Agency Information Collection Activities: Proposed Collection; Comment Request, 38714-38717 [2021-15621]
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38714
Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices
CONTACT PERSON FOR MORE INFORMATION:
Judith Ingram, Press Officer. Telephone:
(202) 694–1220.
Vicktoria J. Allen,
Acting Deputy Secretary of the Commission.
[FR Doc. 2021–15734 Filed 7–20–21; 4:15 pm]
Board of Governors of the Federal Reserve
System, July 19, 2021.
Michele Taylor Fennell,
Deputy Associate Secretary of the Board.
[FR Doc. 2021–15593 Filed 7–21–21; 8:45 am]
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Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality (AHRQ), 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.’’ This proposed
information collection was previously
published in the Federal Register on
May 3rd, 2021 and allowed 60 days for
public comment. AHRQ did not receive
any substantive comments from
members of the public. The purpose of
this notice is to allow an additional 30
days for public comment.
DATES: Comments on this notice must be
received by August 23, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain . Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
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 Catheter-
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Sfmt 4703
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
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
has 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
E:\FR\FM\22JYN1.SGM
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38715
Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices
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 an
interrupted time series design to assess
MRSA invasive infections (defined as
MRSA bacteremia) and secondary
clinical outcomes, using 18 months of
implementation data and 12 months of
retrospective data. We will also assess
needs of participating units and
capacity to implement the intervention,
awareness of MRSA prevention,
implementation fidelity and
effectiveness, communication and
teamwork, and changes in patient safety
culture and behavior using a pre-post
design.
The primary data collection includes
the following:
(1) Unit or Facility-level clinical
outcome change data: The program will
use a secure online portal to collect
clinical outcomes measures extracted
from site electronic health record (EHR)
systems for the 12 month period prior
to the start of the implementation, as
well as for the 18 month
implementation period. These data will
be used to evaluate the effectiveness of
the AHRQ Safety Program for MRSA
Prevention.
(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) Infrastructure Assessment Tool—
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.
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
11,552 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents +
lotter on DSK11XQN23PROD with NOTICES1
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-implementation for ICU
(400), non-ICU (400), and surgical (300) cohorts, 1,100 units total) ..........
NHSOPS (25 respondents per facility, one response per pre- and post-implementation for LTC cohort, 300 facilities total) .........................................
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9,167
2
0.25
4,584
2,500
2
0.25
1,250
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38716
Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents +
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Infrastructure Assessment
Gap Analysis (1 assessment per unit or facility, pre and post-implementation for all four cohorts, 1,400 sites total) ....................................................
467
2
1
934
367
18
0.17
1,123
100
18
0.17
306
27
1
5
135
267
1
3.5
935
27
1
0.5
14
20
100
1
1
0.5
5
10
500
267
6
0.5
801
20
6
0.5
60
100
18
0.5
900
13,429
........................
........................
11,552
Implementation Assessments
Team Checkup Tool (1 checklist conducted monthly during the 18 months
of implementation for ICU, non-ICU, and Surgical cohorts, 1,100 units
total) .............................................................................................................
Team Checkup Tool (1 checklist conducted monthly per facility during the
18 month implementation period for LTC cohort, 300 facilities total) ..........
Electronic Health Record (EHR) Extracts
Initial data pull for 10% of hospitals that do not confer rights to their NHSN
data (once at baseline for ICU and non-ICU cohorts, 800 units total) ........
Initial data pull for hospital onset bacteremia (including MSSA) and MRSApositive clinical cultures (not available in NHSN) (once at baseline for ICU
and non-ICU cohorts, 800 units total) ..........................................................
Initial data pull for 10% of units that submit point prevalence survey data
(once at baseline for ICU and non-ICU cohorts, 800 units total) ................
Initial data pull for 20% of surgical units that do not confer rights to NHSN
data (once at baseline for Surgical cohort, 300 settings total) ....................
Initial data pull (once at baseline for LTC cohort, 300 facilities total) .............
Quarterly data collection of monthly data (quarterly during 18 months of implementation for ICU and non-ICU, cohorts, 800 units total) ......................
Quarterly data collection of monthly data for 20% of hospitals that do not
confer rights to their NHSN data (quarterly during 18 months of implementation for surgical cohorts, 300 units total) ............................................
Monthly data (monthly per facility during 18 months of implementation 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 $540,325.83.
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 (25 respondents per unit, pre- and post-implementation for ICU
(400), non-ICU (400), and surgical (300) cohorts, 1,100 units total) ..........
NHSOPS (25 respondents per facility, one response per pre- and post-implementation 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
100
306
* 51.53
15,768.18
Infrastructure Assessment
Gap Analysis (1 assessment per unit or facility, pre and post-implementation for all four cohorts, 1,400 sites total) ....................................................
lotter on DSK11XQN23PROD with NOTICES1
Implementation Assessments
Team Checkup Tool (1 checklist conducted monthly during 3 months of
ramp-up and 15 months of implementation periods for ICU, non-ICU, and
Surgical cohorts, 1,100 units total) ..............................................................
Team Checkup Tool (1 checklist conducted monthly per facility during 18
months of implementation for LTC cohort, 300 facilities total) ....................
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Federal Register / Vol. 86, No. 138 / Thursday, July 22, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate
Total cost
burden
Electronic Health Record (EHR) Extracts
Initial data pull for 10% of hospitals that do not confer rights to their NHSN
data (once at baseline for ICU and non-ICU cohorts, 800 units total) ........
Initial data pull for hospital onset bacteremia (including MSSA) and MRSApositive clinical cultures (not available in NHSN) (once at baseline for ICU
and non-ICU cohorts, 800 units total) ..........................................................
Initial data pull for 10% of units that submit point prevalence survey data
(once at baseline for ICU and non-ICU cohorts, 800 units total) ................
Initial data pull for 20% of surgical settings that do not confer rights to
NHSN data (once at baseline for Surgical cohort, 300 settings total) ........
Initial data pull (once at baseline for LTC cohort, 300 facilities total) .............
Quarterly data (quarterly during 18 months of implementation for ICU and
non-ICU cohorts, 1,100 units total) ..............................................................
Quarterly data collection of monthly data for 20% of hospitals that do not
confer rights to their NHSN data (quarterly during 18 months of implementation for surgical cohorts, 300 units total) ............................................
Monthly data (monthly per facility during 18 months of implementation for
LTC cohort, 100 facilities total) ....................................................................
Total ..........................................................................................................
27
135
∧ 35.17
4,747.95
267
935
∧ 35.17
32,866.37
27
14
∧ 35.17
474.80
20
100
10
500
∧ 35.17
∧ 35.17
351.70
17,585.00
267
801
∧ 35.17
28,171.17
20
60
∧ 35.17
2,110.20
100
900
∧ 35.17
31,653.00
13,429
11,552
........................
540,325.83
* 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).
lotter on DSK11XQN23PROD with NOTICES1
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: July 19, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–15621 Filed 7–21–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Public Health Determination Regarding
an Exception for Unaccompanied
Noncitizen Children From the Order
Suspending the Right To Introduce
Certain Persons From Countries
Where a Quarantinable Communicable
Disease Exists
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), a
component of the Department of Health
and Human Services (HHS), announces
an Order excepting unaccompanied
noncitizen children (UC) from the Order
Suspending the Right to Introduce
Certain Persons from Countries Where a
Quarantinable Communicable Disease
Exists, issued on October 13, 2020
(October Order). CDC finds that, at this
time, there is appropriate infrastructure
in place to protect the children,
caregivers, and local communities from
elevated risk of COVID–19 transmission
as a result of the introduction of UC,
and U.S. healthcare resources are not
significantly impacted by providing UC
necessary care. CDC believes the
SUMMARY:
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Fmt 4703
Sfmt 4703
COVID–19-related public health
concerns associated with UC
introduction can be adequately
addressed without the UC being subject
to the October Order, thereby permitting
the government to better address the
humanitarian challenges for these
children. Therefore, CDC is fully
excepting UC from the October Order,
and the Notice regarding the temporary
exception of UC published February 17,
2021 is hereby superseded.
DATES: This Order went into effect July
16, 2021.
FOR FURTHER INFORMATION CONTACT:
Tiffany Brown, Deputy Chief of Staff,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–10, Atlanta, GA 30329. Phone:
404–639–7000. Email: cdcregulations@
cdc.gov.
As part of
government efforts to mitigate the
introduction, transmission, and spread
of COVID–19, CDC issued the October
Order,1 suspending the right to
SUPPLEMENTARY INFORMATION:
1 Order Suspending the Right to Introduce Certain
Persons from Countries Where a Quarantinable
Communicable Disease Exists, 85 FR 65806 (Oct.
16, 2020). The October Order replaced the Order
Suspending Introduction of Certain Persons from
Countries Where a Communicable Disease Exists,
issued on March 20, 2020. 85 FR 17060 (Mar. 26,
2020); Extension of Order Under Sections 362 and
365 of the Public Health Service Act; Order
Suspending Introduction of Certain Persons From
Countries Where a Communicable Disease Exists,
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]]>Agencies
[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38714-38717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15621]
=======================================================================
-----------------------------------------------------------------------
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 (AHRQ), 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.'' This proposed information
collection was previously published in the Federal Register on May 3rd,
2021 and allowed 60 days for public comment. AHRQ did not receive any
substantive comments from members of the public. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by August 23, 2021.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain . Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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 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
has 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
[[Page 38715]]
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 an interrupted time series design to
assess MRSA invasive infections (defined as MRSA bacteremia) and
secondary clinical outcomes, using 18 months of implementation data and
12 months of retrospective data. We will also assess needs of
participating units and capacity to implement the intervention,
awareness of MRSA prevention, implementation fidelity and
effectiveness, communication and teamwork, and changes in patient
safety culture and behavior using a pre-post design.
The primary data collection includes the following:
(1) Unit or Facility-level clinical outcome change data: The
program will use a secure online portal to collect clinical outcomes
measures extracted from site electronic health record (EHR) systems for
the 12 month period prior to the start of the implementation, as well
as for the 18 month implementation period. These data will be used to
evaluate the effectiveness of the AHRQ Safety Program for MRSA
Prevention.
(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) Infrastructure Assessment Tool--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.
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 11,552 hours.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Number of
Form name respondents responses per Hours per Total burden
\+\ respondent response hours
----------------------------------------------------------------------------------------------------------------
Survey of Patient Safety Culture
----------------------------------------------------------------------------------------------------------------
HSOPS (25 respondents per unit, pre- and post- 9,167 2 0.25 4,584
implementation 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-implementation for
LTC cohort, 300 facilities total)..............
----------------------------------------------------------------------------------------------------------------
[[Page 38716]]
Infrastructure Assessment
----------------------------------------------------------------------------------------------------------------
Gap Analysis (1 assessment per unit or facility, 467 2 1 934
pre and post-implementation 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 implementation 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 implementation
period for LTC cohort, 300 facilities total)...
----------------------------------------------------------------------------------------------------------------
Electronic Health Record (EHR) Extracts
----------------------------------------------------------------------------------------------------------------
Initial data pull for 10% of hospitals that do 27 1 5 135
not confer rights to their NHSN data (once at
baseline for ICU and non-ICU cohorts, 800 units
total).........................................
Initial data pull for hospital onset bacteremia 267 1 3.5 935
(including MSSA) and MRSA-positive clinical
cultures (not available in NHSN) (once at
baseline for ICU and non-ICU cohorts, 800 units
total).........................................
Initial data pull for 10% of units that submit 27 1 0.5 14
point prevalence survey data (once at baseline
for ICU and non-ICU cohorts, 800 units total)..
Initial data pull for 20% of surgical units that 20 1 0.5 10
do not confer rights to NHSN data (once at
baseline for Surgical cohort, 300 settings
total).........................................
Initial data pull (once at baseline for LTC 100 1 5 500
cohort, 300 facilities total)..................
Quarterly data collection of monthly data 267 6 0.5 801
(quarterly during 18 months of implementation
for ICU and non-ICU, cohorts, 800 units total).
Quarterly data collection of monthly data for 20 6 0.5 60
20% of hospitals that do not confer rights to
their NHSN data (quarterly during 18 months of
implementation for surgical cohorts, 300 units
total).........................................
Monthly data (monthly per facility during 18 100 18 0.5 900
months of implementation for LTC cohort, 300
facilities total)..............................
---------------------------------------------------------------
Total....................................... 13,429 .............. .............. 11,552
----------------------------------------------------------------------------------------------------------------
\+\ 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 $540,325.83.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form name respondents hours wage rate burden
----------------------------------------------------------------------------------------------------------------
Survey of Patient Safety Culture
----------------------------------------------------------------------------------------------------------------
HSOPS (25 respondents per unit, pre- and post- 9,167 4,584 * $51.53 $236,187.76
implementation for ICU (400), non-ICU (400),
and surgical (300) cohorts, 1,100 units total).
NHSOPS (25 respondents per facility, one 2,500 1,250 * 51.53 64,412.50
response per pre- and post-implementation for
LTC cohort, 300 facilities total)..............
----------------------------------------------------------------------------------------------------------------
Infrastructure Assessment
----------------------------------------------------------------------------------------------------------------
Gap Analysis (1 assessment per unit or facility, 467 934 * 51.53 48,129.02
pre and post-implementation for all four
cohorts, 1,400 sites total)....................
----------------------------------------------------------------------------------------------------------------
Implementation Assessments
----------------------------------------------------------------------------------------------------------------
Team Checkup Tool (1 checklist conducted monthly 367 1,123 * 51.53 57,868.19
during 3 months of ramp-up and 15 months of
implementation periods for ICU, non-ICU, and
Surgical cohorts, 1,100 units total)...........
Team Checkup Tool (1 checklist conducted monthly 100 306 * 51.53 15,768.18
per facility during 18 months of implementation
for LTC cohort, 300 facilities total)..........
----------------------------------------------------------------------------------------------------------------
[[Page 38717]]
Electronic Health Record (EHR) Extracts
----------------------------------------------------------------------------------------------------------------
Initial data pull for 10% of hospitals that do 27 135 [supcaret] 4,747.95
not confer rights to their NHSN data (once at 35.17
baseline for ICU and non-ICU cohorts, 800 units
total).........................................
Initial data pull for hospital onset bacteremia 267 935 [supcaret] 32,866.37
(including MSSA) and MRSA-positive clinical 35.17
cultures (not available in NHSN) (once at
baseline for ICU and non-ICU cohorts, 800 units
total).........................................
Initial data pull for 10% of units that submit 27 14 [supcaret] 474.80
point prevalence survey data (once at baseline 35.17
for ICU and non-ICU cohorts, 800 units total)..
Initial data pull for 20% of surgical settings 20 10 [supcaret] 351.70
that do not confer rights to NHSN data (once at 35.17
baseline for Surgical cohort, 300 settings
total).........................................
Initial data pull (once at baseline for LTC 100 500 [supcaret] 17,585.00
cohort, 300 facilities total).................. 35.17
Quarterly data (quarterly during 18 months of 267 801 [supcaret] 28,171.17
implementation for ICU and non-ICU cohorts, 35.17
1,100 units total).............................
Quarterly data collection of monthly data for 20 60 [supcaret] 2,110.20
20% of hospitals that do not confer rights to 35.17
their NHSN data (quarterly during 18 months of
implementation for surgical cohorts, 300 units
total).........................................
Monthly data (monthly per facility during 18 100 900 [supcaret] 31,653.00
months of implementation for LTC cohort, 100 35.17
facilities total)..............................
---------------------------------------------------------------
Total....................................... 13,429 11,552 .............. 540,325.83
----------------------------------------------------------------------------------------------------------------
* 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).
[supcaret] 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: July 19, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-15621 Filed 7-21-21; 8:45 am]
BILLING CODE 4160-90-P
