A13 Brand Name Justification Millipore_Redacted.pdf

Rev. 5/14/19

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 combination of Milipore IQ 7000 and The Millipore IQ Element POD connected to the building distilled water system will provide ASTM Type 1 lab water (resistivity >18 MOhm*cm). Of the water systems considered, this water system also produced water with the lowest elemental concentrations of contaminants compared to technical notes and literature reviews published with data on elemental concentrations measured in the Speciation and Elemental Analysis labs in the IRAT Branch for all water units researched. The Speciation and Elemental labs measure elemental concentrations in biological samples with a goal of measuring concentrations as low as possible. The presence of elemental contaminants in the purified water used to prepare reagents has a cascade effect on the measured accuracy and precision for these analytical measurements. ASTM Type 1 lab water is used to prepare reagents used in the analysis of these biological samples and the lowest amount of contamination possible in reagents is desired to reduce the background presence of the elements measured analytically by these lab tests. A comparison of 3rd party literature and manufacturer brochures provided by three water purification system manufactures was performed as part of the market research. The Millipore system was chosen for the lowest elemental concentrations of elements measured in our lab (e.g. Pb, Hg, As, Ni) and elements that interfere with analytical measurement of those same elements (e.g., Ca, Al, K).

A unique feature of the Millipore IQ system is the use of a foot pedal faucet trigger allowing for hands free operation which can also reduce contamination in a chemical laboratory by providing fewer touch surface points for gloved hands. The Millipore IQ 7000 and Millipore IQ Element water purification system and consumables are a logical follow-up purchase, because lab already has water purification units of this model type installed, consolidating the type and amount of consumable parts needed in the lab and reducing training time for employees using a consistent model of water unit.

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

The Millipore IQ 7000 and Millipore IQ Element combination water purification system is a logical follow-up purchase, because our lab already uses water purification units of this model type and may reduce the total number of future purchase requisitions and staff training necessary to support continued operation of a single model of water purification system throughout the lab. Other water purification systems considered were the Barnstead GenPure Pro and the evoQUA PureLAB Chorus water purification systems. Though both systems provide Type 1 lab water, the Barnstead does not provide an extra reduction in ionic concentration that is needed for ICP-MS applications. Neither system has remote dispensing capabilities or foot pedals for hands-free operation.

3. Program Office efforts to seek potential offerors:

Market research was performed by internet searches for water purification systems that can produce type 1 lab water. Market research was also conducted on GSA Advantage for products already under a purchase agreement with the government. Systems were then compared for the lowest ionic concentrations provided.

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: Kristen Wallon

Center/Institute/Office COR/Program Official Signature:

Certification Date: August 11, 2023

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.

Kristen L. Wallon -S Digitally signed by Kristen L.

Wallon -S Date: 2023.08.11 13:19:07 -04'00'

Lauren Peel -S Digitally signed by Lauren Peel -S Date: 2023.08.15 12:35:41 -04'00'