D_SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Deoxyribonucleic acid (DNA) extraction and multi-gene analysis from rodent tissue samples.

Statement of Need and Purpose:

National Institute on Aging (NIA) requires DNA extraction and multi-gene analysis from rodent tissue samples. Once samples are processed and analyzed, the results must be posted in an information database accessible to NIA investigators; in addition, the results must be transferred into the NIA progeny database. Testing results must be >98% accurate and posted to database within 72 hours of sample receipt.

Background Information and Objective:

This requirement is for outsourcing tissue samples for genotyping of NIA research mice. High quality genotyping results with a 72-hour tum-around time are vital to mouse colony population management, breeding schemes, and researcher animal study proposals. Given the size of the program and the number of investigators whose research is dependent upon rodent studies, eliminating mistakes (variables) in genotype testing is critical to the research mission at the NIA/Intramural Research Program (IRP).

Period of Performance:

Indefinite Delivery Indefinite Quantity ordering period of April 4, 2022 – April 3, 2026

SCOPE OF WORK

General Requirements:

The Genotyping Support contractor shall provide for DNA extraction and multi-gene analysis from submitted specimens and accompanying bioinformatics support. The majority of biological samples will be rodent tail clip, ear punch, and toe clip samples. There will be approximately 2,700 samples per month and may increase to 3,100 samples (37,200 total samples per performance period of one year, if animal population significantly increases).

Sample storage and preservation are recognized as a critical component for subsequent nucleic acid analysis. Samples should be held until requested for return to the NIA Contracting Officer Representative (COR) or NIA Investigator, for a minimum of six months. Alternatively, samples may be disposed of by the contractor, but only after obtaining approval from the NIA COR and NIA Investigator. All available specimen information will be provided to the contractor prior to analysis.

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government and as needed to perform the Statement of Work below:

Specific Requirements:

1. Perform high quality DNA extraction on submitted rodent tissue samples.

2. Design Polymerase chain reaction (PCR) assays to perform genotyping analysis for all strains submitted.

3. Run PCR analysis on samples, some of which may only require 1 gene to be analyzed and others may require multiple genes (unlimited cap on alleles) to be analyzed.

4. Perform quality assurance analysis on 1% of submitted samples weekly.

5. The government will not incur additional cost if sample submitted has multiple genes.

6. Re-test any failed sample/reactions or questionable results at no additional cost to NIA.

7. Provide reproducible genotyping assay for each strain, if requested.

8. Provide any raw data obtained in genotyping analysis, if requested.

9. Analyze all PCR results and provide annotation (e.g. homozygous, heterozygous, etc.)

10. Provide bioinformatics database that allows for NIA investigators to quickly access test results.

11. With coordination of NIA/Biomedical Research Center (BRC) IT department, have the capability to send results automatically to the NIA/BRC Progeny database where the results will upload into said database. This data sharing portal MUST be completed one

(1) week within contract inception.

12. Genotyping results shall be completed within 72 hours of receipt of samples.

13. Hold all samples and remaining tissue for a minimum of 6 months.

14. Provide sample collection and storage material (supplies) to the NIA animal colony for tissue collection.

15. All shipping and courier related cost to receive samples from NIA shall be at no additional cost to the government.

16. Samples should be sent overnight express or picked up from NIA at least 3 times per week.

LEVEL OF EFFORT:

The level of effort will solely be the responsibility of the contractor to meet the 72 hours sample testing result tum-around time, including gene annotation and subsequent data results uploaded into the NIA/BRC Progeny database. The contactor will also be responsible for providing knowledgeable staff to design new PCR assays (probes) for all reactions to be performed.

GOVERNMENT RESPONSIBILITIES

It is undetermined at this time if the contractor will need facility access; logistics of sample pick up is TBD. The government will collect all rodent tissue samples, place in contractor provided 96 well plates or other contractor provided tissue transport containers. The government will place 96 well plates and or other tissue containers into contractor provided shipping package and place into collection receptacle.

The government will furnish contractor with any requested genotyping protocols that have been developed and/or any documentation of rodent models (e.g., construct sequences, manuscripts, etc).

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and make recommendations of changes in requirements g to the Contracting Officer; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this Contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in the contract.

The Government may unilaterally change its COR designation.

DELIVERY OR DELIVERABLES

The Contractor shall:

a. Provide all necessary sample collection material for the shipment of samples including, but not limited to: sample collection plate or vial, refrigerated sample storage for holding samples prior to genotyping analysis, appropriate pre-paid shipping containers, and a sample record tracking system/method.

b. Send by overnight express and/or pick up three times per week all samples from NIA.

c. Package, mark and ship all samples required under this contract in accordance with the shipping specifications outlined in the Statement of Work.

d. At a minimum, mark all deliverables with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable conditions.

REPORTING REQUIREMENTS

1. Sample testing results and annotation must be posted to database within 72 hours of receipt.

2. Immediate notification to the COR for any strains/assays that the contractor is finding problematic.

OTHER CONSIDERATIONS

Travel:

There will be no required contractor travel; no reimbursable expenses are expected.

Key Personnel:

1. Genotyping Lab Manager

2. Quality Assurance Manager

The key personnel specified in this contract are considered essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts, the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days' notice, the Contractor shall provide the maximum notice practicable under the circumstances.

The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

Information System Security Plan:

The contractor will not be required to host or maintain any federal information system.

Data Rights:

The National Institute on Aging, HANDLS study shall have unlimited rights to and ownership of all deliverables provided under this purchase order including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic purchase order and any optional task deliverables exercised by the contracting officer.

In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.”

FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor will produce information that will be maintained in a database accessible to the NIA COR and NIA investigators. The public will not have access to the data.

Publications and Publicity:

The contractor will not publish scientific data based on the requirements of the SOW.

Confidentiality of Information:

No information of a personal nature will be disclosed by the government to the contractor.

Testing results are expected to be considered confidential information.