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Agency Information Collection Activities: Proposed Collection; Comment Request

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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: “Pilot Study of the Hospital Adverse Event Reporting Survey”. In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506j(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.


Comments on this notice must be received by November 22, 2002.


Written comments should be submitted to: Cynthia D. McMichael, Reports Clearance Officer, AHRQ, 2101 East Jefferson Street, Suite 500, Rockville, MD 20852-4908.

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) 594-3132.

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Proposed Project

Pilot Study of the Hospital Adverse Event Reporting Survey

The Pilot Study of the Hospital Adverse Event Reporting Survey will pilot test 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 U.S. non-Federal hospitals. The Pilot Study will test the survey and the methodology of its administration at 40 hospitals. Different staff, specifically, risk managers; directors of nursing, pharmacy, laboratory medicine, and transfusion medicine; infrection control officers; and medical directors will complete a questionnaire. Two versions of the questionnaire have been developed: one to be administered to hospital risk managers, and the other to be administered to the above-named departmental managers.

To achieve responses from 40 hospitals, we will contact 50 hospitals to enlist their cooperation (thus, we anticipate an 80% response rate). Contacting 50 hospitals should yield 40 risk managers with whom to conduct an interview. In addition, we plan to conduct interviews with six specific Department heads. Not all hospitals will have such positions, and thus, we anticipate at most, 240 interviews with Department managers (assuming an 80% response rate).

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. If 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 is database is close to 100 percent complete. AHA gathers additional information directly from hospitals via an annual survey. The resulting database includes over 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, we will include only non-Federal hospitals and we will aim to pilot the instruments 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 (Rpt.-107-84), AHRQ was given the following specific requirements:

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 healthcare professionals; how many hospitals and other healthcare facilities record and track medical errors; how medical error information is used to improve patient safety; what types of incentives and/or disincentive have helped healthcare professionals reduce medical errors and; a list of the most common root causes of medical errors.

This project is sponsored by the Federal Quality Interagency Taskforce (QuIC) Errors Workgroup. The QuIC is responsible for the Federal Interagency coordination of patient safety efforts. AHRQ serves as provider of operational support to the chair of the QuIC.

Method of Collection

As a pilot study, this survey offers researchers the opportunity to experiment with the mode in which to collect the information. Accordingly, in this pilot study, respondents from one-Start Printed Page 59525half of the hospitals will be mailed a self-administered questionnaire. Respondents from the other hospitals will be telephoned and administered the questionnaire by a trained interviewer. The following steps outline the data collection procedures.

1. All sample hospitals will be contacted and “screened” to obtain the Risk Manager's name, direct telephone number, Fax number and verify the hospital's mailing address.

2. Half of the sample will then be randomly assigned to either the mail or telephone mode of data collection.

3. All Risk Managers will receive an advance letter explaining the study and notifying them that they will soon receive a telephone call or survey in the mail.

4. When the Risk Manager receives the survey/telephone call, he/she will be asked to provide the names of Departmental Managers.

5. The Departmental Managers will be contacted in the same fashion (telephone or mail) as their institution's Risk Manager. Thus, they will receive an advance letter and then a telephone call or mail survey.

A thank you/reminder postcard will be sent to all mail respondents. A second questionnaire will be mailed to the nonrespondents in the mail mode. Finally, all the mail nonrespondents will be contacted by telephone to complete the questionnaire.

Estimated Annual Respondent Burden

The estimated annual hour burden is as follows:

Type of respondentNumber of respondentsEstimated time per respondent in hoursEstimated total burden hoursEstimated annual cost to the government
Risk manager40.5823.2$628.72
Departmental Manager240.42100.84,048.13

Request for Comments

In accordance with the above-cited 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: September 17, 2002.

Carolyn M. Clancy,

Acting Director.

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[FR Doc. 02-24183 Filed 9-20-02; 8:45 am]