Sole Source Justification-Nivo 3F 3.29.22.signed.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:

PPLB/DVD/NCIRD

Roybal Campus Building 17/6011 H17-6 Centers for Disease Control and Prevention Atlanta, GA 30329

B. Contracting Activity:

Centers for Disease Control and Prevention Office of Financial Resources Polio and Picornavirus Laboratory Branch

C. Identification of Requirement:

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

a. Sole source acquisition of: Perkin Elmer VICTOR Nivo basic F Multimode Plate Reader with a Nivo stacker and laptop to control instrument

b. Procurement Request (PR) Number (if available): 00HCVGEC-2022-65774

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

a. Proposed Vendor: Perkin Elmer Health Sciences Inc, 710 Bridgeport Avenue, Shelton, CT, 06484-4794

b. Estimated Procurement Amount: $

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

If yes, provide schedule number: n/a

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?

The Perkin Elmer VICTOR Nivo Basic F Multimode Plate reader with a Nivo stacker and laptop computer to control instrument meets several characteristics that are essential for its use with the high-throughput poliovirus microneutralization assay.

This multimode plate reader will be replacing an older Perkin Elmer VICTOR plate reader which is part of 3 plate readers that are used at the same time for the high-throughput testing of poliovirus serological samples (the Population Immunity Laboratory tested over 18000 serological samples in 2021). It is essential that the instrument works in tandem with other Perkin Elmer VICTOR plate readers that are already in the Population Immunity Laboratory. The plate reader needs to:

1. Have similar read sensitivities to our current plate readers and output data in a similar format for downstream analysis.

2. Have a stacker unit to allow testing of multiple multiwell plates.

3. Have a small footprint that fits available laboratory space

4. Perform absorbance readings at a 595 nm wavelength (standard microneutralization assay) and luminescence readings (Dried Blood Spot microneutralization assay)

Rev. 5/14/19

5. Read plates from the top and bottom.

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

We considered multimode plate readers from several other companies. A multimode plate reader from Biotek/Agilent, the Synergy H1 plate reader. The Synergy H1 has similar characteristics to the VICTOR Nivo, including the ability to read plates from top and bottom, perform absorbance at 595 nm wavelengths, luminescence functionality, and has a stacker option. However, the location of the plate stacker doubles the footprint of the instrument, which would not fit our current laboratory space and the Synergy H1 reader outputs data in a different format than the VICTOR Nivo and uses different software than the Perkin Elmer Nivo. Also, the Synergy H1 sensitivity is different than the Perkin Elmer Nivo. Because of the significant lack of integration of the Synergy H1 with the current plate readers in the Population Immunity Laboratory, we chose the Perkin Elmer Nivo. Similar to the Synergy H1, the SpectraMax iD5 does not meet all of the specifications needed for our high-throughput workflow.

3. Program Office efforts to seek potential offerors:

We did substantial research with regards to the specifications of the Perkin Elmer Nivo and identified that Perkin Elmer is the main distributor of this instrument in the United States. We also looked at the specifications and performed market research with regards to the Biotek Synergy H1 and the Molecular Devices SpectraMax iD5 Microplate Reader. However, because the Synergy H1 and the SpectraMax iD5 did not meet all the specifications listed above, we decided to move forward with the Perkin Elmer VICTOR Nivo.

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: DDID/NCIRD/DVD/PPLB COR Level II, Public Health Analyst, Center/Institute/Office COR/Program Official Signature:

Certification Date: April 30, 2023

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.