75D301-26-Q-95343_Questions and Answers.xlsx

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Such direction is not intended to constitute an expansion of the Contractor’s scope of work or to require the Contractor to perform materially different or additional work beyond the requirements contemplated by the solicitation. The Contractor should base its proposal and pricing on the requirements stated in the solicitation and the anticipated range of specimen collection activities described therein.

Any Government-directed change that would constitute a material change to the scope of work would be addressed in accordance with the terms and conditions of the resulting contract and applicable Federal acquisition regulations.

Section 4, 1.e./Task 2 8 Task 1.e. states that biospecimens stored externally to CDC will be stored for a period determined by the contract award, while Task 2 states that the Contractor shall arrange for collection, transport, and storage to a designated CDC facility. Can the Government clarify whether non-CDC (external) storage of biospecimens will be required under this contract? Transport of specimens is not required for this contract at this time. Section 4, Task 1.e. refers specifically to post-mortem biospecimens that are currently stored at locations external to CDC. The Contractor’s responsibilities under this task relate to the management and storage of these existing externally stored post-mortem biospecimens for the period specified under the contract.

In contrast, Section 4, Task 2 addresses pre-mortem tissue, as expressly stated in the task language. This task requires the Contractor to arrange for the collection, transportation, and storage of pre-mortem tissue at a designated CDC facility.

Accordingly, the external storage referenced in Task 1.e. pertains to the existing post-mortem biospecimen collection and should not be interpreted as a general requirement for the Contractor to establish or maintain external storage for biospecimens collected under Task 2. The two requirements address different specimen types and circumstances.

Section 4, Task 5 10 Task 5 references transfer of biofluid and biospecimen samples from the processing laboratory to the CDC Biorepository. Given that Contractor personnel cannot direct or instruct Federal employees or other contractor staff, can the Government confirm what support it will provide to facilitate this transfer? Transfer of biospecimens has been completed by the Government. Laboratory processing will be done by CDC and not an external processing lab. Section 4, Task 5 (page 13), addresses the proper transfer and handling of both (1) collected blood specimens from the collection site to the CDC sample processing laboratory and (2) processed/stored samples from the CDC Biorepository to the researcher for dissemination and research use.

The Government can coordinate with the Contractor, as appropriate, to facilitate the transfer of collected blood specimens from the patient’s home or other collection location to the CDC sample processing laboratory. However, Contractor personnel will not direct or instruct Federal employees or other contractor personnel in the performance of their duties.

The Government would like to clarify that Task 5 also includes supporting the distribution of samples from the CDC Biorepository to the researcher. At this time, ATSDR does not have established transfer logistics or procedures in place for this downstream sample dissemination. The Contractor should therefore be prepared to support the development and coordination of an appropriate process for transferring samples from the CDC Biorepository to the designated researcher, consistent with applicable CDC requirements, policies, and procedures. Shipment of the blood collection kit to the patient's residence and/or also shipment of the donated blood from the patient's residence to CDC sample processing lab and/or also identified samples for distribtuion to the designated researcher.

Specific roles, responsibilities, and logistics for these transfers will be coordinated between the Government and Contractor following contract award.

Section 8 - Deliverables/Reporting Schedule, Task 7 12 Will the Contractor have access to the CDC Biorespository to conduct a facility audit? No. Physical access to the CDC Biorepository for the purpose of conducting a facility audit would not be feasible. However, the Contractor, or any party responsible for identifying and locating samples that meet a researcher’s specified criteria, will need to have sufficient familiarity with the Biorepository’s inventory and associated data.

At this time, the specific means by which the Contractor may access the CDC’s digital inventory system, if such access is necessary to perform the required tasks, has not been determined. The Government anticipates that the Contractor may initially accomplish this requirement through the review and analysis of available inventory data, such as inventory spreadsheets and related documentation, during the first 90 days following contract award.

The Contractor should therefore demonstrate in its proposal the capability and experience necessary to effectively review, interpret, and work with biorepository inventory data to support the identification of samples in accordance with researcher requirements.

Section F - Instructions to Offerors/II. Technical Proposal Contents/Tab 2: Similar Experience 62 The solicitation references the potential use of subcontractors in multiple sections, and Tab 2 (Similar Experience) requires the Offeror to submit three relevant contract references demonstrating comparable scope, size, and complexity. Can the Government confirm whether similar experience references from proposed subcontractors may be submitted to satisfy this requirement? Yes, this will suffice. Offeror must demonstrate in their proposal they are experienced working and ALS patients and repositories. Yes. Relevant experience references from proposed subcontractors may be submitted to satisfy the Similar Experience requirement, provided the Offeror clearly identifies the subcontractor’s role and demonstrates how the referenced experience is relevant to the scope, size, and complexity of the requirements. The Offeror must also demonstrate in its proposal that the proposed team collectively has sufficient experience working with patients and repositories, as applicable to the requirements of the solicitation.