[Federal Register Volume 69, Number 71 (Tuesday, April 13, 2004)]
[Notices]
[Pages 19428-19431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-8292]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Assessment of Best Practices for Standardized Quality Assurance 
Activities in Pathology and Laboratory Medicine

    Announcement Type: New.
    Funding Opportunity Number: 04140.
    Catalog of Federal Domestic Assistance Number: 93.064.
    Key Dates:
    Letter of Intent Deadline: May 13, 2004.
    Application Deadline: June 14, 2004.
    Executive Summary: This program will evaluate the effectiveness of 
standardized approaches to quality assurance in pathology and 
laboratory medicine, in order to determine approaches that produce 
measurable and sustainable improvements against established benchmarks. 
Areas of primary interest are: pre-analytic process, including the test 
requisition; post-analytic processes, including the test report; 
implementation of CLIA-waived tests in point of service environments; 
error identification and reduction; and quality assurance activities in 
anatomic pathology (autopsies, surgical pathology, cytopathology and/or 
genetic testing).

I. Funding Opportunity Description

    Authority: This program is authorized under section 317 (k) (2) 
of the Public Health Service Act, 42 U.S.C. 247b (k)(2), as amended.

    Purpose: The purpose of the program is to determine standardized 
approaches to quality assurance in pathology and laboratory medicine 
that can be applied in multiple, diverse settings (e.g. community 
hospitals, academic medical centers, and independent laboratories) that 
demonstrate measurable and sustainable improvements over time. The 
program focuses on specific opportunities for error reduction, or 
process improvement in: pre-analytic processes, including test 
requisitions; post-analytic processes, including test reports; 
implementation of CLIA-waived tests in point of service environments, 
and; anatomic pathology (autopsies, surgical pathology, and cytology 
and/or genetic testing). This program addresses the ``Healthy People 
2010'' focus area(s) of ``Access to Quality Health Services'' and 
``Public Health Infrastructure''.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the Public Health Practice Program 
Office (PHPPO): To assure that public health infrastructure at the 
Federal, state, and local levels has the capacity to provide essential 
public health services to the citizens of the nation to respond to 
bioterrorism, other infectious disease outbreaks, other public health 
threats, emergencies and prepare frontline state and local health 
departments and laboratories to respond to current and emerging public 
health threats.''

Activities

    Awardee activities for this program are as follows:
     Evaluate quality assurance methods that have 
been standardized and implemented in multiple, diverse laboratory 
settings for common laboratory practices.
     Determine best practices in quality assurance 
methods for addressing pre-analytic components of laboratory testing, 
including the test requisition.
     Determine best practices in quality assurance 
methods for addressing post-analytic components of laboratory testing, 
including the test report.
     Determine best practices in quality assurance 
methods for addressing implementation of CLIA-waived tests in the point 
of service test environment.
     Determine best practices in quality assurance 
methods in anatomic pathology (autopsy, surgical pathology and/or 
cytopathology).
     Provide leadership in assessing the impact of 
reporting surgical pathology results in a template format.
     Provide leadership in developing strategies that 
lead to wider use of proven methods of quality assurance and error 
reduction.
     Provide leadership in developing strategies that 
lead to improved use of CLIA-waived tests.
     Provide leadership in developing programs that 
evaluate and improve laboratory practice over a specified time period.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
     Provide consultation and technical assistance in 
the planning, implementation, and evaluation of program activities.
     Provide information on numbers and types of 
laboratories and numbers and types of waived tests.
     Provide consultation and technical assistance 
related to scientific information on errors in laboratory medicine.
     Provide information on CLIA regulations and 
their impact on laboratory testing.
     Provide information from the CDC-sponsored 
Institute for Quality in Laboratory Medicine.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $100,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $100,000.
    Floor of Award Range: None.
    Ceiling of Award Range: $100,000 (This ceiling is for the first 12-
month budget period.).
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies, such as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     Universities.
     Research institutions.
     Community-based organizations.
     Faith-based organizations.
     State and local governments or their Bona Fide 
Agents (this includes the District of Columbia, the Commonwealth of 
Puerto Rico, the Virgin Islands, the Commonwealth of the Northern 
Mariana Islands, American Samoa, Guam, the Federated States of 
Micronesia, the Republic of the Marshall Islands, and the Republic of 
Palau).
    A Bona Fide Agent is an agency/organization identified by the state 
as

[[Page 19429]]

eligible to submit an application under the state eligibility in lieu 
of a state application. If you are applying as a bona fide agent of a 
state or local government, you must provide a letter from the state or 
local government as documentation of your status. Place this 
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    If your application is incomplete or non-responsive to the 
requirements listed in this section, it will not be entered into the 
review process.
    You will be notified that your application did not meet submission 
requirements.
    Applicants must have experience in the administration and 
evaluation of standardized quality assurance programs in multiple, 
diverse laboratory sites (including community hospitals and academic 
medical centers). This experience is required for an applicant to be 
able to assess the effectiveness of these quality assurance programs 
and to determine best practices.

    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.

IV. Application and Submission Information

IV.1. Address to Request Application Package

    To apply for this funding opportunity use application form PHS 
5161. Application forms and instructions are available on the CDC Web 
site, at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: two.
     Font size: 12-point unreduced.
     Single spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:
     Description of organization.
     Goals and objectives.
     Methods and Technical Approach.
     Project Management and Staffing (Expertise in 
standardized processes for quality assurance in laboratory medicine and 
pathology).
     Budget--total funds to be requested.
    Application: You must submit a project narrative with your 
application forms. The narrative must be submitted in the following 
format:
     Maximum number of pages: 30. If your narrative 
exceeds the page limit, only the first pages, which are within the page 
limit, will be reviewed.
     Font size: 12 point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Held together only by rubber bands or metal 
clips; not bound in any other way.
     Double spaced.
    Your narrative should address activities to be conducted over the 
entire project period, and must include the following items in the 
order listed:
     Applicant's knowledge of and experience with 
standardized approaches to quality assurance in laboratory medicine and 
pathology.
     Applicant's knowledge of and experience with 
quality assurance activities addressing pre-analytic processes 
(including test requisition), post-analytic processes (including test 
report), implementation of CLIA-waived tests in point of service 
environments, error identification and reduction; anatomic pathology 
and/or genetic testing.
     Applicant's proposal (including plan, methods, 
objectives, timeline, and staff) to evaluate the effectiveness of 
standardized approaches to quality assurance activities in pre-analytic 
processes (including test requisition), post-analytic processes 
(including test report), implementation of CLIA-waived tests in point 
of service environments, error identification and reduction; anatomic 
pathology and/or genetic testing.
     Applicant's proposed performance measures.
     Applicant's proposed budget and budget 
justification (which will not be counted toward the page limit for the 
narrative).
    Additional information may be included in the application 
appendices. The appendices will not be counted toward the narrative 
page limit. This additional information includes:
     Examples of past work on standardized quality 
assurance measures in pathology and laboratory medicine.
     Publications in standardized approaches to 
quality assurance in pathology and laboratory medicine.
     Organizational charts.
     Letters of support.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    If your application form does not have a DUNS number field, please 
write your DUNS number at the top of the first page of your 
application, and/or include your DUNS number in your application cover 
letter.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

IV.3. Submission Dates and Times

    LOI Deadline Date: May 13, 2004.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not required, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: June 14, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (1) 
Carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carriers guarantee.

[[Page 19430]]

If the documentation verifies a carrier problem, CDC will consider the 
application as having been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     None.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.
    Guidance for completing your budget can be found on the CDC Web 
site, at the following Internet address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or E-mail to: Tracy L. Carter, M.P.H., Centers for 
Disease Control and Prevention, Division of Laboratory Systems, Public 
Health Practice Program Office, 4770 Buford Highway NE, MS-G25, 
Atlanta, GA 30341, Telephone: 770 488-2523, Fax: 770-488-8282, E-mail: 
[email protected].
    Application Submission Address: Submit the original and two hard 
copies of your application by mail or express delivery service to: 
Technical Information Management--PA 04140, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    Your application will be evaluated against the following criteria:
1. Methods and Technical Approach (30 Points)
    a. Are the proposed methods feasible?
    b. Will the proposed methods achieve the program goals and 
objectives?
    c. Do the proposed methods address pre-analytic processes?
    d. Do the proposed methods address post-analytic processes?
    e. Do the proposed methods address implementation of waived tests 
in the point of service environment?
    f. Do the proposed methods address anatomic pathology?
2. Project Management and Staffing (30 Points)
    a. Does the applicant have the staff, knowledge, and expertise 
required to perform the responsibilities associated with the project?
    b. Are adequate qualified personnel committed to the project?
3. Program Goals and Objectives (20 Points)
    Does the proposal address the program goals and objectives?
4. Evaluation Plan (20 Points)
    Does the applicant describe a feasible schedule for accomplishing 
the activities related to this project and a plan for evaluating their 
progress?

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by PHPPO. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    An objective review panel will evaluate complete and responsive 
applications according to the criteria listed in the ``V.1. Criteria'' 
section above.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-10 Smoke-Free Workplace Requirements.
     AR-11 Healthy People 2010.
     AR-12 Lobbying Restrictions.
     AR-15 Proof of Non-Profit Status.
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting Requirements

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, no less than 90 days before the end of 
the budget period. The progress report will serve as your non-competing 
continuation application, and must contain the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Additional Requested Information.
    f. Measures of Effectiveness.
    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.
    These reports must be mailed to the Grants Management or Contract

[[Page 19431]]

 Specialist listed in the ``Agency Contacts'' section of this 
announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For program technical assistance, contact: Toby L. Merlin, MD, 
Project Officer, Centers for Disease Control and Prevention, Division 
of Laboratory Systems, Public Health Practice Program Office, 4770 
Buford Highway NE, MS-G25, Telephone: 770-488-8256, E-mail: 
[email protected].
    For financial, grants management, or budget assistance, contact: 
Sharon Robertson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, E-mail: [email protected].

    Dated: April 7, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-8292 Filed 4-12-04; 8:45 am]
BILLING CODE 4163-18-P