[Federal Register Volume 67, Number 88 (Tuesday, May 7, 2002)]
[Notices]
[Pages 30688-30691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11249]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02148]


Building Regional Coalitions to Promote Patient Safety; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for building regional coalitions to promote patient safety. 
This program addresses the ``Healthy People 2010'' focus areas of 
Access to Quality Health Services and Immunization and Infectious 
Diseases.
    The purpose of the program is to support and develop a regional 
coalition that combines the efforts of major healthcare stakeholders to 
promote patient safety by preventing adverse events associated with 
healthcare, including evaluation of prevention effectiveness and cost 
effectiveness. Adverse events associated with healthcare to be targeted 
for preventions include, but are not limited to, healthcare associated 
infections, including those caused by antimicrobial resistant 
organisms. The goals of this program are to: (1) Support further 
development of an existing regional infrastructure to address issues of 
patient safety in a geographic area encompassing a major metropolitan 
area; (2) support implementation of interventions on a regional level 
designed to prevent adverse events associated with healthcare; (3) 
support interventions that address problems with current systems of 
healthcare delivery and their role in contributing to adverse events; 
(4) support the development of an existing region-wide system of 
surveillance for adverse events associated with healthcare; (5) support 
the development of a common information platform which can be used to 
collect electronic information on a regional level; and(6) evaluate the 
prevention effectiveness and cost effectiveness of regional 
interventions.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations. Faith-based 
organizations are eligible to submit an application.
    Applicants will need to have access to a coalition that actively 
engages a broad spectrum of healthcare quality stakeholders, including, 
but not limited to, healthcare facilities, major insurers, healthcare 
purchasers, physicians, corporate and civic leaders, organized labor, 
and State government.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

A. Availability of Funds

    Approximately $100,000 is available in FY 2002 to fund one award. 
It is expected that the award will begin on or about September 1, 2002 
and will be made for a 12 month budget period within a project period 
of up to three years. The funding estimate may change.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Funding Preferences

    1. Funding preference will be given to applicants who demonstrate 
the presence of an existing regional healthcare coalition with 
documented active engagement of a broad spectrum of healthcare quality 
stakeholders, including, but not limited to, healthcare facilities, 
major insurers, healthcare purchasers, physicians, corporate and civic 
leaders, organized labor, and State government. Applicants should have 
existing community charters signed by senior executive officers of at 
least 25 regional healthcare facilities, insurance companies 
representing at least 50 percent of the privately insured lives in the 
region, and at least 15 of the 30 largest employers in the region. 
These charters should specifically outline participatory actions to 
which the chief executive officers commit.
    2. Funding preference will be given to applicants who can 
demonstrate the existence of a region-wide system of

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surveillance for healthcare-associated infections. The surveillance 
system should include a method of reporting infections back to 
individual participating facilities. The method should utilize 
definitions and methods consistent with CDC's National Nosocomial 
Infection Surveillance System (NNIS).
    3. Funding preference will be given to regional coalitions that can 
document prior and ongoing participation of at least 25 healthcare 
facilities in the geographic region, including the sharing of 
healthcare-associated infection surveillance data with all other 
participating institutions.
    4. Funding preference will be given to applicants who demonstrate a 
prior interest in interventions which take a systems-based approach to 
improving healthcare quality.
    5. Funding preference will be given to applicants who have 
experience in implementing quality improvement techniques adopted from 
non-healthcare industries to prevent adverse events associated with 
healthcare including, but not limited to, healthcare associated 
infections.
    6. Funding preference will be given to applicants who have 
developed a common electronic information platform which has been used 
to collect electronic medical data from at least 20 healthcare 
facilities region-wide. The electronic information platform should be 
compliant with the functional and technical specifications of the 
National Electronic Disease Surveillance System (NEDSS)information 
architecture http://www.cdc.gov/nedss.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. Recipient 
Activities, and CDC will be responsible for the activities listed under 
2. CDC Activities.

1. Recipient Activities

    a. Further develop and implement a regional program to improve 
healthcare quality and assure patient safety by preventing adverse 
events associated with healthcare including, but not limited to, 
healthcare-associated infections.
    b. Regional Program: Continue to build and develop the existing 
regional program designed to reduce healthcare-associated adverse 
events. Establish active involvement of a broad spectrum of 
stakeholders in healthcare quality, including healthcare facilities, 
major insurers, healthcare purchasers, physicians, corporate and civic 
leaders, organized labor, and State government.
    c. Regional Surveillance system: Maintain an established regional 
system for surveillance of healthcare-associated adverse events, and a 
method for reporting the data back to individual healthcare facilities.
    d. Coordination and networking of regional healthcare information 
systems: The regional program should have infrastructure in place that 
allows for electronic information networking and data sharing. Continue 
to develop the network for the purpose of collecting and sharing 
information that promotes healthcare quality in the region, including 
the development and validation of novel strategies for surveillance 
using electronic data.
    e. Development and application of novel intervention strategies: 
Study novel interventions that address problems in healthcare delivery 
systems that contribute to adverse events associated with healthcare. 
Interventions should include strategies adopted from industries other 
than healthcare.
    f. Evaluate prevention effectiveness and cost effectiveness: 
Develop methods for evaluating the prevention effectiveness and cost-
effectiveness of interventions at both the facility and regional level.

2. CDC Activities

    a. Collaborate, as appropriate, with the recipient in all stages of 
the program, and provide programmatic and technical assistance.
    b. Assist in data collection, analysis, and interpretation of data 
from the project, as requested.
    c. Participate in improving program performance through 
consultation based on information and activities of other projects.
    d. Collaborate on appropriate aspects of the program, preventive 
measures, and program strategies for the prevention of adverse 
healthcare-associated events, as needed.
    e. Assist, as needed, in the reporting and dissemination of 
research and other results and relevant healthcare quality prevention 
education and training information, to appropriate Federal, State, and 
local agencies, health-care providers, the scientific community, and 
prevention and service organizations with an interest in healthcare 
quality, and the general public.
    f. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

E. Content

Letter of Intent (LOI)

    An LOI is optional for this program. The narrative should be no 
more than three single spaced pages, printed on one side, with one inch 
margins, and unreduced font. Your letter of intent will be used to 
enable CDC to determine the level of interest in the program. Your 
letter of intent should identify the program announcement number 02148, 
and should include the following information: (1) name and address of 
institution, and (2) name, address, telephone number, e-mail address, 
and fax number of a contact person.

Application

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 25 double-spaced pages, 
printed on one side, with one-inch margins, and unreduced font, and 
should include the following information.
    1. Provide a line-item budget and narrative justification for all 
requested costs. Budgets should be consistent with the purpose, 
objectives and research activities, and include:
    a. Line-item breakdown and justification for all personnel, i.e., 
name, position title, annual salary, percentage of time and effort, and 
amount requested.
    b. For each contract: (1) Name of proposed contractor, (2) 
breakdown and justification for estimated costs, (3) description and 
scope of activities to be performed by contractor, (4) period of 
performance, (5) method of contractor selection (e.g., sole source or 
competitive solicitation), and (6) method of accountability.
    c. A brief five year budget projection should be submitted that 
clearly separates and distinguishes direct from indirect costs.
    d. A description of any financial and in-kind contributions from 
nonfederal sources.
    Additionally, include a one page, single spaced, typed abstract. 
The heading should include the title of the cooperative agreement, 
project title, organization, name and address, project director, and 
telephone number. This abstract should include a work plan identifying 
activities to be developed, activities to be completed, and a time line 
for completion of these activities.

[[Page 30690]]

F. Submission and Deadline

Letter of Intent (LOI)

    On or before June 10, 2002, submit the letter of intent (original 
and two copies) to the Grants Management Specialist identified in the 
``Where to Obtain Additional Information'' section of this 
announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm, or in the application kit.
    On or before July 5, 2002, submit the application to: Technical 
Information Management-PA02148, Procurement and Grants Office, Centers 
for Disease Control and Prevention, 2920 Brandywine Rd., Room 3000, 
Atlanta, GA 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received on or before the deadline date.
    Late Applications: Applications which do not meet the criteria 
above are considered late applications, will not be considered, and 
will be returned to the applicant.

G. Evaluation Criteria

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Understanding the objectives of the Building Regional Coalitions to 
Promote Patient Safety Program (5 points)

    a. Demonstration of a clear understanding of the background and 
objectives of this cooperative agreement program.
    b. Demonstration of a clear understanding of the requirements, 
responsibilities, problems, constraints, and complexities that may be 
encountered in establishing and operating the regional coalition.
    c. Demonstration of a clear understanding of the roles and 
responsibilities of participation in the program.

2. Description of the existing regional coalition (40 points)

    a. Clear description of the regional coalition participants, 
including the specific role of each and evidence of active 
participation. (10 points)
    b. Clear description of the region wide system of surveillance for 
adverse events associated with healthcare, including the methods of 
reporting data back to individual participating facilities. The 
applicant should provide documentation of participation of a large 
proportion of healthcare facilities in the geographic region. (10 
points)
    c. Clear description of the common electronic information platform 
which has been used to collect electronic medical data from healthcare 
facilities region-wide. (10 points)
    d. Clear description of the degree to which the applicant has 
exhibited an ability to comply with the NEDSS information technology 
architecture in the collection of electronic medical data from 
healthcare facilities participating in the regional coalition. (10 
points)

3. Description of Existing Capacity to Actively Engage the Regional 
Participants in Implementing Activities That Support Patient Safety by 
Preventing Adverse Events Associated With Healthcare (25 points)

    a. Description of applicants experience and documentation of 
accomplishments in conducting quality improvement activities.
    b. Description of applicants experience and documentation of 
accomplishments in conducting surveillance and prevention activity in 
the areas of healthcare-associated infections and other adverse events.
    c. Demonstration of the applicants interest and expertise in 
interventions which take a systems based approach to improving 
healthcare quality.
    d. Demonstrate the applicants experience and expertise in quality 
improvement techniques adapted from non-healthcare industries.
    e. Demonstration of applicants ability to develop and maintain 
strong cooperative regional relationships with medical, public health, 
laboratory, academic, and community organizations that are either 
public or private. Evidence of applicant's ability to solicit and 
secure programmatic collaboration, and financial and technical support 
from such organizations.
    f. Demonstration of support from non-applicant participating 
agencies, institutions, organizations, laboratories, individuals, 
consultants, etc., mentioned in the operational plan. Applicant should 
provide (in an appendix) letters of support which clearly indicate each 
collaborator's willingness to participate in the activities of the 
regional coalition.

4. Operational Plan (20 points)

    a. The extent to which the applicants plan for operating and 
maintaining the regional coalition clearly describes the proposed 
activities and clearly identifies the roles and responsibilities of all 
participating individuals, agencies, organizations, and institutions.
    b. Description of the applicants plan for implementing 
interventions designed to promote patient safety through the prevention 
of adverse events associated with healthcare, including healthcare-
associated infections.
    c. Description of the applicants plan to develop and validate novel 
strategies for using electronic surveillance data for improving patient 
safety.
    d. Description of the applicants plan to utilize quality 
improvement techniques adapted from non-healthcare industries to 
promote patient safety.
    e. Consistency of the proposed projects with regard to program 
goals.
    f. Identification of applicant's key professional personnel to be 
assigned to the program and to specific projects as well as key 
professional personnel from other participating or collaborating 
institutions, agencies, and organizations outside of the applicants 
agency that will be assigned to activities (provide curriculum vitae 
for each in an appendix). Clear identification of applicants' 
respective roles in the management and operation of the regional 
coalition.
    g. Description of all support staff and services assigned to the 
regional coalition.
    h. The degree to which the applicant has met the CDC Policy 
requirements regarding the inclusion of women, ethnic, and racial 
groups in the proposed research. This includes (1) the proposed plan 
for the inclusion of both sexes and racial and ethnic minority 
populations for appropriate representation, (2) the proposed 
justification when representation is limited or absent, (3) a statement 
as to whether the design of the study is adequate to measure 
differences when warranted, and (4) a statement as to whether the plans 
for recruitment and outreach for study participants include the process 
of establishing partnerships with community (or communities) and 
recognition of mutual benefits.

5. Evaluation (5 points)

    a. Quality of plan for monitoring and evaluating the prevention 
effectiveness and the cost effectiveness of the interventions.
    b. Quality of plan for monitoring and evaluating progress in 
achieving the purpose and overall goals of this cooperative agreement 
program.

6. Measures of Effectiveness (5 points)

    The extent to which the applicant provides Measures of 
Effectiveness that

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will demonstrate the accomplishments of the various identified 
objectives of the grant. Measures must be objective and quantitative 
and must measure the intended outcome.

7. Budget (not scored)

    The extent to which the line-item budget is detailed, clearly 
justified, and consistent with the purpose and objectives of this 
program.

8. Human Subjects (Not Scored)

    The extent to which the application adequately addresses the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects.

H. Other Requirements

    Technical Reporting Requirements
    Provide CDC with original plus two copies of:
    1. Semiannual progress reports.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-7 Executive Order 12372 Review
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-15 Proof of Non-Profit Status
AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301(a) and 317(k)(2) of 
the Public Health Service Act, [42 U.S.C. sections 241(a) and 
247(k)(2)], as amended. The Catalog of Federal Domestic Assistance 
number is 93.283.

J. Where to Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Yolanda Sledge, Grants Management Specialist, Acquisition and 
Assistance, Team B, Procurement and Grants Office, Centers for Disease 
Control and Prevention, 2920 Brandywine Road, Room 3000 Mailstop K-75, 
Atlanta, GA 30341-4146, Telephone number: 770-488-2787, Fax number: 
770-488-2777, E-mail address: [email protected].
    For program technical assistance, contact: John Jernigan, M.D., 
Centers for Disease Control and Prevention, National Center for 
Infectious Diseases, Division of Healthcare Quality and Promotion, 
Executive Park 57, Suite 4109 Mailstop E-68, Telephone number: (404) 
498-1257, Fax number: 404-498-1244, E-mail address: [email protected].

    Dated: May 1, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 02-11249 Filed 5-6-02; 8:45 am]
BILLING CODE 4163-18-P