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

Forms and Documents

Document Name	Status
Form Form #4 Hospital Information Form Form and Instruction	New
Form Form #3 Patient Safety Improvement Initiatives Form Form and Instruction	New
Form Form #2 Data Use Agreement Form and Instruction	New
Form Form #1 Eligibility/Registration Form and Data Submission Form and Instruction	New
Supporting Statement Part B -- HSOPS Comparative Database 4-27-10.doc Supporting Statement B	2010-04-30
Attachment A-3 -- Parts II III 2009 HSOPS Database Report.pdf Supplementary Document	2009-11-06
Attach B-4 Report on Feedback From Database Users.pdf Supplementary Document	2010-04-30
Attach B-3. HSOPS_Data_File_Specs.doc Supplementary Document	2010-04-30
Attachment B-2 -- Screen Shots Hospital SOPS Forms 8-5-09 .doc Supplementary Document	2010-04-30
Attach B-1. Emails - Hospital SOPS Data Submission.doc Supplementary Document	2010-04-30
Attachment A-6 -- TEP lists.doc Supplementary Document	2009-11-06
Attachment A-5 -- 30 Day Federal Register Notice.pdf Supplementary Document	2009-11-06
Attachment A-4 -- Indiv Trending Hospital Feedback Report.pdf Supplementary Document	2009-11-06
Attachment A-2 -- Part I 2009 HSOPS Database Report.pdf Supplementary Document	2009-11-06
Attachment A-11 -- Public Comments and AHRQs Response.doc Supplementary Document	2009-11-06
Supporting Statement Part A -- HSOPS Comparative Database 4-27-10 (2).doc Supporting Statement A	2010-04-30

IC Document Collections

IC ID	Document Title	Status
191670	Hospital Information Form Form and Instruction	New
191669	Patient Safety Improvement Initiatives Form Form and Instruction	New
191668	Data Use Agreement Form and Instruction	New
191667	Eligibility/Registration Form and Data Submission Form and Instruction	New

ICR Details

OMB Control No: 0935-0162	ICR Reference No: 200912-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Collection of Information for AHRQ's Hospital Survey on Patient Safety Culture Comparative Database
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 with change	Conclusion Date: 05/04/2010
	Date Received in OIRA: 12/27/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2013	36 Months From Approved
Responses	1,625	0	0
Time Burden (Hours)	1,507	0	0
Cost Burden (Dollars)	0	0	0

---

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.

---

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:
	74 FR 45455	09/02/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 57493	11/06/2009
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Eligibility/Registration Form and Data Submission	Form #1	Eligibility and Registration Form
Data Use Agreement	Form #2	Data Use Agreement
Patient Safety Improvement Initiatives Form	Form #3	Patient Safety Improvement Initiatives Form
Hospital Information Form	Form #4	Hospital Information Form

---

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	1,625	0	0	1,625	0	0
Annual Time Burden (Hours)	1,507	0	0	1,507	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 information collection request.

---

Annual Cost to Federal Government: $250,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 12/27/2009

---