategic planning and
oversight, budget formulation and
execution, science and medical policy
oversight and development, industry
expertise, and contract transition
oversight; (2) consults with stakeholders
in carrying out the WTC Health Program
mission, develops and disseminates all
WTC Health Program communications,
and provides oversight for public
relations and media strategy; and (3)
oversees all program statutory directives
in the Zadroga Act to provide medical
monitoring and treatment to eligible
responders and survivors who were
affected by the September 11, 2001,
terrorist attacks.
Healthcare Benefits Branch (CCPB).
The Healthcare Benefits Branch
confirms eligibility for Program benefits
and implements a limited health
benefits model to provide quality and
compassionate medically necessary
treatment and monitoring of WTCrelated health conditions to eligible
members in the WTC Health Program.
Specifically, the branch: (1) develops
recommendations for the Administrator
of the WTC Health Program for medical
coverage determinations including
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16579
medically necessary diagnostic, cancer
screening, and treatment services
allowed under the WTC Health
Program; (2) establishes and maintains
the pharmaceutical formulary and
conducts compliance as well as outlier
audits with the Pharmacy Benefit
Manager, Clinical Centers of Excellence,
and the Nationwide Provider Network
vendors; (3) provides subject matter
expertise to contracting officer
representatives for contracts such as the
Clinical Centers of Excellence,
Nationwide Provider Network, Cost
Avoidance, and Pharmacy Benefit
Manager contract statements of work; (4)
provides enrollment recommendations
to the Administrator of the WTC Health
Program for of WTC responders and
survivors and Pentagon and Shanksville
responders and follows statutory and
regulatory requirements and approved
process and procedures to enroll
members into the WTC Health Program;
(5) processes certification of member’s
WTC-related health conditions eligible
for treatment coverage in the WTC
Health Program and follows statutory
and regulatory requirements and
approved processes and procedures to
issue certification decisions on behalf of
the Administrator of the WTC Health
Program; (6) develops medical and
pharmacy benefit coverage
determinations and issues coverage
decisions on prior authorization
requests for medical services, durable
medical equipment, supplies, and
pharmaceuticals; (7) coordinates
working groups, such as the
Pharmaceutical and Therapeutics
Working Group, with stakeholder
clinicians for continuing education and
alignment with program formulary
changes; (8) provides oversight and
expertise to Clinical Centers of
Excellence and Nationwide Provider
Network on case management, care
coordination, and utilization
management; (9) designs and manages
the medical diagnosis and procedural
services codebook, which supports
benefit access for covered conditions
and approved services with utilization
limitations; (10) supports members
through customer support and by
coordinating and managing call centers,
issues written member correspondence,
and supports member transfers; (11)
coordinates, on behalf of the
Administrator of the WTC Health
Program, certification, enrollment, and
treatment appeals following statutory
and regulatory requirements and
approved processes and procedures;
(12) serves as subject matter experts for
vendors, particularly for outreach and
education vendors on program
E:\FR\FM\07MRN1.SGM
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Agencies
[Federal Register Volume 89, Number 46 (Thursday, March 7, 2024)]
[Notices]
[Pages 16574-16579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04786]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 updates to the
currently approved information collection project: ``Implementation and
Testing of Diagnostic Safety Resources.'' In accordance with the
Paperwork Reduction Act of 1995, AHRQ invites the public to comment on
this proposed information collection.
DATES: Comments on this notice must be received by May 6, 2024.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at REPORTSCLEARANCE
[email protected].
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 email at REPORTSCLEARANCE
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Implementation and Testing of Diagnostic Safety Resources
Patient safety is a pillar of the Agency for Healthcare Research
and Quality's (AHRQ's) mission to support the highest quality
healthcare. While progress has been made in many areas of patient
safety, the field of diagnostic safety has emerged as a particular area
of concern. It is estimated that every person in the United States will
experience a diagnostic error in their lifetime (Institute of Medicine,
2015) which can lead to inappropriate, delayed, or withheld treatment
and ultimately poor health outcomes, distress, and increased costs.
Diagnostic errors can occur for many reasons: lack of meaningful
engagement between clinicians, patients, and families; a fragmented
healthcare system not designed to account for an increasingly complex
diagnostic process; minimal (if any) feedback to clinicians about their
diagnostic performance; and a culture that does not always support
transparent disclosure of diagnostic errors (Institute of Medicine,
2015). Leaders in diagnostic excellence suggest that multi-pronged
efforts are needed to address this complex problem and go beyond
individual behaviors to system-level changes and empowering patients to
engage in their care (Institute of Medicine, 2015; Henriksen, et al.,
2017).
Improving diagnostic safety and quality is an AHRQ priority. In
recognition of the multifaceted approach needed to effectively advance
diagnostic safety, AHRQ recently supported the development of three
tools to prevent diagnostic errors and have prioritized these tools for
implementation and testing. These resources vary in the types of
stakeholders they target, a critical
[[Page 16575]]
advancement in our approach to diagnostic excellence.
Calibrate Dx. This tool, targeted to individual
clinicians, invites users to select a topic or condition, review
diagnostic performance on a sample of cases for insights and learning
opportunities, and debrief with a peer. This resource will be tested in
all settings where clinicians are involved in the diagnostic process,
including both inpatient and ambulatory settings.
Measure Dx. This tool supports healthcare organizations in
building sustainable teams for improving diagnostic excellence,
identifying current capacity gaps, engaging in measurement strategies
as part of a systematic approach to reviewing available data, and
translating findings into learning opportunities. This resource will be
tested in both inpatient and ambulatory settings; it is expected to be
implemented more commonly in inpatient settings.
Toolkit for Engaging Patients to Improve Diagnostic Safety
(Patient Toolkit). This tool prepares patients, families, and health
professionals to work together as partners to improve diagnostic
safety; encourages patients to prepare for visits; and encourages
providers to listen for 60 seconds before interrupting the patient.
This resource will be tested in ambulatory settings only.
The goal of this research is to implement and test these three
diagnostic safety resources to identify specific ways in which each
resource can be used to maximize its value. For each resource the
following will be examined:
(1) Feasibility of implementation--barriers, facilitators, success
factors, and time needed for implementation
(2) Level of adoption--number and type of clinicians aware of and/or
using the resource, number of organizational leaders endorsing the
resource
(3) Effectiveness of the resource--number of diagnostic safety events
(Measure Dx and Patient Toolkit), clinician self-efficacy for
diagnostic decision-making (Calibrate Dx)
(4) Maintenance and sustainability--the number and type of patient
safety processes in place, barriers and facilitators to maintenance and
sustainability
This project will implement and test these three diagnostic safety
resources across a minimum of 150 sites to up to 219 sites (i.e., 50 to
73 sites per resource). An Implementation and Testing period for each
resource will last 12 months, with Calibrate Dx starting implementation
first and Measure Dx and the Toolkit for Engaging Patients starting
implementation six months later. This timing allows for staggered
recruitment to ensure adequate sample size and to pilot implementation
processes with a single diagnostic safety resource first, transferring
lessons learned about implementation and testing to the implementation
of the two other resources. A Sustainability period will begin as soon
as the 12-month Implementation and Testing Period is complete and will
continue for 14 additional months for each resource.
To achieve the goals of this project the following data collections
will be implemented:
1. Site Interest Form--A short form completed once by up to 1,060
sites interested in participating in the project. Used to indicate
interest in the project and by AHRQ to evaluate whether the site meets
the minimum participation criteria.
2. Site Information Form--Completed once by site leaders at 265
sites that begin the project enrollment process, this form collects
additional contact information, data on patient mix, and information on
the organization's diagnostic safety teams, resource commitments, and
capacity for implementing the resources.
3. Safer Dx Checklist--Completed once by 219 sites who fully
complete enrollment activities and begin implementation of one of the
three resources (82.6% of the 265 sites who begin enrollment
activities). The Safer Dx Checklist is a tool that allows healthcare
organizations to understand the current state of their diagnostic
practices, identify areas to improve, and track progress toward
diagnostic excellence over time. This will be completed prior to actual
implementation of the resource.
4. Exit Interviews Protocol--Completed once by an estimated 69
sites (30% of those implementing one of the three resources) that
withdraw from the project, this telephone interview will collect
information on why the site could not sustain their efforts or
participation.
5. A baseline assessment of patient safety culture will be
conducted once for each of the 219 sites that begin participation.
Completed once by site leads depending on the setting:
a. SOPS[supreg] Medical Office Survey with Diagnostic Safety
Supplemental Item Set--Completed once by the site lead for 109
ambulatory clinics.
b. SOPS[supreg] Hospital Survey with Diagnostic Safety Supplemental
Item Set--Completed once by the site lead for 110 inpatient sites.
6. Post-training Evaluation Form--Completed once by 1,350
clinicians and managers (90% of the 1,500 participants) attending the
project's training sessions. The data will be used to track the
perceived value of the training provided to enrolled sites.
7. Post-technical Assistance Evaluation Form--Administered up to 3
times to 1,500 clinicians and managers participating in the project's
Learning Collaborative sessions; an estimated 90% response rate to this
collection with a total of 4,050 forms completed. The data will be used
to track the perceived value of the technical assistance provided to
enrolled sites.
8. Clinical Sustainability Assessment Tool (CSAT)--Completed by 219
site leaders once between months 9 to 12 in advance of the 14-month
sustainability period. The CSAT is a self-assessment to evaluate
sustainability capacity of a clinical practice.
9. Implementation Interviews Protocol--A qualitative, semi-
structured interview will be conducted with 438 site leads and/or
frontline staff (up to 2 individuals from each site) at two points in
time during implementation (e.g., 6- and 18-months). The protocol is
designed to elicit participant perspectives on implementation of the
resource, capture lessons learned and best practices, and when
possible, to provide support for adjustment to the implementation.
In addition to those noted above, the project will implement the
following data collections specific to the individual resources.
For Measure Dx, the following data collections will be implemented:
10. Measure Dx Organizational Self-Assessment--This is one of the
main components of the Measure Dx resource and is designed to gauge the
organization's readiness to engage with Measure Dx. This checklist will
be completed once by up to 73 Measure Dx sites during the project
onboarding process.
11. Measure Dx Declaration of Measurement Strategy--The 73 Measure
Dx sites will complete this form once to indicate their selection of
measurement strategy to be implemented and provide confirmation of
minimum necessary capabilities.
12. Diagnostic Safety Event Report--These reports will provide
aggregate information on diagnostic safety events identified during a
12-month reporting period. The report will be completed by each
participating site 3 times over the course of the testing and
sustainability period at 3-, 12-, and 24-months; a total
[[Page 16576]]
of 219 reports will be completed over the course of the project. Note
that the contractor is not attempting to collect these reports at Month
0. Since part of the Measure Dx resource's goal is to support
implementation of a measurement strategy, Month 3 will serve as the
baseline.
13. Additional information on site safety culture, including use of
diagnostic safety event data, activities to improve the quality of
care, and the work environment will be collected through a survey at 3-
, 12-, and 24-months during the implementation/sustainment. Five
members of the Measure Dx team at each site will be surveyed; the
expected response rate is 85% at each of the three administration
periods. Depending on the setting, the following survey will be
fielded:
a. Omnibus Safety and Culture Survey_Medical Offices--Completed by
clinicians at 36 ambulatory clinics.
b. Omnibus Safety and Culture Survey_Hospitals--Completed by
clinicians at 37 inpatient sites.
For Calibrate Dx, the following data collections will be
implemented:
14. Calibrate Dx Survey--This survey collects clinicians'
reflections on their diagnostic performance for 3-5 cases, with
additional metrics around time to complete the review and the number of
cases reviewed. This will be completed quarterly (following the
Calibrate Dx guidance for implementation) during the implementation and
testing period by up to 5 clinicians per site; with an estimated a 90%
response rate to this collection.
15. Clinician Self-Efficacy Survey--The survey assesses clinician
self-efficacy with diagnostic safety case review and improvement. Up to
5 clinicians per site will be asked to complete this survey two times,
after training and again at the end of the testing phase, with an
estimated 90% response rate to this collection.
For Patient Toolkit, the following data collections will be
implemented:
16. Provider Characteristics Form--This form will be completed once
by up to 15 providers at each of the 73 enrolled sites. This form
collects information on practitioner type, years in practice,
specialty, subspecialty, and percent of time spent in clinical
practice.
17. Patient Toolkit Survey--Provider--This survey assesses
provider-perceived skills and quality of communication. It will be
administered to up to 15 providers at each site at five timepoints
(Baseline, 3-, 6-, 9-, and 12-months), with a 90% anticipated response
rate.
18. Provider Interview Protocol--A total of 50 qualitative, semi-
structured interviews with site clinicians will be conducted during
implementation. The interview protocol collects information related to
diagnostic safety events; patient safety culture; feasibility,
acceptability, utility, adoption, and spread of the Patient Toolkit;
and insights into clinician experience.
19. Patient Toolkit Survey--Patient--The survey assesses patient-
perceived experience and quality of communication, and collects basic
patient demographics (e.g., age, gender, education, race, ethnicity).
This will be administered to site patients over a 1-week period at five
timepoints (Baseline, 3-, 6-, 9-, and 12-months). The survey will be
provided to patients upon check-out from a healthcare visit. A total of
12,500 surveys will be completed during each 1-week period.
20. Patient Interview Protocol--A total of 50 qualitative, semi-
structured interviews will be completed with site patients during
implementation. The interview protocol collects information on reason
for visit, provider communication, and other insights into patient
experience.
This study is being conducted by AHRQ through its contractor, RAND,
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
The data collection methods for this evaluation were selected to
reduce participant burden and, where possible, to allow participants a
choice of response mode. In addition, technology is used for data
capture and qualitative coding and analysis.
Several forms and data collection instruments will be administered
using a web mode. Site leads and participants will receive a link
allowing them to complete the form online. The Site Interest Form will
also be accepted as a hardcopy should organizations prefer to mail or
fax these forms. All other forms will be administered either by a
fillable form that can be returned via email, mail, or fax depending on
the site or participant preference.
Interviews will be conducted by phone or video call (e.g.,
Microsoft Teams, Zoom) with interviewers using a hardcopy version of
the protocol. Interviews will be audio-recorded and transcribed,
following verbal consent from participants. Qualitative software will
be used for data coding and analysis of interviews.
The patient surveys will be provided to patients upon check-out
from a healthcare visit and they will be encouraged to complete the
survey before leaving the office. The survey will include a QR code to
allow patients to access a web version of the form. Alternatively, the
patient can complete the paper survey and it will be collected at the
site, minimizing the need for patients to return the paper survey by
mail. The paper surveys will be formatted for data scanning, and data
from all paper surveys returned to the contractor will be scanned into
an electronic datafile.
Estimated Annual Respondent Burden
This section summarizes the total burden hours for this information
collection effort in addition to the cost associated with those hours.
Exhibit 1 contains estimated response burdens for each subject
population participating in the evaluation's data collection
activities.
1. Site Interest Form--A physician or manager at an interested site
will complete the form only once to indicate interest in participating.
The form will be completed by 1,060 respondents and requires 6 minutes
to complete.
2. Site Information Form--A physician or manager at an interested
site will complete the form only once to provide additional contact
information, data on patient mix, and information on the organization's
diagnostic safety teams, resource commitments, and capacity for
implementing the resources. The form will be completed by 265
respondents and requires 20 minutes to complete.
3. Safer Dx Checklist--A physician or manager at participating
sites will complete the form only once to allow the participating site
to understand the current state of their diagnostic practices, identify
areas to improve, and track progress toward diagnostic excellence over
time. The form will be completed by 219 respondents and requires 15
minutes to complete.
4. Exit Interviews Protocol--A physician or manager at sites that
withdraw from the project will complete the form once to provide
information on why the site could not sustain their efforts or
participation. The form will be completed by 69 respondents and
requires 10 minutes to complete.
5a. SOPS[supreg] Medical Office Survey with Diagnostic Safety
Supplemental Item Set--A physician or manager at participating
ambulatory sites will
[[Page 16577]]
complete the form to provide a baseline assessment of patient safety
culture. The form will be completed by 109 respondents and requires 15
minutes to complete.
5b. SOPS[supreg] Hospital Survey with Diagnostic Safety
Supplemental Item Set--A physician or manager at participating hospital
sites will complete the form to provide a baseline assessment of
patient safety culture. The form will be completed by 110 respondents
and requires 15 minutes to complete.
6. Post-training Evaluation Form--A physician, nurse practitioner,
physician assistant, or manager will complete the form once to indicate
the perceived value of the training provided to participating sites.
The form will be completed by 1350 respondents and requires 3 minutes
to complete.
7. Post-technical Assistance Evaluation Form--A physician, nurse
practitioner, physician assistant, or manager will complete the form up
to three times to indicate the perceived value of the technical
assistance provided to participating sites. The form will be completed
by 1350 respondents, three times, and requires 2 minutes to complete.
8. Clinical Sustainability Assessment Tool (CSAT)--A physician or
manager at participating sites will complete the form to evaluate the
sustainability capacity of a clinical practice. The form will be
completed by 219 respondents and requires 15 minutes to complete.
9. Implementation Interviews Protocol--A physician, nurse
practitioner, physician assistant, or manager will participate in an
interview two times to provide their perspectives at different stages
of the implementation. The interview will be completed by up to 438
respondents, two times, and requires 1 hour to complete.
10. Measure Dx Organizational Self-Assessment--A physician, nurse
practitioner, physician assistant, or manager will complete the form
only once to gauge the organization's readiness to engage with Measure
Dx. The form will be completed by 73 respondents and requires 30
minutes to complete.
11. Measure Dx Declaration of Measurement Strategy--A physician,
nurse practitioner, physician assistant, or manager will complete the
form only once to indicate their selection of measurement strategy to
be implemented and provide confirmation of minimum necessary
capabilities. The form will be completed by 73 respondents and requires
5 minutes to complete.
12. Diagnostic Safety Event Report--A physician, nurse
practitioner, physician assistant, or manager will complete the form
three times to provide aggregate information on diagnostic safety
events. The form will be completed by 73 respondents, three times, and
requires 1 hour to complete.
13a. Omnibus Safety and Culture Survey_Medical Offices--A
physician, nurse practitioner, physician assistant, or manager will
complete the form three times to provide information on safety culture
at ambulatory sites. The form will be completed by 162 respondents,
three times, and requires 20 minutes to complete.
13b. Omnibus Safety and Culture Survey_Hospitals--A physician,
nurse practitioner, physician assistant, or manager will complete the
form three times to provide information on safety culture at inpatient
sites. The form will be completed by 167 respondents, three times, and
requires 20 minutes to complete.
14. Calibrate Dx Survey--A physician, nurse practitioner, or
physician assistant will complete the form four times to provide
reflections on their diagnostic performance for 3-5 cases, with
additional metrics around time to complete the review and the number of
cases reviewed. The form will be completed by 329 respondents, four
times, and requires 30 minutes to complete.
15. Clinician Self-Efficacy Survey--A physician, nurse
practitioner, or physician assistant will complete the form two times
to provide information on their self-efficacy with diagnostic safety
case review and improvement. The form will be completed by 329
respondents, two times, and requires 3 minutes to complete.
16. Provider Characteristics Form--A physician, nurse practitioner,
or physician assistant will complete the form once to provide
information on practitioner type, years in practice, specialty,
subspecialty, and percent of time spent in clinical practice. The form
will be completed by 986 respondents and requires 1 minute to complete.
17. Patient Toolkit Survey--Provider--A physician, nurse
practitioner, or physician assistant will complete the form five times
to provide information on provider-perceived skills and quality of
communication. The form will be completed by 986 respondents, five
times, and requires 2 minutes to complete.
18. Provider Interview Protocol--A physician, nurse practitioner,
or physician assistant will participate in an interview once to provide
information related to diagnostic safety events; patient safety
culture; feasibility, acceptability, utility, adoption, and spread of
the Patient Toolkit; and insights into clinician experience. The
interview will be completed by up to 50 respondents and requires 45
minutes to complete.
19. Patient Toolkit Survey--Patient--Patients will complete the
form only once to provide information on their experience and quality
of communication, and demographics information. The form will be
completed by 62,500 respondents and requires 5 minutes to complete.
20. Patient Interview Protocol--Patients will participate in an
interview once to provide information on reason for visit, provider
communication, and other insights into patient experience. The
interview will be completed by up to 50 respondents and requires 45
minutes to complete.
For the three-year clearance period, the estimated annualized
burden hours for the data collection activities are 8,195.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
1: Site Interest Form........................... 1,060 1 6/60 106
2: Site Information Form........................ 265 1 20/60 88
3: Safer Dx Checklist........................... 219 1 15/60 55
4: Exit Interviews Protocol..................... 69 1 10/60 12
5a: SOPS[supreg] Medical Office Survey with 109 1 15/60 27
Diagnostic Safety Supplemental Item Set........
5b: SOPS[supreg] Hospital Survey with Diagnostic 110 1 15/60 28
Safety Supplemental Item Set...................
[[Page 16578]]
6: Post-training Evaluation Form................ 1,350 1 3/60 68
7: Post-technical Assistance Evaluation Form.... 1,350 3 2/60 135
8: Clinical Sustainability Assessment Tool 219 1 15/60 55
(CSAT).........................................
9: Implementation Interviews Protocol........... 438 2 1 876
10: Measure Dx Organizational Self-Assessment... 73 1 30/60 37
11: Measure Dx Declaration of Measurement 73 1 5/60 6
Strategy.......................................
12: Diagnostic Safety Event Report.............. 73 3 1 219
13a: Omnibus Safety and Culture Survey_Medical 162 3 20/60 162
Offices........................................
13b: Omnibus Safety and Culture Survey_Hospitals 167 3 20/60 167
14: Calibrate Dx Survey......................... 329 4 30/60 657
15: Clinician Self-Efficacy Survey.............. 329 2 3/60 33
16: Provider Characteristics Form............... 986 1 1/60 16
17: Patient Toolkit Survey-Provider............. 986 5 2/60 164
18: Provider Interview Protocol................. 50 1 45/60 38
19: Patient Toolkit Survey--Patient............. 62,500 1 5/60 5,208
20: Patient Interview Protocol.................. 50 1 45/60 38
---------------------------------------------------------------
Total....................................... .............. .............. .............. 8,195
----------------------------------------------------------------------------------------------------------------
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to complete the data collection forms. The total cost
burden is estimated to be $457,432.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate * burden
----------------------------------------------------------------------------------------------------------------
1: Site Interest Form........................... 1060 106 \a\ $97.30 $10,314
2: Site Information Form........................ 265 88 \a\ 97.30 8,562
3: Safer Dx Checklist........................... 219 55 \a\ 97.30 5,352
4: Exit Interviews Protocol..................... 69 12 \a\ 97.30 1,168
5a: SOPS[supreg] Medical Office Survey with 109 27 \a\ 97.30 2,627
Diagnostic Safety Supplemental Item Set........
5b: SOPS[supreg] Hospital Survey with Diagnostic 110 28 \a\ 97.30 2,724
Safety Supplemental Item Set...................
6: Post-training Evaluation Form................ 1350 68 \b\ 102.90 6,997
7: Post-technical Assistance Evaluation Form.... 1350 135 \b\ 102.90 13,892
8: Clinical Sustainability Assessment Tool 219 55 \a\ 97.30 5,352
(CSAT).........................................
9: Implementation Interviews Protocol........... 438 876 \b\ 102.90 90,140
10: Measure Dx Organizational Self-Assessment... 73 37 \b\ 102.90 3,807
11: Measure Dx Declaration of Measurement 73 6 \b\ 102.90 617
Strategy.......................................
12: Diagnostic Safety Event Report.............. 73 219 \b\ 102.90 22,535
13a: Omnibus Safety and Culture Survey_Medical 162 162 \b\ 102.90 16,670
Offices........................................
13b: Omnibus Safety and Culture Survey_Hospitals 167 167 \b\ 102.90 17,184
14: Calibrate Dx Survey......................... 329 657 \c\ 102.83 67,559
15: Clinician Self-Efficacy Survey.............. 329 33 \c\ 102.83 3,393
16: Provider Characteristics Form............... 986 16 \c\ 102.83 1,645
17: Patient Toolkit Survey-Provider............. 986 164 \c\ 102.83 16,864
18: Provider Interview Protocol................. 50 38 \c\ 102.83 3,908
19: Patient Toolkit Survey--Patient............. 62500 5208 \d\ 29.76 154,990
20: Patient Interview Protocol.................. 50 38 \d\ 29.76 1,131
---------------------------------------------------------------
Total....................................... .............. .............. .............. 457,432
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2022, ``U.S. Department of Labor,
Bureau of Labor Statistics.''
\a\ Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29-1210; 60%) and
Medical and Health Services Managers ($61.53; Code 11-9111; 40%).
\b\ Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29-1210; 70%); nurse
practitioners (broad) ($59.94; occupation code 29-1170; 15%); physician assistants (broad) ($60.23; occupation
code 29-1070; 10%); and medical and health services managers (broad) ($61.53; Code 11-9111; 5%).
\c\ Based on the weighted mean hourly wage for physicians (broad) ($121.15; occupation code 29-1210; 70%); nurse
practitioners (broad) ($59.94; occupation code 29-1170; 15%); and physician assistants (broad) ($60.23;
occupation code 29-1070; 15%).
\d\ Based on the mean wages for All Occupations (Code 00-0000).
[[Page 16579]]
Request for Comments
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, 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's 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: March 1, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-04786 Filed 3-6-24; 8:45 am]
BILLING CODE 4160-90-P