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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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Agency for Healthcare Research and Quality, HHS.




This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “National Study of the Hospital Adverse Event Reporting Follow-Up Survey.” In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506()(2)(A), AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on July 24th, 2008 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. Changes were made to this 30 day notice to account for the electronic patient records review which were not accounted for in the 60 day notice.


Comments on this notice must be received by December 1, 2008.


Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at (attention: AHRQ's desk officer).

Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at

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Proposed Project

“National Study of the Hospital Adverse Event Reporting Follow-Up Survey”

This proposed information collection will conduct a survey similar to a previous AHRQ baseline survey conducted in 2005, which examined and characterized adverse event reporting in the Nation's hospitals (Farley DO, Haviland A, Champagne S, Jain AK, Battles JB, Munier WB, Loeb JM. Adverse Event Reporting Practices by U.S. Hospitals: Results of a National Survey, under review for publication). The follow-up survey will allow AHRQ to examine how hospitals' use of adverse event reporting systems has changed over time. The baseline survey was completed by 1,652 hospital risk managers selected from a nationally representative sample frame. The follow-up survey will consist of a random sample of 1,200 of the respondents to the baseline survey. We anticipate an 85% response rate for the follow-up survey, resulting in 1,020 completed questionnaires.

Similar to the baseline survey, the follow-up survey will ascertain whether hospitals collect information on adverse events, and how the information is stored. Information will also be collected regarding the hospital's case definition of a reportable event, whether information on the severity of the adverse event is collected, who might report this information and whether they can report to a system which is confidential and/or anonymous. The questionnaire also asks about the uses of the data that are collected, and whether information is used for purposes including analytic uses, personnel action, and improvement interventions. Finally, the questionnaire asks about the other sources of information that are useful to hospitals for patient safety-related interventions.

This project is being conducted pursuant to AHRQ's statutory mandates to (1) promote health care quality improvement by conducting and supporting research that develops and presents scientific evidence regarding all aspects of health care, including methods for measuring quality and strategies for improving quality (42 U.S.C. 299(b)(1)(F)) and (2) conduct and support research on health care and on systems for the delivery of such care, including activities with respect to quality measurement and improvement (42 U.S.C. 299a(a)(2)). In addition, Congress has, in report language, directed AHRQ to provide a report detailing the results of its efforts to reduce medical errors. See Report for the Departments of Labor, Health and Human Services, and Education, and related agencies Appropriation Bill for Fiscal Year 2002, S. Rep. 107-84, at 11 (2001),

This project is being funded by AHRQ and conducted by the RAND Corporation as part of a contract under which RAND serves as the Patient Safety Evaluation Center for AHRQ's patient safety initiative.

Method of Collection

The baseline survey and data collection procedures have been previously conducted and reviewed (under OMB Number 0935-0125, Expiration Date 07/31/2008). The follow-up survey will include an initial mailed survey with two waves of mailed follow-ups as needed, and a Computer-Assisted Telephone Interviewing (CATI) survey follow-up for the remaining non-responders. The survey will be completed by one Risk Manager per hospital.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this information collection. The questionnaire is expected to require 25 minutes to complete, resulting in a total burden of 425 hours.

Exhibit 2 shows the estimated annualized cost burden for the respondents, which is estimated to be $11,518. The respondents will not incur any other costs beyond those associated with their time to participate.

Exhibit 1—Estimated Annualized Burden Hours

Form nameNumber of respondentsNumber of responses per respondentHours per responseTotal burden hours
Risk manager questionnaire1,020125/60425
1 Not applicable.
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Exhibit 2—Estimated Annualized Cost Burden

Form nameNumber of respondentsTotal burden hoursAverage hourly wage rate1Total cost burden
Risk manager questionnaire1,020425$27.10$11,518
1 Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2006, “U.S. Department of Labor, Bureau of Labor Statistics.”
2 Not applicable.

Estimated Annual Costs to the Federal Government

The Agency is supporting the conduct of this survey and analysis of survey data as part of a contract with the RAND Corporation under which RAND serves as the Patient Safety Evaluation Center for AHRQ's patient safety initiative. The estimated cost for this work is $240,000, including $190,000 for data collection activities and $50,000 to design the study, analyze the data and report the findings.

Request for Comments

In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research, quality improvement and information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

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Dated: September 19, 2008.

Carolyn M. Clancy,


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[FR Doc. E8-23370 Filed 10-1-08; 8:45 am]