Agency Information Collection Activities: Proposed Collection; Comment Request, 43169-43172 [2010-17796]
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
Department of Health and Human
Services, is publishing the following
summary of proposed collections for
public comment. Interested persons are
invited to send comments regarding this
burden estimate or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Prescription Drug Benefit Plan; Use:
Section 101 of Title I of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 added
sections 1860D–1 through D–42 to
establish this new program. Part D plans
use the information discussed to comply
with the eligibility and associated Part
D participating requirements. CMS will
use this information to approve contract
applications, monitor compliance with
contract requirements, make proper
payment to plans, and to ensure that
correct information is disclosed to
enrollees, both potential enrollees and
enrollees. Form Number: CMS–10141
(OMB#: 0938–0964); Frequency: Yearly;
Affected Public: Individuals and
households, and business or other forprofit and not-for-profit institutions;
Number of Respondents: 19,937,660;
Total Annual Responses: 43,153,271;
Total Annual Hours: 36,520,101. (For
policy questions regarding this
collection contact Christine Hinds at
410–786–4578. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Consumer
Assessment of Health Care Providers
and Systems (CAHPS); Use: CMS is
required to collect and report
information on the quality of health care
services and prescription drug coverage
available to persons enrolled in a
Medicare health or prescription drug
plan under provisions in the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).
Specifically, the MMA under Sec.
1860D–4 (Information to Facilitate
Enrollment) requires CMS to conduct
consumer satisfaction surveys regarding
Medicare prescription drug plans and
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Medicare Advantage plans and report
this information to Medicare
beneficiaries prior to the Medicare
annual enrollment period. The Medicare
CAHPS survey meets the requirement of
collecting and publicly reporting
consumer satisfaction information. Refer
to the supporting documents to review
the current collection changes. Form
Number: CMS–R–246 (OMB#: 0938–
0732); Frequency: Yearly; Affected
Public: Individuals and households, and
business or other for-profit and not-forprofit institutions; Number of
Respondents: 567,324; Total Annual
Responses: 567,324; Total Annual
Hours: 242,376. (For policy questions
regarding this collection contact
Elizabeth Goldstein at 410–786–6665.
For all other issues call 410–786–1326.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Notice of Denial
of Medicare Prescription Drug Coverage:
Use: Section 1860D–4(g)(1) of the Social
Security Act requires Part D plan
sponsors that deny prescription drug
coverage to provide a written notice of
the denial to the enrollee. The purpose
of this notice is to provide information
to enrollees when prescription drug
coverage has been denied, in whole or
in part, by their Part D plans. The notice
must be readable, understandable, and
state the specific reasons for the denial.
The notice must also remind enrollees
about their rights and protections
related to requests for prescription drug
coverage and include an explanation of
both the standard and expedited
redetermination processes and the rest
of the appeal process. For a list of
changes, refer to the summary of
changes document. Form Number:
CMS–10146 (OMB#: 0938–0976);
Frequency: Daily; Affected Public:
Business or other for-profits; Number of
Respondents: 456; Total Annual
Responses: 290,344; Total Annual
Hours: 145,172. (For policy questions
regarding this collection contact
Kathryn M. Smith at 410–786–7623. For
all other issues call 410–786–1326.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Detailed
Explanation of Non-Coverage (42 CFR
422.626(e)(1)), and Notice of Medicare
Non-Coverage (42 CFR 422.624(b)(1));
Use: Under section 42 CFR 422.624
(b)(1), skilled nursing facilities (SNFs),
home health agencies (HHAs), and
comprehensive outpatient rehabilitation
facilities (CORFs) must deliver to
Medicare health plan enrollees a 2-day
advance notice of termination of
services. Per requirements at 42 CFR
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43169
422.626(e)(1), plans must deliver
detailed notices to the Quality
Improvement Organization (QIO) and
enrollees whenever an enrollee appeals
a termination of services. The Notice of
Medicare Non-Coverage (NOMNC) and
the Detailed Explanation of NonCoverage (DENC) fulfill these regulatory
requirements. Additionally, 42 CFR
417.600(b) provides that cost plans must
follow these same fast track appeal
notification procedures for their
enrollees in SNFs, HHAs and CORFs.
Refer to the crosswalk document for a
list of changes. Form Number: CMS–
10095 (OMB#: 0938–0910); Frequency:
Yearly; Affected Public: Business or
other for-profits and not-for-profit
institutions; Number of Respondents:
25,655; Total Annual Responses:
100,785; Total Annual Hours: 45,353.25
(For policy questions regarding this
collection contact Stephanie Simons at
206–615–2420. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
E-mail your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on August 23, 2010. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer; Fax
Number: (202) 395–6974; E-mail:
OIRA_submission@omb.eop.gov.
Dated: July 19, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–17898 Filed 7–22–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
AGENCY:
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ACTION:
Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
Notice.
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:
‘‘Reduction of Clostridium difficile
Infections in a Regional Collaborative of
Inpatient Healthcare Settings through
Implementation of Antimicrobial
Stewardship.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must be
received by September 21, 2010.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
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:
SUMMARY:
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Proposed Project
Reduction of Clostridium Difficile
Infections in a Regional Collaborative of
Inpatient Healthcare Settings Through
Implementation of Antimicrobial
Stewardship
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
since then. Alarmingly, 70% of HAIs are
due to bacteria that are resistant to
commonly used antibiotics (Huang
2007). This project is designed to
evaluate the implementation of a
program to reduce Clostridium difficile
Infection (CDI) in acute care facilities
via Antimicrobial Stewardship
Programs (ASPs). Working with an
already existing collaborative network
of acute care facilities in New York that
currently collect and report mandatory
data on CDI rates and practice strict
environmental controls, this project will
go beyond environmental strategies in
order to attempt to reduce rates of CDI.
ASPs seek to promote the appropriate
use of antimicrobials via several
methods including selecting the
appropriate dose, duration and route of
administration of antibiotics. Using
antibiotics appropriately can potentially
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improve efficacy, reduce costs, and keep
drug-related adverse events to a
minimum. The project is a partnership
with Boston University School of Public
Health (BUSPH), Montefiore Medical
Center (MMC), and Greater New York
Hospital Association (GNYHA).
The overall aims of the research are to
evaluate the implementation of ASPs
specific to CDI at 11 participating
hospitals (6 intervention sites and 5
control sites) and to create a draft ASP
Toolkit. More specifically, the pilot
study has been designed to provide
information to meet the following
objectives:
1. Identify the antimicrobial
stewardship activities, both currently in
place and those yet to be identified,
specific to each site’s individual needs,
to optimize antimicrobial prescribing
practices to reduce CDI
2. Assess prescriber perceptions
related to ASP
3. Assess barriers and facilitators to
ASP implementation
4. Develop a draft ASP Toolkit to help
hospitals optimize their antimicrobial
prescribing practices to reduce CDI.
New York (NY) State currently
requires ongoing reporting of C-difficile
data for both clinical and surveillance
purposes. As part of an arrangement
with NY State, the Greater New York
Hospital Association (GNYHA) also
collects and analyzes these data through
their CDI collaborative. These data
include tracking baseline rates of CDI,
including pharmacy data, data related to
rates of CDI, patient outcomes, and data
about infection control practices (such
as hand-washing and other
environmental controls to prevent
spread of infection). The data are
collected on standardized forms that are
required by both the state and the
Centers for Disease Control and
Prevention (CDC). The data collected at
these participating hospitals are also
collected at multiple hospitals
nationwide as part of routine patient
care and quality. In addition to new data
collections initiated specifically for this
project, this routine and ongoing
mandatory data collection will serve as
the project’s knowledge base to allow
the assessment of ASP programs.
From the GNYHA data, a three-month
sample from the participating hospitals
will be analyzed by Montefiore Medical
Center (MMC) and GNYHA to obtain
baseline information. This data will
enable a comparison of the rates of CDI
before and after the implementation of
an ASP. The ASP will be implemented
at 6 hospitals (intervention sites), while
5 other hospitals will serve as control
sites and continue with their current
practices, including conducting general
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infection and environmental controls.
The specific elements of the ASPs will
vary by hospital based on priorities and
what is possible at each facility as well
as by the antibiotic(s) targeted and will
likely include some of the following:
• Formulary review/changes,
restrictions and preauthorization of
implicated antimicrobials
• Feedback to providers of implicated
antimicrobials
• Processes and algorithms for
empiric and streamlined regimens for
specific diagnoses/pathogens
• Antibiotic order form with
automatic stop orders
• Novel combinations of approaches
to the use of stewardship staff or
technology for stewardship (e.g.,
software, text paging, pyxis pharmacy
machines for tracking and promoting
proper antibiotic prescribing), and
• Educational efforts for clinicians
and patients upon diagnosis.
While the ongoing mandatory
reporting will allow the measurement of
change over time in CDI rates, it does
not provide the necessary information
that hospitals need about the challenges
of implementing an ASP.
Method of Collection
The following data collection
activities will be implemented to
achieve the objectives of this project:
1. Focus Groups with no more than 6
staff members at the intervention and
control hospitals. The focus groups will
be conducted one time only, by
telephone and approximately 12 months
after the implementation begins. The
focus group guides will differ for the
intervention and control sites, although
there will be a common core of
questions. The common core of the
focus group protocol will address the
following: issues related to experience
with the GNYI-[A] environmental and
infection control practices they have
already been utilizing, strategies they
have already used to reduce CDI and
perceptions of those strategies, barriers
to the environmental practices,
particular areas of challenge, facilitators,
and factors they think have contributed
most to their institution’s CDI rates. For
the intervention sites, the goal of the
focus group will be to understand in a
more in-depth and qualitative manner,
the experience of actually implementing
the ASP. For the control sites, the goal
will be to understand what they have
learned in being a control site and their
plans moving forward. In addition to the
core questions, questions will be asked
about their interest in starting an ASP
program, goals and priorities,
expectations of facilitators and barriers
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
and if and when they plan to implement
an ASP.
2. ASP Questionnaire will be
administered twice, pre and post
implementation, to a sample of about 70
hospital staff at both the intervention
and control hospitals. Intervention and
control facilities will receive the same
questionnaire. The purpose of this
survey is to measure the staff’s
perception of the scope of CDI at their
facility, current antibiotic prescribing
practices, the perceived need for ASPs
and how these change over time. The
questionnaire also collects some
background information such as the
staff members’ primary work area, time
worked in their profession and time
worked in this hospital.
While the reporting/surveillance data
required by the State of NY and the CDC
can measure rates of CDI and compare
how hospitals are doing, these data do
not capture many important issues. A
major reason that most hospitals do not
have active, robust ASPs is because they
can be incredibly challenging to
develop, administer and manage. They
require changes in prescribing practices
and the active agreement and
participation of physicians, pharmacists
and administrators. Physicians and
pharmacists may challenge restrictions
in formularies and determine that a
patient may not be given a specific
antibiotic. But the severity of CDI makes
it very important for hospitals to
determine optimal methods for
implementing successful ASPs. This
pilot study will collect data to allow the
comparison of perceptions and
experiences between hospitals that do
and do not attempt to implement an
ASP. Reflections and feedback directly
from prescribers and the ASP team
using qualitative data collection
procedures are needed to fully
understand what it means or would
mean to implement an ASP. The lessons
learned from this project will be useful
to health care facilities considering
implementing an ASP, and will inform
the development of a draft ASP Toolkit;
this Toolkit will be evaluated in a
separate project before being
disseminated.
This study is being conducted by
AHRQ through its contractor, BUSPH
and their partners Montefiore Medical
Center (MMC), and Greater New York
Hospital Association (GNYHA),
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).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
pilot study. Focus Groups will be
conducted post-intervention with
approximately 6 staff members at each
of the 11 study sites (5 control sites and
6 intervention sites) for a total of 66
individuals, approximately 36 at the
intervention sites and approximately 30
at the control sites. The control site
focus groups will last approximately 45
minutes. The intervention site focus
groups will last approximately 60
minutes.
The ASP questionnaire will be
administered twice, pre and postintervention, to about 70 staff members
at each of the 11 participating sites and
takes about 7 minutes to complete. The
total annualized burden is estimated to
be 239 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this study. The total cost burden is
estimated to be $15,037.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
hospitals
Form Name
Number of
responses
per hospital
Hours per
response
Total burden
hours
Focus groups at intervention sites ..................................................................
Focus groups at control sites ..........................................................................
ASP Questionnaire ..........................................................................................
6
5
11
6
6
140
1
45/60
7/60
36
23
180
Total ..........................................................................................................
22
n/a
n/a
239
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
hospitals
Form Name
Total burden
hours
Average
hourly wage
rate*
Total cost
burden
6
5
11
36
23
180
$57.38
57.38
64.73
$2,066
1,320
11,651
Total ..........................................................................................................
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Focus groups at intervention sites ..................................................................
Focus groups at control sites ..........................................................................
ASP Questionnaire ..........................................................................................
22
237
n/a
15,037
* The hourly wage for the focus groups is based upon the mean of the average wages for physicians ($79.33), pharmacists ($50.13), and medical and health services managers ($42.67). The hourly wage for the surveys is based upon the average wages for physicians ($79.33) and
pharmacists ($50.13). These data come from the May 2008 National Occupational Employment and Wage Estimates, United States, U.S. Bureau
of Labor Statistics Division of Occupational Employment Statistics, May 2008, National Occupational Employment and Wage Estimates, https://
www.bls.gov/oes/2008/may/oes_nat.htm#b11–0000.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the annualized and
total cost to the federal government for
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this two year research project. Project
Management includes activities related
to coordination between BUSPH staff,
contracted staff at MMC and GNYHA,
and monthly phone calls with the task
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order officer. Project development
covers steps taken to revise the research
plan and begin implementation. The
total cost is estimated to be $999,995.
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Federal Register / Vol. 75, No. 141 / Friday, July 23, 2010 / Notices
EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST TO THE GOVERNMENT
Cost component
Annualized cost
Total cost
Project Management ................................................................................................................................
Project Development ...............................................................................................................................
Data Collection and Analysis ...................................................................................................................
Technical Assistance and Consultation ...................................................................................................
Confirmatory lab testing ...........................................................................................................................
Travel .......................................................................................................................................................
Project Supplies and materials ................................................................................................................
Overhead .................................................................................................................................................
$28,315
84,944
169,888
60,750
20,000
7,500
2,450
126,395
$56,629
169,400
339,776
121,500
40,000
15,000
4,900
252,790
Total ..................................................................................................................................................
499,998
999,995
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: July 9, 2010.
Carolyn M. Clancy,
Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
[FR Doc. 2010–18063 Filed 7–22–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
International Conference on
Harmonisation; Draft Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 13 on
Bulk Density and Tapped Density of
Powders General Chapter; Availability;
Correction
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AGENCY:
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR): Notice of Charter Renewal
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the Board
of Scientific Counselors, Agency for
15:15 Jul 22, 2010
Dated: July 15, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[Docket No. FDA–2010–D–0347]
[FR Doc. 2010–17796 Filed 7–22–10; 8:45 am]
VerDate Mar<15>2010
Toxic Substances and Disease Registry,
of the Department of Health and Human
Services, has been renewed for a 2-year
period extending through May 21, 2012.
For further information, contact Paula
Burgess, M.D., Ph.D., Designated
Federal Officer, BSC, NCEH/ATSDR,
1600 Clifton Road, NE, Mailstop E–28,
Atlanta, Georgia 30333, telephone 404/
488–0574, e-mail.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
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Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of July 14, 2010 (75 FR 40843).
The document announced the
availability of a draft guidance entitled
‘‘Q4B Evaluation and Recommendation
SUMMARY:
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of Pharmacopoeial Texts for Use in the
ICH Regions; Annex 13: Bulk Density
and Tapped Density of Powders General
Chapter.’’ The document was published
with an incorrect docket number. This
document corrects that error.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning
and Budget, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3208, Silver Spring,
MD 20993–0002, 301–796–9148.
SUPPLEMENTARY INFORMATION: In FR Doc.
2010–17055, appearing on page 40843
in the Federal Register of Wednesday,
July 14, 2010, the following correction
is made:
On page 40843, in the first column, in
the headings section of the document,
‘‘[Docket No. FDA–2010–N–0344]’’ is
corrected to read ‘‘[Docket No. FDA–
2010–D–0347]’’.
Dated: July 20, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–18119 Filed 7–22–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Administration for Children and
Families
Maternal, Infant, and Early Childhood
Home Visiting Program
Health Resources and Services
Administration and Administration for
Children and Families, HHS.
ACTION: Request for public comment on
criteria for evidence of effectiveness of
home visiting program models for
pregnant women, expectant fathers, and
caregivers of children birth through
kindergarten entry.
AGENCY:
The Health Resources and
Services Administration and
SUMMARY:
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]]>Agencies
[Federal Register Volume 75, Number 141 (Friday, July 23, 2010)]
[Notices]
[Pages 43169-43172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17796]
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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.
[[Page 43170]]
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: ``Reduction of Clostridium difficile Infections in a Regional
Collaborative of Inpatient Healthcare Settings through Implementation
of Antimicrobial Stewardship.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment
on this proposed information collection.
DATES: Comments on this notice must be received by September 21, 2010.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
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
Reduction of Clostridium Difficile Infections in a Regional
Collaborative of Inpatient Healthcare Settings Through Implementation
of Antimicrobial Stewardship
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 since then. Alarmingly,
70% of HAIs are due to bacteria that are resistant to commonly used
antibiotics (Huang 2007). This project is designed to evaluate the
implementation of a program to reduce Clostridium difficile Infection
(CDI) in acute care facilities via Antimicrobial Stewardship Programs
(ASPs). Working with an already existing collaborative network of acute
care facilities in New York that currently collect and report mandatory
data on CDI rates and practice strict environmental controls, this
project will go beyond environmental strategies in order to attempt to
reduce rates of CDI. ASPs seek to promote the appropriate use of
antimicrobials via several methods including selecting the appropriate
dose, duration and route of administration of antibiotics. Using
antibiotics appropriately can potentially improve efficacy, reduce
costs, and keep drug-related adverse events to a minimum. The project
is a partnership with Boston University School of Public Health
(BUSPH), Montefiore Medical Center (MMC), and Greater New York Hospital
Association (GNYHA).
The overall aims of the research are to evaluate the implementation
of ASPs specific to CDI at 11 participating hospitals (6 intervention
sites and 5 control sites) and to create a draft ASP Toolkit. More
specifically, the pilot study has been designed to provide information
to meet the following objectives:
1. Identify the antimicrobial stewardship activities, both
currently in place and those yet to be identified, specific to each
site's individual needs, to optimize antimicrobial prescribing
practices to reduce CDI
2. Assess prescriber perceptions related to ASP
3. Assess barriers and facilitators to ASP implementation
4. Develop a draft ASP Toolkit to help hospitals optimize their
antimicrobial prescribing practices to reduce CDI.
New York (NY) State currently requires ongoing reporting of C-
difficile data for both clinical and surveillance purposes. As part of
an arrangement with NY State, the Greater New York Hospital Association
(GNYHA) also collects and analyzes these data through their CDI
collaborative. These data include tracking baseline rates of CDI,
including pharmacy data, data related to rates of CDI, patient
outcomes, and data about infection control practices (such as hand-
washing and other environmental controls to prevent spread of
infection). The data are collected on standardized forms that are
required by both the state and the Centers for Disease Control and
Prevention (CDC). The data collected at these participating hospitals
are also collected at multiple hospitals nationwide as part of routine
patient care and quality. In addition to new data collections initiated
specifically for this project, this routine and ongoing mandatory data
collection will serve as the project's knowledge base to allow the
assessment of ASP programs.
From the GNYHA data, a three-month sample from the participating
hospitals will be analyzed by Montefiore Medical Center (MMC) and GNYHA
to obtain baseline information. This data will enable a comparison of
the rates of CDI before and after the implementation of an ASP. The ASP
will be implemented at 6 hospitals (intervention sites), while 5 other
hospitals will serve as control sites and continue with their current
practices, including conducting general infection and environmental
controls. The specific elements of the ASPs will vary by hospital based
on priorities and what is possible at each facility as well as by the
antibiotic(s) targeted and will likely include some of the following:
Formulary review/changes, restrictions and
preauthorization of implicated antimicrobials
Feedback to providers of implicated antimicrobials
Processes and algorithms for empiric and streamlined
regimens for specific diagnoses/pathogens
Antibiotic order form with automatic stop orders
Novel combinations of approaches to the use of stewardship
staff or technology for stewardship (e.g., software, text paging, pyxis
pharmacy machines for tracking and promoting proper antibiotic
prescribing), and
Educational efforts for clinicians and patients upon
diagnosis.
While the ongoing mandatory reporting will allow the measurement of
change over time in CDI rates, it does not provide the necessary
information that hospitals need about the challenges of implementing an
ASP.
Method of Collection
The following data collection activities will be implemented to
achieve the objectives of this project:
1. Focus Groups with no more than 6 staff members at the
intervention and control hospitals. The focus groups will be conducted
one time only, by telephone and approximately 12 months after the
implementation begins. The focus group guides will differ for the
intervention and control sites, although there will be a common core of
questions. The common core of the focus group protocol will address the
following: issues related to experience with the GNYI-[A] environmental
and infection control practices they have already been utilizing,
strategies they have already used to reduce CDI and perceptions of
those strategies, barriers to the environmental practices, particular
areas of challenge, facilitators, and factors they think have
contributed most to their institution's CDI rates. For the intervention
sites, the goal of the focus group will be to understand in a more in-
depth and qualitative manner, the experience of actually implementing
the ASP. For the control sites, the goal will be to understand what
they have learned in being a control site and their plans moving
forward. In addition to the core questions, questions will be asked
about their interest in starting an ASP program, goals and priorities,
expectations of facilitators and barriers
[[Page 43171]]
and if and when they plan to implement an ASP.
2. ASP Questionnaire will be administered twice, pre and post
implementation, to a sample of about 70 hospital staff at both the
intervention and control hospitals. Intervention and control facilities
will receive the same questionnaire. The purpose of this survey is to
measure the staff's perception of the scope of CDI at their facility,
current antibiotic prescribing practices, the perceived need for ASPs
and how these change over time. The questionnaire also collects some
background information such as the staff members' primary work area,
time worked in their profession and time worked in this hospital.
While the reporting/surveillance data required by the State of NY
and the CDC can measure rates of CDI and compare how hospitals are
doing, these data do not capture many important issues. A major reason
that most hospitals do not have active, robust ASPs is because they can
be incredibly challenging to develop, administer and manage. They
require changes in prescribing practices and the active agreement and
participation of physicians, pharmacists and administrators. Physicians
and pharmacists may challenge restrictions in formularies and determine
that a patient may not be given a specific antibiotic. But the severity
of CDI makes it very important for hospitals to determine optimal
methods for implementing successful ASPs. This pilot study will collect
data to allow the comparison of perceptions and experiences between
hospitals that do and do not attempt to implement an ASP. Reflections
and feedback directly from prescribers and the ASP team using
qualitative data collection procedures are needed to fully understand
what it means or would mean to implement an ASP. The lessons learned
from this project will be useful to health care facilities considering
implementing an ASP, and will inform the development of a draft ASP
Toolkit; this Toolkit will be evaluated in a separate project before
being disseminated.
This study is being conducted by AHRQ through its contractor, BUSPH
and their partners Montefiore Medical Center (MMC), and Greater New
York Hospital Association (GNYHA), 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).
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for the
respondents' time to participate in this pilot study. Focus Groups will
be conducted post-intervention with approximately 6 staff members at
each of the 11 study sites (5 control sites and 6 intervention sites)
for a total of 66 individuals, approximately 36 at the intervention
sites and approximately 30 at the control sites. The control site focus
groups will last approximately 45 minutes. The intervention site focus
groups will last approximately 60 minutes.
The ASP questionnaire will be administered twice, pre and post-
intervention, to about 70 staff members at each of the 11 participating
sites and takes about 7 minutes to complete. The total annualized
burden is estimated to be 239 hours.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents' time to participate in this study. The total cost
burden is estimated to be $15,037.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form Name Number of responses per Hours per Total burden
hospitals hospital response hours
----------------------------------------------------------------------------------------------------------------
Focus groups at intervention sites.............. 6 6 1 36
Focus groups at control sites................... 5 6 45/60 23
ASP Questionnaire............................... 11 140 7/60 180
---------------------------------------------------------------
Total....................................... 22 n/a n/a 239
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Form Name hospitals hours wage rate* burden
----------------------------------------------------------------------------------------------------------------
Focus groups at intervention sites.............. 6 36 $57.38 $2,066
Focus groups at control sites................... 5 23 57.38 1,320
ASP Questionnaire............................... 11 180 64.73 11,651
---------------------------------------------------------------
Total....................................... 22 237 n/a 15,037
----------------------------------------------------------------------------------------------------------------
* The hourly wage for the focus groups is based upon the mean of the average wages for physicians ($79.33),
pharmacists ($50.13), and medical and health services managers ($42.67). The hourly wage for the surveys is
based upon the average wages for physicians ($79.33) and pharmacists ($50.13). These data come from the May
2008 National Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics
Division of Occupational Employment Statistics, May 2008, National Occupational Employment and Wage Estimates,
https://www.bls.gov/oes/2008/may/oes_nat.htm#b11-0000.
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 Management
includes activities related to coordination between BUSPH staff,
contracted staff at MMC and GNYHA, and monthly phone calls with the
task order officer. Project development covers steps taken to revise
the research plan and begin implementation. The total cost is estimated
to be $999,995.
[[Page 43172]]
Exhibit 3--Estimated Total and Annualized Cost to the Government
------------------------------------------------------------------------
Cost component Annualized cost Total cost
------------------------------------------------------------------------
Project Management.............. $28,315 $56,629
Project Development............. 84,944 169,400
Data Collection and Analysis.... 169,888 339,776
Technical Assistance and 60,750 121,500
Consultation...................
Confirmatory lab testing........ 20,000 40,000
Travel.......................... 7,500 15,000
Project Supplies and materials.. 2,450 4,900
Overhead........................ 126,395 252,790
---------------------------------------
Total....................... 499,998 999,995
------------------------------------------------------------------------
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: July 9, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-17796 Filed 7-22-10; 8:45 am]
BILLING CODE 4160-90-M
