[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
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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
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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
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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
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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