A13. JOFOC- Sam.gov.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:

Project Officer: Reba Williams End User: Deanna Jones Division of Laboratory Sciences 4770 Buford Hwy, Bldg. 110, Rm 5209A MS S110-5 Centers for Disease Control and Prevention Atlanta, GA 30341-3717

B. Contracting Activity:

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

C. Identification of Requirement:

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

a. Sole source acquisition of: ESI Consumables FY22

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

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

a. Proposed Vendor: Elemental Scientific, Inc.

b. Estimated Procurement Amount:

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

If yes, provide schedule number:

Rev. 5/15/17

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 OEM part numbers provided for this requisition are exact fits for the specific requirements, such as size and material composition, for the analytical instrumentation already in use within our laboratory. These instruments have been used in our laboratory for several years. Prior to deeming them suitable for use, a substantial amount of testing was performed to determine that the components (consumables) used with the instruments worked with our analytical instrumentation and gave us acceptable performance (high quality, accurate results) when analyzing patient samples. Procuring consumables that meet our required specifications for working with the Elemental Scientific, Inc. (ESI) autosamplers and prepFAST units ensures continuous operation of all instruments. Alternative parts have not been tested in our laboratory and may not be able to meet our specifications and ensure the proper functioning of our instruments. The most significant consideration is that while some of the required OEM consumables can be provided by other vendors, the software can only be supplied by ESI. Our CLIA method has been validated using this particular software package which has proven to fit our needs.

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

The other products that were considered for this requirement did not meet the needed specifications. The exact OEM part numbers for the consumables specified in the equipment list are required for continued compatibility with the Elemental Scientific equipment already in place in our laboratory. Our recently developed analytical method was validated using this particular software package that is only provided by ESI. Changing the software package would require the validation to be repeated which means repeating over a year’s worth of validation work with no guarantee that a new software platform will suit our needs. Since our laboratory is involved with both biomonitoring and emergency response, it is essential that the instruments operate continuously to be able to provide critical patient and public health data.

3. Program Office efforts to seek potential offerors:

A search was conducted for any vendors that could provide all of the items in this requirement. Only one vendor was identified to provide all of the items requirement:

Elemental Scientific, Inc.

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:

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.

Digitally signed by Howard D.

Bish -S Date: 2022.05.04 17:41:57 -04'00'

Contracting Officer Signature:

Certification Date: Click here to enter a date.

Howard D. Bish -S