Expanding the Comprehensive Unit-based Safety Program (CUSP) to reduceCentral Line-Associated Blood Stream Infections (CLABSI) and Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Ca

Forms and Documents

Document Name	Status
Form 3 Site Visits Form and Instruction	New
Form 2 ICU Action Plan Form and Instruction	New
Form 1 Attachment A: ICU Assessment Form and Instruction	New
Supporting Statement Part B AHRQ CLABSI AND CAUTI ICU.doc Supporting Statement B	2018-02-07
Supporting Statement Part A AHRQ CLABSI AND CAUTI ICU.doc Supporting Statement A	2018-02-07
Attachment E.Draft Delivery Schedule.mam.docx Supplementary Document	2018-02-07

IC Document Collections

IC ID	Document Title	Status
229994	Site Visits Form and Instruction	New
229992	ICU Action Plan Form and Instruction	New
229990	Attachment A: ICU Assessment Form and Instruction	New

ICR Details

OMB Control No: 0935-0240	ICR Reference No: 201802-0935-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Expanding the Comprehensive Unit-based Safety Program (CUSP) to reduceCentral Line-Associated Blood Stream Infections (CLABSI) and Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Ca
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/17/2018
	Date Received in OIRA: 02/08/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2021	36 Months From Approved
Responses	400	0	0
Time Burden (Hours)	888	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: DHHS Action Plan to Prevent Healthcare-Associated Infections In January 2009, the Department of Health and Human Services (HHS) released the first iteration of the National Action Plan to Prevent Healthcare-Associated Infections (HAI NAP). The HAI NAP was developed by the HHS Office of Public Health and Science, AHRQ, Centers for Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Services (CMS), and other offices and operating divisions of HHS. As part of the Department of Health and Human Services (DHHS) National Action Plan (NAP) to Prevent Healthcare-Associated Infections (HAI), 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 is applying the principles and concepts that have been learned from these HAI reduction efforts to ICUs with persistently elevated infection rates. Results of Implementation of CUSP for CLABSI and CAUTI The nationwide CUSP for CLABSI project implemented CUSP with ICU teams at more than 1,100 adult ICUs in 44 states over a 4-year period. ICUs participating in this project reduced the rate of CLABSIs nationally from 1.915 infections per 1,000 central line days to 1.133 infections per 1,000 line days, an overall reduction of 41 percent. However, not all ICUs performed equally well. The CUSP for CAUTI project implemented CUSP in nine cohorts, representing over 1,600 hospital units in over 1,200 hospitals located across 40 states, the District of Columbia, and Puerto Rico. Inpatient CAUTI rates in non-ICUs were decreased by 30%. However, CAUTI rates in ICUs were not reduced significantly. In other words, while the overall results of the implementation of CUSP for CLABSI and CUSP for CAUTI have shown remarkable progress, not all ICUs in the projects have achieved the intended rate reductions, nor have all ICUs participated in the two projects. Moreover, a significant number of institutions and ICUs continue to have persistently elevated infection rates. There are institutions that have varying rates of infections within the same institution indicating that infection control is often a unit-based issue. In sum, despite the significant overall reductions in CLABSI and CAUTI rates that have been achieved in these two projects, there is evidence that ICUs have generally faced challenges in reducing CAUTI rates, and that many hospitals still are not where they should be in CLABSI rates. Modified approaches and strategies for the CUSP intervention need to be developed and implemented to reach ICUs with persistently elevated CLABSI and CAUTI rates and help them succeed in preventing these infections. To address this need, AHRQ will launch this project aimed at spreading nationally implementation of an adaptation of CUSP for CLABSI and CAUTI for ICUs with persistently elevated rates, optimizing the approach to maximize effectiveness, and further preventing these infections throughout the United States. This project has the following goals: • Reduce central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI) in ICUs with persistently elevated rates. • Revise and augment current CUSP training resources and materials for CUSP for CLABSI and CAUTI in ICUs with persistently elevated rates. The resulting toolkit will be intended for use in ICUs whose infection rates for either or both of these HAIs are persistently elevated compared to other ICUs. • Recruit 450-600 ICUs with persistently elevated rates nationally to demonstrate the utility of applying a modified CUSP for CLABSI and CUSP for CAUTI during the performance period to reduce rates of CLABSI and CAUTI in these ICUs. • Assess the adoption of the modified CUSP for CLABSI and CAUTI and evaluate the effectiveness of the intervention in the participating ICUs

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Agency for Healthcare Research and Quality Act 1999
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 35210	07/28/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 5262	02/06/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Attachment A: ICU Assessment	1	Attachment A ICU Assessment
ICU Action Plan	2	Attachment B ICU Action Planning Template
Site Visits	3	Attachment C ICU Site Visit

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	400	0	0	400	0	0
Annual Time Burden (Hours)	888	0	0	888	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $1,559,243

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/08/2018

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