[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Notices]
[Pages 71971-71972]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30630]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: 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.

DATES: Comments on this notice must be received by January 2, 2003.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports 
Clearance Officer, (301) 594-3132.

SUPPLEMENTARY INFORMATION:

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 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.

[[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:

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                                                                  Estimated time     Estimated       Estimated
               Type of respondent                    Number of    per respondent   total burden   annual cost to
                                                    respondents      in hours          hours      the government
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Risk Manager....................................              40             .58            23.2         $628.72
Departmental Manager............................             240             .42           100.8       $4,048.13
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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.

    Dated: November 22, 2002.
Carolyn M. Clancy,
Acting Director.
[FR Doc. 02-30630 Filed 12-2-02; 8:45 am]
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