Notice2022-21991
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
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Published
October 11, 2022
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 revised 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 July 21, 2022 and allowed 60 days for public comment. AHRQ did not receive substantive comments during public review period. The purpose of this notice is to allow an additional 30 days for public comment.
Full Text
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<title>Federal Register, Volume 87 Issue 195 (Tuesday, October 11, 2022)</title>
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[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61323-61326]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21991]
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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.
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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 revised 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 July 21, 2022 and allowed 60 days for public
comment. AHRQ did not receive substantive comments during public review
period. The purpose of this notice is to allow an additional 30 days
for public comment.
DATES: Comments on this notice must be received by November 10, 2022.
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#8aeee5f8e3f9a4e6efece1e5fde3fef0cacbc2d8dba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="cbafa4b9a2b8e5a7aeada0a4bca2bfb18b8a83999ae5a3a3b8e5aca4bd">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Proposed Project
AHRQ Safety Program for Methicillin-Resistant Staphylococcus Aureus
(MRSA) Prevention
The Agency for Healthcare Research and Quality (AHRQ) requests to
revise the currently approved AHRQ Safety Program for Methicillin-
Resistant Staphylococcus aureus (MRSA) Prevention. The AHRQ Safety
Program for MRSA Prevention's purpose is to reduce the incidence and
prevalence of infections caused by MRSA in a variety of settings.
The AHRQ Safety Program for MRSA Prevention was last approved by
OMB on August 31, 2021 and will expire on August 31, 2024. The OMB
control number for the AHRQ Safety Program for MRSA Prevention is 0935-
0260. All of the supporting documents for the current AHRQ Safety
Program for MRSA Prevention can be downloaded from OMB's website at
<a href="https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0935-003">https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0935-003</a>.
The revision for the AHRQ Safety Program for MRSA Prevention
includes the following modifications:
1. ICU/Non-ICU cohort: The optional point prevalence data will be
collected at baseline (pre-intervention) and every six months
throughout the 18-month implementation period rather than only at
baseline. Thus, it will be collected a total of four times. The
clinical outcomes measures for the ICU/Non-ICU cohort have been updated
from the version included in the original OMB review.
In addition to the change in the frequency of collection of point
prevalence data, the program will accept hospital data collected using
the new Version 2.0 of the AHRQ Hospital Survey on Patient Safety
Culture (HSOPS) as an alternative to the original HSOPS Version 1.0.
HSOPS Version 2.0 is a shorter instrument with a total of 40 survey
items compared with 51 survey items in the HSOPS Version 1.0.
2. Surgical Services cohort: After a discussion with the program's
Technical Expert Panel (TEP), it was decided to collect surgical site
infection (SSI) outcome data on a different subset of surgical
procedures performed within the cardiac surgery, orthopedic surgery,
and neurosurgery specialty areas. The clinical outcomes measures for
the Surgical Services cohort have been updated from the version
included in the original OMB review to reflect the changes in surgical
types.
For all three surgical specialties, hospitals will have the
opportunity to confer rights to the program to their SSI data submitted
via National Healthcare Safety Network (NHSN). Hospitals confer rights
to their NHSN data by giving the program permission to access their
data directly from NHSN. In addition, hospitals with cardiac surgery
teams enrolled in the program will be asked to provide data elements
that are regularly collected and submitted to the Society of Thoracic
Surgeons (STS). STS data elements for cardiac surgeries will include
procedures that involve sternotomy and hospital readmission due to
Endocarditis, infection (conduit harvest site), infection (deep
sternum/mediastinitis), Pneumonia, Sepsis, or wound (drainage,
cellulitis).
We estimate that 50% of 300 enrolled units (n=150) will be
orthopedic and neurosurgical specialties that will confer NHSN data
rights to the program. These hospitals will not need to submit any data
directly to the program.
The remaining 50% of 300 enrolled units (n=150) are estimated to be
either cardiac surgical specialties that need to submit STS data or
orthopedic or neurosurgical specialties that do not confer NHSN data
rights to the program. These hospitals are assumed to have some burden
for either pulling and submitting STS data extracts for cardiac
surgical specialties or pulling and submitting NHSN data elements for
orthopedic or neurosurgical specialties that do not confer rights to
NHSN. We assume 1 hour for the initial data pull and 30 minutes for
each subsequent quarterly data pull.
In addition to the changes in clinical outcomes described above,
the program will use the new HSOPS Version 2.0 instead of the original
HSOPS Version 1.0 to assess patient safety culture within enrolled
surgical services teams.
3. Long-Term Care (LTC) cohort: The LTC cohort will now also submit
the Minimum Data Set (MDS) 3.0 M Skin Conditions data elements. These
elements are currently collected by CMS-certified LTC facilities to
remain compliant. Since the MDS 3.0 data is already being collected for
CMS, LTC facilities would be asked to submit the same data to the
program after transmittal to CMS. As a result, there is a minimal
change in burden (i.e. from five hours to six hours for the initial
data pull and from 30 minutes to 45 minutes for additional pulls). The
clinical outcomes measures for the LTC cohort have been updated from
the version included in the original OMB review.
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
[[Page 61324]]
the prevention of diseases and other health conditions (42 U.S.C. 299).
Method of Collection
The data collection will include both primary and secondary data
sources. The primary data collection includes the following:
(1) Unit-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. The
clinical outcomes measures for the ICU/non-ICU and Surgical Services
and Long-Term Care cohorts have been updated from the version included
in the original OMB review.
For the ICU and non-ICU cohorts, the clinical outcomes data will be
collected quarterly and will include:
<bullet> Hospital onset MRSA invasive infection (MRSA bacteremia
LabID Day 3 or after of admission).
<bullet> Community onset MRSA invasive infection (MRSA bacteremia
LabID prior to Day 3 after admission).
<bullet> Patient days.
<bullet> Central Line-Associated Blood Stream Infections with
causative organism(s).
<bullet> Central Line Days.
<bullet> Hospital onset bacteremia (Day 3 or after of admission)
with causative organisms, including MSSA.
<bullet> MRSA-positive clinical cultures.
In addition, hospitals that are already conducting MRSA point
prevalence surveys in participating ICU and non-ICU units will be asked
to submit this optional data via the secure online portal. Hospitals
will be asked to submit baseline data at the start of the program and
then submit data once every six months for the duration of the 18-month
implementation period. Thus, it will be collected a total of four
times.
For the surgical services cohort, the clinical outcomes data will
be collected quarterly and will include:
<bullet> Surgical site infection (SSI) events and causative
organisms.
<bullet> Number of surgical procedures performed, by type of
surgical procedure.
<bullet> Hospital readmissions.
For the LTC cohort, the clinical outcomes data will be collected
monthly via the secure online portal, or via fax submission, and will
include:
<bullet> Transfer of facility resident(s) to an acute care
hospital, with reason of suspected or confirmed infection.
<bullet> Transfer of facility resident(s) to an acute care
hospital, with reason other than infection.
<bullet> All-cause bacteremia with causative organisms.
<bullet> Resident days.
<bullet> MDS 3.0 Section M Skin Conditions data elements.
(2) Survey of Patient Safety: The program 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 (month 1) and end (month 18) of the implementation. 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 (NHSOPS) in the LTC cohort. We will accept either
HSOPS Version 1.0 or Version 2.0 for the ICU and non-ICU cohort and
will accept HSOPS Version 2.0 for the surgical services cohort. These
surveys ask questions about patient safety issues, medical errors, and
event reporting in the respective setting. The program 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 program will
administer the Gap Analysis at month 1 and month 18 of the
implementation 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. The Gap Analysis for the
surgical services cohort has been updated from the version included in
the original OMB review.
(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
frontline staff (most commonly a nurse) per unit. The program will use
the Team Checkup Tool to monitor key actions of staff. The Tool asks
about use of safety guidelines, tools, and resources throughout three
different phases: Assessment; Planning, Training, and Implementation;
and Sustainment. The Team Checkup Tools for the LTC and Surgical
Services cohorts have been updated from the versions included in the
original OMB review.
The secondary data collection strategy includes use of NHSN data
from hospitals that confer rights to the AHRQ Safety Program for MRSA
Prevention to use their NHSN data for the evaluation. NHSN data will
serve as secondary data sources for clinical outcomes in ICU, non-ICU,
and surgical services units. Clinical outcome measures in LTC settings
are not available in NHSN.
For hospitals that confer NHSN rights to the program for the ICU
and non-ICU cohorts, the secondary data will include the five out of
seven clinical outcome measures that are available via NHSN:
<bullet> Hospital onset MRSA invasive infection (MRSA bacteremia
LabID Day 3 or after of admission).
<bullet> Community onset MRSA invasive infection (MRSA bacteremia
LabID prior to Day 3 after admission).
<bullet> Patient days.
<bullet> Central Line-Associated Blood Stream Infections with
causative organism(s).
<bullet> Central Line Days.
For hospitals that confer NHSN rights to the program for the
surgical services cohort, the secondary data will include the two
clinical outcome measures that are available via NHSN:
<bullet> Surgical site infection (SSI) events and causative
organisms.
<bullet> Number of surgical procedures performed, by type of
surgical procedure.
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
12,052 hours.
[[Page 61325]]
Exhibit 1 Estimated Annualized Burden Hours
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Number of
Form name Number of responses per Hours per Total burden
respondents + respondent response hours
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Survey of Patient Safety Culture
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HSOPS Version 1.0 (25 respondents per unit, pre- 6667 2 0.25 3334
and post-implementation for ICU and non-ICU)...
HSOPS Version 2.0 (25 respondents per unit, pre- 2500 2 0.21 1050
and post-implementation for ICU and non-ICU)...
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)..............
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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)...
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Electronic Health Record (EHR) Extracts
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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)..
Subsequent data pull for 10% of units that 27 3 0.25 20
submit point prevalence data (every six months
during 18 months of implementation for ICU and
non-ICU cohorts, 800 units total)..............
Initial data pull for 50% of surgical units that 50 1 1 50
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 6 600
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 50 6 0.5 150
50% 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 0.75 1350
months of implementation for LTC cohort, 300
facilities total)..............................
---------------------------------------------------------------
Total....................................... 13,516 .............. .............. 12,052
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+ 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 $554,699.76.
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 Version 1.0 (25 respondents per unit, pre- 6,667 3,334 * $51.53 $171,801.02
and post-implementation for ICU and non-ICU
cohorts).......................................
HSOPS Version 2.0 (25 respondents per unit, pre- 2,500 1,050 * 51.53 54,106.50
and post- implementation surgical cohort)......
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)..............
----------------------------------------------------------------------------------------------------------------
[[Page 61326]]
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)..........
----------------------------------------------------------------------------------------------------------------
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] 32,883.95
(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] 492.38
point prevalence survey data (once at baseline 35.17
for ICU and non-ICU cohorts, 800 units total)..
Subsequent data pull for 10% of units that 27 20 [supcaret] 703.40
submit point prevalence data (every six months 35.17
during 18 months of implementation for ICU and
non-ICU cohorts, 800 units total)..............
Initial data pull for 50% of surgical settings 50 50 [supcaret] 1,758.50
that do not confer rights to NHSN data--(once 35.17
at baseline for Surgical cohort, 300 settings
total).........................................
Initial data pull--(once at baseline for LTC 100 600 [supcaret] 21,102.00
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 50 150 [supcaret] 5,275.50
50% 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 1,350 [supcaret] 47,479.50
months of implementation for LTC cohort, 100 35.17
facilities total)..............................
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Total....................................... 13,516 12,052 .............. 554,699.76
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* 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: October 4, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-21991 Filed 10-7-22; 8:45 am]
BILLING CODE 4160-90-P
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