ATTACHMENT 5 - Addl Tech Prop Inst_Rev.Amend.2_Final.pdf

ATTACHMENT 5 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS revised April 29, 2020 1 RFP Number 75N93020R00006

ATTACHMENT 5: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

Revised April 29, 2020

NIAID Specimen Repository RFP Number: 75N93020R00006

It is strongly recommended that offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal.

While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the solicitation as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

SECTION 1:

1) PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, DUNS number, and identify if the proposal is an original or a copy. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall also include the legend regarding Restriction on Disclosure and Use of Data prescribed by FAR 52.215-1(e)]

2) TABLE OF CONTENTS

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 3-page maximum) Provide a brief overview of the Technical Proposal, including:

1) A brief description of the activities proposed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key https://www.acquisition.gov/sites/default/files/current/far/html/52_215.html

ATTACHMENT 5 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS revised April 29, 2020 2 personnel for the offeror and the proposed subcontractors with degrees, titles and role in the project.

2) By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

3) A brief description of the facilities and equipment to be made available by the offeror and all proposed subcontractors.

SECTION 3: TECHNICAL PLAN/APPROACH

A) Conform to the current best practices for repositories.

Describe the proposed plans and procedures to maintain the current best practices for the collection, preservation, storage, retrieval and distribution of the biological samples in the NSR. Discuss your knowledge and use of current international, Federal, State and local regulations and policies and/or guidelines in your repository operations.

B) Manage logistics for receiving, processing, recording and storing incoming shipments;

Describe your experience, approach and plans for receiving shipments of biological specimens. Discuss how you will handle changes in work distribution as volume of work varies. Discuss how you will maintain consistency and standardization, as well as accurate documentation.

C) Prepare specimen aliquots, and provide research materials;

Describe your experience, approach and plans for generating and labeling specimen aliquots. Describe your approach to providing or producing cellular DNA or cDNA. There are currently no renewable specimens or immortalized cell lines in the NIAID Specimen Repository. They do not need to be budgeted for, but you must have the capability to store and maintain them, if necessary.

D) Package, handle and coordinate specimen shipments to domestic and international sites;

Describe your experience, approach and plans for distribution of specimens. Describe procedures for tracking, monitoring and verifying receipt of shipments.

E) Withdraw and destroy specimens from the repository;

Describe your experience, approach and plans for withdrawal and destruction of specimens in a manner that meets all public and occupational health, safety, and environmental protection regulations.

F) Maintain high quality, secure information systems;

1) Describe the inventory and tracking system, including sample descriptions of inventory control procedures and an example of sample tracking from receipt to ultimate distribution.

2) Provide an architecture diagram of the system components to be used for this contract. Provide the current User Guide for your Inventory Management system.

3) Discuss your experience, approach and plans for maintaining a real-time electronic inventory of specimens, including hardware and software (including versions) currently in use. Describe how it will be accessible to Study Groups. If you use a software-as-a-service model for components describe the integration and factors that support this approach. Discuss the integration of data between system components. The study

ATTACHMENT 5 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS revised April 29, 2020 3 groups track specimen collection in LDMS, a laboratory information management system, and send electronic manifests as email attachments in .txt or .cvs format.

4) Describe proposed plans for oversight and security procedures of data management functions, including communications with technical staff.

5) Describe your experience and approach to managing a large inventory for specimens, including storage organization and consolidation over time.

G) Develop and implement a validated Quality Assurance/Quality Control program covering all activities related to the successful operation of a biological specimen repository.

1) Provide a QA/QC Plan that addresses:

a. validated and annually updated standard protocols (SOP's) for all repository operations, including physical management and IT tracking of specimens;

b. measures/metrics to be used to assess performance and quality of repository functions;

c. approaches/methods to document and address problems and deficiencies, including improvements in the QA/QC plan; and

d. plans for training contractor staff on standard protocols and measures used for

QA/QC.

2) Describe plans and procedures for monitoring of:

a. receipt of specimens with inspection at the vial, box and shipment level;

b. aliquotting of specimens;

c. storage conditions at the box and storage unit level;

d. shipping containers;

e. storage facilities, including central alarm system and individual storage unit temperature alarms;

f. air conditioning systems, and the back-up power system;

g. IT hardware and software used for data management;

h. shipping of all requested materials; and

i. equipment replacement practices.

H) Implement the initial and final transition plans including description of the relocation of the repository without damage and with minimal disruption to the performance of repository activities.

Describe the plans for the initial transition of the current program from the incumbent, including all specimens, government furnished property and all data and data systems.

Include plans for coordinating with the incumbent contractor in accordance with the requirements of the Statement of Work. Timelines for accomplishment of all transition activities should be included.

Describe general plans for transition of the program to another Offeror at the end of the contract.

SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL

Provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of all contract requirements. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the contract.

ATTACHMENT 5 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS revised April 29, 2020 4

1) Principal Investigator (PI): Describe the experience, training, expertise, and qualifications, and level of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under this contract.

2) Other Key Scientific and Technical Personnel: Describe the experience, training, expertise and qualifications, as well as the level of effort, for all proposed key scientific and technical personnel.

3) IT Personnel: Describe the experience, training, expertise, and qualifications, and level of effort of the IT staff that support the project including experience supporting biological and/or biomedical applications. Identify any subcontractors.

SECTION 5: FACILITIES, EQUIPMENT, AND OTHER RESOURCES

The Technical Proposal should document availability and adequacy of facilities, equipment, space and other resources necessary to carry out the Statement of Work, including:

1) Location and features of facilities including a floor plan and a list of equipment and resources dedicated to the project for the prime contractor and any proposed subcontractors (lease or ownership information should be provided).

2) Identification and description of ALL support resources (including information technology systems) that will be required to effectively complete the SOW. Describe the physical location of IT resources.

SECTION 6: PROJECT MANAGEMENT

1) Provide a Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks identified in the Statement of Work. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).

2) Provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants.

Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Identify the point(s) of contact for communication with Study Groups. Include a chart of the proposed organizational/management structure for the project.

2) Describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. The plan must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

3) Outline how the PI (or Project Manager) will communicate with the COR and CO and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

4) Discuss approaches for providing an orderly, secure, and efficient transition of contract activities and contract-related data, documents and other materials from (initial transition) and to (final transition) another contractor in the event that a transition is required.

ATTACHMENT 5 – ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS revised April 29, 2020 5

SECTION 7: OPTIONS

Options should be presented as a separate part of the Technical Proposal and clearly identified as such.

1) OPTIONS 1 through 6: Extend the Term of the Contract Discuss plans and procedures for continuing and providing the same services indicated in the Statement of Work beyond the contract base period. To address this option, offerors should describe the methods and procedures to maintain the operations specified in the Statement of Work beyond the base period, including retaining or recruiting necessary staff, and maintaining and/or acquiring required equipment and facility space.

2) OPTION 7 through 20: Increase Level of Effort Discuss approaches for incrementally increasing the level of effort by 1 FTE to respond to the need for unanticipated additional capacity related to work conducted in accordance with the Statement of Work. Each increase should be a separate option.

Describe plans for accommodating an increase in level of effort to perform all of the functions stated in the SOW in the event that the Government elects to exercise options in response to, for example, the acquisition of specimens from additional clinical trials or cohort studies not available prior to the writing of this solicitation. Offerors should address the need for an increased level of effort of 1.0 FTE and associated equipment and supply needs, to be exercised up to twice during any performance year.

SECTION 8: OTHER CONSIDERATIONS

Other than those detailed in the Government Furnished Property clause or otherwise publicly available, the offeror shall not propose government furnished resources, to include government employees, facilities, intellectual property or biological materials. If you propose government furnished resources your proposal will not be considered further for award.