The AHRQ Safety Program for Improving Antibiotic Use

Forms and Documents

Document Name	Status
Form 4 - b Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners Form and Instruction	New
Form 4 - I Semi-structured qualitative interviews (Cohort 1): Physicians Form and Instruction	New
Form 3d 3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4) Form and Instruction	New
Form 3c 3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3) Form and Instruction	New
Form 3b The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2) Form and Instruction	New
Form 3a AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1) Form and Instruction	New
Form D Team Antibiotic Review Form (Cohorts 1, 2, and 3) Form and Instruction	New
Form b1. Structural Ass Structural Assessments – Cohort 4 (baseline) Form and Instruction	New
Form a1 Structural Asse Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention) Form and Instruction	New
Supporting Statement Part A Clean (2).doc Supporting Statement A	2017-07-28
Supporting Statement Part B AHRQ Clean.docx Supporting Statement B	2017-07-27
Att P draft evaluation schedule.docx Supplementary Document	2017-07-27
Att O TEP members.docx Supplementary Document	2017-07-27
Att M AHRQ Safety Program for Improving Antibiotic Use FAQ and data collection timeline.docx Supplementary Document	2017-07-27

IC Document Collections

IC ID	Document Title	Status
227723	EHR data (Cohorts 1, 2, and 3) Instruction	New
227722	Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners Form and Instruction	New
227718	Semi-structured qualitative interviews (Cohort 1): Physicians Form and Instruction	New
227706	3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4) Form and Instruction	New
227705	3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3) Form and Instruction	New
227704	The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2) Form and Instruction	New
227703	AHRQ Patient Safety Culture Surveys:HSOPS, NHSOPS, MOSOPS (Cohort 1) Form and Instruction	New
227702	Team Antibiotic Review Form (Cohorts 1, 2, and 3) Form and Instruction	New
227701	Structural Assessments – Cohort 4 (baseline) Form and Instruction	New
227697	Structural Assessments – Cohorts 1, 2 and 3 (baseline, post-intervention) Form and Instruction	New

ICR Details

OMB Control No: 0935-0238	ICR Reference No: 201707-0935-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: The AHRQ Safety Program for Improving Antibiotic Use
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: 09/25/2017
	Date Received in OIRA: 07/28/2017
Terms of Clearance:

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

---

Abstract: 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

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 21233	05/05/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 34952	07/27/2017
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
Structural Assessments – Cohort 4 (baseline)	b1. Structural Assessments – Cohort 4 (baseline)	Attachment B Structural Assessment for Ambulatory Care Setting
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)
The AHRQ Safety Program for Improving Antibiotic Use b. HSOPS (Cohort 2)	3b	Attachment F: The Hospital Survey on Patient Safety Culture (HSOPS)
EHR data (Cohorts 1, 2, and 3)
Semi-structured qualitative interviews (Cohort 1): Other Health Practitioners	4 - b	Attachment J: Draft Interview Guide for Semi-Structured Interviews – Frontline workers
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
Semi-structured qualitative interviews (Cohort 1): Physicians	4 - I	Attachment I: Draft Interview Guide for Semi-Structured Interviews – Antibiotic
3. AHRQ Patient Safety Culture Surveys:d. MOSOPS (Cohort 4)	3d	Attachment H: The Medical Office Survey on Patient Safety Culture (MOSOPS)
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
3. AHRQ Patient Safety Culture Surveys:c. NHSOPS (Cohort 3)	3c	Attachment G: The Nursing Home Survey on Patient Safety Culture (NHSOPS)

---

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	56,372	0	0	56,372	0	0
Annual Time Burden (Hours)	22,442	0	0	22,442	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.

---

Annual Cost to Federal Government: $1,983,765

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

---

Common Form ICR:  No

---

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: 07/28/2017

---