Pilot Test of the Proposed Hospital Survey on Patient Safety Culture Version 2.0

Forms and Documents

Document Name	Status
Form 3 Pilot test and bridge study Form and Instruction	New
Form 2 – Draft Health IT Patient Safety Supplemental Item Set Cognitive Interview Guide Form and Instruction	New
Form 1 Attachment C – Draft HSOPS 2.0 Cognitive Interview Guide Form and Instruction	New
Supporting Statement Part A -- Pilot Test of HSOPS 2 0 -- 9-2-15.docx Supporting Statement A	2015-09-02
ENA Reply.docx Supplementary Document	2015-09-02
Attachment H - TEP Members_3-20-15.docx Supplementary Document	2015-08-28
Supporting Statement Part B -- Pilot Test of HSOPS 2 0 -- 3-20-15.docx Supporting Statement B	2015-08-28

IC Document Collections

IC ID	Document Title	Status
218086	Pilot test and bridge study Form and Instruction	New
218049	– Draft Health IT Patient Safety Supplemental Item Set Cognitive Interview Guide Form and Instruction	New
218047	Attachment C – Draft HSOPS 2.0 Cognitive Interview Guide Form and Instruction	New

ICR Details

OMB Control No: 0935-0230	ICR Reference No: 201508-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Pilot Test of the Proposed Hospital Survey on Patient Safety Culture Version 2.0
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: 01/21/2016
	Date Received in OIRA: 09/03/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved
Responses	9,260	0	0
Time Burden (Hours)	2,387	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In 2004, AHRQ developed and published a measurement tool to assess the culture of patient safety in hospitals (OMB control no. 0935-0115). The Hospital Survey on Patient Safety Culture (HSOPS) is a survey of providers and staff that can be implemented by hospitals to identify strengths and areas for patient safety culture improvement as well as raise awareness about patient safety. When conducted routinely, the survey can be used to examine trends in patient safety culture over time and evaluate the cultural impact of patient safety initiatives and interventions. The data can also be used to make comparisons across hospital units. AHRQ also produced a survey user's guide to assist hospitals in conducting the survey successfully. The guide addresses issues such as which providers and staff should complete the survey, how to select a sample of hospital providers and staff, how to administer the questionnaire, and how to analyze and report on the resulting data. Since 2004, thousands of hospitals within the U.S. and internationally have implemented the survey. In response to requests for comparative data from other hospitals, AHRQ funded the development of a comparative database on the survey in 2006 (OMB control no. 0935-0162). The database is currently compiled every two years, using the latest data provided by participating hospitals (and retaining submitted data for no more than 2 years). Reports describing the findings from analysis of the database are made available on the AHRQ website to assist hospitals in comparing their results. The 2014 database contains data from 405,281 hospital provider and staff respondents within 653 participating hospitals. The 2014 User Comparative Database Report presents results by hospital characteristics (e.g., number of beds, teaching status, geographic location) and respondent characteristics (e.g., position type, work area/unit). The survey constructed in 2004 remains in use today, more than10 years after its initial launch. Since the launch of HSOPS, AHRQ has funded development of patient safety culture surveys for other settings. In 2008, surveys were published for outpatient medical offices (OMB control no. 0935-0131) and nursing homes (OMB control no. 0935-0132). In 2012, a survey for community pharmacies (OMB control no. 0935-0183) was released. Surveys for each setting built upon the strengths of HSOPS but improved and updated items where appropriate. Users of HSOPS have provided feedback over the years suggesting that changes to the instrument would be valuable and welcomed. The comparative database registrants provided feedback about potential changes in 2013, and telephone interviews were conducted with 8 current survey users and vendors to gain an in-depth understanding of their thoughts on the current survey and possible changes. As a result of this feedback, the Hospital Survey on Patient Safety Culture Version 2.0 (HSOPS 2.0) is being constructed with the following 8 objectives in mind.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research 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:
	80 FR 26258	05/07/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 50005	08/18/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Attachment C – Draft HSOPS 2.0 Cognitive Interview Guide	1	Draft HSOPS 2.0 Cognitive Interview Guide
Pilot test and bridge study	3, 4	Crosswalk Between the Original AHRQ Hospital Survey on Patient Safety Culture and Draft Version 2.0 ,   Draft Health IT Patient Safety
– Draft Health IT Patient Safety Supplemental Item Set Cognitive Interview Guide	2	– Draft Health IT Patient Safety Supplemental Item Set Cognitive Interview Guide

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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	9,260	0	0	9,260	0	0
Annual Time Burden (Hours)	2,387	0	0	2,387	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 activity.

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Annual Cost to Federal Government: $192,667

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

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]? 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: 09/03/2015

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