The AHRQ Safety Program for Improving Antibiotic Use

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Attachment M Attachment M: Monthly template for ambulatory care EHR data extracts (updated)	Form and Instruction	New	Available
Form 4 - b Attachment J: Draft Interview Guide for Semi-Structured Interviews – Frontline workers	Form and Instruction	Modified	Available
Form 4 - I Attachment I: Draft Interview Guide for Semi-Structured Interviews – Antibiotic	Form and Instruction	Modified	Available
Form 3d Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)	Form and Instruction	Modified	Available
Form 3c Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)	Form and Instruction	Modified	Available
Form 3b Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)	Form and Instruction	Modified	Available
Form 3a3 Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)	Form and Instruction	Modified	Available
Form 3a2 Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)	Form and Instruction	Modified	Available
Form 3a Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)	Form and Instruction	Modified	Available
Form E Attachment E: Completion Guide for Team Antibiotic Review Form	Form and Instruction	Modified	Available
Form D Attachment D: Team Antibiotic Review Form	Form and Instruction	Modified	Available
Form b1. Structural Ass Attachment B Structural Assessment for Ambulatory Care Setting	Form and Instruction	Modified	Available
Form a3 Structural Asse Attachment C: Structural Assessment for Long Term Care Setting	Form and Instruction	Modified	Available
Form a2 Structural Asse a2 Structural Assessments – Cohorts 1, 2 and 3	Form and Instruction	Modified	Available
Form a1 Structural Asse Attachment A: Structural Assessment for Acute Care Setting	Form and Instruction	Modified	Available
Attachment Q Ambulatory TEP Members.docx	Supplementary Document	Uploaded 2019-06-07	Available
Supporting Statement Part A AHRQ Revision 03.15.19.clean.docx	Supporting Statement A	Uploaded 2019-06-26	Available
Supporting Statement Part B AHRQ Clean.docx	Supporting Statement B	Uploaded 2017-07-27	Available
Att P draft evaluation schedule.docx	Supplementary Document	Uploaded 2017-07-27	Available
Att M AHRQ Safety Program for Improving Antibiotic Use FAQ and data collection timeline.docx	Supplementary Document	Uploaded 2017-07-27	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
236387	Monthly template for ambulatory care EHR data extracts (updated	Form and Instruction	New	Attachment M: Monthly template for ambulatory care EHR data extracts (updated)
227723	EHR data (Cohorts 1, 2, and 3)	Instruction	Modified
227722	Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners	Form and Instruction	Modified	Attachment J: Draft Interview Guide for Semi-Structured Interviews – Frontline workers
227718	Semi-structured qualitative interviews (Cohort 1): Physicians	Form and Instruction	Modified	Attachment I: Draft Interview Guide for Semi-Structured Interviews – Antibiotic
227706	3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4)	Form and Instruction	Modified	Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
227705	3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3)	Form and Instruction	Modified	Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)
227704	The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2)	Form and Instruction	Modified	Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)
227703	AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1)	Form and Instruction	Modified	Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
227703	AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1)	Form and Instruction	Modified	Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)
227703	AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1)	Form and Instruction	Modified	Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)
227702	Team Antibiotic Review Form (Cohorts 1, 2, and 3)	Form and Instruction	Modified	Attachment E: Completion Guide for Team Antibiotic Review Form
227702	Team Antibiotic Review Form (Cohorts 1, 2, and 3)	Form and Instruction	Modified	Attachment D: Team Antibiotic Review Form
227701	Structural Assessments – Cohort 4 (baseline)	Form and Instruction	Modified	Attachment B Structural Assessment for Ambulatory Care Setting
227697	Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention)	Form and Instruction	Modified	Attachment C: Structural Assessment for Long Term Care Setting
227697	Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention)	Form and Instruction	Modified	a2 Structural Assessments – Cohorts 1, 2 and 3
227697	Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention)	Form and Instruction	Modified	Attachment A: Structural Assessment for Acute Care Setting

ICR Details

OMB Control No: 0935-0238	ICR Reference No: 201906-0935-002
Status: Historical Active	Previous ICR Reference No: 201707-0935-003
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: The AHRQ Safety Program for Improving Antibiotic Use
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/30/2019
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/26/2019
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	09/30/2020
Responses	63,211	0	56,372
Time Burden (Hours)	27,064	0	22,442
Cost Burden (Dollars)	0	0	0

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Abstract: The Agency for Healthcare Research and Quality (AHRQ) requests to revise and extend the currently approved AHRQ Safety Program for Improving Antibiotic Use. The AHRQ Safety Program for Improving Antibiotic Use aims to help facilities implement antibiotic stewardship programs and to reduce unnecessary antibiotic prescribing. The Safety Program has already been implemented in a pilot of integrated delivery systems and a national cohort of 400 acute care hospitals, and is currently being implemented in a national cohort of 500 long-term care facilities. The AHRQ Safety Program for Improving Antibiotic Use was last approved by OMB on September 25, 2017 and will expire on September 30, 2020. The request for extension is to allow for completion of activities and data collection in the AHRQ Safety Program, which are scheduled to occur through March 30, 2021. The OMB control number for the AHRQ Safety Program for Improving Antibiotic Use is 0935-0238. All of the supporting documents for the current AHRQ Safety Program for Improving Antibiotic Use can be downloaded from OMB’s website at https://omb.report/icr/201707-0935-003 The 2017 AHRQ Safety Program for Improving Antibiotic Use OMB clearance included one response for the Structural Assessment and the Medical Office Survey on Patient Safety Culture (MOSOPS) but did not include electronic health record (EHR) data or a second response for the Structural Assessment or MOSOPS. This was because our OMB clearance expiration date fell in the middle of the planned 4th cohort, set in ambulatory care settings, so the second Structural Assessment and MOSOPS were not within the timeframe, and EHR data collection would have been incomplete. In addition, we were not certain that the ambulatory care practices would be able to access EHR data, however based on the experience of the pilot cohort, we believe that many ambulatory practices can access this data, and that these practices are more likely to feasibly participate in the AHRQ Safety Program. The revision also updates the estimated annual burden accordingly, and includes changes to the data collection forms which will be used for the ambulatory care cohort based on lessons learned during the pilot cohort. Antibiotics can have serious adverse effects including Clostridium difficile infections (CDI), organ dysfunction, allergic reactions, and the development of antibiotic resistance on both a patient level and population level. This project will assist acute care, long-term care and ambulatory care settings across the United States in adopting and implementing antibiotic stewardship programs, which are coordinated efforts to improve the use of antibiotics by promoting the selection of the optimal antibiotic regimen, dose, route of administration, and duration of therapy. More specifically, this project has the following goals: • Identify best practices in the delivery of antibiotic stewardship in the acute care, long-term care and ambulatory care settings • Adapt the Comprehensive Unit-Based Safety Program (CUSP) model to enhance antibiotic stewardship efforts in the health care settings • Assess the adoption of CUSP for antibiotic stewardship and evaluate the effectiveness of the intervention in the participating health care systems • Develop a bundle of technical and adaptive interventions and associated tools and educational materials designed to support enhanced antibiotic stewardship efforts • Provide technical assistance and training to health care organizations nationwide, using a phased approach, to implement effective antibiotic stewardship programs and interventions • Improve communication and teamwork between health care workers surrounding antibiotic decision-making • Improve communication between health care workers and patients/families surrounding antibiotic decision-making

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 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:
	84 FR 12251	04/01/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 27123	06/11/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 11

table that charts list of burden

IC Title	Form No.	Form Name
3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3)	3c	Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)
3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4)	3d	Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1)	3a2, 3a3, 3a	Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS) ,   Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS) ,   Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
EHR data (Cohorts 1, 2, and 3)
Monthly template for ambulatory care EHR data extracts (updated	Attachment M	Attachment M: Monthly template for ambulatory care EHR data extracts (updated)
Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners	4 - b	Attachment J: Draft Interview Guide for Semi-Structured Interviews – Frontline workers
Semi-structured qualitative interviews (Cohort 1): Physicians	4 - I	Attachment I: Draft Interview Guide for Semi-Structured Interviews – Antibiotic
Structural Assessments – Cohort 4 (baseline)	b1. Structural Assessments – Cohort 4 (baseline)	Attachment B Structural Assessment for Ambulatory Care Setting
Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention)	a1 Structural Assessments – Cohorts 1, 2 and 3, a3 Structural Assessments – Cohorts 1, 2 and 3 , a2 Structural Assessments – Cohorts 1, 2 and 3	Attachment A: Structural Assessment for Acute Care Setting ,   a2 Structural Assessments – Cohorts 1, 2 and 3 ,   Attachment C: Structural Assessment for Long Term Care Setting
Team Antibiotic Review Form (Cohorts 1, 2, and 3)	E, D	Attachment D: Team Antibiotic Review Form ,   Attachment E: Completion Guide for Team Antibiotic Review Form
The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2)	3b	Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)

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ICR Summary of Burden

table that charts list 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	63,211	56,372	0	6,839	0	0
Annual Time Burden (Hours)	27,064	22,442	0	4,622	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 revision to the current clearance adds the monthly HER data collection and endline data collection activities for the ambulatory care cohort, which are scheduled to begin in December 2019 and end in January 2021. The estimated annual burden has been adjusted accordingly.

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Annual Cost to Federal Government: $1,887,609

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: 06/26/2019

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