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. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
The proposed information collection was previously published in the Federal Register on September 23, 2002, 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 January 2, 2003.
Written comments should be submitted to: OMB Desk Officer at the following address: Allison Eydt, Human Resources and Housing Branch, Office of Information and Regulatory Affairs, OMB: New Executive Office Building Room 10235; Washington, DC 20503.
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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Cynthia D. McMichael, AHRQ Reports Clearance Officer, (301) 594-3132.End Further Info End Preamble Start Supplemental Information
“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 methodology of its administration at 40 hospitals. Different staff, specifically, risk managers, directors of nursing, pharmacy, laboratory medicine, and transfusion medicine, infection 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, AHRQ will contact 50 hospitals to enlist their cooperation (thus, AHRQ anticipates 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 Departmental 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. 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 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 specialties.
Their survey results are published annually in the AHA Guide. In our sample, AHRQ 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 disincentives 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-half 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.Start Printed Page 71972
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 respondent||Number of respondents||Estimated time per respondent in hours||Estimated total burden hours||Estimated annual cost to the government|
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.Start Signature
Dated: November 22, 2002.
Carolyn M. Clancy,
[FR Doc. 02-30630 Filed 12-2-02; 8:45 am]
BILLING CODE 4160-90-M