SpecimenRespository_ Amendment2_Final.pdf

AMENDMENT #2, RFP No. 75N93020R00006

Amendment No. 2

RFP No. 75N93020R00006 “NIAID Specimen Repository”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

75N93020R00006

Two (2)

April 29, 2020

Response Date:

May 20, 2020 at 3:00 PM, Local Time (Unchanged)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY:

kim.brookens@nih.gov Kim Brookens, Contracting Officer Phone: 301-761-5140

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 240-669-5156

The purpose of this amendment is to answer questions from a potential offerors regarding the solicitation.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

mailto:kim.brookens@nih.gov mailto:anhughes@niaid.nih.gov

Questions from Potential Offerors:

Question 1:

Please confirm our assumption that the 250-page limit for the Technical Proposal is inclusive of all attachments and tables.

Response to Question 1:

Yes, the page limitation is inclusive of attachments and tables. Please refer to ATTACHMENT 1, PACKAGING AND DELIVERY OF PROPOSALS FOR USE WITH eCPS, Paragraph II, FORMATTING AND PAGE LIMITATIONS, Paragraph B, Page Limitations.

Question 2:

If the collection is transferred will the samples be transported inside the freezer units where they are currently stored?

Response to Question 2:

Samples will be transported in freezers. The details of the transportation will be developed during transition planning.

Question 3:

If the collection is transferred will the cost of transferring the collection be covered by the current contract?

Response to Question 3:

The details will be finalized during transition planning. The current contractor will be responsible for transferring the collection, and the new contractor will be responsible for receiving the collection. Please refer to Attachment 6: Additional Business Proposal Instructions and Uniform Cost Assumptions, and Attachment 8 – Government Furnished Property, for information regarding the number of specimens and government property an offeror could anticipate receiving as a result of transition. Final numbers are subject to change and will be determined during transition planning.

Question 4:

Some of the freezer units appear to be old and may need to be replaced. Can we incorporate the cost of new freezer units into the annual budget?

Response to Question 4:

See Attachment 6:, Additional Business Proposal Instructions and Uniform Cost Assumptions, Section 3, Uniform Cost Assumptions, Paragraph a, Technical Cost Assumptions, subparagraph 5, Ongoing activities during the contract period of performance, paragraph b, Store specimens under optimal conditions to minimize loss, damage or contamination, 3rd paragraph which states: “Offerors should assume the purchase of 22 new -80°C mechanical freezers per year and 1 new liquid nitrogen freezers per year, as well as account for the cost of the associated space necessary to house the expanded freezer acquisitions. Freezers shall be purchased as needed to accommodate sample inventory received, to replace broken freezers, as well as to keep that age of the freezers under 20 years old.”

Question 5:

Will we have access to the BSI LIMS if the collection is transferred, and is there a preference about whether to continue using the BSI LIMS?

Response to Question 5:

See Attachment 6, Additional Business Proposal Instructions and Uniform Cost Assumptions, subparagraph 5, Ongoing activities during the contract period of performance, paragraph b, Store specimens under optimal conditions to minimize loss, damage or contamination, 6th paragraph which states: “The Offeror shall assume the license fee and other costs for the BSI software for at least one year or until a different electronic inventory and management system is implemented. Currently, the license, hosting, support and enhancement costs for BSI are $96,208 per year. The offeror shall use an inventory management system that is able to fulfill the requirements of the contract.”

Question 6:

What additional data, if any, will accompany the samples (e.g. QC data, clinical data, electronic health records, etc.)?

Response to Question 6:

Only the data that is in BSI will accompany the samples. The NSR does not have access to clinical data or the electronic health records of the participants in these studies.

Question 7 (two parts): How are the samples for this collection distributed?

Question 7a: Will samples be made publicly available through a website, or is sample distribution limited to consortia/study members?

Response to Question 7a: Sample distribution is managed through authorized personnel at the data centers for each study group. There is not a publicly available website for sample distribution.

Question 7b:

How are requests for samples currently placed?

Response to Question 7b: The Study Groups request distribution of samples through the electronic inventory management system.

Question 8 (two parts):

The RFP suggests that sample processing is limited to aliquoting, but that other types of wet lab work may be requested in the future.

Question 8a:

Are there specific examples of wet lab work we may be asked to perform?

Response to Question 8a:

No. We do not currently have the NSR perform wet lab work.

Question 8b:

If this work is requested in the future, can a supplementary budget be submitted to cover the up-scope in work?

Response to Question 8b:

The Government will ensure that the wet lab work does not result in the need for supplemental funds. The Contractor is expected to perform the work based on the amount of funds obligated and the total value of the contract. If wet lab work is needed and the Contractor notifies the Government that additional funds are needed to complete the wet lab work, the COR will identify activities in the Statement of Work that can be reduced to allow for the wet lab work without adding funds to the contract.

Question 9:

Should preparation/distribution of sample collection kits be included in the budget, or are sample collection kits provided by another vendor?

Response to Question 9:

The Contractor is not responsible for providing sample collection kits. Each Study Group is responsible for their own sample collection supplies and materials.

Question 10:

Will we have access to the Manual of Operations, SOPs and Work Instructions currently being used by clinical sites to collect, package and ship samples?

Response to Question 10:

Once a contract has been awarded, the current contractor will transmit appropriate procedural information as part of an agreed upon transition plan. In addition, SOP’s from the study groups will be forwarded to a successful offeror.

Question 11:

Should we build the KPR format into the budget (excel template) or is this something that is governed external to the document?

Response to Question 11:

No, please develop the files as directed in the RFP in Attachment 6: Additional Business Proposal Instructions and Uniform Cost Assumptions. Also, please refer to Attachment 1, Packaging and Delivery of Proposals for Use With eCPS, for instructions on file formats.

Question 12:

The government notes the requirements for SOPs as deliverables within 30 calendar days of award. Are there existing SOPs that are owned by the Government for the NSR?

If yes, can the existing NSR SOPs be made available to the proposers for the purposes of budget preparation to account for the proper costs in accordance with the established operating procedures?

Response to Question 12:

The SOPs for the NSR are not “owned” by the Government. We are interested in each offeror’s individual approach to carrying out the work. Regarding budget preparation, please follow the uniform cost assumptions to develop your budget which can be found in Attachment 6: Additional Business Proposal Instructions and Uniform Cost Assumptions.

Question 13:

Fingerprint checks are noted. Are fingerprint checks required of all employees that would work on the contract as mentioned in the security requirements? IF yes, are these included in the Government investigation conducted at no cost to the Contractor (item 7, page 60)?

Response to Question 13:

In the event that an employee is not already cleared, please follow the instructions as described in the RFP under Article C.2. Reporting Requirements, Information and/or Physical Security: Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI). Please also note the following in the RFP: “Typically, the Government investigates personnel at no cost to the Contractor. However, multiple investigations for the same position may, at the Contracting Officer's discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).”

Question 14:

Are all the storage GFE full of samples or is the provided GFE also inclusive of the required 10% backup capacity (in ready state) for each storage condition?

Response to Question 14:

The current GFE includes 10% backup capacity.

Question 15:

When samples have been withdrawn for destruction or distribution, have the vacancies that have been made in the boxes been backfilled with new samples as they have come in?

Response to Question 15:

Sometimes vacancies are backfilled. In addition, the Contractor periodically does a consolidation of samples to free up space.

Question 16:

Attachment 3, Number 5b. Can the government please clarify what is required for validation of procedures: “Utilize validated procedures for preparation and distribution of specimens as requested by the Study Groups”.

Response to Question 16:

See Attachment 3, Performance Work Statement, Paragraph C.1.a – The Contractor shall comply with all Federal, State and local requirements and current best practices for the collection, handling, preservation, storage, retrieval and distribution of biological material for scientific research including:

1) The National Cancer Institute Best Practices for Biospecimen Resources.

2) The International Society of Biological and Environmental Repository Best Practices for Repositories. Standards for biologically hazardous materials as Biological Substance Category B, UN3373.

3) Shipments shall comply with current standards as indicated by international, Federal, State, and local government regulations, as well as the International Air Transport Association (IATA) Guidance Document for Infectious Substances.

4) OSHA standards 29 CFR 1910.1030 and Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition for handling biological specimens with potential or known blood borne or other potentially infectious pathogens.

Question 17:

Does the government require the use of qualified shippers and validated packout procedures?

Response to Question 17:

Please refer to the response to Question 16 above.

Question 18:

Would the incumbent allow interested bidders to visit the existing site for a tour?

Response to Question 18:

The current contract does not include a requirement that the current contractor allow tours of their facilities by interested offerors. If you are interested in a tour of the contractor’s facility, we suggest you contact the contractor.

Question 19:

Does the government require temptales or similar temperature monitoring devices to be included with shipments of samples?

Response to Question 19:

Please refer the response to Question 16 above.

Question 20:

Attachment 5, Section 3, F) 2 RFP instructions are to provide an architecture diagram of the system components. Can the government provide the architecture diagram of the system components of the current system?

Response to Question 20:

The requirement for an architecture diagram has been removed. Please see the updated Attachment 5: Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, included with this amendment. However, please be advised that an architecture diagram may be requested by the government during negotiations.

Question 21:

Attachment 5, Section 3, F) 2) RFP instructions are to provide an architecture diagram of the system components. Is an architecture of a system we currently use acceptable?

Response to Question 21:

Please refer to the response to Question 20 above.

Question 22: Attachment 5, Section 3, F) 2 RFP instructions are to provide the current User Guide for our Inventory Management System. These documents are very large and cannot be provided without exceeding page limitations of the RFP. Can we provide a Table of Contents in lieu of a large user guide?

Response to Question 22:

The requirement for a user guide has been removed. Please see the updated Attachment 5: Additional Technical Proposal Instructions, Format for Technical Proposal, and Table of Contents, included with this amendment. However, please be advised that a user guide may be requested by the government during negotiations.