PR 68722 SSJ for HELMED_Redacted.pdf

JUSTIFICATION FOR SOLE SOURCE PROCUREMENT (OPEN MARKET OR GSA)

UNDER $250,000

Sole source acquisitions may be used on a limited basis and only when the Contracting Officer’s Representative (COR)/Program Official has provided sufficient justification and the Contracting Officer has determined that the circumstances warrant such action. The content for a justification must contain detailed facts and rationale to justify the sole source acquisition. Soliciting from a single source must be done in accordance with FAR 13.106-1(b) or 8.405-6. At a minimum, the following information must be included:

Identif ication of Program Office, Contracting Activity, and Proposed Requirement, Justification and Program Office Certification:

A. Program Office:

NCEZID/DVBD/RZB

Roybal Building 24 Room 10103 MS 24-10 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Off ice of Financial Resources Acquisition Branch Click here to enter text.

C. Identif ication of Requirement:

1. Nature of Action to be Approved by Contracting Officer:

a. Sole source acquisition of: HELMED HTC, an IFA system

b. Procurement Request (PR) Number (if available): 00HCVLJE-2022-68722

2. Proposed Vendor and Estimated Procurement Amount (if available):

a. Proposed Vendor: AESKU.Systems

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number:

Rev. 5/14/19

D. Justification:

1. The justif ication for this non-competitive action is:

In accordance with FAR 13.106-1(b)(1), “only one source [is] reasonably available” which states that, “For purchases not exceeding the simplified acquisition threshold. (i) Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name or industrial mobilization). (ii) Where a single source is identified to provide a portion of a purchase because that portion of the purchase specifies a particular brand-name item, the documentation in paragraph (b)(1)(i) of this section only applies to the portion of the purchase requiring brand-name item. The documentation should state it is covering only the portion of the acquisition which is brand- name.”

Urgency

Exclusive licensing agreements/Proprietary data

Brand name required

Industrial mobilization

Other (e.g., compatibility, space issues, continuity, compatibility, etc.)

In accordance with FAR 8.405-6 “Limiting Sources” which states that, “the only circumstances that may justify the action are – (A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays; (B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or (C) In the interest of economy and efficiency, the new work is a logical follow-up to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original BPA must not have been previously issued under sole-source or limited-sources procedures.”

Urgency

Only One Source

Logical Follow Up

Brand name required

2. Other facts supporting sole source procurement:

a. What can this product/service do that other products/services cannot do?

The Autoimmune Helmed by Aesku Group reliably performs all liquid handling steps needed to run the IFA assay. The Helmed is a fully automated multiprobe, multi-syringe system. HELMED HTC is the only device that allows control of humidity and temperature for the highest level of standardization in IFA.

Advantages include: Optimize workflow - processes up to 20 slides and 4 different tests per run. High throughput - processes up to 106 different samples in one single run. Reduce operator time - reduces labor via automation performing all of the steps of IFA processing. Improve traceability - reduces errors with automated detection and scanning of sample tube IDs using the built-in bar code reader. Open format - supports slides from different manufacturers independently of different thicknesses, number of wells, and formats. Flexible protocol programming allows the user to define conjugate/counterstain or multi-step reagent addition immediately after a specific well is washed. The Helmed system provides consistent results with complete automation of all of the IFA processing steps. Standardization