Attachment_7_Business_Proposal_Instructions.pdf

Attachment 7 Page 1 of 4

Attachment 7: Additional Business Proposal Instructions

A budget is not required for the Base IDIQ Contract Statement of Work (SOW). Prepare a separate budget for Task Area A and or Task Area B of the Sample Task Order. If the Offeror is proposing on both Task A and Task B then a summary budget is required.

This acquisition will utilize a fixed price structure. 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.

Task Area A: Biospecimen Processing Center (BPC)

Cost Assumptions

Assume 2,500 cases per year. A case is defined as: tumor sample + germline DNA sample + recurrent tumor sample + metastatic tumor sample + normal solid tissue. Use the assumption that recurrent, metastatic, and normal solid tissue will be received in approximately 10% of the cases or approximately

250 cases.

1. The Contractor shall support the following storage environments:

i) vapor phase liquid nitrogen freezers (-190°C to -150°C)

ii) -80°C and -20°C mechanical freezers

iii) humidity and room temperature controlled areas

iv) 4°C refrigeraion

2. The Contractor shall support storage for:

i) Tumor FFPE blocks, FFPE scrolls, and slides or

ii) Tumor frozen tissue cryovials or

iii) Tumor frozen tissue in OCT blocks

iv) Normal tissue and cell pellets in cryotubes and/or

v) Normal blood and blood components in liquid and pellet form.

vi) DNA/RNA aliquots in cryovials and dilution plates

3. It is anticipated that working storage space will be required to accommodate new case objects per year. Estimated numbers for pricing calculations are as follows:

i) 22,000 glass slides stored at room temperature

ii) 500 normal tissue samples stored at -190° C

iii) 5,300 DNA samples stored at -80° C

iv) 2,800 RNA samples stored at -190° C or -80° C

v) 2,800 normal blood-derived normal stored at -190° C or -80° C

vi) 2,800 tumor FFPE blocks stored at 4° C

vii) 1,000 dilution plates stored in -80° C

The Contractor shall provide additional working storage space in the above environments to support the internal operations of the BPC for activities such as Quality Control (QC), backup, and working storage prior to shipment of analytes.

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Fixed Price

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 direct and indirect costs), price for the following work:

1. The costs of sample processing at the BPC, per case, entering the BPC and for processing a case for histological verification, the cost for processing molecular analytes and the cost per case leaving the BPC (qualified case) should be provided.

a. Specifically provide 3 costing scenarios:

i. Cost per case from intake of sample through histological verification.

ii. Cost per case from intake through molecular qualification.

iii. Cost per case from intake through shipping to GCC.

2. Cost breakdown should include administrative and professional labor, logistics, materials & supplies. All indirect costs should be included in the total cost and be presented as a total cost per case, (total loaded cost divided by the number of cases).

3. Additionally, the Offerors should determine, for example, what flow rate of samples must be guaranteed in the door at the BPC to ensure staffing can be maintained at the levels described in their offer. Provide this estimate in terms of cases per month.

4. The Government expects that general process improvement of established processes and staff training would be part of an Offeror’s Quality Management System (QMS) and thus should be a part of the Institution’s G&A or general operations infrastructure.

5. If Process Improvement is required that involves stand up of new procedures or processes, then a separate task order request will be issued with separate pricing; i.e., do not include new process implementation in the case costs, only current operating procedures.

6. A Cost reimbursement type contract is not requested, the Offeror may propose their own unique workflow structure, as long as it is first broken down into the individuals cost elements to determine reasonable, allowable and allocable costs, then rolled up into a fixed unit pricing structure. For direct labor consider the inclusion of both administrative and quality/regulatory personnel. All personnel, materials and supplies, other direct costs, associated F&A/G&A and fee should be itemized in a budget breakdown. Then the budget should be rolled up and divided by the number of expected cases (2500 cases/year for BPC) to obtain the case cost. If multiple case costs are proposed, a separate budget breakdown should be provided for each one. Provide a budget to include a one-year base and 4 one-year options. A budget narrative should accompany each budget.

7. Any related travel will be in a separate task order; do not include travel in the case costs.

8. It is recommended that cross-utilization of personnel across Task Areas A and B be considered if

Offerors propose on both Tasks.

9. A table with task breakdown by type and process is provided (Figure). Offerors may propose multiple case costs based on the table.

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Tissue Processing Task

Primary

Tumor Blood

Recurrent

Tumor

Metastatic

Tumor

Normal

Tissue

Primary

Tumor Blood

Recurrent

Tumor

Metastatic

Tumor

Normal

Tissue

Inbound shipping X X Optional Optional Optional X X Optional Optional Optional

Case registration X X Optional Optional Optional X X Optional Optional Optional

* Histology verification X X Optional Optional Optional X X Optional Optional Optional

RNA DNA co-isolation X X Optional Optional Optional X X Optional Optional Optional

*Analyte QC (SNP genotyping) X X Optional Optional Optional X X Optional Optional Optional

MSI testing (optional) X X X X

HPV testing (optional) X X X X

* Distribution (shipping) X X Optional Optional Optional X X Optional Optional Optional

* Roll-up costs to these points in the processing workflow to account for cases that may not pass the qualification steps;

i.e. fail at histology review, fail at molecular QC, or complete the processing pipeline and ship.

FFPE Frozen Tissue

Task Area B: CCG Biorepository and Archive (CBA)

For prposal preparation purposes, assume 11,000 cases will be received in Year 1, 0 new cases in year 2, up to 100 new cases in Year 3, 2000 cases in Year 4, 3000 cases in Year 5. A case is defined as: tumor sample + germline DNA sample + (sometimes) recurrent tumor sample + (sometimes) metastatic tumor sample + (sometimes) normal solid tissue and up to 8 slides per case. Use the assumption that recurrent, metastatic, and normal solid tissue will be received in approximately 10% of the cases or approximately

1,100 cases.

1) The Contractor shall support the following storage environments:

i. vapor phase liquid nitrogen freezers (-190°C to -150°C)

ii. -80°C and -20°C mechanical freezers

iii. humidity and room temperature controlled areas

iv. 4*C refrigeration

2) The Contractor shall support repositories for:

i. FFPE blocks, FFPE scrolls, and slides

ii. frozen tissue cryovials

iii. frozen tissue in OCT blocks

iv. tissue and cell pellets in cryotubes

v. blood and blood components in liquid and pellet form

vi. DNA/RNA aliquots in cryovials and dilution plates

3) The Contractor shall be able to store long-term an initial number of the following such as:

i. 70,000 glass slides stored at room temperature;

ii. 58,000 tissue samples stored at -190° C;

iii. 49,000 DNA samples stored at -80° C;

iv. 38,000 RNA samples stored at -190° C or -80° C;

v. 27,000 Whole Genome Amplification (WGA) DNA samples stored at -80°

C;

vi. 17,000 blood-derived normal stored at -190° C or -80° C;

vii. 700 FFPE blocks stored at 4° C; and

viii. 1,000 dilution plates stored in -80° C.

Attachment 7 Page 4 of 4

4) It is also anticipated that additional working storage space will be required to accommodate new case objects per year. Assume 0 cases for year 2, 100 cases year three, 1000 cases year 4 and 3000 cases year 5. Estimated numbers for pricing calculations are as follows (based on year 5 or 3000 cases):

i) 22,000 glass slides stored at room temperature

ii) 1,000 tissue samples stored at -190° C

iii) 5,800 DNA samples stored at -80° C

iv) 2,800 RNA samples stored at -190° C or -80° C

v) 2,800 blood-derived normal stored at -190° C or -80° C

vi) 2,800 FFPE blocks stored at 4° C

vii) 1,000 dilution plates stored in -80° C

Specific requirements for each of the above can change and new guidance will be provided by the NCI COR as needed. The Contractor shall provide additional working storage space in the above environments to support the internal operations of the CBA for activities such as QC, backup, and working storage prior to shipment of analytes.

Fixed Price

The Offeror shall provide a detailed proposal of their fully-loaded (including all labor, fringe, other direct costs, indirect costs, and fee involved) price for the following work:

1) The total costs of sample storage at the CBA, per case, entering the CBA (i.e. initial intake), cost per case to store and maintain (i.e. repository/archive), and the cost per case leaving the

CBA (optional) should be provided.

2) An escalation rate will be applied to each price per year based on the Consumer Price Index projection of 2.4%.

3) A Cost reimbursement type contract is not requested. The Offeror may propose their own unique workflow structure, as long as it is first broken down into the individuals cost elements to determine reasonable, allowable and allocable costs, then rolled up into a fixed unit pricing structure. For direct labor consider the inclusion of both administrative and quality/regulatory personnel. All personnel, materials and supplies, other direct costs, associated F&A/G&A and fee should be itemized in a budget breakdown. Then the budget should be rolled up and divided by the number of expected cases (2500 cases/year for BPC) to obtain the case cost. If multiple case costs are proposed, a separate budget breakdown should be provided for each one. Provide a budget to include a one-year base and 4 one-year options. A budget narrative should accompany each budget.

4) Any related travel will be in a separate task order; do not include travel in the case costs.

5) It is recommended that cross-utilization of personnel across Task Areas A and B be considered if Offerors propose on both Tasks.