Amendment_3_N02CO57019-02.pdf

RFP Number : N02CO57019-02 Amendment 3

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OFFICE OF ACQUISITIONS

NATIONAL CANCER INSTITUTE

REQUEST FOR PROPOSAL NUMBER: N02CO57019-02

Amendment No.: 3

Date of Issuance: 07/17/2015

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of Offerors remains unchanged: 2:00PM EPT 8/03/15.

Offerors MUST acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by separate letter, telegram, or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.

This Amendment #3 provides responses to questions received as stated below and revises the RFP by removing the CLIA certification requirement as a Mandatory Criteria. The following attachments have also been revised accordingly: Attachment 3: Statement of Work, Attachment 18: Additional Business Proposal Instructions and Attachment 11: Additional Technical Proposal Instructions. These attachments have been embedded in this Amendment.

Inquiry 1 -

Question 1: Could you please clarify how the NCI-OTS will manage sample identifiers?

Answer 1: The NCI-OTS will also use Universally Unique Identifiers as specified in section E.4.c. of the SOW.

Question 2: Are there data and samples to be transferred from the current CPTAC BCR? Are there other transition expectations?

Answer 2: No, the data and samples will not be transferred from the current CPTAC BCR to the BCR in this RFP.

Question 3: What data will need to be managed by the BCR to warrant the need for FISMA - moderate? It appears the data are a Limited Data Set with no directly identifying information. If a respondent proposes and justifies FISMA - low, would the application be disqualified as "non-responsive"?

Answer 3: Yes, a FISMA-low application would be considered non-responsive. The FISMA requirements have already been reviewed and determined by the NCI ISSO. The Contractor must comply with the moderate rating. Justifying it any other way is not acceptable.

Inquiry 2 -

Question 1: On page 21 of the SOW, Section E.4.d., 1 b, it refers to "contamination testing". What type of contamination are they referring to?

Answer 1: "Contamination testing" here refers to general impurity of the cellularity of the sample, for example, extracellular matrix.

Question 2: On page 25 of the SOW, Section E.5.b, 7, it states that the contractor shall store images in the system of the NCI-OTS-CDR. What file formats are acceptable for that system and what is the preferred file format?

Answer 2: The Aperio format is the preferred file format.

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Question 3: Are there any current guidelines with respect to the range of acceptable fixed fees for the contract?

Answer 3: Please refer to FAR 15.404-4 Profit.

Inquiry 3 -

Question 1: Would it be acceptable to have a Board Certified Pathologist review digital images or slides for all cases?

Answer 1: Please see amended SOW for clarification on CLIA certification. In summary, there is an option subtask for potential immunohistochemistry that will need to be done in a CLIA lab. Otherwise, the only other data that need to be CLIA validated are those that may go back to the patient participant. Returnable data may include a finding at the BCR that is outside standard of care (the participant's healthcare provider is unlikely to have ascertained the same finding) that is medically significant and clinically actionable.

Question 2: If the answer to Question 1 is no, can we work with a CLIA certified lab for just the histology component of the project? This appears to be the case, but we want to verify this.

Answer 2: Yes, a CLIA-certified lab can handle the IHC and validation portions of the project.

Question 3: If the answer is yes to Question 2, is it sufficient to have the CLIA certified lab review the digital images or slides or must the CLIA certified lab actually cut the slides. We have PhD histologist / immunohistochemist, who works as a partner. He has over 25 years' experience in this field. He is the author of numerous publications and books relating to histopathology and he can readily oversee the slide cutting. Is that acceptable or viewed negatively, if the CLIA lab does the final review?

Answer 3: Yes, again, only data that may go back to individual participants is subject to CLIA validation.

Question 4: Lastly, the solicitation (p. 57) estimates that it will require approximately 7771 hours to prepare our proposal. If my calculations are correct, that would require over 30 people working 7 days a week, 8 hours per day to complete during the current open period. We realize that we will already have some components of the proposal in place and we can comply with the current due date. However, if possible, an additional week would be helpful in enabling us to prepare a more thorough and well thought out proposal. Is that possible?

Answer 4: The estimate of effort is not provided to base the actual preparation of your proposal off of. The Government considers that amount of effort for the entirety of the project. At this time, there will be no extensions granted for this solicitation. A firm response date of 2:00 PM EPT on 8/3/15 remains unchanged.

Question 5: On page 30 of the SOW, it states that only 3 shipments will be made to the GCC over the five year term of the contract. Is that correct?

Answer 5: No, that is incorrect. The first paragraph of the same section states the correct number of up to 60 batches.

The SOW has been corrected to reflect up to 60 batches. See revised SOW dated 7/15/15.

Attachment3RevisedSOW.pdf

Inquiry 4 -

Question 1: Please verify that offerers need to be CLIA certified at the time of [technical proposal submission] or that CLIA certification within 90 days of award is acceptable. This requirement is described differently within the solicitation document.

Page 19, "CLIA certificate for pathology component, Must show within 90 days of contract execution" Page 107, "Listed below is a mandatory qualification criterion. Offerors shall include all information which documents and/or supports the qualification criterion. The qualification criterion establishes conditions that must be met at the time of receipt of Technical Proposals by the Contracting Officer in order for proposals to be considered any further for award.

1. Current Clinical Laboratory Improvement Amendments (CLIA) accreditation." Please clarify.

http://dgs.nci.nih.gov/downloadFile.do?id=3560119&fn=Attachment3RevisedSOW.pdf

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Answer 1: The Two (2) Option Subtasks that were added (Immunohistochemistry and Returning Data to Tissue Source Site) require CLIA certification. Therefore, the CLIA certification requirement as a Mandatory Criteria on Page 107 of the solicitation is hereby removed and on page 19 of the solicitation under Article F.2. Deliveries, item #17 is hereby modified as follows:

Item Description Qty Delivery Schedule

(17) CLIA Certificate (see Section D.5.d, Option 1 Subtask 5.4 Immunohistochemistry and Section D.8.c, Option 2 Subtask 8.3 Returning Data to Tissue Source Site)

1 At the request of the COR

The revised Additional Technical and Business Proposal Instructions are provided below:

RevisedAttach11AddTechPropInstru.pdf

RevisedAttach18AddtlBusProposalInstr.pdf

Inquiry 5 -

Question 1: How many BCRs do NCI consider to fund if it is outside of US?

Answer 1: Per page 57 of the solicitation, NCI anticipates awarding only one (1) BCR contract from this solicitation.

Inquiry 6 -

Question 1: Can you share the names of the individuals or companies/institutions who have contacted you about this solicitation (CPTAC)?

Answer 1: No.

END OF AMENDMENT #3.

http://dgs.nci.nih.gov/downloadFile.do?id=3560119&fn=RevisedAttach11AddTechPropInstru.pdf http://dgs.nci.nih.gov/downloadFile.do?id=3560119&fn=RevisedAttach18AddtlBusProposalInstr.pdf