Notice2021-15621
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 22, 2021
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 86 Issue 138 (Thursday, July 22, 2021)</title>
</head>
<body><pre>
[Federal Register Volume 86, Number 138 (Thursday, July 22, 2021)]
[Notices]
[Pages 38714-38717]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a> . 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
<a href="/cdn-cgi/l/email-protection#6e0a011c071d40020b08050119071a142e2f263c3f4006061d40090118"><span class="__cf_email__" data-cfemail="d9bdb6abb0aaf7b5bcbfb2b6aeb0ada39998918b88f7b1b1aaf7beb6af">[email protected]</span></a>.
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:
<bullet> At least 400 ICUs
<bullet> at least 400 non-ICUs
<bullet> at least 300 hospital surgical services
<bullet> 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 (<a href="https://www.bls.gov/oes/current/oes_nat.htm#00-0000">https://www.bls.gov/oes/current/oes_nat.htm#00-0000</a>).
[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 (<a href="https://www.bls.gov/oes/current/oes_nat.htm#00-0000">https://www.bls.gov/oes/current/oes_nat.htm#00-0000</a>).
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 22, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.