A PROTOTYPE CONSUMER REPORTING SYSTEM FOR PATIENT SAFETY EVENTS

Forms and Documents

Document	Type	Status	Availability
Form Form #4 Health care provider follow up	Form and Instruction	New	Available
Form Form #1 Safety event intake form and follow up	Form and Instruction	New	Available
SA Part B -- A Prototype Consumer Reporting Sys for PS Events_3-20-2013.docx	Supporting Statement B	Uploaded 2013-06-06	Available
Attachment J -- Illustrative example of no-retaliation policy.pdf	Supplementary Document	Uploaded 2013-06-06	Available
Attachment H -- Revisions and Responses to FRN Comments.docx	Supplementary Document	Uploaded 2013-06-06	Available
Attachment I -- Public Comments.pdf	Supplementary Document	Uploaded 2013-06-06	Available
Attachment L -- Federal Register Notice.pdf	Supplementary Document	Uploaded 2013-06-06	Available
Attachment K -- Example of process and policy for no-blame policy for providers.pdf	Supplementary Document	Uploaded 2013-06-06	Available
Attachment F -- Marketing Flyer.pdf	Supplementary Document	Uploaded 2013-06-06	Available
Attachment C -- FAQs List.docx	Supplementary Document	Uploaded 2013-06-06	Available
Attachment A -- Introductory Pages of Website.docx	Supplementary Document	Uploaded 2013-06-06	Available
SS Part A -- A Prototype Consumer Reporting Sys for PS Events 6-6-2013.docx	Supporting Statement A	Uploaded 2013-06-06	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
207256	Health care provider follow up	Form and Instruction	New
207255	Safety event intake form and follow up	Form and Instruction	New

ICR Details

OMB Control No: 0935-0214	ICR Reference No: 201306-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No: 19751
Title: A PROTOTYPE CONSUMER REPORTING SYSTEM FOR PATIENT SAFETY EVENTS
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: 08/23/2013
	Date Received in OIRA: 06/10/2013
Terms of Clearance: The agency made significant adustments to the concerns raised in public comment.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	18 Months From Approved
Responses	924	0	0
Time Burden (Hours)	518	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for a Prototype Consumer Reporting System for Patient Safety Events. This project aims to design and evaluate a prototype system that can collect voluntary reports from patients about health care safety using standard definitions and formats that would enable systematic analysis and identification of opportunities for safety 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:
	77 FR 55475	09/11/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 34101	06/06/2013
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Safety event intake form and follow up	Form #1, Form #2, Form #3	Intake reporting form - web version ,   Intake reporting form - phone version ,   Intake reporting form follow up
Health care provider follow up	Form #4	Health care provider follow-up 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	924	0	0	924	0	0
Annual Time Burden (Hours)	518	0	0	518	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.

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Annual Cost to Federal Government: $599,885

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: 06/10/2013

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