J_A - Dako Autostainer Link 48.pdf

Control No: 25-MRCO-WEST-91

MEMORANDUM FOR RECORD

Limiting Competition at or below the Simplified Acquisition Threshold

1. Contracting Activity: Medical Readiness Contracting Office - West, United States Army Health Contracting Activity.

2. Description of Action: One-time equipment purchase of Dako Autostainer Link 48.

Nature: D New Requirement [X] Follow-on Requirement

Contract Vehicle: [xJ Purchase Order Number 0012231878

□ Blanket Purchase Agreement (BP A) Number ______ _ D Order/BP A# ___ against FSS Contract # D Order # ____ against Multiple Award IDIQ Contract Name or

D 0-rd_ e_r _#======-a-gainst a single award IDC Contract

□ Modification # ___ to existing PO/TO/DO/Call Order

Pricing/Contract Type: m D

Fixed Price Hybrid

D Time & Materials/Labor Hours D Cost Reimbursable

Funds: D Operations & Maintenance, Army (OMA)

FY: 2025

@Other Funds: DHP

Names of Potential Contractor( s):

Name UEI Business Size/Type

Brand Name Buy: [x]Yes D No

3. Description of Services or Supplies: Dako Autostainer Link 48, estimated total price of

4. Authority: FAR 13 .106-1

Version - February 2017

[Redacted]

[Redacted]

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5. Reasons for Authority Cited: The standard for use of a brand-name description is that use of such a consideration of a product manufactured by another company. In this acquisition, use of a brand-name description and safety.

The Evans Army Community Hospital (EACH) needs to replace one of its two Dako Autostainer Link 48 immunohistochemical autostainers. The Original Equipment Manufacturer (OEM) can no longer support this piece of equipment due to its age, and its output indicates that it is reaching the end of its service life.

An autostainer is an automated device used to apply stains to tissue samples on slides, which study of tissue samples under a microscope, typically by a pathologist, to examine the microanatomy of the tissues for diagnosis and research purposes.

A subset of histological analysis is immunohistochemistry (IHC), which is a specialized technique used to identify specific antigens (a substance that triggers an immune response in the body) in a tissue sample. IHC requires the addition of an antibody specific to a targeted antigen to the tissue sample in order to produce an antigen-antibody reaction during incubation. The antibody is labeled with a visualizing agent fluorescent or pigmented material so that the tissue samples can be examined under a microscope for the presence of the targeted antigen.

EACH uses IHC for fast and accurate diagnosis of cancer, infectious diseases, and other pathological disorders.

An IHC autostainer is an automated, highly sophisticated instrument that streamlines and standardizes the process of applying specific antibodies to tissue sections on microscope slides for IHC staining. The IHC autostainer automates the multi-step process of immunostaining, which provides increased efficiency, improved consistency, reduced errors, reduced labor, and improved workflow. In essence, an IHC autostainer enhances the reliability and efficiency of this critical diagnostic technique, thereby materially contributing to improved patient care and outcomes.

EACH has requested to replace its aging Dako Autostainer Link 48 with a new one to ensure proper patient care and safety for the following reasons:

Autostainer Link 48. Swapping to a different autostainer would require extensive technical training for the new equipment, with the concomitant errors that go with learning new equipment, as well as the ongoing challenge of switching back and forth between different types of autostainers.

A new autostainer, regardless of manufacturer and model, requires validation, to include:

instrument verification; stain protocol optimization; and validation of the staining protocols. One-for-one replacement of an autostainer will shorten the validation time description is essential to the Government's requirements, thereby precluding is essential to the Government's requirements for ensuring proper patient care makes the tissue's cellular structures visible for histological analysis. Histological analysis is the

• EACH's IHC technicians are thoroughly conversant with operation of the Dako considerably because of the facility's familiarity and expertise with the Dako Autostainer Link 48, while a different model would require weeks to validate.

• A different manufacturer's autostainer would require different reagents due to their proprietary nature. EACH uses over 40 different reagents for its autostainer, and every single new reagent (for a different autostainer) would require validation. Tests necessary for reagent validation include without limitation: specification ( content, purity, pH);

performance (sensitivity, specificity, accuracy); stability (storage shelf-life under differing conditions); interference (how the reagent reacts to substances that may be present in the tissue sample); and compatibility (with other reagents and lab equipment).

New reagent validation would add additional weeks to the validation process.

• Most importantly, there are significant differences between different autostainer results in terms of specificity and sensitivity. Specifically, different types of autostainers produce slides that have different levels of staining intensity, background staining, and false positives/negatives. In short, different autostainers produce slides from the same material that nonetheless look different. This matters because the ultimate purpose of EACH's autostainers is to produce a stained tissue slide for cancer and infectious disease diagnosis by a pathologist. Accurate diagnosis requires consistent autostainer slide results because a reliable and repeatable staining process ensures that the visual characteristics of tissue samples on each slide are identical, allowing the pathologist to accurately interpret the features and make a consistent diagnosis across different patient samples, minimizing the risk of misinterpretation due to variations in staining intensity or color balance caused by different autostainers. Proper patient care and safety thus depends on consistent autostainer slide results, necessitating use of the same type of autostainers.

For the foregoing reasons, replacement of EACH's aging Dako Autostainer Link 48 with the same make and model is essential to the Government's requirements for ensuring proper patient care and safety.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and sy !Xpr s requirements of FAR 5.101 and FAR 5 .203 D do not apply due to the $ threshold, apply and will be followed, Dor do not apply due to an exception at 5.202

Requirement to post justification in accordance with FAR 8.405-6(b)(3), FAR 13.105(c), or FAR 16.505(a)(4)(iii)(A)

OAction is NOT a brand name restriction and is under $250K, no posting required D Action is a brand name restriction, under $25K, no posting required [x]Action is a brand name restriction, over $25K. It will be redacted and posted with the solicitation, in accordance with FAR 5.102(a)(6).

D Action is a brand name restriction over $25K but will not be posted due to exception:

□ FAR 6.305(f) D FAR 8.405-6(b )(3)(iii)(A) D FAR 8.405-6(b )(3)(iii)(B)

Version - February 2017

□ FAR 8.405-6(b )(3)(iii)(C) D FAR 16.505(a)(4)(iii(C)

Control No: 25-MRCO-WEST-91

7. Market Research: A complete market research report was drafted in support of this requirement, dated 21 February 2025, to include the following sources: quotes requested from potential sources; a Sources Sought Notice; and a query of the following databases: Contract Opportunities via SAM.gov; the Federal Procurement Data System; GSA Advantage!;

AbilityOne; UNICOR; CHESS; NASA SEWP; and the VA's National Acquisition Center. Based on the market research results, it appears that there is a reasonable expectation that two responsive quotes will be received from responsible businesses [Redacted] in response to a solicitation posted on Contract Opportunities.

8. Other Facts: The Dako Autostainer Link 48 in need of replacement was purchased in 2008, but there are no details regarding this acquisition because the contract file should have been destroyed in 2014.

9. Technical/Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Typed Name: Charisma Muse Date: 25 February 2025 Title: Evans Army Community Hospital New Equipment Manager/Coordinator

10. Contracting Officer Certification/ Approval:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon pricing analysis.

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government.

Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name: Christopher A. Gregory Date: 25 February 2025 Title: Contracting Officer

Signature

Version - February 2017

Signature

[Signature Redacted]

[Signature Redacted]