Limited Source Justification - Sorval X4R Pro-MD Centrifuge.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: (1) Sorvall refrigerated centrifuge and rotor: (2) Fisher Scientific Scientific Sorvall X4R Pro-MD 120V Centrifuge Catalog #75009521 and (1) Fisher Scientific Microliter 48X2 mL Rotor Catalog #75003602 The purchase of the above items are needed to fulfill the sample preparation needs in human specimen separation as part of the target value assignment for the Total Glyceride and Glucose methods of the Lipids Reference Lab and the biomonitoring activities of the PTH project.

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

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

a. Proposed Vendor: Fisher Scientific

Rev. 5/15/17

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 and the PTH project, separation of the aqueous and organic layers from samples during preparation is required. The microcentrifuge tubes containing samples are centrifuged at a controlled temperature during sample preparation. This is essential because it ensures that the extracted samples are completely free of interfering analytes and residues that would otherwise cause interference during GC/MS and LC/MS analysis.

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The Fisher Scientific Sorvall X4R Plus Centrifuge and Rotor offers high centrifugation speeds of up to 15,200 rpm. This speed is essential for these methods because they regularly need speeds of 13,000 rpm. The motorized lid ensures ease of use by needing very little pressure before the instrument locks, requiring only one hand to operate. The automatic rotor recognition, along with the maximized acceleration, braking, and imbalance detection ensures the safety of the analysts, while also providing ease of use. The temperature operates in a range from -10 oC to 40 oC, measuring the temperature of the air in the chamber, as well as the sample temperature, allowing for all the parameters to be met in the different applications of the methods that will utilize these instruments. This benchtop centrifuge has a compact design of 27.2 x 29.4 x 14.2 in, allowing for a small footprint in the lab while also meeting ergonomic standards with the easy sample loading/unloading and cleaning capabilities. The touch screen allows for ease of programming, while also offering the options to monitor the health of the centrifuge. The efficient design allows for up to a 40% reduction in energy consumption during the routine methods.

The Fisher Scientific Sorvall X4R Centrifuge and Rotor meet all the required parameters for the Lipids Reference Lab and the PTH project while providing a heightened level of safety and energy efficiency. Therefore, it is the centrifuge we need for the Lipids Reference Lab and PTH project.

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

In addition to the above centrifuge and rotor, the Eppendorf 5430R and the Eppendorf 5804R refrigerated centrifuges were considered, as well as the Fisher Scientific Sorvall ST4R. All of these centrifuges are tabletop centrifuges that would be able to be conveniently placed in the lab. However, the 5804R model can only reach a speed of 13,000 rpm, so we would be operating at the maximum speed every time that it is being used. This would lead to degradation of the instrument over time. The 5430R model can reach up to speeds of 17,5000 rpm, which is higher than we need.

However, neither centrifuge can operate with more than 30 samples at once. This would mean that the centrifugation step of the sample preparation would have to be split. This would leave room for sample preparation error since the samples would have the opportunity to mix after being separated. The Fisher Scientific Sorvall ST4R centrifuge provides the same specifications as the X4R centrifuge. However, this centrifuge is being discontinued by Fisher Scientific for the more efficient X4R centrifuge. The ST4R centrifuge is also compatible with fewer rotors, limiting future method adaptation. Furthermore, the discontinuation of the ST4R centrifuge may pose future problems, as replacement parts and machine service options become more limited. The Fisher Scientific Sorvall X4R Centrifuge and Rotor is the only option that provides the refrigeration, speed, and sample quantity capacity that is necessary for successful sample preparation, as well as increased method adaptability.

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 centrifuge; (2) Past performance and ease of use; (3) Best value; and (4) Maintenance service. In addition to the Fisher Scientific Sorvall ST4R Plus, different centrifuges from Eppendorf were considered. Only Fisher Sorvall X4R Centrifuge 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.