[Federal Register Volume 87, Number 139 (Thursday, July 21, 2022)]
[Notices]
[Pages 43521-43525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15627]


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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.''

DATES: Comments on this notice must be received by September 19, 2022.

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

[[Page 43522]]

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

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 
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202107-0935-003.
    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 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:

 Hospital onset MRSA invasive infection (MRSA bacteremia LabID 
Day 3 or after of admission)
 Community onset MRSA invasive infection (MRSA bacteremia LabID 
prior to Day 3 after admission)
 Patient days
 Central Line-Associated Blood Stream Infections with causative 
organism(s)
 Central Line Days
 Hospital onset bacteremia (Day 3 or after of admission) with 
causative organisms, including MSSA
 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.

[[Page 43523]]

    For the surgical services cohort, the clinical outcomes data will 
be collected quarterly and will include:

 Surgical site infection (SSI) events and causative organisms
 Number of surgical procedures performed, by type of surgical 
procedure
 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:

 Transfer of facility resident(s) to an acute care hospital, 
with reason of suspected or confirmed infection
 Transfer of facility resident(s) to an acute care hospital, 
with reason other than infection
 All-cause bacteremia with causative organisms
 Resident days
 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:

 Hospital onset MRSA invasive infection (MRSA bacteremia LabID 
Day 3 or after of admission)
 Community onset MRSA invasive infection (MRSA bacteremia LabID 
prior to Day 3 after admission)
 Patient days
 Central Line-Associated Blood Stream Infections with causative 
organism(s)
 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:

 Surgical site infection (SSI) events and causative organisms
 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.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                     Number of       Number of
                    Form name                       respondents    responses per     Hours per     Total burden
                                                        \+\         respondent       response          hours
----------------------------------------------------------------------------------------------------------------
                                        Survey of Patient Safety Culture
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HSOPS Version 1.0 (25 respondents per unit, pre-           6,667               2            0.25           3,334
 and post-implementation for ICU and non-ICU)...
HSOPS Version 2.0 (25 respondents per unit, pre-           2,500               2            0.21           1,050
 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)..............
----------------------------------------------------------------------------------------------------------------
                                            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).........................................

[[Page 43524]]

 
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           1,350
 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
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours           rate           burden
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                                        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)..............
----------------------------------------------------------------------------------------------------------------
                                            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).........................................

[[Page 43525]]

 
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)..............................
                                                 ---------------------------------------------------------------
    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 (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/oescurrent/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 18, 2022.
Marquita Cullom,
Associate Director.
[FR Doc. 2022-15627 Filed 7-20-22; 8:45 am]
BILLING CODE 4160-90-P