SOW-NOI.pdf

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REQUIREMENTS JUSTIFICATION:

Acquisition of Metaphase Harvesters Systems

1. Intent

2. Background

In June 11, 2015 (DoD 2016 Appropriations Bill) Congress stated that “DHA, in coordination with the Departments of Health and Human Services, Homeland Security, Food and Drug Administration, and other agencies, as appropriate, have a congressional mandate to establish a Biodosimetry Network for Radiological/Nuclear Events.” [2016 – Senate Committee on Appropriations (Report 114-63) and 2017 – Senate Committee on Appropriations (Report 114- 263)] The DoD/DoW Biodosimetry Network became a DHA Program of record (Gov ID: 0181214-

343) in 2016.

The Department of War (DoW) would use biodosimetry for assessing Service members’ radiological doses post exposure to help determine treatment to save lives, the prognoses of casualties, and the important process of return-to-duty in a contested field environment. The DoW is developing a Biodosimetry network for the prompt, coordinated and integrated response to radiological/nuclear incidents/accidents affecting individuals or mass casualties. The network will use a multiparameter approach that combines clinical, biological, and physical/biophysical modalities.

In 2016, the Department of Defense identified the Armed Forces Radiobiology Research Institute (AFRRI) and Naval Dosimetry Center (NDC) as the lead institutions to start the first phase in the agreed Concept of Operations, development of capability.

The present phase would require the acquisition of equipment to support the network/program under the leadership of the Defense Health Agency, to advance the DoW Biodosimetry Network.

Most recent developments include: (1) first application of fast-dose assessment technique in fingernail samples collected from a radiation incident victim; (2) participation in several international inter-comparisons involving various biodosimetry techniques; (3) EPR-dose reconstruction using tooth enamel samples from former U.S. nuclear workers; (4) establishment of a cytogenetic biodosimetry process to access partial body radiation exposure; (5) preparation of standard operating procedures for a clinical laboratory performing dose assessment by cytogenetics; and (6) publication of severity-scoring system worksheets for use by first-responders to collect and perform early-phase diagnostics of acute-radiation-syndrome severity to drive medical management.

This document outlines the requirements and justification for the procurement of the Metaphase Harvesters Systems in support of the DoW Biodosimetry Network, a congress mandated, DHA led, Armed Forces Radiobiology Research Institute/Naval Dosimetry Center executed program. The total estimated cost for this acquisition is $754,600.00. Procurement of these systems is vital to the advancement of the DoW Biodosimetry Network in support of the DHA combat support mission.

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The advancement of the DoW Biodosimetry Network enhances the level of Servicemembers’ readiness and the Department’s ability to support in the battlefield.

The agreement with the Services and the DoD during the CONOPS phase of the Network was that the network will use state of the art modalities already documented in DoD policy (Biodosimetry modalities in Multi-service Tactics, Techniques, and Procedures for Treatment of Nuclear and Radiological Casualties - ATP 4-02.83, MCRP 4-11.1B, NTRP 4.02.21, AFMAN 44- 161(I), May 2014)

• Aside from using signs and symptoms, personal/area dosimetry data, and radioactivity assessment, the modalities are:

o Cytogenetics (AFRRI) o Electron Paramagnetic Resonance (NDC) o Hematology (AFRRI) o Serum amylase (AFRRI) o C-reactive protein (AFRRI)

• AFRRI would handle all confirmatory readings of blood, as biological samples

• NDC would handle the hard tissue samples and the EPR technology

In an event, either CONUS or OCONUS, collected blood samples at the different echelons of healthcare can end up at AFRRI for analysis and a prediction of radiological dose. Radiological dose will drive potential treatment for the following determinations: (1) return to duty, (2) immediate care to avoid symptoms and save lives (maybe asymptomatic for 24-hrs (golden time)), or (3) offer palliative treatment.

3. Strategic Alignment with DHA Combat Support Mission

In developing capability, the DoW Biodosimetry Network needs to have the ability to determine radiological dose based on the processing of biological samples (blood and hard tissues such as fingernails, teeth, bones, hair) as biomarkers for radiation exposure. DoW is the only department that will intentionally send its members to a potential radiologically/nuclear contaminated environment to perform a military mission. Biological samples offer the best estimate of radiation dose to safe lives and support warfighters. As a Combat Support Agency, DHA support to the biodosimetry network aligns with its mission set.

4. Current deficiencies/Gaps

DHA has not been able to fully support the DoW Biodosimetry Network as a program of record and can only advance in the development of capability when funding is available. The proposed purchase bridges a gap in capability and pushes the program into the development of capacity for supporting the network and increasing readiness.

AFRRI purchased Hanabi Metaphase Harvesters over 7 years ago. These equipment are now “end-of-life” as the Vendor can no longer provide replacement parts. End-of-Life letters are included in the submission package.

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5. Requirement

The requested automated harvester equipment is to perform automatically harvest metaphase spreads from a culture using the steps described above for over 100 blood culture samples simultaneously.

The 2 Metaphase Chromosome Harvesters support the DHA Biodosimetry program effort in automating the process of exposed and/or contaminated blood for identifying chromosome changes unique to radiation exposure. They facilitate the automation (sample processing, standardization, quality, and workflow efficiency) of blood cell preparation for cytogenetic, hematology, serum amylase, and c-reactive protein studies. All these support the DoD biodosimetry network.

6. Justification and Description

DHA requested AFRRI to setup a multiple-parameter biodosimetry network including the ability to assess radiation exposure using cytogenetic biodosimetry. Typically the Cytogenetic Biodosimetry Laboratory receives blood samples and sets up blood cultures for a 48-h incubation at 37oC, where lymphocytes are stimulated to divide using a mitogen. The harvest of these 48-h culture involves a series of laborious steps including: a) centrifugation to pellet cells, b) aspiration of the supernatant, c) addition of hypotonic solution to cell to lysis RBCs for a define time, c) vortexing to mix cultures, d) repeated centrifugation to pellet cells, e) aspiration of the supernatant, f) addition of Carnoy Solution to wash cells g) vortexing of the samples, h) centrifugation of the solution, i) aspiration of the supernatant, and repeating twice again steps g, h, and I for multiple culture samples. These manual steps typically take approximately 2 h. All steps are timed and performed automatically.