[Federal Register: December 3, 2002 (Volume 67, Number 232)]
[Notices]
[Page 71971-71972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de02-95]
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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.
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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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