Revised_Statement of Work._blood samples_ELR-8-25-26.docx

STATEMENT OF WORK

PROJECT TITLE: Blood Bank Samples: Healthy Leukopaks and Fresh Healthy Whole Blood NIST UNIT: MML / Biomolecular Measurement Division (645.06)

DATE: AUGUST 20, 2026

1. BACKGROUND

The Biomolecular Measurement Division (BMD) of the Material Measurement Laboratory (MML) at the National Institute of Standards and Technology (NIST) mission is to provide measurement science, reference materials, reference data, and technologies to foster innovation and confidence in measurements needed to advance biotechnology, DNA forensics, biomedical and bioscience research, and health care.

This supports the NIST mission by providing essential biological starting materials used for forensic DNA testing, Standard Reference Material (SRM) production, inter-laboratory studies, and the publication of allele frequencies.

2. OBJECTIVE

The purpose of this acquisition is to procure Healthy Leukopaks and Fresh Healthy Whole Blood samples for forensic DNA testing, SRM production, inter-laboratory studies, and publication of allele frequencies.

3. SCOPE OF WORK & METHODOLOGY

LOT

Specifications for Line Item 001 and Line Item 002:

a. DONOR CRITERIA Donors must be IRB-consented with clinically confirmed healthy status. Donors will be requested to provide verbal healthy diagnosis and de-identified demographics (age, sex, race/ethnicity).

b. INFORMED CONSENT Informed consent must explicitly identify sample and data sharing with law enforcement and academia, and allow publication of genotyping/sequencing results. Samples must be eligible for use in SRM production, redistribution, and commercialization. NIST shall review and approve the informed consent forms prior to order fulfillment.

c. COLLECTION Healthy Leukopaks collected via leukapheresis and fresh healthy whole blood. Collection and shipping should occur within 24 hours. Custom tubes and anticoagulants as requested.

d. PROCESSING Full clinical screening and viral testing required.

e. STORAGE & CHAIN OF CUSTODY The Contractor shall deliver samples to NIST within 72 hours of collection. Deliveries must occur during standard business hours (8:30 am to 5:00 pm ET) on weekdays. No weekend shipments or deliveries are permitted.

Shipping Method: Cold shipment (approx. 4°C) using freezer packs. Tracking information must be shared with NIST for each shipment.

Specification for Line Item 0003 Description: Informed Consent Template Quantity: 1 The contractor shall prepare a informed consent template. The template must explicitly identify sample and data sharing with law enforcement and academia, and allow publication of genotyping/sequencing results. Samples must be eligible for use in SRM production, redistribution, and commercialization. NIST shall review and approve the informed consent forms prior to order fulfillment.

Specifications for Line Item 004 and Line Item 005 – Option Period:

a. DONOR CRITERIA Donors must be IRB-consented with clinically confirmed healthy status. Donors will be requested to provide verbal healthy diagnosis and de-identified demographics (age, sex, race/ethnicity).

b. INFORMED CONSENT Informed consent must explicitly identify sample and data sharing with law enforcement and academia, and allow publication of genotyping/sequencing results. Samples must be eligible for use in SRM production, redistribution, and commercialization. NIST shall review and approve the informed consent forms prior to order fulfillment.

c. COLLECTION Healthy Leukopaks collected via leukapheresis and fresh healthy whole blood. Collection and shipping should occur within 24 hours. Custom tubes and anticoagulants as requested.

d. PROCESSING Full clinical screening and viral testing required.

e. STORAGE & CHAIN OF CUSTODY The Contractor shall deliver samples to NIST within 72 hours of collection. Deliveries must occur during standard business hours (8:30 am to 5:00 pm ET) on weekdays. No weekend shipments or deliveries are permitted.

Shipping Method: Cold shipment (approx. 4°C) using freezer packs. Tracking information must be shared with NIST for each shipment.

4. DELIVERABLES

BASE PERIOD – CLIN 0001

BASE PERIOD – CLIN 0002

BASE PERIOD – CLIN 0003

OPTION PERIOD – CLIN 0004

OPTION PERIOD – CLIN 0005

SHIPPING – CLIN 0006

5. PERIOD OF PERFORMANCE

The period of performance shall base period will be one year with one year option period.

6. INSPECTION & ACCEPTANCE

NIST will inspect the viral report upon receipt. If a viral positive sample is received (shipped prior to testing completion), the Contractor has one (1) month to resolve the shipment. Confirmation of acceptance will be provided within one (1) week.

7. DELIVERY REQUIREMENTS

Delivery must be F.O.B. Destination, and must occur in accordance with the delivery due dates provided in the table above.

The contractor must deliver all line items to:

National Institute of Standards and Technology 100 Bureau Drive, Building TBD Gaithersburg, MD 20899

All line items must be shipped in the original manufacturer’s packaging.

FOB Destination means: The contractor must pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for any loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery.

8. INSPECTION & ACCEPTANCE

The Government will inspect the products (if applicable, add “including installation and training”) within 10 business days of receipt. The Contractor has the right to be present during the tests and evaluations, if performed, at the Contractor’s expense.

The Government has sole discretion to require repair or replacement of damaged and/or nonconforming supplies at no cost to the Government. The Government at any time prior to acceptance may reject the products due to defects and/or nonconformance.