Amendment_01-HHS-NIH(AG)-RFP-17-027.pdf

Solicitation No. HHS-NIH-NIDA(AG)-RFP-17-027 Amendment No. 01

SPECIAL PROVISIONS

Question 1. Is this a new requirement?

Response 1. Yes, this is a new requirement.

Question 2. Reference to Task Area 5.B:

a. Do replicate aliquots of samples currently exist in separate freezer units?

Response 2a. Yes.

b. Are the freezer units, which contain separate aliquots of samples, easily identifiable so as to facilitate their separation to different facilities?

Response 2b. Yes.

c. To facilitate storing aliquots of each sample in a back-up facility located at a separate site; can one facility be located domestic and the other facility located international?

Response 2c. No.

Question 3. Please describe if there is a distance criterion/restriction between these back-up facilities.

Response 3. Back-up facility or facilities must be located in the United States.

Question 4. Reference to Task Area 3.A: Will any specimens require BSL3 conditions for handling and processing (e.g., aliquotting, etc.)? If so, please identify the possible pathogens.

Response 4. As stated on page 4 of Attachment 3 – Statement of Work, the Government does not anticipate this kind of issue; however, the Offeror is expected to be knowledgeable and have the capacity to adequately address and manage BSL3 conditions if needed.

Question 5. Reference to Task Area 4.B: Since migration of inventories is required under BSI II, are samples labelled appropriately from Core LIMS and Freezerworks for compatibility/readability into BSI II?

Response 5. Yes. The Offeror is expected to have knowledge with available inventory systems for biorepositories and experience with migrating data from different systems.

Question 6. Are consent forms required to be tracked?

Response 6. Consent tracking may not be absolutely necessary during the duration of the contract. However, its need will be determined on a case by case basis.

Question 7. What is the expected growth/addition of samples to this collection per year?

Response 7. The Government cannot precisely determine the number of samples at this point, but anticipate that in total (not per year) 2,500 new biospecimens may be generated by the study.

Question 8. From time of award, how soon would the NIA investigators request sample distribution or require sample accessioning and/or processing efforts?

Response 8. There is no way of predicting this. Refer to Attachment 3 – Statement of Work, Task Area 4, which states…”The transfer of biospecimens and related data to the future NIA Central Biorepository shall be completed within three months of the award of the contract.”

Question 9. Please confirm the expected freezer type that would be purchased during the contract period. Should -80C So Low Mechanical Chest Freezers be assumed as the freezer type?

Response 9. The freezer type currently in use and being provided by the Federal Government is listed on page 2 of Attachment 4 - Government Furnished Property.

Question 10. Task 1.F states that the contractor is to perform fully documented inspected and verification of all incoming and outgoing shipments. How many incoming shipments will be received per year?

Response 10. As relates to incoming shipments, it is anticipated that in total (not per year) 2,500 new biospecimens may be generated by the study. As relates to outgoing shipments, it is impossible to predict quantity or number of outgoing shipments at this time because these depend on investigators’ interest in pursuing research using the biorepository’s resources.

Question 11. Could the specifics around double-keying data for the physical condition of the cryovial, volume, and shipping conditions into the inventory management database be explained?

Response 11. This is part of the expertise to be provided by the Offeror, which includes specific aspects of inventory management and use of inventory systems.

Question 12. Please confirm only an electronic submission is required via the eCPS website.

Response 12. The Government will be accepting only electronic submissions via eCPS website.

Question 13. Please clarify if this is a Cost Plus Fixed Fee contract or a Fixed Fee contract.

Response 13. As specified on page 46, paragraph c.2. of the Solicitation, it is anticipated that the award from this solicitation will be a multiple-year cost-reimbursement type completion contract with a Period of Performance of one (1) 12-month base period and four (4) 12-month option periods.

Question 14. Are Optional Tasks A and B a Fixed Fee or Cost Plus reimbursement?

Response 14. As specified on page 46, paragraph c.2. of the Solicitation, it is anticipated that the award from this solicitation will be a multiple-year cost-reimbursement type completion contract with a Period of Performance of one (1) 12-month base period and four (4) 12-month option periods.

Question 15. Can the Source Code and Object Code requirement be removed from the contract given that the BSI system is hosted and owned by IMS?

Response 15. No, the Source Code and Object Code cannot be removed.

Question 16. Are there any specific qualifications the proposed key personnel must adhere other than those listed on Page 82 of the RFP, such as certain years of experience, number of specimens managed, etc.?

Response 16. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems. Any other additional qualifications that the offeror feels are relevant and available shall be provided in offeror’s proposal.

Question 17. For the culling of the 100,000 samples, will the contractor be required to provide certificates of destruction for batches of samples destroyed? Should the contractor include pricing for sample consolidation as part of the cull to minimize storage space/costs?

Response 17. Yes, certificates of destruction for batches of samples will be required in the event the Offeror performs culling. At this time, it is unclear whether culling will be necessary during the duration of the contract, but it is appropriate to plan culling for 20,000 biospecimens per year.

Question 18. How many of the freezers listed are back up freezers?

Response 18. The back-up freezers are included in the list of freezers on page 2 of Attachment 4 - Government Furnished Property.

Question 19. We understand that the Biorepository should store aliquots of each sample at a back-up facility at a second site, please could you provide numbers/sizes of vials and the storage temperatures required for each category of vial to be stored at a back-up location?

Response 19. Storage conditions should be the same for back-up storage and primary storage of samples (parent samples). Amount will depend on demand for biospecimens.

Question 20. Are back-up vials for this collection currently stored at a second location, and if not is there provision within the budget to retrieve back-up vials and transport to a back-up location – or does this requirement only pertain to future samples collected for this biorepository?

Response 20. Refer to page 8, Task Area 5, Attachment 3 – Statement of Work.

Samples shall be managed/transported consistently as needed.

Question 21. Is the 13,000 labor hours per year to be assumed across all labor resources and tasks? Would it be possible to receive a breakdown of the 13,000 labor hours by role or task?

Response 21. As specified on page 48 of the Solicitation, the Estimate of Effort is approximately 13,000 labor hours. This information is furnished for the offeror’s information only and is not to be considered restrictive for proposal purposes. The 13,000 labor hours is estimated per year.

Question 22. The RFP lists two optional tasks: Optional Tasks A and B. How many freezers are occupied per task? Is it possible to receive a report of the Government furnished property per task?

Response 22. No report on Government Furnished Property for Optional tasks A and B is available at this time. However, current number of freezers for Optional Task Area A include four (4) 27 cu ft. -80C freezers current number of freezer for Optional Task Area B include three (3) mechanical -80C freezers.

Question 23. Page 91 of 209 of the RFP/ Attachment 3 – SOW/ Task Area 3 – Paragraph D - States: “Although not expected, the Contractor shall plan/budget for potential culling sometime during the duration of the contract of approximately 100,000 biospecimens less frequently requested for new research use.” Should the contractor plan/ budget for 20,000 biospecimens per year based on the 5-year duration of the contracts, or can NIDA provide the desired number of biospecimens per year to be estimated to ensure all bidders are bidding to the same culling schedule?

Response 23. At this time, it is unclear whether culling will be necessary during the duration of the contract, but it is appropriate to plan culling for 20,000 biospecimens per year.

Question 24. Page 101 of 209 of the RFP/ Attachment 3 – SOW / Optional Task Areas A & B - To ensure all bidders use the same period of performance for estimating purposed, what period of performance should be used on pricing for Optional Tasks A and B?

Response 24. For estimation purpose, anticipate budget period starting 6 months after award of the contract. However, no guarantee exists that these options will be exercised at that time or at all.

Question 25. Attachment No. 6. XL sheet titled -Technical Proposal Cost Information/Summary of Labor and Direct Costs - Table notes Year 1 through 7. Since this is a five (5) year program with two (2) Optional Tasks, should the column for Year 6 & 7 be changed to read Optional Task A & Optional Task B, with the total cost representing the Base year + Option 1 through Option 4 + Optional Tasks A and B? Or does NIDA prefer a separate Table or Tables to segregate the Costs associated with Optional Task A and B? The answer will ensure all bidders provide costs in the same format and facilitate cost comparisons of the various bidders.

Response 25. Optional tasks A and B should be budgeted separately. Separate tables or separate columns in a table can be used to segregate costs associated with each optional task.

Question 26. Page 88 of 209 of the RFP/ Attachment 3 – SOW / Last paragraph under Scope - How many individual shipments are needed to ship the 15,000 specimens annually?

Response 26. It is not possible to predict the number of individual shipments at this time as these depend on approved proposed analyses or requests for new studies from investigators interested in using biospecimens and related resources.

Question 27. Page 88 of 209 of the RFP/ Attachment 3 – SOW / Task Area 1 - Are shipments both domestic and international? If yes, what percentage is international?

Response 27. An important aspect of the future NIA Central Biorepository is to enhance the use of biospecimens and related data by the scientific community. While the Government expects to have both domestic and international interest for the biorepository resources, no percentage can be established at this time.

Question 28. Page 88 of 209 of the RFP/ Attachment 3 – SOW / Task Area 1 – To adequately estimate the shipping costs, can NIA provide list of destination countries that shipments would be sent to?

Response 28. Related to previous question/answer, the Government cannot predict, at this point, which country(ies) will make requests for use of biospecimens.

Question 29. Page 89 of 209 of the RFP/ Attachment 3 – SOW / Task Area 1 - The RFP references the need for aliquoting. Can NIA specify how many parent samples will be aliquoted and how many child vials will be created from the parent sample? E.g. 1 parent sample aliquoted to 10 child vials.

Response 29. No. Generation of further aliquot or samples will depend on demand. The Government cannot predict how many parent samples will be aliquoted or how many child vials will be created at this time.

Question 30. Page 89 of 209 of the RFP/ Attachment 3 – SOW / Task Area 1 - When aliquoting a child vial for a 3rd party researcher, would NIA want the repository to make additional child aliquots at the same time so as to avoid additional freeze/thaw cycles of the parent? If so, how many additional child aliquots would be produced and would the costs to produce and store the additional children be borne by the 3rd party researcher or by the prime contract?

Response 30. If thawing of parent aliquot is required, it shall be paid by the requester.

The demand will help inform the need for generation of additional aliquotes from parent samples.

Question 31. Page 91 and 92 of 209 of the RFP/Attachment 3 –SOW / Task Area 4 - The RFP states that migration or consolidation of inventories from NIA-funded studies under one system – BSI-II – shall be accomplished within 90 calendar days of the award of contract. Is use of BSI-II (or any version of BSI) a mandatory requirement? Or can a similar web based inventory management system be used?

Response 31. BSI-II is highly preferred. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems.

Question 32. Can NIA provide the physical address of the current freezer locations to enable bidders to accurately estimate the transportation costs?

Response 32. No. However, as indicated in the Solicitation, biospecimens are currently located in Frederick, MD.

Question 33. Page 89 of 209 of the RFP document/Attachment 3 –SOW, Paragraph 2 - The Statement of Work, Paragraph 2 stated: Epstein Barr virus cells and cell pellets (22,552). These biospecimens are typically stored in LN2 tanks rather than -80C freezers.

Please confirm if the 22,552 are currently stored in -80C freezers. If the samples are stored in a LN2 tank(s), will the LN2 tank(s) be provided as Government Furnished Property (GFP) and added to the Attachment 4-Government Property List?

Response 33. No samples are currently stored in LN2 tanks.

Question 34. Will NIA consider providing the vendors an opportunity to submit a 2nd round of questions based on NIA’s response to 1st round of questions?

Response 34. No, there will not be a 2nd round of questions.

Question 35. Per SOW Task Area 4.B: “Migration or consolidation of inventories from NIA-funded studies under one system - BSI-II - shall be accomplished within 90 calendar days” Is the BSI-II System included as GFP/GFE?

Response 35. No.

Question 36. Sample “processing”, “aliquotting”, and testing on “pooled specimens” are mentioned in the SOW. Please clarify the requirements for these three (3) Tasks. For example, does “processing” include Fractionation of blood, Expansion of primary cells or Nucleic acid extraction? What processing may be required on “pooled specimens”?

Should pricing for any of these Tasks be included in the Estimated Cost? If so, please provide plug numbers for each process for standardized costing purposes.

Response 36. The Government foresees the need to use pooled specimens only as part of a quality control or in response to potential methodological issues detected by an investigator’s analyses or systems.

Question 37. SOW Task Area 5.B indicates the Contractor shall “store aliquots of each sample in a back-up facility”. Are the duplicate samples already aliquoted or does this need to be performed? Are duplicate sample number already included in the numbers of samples provided? If not, can an estimate be provided for costing purposes?

Response 37. Yes, they are already aliquoted and accounted in the number of samples specified.

Question 38. Per SOW Task Area 1 J, Contractor shall “develop a fee schedule for biospecimen distribution”. For costing purposes, please confirm Contractor will not be performing Accounts Payable and Accounts Receivable functions for the cost recovery from Repository users.

Response 38. The Offeror will receive additional information on cost recovery policy upon award of the contract. However, it is very likely that the Offeror or contract awardee may have to perform accounting functions.

Question 39. How will requests for distribution be relayed to the successful contractor?

Is there a requirement for the successful contractor to create and implement a workflow for sample requests and distribution?

Response 39. Refer to pages 5-7, Task Area 4 of Attachment 3 – Statement of Work.

Question 40. Please confirm that the repository will be housed at the offeror’s location, not at the current facility in Frederick, MD?

Response 40. Yes, the respository will be housed at the Offeror’s/Contractor’s location.

Question 41. Assuming the samples will be transferred to the contractor outside of Frederick, MD, what time frame can be allowed for the transfer of all samples?

Response 41. Refer to Attachment 3 – Statement of Work, pages 5-6, Task Area 4, item B.

Question 42. Please confirm if there are incumbents currently performing this work, or whether this is currently being supported with Government employee staff.

Response 42. Storage and management of samples is currently under the responsibility of the investigator(s) of the study.

Question 43. What is the process for sample transfer? Will the samples be transported in the freezers or individually repackaged and transported?

Response 43. The Offeror shall propose the best method to transport biosamples and/or freezers.

Question 44. Are all 1.8M samples located in a single facility or over multiple buildings?

At what floor level do the majority of the samples currently reside?

Response 44. All biospecimens are currently stored in Frederick, MD.

Question 45. What labeling system (label stock, identifier scheme, etc.) has been used for sample storage in current inventory? Do samples have Code 128 barcodes on them?

Response 45. Refer to pages 5 (item B) and 6 (item D), Task Area 4, Attachment 3 – Statement of Work. The Offeror is expected to have knowledge of available inventory systems for biorepositories and experience with migrating data from different systems.

Question 46. How accurately does the sample break-out (67% urine, 23% serum, 8% plasma, 1.3% Epstein-Barr, 0.6% DNA, 0.1% buccal) in the RFP align with actual sample volumes in storage? Are there additional sample types (lower volumes) not listed in RFP?

Response 46. The sample breakout reflects actual volume as much as possible. While procurement is ongoing, however, volume may change due to demands for biospecimens. The Offeror should use this breakdown for proposal preparation.

ALL OTHER CONTRACT TERMS AND CONDITIONS OF THIS SOLICITATION REMAIN UNCHANGED.