Agency Information Collection Activities: Proposed Collection; Comment Request, 23366-23369 [2021-09138]
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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
Estimated Annual Burden Hours:
452,318 hours.
Estimated Annual Labor Costs:
$26,890.
Estimated Annual Non-Labor Costs:
$0.
Request for Comment: On January 11,
2021, the Commission sought comment
on the information collection
requirements associated with the FTC’s
Administrative Activities. 86 FR 1971
(Jan. 11, 2021). No relevant comments
were received. Pursuant to the OMB
regulations, 5 CFR part 1320, the FTC is
providing this second opportunity for
public comment while seeking OMB
approval to renew clearance for the
Rule’s information collection
requirements.
Your comment—including your name
and your state—will be placed on the
public record of this proceeding.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, like anyone’s Social
Security number, date of birth, driver’s
license number or other state
identification number or foreign country
equivalent, passport number, financial
account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment does
not include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, do not include
any ‘‘[t]rade secret or any commercial or
financial information which is . . .
privileged or confidential’’ as provided
in Section 6(f) of the FTC Act 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns devices,
manufacturing processes, or customer
names.
Josephine Liu,
Assistant General Counsel for Legal Counsel.
[FR Doc. 2021–09225 Filed 4–30–21; 8:45 am]
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BILLING CODE 6750–01–P
GENERAL SERVICES
ADMINISTRATION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Notice–MA–2020–14; Docket No. 2020–
0002; Sequence No. 40]
Agency for Healthcare Research and
Quality
Mail Management—Deployment of the
Simplified Mail Accountability and
Reporting Tool (SMART) and
Temporary Waiver of Federal
Management Regulation (FMR)
Sections 102–192.85–105 Reporting
Requirements
Office of Government-wide
Policy, General Services Administration
(GSA).
AGENCY:
Availability of GSA Bulletin
FMR G–07.
ACTION:
GSA has issued FMR Bulletin
G–07, which announces GSA’s decision
to deploy the SMART and resume
Federal Agency mail program data
collections when the SMART is fully
deployed. Additionally, FMR Bulletin
G–07 temporarily waives the annual
mail management reporting requirement
for large Federal agencies.
SUMMARY:
Applicability Date: This notice is
effective upon signature and
retroactively applies to relevant
reporting requirements for FY 2017,
2018, 2019, and 2020.
DATES:
For
clarification of content, contact Mr.
Michael DeMale, Office of Asset and
Transportation Management, GSA, at
202–805–8167, or email federal.mail@
gsa.gov. Please cite Notice of FMR
Bulletin G–07.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Background: Federal agencies must
comply with FMR part 102–192,
authorized by 44 U.S.C. 2901–2906,
when developing and administering
Federal agency mail programs. GSA is
announcing the deployment of the
SMART for collecting large Federal
agency mail program data as required by
FMR 102—sections 192.85–105. This
FMR Bulletin is available at https://
www.gsa.gov/policy-regulations/
regulations/federal-managementregulation/federal-managementregulation-fmr-relatedfiles#MailManagement. Annual large
agency mail management reporting
requirements are temporarily waived
until the SMART is deployed.
Krystal J. Brumfield,
Associate Administrator, Office of
Government-wide Policy, General Services
Administration.
[FR Doc. 2021–09140 Filed 4–30–21; 8:45 am]
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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
information collection project ‘‘The
AHRQ Safety Program for MethicillinResistant Staphylococcus aureus
(MRSA) Prevention.’’
DATES: Comments on this notice must be
received by July 2, 2021.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@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 doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Proposed Project
The AHRQ Safety Program for
Methicillin-Resistant Staphylococcus
aureus (MRSA) Prevention
As part of the HHS HAI National
Action Plan (NAP), AHRQ has
supported the implementation and
adoption of the Comprehensive Unitbased Safety Program (CUSP) to reduce
Central-Line Associated Bloodstream
Infections (CLABSI) and CatheterAssociated Urinary Tract Infections
(CAUTI), and subsequently applied
CUSP to other clinical challenges,
including reducing surgical site
infections and improving care for
mechanically ventilated patients. As
part of the National Action Plan for
Combating Antibiotic-Resistant Bacteria
(CARB NAP), the HHS HAI National
Action Plan, and Healthy People 2030
goals, AHRQ will now apply the
principles and concepts that have been
learned from these HAI reduction efforts
to the prevention of MRSA invasive
infections.
Healthcare-associated infections, or
HAIs, are a highly significant cause of
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03MYN1
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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
illness and death for patients in the U.S.
At any given time, HAIs affect one out
of every 31 hospital inpatients. More
than a million of these infections occur
across our health care system every
year. This leads to significant patient
harm and loss of life, and costs billions
of dollars each year in medical and nonmedical costs. In addition, the 3 million
Americans currently residing in U.S.
nursing homes experience a staggering
2–3 million HAIs each year.
Particular concern has arisen related
to the persistent prevalence of
methicillin-resistant Staphylococcus
aureus (MRSA). This bacterium affects
both communities and healthcare
facilities, but the majority of morbidity
and mortality occurs in critically and
chronically ill patients. While MRSA
was rare in the US through the 1970s,
its prevalence in US health care
facilities began rising in the 1980s and
had continued to do so. In 2000, MRSA
was responsible for 133,510
hospitalizations in children and adults.
This number more than doubled by
2005, with 278,203 hospitalizations
along with 56,248 septic events and
6,639 deaths being attributed to MRSA.
MRSA has become a major form of
hospital associated Staphylococcus
aureus infection.
For various patient safety initiatives,
AHRQ has promoted the
implementation and adoption of the
Comprehensive Unit-based Safety
Program (CUSP) approach which
combines clinical and cultural (i.e.,
technical and adaptive) intervention
components to facilitate the
implementation of technical bundles to
improve patient safety. For MRSA
prevention, it is likely that a
combination of technical approaches is
indicated, including decolonization
along with classic infection control
practices such as hand hygiene,
environmental cleaning, general HAI
prevention, and contact precautions/
isolation. Implementation of these
technical approaches would benefit
greatly from the cultural and behavioral
interventions incorporated in CUSP.
AHRQ expects that this approach,
which includes a focus on teamwork,
communication, and patient
engagement, will enhance the
effectiveness of interventions to reduce
MRSA infection that will be
implemented and evaluated as part of
this project.
This project will assist hospital units
and long-term care facilities in adopting
and implementing technical approaches
to reduce MRSA infections. It will be
implemented in four cohorts:
• At least 400 ICUs
• at least 400 non-ICUs
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• at least 300 hospital surgical
services
• at least 300 long-term care facilities.
The goals of this project are to (1)
develop and implement a program to
prevent MRSA invasive infection in
intensive care units (ICUs), non-ICUs,
inpatient surgery, and long-term care
facilities, (2) assess the adoption of
CUSP for MRSA Prevention, and (3)
evaluate the effectiveness of the
intervention in the participating units.
AHRQ is requesting a 3-year clearance
to perform the data collection activities
needed to assess the adoption of the
program and evaluate its effectiveness
in the participating units and facilities.
The project is being conducted by
AHRQ through its contractor, Johns
Hopkins University (JHU) and JHU’s
subcontractor, NORC at the University
of Chicago. The project is being
undertaken pursuant to AHRQ’s mission
to enhance the quality, appropriateness,
and effectiveness of health services, and
access to such services, through the
establishment of a broad base of
scientific research and through the
promotion of improvements in clinical
and health systems practices, including
the prevention of diseases and other
health conditions (42 U.S.C. 299).
Method of Collection
The evaluation will utilize a pre-post
design, using quarterly data collected
over a 12-month baseline period and an
18-month implementation period for a
total of 4 baseline data points and 6
implementation data points. In addition
to a pre-post-intervention analysis, we
plan to make use of the multiple
baseline observations to conduct an
interrupted time-series analysis for each
of the four healthcare settings (ICU, nonICU, surgical services, and long-term
care).
The primary data collection includes
the following:
(1) Unit or Facility-level clinical
outcome change data: During each
quarter of the program for ICU, non-ICU
and surgical settings, each participating
unit will be asked to submit clinical
measures related to MRSA prevention
through a secure online portal; longterm care settings will submit this
information on a monthly basis. Units
from all settings will also provide
retrospective data for the 12 months
prior to the start of the intervention
period. These data will be used to
evaluate the effectiveness of the AHRQ
Safety Program for MRSA Prevention
program.
(2) Survey of Patient Safety Culture:
The NORC/JHU team will administer
AHRQ Surveys of Patient Safety Culture
to all eligible AHRQ Safety Program for
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MRSA Prevention staff at the
participating units or facilities at the
beginning and end of the intervention.
We will administer the Hospital Survey
of Patient Safety Culture (HSOPS) in the
ICU, non-ICU, and surgical cohorts, and
the Nursing Home Survey on Patient
Safety Culture (NHSOPS) in the long
term care cohort. These surveys ask
questions about patient safety issues,
medical errors, and event reporting in
the respective setting. NORC/JHU will
request that all staff on the unit or
facility that is implementing the AHRQ
Safety Program for MRSA Prevention
complete the survey. As unit and
facility size vary, we estimate the
average number of respondents to be 25
for each unit.
(3) Gap Analysis: The NORC/JHU
team will administer the Gap Analysis
during the first month of the
intervention to an Infection
Preventionist and one of the unit’s team
leaders (most likely a nurse).
Information on current practices in
MRSA prevention on the unit will be
collected.
(4) Implementation Assessments—
Team Checkup Tool: The
implementation assessments will be
conducted to monitor the program’s
progress and determine what the
participating sites have learned through
participating in the program. The Team
Checkup Tool will be requested
monthly, and we anticipate
participation from approximately 1 staff
(most commonly a nurse) per unit. The
program will use the Team Checkup
Tool to monitor key actions of staff
members. The Tool asks about use of
safety guidelines, tools, and resources
throughout three different phases:
Assessment (1), Planning, Training, and
Implementation (2), and Sustainment
(3).
This data collection effort will be part
of a comprehensive evaluation strategy
to assess the adoption of the
Comprehensive Unit-Based Safety
Program (CUSP) for MRSA Prevention
in ICUs, non-ICUs, surgical services,
and long-term care settings; and
measure the effectiveness of the
interventions in the participating
facilities or units. The evaluation has
four main goals:
1. Program participation: Assess the
ability of sites to successfully encourage
full participation of unit/facility staff in
educational activities.
2. Implementation and adoption:
Assess the implementation and
adoption of CUSP for MRSA prevention.
3. Program effectiveness: Measure the
effectiveness of the CUSP for MRSA
prevention bundle.
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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
4. Causal pathways: Describe the
characteristics of teams that are
associated with successful
implementation and improvement
outcomes.
Estimated Annual Respondent Burden
Exhibit 1 shows the total estimated
annualized burden hours for the data
collection efforts. All data collection
activities are expected to occur within
the three-year clearance period. The
total estimated annualized burden is
13,151 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents ∂
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Survey of Patient Safety Culture
HSOPS (25 respondents per unit, pre- and post-intervention for ICU (400),
non-ICU (400), and surgical (300) cohorts, 1,100 units total) .....................
NHSOPS (25 respondents per facility, one response per pre- and postintervention for LTC cohort, 300 facilities total) ...........................................
9,167
2
0.25
4,584
2,500
2
0.25
1,250
467
2
1
934
367
18
0.17
1,123
100
18
0.17
306
267
100
100
1
1
1
9
0.5
5
2,403
50
500
367
6
0.5
1,101
100
18
0.5
900
13,535
........................
........................
13,151
Infrastructure Assessment
Gap Analysis (1 assessment per unit or facility, pre and post-intervention
for all four cohorts, 1,400 sites total) ...........................................................
Implementation Assessments
Team Checkup Tool (1 checklist conducted monthly during the 18 months
of intervention for ICU, non-ICU, and Surgical cohorts, 1,100 units total) ..
Team Checkup Tool (1 checklist conducted monthly per facility during the
18 month intervention period for LTC cohort, 300 facilities total) ...............
Electronic Health Record (EHR) Extracts
Initial datapull—(once at baseline for ICU and non-ICU cohorts, 800 units
total) .............................................................................................................
Initial datapull—(once at baseline for Surgical cohort, 300 settings total) ......
Initial datapull—(once at baseline for LTC cohort, 300 facilities total) ............
Quarterly data—(quarterly during 18 months of intervention for ICU, nonICU, and Surgical cohorts, 1,100 units total) ...............................................
Monthly data—(monthly per facility during 18 months of intervention for LTC
cohort, 300 facilities total) ............................................................................
Total ..........................................................................................................
+ The number of respondents per data collection effort is calculated by multiplying the number of respondents per unit by the total number of
units. The result is divided by three to capture an annualized number.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to complete the data
collection activities. The total
annualized cost burden is estimated to
be $596,597.83.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate
Total cost
burden
Survey of Patient Safety Culture
HSOPS (Attachment N) (25 respondents per unit, pre- and post-intervention
for ICU (400), non-ICU (400), and surgical (300) cohorts, 1,100 units
total) .............................................................................................................
NHSOPS (Attachment O) (25 respondents per facility, one response per
pre- and post-intervention for LTC cohort, 300 facilities total) ....................
9,167
4,584
* $51.53
$236,187.76
2,500
1,250
* 51.53
64,412.50
467
934
* 51.53
48,129.02
367
1,123
* 51.53
57,868.19
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Infrastructure Assessment
Gap Analysis (Attachments B–D) (1 assessment per unit or facility, pre and
post-intervention for all four cohorts, 1,400 sites total) ...............................
Implementation Assessments
Team Checkup Tool (Attachments H and I) (1 checklist conducted monthly
during 3 months of ramp-up and 15 months of intervention periods for
ICU, non-ICU, and Surgical cohorts, 1,100 units total) ...............................
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23369
Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Team Checkup Tool (Attachment J) (1 checklist conducted monthly per facility during 18 months of intervention for LTC cohort, 300 facilities total)
Total burden
hours
100
Average
hourly wage
rate
Total cost
burden
306
* 51.53
15,768.18
267
2,403
— 35.17
84,513.51
100
50
— 35.17
1,758.50
100
500
— 35.17
17,585.00
367
1,101
— 35.17
38,722.17
100
900
— 35.17
31,653.00
13,535
13,151
........................
596,597.83
Electronic Health Record (EHR) Extracts
Initial data pull (Attachment P)—(once at baseline for ICU and non-ICU cohorts, 800 units total) ...................................................................................
Initial data pull (Attachment Q)—(once at baseline for Surgical cohort, 300
settings total) ................................................................................................
Initial data pull (Attachment R)—(once at baseline for LTC cohort, 300 facilities total) .......................................................................................................
Quarterly data (Attachments P and Q)—(quarterly during 18 months of
intervention for ICU, non-ICU, and Surgical cohorts, 1,100 units total) ......
Monthly data (Attachment R)—(monthly per facility during 18 months of
intervention for LTC cohort, 100 facilities total) ...........................................
Total ..........................................................................................................
* This is an average of the average hourly wage rate for physician, nurse, nurse practitioner, physician’s assistant, and nurse’s aide from the
May 2019 National Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).
¥ This is an average of the average hourly wage rate for nurse and IT specialist from the May 2019 National Occupational Employment and
Wage Estimates, United States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).
Request for Comments
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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: April 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–09138 Filed 4–30–21; 8:45 am]
BILLING CODE 4160–90–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.
AGENCY:
ACTION:
Notice
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 renewal of
the information collection project
‘‘Medical Office Survey on Patient
Safety Culture Database.’’
SUMMARY:
Comments on this notice must be
received by July 2, 2021
DATES:
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
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Proposed Project
Medical Office Survey on Patient Safety
Culture Database
In 1999, the Institute of Medicine
called for health care organizations to
develop a ‘‘culture of safety’’ such that
their workforce and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health
System). To respond to the need for
tools to assess patient safety culture in
health care, AHRQ developed and pilot
tested the Medical Office Survey on
Patient Safety Culture with OMB
approval (OMB NO.0935–0131;
Approved July 5, 2007).
The survey is designed to enable
medical offices to assess provider and
staff perspectives about patient safety
issues, medical error, and error
reporting. The survey includes 38 items
that measure 10 composites of patient
safety culture. In addition to the
composite items, 14 items measure staff
perceptions how often medical offices
have problems exchanging information
with other settings as well as other
patient safety and quality issues. AHRQ
made the survey publicly available
along with a Survey User’s Guide and
other toolkit materials in December
2008 on the AHRQ website.
The AHRQ Medical Office SOPS
Database consists of data from the
AHRQ Medical Office Survey on Patient
Safety Culture and may include
reportable, non-required supplemental
items. Medical offices in the U.S. can
voluntarily submit data from the survey
to AHRQ, through its contractor, Westat.
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]]>Agencies
[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23366-23369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09138]
=======================================================================
-----------------------------------------------------------------------
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 information collection
project ``The AHRQ Safety Program for Methicillin-Resistant
Staphylococcus aureus (MRSA) Prevention.''
DATES: Comments on this notice must be received by July 2, 2021.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at
[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
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
The AHRQ Safety Program for Methicillin-Resistant Staphylococcus aureus
(MRSA) Prevention
As part of the HHS HAI National Action Plan (NAP), AHRQ has
supported the implementation and adoption of the Comprehensive Unit-
based Safety Program (CUSP) to reduce Central-Line Associated
Bloodstream Infections (CLABSI) and Catheter-Associated Urinary Tract
Infections (CAUTI), and subsequently applied CUSP to other clinical
challenges, including reducing surgical site infections and improving
care for mechanically ventilated patients. As part of the National
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP), the
HHS HAI National Action Plan, and Healthy People 2030 goals, AHRQ will
now apply the principles and concepts that have been learned from these
HAI reduction efforts to the prevention of MRSA invasive infections.
Healthcare-associated infections, or HAIs, are a highly significant
cause of
[[Page 23367]]
illness and death for patients in the U.S. At any given time, HAIs
affect one out of every 31 hospital inpatients. More than a million of
these infections occur across our health care system every year. This
leads to significant patient harm and loss of life, and costs billions
of dollars each year in medical and non-medical costs. In addition, the
3 million Americans currently residing in U.S. nursing homes experience
a staggering 2-3 million HAIs each year.
Particular concern has arisen related to the persistent prevalence
of methicillin-resistant Staphylococcus aureus (MRSA). This bacterium
affects both communities and healthcare facilities, but the majority of
morbidity and mortality occurs in critically and chronically ill
patients. While MRSA was rare in the US through the 1970s, its
prevalence in US health care facilities began rising in the 1980s and
had continued to do so. In 2000, MRSA was responsible for 133,510
hospitalizations in children and adults. This number more than doubled
by 2005, with 278,203 hospitalizations along with 56,248 septic events
and 6,639 deaths being attributed to MRSA. MRSA has become a major form
of hospital associated Staphylococcus aureus infection.
For various patient safety initiatives, AHRQ has promoted the
implementation and adoption of the Comprehensive Unit-based Safety
Program (CUSP) approach which combines clinical and cultural (i.e.,
technical and adaptive) intervention components to facilitate the
implementation of technical bundles to improve patient safety. For MRSA
prevention, it is likely that a combination of technical approaches is
indicated, including decolonization along with classic infection
control practices such as hand hygiene, environmental cleaning, general
HAI prevention, and contact precautions/isolation. Implementation of
these technical approaches would benefit greatly from the cultural and
behavioral interventions incorporated in CUSP. AHRQ expects that this
approach, which includes a focus on teamwork, communication, and
patient engagement, will enhance the effectiveness of interventions to
reduce MRSA infection that will be implemented and evaluated as part of
this project.
This project will assist hospital units and long-term care
facilities in adopting and implementing technical approaches to reduce
MRSA infections. It will be implemented in four cohorts:
At least 400 ICUs
at least 400 non-ICUs
at least 300 hospital surgical services
at least 300 long-term care facilities.
The goals of this project are to (1) develop and implement a
program to prevent MRSA invasive infection in intensive care units
(ICUs), non-ICUs, inpatient surgery, and long-term care facilities, (2)
assess the adoption of CUSP for MRSA Prevention, and (3) evaluate the
effectiveness of the intervention in the participating units. AHRQ is
requesting a 3-year clearance to perform the data collection activities
needed to assess the adoption of the program and evaluate its
effectiveness in the participating units and facilities.
The project is being conducted by AHRQ through its contractor,
Johns Hopkins University (JHU) and JHU's subcontractor, NORC at the
University of Chicago. The project is being undertaken pursuant to
AHRQ's mission to enhance the quality, appropriateness, and
effectiveness of health services, and access to such services, through
the establishment of a broad base of scientific research and through
the promotion of improvements in clinical and health systems practices,
including the prevention of diseases and other health conditions (42
U.S.C. 299).
Method of Collection
The evaluation will utilize a pre-post design, using quarterly data
collected over a 12-month baseline period and an 18-month
implementation period for a total of 4 baseline data points and 6
implementation data points. In addition to a pre-post-intervention
analysis, we plan to make use of the multiple baseline observations to
conduct an interrupted time-series analysis for each of the four
healthcare settings (ICU, non-ICU, surgical services, and long-term
care).
The primary data collection includes the following:
(1) Unit or Facility-level clinical outcome change data: During
each quarter of the program for ICU, non-ICU and surgical settings,
each participating unit will be asked to submit clinical measures
related to MRSA prevention through a secure online portal; long-term
care settings will submit this information on a monthly basis. Units
from all settings will also provide retrospective data for the 12
months prior to the start of the intervention period. These data will
be used to evaluate the effectiveness of the AHRQ Safety Program for
MRSA Prevention program.
(2) Survey of Patient Safety Culture: The NORC/JHU team will
administer AHRQ Surveys of Patient Safety Culture to all eligible AHRQ
Safety Program for MRSA Prevention staff at the participating units or
facilities at the beginning and end of the intervention. We will
administer the Hospital Survey of Patient Safety Culture (HSOPS) in the
ICU, non-ICU, and surgical cohorts, and the Nursing Home Survey on
Patient Safety Culture (NHSOPS) in the long term care cohort. These
surveys ask questions about patient safety issues, medical errors, and
event reporting in the respective setting. NORC/JHU will request that
all staff on the unit or facility that is implementing the AHRQ Safety
Program for MRSA Prevention complete the survey. As unit and facility
size vary, we estimate the average number of respondents to be 25 for
each unit.
(3) Gap Analysis: The NORC/JHU team will administer the Gap
Analysis during the first month of the intervention to an Infection
Preventionist and one of the unit's team leaders (most likely a nurse).
Information on current practices in MRSA prevention on the unit will be
collected.
(4) Implementation Assessments--Team Checkup Tool: The
implementation assessments will be conducted to monitor the program's
progress and determine what the participating sites have learned
through participating in the program. The Team Checkup Tool will be
requested monthly, and we anticipate participation from approximately 1
staff (most commonly a nurse) per unit. The program will use the Team
Checkup Tool to monitor key actions of staff members. The Tool asks
about use of safety guidelines, tools, and resources throughout three
different phases: Assessment (1), Planning, Training, and
Implementation (2), and Sustainment (3).
This data collection effort will be part of a comprehensive
evaluation strategy to assess the adoption of the Comprehensive Unit-
Based Safety Program (CUSP) for MRSA Prevention in ICUs, non-ICUs,
surgical services, and long-term care settings; and measure the
effectiveness of the interventions in the participating facilities or
units. The evaluation has four main goals:
1. Program participation: Assess the ability of sites to
successfully encourage full participation of unit/facility staff in
educational activities.
2. Implementation and adoption: Assess the implementation and
adoption of CUSP for MRSA prevention.
3. Program effectiveness: Measure the effectiveness of the CUSP for
MRSA prevention bundle.
[[Page 23368]]
4. Causal pathways: Describe the characteristics of teams that are
associated with successful implementation and improvement outcomes.
Estimated Annual Respondent Burden
Exhibit 1 shows the total estimated annualized burden hours for the
data collection efforts. All data collection activities are expected to
occur within the three-year clearance period. The total estimated
annualized burden is 13,151 hours.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents + respondent response hours
----------------------------------------------------------------------------------------------------------------
Survey of Patient Safety Culture
----------------------------------------------------------------------------------------------------------------
HSOPS (25 respondents per unit, pre- and post- 9,167 2 0.25 4,584
intervention for ICU (400), non-ICU (400), and
surgical (300) cohorts, 1,100 units total).....
NHSOPS (25 respondents per facility, one 2,500 2 0.25 1,250
response per pre- and post-intervention for LTC
cohort, 300 facilities total)..................
----------------------------------------------------------------------------------------------------------------
Infrastructure Assessment
----------------------------------------------------------------------------------------------------------------
Gap Analysis (1 assessment per unit or facility, 467 2 1 934
pre and post-intervention for all four cohorts,
1,400 sites total).............................
----------------------------------------------------------------------------------------------------------------
Implementation Assessments
----------------------------------------------------------------------------------------------------------------
Team Checkup Tool (1 checklist conducted monthly 367 18 0.17 1,123
during the 18 months of intervention for ICU,
non-ICU, and Surgical cohorts, 1,100 units
total).........................................
Team Checkup Tool (1 checklist conducted monthly 100 18 0.17 306
per facility during the 18 month intervention
period for LTC cohort, 300 facilities total)...
----------------------------------------------------------------------------------------------------------------
Electronic Health Record (EHR) Extracts
----------------------------------------------------------------------------------------------------------------
Initial datapull--(once at baseline for ICU and 267 1 9 2,403
non-ICU cohorts, 800 units total)..............
Initial datapull--(once at baseline for Surgical 100 1 0.5 50
cohort, 300 settings total)....................
Initial datapull--(once at baseline for LTC 100 1 5 500
cohort, 300 facilities total)..................
Quarterly data--(quarterly during 18 months of 367 6 0.5 1,101
intervention for ICU, non-ICU, and Surgical
cohorts, 1,100 units total)....................
Monthly data--(monthly per facility during 18 100 18 0.5 900
months of intervention for LTC cohort, 300
facilities total)..............................
---------------------------------------------------------------
Total....................................... 13,535 .............. .............. 13,151
----------------------------------------------------------------------------------------------------------------
+ The number of respondents per data collection effort is calculated by multiplying the number of respondents
per unit by the total number of units. The result is divided by three to capture an annualized number.
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to complete the data collection activities. The total
annualized cost burden is estimated to be $596,597.83.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate burden
----------------------------------------------------------------------------------------------------------------
Survey of Patient Safety Culture
----------------------------------------------------------------------------------------------------------------
HSOPS (Attachment N) (25 respondents per unit, 9,167 4,584 * $51.53 $236,187.76
pre- and post-intervention for ICU (400), non-
ICU (400), and surgical (300) cohorts, 1,100
units total)...................................
NHSOPS (Attachment O) (25 respondents per 2,500 1,250 * 51.53 64,412.50
facility, one response per pre- and post-
intervention for LTC cohort, 300 facilities
total).........................................
----------------------------------------------------------------------------------------------------------------
Infrastructure Assessment
----------------------------------------------------------------------------------------------------------------
Gap Analysis (Attachments B-D) (1 assessment per 467 934 * 51.53 48,129.02
unit or facility, pre and post-intervention for
all four cohorts, 1,400 sites total)...........
----------------------------------------------------------------------------------------------------------------
Implementation Assessments
----------------------------------------------------------------------------------------------------------------
Team Checkup Tool (Attachments H and I) (1 367 1,123 * 51.53 57,868.19
checklist conducted monthly during 3 months of
ramp-up and 15 months of intervention periods
for ICU, non-ICU, and Surgical cohorts, 1,100
units total)...................................
[[Page 23369]]
Team Checkup Tool (Attachment J) (1 checklist 100 306 * 51.53 15,768.18
conducted monthly per facility during 18 months
of intervention for LTC cohort, 300 facilities
total).........................................
----------------------------------------------------------------------------------------------------------------
Electronic Health Record (EHR) Extracts
----------------------------------------------------------------------------------------------------------------
Initial data pull (Attachment P)--(once at 267 2,403 _ 35.17 84,513.51
baseline for ICU and non-ICU cohorts, 800 units
total).........................................
Initial data pull (Attachment Q)--(once at 100 50 _ 35.17 1,758.50
baseline for Surgical cohort, 300 settings
total).........................................
Initial data pull (Attachment R)--(once at 100 500 _ 35.17 17,585.00
baseline for LTC cohort, 300 facilities total).
Quarterly data (Attachments P and Q)--(quarterly 367 1,101 _ 35.17 38,722.17
during 18 months of intervention for ICU, non-
ICU, and Surgical cohorts, 1,100 units total)..
Monthly data (Attachment R)--(monthly per 100 900 _ 35.17 31,653.00
facility during 18 months of intervention for
LTC cohort, 100 facilities total)..............
---------------------------------------------------------------
Total....................................... 13,535 13,151 .............. 596,597.83
----------------------------------------------------------------------------------------------------------------
* This is an average of the average hourly wage rate for physician, nurse, nurse practitioner, physician's
assistant, and nurse's aide from the May 2019 National Occupational Employment and Wage Estimates, United
States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).
- This is an average of the average hourly wage rate for nurse and IT specialist from the May 2019 National
Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).
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: April 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-09138 Filed 4-30-21; 8:45 am]
BILLING CODE 4160-90-P
