Attachment_1_General_BPC_CBA_SOW.doc

Attachment 1: Statement of Work

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services , qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work to support the National Cancer Institute (NCI) mission.

TASK AREA A

: Biospecimen Processing Center (BPC) Services A. Scope

The purpose of Task Area A of this contract is to provide biospecimen receipt, processing to molecular analyte, and distribution services for an expanding list of National Cancer Institute (NCI) -supported genomics projects. The Contractor shall have the capability or the ability to procure and provide services for other molecular testing and pathology services. These specific or mandatory requirements will be identified in a separate Task Order statement of work. The Contractor shall perform the following tasks:

1) Biospecimen and Associated Data Procurement

2) Biospecimen Management and Biorepository Operations

3) Biospecimen Quality Control

4) Biospecimen Processing into Molecular Analytes

5) Biospecimen and Analyte Distribution

6) Data Export

7) Other BPC-related Services

8) Pilot Studies

9) Transition Activities B. Description of Work

1) Biospecimen and Associated Data Procurement

The Contractor shall:

i. Develop case and sample inclusion criteria as maintained in Standard Operating Procedures (SOPs).

ii. Implement a Laboratory Information Management System (LIMS) system which supports and logs all sample receipts, locations, accesses, movements, processes and modifications, process results, and distributions.

iii. Procure biospecimens to meet the biospecimen needs for each genomics study and ensure that samples are collected, handled, shipped and received with full maintenance of quality in accordance with contracts and SOPs.

iv. Execute and maintain Material Transfer Agreements (MTAs)/Data Use Agreements (DUAs) with each source entity for transfer of biospecimens.

v. Coordinate with other program entities including but not limited toBiospecimen Repository and Archive (BCA), Clinical Data Coordinating Center (CDCC), Genome Characterization Center(s) (GCC), Tissue Source Sites (TSS), Genomic Data Commons (GDC), and NCI to meet project needs.

vi. Establish a Quality Assurance (QA) program and Quality Control (QC) results of all inventory processes, and electronically record the status of samples as they progress through receipt and storage.

vii. Establish all the necessary policies, systems, and technologies to ensure patient protection as specified by regulation, and ensure that National Institutes of Health (NIH) policies are met.

viii. Transfer biospecimen associated data to a designated data center(s).

2) Biospecimen Management and Biorepository Operations The Contractor shall:

1) Store all biospecimens according to standardized protocols and best practices

2) Implement SOPs, systems, software, and technology to ensure documentation of biospecimen access, control, and access logging.

3) Provide working storage space in the appropriate environments to support the internal operations of the BPC for activities such as processing, QC, backup, and working storage prior to shipment of analytes

4) Store materials for the expected duration of the study or as required by the NCI Contracting Officer (CO).

5) Develop plans and SOP to govern the eventual transfer of materials to a designated NCI long-term biorepository or as required by CO.

3) Biospecimen Quality Control The Contractor Shall:

1) Implement necessary systems and SOPs to implement histology laboratory services to verify and document the consistency of received research sample characteristics with the donor institution’s diagnostic result such as correct tissue and tumor content, and to evaluate each biospecimen’s suitability for use in its genomics study.

2) Collect digital images at an appropriate resolution to allow histological review on the digital image.

3) Make available all histological QC data online and export to the designated data center.

4) Conduct proper storage, quality maintenance and shipping as required by Contracting Officer’s Representative (COR).

4) Biospecimen Processing into Molecular Analytes

The Contractor shall:

1) Perform the following biospecimen processing activities upon receipt of specimens:

i) DNA and RNA extraction from frozen or Formalin Fixed Paraffin Embedded (FFPE )tumor tissue using an approved protocol, and

ii) Germline DNA extraction from blood and/or lymphocytes and/or frozen normal solid tissue and/or buccal using an approved protocol.

2) Store stock plates of nucleic acids.

3) Distribute nucleic acid as required to meet study needs.

4) Use laboratory automation whenever possible to improve economy of scale.

5) As required, develop and implement new isolation technologies for different cancer tissues, different types of analytes and/or initiate different methods of preparation if the genomics study will require it.

6) Implement testing systems, including laboratory protocols and information systems to perform molecular QC processes as required to meet study needs.

7) Document and report biospecimen molecular extract quality data for each type of analyte created, and these data shall be available on a web-based portal for NCI COR designated parties.

8) Develop protocols to minimize or eliminate cross-contamination, and to measure rates of contamination.

9) Electronically record in the LIMS the results of all QC processes, and the status of samples as they progress through QC and make available online.

5) Biospecimen and Analyte Distribution

The Contractor shall:

1) Develop and implement SOPs to distribute analytes and tissues to GCC(s) in compliance with DOT requirements.

2) Execute MTAs with institutions that shall be receiving materials. MTAs shall be approved by the COR

3) Develop and deploy a support system for GCCs, to rapidly analyze, understand and correct analyte quantity, quality and logistics issues.

4) Record all analyte/tissue shipments and related QC in the LIMS.

5) Data export

The Contractor shall:

1) Export data to a designated data center via processes supported by the data center.

2) Export data in a format supported by the data center at the time of data export.

3) Export biospecimen and analyte GCC shipment data within one (1) business day of the material’s shipment.

7) Other BPC-related Services

The Contractor shall perform services for other molecular testing and pathology services.

8) Pilot Studies

The Contractor shall perform additional pilot studies and submit required deliverables.

9) Transition Activities

C.

i. The Contractor Shall:

i. Prepare a Start-up transition plan outlining processes for commencement of operations, including specifically the scale up of staffing (including key personnel) and operational resources as well as the incorporation of data, SOPs, and materials and other transition information. These materials will be made available by NCI to the Contractor.

ii. Prepare a Close-out transition plan for the end of the contract. The plan shall include mechanisms for transmission of data (including computer-based data) and materials to parties designated by the Contracting Officers Representative (COR) or as contractually obligated.

iii.

TASK AREA B: CCG Biorepository and Archive (CBA) Services D. Scope

The Center for Cancer Genomics (CCG) Biorepository and Archive (CBA) provides long-term biorepository and biospecimen archive services for an expanding list of CCG-supported genomics projects. The Contractor shall provide the following services:

1) Biospecimen and Associated Data Receipt and Storage: receive samples and associated data from the other CCG biospecimen source entities and other sources to provide long-term storage.

2) Biospecimen Management and Biorepository Operations :provide biospecimen management services encompassing the logistics of the biospecimens collected, including receipt, annotation, storage management, location management, internal movement and distribution.

3) Biospecimen and Analyte Distribution :distribute molecular analyte aliquots and other biospecimens using strictly controlled procedures and documentation.

1) Description of Work

1) Biospecimen and Associated Data Receipt and Storage

The Contractor shall:

1) Receive, store, and index bulk archival shipment/collections. The Contractor shall support the following storage environments to include but not be limited to:

i) vapor phase liquid nitrogen freezers (-190°C to -150°C).

ii) -80°C and -20°C mechanical freezers.

iii) humidity and room temperature controlled areas.

2) Receive, store, and index bulk archival shipment/collections as needed when studies conclude.

3) Coordinate with the Institutions providing the archival collection.

4) Store and maintain, in the long-term, biospecimens and materials to support Task Area B

2)

3) Biospecimen Management and Biorepository Operations

The Contractor shall:

1) Store all biospecimens according to best practices.

2) Execute and maintain MTAs/Data Use Agreements (DUAs) with each source entity for transfer of biospecimens.

3) Implement a Quality Assurance program, SOPs, systems, software, and technology to ensure documentation of biospecimen access, control, and access logging.

4) Provide working storage space in the appropriate environments to support the internal operations of the CBA for activities such as intake, storage, and QC.

5) Provide long term storage of materials to meet the needs of the NCI.

6) Develop plans and SOP to govern the eventual transfer of materials to a designated CCG long-term biorepository.

3) Biospecimen and Analyte Distribution (optional)

The Contractor shall:

1) Retrieve, process and ship individual and aggregate biospecimens as needed to support Task Area B.

2) Coordinate with the Institutions to ship biospecimens as needed.

�General Title for the IDIQ SOW?

�Title for Task Area 1. ?? The� Center for Cancer Genomics (CCG) Biospecimen Processing Center (BPC)??

Or Biospecimen Core Resource (BCR) services for biospecimen processing, for Biospecimen Processing Center (BPC)??

�As Dawn noted, need title for Task Area A.

�NCI?

�NCI?

�?? Contradictory statement

�Industry Best Practices? NCI?

�Offerors should know this

�Will be addressed in #5

�Is the contractor responsible for shipping the analytes? Any Regulatory considerations? Training considerations?

�Spell out at first use.

�Spell out at first use.

�Spell out at first use.

�Where online and who will have access?

�Yes, this is an option or optional effort that we would like to have them include in the capability statement because we may include it in the Solicitation.