National Hospital Adverse Event Reporting System: Questionnaire Redesign and Testing

Forms and Documents

Document Name	Status
Form Form #2 Cognitive interviews Form and Instruction	New
Form Form #1 Semi-structured interviews Form and Instruction	New
Supporting Statement Part B -- National Study of the Hospital AERS 3-26-2010.doc Supporting Statement B	2010-07-08
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2010-07-08
Attachment D -- Federal Register Notice.pdf Supplementary Document	2010-07-08
Supporting Statement Part A -- National Study of the Hospital AERS 3-29-2010.doc Supporting Statement A	2010-07-08

IC Document Collections

IC ID	Document Title	Status
193932	Cognitive interviews Form and Instruction	New
193931	Semi-structured interviews Form and Instruction	New

ICR Details

OMB Control No: 0935-0169	ICR Reference No: 201007-0935-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: National Hospital Adverse Event Reporting System: Questionnaire Redesign and Testing
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: 10/04/2010
	Date Received in OIRA: 07/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	12 Months From Approved
Responses	39	0	0
Time Burden (Hours)	39	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: As provider of operational support to the chair of the Quality Interagency Task Force (QuIC), AHRQ coordinated the Federal response to the Institute of Medicine's (IOM) 1999 report on medical errors and outlined specific initiatives the QuIC agencies will take. The Errors Workgroup within the QuIC identified the need for measures to evaluate the use of adverse medical event reporting for managing and improving patient safety within healthcare institutions. In response, AHRQ created the Hospital Adverse Event Reporting Survey to provide national estimates. This survey has been fielded twice, first in 2005 and again in 2008. Revisions to the questionnaire and sample selection are now necessary in response to the Patient Safety and Quality Improvement Rule (Patient Safety Rule), 42 CFR Part 3, issued by the United States Department of Health and Human Services, which implements the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), 42 U.S.C. 299b-21 through 299b-26. The Patient Safety Rule and Patient Safety Act authorize the creation of Patient Safety Organizations (PSO) to enhance quality and safety by collecting patient safety reports of adverse events. AHRQ started listing PSOs in late 2008 pursuant to the Patient Safety Act. These organizations have begun working with hospitals and other providers to monitor patient safety events according to common reporting formats, and to improve patient safety. This revised survey will be used for the third round of data collection in 2011, under a separate OMB clearance, to assess the impact of the PSOs and the Patient Safety Act on the use of adverse event reporting systems and will incorporate questions about reporting using the AHRQ Common Formats, and reporting information to a Patient Safety Organization.

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Authorizing Statute(s): US Code: 41 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:
	75 FR 32371	05/03/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 38102	07/01/2010
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Semi-structured interviews	Form #1	Semi-structured interview guide
Cognitive interviews	Form #2	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	39	0	0	39	0	0
Annual Time Burden (Hours)	39	0	0	39	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: $120,000

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]? 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

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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: 07/26/2010

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