SOW.pdf

FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SOW) SERVICES

Genotyping Support Services

GENERAL INFORMATION

Title of Project:

Genotyping Support Services

Statement of Need, Purpose, and/or Objective:

The purpose of this requirement is to provide the National Institute of Aging (NIA) with

DNA extraction and multi-gene analysis services for rodent tissue samples on an indefinite-delivery indefinite-quantity basis.

Background Information:

The National Institute on Aging (NIA) has historically performed rodent genotyping services internally to support investigative research staff. However, it was recently determined that NIA will no longer perform this work. Accordingly, contractor support is required for rodent tissue sample genotyping services.

Period of Performance:

The period of performance for this indefinite-delivery/indefinite-quantity requirement shall be April 4,2026 through April 3,2031. Sample analysis unit costs may be separately priced for each contract period of performance.

Place of Performance:

The place of performance for this requirement shall be the contractor’s worksite.

Type of Contract Contemplated:

An indefinite-indefinite delivery indefinite-quantity contract is contemplated. The order shall be sourced via the Open Market and is expected to exceed $150,000.

SCOPE OF WORK

General Requirements:

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 below.

Specific Requirements:

The contractor shall provide the genotyping support services, which include DNA extraction and multi-gene analysis, detailed below.

• Perform DNA extraction and isolation from rodent biological samples, from either an ear punch, rodent tail clip, or a toe clip sample. A minimum of 25,200 samples and a maximum of 37,200 samples shall be processed during each contract period of performance.

• Perform polymerase chain reaction (PCR) assay for genotyping of all biological samples provided. PCR analysis includes one or up to ten genes per sample.

• Perform re-test of any failed analyses or questionable results. Each test shall include all analyses documentation, not just quality-assurance-type analyses. A Re-test, if required, shall be the responsibility of the contractor and shall not be charged to the Government.

• Perform quality assurance analysis on 1% of samples provided each week.

Quality assurance results shall be provided to the Government within one week.

Additionally, all concerning items shall be reported to the Government immediately.

• All DNA extraction, PCR assays, and assay results must be completed within 72 hours of contractor receipt of samples.

• Provide reproducible genotyping assay information and any raw data obtained in genotyping analysis for all samples provided by the Government, upon request.

• Provide results of DNA extraction, PCR assays, and assay results with annotation.

• Provide genotype results via an online bioinformatics database which the Government may easily access. The database must be provided and hosted by the contractor and all results shall be included therein within 72 hours of contractor receipt of samples. The database shall be password protected and must meet Section 508 standards, though the database shall not be available to the public.

• The online bioinformatics database must be able to interface, using XML or comparable language, with an existing Government database known as the NIA Progeny Database which holds existing genotyping data. The contractor database information shall interface with the NIA database, and the contractor database shall be able to accept information from the NIA database if needed. All information must be kept secure.

• Store all provided samples and remaining biological tissues appropriately for preservation for 6 months after receipt from the Government. Stored samples and remaining tissues shall be in maintained in such condition that subsequent nucleic acid analyses may be performed. Stored samples shall be returned to the Government upon request. Following the 6-month holding period, the contractor shall obtain approval from the Government to either return or destroy samples.

• Provide sample collection and storage material supplies to the Government for tissue collection. Supplies shall include 96 well plates and/or vials for sample collection, reagents, pipette tips, cap strips, probes, refrigerated sample storage units for holding samples prior to genotyping analysis, appropriate pre-paid shipping containers, and a sample record tracking system/method.

• Provide all shipping and courier related costs for the Government to send and receive samples, including shipping containers/packages. Samples must be picked up by the Contractor from the Government at least three (3) times per week. The Contractor shall provide a drobox for samples to be placed for pickup.

Samples returned to the Government must be shipped via overnight express, refrigeration is not needed.

Provide telephone support to the Government between the hours of 7:30AM and 3:30PM, Monday through Friday, Maryland local time.

Ordering and Receiving:

The maximum quantity that the government may order over the life of the IDIQ contract is detailed in the table below. The minimum quantity which may be ordered for the life of the contract is detailed in the same table.

IDIQ Contract Annual Requirements

Service Unit Minimum Quantity Maximum Quantity

Genotyping Support Services One Sample 25,200 37,200

IDIQ Contract Overall 5-Year Requirements

Service Unit Minimum Quantity Maximum Quantity

Genotyping Support Services One Sample 25,200 186,000

Orders issued under this contract may be placed in writing or via electronic mail (e-mail) by the Contracting Officer’s Representative (COR). The COR shall be identified at the time of award. The Contractor representative(s) authorized to receive and accept orders shall also be identified at the time of award.

All orders delivered under this contract must be verified by an authorized COR. The authorized COR shall formally document all work performed by the Contractor and the

Contractor shall assist in this process. The COR will inspect ordered support for completion within 72 hours, as gauged by results data uploaded into the online database, as well as for appropriate re-test and delivery of samples which did not meet quality assurance requirements, prior to invoice approval.

Please note that the Government shall not be obligated to purchase services beyond the minimum quantity included on any resulting contract award. All services ordered shall be purchased via delivery order against the parent indefinite-delivery/indefinite-quantity contract. The parent contract shall not obligate funding; only delivery orders shall obligate funding.

Delivery Requirements:

Genotype results shall be provided via contractor-hosted database. Samples shall be picked up from and returned to the Government site located at 251 Bayview Blvd, Baltimore MD 21224.

GOVERNMENT RESPONSIBILITIES

Government Furnished Property and Information:

The Government will provide rodent biological tissue samples for contractor analyses.

The Government shall also furnish the contractor with existing genotyping protocols and other documentation developed for the rodent samples, such as construct sequences and manuscripts. FAR Clause 52.245-1 Government Property shall be applicable to this requirement.

OTHER CONSIDERATIONS

Travel:

No travel is expected nor shall travel reimbursement be provided for this requirement.

Key Personnel:

The following key personnel are required:

1. One (1) Genotyping Lab Manager

The Genotyping Lab Manager must possess a B.S. in a biological, chemical, or genetic science and must have a minimum of five (5) years of experience in assay design and development, data interpretation and troubleshooting, and use of high throughput DNA isolation and real time PCR genotyping systems.

2. One (1) Quality Assurance Manager

The Quality Assurance Manager must possess a B.S. in a science or engineering discipline and must have a minimum of five (5) years of experience in analysis and interpretation of data results and data integrity management. The Quality Assurance Manager must also have a minimum of five (5) years of experience performing process validations, equipment qualifications and regulatory compliance.

3. One (1) Local Technical Representative

The Local Technical Representative must possess a minimum of three (3) years of experience in a customer service-related field. Experience must include serving as a liaison between contractor and customer, troubleshooting, and data dissemination.

The proposed Key Personnel will become subject to the provisions of Health and

Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key

Personnel as follows:

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. 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 Systems Security:

The Contractor must ensure that all computer systems used in the course of this contract shall include the following features:

1. Any computer used in relation to this contract must be patched with most updated IT Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/ .

5. Contractors are required to sign the NIH non-disclosure agreement.

http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf .

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the loss or theft, even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx .

8. Any computers used in reference to this contract must be assessed for vulnerable areas.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled, such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ, at a minimum, username and password authentication, or if possible two factor authentication.

12. Any computers used in relation to this contract must be password protected. All

Passwords must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analysis results, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. All data provided and produced in relation to this requirement shall be solely owned by the Government. The contractor will not publish scientific data based on this requirement. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause http://irtsectraining.nih.gov/ http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

52.227-14, “Rights in Data-General,” shall be incorporated into any resulting award by reference.

Section 508—Electronic and Information Technology Standards:

Section 508 of the Rehabilitation Act of 1973 requires that Federal agencies’ electronic and information technology (EIT) is accessible to people with disabilities. The Federal

Acquisition Regulations (FAR) Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm. The contractor must state that they will comply with the requirements of Section 508 or cite a justifiable reason for an exception.

Confidentiality of Information:

Confidential Information means information or data of a personal nature about an individual, or proprietary information, or data submitted by, or pertaining to an institution, or organization. Confidential Information or records shall not be disclosed by the

Contractor without written authorization from the Contracting Officer. Whenever the

Contractor is uncertain regarding the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting

Officer prior to any release, disclosure, dissemination, or publication. No information of personal nature will be disclosed by the government to the contractor. HHSAR Clause

352.224-71 Confidential Information shall be applicable to this requirement. Testing results shall be considered confidential information.

Non-Personal Service Statement

Contractor employees performing services will be controlled, directed, and always supervised by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).

https://www.section508.gov/ https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards