A13 - Sole Source Justification 051419_Sheldon_Agilent_v4-COSign.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 Financial Resources Acquisition Branch 4

C. Identification of Requirement:

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

a. Sole source acquisition of: Agilent BioTek Synergy LX Multimode Microplate Reader with necessary 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: Agilent Technologies

b. Estimated Procurement Amount: $25,576.87

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 13.106-1(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?

Our laboratory requires the Agilent BioTek Synergy Lx multimode microplate reader to replace our existing BioTek FLx800 as it is no longer supported, preventing annual maintenance, required by the

CDC QMML.

Agilent BioTek Synergy Lx multimode microplate reader is the only commercially available instrument that meets all our essential requirements for nucleic acid analysis and Next Generation Sequencing library analysis for testing human clinical samples. We required that the instrument uses the same Gen5 analysis software for continuity with current validated procedures and protocols. The instrument must also support common endpoint assays; have capability to quantify nucleic acids with fluorescence using filters that can read excitation/emission at 480/530 nm (filter-based readers provide higher sensitivity which is very important for our work); and to do absorbance readings for nucleic acid and protein quantification, and turbidity measurements with continuous UV-Vis wavelength selection from 200 to 999 nm with broad, filter-free range for absorbance measurements. Moreover, the instrument must fit into the existing space having a footprint of 15”W x 16”D or smaller; must be compatible with 6- 384-well microplates, making it scalable and compatible with our high throughput needs. Finally, the instrument must also have the ability for on-instrument micro-volume nucleic acid quantification of 2 µl for multiple samples at one time with on-instrument analysis and experiment set up using a touchscreen.

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

There are several companies that advertise an instrument capable of this type of nucleic acid and Next Generation Sequencing analysis, though none meet the requirements needed for our research. The instruments analyzed during market research, grouped by manufacturer: Agilent Technologies (several models including the BioTek Synergy Lx), BMG Labtech (PHERAstar FSX, FLUOstar Omega, and Vantastar), ThermoFisher (Varioskan LUX and Multiskan SkyHigh), Molecular Devices (SpecraMax: iD5, iD3, M2, M23, and the Gemini Series), Promega (GloMax), Tecan (Infinite 200 Pro), Accuris Instruments (Smartreader multimode), and Molecular BioProducts (Varioskan Lux).

Of the multimode microplate readers available from Agilent Technologies, the BioTek Synergy Lx (SLXFATS-SN) is the most affordable, easiest to use, and fits all our requirements. Agilent is the only manufacturer that has instruments compatible with the Gen5 Software. Changing software would require re-writing protocols and re-validating procedures, which would be time-consuming and delay progress on testing human clinical samples. The BioTek Synergy Lx is the smallest footprint of all instruments analyzed and meets our criteria for an instrument the same size or smaller than our existing instrument at 15”W x 15”D.

The ThermoFisher Multiskan SkyHigh Microplate Spectrophotometer, Molecular Devices Gemini series, and Tecan Infinite Pro 200 are closest in size, but are lacking other critical characteristics. The Multiskan SkyHigh does have a touchscreen option, but can only read UV/Vis absorption, not fluorescence readings. The Gemini series does not have filter-based fluorescence, on- instrument analysis using a touch screen, the ability to do micro-volume quantification of nucleic acids, and only has continuous wavelength of 250 – 850 nm. The Infinite 200 Pro M nano does have the option for multiple sample micro-volume quantification and can do both absorbance and fluorescence readings but does not have on-instrument analysis and experiment set up using a touchscreen.

Of the instruments with a larger footprint that use different software, none of them fit our other requirements. The BMG Labtech, ThermoFisher, and Molecular BioProducts do not have a touchscreen interface or onboard software to do on-instrument analysis and experiment set up. The Promega GloMax does not have the required continuous wavelength selection for UV-Vis measurements required, with a spectra range of 200 – 600 nm. The BMG Labtech Vantastar, ThermoFisher Varioskan, Promega GloMax, Accuris Smartreader, and Molecular BioProducts do not have the ability for micro-volume quantification. The Molecular Devices SpectraMax products do not have filter-based fluorescence. For these reasons, no other manufacturer’s product possesses all the features we require.

Therefore, we are requesting to purchase the Agilent BioTek Synergy Lx (SLXFATS-SN) multimode microplate reader to meet our testing lab requirements.

3. Program Office efforts to seek potential offerors:

We conducted an extensive search for instruments meeting the performance parameters listed in 2a.

using GSA Advantage and additional internet searches; researched and compared 17 instruments from 8 manufacturers. None of the other instruments fit all our criteria. We determined that the Agilent Technologies Synergy Lx (SLXFATS-SN) is the only instrument that meets all our needs.

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: Irina Goodrich, COR

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.