[Federal Register: January 24, 2005 (Volume 70, Number 14)]
[Notices]
[Page 3372-3374]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ja05-44]
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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: ``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.
DATES: Comments on this notice must be received by March 25, 2005.
ADDRESSES: Written comments should be submitted to: Cynthia D.
McMichael, Reports Clearance Officer, AHRQ, 540 Gaither Road, Room
5022, Rockville, MD 20850.
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.
[[Page 3373]]
FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports
Clearance Officer, (301) 427-1651.
SUPPLEMENTARY INFORMATION:
Proposed Project
``National Safety 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 (a scientifically sound
representative national sample of US 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 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, we will include
approximately 5,795 non-Federal hospitals (public hospitals operated by
cities, countries, and States and private hospitals including both for
profit and not-for-profit), and we will aim 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
Department 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 mailed 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 960 surveys
will be obtained from one Risk Manager per hospital.
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 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:
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Estimated
Number of Estimated time per Estimated annual cost
Type of respondent respondents respondent in hours total burden to each
hours hospital
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Risk Manager........................ 960 .42 403.20 $11.38
(25 minutes)
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[[Page 3374]]
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.
Dated: January 7, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-1187 Filed 1-21-05; 8:45 am]
BILLING CODE 4160-90-M