Pharmacy Survey on Patient Safety Culture Comparative Database

Forms and Documents

Document Name	Status
Form 3 Pharmacy SOPS Database Data Use Agreement Form and Instruction	New
Form 2 Pharmacy Background Characteristics Form Form and Instruction	New
Form 1 Pharmacy SOPS Registration Form Form and Instruction	New
Supporting Statement Part B -- Pharm SOPS Comparative Database for submission_sfs .doc Supporting Statement B	2014-04-01
Supporting Statement Part A -- Pharm SOPS Comparative Database FINAL.doc Supporting Statement A	2014-06-10
Attachment H - 30 Day Federal Register Notice.pdf Supplementary Document	2014-04-01
Attachment G - PharmSOPS_PilotResults.pdf Supplementary Document	2014-04-01
Attachment F - SOPS databases TEP list_10-23-13.doc Supplementary Document	2014-04-01
Attachment E - Pharmacy SOPS Survey Data File Specifications.docx Supplementary Document	2014-04-01

IC Document Collections

IC ID	Document Title	Status
211073	Data Submission Emails Instruction	New
211068	Pharmacy SOPS Database Data Use Agreement Form and Instruction	New
211067	Pharmacy Background Characteristics Form Form and Instruction	New
211034	Pharmacy SOPS Registration Form Form and Instruction	New

ICR Details

OMB Control No: 0935-0218	ICR Reference No: 201403-0935-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Pharmacy 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: 06/12/2014
	Date Received in OIRA: 04/02/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	36 Months From Approved
Responses	1,950	0	0
Time Burden (Hours)	296	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database consists of data from the AHRQ Pharmacy Survey on Patient Safety Culture. Pharmacies in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Pharmacy SOPS Database is modeled after three other SOPS databases: Hospital SOPS [OMB NO. 0935-0162; Approved 05/04/2010]; Medical Office SOPS [OMB NO. 0935-0196; Approved 06/12/12]; and Nursing Home SOPS [OMB NO. 0935-0195; Approved 06/12/12] that were originally developed by AHRQ in response to requests from hospitals, medical offices, and nursing homes interested in knowing how their patient safety culture survey results compare to those of other similar health care organizations. The goal of this project is to create the Pharmacy SOPS Comparative Database. This database will: 1) allow pharmacies to compare their patient safety culture survey results with those of other pharmacies, 2) provide data to pharmacies to facilitate internal assessment and learning in the patient safety improvement process, and 3) provide supplemental information to help pharmacies identify their strengths and areas with potential for improvement in patient safety culture.

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Authorizing Statute(s): US Code: 42 USC Sec.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:
	78 FR 73540	12/06/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 9209	02/18/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Pharmacy Background Characteristics Form	2	Pharmacy Background Characteristics Form
Data Submission Emails	4	Example Screen Shots of Pharmacy Survey on Patient Safety Culture Data Submission Web Site Information Collection
Pharmacy SOPS Database Data Use Agreement	3	Pharmacy SOPS Database Data Use Agreement
Pharmacy SOPS Registration Form	1	Pharmacy SOPS Registration Form

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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	1,950	0	0	1,950	0	0
Annual Time Burden (Hours)	296	0	0	296	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: The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database consists of data from the AHRQ Pharmacy Survey on Patient Safety Culture. Pharmacies in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Pharmacy SOPS Database is modeled after three other SOPS databases: Hospital SOPS [OMB NO. 0935-0162; Approved 05/04/2010]; Medical Office SOPS [OMB NO. 0935-0196; Approved 06/12/12]; and Nursing Home SOPS [OMB NO. 0935-0195; Approved 06/12/12] that were originally developed by AHRQ in response to requests from hospitals, medical offices, and nursing homes interested in knowing how their patient safety culture survey results compare to those of other similar health care organizations.

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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

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: 04/02/2014

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