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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 the Office of Management and Budget (OMB) to allow the proposed information collection project: “National Study of the Hospital Adverse Event Reporting Survey”. In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(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 January 24, 2005, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.


Comments on this notice must be received by April 28, 2005.


Written comments should be submitted to: John Kraemer, at the Office of Information and Regulatory Affairs, OMB at the e-mail address and the fax number is (202) 395-6974.

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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Cynthia D. McMichael, AHRQ Reports Clearance Officer, (301) 427-1651.

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Proposed Project

“National Study of the Hospital Adverse Event Reporting Survey”

The National Study of the Hospital Adverse Event Reporting Survey will use a survey instrument which was developed to examine and characterize adverse event reporting in the Nation's hospitals. The survey will collect information from staff for a nationally representative sample of non-Federal hospitals. Risk managers will complete the questionnaire.

To achieve responses from 960 hospitals, we will contact 1200 hospitals to enlist their cooperation (thus, we anticipate an 80% response rate). Contacting 1200 hospitals should yield 960 Risk Managers with whom to conduct an interview.

The questionnaire will ask whether hospitals collect information on adverse events, and how the information is stored. The questionnaire also asks about the hospital's case definition of a reportable event and whether information on the severity of the adverse event is collected. It inquires about who might report 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, reporting systems, and whether information is used for purposes including analytic uses, personnel action, and intervention design. Finally, the questionnaire asks about the other sources of information that are useful for patient safety-related interventions.

The sample will be randomly drawn from the American Hospital Association Field Guide (the “AHA Guide”). The AHA Guide is a listing of 5,890 registered hospitals, which include Department of Defense, and Veteran's Administration hospitals. The AHA believes its database is close to 100 percent complete. AHA gathers information directly from hospitals via an annual survey. The resulting database includes 0ver 600 fields in areas such as organizational structure, facilities, bed numbers, finances and services specialities. Their survey results are published annually in the AHA Guide. In our sample frame, we will include approximately 5,795 non-Federal hospitals (public hospitals operated by cities, counties, and States and private hospital including both for profit and not-for-profit), and we will Start Printed Page 15860aim to administer the surveys in large, medium and small hospitals.

Mandate for Data Collection; Sponsorship

In the Fiscal Year 2002 Senate Appropriations Report for the Departments of Labor, HHS, and Education (Report—107-84), AHRQ was given the following congressional direction:

The Committee further directs AHRQ to provide a report detailing the results of its efforts to reduce medical errors. The report should include how hospitals and other healthcare facilities are reducing medical errors; how these strategies are being shared among health care professionals; how many hospitals and other health care facilities record and track medical errors; how medical error information is used to improve patient safety; what types of incentives and/or disincentives have helped health care professionals reduce medical errors and; a list of the most common root causes of medical errors.

This project is an AHRQ-funded activity as part of its Patient Safety Evaluation Contract.

Method of Collection

The survey and data collection procedures have been previously piloted (under OMB #0935-0114 which expired 01/31/2004). The survey mode will be an initial survey with two waves of mailed follow-ups as needed, and a Computer-Assisted Telephone Interviewing (CATI) telephone survey follow-up for the remaining non-responders.

The CATI survey will be tested by survey coordinators at the RAND Survey Research Group prior to fielding to ensure that the questionnaire items appear on the interviewer computer screens as designed, that appropriate range checks are programmed (so that interviewers cannot enter out of range values), that skip patterns are programmed appropriately, and that the data recording is being done correctly. The survey will take approximately 25 minutes to complete. The steps in the process are as follows:

1. For each hospital, telephone interviewers will contact the hospital and “screen” for the Risk Manager's name, direct telephone number, and FAX number and will verify the hospital's mailing address. The initial hospital information will come from the 2002 AHA database.

2. All confirmed Risk Managers will receive an advance letter and a copy of the survey in the mail.

3. A reminder letter will be sent to those who have not returned the survey within 2 weeks of the initial mailing, and a re-mail of a the survey will be sent 2 weeks after the reminder letter is sent.

4. If a survey has not been returned after the second re-mail, then a telephone interviewer will attempt to complete the survey with the Risk Manager over the telephone. The interviewer will record responses electronically using specially prepared software.

5. It is anticipated that there will be a follow-up survey (using a similar survey strategy) administered 2 or 3 years later.

Estimated Annual Respondent Burden

It is estimated that 960 Risk Managers will participate in the 25 minute national study. This yields a 403.2 hour burden per year and at an estimated $27.10 per hour, the annualized cost to the surveyed 960 (approximately 1000) hospitals would be a total of $10,926.72 or about $11.38 each. The figures are summarized in the table below:

Type of respondentNumber of respondentsEstimated time per respondent in hoursEstimated total burden hoursEstimated annual cost to each hospital
Risk Manager960.42 (25 minutes)403.20$11.38

Request for Comments

In accordance with the above-cited Paperwork Reduction Act legislation, comments on the AHRQ information collection proposal are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden (including hours and costs) of the proposed collection 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 on 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 request for OMB approval of the proposed information collection. All comments will become a matter of public record.

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Dated: March 10, 2005.

Carolyn M. Clancy,


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[FR Doc. 05-6172 Filed 3-28-05; 8:45 am]