RFP_2016-N-17941_Questions_and_Answers.docx

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

1. Question: Section 4.0 – What liability for product will the Contractor be expected to incur relating to; losses, damages, spoilage?

a. Within contractor facilities.

b. Within transit to sites.

Answer 1:

a. With the appropriate internal and quality controls in place, we would not expect any specimen losses, damages, or spoilage during the contract period of performance. In the rare event of loss, damage, or spoilage of samples within contractor facilities, the contractor will incur punitive fees and/or the cost of recollecting samples from study participants at the following levels:

· $1,000 per aliquot for loss or damage of each aliquot;

· $30,000 total for loss or damage of all aliquots from one study participant;

These specimens were collected up to 20 years ago and current costs to locate and re-collect specimens will be substantial. As stated in the RFP, it is critical that the facility, equipment, and standard operating procedures be maintained to avoid sample loss, damage, or spoilage. This includes separating sister aliquots from one participant into a minimum of two designated freezer units, maintaining additional empty freezer units at temperature, maintaining back-up generators, using freezer units with working alarm systems, and limiting access to dedicated freezers. This list is not all-inclusive since the contractor may have additional policies and procedures for protecting the specimens.

b. With the appropriate internal and quality controls in place, we would not expect any specimen losses, damages, or spoilage during the contract period of performance. In the rare event of loss, damage, or spoilage of samples within transit to sites that is due to errors made by the contractor including improper specimen packaging (e.g., using damaged shipping containers or insufficient tape), mislabeling the shipping carton or using non-priority overnight shipping, insufficient dry ice, loose aliquot vial caps, etc., the contractor will incur punitive fees and/or the cost of recollecting samples from study participants at the following levels:

· $1,000 per aliquot for loss or damage of each aliquot;

· $30,000 total for loss or damage of all aliquots from one study participant.

These specimens were collected up to 20 years ago and current costs to locate and re-collect specimens will be substantial. As stated in the RFP, it is critical that sample retrieval and shipping standard operating procedures be maintained to avoid sample loss, damage, or spoilage. This includes maintaining specimens at temperature during retrieval, maintaining compliance with Department of Transportation regulations, shipping in cryogenic containers with dry ice sufficient for 72 hours, and shipping specimens via priority overnight. This list is not all-inclusive since the contractor may have additional policies and procedures for protecting the specimens during transit.

2. Question: Section 7.18 – Will the Contractor be responsible for transportation management of product? If so, what methods of transportation are required and what are the distribution points?

Answer 2: The Contractor will be responsible for transportation management of product. Per the RFP, shipments will be made via Priority Overnight in cryogenic containers with dry ice sufficient for 72 hours. The current shipping addresses of the grantees were provided in Attachment 2 of the RFP. These addresses are not expected to change; however, if they do, an advance notice will be provided via e-mail a minimum of 2 weeks before the estimated shipping date and the contract will be modified to change shipping addressed from those listed in the contract.

3. Question: organization would like clarification as to whether or not equipment purchases (e.g. freezers, liquid nitrogen tanks) may be listed in the budget and procured with this contract's funds.

Answer 3: Yes. All equipment purchases (e.g. freezers, liquid nitrogen tanks) shall be included in the cost proposal and shall be procured under this contract.