D1 SOW with Attachment.pdf
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- Attached to
- Natural Killer (NK) Cell Function Testing Federal contract opportunity
- Solicitation number
- 75N95024Q00193
About this file
This statement of work describes natural killer (NK) cell function testing requirements for post-acute sequelae of SARS-CoV-2 (PASC) and Gulf War illness studies at the National Institutes of Health (NIH). The selected contractor will receive blood samples from NIH and perform NK cell function analysis within 24 hours using chromium release methodology. Key deliverables include providing results by fax within seven business days reviewed by a medical doctor. The base period of performance is one year from March 2024 to March 2025, with two optional one-year extensions. A minimum of 15 samples will be tested annually with options to increase the quantity in increments of five samples per option year. The National Institute on Drug Abuse will award a purchase order to the Cincinnati Children's Hospital Medical Center as the only source able to compare results to prior natural killer cell data from the same studies due to standardized sample handling and methodology.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| D3 FAR Provision 52.212-3 (Feb 2024).docx | DOCX document | |
| D4 FAR 52.212-5 (Feb 2024).pdf | ||
| D5 Invoice Provisions (Mar 2023).pdf | ||
| D 75N95024Q00193_CSS.pdf | ||
| D2 FAR 52.212-1 (Sep 2023) (TAILORED).pdf |
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Text version
Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
STATEMENT OF WORK
(SOW)
GENERAL INFORMATION
Title of Project:
Natural Killer (NK) Function Testing for Post-Acute Sequelae SARS-CoV-2 (PASC) and Gulf War Illness Studies at NIH.
Statement of Need and Purpose:
The PASC and GWI protocols (Protocols 00089 and 00051) require Natural Killer (NK) cell function to be measured. The contractor shall provide testing of NK cell function and provide a report of the results.
Protocols 00089 and 00051 are available on clinicaltrials.gov.
Background Information and Objective:
NINDS has initiated an effort to study PASC and GWI (details on disorders and study) that dovetails on the deep phenotyping work that was part of the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) protocol that has been completed.
Natural Killer (NK) cells are a type of cytotoxic lymphocyte critical to the innate immune system.
They respond quickly to virally-infected cells and tumor formation. Successful phenotyping of our study participants will require measurements of NK cell function. The projects also need to be able to compare the results from PASC and GWI participants to previously collected NK cell measurements from the ME/CFS participants.
Period of Performance:
One base year with two option years to begin on or about:
Base Year: 03/15/2024 – 03/14/2025 Option Year 1: 03/15/2025 – 03/14/2026 Option Year 2: 03/15/2026 – 03/14/2027
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 specific requirements listed below:
Specific Requirements:
The contractor will perform NK cell function analysis on the samples. Specifically:
RFQ No. 75N95024Q00193
Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
1. Using chromium release methodology, natural killer cells (NK cells), obtained from peripheral blood mononuclear cells are assayed for the ability to lyse target cells at four different effectors: target (E:T) ratios. Lytic units are a calculated measure based on the cytotoxicity results. CD16/56 (NK Cell) percentage of the mononuclear cell preparation is measured and reported to confirm the presence of NK cells in the plated sample.
2. The laboratory shall be regulated under Clinical Laboratory Improvement Amendments (CLIA) as qualified to performa high-complexity clinical laboratory testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.
3. The contractor will receive individual blood samples shipped from NIH. The contractor shall perform NK cell function analysis on the samples within a 24 hour time window required for proper testing.
4. The contractor is anticipated to receive a minimum of 15 blood samples for testing annually. The Government has the option to increase this quantity in increments of 5 samples (3 options to add 5 samples) within each year of the contract.
GOVERNMENT RESPONSIBILITIES
The NIH protocol team will send by FedEx a 10mL whole blood sample collected in a heparizied tube and maintained at room temperature. The samples will be sent with a deidentified patient code specific to Protocol(s) 00089, 00051.
DELIVERY OR DELIVERABLES
Performance period
Minimum number of samples tested
Option quantity 1 Option quantity 2 Option quantity 3
Base Year 15 5 5 5 Option Year 1 15 5 5 5 Option Year 2 15 5 5 5
REPORTING REQUIREMENTS
The contractor shall provide results by fax within 7 business days. All results must be reviewed by a medical doctor for accuracy before submission to the Government. See Attachment A for suggested report format. Each sample is coded with a study specific identifier number. The numbers are untraceable back to the NIH study participant. As a result, there is no confidential information in the report.
OTHER CONSIDERATIONS
Publications and Publicity:
The contractor will not have any influence or reference in, or on any publication produced as a result of this requirement.
ATTACHMENTS
1. Attachment A – suggested report format
| B Statement of Work |
| SCOPE OF WORK |
| DELIVERY OR DELIVERABLES |
B SOW_Attachment 1
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