[Federal Register Volume 73, Number 192 (Thursday, October 2, 2008)]
[Notices]
[Pages 57362-57363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-23370]



[[Page 57362]]

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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 that the Office of 
Management and Budget (OMB) approve the proposed information collection 
project: ``National Study of the Hospital Adverse Event Reporting 
Follow-Up Survey.'' In accordance with the Paperwork Reduction Act of 
1995, 44 U.S.C. 3506()(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 July 24th, 2008 and allowed 60 days for public 
comment. No comments were received. The purpose of this notice is to 
allow an additional 30 days for public comment. Changes were made to 
this 30 day notice to account for the electronic patient records review 
which were not accounted for in the 60 day notice.

DATES: Comments on this notice must be received by December 1, 2008.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
e-mail at <a href="/cdn-cgi/l/email-protection#430c0a11021c3036212e2a30302a2c2d032c2e216d262c336d242c35"><span class="__cf_email__" data-cfemail="66292f3427391513040b0f15150f090826090b044803091648010910">[email protected]</span></a> (attention: AHRQ's desk 
officer).
    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: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by e-mail at 
<a href="/cdn-cgi/l/email-protection#791d160b100a57151c1f12160e100d033918110b085711110a571e160f"><span class="__cf_email__" data-cfemail="74101b061d075a1811121f1b031d000e34151c06055a1c1c075a131b02">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

``National Study of the Hospital Adverse Event Reporting Follow-Up 
Survey''
    This proposed information collection will conduct a survey similar 
to a previous AHRQ baseline survey conducted in 2005, which examined 
and characterized adverse event reporting in the Nation's hospitals 
(Farley DO, Haviland A, Champagne S, Jain AK, Battles JB, Munier WB, 
Loeb JM. Adverse Event Reporting Practices by U.S. Hospitals: Results 
of a National Survey, under review for publication). The follow-up 
survey will allow AHRQ to examine how hospitals' use of adverse event 
reporting systems has changed over time. The baseline survey was 
completed by 1,652 hospital risk managers selected from a nationally 
representative sample frame. The follow-up survey will consist of a 
random sample of 1,200 of the respondents to the baseline survey. We 
anticipate an 85% response rate for the follow-up survey, resulting in 
1,020 completed questionnaires.
    Similar to the baseline survey, the follow-up survey will ascertain 
whether hospitals collect information on adverse events, and how the 
information is stored. Information will also be collected regarding the 
hospital's case definition of a reportable event, whether information 
on the severity of the adverse event is collected, who might report 
this 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, and whether information is used 
for purposes including analytic uses, personnel action, and improvement 
interventions. Finally, the questionnaire asks about the other sources 
of information that are useful to hospitals for patient safety-related 
interventions.
    This project is being conducted pursuant to AHRQ's statutory 
mandates to (1) promote health care quality improvement by conducting 
and supporting research that develops and presents scientific evidence 
regarding all aspects of health care, including methods for measuring 
quality and strategies for improving quality (42 U.S.C. 299(b)(1)(F)) 
and (2) conduct and support research on health care and on systems for 
the delivery of such care, including activities with respect to quality 
measurement and improvement (42 U.S.C. 299a(a)(2)). In addition, 
Congress has, in report language, directed AHRQ to provide a report 
detailing the results of its efforts to reduce medical errors. See 
Report for the Departments of Labor, Health and Human Services, and 
Education, and related agencies Appropriation Bill for Fiscal Year 
2002, S. Rep. 107-84, at 11 (2001),
    This project is being funded by AHRQ and conducted by the RAND 
Corporation as part of a contract under which RAND serves as the 
Patient Safety Evaluation Center for AHRQ's patient safety initiative.

Method of Collection

    The baseline survey and data collection procedures have been 
previously conducted and reviewed (under OMB Number 0935-0125, 
Expiration Date 07/31/2008). The follow-up survey will include an 
initial mailed survey with two waves of mailed follow-ups as needed, 
and a Computer-Assisted Telephone Interviewing (CATI) survey follow-up 
for the remaining non-responders. The survey will be completed by one 
Risk Manager per hospital.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents' time to participate in this information collection. The 
questionnaire is expected to require 25 minutes to complete, resulting 
in a total burden of 425 hours.
    Exhibit 2 shows the estimated annualized cost burden for the 
respondents, which is estimated to be $11,518. The respondents will not 
incur any other costs beyond those associated with their time to 
participate.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                Number of
                Form name                     Number of       responses per       Hours per       Total burden
                                             respondents       respondent         response            hours
----------------------------------------------------------------------------------------------------------------
Risk manager questionnaire..............             1,020                 1             25/60               425
    Total...............................             1,020             (\1\)             (\1\)              425
----------------------------------------------------------------------------------------------------------------
\1\ Not applicable.


[[Page 57363]]


                                   Exhibit 2--Estimated Annualized Cost Burden
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                                              Number of       Total burden     Average hourly      Total cost
                Form name                    respondents          hours         wage rate\1\         burden
----------------------------------------------------------------------------------------------------------------
Risk manager questionnaire..............             1,020               425            $27.10           $11,518
    Total...............................             1,020               425             (\2\)          $11,518
----------------------------------------------------------------------------------------------------------------
\1\ Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
  States 2006, ``U.S. Department of Labor, Bureau of Labor Statistics.''
\2\ Not applicable.

Estimated Annual Costs to the Federal Government

    The Agency is supporting the conduct of this survey and analysis of 
survey data as part of a contract with the RAND Corporation under which 
RAND serves as the Patient Safety Evaluation Center for AHRQ's patient 
safety initiative. The estimated cost for this work is $240,000, 
including $190,000 for data collection activities and $50,000 to design 
the study, analyze the data and report the findings.

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, comments on AHRQ's information collection are requested 
with regard to any of the following: (a) Whether the proposed 
collection of information is necessary for the proper performance of 
AHRQ health care research, quality improvement and information 
dissemination functions, including whether the information will have 
practical utility; (b) the accuracy of AHRQ's estimate of burden 
(including hours and costs) of the proposed collection(s) 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 upon the 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 Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: September 19, 2008.
Carolyn M. Clancy,
Director.
 [FR Doc. E8-23370 Filed 10-1-08; 8:45 am]
BILLING CODE 4160-90-M


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