Attachment_11_Additional_Technical_Proposal_Instructions.pdf

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Additional Technical Proposal Instructions

Biospecimen Core Resource (BCR)

These Additional Technical Proposal instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH solicitations, these Additional Technical Proposal instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used, along with Section L. to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal.

Offerors are advised to give careful consideration to the Statement of Work (SOW) and Sample Task Order, Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

A detailed work plan should be submitted indicating how each aspect of the Statement of Work is to be accomplished. Offerors’ responses should include discussion of technical approach, personnel proposed, organizational experience and capabilities, facilities and equipment. Proposals that merely restate the requirements of the Government’s Statement of Work will not be eligible for award.

Offerors should submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the objectives of the Statement of Work.

Record and discuss specific factors not included elsewhere, which support your proposal. Using specifically titled subparagraphs, items may include unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

The Offeror must adhere to a 120 page limit. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated. Pages shall be of standard size (8.5x11) with a font size of 10 points or larger. Proposal pages shall be numbered “Page 1 of 120”, “Page 2 of 120” and so on. The 120 page limit excludes the cover sheet, resumes, and all appendices or attachments. The 120 page limit also excludes the proposals for the Sample Task Orders.

SECTION 1: COVER PAGES AND TABLE OF CONTENTS

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, proposal part, and identify if the proposal is an original or a copy;

B. PROJECT OBJECTIVES;

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS;

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043);

E. TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion.

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SECTION 2: TECHNICAL DISCUSSIONS

A. A detailed work plan should be submitted indicating how each aspect of the Statement of Work is to be accomplished. Offerors’ responses should include discussion of technical approach, personnel proposed, organizational experience and capabilities, facilities and equipment. Proposals that merely restate the requirements of the Government’s Statement of Work (SOW) will not be eligible for award. Offeror’s should submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the objectives of the Statement of Work

(SOW)

B. Technical Approach

Offerors should submit a proposal that addresses the Task Areas of the Statement of Work. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter(s) of commitment from the subcontractor(s), plus documentation of subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the Offeror will manage the subcontractor(s).

Separate discussions should be prepared for the different types of tasks outlined in the SOW:

Biospecimen Processing Center (BPC) and CCG Biorepository and Archive (CBA).

Program Management Plan (BPC and CBA). The Offeror shall demonstrate its understanding of the tasks outlined in the SOW, including thoroughness in planned execution in a detailed Draft Program Management Plan that addresses allocation of personnel and resources. The section of the technical proposal addressing the Offeror's technical approach shall address all of the general requirements and detailed functions outlined in the SOW.

The Offeror shall describe its experience in providing biospecimen processing services and biorepository and archive services. The description shall include examples of the previous and present contracting organizations with identical or similar projects as the ones outlined in the Statement of Work. Also, include the depth of additional staff and resources to support varying workloads or to provide back up for members of the project staff. In addition, describe the organization’s experience in appropriate use of subcontractors to supplement areas of expertise.

In addition, the narrative shall provide key aspects of deliverables that ensure attainment of programmatic goals, describe any special expertise the Offeror brings to this contract, and include descriptions of staffing, resources, and experience in biospecimen processing and biorepository.

C. Transition Plan.

The Offeror shall include a Draft Transition-In Plan comprised of the following:

The Offeror shall include a start-up plan of how the Contractor shall commence operations, including specifically the scale up of staffing (including key personnel) and operational resources as well as the incorporation of data, SOPs, and materials and other transition information.

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The Transition-In Plan shall be included in the Program Management Plan submitted with the proposal.

D. Team and Key Personnel Qualifications (BPC and CBA)

The Technical Proposal should include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. Clearly identify in a list or table showing name, highest degree, organizational affiliation (employer), role on the project and percentage of effort to be committed to the project for all Personnel including any Subcontract or Consultant Personnel. Include for each named person a Curricula Vitae (CV), that is limited to 2-3 pages and which provides selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity. Include a “Role / Personnel” organizational chart with appropriate staffing devoted to specific BPC and CBA functions (pathology review, molecular analyte isolation, quality program, etc). This organizational chart shall be responsive to the Key Personnel requirements in the following section.

1. Principal Investigator (One for each Task Area). This individual shall have a doctorate-level degree or equivalent experience, and sufficient biomedical and molecular biology knowledge to interact with other CCG investigators. This individual shall have primary responsibility for compliance with human subject’s regulations and CCG policies on human subjects as requisite for biospecimen receipt and processing. In addition s/he shall participate in scientific and policy discussions as requested by the COR or designee.

2. Project Director (One for each Task Area). This individual shall serve as overall project manager.

The project manager shall be the primary contact for day-to-day non-technical including biospecimen logistics, processing status, inventory management, and reports. This individual shall not be the same person as the Principal Investigator.

3. Laboratory Operations Director (BPC). This individual shall oversee molecular analyte processing activities at the BPC. This individual shall be Doctorate-level or equal experience in high throughput laboratories isolating and/or analyzing nucleic acids. This individual shall be the primary technical contact with the Contracting Officer Representative (COR) or designee. An individual with FACMG (Fellow, College of Molecular Genetics) certification is preferred.

4. BPC Coordinator (BPC). This individual shall serve as liaison to the CCG Genome Characterization Centers. This individual shall be qualified at a master’s degree level with extensive experience or doctorate level to understand molecular biology, genomics, oncology, and shall establish roles and systems to coordinate analyte distribution activities with the GCCs and the GSCs. Such systems will include mechanisms to collect feedback on quality of analytes.

This individual may be the same person as the Laboratory Operations Director, above.

5. Informatics Project Manager (BPC). This individual shall direct the design, operations, quality management, and process improvements for all data related operations at the BPC. An individual with a degree in computer science or information technology and with project management experience is preferred.

6. Quality Manager (BPC and CBA). This individual shall serve as a quality manager with oversight of the Quality Management System (see below) and shall have responsibility for:

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i. Proposing and establishing quality criteria for production which shall be reviewed by the COR or designee

ii. Generating reports on production to be included in the regular reports required by this

SOW

The Quality Manager shall not function as a member of the production pipeline responsible for processing samples. The Quality Manager shall be the BPC Contractor’s BPC representative to the CCG project-wide Quality Control working group.

7. Support Staff (BPC and CBA): The Offeror shall provide qualified personnel to:

i. manage all operations necessary to comply with ethical, legal, and policy regulations and policies related to human subjects’ research

ii. obtain, develop, update and manage protocols (including all SOPs) as necessary in all key aspects of the operations

iii. provide administrative support for meeting scheduling and documentation.

E. Organizational Experience

The Offeror shall demonstrate its prior organizational experience in clinical studies with specimen and data collection, and/or biorepository services with prior projects of the size, scope, and magnitude of this RFP for relevant projects. The Offeror shall include a list of all relevant projects, with descriptions, size and dollar amounts of the contracts or grants awarded, and other pertinent information. Demonstrated experience in the technologies, procedures, and multi-institutional high-through-put programs required to execute this project.

F. Standard Operating Procedures (SOPs)

Offerors shall provide current copies of all SOPs that it utilizes, or intends to utilize, to perform work under this SOW as part of the technical proposal. Offerors have the option to submit their own SOPs for the areas provided below, or to submit the SOPs provided in Attachment 27, Information for Offerors. The SOPs provided in Attachment 27, Information for Offerors, document processes that have been developed for The Cancer Genome Atlas Biospecimen Core Resource (BCR).

Offerors shall include SOPs for the following areas in their technical proposal, as part of the Program Management Plan:

1. Administrative – SOPs for administrative processes, results capture and other metrics

2. Logistics – SOPs for shipping, preparation, storage and maintenance of samples

3. Histology – SOPs for procedures for slide handling and sample preparation

4. Logistics and Histology – SOPs for processes involved in cancer tissue sample receipt, storage and distribution

5. Molecular – SOPs for DNA and RNA molecular analyte distribution

G. Facilities and Equipment

1. Facilities Information in this section is used to assess the adequacy of the organizational resources available to perform the proposed work. Identify the facilities to be used (laboratory, computer, office, and other). If appropriate, indicate their capacities, pertinent capabilities, relative

Attachment 11 Page 5 of 5 proximity and extent of availability to the project. Describe only those resources that are pertinent to the proposed project. Provide any information describing other resources available to the project and the extent to which they would be available to the project (e.g. Increases in capacity, monitoring, backup power resources, etc). Address how the environment will contribute to the probability of success of the proposed work. Also note any unique features or resources that would contribute to the probable success of the work proposed. If facilities and resources outside of the Offeror’s facilities/resources will be used to carry out the project, describe those facilities in a separate section of the document.

2. Equipment During performance of the Statement of Work, the Contractor is responsible for providing the required equipment needed to perform the work. Briefly describe major items of equipment available for the project, together with their location and pertinent capabilities, if appropriate.

Only include equipment that will be necessary to conduct the project being proposed.

Some Government Furnished Equipment (GFE) is available if needed (see Government Furnished Equipment Attachment). If an Offeror has need of any of the available GFE, the Offeror should indicate this in the technical proposal and discuss management controls for the protection of Government owned property and equipment. Following contract award, such equipment as indicated will be made available to the BPC Contractor.

3. Information Technology Systems and Support

Workflow Informatics. Describe the laboratory information management system (LIMS) and how it will be used to store, track and ship biospecimens.

Informatics and Data Delivery. Describe the systems and approach for data structure, handling, and transmittal in the framework of the requirements provided in this SOW.

H. Sample Task Order

Provide a response to the Sample Task Order Areas A and B attached to these Additional Technical Proposal Instructions.

The response to the Sample Task Order should be included as a separate section (appropriately marked) in the Technical Proposal. The page limit for the Sample Task Order proposal is 60 pages.

The Sample Task Order 60 page limit excludes the cover sheet, resumes, and all appendices or attachments. The Sample Task Order response does not count towards the technical proposal 120 page limit. The Offeror’s response to the Sample Task Order should include discussion of technical approach, personnel proposed, organizational experience, facilities and equipment.

See Attachment 26 (Sample Task Order) for details of Sample Task Order and Attachment 19, Business Proposal Instructions, for budget information.