RevisedAttach18AddtlBusProposalInstr.pdf

Attachment 18 – Additional Business Proposal Instructions, Revised 7/16/15

Additional Business Proposal Instructions

In addition to the instructions and format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this attachment is intended to provide uniform cost assumptions that apply to the solicitation.

Offerors are advised to give careful consideration to the Statement of Work, all reference material provided as attachments, the technical evaluation criteria and the RFP, as a whole, in the development of the proposal. The information requested here should be used as further guidance for the development of the Business Proposal.

D.5.d and E.5.d Option 1 Subtask 5.4 Immunohistochemistry D.8.c and E.8.c Option 2 Subtask 8.3 Returning Data to Tissue Source Site

Both of the above option subtasks will be exercised at the request of the COR and shall be conducted in a CLIA certified laboratory. These subtasks shall be exercised within the appropriate period of performance at the discretion of the Government. Offerors must propose on all tasks and subtasks, including the two subtasks noted above. However, Offerors must price both Option 1 and Option 2 Subtasks separately for the base period and all options.

Section L of the RFP specifies the minimum documentation required for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section. Cost and pricing support should be provided for all proposed subcontractors.

This acquisition will utilize a hybrid approach that combines both cost reimbursement and fixed price elements. In preparing the business proposal and budget, the offerors shall provide a detailed description of how their proposed work breakdown structure is reflected in their budget. Offerors shall provide sufficient detail on how the different assumptions described in the Statement of Work affect their budget, staffing and costs at each level of the workflow performed at the BCR.

Cost Assumptions

For the option years, it is expected that the BCR will process more tissue and spend less time on the cost reimbursement elements; therefore, there is an anticipated reduction in the cost reimbursement elements of 50% and a > 100% increase in tissue processing. In Year 5 of the project, the work should begin to scale back to processing only out-year clinical research forms. The budget shall reflect these assumptions in addition to those described in the Statement of Work.

Cost Reimbursement

Information on the costs for the below elements of the Statement of Work should be reflected in the cost reimbursement section of the budget:

Attachment 18 – Additional Business Proposal Instructions, Revised 7/16/15

The cost for developing clinical data collection forms (including attendance of biospecimen working group and tissue accrual network calls).

The cost for developing standard operating procedures and coordinating for development of these SOPs with other BCR contractors.

The cost for implementation of automation and robotics for different steps of the pipeline. Both the costs of implementing automation and the value of automation at specific steps of the tissue processing pipeline should be enumerated.

The cost for technology development, including software development and modifications, development of new protocols (e.g. performing WGA onsite instead of shipping to subcontractor).

The cost for risk of accelerating and/or decelerating tissue processing pipeline;

due the likelihood of variability in tissue accrual over time, there may be times where the BCR needs to substantially increase throughput in order to process tissues in a timely fashion. The offeror should delineate the risk of any costs associated with this acceleration and subsequent deceleration.

The cost for performing training for a specific site, including all teleconferences and on-site training.

The cost for 5 total members of the Contractor’s staff to attend two steering committee meetings per year.

Fixed Price

A number of elements of this Statement of Work will be funded using a fixed-price mechanism on a per-case basis. Therefore the offeror shall provide a detailed proposal of their fully-loaded (including all personnel labor involved), price for the following work:

The cost of clinical data collection should be described on a per TSS and per case basis and offerors shall describe the variables that affect the range of costs associated with collection of clinical data.

Offerors should provide the cost for the initial data collection as well as any costs associated with follow-up data collection at 6-month intervals or at an additional time point, as described in the SOW.

The cost of clinical data conversion, per case, to the required format for distribution to the OTS-CDR.

The total costs of sample processing at the BCR, per case, entering the BCR (i.e.

prior to required pathology and molecular analyte steps), the cost of processing a case for pathology, the cost for processing molecular analytes and the cost per case leaving the BCR (qualified case) should be provided.

Additionally, the costs on a per-tumor basis should also be provided and the variables that pose as risks to achieving this cost. The offerors should determine, for example, what flow rate of samples must be guaranteed in the door at BCR to ensure staffing can be maintained at the levels described in their offer.