National Study of the Hospital Adverse Event Reporting Survey

Forms and Documents

Document Name	Status
Form Form #1 Adverse Event Reporting Follow-up Survey Form and Instruction	Modified
Dec 11 2008 memo.doc Supplementary Document	2009-01-05
AERS_ResponseByStrata(122208).xls Supplementary Document	2009-01-05
Adverse Event Reporting.pdf Supplementary Document	2009-01-05
Supporting Statement Part B -- National Study of the Hospital AERS 8-18-08.doc Supporting Statement B	2008-10-06
30 Day FRN -- National Study of the Hospital AERS.pdf Supplementary Document	2008-10-06
Attachment F -- Phone Survey Intro Script.doc Supplementary Document	2008-10-06
Attachment E -- Remail Cover Letter.doc Supplementary Document	2008-10-06
Attachment D -- Reminder Post Card.doc Supplementary Document	2008-10-06
Attachment C -- Questionnaire Cover Letter.doc Supplementary Document	2008-10-06
Supporting Statement Part A -- National Study of the Hospital AERS 8-18-08.doc Supporting Statement A	2008-10-06

IC Document Collections

IC ID	Document Title	Status
7729	Adverse Event Reporting Follow-up Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0125	ICR Reference No: 200810-0935-002
Status: Historical Active	Previous ICR Reference No: 200505-0935-001
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: National Study of the Hospital Adverse Event Reporting Survey
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/08/2009
	Date Received in OIRA: 10/09/2008
Terms of Clearance: This ICR is approved consistent with AHRQ memo of 12/11/08 and information about response rates by strata.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	12 Months From Approved
Responses	1,020	0	0
Time Burden (Hours)	425	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: This proposed information collection is to conduct a national follow-up survey on adverse event reporting within hospitals to understand how hospital reporting systems have changed over time. This survey will provide data for a second point in time on the status of hospital reporting systems, following upon baseline data established by a baseline survey completed in 2005.

---

Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 43238	07/24/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 57362	10/02/2008
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Adverse Event Reporting Follow-up Survey	Form #1, Form #2	Questionnaire -- Mailed Version ,   Questionnaire -- Telephone Version

---

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	1,020	0	0	1,020	0	0
Annual Time Burden (Hours)	425	0	0	425	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 burden for this follow-up survey is slightly higher than the original survey due to the larger number of respondents.

---

Annual Cost to Federal Government: $190,000

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]? Uncollected

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)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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: 10/09/2008

---