SSJ MilliporeSigma MilliQ Velez Revised CO signed 29 Aug 2024.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:

Centers for Disease Control and Prevention Division of Vector Borne Diseases 3156 Rampart Road Fort Collins, CO 80521

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Acquisition Services Chamblee Campus, Bldg. 102 Mail Stop S102-4 4770 Buford Hwy.

Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: MilliporeSigma Milli-Q® IX 7005 water purification system, Quote Reference (R-9066364.2)

b. Procurement Request (PR) Number (if available): 00HCVLJB-2024-87626

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

a. Proposed Vendor: MilliporeSigma

b. Estimated Procurement Amount: $16,199.91

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, 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?

This product will be a cost savings replacement for the alternative of using purchased bottled Type 2 water for use in reagents and buffers used in the arboviral analytical biochemistry assay, Enzyme-linked Immunosorbent Assay (ELISA). It is required and necessary for pure Type 2 water to be used in the ELISA for human diagnostics in the Arboviral Diseases Branch, and no other water is suitable for the requirements. It is also needed for the highly sensitive Microsphere Immune Assay (MIA) for the detection of specific human arboviral antibodies. Other units investigated would not fit in the space available. This unit also meets the specific electrical requirements (120V and 60 hz) based on the outlets available in the space and maximum benchtop capacity. Other units did not offer the 2 Liter/minute flow level required or had different electrical requirements that would not work with our outlets. This unit also allows for Systems Consumables Traceability via Radio Frequency Identification (RFID) tag technology for Quality Manual for Microbiological Laboratories (QMML). It stores the water and system data in system memory in order to monitor data quality, reliability, and traceability to print reports for QMML. This unit meets the QMML compliance requirements for detailed water standards (per QMML Section 16.2 that references the CDC Lab Water quality assurance policy).

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

We have specific requirements: the unit needs to be Quality Manual for Microbiological Laboratories (QMML) compliant, which requires detailed water standards (per QMML Section 16.2 that references the CDC Lab Water quality assurance policy). Type 2 water purification is required, along with at least a flow rate of 2 liters/minute, and a 25 liter tank that supplies 65 liters in 8 hours. Another requirement is for light-emitting diode (LED)-based, mercury-free ultraviolet (UV) lamps for sterilization in the water system and storage tank. The unit must dispense pure water in two modes: (1) manual, variable flow, and (2) volumetric dispensing.

Combined Reverse Osmosis and EDI (Electrodeionization) technology for Type 2 Deionization (DI) water production are needed. We need Systems Consumables Traceability via Radio Frequency Identification (RFID) tag technology for QMML. All water and system data must be stored in system memory to monitor data quality, reliability and traceability to print reports for QMML. This MilliporeSigma unit will give us water of known Type 2 purity to fulfill regulatory requirements (per the Policy/Table 1 - Minimum Standards for Clinical Laboratory Reagent Water (CLRW) is > 10 M W·cm and < 14 M W·cm). It also allows us to print and maintain full water quality records in addition to quality weekly sampling reports. We will be able to record and track water resistance with this unit, which is required under new lab quality regulations CDC-wide. The dimensions of this unit will fit the space available without any costly facility structural reconfiguration. We looked at a similar unit from ELGA, but it only has a 1.2 L/m flow rate rather than the 2 L/m flow rate required. An Invitrogen unit we researched did not provide the required UV lamp unless hooked up to a 230 volt outlet, which we do not have in our space. Units from ResinTech were for Type 1 water purification rather than Type 2.

3. Program Office efforts to seek potential offerors:

Online research was conducted on units available from ELGA, Invitrogen, and ResinTech. None of those units provided all the requirements needed for water purification in our lab. MilliporeSigma is the most reputable laboratory water quality manufacturer, and the MilliQ system meets all of the requirements as outlined above.

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: Click here to enter text.

Center/Institute/Office COR/Program Official Signature:

Certification Date: Click here to enter a date.

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.