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[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]

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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 (AHRQ), 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 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
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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 $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
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