Study on Hospitalization of Tuberculosis (TB) Patients and Tuberculin Skin Testing Demonstration Projects (Supplement to TB Elimination Cooperative Agreements)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 472]

Study on Hospitalization of Tuberculosis (TB) Patients and

Tuberculin Skin Testing Demonstration Projects (Supplement to TB

Elimination Cooperative Agreements)

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1994 funds to provide support for a:

(1) Study on Hospitalization of TB Patients, and (2) Tuberculin Skin

Testing Demonstration Projects. Applicants who meet the stated

eligibility criteria may apply for one or both of the projects

described in this program announcement. (For more information, see the

section ``Eligible Applicants''.)

The Public Health Service (PHS) is committed to achieving the

health promotion and disease prevention objectives of ``Healthy People

2000,'' a PHS-led national activity to reduce morbidity and mortality

and improve the quality of life. This announcement is related to the

priority area of HIV Infection and Immunization and Infectious

Diseases. (For ordering a copy of ``Healthy People 2000,'' see the

section ``Where to Obtain Additional Information''.)

Authority

This program is authorized under sections 301(a) and 317(k) of the

Public Health Service Act, [42 U.S.C 241(a) and 247b(k)], as amended.

Applicable program regulations are found in 42 CFR 51b, subpart A,

which contains general provisions relating to this program.

Smoke-free workplace

The Public Health Service strongly encourages all grant recipients

to provide a smoke-free workplace and promote the non-use of all

tobacco products. This is consistent with the PHS mission to protect

and advance the physical and mental health of the American people.

Eligible Applicants

1. Study on Hospitalization of TB Patients. Eligible applicants are

the State and local health departments who are the current cooperative

agreement recipients under Announcement 211 ``Tuberculosis Elimination

Cooperative Agreements'', that reported 200 or more TB cases in 1993.

Tuberculosis control programs that have a caseload of at least 200 new

TB cases per year will assure an adequate proportion of

hospitalizations, cases with HIV infection, or cases of multidrug-

resistant (MDR) TB among patients enrolled in the study. Applicants may

either choose the entire project area or a selected area thereof from

which to enroll patients; however, the selected area must have access

to at least 200 cases per year.

2. Tuberculin Skin Testing Demonstration Projects. Eligible

applicants are the State and local health departments who are the

current cooperative agreement recipients under Announcement 211

``Tuberculosis Elimination Cooperative Agreements'', that reported 100

or more TB cases in 1993. Applicants may either choose the entire

project area or a selected area from it to include as part of the

study; however, the selected area must have access to at least 100

cases per year.

Applicants who meet the above stated eligibility criteria may apply

for one or both of the projects referenced in this program

announcement.

Availability of Funds

The total amount of funds expected to be available to supplement TB

elimination cooperative agreements is $1,250,000. It is expected that

awards will begin on or about August 1, 1994, and will be made a part

of the remaining FY 1994 budget period ending January 31, 1995. Funding

estimates may vary and are subject to change.

1. Study on Hospitalization of TB Patients. Approximately $350,000

is available to fund 7-10 projects. Awards are expected to range from

$35,000 to $50,000. Projects are expected to be completed within 36

months.

2. Tuberculin Skin Testing Demonstration Projects. Approximately

$900,000 is available to fund 4-5 projects. Awards are expected to

range from $150,000 to $200,000. Projects are expected to be completed

within 24 months.

Use Of Funds

Funds may be used to support personnel and to purchase equipment,

supplies, and services directly related to project activities. Funds

may not be used to supplant State or local health department funds

available for TB control, provide inpatient care, purchase drugs, or to

support construction or renovation of facilities.

Purpose

1. Study on Hospitalization of TB Patients. The purpose of this

project is to determine: (1) the rate of hospitalizations for persons

with active TB, including hospitalizations connected with the initial

diagnosis of TB, (2) indications for, and the costs of, these

hospitalizations, (3) the length of stay for these hospitalizations,

(4) the impact of HIV infection on hospitalization and hospitalization

costs of TB patients, and (5) the impact of MDR-TB on hospitalization

and hospitalization costs of TB patients.

2. Tuberculin Skin Testing Demonstration Projects. The purpose of

this project is to: (1) develop model tuberculin skin testing programs

in health departments and health care facilities, (2) track and monitor

tuberculin skin test data and TB infections among health care workers,

and (3) pilot a microcomputer software system developed by CDC to

assist in the collection, tracking, management, and analysis of

occupational TB exposures and infections.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient shall be responsible for the activities under A.

(Recipient Activities), and CDC will be responsible for the activities

listed under B. (CDC Activities).

1. Study on Hospitalization of TB Patients

A. Recipient Activities

1. Implement a research protocol jointly developed with CDC for the

study of hospitalization for TB. This study will be a prospective study

of hospitalization of TB patients. The subjects will be all the

incident cases of TB entered in the TB case register during a period of

six consecutive months, or the first 200 cases entered in the register

from the beginning of the study period, whichever comes first. The

grantee will be responsible for appointing someone with public health

experience, (e.g., public health advisor, nurse, medical student) to

enroll the patients in the study and gather the following information:

(1) determine if and when the hospitalization took place, (2) establish

contact with hospital clerks to facilitate abstraction of hospital

records, (3) obtain informed consent and/or release of record

information forms, if applicable, and (4) complete a data extraction

form for each patient. CDC will provide training on uniform data

collection procedures to be employed in the protocol.

A minimum of 80% of the patients enrolled in the study should be

followed for a period of 1 year after their enrollment or until

completion of treatment, whichever comes first. All of the patient's

hospitalizations during that period should be documented. Data to be

collected on enrollment include: (a) age, (b) sex, (c) race/ethnicity,

(d) country of origin, (e) history of substance abuse, (f) anatomic

site of TB disease, (g) HIV serostatus, (h) income, and (i) housing

status. Data to be collected for each hospitalization include: (a)

admission date, (b) admission diagnoses, (c) indications for

hospitalization, (d) type of hospital, (e) days in acid-fast bacillus

(AFB) isolation, (f) discharge date, (g) discharge diagnoses, (h)

reasons for extended length of stay (if applicable), (i) patient

disposition upon discharge, (j) hospital charges, (k) charges per

service, including isolation, and (l) third party payer.

2. Develop procedures to adequately monitor patient enrollment and

follow-up, data collection, and data management.

3. Develop and implement a quality assurance plan to monitor the

effectiveness of protocol implementation.

B. CDC Activities

1. Jointly develop a research protocol for the study of

hospitalization for TB.

2. Train health department employees in protocol study procedures

and data collection forms.

3. Develop a plan for data management, specifically, the methods

for data transfer. Develop a timeline for data transfer and submission

of quarterly reports.

4. Review site performance and ensure compliance with the study

protocol.

5. Conduct data analysis and summarize and present findings.

2. Tuberculin Skin Testing Demonstration Projects

A. Recipient Activities

1. Conduct a tuberculin skin test (TST) program for health

department personnel with direct patient contact or contract with a

hospital to perform tuberculin skin testing of hospital employees. If

contracting with a hospital, the hospital should have reported at least

50 cases of TB within the preceding year.

In conducting the program the applicant will perform skin testing

at one or more health department facilities or hospitals where health

care workers (HCWs) are potentially exposed to TB. Where employees have

been exposed, the applicant will:

a. Perform contact investigations of HCWs exposed to an infectious

TB patient who was not recognized and appropriately isolated.

b. Collect information on the circumstances surrounding these HCW

exposures.

c. Initiate appropriate TST for exposed HCWs, including baseline

and follow-up testing.

d. Clinically evaluate all employees with a TST conversion.

The applicant in performing the TST program for employees on a

routine basis will be required to:

(1) Use a two-step Mantoux test for all initial tests to minimize

the likelihood of interpreting a boosted reaction as a true conversion

due to recent infection.

(2) Place and read a TB skin test on all HCWs. This will include

measures or incentives likely to enhance workers' compliance with such

testing;

(3) Perform subsequent Mantoux testing annually (or more frequently

if appropriate for the level of risk in the occupational group or

facility) of all employees whose initial skin tests were negative.

(4) Directly observe the reading of the TB skin test (in mm of

induration) by personnel trained in correct placement and reading of

Mantoux skin tests.

(5) Confidentially assess potential pertinent demographic factors,

(such as, sex, race/ethnicity, country of birth, and history of receipt

of Bacille Calmette-Guerin) and occupational factors, (such as,

occupation and worksite) which may place HCWs at risk for TB exposure.

2. Pilot CDC-developed software to assist in the collection,

tracking, management, and analysis of data from tuberculin skin testing

programs.

3. Follow CDC guidelines for tuberculin skin testing. A copy of the

guidelines will be included in the application kit.

4. Implement a research protocol jointly developed with CDC for the

TST demonstration project.

5. Use CDC-developed skin test software to enter all tuberculin

skin test information onto the software and send a diskette of the

database to CDC on a monthly basis.

6. Develop forms appropriate to their sites for the collection of

data including HCW's demographics, occupational information, tuberculin

skin test information, and results of follow-up clinical evaluations

for persons with reactive skin tests.

7. Ensure that all data are kept confidential and in secured files.

B. CDC Activities

1. Jointly develop a research protocol for the TST demonstration

project.

2. Provide technical assistance in implementation of the TST

program.

3. Provide one or more version of microcomputer software for use in

the project.

4. Train health department personnel in the use of the software.

5. Develop a plan for data management and for data transfer to CDC.

6. Review site performance and ensure compliance with the study

protocol.

7. Conduct data analysis and summarize and present findings.

Evaluation Criteria

1. Study on Hospitalization of TB Patients

Applications will be reviewed and evaluated according to the

following criteria. (100 total points maximum)

A. The extent of the problem of TB, HIV, and MDR-TB in the

applicant's area. (25 Points)

B. The extent to which the applicant's proposed staff and

description of duties meet project requirements; the extent to which

the applicant can demonstrate that institutional barriers will not

impede the initiation, implementation, and completion of the project.

(25 Points)

C. The ability of the applicant to manage local data and ensure the

quality of the data collected. The ability of the applicant to ensure

that the data will be received at CDC in a timely manner. (25 Points)

D. The extent to which the evaluation plan is appropriate to assess

the study objectives. (25 Points)

In addition, consideration will be given to the extent to which the

budget is reasonable, clearly justifiable, and consistent with the

intended use of funds.

2. Tuberculin Skin Testing Demonstration Projects

Applications will be reviewed and evaluated according to the

following criteria. (100 total points maximum)

A. The extent of the problem of TB, HIV, MDR TB, and TB/AIDS in the

applicant's area. (10 Points)

B. The extent to which an efficient and effective tuberculin skin

testing program exists in the facility proposed for the project. This

includes the compliance rate with the tuberculin skin testing program.

If compliance rates are sub-optimal, the extent to which the

applicant's plan for improving compliance during the project period is

likely to succeed. (30 Points)

C. Agreement by the applicant to pilot test CDC-developed software

and provide diskettes of the database to CDC on a monthly basis. The

extent to which the applicant's data management plan demonstrates an

ability to ensure the integrity of the data. (30 Points)

D. The extent to which the applicant describes how the study will

be administered, including the size, qualifications, duties and

responsibilities, and time allocation of the proposed staff; the

availability of the facilities to be used, and a schedule for

accomplishing the activities, including time frames. If a contract with

a hospital is proposed, a letter of support must be included. (30

Points)

In addition, consideration will be given to the extent to which the

budget is reasonable, clearly justifiable, and consistent with the

intended use of funds.

Funding Priority

Study on Hospitalization of TB Patients

Funding preference may be given to applicants with the highest

number of TB cases. Priority may also be given to ensure geographic

balance, urban and rural balance, high prevalence of HIV-infection, and

high prevalence of MDR-TB.

Tuberculin Skin Testing Demonstration Projects

Funding preference may be given to applicants that have established

tuberculin skin testing programs for employees and include TB clinics

and field workers in the project. Priority may also be given to ensure

geographic balance, urban and rural balance, high and low prevalence of

HIV infection.

Interested persons are invited to comment on the proposed funding

priority. All comments received on or before July 20, 1994, will be

considered before the final funding priority is established. If the

funding priority should change as a result of any comments received, a

revised Announcement will be published in the Federal Register prior to

the final selection of awards.

Written comments should be addressed to: Elizabeth M. Taylor,

Grants Management Officer, Grants Management Branch, Procurement and

Grants Office, Centers for Disease Control and Prevention (CDC), 255

East Paces Ferry Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets

up a system for State and local government review of proposed Federal

assistance applications. Applicants should contact their State Single

Point of Contact (SPOC) as early as possible to alert them to the

prospective applications and receive any necessary instructions on the

State process. For proposed projects serving more than one State, the

applicant is advised to contact the SPOC for each affected State. A

current list of SPOCs is included in the application kit. If SPOCs have

any State process recommendations on applications submitted to CDC,

they should send them to Elizabeth M. Taylor, Grants Management

Officer, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Atlanta, GA 30305, not later than 60 days after due date for

receipt of applications. The Program Announcement Number and Program

Title should be referenced on the document. CDC does not guarantee to

``accommodate or explain'' State process recommendations it receives

after that date.

Public Health System Reporting Requirements

This program is not subject to the Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.116.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by the cooperative agreement will be subject to

review by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

Confidentiality

Applicants must have in place systems to ensure the confidentiality

of all patient records.

Human Subjects

The applicant must comply with the Department of Health and Human

Services Regulations regarding the protection of human subjects.

Assurances must be provided to demonstrate that the project will be

subject to initial and continuing review by an appropriate

institutional review committee.

Application Submission and Deadline

Each application must be complete as it will be evaluated without

reference to any other application. The original and two copies of each

application must be submitted to Elizabeth M. Taylor, Grants Management

Officer, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 300, Mailstop E-16, Atlanta, GA 30305, on or before

July 15, 1994.

1. Deadline: Applications shall be considered as meeting the

deadline if they are:

A. Received on or before the deadline date, or

B. Sent on or before the deadline date and received in time for

submission to the independent review committee. (Applicants must

request a legibly dated U.S. Postal Service postmark or obtain a

legibly dated receipt from a commercial carrier or the U.S. Postal

Service. Private metered postmarks will not be acceptable as proof of

timely mailing.)

2. Late Applications: Applications that do not meet the criteria in

1.A. or 1.B. are considered late applications. Late applications will

not be considered in the current competition and will be returned to

the applicant.

Where To Obtain Additional Information

A complete program description, information on application

procedures, an application package, and business management technical

assistance may be obtained from Manuel Lambrinos, Grants Management

Specialist, Grants Management Branch, Procurement and Grants Office,

Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 300, Atlanta, GA 30305, telephone (404) 842-6777.

Programmatic technical assistance for the Study on Hospitalization

of TB Patients may be obtained from Nilka M. Rios, Division of

Tuberculosis Elimination, National Center for Prevention Services,

Centers for Disease Control and Prevention (CDC), 1600 Clifton Road,

Mailstop E10, Atlanta, GA 30333, telephone (404) 639-8123.

Programmatic technical assistance for the Tuberculin Skin Testing

Demonstration projects may be obtained from Dale R. Burwen, M.D.,

Division of Tuberculosis Elimination, National Center for Prevention

Services, Centers for Disease Control and Prevention (CDC), 1600

Clifton Road, Mailstop E10, Atlanta, GA 30333, telephone (404) 639-

8117.

Please refer to Announcement 472 ``Study on Hospitalization of TB

Patients and Tuberculin Skin Testing Demonstration Projects'' when

requesting information or submitting an application.

Potential applicants may obtain a copy of ``Healthy People 2000''

(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''

(Summary Report, Stock No. 017-001-00473-1) referenced in the

``Introduction'' through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238.

Dated: June 14, 1994.

Ladene H. Newton,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 94-14908 Filed 6-17-94; 8:45 am]

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