Ambulatory Surgery Center Survey on Patient Safety Culture Database

Forms and Documents

Document Name	Status
Form 4 Data Files Submission Form and Instruction	Modified
Form 3 ASC Site Information Form Form and Instruction	Modified
Form 2 Data Use Agreement Form and Instruction	Modified
Form 1 Eligibility and Registration Form Form and Instruction	Modified
Attachment G - Example Screenshots of SOPS ASC Data Submission Website.docx Supplementary Document	2021-09-02
Attachment F - SOPS Databases TEP List.docx Supplementary Document	2021-09-02
Attachment D - ASC Data Submission Emails.docx Supplementary Document	2021-09-02
Supporting Statement Part A -- ASC SOPS_Renewal 3-1-21 EC.docx Supporting Statement A	2021-09-07
Supporting Statement Part B -- ASC SOPS_Renewal 3-1-21.docx Supporting Statement B	2021-09-02

IC Document Collections

IC ID	Document Title	Status
232084	Data Files Submission Form and Instruction	Modified
232083	ASC Site Information Form Form and Instruction	Modified
232082	Data Use Agreement Form and Instruction	Modified
232081	Eligibility and Registration Form Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0242	ICR Reference No: 202109-0935-001
Status: Received in OIRA	Previous ICR Reference No: 201807-0935-001
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Ambulatory Surgery Center Survey on Patient Safety Culture Database
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/08/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2021
Responses	400	400
Time Burden (Hours)	121	121
Cost Burden (Dollars)	0	0

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Abstract: Background on the Ambulatory Surgery Center Survey on Patient Safety Culture (ASC SOPS): The survey is designed to enable ASCs to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 27 items that measure 8 composites of patient safety culture. In addition to the composite items, the survey includes one item measuring how often ASCs document near-misses; one item asking whether the respondent is in the room during surgeries, procedures, or treatments; and three items about communication before and after surgeries, procedures, or treatments. The survey also includes an overall rating item on patient safety, two items about respondent characteristics, and a section for open-ended comments. AHRQ made the survey publicly available along with a Survey User’s Guide and other toolkit materials in May 2015 on the AHRQ website. The AHRQ ASC SOPS Database consists of data from the AHRQ ASC Survey on Patient Safety Culture. Ambulatory surgery centers in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The ASC SOPS Database (OMB NO. 0935-0242; Approved September 10, 2018) was developed by AHRQ in 2019 in response to requests from ASCs interested in tracking their own survey results. Organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other ASCs submitting data. These reports are used to assist ASC staff in their efforts to improve patient safety culture in their organizations. Rationale for the information collection. The ASC SOPS and the ASC SOPS Database support AHRQ’s goals of promoting improvements in the quality and safety of health care in ASCs. The survey, toolkit materials, and database results are all made publicly available on AHRQ’s website. Technical assistance is provided by AHRQ through its contractor at no charge to ASCs, to facilitate the use of these materials for ASC patient safety and quality improvement. Rationale for information collection approval. The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) reapprove, under the Paperwork Reduction Act of 1995, AHRQ’s collection of information for the AHRQ ASC SOPS Database; OMB NO. 0935-0242; Approved September 10, 2018. This database will: 1. Present results from ASCs that voluntarily submit their data; 2. Provide data to ASCs to facilitate internal assessment and learning in the patient safety improvement process; and 3. Provide supplemental information to help ASCs identify their strengths and areas with potential for improvement in patient safety culture.

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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:
	86 FR 28111	05/25/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 48703	08/31/2021
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
ASC Site Information Form	3	ASC Site Information Form
Data Files Submission	4	Data Files Submission
Data Use Agreement	2	Data Use Agreement
Eligibility and Registration Form	1	Eligibility and Registration Form

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ICR Summary of Burden

	Total Request	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	400	400	0	0	0	0
Annual Time Burden (Hours)	121	121	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $200,000

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? No

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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: 09/08/2021

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