[Federal Register Volume 75, Number 126 (Thursday, July 1, 2010)]
[Notices]
[Pages 38102-38103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15797]


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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 Hospital Adverse Event Reporting System: 
Questionnaire Redesign and Testing.'' In accordance with the Paperwork 
Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment 
on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on May 3rd 2010 and allowed 60 days for public 
comment. One comment was 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 August 2, 2010.

ADDRESSES: Written comments should be submitted to: AHRQs OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQs desk officer) or by 
e-mail at [email protected] (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 
doris.lefkowitz(AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION: 

Proposed Project

National Hospital Adverse Event Reporting System: Questionnaire 
Redesign and Testing

    As provider of operational support to the chair of the Quality 
Interagency Task Force (QuIC), AHRQ coordinated the Federal response to 
the Institute of Medicine's (IOM) 1999 report on medical errors and 
outlined specific initiatives the QuIC agencies will take. The Errors 
Workgroup within the QuIC identified the need for measures to evaluate 
the use of adverse medical event reporting for managing and improving 
patient safety within healthcare institutions. In response, AHRQ 
created the Hospital Adverse Event Reporting Survey to provide national 
estimates. This survey has been fielded twice, first in 2005 and again 
in 2008.
    Revisions to the questionnaire and sample selection are now 
necessary in response to the Patient Safety and Quality Improvement 
Rule (Patient Safety Rule), 42 CFR Part 3, issued by the United States 
Department of Health and Human Services, which implements the Patient 
Safety and Quality Improvement Act of 2005 (Patient Safety Act), 42 
U.S.C. 299b-21 through 299b-26. The Patient Safety Rule and Patient 
Safety Act authorize the creation of Patient Safety Organizations (PSO) 
to enhance quality and safety by collecting patient safety reports of 
adverse events. AHRQ started listing PSOs in late 2008 pursuant to the 
Patient Safety Act. These organizations have begun working with 
hospitals and other providers to monitor patient safety events 
according to common reporting formats, and to improve patient safety. 
This revised survey will be used for the third round of data collection 
in 2011, under a separate OMB clearance, to assess the impact of the 
PSOs and the Patient Safety Act on the use of adverse event reporting 
systems and will incorporate questions about reporting using the AHRQ 
Common Formats, and reporting information to a Patient Safety 
Organization.
    This project is being conducted by AHRQ's contractor, Westat, 
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).

Method of Collection

    This project will include the following data collections:
    (1) Semi-structured interviews will be conducted with one risk 
manager or other representative responsible for adverse event reporting 
from 7 participating hospitals and with one person from the two 
participating PSOs. These interviews will be conducted to learn more 
about the current hospital adverse event reporting environment and to 
understand how adverse event reporting may have changed in response to 
the Patient Safety Act. Survey developers will use the information from 
these interviews to develop questions for the revised questionnaire.
    (2) Cognitive interviews will be conducted with one risk manager or 
other representative responsible for adverse event reporting in 30 
participating hospitals. The purpose of these cognitive interviews is 
to test and refine the revised questionnaire. The

[[Page 38103]]

questionnaire will be tested among respondents in hospitals with no 
reporting affiliation with a PSO, with reporting affiliations with one 
PSO, and with reporting affiliations with more than one PSO.
    Results from these interviews will help inform actions by AHRQ to 
encourage effective adverse event reporting by hospitals, as part of 
its patient safety initiative, including standardization of reporting 
so that consistent concepts, information, and terminology are used in 
the patient safety arena. The survey can also serve as a baseline for 
changes about hospital-based adverse event reporting to Patient Safety 
Organizations and how the Patient Safety Act might have affected 
reporting structures and processes.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondents time to participate in this project. Semi-structured 
interviews will be conducted with 9 persons representing 7 hospitals 
and 2 PSOs and will last for about an hour. Cognitive interviews will 
be conducted with one person in each of 30 participating hospitals and 
are expected to take one hour to complete. The total annual burden 
hours are estimated to be 39 hours. Exhibit 2 shows the estimated 
annual cost burden associated with the respondents' time to participate 
in the research. The total annual cost burden is estimated to be 
$1,664.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                   organizations   organization      response          hours
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Semi-structured interviews......................               9               1               1               9
Cognitive interviews............................              30               1               1              30
                                                 ---------------------------------------------------------------
    Total.......................................              39              NA              NA              39
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                   organizations       hours           rate*          burden
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Semi-structured interviews......................               9               9          $42.67            $384
Cognitive interviews............................              30              30           42.67           1,280
                                                 ---------------------------------------------------------------
    Total.......................................              39              39              NA           1,664
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* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
  States 2008, ``U.S. Department of Labor, Bureau of Labor Statistics.''

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the estimated total and annualized cost to the 
Federal government to conduct this redesign of the Adverse Event 
Reporting Questionnaire and associated sample design. Since this 
project will last for one year the total and annualized costs are the 
same. The total cost is estimated to be $120,000.

             Exhibit 3--Estimated Total and Annualized Cost
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                                                            Annualized
             Cost component                 Total cost         cost
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Project Development.....................         $24,000         $24,000
Data Collection Activities..............          46,000          46,000
Data Processing and Analysis............          26,000          26,000
Project Management......................          24,000          24,000
                                         -------------------------------
    Total...............................         120,000         120,000
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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 healthcare research and healthcare 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: June 22, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-15797 Filed 6-30-10; 8:45 am]
BILLING CODE 4160-90-M