Justification FAR Part 13 (JandA) (JUNE 2025) Redacted.pdf

CUI//SP-PROCURE//FEDCON

Control Number: 25-MRCO-WEST-230

JUNE 2025

IgG, and Treponema Total testing. Diasorin, Inc. is currently the only vendor who can fully satisfy this requirement for the government. Diasorin, Inc. is the only vendor that can fully support Varicella Zoster Virus IgG (VZV IgG), Measles IgG, Mumps IgG, and Treponema Total testing. The testing supports the basic training mission troops, active-duty soldiers, retirees and beneficiaries on the MACH platform. Diasorin Inc. analyzers (currently in place at Martin Army Community Hospital) provides the proprietary reagents needed to operate the analyzers. The Liaison XL analyzers can be used to test thousands of samples for Varicella Zoster Virus IgG (VZV IgG), Measles IgG, Mumps IgG, and Treponema Total prophylaxis screening on all new basic trainees to determine immunization status prior to vaccination. Screening is beneficial for the government and the trainees, as this will establish status of the trainee instead of giving each trainee a full complement of vaccinations if they do not require them. The system's ease of use and high throughput is very crucial to fast screening results. Without approval, the laboratory will be unable to provide 30th Adjutant General Battalion (3Qth AG BN) with timely immunization screens. Each trainee will receive a full complement of costly vaccinations because if we ship the test out to a reference laboratory for evaluation, the 72-hour result time will not be met before day one of basic training begins and the soldiers are placed in close quarters.

• Varicella Zoster Virus IgG (VZV IgG)-The Varicella Zoster Virus IgG (VZV IgG) test is a blood test used to determine if a person has been previously infected with or vaccinated against the varicella-zoster virus (VZV), the virus that causes chickenpox and shingles. It detects the presence of IgG antibodies, which are produced by the body's immune system in response to a past infection or vaccination. A positive VZV IgG result indicates that the individual has either had chickenpox in the past or has been vaccinated against it.

• Measles IgG-A measles IgG test, also known as an MMR titer test, measures the level of IgG antibodies in the blood to determine if someone is immune to measles. These antibodies are produced by the immune system in response to a measles infection or vaccination. A positive result generally indicates immunity, while a negative or equivocal result may suggest susceptibility to measles. The test helps assess an individual's immunity to measles, which is important for determining if they are protected against infection.

• Mumps IgG- A Mumps IgG screen is a blood test that detects the presence of IgG antibodies to the Mumps virus. These antibodies indicate past exposure to the virus, either through natural infection or vaccination, and suggest immunity to future infection. The test does not diagnose a current, active infection. The Mumps IgG test helps determine if an individual has developed immunity to the Mumps virus.

• A Treponema Total test, also known as a syphilis total antibody test, is a blood test used to detect antibodies to Treponema pallidum, the bacteria that causes syphilis. It's a treponemal test, meaning it specifically targets antibodies to the bacteria itself. These tests are typically used to confirm a reactive result from a non-

JUNE 2025

treponemal test or to evaluate patients with signs suggestive of syphilis, especially in early primary infections where non-treponemal tests might not yet be reactive. The test helps determine if a person has been infected with syphilis, either currently or in the past.

a. Alternatives:

This requirement may be competitively solicited. Soliciting this requirement is anticipated to be unproductive due to the previous two actions over the last seven years being sole source requirements with no interest from other vendors. There are no practical alternatives available to increase competition for this requirement due to the items being proprietary to Diasorin Inc. as only Diasorin Inc. analyzers (currently in place at Martin Army Community Hospital) provides the proprietary reagents needed to operate the analyzers.

MACH may be able to make a capital equipment purchase of the necessary analyzers, procuring the reagents and consumables, and procuring a separate analyzer maintenance services as necessary. The current requirement is a reagent rental lease contract. The lease of the equipment is included at no additional cost to the government when reagents are purchased through the supplier. The reagents may be able to be procured via Electronic Catalogue (ECAT), a federal supply schedule contract or on the open market. The purchase of reagents would exceed the Government Purchase Card (GPC) limit, necessitating procurement of other contracts, which may lead to a Justification and Approval (J&A) for the reagents. The cost, complexity, and attrition of procuring and maintaining these analyzers will likely result in the government spending more money, time, and manpower resources to sustain the equipment, supplies and consumables. This alternative is not in the best interest of the government and is therefore not acceptable.

b. Impact if not approved:

Without this contract/equipment for Varicella Zoster Virus IgG (VZV IgG), Measles IgG, Mumps IgG, and Treponema Total testing platform, MACH’s Laboratory will lose the capability to perform in-house testing support for the new trainee population at Fort Benning and any possible testing needs for beneficiaries to include active duty, families, and retirees. The MAHC’s laboratory would have to ship out these tests to other Military Treatment Facilities or commercially contracted reference laboratory which would in turn result in delay of training for the new trainees arriving at Fort Benning. This could result in high shipping costs, possible risk of compromised or lost samples during transport to other facilities, longer wait times for results, and may possibly negatively impact overall soldier readiness and patient care. In the absence of timely results, any infectious diseases are likely to spread throughout and further impact soldier readiness.

7. Efforts to Obtain Competition: The Contracting Officer will publish the notices required by FAR 5.201 and any bids or proposals received shall be considered.

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a. Effective competition: A sources sought notice for two (2) Waterless Immuno- Chemistry Analyzers and Tests were posted with the minimum requirements to https://SAM.gov from 3 June 2024 through 10 June 2024. There was one response to the sources sought. DiaSorin, Inc. a large business. Diasorin, Inc. is the current awardee and has been the incumbent for the last seven years.

a. Subcontracting competition:

There are no current subcontracting opportunities available. Diasorin Inc. has no teaming agreement with any small businesses. Therefore, there are no current subcontracting opportunities available

8. Actions to Increase Competition:

This requirement is a follow-on to contract W91YTZ20P029 (1 October 2020 through 30 September 2025) and W91YTZ18P0181 (03 April 2018 (short base) through 30 September 2020), which were not competitively competed.

As part of the efforts to obtain competition, in accordance with FAR 5.202, a Notice of Intent to Award Sole Source, with the redacted Justification and Approval document will be posted on sam.gov as required by FAR Subpart 5.2.

In the event MACH continues to have a need for this testing support beyond the conclusion of FY28, continued market research will be performed, a sources sought notice will be posted to the Government Point of Entry (GPE) to continue to foster competition and ensure that there is fair and reasonable pricing for any future requirements by the government.

Market Research:

An SBA Dynamic small business search and Quick Market search was conducted on 18 June 2025 using key words “325413” and “Immunochemistry Analyzer” with no small businesses found as shown in the table below.

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The services are not available from wholesale supply sources (e.g. General Services Administration, Defense Logistics Agency, Department of Veterans Affairs, and military control points.) The contract specialist reviewed the DLA and ECAT platforms on 18 June 2025 and although the requested reagents are currently available, the waterless analyzers are only offered for purchase.

On the ECAT and Medical Master catalog platform there are cleaning kits available however there are no waterless analyzers available.

Federal Supply Schedules, government wide acquisition contracts, multi-agency contracts, and any other procurement instruments intended for use by multiple agencies, including blanket purchase agreements (BPAs) under Federal Supply Schedule contracts (e.g., Federal Strategic Sourcing Initiative (FSSI) agreements accessible at http://www.gsa.gov/fssi Federal Service Schedules (see Subpart 8.4).

The FSSI was searched 18 June 2025 with no testing services available.

FAR Part 8/DFARS Part 208 Sources Screened to include – Ability One Program, Federal Prison Industries, Federal Supply Schedules, Enterprise Software Agreements (incl CHESS) or other Preferred Sources:

Services which are on the Procurement List maintained by the Committee for Purchase from People Who Are Blind or Severely Disabled (see Subpart 8.7). A search for the required items on 18 June 2025 on the Ability One website http://www.abilityone.gov and are currently not available.

Federal Prison Industries, Inc. (see Subpart 8.6) website http://www.unicor.gov was checked on 18 June 2025 and the required services were not found on Unicor’s website.

9. Interested Sources: To date, no other sources have written to express an interest.

10. Other Facts:

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Diasorin, Inc. provided a sole source letter that they are the original equipment manufacturer, distributor, maintenance provider and supplier for the reagents that are used on their analyzers.

Currently MAHC does not have the appropriate personnel to support the maintenance requirements for an immunochemistry analyzer and tests.

Market Research results indicate that there is currently only one (1) vendor who can fully satisfy this requirement for the government. Diasorin, Inc. is the only vendor that can fully support Varicella Zoster Virus IgG (VZV IgG), Measles IgG, Mumps IgG, and Treponema Total testing.