[Federal Register Volume 75, Number 106 (Thursday, June 3, 2010)]
[Notices]
[Pages 31445-31447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13107]
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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: ``Reductions of Infection Caused by Carbapenem Resistant
Enterobacteriaceae (KPC) Producing Organisms through the Application of
Recently Developed CDC/HICPAC Recommendations.'' 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 March 31st, 2010 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.
DATES: Comments on this notice must be received by July 6, 2010.
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 [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
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Reductions of Infections Caused by Carbapenem Resistant
Enterobacteriaceae (KPC) Producing Organisms Through the Application of
Recently Developed CDC/HICPAC Recommendations.
Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths
among the 2.1 million people who acquired infections while hospitalized
in 2000, and HAI rates have risen relentlessly
[[Page 31446]]
since then. On March 20, 2009, the Centers for Disease Control (CDC)
and the Healthcare Infections Control Practices Advisory Committee
(HICPAC) developed infection control (IC) guidance for Klebsiella
pneumonia carbapenemase-producing (KPC) isolates, as they have been
rapidly emerging as a significant challenge in healthcare settings. The
danger of these bacteria is that they are resistant to carbapenem (a
class of beta-lactam antibiotics with a broad spectrum of antibacterial
activity) and cannot be treated by the most commonly prescribed
antibiotics. Limited treatment options mean that infections caused by
carbapenem-resistant bacteria result in substantial mortality and
morbidity.
The CDC and HICPAC recommendations draw on infection control
strategies which have been applied to these pathogens in other
settings, and other evidence-based strategies in infection control.
There has been little research, however, on the implementation of
control strategies to prevent the spread of these KPC infections. The
goal of this project is to understand how these recommendations can
best be implemented and how effective these recommendations will be in
practice. This research will advance private and public efforts to
improve health care quality by improving measures to control the spread
of a dangerous organism. This research will also provide data for the
development of an implementation toolkit that hospitals can use to
prevent the spread of carbapenem resistant bacteria. The toolkit may
include the following types of resources: General information about the
implementation of evidence-based clinical practices, resource
materials, and tools and methods that users can adopt to conduct point
prevalence surveys, protocols and tools that users can adopt to specify
when active KPC surveillance is needed, and resources for approaching
the problem as a team-based quality-improvement effort. OMB clearance
will be sought for this toolkit once it is developed.
This study is being conducted by AHRQ through its contractor,
Boston University, pursuant to AHRQ's statutory authority to conduct
and support research on healthcare and on systems for the delivery of
such care, including activities with respect to the quality,
effectiveness, efficiency, appropriateness and value of healthcare
services and with respect to quality measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
This project will include the following data collections from the
intensive care unit (ICU) staff within each of three participating
hospitals:
(1) Pre-intervention focus groups will be conducted separately with
managers and staff. The purpose of these focus groups is to identify
potential problems in the implementation that can be addressed through
various means (e.g., additional education, other changes in process).
Another purpose is to understand the existing approach to quality
improvement, the connection(s) between overall approach to quality
improvement and to KPC infection control practices, current practices
at the hospital of quality reporting and accountability, and
constraints and obstacles to quality improvement as seen in their
roles. Staff members identified for the focus groups will be those with
the most first-hand knowledge of existing quality improvement efforts,
and KPC infection control practices.
(2) Clinical staff survey. Factors identified in the pre-
intervention focus groups will be used to inform the development of a
self-administered survey of staff knowledge of and attitudes toward KPC
surveillance and infection control procedures. Respondents will be
health care workers on the units where these new guidelines have been
implemented. Findings from the survey will be used to assess barriers
perceived by the staff, potential differences across units, and
potential differences by employee/occupational group.
(3) Post-intervention focus groups (6 months after implementation
of new KPC IC guidelines) will be conducted separately with managers
and staff. The purpose of these focus groups is to identify actual
problems experienced in the initial implementation and possible
measures to address, and to identify successful practices to include in
a toolkit that hospitals can use to implement the CDC and HICPAC
recommendations.
In addition to developing a toolkit, AHRQ plans to disseminate the
lessons learned from this project about how hospitals can best
implement the CDC guidance for KPC screening and infection control, in
order to inform efforts to change practice in this area.
Estimated Annual Respondent Burden
The estimated annualized burden hours for respondents to
participate in this two year research project are presented in Exhibit
1. Pre-intervention focus groups with clinical staff will be conducted
with 18 staff members (an average of 9 per year for 2 years) from each
of the 3 participating hospitals and will take about 1 hour. Pre-
intervention focus groups with also be conducted with 2 managers (an
average of I per year for 2 years) from each hospital and will take
about an hour to complete.
The clinical staff survey will be administered to 20 clinical staff
(an average of 10 per year for years) from each hospital and will take
15 minutes to complete.
Finally, respondents from the pre-intervention focus groups will
participate in post-intervention focus groups approximately four months
after the initiation of the intervention. They will not last more than
an hour each. The total annualized burden hours are estimated to be 68
hours.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
annualized cost burden is estimated to be $3,108.
Exhibit 1. Estimated Annualized Burden Hours
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Number of
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
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Pre-intervention focus groups with clinical 3 9 1 27
staff \*\......................................
Pre-intervention focus groups with managers\*\.. 3 1 1 3
Clinical staff survey........................... 3 10 15/60 8
Post-intervention focus groups with clinical 3 9 1 27
staff \*\......................................
Post-intervention focus groups with managers\*\. 3 1 1 3
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Total....................................... 15 n/a n/a 68
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\*\ Individuals that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC
leaders, QI team members and unit staff. Managers include the chief nursing officer and chief medical officer.
Exhibit 2. Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total cost
Data collection respondents hours wage rate burden
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Pre-intervention focus groups with clinical 3 27 $36.73 \*\ $992
staff \*\......................................
Pre-intervention focus groups with managers \*\. 3 3 $138.38 \**\ $415
Clinical staff survey........................... 3 8 $36.73 \*\ $294
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Post-intervention focus groups with clinical 3 27 $36.73 \*\ $992
staff \*\......................................
Post-intervention focus groups with managers \*\ 3 3 $138.38 \**\ $415
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Total....................................... 15 68 na $3,108
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\*\ Based upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the
Bureau of Labor Statistics in May 2008.
\**\ Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published
by http://www.saIary.com; 3 chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the annualized and total cost to the federal
government for this two year research project. Project development
covers steps taken to revise the research plan and begin
implementation. The total cost is estimated to be $500,001.
Exhibit 3. Annualized and Total Cost to the Federal Government
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Annualized
Cost component cost Total cost
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Project Management...................... $125,526 $251,052
Project Development..................... $54,622 $109,244
Data Collection Activities.............. $41,864 $83,728
Travel.................................. $4,000 $8,000
Overhead................................ $23,754 $47,507
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Total............................... $250,001 $500,001
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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 will become a matter of public
record.
Dated: May 21, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-13107 Filed 6-2-10; 8:45 am]
BILLING CODE 4160-90-M