[Federal Register: March 29, 2005 (Volume 70, Number 59)]
[Notices]
[Page 15859-15860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr05-67]
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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.
This proposed information collection was previously published in
the Federal Register on January 24, 2005, 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 April 28, 2005.
ADDRESSES: Written comments should be submitted to: John Kraemer, at
the Office of Information and Regulatory Affairs, OMB at the e-mail
address John_Kraemer@omb.eop.gov and the fax number is (202) 395-6974.
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.
FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports
Clearance Officer, (301) 427-1651.
SUPPLEMENTARY INFORMATION:
Proposed Project
``National Study 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, 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 0ver
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 frame, we will
include approximately 5,795 non-Federal hospitals (public hospitals
operated by cities, counties, and States and private hospital including
both for profit and not-for-profit), and we will
[[Page 15860]]
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
Departments 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 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 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 a
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 time Estimated Estimated
Type of respondent Number of per respondent total burden annual cost to
respondents in hours hours each hospital
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Risk Manager.................................... 960 .42 403.20 $11.38
(25 minutes)
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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: March 10, 2005.
Carolyn M. Clancy,
Director.
[FR Doc. 05-6172 Filed 3-28-05; 8:45 am]
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