RFTOP.JZ.doc

DEPARTMENT OF HEALTH AND HUMAN SERVICES

PUBLIC HEALTH SERVICE

CENTERS FOR DISEASE CONTROL AND PREVENTION

National Center for Emerging Zoonotic and Infectious Diseases

ATLANTA, GEORGIA

PART 1 - REQUEST FOR TASK ORDER (TO) PROPOSALS

1. Point of Contact Name Linda Williams Email: lwilliams6@cdc.gov

Phone: 770-488-2692 Mailing Address:

CDC/PGO

Linda Williams, Contract Specialist 2920 Brandywine Road, Room 3626 Atlanta, GA 30341-5539

2. Proposed Period of Performance: Work shall begin from date of award of the order and shall continue for a period of 24 months.

3. Severability: Non severable

4. Proposal Instructions: Proposals are to be submitted via email to Linda Williams, lwilliams6@cdc.gov by XXX EST on __________.

Questions are also to be submitted via email to Linda Williams, lwilliams6@cdc.gov by COB ___________.

5. Contract reference: This Request for Task Order Proposal is consistent with the purposes for which the Healthcare Epidemiology and Infection Control contract was awarded. .

6. Page Suggestion: The Contractor shall limit the proposal for this task order to [25] single-spaced pages of text for the technical proposal; the page limit does not include appendices, resumes, or the budget spreadsheets. The narrative plan shall include a general approach, a staffing and management plan, organization chart and key deadline dates.

7. Price proposal format suggestion: The budget shall be included as an appendix as an Excel spreadsheet, with an itemized budget per task, including itemized budgets for any subcontracted work. Budgets, staff hours, and other direct costs for this task order request shall be organized around the tasks and related deliverables described herein. Budgets for any additional or alternative proposals by the contractor shall be presented as optional budget spreadsheets. For tasks with multiple deliverables CDC requests the contractor to provide budgets for each major activity.

PART II – DESCRIPTION OF WORK

1. Identification Section:

a. RFTOP Descriptive Title: [Environmental Interventions to Prevent Healthcare Associated Infections]

b. RFTOP No.: [________________]

c. Functional Domain:

FORMCHECKBOX

1 - Research Implementation

FORMCHECKBOX

2- Research Development

FORMCHECKBOX

3 - Evaluation

FORMCHECKBOX

4 - Project Support Services

STATEMENT OF WORK

Background and Need The Centers for Disease Control and Prevention is seeking to partner with healthcare delivery systems to evaluate the impact of interventions designed to prevent healthcare associated infections. The goal is to create a clinical research network in which actionable new knowledge about prevention of HAIs can be created. The purpose of this sample task order is to provide an opportunity for Offerors to demonstrate the capacity to implement multicenter HAI prevention research.

Objectives In recent year, there has been increased national attention to the role of contamination of the patient care environment in the transmission of epidemiologically important pathogens such as C. difficile. For the purposes of this task order, Offerors should assume they would be provided with a detailed study protocol designed to test the impact of a novel environmental cleaning agent that is highly effective at killing microorganisms on environmental surfaces. In developing the research implementation plan, the Offeror should assume that the novel environmental cleaning agent is identical in cost to agents currently used in study hospitals, and is applied using methods identical to those currently used in study hospitals.

The overall objective of this project is to test the hypothesis that routine use of the novel cleaning agent for routine environmental cleaning in hospitals will reduce HAI rates in comparison to standard cleaning agents.

The two specific tasks are as follows:

1. In a multicenter cluster randomized trial, compare the effectiveness of use of the novel cleaning agent for routine environmental cleaning for prevention of HAI in hospitals.

2. Develop a searchable database from source data.

Scope of Work The contractor shall provide all labor, expertise, materials, supplies and perform all services required to carry out the work under this contract. The Offeror should describe their capacity and approach to implementing the study protocol, which will be a cluster randomized, multicenter trial designed to test the effectiveness of routine use of the novel cleaning agent as a strategy for preventing HAIs.

General Information Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and/or associated healthcare facilities as required.

Type of Contract: The government will award a cost plus task order, with a request for a second CLIN for reimbursable travel; costs as indicated below.

Contractor Travel: Contractor will be required to travel during the performance of this contract for data collection. It is anticipated that site visits may be required to each site. Travel costs are estimated to be 40 trips @ $1,250 per trip. Total estimated travel costs: $50,000. Contractor will be authorized travel expenses consistent with the substantive provisions of the Federal Travel Regulation (FTR) and the limitation of funds specified in this contract.

Data Rights (If applicable): The Government has unlimited rights to all documents/material produced under this contract. All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

Confidentiality of Information: Work on this project may require that personnel have access to Privacy Information. Personnel shall adhere to the Privacy act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations. The user agency will identify and provide direction and guidance for safeguarding all information subject to the Privacy Act. Reports and case files containing individual personal information are confidential. The CDC is not authorized to release individual case reports, and access to individual case data is strictly controlled. The contractor personnel are required to work with case records as well as databases. It is a requirement that the data remain in a controlled access environment.

Section 508: Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

Regardless of format, all Web content or communications materials produced for publication on or delivery via CDC Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an CDC-funded or CDC-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material. Checklists for various file formats are available at http://www.hhs.gov/web/508/index.html.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

36 CFR 1194.21 (for software and programmatic elements in websites), 36 CFR 1194.22 (for documents and websites), and 36 CFR 1194.24 (for video and multimedia content) References:

HHS Policy for Section 508 Electronic and Information Technology (E&IT) (January 2005): http://www.hhs.gov/od/Final_Section_508_Policy.html HHS Section 508 Web site: http://508.hhs.gov/ HHS ASPA Web Communications Division Web site: http://www.hhs.gov/web/policies/index.html US General Services Administration (GSA) Section 508 Web site: http://www.section508.gov/index.cfm 1 Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

Other or Special Considerations CDC Collaboration & Scientific Input. The investigative team is expected to work collaboratively with the CDC program staff on scientific and analytic issues. CDC and designated staff will provide clinical, methodological, or other expertise project based on their training, experience and research interests.

The vendor will work in concert with a study Steering Committee for the project comprised of experts from CDC and its affiliated Investigators, and other experts as needed.

Government Furnished Property, Equipment, and Services None Tasks The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract.

Task 1: Start Up Meeting

· The Contractor shall arrange and conduct an initial meeting (either in person or by teleconference) with the CDC Project Officer and other relevant staff within 2 weeks of the effective date of the task order. The purpose of the meeting will be to review and clarify the scope of work and delivery schedule for tasks, to delineate roles and responsibilities, and to establish communication protocols. Each task and deliverable will be reviewed.

· The Contractor shall submit an agenda for the above meeting within 1 week of the effective date of the task order.

Task 2: Maintain Communication with the Project Officer

· The Contractor shall coordinate with the CDC Project Officer. The Contractor shall maintain regular communications with the Project Officer and CDC staff involved with the project. The chief means of communication will be via conference calls that will be scheduled every month throughout the project period required to complete the project. Additional calls will be scheduled as needed. The Contractor shall provide an agenda and meeting minutes for each call. All conference calls shall be scheduled and administered by the Contractor. The Contractor shall respond to all emails and telephone communications from the Project Officer within 2-3 working days.

Task 3: Quarterly Progress Reports

· On the 10th day following the 3 months being reported, the contractor shall prepare and submit a quarterly progress report containing the current status of work and a financial status report. The report shall contain, at a minimum, the current progress on each of the requirements set forth below, the financial status of the project, problems encountered during the month, solutions implemented, planned activity for the upcoming month and any other information mutually agreed upon between the contractor and the CDC Project Officer.

Task 4: Develop Overall Research Plan

· Research Design: The study will follow a protocol provided by CDC to be available at time of award. The study design will be a cluster randomized trial that assesses the comparative effectiveness of routine environmental cleaning with the novel cleaning agent and a comparator cleaning agent. Participating hospitals will be randomized to one of two arms in which routine environmental cleaning will be performed using either the novel cleaning agent or the comparator agent. The intervention period will last for 6 months. The Offeror should assume that the novel and comparator cleaning agents are identical in cost to agents currently used in study hospitals, and are applied using methods identicial to those currently used in study hospitals. The offeror should assume that compliance with use of the study and comparator agents will be monitored through volume of product used and direct observation on a sample of daily patient room cleanings. The primary outcome will be the hospital-wide incidence of HAI as defined using CDC surveillance definitions (see section C). Secondary outcomes will include the hospital-onset incidence of all-cause bacteremia, and the incidence of certain multi-drug-resistant organisms (see section C).

Task 5: Facility Recruitment

· At least 10 hospitals shall be recruited to participate.

· The Contractor should include plans for a formal mechanism to conduct the proposed intervention.

Task 6: Preparation of IRB packages

· If required, the Contractor shall prepare all forms and materials to submit the data collection tool for IRB Clearance. All evaluation instruments must be approved by CDC staff prior to submission for IRB clearance and/or administration to prospective respondents. In conjunction with CDC, the Contractor will respond to all questions from OMB and will prepare the final package for clearance by OMB.

Task 7: Data Collection and Analysis Database: The vendor shall create a database of all source data from the project that is searchable. The database will include elements related to intervention assignment and implementation, hospital location, compliance with intervention, data sufficient for calculating incidence rates for HAI (central line-associated bloodstream infections, ventilator-associated pneumonia, catheter associated urinary tract infections). As a secondary outcomes, the incidence of bacteremia (as defined by a positive blood culture), as well as incidence of MRSA, C. difficile, and multidrug-resistant Acinetobacter spp. using the method defined by the Society for Healthcare Epidemiology’s white paper entitled “Recommendations for Metrics for Multidrug‐Resistant Organisms in Healthcare Settings: SHEA/HICPAC Position Paper” (Cohen et al, Infection Control and Hospital Epidemiology.2008;29:901-913) In addition, Administrative data sufficient for case mix adjustment, and data related to emergence of relevant antimicrobial resistance patterns Analysis: The vendor shall make the database available to CDC investigators for analysis. It is expected that the results of the study will be prepared for publication in peer-review scientific literature. The vendor may participate in manuscript preparation and authorship as appropriate if desired.

Task 8: Final Report

· There will be total of 3 reports submitted for CDC approval, preliminary, final draft, and final. The Contractor shall present a final report of the project to the CDC Project Officer within 4 weeks after receiving comments and recommendations on the draft report. The Contractor shall submit the final report, incorporating CDC’s comments and recommendations. The report shall include with it, all documentation including raw and computed data and programming collected with this task order. The submission shall be in both paper and electronic format.

· The Contractor will electronically submit the final report to the PO. The finalized report is to be “camera ready”, meaning that the report should be accurate, complete, and suitable for preparation of negatives.

· Camera-ready copy is printed on one side of the page only; pages are numbered according to CDC’s convention (e.g., lower case roman numerals for front matter; Arabic numbers for body of the report); pages have a 1-inch margin all around; margin for side that will be bound must be 1 inch to avoid losing text. Endnote or other reference manager software should be used to compile reference lists and bibliography. Citations should be “grabbed” electronically by the software from PubMed or another source to render them as accurate as possible. In addition to hard copy, the report is to be submitted on disks (WordPerfect or Microsoft Word) for use in Web preparation. Appendices should be submitted only electronically on a CD. Electronic files for charts, etc., prepared in another program (e.g., Excel) must be submitted. Tables and charts must be delinked from underlying databases.

Deliverables Summary Table The following deliverables shall be provided to the Project Officer and relevant CDC staff no later than the dates specified below:

Frequency Due Date

Preliminary Evaluation Plan with proposed design, methodology, analytic strategy, timeline, and budget Final Evaluation Design and Executive Summary 1 Draft 1 Final As scheduled in evaluation work plan

1 Final As scheduled in evaluation work plan

Final IRB Clearance Package 1 Draft 1 Final Within 10 days of CDC approval Within 5 days of receipt of comments on draft IRB Clearance Package CDC

Coordination of multiple data collection activities Periodic review of data collection procedures and quality

Electronic report Electronic and paper copy of the final report, and all data collection and analysis instruments 1 Preliminary Draft 1 Final Draft 1 Final Report

Within 20 months of contract award Within 21 months of contract award Within 23 months of contract award

TECHNICAL EVALUATION CRITERIA

Award: This Task Order will be awarded to the Offeror whose proposal is considered to be the most advantageous to the Government, price and other factors (identified below) considered. For purposes of this evaluation; technical factors, (methodology/approach, staffing/management and experience) are more important in making the award determination. The Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance.

Technical Evaluation: Technical proposals will be evaluated according to the criteria set forth below:

Points or relative Criteria

Value of Criteria

Methodology and Approach

Similar Experience

Staffing and Management

TOTAL SCORE

1) Methodology and Approach (40 points)

a. The Offeror shall provide a brief review of the issues(s)/problem(s) associated with performing this type of research which underscore the concept of and need for this RFTO.

b. The plan should describe in detail the current relationship the vendor has to potential study hospitals, including detailed description of the hospitals (bed size, populations, geographic location, for-profit status, academic affiliation, etc.), a detailed plan for hospital recruitment, a detailed description of current infrastructure among potentially participating hospitals that will facilitate both implementation of the intervention as well as collection of process and outcome data necessary for analysis.

c. The plan should include a detailed plan for outcome data collection, including current HAI surveillance methods in place in potentially participating hospitals, laboratory and other clinical information systems currently in use in potential participating hospitals that will facilitate collection of process and outcome data.

d. The proposal shall be evaluated on the Offeror’s demonstrated capability for recruiting hospitals into the project. Offerors who already have recruited hospitals and submit signed letters of commitment with their proposal shall receive full points.

e. The technical approach shall be evaluated on the completeness, reasonableness, clarity, and feasibility of the approach to satisfy the requirements of the Task Order.

2) Similar Experience (25 points)

a. The proposal shall be evaluated on the Offeror‘s demonstrated experience in conducting and managing projects relevant to the content and complexity of this Task Order.

5). Staffing and Management: (35 points)

a. Contractors are to provide (1) a staffing plan that demonstrates and understanding of the labor requirements for this task order; and (2) a management plan that describes the approach for managing the work, to include subcontract management if applicable. Curriculum vitae should be provided, detailing relevant training and experience for each key person. Ideal staffing to successfully accomplish the tasks of this acquisition:

1. Principal investigator with sufficient time devoted to overseeing the implementation of the project. This person should have experience executing evaluation research projects related to Public Health or Infectious Disease. Demonstrated experience specifically with Healthcare-associated infections or infection control and prevention settings will be considered a plus.

2. Project co-coordinator with experience in developing and executing research projects.

3. Epidemiologist/Statistician/Research Associate with experience in quantitative and qualitative data collection and analysis.

This criterion will be evaluated according to the soundness, practicality, and feasibility of the offeror’s staffing and management plans for this task order.

6). Cost Evaluation: (Not scored)

b. A cost analysis of the business cost proposal shall be conducted to determine the reasonableness of the proposal.