RFTOP.JY.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: [Cohort study of patients at risk for C.diff infection]

b. RFTOP No.: [________________]

c. Functional Domain:

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1 - Research Implementation

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2 - Research Development

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3 - Evaluation

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4 - Project Support Services

STATEMENT OF WORK

Background and Need The Centers for Disease Control and Prevention is seeking to partner with integrated systems of healthcare, health insurance plans, and other providers of healthcare data to perform studies relevant to the prevention of 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 research using data routinely collected during the course of providing healthcare, and in particular the existing capacity to collect such data in standardized fashion from large numbers of healthcare facilities and/or across large numbers of lives covered by insurance providers.

Objectives The specific task is to create and provide a dataset that can be analyzed to accomplish the study aims, which are as follows:

1. Determine the background rate of CDI among patients in a large number of healthcare facilities and/or among patients covered by a specific insurance provider or group of providers and document any trends.

2. Describe the demographics and other potential risk factors related to these infections and document any changes over time. Other risk factors may include specific medical procedures, pre-existing conditions, length of stay, antibiotics and other medications prescribed, previous hospitalizations, etc.

3. Describe the frequency of reoccurrence of these infections among persons, any potential risk factors for reoccurrence, and any resulting morbidity/mortality from CDI, including re-hospitalization.

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. Clostridium difficile infection (CDI) is one of the most common healthcare associated infections and is a potentially serious infection which may result in death. Especially within the last decade, the incidence of CDI has been increasing over time, and the risk of CDI is higher among older patients as well as those admitted to healthcare facilities. However, the epidemiology of CDI is still not well understood, especially regarding the reoccurrence of disease and how reoccurrence impacts resource utilization across the spectrum of care settings. At the time of award offerors will be provided with a detailed protocol for a descriptive epidemiologic study which will follow patient cohorts over time longitudinally to determine the background rate of CDI as well as seek to identify any particular factors or trends related to CDI. In addition, a sub-cohort of participants who experience at least one infection will be created in order to study potential factors related to occurrence of CDI, the reoccurrence of CDI, any factors or trends in the reoccurrence of infection, and potentially any resulting morbidity/mortality of CDI, including re-hospitalization.

General Information Place of Performance: The work to be performed under this contract will be performed at the Contractor’s facility and 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 NOT be required to travel during the performance of this contract for data collection.

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 Offeror, will be invited to participate in a study steering group and participate in authorship of any manuscripts that might result.

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: This is a retrospective epidemiologic study in which will follow a cohort of patients over time longitudinally to determine the background rate of these infections as well as seek to identify any particular factors or trends related to CDI infection. The retrospective study period over which the cohort will be followed should span a minimum of at least two years, but up to 10 years or more is desirable. For insurance providers who are able to follow patients across the continuum of inpatient and outpatient care, the exposed cohort will consist of adults and children with at least one year of continuous health plan enrollment without any listed CDI within the study period. For Offerors who have access only to information collected during inpatient stays, the exposed cohort will consist of hospitalized adults and children without any evidence of CDI identified within that hospital during the study period. A case of CDI will be defined as a hospitalization of greater than 1 day with the ICD9 Code: 008.45. In addition, Offerors who are able to supplement administrative claims data with C. difficile laboratory test results are preferred. A number of potential factors that could be related to trends in CDI or in the incidence of re-occurrence of CDI will be examined and may include: age, gender, time, season, length of prior hospital stay, and occurrence of certain medical procedures. This information will be obtained from various electronic data sources, including clinical, administrative and operational data. In addition, a sub-cohort of participants who experience at least one infection will be created in order to study potential factors related to occurrence of CDI, the reoccurrence of CDI, any factors or trends in the reoccurrence of infection, and potentially any resulting morbidity/mortality of CDI.

Task 5: Facility Recruitment

· Data from at least 20 hospitals or from integrated systems of care or insurance providers that cover at least 900,000 lives should be included. Systems that are able to collect data from larger numbers of facilities or for larger numbers of covered lives are preferred.

· 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 the study question including, but not limited to, data sufficient for calculating incidence rates for CDI by location (hospital unit or outpatient setting), relevant clinical data including pharmacy, laboratory, procedure data and admission discharge transfer (including ICD-9 codes. Patient specific identifiers that allow for linking data from the same patient across multiple hospitalizations is necessary.

· 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 between vendor and participating hospitals or insured populations and the hospitals where they receive care, including whether or not there is currently an existing administrative relationship between vendor and facilities or between participating facilities.

c. The plan should describe in detail the pool of hospitals or insured populations from which participants will be recruited.

d. The plans should describe in detail the plan for hospital or insurance provider recruitment including justification for why successful recruitment can be anticipated.

e. The plan should describe a detailed description of laboratory and other clinical information systems (e.g. electronic medical record or shared platform for collecting clinical and laboratory data in a standardized format) among potential hospital or insurance provider participants and how this infrastructure can be used to facilitate collection of data. Offerors who have an established infrastructure for collecting electronic clinical data in a standardized fashion from multiple facilities or from a large insured population in a short period of time are preferred. The information systems should have the capacity to track individuals across multiple hospitalizations and/or other contacts with the healthcare system.

f. The plan should describe in detail how issues related to data sharing among facilities or insurance providers will be addressed.

h. The plan should include letters of support from one or more potential hospital participants. If applicable, past evidence of research partnerships with the identified stakeholder should be described. Stakeholders should indicate their willingness to participate in HAI prevention research.

i. 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.

3) 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.

4) Cost Evaluation: (Not scored)

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