# Agency Information Collection Activities: Proposed Collection; Comment Request
**AGENCY:**
Agency for Healthcare Research and Quality, 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 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 *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**
**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.
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.
| Form name | Number of | Number of | Hours per | Total burden hours |
| --- | --- | --- | --- | --- |
| | | | | |
| HSOPS Version 1.0 | 6667 | 2 | 0.25 | 3334 |
| HSOPS Version 2.0 | 2500 | 2 | 0.21 | 1050 |
| NHSOPS | 2,500 | 2 | 0.25 | 1,250 |
| | | | | |
| Gap Analysis | 467 | 2 | 1 | 934 |
| | | | | |
| Team Checkup Tool | 367 | 18 | 0.17 | 1,123 |
| Team Checkup Tool | 100 | 18 | 0.17 | 306 |
| | | | | |
| Initial data pull for 10% of hospitals that do not confer rights to their NHSN data—(
) | 27 | 1 | 5 | 135 |
| Initial data pull for hospital onset bacteremia (including MSSA) and MRSA-positive clinical cultures (not available in NHSN) (
) | 267 | 1 | 3.5 | 935 |
| Initial data pull for 10% of units that submit point prevalence survey data (
l) | 27 | 1 | 0.5 | 14 |
| Subsequent data pull for 10% of units that submit point prevalence data (
) | 27 | 3 | 0.25 | 20 |
| Initial data pull for 50% of surgical units that do not confer rights to NHSN data—(
) | 50 | 1 | 1 | 50 |
| Initial data pull—(
) | 100 | 1 | 6 | 600 |
| Quarterly data collection of monthly data— | 267 | 6 | 0.5 | 801 |
| Quarterly data collection of monthly data for 50% of hospitals that do not confer rights to their NHSN data (
) | 50 | 6 | 0.5 | 150 |
| Monthly data— | 100 | 18 | 0.75 | 1350 |
| Total | 13,516 | | | 12,052 |
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.
| Form name | Number of | Total | Average | Total |
| --- | --- | --- | --- | --- |
| | | | | |
| HSOPS Version 1.0 | 6,667 | 3,334 | * $51.53 | $171,801.02 |
| HSOPS Version 2.0 | 2,500 | 1,050 | * 51.53 | 54,106.50 |
| NHSOPS | 2,500 | 1,250 | * 51.53 | 64,412.50 |
| | | | | |
| Gap Analysis | 467 | 934 | * 51.53 | 48,129.02 |
| | | | | |
| Team Checkup Tool | 367 | 1,123 | * 51.53 | 57,868.19 |
| Team Checkup Tool | 100 | 306 | * 51.53 | 15,768.18 |
| | | | | |
| Initial data pull for 10% of hospitals that do not confer rights to their NHSN data— | 27 | 135 | ^ 35.17 | 4,747.95 |
| Initial data pull for hospital onset bacteremia (including MSSA) and MRSA-positive clinical cultures (not available in NHSN) | 267 | 935 | ^ 35.17 | 32,883.95 |
| Initial data pull for 10% of units that submit point prevalence survey data | 27 | 14 | ^ 35.17 | 492.38 |
| Subsequent data pull for 10% of units that submit point prevalence data | 27 | 20 | ^ 35.17 | 703.40 |
| Initial data pull for 50% of surgical settings that do not confer rights to NHSN data— | 50 | 50 | ^ 35.17 | 1,758.50 |
| Initial data pull— | 100 | 600 | ^ 35.17 | 21,102.00 |
| Quarterly data— | 267 | 801 | ^ 35.17 | 28,171.17 |
| Quarterly data collection of monthly data for 50% of hospitals that do not confer rights to their NHSN data | 50 | 150 | ^ 35.17 | 5,275.50 |
| Monthly data— | 100 | 1,350 | ^ 35.17 | 47,479.50 |
| Total | 13,516 | 12,052 | | 554,699.76 |
**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.