Agency Information Collection Activities: Proposed Collection; Comment Request

CourtAgency For Healthcare Research And Quality, Health And Human Services Department
Citation86 FR 23366
Publication Date03 May 2021
Record Number2021-09138
Federal Register, Volume 86 Issue 83 (Monday, May 3, 2021)
[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
                [Notices]
                [Pages 23366-23369]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-09138]
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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 proposed information collection
                project ``The AHRQ Safety Program for Methicillin-Resistant
                Staphylococcus aureus (MRSA) Prevention.''
                DATES: Comments on this notice must be received by July 2, 2021.
                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 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
                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
                [[Page 23367]]
                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
                had 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 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 a pre-post design, using quarterly data
                collected over a 12-month baseline period and an 18-month
                implementation period for a total of 4 baseline data points and 6
                implementation data points. In addition to a pre-post-intervention
                analysis, we plan to make use of the multiple baseline observations to
                conduct an interrupted time-series analysis for each of the four
                healthcare settings (ICU, non-ICU, surgical services, and long-term
                care).
                 The primary data collection includes the following:
                 (1) Unit or Facility-level clinical outcome change data: During
                each quarter of the program for ICU, non-ICU and surgical settings,
                each participating unit will be asked to submit clinical measures
                related to MRSA prevention through a secure online portal; long-term
                care settings will submit this information on a monthly basis. Units
                from all settings will also provide retrospective data for the 12
                months prior to the start of the intervention period. These data will
                be used to evaluate the effectiveness of the AHRQ Safety Program for
                MRSA Prevention program.
                 (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) 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.
                [[Page 23368]]
                 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 13,151 hours.
                 Exhibit 1--Estimated Annualized Burden Hours
                ----------------------------------------------------------------------------------------------------------------
                 Number of
                 Form name Number of responses per Hours per Total burden
                 respondents + respondent response hours
                ----------------------------------------------------------------------------------------------------------------
                 Survey of Patient Safety Culture
                ----------------------------------------------------------------------------------------------------------------
                HSOPS (25 respondents per unit, pre- and post- 9,167 2 0.25 4,584
                 intervention 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-intervention for LTC
                 cohort, 300 facilities total)..................
                ----------------------------------------------------------------------------------------------------------------
                 Infrastructure Assessment
                ----------------------------------------------------------------------------------------------------------------
                Gap Analysis (1 assessment per unit or facility, 467 2 1 934
                 pre and post-intervention 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 intervention 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 intervention
                 period for LTC cohort, 300 facilities total)...
                ----------------------------------------------------------------------------------------------------------------
                 Electronic Health Record (EHR) Extracts
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                Initial datapull--(once at baseline for ICU and 267 1 9 2,403
                 non-ICU cohorts, 800 units total)..............
                Initial datapull--(once at baseline for Surgical 100 1 0.5 50
                 cohort, 300 settings total)....................
                Initial datapull--(once at baseline for LTC 100 1 5 500
                 cohort, 300 facilities total)..................
                Quarterly data--(quarterly during 18 months of 367 6 0.5 1,101
                 intervention for ICU, non-ICU, and Surgical
                 cohorts, 1,100 units total)....................
                Monthly data--(monthly per facility during 18 100 18 0.5 900
                 months of intervention for LTC cohort, 300
                 facilities total)..............................
                 ---------------------------------------------------------------
                 Total....................................... 13,535 .............. .............. 13,151
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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 $596,597.83.
                 Exhibit 2--Estimated Annualized Cost Burden
                ----------------------------------------------------------------------------------------------------------------
                 Average
                 Form name Number of Total burden hourly wage Total cost
                 respondents hours rate burden
                ----------------------------------------------------------------------------------------------------------------
                 Survey of Patient Safety Culture
                ----------------------------------------------------------------------------------------------------------------
                HSOPS (Attachment N) (25 respondents per unit, 9,167 4,584 * $51.53 $236,187.76
                 pre- and post-intervention for ICU (400), non-
                 ICU (400), and surgical (300) cohorts, 1,100
                 units total)...................................
                NHSOPS (Attachment O) (25 respondents per 2,500 1,250 * 51.53 64,412.50
                 facility, one response per pre- and post-
                 intervention for LTC cohort, 300 facilities
                 total).........................................
                ----------------------------------------------------------------------------------------------------------------
                 Infrastructure Assessment
                ----------------------------------------------------------------------------------------------------------------
                Gap Analysis (Attachments B-D) (1 assessment per 467 934 * 51.53 48,129.02
                 unit or facility, pre and post-intervention for
                 all four cohorts, 1,400 sites total)...........
                ----------------------------------------------------------------------------------------------------------------
                 Implementation Assessments
                ----------------------------------------------------------------------------------------------------------------
                Team Checkup Tool (Attachments H and I) (1 367 1,123 * 51.53 57,868.19
                 checklist conducted monthly during 3 months of
                 ramp-up and 15 months of intervention periods
                 for ICU, non-ICU, and Surgical cohorts, 1,100
                 units total)...................................
                [[Page 23369]]
                
                Team Checkup Tool (Attachment J) (1 checklist 100 306 * 51.53 15,768.18
                 conducted monthly per facility during 18 months
                 of intervention for LTC cohort, 300 facilities
                 total).........................................
                ----------------------------------------------------------------------------------------------------------------
                 Electronic Health Record (EHR) Extracts
                ----------------------------------------------------------------------------------------------------------------
                Initial data pull (Attachment P)--(once at 267 2,403 _ 35.17 84,513.51
                 baseline for ICU and non-ICU cohorts, 800 units
                 total).........................................
                Initial data pull (Attachment Q)--(once at 100 50 _ 35.17 1,758.50
                 baseline for Surgical cohort, 300 settings
                 total).........................................
                Initial data pull (Attachment R)--(once at 100 500 _ 35.17 17,585.00
                 baseline for LTC cohort, 300 facilities total).
                Quarterly data (Attachments P and Q)--(quarterly 367 1,101 _ 35.17 38,722.17
                 during 18 months of intervention for ICU, non-
                 ICU, and Surgical cohorts, 1,100 units total)..
                Monthly data (Attachment R)--(monthly per 100 900 _ 35.17 31,653.00
                 facility during 18 months of intervention for
                 LTC cohort, 100 facilities total)..............
                 ---------------------------------------------------------------
                 Total....................................... 13,535 13,151 .............. 596,597.83
                ----------------------------------------------------------------------------------------------------------------
                * 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).
                - 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: April 27, 2021.
                Marquita Cullom,
                Associate Director.
                [FR Doc. 2021-09138 Filed 4-30-21; 8:45 am]
                BILLING CODE 4160-90-P