Collection of Information for AHRQ's Hospital Survey on Patient Safety Culture Comparative Database

Forms and Documents

Document Name	Status
Form Attachment D Data Files Submission Form and Instruction	New
Form Form # 3 Hospital Information Form Form and Instruction	Modified
Form Form # 2 Data Use Agreement Form and Instruction	Modified
Form Form # 1 Eligibility/Registration Form and Data Submission Form and Instruction	Modified
Attachment G - Example Screenshots of Hospital SOPS Data Submission Web Site.docx Supplementary Document	2019-06-07
Attachment F - SOPS Databases TEP List.doc Supplementary Document	2019-06-07
Attachment E - Hospital Survey Data File Specifications.pdf Supplementary Document	2019-06-07
Supporting Statement Part B -- HSOPS DB Renewal_1-11-2019.docx Supporting Statement B	2019-06-24
Supporting Statement Part A -- HSOPS DB Renewal_1-11-2019.docx Supporting Statement A	2019-06-26

IC Document Collections

IC ID	Document Title	Status
236390	Data Files Submission Form and Instruction	New
191670	Hospital Information Form Form and Instruction	Modified
191668	Data Use Agreement Form and Instruction	Modified
191667	Eligibility/Registration Form and Data Submission Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0162	ICR Reference No: 201906-0935-003
Status: Active	Previous ICR Reference No: 201606-0935-003
Agency/Subagency: HHS/AHRQ	Agency Tracking No: 20206
Title: Collection of Information for AHRQ's Hospital Survey on Patient Safety Culture Comparative Database
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/21/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	10/31/2019
Responses	2,040	0	1,520
Time Burden (Hours)	459	0	410
Cost Burden (Dollars)	0	0	0

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Abstract: Background on the Hospital SOPS: In 1999, the Institute of Medicine called for health care organizations to develop a "culture of safety" such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Hospital Survey on Patient Safety Culture with OMB approval (OMB NO. 0935-0115; Approved 2/4/2003). The survey was designed to enable hospitals to assess staff opinions about patient safety issues, medical error, and error reporting and includes 42 items that measure 12 dimensions of patient safety culture. AHRQ released the survey in the public domain along with a Survey User's Guide and other toolkit materials in November 2004 on the AHRQ web site. Since its release, the survey has been voluntarily used by hundreds of hospitals in the U.S. Rationale for the information collection: The Hospital SOPS survey and the Hospital SOPS Comparative Database are supported by AHRQ to meet its goals of promoting improvements in the quality and safety of health care in hospital settings. The surveys, toolkit materials, and comparative database results are all made available in the public domain along with technical assistance, provided by AHRQ through its contractor at no charge to hospitals, to facilitate the use of these materials for hospital patient safety and quality improvement.

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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 10077	03/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 27121	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: 4

IC Title	Form No.	Form Name
Eligibility/Registration Form and Data Submission	Form # 1	Attachment A: Hospital Eligibility and Registration Form
Data Use Agreement	Form # 2	Attachment B: Hospital Data Use Agreement
Hospital Information Form	Form # 3	Attachment C: Hospital Site Information Form
Data Files Submission	Attachment D	Data Files Submission

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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	2,040	1,520	0	520	0	0
Annual Time Burden (Hours)	459	410	0	49	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The estimated hour burden for each respondent participating in the Hospital SOPS database remains the same from the previous information collection request (ICR). However, due to increasing popularity with submission to the database, we are anticipating more respondents potentially participating and thus, estimate a greater overall annualized burden.

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Annual Cost to Federal Government: $200,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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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