A13. SSJ SAM.gov.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 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:

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

A. Program Office:

Chronic Viral Diseases Branch (CVDB), MS H23-4 Division of High Consequence Pathogens and Pathology (DHCPP)/NCEZID Centers for Disease Control and Prevention Atlanta, GA 30329-4018

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch and Assistance Branch II 2920 Brandywine Road; Atlanta GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: Assist Plus Automated Pipetting System, with pipettes and automation accessories

b. Procurement Request (PR) Number (if available): Click here to enter text.

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

a. Proposed Vendor: Integra Biosciences Corp; 2 Wentworth Dr, Hudson, NH 03061 Phone 603-578-5800; Fax 603-577-5529

b. Estimated Procurement Amount:

3. Is the requirement on GSA Schedule? Yes No

If yes, provide schedule number: Click here to enter text.

Rev. 5/14/19

D. Justification:

1. The justification for this non-competitive action is:

In accordance with FAR 13.106-

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-

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-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-

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?

CVDB currently has two Assist Plus systems in the lab. The purchase of an additional system is to improve and increase specimen processing capacity based on the system s reliability and reproducibility capabilities. Integra Biosciences Corp is the only known responsible source capable of providing the Assist Plus automated pipetting system. With our existing Assist Plus systems, we have programmed assay scripts that can easily be copied onto a new Assist Plus as well as automated pipettes that can be shared between systems. We also have staff trained to use and program the Assist Plus. Acquisition of a different instrument would require additional cost in staff hours to program new assay scripts, to validate the assay scripts, and to train on the new instrument. The system should be able to automatically pipette 96 samples with a single base unit with volumes ranging from 0.5 µl to 1250 µl. In addition, the system should meet additional unique features like electronic tip loading and tip rejection and with an adjustable pipette will allow for the transfer of material from various tube types and sizes. The on-the-fly adjustment of the tips using the adjustable pipette enables the spacing of the tips, which gives access to various labware types. The system will also allow us to share existing labware and pipette tips used with existing Assist Plus and Viaflo 96 systems in the labs, thereby reducing

Rev. 5/14/19 waste and improving efficiency and saving time/cost (possible discounts for bulk orders) when purchasing supplies. Only Integra Biosciences Corp can supply the requested Assist Plus system can use the existing assay scripts, has all the unique features, and is able to interchange pipettes and/or supplies with the Assist Plus currently used in the lab.

b. What other products/services were considered and why did they not meet the need?

No other products were considered since only Integra Biosciences Corp can supply the requested Assist Plus system with all the unique features including pipettes that are interchangeable with the Viaflo 96 system we currently have.

3. Program Office efforts to seek potential offerors:

The program did not seek other potential offers since the requested Assist Plus system with all the unique feature is supplied only by Integra Biosciences Corp. The program did an internet search on GSA Advantage and found a third-party vendor which supplies the Assist Plus base. The GSA vendor is offering the base unit alone (no accessories) and do not carry the additional communication cables and modules needed in the program to carry out established laboratory procedures.

E. Program Office Certification:

I have reviewed this sole source justification and certify the justification is true and accurate to the best of my knowledge and adequate to support other than full and open competition.

Center/Institute/Office COR/Program Official Name/Title:

Center/Institute/Office COR/Program Official Signature:

Certification Date: May 24, 2024

F. Contracting Office Certification:

I have fully relied on the information provided herein and hereby certify that this justification is accurate and complete to the best of my knowledge and belief:

Contracting Officer Name: Click here to enter text.

Contracting Officer Signature:

Certification Date: Click here to enter a date.