Attachment 1 - SOW_olink services.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

OLink Explore HT Processing Service

Statement of Need and Purpose:

The Infections of the Nervous System Section, INSS, National Institutes of Health, NIH, requires purchase of the OLink Explore HT processing services, to develop protein expression profiles of patient samples to discover biomarkers of neurological disorders.

Background Information and Objective:

The mission of the National Institute of Neurological Disorders and Stroke (NINDS), Infections of the Nervous Systems Section (INSS) lab is to study the neuropathogenesis of neurological disorders including SARS-COV2, HIV, ALS and others. The INSS follows several cohorts of patients who generously provide their blood and cerebrospinal fluid to NINDS repositories for these study purposes. The goal of our research is to examine these samples in a way in which we can deduce disease processes over time and/or before and after experimental intervention.

The OLink technique, is similar to a commonly used technique in research labs called ELISA (enzyme-linked immunosorbent assay) in which two antibodies capture the protein to be detected/ measured and a reaction, generated from their proximity to one another, yields a measurable product e.g., color, light, etc. Assays have been developed in recent years that allow more than one protein to be measured at one time by using various “multi-plexing” strategies, such a 2, 4, 8, even a few dozen targets, often requiring escalating volumes of precious sample. OLink provides the technology, the automation, and analysis techniques to measure 5,300 proteins using only 2 microliters of human biofluid. This allows broad coverage of candidate biomarker measurements that can be provided by few other techniques and the specificity of OLink technology is touted as the best of the competing technologies. Using this high throughput approach on the samples being submitted for use with this OLink Explore HT technology, we hope to better understand the natural history of neurological disorders like ALS, long COVID, and HIV.

Period of Performance:

The period of performance will be approximately three months from date of award, with data required within 60 days of sample receipt.

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:

The Contractor will perform the OLink Explore HT Biomarker discovery protocol analysis by Illumina Novaseq 6000 platform. Samples will be submitted to the vendor for one run of the Explore HT OLink platforms, consisting of 172 samples in the one run. After completion of the work and acceptance of the data by the NINDS Bioinformatics Core Facility, these samples will be returned to the investigator on dry ice.

Specific Requirements:

• Project will be initiated by a virtual meeting between the Contractor and government, INSS lab personnel.

• One hundred seventy-two CSF samples randomized by the Nath Lab personnel will be shipped to the Contractor on dry ice and registered upon receipt by the Contractor, by comparing to the government-provided electronic manifest to the samples received by the Contractor.

• The Contractor agrees to receive these samples, which include HIV-patient derived cerebrospinal fluids, into their BSL2 facility.

• The Contractor must be able to process BSL2 samples.

• Samples will be transferred by the Contractor from the government-provided tubes to an assay-appropriate receptacle during regular business hours.

• The Contractor will perform the OLink Explore HT Biomarker discovery protocol on these samples and analyze the data using the Illumina Novaseq 6000 platform.

• After completion of the work and acceptance of the data by NINDS Bioinformatics Core

Facility computers, these samples will be returned to the NINDS Nath Lab on dry ice at the government’s expense.

• The Contractor must be certified by OLink to perform the OLink Explore HT platform.

• Oversight by expert personnel provided by the Contractor is expected throughout the project.

GOVERNMENT RESPONSIBILITIES

The Government anticipates shipping vials of cerebrospinal fluid samples to the Contractor in sample boxes in a randomized order on dry ice, as well as deliver, by email, an electronic manifest of those samples. The Government anticipates upon acceptance of data, arranging for the return of the samples on dry ice via overnight delivery.

DELIVERABLES

Data shall be delivered electronically to NINDS researchers within 60 days of sample receipt.

OTHER CONSIDERATIONS

Travel:

Not Applicable.

Information System Security Plan:

Samples are de-identified to protect patient identities; no PHI is included on the vial labels or on the manifest. Electronic data delivery will be facilitated by the NINDS Bioinformatics core facility.

Data Rights:

It is expected that all data generated on the samples will be held confidential and provided only to the Government and the party supplying the compounds for testing.

The Contractor shall guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the purchase order. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature and shall not be released, disclosed, or otherwise disseminated to any person, organization, etc., except as otherwise directed by the Government.

Section 508—Electronic and Information Technology Standards:

The Contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998. All tasks for testing of functional and/or technical requirements must include specific testing for Section 508 compliance, and must use NIH approved testing methods and tools.

Publications and Publicity:

Contractor will ensure protection of the Government Sponsored Studies. Contractor shall not publish any articles as a result of fulfilling this requirement.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Confidentiality of Information:

All data and the results emanating from or generated on the compounds or samples provided by the Government, along with any data compiled, are considered confidential based on the pre-existing agreements that the NINDS has established with compound sponsors. The contract restricts and prohibits the Contractor’s right to use, release to others, reproduce, distribute or publish data or other information resulting from testing/evaluations performed under purchase order. Such data shall not be releasable under the Freedom of Information Act (FOIA) as it is considered proprietary, i.e., trade secrets, and, therefore, could be determined to be exempt from FOIA. Restricted access to data and materials will be maintained at the Contractor’s facility in a secure manner. Special notices or other safeguards will be affixed to any packages containing such data.