SSJ_Postnova Replacement Parts_CO Signed.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:

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

A. Program Office:

Division of Laboratory Sciences Chamblee Campus 4770 Buford Hwy Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Acquisition Branch II

C. Identification of Requirement:

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

a. Sole source acquisition of: The purchase of equipment from Postnova Analytics, to replace components of our current AF4 systems that malfunctioned and are irreparable. Specifically requesting one PN7520 4-Channel Degasser, one PN1130 Isocratic Pump, and one Cross Flow Syringe Pump.

b. Procurement Request (PR) Number (if available): 68633

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

a. Proposed Vendor: Postnova Analytics, Inc.; 230 South 500 East, Suite 110; Salt

Lake City, UT 84102; phone 801-839-6709

b. Estimated Procurement Amount: $16,433.00

3. Is the requirement on GSA Schedule? ☐ Yes ☒ No

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

D. Justification:

Rev. 5/14/19

1. The justification 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?

Postnova Analytics, Inc. is the inventor and manufacturer of the separation system called Asymmetric Flow Field Flow Fractionator (AF4). The Postnova AF4 system separates nm scale lipid particles on a preparative scale with uniquely high resolution. Postnova uses patented electronics and communication system built-in to its components that enable transfer of data between the modules for correct operation. There are three Postnova AF4 systems currently in use in the CCB laboratory that are used for the separation, fractionation, and measurement of lipid biomarkers that play an important role in Cardiovascular Disease (CVD) risk assessment. Due to the proprietary built-in electronics and communication system and specialized components designed to provide the most accurate and consistent results when operating together as a system, attempting to use equipment manufactured by any other company than Postnova simply would not be compatible with our laboratory’s existing Postnova AF4 systems and would make them unusable. The Postnova degasser and pumps are necessary on the existing units to ensure uninterrupted operations and the continuity of the lipids program to meet CDC’s mission.

Rev. 5/14/19

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

The only other vendor available that produces AF4 systems is Wyatt Technologies.

Use of any Wyatt AF4 individual components would not function with our current Postnova AF4 systems due to both hardware and electronic communication incompatibilities. Simply put, the Postnova built-in electronics and communication system that controls all the components of our current AF4 systems would not be able to “communicate with” or control any Wyatt hardware components making the entire system non-functional if we cannot replace our broken components with Postnova equipment.

3. Program Office efforts to seek potential offerors:

The only other manufacturer of Asymmetric Flow Field Flow Fractionation systems is Wyatt Technologies. Wyatt and Postnova AF4 components are not compatible with one another. No other vendor was considered because (1) no other manufacturer of AF4 systems besides Wyatt Technologies exists, (2) the need for brand consistency, and (3) due to the hardware and electronic communication compatibility issues with our laboratory’s existing Postnova system.

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: Lisa McWilliams NCEH/Clinical Chemistry Branch – COR Level-1 – Associate Service Fellow

Center/Institute/Office COR/Program Official Signature:

Certification Date: September 22, 2020

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.

08/11/2022