Sole Sourec Justification (00HCUGDD-2020-45859).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 National Center for Environmental Health Division of Laboratory Services Clinical Chemistry Branch/Lipid Reference Laboratory Chamblee Campus 4770 Buford Hwy NE, MS F25 Building 110 Atlanta, GA 30341

B. Contracting Activity:

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

2920 Brandywine Road, Mail Stop K-69 Atlanta, GA 30341

C. Identification of Requirement:

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

a. Sole source acquisition of: two (2) Agilent Technologies 8890B/5977B Series GC/MSD System Catalog #G7078BA includes 5977B Inert Plus MSD Turbo EI/CI Bundle includes Extractor EI Source, CI Source, Data System (Software, Monitor and PC), additional G1710FA Data License and Ion Gauge Kit with addition of ChemStation DA w/ MassHunter, Substitute Oil Free Diaphragm Pump installation and Familiarization at Installation, 1 Year SW Update/Phone Assist, 1YR PC Image Recovery Service ; two (2) Agilent Technologies Mainframe MS Software Catalog #G3542A, 8890 Mainframe MS Ready S/SL.

The purchase of the above items are needed to fulfill the sample preparation needs in human specimen analysis as part of the target value assignment for the Glucose, Total Cholesterol, and Total Glyceride reference methods of the Lipids Reference Lab.

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

Rev. 4/21/2020

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

a. Proposed Vendor: Agilent Technologies

b. Estimated Procurement Amount: $

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

If yes, provide schedule number: GS07F161BA

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?

As part of the target value assignment of the Lipids Reference Lab for the Glucose, Total Cholesterol, and Total Glyceride methods, it is essential that sample analysis is performed using high sensitivity and high specificity GC/MS instrumentation. In addition, the instrumentation needs to have a high reproducibility capability. The 8890B/5977B Series GC/MSD is able to provide reliable, reproducible data due to the precise gas and temperature controls, offering a retention time reproducibility less than 0.0008 minutes and area reproducibility less than 0.5% relative standard deviation. The microchannel-based electron pneumatics control structure on the GC extends the life of the instrument consumables by providing a significant improvement in reliability and longevity against gas contaminants. Meanwhile, the system is compatible with three different EI sources and offers a variety of sample introduction options that allow for all of these methods to be performed with ease, while also offering new method adaptability in the future. The adaptability does not lower the sensitivity, for the High Efficiency Source (HES) that can be used offers the lowest detection limit in the market. The HES allows for an increase in MS signal by ten-fold, requiring only one-tenth the sample size of what is used on most instruments. In the long run, this will reduce the operating costs for each method and also allow for a more environmentally friendly operation due to the reduction in waste.

The lower detection limit will allow for all of these reference methods to provide all characterization data with the greatest level of confidence possible. In addition, contamination and neutral noise can be eliminated due to the heated monolithic quartz gold quadrupole and triple axis detector, respectively.

The latest software with the instrument allows the ease-of-use of the current program, while improving on the efficiency of creating and updating methods. The software allows the instrument to be more environmentally friendly because it has an automated sleep feature to ensure that gas and power consumption are at a minimum when the instrument is not in use.

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

In addition to the Agilent GC/MS system mentioned above, two other manufacturers were considered for the single-quadrupole GC/MS : Shimadzu (GCMS-QP2020 NX and GCMS-QP2010 SE) and Thermo Fisher Scientific (ISQ 7000). All three of these instruments offer an increase in efficiency. The Shimadzu GCMS-QP2020 NX has a high-speed scan that scans at 20,000 u/second. The Shimadzu GCMS-QP2010 SE has a front-opening ion source chamber that can minimize downtime during maintenance, but only a scanning speed potential of 10,000 u/second. The Thermo Fisher ISQ 7000 has the NeverVent technology that allows maintenance to be performed without having to vent the instrument, reducing instrument downtime for maintenance and reducing any potential for contaminants to get into the instrument.

However, the Agilent model has the capacity to scan at 20,000 u/sec while maintaining the lowest detection limit in the industry. In addition, it has the JetClean self-cleaning ion source that greatly reduces or even eliminates the need for manual source cleaning, helping to prevent maintenance from being needed outside of routine maintenance. The work of the Lipids Reference Lab has a global impact and requires the highest level of efficiency and sensitivity. The Agilent 8890B/5977B GC/MSD allows for the Lipids Reference Lab to maintain the best analyte characterization allowable while improving on efficiency and environmental impact.

3. Program Office efforts to seek potential offerors:

Market research was performed using vendor information, internet searches and knowledge based on prior usage of the products meeting the performance parameters:

(1) Whether they represent the state of the art in commercially available GC/MS; (2) Past performance and ease of use; (3) Best value; and (4) Maintenance service. In addition to the Agilent Technologies 8890B/5977B Series GCMSD, three different instruments were considered. After thoroughly reviewing all of the instruments, the Agilent Technologies GC/MSD system is the only one that meets the compatibility and compelling project requirements.

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:

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.