Sole Source JA (00HCUGDD-2020-41144).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:

NCEH, Clinical Chemistry Branch, Division of Laboratory Science Cardiovascular Biomarker Group, Chamblee Bldg. 110, Rm 5112 Centers for Disease Control and Prevention Atlanta, GA 30341

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: Purchasing Eclipse® DualTec Asymmetric-Flow Field- Flow Fractionation (AF4 or FFF) System with Dual-function light scattering detector (MALS and QELS) from Wyatt Technologies.

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

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

a. Proposed Vendor: Wyatt Technologies

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 13.106-1(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?

Unique flow stability of the Wyatt Eclipse FFF system is produced by the following technical features:

A single pump generates all flows. The single-pump configuration results in superior signal-to-noise ratios compared to other commercial FFF systems with multi-pump configuration. The Wyatt Eclipse® is the only AF4 system which generates all required flow streams from one main pump flow.

Eliminates the need for purchasing compatible liquid pump modules. The Wyatt Eclipse FFF system is the only commercial FFF system to make use of industry-leading liquid chromatography (HPLC) pump and fraction collection modules. The Wyatt software can control various other vendors including Agilent, Thermo Scientific, and Shimadzu. These modules from leading vendors already exists in our laboratory, resulting in substantial savings in cost.

Coriolis-principle cross-flow regulation. The Eclipse FFF system incorporates a high-performance flow regulator that utilizes the Coriolis effect for regulation of the “cross flow” (flow applied across the separation channel), simultaneously with other inlet and outlet flows. The Eclipse FFF systems are the only commercial FFF systems that incorporate Coriolis-principle for cross-flow regulation. Consequently, the system can regulate all necessary flows from 0.07 to 8.3 mL/min with excellent precision independent of solvent type, pressure or temperature. The Coriolis-based flow regulator eliminates pulsation allowing better detector stability and sensitivity.

Dual, zero-dead-volume pressure transducers. The Eclipse FFF systems is the only FFF system that utilizes dual pressure transducers to monitor membrane pressure both inside of the membrane wall in the FFF channel with zero dead volume. Other vendors use a single pressure transducer to monitor the pressure only inside the FFF channel. The Eclipse AF4 incorporates a second transducer to monitor pressure below the semi-permeable membrane at the bottom of the channel. This dual pressure monitoring provides the capability of measuring the pressure drop across the membrane wall. This unique measurement provides operators a reliable metric to monitor system performance. In addition, the Eclipse systems utilize proprietary, zero-dead-volume transducers that eliminate issues associated with dead volume such as trapped air leading to pressure fluctuations, and bacterial growth.

Low dead-volume dual function light scattering detector: The Wyatt FFF system incorporates unique DAWN HELEOS II detector that is capable of simultaneous multi angle light scattering (MALS) detection and dynamic light scattering (DLS) detection flow cells. The combination of these allows for simultaneous determination of molecular mass, shape, and hydrodynamic size at the same time. This detector has a small total of 70 microliter dead volume that minimizes the effect of mixing within, and peak broadening. This is a critical feature especially fractions need to be collected after the detector without diminishing chromatographic resolution by mixing in the flow path. The DAWN HELEOS II detector also incorporate a unique ultrasonic transducer that agitates fluid within the flow cell and cleans the detection path, called COMET mode. This feature improves instrument sensitivity and reproducibility and decreases the need for maintenance.

In addition, our laboratory purchased a DAWN HELEOS II detector. Wyatt provided excellent service, training, and technical support.

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

The only other existing FFF system vendor is Postnova Analytics, their AF2000 systems which lack several features included with the Wyatt Eclipse FFF:

Multi-pump configuration. The Postnova systems use three pumps which decreases flow stability, reproducibility, and signal to noise ratio relative to the single pump configuration. In the Postnova multi-pump system, each pump pulses at different times leading to unharmonized pressure and flow rates during the size separation. This results in decreased reproducibility and increased detector noise compared to a single pump configuration.

Increased cost due to need for purchasing liquid pumps. Postnova requires the purchase of Postnova liquid pumps that are lower quality relative to other industry leading vendors.

Variable Cross Flow Regulation. Postnova vendors do not have Coriolis-based flow regulators, and require calibration and compensation for each solvent type, pressure range and/or temperature. The Wyatt Coriolis-based flow regulators require no such calibration or compensation, and therefore greatly simplify operation of the FFF system under different conditions with higher accuracy.

Single Pressure Transducer. The AF2000 systems offered by Postnova have a single pressure transducer in their FFF channels. This allows for the measurement of pressure in the AF4 channel only, and not across the membrane at the bottom of the channel. A dual pressure measurement, as offered by Wyatt’s Eclipse FFF is extremely useful for system monitoring and method optimization.

Software Incompatibility with needed detectors. The Postnova software does not allow full control of the detectors that is needed to be coupled to the FFF system for size measurement. The operation of a Postnova FFF/detector system requires a complex multiple software platform for running batch experiments, data collection, and data analysis.

Overall, the Postnova system may cost less in terms of the purchasing cost, however

Bish -S because of inherent technical disadvantages, the long-term operation cost is higher in terms of more working hours needed for frequent instrument maintenance, setting up batch operations and data processing.

3. Program Office efforts to seek potential offerors:

Spoke with users from other institutions who had hands-on experience with both Wyatt and Postnova FFF systems. (Colorado School of Mines, Golden, CO; and PPG Industries, Pittsburg, PA). Sent standard samples to both Postnova Analytics (230 South 500 East, S.

#120Salt Lake City, Utah 84102, USA) and Wyatt Technologies (6330 Hollister Ave Santa Barbara, California 93117, USA). Discussed results of standard tests and obtained data for comparison. Conducted internet and/or catalog search for instruments specifications and performance parameters on the web site of all three companies (Wyatt, Postnova, and Malvern)

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.

Howard D. Bish Digitally signed by Howard D.

Date: 2020.03.11 17:04:29 -04'00'

Contracting Officer Signature:

Certification Date: Click here to enter a date.

-S