Cooperative Agreements To Refine a National Surveillance System for Hospital Health Care Workers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Announcement 786]

Cooperative Agreements To Refine a National Surveillance System

for Hospital Health Care Workers

Introduction

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

availability of fiscal year (FY) 1997 funds for cooperative agreements

to refine a surveillance system for health care workers (HCWs) in

hospital settings that will lead to the prevention of occupational

transmission of bloodborne infections, vaccine-

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preventable diseases, tuberculosis (TB), and other occupational

hazards.

CDC is committed to achieving the health promotion and disease

prevention objectives of Healthy People 2000, a national activity to

reduce morbidity and mortality and improve the quality of life. This

announcement is related to the priority area of 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, 304, 306, 308(d),

and 317(k)(2) of the Public Health Service Act, as amended [42 U.S.C.

241, 242b, 242k, 242m(d) and 247b(k)(2)]. Applicable program

regulations are found in 42 CFR 51b and 52, Project Grants for

Preventive Health Services and Research Projects.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the nonuse of all tobacco products, and

Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in

certain facilities that receive Federal funds in which education,

library, day care, health care, and early childhood development

services are provided to children.

Eligible Applicants

Eligible applicants include only U.S. public and non-profit private

hospitals. Applicants must have an established surveillance system or

program for occupational exposures to HCWs which includes a written

protocol, plan, or policy including data collection forms. Eligibility

requirements must be clearly specified under background information in

Application Content.

Competition is limited to hospitals as defined above because the

purpose of this program is to refine a surveillance system for HCWs in

hospital settings.

Identifiable information provided to CDC through this agreement

will be maintained in accordance with the assurance of confidentiality

provided to hospitals participating in the National Surveillance System

for Hospital HCWs (NaSH) System under Section 308(d) of the Public

Health Service Act [42 U.S.C. 242m(d)].

Availability of Funds

Approximately $350,000 is available in FY 1997 to fund

approximately 8 awards. It is expected that the average award will be

$45,000, ranging from $30,000 to $60,000. It is expected that the

awards will begin on or about September 30, 1997, and will be made for

a 12-month budget period within a one-year project period. Funding

estimates may vary and are subject to change.

Note: Effective January 1, 1996, Public Law 104-65 states that

an organization described in section 501(c)(4) of the Internal

Revenue Code of 1986 which engages in Lobbying activities shall not

be eligible for the receipt of Federal funds constituting an award,

grant (cooperative agreement), contract, loan, or any other form.

Use of Funds

Cooperative agreement funds will not be used for the delivery of

clinical/therapeutic services.

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of Department

of Health and Human Services (HHS) funds for lobbying of Federal or

State legislative bodies. Under the provisions of 31 U.S.C. Section

1352 (which has been in effect since December 23, 1989), recipients

(and their subtier contractors) are prohibited from using appropriated

Federal funds (other than profits from a Federal contract) for lobbying

Congress or any Federal agency in connection with the award of a

particular contract, grant, cooperative agreement, or loan. This

includes grants/cooperative agreements that, in whole or in part,

involve conferences for which Federal funds cannot be used directly or

indirectly to encourage participants to lobby or to instruct

participants on how to lobby.

In addition, the FY 1997 Departments of Labor, HHS, and Education,

and Related Agencies Appropriations Act, which became effective October

1, 1996, expressly prohibits the use of 1997 appropriated funds for

indirect or ``grass roots'' lobbying efforts that are designed to

support or defeat legislation pending before state legislatures.

Section 503 of this new law, as enacted by the Omnibus Consolidated

Appropriations Act, 1997, Division A, Title I, Section 101(e), Public

Law 104-208 (September 30, 1996), provides as follows:

Section 503(a) No part of any appropriation contained in this

Act shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * *

except in presentation to the Congress or any State legislative body

itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any

activity designed to influence legislation or appropriations pending

before the Congress or any State legislature.

Background

In recent years, occupational hazards faced by HCWs in the United

States have received increasing attention. Existing surveillance

systems are often inadequate to describe the scope and magnitude of

occupational exposures to infectious agents and other occupational

hazards that HCWs experience, the outcomes of these exposures, and the

impact of preventive measures. Hospital groups and experts in

infectious disease have requested guidance and assistance from CDC to

develop a system for hospital data management, so that hospitals may

develop prevention strategies, identify emerging problems, and in

general create a safe and healthy working environment for patients and

HCWs, in accordance with Occupational Safety and Health Administration

(OSHA) requirements and CDC Guidelines for the Prevention and

Management of Occupational Exposures to Tuberculosis, Bloodborne

Pathogens and Vaccine-preventable Diseases (MMWR 1994, Vol. 43 No. RR-

13; MMWR 1990, Vol 39 No. RR-1; MMWR 1991, Vol 40 No. RR-12). Many

hospitals around the United States have requested technical assistance

from CDC to improve current surveillance systems for a variety of

occupationally acquired infections and other work-related hazardous

conditions and exposures.

CDC has developed a surveillance system that focuses on

surveillance of exposures and infections among hospital-based HCWs.

This system, modeled after the National Nosocomial Infections

Surveillance (NNIS) system for patient infections, includes

standardized methodology and software for various occupational health

issues. The system is called the National Surveillance System for

Hospital HCWs, or (NaSH). The Hospital Infections Program (National

Center for Infectious Diseases (NCID)) has developed this system in

collaboration with the Hepatitis Branch (Division of Viral and

Rickettsial Diseases, NCID), the Division of Tuberculosis Elimination

(National Center for HIV, STD, and TB Prevention), the National

Immunization Program, and the National Institute for Occupational

Safety and Health (NIOSH). Currently, the NaSH system consists of the

following surveillance modules: HCW Baseline Assessment; Routine

Tuberculin Skin Testing; Exposures to Blood/Body Fluids and Blood borne

Pathogens; Exposures to and Infections with Vaccine-Preventable

Diseases; Exposures to Infectious

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Tuberculosis Patients/HCWs; Non-infectious Injuries; and Annual HCW

Survey.

The ultimate goal and primary benefit of this cooperative agreement

program is to improve hospital surveillance methods for management of

occupational health information and the prevention of exposures at

participating hospitals. Hospitals will receive technical assistance in

order to better comply with current OSHA and CDC Guidelines for

Occupational Exposures to Tuberculosis, Bloodborne Pathogens and

Vaccine-Preventable Diseases. Technical assistance will also be

provided in the development of a standardized system of data management

for the Employee Health data for their HCWs. Information provided by

the participating hospitals about their needs will allow CDC to refine

the NaSH system, including data collection forms and software, in order

to make the NaSH system more suitable for each collaborating hospital.

Purpose

The purpose of this cooperative agreement is to assist hospitals to

improve their current methods of assessing rates and reducing

transmission of occupationally-acquired infections and other

occupationally-related adverse medical outcomes in their facilities.

With a comprehensive, organized surveillance system, hospitals will be

able to systematically monitor trends in exposures, assess the risk for

occupational infection and injury, and evaluate preventive measures

including engineering controls work practices, protective equipment,

and postexposure prophylaxis to prevent occupationally-acquired

infections.

Program Requirements

In conducting activities to achieve the purpose of this cooperative

agreement, the recipient will be responsible for the activities under

A. below, and CDC will be responsible for conducting activities under

B. below.

A. Recipient Activities

1. Improve its surveillance system for occupational exposures and

infections in order to have a comprehensive and integrated surveillance

system that includes: (a) Immunizing HCWs; (b) periodic tuberculin skin

testing; (c) reporting, follow-up, and management of occupational

blood/body fluid and bloodborne exposures; (d) reporting, management,

and follow-up of exposures to, and infections with, measles, mumps,

rubella, influenza, varicella, and TB; (e) reporting, management, and

follow-up of non-infectious occupational injuries (e.g., sprains, back

injuries).

2. Assess the level of needlestick reporting and distribute the

``Health Care Worker Survey Form'' for HCWs in occupational groups with

higher risk of needlesticks.

3. Attend a single planning/training meeting in Atlanta.

Optional Recipient Activity:

4. Recipients may elect to collect and send blood specimens from

source patients and HCWs involved in exposures to hepatitis C virus

(HCV) to CDC for PCR testing for HCV RNA.

B. CDC Activities

1. Modify the NaSH surveillance system as requested by the

recipients to maximize its usefulness to collaborating hospitals.

2. Provide technical assistance in the conduct of the surveillance

program.

3. Provide technical assistance in the improvement of on-site

hospital data management systems, such as developing data fields

customized to the institution, etc.

4. Provide training regarding the use and adaptation of NaSH

software to personnel involved in data management at the participating

hospitals.

5. Assist in the coordination of data analysis, dissemination, and

presentation of aggregated data.

6. CDC will perform:--For those hospitals that elect to send

specimens to CDC for additional HCV testing and after appropriate

informed consents are obtained--(a) supplemental testing and PCR

testing for HCV RNA of source-patients who are anti-HCV positive and

(b) PCR testing for HCV RNA at 3 and 6 month follow-up of HCWs exposed

to these source patients. PCR testing for HCV is currently not

available for commercial use in hospitals.

Technical Reporting Requirements

An original and two copies of progress reports must be submitted to

CDC, semiannually. Progress reports are due no later than 30 days after

each reporting period. The semiannual progress reports should include

annual data (e.g., inpatient days, FTEs for some occupational groups)

to calculate rates for the events for which surveillance is conducted

in this system. Progress reports should also address progress toward

overall objectives as represented in the Purpose and Recipient

Activities sections of this announcement.

A final performance report and financial status report are due no

later than 90 days after the end of the project period. Please send all

reports or other correspondence to: Sharron P. Orum, Grants Management

Officer, Grants Management Branch, Procurement and Grants Office,

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

Road, NE., Mailstop E-18, Room 314, Atlanta, Georgia 30305.

Application Content

Narrative

All applicants must develop their applications in accordance with

the Public Health Service (PHS) Form 5161-1, information contained in

this program announcement, and the instructions outlined below. Also,

the narrative must be limited to 10 pages excluding appendices and

should include the following:

1. Background information about the facility including: Eligibility

requirements (documentation about surveillance system or program for

occupational exposures to HCWs which includes a written protocol, plan,

or policy). Provide the names and job titles for all personnel in the

Employee Health and Infection Control Departments of the medical

center. Applicant should provide information about: (1) The patient

population (i.e., annual number of outpatient visits, inpatient

admissions, patients with HIV/AIDS, and patients with TB); (2) the HCW

population (i.e., total number of HCWs, number of nurses, physicians,

and housekeepers); and (3) the occupational exposures in previous year

(i.e., number of exposure-events and HCWs exposed to measles, varicella

and TB; total number of percutaneous injuries and number of

percutaneous injuries involving source patients infected with HIV and

with HCV.)

2. Information about how the project is to be organized, staffed,

and managed. This information should demonstrate an understanding of

important events or tasks and their management. Include the names and

proposed duties of professional personnel assigned to the project and

resumes with information on education, background, recent experience,

and specific scientific or technical accomplishments. The approximate

percentage of time each individual will be available for this project

must be stated. The proposed staff hours for each individual should be

allocated against each project task or subtask.

3. Information about the facilities and computer equipment to be

used in the performance of the cooperative agreement.

4. The objectives of the proposed project which are consistent with

the purposes of the cooperative agreement and which are measurable and

time-phased.

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5. The methods which will be used to accomplish the objectives of

the cooperative agreement. Describe activities and methods and

supporting resources already in place and/or planned, including

capacity and experience to coordinate data collection and analysis.

6. An evaluation plan to monitor progress toward the achievement of

the proposed objectives.

7. Letters of support to demonstrate appropriate collaboration with

other departments, divisions, etc., in the hospital, if applicable,

(e.g., administrative officers, employee health, infectious diseases,

and department chair).

8. A budget which is reasonable and consistent with the purpose and

objectives of the cooperative agreement. All budget items should be

itemized and items individually justified.

The application should be presented in a manner which demonstrates

the applicant's ability to address the proposed activities in a

collaborative manner with CDC.

Format

Pages must be clearly numbered, and a complete index to the

application and its appendices must be included. Please begin each

separate section on a new page. The original and each copy of the

application set must be submitted unstapled and unbound. All material

must be typewritten, single-spaced, with unreduced type on 8\1/2\'' by

11'' paper, with at least 1'' margins, headings and footers, and

printed on one side only.

Evaluation Criteria

Applications will be reviewed and evaluated based on the following

criteria: (Total 100 points)

1. The applicant's understanding of the purpose of the proposed

program objectives and the willingness to cooperate with CDC. (20

points)

2. The extent to which the applicant demonstrates understanding of

the need for systematic and integrated surveillance, and for utilizing

data to assist in prevention of occupational transmission of bloodborne

infections, vaccine-preventable diseases, TB, and other occupational

hazards. (15 points)

3. The extent that the applicant has the organizational structure,

administrative support, and ability to access appropriately defined

target populations. (10 points)

4. A statement of the applicant's demonstrated capabilities and

experience in conducting surveillance of occupational exposures and

infections. (15 points)

5. The adequacy of the plans to coordinate and conduct the project

objectives described under recipient activities and supporting evidence

that applicant can successfully perform these activities. (25 points)

6. The degree to which the proposed objectives are consistent with

the defined purpose of this program, specific, measurable, and time-

phased. The degree to which the applicant has met the CDC policy

requirements regarding the inclusion of women, ethnic, and racial

groups in proposed research. This includes: (a) The proposed plan for

the inclusion of both sexes and racial and ethnic minority populations

for appropriate representation; (b) the proposed justification when

representation is limited or absent; (c) a statement as to whether the

design of the study is adequate to measure differences when warranted;

and (d) documentation of plans for recruitment and outreach for study

participants that includes the process of establishing partnerships

with community(ies) and recognition of mutual benefits. (15 points)

7. Human Subjects: If the proposed project involves human subjects,

whether or not exempt from the DHHS regulations, the extent to which

adequate procedures are described for the protection of human subjects.

Recommendations on the adequacy of protections include: (a) Protections

appear adequate and there are no comments to make or concerns to raise,

(b) protections appear adequate, but there are comments regarding the

protocol, (c) protections appear inadequate and the ORG has concerns

related to human subjects, (d) disapproval of the application is

recommended because the research risks are sufficiently serious and

protection against the risks are inadequate as to make the entire

application unacceptable. (not scored)

8. The extent to which the budget is reasonable, clearly

justifiable, and consistent with the intended use of cooperative

agreement funds. (not scored)

Executive Order Review 12372 Review

Applicants are subject to Intergovernmental Review of Federal

Programs as governed by Executive Order 12372. E.O. 12372 sets up a

system for State and local 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 in the State

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

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

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

any state process recommendations on applications to CDC, they should

forward them to Sharron P. Orum, 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-18, Atlanta, Georgia 30305, no later than 30 days after the

application deadline date. The granting agency does not guarantee to

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

receives after that date.

Public Health System Reporting Requirement

This program is subject to the Public Health System Reporting

Requirements. Under these requirements, all community-based

nongovernmental applicants must prepare and submit the items identified

below to the head of the appropriate State or local health agency(s) in

the program area(s) that may be impacted by the proposed project no

later than the receipt date of the Federal application. The appropriate

State or local health agency is determined by the applicant. The

following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled ``Public Health

System Impact Statement'' (PHSIS), not to exceed one page, and should

include the following:

1. A description of the population to be served.

2. A summary of the services to be provided.

3. A description of the coordination plans with the appropriate

State or local health agencies.

If the State and/or local health official desires a copy of the entire

application, it may be obtained from the State Single Point of Contact

(SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance number is 93.283.

Other Requirements

Paperwork Reduction Act

Approval for data collection initiated under this cooperative

agreement is going through the Office of Management and Budget (OMB)

reports clearing process.

[[Page 39000]]

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the DHHS Regulations (45 CFR Part 46)

regarding the protection of human subjects. Assurance must be provided

to demonstrate that the project will be subject to initial and

continuing review by an appropriate institutional review committee. The

applicant will be responsible for providing evidence of this assurance

in accordance with the appropriate guidelines and form provided in the

application kit.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for Disease Control and Prevention

(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)

to ensure that individuals of both sexes and the various racial and

ethnic groups will be included in CDC/ATSDR-supported research projects

involving human subjects, whenever feasible and appropriate. Racial and

ethnic groups are those defined in OMB Directive No. 15 and include

American Indian, Alaskan Native, Asian, Pacific Islander, Black and

Hispanic. Applicants shall ensure that women, racial and ethnic

minority populations are appropriately represented in applications for

research involving human subjects. Where clear and compelling rationale

exist that inclusion is inappropriate or not feasible, this situation

must be explained as part of the application. This policy does not

apply to research studies when the investigator cannot control the

race, ethnicity and/or sex of subjects. Further guidance to this policy

is contained in the Federal Register, Vol. 60, No. 179, pages 47947-

47951, dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the application PHS Form 5161-1

(revised 5/96, OMB Number 0937-0189) must be submitted to Sharron P.

Orum, Grants Management Officer, Grants Management Branch, Procurement

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

255 East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta,

Georgia 30305, on or before August 22, 1997.

1. Deadline: Applications shall be considered to meet the deadline

if they are either: 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 group. (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 proof of timely mailing.)

2. Late applications: applications which do not meet the criteria

in 1.a. or 1.b. above are considered late applications. Late

applications will not be considered and will be returned to the

applicant.

Where To Obtain Additional Information

To receive additional written information call (404) 332-4561.

You will be asked to leave your name, address, and telephone number

and will need to refer to Announcement Number 786. You will receive a

complete program description, information on application procedures,

and application forms.

If you have questions after reviewing the contents of all

documents, business management technical assistance may be obtained

from Locke Thompson, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-18, Room

314, Atlanta, Georgia 30305, telephone (404) 842-6595, or through the

Internet or CDC WONDER electronic mail at: [email protected]. Programmatic

technical assistance may be obtained from Scott Campbell, R.N., MSPH,

or Denise Cardo, M.D., HIV Infections Branch, Hospital Infections

Program, National Center for Infectious Diseases, Centers for Disease

Control and Prevention (CDC), Mailstop E-68, Atlanta, Georgia 30333,

telephone (404) 639-6425, or through the Internet or CDC WONDER

electronic mail at: [email protected].

You may obtain this and other CDC announcements from one of two

Internet sites on the actual publication date: CDC's homepage at http:/

/www.cdc.gov or at the Government Printing Office homepage (including

free on-line access to the Federal Register at http://

www.access.gpo.gov).

Please refer to Program Announcement Number 786 when requesting

information and submitting an application on the Request for

Assistance.

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) 512-1800.

Dated: July 15, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-19060 Filed 7-18-97; 8:45 am]

BILLING CODE 4163-18-P