[Federal Register Volume 70, Number 59 (Tuesday, March 29, 2005)]
[Notices]
[Pages 15859-15860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6172]


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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 [email protected] 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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