RFP_2016-N-17941_Follow_up_Questions_and_Answers.docx

Follow up Questions and Answers Biologic Specimen Repository and Inventory Management for the National Center on Birth Defects and Developmental Disabilities (NCBDDD) Projects

RFP #2016-N-17941

10/20/2016

1. Question 1: Will the incumbent be keeping their equipment (freezers and tanks) necessitating a purchase of new equipment for the transition?

Answer 1: Yes, the incumbent will keep their equipment. Offerors have the option of purchasing or leasing new equipment or using their existing equipment.

2. Question 2: As X compiles our technical overview and proposal, a component of our response is toward the insurance requirements required for X to store and distribute the specimens within the solicitation. While X would certainly maintain the required Quality Control and infrastructure requirements, our insurance coverage would require further clarification regarding the specimen product based on the Q&A responses.

Specifically, the liability/punitive fees listed within the answers stated that awardee would be responsible for:

1. $1,000 per aliquot for loss or damage (spoilage) of each aliquot

2. $30,000 total for loss or damage (spoilage) of all aliquots from one study participant

A) Firstly, would this statement mean that there is no limitation of liability to awardee for the total specimens managed, aside from the values assigned?

B) Secondly, would the $30,000 value for total loss or damage (one study participant) be treated as a cap? Meaning, if a study participant has over 30 samples within awardee site, this would be a cap to punitive fees? Or would this mean that if a study participant had 1-30 samples within awardee site, which were lost, damaged (spoiled), an entirety for this participant, awardee would be required to pay in punitive fees the $30,000 value?

C) Furthermore, would there be any other provisions within the solicitation toward indemnification of awardee for any measures?

D) Lastly, the solicitation states the various ranges of temperature requirements both within facility of awardee and during transport; within this what are the acceptable excursion ranges?

Answer 2:

A) The liability is limited to the loss of the specific specimen.

B) Correct, the $30,000 would be the maximum for loss of all aliquots for that 1 study participant. If there were a loss of several aliquots from that 1 study participant within 1 freezer, the liability would be $1,000 per aliquot per study participant in that freezer. For example, if the offeror has 5 aliquots stored for that study participant in the 1 freezer that failed, the fee would be $5,000 for that 1 study participant.

C) No.

D) We anticipate the event deviation temperature range would be -70C through -90C for the -80C freezers and -135C through -195C for the vapor phase LN2 freezers.

3. Question 3: Will the government accept the concept of a use-rate on corporate owned equipment in lieu of direct purchase?

Answer 3: Yes, the Government will accept a monthly rate per freezer.

4. Question 4: Current SOPs are considered proprietary. Is a list of current SOPs acceptable at this time?

Answer 4: Yes, a list is acceptable with a brief 1-2 paragraph summarization of the content.

5. Question 5: Will the government provide the current SOPs used on the program as Government Furnished Information?

Answer 5: The Government will not provide the current incumbent contractor’s SOPs since the documents are proprietary information.

6. Question 6: Will the government provide the transition out plan from the incumbent?

Answer 6: No. Generally, upon notification by the Government, the current incumbent contractor will start ramping down activities, finalize specimen inventory, collaborate with the Government and new contractor on shipping timeline, and package and ship (estimated 4 trips via truck) the specimens to the new contractor’s facility within a 30 day timeframe. Some additional time for full transition may be needed for the new contractor to set up and certify the freezers, but transition will not exceed 90 days.

7. Question 7: What Inventory Management systems are being used to support all NCBDDD programs?

Answer 7: Current incumbent contractor uses their proprietary specimen inventory system and provides access and reports to the Government. The Government also maintains separate specimen databases (Access, etc.) for each project.

8. Question 8: If option 1, 2, 3, or 4 is not exercised by the Government, will Specimen Transfer be reimbursed on a T&M basis from the Bio-repository and Inventory Management CLIN X001?

Answer 8: We anticipate that Options 1-4 will be exercised. The offerors should include the transition in and out activities and cost in their proposal. The specimen transfer is a separate optional CLIN # 4002 (optional line item), which is included in RFP and should be priced accordingly and will be reimbursed on Firm-Fixed Price basis. If option 1, 2, 3, or 4 is not exercised then the optional line item 4002 will be exercised to transfer specimens to a new location.

9. Question 9: Reference PWS Section V, No. 2: Will the Government provide the list of Government Furnished Information with the solicitation for pricing by the contractor?

Answer 9: The list in Section V, No 2 is an example of possible items. We are not anticipating the current use of cytobrushes. The contractor should already have a scanner and printer for labels appropriate for -80C and vapor phase LN2 freezers but the description in the SOW is “Handheld scanner and printer for bar-coded labels; software to generate barcodes with the same format and variables that are currently included on labels (8-digit barcoded alphanumeric ID, 9-digit human readable numeric ID, 8-digit human readable numeric ID with additional human readable alphanumeric notations that vary by label).”

10. Question 10: Under what RFP provision does the contractor incur punitive fees and/or costs of recollecting samples?

Answer 10: Upon specimen damage during contractor storage or transit.